Patent Application
20240122709
The native heart valves (i.e., the aortic, pulmonary, tricuspid, and mitral valves) serve critical functions in assuring the forward flow of an adequate supply of blood through the cardiovascular system. These heart valves may be damaged, and thus rendered less effective, for example, by congenital malformations, inflammatory processes, infectious conditions, disease, etc. Such damage to the valves may result in serious cardiovascular compromise or death. Damaged valves may be surgically repaired or replaced during open heart surgery. However, open heart surgeries are highly invasive, and complications may occur. Transvascular techniques can be used to introduce and implant devices to treat a heart in a manner that is much less invasive than open heart surgery. As one example, a transvascular technique useable for accessing the native mitral and aortic valves is the trans-septal technique. The trans-septal technique comprises advancing a catheter into the right atrium (e.g., inserting a catheter into the right femoral vein, up the inferior vena cava and into the right atrium). The septum is then punctured, and the catheter passed into the left atrium. A similar transvascular technique can be used to implant a device within the tricuspid valve that begins similarly to the trans-septal technique but stops short of puncturing the septum and instead turns the delivery catheter toward the tricuspid valve in the right atrium.
A healthy heart has a generally conical shape that tapers to a lower apex. The heart is four-chambered and comprises the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall generally referred to as the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomy than other native heart valves. The mitral valve includes an annulus portion, which is an annular portion of the native valve tissue surrounding the mitral valve orifice, and a pair of cusps, or leaflets, extending downward from the annulus into the left ventricle. The mitral valve annulus may form a “D”-shaped, oval, or otherwise out-of-round cross-sectional shape having major and minor axes. The anterior leaflet may be larger than the posterior leaflet, forming a generally “C”-shaped boundary between the abutting sides of the leaflets when they are closed together.
When operating properly, the anterior leaflet and the posterior leaflet function together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle dilates (also referred to as “ventricular diastole” or “diastole”), the oxygenated blood that is collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract (also referred to as “ventricular systole” or “systole”), the increased blood pressure in the left ventricle urges the sides of the two leaflets together, thereby closing the one-way mitral valve so that blood cannot flow back to the left atrium and is instead expelled out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding back through the mitral annulus toward the left atrium, a plurality of fibrous cords called chordae tendineae tether the leaflets to papillary muscles in the left ventricle.
Valvular regurgitation involves the valve improperly allowing some blood to flow in the wrong direction through the valve. For example, mitral regurgitation occurs when the native mitral valve fails to close properly and blood flows into the left atrium from the left ventricle during the systolic phase of heart contraction. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation may have many different causes, such as leaflet prolapse, dysfunctional papillary muscles, stretching of the mitral valve annulus resulting from dilation of the left ventricle, more than one of these, etc. Mitral regurgitation at a central portion of the leaflets can be referred to as central jet mitral regurgitation and mitral regurgitation nearer to one commissure (i.e., location where the leaflets meet) of the leaflets can be referred to as eccentric jet mitral regurgitation. Central jet regurgitation occurs when the edges of the leaflets do not meet in the middle and thus the valve does not close, and regurgitation is present. Tricuspid regurgitation may be similar, but on the right side of the heart.
This summary is meant to provide some examples and is not intended to be limiting of the scope of the invention in any way. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly recite the feature. Also, the features, components, steps, concepts, etc. described in examples in this summary and elsewhere in this disclosure can be combined in a variety of ways. Various features and steps as described elsewhere in this disclosure can be included in the examples summarized here.
In some implementations, there is provided an implantable device or implant (e.g., implantable device, etc.) that is configured to be positioned within a native heart valve to allow the native heart valve to form a more effective seal.
In some implementations, an implantable device or implant includes an anchor portion. Each anchor includes a plurality of paddles that are each moveable between an open position and a closed position.
In some implementations, an implantable device or implant is configured to be positioned within a native heart valve to allow the native heart valve to form a more effective seal. The implantable device or implant can include a paddle frame that includes an inner frame portion and an outer frame portion. A cover is configured to prevent or inhibit regurgitant blood flow between the inner frame portion and the outer frame portion.
In some implementations, the implantable device or implant includes a first anchor and a second anchor, where each of the first and second anchors have a paddle frame that includes an inner frame portion and an outer frame portion. The anchors are configured to be move to a closed position in which the inner frame portions and the outer frame portions compress one or more leaflets (e.g., leaflets of a heart valve, such as the mitral valve, tricuspid valve, etc.) within inner and outer pinch points (e.g., pinch regions or regions where the frame members press the leaflet(s)) to secure the implantable device to a native valve of a patient. The implantable device or implant further includes a cover that is attached to the paddle frames of the anchors. The cover is configured block or inhibit blood flow between the anchors.
In some implementations, the implantable device or implant includes anchors and/or paddle frames that are adjustable in width to a variety of different widths. In some implementations, the cover is configured to block blood flow between the anchors at any width of the anchors and/or paddle frames.
In some implementations, the paddle frames of the implantable device include an outer frame portion that is movable between a narrowed position and an expanded position. The proximal width of a proximal end of the outer frame portion is greater than a distal width of a distal end of the outer frame portion when the outer frame portion is in the expanded position.
In some implementations, the paddle frames of the implantable device include an outer frame portion that is movable between a narrowed position and an expanded position. The distal width of a distal end of the outer frame portion is greater than a proximal width of a proximal end of the outer frame portion when the outer frame portion is in the expanded position.
In some implementations, there is provided an implantable device or implant comprising a first anchor and a second anchor, wherein the first anchor and the second anchor are configured to be moved to a closed position in which the first anchor and the second anchor compress one or more leaflets of a native valve within a first pinch point and a second pinch point such that the implantable device is secured to the native valve. The first pinch point and the second pinch point can be between portions of the first anchor and the second anchor. A cover is attached to the first anchor and the second anchor and extends between the first anchor and the second anchor.
In some implementations, the first pinch point is formed between first frame members of the first and second anchors. In some implementations, the second pinch point is formed between second frame portions (e.g., outer frame portions) of the first and second anchors.
In some implementations, the first frame members are separate and distinct from the second frame members. In some implementations, the first frame members are integrally formed with the second frame members for each of the first and second anchor.
In some implementations, the first frame members are protrusions or protruding portions of the first and second anchors, e.g., protruding or extending from a surface of the first and second anchors. In some implementations, the second frame members are protrusions or protruding portions of the first and second anchors, e.g., protruding or extending from a surface of the first and second anchors.
In some implementations, the first anchor comprises an inner frame portion that is rigid and an outer frame portion member that is flexible.
In some implementations, the cover extends across an inner surface of the first anchor. In some implementations, the cover extends across an outer surface of the first anchor.
In some implementations, the cover is positioned between at least a portion of an area defined by an interior surface of the first anchor. In some implementations, the cover extends across an entirety of an area defined by an interior surface of the first anchor.
In some implementations, the cover encapsulates at least a portion of an outer paddle of each of the first and second anchors. In some implementations, the cover encapsulates an entirety of an outer paddle of each of the first and second anchors.
In some implementations, the cover comprises a first membrane that attaches to a paddle frame of the first anchor and a second membrane that attaches to a paddle frame of the second anchor.
In some implementations, the first and second membranes are connected such together to block blood flow between the first and second anchors.
In some implementations, the cover comprises a single membrane that attaches to paddle frames of both of the first and second anchors.
In some implementations, the cover (e.g., the single membrane, multiple membranes, etc.) is configured to form a canopy that extends between the first and second anchors.
In some implementations, the cover is made of a porous material that becomes impermeable to blood flow over time.
In some implementations, the cover is configured to provide a compressive force against the one or more leaflets in an area between the first pinch point and the second pinch point.
In some implementations, the first anchor and the second anchor are configured to be moved between a narrowed position having a first width and expanded position having a second width greater than the first width.
In some implementations, the cover is configured to be in a taut state when the outer frame portion is in the narrowed position, and wherein the cover is configured to stretch when the outer frame portion is in the expanded position.
In some implementations, the cover is configured to be in a taut state when the outer frame portion is in the narrowed position, and the cover includes one or more stretchable portions that allow the cover to stretch when the outer frame is are in the expanded position.
In some implementations, there is provided an implantable device or implant comprising a first anchor and a second anchor, wherein the first anchor and the second anchor are configured to be moved between a narrowed configuration having a first width and an expanded configuration having a second width greater than the first width, and wherein the first anchor and the second anchor are configured to be moved to a closed position in which the first anchor and the second anchor compress one or more leaflets of a native valve between portions thereof. The device or implant comprises a flexible cover attached to the first anchor and the second anchor.
In some implementations, the cover is configured to provide a compressive force against the one or more leaflets in an area between the portions compressing the one or more leaflets when the implantable device is secured to the native valve.
In some implementations, the first anchor and the second anchor are configured to be moved to a closed position in which the first anchor and the second anchor compress one or more leaflets of a native valve between a first pinch point and a second pinch point such that the implantable device is secured to the native valve. In some implementations, the cover is configured to provide a compressive force against the one or more leaflets in an area between the first pinch point and the second pinch point when the implantable device is secured to the native valve.
In some implementations, the cover is configured to be in a taut state when the first anchor and the second anchor are in the narrowed configuration, and the cover is configured to stretch when the first anchor and the second anchor are in the expanded configuration (e.g., remain in a taut state in the narrowed configuration, in the expanded configuration, and in positions between the narrowed configuration and the expanded configuration).
In some implementations, the implantable device is secured to the native valve first anchor comprises an inner frame portion that is rigid and an outer frame portion that is flexible.
In some implementations, the cover is connected to the first anchor by one or more stitches.
In some implementations, the cover extends across an inner surface of the first anchor. In some implementations, the cover extends across an outer surface of the first anchor.
In some implementations, the cover is positioned between at least a portion of an area defined by an interior surface of the first anchor. In some implementations, the cover extends across an entirety of an area defined by an interior surface of the first anchor.
In some implementations, the cover encapsulates at least a portion of an outer paddle of each of the first and second anchors. In some implementations, the cover encapsulates an entirety of an outer paddle of each of the first anchor and the second anchors.
In some implementations, the cover comprises a first membrane that attaches to the first anchor and a second membrane that attaches to the second anchor.
In some implementations, the first membrane and the second membrane are not connected such that a gap exists between bottom edges of the first membrane and the second membrane.
In some implementations, the cover comprises a single membrane that attaches to both of the first anchor and the second anchor.
In some implementations, the single membrane creates or forms a canopy that extends between the first anchor and the second anchor.
In some implementations, the cover is made of a porous material. In some implementations, the cover is made of an impermeable material.
In some implementations, an implantable device or implant includes a coaptation element (e.g., spacer, plug, filler, foam, sheet, membrane, coaption element, wedge, barrier, balloon, etc.) and one or more anchors. The coaptation element defines a first area when viewed from above. The one or more anchors are coupled to the coaptation element. The anchors are movable between an open position and a closed position. The one or more anchors are configured to attach to one or more leaflets of a native heart valve. Each of the anchors includes a paddle frame.
In some implementations, the paddle frame defines an outer portion of the implantable device when viewed from above and the anchors are in the closed position. In some implementations, the outer portion of the device has a second area when viewed from above. In some implementations, a ratio of the second area to the first area is greater than or equal to 2 to 1.
In some implementations, the ratio of the second area to the first area can be greater than or equal to 3 to 1, 4 to 1, 5 to 1, or 6 to 1.
In some implementations, the coaptation element can comprise one or more planar side surface and/or tapered side surfaces. The coaptation element can include a first portion that is rectangular and a second portion that is rounded.
In some implementations, the coaptation element can be injection molded. The coaptation element can comprise a polymer material.
In some implementations, the implantable device can comprise an attachment portion having a collar that is configured to attach to a delivery device. The collar of the attachment portion can be integral to the coaptation element.
In some implementations, the coaptation element comprises one or more attachment openings for aligning with one or more openings of a component of the anchors such that the component of the anchors can be attached to the coaptation element.
In some implementations, the anchors can include an inner paddle and an outer paddle and/or clasp. The paddle frame of the each of the anchors can comprise an inner paddle frame and an outer paddle frame.
In some implementations, the outer paddle frame defines the outer portion of the implantable device when viewed from above and the anchors are in the closed position.
In some implementations, the implantable devices or implants described above are incorporated into a system, e.g., a valve repair system comprising, for example, a delivery system and the implantable device or implant.
In some implementations, a valve repair system for repairing a native valve of a heart includes a delivery device, an implantable device, and a coupler. The delivery device has a width adjustment element (e.g., a width adjustment control, line, shaft, wire, tether, etc.) that includes an external threaded portion. The implantable device is configured to be implanted on the native valve. The anchor portion has one or more anchors. The one or more anchors are configured to attach to one or more leaflets of a native valve.
In some implementations, each of the anchors can have a paddle frame that includes an inner end.
In some implementations, the coupler removably connects the width adjustment element of the delivery device to the inner end of the anchors. In some implementations, the coupler comprises one or more attachment projections that extend inward from a body of the coupler. In some implementations, the attachment projections are configured to removably attach to the external threaded portion of the width adjustment element. The width adjustment element is configured to move the inner end of the anchors to move the paddle frame between a narrowed position and an expanded position.
In some implementations, the one or more attachment projections can include a first attachment projection and a second attachment projection. The first attachment projection can be offset from the second attachment projection along a height of the body of the coupler.
In some implementations, the coupler can have arms that are movable between a normal position and an engaged position. When the arms are in the normal position when the coupler is disconnected from the implantable device, and wherein the arms are in the engaged position when the coupler is connected to the width adjustment element.
In some implementations, a valve repair system for repairing a native valve of a patient includes a delivery device, an implantable device, and a coupler. The delivery device can have a width adjustment element (e.g., a width adjustment control, line, shaft, wire, tether, etc.). The implantable device can be configured to be implanted on the native valve of the patient. The implantable device includes an anchor portion having one or more anchors. The one or more anchors are configured to attach to one or more leaflets of a native valve.
In some implementations, the implantable device has a receiver (e.g., an internally threaded element, a column, a conduit, a hollow member, a notched receiving portion, a tube, a shaft, a sleeve, a post, a housing, tracks, a cylinder. etc.) defining a lumen that includes internal threads.
In some implementations, the receiver has an unattachable portion that prevents a coupler from connecting to the receiver when the coupler is disposed within the unattachable portion.
In some implementations, each of the anchors have a paddle frame that includes an inner end.
In some implementations, the coupler removably connects the width adjustment element of the delivery device to the inner end of the anchors.
In some implementations, the coupler comprises at least two arms that are movable between a normal position and an engaged position. In some implementations, the arms are in the normal position when the coupler is disconnected from the width adjustment element, and the arms are in the engaged position when the coupler is connected to the width adjustment element.
In some implementations, the arms are configured to attach to internal threads of the lumen of the receiver when the arms are in the normal position.
In some implementations, the arms can include one or more tabs that are configured to be inserted into one or more slots of the body of the coupler when the arms are in the normal position.
In some implementations, the arms are configured to allow the coupler to move within the lumen of the receiver when in the engaged position.
In some implementations, a first arm of the arms is offset from a second arm along a height of a body of the coupler.
In some implementations, a first portion of each arm extends into a lumen of the coupler when the arms are in the normal position and a second portion of each arm extends away from an exterior of a body of the coupler when the arms are in the normal position.
In some implementations, the arms can extend away from an exterior surface of a body of the coupler by between about 20 degrees and about 45 degrees when the arms are in the normal position.
In some implementations, the coupler comprises an upper body, a lower body, and a plurality of struts connected to the upper and lower bodies. The coupler is movable between a first position in which the plurality of struts are in a straight configuration and a second position in which the plurality of struts are in a spiraled configuration.
In some implementations, the coupler is configured to attach to the internal threads of the receiver when the plurality of struts are in the spiraled configuration.
In some implementations, the plurality of struts are normally in the spiraled configuration.
In some implementations, the coupler comprises at least two arms that are movable between a normal position and an engaged position. Each of the arms have a central portion, a first connection member that connects the central portion to a proximal end of the coupler, and a second connection member that connects the central portion to a distal end of the coupler.
In some implementations, the arms are configured to attach to the internal threads of the receiver when the arms are in the normal position.
In some implementations, the first and second connection members are normally in torsion such that a first portion of the central portion is disposed within a lumen of the coupler and a second portion of the central portion extends away from an exterior of the coupler.
In some implementations, the arms of the coupler have a “T” shape.
In some implementations, an implantable device or implant includes a coaptation element (e.g., spacer, plug, filler, foam, sheet, membrane, coaption element, wedge, barrier, balloon, etc.), an anchor portion, a cap, and a distal cover element (e.g., a cover, covering, fabric, polymer, weave, braid, a portion thereof, etc.). The coaptation element has a lumen for receiving one or more actuation elements of the delivery device. Each anchor is movable between an open position and a closed position.
In some implementations, the cap is operatively connected to the anchors such that movement of the cap relative to the coaptation element by the one or more actuation elements of the delivery device causes the anchors to move between the open and closed positions. In some implementations, the cap has a distal opening that is in communication with the lumen of the coaptation element.
In some implementations, the distal cover element is positioned to prevent or inhibit blood from moving through the distal opening of the cap and into an interior of the implantable device.
In some implementations, each anchor has a paddle frame having an inner end that is movable relative to the cap such that at least a portion of the paddle frame is capable of moving through the distal opening of the cap.
In some implementations, there is provided an implantable device having an anchor portion comprising a first anchor and a second anchor (e.g., which can be similar to or the same as any anchor shown or described anywhere herein), each of the first and second anchors comprising a paddle frame, wherein the paddle frame is configured to be moved between a narrowed configuration and expanded configuration, wherein the first and second anchors are configured to be moved to a closed position in which the first and second anchors compress one or more native leaflets such that the implantable device is secured to the native valve.
In some implementations, the implantable device further comprises a flexible cover (e.g., which can be similar to or the same as any cover shown or described anywhere herein) attached to the paddle frame, wherein the flexible cover is configured to be in a taut state when the paddle frame is in the narrowed configuration, and wherein the flexible cover is configured to stretch when the paddle frame is in the expanded configuration.
In some implementations, the paddle frame comprises an inner frame portion and an outer frame portion, and wherein the inner frame portion is rigid, and the outer frame portion is flexible.
In some implementations, the flexible cover comprises a first membrane that attaches to the paddle frame of the first anchor and a second membrane that attaches to the paddle frame of the second anchor.
In some implementations, the flexible cover comprises a single membrane that attaches to the paddle frame of both of the first and second anchors.
In some implementations, the paddle frame of each of the first and second anchors includes an inner frame portion and an outer frame portion, and wherein the paddle frame is configured such that the outer frame portion of the paddle frame changes shape as the paddle frame is moved between the narrowed configuration and the expanded configuration.
In some implementations, the paddle frame of each of the first and second anchors includes an inner frame portion and an outer frame portion, and wherein the first and second anchors are configured such that, in the closed position, the inner frame portion of each of the first and second anchors can compress the one or more native leaflets between an inner pinch point and the outer frame portion of each of the first and second anchors can compress the one or more native leaflets between an outer pinch point such that the implantable device is secured to the native valve.
In some implementations, there is provided an implantable device having an anchor portion comprising an anchor (e.g., which can be similar to or the same as any anchor shown or described anywhere herein), the anchor comprising a paddle frame, wherein the paddle frame is configured to be moved between a narrowed configuration and expanded configuration, and wherein the anchor is configured to be moved to a closed position in which the anchor compresses at least one native leaflet such that the implantable device is secured to a native valve.
In some implementations, the implantable device further comprises a cover (e.g., which can be similar to or the same as any cover shown or described anywhere herein) attached to the paddle frame, wherein the cover is configured to be in a taut state when the paddle frame is in the narrowed configuration, and wherein the cover is configured to stretch when the paddle frame is in the expanded configuration.
In some implementations, the paddle frame includes an inner frame portion and an outer frame portion, and wherein the inner frame portion is rigid, and the outer frame portion is flexible.
In some implementations, the cover extends across at least a portion of an inner surface of the paddle frame.
In some implementations, the cover extends across an entirety of an area defined by an inner surface of the paddle frame.
In some implementations, the anchor is a first anchor and the implantable device also includes a second anchor, and wherein the cover comprises a single membrane that attaches to the paddle frame of the first anchor and the second anchor. In some implementations, the single membrane creates or forms a canopy that extends between the first anchor and the second anchor.
In some implementations, the anchor is a first anchor and the implantable device includes a second anchor that also comprises a paddle frame, wherein the paddle frame of both the first anchor and the second anchor includes an inner frame portion and an outer frame portion, and wherein the cover is attached to the inner frame portion and the outer frame portion of the first and second anchors, and wherein the cover extends between the first anchor and the second anchor.
In some implementations, the paddle frame includes an inner frame portion and an outer frame portion, and wherein the paddle frame is configured such that when the paddle frame is moved between the narrowed configuration and the expanded configuration, the outer frame portion of the paddle frame changes shape between the narrowed configuration and the expanded configuration.
In some implementations, the paddle frame includes an inner frame portion and an outer frame portion, and wherein the anchor is configured such that, in the closed position, the inner frame portion of the anchor can compress the at least one native leaflet between an inner pinch point and the outer frame portion of each of the anchor can compress the at least one native leaflet between an outer pinch point such that the implantable device is secured to the native valve.
In some implementations, there is provided a valve repair system for repairing a native valve of a patient, the valve repair system comprising (A) a delivery device having a width adjustment element (e.g., which can be similar to or the same as any width adjustment element shown or described anywhere herein), and (B) an implantable device configured to be implanted at the native valve of the patient, the implantable device having: (i) an anchor portion having one or more anchors (e.g., which can be similar to or the same as any anchor shown or described anywhere herein), each of the one or more anchors having a paddle frame, wherein the one or more anchors are configured to attach to one or more leaflets of a native valve; and (ii) a coupler (e.g., which can be similar to or the same as any coupler shown or described anywhere herein) for removably connecting the width adjustment element of the delivery device to an end of the one or more anchors, wherein the coupler is configured such that it can secure the end of the one or more anchors in one of multiple potential positions within the implantable device such that the anchors are held in one of multiple potential configurations selected from the group comprising a narrowed configuration, an extended configuration, and an intermediate configuration between the narrowed configuration and the extended configuration.
In some implementations, the coupler comprises at least two arms that are movable between a normal position and an engaged position, wherein the arms are in the normal position when the coupler is disconnected from the width adjustment element, and wherein the arms are in the engaged position when the coupler is connected to the width adjustment element.
In some implementations, the coupler comprises an upper body, a lower body, and a plurality of struts connected to the upper and lower bodies.
In some implementations, a coaptation element defines a first area when viewed from above, wherein the paddle frames of the one or more anchors define an outer region of the implantable device when viewed from above and the one or more anchors are in a closed position, wherein the outer region of the implantable device has a second area when viewed from above, and wherein a ratio of the second area to the first area is greater than or equal to about 2 to 1.
In some implementations, the paddle frame comprises a connector that includes the end.
In some implementations, the implantable device further comprises a cover attached to the paddle frame.
In some implementations, the cover is configured to be in a taut state when the paddle frame is in the narrowed configuration, and wherein the cover is configured to stretch as the paddle frame transitions from the narrowed configuration to the expanded configuration.
In some implementations, the paddle frame includes an inner frame portion and an outer frame portion, and wherein the paddle frame is configured such that when the paddle frame is moved between the narrowed configuration and the expanded configuration, the outer frame portion of the paddle frame changes shape between the narrowed configuration and the expanded configuration.
In some implementations, the paddle frame includes an inner frame portion and an outer frame portion, and wherein the anchor is configured such that the anchor can be moved to a closed position in which the inner frame portion of the anchor can compress the one or more native leaflets between an inner pinch point and the outer frame portion of each of the anchor compresses the one or more native leaflets between an outer pinch point.
In some implementations, the width adjustment element includes an external threaded portion.
In some implementations, the coupler comprises one or more attachment projections that extend inward from a body of the coupler. In some implementations, the one or more attachment projections are configured to removably attach to the external threaded portion of the width adjustment element.
In some implementations, the system (e.g., a portion of the delivery device and/or the implantable device) includes a receiver (e.g., which can be similar to or the same as any receiver shown or described anywhere herein). In some implementations, the receiver defines a lumen that includes internal threads.
In some implementations, the coupler comprises at least two arms that are movable between a normal position and an engaged position, wherein the arms are in the normal position when the coupler is disconnected from the width adjustment element, wherein the arms are in the engaged position when the coupler is connected to the width adjustment element, and wherein the arms are configured to attach to the internal threads of the lumen of the receiver when the arms are in the normal position.
In some implementations, the receiver comprises an unattachable portion. In some implementations, the coupler is configured to be removably coupled to the receiver (e.g., to internal threads of the receiver, etc.) to secure the inner end of the one or more anchors in a desired position relative to the receiver. In some implementations, the unattachable portion of the receiver prevents the coupler from connecting to the receiver when the coupler is disposed within the unattachable portion.
In some implementations, the implantable device further comprises a coaptation element.
In some implementations, the implantable device further comprises a cap operatively connected to the one or more anchors such that movement of the cap relative to another portion of the implantable device (e.g., relative to a coaptation element, collar, proximal end, distal end, etc.) by one or more actuation elements of the delivery device causes the one or more anchors to move between an open position and a closed position.
A further understanding of the nature and advantages of the present invention are set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts bear like reference numerals.
To further clarify various aspects of implementations of the present disclosure, a more particular description of the certain examples and implementations will be made by reference to various aspects of the appended drawings. These drawings depict only example implementations of the present disclosure and are therefore not to be considered limiting of the scope of the disclosure. Moreover, while the FIGS. can be drawn to scale for some examples, the FIGS. are not necessarily drawn to scale for all examples. Examples and other features and advantages of the present disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
The following description refers to the accompanying drawings, which illustrate example implementations of the present disclosure. Other implementations having different structures and operation do not depart from the scope of the present disclosure.
Example implementations of the present disclosure are directed to systems, devices, methods, etc. for repairing a defective heart valve. For example, some implementations of implantable devices, valve repair devices, implants, and systems (including systems for delivery thereof) are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, individual components of the disclosed devices and systems can be combined unless mutually exclusive or otherwise physically impossible. Further, the treatment techniques and methods herein can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc.
As described herein, when one or more components are described as being connected, joined, affixed, coupled, attached, or otherwise interconnected, such interconnection can be direct as between the components or can be indirect such as through the use of one or more intermediary components. Also as described herein, reference to a “member,” “component,” or “portion” shall not be limited to a single structural member, component, or element but can include an assembly of components, members, or elements. Also as described herein, the terms “substantially” and “about” are defined as at least close to (and includes) a given value or state (preferably within 10% of, more preferably within 1% of, and most preferably within 0.1% of).
The left atrium LA receives oxygenated blood from the lungs. During the diastolic phase, or diastole, seen in
Referring now to
Various disease processes can impair proper function of one or more of the native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow's Disease, fibroelastic deficiency, etc.), inflammatory processes (e.g., Rheumatic Heart Disease), and infectious processes (e.g., endocarditis, etc.). In addition, damage to the left ventricle LV or the right ventricle RV from prior heart attacks (i.e., myocardial infarction secondary to coronary artery disease) or other heart diseases (e.g., cardiomyopathy, etc.) may distort a native valve's geometry, which may cause the native valve to dysfunction. However, the majority of patients undergoing valve surgery, such as surgery to the mitral valve MV, suffer from a degenerative disease that causes a malfunction in a leaflet (e.g., leaflets 20, 22) of a native valve (e.g., the mitral valve MV), which results in prolapse and regurgitation.
Generally, a native valve may malfunction in different ways: including (1) valve stenosis; and (2) valve regurgitation. Valve stenosis occurs when a native valve does not open completely and thereby causes an obstruction of blood flow. Typically, valve stenosis results from buildup of calcified material on the leaflets of a valve, which causes the leaflets to thicken and impairs the ability of the valve to fully open to permit forward blood flow. Valve regurgitation occurs when the leaflets of the valve do not close completely thereby causing blood to leak back into the prior chamber (e.g., causing blood to leak from the left ventricle to the left atrium).
There are three main mechanisms by which a native valve becomes regurgitant— or incompetent—which include Carpentier's type I, type II, and type III malfunctions. A Carpentier type I malfunction involves the dilation of the annulus such that normally functioning leaflets are distracted from each other and fail to form a tight seal (i.e., the leaflets do not coapt properly). Included in a type I mechanism malfunction are perforations of the leaflets, as are present in endocarditis. A Carpentier's type II malfunction involves prolapse of one or more leaflets of a native valve above a plane of coaptation. A Carpentier's type III malfunction involves restriction of the motion of one or more leaflets of a native valve such that the leaflets are abnormally constrained below the plane of the annulus. Leaflet restriction may be caused by rheumatic disease or dilation of a ventricle.
Referring to
In any of the above-mentioned situations, a valve repair device or implant is desired that is capable of engaging the anterior leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent or inhibit regurgitation of blood through the mitral valve MV. As can be seen in
Although stenosis or regurgitation may affect any valve, stenosis is predominantly found to affect either the aortic valve AV or the pulmonary valve PV, and regurgitation is predominantly found to affect either the mitral valve MV or the tricuspid valve TV. Both valve stenosis and valve regurgitation increase the workload of the heart H and may lead to very serious conditions if left un-treated; such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. Because the left side of the heart (i.e., the left atrium LA, the left ventricle LV, the mitral valve MV, and the aortic valve AV) are primarily responsible for circulating the flow of blood throughout the body. Accordingly, because of the substantially higher pressures on the left side heart dysfunction of the mitral valve MV or the aortic valve AV is particularly problematic and often life threatening.
Malfunctioning native heart valves can either be repaired or replaced. Repair typically involves the preservation and correction of the patient's native valve. Replacement typically involves replacing the patient's native valve with a biological or mechanical substitute. Typically, the aortic valve AV and pulmonary valve PV are more prone to stenosis. Because stenotic damage sustained by the leaflets is irreversible, treatments for a stenotic aortic valve or stenotic pulmonary valve can be removal and replacement of the valve with a surgically implanted heart valve, or displacement of the valve with a transcatheter heart valve. The mitral valve MV and the tricuspid valve TV are more prone to deformation of leaflets and/or surrounding tissue, which, as described above, may prevent the mitral valve MV or tricuspid valve TV from closing properly and allows for regurgitation or back flow of blood from the ventricle into the atrium (e.g., a deformed mitral valve MV may allow for regurgitation or back flow from the left ventricle LV to the left atrium LA as shown in
The devices and procedures disclosed herein often make reference to repairing the structure of a mitral valve. However, it should be understood that the devices and concepts provided herein can be used to repair any native valve, as well as any component of a native valve. Such devices can be used between the leaflets 20, 22 of the mitral valve MV to prevent or inhibit regurgitation of blood from the left ventricle into the left atrium. With respect to the tricuspid valve TV (
An example implantable device or implant can optionally have a coaptation element (e.g., spacer, plug, filler, foam, sheet, membrane, coaption element, wedge, barrier, balloon, etc.) and at least one anchor (e.g., one, two, three, or more). In some implementations, an implantable device or implant can have any combination or sub-combination of the features disclosed herein without a coaptation element. When included, the coaptation element is configured to be positioned within the native heart valve orifice to help fill the space between the leaflets and form a more effective seal, thereby reducing or preventing or inhibiting regurgitation described above. The coaptation element can have a structure that is impervious to blood (or that resists blood flow therethrough) and that allows the native leaflets to close around the coaptation element during ventricular systole to block blood from flowing from the left or right ventricle back into the left or right atrium, respectively. The device or implant can be configured to seal against two or three native valve leaflets; that is, the device can be used in the native mitral (bicuspid) and tricuspid valves. The coaptation element is sometimes referred to herein as a spacer because the coaptation element can fill a space between improperly functioning native leaflets (e.g., mitral leaflets 20, 22 or tricuspid leaflets 30, 32, 34) that do not close completely.
The optional coaptation element (e.g., spacer, coaption element, gap filler, plug, wedge, balloon, barrier, etc.) can have various shapes. In some implementations, the coaptation element can have an elongated cylindrical shape having a round cross-sectional shape. In some implementations, the coaptation element can have an oval cross-sectional shape, an ovoid cross-sectional shape, a crescent cross-sectional shape, a rectangular cross-sectional shape, or various other non-cylindrical shapes. In some implementations, the coaptation element can have an atrial portion positioned in or adjacent to the atrium, a ventricular or lower portion positioned in or adjacent to the ventricle, and a side surface that extends between the native leaflets. In some implementations configured for use in the tricuspid valve, the atrial or upper portion is positioned in or adjacent to the right atrium, and the ventricular or lower portion is positioned in or adjacent to the right ventricle, and the side surfaces extend between the native tricuspid leaflets.
In some implementations, the anchor can be configured to secure the device to one or both of the native leaflets such that the coaptation element is positioned between the two native leaflets. In some implementations configured for use in the tricuspid valve, the anchor is configured to secure the device to one, two, or three of the tricuspid leaflets such that the coaptation element is positioned between the three native leaflets. In some implementations, the anchor can attach to the coaptation element at a location adjacent the ventricular portion of the coaptation element. In some implementations, the anchor can attach to an actuation element, such as a shaft or actuation wire, to which the coaptation element is also attached. In some implementations, the anchor and the coaptation element can be positioned independently with respect to each other by separately moving each of the anchor and the coaptation element along the longitudinal axis of the actuation element (e.g., actuation shaft, actuation rod, actuation tube, actuation wire, etc.). In some implementations, the anchor and the coaptation element can be positioned simultaneously by moving the anchor and the coaptation element together along the longitudinal axis of the actuation element, e.g., shaft, actuation wire, etc.). The anchor can be configured to be positioned behind a native leaflet when implanted such that the leaflet is grasped by the anchor.
The device or implant can be configured to be implanted via a delivery system or other means for delivery. The delivery system can comprise one or more of a guide/delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, tube, combinations of these, etc. The coaptation element and the anchor can be compressible to a radially compressed state and can be self-expandable to a radially expanded state when compressive pressure is released. The device can be configured for the anchor to be expanded radially away from the still-compressed coaptation element initially in order to create a gap between the coaptation element and the anchor. A native leaflet can then be positioned in the gap. The coaptation element can be expanded radially, closing the gap between the coaptation element and the anchor and capturing the leaflet between the coaptation element and the anchor. In some implementations, the anchor and coaptation element are optionally configured to self-expand. The implantation methods for some implementations can be different and are more fully discussed below with respect to each implementation. Additional information regarding these and other delivery methods can be found in U.S. Pat. No. 8,449,599 and U.S. Patent Application Publication Nos. 2014/0222136, 2014/0067052, 2016/0331523, and PCT patent application publication Nos. WO2020/076898, each of which is incorporated herein by reference in its entirety for all purposes. These method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc. mutatis mutandis.
The disclosed devices or implants can be configured such that the anchor is connected to a leaflet, taking advantage of the tension from native chordae tendineae to resist high systolic pressure urging the device toward the left atrium. During diastole, the devices can rely on the compressive and retention forces exerted on the leaflet that is grasped by the anchor.
Referring now to
The device or implant 100 is deployed from a delivery system 102. The delivery system 102 can comprise one or more of a catheter, a sheath, a guide catheter/sheath, a delivery catheter/sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations of these, etc. The device or implant 100 includes a coaptation portion/coaptation region 104 and an anchor portion/anchor region 106.
In some implementations, the coaptation portion 104 of the device or implant 100 includes a coaptation element or means for coapting 110 (e.g., spacer, plug, filler, foam, sheet, membrane, coaption element, wedge, barrier, etc.) that is adapted to be implanted between leaflets of a native valve (e.g., a native mitral valve, native tricuspid valve, etc.) and is slidably attached to an actuation element 112 (e.g., actuation wire, actuation shaft, actuation tube, etc.). The anchor portion 106 includes one or more anchors 108 that are actuatable between open and closed conditions and can take a wide variety of forms, such as, for example, paddles, gripping elements, or the like. Actuation of the actuation element 112 opens and closes the anchor portion 106 of the device 100 to grasp the native valve leaflets during implantation. The actuation element 112 (as well as other means for actuating and actuation elements disclosed herein) can take a wide variety of different forms (e.g., as a wire, rod, shaft, tube, screw, suture, line, strip, combination of these, etc.), be made of a variety of different materials, and have a variety of configurations. As one example, the actuation element can be threaded such that rotation of the actuation element moves the anchor portion 106 relative to the coaptation portion 104. Or, the actuation element can be unthreaded, such that pushing or pulling the actuation element 112 moves the anchor portion 106 relative to the coaptation portion 104.
The anchor portion 106 and/or anchors of the device 100 include outer paddles 120 and inner paddles 122 that are, in some implementations, connected between a cap 114 and coaptation element 110 by portions 124, 126, 128. The portions 124, 126, 128 can be jointed and/or flexible to move between all of the positions described below. The interconnection of the outer paddles 120, the inner paddles 122, the coaptation element 110, and the cap 114 by the portions 124, 126, and 128 can constrain the device to the positions and movements illustrated herein.
In some implementations, the delivery system 102 includes a steerable catheter, implant catheter, and the actuation element 112 (e.g., actuation wire, actuation shaft, etc.). These can be configured to extend through a guide catheter/sheath (e.g., a transseptal sheath, etc.). In some implementations, the actuation element 112 extends through a delivery catheter and the coaptation element 110 to the distal end (e.g., a cap 114 or other attachment portion at the distal connection of the anchor portion 106). Extending and retracting the actuation element 112 increases and decreases the spacing between the coaptation element 110 and the distal end of the device (e.g., the cap 114 or other attachment portion), respectively. In some implementations, a collar or other attachment element removably attaches the coaptation element 110 to the delivery system 102, either directly or indirectly, so that the actuation element 112 slides through the collar or other attachment element and, in some implementations, through a coaptation element 110 during actuation to open and close the paddles 120, 122 of the anchor portion 106 and/or anchors 108.
In some implementations, the anchor portion 106 and/or anchors 108 can include attachment portions or gripping members. In some implementations, as illustrated, gripping members can comprise clasps 130 that include a base or fixed arm 132, a moveable arm 134, optional friction-enhancing elements or other means for securing 136 (e.g., barbs, protrusions, ridges, grooves, textured surfaces, adhesive, etc.), and a joint portion 138. The fixed arms 132 are attached to the inner paddles 122. In some implementations, the fixed arms 132 are attached to the inner paddles 122 with the joint portion 138 disposed proximate the coaptation element 110. The joint portion 138 provides a spring force between the fixed and moveable arms 132, 134 of the clasp 130. The joint portion 138 can be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, or the like. In some implementations, the joint portion 138 is a flexible piece of material integrally formed with the fixed and moveable arms 132, 134. The fixed arms 132 are attached to the inner paddles 122 and remain stationary or substantially stationary relative to the inner paddles 122 when the moveable arms 134 are opened to open the clasps 130 and expose the barbs or other friction-enhancing elements 136.
In some implementations, the clasps 130 are opened by applying tension to actuation lines 116 attached to the moveable arms 134, thereby causing the moveable arms 134 to articulate, flex, or pivot on the joint portions 138. The actuation lines 116 extend through the delivery system 102 (e.g., through a steerable catheter and/or an implant catheter). Other actuation mechanisms are also possible.
The actuation line 116 can take a wide variety of forms, such as, for example, a line, a suture, a wire, a rod, a catheter, or the like. The clasps 130 can be spring loaded so that in the closed position the clasps 130 continue to provide a pinching force on the grasped native leaflet. Optional barbs or other friction-enhancing elements 136 of the clasps 130 can grab, pinch, and/or pierce the native leaflets to further secure the native leaflets.
During implantation, the paddles 120, 122 can be opened and closed, for example, to grasp the native leaflets (e.g., native mitral valve leaflets, etc.) between the paddles 120, 122 and/or between the paddles 120, 122 and a coaptation element 110 (e.g., spacer, plug, filler, foam, sheet, membrane, coaption element, wedge, barrier, etc.). The clasps 130 can be used to grasp and/or further secure the native leaflets by engaging the leaflets with barbs or other friction-enhancing elements 136 and pinching the leaflets between the moveable and fixed arms 134, 132. The barbs or other friction-enhancing elements 136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesive, etc.) of the clasps or barbed clasps 130 increase friction with the leaflets or can partially or completely puncture the leaflets. The actuation lines 116 can be actuated separately so that each clasp 130 can be opened and closed separately. Separate operation allows one leaflet to be grasped at a time, or for the repositioning of a clasp 130 on a leaflet that was insufficiently grasped, without altering a successful grasp on the other leaflet. The clasps 130 can be opened and closed relative to the position of the inner paddle 122 (as long as the inner paddle is in an open or at least partially open position), thereby allowing leaflets to be grasped in a variety of positions as the particular situation requires.
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Any of the features disclosed by the present application can be used in a wide variety of different valve repair devices.
Referring now to
In some implementations, the implantable device or implant 200 includes a coaptation portion/region 204, a proximal or attachment portion 205, an anchor portion 206, and a distal portion 207. In some implementations, the coaptation portion 204 of the device optionally includes a coaptation element 210 (e.g., a spacer, coaption element, plug, membrane, sheet, gap filler, etc.) for implantation between leaflets of a native valve. In some implementations, the anchor portion 206 includes a plurality of anchors 208. The anchors can be configured in a variety of ways. In some implementations, each anchor 208 includes outer paddles 220, inner paddles 222, paddle extension members or paddle frames 224, and clasps 230. In some implementations, the attachment portion 205 includes a first or proximal collar 211 (or other attachment element) for engaging with a capture mechanism of a delivery system. A delivery system for the device 200 can be the same as or similar to delivery system 102 described above and can comprise one or more of a catheter, a sheath, a guide catheter/sheath, a delivery catheter/sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations of these, etc.
In some implementations, the coaptation element 210 and paddles 220, 222 are formed from a flexible material that can be a metal fabric, such as a mesh, woven, braided, or formed in any other suitable way or a laser cut or otherwise cut flexible material. The material can be cloth, shape-memory alloy wire—such as Nitinol—to provide shape-setting capability, or any other flexible material suitable for implantation in the human body.
An actuation element (e.g., actuation shaft, actuation rod, actuation tube, actuation wire, actuation line, etc.) can extend from a delivery system (not shown) to engage and enable actuation of the implantable device or implant 200. In some implementations, the actuation element extends through the proximal collar 211, and spacer or coaptation element 210 to engage a cap 214 of the distal portion 207. The actuation element can be configured to removably engage the cap 214 with a threaded connection, or the like, so that the actuation element can be disengaged and removed from the device 200 after implantation.
The coaptation element 210 extends from the proximal collar 211 (or other attachment element) to the inner paddles 222. In some implementations, the coaptation element 210 has a generally elongated and round shape, though other shapes and configurations are possible. In some implementations, the coaptation element 210 has an elliptical shape or cross-section when viewed from above and has a tapered shape or cross-section when seen from a front view and a round shape or cross-section when seen from a side view. A blend of these three geometries can result in the three-dimensional shape of the illustrated coaptation element 210 that achieves the benefits described herein. The round shape of the coaptation element 210 can also be seen, when viewed from above, to substantially follow or be close to the shape of the paddle frames 224.
The size and/or shape of the coaptation element 210 can be selected to minimize the number of implants that a single patient will require (preferably one), while at the same time maintaining low transvalvular gradients. In some implementations, the anterior-posterior distance at the top of the coaptation element is about 5 mm, and the medial-lateral distance of the coaptation element at its widest is about 10 mm. In some implementations, the overall geometry of the device 200 can be based on these two dimensions and the overall shape strategy described above. It should be readily apparent that the use of other anterior-posterior distance anterior-posterior distance and medial-lateral distance as starting points for the device will result in a device having different dimensions. Further, using other dimensions and the shape strategy described above will also result in a device having different dimensions.
In some implementations, the outer paddles 220 are jointably attached to the cap 214 of the distal portion 207 by connection portions 221 and to the inner paddles 222 by connection portions 223. The inner paddles 222 are jointably attached to the coaptation element by connection portions 225. In this manner, the anchors 208 are configured similar to legs in that the inner paddles 222 are like upper portions of the legs, the outer paddles 220 are like lower portions of the legs, and the connection portions 223 are like knee portions of the legs.
In some implementations, the inner paddles 222 are stiff, relatively stiff, rigid, have rigid portions and/or are stiffened by a stiffening member or a fixed portion of the clasps 230. The inner paddle 222, the outer paddle 220, and the coaptation element can all be interconnected as described herein.
In some implementations, the paddle frames 224 are attached to the cap 214 at the distal portion 207 and extend to the connection portions 223 between the inner and outer paddles 222, 220. In some implementations, the paddle frames 224 are formed of a material that is more rigid and stiff than the material forming the paddles 222, 220 so that the paddle frames 224 provide support for the paddles 222, 220.
The paddle frames 224 can provide additional pinching force between the inner paddles 222 and the coaptation element 210 and assist in wrapping the leaflets around the sides of the coaptation element 210. That is, the paddle frames 224 can be configured with a round three-dimensional shape extending from the cap 214 to the connection portions 223 of the anchors 208. The connections between the paddle frames 224, the outer and inner paddles 220, 222, the cap 214, and the coaptation element 210 can constrain each of these parts to the movements and positions described herein. In particular the connection portion 223 is constrained by its connection between the outer and inner paddles 220, 222 and by its connection to the paddle frame 224. Similarly, the paddle frame 224 is constrained by its attachment to the connection portion 223 (and thus the inner and outer paddles 222, 220) and to the cap 214.
The wide configuration of the paddle frames 224 provides increased surface area compared to the inner paddles 222 alone. The increased surface area can distribute the clamping force of the paddles 220 and paddle frames 224 against the native leaflets over a relatively larger surface of the native leaflets in order to further protect the native leaflet tissue.
Additional features of the device 200, modified versions of the device, delivery systems for the device, and methods for using the device and delivery system are disclosed by Patent Cooperation Treaty International Application No. PCT/US2018/028189 (International Publication No. WO 2018/195215) and U.S. Provisional Patent App. No. 63/217,622, filed on Jul. 1, 2021. Any combination or sub-combination of the features disclosed by the present application can be combined with any combination or sub-combination of the features disclosed by Patent Cooperation Treaty International Application No. PCT/US2018/028189 (International Publication No. WO 2018/195215) and/or U.S. Provisional Patent App. No. 63/217,622. Patent Cooperation Treaty International Application No. PCT/US2018/028189 (International Publication No. WO 2018/195215) and U.S. Provisional Patent App. No. 63/217,622 are incorporated herein by reference in their entirety for all purposes.
Referring now to
The implantable device or implant 300 includes a proximal or attachment portion 305, an anchor portion 306, and a distal portion 307. In some implementations, the device/implant 300 includes a coaptation portion/region 304, and the coaptation portion/region 304 can optionally include a coaptation element 310 (e.g., spacer, plug, membrane, sheet, gap filler, etc.) for implantation between the leaflets 20, 22 of the native valve. In some implementations, the anchor portion 306 includes a plurality of anchors 308. In some implementations, each anchor 308 can include one or more paddles, e.g., outer paddles 320, inner paddles 322, paddle extension members or paddle frames 324. The anchors can also include and/or be coupled to clasps 330. In some implementations, the attachment portion 305 includes a first or proximal collar 311 (or other attachment element) for engaging with a capture mechanism of a delivery system.
The anchors 308 can be attached to the other portions of the device and/or to each other in a variety of different ways (e.g., directly, indirectly, welding, sutures, adhesive, links, latches, integrally formed, a combination of some or all of these, etc.). In some implementations, the anchors 308 are attached to a coaptation element 310 by connection portions 325 and to a cap 314 by connection portions 321.
The anchors 308 can comprise first portions or outer paddles 320 and second portions or inner paddles 322 separated by connection portions 323. The connection portions 323 can be attached to paddle frames 324 that are hingeably attached to a cap 314 or other attachment portion. In this manner, the anchors 308 are configured similar to legs in that the inner paddles 322 are like upper portions of the legs, the outer paddles 320 are like lower portions of the legs, and the connection portions 323 are like knee portions of the legs.
In implementations with a coaptation member or coaptation element 310, the coaptation member or coaptation element 310 and the anchors 308 can be coupled together in various ways. As shown in the illustrated example, the coaptation element 310 and the anchors 308 can be coupled together by integrally forming the coaptation element 310 and the anchors 308 as a single, unitary component. This can be accomplished, for example, by forming the coaptation element 310 and the anchors 308 from a continuous strip 301 of a braided or woven material, such as braided or woven nitinol wire. In the illustrated example, the coaptation element 310, the outer paddle portions 320, the inner paddle portions 322, and the connection portions 321, 323, 325 are formed from a continuous strip of fabric 301.
Like the anchors 208 of the implantable device or implant 200 described above, the anchors 308 can be configured to move between various configurations by axially moving the distal end of the device (e.g., cap 314, etc.) relative to the proximal end of the device (e.g., proximal collar 311 or other attachment element, etc.). This movement can be along a longitudinal axis extending between the distal end (e.g., cap 314, etc.) and the proximal end (e.g., collar 311 or other attachment element, etc.) of the device.
In some implementations, in the straight configuration, the paddle portions 320, 322 are aligned or straight in the direction of the longitudinal axis of the device. In some implementations, the connection portions 323 of the anchors 308 are adjacent the longitudinal axis of the coaptation element 310 (e.g., similar to the configuration of device 200 shown in
In some implementations, the clasps comprise a moveable arm coupled to an anchor. In some implementations, the clasps 330 include a base or fixed arm 332, a moveable arm 334, optional barbs/friction-enhancing elements 336, and a joint portion 338. The fixed arms 332 are attached to the inner paddles 322, with the joint portion 338 disposed proximate the coaptation element 310. The joint portion 338 is spring-loaded so that the fixed and moveable arms 332, 334 are biased toward each other when the clasp 330 is in a closed condition.
The fixed arms 332 are attached to the inner paddles 322 through holes or slots with sutures. The fixed arms 332 can be attached to the inner paddles 322 with any suitable means, such as screws or other fasteners, crimped sleeves, mechanical latches or snaps, welding, adhesive, or the like. The fixed arms 332 remain substantially stationary relative to the inner paddles 322 when the moveable arms 334 are opened to open the clasps 330 and expose the barbs 336. The clasps 330 are opened by applying tension to actuation lines attached to the moveable arms 334, thereby causing the moveable arms 334 to articulate, pivot, and/or flex on the joint portions 338.
In short, the implantable device or implant 300 is similar in configuration and operation to the implantable device or implant 200 described above, except that the coaptation element 310, outer paddles 320, inner paddles 322, and connection portions 321, 323, 325 are formed from the single strip of material 301. In some implementations, the strip of material 301 is attached to the proximal collar 311, cap 314, and paddle frames 324 by being woven or inserted through openings in the proximal collar 311, cap 314, and paddle frames 324 that are configured to receive the continuous strip of material 301. The continuous strip 301 can be a single layer of material or can include two or more layers. In some implementations, portions of the device 300 have a single layer of the strip of material 301 and other portions are formed from multiple overlapping or overlying layers of the strip of material 301.
For example,
As with the implantable device or implant 200 described above, the size of the coaptation element 310 can be selected to minimize the number of implants that a single patient will require (preferably one), while at the same time maintaining low transvalvular gradients. In particular, forming many components of the device 300 from the strip of material 301 allows the device 300 to be made smaller than the device 200. For example, in some implementations, the anterior-posterior distance at the top of the coaptation element 310 is less than 2 mm, and the medial-lateral distance of the device 300 (i.e., the width of the paddle frames 324 which are wider than the coaptation element 310) at its widest is about 5 mm.
Additional features of the device 300, modified versions of the device, delivery systems for the device, and methods for using the device and delivery system are disclosed by Patent Cooperation Treaty International Application No. PCT/US2019/055320 (International Publication No. WO 2020/076898) and U.S. Provisional Patent App. No. 63/217,622. Any combination or sub-combination of the features disclosed by the present application can be combined with any combination or sub-combination of the features disclosed by Patent Cooperation Treaty International Application No. PCT/US2019/055320 (International Publication No. WO 2020/076898) and/or U.S. Provisional Patent App. No. 63/217,622. Patent Cooperation Treaty International Application No. PCT/US2019/055320 (International Publication No. WO 2020/076898) and U.S. Provisional Patent App. No. 63/217,622 are incorporated herein by reference in their entirety for all purposes.
The valve repair device 40256 includes a base assembly 40456, a pair of paddles 40656, and a pair of gripping members 40856. In one example, the paddles 40656 can be integrally formed with the base assembly. For example, the paddles 40656 can be formed as extensions of links of the base assembly. In the illustrated example, the base assembly 40456 of the valve repair device 40256 has a shaft 40356, a coupler 40556 configured to move along the shaft, and a lock 40756 configured to lock the coupler in a stationary position on the shaft. The coupler 40556 is mechanically connected to the paddles 40656, such that movement of the coupler 40556 along the shaft 40356 causes the paddles to move between an open position and a closed position. In this way, the coupler 40556 serves as a means for mechanically coupling the paddles 40656 to the shaft 40356 and, when moving along the shaft 40356, for causing the paddles 40656 to move between their open and closed positions.
In some implementations, the gripping members 40856 are pivotally connected to the base assembly 40456 (e.g., the gripping members 40856 can be pivotally connected to the shaft 40356, or any other suitable member of the base assembly), such that the gripping members can be moved to adjust the width of the opening 41456 between the paddles 40656 and the gripping members 40856. The gripping member 40856 can include a barbed portion 40956 for attaching the gripping members to valve tissue when the valve repair device 40256 is attached to the valve tissue. When the paddles 40656 are in the closed position, the paddles engage the gripping members 40856, such that, when valve tissue is attached to the barbed portion 40956 of the gripping members, the paddles secure the valve repair device 40256 to the valve tissue. In some implementations, the gripping members 40856 are configured to engage the paddles 40656 such that the barbed portion 40956 engages the valve tissue member and the paddles 40656 to secure the valve repair device 40256 to the valve tissue member. For example, in certain situations, it can be advantageous to have the paddles 40656 maintain an open position and have the gripping members 40856 move outward toward the paddles 40656 to engage valve tissue and the paddles 40656.
While the example shown in
In some implementations, the valve repair system 40056 includes a placement shaft 41356 that is removably attached to the shaft 40356 of the base assembly 40456 of the valve repair device 40256. After the valve repair device 40256 is secured to valve tissue, the placement shaft 41356 is removed from the shaft 40356 to remove the valve repair device 40256 from the remainder of the valve repair system 40056, such that the valve repair device 40256 can remain attached to the valve tissue, and the delivery device 40156 can be removed from a patient's body.
The valve repair system 40056 can also include a paddle control mechanism 41056, a gripper control mechanism 41156, and a lock control mechanism 41256. In some implementations, the paddle control mechanism 41056 is mechanically attached to the coupler 40556 to move the coupler along the shaft, which causes the paddles 40656 to move between the open and closed positions. The paddle control mechanism 41056 can take any suitable form, such as, for example, a shaft, wire, tube, rod, line, etc. For example, the paddle control mechanism can comprise a hollow shaft, a catheter tube or a sleeve that fits over the placement shaft 41356 and the shaft 40356 and is connected to the coupler 40556.
The gripper control mechanism 41156 is configured to move the gripping members 40856 such that the width of the opening 41456 between the gripping members and the paddles 40656 can be altered. The gripper control mechanism 41156 can take any suitable form, such as, for example, a line, a suture or wire, a rod, a catheter, etc.
The lock control mechanism 41256 is configured to lock and unlock the lock. The lock 40756 locks the coupler 40556 in a stationary position with respect to the shaft 40356 and can take a wide variety of different forms and the type of lock control mechanism 41256 can be dictated by the type of lock used. In examples in which the lock 40756 includes a pivotable plate, the lock control mechanism 41256 is configured to engage the pivotable plate to move the plate between the tilted and substantially non-tilted positions. The lock control mechanism 41256 can be, for example, a rod, a suture, a wire, or any other member that is capable of moving a pivotable plate of the lock 40756 between a tilted and substantially non-tilted position.
The valve repair device 40256 is movable from an open position to a closed position. The base assembly 40456 includes links that are moved by the coupler 40556. The coupler 40556 is movably attached to the shaft 40356. In order to move the valve repair device from the open position to the closed position, the coupler 40556 is moved along the shaft 40356, which moves the links.
The gripper control mechanism 41156 is moves the gripping members 40856 to provide a wider or a narrower gap at the opening 41456 between the gripping members and the paddles 40656. In the illustrated example, the gripper control mechanism 41156 includes a line, such as a suture, a wire, etc. that is connected to an opening in an end of the gripper members 40856. When the line(s) is pulled, the gripping members 40856 move inward, which causes the opening 41456 between the gripping members and the paddles 40656 to become wider.
In order to move the valve repair device 40256 from the open position to the closed position, the lock 40756 is moved to an unlocked condition by the lock control mechanism 41256. Once the lock 40756 is in the unlocked condition, the coupler 40556 can be moved along the shaft 40356 by the paddle control mechanism 41056.
After the paddles 40656 are moved to the closed position, the lock 40756 is moved to the locked condition by the locking control mechanism 41256 to maintain the valve repair device 40256 in the closed position. After the valve repair device 40256 is maintained in the locked condition by the lock 40756, the valve repair device 40256 is removed from the delivery device 40156 by disconnecting the shaft 40356 from the placement shaft 41356. In addition, the valve repair device 40256 is disengaged from the paddle control mechanism 41056, the gripper control mechanism 41156, and the lock control mechanism 41256.
Additional features of the device 40256, modified versions of the device, delivery systems for the device, and methods for using the device and delivery system are disclosed by Patent Cooperation Treaty International Application No. PCT/US2019/012707 (International Publication No. WO 2019139904) and U.S. Provisional Patent App. No. 63/217,622. Any combination or sub-combination of the features disclosed by the present application can be combined with any combination or sub-combination of the features disclosed by Patent Cooperation Treaty International Application No. PCT/US2019/012707 (International Publication No. WO 2019139904) and/or U.S. Provisional Patent App. No. 63/217,622. Patent Cooperation Treaty International Application No. PCT/US2019/012707 (International Publication No. WO 2019139904) and U.S. Provisional Patent App. No. 63/217,622 are incorporated herein by reference in their entirety for all purposes.
Clasps or leaflet gripping devices disclosed herein can take a wide variety of different forms. Examples of clasps are disclosed by Patent Cooperation Treaty International Application No. PCT/US2018/028171 (International Publication No. WO 2018195201). Any combination or sub-combination of the features disclosed by the present application can be combined with any combination or sub-combination of the features disclosed by Patent Cooperation Treaty International Application No. PCT/US2018/028171 (International Publication No. WO 2018195201). Patent Cooperation Treaty International Application No. PCT/US2018/028171 (International Publication No. WO 2018195201) is incorporated herein by reference in its entirety.
Referring to
The spacer or coaptation element 3800 can be coupled to the valve repair device 40256 in a variety of different ways. For example, the spacer or coaptation element 3800 can be fixed to the shaft 40356, can be slidably disposed around the shaft, can be connected to the coupler 40556, can be connected to the lock 40756, and/or can be connected to a central portion of the clasps or gripping members 40856. In some implementations, the coupler 40556 can take the form of the spacer element 3800. That is, a single element can be used as the coupler 40556 that causes the paddles 40656 to move between the open and closed positions and the spacer element 3800 that closes the gap between the leaflets 20, 22 when the valve repair device 40256 is attached to the leaflets.
The spacer or coaptation element 3800 can be disposed around one or more of the shafts or other control elements of the valve repair system 40056. For example, the spacer or coaptation element 3800 can be disposed around the shaft 40356, the shaft 41356, the paddle control mechanism 41056, and/or the lock control mechanism 41256.
The valve repair device 40256 can include any other features for a valve repair device discussed in the present application, and the valve repair device 40256 can be positioned to engage valve tissue as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application). Additional features of the device 40256, modified versions of the device, delivery systems for the device, and methods for using the device and delivery system are disclosed by Patent Cooperation Treaty International Application No. PCT/US2019/012707 (International Publication No. WO 2019139904). Any combination or sub-combination of the features disclosed by the present application can be combined with any combination or sub-combination of the features disclosed by Patent Cooperation Treaty International Application No. PCT/US2019/012707 (International Publication No. WO 2019139904).
In the example illustrated in
In some implementations, the connector 8266 (e.g., shaped metal component, shaped plastic component, tether, wire, strut, line, cord, suture, etc.) attaches to the outer frame portions 8256 at outer ends of the connector 8266 and to a coupler 8972 at an inner end 8968 of the connector 8266 (see
The inner frame portions 8260 extend from the proximal portion 8205 toward the distal portion 8207. The inner frame portions 8260 then extend inward to form retaining portions 8272 that are attached to the actuation cap 8214. The retaining portions 8272 and the actuation cap 8214 can be configured to attach in any suitable manner.
In some implementations, the inner frame portions 8260 are rigid frame portions, while the outer frame portions 8256 are flexible frame portions. The proximal end of the outer frame portions 8256 connect to the proximal end of the inner frame portions 8260, as illustrated in
A width adjustment element 8211 (e.g., width adjustment control, width adjustment wire, width adjustment shaft, width adjustment tube, width adjustment line, width adjustment cord, width adjustment suture, width adjustment screw or bolt, width adjustment tether, etc.) is configured to move the outer frame portions 8256 from the expanded position to the narrowed position by pulling the inner end 8968 (
As shown in
The width adjustment element 8211 allows a user to expand or contract the outer frame portions 8256 of the implantable device 8200. In the example illustrated in
In some implementations, the receiver 8912 can be integrally formed with a distal cap 8214. Moving the cap 8214 relative to a body of the attachment portion 8205 opens and closes the paddles. In the illustrated example, the receiver 8912 slides inside the body of the attachment portion. When the coupler 8972 is detached from the width adjustment element 8211, the width of the outer frame portions 8256 is fixed while the actuation element 8102 moves the receiver 8912 and cap 8214 relative to a body of the attachment portion 8205. Movement of the cap can open and close the device in the same manner as some implementations disclosed above.
In the illustrated example, a driver head 8916 is disposed at a proximal end of the actuation element 8102. The driver head 8916 releasably couples the opening/closing actuation element 8102 to the receiver 8912. In the illustrated example, the width adjustment element 8211 extends through the actuation element 8102. The actuation tube is axially advanced in the direction opposite to direction Y to move the distal cap 8214. Movement of the distal cap 8214 relative to the attachment portion 8205 is effective to open and close the paddles, as indicated by the arrows in
Also illustrated in
Referring to
The width adjustment element 8211 can extend distally from the paddle width control 1628, through the paddle actuation control 1626 and through the actuation element 8102 (and, consequently, through the handle 1616, the outer shaft of the implant catheter assembly 1611, and through the device 8200), where it couples with the coupler 8972. The width adjustment element 8211 can be axially movable relative to the actuation element 8102, the outer shaft of the catheter assembly 1611, and the handle 1616. The clasp actuation lines 624 can extend through and be axially movable relative to the handle 1616 and the outer shaft of the catheter assembly 1611. The clasp actuation lines 624 can also be axially movable relative to the actuation element 8102.
Referring to
In the examples of
A Referring to
When the paddle frames 1524 are in the narrowed position, the friction between the native structures of the heart and the device 1500 is reduced. The device 1500 can include any other features for an implantable device or implant discussed in the present application or in the applications and patents incorporated by reference herein, and the device 1500 can be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application). In addition, any of the devices described herein can incorporate the features of the device 1500.
The implantable device or implant 1500 includes a coaptation portion 1504, a proximal or attachment portion 1505, an anchor portion 1506, and a distal portion 1507. The coaptation portion 1504, attachment portion 1505, and distal portion 1507 can take any suitable form, such as, for example, the form for these portions of the device 200 shown in
The attachment portion 1505 includes a first or proximal collar 1511 for engaging with a capture mechanism of a delivery system. The proximal collar 1511 can take any suitable form, such as, for example, any form described in the present application. The capture mechanism 1513 can take any suitable form, such as, for example, any form described in the present application.
The distal portion 1507 includes a cap 1514 that is attached to anchors 1508 of the anchor portion 1506 such that movement of the cap 1514 causes the anchors 1508 to move between open and closed positions. The cap 1514 can take any suitable form, such as, for example, any form described in the present application. In the illustrated example, an actuation element 1512 (e.g., an actuation wire, actuation shaft, etc.) extends from a delivery system (e.g., any delivery system described in the present application) and engages the cap 1514 to move the cap 1514 relative to the coaptation element or spacer 1510 to enable actuations of the device 1500. The actuation element 1512 can engage and move the cap by any suitable means, such as, for example, any means provided in the present application.
The anchor portion 1506 of the device 1500 can take any suitable form, such as, for example, the form of the anchor portion 206 of the device 200 shown in
The paddle frame 1524 includes a main support section 1585, first connection members for attaching to a cap of the implantable device or implant, and second connection members for attaching to anchors of the device. The connection members can be the same as or similar to other connection members described elsewhere herein. The paddle frame 1524 can attach to the connection portion of the anchors and the cap by any suitable means, such as, for example, any means described in the present application. The thickness and width of the paddle frame can take any suitable form, such as, for example, the thickness can be substantially identical to the width, the thickness can be greater than the width (as shown in
The main support section 1585 includes a rigid inner portion 1572 and a flexible outer portion 1574. The rigid inner portion 1572 has a first end 1581 that connects to the cap 1514 and a second end 1583 that connects to the anchors 1508. Referring to
Referring again to
The total width of the flexible outer portion 1574 can be 5 mm and 15 mm, such as between 7 mm and 12 mm, such as between 9 mm and 11 mm, such as about 10 mm. The width of the inner portion 1572 can be between 2 mm and 8 mm, such as between 4 mm and 6 mm, such as about 5 mm.
In some implementations, the flexible outer portion 1574 are shaped set inward such that the total width of the outer portion 1574 narrows when the anchors 1508 are in the open position, and such that the outer portion moves back to its normal total width when the anchors 1508 are moved to the closed position.
While the illustrated example, shows rigid inner portion 1572 and the flexible inner portion 1574 having rounded shapes, it should be understood that the inner and outer portions 1572, 1574 can take any form that allows the device 1500 to more easily maneuver into position for implantation in the heart while providing sufficient support for facilitating coaptation of the leaflets of a native heart valve against the coaptation element 1510.
Referring to
The implantable device or implant 1800 includes a coaptation portion 1804, a proximal or attachment portion 1805, an anchor portion 1806, and a distal portion 1807. The coaptation portion 1804, attachment portion 1805, and distal portion 1807 can take any suitable form, such as, for example, the form for these portions of the device 200 shown in
The attachment portion 1805 includes a first or proximal collar 1811 for engaging with a capture mechanism of a delivery system. The capture mechanism and delivery system can be the same as or similar to other capture mechanisms and delivery systems described elsewhere herein. The proximal collar 1811 can take any suitable form, such as, for example, any form described in the present application.
The distal portion 1807 includes a cap 1814 that is attached to anchors 1808 of the anchor portion 1806 such that movement of the cap 1814 causes the anchors 1508 to move between open and closed positions. The cap 1814 can take any suitable form, such as, for example, any form described in the present application. In the illustrated example, an actuation element 1812 (e.g., an actuation wire, an actuation shaft, etc.) extends from a delivery system (e.g., any delivery system described in the present application) and engages the cap 1814 to move the cap 1814 relative to the coaptation element or spacer 1810 to enable actuations of the device 1800. The actuation element 1812 can engage and move the cap by any suitable means, such as, for example, any means provided in the present application.
The anchor portion 1806 can take any suitable form, such as, for example, the form of the anchor portion 206 of the device 200 shown in
The paddle frame 1824 includes an end 1801 that is configured to be attached to the cap 1814 and a free end 1803. The paddle frame 1824 includes a first opening 1891 and a second opening 1892 for receiving one or more width adjustment lines 1890 of the delivery system. Referring to
Referring to
Referring to
Referring to
The attachment portion 2005 includes a first or proximal collar 2011 for engaging with a capture mechanism of a delivery system. The capture mechanism and delivery system can be the same as or similar to other capture mechanisms and delivery systems described elsewhere herein. The proximal collar 2011 can take any suitable form, such as, for example, any form described in the present application.
The distal portion 2007 includes a cap 2014 that is attached to anchors 2008 of the anchor portion 2006 such that movement of the cap 2014 causes the anchors 2008 to move between open and closed positions. The cap 2014 can take any suitable form, such as, for example, any form described in the present application. An actuation element (e.g., the same as or similar to actuation element 112 shown in
The anchor portion 2006 can take any suitable form, such as, for example, the form of the anchor portion 206 of the device 200 shown in
Referring to
Referring to
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Referring to
Referring to
The attachment portion 2805 includes a first or proximal collar 2811 for engaging with a capture mechanism of a delivery s system 2802. The capture mechanism and the delivery system 2802 can take any suitable form, such as, for example, any form described in the present application. The delivery system 2802 can be the same as or similar to other delivery systems herein, e.g., 102, 402, 502, etc. and can comprise one or more of a catheter, a sheath, a guide catheter/sheath, a delivery catheter/sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations of these, etc. The proximal collar 2811 can take any suitable form, such as, for example, any form described in the present application.
The distal portion 2807 includes a cap 2814 that is attached to anchors 2808 of the anchor portion 1806 such that movement of the cap 2814 causes the anchors 2808 to move between open and closed positions. The cap 2814 can take any suitable form, such as, for example, any form described in the present application. In the illustrated example, an actuation element (e.g., the same as or similar to actuation element 112 shown in
The anchor portion 2806 can take any suitable form, such as, for example, the form of the anchor portion 206 of the device 200 shown in
The paddle frame 2824 includes an inner portion 2872 and an outer portion 2874. The inner portion 2872 has arms 2880 that extend from the connection members 2801 to a proximal portion of the paddle frame 2824. The outer portion 2874 includes arms 2882 that are connected to arms 2880 at connection point 2871 and extend outward from arms 2880. The arms 2882 define a total width TW of the anchors 2808. The arms 2882 can have one or more openings for receiving one or more width adjustment lines 2890 such that the width adjustment lines 2890 can be engaged by a user to move the paddle frame 2824 to the narrowed position by moving the arms 2882 in the inward direction X. In the illustrated example, each of the arms 2882 have a first opening 2892 and a second opening 2891 that is positioned distally from the first opening 2892. The inner portion 2872 can include one or more openings 2893 that can be used for connecting to the connection portion 2823 of the anchors 2808 and/or for receiving one or more width adjustment lines 2890.
Referring to
Referring to
Referring to
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Referring to
Referring to
The outer portion 3074 of each of the paddle frames 3024 has a pair of arms 3082 having a proximal end 3093 and a distal end 3094. The proximal ends 3093 can be configured to attach to the proximal ends 3090 of the inner portion 3072. For example, the proximal ends 3090, 3093 of both the inner and outer portions 3072, 3074 can include openings 3095, 3096 for receiving a fastener that connects the inner and outer portions 3072, 3074 together. The distal ends 3094 are connected together at connection point or inner end 3083. The arms 3082 can be curved such that the distal ends 3094 extend above at least a portion of the remainder of the arms 3082. For example, in the illustrated example, the arms 3082 include curved portions 3084. In some implementations, the connection point or inner end 3083 of the distal ends of the arms 3082 is connected to the distal ends 3091 of the arms 3080 of the inner portion 3072 such that the distal ends 3091, 3094 can move together in the proximal direction PD or the distal direction DD with the connection point or inner end 3083 as it is moved in the proximal direction PD or the distal direction DD.
In some implementations, the arms 3082 are more flexible than the arms 3080. This increased flexibility allows the arms 3082 to flex when the connection portion or inner end 3083 is pulled into the arms 3080. This flexing allows the arms 3082 to narrow. The stiffer arms 3080 allow the paddles of the device to open and closed in the same or a similar manner to that shown in
Referring to
Referring to
The connection point or inner end 3083 can be moved in the distal direction DD or the proximal direction PD by a user with a width adjustment element (e.g., width adjustment element 8211 shown in
In some implementations, the paddle frames 3024 illustrated by
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A driver head 81106 is disposed at a proximal end of the shaft 81102 and is configured to rotatably drive the shaft 81102 into or out of the threaded element or column 81104. The driver head 81106 can take any form, such as for example, any form described in the present application. Referring to
Referring to
Still referring to
Still referring to
Conversely, when the actuator 81502 is driven downwards, the projections 81510 of the actuator 81502 push against resilient, sloped surfaces 81514 of the coupler 81506. As such, the projections 81510 cause the resilient fingers 81512 to disengage from the rack 81504. As such, the coupler 81506 is disengaged from the rack 81504 when the actuator is moved in a downward or distal direction to expand the paddle frames 81530.
Referring to
The paddle frames 91024 are configured to allow the device 91000 to maneuver more easily into position for implantation in the heart by reducing the contact and/or friction between the native structures of the heart—e.g., chordae—and the device. That is, the paddle frames 91024 are configured to move between an expanded condition and a narrowed condition. When the paddle frames 91024 are in the narrowed condition, the contact between the native structures of the heart and the device 91000 is reduced. The device 91000 can include any other features for an implantable device or implant discussed in the present application or in the applications and patents incorporated by reference herein, and the device 91000 can be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application). In addition, any of the devices described herein can incorporate the features of the device 91000.
In the illustrated example of
In the illustrated example in
The intermediate frame members 91058 extend from a connection portion 91064 with the outer frame portions 91056 near or at the proximal portion 91005 and are attached at the distal portion 91007 via connection portions 91066. The intermediate frame members 91058 also include an inner end, which in the illustrated example is configured as a projection or post 91068 (
The inner frame portions 91060 extend from a connection portion 91070 with the outer frame portions 91056 near or at the proximal portion 91005 and include retaining portions 91072 near or adjacent the distal portion 91007 for engaging the post 91068. The retaining portions 91072 are described below in more detail with regard to
The first frame side 91052 and a second frame side 91054 can optionally be in contact with each other along axis Y toward the distal portion 91007 and are separated toward the proximal end 91005 to form a V-shape, as shown, for example, in
Referring to
Referring to
The inner side surfaces 91086 of the inner frame portions 91060 include inward transition portions 91090 that form a seat. In the illustrated example, the inward transition portions 91090 are formed as inward curved surfaces. In some implementations, however, the inward transition portions 91090 can be formed in any suitable manner, such as for example, as angled or tapered surfaces, stepped surfaces, or any other suitable inward transition. The inner side surfaces 91086 extend axially from the inward transition portion 91090 toward the distal portion 91007 to form a gap 91092 configured to receive the post 91068.
Each of the outer side surfaces 91088 of the inner frame portions 91060 includes a first recessed portion 91094. In the illustrated example, the first recessed portion 91094 is formed axially nearer to the distal portion 91007 than the inward transition portion 91090 is located. Each of the first recessed portions 91094 include a second recessed portion 91096 that is recessed relative to the first recessed portion 91094. In the illustrated example, the second recessed portion 91096 is located at a portion of the first recessed portion 91094 that is closest to the distal portion 91007. The second recessed portions 91096 are configured to receive the connecting portions 91021 of the outer paddles 91020.
The first recessed portions 91094 are configured to receive an annular retainer 91098. The annular retainer 91098 can be a ring, a washer, a nut, or the like. The annular retainer 91098 includes an inner passage 91100 configured to receive the post 91068 therethrough. The inner passage 91100 has a diameter D1 which is less than the combined width W11 of the distal ends 91087 and gap 91092 in an uncompressed state as shown in
The paddle frames 91024 can be made from or comprise a material that allows the post 91068 and connecting portion 91066 of the intermediate frame members 91058 and the retaining portion 91072 of the inner frame portions 91060 to be pulled away from each other. For example, the paddle frames 91024, or a portion thereof, can be made of a metal fabric, such as a mesh, woven, braided, or formed in any other suitable way or a laser cut or otherwise cut flexible material. The material can be cloth, shape-memory alloy wire—such as Nitinol—to provide shape-setting capability, or any other flexible material suitable for implantation in the human body.
In some implementations, some portions of the paddle frames 91024 can be stiffer or more rigid than other portions. For example, in the illustrated example of the paddle frames 91024, the inner frame portions 91060 can be configured to be stiffer than the outer frame portions 91056. The inner frame portions 91060 can be configured in a variety of ways to be stiffer or more rigid. For example, the thickness of the inner frame portions 91060 and/or the material used for the inner frame portions 91060 can provide more rigidity. In some implementations, the thickness of the inner frame portions 91060 can be greater than the outer frame portions 91056 to provide more rigidity. Further, in some implementations, the material used in the inner frame portions 91060 can be a more rigid material to provide more rigidity.
Once the post 91068 and the connecting portion 91066 are separated from the retaining portion 91072, the annular retainer 91098 and the connecting portions 91021 of the outer paddles 91020 can be placed therebetween. As shown by arrows H in
As shown in
The distal ends 91087 can be configured to provide an outward bias on the annular retainer and/or the connecting portions 91021 of the outer paddles 91020 to provide a secure attachment between the annular retainer and/or the connecting portions 91021 of the outer paddles 91020. As shown in
Referring to
In the illustrated example, the actuation portion 91050 includes a receiver, such as the illustrated sleeve 91102, configured to receive a portion of the post 91068 and a coupler, such as the illustrated plug 91103 configured to move the post axially within the sleeve 91102. During assembly, the sleeve 91102 can be received onto the post 91068 as shown by arrow K. The receiver and coupler can be the same as or similar to other implementations of these described herein.
The sleeve 91102 can be configured in a variety of ways. In the illustrated example, the sleeve 91102 includes a cylindrical sidewall 91104 extending between a proximal end 91106 to a distal end 91108 of the annular retainer 91098. The sleeve 91102 can optionally be integrally formed with the annular retainer 91098. The sleeve 91102 defines an internal passage 91110.
The sleeve 91102 has a length L1 and the internal passage 91110 extends through the entire length L1 of the sleeve 91102 from the proximal end 91106 and a distal end 91108. The passage 91110 has a diameter D2 that is sufficient to allow the post 91068 to be received into the passage 91110 and includes an internal threaded portion 91112.
As shown by arrow Lin
As shown
The proximal end 91114 includes a drive interface 91120 configured to engage a drive member capable of rotating the plug 91103 to axially move the plug 91103 relative to the sleeve 91102. The drive interface 91120 can be any suitable interface. For example, the drive interface 91120 can be a drive recess, such as a slotted, hexagonal, Torx, Frearson, Phillips, square, or other suitable interface. The distal end 91116 forms an engagement surface configured to engage the proximal end 91071 of the post 91068.
As shown in
As shown in
Referring to
As shown in
When the device 91000 narrows in width to the narrowed position, the device 91000 can also widen in the depth dimension, as shown by arrows P in
Referring to
In the illustrated example of
In the illustrated example, the paddle frames 91224 include outer frame portions 91256 and inner frame portions 91260. In
The outer frame portions 91256 are flexibly attached at the proximal portion 91205 and are flexibly attached at the distal portion 91207. The outer frame portions 91256 are attached at the distal portion 91207 by connecting portions 91266. The outer frame portions 91256 are curved and form a generally circular or oval shape. In some implementations, however, the outer frame portions 91256 can be otherwise shaped.
The outer frame portions 91256 also include an inner end, which can be configured as a projection or post 91268 extending axially along axis V from the distal portion 91207 toward the proximal portion 91205. The inner end or post 91268 can be configured in a variety of ways. In the illustrated example, the inner end is configured as post 91268, which has an outer surface 91269 that can be formed by a plurality of side walls forming a polygonal cross section or the outer surface 91269 can have one flat side and a-half cylindrical surface. The post 91268 can have an end surface 91271 that is perpendicular to the side walls.
The inner frame portions 91260 extend from first connection portions 91270 with the outer frame portions 91256 near or at the proximal portion 91205 and include second connection portions 91272 near or adjacent the distal portion 91207 that connect to the post 91268. The first frame side 91252 and a second frame side 91254 can be in contact with each other along axis T toward the distal end 91207 and are separated toward the proximal end 91205 to form a V-shape, as shown, for example, in
The inner members 91209 can be a portion of a coaptation element, such as coaptation element 210 of
In this manner, the anchors are configured similar to legs in that the inner paddles 91222 are like upper portions of the legs, the outer paddles 91220 are like lower portions of the legs, and the connection portions 91223 are like knee portions of the legs
Referring to
The retaining portions 91282, 91284 extend axially from the inward transition portions 91290 toward the distal end 91207 to form a gap 91292 configured to receive the post 91268. Each of the retaining portions 91282, 91284 includes an outer recessed portion 91294. In the illustrated example, the recessed portions 91294 are formed axially nearer to the distal end 91207 than the inward transition portion 91290 is located.
The recessed portions 91294 are configured to receive an annular retainer 91098 of the post 91268 and the connecting portions 91221 of the outer paddles 91220. The annular retainer 91098 can be configured similar to the annular retainer 91098; thus, the description of the annular retainer 91098 applies equally to the annular retainer 91098. The annular retainer 91098 can be a ring, a washer, a nut, or that like that is connected to the post 91268. In the illustrated example, the annular retainer 91098 is integrally formed with the post 91268.
The paddle frames 91224 can be made from or comprise a material that allows the post 91268 and connecting portion 91266 of the outer frame portions 91256 and the connection portion 91272 of the inner frame portions 91260 to be pulled away from each other. For example, the paddle frames 91224, or a portion thereof, can be made of a laser cut or otherwise formed flexible material, such as metal, plastic, etc.
In the illustrated example of
Once the post 91268 and the connecting portion 91266 are separated from the connection portion 91272, the annular retainer 91098 and the connecting portions 91221 of the outer paddles 91220 can be placed therebetween and the distal ends of the first retaining portion 91282 and a second retaining portion 91284 can be compressed toward each other. In the compressed state, the annular retainer 91098 can be received over the first retaining portion 91282 and a second retaining portion 91284.
The annular retainer 91098 and the connecting portion 91221 of the outer paddles 91220 can be aligned with the recessed portions 91294 and the retaining portions 91282, 91284 can then be released to return toward the uncompressed state to capture the annular retainer 91098 and the connecting portion 91221 of the outer paddles 91220 in the recessed portions 91294.
Once the annular retainer 91098 and the connecting portions 91221 of the outer paddles 91220 are received in the recessed portions 91294, the post 91268 and the connecting portions 91266 of the outer frame portions 91256 can be released, which allows the post 91268 to be received through the gap 91292 and the end surface 91271 extends past the inward transition portions 91290.
The actuation portion 91050 of the device or implant 91200 is configured to both move the paddle frames 91224 between an expanded position and a narrowed position and to move the paddles between the closed position and the open position. The actuation portion 91050 can be configured in a variety of ways. Any structure capable of selectively moving the paddle frames 91224 between an expanded position and a narrowed position and opening and closing the device can be used, such as for example, the actuation portion 91050 of
Referring to
As shown in
Referring to
Movement of the post 91268 away from the proximal portion 91205, as shown by arrow Q in
As shown in
Referring to
In the illustrated example of
In the illustrated example, the paddle frames 92124 include outer frame portions 92156 and inner frame portions 92160. In
The outer frame portions 92156 are flexibly attached to an attachment portion 92168 at the distal portion 92107 via connection portions 92166 and are coupled to the inner frame portions 92160 at the proximal portion 92105 via connection portions 92167. Between the connection portions 92166 and the connection portions 92167, the outer frame portions 92156 form a curved, convex shape. For example, in the illustrated example, the shape of the outer frame portions 92156 resembles an apple shape in which the outer frame portions are wider toward the proximal portion 92105 and narrower toward the distal portion 92107. In some implementations, however, the outer frame portions 92156 can be otherwise shaped.
The attachment portion 92168 is configured to attach to the width adjustment device 81500 to the outer frame portions 92156. The attachment portion 92168 can be configured in a variety of ways. Any configuration that can suitably attach the outer frame portions 92156 to the width adjustment device 81500 to allow the width adjustment device 81500 to move the outer frame portions 92156 between a narrowed position and an expanded position can be used.
The inner frame portions 92160 are jointly attached to the outer frame portions 92156 at the proximal portion 92105 via connection portions 92170 and extend from the connection portions 92170 to the distal portion 92107. The inner frame portions 92160 include retaining portions 92172 near or adjacent the distal portion 92107 for attaching to the width adjustment device 81500. The retaining portions 92172 and the width adjustment device 81500 can be configured to attach in any suitable manner.
The width adjustment device 81500 is configured to move the outer frame portions 92156 from the expanded position to the narrowed position by pulling the attachment portion 92168 and portions of the connecting portions 92166 into the width adjustment device 81500. The width adjustment device 81500 is configured to move the inner paddle frame portions 92160 to open and close the paddles in the same or a similar manner to that shown in
The width adjustment device 81500 includes a width adjustment connection or actuator 81502, a receiver (which can be configured the as parallel racks 81504), and a coupler 81506. Each rack 81504 includes teeth 81505 that are configured to limit the motion of the coupler 81506 to a single direction (e.g., a ratchet mechanism) when the coupler is in an engaged state. In the illustrated example, the coupler 81506 is coupled to outer paddle frames 92156 by a connection portion 92168.
Still referring to
Still referring to
Conversely, when the actuator 81502 is driven downwards, the projections 81510 of the actuator 81502 push against resilient, sloped surfaces 81514 of the coupler 81506. As such, the projections 81510 cause the resilient fingers 81512 to disengage from the rack 81504. As such, the coupler 81506 is disengaged from the rack 81504 when the actuator is moved in a downward or distal direction to expand the outer paddle frame portions 92156.
The paddle frames 92124 can be made from or comprise a material that allows the attachment portion 92168 and portions of the connecting portions 92166 to be pulled into the width adjustment device 81500. For example, the paddle frames 92124, or a portion thereof, can be made of a flexible metal, plastic, fabric, suture, etc. The paddle frames can be formed using a variety of different manufacturing processes, such as cutting, such as laser cutting, molding, forging, stamping, casting, bending, heat treating, shape setting, etc.
Referring to
The flexible outer frame 7675 comprises a first portion 7671A and a second portion 7671B. The proximal end 7674A of the first portion 7671A is configured to connect to the rigid inner portion 7672 via the first orifice 7673A. The proximal end 7674B of the second portion 7671B is configured to connect to the rigid inner portion 7672 via the second orifice 7673B. These connections can comprise pin connections such that a pin (not shown) extends through the first orifice 7673A and the proximal end 7674A of the first portion 7671A of the flexible outer portion 7675, and a pin extends through the second orifice 7673B and the proximal end 7674B of the second portion 7671B of the flexible outer portion 7675. The pins can also be stitches, connector elements, or integral extensions of the proximal ends 7674A, 7674B of the first and second portions 7671A, 7671B of the flexible outer frame 7675.
Referring to
The proximal ends of the rigid inner portion 7672 and flexible outer portion 7675 can connect via at least one pivot. In some implementations, the proximal end of the rigid inner portion 7672 has a first and second orifice 7673A, 7673B for receiving a pin, a stitch, connection element, or pin portions of the flexible outer frame 7675. The flexible outer frame 7675 comprises a first portion 7671A and a second portion 7671B. A first pivot point 7677A of the first portion 7671A is configured to connect to the rigid inner portion 7672 via the first orifice 7673A. The second pivot point 7677B of the second portion 7671B is configured to connect to the rigid inner portion 7672 via the second orifice 7673B. These connections can comprise pin connections such that a pin (not shown) extends through the first orifice 7673A and the proximal end 7674A of the first portion 7671A of the flexible outer portion 7675, and a pin extends through the second orifice 7673B and the proximal end 7674B of the second portion 7671B of the flexible outer portion 7675. The pins can also be integral extensions of the proximal ends 7674A, 7674B of the first and second portions 7671A, 7671B of the flexible outer frame 7675.
Referring to
Referring to
The radiused hole or entry point 100110 provides a mechanism via which the cap 100100 can control the paddle frame 224 deflection in a manner that introduces less stress to the paddle frame 224. In particular, the radiused hole 100110 has a radius 100112a at the distal end 100100a of the cap 100100 that is larger than radius 100112b at the proximal end 100100b (
The paddle frame 224 can include an attachment portion 224c that allows the paddle frame 224 to attach directly to another portion of the device for mechanical communication. For example, attachment portion 224c can be attached to a mechanism for pulling of the paddle frames 224 into the cap to reduce the width of the paddle frames and pushing the paddle frames 224 out of the cap to increase the width of the paddle frames.
Deflection of the paddle frame 224 via cap 100100 is shown in more detail in
In
As discussed above, in some implementations, the paddle frames 224 can be narrowed/widened, stopped, locked, and held in fully expanded, fully narrowed, and in intermediate positions. Locking can also be particularly helpful prior to leaflet the capture in keeping the paddle frames 224 narrow to traverse potential obstructions, such as the chordae tendineae (CT,
In some implementations, the paddle narrowing and widening adjustment mechanism automatically holds the paddle frames 224 in the adjusted position when the mechanism is released. A wide variety of different mechanisms can be used to narrow and widen the paddle frames and automatically hold the paddle frames 224 in any adjusted position. For example, a screw mechanism, a ratchet mechanism, a cam mechanism, etc. can be used. Such mechanisms allow the user to set and maintain the paddle frames 224 at any width so that a particular the paddle width is maintained without active tensioning action by the user. Additionally, such mechanisms can facilitate more precise control of narrowing/widening.
In some implementations, the paddle narrowing and widening adjustment mechanism 100299 is a helical screw system that extends the paddle frames 224 by moving the inner end 224a along the axis A2. The details of this mechanism are discussed below. The motion of rotational member 100300 can be driven by components located in the proximal portion 100300d of the device. It is to be understood that the configuration shown in
Mechanisms for actuating the rotation of helical portion 100300a can include, for example, a user rotated rod, handle, or other fixture. The rotation can be manually activated, electronically activated, and/or controlled via software/computer interface. Other implements can include using a stepper motor, remotely or locally controlled, and/or any other suitable actuator. Such mechanisms can be coupled to the proximal portion 100300d in a wide variety of different ways, such as by any of the coupling arrangements disclosed in the present application. In some implementations, the coupling to the proximal portion 100300d facilitated both rotation of the helical portion 100300a to adjust the width of the paddle frames and linear extension of the entire paddle narrowing and widening adjustment mechanism 100299 relative to a delivery catheter and/or a coaptation element to open and close the paddles of the device.
Continuing this rotation results in the reduced amount of the paddle frames 224 extending from the cap 100100 shown in
Continuing the rotation of helical portion 100300a around axis A2 further pushes protrusion 224d towards the proximal end of member 100300 (i.e., toward 100300d). The result is shown in
In some implementations, the paddle frames 224 are actively narrowed and passively expanded. As such, the expanded condition can be the natural or substantially unstressed shape of the paddle frames. To move the paddle frames to the narrowed condition the paddle frames are stressed to flex the paddle frames from the expanded state to the narrowed state. This stress can be concentrated in certain areas of the paddle frames 224, such as at the area where the paddles enter the cap. As described above, one way of reducing this stress is to provide a radiused or tapered entry for the paddles into the cap.
In some implementations, the paddle frames are structurally modified to reduce the stress in the area where the paddle frames enter the cap. The paddle frames can be structurally modified to reduce the stress in the area where the paddle frames enter the cap in a variety of different ways. For example, the area where the paddle frames enter the cap can be moveably connected to the remainder of the paddle frame, the area where the paddle frames enter the cap can be decoupled from the remainder of the paddle frame, the area where the paddle frames enter the cap connected to the remainder of the paddle frame by a flexible component, etc.
In some implementations, the bowing of the upper portion 224g is resisted and/or provided with a countervailing restoring force by resilient element 224h. Resilient element 224h can allow the active narrowing or widening of the paddle frame 224 width to be automatically or passively reversed. The resilient element 224h can include a spring, as shown in
As shown in
Using the pivot point 224f to connect a segmented upper 224g and lower 224e portions of the paddle frames 224 can facilitate certain manufacturing advantages. Segmenting the upper 224g and lower 224e portions allows these portions to be fabricated from different materials and/or via different methods. For example, the lower frame portion 224e can be fabricated by stamping or laser cutting a ribbon of more flexible material and/or a stronger material that can withstand the application of higher strains, while upper portion 224g can be fabricated using a less flexible and/or weaker materials. The upper portion 224g can be made of a less expensive material, such as a bent wire.
As discussed above, there are advantages to fabricating portions of the disclosed the devices (e.g., implantable device/implant 200) out of bulk materials, such a sheet material, such as a sheet of metal or plastic, rather than from a braided or woven networks of wire. Braided or woven networks can facilitate flexibility of design by which the device can elongate and compress into a tracking condition to enable delivery through a delivery system and intraprocedural maneuvering and expand into the shape of the implantable device or implant. However, devices made from or comprise a braided or woven network of wires can be expensive to manufacture. In some implementations, portions of the valve repair device or implant can be made from a flat sheet of material. For example, coaptation element supports, inner paddle portions, outer paddle portions, and/or a paddle frame connection portion can be made from a flat sheet of material.
Comparison of
The components of the paddle structure 100450 operate substantially similarly to their functional equivalents identified in Table 1. That is, the descriptions of the functional equivalents in the context of
As shown in
A cap/paddle frame connection portion 100462 in
Turning back to
The position of the valve repair device or implant shown in
More particularly, referring to
In any case, force can be communicated to restoring component 100754 along direction D6 via length of outer the paddle frame portion 100752 and joint mechanism 100754a. The communicated force then pivots the paddle frame portion 100752 about the joint mechanism 100754a and compresses the center portion 100754b and/or introduces a displacement of the center portion 100754b of the restoring component 100754 along direction D7. Compression and/or displacement of center portion 100754b stores energy as a restoring force that can be used to ultimate move outer the paddle frame portion 100752 back to its original shape and configuration. Once the force causing displacement along D5 ceases (e.g., the device 100700 moves clear of an interaction with biological material), outer the paddle frame portion 100752 can tend to return to its original shape. Center portion 100754b of the restoring component 100754 assists this process by applying a restoring force in the direction opposite to D7. The restoring force is then transmitted to the outer the paddle frame portion 100752, causing it to flex in the opposite direction as D5. Subsequently, outer the paddle frame portion 100752 returns to its original shape, as shown in
Another advantageous aspect of the paddle configuration 100750 is that the outer the paddle frame portions 100752 can still be opened and closed even during a deflection of the end(s) along the direction D5. That is to say, outer the paddle frame portions 100752 can be made of substantially stiff material such that a deflection along D5 does not prevent the user from opening or closing the paddles. For example, the paddles can still be opened and closed even when there is a substantial obstruction or interaction with biological material.
Although the restoring component 100754 shown in
The outer paddle frame portions 100752, the inner paddle frames 100756, the restoring component 100754, can be constructed using laser cutting, die casting, 3D printing, or other advanced manufacturing techniques. These components can be fabricated separately and assembled when finished. Such a manufacturing technique can be amenable to simple, scalable, mass production.
Referring to
In the illustrated example, the connector 100924 is symmetric along longitudinal axis ZZ (
Referring to
The connector 100924 has an inner end 100968 that engages with the actuation portion 100910 such that a user can move the inner end 100968 relative to the actuation portion 100910 to move the connector 100924 between a narrowed position and an expanded position, as described in more detail below. In the illustrated example, the inner end 100968 includes a post 100970 that attaches to the connector 100924 and a threaded receiving portion 100972 that extends from the post 100970. The inner end 100968 can, however, be configured in a variety of ways. Any configuration that can suitably attach the connector 100924 to the actuation portion 100910 to allow the actuation portion 100910 to move the connector 100924 between the narrowed position and the expanded position can be used.
The actuation portion 100910 allows a user to expand or contract the connector 100924 of the implantable device width adjustment assembly 100900. In the illustrated example, the actuation portion 100910 includes a coupler, such as the illustrated externally threaded shaft 100912 that is disposed within a receiver 100914 (e.g., an internally threaded element, a notched receiving portion, column, lumen, tube, shaft, sleeve, post, housing, tracks, cylinder etc.) and rotatably engaged with the threaded receiving portion 100972 of the inner end 100968 of the connector 100924. In some implementations, the receiver 100914 can be integrally formed with a distal cap 100915 of the distal portion 100907.
A driver head 100916 is disposed at a proximal end of the shaft 100912. The driver head 100916 is configured to receive a width adjustment element (e.g., width adjustment control, width adjustment wire, width adjustment shaft, width adjustment tube, width adjustment line, width adjustment cord, width adjustment suture, width adjustment tether, etc.) such that a user can rotate the width adjustment element to rotatably drive the shaft 100912 within the receiver 100914 in a direction R. The shaft 100912 extends through an opening of the receiving portion 100972 such that the external threads of the shaft 100912 engage internal threads of the opening of the receiving portion 100972. When the driver head 100916 is driven to rotate the shaft 100912, the engagement between the internal threads of the receiving portion 100972 and the external threads of the shaft 100912 causes the receiving portion 100972 (and, consequently, the post 100970) to move in a direction Y within the receiver 100914 and relative to the shaft 100912. The offset positioning between the shaft 100912 and the post 100970 of the inner end 100968 allows the post 100970 to move alongside the shaft 100912. In some implementations, rotation of the shaft 100912 in a counterclockwise direction causes the inner end 100968 to move toward the proximal end of the actuation portion 100910, and rotation of the shaft 100912 in a clockwise direction causes the inner end 100968 to move toward the distal end of the actuation portion 100910. However, it should be understood that other configurations are also contemplated.
In the illustrated example, the connection between the connector 100924 and the post 100970 of the inner end 100968 causes distal ends 100966 of the connector 100924 to move in the direction X (
The movement of the connector 100924 to the narrowed position allows the device or implant to maneuver more easily into position for implantation in the heart by reducing the contact and/or friction between the native structures of the heart—e.g., chordae— and the device. The movement of the connector 100924 to the expanded position provides the anchor portion of the device or implant with a larger surface area to engage and capture leaflet(s) of a native heart valve.
In some implementations, the connector 100924 can be made from or comprise a material that allows the inner end 100968 and portions of the connector 100924 (e.g., the distal ends 100966) to be pulled into the actuation portion 100910. For example, the connector 100924, or a portion thereof, can be made of any flexible material, including but not limited to, metal, plastic, fabric, suture, etc. The connector 100924 can be made using a variety of processes, including, but not limited to, cutting, such as laser cutting, stamping, casting, molding, heat treating, shape setting, etc. The connector 100924 can be made from or comprise a shape memory material, —such as Nitinol—to provide shape-setting capability.
Referring to
In the illustrated example, the connector 101024 are symmetric along longitudinal axis AAA (
In the illustrated example, the connector 101024 are W-shaped frames that have proximal ends 101067 and distal ends 101066. The connector 101024 can have a width W13 (
The connector 101024 has a coupler 101068 that engages with a width adjustment element 101011 (e.g., width adjustment control, width adjustment wire, width adjustment shaft, width adjustment tube, width adjustment line, width adjustment cord, width adjustment suture, width adjustment tether, etc.). The coupler 101068 can be configured in a variety of different ways. For example, the coupler 8972 can include one or more of a threaded connection, features that mate with threads, detent connections, such as outwardly biased arms or portions, flexible projections etc. The coupling between the width adjustment element 101011 and the coupler 101068 allows a user to move the coupler 101068 of the width adjustment device 101010 to move the connector 101024 between a narrowed position and an expanded position, as described in more detail below. In the illustrated example, the coupler 101068 includes a post 101070 that attaches to the connector 101024 and flexible projections 101072 that extend from the post 101070. The coupler 101068 can be configured to receive a width adjustment element 101011 (e.g., an actuation wire, actuation shaft, etc.) that allows a user to move the coupler 101068 in the direction Y. For example, the post 101070 can have a coupler, such as the illustrated threaded receiving portion 101073 (
The width adjustment device 101010 allows a user to expand or contract the connector 101024 of the implantable device 101000. In the illustrated example, the width adjustment device 101010 includes a receiver 101014 (e.g., an internally threaded element, a notched receiving portion, column, lumen, tube, shaft, post, housing, tracks, cylinder etc.) that has a plurality of slots 101015 (
A connection feature 101016 is disposed at a proximal end of the implantable device 101000 for receiving an actuation element 101002 (e.g., actuation shaft, actuation tube, actuation lumen, conduit, etc.) of a delivery device. In the illustrated example, the connection feature 100916, such as the illustrated driver head, includes internal threads for connecting to external threads of the actuation element 101002. The connection feature 101016 can, however, have any configuration that can receive and attach to the actuation element 101002.
A width adjustment element 101011 extends through the actuation element 101002 of the delivery device and into the receiver 101014 of the width adjustment device 101010 of the implantable device 101000. The width adjustment element 101011 removably connects to the post 101070 of the coupler 101068 such that a user can move the width adjustment element 101011 in the direction Y to cause the coupler 101068 to move in the direction Y. In the illustrated example, the width adjustment element 101011 includes external threads for connecting to internal threads of the post 101070. The width adjustment element 101011 can, however, have any configuration that can attach to the coupler 101068 and allow a user to move the coupler 101068.
Referring to
Referring to
In the illustrated example, movement of the post 101070 toward a proximal end of the width adjustment device 101010 causes the proximal ends 101067 of the connector 101024 to move toward the width adjustment device 101010 such that the connector 101024 moves to a narrowed position. Conversely, movement of the post 101070 toward a distal end of the width adjustment device 101010 causes the proximal ends 100967 of the connector 100924 to move in the direction away from the width adjustment device 101010 such that the connector 101024 moves to an expanded position. However, it should be understood that other configurations are also contemplated. In some implementations, the distal ends 101066 of the connector 101024 can move into the receiver 101014 when the connector 101024 is moved to the narrowed position, and the distal ends 101066 can move out of the receiver 101014 when the connector 101024 is moved to the expanded position. However, it should be understood that other configurations are also contemplated.
Movement of the coupler 101068 in the direction Y within the receiver 101014 causes the flexible projections 101072 to flex in the direction F, which allows the flexible projections 101072 to move between a flexed position in which the flexible projections engage an interior surface of the receiver 101014 and an extended position in which the flexible projections 101072 are disposed within a slot 101015 of the receiver. When the flexible projections 101072 are in the extended position and disposed within a slot 101015, the width W13 of the connector 101024 is maintained in the position associated with the location of the coupler 101068 relative to the receiver 101014. The user can adjust the width W13 of the connector 101024 by moving the width adjustment element 101011 in the direction Y, which causes the flexible projections 101072 to flex and allow the coupler 101068 to move within the receiver 101014. In some implementations, the interior surface of the receiver includes channels 101017 (
The movement of the connector 101024 to the narrowed position allows the device or implant 101000 to maneuver more easily into position for implantation in the heart by reducing the contact and/or friction between the native structures of the heart—e.g., chordae— and the device 101000. The movement of the connector 101024 to the expanded position provides the anchor portion of the device or implant 101000 with a larger surface area to engage and capture leaflet(s) of a native heart valve.
In some implementations, the connector 101024 can be made from or comprise a material that allows the coupler 101068 and portions of the connector 101024 (e.g., the distal ends 101066) to be pulled into the actuation portion 100910. For example, the connector 101024, or a portion thereof, can be made of any flexible material, including but not limited to, metal, plastic, fabric, suture, etc. The connector 101024 can be made using a variety of processes, including, but not limited to, cutting, such as laser cutting, stamping, casting, molding, heat treating, shape setting, etc. The connector 101024 can be made from or comprise a shape memory material, —such as Nitinol—to provide shape-setting capability.
A distal end 101131 of the actuation element 101102 has a connection feature 101161 that includes a pair of arms 101163 that are movable between a normal, expanded position (e.g., as shown in
A proximal end 101130 of the implantable device 101100 has a connection feature 101160 that includes an opening 101162 for receiving the arms 101163 of the actuation element 101102. Referring to
Referring to
Referring to
Referring to
A distal end 101231 of the actuation element 101202 has a connection feature 101261 that includes a pair of arms 101263 that are movable between a normal, expanded position (e.g., as shown in
A proximal end 101230 of the implantable device 101200 has a connection feature 101260 that includes an opening 101262 for receiving the arms 101263 of the actuation element 101202. Referring to
When the implantable device 101200 is being delivered to a native valve of a patient by the delivery device, the actuation element 101202 is attached to the implantable device 101200. That is, the arms 101263 of the actuation element 101202 extend into the distal portion 101264 of the opening 101262 of the implantable device 101200. When the arms 101263 are in the normal position, a width W (
A width adjustment element 101211 (which can be the same as or similar to other width adjustment elements shown or described herein) can extend through the actuation element 101202 and the connection feature 101260 of the implantable device 101200 such that the width adjustment element 101211 can be engaged by a user to control various movements of the implantable device 101200, such as the width of the paddles and decoupling of the actuation element from the device. In some implementations, the width adjustment element 101211 is sized and positioned within the actuation element 101202 to exert an outward force on the arms 101263 to maintain the arms 101263 in the distal portion 101264 of the opening 101262 and prevent or inhibit disengagement between the actuation element 101202 and the implantable device 101200. In these implementations, when the width adjustment element 101211 is extending through the actuation element 101202 and the implantable device 101200, the width adjustment element 101211 can prevent or inhibit removal of the actuation element 101202 from the implantable device 101200 even if a user provides a force to the actuation element 101202 in the direction Y. That is, the force exerted by the width adjustment element 101211 on the arms 101263 prevents or inhibits the arms 101263 from moving to a compressed position. In some implementations, the normal position of the arms 101263 of the actuation element 101202 can be biased inward (rather than biased outward as described above) for easy removal from the actuation element 101202 from the implantable device 101200, and the force by the width adjustment element 101211 on the arms 101263 is the main force used to maintain the arms in an expanded position such that the actuation element 101202 maintains a connection with the implantable device 101200.
Referring to
Referring to
Referring to
In the illustrated example, the connector 101324 is a W-shaped frame that has proximal ends 101367 and distal ends 101366. The connector 101324 can be made of any suitable material that allows the connector 101324 to be moved between an expanded position and a narrowed position, such as, for example, any flexible material for paddle frames disclosed in the present application. While the connector 101324 are shown as having a W-shape, it should be understood that the connector 101324 can take any suitable form, such as, for example, any form described in the present application.
The connector 101324 has an inner end 101368 that is configured to be connected through an opening in a coupler 101313. The coupler 101313 releasably connects with the width adjustment element 101311. The coupler 101313 allows a user to move the width adjustment element 101311 and connected inner end 101368, which causes the paddle frame portions to be moved between the narrowed and expanded positions. For example, in some implementations, the implant can include an actuation portion (e.g., any actuation portion of an implant described in the present application), and the user can move the inner end 101368 relative to the actuation portion to move the connector 101324 between a narrowed position and an expanded position.
In the illustrated example, the inner end 101368 includes a post 101370 attached to the distal ends 101366 of the connector 101324 and a retention feature 101372 for attaching to the width adjustment element 101311. The retention feature 101372 can include flexible arms 101373 (
The width adjustment element 101311 can include or be coupled to, for example, an actuation wire, actuation shaft, or any other suitable element that a user can engage to move the connector 101324 between the narrowed and expanded positions. A distal end of the width adjustment element 101311 can be releasably or permanently connected to the coupler 101313. The connector or connection feature can receive and connect to the retention feature 101372 of the connector 101324. The coupler 101313 include openings 101314 for receiving the arms 101373 of connector 101324. In the illustrated example, the coupler 101313 is a separate component from the remainder of the width adjustment element 101311. For example, a proximal end of the coupler 101313 can be configured to attach to the remainder of the width adjustment element 101311. In the illustrated example, the coupler 101313 includes a connection opening 101315 for receiving a connection element 101317 (
In some implementations, the coupler 101313 is connected to the retention feature 101372 of the connector 101324 by a snap-fit connection. For example, the coupler 101313 is placed over the retention feature 101372 of the connector 101324 such that the arms 101373 move to the compressed position. As the coupler 101313 is being placed over the retention feature 101372, extended portions of the arms 101373 will move into the openings 101314 of the coupler 101313 such that the arms 101373 will move back to the normal, expanded position, which secures the connector 101324 to the coupler 101313. In some implementations, this connection between the connector 101324 and the coupler 101313 is permanent.
Referring to
In the illustrated example, the connector 101424 is symmetric along longitudinal axis BBB (
In the illustrated example, the connector 101424 are W-shaped frames that have proximal ends 101467 and distal ends 101466. The connector 101424 can have a width W14 (
The connector 101424 have an inner end (not shown) that engages with the actuation portion 101410 such that a user can move the inner end relative to the actuation portion 101410 to move the connector 101424 between a narrowed position and an expanded position, as described in more detail below. The inner end can take any suitable form, such as, for example, the form of the inner end 101368 shown in
The actuation portion 101410 allows a user to open and close the paddle frames of the device by moving the actuation portion 101410 relative to the proximal portion of the device. The actuation portion 101410 also allows a user to expand or contract the connector 101424 of the implantable device 101400 by moving the connector 101424 into or out of the actuation portion 101410. In the illustrated example, the actuation portion 101410 includes a receiver 101414 (e.g., an internally threaded element, a notched receiving portion, column, lumen, tube, shaft, sleeve, post, housing, tracks, cylinder etc.) and a coupler 101411 that is configured to extend through the receiver 101414 and be moved by a user relative to the receiver 101414. For example, the coupler 101411 can include one or more of a threaded connection, features that mate with threads, detent connections, such as outwardly biased arms or portions, flexible projections etc. The coupler 101411 attaches to the connector 101424 such that movement of the width adjustment element relative to the receiver 101414 causes the connector 101424 between the narrowed and expanded positions. In some implementations, the receiver 101414 can be integrally formed with a distal cap 101415 of the distal portion 101407 of the implantable device 101400. While described here as a receiver, other structures or openings in structures of a variety of shapes and sizes that can accomplish the same purpose can be used as well.
The coupler 101411 can be connected to or can include, for example, an actuation wire, actuation shaft, or any other suitable element that a user can engage to move the connector 101424 between the narrowed and expanded positions. For example, a distal end, a proximal end, or another portion of the coupler 101411 can include a connection feature 101413 for receiving and connecting to a retention feature of the connector 101424 (e.g., the retention feature 101372 of the connector 101324 shown in
The connection feature 101413 can have one or more protruding side wall portions 101461 (
Referring to
While the protruding side wall portions 101461 are described as being a component of the coupler 101411, in some implementations, it should be understood that the protruding side wall portions 101461 that engage the openings 101465 of the receiver 101414 can be a component of the connector 101424. For example, the protruding side wall portions can be attached to or integral to the inner end of the connector 101424.
In some implementations, movement of the connection feature 101413 in the proximal direction P causes the connector 101424 to move such that the width W14 (
The movement of the connector 101424 to the narrowed position allows the device or implant 101400 to maneuver more easily into position for implantation in the heart by reducing the contact and/or friction between the native structures of the heart—e.g., chordae— and the device 101400. The movement of the connector 101424 to the expanded position provides the anchor portion of the device or implant 101400 with a larger surface area to engage and capture leaflet(s) of a native heart valve.
In some implementations, the connector 101424 can be made from or comprise a material that allows the inner end and portions of the connector 101424 (e.g., the distal ends 101066) to be pulled into the actuation portion 101410. For example, the connector 101424, or a portion thereof, can be made of any flexible material, including but not limited to, metal, plastic, fabric, suture, etc. The connector 101424 can be made using a variety of processes, including, but not limited to, cutting, such as laser cutting, stamping, casting, molding, heat treating, shape setting, etc. The connector 101424 can be made from or comprise a shape memory material, —such as Nitinol—to provide shape-setting capability.
Referring to
Referring to
In some implementations, the anchor portion 101506 can include at least one anchor 101508, where the anchor 101508 has an outer paddle 101520, an inner paddle 101522, a paddle extension member or paddle frame 101524, clasps (not shown), and a cover 101551. The outer and inner paddles 101520, 101522 can take any suitable form, such as, for example, any form described in the present application. The paddle frame 101524 can have an inner frame portion 101572 and an outer frame portion 101574, such as, for example, similar to any other paddle frame disclosed in the present application that includes an inner frame portion and an outer frame portion.
The inner frame portion 101572 can be rigid our substantially rigid such that it is configured to support the paddles and provide a sufficient force to leaflets of the native valve during capture. The inner frame portion 101572 can be made of, for example, metals, plastics, etc. The outer frame portions 101574 can be connected to the inner frame portions 101572 such that the outer frame portions 101574 define the total width of the paddle frame 101524. The outer frame portions 101574 can be flexible such that the outer frame portions can move between an expanded position and a narrowed position. For example, the outer frame portions 101574 can be operatively connected to an actuation portion of the implantable device such that a user can engage the paddle frame 101524 to move the outer frame portions 101574 between the expanded and narrowed positions. The outer frame portions 101574 can be made of, for example, metals, and plastics.
Referring to
In some implementations, the pinch points/regions can be formed between other components or portions (e.g., protrusions, extensions, wings, bars, rods, clips, etc.) of anchors of the device in various different configurations. For example, other anchor designs can be used that do not include the same inner and outer frame portions but include other components or portions compressing the leaflets. The cover can be configured to extend between those other components or portions.
Referring to
In the illustrated example, each anchor 101508 includes a separate sheet, material, fabric, layer, and/or membrane 101553 such that a gap 101557 (
When the anchors 101508 are compressing the leaflets, the cover 101551 engages the leaflets between the pinch points 101581, 101583 to assist in coapting the leaflets and preventing or inhibiting regurgitation of blood through the native valve. In addition to providing force to the leaflets, when the cover 101551 forms a canopy, the cover can further prevent or inhibit regurgitation of blood by acting as a barrier that blocks, inhibits, or diverts the movement of blood through the native valve. In some implementations, the sheet, material, fabric, layer, and/or membrane 101553 of the cover 101551 is flexible and/or stretchable to allow for movement of the paddle frames 101524 between narrowed and expanded positions. For example, the inner frame portions 101572 can be fixed, and the width of the outer frame portions 101574 can be adjustable, and as the outer frame portions are moved to an expanded position, the sheet, material, fabric, layer, and/or membrane 101553 of the cover 101551 can be configured to stretch or otherwise expand. The flexibility and/or resilience of the sheet, material, fabric, layer, and/or membrane 101553 can be selected to allow the cover 101551 to maintain a taut state when the paddle frames 101524 are in a narrowed position. This helps the cover prevent or inhibit leakage in whatever size the adjustable frame members are adjusted to or set and avoid gaps or openings forming as components of the device are adjusted to different sizes.
The cover 101551 can be configured to cover or not cover any component or portion of the implantable device. For example, referring to
Referring to
In some implementations, the anchor portion 101606 can include at least one anchor 101608, where the anchor 101608 has an outer paddle 101620, an inner paddle 101622, a paddle extension member or paddle frame 101624, clasps (not shown), and a cover 101651. The paddles 101620, 101622 can take any suitable form, such as, for example, any form described in the present application. The paddle frame 101624 can have an inner frame portion 101672 and an outer frame portion 101674, such as, for example, similar to any other paddle frame disclosed in the present application that includes an inner frame portion and an outer frame portion.
The inner frame portion 101672 can be rigid such that it is configured to support the paddles and provide a sufficient force to leaflets of the native valve during capture. The inner frame portion 101672 can be made of, for example, metals, plastics, etc. The outer frame portions 101674 can be connected to the inner frame portions 101672 such that the outer frame portions 101674 define the total width of the paddle frame 101624. The outer frame portions 101674 can be flexible such that the outer frame portions can optionally be manipulated by a user between an expanded position and a narrowed position. For example, the outer frame portions 101674 can be operatively connected to an actuation portion of the implantable device such that a user can engage the paddle frame 101624 to move the outer frame portions 101674 between the expanded and narrowed positions. The outer frame portions 101674 can be made of, for example, metals, and plastics. Referring to
Referring to
Referring to
When the anchors 101608 are compressing the leaflets, the cover 101651 engages the leaflets between the pinch points 101681, 101683 to assist in coapting the leaflets and preventing or inhibiting regurgitation of blood through the native valve. In addition to providing force to the leaflets, the cover 101651 can further prevent or inhibit regurgitation of blood by acting as a barrier that prevents or inhibits the movement of blood through the native valve. The canopy 101667 can act as a further barrier for preventing or inhibiting blood from moving through the native valve. In some implementations, the sheet, material, fabric, layer, and/or membrane 101653 of the cover 101651 is flexible to allow for movement of the paddle frames 101624 between narrowed and expanded positions. For example, the inner frame portions 101672 can be fixed, and the width of the outer frame portions 101674 can be adjustable, and as the outer frame portions are moved to an expanded position, the sheet, material, fabric, layer, and/or membrane 101653 of the cover 101651 can be configured to stretch or otherwise expand. The flexibility and/or resiliency of the sheet, material, fabric, layer, and/or membrane 101653 allows the cover 101651 to maintain a taut state when the paddle frames 101624 are in a narrowed position. This helps the cover prevent or inhibit leakage in various sizes of the adjustable frame members, without forming leakage gaps or openings between components of the device.
The cover 101651 can be configured to cover or not cover any component or portion of the implantable device. For example, referring to
Referring to
In some implementations, the anchor portion 101706 can include at least one anchor 101708, where the anchor 101708 has an outer paddle 101720, an inner paddle (not shown), a paddle extension member or paddle frame 101724, clasps (not shown), and a cover 101751. The inner and outer paddles can take any suitable form, such as, for example, any form described in the present application. The paddle frame 101724 can have an inner frame portion 101772 and an outer frame portion 101774, such as, for example, similar to any other paddle frame disclosed in the present application that includes an inner frame portion and an outer frame portion.
The inner frame portion 101772 can be rigid such that it is configured to support the paddles and provide a sufficient force to leaflets of the native valve during capture. The inner frame portion 101772 can be made of, for example, metals, plastics, etc. The outer frame portions 101774 can be connected to the inner frame portions 101772 such that the outer frame portions 101774 define the total width of the paddle frame 101724. The outer frame portions 101774 can be flexible such that the outer frame portions can optionally be manipulated by a user between an expanded position and a narrowed position. For example, the outer frame portions 101774 can be operatively connected to an actuation portion of the implantable device such that a user can engage the paddle frame 101724 to move the outer frame portions 101774 between the expanded and narrowed positions. The outer frame portions 101774 can be made of, for example, metals, and plastics. Referring to
Referring to
While the illustrated example is shown as having a pair of anchors 101708, it should be understood that the implantable device 101700 can have any suitable number of anchors that include a cover 101751. When the anchors 101708 are compressing the leaflets, the leaflets are engaged at the pinch points (e.g., pinch regions) between the anchors 101708. That is, the leaflets are engaged at a first pinch point 101781 between the inner frame portions 101772 of the anchors 101708, and the leaflets are engaged at a second pinch point 101783 between outer frame portions 101774 of the anchors 101708.
In some implementations, the pinch points/regions can be formed between other components or portions (e.g., protrusions, extensions, wings, bars, rods, clips, etc.) of anchors of the device in various different configurations. For example, other anchor designs can be used that do not include the same inner and outer frame portions but include other components or portions compressing the leaflets. The cover can be configured to extend between those other components or portions.
Referring to
In the illustrated example, the sheet, material, fabric, layer, and/or membrane 101753 is attached to the frame portions 101772, 101774 such that the sheet, material, fabric, layer, and/or membrane extends across an outer surface 101775 (
When the anchors 101708 are compressing the leaflets, the cover 101751 engages the leaflets between the pinch points 101781, 101783 to assist in coapting the leaflets and preventing or inhibiting regurgitation of blood through the native valve. In addition to providing force to the leaflets, the cover 101751 can further prevent or inhibit regurgitation of blood by acting as a barrier that prevents or inhibits the movement of blood through the native valve. The canopy 101767 can act as a further barrier for preventing or inhibiting blood from moving through the native valve. In some implementations, the sheet, material, fabric, layer, and/or membrane 101753 of the cover 101751 is flexible to allow for movement of the paddle frames 101724 between narrowed and expanded positions. For example, the inner frame portions 101772 can be fixed, and the width of the outer frame portions 101774 can be adjustable, and as the outer frame portions are moved to an expanded position, the sheet, material, fabric, layer, and/or membrane 101753 of the cover 101751 can be configured to stretch or otherwise expand. The flexibility of the sheet, material, fabric, layer, and/or membrane 101753 allows the cover 101751 to maintain a taut state when the paddle frames 101724 are in a narrowed position. This helps the cover prevent or inhibit leakage in various sizes of the adjustable frame members, without forming leakage gaps or openings between components of the device.
The cover 101751 can be configured to cover or not cover any component or portion of the implantable device. For example, referring to
Referring to
In some implementations, the anchor portion 101806 can include at least one anchor 101808, where the anchor 101808 has an outer paddle 101820, an inner paddle 101822, a paddle extension member or paddle frame 101824, clasps (not shown), and a cover 101851. The paddles 101820, 101822 can take any suitable form, such as, for example, any form described in the present application. The paddle frame 101824 can have an inner frame portion 101872 and an outer frame portion 101874, such as, for example, similar to any other paddle frame disclosed in the present application that includes an inner frame portion and an outer frame portion.
The inner frame portion 101872 can be rigid such that it is configured to support the paddles and provide a sufficient force to leaflets of the native valve during capture. The inner frame portion 101872 can be made of, for example, metals, plastics, etc. The outer frame portions 101874 can be connected to the inner frame portions 101872 such that the outer frame portions 101874 define the total width of the paddle frame 101824. The outer frame portions 101874 can be flexible such that the outer frame portions can optionally be manipulated by a user between an expanded position and a narrowed position. For example, the outer frame portions 101874 can be operatively connected to an actuation portion of the implantable device such that a user can engage the paddle frame 101824 to move the outer frame portions 101874 between the expanded and narrowed positions. The outer frame portions 101874 can be made of, for example, metals, and plastics. Referring to
Referring to
In some implementations, the pinch points/regions can be formed between other components or portions (e.g., protrusions, extensions, wings, bars, rods, clips, etc.) of anchors of the device in various different configurations. For example, other anchor designs can be used that do not include the same inner and outer frame portions but include other components or portions compressing the leaflets. The cover can be configured to extend between those other components or portions.
Referring to
In the illustrated example, the sheet, material, fabric, layer, and/or membrane 101853 is attached to the frame portions 101872, 101874 such that the sheet, material, fabric, layer, and/or membrane extends across an outer surface 101875 (
When the anchors 101808 are compressing the leaflets, the cover 101851 engages the leaflets between the pinch points 101881, 101883 to assist in coapting the leaflets and preventing or inhibiting regurgitation of blood through the native valve. In addition to providing force to the leaflets, the cover 101851 can further prevent or inhibit regurgitation of blood by acting as a barrier that prevents or inhibits the movement of blood through the native valve. The canopy 101867 can act as a further barrier for preventing or inhibiting blood from moving through the native valve. In some implementations, the sheet, material, fabric, layer, and/or membrane 101853 of the cover 101851 is flexible to allow for movement of the paddle frames 101824 between narrowed and expanded positions. For example, the inner frame portions 101872 can be fixed, and the width of the outer frame portions 101874 can be adjustable, and as the outer frame portions are moved to an expanded position, the sheet, material, fabric, layer, and/or membrane 101853 of the cover 101851 can be configured to stretch. The flexibility of the sheet, material, fabric, layer, and/or membrane 101853 allows the cover 101851 to maintain a taut state when the paddle frames 101824 are in a narrowed position.
The cover 101851 can be configured to cover or not cover any component or portion of the implantable device. For example, referring to
Referring to
In some implementations, the anchor portion 101906 can include at least one anchor 101908, where the anchor 101908 has an outer paddle 101920, an inner paddle (not shown), a paddle extension member or paddle frame 101924, clasps 101930, and a cover 101951. The paddles 101920, 101922 can take any suitable form, such as, for example, any form described in the present application. The paddle frame 101924 can have an inner frame portion 101972 and an outer frame portion 101974, such as, for example, similar to any other paddle frame disclosed in the present application that includes an inner frame portion and an outer frame portion.
The inner frame portion 101972 can be rigid such that it is configured to support the paddles and provide a sufficient force to leaflets of the native valve during capture. The inner frame portion 101972 can be made of, for example, metals, plastics, etc. The outer frame portions 101974 can be connected to the inner frame portions 101972 such that the outer frame portions 101974 define the total width of the paddle frame 101924. The outer frame portions 101974 can be flexible such that the outer frame portions can optionally be manipulated by a user between an expanded position and a narrowed position. For example, the outer frame portions 101974 can be operatively connected to an actuation portion of the implantable device such that a user can engage the paddle frame 101924 to move the outer frame portions 101974 between the expanded and narrowed positions. The outer frame portions 101974 can be made of, for example, metals, and plastics. Referring to
Referring to
In some implementations, the pinch points/regions can be formed between other components or portions (e.g., protrusions, extensions, wings, bars, rods, clips, etc.) of anchors of the device in various different configurations. For example, other anchor designs can be used that do not include the same inner and outer frame portions but include other components or portions compressing the leaflets. The cover can be configured to extend between those other components or portions.
Referring to
In the illustrated example, the sheet, material, fabric, layer, and/or membrane 101953 is attached to the frame portions 101972, 101974 such that the sheet, material, fabric, layer, and/or membrane extends across an outer surface 101975 (
When the anchors 101908 are compressing the leaflets, the cover 101951 engages the leaflets between the pinch points 101981, 101983 to assist in coapting the leaflets and preventing or inhibiting regurgitation of blood through the native valve. In addition to providing force to the leaflets, the cover 101951 can further prevent or inhibit regurgitation of blood by acting as a barrier that prevents or inhibits the movement of blood through the native valve. The canopy 101967 can act as a further barrier for preventing or inhibiting blood from moving through the native valve. In some implementations, the sheet, material, fabric, layer, and/or membrane 101953 of the cover 101951 is flexible to allow for movement of the paddle frames 101924 between narrowed and expanded positions. For example, the inner frame portions 101972 can be fixed, and the width of the outer frame portions 101974 can be adjustable, and as the outer frame portions are moved to an expanded position, the sheet, material, fabric, layer, and/or membrane 101953 of the cover 101951 can be configured to stretch or otherwise expand. The flexibility of the sheet, material, fabric, layer, and/or membrane 101953 allows the cover 101951 to maintain a taut state when the paddle frames 101924 are in a narrowed position. This helps the cover prevent or inhibit leakage in various sizes of the adjustable frame members, without forming leakage gaps or openings between components of the device.
The cover 101951 can be configured to cover or not cover any component or portion of the implantable device. For example, referring to
Referring to
In some implementations, the anchor portion 102006 can include at least one anchor 102008, where the anchor 102008 has an outer paddle 102020, an inner paddle (not shown), a paddle extension member or paddle frame 102024, clasps 102030, and a cover 102051. The paddles can take any suitable form, such as, for example, any form described in the present application. The paddle frame 102024 can have an inner frame portion 102072 and an outer frame portion 102074, such as, for example, similar to any other paddle frame disclosed in the present application that includes an inner frame portion and an outer frame portion.
The inner frame portion 102072 can be rigid such that it is configured to support the paddles and provide a sufficient force to leaflets of the native valve during capture. The inner frame portion 102072 can be made of, for example, metals, plastics, etc. The outer frame portions 102074 can be connected to the inner frame portions 102072 such that the outer frame portions 102074 define the total width of the paddle frame 102024. The outer frame portions 102074 can be flexible such that the outer frame portions can optionally be manipulated by a user between an expanded position and a narrowed position. For example, the outer frame portions 102074 can be operatively connected to an actuation portion of the implantable device such that a user can engage the paddle frame 102024 to move the outer frame portions 102074 between the expanded and narrowed positions. The outer frame portions 102074 can be made of, for example, metals, and plastics. Referring to
Referring to
In some implementations, the pinch points/regions can be formed between other components or portions (e.g., protrusions, extensions, wings, bars, rods, clips, etc.) of anchors of the device in various different configurations. For example, other anchor designs can be used that do not include the same inner and outer frame portions but include other components or portions compressing the leaflets. The cover can be configured to extend between those other components or portions.
Referring to
In the illustrated example, the sheet, material, fabric, layer, and/or membrane 102053 is attached to the frame portions 102072, 102074 such that the sheet, material, fabric, layer, and/or membrane extends across an inner surface 102085 (
When the anchors 102008 are compressing the leaflets, the cover 102051 engages the leaflets between the pinch points 102081, 102083 to assist in coapting the leaflets and preventing or inhibiting regurgitation of blood through the native valve. In addition to providing force to the leaflets, the cover 102051 can further prevent or inhibit regurgitation of blood by acting as a barrier that prevents or inhibits the movement of blood through the native valve. The canopy 102067 can act as a further barrier for preventing or inhibiting blood from moving through the native valve. In some implementations, the sheet, material, fabric, layer, and/or membrane 102053 of the cover 102051 is flexible to allow for movement of the paddle frames 102024 between narrowed and expanded positions. For example, the inner frame portions 102072 can be fixed, and the width of the outer frame portions 102074 can be adjustable, and as the outer frame portions are moved to an expanded position, the sheet, material, fabric, layer, and/or membrane 102053 of the cover 102051 can be configured to stretch or otherwise expand. The flexibility of the sheet, material, fabric, layer, and/or membrane 102053 allows the cover 102051 to maintain a taut state when the paddle frames 102024 are in a narrowed position. This helps the cover prevent or inhibit leakage in various sizes of the adjustable frame members, without forming leakage gaps or openings between components of the device.
The cover 102051 can be configured to cover or not cover any component or portion of the implantable device. For example, referring to
Referring to
In some implementations, the anchor portion 102106 can include at least one anchor 102108, where the anchor 102108 has an outer paddle 102120, an inner paddle (not shown), a paddle extension member or paddle frame 102124, clasps 102130, and a cover 102151. The paddles can take any suitable form, such as, for example, any form described in the present application. The paddle frame 102124 can have an inner frame portion 102172 and an outer frame portion 102174, such as, for example, similar to any other paddle frame members disclosed in the present application that includes an inner frame portion and an outer frame portion.
The inner frame portion 102172 can be rigid such that it is configured to support the paddles and provide a sufficient force to leaflets of the native valve during capture. The inner frame portion 102172 can be made of, for example, metals, plastics, etc. The outer frame portions 102174 can be connected to the inner frame portions 102172 such that the outer frame portions 102174 define the total width of the paddle frame 102124. The outer frame portions 102174 can be flexible such that the outer frame portions can optionally be manipulated by a user between an expanded position and a narrowed position. For example, the outer frame portions 102174 can be operatively connected to an actuation portion of the implantable device such that a user can engage the paddle frame 102124 to move the outer frame portions 102174 between the expanded and narrowed positions. The outer frame portions 102174 can be made of, for example, metals, and plastics. Referring to
Referring to
In some implementations, the pinch points/regions can be formed between other components or portions (e.g., protrusions, extensions, wings, bars, rods, clips, etc.) of anchors of the device in various different configurations. For example, other anchor designs can be used that do not include the same inner and outer frame portions but include other components or portions compressing the leaflets. The cover can be configured to extend between those other components or portions.
Referring to
In the illustrated example, the sheet, material, fabric, layer, and/or membrane 102153 is attached to the frame portions 102172, 102174 such that the sheet, material, fabric, layer, and/or membrane extends across an inner surface 102185 (
When the anchors 102108 are compressing the leaflets, the cover 102151 engages the leaflets between the pinch points 102181, 102183 to assist in coapting the leaflets and preventing or inhibiting regurgitation of blood through the native valve. In addition to providing force to the leaflets, the cover 102151 can further prevent or inhibit regurgitation of blood by acting as a barrier that prevents or inhibits the movement of blood through the native valve. The canopy 102167 can act as a further barrier for preventing or inhibiting blood from moving through the native valve. In some implementations, the sheet, material, fabric, layer, and/or membrane 102153 of the cover 102151 is flexible to allow for movement of the paddle frames 102124 between narrowed and expanded positions. For example, the inner frame portions 102172 can be fixed, and the width of the outer frame portions 102174 can be adjustable, and as the outer frame portions are moved to an expanded position, the sheet, material, fabric, layer, and/or membrane 102153 of the cover 102151 can be configured to stretch. The flexibility of the sheet, material, fabric, layer, and/or membrane 102153 allows the cover 102151 to maintain a taut state when the paddle frames 102124 are in a narrowed position. This helps the cover prevent or inhibit leakage in various sizes of the adjustable frame members without forming leakage gaps.
The cover 102151 can be configured to cover or not cover any component or portion of the implantable device. For example, referring to
Referring now to
In some implementations, the anchor portion 102206 includes a plurality of anchors 102208. The anchors 102208 can be configured in a variety of ways, such as, for example, any of the ways described in the present application. In the illustrated example, the anchor portion 102206 includes two anchors 102208 with each anchor 102208 having outer paddles 102220, inner paddles 102222, paddle extension members or paddle frames 102224, and clasps 102230. The outer paddles 102220, inner paddles 102222, paddle frames 102224, and clasps 102230 can take any suitable form, such as, for example, any form described in the present application. In some implementations, the paddle frames 102224 can have an inner frame portion 102272 and an outer frame portion 102274, such as, for example, similar to any other paddle frame disclosed in the present application that includes an inner frame portion and an outer frame portion. The anchors 102208 can include an optional cover, such as, for example, any of the covers disclosed in
The attachment portion 102205 and distal portion 102207 can take any suitable form, such as, for example, any form described in the present application. In the illustrated example, the attachment portion 102205 includes a first or proximal collar 102211 (or other attachment element) for engaging with a coupler of a delivery system. In the illustrated example, the distal portion 102207 includes a cap 102214 that is operatively connected to the anchor portion 102206 of the device 102200 such that movement of the cap 102214 relative to a spacer or coaptation element 102210 of the coaptation portion 102204 causes the anchors 102208 to move between open and closed positions.
The coaptation portion 102204 of the device can include a coaptation element 102210 (e.g., a spacer, coaption element, bushing, etc.) for implantation between leaflets of a native valve. The coaptation element 102210 extends from the proximal collar 102211 (or other attachment element) to a distal end 102251 and includes a lumen 102253 for receiving the actuation element (e.g., actuation shafts, actuation rods, actuation tubes, actuation wires, actuation lines, etc.) and the width adjustment element (e.g., width adjustment control, width adjustment wire, width adjustment shaft, width adjustment tube, width adjustment line, width adjustment cord, width adjustment suture, width adjustment tether, etc.) of the implantable device 102200. In the illustrated example, the proximal collar 102211 of the attachment portion 102205 is integral with the coaptation element 102210.
The coaptation element 102210 can have attachment openings 102240 (
The proximal end of the coaptation element 102210 has a proximal opening 102255 that allows an actuation element and/or a width adjustment element to move relative to the lumen 102253. The proximal opening 102255 allows the actuation element and/or the width adjustment element to engage one or more controllable components of the device or implant 102200. The distal end 102251 of the coaptation element 102210 can include a distal opening 102257. An actuation element and/or one or more components that couple the cap to the actuation element can extend through the distal opening 102257 and attach to the cap. In some implementations, an actuation element extends from the delivery system to engage and enable actuation of the device 102200 between the open and closed positions and/or a width adjustment element extends from the delivery system to adjust widths of the paddles. Movement of the cap 102214 away from the coaptation element 102210 can cause the anchors 102208 to move to the open position, and movement of the cap 102214 toward the coaptation element 102210 can cause the anchors 102208 to move to the closed position. The actuation element, the cap, and any components that couple the cap to the actuation element can be configured to removably engage the cap 102214 in any suitable manner that allows the actuation element to be disengaged and removed from the device 102200 after implantation, such as, for example, any manner described in the present application.
In some implementations, one or more width adjustment elements extend through the lumen 102253 of the coaptation element 102210 and engage the paddle frames 102224 to move the paddle frames 102224 between a narrowed position and an expanded position. For example, a connector 102266 or other component that is coupled to the paddle frames 102224 can extend through the cap 102214, through the distal opening 102257 and into the lumen 102253 of the coaptation element 102210. The width adjustment(s) can be configured to engage and move the connector 102266 or other component of the paddle frames 102224 relative to the cap 102214. In some implementations, movement of the connector 102266 or other component of the paddle frames 102224 in a distal direction relative to the cap 102214 can cause the paddle frames 102224 to move to an expanded position, and movement of the connector 102266 or other component of the paddle frames 102224 in a proximal direction relative to the cap 102214 can cause the paddle frames 102224 to move to a narrowed position. The width adjustment element can be configured to removably engage the paddle frames 102224 in any suitable manner that allows the width adjustment element to be disengaged and removed from the device 102200 after implantation, such as, for example, any manner described in the present application.
In some implementations, when viewed from above (as shown in
The smaller size of the coaptation element 102210 can allow for easier movement of the various components of the anchors 102208 as the anchors 102208 are moved between the open and closed positions. For example, the coaptation element 102210 can include planar surfaces 102244 (
Referring to
Referring to
In some implementations, for example, in the illustrated example, the coaptation portion 102304 includes a coaptation element 102310 that takes the form of the coaptation element 102210 shown in
In the illustrated example, the paddle frames 102324 are symmetric along longitudinal axis CCC (
Referring to
In the illustrated example, a connector 102366 (e.g., shaped metal component, shaped plastic component, tether, wire, strut, line, cord, suture, etc.) includes an inner end or post 102368 that is engaged by a paddle width adjustment element 102311 (e.g., width adjustment control, width adjustment wire, width adjustment shaft, width adjustment tube, width adjustment line, width adjustment cord, width adjustment suture, width adjustment tether, or any other suitable type of adjustment element) such that a user can move the inner end or post 102368 relative to the receiver 102302 and the cap 102314. Movement of the paddle width adjustment element 102311 relative to the receiver 102302 and the cap 102314 moves the paddle frames 102324 between the narrowed and expanded positions. as described in more detail below. In the illustrated example, the inner end or post 102368 includes prongs 102370 that attach to a coupler 102313 that is releasably attachable to the paddle width adjustment element 102311. The inner end or post 102368 of the connector 102366 can take any suitable form, such as, for example, the form of the inner end 101368 of the connector 101324 shown in
The width adjustment element 102311 can be releasably connected to the coupler or connection feature 102313, and thus, the prongs 102370. For example, the width adjustment element 102311 can be releasably connected to the coupler 102313 by a threaded connection. When connected to the coupler 102313, the width adjustment element can move the coupler 102313 to move relative to the receiver 102302.
In some implementations, referring to
The prongs 102370 of the paddle frames 102324 can connect to the coupler 102313 by any suitable means, such as, for example, any means described in the present application. In the illustrated example, the prongs 102370 connects to the coupler 102313 similar to the implementation shown in
The coupler 102313 can be made of any suitable material that allows for the attachment projections 102388, 102390 to be positioned to engage the external threads of the width adjustment element 102311. For example, the coupler 102313 can be made from or comprise metal or polymer materials. In some implementations, the coupler can be made from or comprise a sheet metal material that includes the attachment projections 102388, 102390, such as, for example, the sheet metal material 102401 shown in
Referring to
The movement of the paddle frames 102324 to the narrowed position allows the device or implant 102300 to maneuver more easily into position for implantation in the heart by reducing the contact and/or friction between the native structures of the heart—e.g., chordae— and the device 102300. The movement of the paddle frames 102324 to the expanded position provides the anchor portion of the device or implant 102300 with the flexibility to select a range of surface areas to engage and capture leaflet(s) that best suits the individual native heart valve.
In some implementations, the paddle frames 102324 can be made from or comprise a material that allows the paddle frames 102324 to be pulled and flexed between narrow and wide configurations. For example, the paddle frames 102324, or a portion thereof, can be made of any flexible material, including but not limited to, metal, plastic, fabric, suture, etc. The paddle frames 102324 can be made using a variety of processes, including, but not limited to, cutting, such as laser cutting, stamping, casting, molding, heat treating, shape setting, etc. The paddle frames 102324 can be made from or comprise a shape memory material, —such as Nitinol—to provide shape-setting capability.
In some implementations, the adjustable width paddle frames can be adjusted to a selected width and be set or fixed at the selected width to remain at the selected width. The adjustable width paddle frames can be adjusted to a selected width and be set or fixed at the selected width to remain at the selected width in a variety of different ways. Any configuration that allows the width of the paddle frames to be adjusted between a narrow configuration and a wide configuration and then set or fixed at the selected configuration can be used. In some implementations, connecting a paddle width adjustment element to a coupler allows the coupler to move to adjust the width of the adjustable width paddle frame(s) and disconnecting the paddle width adjustment element from the coupler fixes the position of the coupler relative to one or more components of the valve repair device to set the width of the adjustable width paddle frame(s). For example, connecting a paddle width adjustment element to a coupler can allow the coupler to move relative to the cap and/or receiver to adjust the width of the adjustable width paddle frame(s) and disconnecting the paddle width adjustment element from the coupler fixes the position of the coupler relative to the cap and/or receiver to set the width of the adjustable width paddle frame(s).
Referring to
In the illustrated example, the connector 102466 is symmetric along longitudinal axis DDD (
The width adjustment element 102411 can be releasably connected to the coupler 102413, and the inner end 102468 is connected to the coupler 102413. When the width adjustment element 102411 is connected to the coupler 102413, the coupler disengages from the receiver 102402. When the coupler 102413 is disengaged from the receiver 102402, movement of the width adjustment element causes the coupler 102413 and, consequently, the prongs 102470 to move relative to the receiver 102402 to widen and narrow the paddle frames. When the width adjustment element 102411 is disconnected from the coupler 102413, the coupler engages the receiver 102402. When the coupler 102413 is engaged with the receiver 102402, movement of the width adjustment element 102411, the coupler 102413, and the prongs 102470 is prevented, thereby setting or fixing the width of the paddle frame.
In the illustrated example, referring to
The post or inner end 102468 of the paddle frame connector 102466 can connect to the coupler 102413 by any suitable means, such as, for example, any means described in the present application. In the illustrated example, the prongs 102470 on the inner end 102468 connect to the coupler 102413 in the same or similar manner as the implementation shown in
The coupler 102413 can also include a first arm 102494 and a second arm 102496 for engaging internal threads 102491 or other recesses or cutouts (
The first and second arms 102494, 102496 extend from cutouts of the body 102481. Referring to
Referring to
Referring to
Referring to
The coupler 102413 can be made using a variety of processes, including, but not limited to, cutting, such as laser cutting, stamping, casting, molding, heat treating, shape setting, etc. The coupler 102413 can be made of any suitable material that allows for the arms 102494, 102496 to be moved from the normal to expanded positions. For example, referring to
Referring to
The movement of the paddle frame portions to the narrowed position allows the device or implant 102400 to maneuver more easily into position for implantation in the heart by reducing the contact and/or friction between the native structures of the heart—e.g., chordae— and the device 102400. The movement of the connector 102466 and paddle frames to the expanded position provides the anchor portion of the device or implant 102400 with a larger surface area to engage and capture leaflet(s) of a native heart valve.
In some implementations, the connector 102466 can be made from or comprise a material that allows arms of the connector 102466 to be pulled into the receiver 102402. For example, the connector 102466, or a portion thereof, can be made of any flexible material, including but not limited to, metal, plastic, fabric, suture, etc. The connector 102466 can be made using a variety of processes, including, but not limited to, cutting, such as laser cutting, stamping, casting, molding, heat treating, shape setting, etc. The connector 102466 and paddle frames can be made from or comprise a shape memory material, —such as Nitinol—to provide shape-setting capability.
Referring to
The implantable device 102500 can include a proximal or attachment portion 102505, an anchor portion 102506 (e.g., any anchor portion described in the present application) having paddle frames 102524 (attached to the connector—See
In the illustrated example, the connector 102566 is symmetric along longitudinal axis EEE (
Referring to
The coupler 102513 has a body 102581 that includes a proximal opening 102582, a distal opening 102584, and a lumen 102586 that extends from the proximal to distal opening. The proximal end of the coupler 102513 has a connection portion 102515 for removably connecting to the width adjustment element 102511 (
Referring to
Referring to
In the illustrated example, movement of the width adjustment element 102511 proximally causes the paddle frame 102524 to narrow. Conversely, movement of the width adjustment element 102511 distally causes the paddle frame 102524 to expand or widen. Once the paddle frame 102524 is in the desired position, the user can disconnect the width adjustment element 102511 from the coupler 102513, which will cause the arms 102594, 102596 of the coupler 102513 to move to the normal position and engage the internal threads 102591 of the receiver 102502 such that the paddle frame 102524 is set or maintained at the desired width.
The movement of the paddle frames 102524 to the narrowed position allows the device or implant 102500 to maneuver more easily into position for implantation in the heart by reducing the contact and/or friction between the native structures of the heart—e.g., chordae— and the device 102500. The movement of the paddle frames 102524 to the expanded position provides the anchor portion of the device or implant 102500 with a larger surface area to engage and capture leaflet(s) of a native heart valve and/or to block a larger area of regurgitant flow through the native heart valve.
In some implementations, the connector 102566 can be made from a material that allows the connector 102566 to be pulled into the receiver 102502. For example, the connector 102566, or a portion thereof, can be made of any flexible material, including but not limited to, metal, plastic, fabric, suture, etc. The connector 102566 can be made using a variety of processes, including, but not limited to, cutting, such as laser cutting, stamping, casting, molding, heat treating, shape setting, etc. The paddle frame 102524 (attached to the connector) can be made from a shape memory material, —such as Nitinol—to provide shape-setting capability.
Referring to
In the illustrated examples, the unattachable portion 102541 is located at a proximal end 102509 of the receiver 102502. For example, a distance Y between a bottom 102543 of the receiver 102502 and a bottom 102545 of the unattachable portion 102541 can be between about 4 mm and about 10 mm or any subrange between 3 mm and 10 mm. In s implementations, a height H of the unattachable portion 102541 can be between about 0.5 mm and about 5 mm or any subrange between 0.5 mm and 5 mm. The unattachable portion 102541 prevents the paddle frames 102524 from being locked in a position that may cause a sustained stress or strain on the paddle frames 102524 that exceeds a maximum allowable permanent or set level of stress or strain, while also allowing the paddle frames 102524 to be temporarily moved to a fully narrowed position by moving the coupler 102513 through the unattachable portion 102541 of the receiver 102502. That is, the paddle frames 102524 can be moved to a narrower width during positioning of the device than the final width that the paddle frames can be set at.
Referring to
Referring to
In some implementations, the receiver 102502 can include a window (not shown) at its distal end that allows a user to view the connection between coupler 102513 and width adjustment element 102511. In these implementations, the window can take a form similar to the window 102531 shown in
Referring to
The coupler 102613 can have an upper body portion 102631, a lower body portion 102633, and a plurality of struts 102635 extending between and connected to both of the upper and lower body portions. The upper body portion 102631 can have an opening 102637 for receiving the width adjustment element of the implantable device, and the lower body portion 102633 can have an opening 102639 for receiving an inner end of the connector connected to the paddle frame. In some implementations, the opening 102637 of the upper body portion 102631 and the opening 102639 of the lower body portion 102633 can be aligned such that the width adjustment element extends through the upper body portion 102631 and is received by the opening 102639 of the lower body portion 102633. The upper body portion 102631 and/or the lower body portion 102633 can have a width adjustment element connection feature(s) that allows the width adjustment element to be removably connected to the coupler 102613. The width adjustment element connection feature(s) can be, for example, a threaded connection, a snap-fit connection, the form for connecting the width adjustment element 102311 and coupler 102313 shown in
In some implementations, the coupler 102613 is movable between one or more unlocked positions and one or more locking positions. When in an unlocked position, the coupler 102613 can be in a position in which the struts 102635 can be in a substantially untwisted configuration (as shown in
In some implementations, the coupler 102613 is normally in or biased to the locking position such that the struts 102635 are in the compressed, spiraled configuration, and attachment of the width adjustment element to the coupler 102613 causes the coupler 102613 to move to the unlocked position. For example, the width adjustment element can be attached to one or both of the upper and lower body portions 102631, 102633 of the coupler 102613 and rotation of the width adjustment element provides torque to the coupler 102613 that causes the struts 102635 to move from the spiraled configuration illustrated by
In some implementations, the upper body portion 102631 has a width adjustment element connection feature, and the lower body portion 102633 has both a width adjustment element connection feature and a connection feature that attaches to a connector that attaches to adjustable width paddle frames or that attaches directly to adjustable width paddle frames. In these implementations, the width adjustment element can be attached to both the upper and lower body portions 102631, 102633 by a threaded connection. In some implementations, the continued rotation of the width adjustment element after being connected to the coupler 102613 provides torque to the coupler 102613 that causes the struts 102635 to move from the locking position to the unlocked position. The direction of the threaded connection between the width adjustment element and the coupler 102613 can be opposite the direction of the spirals of the struts 102635. For example, when the struts 102635 are normally spiraled in a counterclockwise direction, rotation of the width adjustment element in the clockwise direction connects the width adjustment element to the coupler 102613 and moves the coupler 102613 from the locking position to the unlocked position, and vice versa. The threaded connection between the width adjustment element and both the upper and lower body portions 102631, 102633 can promote elongation of the coupler 102613 such that the coupler moves from the configuration illustrated by
In some implementations, when the coupler 102613 is in the unlocked position, a user can move the width adjustment element and, consequently, the coupler 102613 and connector connected to the paddle frame within the receiver to move the paddle frame between narrowed and expanded positions. When the width adjustment element is disconnected from the coupler 102613, the coupler 102613 moves to the locking position
The coupler 102613 can be made of any suitable material that allows for the upper and lower body portions 102631, 102633 to be moved between the compressed and expanded configurations and allows the struts 102635 to be moved between the spiraled and straight configurations. In some implementations, the coupler 102613 is made from a shape memory material, —such as Nitinol—to provide shape-setting capability. For example, the coupler 102613 can be a laser cut, Nitinol hypotube that is shape set in the compressed, spiraled configuration.
Referring to
In the illustrated example, the coupler 102713 has a body 102781 that includes a proximal opening 102782, a distal opening 102784, a lumen 102786 that extends from the proximal to distal opening. The coupler 102713 can have a width adjustment element connection feature (not shown) for connecting to the width adjustment element. The width adjustment element connection feature can take any suitable form that allows for a connection between the width adjustment element and the coupler 102713, such as, for example, a threaded connection, a snap-fit connection, or any other suitable type of connection described in the present application. In some implementations, the width adjustment element connection feature takes the form for connecting the width adjustment element 102311 and coupler 102313 shown in
The coupler 102713 can also include a first arm 102794 and a second arm 102796 that extend from cutouts 102793 of the body 102781. When the coupler 102713 is disconnected from the width adjustment element and in the locking, normal position (as shown in
Each of the arms 102794, 102796 can have a central portion 102761 and connection members 102763, that connect the central portion 102761 to the proximal and distal ends of the body 102781. In some implementations, the connection members 102763 are normally in torsion, such that at least a portion of the central portion 102761 of the arms 102794, 102796 is disposed within the lumen 102786 and another portion of the central portion 102761 of the arms 102794, 102796 extends away from the body 102781 when the coupler 102713 is in the locking, normal position. In some implementations, the heights H1, H2 of the upper lower connection members 102763 are identical. In some implementations, the height H1 of the upper connection member is greater than the height H2 of the lower connection member, or vice versa. In the illustrated example, the arms 102794, 102796 have a “t” shape, and the cutouts 102793 are configured to allow the central portion 102761 of the arms 102794, 102796 to move from the normal position to a substantially aligned position with the body 102781. However, it should be understood that other configurations/shapes are also contemplated.
In some implementations, the first arm 102794 is offset from the second arm 102796 such that the arms 102794, 102796 are configured to connect to the internal threads of the receiver when in the normal position (e.g., the position shown in
Referring to
Once the coupler 102713 is in the desired position relative to the receiver, the width adjustment element is disconnected from the coupler 102713 such that the coupler 102713 moves to the normal, locking position. In some implementations, the connection between the width adjustment element and the body 102781 of the coupler 102713 allows the coupler 102713 to be moved to the normal, locking position prior to the width adjustment element being disconnected from the coupler 102713. That is, at least a portion of the removable connection between the coupler 102713 and the width adjustment element does not cause the coupler 102713 to be moved to the unlocked position (e.g., because the width adjustment element is not engaging the arms 102794, 102796 when the width adjustment element is still connected to the body 102781), which allows for a continued connection between the coupler 102713 and width adjustment element when the coupler 102713 is in the locking position. This is advantageous because it allows a user to confirm that the coupler 102713 is in a desired position before finally removing the width adjustment element from the coupler 102713.
The coupler 102713 can be made of any suitable material that allows for the arms 102794, 102796 to move between the normal position and the engaged position. In some implementations, the coupler 102713 is made from a shape memory material, —such as Nitinol—to provide shape-setting capability. For example, the coupler 102713 can be a laser cut, Nitinol hypotube that is shape set in the locking position (as shown in
Referring now to
In some implementations, the anchor portion 102806 includes a plurality of anchors 102808. The anchors 102808 can be configured in a variety of ways, such as, for example, any of the ways described in the present application. In the illustrated example, the anchor portion 102806 includes two anchors 102208 with each anchor 102808 having outer paddles 102820, inner paddles 102822, paddle frames 102824, and clasps 102830. The outer paddles 102820, inner paddles 102822, paddle frames 102824, and clasps 102830 can take any suitable form, such as, for example, any form described in the present application. In some implementations, the paddle frames 102824 can have inner frame portions 102872 (
The attachment portion 102805 and distal portion 102807 can take any suitable form, such as, for example, any form described in the present application. In the illustrated example, the attachment portion 102805 includes a first or proximal collar 102811 (or other attachment element) for engaging with a coupler of a delivery system. In the illustrated example, the distal portion 102807 includes a cap 102814 that is operatively connected to the anchor portion 102806 of the device 102800 such that movement of the cap 102814 relative to a spacer or coaptation element 102810 of the coaptation portion 102804 causes the anchors 102808 to move between open and closed positions.
The coaptation portion 102804 of the device can include a coaptation element 102810 (e.g., a spacer, coaption element, bushing, etc.) for implantation between leaflets of a native valve. The coaptation element 102810 can take any suitable form, such as, for example, the form shown in
The proximal end of the coaptation element 102810 has a proximal opening (not shown) that allows one or more actuation elements to move relative to the lumen of the coaptation element 102810. The proximal opening allows one or more actuation elements to engage one or more controllable components of the device or implant 102800. The distal end of the coaptation element 102810 can include a distal opening (not shown). An actuation element and/or one or more components that couple the cap 102814 to the actuation element can extend through the distal opening and attach to the cap 102814. In some implementations, an actuation element extends from the delivery system to engage and enable actuation of the device 102800 between the open and closed positions and/or a width adjustment member extends from the delivery system to adjust widths of the paddles. Movement of the cap 102814 away from the coaptation element 102810 can cause the anchors 102808 to move to the open position, and movement of the cap 102814 toward the coaptation element 102810 can cause the anchors 102808 to move to the closed position. The actuation element, the cap, and any components that couple the cap to the actuation element can be configured to removably engage the cap 102814 in any suitable manner that allows the actuation element to be disengaged and removed from the device 102800 after implantation, such as, for example, any manner described in the present application.
In some implementations, one or more width adjustment elements extend through the lumen of the coaptation element 102810 and engage the paddle frames 102824 to move the paddle frames 102824 between a narrowed position and an expanded position. For example, a connector 102866 (e.g., shaped metal component, shaped plastic component, tether, wire, strut, line, cord, suture, etc.) or other component that is coupled to the paddle frames 102824 can extend through an opening 102841 of the cap 102814 and into the lumen of the coaptation element 102810. The width adjustment element(s) can be configured to engage and move the connector 102866 or other component of the paddle frames 102824 relative to the cap 102814. In some implementations, movement of the connector 102866 or other component of the paddle frames 102824 in a distal direction relative to the cap 102814 can cause the paddle frames 102824 to move to an expanded position, and movement of the connector 102866 or other component of the paddle frames 102824 in a proximal direction relative to the cap 102814 can cause the paddle frames 102824 to move to a narrowed position. The paddle frames 102824 can be configured to move between the expanded and narrowed positions by any suitable means, such as, for example, any means described in the present application.
Referring to
The cover element 102850 can be positioned at a distal end of the device 102800 and cover the opening 102841 (
In the illustrated example, referring to
The cover element 102850 can be made of any suitable type of material that prevents or inhibits movement of blood. For example, the cover element 102850 can be made from a cloth material, such as flexible material, a porous material, and/or a material that is impermeable to blood flow. In some implementations, the cover element 102850 is made from a biocompatible material, such as a woven biocompatible fabric that is configured to promote tissue ingrowth.
Referring to
The cover 102951 can be attached to the paddle frame and configured to provide further engagement between the implantable device and the leaflets when implanted. The cover 102951 can include a sheet, material, fabric, layer, or membrane that is attached to the paddle frames of the implantable device by a plurality of connectors (e.g., stitches, adhesive, mechanical fasteners, ultrasonic welds, etc.). The sheet, material, fabric, layer, or membrane can be made of a flexible material, a porous material, and/or a material that is impermeable to blood flow. In some implementations, the sheet, material, fabric, layer, or membrane is made from a biocompatible material, such as a woven biocompatible fabric that is configured to promote tissue ingrowth. In implementations in which the implantable device has paddle frames having inner and outer paddle frame portions, it should be understood that the cover 102951 can be attached to one or both of the inner and outer paddle frame portions. The cover 102951 can be configured to cover or not cover any component or portion of the implantable device. The cover 102951 can be attached to and positioned relative to the inner and/or outer paddle frame portions in any way described in the present application.
The cover 102951 can have one or more stretchable portions 102953 allow the cover 102951 to maintain a substantially taut state when in a normal position, while also allowing the cover 102951 to stretch to an expanded state. This is advantageous for situations in which the cover 102951 is attached to paddle frames that are movable between narrowed and expanded positions. That is, the cover 102951 maintaining a taut state when in a normal position, and when paddle frames are in a narrowed position, reduces any excess material on the implantable device that can contact vasculature. The stretchability of the cover 102951 then allows the paddle frames to move to an expanded state with the cover 102951 maintaining a substantially taut state and maintaining a covering for the implantable device that prevents or inhibits regurgitation of blood by acting as a barrier that prevents or inhibits the movement of blood through the native valve. The stretchable portions 102953 can take a wide variety of different forms. Any material that can stretch and return to its original size or substantially to its original size can be used.
Referring to
Referring to
Referring to
Referring to
In some implementations, the floats 102971 can have a width W1 (
In some implementations, the cover 102951 is configured to maintain a substantially taut state when in a normal position, while also allowing the cover 102951 to stretch to an expanded state, but the cover 102951 does not include the discrete stretchable portions 102953. The cover 102951 can be configured to be stretchable and/or resilient in a variety of different ways. In some implementations, the cover 102951 is made to be stretchable by rotating the material of the cover such that the horizontal and vertical yarns of the weave are no longer horizontal and vertical before the cover is cut from the material. For example, the material that forms the cover can be rotated between 30 degrees and 60 degrees, such as between 40 and 50 degrees, such as about 45 degrees or 45 degrees. The rotation of the fabric that forms the material of the cover allows the cover to stretch as the paddle frames are moved between the narrow and wide configurations. It should be understood, however, that the cover 102951 can be configured to stretch in a wide variety of different ways.
Referring to
The cover 102951 is advantageous in preventing or inhibiting bunching or wrinkling as the paddle frames are moved from a wide configuration to a narrow configuration. For example, referring to
The implantable device or implant 103000 can include an optional coaptation portion, a proximal or attachment portion 103005, an anchor portion 103006, and a distal portion 103007. The coaptation portion, attachment portion 103005, and distal portion 103007 can take any suitable form, such as, for example, any form described in the present application. In some implementations, the coaptation portion optionally includes a coaptation element (e.g., a spacer, coaption element, gap filler, etc.) that can be used, for example, for implantation between the leaflets 20, 22 of the native mitral valve MV. The coaptation element, etc. can take any suitable form, such as, for example, any form described in the present application.
In some implementations, the attachment portion 103005 includes a first or proximal collar 103011 for engaging with a capture mechanism of a delivery system. The capture mechanism and the delivery system can take any suitable form, such as, for example, any form described in the present application. The delivery system can be the same as or similar to other delivery systems herein, e.g., 102, 402, 502, etc. and can comprise one or more of a catheter, a sheath, a guide catheter/sheath, a delivery catheter/sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations of these, etc. The proximal collar 103011 can take any suitable form, such as, for example, any form described in the present application.
In some implementations, the distal portion 103007 includes a cap 103014 that is attached to anchors 103008 of the anchor portion 103006 such that movement of the cap 103014 causes the anchors 103008 to move between open and closed positions. The cap 103014 can take any suitable form, such as, for example, any form described in the present application. In the illustrated example, an actuation element 103012 (e.g., the same as or similar to actuation element 112 shown in
The anchor portion 103006 can take any suitable form, such as, for example, the form of the anchor portion 206 of the device 200 shown in
In the illustrated example, the paddle frame 103024 has an optional inner frame portion 103072 and an outer frame portion 103074. The inner frame portion 103072 can be rigid such that it is configured to support the paddles 103020, 103022 and provide a sufficient force to leaflets of the native valve during capture. The inner frame portion 103072 can be made of, for example, metals, plastics, etc.
In some implementations, the outer frame portions 103074 can be connected to the optional inner frame portions 103072 such that the outer frame portions 103074 define the total width of the paddle frame 103024. The outer frame portions 103074 can be flexible such that the outer frame portions can optionally be manipulated by a user between an expanded position and a narrowed position. For example, the outer frame portions 103074 can be operatively connected to width adjustment element(s) 103090 by a connector 103096 of the implantable device. A user can engage the paddle frame 103024 by moving a portion of the connector 103096 into/out of the cap 103014 to move the outer frame portions 103074 between the expanded and narrowed positions. In the illustrated example, the outer frame portion 103074 has a pair of openings 103092 for connection to the connector 103096. The outer frame portions 103074 can be made of, for example, metals, and plastics.
In some implementations, the paddle frame 103024 can be configured to connect to the cap 103014 such that movement of the cap relative to other portions of the device 103000 (e.g., the coaptation element) causes the anchors 103008 to move between the open and closed positions. The paddle frame 103024 can be connected to the cap 103014 by any suitable means, such as, for example, any means described in the present application.
Referring to
Referring to
Referring to
Referring to
In the illustrated example, the inner and outer portions 103072, 103074 are substantially the same size when the paddle frame 103024 is in the fully narrowed position. As such, the proximal end of the device has narrowed more than the distal end of the device when the device moved from the second intermediate position to the full narrowed position. Said another way, the paddle frame 103024 changes shape in two different phases. In the first phase, starting at the widest width, the distal end of the device narrows more quickly than the proximal end of the paddle frame 103024. In a second phase, starting at an intermediate width, the proximal end of the paddle frame 103024 narrows more quickly than the distal end of the device.
In the illustrated example, the total width TW1 (
In some implementations, when the width adjustment element 103090 is halfway between the fully widened position and the fully narrowed position, the width TW2 can be substantially the same as the with TW1. In some implementations, when the width adjustment element 103090 is halfway between the fully widened position and the fully narrowed position, the width TW3 can be substantially the same as the with TW1.
Referring to
Referring to
Referring to
An implantable device 103000 capable of having a paddle frame 103024 with a wider proximal end 103095 is also advantageous for securing the implantable device 103000 to the native valve when the leaflets 20, 22 are not inserted deep within anchors 103008 of the implantable device 103000 as the anchors 103008 are moved from the opened position to the closed position. That is, the larger area of the proximal end 103095 of the paddle frame 103024 allows for the implantable device 103000 to engage a larger area of the leaflets 20, 22 even if the leaflets are not inserted deep within the implantable device 103000 during closing of the anchors 103008.
The implantable device or implant 103100 can include an optional coaptation portion (not shown), a proximal or attachment portion 103105, an anchor portion 103106, and a distal portion 103107. The coaptation portion, attachment portion 103105, and distal portion 103107 can take any suitable form, such as, for example, any form described in the present application. In some implementations, the coaptation portion optionally includes a coaptation element (e.g., a spacer, coaption element, gap filler, etc.) that can be used, for example, for implantation between the leaflets 20, 22 of the native mitral valve MV. When included, the coaptation element, etc. can take any suitable form, such as, for example, any form described in the present application.
In some implementations, the attachment portion 103105 can include a first or proximal collar for engaging with a capture mechanism of a delivery system. The capture mechanism and the delivery system can take any suitable form, such as, for example, any form described in the present application. The delivery system can be the same as or similar to other delivery systems herein, e.g., 102, 402, 502, etc. and can comprise one or more of a catheter, a sheath, a guide catheter/sheath, a delivery catheter/sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations of these, etc. The proximal collar can take any suitable form, such as, for example, any form described in the present application.
In some implementations, the distal portion 103107 includes a cap 103114 that is attached to anchors 103108 of the anchor portion 103106 such that movement of the cap 103114 causes the anchors 103108 to move between open and closed positions. The cap 103114 can take any suitable form, such as, for example, any form described in the present application. Referring to
The anchor portion 103106 can take any suitable form, such as, for example, the form of the anchor portion 206 of the device 200 shown in
In the illustrated example, the paddle frame 103124 has an optional inner frame portion 103172 and an outer frame portion 103174. The inner frame portion 103172 can be rigid such that it is configured to support the paddles and provide a sufficient force to leaflets of the native valve during capture. The inner frame portion 103172 can be made of, for example, metals, plastics, etc. The outer frame portions 103174 can be connected to the inner frame portions 103172 such that the outer frame portions 103174 define the total width of the paddle frame 103124. The outer frame portions 103174 can be flexible such that the outer frame portions can optionally be manipulated by a user between an expanded position and a narrowed position. For example, the outer frame portions 103174 can be operatively connected to the width adjustment element 103111 (e.g., any width adjustment element shown or described in the present application) such that a user can engage the paddle frame 103124 to move the outer frame portions 103174 between the expanded and narrowed positions. In the illustrated example, paddle frame 103124 includes a connector 103166 that is engaged by the width adjustment element 103111 such that the connector 103166 moves relative to (into/out of) the cap 103114. This movement of the connector 103166 relative to the cap 103114 causes the outer portion 103174 of the paddle frame 103124 to move between the narrowed and expanded positions. The outer frame portions 103074 can be made of, for example, metals, and plastics.
In some implementations, the paddle frame 103124 can be configured to connect to the cap 103114 such that movement of the cap relative to other portions of the device 103100 (e.g., the coaptation element) causes the anchors 103108 to move between the open and closed positions. The paddle frame 103124 can be connected to the cap 103114 by any suitable means, such as, for example, any means described in the present application.
Referring to
The distal end 103197 of the paddle frame 103124 can be maintained at any distal width between the distal widths DW1 and DW2 as the device is being implanted on a native valve of a patient. In certain implementations, the proximal width of the proximal end 103195 of the paddle frame 103124 is substantially constant as the paddle frame 103124 is moved between the fully expanded and fully narrowed positions. That is, PW1 (
In some implementations, the proximal widths PW1, PW2 for the fully wide configuration and the narrowest width configurations can be close to one another. For example, widths PW1, PW2 can be within 20% of one another, such as within 10% of one another, such as within 5% of one another.
In the illustrated example, the distal width DW1 (
Referring to
Referring to
Referring again to
Example 1. An implantable device, comprising: (i) an anchor portion comprising a first anchor and a second anchor, each of the first and second anchors comprising a paddle frame that includes an inner frame portion and an outer frame portion, wherein the first and second anchors are configured to be moved to a closed position in which the inner frame portion of each of the first and second anchors compress native valve leaflets between an inner pinch point and the outer frame portion of each of the first and second anchors compress the leaflets between an outer pinch point such that the implantable device is secured to the native valve leaflets; and (ii) a cover attached to at least one of the inner frame portion and the outer frame portion of the first and second anchors such that a compressive force can be applied against the leaflets in an area between the inner and outer pinch points when the implantable device is secured to the native valve leaflets.
Example 2. The implantable device according to example 1, wherein the inner frame portion is rigid, and the outer frame portion is flexible.
Example 3. The implantable device according to any one of examples 1-2, wherein the outer frame portion is movable between a narrowed position and an expanded position.
Example 4. The implantable device according to any one of examples 1-3, wherein the cover is connected to the paddle frame by one or more stitches.
Example 5. The implantable device according to any one of examples 1-4, wherein the cover extends across an inner surface of the paddle frame.
Example 6. The implantable device according to any one of examples 1-5, wherein the cover extends across an outer surface of the paddle frame.
Example 7. The implantable device according to any one of examples 1-6, wherein the cover is attached to both the inner frame portion and the outer frame portion.
Example 8. The implantable device according to any one of examples 1-7, wherein the cover is made of a flexible material.
Example 9. The implantable device according to example 8, wherein the outer frame portion is movable between a narrowed position and an expanded position, wherein the cover is configured to be in a taut state when the paddle frame is in the narrowed position, and wherein the cover is configured to stretch when the paddle frame is in the expanded position.
Example 10. The implantable device according to example 8, wherein the inner frame portion is rigid and the outer frame portion is flexible, wherein the outer frame portion is configured to be moved between a narrowed position and an expanded position, and wherein the cover is attached to both the inner frame portion and the outer frame portion such that the cover is in a taut state when the outer frame portion is in the narrowed position and the cover stretches when the outer frame portion is moved to the expanded position.
Example 11. The implantable device according to any one of examples 1-10, wherein the cover is positioned between at least a portion of an area defined by an interior surface of the inner frame portion.
Example 12. The implantable device according to any one of examples 1-11, wherein the cover extends across an entirety of an area defined by an interior surface of the inner frame portion.
Example 13. The implantable device according to any one of examples 1-12, wherein the cover encapsulates at least a portion of an outer paddle of each of the first and second anchors.
Example 14. The implantable device according to any one of examples 1-13, wherein the cover encapsulates an entirety of an outer paddle of each of the first and second anchors.
Example 15. The implantable device according to any one of examples 1-14, wherein the cover comprises a first membrane that attaches to the paddle frame of the first anchor and a second membrane that attaches to the paddle frame of the second anchor.
Example 16. The implantable device according to example 15, wherein the first and second membranes are not connected such that a gap exists between bottom edges of the first membrane and the second membrane.
Example 17. The implantable device according to any one of examples 1-16, wherein the cover comprises a single membrane that attaches to the paddle frame of both of the first and second anchors.
Example 18. The implantable device according to example 17, wherein the single membrane creates a canopy that extends between the first and second anchors.
Example 19. The implantable device according to any one of examples 1-18, wherein the cover is made of a porous material.
Example 20. The implantable device according to any one of examples 1-19, wherein the cover is made of a material that is impermeable to blood flow.
Example 21. An implantable device, comprising: (i) an anchor portion comprising a first anchor and a second anchor, each of the first and second anchors comprising a paddle frame that includes an inner frame portion and an outer frame portion, wherein the outer frame portion is configured to be moved between a narrowed position and expanded position, wherein the first and second anchors are configured to be moved to a closed position in which the inner frame portion of each of the first and second anchors compress the leaflets between an inner pinch point and the outer frame portion of each of the first and second anchors compress the leaflets between an outer pinch point such that the implantable device is secured to the native valve; and (ii) a flexible cover attached to the inner frame portion and the outer frame portion of the first and second anchors such that the cover can apply a compressive force against the leaflets in an area between the inner and outer pinch points when the implantable device is secured to the native valve, wherein the cover is configured to be in a taut state when the outer frame portion is in the narrowed position, and wherein the cover is configured to stretch when the outer frame portion is in the expanded position.
Example 22. The implantable device according to example 21, wherein the inner frame portion is rigid, and the outer frame portion is flexible.
Example 23. The implantable device according to any one of examples 21-22, wherein the cover is connected to the paddle frame by one or more stitches.
Example 24. The implantable device according to any one of examples 21-23, wherein the cover extends across an inner surface of the paddle frame.
Example 25. The implantable device according to any one of examples 21-24, wherein the cover extends across an outer surface of the paddle frame.
Example 26. The implantable device according to any one of examples 21-25, wherein the cover is positioned between at least a portion of an area defined by an interior surface of the inner frame portion.
Example 27. The implantable device according to any one of examples 21-26, wherein the cover extends across an entirety of an area defined by an interior surface of the inner frame portion.
Example 28. The implantable device according to any one of examples 21-27, wherein the cover encapsulates at least a portion of an outer paddle of each of the first and second anchors.
Example 29. The implantable device according to any one of examples 21-28, wherein the cover encapsulates an entirety of an outer paddle of each of the first and second anchors.
Example 30. The implantable device according to any one of examples 21-29, wherein the cover comprises a first membrane that attaches to the paddle frame of the first anchor and a second membrane that attaches to the paddle frame of the second anchor.
Example 31. The implantable device according to example 30, wherein the first and second membranes are not connected such that a gap exists between bottom edges of the first membrane and the second membrane.
Example 32. The implantable device according to any one of examples 21-31, wherein the cover comprises a single membrane that attaches to the paddle frame of both of the first and second anchors.
Example 33. The implantable device according to example 32, wherein the single membrane creates a canopy that extends between the first and second anchors.
Example 34. The implantable device according to any one of examples 21-33, wherein the cover is made of a porous material.
Example 35. The implantable device according to any one of examples 21-34, wherein the cover is made of a material that is impermeable to blood flow.
Example 36. An implantable device, comprising: (i) an anchor portion comprising a first anchor and a second anchor, each of the first and second anchors comprising a paddle frame that includes an inner frame portion and an outer frame portion, wherein the first and second anchors are configured to be moved to a closed position in which the inner frame portion of each of the first and second anchors compress the leaflets between an inner pinch point and the outer frame portion of each of the first and second anchors compress the leaflets between an outer pinch point such that the implantable device is secured to the native valve; and (ii) a cover attached to the inner frame portion and the outer frame portion of the first and second anchors, wherein the cover extends between the first anchor and the second anchor.
Example 37. The implantable device according to example 36, wherein the inner frame portion is rigid, and the outer frame portion is flexible.
Example 38. The implantable device according to any one of examples 36-37, wherein the cover is connected to the paddle frame by one or more stitches.
Example 39. The implantable device according to any one of examples 36-38, wherein the cover extends across an inner surface of the paddle frame.
Example 40. The implantable device according to any one of examples 36-39, wherein the cover extends across an outer surface of the paddle frame.
Example 41. The implantable device according to any one of examples 36-40, wherein the cover is positioned between at least a portion of an area defined by an interior surface of the inner frame portion.
Example 42. The implantable device according to any one of examples 36-41, wherein the cover extends across an entirety of an area defined by an interior surface of the inner frame portion.
Example 43. The implantable device according to any one of examples 36-42, wherein the cover encapsulates at least a portion of an outer paddle of each of the first and second anchors.
Example 44. The implantable device according to any one of examples 36-43, wherein the cover encapsulates an entirety of an outer paddle of each of the first and second anchors.
Example 45. The implantable device according to any one of examples 36-44, wherein the cover comprises a first membrane that attaches to the paddle frame of the first anchor and a second membrane that attaches to the paddle frame of the second anchor.
Example 46. The implantable device according to example 30, wherein the first and second membranes are connected such together to block blood flow between the first and second anchors.
Example 47. The implantable device according to any one of examples 21-31, wherein the cover comprises a single membrane that attaches to the paddle frames of both of the first and second anchors.
Example 48. The implantable device according to example 32, wherein the single membrane creates a canopy that extends between the first and second anchors.
Example 49. The implantable device according to any one of examples 21-33, wherein the cover is made of a porous material that becomes impermeable to blood flow over time.
Example 50. The implantable device according to any one of examples 21-34, wherein the cover is made of a material that is impermeable to blood flow.
Example 51. An implantable device comprising: (i) a coaptation element that defines a first area when viewed from above; (ii) one or more anchors coupled to the coaptation element, the anchors being movable between an open position and a closed position and configured to attach to one or more leaflets of a native heart valve, each of the anchors comprising a paddle frame, wherein the paddle frame defines an outer portion of the implantable device when viewed from above and the anchors are in the closed position, wherein the outer portion of the device has a second area when viewed from above, wherein a ratio of the second area to the first area is greater than or equal to 2 to 1.
Example 52. The implantable device according to example 51, wherein the ratio of the second area to the first area is greater than or equal to 3 to 1.
Example 53. The implantable device according to example 51, wherein the ratio of the second area to the first area is greater than or equal to 4 to 1.
Example 54. The implantable device according to example 51, wherein the ratio of the second area to the first area is greater than or equal to 5 to 1.
Example 55. The implantable device according to example 51, wherein the ratio of the second area to the first area is greater than or equal to 6 to 1.
Example 56. The implantable device according to any one of examples 51-55, wherein the coaptation element comprises one or more planar side surfaces.
Example 57. The implantable device according to any one of examples 51-56, wherein the coaptation element comprises one or more tapered side surfaces.
Example 58. The implantable device according to any one of examples 51-57, wherein the coaptation element comprises a first portion that is rectangular and a second portion that is rounded.
Example 59. The implantable device according to any one of examples 51-58, wherein the coaptation element is injection molded.
Example 60. The implantable device according to any one of examples 51-59, wherein the coaptation element comprises a polymer material.
Example 61. The implantable device according to any one of examples 51-60, further comprising an attachment portion having a collar that is configured to attach to a delivery device.
Example 62. The implantable device according to example 61, wherein the collar of the attachment portion is integral to the coaptation element.
Example 63. The implantable device according to any one of examples 51-62, wherein the coaptation element comprises one or more attachment openings for aligning with one or more openings of a component of the anchors such that the component of the anchors can be attached to the coaptation element.
Example 64. The implantable device according to any one of examples 51-63, wherein the anchors further comprise an inner paddle and an outer paddle.
Example 65. The implantable device according to any one of examples 51-64, wherein the anchors further comprise a clasp.
Example 66. The implantable device according to any one of examples 51-65, wherein the paddle frame of the each of the anchors comprises an inner paddle frame and an outer paddle frame.
Example 67. The implantable device according to example 66, wherein the outer paddle frame defines the outer portion of the implantable device when viewed from above and the anchors are in the closed position.
Example 68. The implantable device according to any one of examples 51-67, wherein the coaptation element has a length of between about 10 mm and about 40 mm.
Example 69. The implantable device according to any one of examples 51-68, wherein the coaptation element has a width of between about 3 mm and about 10 mm.
Example 70. The implantable device according to any one of examples 51-69, further comprising a distal portion having a cap.
Example 71. The implantable device according to example 70, wherein the cap is operative connected to the anchors such that movement of the cap away from the coaptation element causes the anchors to move to the opened position and movement of the cap toward the coaptation element causes the anchors to move to the closed position.
Example 72. The implantable device according to any one of examples 51-71, further comprising a flexible cover attached to the paddle frame.
Example 73. The implantable device according to example 72, wherein the cover creates a canopy that extends between the first and second anchors.
Example 74. The implantable device according to any one of examples 51-73, wherein the cover comprises a single piece of material.
Example 75. The implantable device according to any one of examples 51-74, wherein the cover comprises a multiple pieces of material.
Example 76. The implantable device according to any one of examples 51-75, wherein the cover is made of a porous material that becomes impermeable to blood flow over time.
Example 77. The implantable device according to any one of examples 51-75, wherein the cover is made of a material that is impermeable to blood flow.
Example 78. A valve repair system for repairing a native valve of a patient, the valve repair system comprising: (A) a delivery device having a width adjustment element that includes an external threaded portion; (B) an implantable device configured to be implanted on the native valve of the patient, the implantable device having: (i) an anchor portion having one or more anchors, each of the anchors having a paddle frame that includes an inner end, wherein the one or more anchors are configured to attach to one or more leaflets of a native valve; (ii) a coupler for removably connecting the width adjustment element of the delivery device to the inner end of the anchors; wherein the coupler comprises one or more attachment projections that extend inward from a body of the coupler; wherein the attachment projections are configured to removably attach to the external threaded portion of the width adjustment element; and wherein the width adjustment element is configured to move the paddle frame between a narrowed position and an expanded position.
Example 79. The valve repair system according to example 78, wherein the one or more attachment projections includes a first attachment projection and a second attachment projection.
Example 80. The valve repair system according to example 79, wherein the first attachment projection is offset from the second attachment projection along a height of the body of the coupler.
Example 81. The valve repair system according to any one of examples 78-80, wherein the coupler comprises at least two arms that are movable between a normal position and an engaged position, wherein the arms are in the normal position when the coupler is disconnected from the implantable device, and wherein the arms are in the engaged position when the coupler is connected to the width adjustment element.
Example 82. The valve repair system according to example 81, wherein the arms are configured to attach to internal threads when the arms are in the normal position.
Example 83. The valve repair system according to example 81, wherein the arms comprise one or more tabs that are configured to be inserted into one or more slots of the body of the coupler when the arms are in the normal position.
Example 84. The valve repair system according to example 81, wherein the arms are configured to allow the coupler to move within a lumen of a receiver when in the engaged position.
Example 85. The valve repair system according to any one of examples 78-84 wherein a coaptation element defines a first area when viewed from above, wherein the paddle frames of the anchors define an outer portion of the implantable device when viewed from above and the anchors are in the closed position, wherein the outer portion of the device has a second area when viewed from above, and wherein a ratio of the second area to the first area is greater than or equal to about 2 to 1.
Example 86. The valve repair system according to example 85, wherein the ratio of the second area to the first area is greater than or equal to 3 to 1.
Example 87. The valve repair system according to example 85, wherein the ratio of the second area to the first area is greater than or equal to 4 to 1.
Example 88. The valve repair system according to example 85, wherein the ratio of the second area to the first area is greater than or equal to 5 to 1.
Example 89. The valve repair system according to example 85, wherein the ratio of the second area to the first area is greater than or equal to 6 to 1.
Example 90. The valve repair system according to any one of examples 85-89, wherein the coaptation element comprises one or more planar side surfaces.
Example 91. The valve repair system according to any one of examples 85-90, wherein the coaptation element comprises one or more tapered side surfaces.
Example 92. The valve repair system according to any one of examples 85-91, wherein the coaptation element comprises a first portion that is rectangular and a second portion that is rounded.
Example 93. The valve repair system according to any one of examples 85-92, wherein the coaptation element is injection molded.
Example 94. The valve repair system according to any one of examples 85-93, wherein the coaptation element comprises a polymer material.
Example 95. The valve repair system according to any one of examples 85-94, wherein the coaptation element has a length of between about 10 mm and about 40 mm.
Example 96. The valve repair system according to any one of examples 85-95, wherein the coaptation element has a width of between about 3 and about 10 mm.
Example 97. The valve repair system according to any one of examples 78-96, further comprising a distal portion having a cap.
Example 98. The valve repair system according to example 97, wherein the cap is operative connected to the anchors such that movement of the cap away from a coaptation element causes the anchors to move to an opened position and movement of the cap toward the coaptation element causes the anchors to move to a closed position.
Example 99. The valve repair system according to any one of examples 78-98, further comprising a flexible cover attached to the paddle frame.
Example 100. The valve repair system according to example 99, wherein the cover creates a canopy that extends between first and second anchors of the one or more anchors.
Example 101. The valve repair system according to any one of examples 99-100, wherein the cover comprises a single piece of material.
Example 102. The valve repair system according to any one of examples 99-100, wherein the cover comprises multiple pieces of material.
Example 103. The valve repair system according to any one of examples 99-102, wherein the cover is made of a porous material that becomes impermeable to blood flow over time.
Example 104. The valve repair system according to any one of examples 99-102, wherein the cover is made of a material that is impermeable to blood flow.
Example 105. The valve repair system according to any one of examples 78-104, wherein the paddle frame comprises a connector that connects the width adjustment element to the paddle frames.
Example 106. A valve repair system for repairing a native valve of a patient, the valve repair system comprising: (A) a delivery device having a width adjustment element; (B) an implantable device configured to be implanted on the native valve of the patient, the implantable device having: (i) a receiver defining a lumen that includes internal threads; (ii) an anchor portion having one or more anchors, each of the anchors having a paddle frame, wherein the one or more anchors are configured to attach to one or more leaflets of a native valve; and (iii) a coupler for removably connecting the width adjustment element of the delivery device to an inner end of the anchors, wherein the coupler comprises at least two arms that are movable between a normal position and an engaged position, wherein the arms are in the normal position when the coupler is disconnected from the width adjustment element, and wherein the arms are in the engaged position when the coupler is connected to the width adjustment element, wherein the arms are configured to attach to internal threads of the lumen of the receiver when the arms are in the normal position.
Example 107. The valve repair system according to example 106, wherein the arms comprise one or more tabs that are configured to be inserted into one or more slots of the body of the coupler when the arms are in the normal position.
Example 108. The valve repair system according to example 106, wherein the arms are configured to allow the coupler to move within the lumen of the receiver when in the engaged position.
Example 109. The valve repair system according to any of examples 106-108, wherein a first arm of the at least two arms is offset from a second arm along a height of a body of the coupler.
Example 110. The valve repair system according to any of examples 106-109, wherein a first portion of each arm extends into a lumen of the coupler when the arms are in the normal position, and wherein a second portion of each arm extends away from an exterior of a body of the coupler when the arms are in the normal position.
Example 111. The valve repair system according to any of examples 106-110, wherein the arms extend away from an exterior surface of a body of the coupler by between about 20 degrees and about 45 degrees when the arms are in the normal position.
Example 112. The valve repair system according to any of examples 106-111, wherein the coupler further comprises one or more attachment projections that extend inward from a body of the coupler to removably attach to external threads of the width adjustment element by a threaded connection.
Example 113. The valve repair system according to example 112, wherein the one or more attachment projections includes a first attachment projection and a second attachment projection.
Example 114. The valve repair system according to example 113, wherein the first attachment projection is offset from the second attachment projection along a height of a body of the coupler.
Example 115. The valve repair system according to any one of examples 106-114, wherein a coaptation element defines a first area when viewed from above, wherein the paddle frames of the anchors define an outer portion of the implantable device when viewed from above and the anchors are in the closed position, wherein the outer portion of the device has a second area when viewed from above, and wherein a ratio of the second area to the first area is greater than or equal to about 2 to 1.
Example 116. The valve repair system according to example 115, wherein the ratio of the second area to the first area is greater than or equal to 3 to 1.
Example 117. The valve repair system according to example 115, wherein the ratio of the second area to the first area is greater than or equal to 4 to 1.
Example 118. The valve repair system according to example 115, wherein the ratio of the second area to the first area is greater than or equal to 5 to 1.
Example 119. The valve repair system according to example 115, wherein the ratio of the second area to the first area is greater than or equal to 6 to 1.
Example 120. The valve repair system according to any one of examples 115-119, wherein the coaptation element comprises one or more planar side surfaces.
Example 121. The valve repair system according to any one of examples 115-120, wherein the coaptation element comprises one or more tapered side surfaces.
Example 122. The valve repair system according to any one of examples 115-121, wherein the coaptation element comprises a first portion that is rectangular and a second portion that is rounded.
Example 123. The valve repair system according to any one of examples 115-122, wherein the coaptation element is injection molded.
Example 124. The valve repair system according to any one of examples 115-123, wherein the coaptation element comprises a polymer material.
Example 125. The valve repair system according to any one of examples 115-124, wherein the coaptation element has a length of between about 10 mm and about 40 mm.
Example 126. The valve repair system according to any one of examples 115-125, wherein the coaptation element has a width of between about 3 mm and about 10 mm.
Example 127. The valve repair system according to any one of examples 106-126, further comprising a distal portion having a cap.
Example 128. The valve repair system according to example 127, wherein the cap is operative connected to the anchors such that movement of the cap away from a coaptation element causes the anchors to move to an opened position and movement of the cap toward the coaptation element causes the anchors to move to a closed position.
Example 129. The valve repair system according to any one of examples 106-128, further comprising a flexible cover attached to the paddle frame.
Example 130: The valve repair system according to example 129, wherein the flexible cover includes a plurality of discreet flexible portions.
Example 131. The valve repair system according to example 129, wherein the cover creates a canopy that extends between first and second anchors of the one or more anchors.
Example 132. The valve repair system according to example 131, wherein the cover comprises a single piece of material.
Example 133. The valve repair system according to any one of examples 131-132, wherein the cover comprises multiple pieces of material.
Example 134. The valve repair system according to any one of examples 131-133, wherein the cover is made of a porous material that becomes impermeable to blood flow over time.
Example 135. The valve repair system according to any one of examples 131-133, wherein the cover is made of a material that is impermeable to blood flow.
Example 136. The valve repair system according to any one of examples 106-135, wherein a connector is connected to the paddle frames and the connector includes the inner end.
Example 137. A valve repair system for repairing a native valve of a patient, the valve repair system comprising: (A) a delivery device having a width adjustment element; (B) an implantable device configured to be implanted on the native valve of the patient, the implantable device having: (i) a receiver defining a lumen that includes internal threads and an unattachable portion; (ii) an anchor portion having one or more anchors, each of the anchors having a paddle frame, wherein the one or more anchors are configured to attach to one or more leaflets of a native valve; and (iii) a coupler for removably connecting the width adjustment element of the delivery device to an inner end of the anchors, wherein the coupler is configured to be removably coupled to the internal threads of the receiver to secure the inner end of the anchors in a desired position relative to the receiver, wherein the unattachable portion of the receiver prevents the coupler from connecting to the receiver when the coupler is disposed within the unattachable portion.
Example 138. The valve repair system according to example 137, wherein the unattachable portion comprises a non-threaded portion.
Example 139. The valve repair system according to example 138, wherein the unattachable portion comprises a window that extends through the receiver.
Example 140. The valve repair system according to any of examples 137-139, wherein the coupler is movable within the unattachable portion.
Example 141. The valve repair system according to any of examples 137-140, wherein the coupler is movable within the unattachable portion when arms of the coupler are extended.
Example 142. The valve repair system according to any of examples 137-141, wherein the coupler comprises at least two arms that are movable between a normal position and an engaged position, wherein the arms are in the normal position when the coupler is disconnected from the width adjustment element, and wherein the arms are in the engaged position when the coupler is connected to the width adjustment element, wherein the arms are configured to attach to internal threads of the lumen of the receiver when the arms are in the normal position.
Example 143. The valve repair system according to example 142, wherein the arms comprise one or more tabs that are configured to be inserted into one or more slots of the body of the coupler when the arms are in the normal position.
Example 144. The valve repair system according to example 142, wherein the arms are configured to allow the coupler to move within the lumen of the receiver when in the engaged position.
Example 145. The valve repair system according to any of examples 142-144, wherein a first arm of the at least two arms is offset from a second arm along a height of a body of the coupler.
Example 146. The valve repair system according to any of examples 142-145, wherein a first portion of each arm extends into a lumen of the coupler when the arms are in the normal position, and wherein a second portion of each arm extends away from an exterior of a body of the coupler when the arms are in the normal position.
Example 147. The valve repair system according to any of examples 142-146, wherein the arms extend away from an exterior surface of a body of the coupler by between about 20 degrees and about 45 degrees when the arms are in the normal position.
Example 148. The valve repair system according to any of examples 142-147, wherein the coupler further comprises one or more attachment projections that extend inward from a body of the coupler to removably attach to external threads of the width adjustment element by a threaded connection.
Example 149. The valve repair system according to example 148, wherein the one or more attachment projections includes a first attachment projection and a second attachment projection.
Example 150. The valve repair system according to example 149, wherein the first attachment projection is offset from the second attachment projection along a height of a body of the coupler.
Example 151. The valve repair system according to example 142, wherein each of the arms comprise a central portion, a first connection member that connects the central portion to a proximal end of the coupler, and a second connection member that connects the central portion to a distal end of the coupler.
Example 152. The valve repair system according to example 151, wherein each of the arms has a “t” shape.
Example 153. The valve repair system according to any of examples 151-152, wherein the first and second connection members are normally in torsion such that a first portion of the central portion is disposed within a lumen of the coupler and a second portion of the central portion extends away from a body of the coupler when the coupler is in the normal position.
Example 154. The valve repair system according to any of examples 151-153, wherein the central portion of each of the arms is substantially aligned with a body of the coupler when the coupler is in the engaged position.
Example 155. The valve repair system according to any of examples 137-141, wherein the coupler comprises an upper body, a lower body, and a plurality of struts connected to the upper and lower bodies.
Example 156. The valve repair system according to example 155, wherein the coupler is movable between a first position in which the plurality of struts is in a straight configuration and a second position in which the plurality of struts are in a spiraled configuration.
Example 157. The valve repair system according to example 156, wherein a first width of the coupler when the coupler is in the first position is less than a second width of the coupler when the coupler is in the second position.
Example 158. The valve repair system according to any of examples 156-157, wherein the coupler is configured to attach to the receiver when the plurality of struts are in the spiraled configuration.
Example 159. The valve repair system according to any of examples 156-158, wherein the coupler is configured to move within the lumen of the receiver when the plurality of struts are in the straight configuration.
Example 160. The valve repair system according to any of examples 156-159, wherein the coupler is in an expanded configuration when in the first position and a compressed configuration when in the second position.
Example 161. The valve repair system according to example 160, wherein the coupler is normally in the compressed configuration.
Example 162. The valve repair system according to any of examples 155-161, wherein the coupler comprises four struts.
Example 163. The valve repair system according to any of examples 155-162, wherein the upper body comprises an upper opening for receiving the width adjustment element of the delivery device.
Example 164. The valve repair system according to any of examples 155-163, wherein the lower body comprises a lower opening for receiving the inner end of the paddle frame.
Example 165. The valve repair system according to example 164, wherein the lower opening of the lower body is further configured to receive the width adjustment element.
Example 166. The valve repair system according to any one of examples 137-165, wherein a coaptation element defines a first area when viewed from above, wherein the paddle frames of the anchors define an outer portion of the implantable device when viewed from above and the anchors are in the closed position, wherein the outer portion of the device has a second area when viewed from above, and wherein a ratio of the second area to the first area is greater than or equal to about 2 to 1.
Example 167. The valve repair system according to example 166, wherein the ratio of the second area to the first area is greater than or equal to 3 to 1.
Example 168. The valve repair system according to example 166, wherein the ratio of the second area to the first area is greater than or equal to 4 to 1.
Example 169. The valve repair system according to example 166, wherein the ratio of the second area to the first area is greater than or equal to 5 to 1.
Example 170. The valve repair system according to example 166, wherein the ratio of the second area to the first area is greater than or equal to 6 to 1.
Example 171. The valve repair system according to any one of examples 166-170, wherein the coaptation element comprises one or more planar side surfaces.
Example 172. The valve repair system according to any one of examples 166-171, wherein the coaptation element comprises one or more tapered side surfaces.
Example 173. The valve repair system according to any one of examples 166-172, wherein the coaptation element comprises a first portion that is rectangular and a second portion that is rounded.
Example 174. The valve repair system according to any one of examples 166-173, wherein the coaptation element is injection molded.
Example 175. The valve repair system according to any one of examples 166-174, wherein the coaptation element comprises a polymer material.
Example 176. The valve repair system according to any one of examples 166-175, wherein the coaptation element has a length of between about 10 mm and about 40 mm.
Example 177. The valve repair system according to any one of examples 166-176, wherein the coaptation element has a width of between about 3 mm and about 10 mm.
Example 178. The valve repair system according to any one of examples 137-177, further comprising a distal portion having a cap.
Example 179. The valve repair system according to example 178, wherein the cap is operative connected to the anchors such that movement of the cap away from a coaptation element causes the anchors to move to an opened position and movement of the cap toward the coaptation element causes the anchors to move to a closed position.
Example 180. The valve repair system according to any off examples 178-179, wherein the cap has a distal opening that allows at least a portion of the paddle frame of each anchor to move in and out of the implantable device.
Example 181. The valve repair system according to example 180, wherein the implantable device further comprises a distal cover element that is positioned to inhibits blood from moving through the distal opening of the cap and into an interior of the implantable device.
Example 182. The valve repair system according to any one of examples 137-181, further comprising a cover attached to the paddle frame.
Example 183. The valve repair system according to example 182, wherein the cover creates a canopy that extends between first and second anchors of the one or more anchors.
Example 184. The valve repair system according to any of examples 182-183, wherein the cover comprises a single piece of material.
Example 185. The valve repair system according to any one of examples 182-183, wherein the cover comprises multiple pieces of material.
Example 186. The valve repair system according to any one of examples 182-185, wherein the cover is made of a porous material that becomes impermeable to blood flow over time.
Example 187. The valve repair system according to any one of examples 182-185, wherein the cover is made of a material that is impermeable to blood flow.
Example 188. The valve repair system according to any one of examples 182-187, wherein the cover comprises one or more stretchable portions.
Example 189. The valve repair system according to example 188, wherein the stretchable portions comprise a pair of Leno weaves with a float positioned therebetween.
Example 190. The valve repair system according to any one of examples 137-189, wherein the paddle frame comprises a connector that includes the inner end.
Example 191. A valve repair system for repairing a native valve of a patient, the valve repair system comprising: (A) a delivery device having a width adjustment element; (B) an implantable device configured to be implanted on the native valve of the patient, the implantable device having: (i) a receiver defining a lumen that includes internal threads; (ii) an anchor portion having one or more anchors, each of the anchors having a paddle frame, wherein the one or more anchors are configured to attach to one or more leaflets of a native valve; and (iii) a coupler for removably connecting the width adjustment element of the delivery device to an inner end of the anchors, wherein the coupler comprises an upper body, a lower body, and a plurality of struts connected to the upper and lower bodies, wherein the coupler is movable between an unlocked position in which the plurality of struts are positioned to be disengaged from the internal threads of the receiver and a locking position in which the plurality of struts are positioned to engage with the internal threads of the receiver.
Example 192. The valve repair system according to example 191, wherein a first width of the coupler when the coupler is in the locked position is less than a second width of the coupler when the coupler is in the locking position.
Example 193. The valve repair system according to any of examples 191-192, wherein the coupler is configured to move within the lumen of the receiver when the plurality of struts are disengaged with the internal threads of the receiver.
Example 194. The valve repair system according to any of examples 191-193, wherein the coupler is in an expanded configuration when in the unlocked position and a compressed configuration when in the locking position.
Example 195. The valve repair system according to example 194, wherein the coupler is normally in the compressed configuration.
Example 196. The valve repair system according to any of examples 191-195, wherein the coupler comprises four struts.
Example 197. The valve repair system according to any of examples 191-196, wherein the upper body comprises an upper opening for receiving the width adjustment element of the delivery device.
Example 198. The valve repair system according to any of examples 191-197, wherein the lower body comprises a lower opening for receiving the inner end of the paddle frame.
Example 199. The valve repair system according to example 198, wherein the lower opening of the lower body is further configured to receive the width adjustment element.
Example 200. The valve repair system according to any of examples 191-199, wherein the coupler is movable from the locking position to the unlocked position by removably connecting the width adjustment element of the delivery device to both of the upper and lower bodies of the coupler.
Example 201. The valve repair system according to example 200, wherein the width adjustment element is removably connected to the upper and lower bodies of the coupler by a threaded connection.
Example 202. The valve repair system according to any of examples 191-201, wherein the plurality of struts are spiraled in a counter-clockwise direction when the coupler is in the locking position.
Example 203. The valve repair system according to any of examples 191-201, wherein the plurality of struts are spiraled in a clockwise direction when the coupler is in the locking position.
Example 204. The valve repair system according to any one of examples 191-203, wherein a coaptation element defines a first area when viewed from above, wherein the paddle frames of the anchors define an outer portion of the implantable device when viewed from above and the anchors are in the closed position, wherein the outer portion of the device has a second area when viewed from above, and wherein a ratio of the second area to the first area is greater than or equal to about 2 to 1.
Example 205. The valve repair system according to example 204, wherein the ratio of the second area to the first area is greater than or equal to 3 to 1.
Example 206. The valve repair system according to example 204, wherein the ratio of the second area to the first area is greater than or equal to 4 to 1.
Example 207. The valve repair system according to example 204, wherein the ratio of the second area to the first area is greater than or equal to 5 to 1.
Example 208. The valve repair system according to example 204, wherein the ratio of the second area to the first area is greater than or equal to 6 to 1.
Example 209. The valve repair system according to any one of examples 204-208, wherein the coaptation element comprises one or more planar side surfaces.
Example 210. The valve repair system according to any one of examples 204-209, wherein the coaptation element comprises one or more tapered side surfaces.
Example 2114. The valve repair system according to any one of examples 204-210, wherein the coaptation element comprises a first portion that is rectangular and a second portion that is rounded.
Example 212. The valve repair system according to any one of examples 204-211, wherein the coaptation element is injection molded.
Example 213. The valve repair system according to any one of examples 204-212, wherein the coaptation element comprises a polymer material.
Example 214. The valve repair system according to any one of examples 204-213, wherein the coaptation element has a length of between about 10 mm and about 40 mm.
Example 215. The valve repair system according to any one of examples 204-214, wherein the coaptation element has a width of between about 3 mm and about 10 mm.
Example 216. The valve repair system according to any one of examples 191-215, further comprising a distal portion having a cap.
Example 217. The valve repair system according to example 216, wherein the cap is operatively connected to the anchors such that movement of the cap away from a coaptation element causes the anchors to move to an opened position and movement of the cap toward the coaptation element causes the anchors to move to a closed position.
Example 218. The valve repair system according to any of examples 216-217, wherein the cap has a distal opening that allows at least a portion of the paddle frame of each anchor to move in and out of the implantable device.
Example 219. The valve repair system according to example 218, wherein the implantable device further comprises a distal cover element that is positioned to inhibit blood from moving through the distal opening of the cap and into an interior of the implantable device.
Example 220. The valve repair system according to any one of examples 191-219, further comprising a cover attached to the paddle frame.
Example 221. The valve repair system according to example 220, wherein the cover creates a canopy that extends between first and second anchors of the one or more anchors.
Example 222. The valve repair system according to any of examples 220-221, wherein the cover comprises a single piece of material.
Example 223. The valve repair system according to any one of examples 220-221, wherein the cover comprises multiple pieces of material.
Example 224. The valve repair system according to any one of examples 220-223, wherein the cover is made of a porous material that becomes impermeable to blood flow over time.
Example 225. The valve repair system according to any one of examples 220-223, wherein the cover is made of a material that is impermeable to blood flow.
Example 226. The valve repair system according to any one of examples 220-225, wherein the cover comprises one or more stretchable portions.
Example 227. The valve repair system according to example 226, wherein the stretchable portions comprise a pair of Leno weaves with a float positioned therebetween.
Example 228. The valve repair system according to any one of examples 189-227, wherein the paddle frame comprises a connector that includes the inner end.
Example 229. A valve repair system for repairing a native valve of a patient, the valve repair system comprising: (A) a delivery device having a width adjustment element; (B) an implantable device configured to be implanted on the native valve of the patient, the implantable device having: (i) a receiver defining a lumen that includes internal threads; (ii) an anchor portion having one or more anchors, each of the anchors having a paddle frame that includes an inner end, wherein the one or more anchors are configured to attach to one or more leaflets of a native valve; and (iii) a coupler for removably connecting the width adjustment element of the delivery device to the inner end of the anchors, wherein the coupler comprises at least two arms that are movable between a normal position and an engaged position, each of the arms comprise a central portion, a first connection member that connects the central portion to a proximal end of the coupler, and a second connection member that connects the central portion to a distal end of the coupler, wherein the arms are configured to attach to internal threads of the lumen of the receiver when the arms are in the normal position.
Example 230. The valve repair system according to example 229, wherein the central portion of a first arm is offset from the central portion of a second arm along a height of a body of the coupler such that the first and second arms are configured to connect to the internal threads of the receiver.
Example 231. The valve repair system according to any of examples 229-230, wherein each of the arms has a “t” shape.
Example 232. The valve repair system according to any of examples 229-231, wherein the first and second connection members are normally in torsion such that a first portion of the central portion is disposed within a lumen of the coupler and a second portion of the central portion extends away from a body of the coupler when the coupler is in the normal position.
Example 233. The valve repair system according to any of examples 229-232, wherein the central portion of each of the arms is substantially aligned with a body of the coupler when the coupler is in the engaged position.
Example 234. The valve repair system according to any of examples 229-233, wherein the width adjustment element of the delivery device removably connects to the coupler by a threaded connection.
Example 235. The valve repair system according to any one of examples 229-234, wherein a coaptation element defines a first area when viewed from above, wherein the paddle frames of the anchors define an outer portion of the implantable device when viewed from above and the anchors are in the closed position, wherein the outer portion of the device has a second area when viewed from above, and wherein a ratio of the second area to the first area is greater than or equal to about 2 to 1.
Example 236. The valve repair system according to example 235, wherein the ratio of the second area to the first area is greater than or equal to 3 to 1.
Example 237. The valve repair system according to example 235, wherein the ratio of the second area to the first area is greater than or equal to 4 to 1.
Example 238. The valve repair system according to example 235, wherein the ratio of the second area to the first area is greater than or equal to 5 to 1.
Example 239. The valve repair system according to example 235, wherein the ratio of the second area to the first area is greater than or equal to 6 to 1.
Example 240. The valve repair system according to any one of examples 235-239, wherein the coaptation element comprises one or more planar side surfaces.
Example 241. The valve repair system according to any one of examples 235-240, wherein the coaptation element comprises one or more tapered side surfaces.
Example 242. The valve repair system according to any one of examples 235-241, wherein the coaptation element comprises a first portion that is rectangular and a second portion that is rounded.
Example 243. The valve repair system according to any one of examples 235-242, wherein the coaptation element is injection molded.
Example 244. The valve repair system according to any one of examples 235-243, wherein the coaptation element comprises a polymer material.
Example 245. The valve repair system according to any one of examples 235-244, wherein the coaptation element has a length of between about 10 mm and about 40 mm.
Example 246. The valve repair system according to any one of examples 235-245, wherein the coaptation element has a width of between about 3 mm and about 10 mm.
Example 247. The valve repair system according to any one of examples 229-246, further comprising a distal portion having a cap.
Example 248. The valve repair system according to example 247, wherein the cap is operative connected to the anchors such that movement of the cap away from a coaptation element causes the anchors to move to an opened position and movement of the cap toward the coaptation element causes the anchors to move to a closed position.
Example 249. The valve repair system according to any off examples 247-248, wherein the cap has a distal opening that allows at least a portion of the paddle frame of each anchor to move in and out of the implantable device.
Example 250. The valve repair system according to example 249, wherein the implantable device further comprises a distal cover element that is positioned to inhibit blood from moving through the distal opening of the cap and into an interior of the implantable device.
Example 251. The valve repair system according to any one of examples 229-250, further comprising a cover attached to the paddle frame.
Example 252. The valve repair system according to example 251, wherein the cover creates a canopy that extends between first and second anchors of the one or more anchors.
Example 253. The valve repair system according to any of examples 251-252, wherein the cover comprises a single piece of material.
Example 254. The valve repair system according to any one of examples 251-252, wherein the cover comprises multiple pieces of material.
Example 255. The valve repair system according to any one of examples 251-254, wherein the cover is made of a porous material that becomes impermeable to blood flow over time.
Example 256. The valve repair system according to any one of examples 251-254, wherein the cover is made of a material that is impermeable to blood flow.
Example 257. The valve repair system according to any one of examples 251-256, wherein the cover comprises one or more stretchable portions.
Example 258. The valve repair system according to example 257, wherein the stretchable portions comprise a pair of Leno weaves with a float positioned therebetween.
Example 259. The valve repair system according to any one of examples 229-258, wherein the paddle frames are connected to the coupler by a connector that includes the inner end.
Example 260. A valve repair system for repairing a native valve of a patient, the valve repair system comprising: (A) a delivery device having one or more actuation elements; (B) an implantable device configured to be implanted on the native valve of the patient, the implantable device having: (i) a coaptation element having a lumen for receiving the one or more actuation elements of the delivery device; (ii) an anchor portion having one or more anchors for attaching to one or more leaflets of a native valve, wherein the anchors are movable between an open position and a closed position; and (iii) a cap operatively connected to the one or more anchors such that movement of the cap relative to the coaptation element by one or more actuation elements of the delivery device causes the anchors to move between the open and closed positions, wherein the cap comprises a distal opening that is in communication with the lumen of the coaptation element; and (iv) a distal cover element that is positioned to inhibit blood from moving through the distal opening of the cap and into an interior of the implantable device.
Example 261. The valve repair system according to example 260, wherein the implantable device further comprises a receiver disposed within the lumen of the coaptation element, wherein the receiver is connected to the cap, and wherein a first actuation element of the one or more actuation elements of the delivery device is configured to engage the receiver to move the receiver and cap relative to the coaptation element to move the anchors between the open and closed positions.
Example 262. The valve repair system according to example 261, wherein an inner end portion of the anchor portion extends through the distal end of the cap.
Example 263. The valve repair system according to example 262, wherein the paddle frames connected to the coupler by a connector that includes the inner end.
Example 264. The valve repair system according to any of examples 262-263, wherein the inner end is connected to the receiver by a coupler, wherein the coupler is configured to be removably connected to a width adjustment element of the one or more actuation elements of the delivery device such that the width adjustment element can cause the inner end to move relative to the receiver to move the paddle frame between narrowed and expanded positions.
Example 265. The valve repair system according to any of examples 260-264, wherein the distal cover element is attached to paddle frames of the anchor portion.
Example 266. The valve repair system according to any of examples 260-264, wherein the distal cover element is attached to the cap.
Example 267. The valve repair system according to any of examples 260-266, wherein the distal cover element has a center portion having a first width and opposing side edges that extend from the center portion and have a second width, and wherein the second width is greater than the first width.
Example 268. The valve repair system according to any of examples 260-267, wherein the distal cover element is curved such that edges of the distal cover element extend upward from a center portion.
Example 269. The valve repair system according to any one of examples 260-268, wherein the coaptation element defines a first area when viewed from above, wherein paddle frames of the anchors define an outer portion of the implantable device when viewed from above and the anchors are in the closed position, wherein the outer portion of the device has a second area when viewed from above, and wherein a ratio of the second area to the first area is greater than or equal to about 2 to 1.
Example 270. The valve repair system according to example 269, wherein the ratio of the second area to the first area is greater than or equal to 3 to 1.
Example 271. The valve repair system according to example 269, wherein the ratio of the second area to the first area is greater than or equal to 4 to 1.
Example 272. The valve repair system according to example 269, wherein the ratio of the second area to the first area is greater than or equal to 5 to 1.
Example 273. The valve repair system according to example 269, wherein the ratio of the second area to the first area is greater than or equal to 6 to 1.
Example 274. The valve repair system according to any one of examples 269-273, wherein the coaptation element comprises one or more planar side surfaces.
Example 275. The valve repair system according to any one of examples 269-274, wherein the coaptation element comprises one or more tapered side surfaces.
Example 276. The valve repair system according to any one of examples 269-275, wherein the coaptation element comprises a first portion that is rectangular and a second portion that is rounded.
Example 277. The valve repair system according to any one of examples 269-276, wherein the coaptation element is injection molded.
Example 278. The valve repair system according to any one of examples 269-277, wherein the coaptation element comprises a polymer material.
Example 279. The valve repair system according to any one of examples 269-278, wherein the coaptation element has a length of between about 10 mm and about 40 mm.
Example 280. The valve repair system according to any one of examples 269-279, wherein the coaptation element has a width of between about 3 mm and about 10 mm.
Example 281. The valve repair system according to any one of examples 260-280, further comprising a cover attached to the anchor portion.
Example 282. The valve repair system according to example 281, wherein the cover is attached to a paddle frame of at least one of the anchors.
Example 283. The valve repair system according to at least one of examples 281-282, wherein the cover creates a canopy that extends between first and second anchors of the one or more anchors.
Example 284. The valve repair system according to any of examples 281-283, wherein the cover comprises a single piece of material.
Example 285. The valve repair system according to any one of examples 281-283, wherein the cover comprises multiple pieces of material.
Example 286. The valve repair system according to any one of examples 281-285, wherein the cover is made of a porous material that becomes impermeable to blood flow over time.
Example 287. The valve repair system according to any one of examples 281-285, wherein the cover is made of a material that is impermeable to blood flow.
Example 288. The valve repair system according to any one of examples 281-287, wherein the cover comprises one or more stretchable portions.
Example 289. The valve repair system according to example 288, wherein the stretchable portions comprise a pair of Leno weaves with a float positioned therebetween.
Example 290. An implantable device, comprising: (i) an anchor portion comprising a first anchor and a second anchor, each of the first and second anchors comprising a paddle frame that is configured to be moved between a narrowed position and expanded position, wherein the first and second anchors are configured to be moved from open position to a closed position to secure the implantable device to leaflets of a native valve; and (ii) a cover attached to the paddle frame of the first and second anchors, wherein the cover is sized to be in a taut state when the paddle frame is in the narrowed position, and wherein the cover comprises one or more stretchable portions that allow the cover to stretch when the paddle frame is in the expanded position.
Example 291. The implantable device according to example 2890, wherein each of the stretchable portions comprise a pair of Leno weaves with a float positioned therebetween.
Example 292. The implantable device according to any of examples 290-291, wherein the cover comprises at least two stretchable portions.
Example 293. The implantable device according to any of examples 290-292, wherein the cover comprises a single piece of material.
Example 294. The implantable device according to any one of examples 290-293, wherein the cover comprises multiple pieces of material.
Example 295. The implantable device according to example 294, wherein one or more pieces of the multiple pieces of material comprise at least one stretchable portion.
Example 296. The implantable device according to any one of examples 290-295 wherein the cover is made of a porous material that becomes impermeable to blood flow over time.
Example 297. The implantable device according to any one of examples 290-295, wherein the cover is made of a material that is impermeable to blood flow.
Example 298. The implantable device according to any one of examples 291-297, wherein the float of the stretchable portion of the cover comprises unwoven threads.
Example 299. The implantable device according to any one of examples 291-298, wherein each of the Leno weaves of the stretchable portion of the cover comprises warp threads and weft threads that are woven in a perpendicular weaving patter and a Leno thread that wraps around the warp threads.
Example 300. The implantable device according to example 299, wherein each of the Leno weaves of the stretchable portion of the cover comprises four warp threads.
Example 301. The implantable device according to any one of examples 290-300, wherein the paddle frame of each anchor includes an inner frame portion and an outer frame portion, wherein the outer frame portion is configured to be moved between the narrow and expanded position.
Example 302. The implantable device according to example 301, wherein the cover is attached to the outer frame portion of the paddle frame.
Example 303. The implantable device according to any of examples 301-302, wherein the cover is attached to the inner frame portion of the paddle frame.
Example 304. The implantable device according to any of examples 301-303, wherein the inner frame portion is rigid, and the outer frame portion is flexible.
Example 305. The implantable device according to any of examples 230-304, wherein the cover creates a canopy that extends between the first and second anchors.
Example 306. The implantable device according to any one of examples 290-305, wherein a coaptation element defines a first area when viewed from above, wherein the paddle frames of the first and second anchors define an outer portion of the implantable device when viewed from above and the first and second anchors are in the closed position, wherein the outer portion of the device has a second area when viewed from above, and wherein a ratio of the second area to the first area is greater than or equal to about 2 to 1.
Example 307. The implantable device according to example 306, wherein the ratio of the second area to the first area is greater than or equal to 3 to 1.
Example 308. The implantable device according to example 306, wherein the ratio of the second area to the first area is greater than or equal to 4 to 1.
Example 309. The implantable device according to example 306, wherein the ratio of the second area to the first area is greater than or equal to 5 to 1.
Example 310. The implantable device according to example 306, wherein the ratio of the second area to the first area is greater than or equal to 6 to 1.
Example 311. The implantable device according to any one of examples 306-310, wherein the coaptation element comprises one or more planar side surfaces.
Example 312. The implantable device according to any one of examples 306-311, wherein the coaptation element comprises one or more tapered side surfaces.
Example 313. The implantable device according to any one of examples 306-312, wherein the coaptation element comprises a first portion that is rectangular and a second portion that is rounded.
Example 314. The implantable device according to any one of examples 306-313, wherein the coaptation element is injection molded.
Example 315. The implantable device according to any one of examples 306-314, wherein the coaptation element comprises a polymer material.
Example 316. The implantable device according to any one of examples 306-315, wherein the coaptation element has a length of between about 10 mm and about 40 mm.
Example 317. The implantable device according to any one of examples 306-316, wherein the coaptation element has a width of between about 3 mm and about 10 mm.
Example 318. The implantable device according to any one of examples 290-317, further comprising a distal portion having a cap.
Example 319. The implantable device according to example 318, wherein the cap is operative connected to the anchors such that movement of the cap away from a coaptation element causes the anchors to move to an opened position and movement of the cap toward the coaptation element causes the anchors to move to a closed position.
Example 320. The implantable device according to any of examples 318-319, wherein the cap has a distal opening that allows at least a portion of the paddle frame of each anchor to move in and out of the implantable device.
Example 321. The implantable device according to example 320, wherein the implantable device further comprises a distal cover element that is positioned to inhibit blood from moving through the distal opening of the cap and into an interior of the implantable device.
Example 322. An implantable device, comprising an anchor portion comprising a first anchor and a second anchor, wherein each of the first and second anchors comprising a paddle frame that includes an outer frame portion, wherein the outer frame portion has a proximal end and a distal end, wherein the outer frame portion is configured to be moved between a narrowed position and an expanded position, wherein a proximal width of the proximal end of the outer frame portion is greater than a distal width of the distal end of the outer frame portion when the outer frame portion is in the expanded position, and wherein the first and second anchors are configured to be moved to a closed position such that the implantable device is secured to the native valve.
Example 323. The implantable device according to example 322, wherein the proximal width of the proximal end of the outer frame portion when the outer frame portion is in the expanded position is between about 8 mm and about 12 mm.
Example 324. The implantable device according to any one of claims 322-323, wherein a ratio of the proximal width of the proximal end of the outer frame portion to a distal width of a distal end of the outer frame portion is between about 1.1 and about 1.5 when the outer frame portion is in the expanded position.
Example 325. The implantable device according to any one of claims 322-3234, wherein engagement between the paddle frame and the native valve when the implantable device is secured to the native valve causes a force on an annulus of the native valve that reshapes the annulus.
Example 326. The implantable device according to any one of claims 322-325, further comprising a cover attached to the outer frame portion.
Example 327 The implantable device according to any one of examples 322-326, where the distal width is maintained as greater than the proximal width as the outer frame portion moves from the expanded position to the narrowed position.
Example 328. The implantable device according to example 326, wherein the cover is sized to be in a taut state when the paddle frame is in the narrowed position, and wherein the cover stretches to move to the expanded position.
Example 329. The implantable device according to any one of claims 326-328, wherein the cover creates a canopy that extends between the first and second anchors.
Example 330. The implantable device according to any one of claims 322-329, wherein a coaptation element defines a first area when viewed from above, wherein the paddle frames of the first and second anchors define an outer portion of the implantable device when viewed from above and the first and second anchors are in the closed position, wherein the outer portion of the device has a second area when viewed from above, and wherein a ratio of the second area to the first area is greater than or equal to about 2 to 1.
Example 331. The implantable device according to any one of claims 322-330, in a first phase, starting at the expanded position and moving to an intermediate position, the distal width narrows at a faster rate than the proximal width.
Example 332. The implantable device according to example 331, in a first second phase, starting at the intermediate position and moving to the narrowed position, the distal width narrows at a faster rate than the proximal width.
Example 333. An implantable device, comprising an anchor portion comprising a first anchor and a second anchor, wherein each of the first and second anchors comprise a paddle frame that includes an outer frame portion, wherein the outer frame portion has a proximal end and a distal end, wherein the outer frame portion is configured to be moved between a narrowed position and an expanded position, wherein a distal width of the distal end of the outer frame portion is greater than a proximal width of the proximal end of the outer frame portion when the outer frame portion is in the expanded position, and wherein the first and second anchors are configured to be moved to a closed position such that the implantable device is secured to the native valve.
Example 334. The implantable device according to example 333, wherein the distal width of the distal end of the outer frame portion when the outer frame portion is in the expanded position is between about 8 mm and about 14 mm.
Example 335. The implantable device according to any one of claims 333-334, wherein a ratio of the distal width of the distal end of the outer frame portion to a proximal width of a proximal end of the outer frame portion is between about 4/1 and about 4/3 when the outer frame portion is in the expanded position.
Example 336. The implantable device according to any one of claims 333-335, wherein the engagement between the paddle frame and the native valve when the implantable device is secured to the native valve causes free edges of leaflets of the native valve to be pinched together.
Example 337. The implantable device according to any one of claims 333-336, further comprising a cover attached to at least one of the inner frame portion and the outer frame portion.
Example 338. The implantable device according to example 337, wherein the cover is sized to be in a taut state when the paddle frame is in the narrowed position, and wherein the cover stretches when the paddle frame moves to the expanded position.
Example 339. The valve repair system according to any one of claims 337-338, wherein the cover creates a canopy that extends between the first and second anchors.
Example 340. The implantable device according to any one of claims 333-339, wherein a coaptation element defines a first area when viewed from above, wherein the paddle frames of the first and second anchors define an outer portion of the implantable device when viewed from above and the first and second anchors are in the closed position, wherein the outer portion of the device has a second area when viewed from above, and wherein a ratio of the second area to the first area is greater than or equal to about 2 to 1.
Example 341. The implantable device according to any one of claims 333-340, further comprising a distal portion having a cap.
Example 342. The implantable device according to example 341, wherein the cap is operatively connected to the anchors such that movement of the cap away from a coaptation element causes the anchors to move to an opened position and movement of the cap toward the coaptation element causes the anchors to move to a closed position.
Example 343. The implantable device according to any of claims 341-342, wherein the cap has a distal opening that allows at least a portion of the paddle frame of each anchor to move in and out of the implantable device.
Example 344. The implantable device according to example 343, wherein the implantable device further comprises a distal cover element that is positioned to inhibit blood from moving through the distal opening of the cap and into an interior of the implantable device.
Example 345. The implantable device according to any one of claims 331-342, where the distal width is maintained as the widest portion of the outer paddle frame when the outer paddle frame moves from the expanded position to the narrowed position.
Example 346. An implantable device, comprising an anchor portion comprising a first anchor and a second anchor, each of the first and second anchors comprising a paddle frame, wherein the paddle frame is configured to be moved between a narrowed configuration and expanded configuration, wherein the first and second anchors are configured to be moved to a closed position in which the first and second anchors compress one or more native leaflets such that the implantable device is secured to the native valve.
Example 347. The implantable device according to example 346, wherein the paddle frame comprises an inner frame portion and an outer frame portion, and wherein the inner frame portion is rigid, and the outer frame portion is flexible.
Example 348. The implantable device according to any one of examples 346-347, further comprising a flexible cover attached to the paddle frame, wherein the flexible cover is configured to be in a taut state when the paddle frame is in the narrowed configuration, and wherein the flexible cover is configured to stretch when the paddle frame is in the expanded configuration.
Example 349. The implantable device according to example 348, wherein the flexible cover comprises a first membrane that attaches to the paddle frame of the first anchor and a second membrane that attaches to the paddle frame of the second anchor.
Example 350. The implantable device according to any one of examples 348-349, wherein the flexible cover comprises a single membrane that attaches to the paddle frame of both of the first and second anchors.
Example 351. The implantable device according to any one of examples 346-350, wherein the paddle frame of each of the first and second anchors includes an inner frame portion and an outer frame portion, and wherein the paddle frame is configured such that the outer frame portion of the paddle frame changes shape as the paddle frame is moved between the narrowed configuration and the expanded configuration.
Example 352. The implantable device according to any one of examples 346-351, wherein the paddle frame of each of the first and second anchors includes an inner frame portion and an outer frame portion, and wherein the first and second anchors are configured such that, in the closed position, the inner frame portion of each of the first and second anchors can compress the one or more native leaflets between an inner pinch point and the outer frame portion of each of the first and second anchors can compress the one or more native leaflets between an outer pinch point such that the implantable device is secured to the native valve.
Example 353. An implantable device, comprising an anchor portion comprising an anchor, the anchor comprising a paddle frame, wherein the paddle frame is configured to be moved between a narrowed configuration and expanded configuration, and wherein the anchor is configured to be moved to a closed position in which the anchor compresses at least one native leaflet such that the implantable device is secured to a native valve.
Example 354. The implantable device according to example 353, wherein the paddle frame includes an inner frame portion and an outer frame portion, and wherein the inner frame portion is rigid, and the outer frame portion is flexible.
Example 355. The implantable device according to any one of examples 353-354, further comprising a cover attached to the paddle frame, wherein the cover is configured to be in a taut state when the paddle frame is in the narrowed configuration, and wherein the cover is configured to stretch when the paddle frame is in the expanded configuration.
Example 356. The implantable device according to example 355, wherein the cover extends across at least a portion of an inner surface of the paddle frame.
Example 357. The implantable device according to any one of examples 355-356, wherein the cover extends across an entirety of an area defined by an inner surface of the paddle frame.
Example 358. The implantable device according to any one of examples 355-357, wherein the anchor is a first anchor and the implantable device also includes a second anchor, and wherein the cover comprises a single membrane that attaches to the paddle frame of the first anchor and the second anchor.
Example 359. The implantable device according to example 358, wherein the single membrane creates a canopy that extends between the first anchor and the second anchor.
Example 360. The implantable device according to any one of examples 355-359, wherein the anchor is a first anchor and the implantable device includes a second anchor that also comprises a paddle frame, wherein the paddle frame of both the first anchor and the second anchor includes an inner frame portion and an outer frame portion, and wherein the cover is attached to the inner frame portion and the outer frame portion of the first and second anchors, and wherein the cover extends between the first anchor and the second anchor.
Example 361. The implantable device according to any one of examples 353-360, wherein the paddle frame includes an inner frame portion and an outer frame portion, and wherein the paddle frame is configured such that when the paddle frame is moved between the narrowed configuration and the expanded configuration, the outer frame portion of the paddle frame changes shape between the narrowed configuration and the expanded configuration.
Example 362. The implantable device according to any one of examples 353-361, wherein the paddle frame includes an inner frame portion and an outer frame portion, and wherein the anchor is configured such that, in the closed position, the inner frame portion of the anchor can compress the at least one native leaflet between an inner pinch point and the outer frame portion of each of the anchor can compress the at least one native leaflet between an outer pinch point such that the implantable device is secured to the native valve.
Example 363. A valve repair system for repairing a native valve of a patient, the valve repair system comprising (A) a delivery device having a width adjustment element, and (B) an implantable device configured to be implanted at the native valve of the patient, the implantable device having: (i) an anchor portion having one or more anchors, each of the one or more anchors having a paddle frame, wherein the one or more anchors are configured to attach to one or more leaflets of a native valve; and (ii) a coupler for removably connecting the width adjustment element of the delivery device to an end of the one or more anchors, wherein the coupler is configured such that it can secure the end of the one or more anchors in one of multiple potential positions within the implantable device such that the anchors are held in one of multiple potential configurations selected from the group comprising a narrowed configuration, an extended configuration, and an intermediate configuration between the narrowed configuration and the extended configuration.
Example 364. The valve repair system according to example 363, wherein the coupler comprises at least two arms that are movable between a normal position and an engaged position, wherein the arms are in the normal position when the coupler is disconnected from the width adjustment element, and wherein the arms are in the engaged position when the coupler is connected to the width adjustment element.
Example 365. The valve repair system according to any of examples 363-364, wherein the coupler comprises an upper body, a lower body, and a plurality of struts connected to the upper and lower bodies.
Example 366. The valve repair system according to any one of examples 363-365, wherein a coaptation element defines a first area when viewed from above, wherein the paddle frames of the one or more anchors define an outer region of the implantable device when viewed from above and the one or more anchors are in a closed position, wherein the outer region of the implantable device has a second area when viewed from above, and wherein a ratio of the second area to the first area is greater than or equal to about 2 to 1.
Example 367. The valve repair system according to any one of examples 363-366, wherein the paddle frame comprises a connector that includes the end.
Example 368. The valve repair system according to any one of examples 363-367, wherein the implantable device further comprises a cover attached to the paddle frame.
Example 369. The valve repair system according to example 368, wherein the cover is configured to be in a taut state when the paddle frame is in the narrowed configuration, and wherein the cover is configured to stretch as the paddle frame transitions from the narrowed configuration to the expanded configuration.
Example 370. The valve repair system according to any one of examples 368-369, wherein the cover comprises a single membrane that attaches to the paddle frame of both of the first and second anchors.
Example 371. The valve repair system according to any one of examples 368-370, wherein the cover is configured to form a canopy that extends between the first and second anchors.
Example 372. The valve repair system according to any one of examples 363-371, wherein the paddle frame includes an inner frame portion and an outer frame portion, and wherein the paddle frame is configured such that when the paddle frame is moved between the narrowed configuration and the expanded configuration, the outer frame portion of the paddle frame changes shape between the narrowed configuration and the expanded configuration.
Example 373. The valve repair system according to any one of examples 363-372, wherein the paddle frame includes an inner frame portion and an outer frame portion, and wherein the anchor is configured such that the anchor can be moved to a closed position in which the inner frame portion of the anchor can compress the one or more native leaflets between an inner pinch point and the outer frame portion of each of the anchor compresses the one or more native leaflets between an outer pinch point.
Example 374. The valve repair system according to any one of examples 363-373, wherein the width adjustment element includes an external threaded portion.
Example 375. The valve repair system according to any one of examples 363-374, wherein the coupler comprises one or more attachment projections that extend inward from a body of the coupler.
Example 376. The valve repair system according to example 375, wherein the one or more attachment projections are configured to removably attach to an external threaded portion of the width adjustment element.
Example 377. The valve repair system according to any one of examples 363-376, wherein the system includes a receiver that defines a lumen that includes internal threads.
Example 378. The valve repair system according to any one of examples 363-377, wherein the coupler comprises at least two arms that are movable between a normal position and an engaged position, wherein the arms are in the normal position when the coupler is disconnected from the width adjustment element, wherein the arms are in the engaged position when the coupler is connected to the width adjustment element.
Example 379. The valve repair system according to example 378, wherein the at least two arms are configured to attach to internal threads of a lumen of a receiver when the arms are in the normal position.
Example 380. The valve repair system according to any one of examples 363-379, further comprising a receiver including an unattachable portion.
Example 381. The valve repair system according to example 380, wherein the coupler is configured to be removably coupled to the receiver to secure the end of the one or more anchors in a desired position relative to the receiver.
Example 382. The valve repair system according to any one of examples 378-381, wherein the unattachable portion of the receiver prevents the coupler from connecting to the receiver when the coupler is disposed within the unattachable portion.
Example 383. The valve repair system according to any one of examples 363-382, wherein the implantable device further comprises a coaptation element.
Example 384. The valve repair system according to any one of examples 363-383, wherein the implantable device further comprises a cap operatively connected to the one or more anchors such that movement of the cap relative to another portion of the implantable device by one or more actuation elements of the delivery device causes the one or more anchors to move between an open position and a closed position.
While various inventive aspects, concepts and features of the disclosures can be described and illustrated herein as embodied in combination in the examples herein, these various aspects, concepts, and features can be used in many alternative examples, either individually or in various combinations and sub-combinations thereof. Unless expressly excluded herein all such combinations and sub-combinations are intended to be within the scope of the present application. Still further, while various alternative examples as to the various aspects, concepts, and features of the disclosures—such as alternative materials, structures, configurations, methods, devices, and components, alternatives as to form, fit, and function, and so on—may be described herein, such descriptions are not intended to be a complete or exhaustive list of available alternative examples, whether presently known or later developed. Those skilled in the art can readily adopt one or more of the inventive aspects, concepts, or features into additional examples and uses within the scope of the present application even if such examples are not expressly disclosed herein.
Additionally, even though some features, concepts, or aspects of the disclosures may be described herein as being a preferred arrangement or method, such description is not intended to suggest that such feature is required or necessary unless expressly so stated. Still further, example or representative values and ranges may be included to assist in understanding the present application, however, such values and ranges are not to be construed in a limiting sense and are intended to be critical values or ranges only if so expressly stated.
Moreover, while various aspects, features and concepts may be expressly identified herein as being inventive or forming part of a disclosure, such identification is not intended to be exclusive, but rather there may be inventive aspects, concepts, and features that are fully described herein without being expressly identified as such or as part of a specific disclosure, the disclosures instead being set forth in the appended claims. Descriptions of example methods or processes are not limited to inclusion of all steps as being required in all cases, nor is the order that the steps are presented to be construed as required or necessary unless expressly so stated. The words used in the claims have their full ordinary meanings and are not limited in any way by the description of the examples in the specification.
The present application is a continuation of Patent Cooperation Treaty application no. PCT/US2022/035672, filed on Jun. 30, 2022, which claims the benefit of U.S. Provisional Patent Application No. 63/308,940, filed on Feb. 10, 2022, U.S. Provisional Patent Application No. 63/278,037, filed on Nov. 10, 2021, and U.S. Provisional Patent Application No. 63/217,622, filed on Jul. 1, 2021, which are all incorporated herein by reference in their entireties for all purposes.
| Number | Date | Country | |
|---|---|---|---|
| 63308940 | Feb 2022 | US | |
| 63278037 | Nov 2021 | US | |
| 63217622 | Jul 2021 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2022/035672 | Jun 2022 | US |
| Child | 18395235 | US |
