Patent Application
20240350262
The present disclosure relates to implantable, mechanically expandable prosthetic heart valves and frame structures for use with mechanically expandable prosthetic heart valves.
The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (for example, stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable.
In one specific example, a prosthetic valve can be mounted in a crimped state on the distal end of a delivery device and advanced through the patient's vasculature (for example, through a femoral artery and the aorta) until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by deploying the prosthetic valve from a sheath of the delivery device so that the prosthetic valve can self-expand to its functional size.
Prosthetic valves that rely on a mechanical actuator for expansion can be referred to as “mechanically-expandable” prosthetic valves. Mechanically-expandable prosthetic valves can provide one or more advantages over self-expandable and balloon-expandable prosthetic valves. For example, mechanically-expandable prosthetic valves can be expanded to various diameters. Mechanically-expandable prosthetic valves can also be compressed after an initial expansion (for example, for repositioning and/or retrieval).
Mechanically-expandable prosthetic valves can include frames that can be radially compressed and/or expanded by means of a mechanical actuator. Despite the recent advances in mechanically-expandable prosthetic valves, there remains a need for improved frames for mechanically-expandable prosthetic valves.
Disclosed herein are examples of a prosthetic valve that can be delivered to an implantation location within a patient's body and examples of a method of delivering the prosthetic valve.
In some examples, a prosthetic valve includes a frame having an axial direction extending from an inflow end to an outflow end, a first frame portion extending in the axial direction, and a first window formed in the first frame portion. The prosthetic valve includes a threaded rod coupled to the first frame portion and extending through the first window. Rotation of the threaded rod relative to the first frame portion in a first direction radially expands the frame, and rotation of the threaded rod relative to the first frame portion in a second direction that is opposite to the first direction radially compresses the frame. The prosthetic valve includes a stopper disposed within the first window and coupled to the threaded rod. The stopper is fixed in axial position relative to the threaded rod and axially movable within the first window by rotation of the threaded rod. The stopper can engage a first edge of the window to produce radial compression of the frame.
In some examples, a prosthetic valve includes a frame having an axial direction extending from an inflow end to an outflow end, a first frame portion extending in the axial direction, a second frame portion extending in the axial direction, a first window formed in the first frame portion, a second window formed in the second frame portion. The first window is positioned axially between the second window and the outflow end in the axial direction. The prosthetic valve includes a threaded rod coupled to the first frame portion and extending through the first window. Rotation of the threaded rod relative to the first frame portion in a first direction radially expands the frame, and rotation of the threaded rod relative to the first frame portion in a second direction that is opposite to the first direction radially compresses the frame. The prosthetic valve includes a stopper fixedly coupled to the threaded rod and disposed within the first window. The stopper can engage a first edge of the first window to produce radial compression of the frame. A valvular structure is disposed inside the frame and has a commissure received in the second window.
In some examples, a prosthetic valve includes a frame having an axial direction extending from an inflow end to an outflow end, a first frame portion extending in the axial direction, the first frame portion comprising a first actuator portion connected to the inflow end at a first apex, a second actuator portion connected to the outflow end at a second apex, and a recess formed in the second apex. The prosthetic valve includes a threaded rod having a head portion. The threaded rod extends through the first actuator portion and the second actuator portion and is threadedly engaged with the first actuator portion with the head portion received in the recess. A height of the head portion is equal to or less than a depth of the recess. Rotation of the threaded rod relative to the first actuator portion in a first direction radially expands the frame, and rotation of the threaded rod relative to the first actuator portion in a second direction that is opposite to the first direction radially compresses the frame.
In some examples, a prosthetic valve includes a frame having an axial direction extending from an inflow end to an outflow end, a plurality of first frame portions spaced about a circumference of the frame, and a first window formed in each of the first frame portions. The prosthetic valve includes a plurality of threaded rods. Each threaded rod is coupled to one of the first frame portions and extends through the respective first window formed in the one of the first frame portions. Rotation of each threaded rod relative to the respective first frame portion in a first direction radially expands the frame, and rotation of each threaded rod relative to the respective first frame portion in a second direction that is opposite to the first direction radially compresses the frame. The prosthetic valve includes at least one stopper fixedly coupled to one of the threaded rods and disposed within the first window receiving the one of the threaded rods. The at least one stopper can engage a first edge of the respective first window to produce radial compression of the frame.
In some examples, a method includes coupling a prosthetic valve to a distal end of a delivery apparatus. The prosthetic valve includes a frame having an axial direction extending from an inflow end to an outflow end and having a first actuator portion and a second actuator portion aligned along the axial direction, a threaded rod coupled to the first actuator portion and extending axially through the second actuator portion, and a stopper fixedly coupled to the threaded rod and disposed within a window formed in the second actuator portion. The method includes rotating the threaded rod in a first direction to cause the stopper to engage a first edge of the window, thereby causing the first actuator portion to move away from the second actuator portion and radially compress the prosthetic valve.
The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present, or problems be solved.
Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth herein. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.
As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and/or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.
As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (for example, out of the patient's body), while distal motion of the device is motion of the device away from the user and toward the implantation site (for example, into the patient's body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.
As used herein, “e.g.” means “for example,” and “i.e.” means “that is.”
As used herein, the term “parallel” refers to an orientation between a component and a reference line that is parallel or substantially parallel, allowing for minor angular orientation or curvature. When discussing the orientation of a component with an elongated geometry, such as a strut or actuator, the orientation of that component is defined by an axis drawn along the component's length (that is, a major axis of the component), through the cross-sectional midpoint of the component. When the component being discussed has a bend or curvature, the axis is drawn through the cross-sectional midpoint of each endpoint of the component along the length of the component. For example, the axis can, in the case of a curved component, be defined by a chord extending between the ends of the component and drawn through the cross-sectional midpoint at each end.
The axis of a component can be substantially parallel to a reference line if only a small angle, such as 10 degrees or less, exists between the component and the reference line. Thus, for example, an axis of a component may be described as extending parallel to a reference line (such as a vertical axis of a frame) if it is parallel to the reference line, or within 10 degrees of parallel to the reference line.
Disclosed herein are various examples of prosthetic heart valves for implantation in the native vasculature of a patient, such as the native annuluses of the patient's heart (for example, the aortic, pulmonary, mitral, or tricuspid valves). The disclosed prosthetic heart valves can also be implanted within vessels in communication with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve, or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries, and vessels of a patient. The disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.
In some examples, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. For instance, in one example, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U.S. Patent Publication No. 2017/0231756, which is incorporated by reference herein. In some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. WO2020/247907, which is incorporated herein by reference. In some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Patent Publication No. 2019/0000615, which is incorporated herein by reference.
To facilitate implantation within a patient, prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valves can be crimped on or retained by an implant delivery apparatus in the radially compressed state during delivery, such as by a delivery system catheter or adjustable loop disposed around the compressed prosthetic heart valve. The prosthetic heart valves can then be expanded by an expansion mechanism, such as an actuator, to the radially expanded state once the prosthetic valve reaches the implantation site. The frames can also be locked in the desired state of radial expansion by means of a locking mechanism, thereby preventing further radial expansion or compression of the prosthetic heart valve frame. It is understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses and can be implanted via various delivery procedures, examples of which is discussed herein.
Because reduced prosthetic heart valve diameters are generally preferred for ease of implantation, and because greater radial compression results in greater axial extension while the prosthetic heart valve is in the radially compressed configuration, it can be advantageous to design the prosthetic heart valve with longer, thinner actuators that support a greater range of axial extension while minimizing the radial profile of the compressed prosthetic heart valve.
The radial compression of the prosthetic heart valves, however, can pose several technical challenges. In particular, the prosthetic heart valve may not radially compress evenly along its axial length, instead radially compressing to a greater degree at either axial end, and to a lesser degree towards the axial center of the prosthetic heart valve. This can result in the prosthetic heart valve frame assuming a “barreled” shape while the prosthetic heart valve is in the radially compressed configuration. This barreled shape, in turn, can apply stress on various components of the prosthetic heart valve frame, such as the frame actuators, and result in plastic deformation and/or buckling of the actuators or other frame components. This challenge is especially problematic in prosthetic heart valve frames having longer actuators with narrower cross sections.
Due to the movement of the frame between the crimped state to the functional state (and vice versa), there is a need for frames for prosthetic heart valves that are flexible to allow for the movement and robust to ensure that the frame functions properly both during and after the implantation procedure.
The prosthetic heart valve frame examples disclosed herein include mechanisms to prevent or mitigate the buckling of the actuation members and other frame components. Various examples disclosed herein can include actuated vertical struts with one or more apertures therein to reduce the rigidity of the actuated vertical struts. Other examples can include heat setting one or more frame elements such as an actuated vertical strut or a commissure window to project either radially inwards or radially outwards from the axis of the prosthetic heart valve frame. Still some examples can include adding additional struts to distribute the elastic forces of compressed frame components more evenly across the entire frame. Any of these examples may be used solely, or in combination with any number of some examples.
In some examples, rod actuators are mounted on a frame of a prosthetic valve. The rod actuators can be rotated in a first direction to radially compress the prosthetic valve to a radially compressed configuration and in a second direction that is opposite to the first direction to radially expand the prosthetic valve to a radially expanded configuration. In some examples, stopper windows are formed in portions of the frame. Stoppers fixedly coupled to the rod actuators are positioned within the stopper windows and can move within the stopper windows as the rod actuators are rotated. In some examples, the stoppers can engage an edge of the stopper windows to facilitate radial compression of the frame. In some examples, apices at an outflow end of the frame can receive head portions of the rod actuators such that the head portions are flush or recessed relative to the outflow end at least when the prosthetic valve is radially expanded to a working diameter.
In view of the above-described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.
The frame 102 (which can also be referred to as “a stent” or “a support structure”) can be configured to support the valvular structure 104 and for securing the prosthetic heart valve 100 within a native heart valve and/or within another support structure (for example, an anchoring frame (such as a coil) and/or a previously implanted prosthetic heart valve (that is, in a valve-in-valve procedure). The frame 102 can further comprise one or more actuators 106 configured to radially expand or radially compress the frame 102, as described herein.
With continued reference to
The frame 102 can comprise a plurality of interconnected angled struts 112 and vertical struts 114. In some examples, the angled struts 112 and the vertical struts 114 define a plurality of frame cells. For example, as illustrated in
As illustrated in
With continued reference to
The frame 102 can further comprise a plurality of leaflet attachment structures. For example, as depicted in
As best illustrated in
The frame 102 can be configured to move between a plurality of radial configurations, as shown, for example in
While the example prosthetic heart valves described herein include mechanically expandable frames that are expanded by actuators 106, it is to be appreciated that in some examples, different frame expansion mechanisms could be used. For example, self-expanding, partially self-expanding, and balloon expandable frames 102 could be used in place of a mechanically actuated frame as previously described.
Referring again to
The actuators 106 can have various forms. For example, in some instances, the actuators 106 can be a rod or shaft. In such instances, the actuators 106 can be formed as separated components from the frame 102, which are then coupled thereto (for example, via welding, adhesive, fasteners, or other means for coupling). Alternatively, the actuators 106 and the frame 102 can be integrally formed as a unitary structure (for example, by forming the frame and actuators from a tube). In some instances, the actuators 106 can be a cable, wire, cord, suture, or other relatively flexible material (that is, compared to a shaft or rod). In such instances, the flexible actuator 106 can be coupled to the frame 102 by tying or looping the actuators 106 around the struts 112, 114 of the frame 102 and/or by coupling the actuator 106 to the frame 102 via a fastener (for example, a grommet), adhesive, and/or other means for coupling.
In some examples, the actuators 106 can be configured for rotational actuation. For example, an actuator 106 may comprise external threads along one or more portions of the actuator 106 (for example, similar to a bolt or screw). As illustrated in
In some examples, the actuators can be configured for linear actuation. In such instances, the actuators 106 comprise fixed end portions fixedly coupled to one portion of the frame (for example, the first end portion) and free end portions movably coupled to another portion of the frame (for example, the second end portion). For example, the fixed end portions of the actuators 106 can be coupled to and/or extend axially from the actuated vertical struts 130 at the inlet end portion of the frame 102, across the primary and second cells and through a lumen traversing the actuated vertical struts 130 at the outlet end portion of the frame 102. The actuator 106 can be used to expand the frame 102 by pulling the actuator 106 toward the outlet end portion of the frame while applying an opposing force on the apices of the outlet end portion of the frame (for example, with a delivery apparatus). These axially-opposing forces together apply a compressive force to the frame and result in radial expansion of the frame. The frame can be radially compressed by reducing tension on the actuators and allowing the elastic properties of the frame to radially compress the frame to its neutral or resting state and/or by an external radially inward force (for example, a crimping device and/or native anatomy within a patient's body).
Each of the actuators can be configured to form a releasable connection with one or more respective actuation shafts of a delivery apparatus. This releasable connection can, for example, include a threaded connection, a plurality of interlocking shafts, and other means of forming a releasable connection. Several examples of releasable connections between the actuators and a delivery apparatus are described herein.
The frame 102 optionally may include a locking mechanism configured to retain the frame 102 in the expanded configuration after the prosthetic heart valve has been radially expanded to the desired diameter. The frame 102 can be configured to freely move between various radially expanded/compressed configurations so long as the locking mechanism is disengaged. When the frame 102 is radially expanded to a desired operational diameter, the locking mechanism can be engaged to prevent further radial expansion and/or contraction of the frame 102.
In some examples, such as examples configured to include rotationally driven actuators, the locking of the prosthetic heart valve 100 can be accomplished by the actuators 106 and the nut 146. In some examples, however, and especially examples using actuators other than rotationally driven actuators, different locking mechanisms, such as locking mechanisms incorporating retention tabs or locking elements may be used instead. Further details regarding prosthetic heart valves, including locking mechanisms and the ways in which locking mechanisms can be incorporated in prosthetic heart valve frames such as frame 102, actuators for radially expanding and compressing prosthetic valves, various frame constructions and methods for assembling prosthetic valves can be found in U.S. Application Nos. 63/085,947, filed Sep. 30, 2020, 63/179,766, filed Apr. 26, 2021, 63/194,285, filed May 28, 2021, and PCT Application No. PCT/US2021/040789, filed Jul. 8, 2021, which are incorporated by reference herein.
The frame 102 can be made of any of various suitable plastically-expandable materials (for example, stainless steel, etc.) or self-expanding materials (for example, Nitinol) as known in the art. When constructed of a plastically-expandable material, the frame 102 (and thus the valve 100) can be crimped to a radially compressed state on a delivery catheter and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 102 (and thus the valve 100) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.
Suitable plastically-expandable materials that can be used to form the frames disclosed herein (for example, the frame 102) include, metal alloys, polymers, or combinations thereof. Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the frame 102 can comprise stainless steel. In some examples, the frame 102 can comprise cobalt-chromium. In some examples, the frame 102 can comprise nickel-cobalt-chromium. In some examples, the frame 102 comprises a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™/UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.
When the frame 102 is constructed from a plastically-expandable material, the expansion force required to radially expand the frame is provided by the actuators 106. In some examples, the angled struts 112 and the vertical struts 114 of the frame can be sufficiently rigid to maintain the frame 102 in the radially expanded state against a surrounding native annulus without the use of any locking mechanism.
When the frame 102 is constructed from a shape-memory material (for example, Nitinol), the frame 102 can be configured to self-expand from a radially compressed state to at least a partially radially expanded state. In such cases, the actuators 106 can be used to assist in radially expanding the frame in cooperation with the inherent resiliency of the shape-memory material that urges the frame toward the radially expanded state. For example, the frame 102 can be self-expandable from a radially compressed state to a partially radially expanded state. After the frame reaches the partially radially expanded state, the actuators 106 can be used to further expand the frame 102 from the partially radially expanded state to a fully radially expanded state. After the frame reaches the fully radially expanded state, the actuators 106 can be used to overexpand the frame and dilate the native annulus in which the prosthetic valve is implanted. One or more locking mechanisms, as described herein, can be used to retain the frame in the overexpand state against the forces of the surrounding annulus.
Returning to
The leaflets 160 of the prosthetic heart valve 100 can be made of a flexible material. For example, the leaflets 160 can be made from in whole or part, biological material, bio-compatible synthetic materials, or other such materials. Suitable biological material can include, for example, bovine pericardium, equine pericardium, porcine pericardium, and/or pericardium from other sources.
The leaflets 160 can be arranged to form commissures 162. The commissures 162 can, for example, be mounted to the frame at the commissure windows 140, as illustrated in
The inlet or cusp edge portions of the leaflets 160 can be coupled to the frame 102 via various techniques and/or mechanisms. For example, the cusp edge portions of the leaflets 160 can be sutured directly to selected angled struts 112 or vertical struts 114 of primary cells 116 located at the first end 108 (that is, inlet end) of the prosthetic heart valve. Alternatively, the cusp edge portions of the leaflets 160 can be sutured to an inner skirt (for example, a fabric skirt, not shown), which in turn can be sutured to selected angled struts 112 or vertical struts 114 of primary cells 116 located at the first end 108 (that is, the inlet end) of the prosthetic heart valve. The inlet portions of the leaflets 160 can also, in some examples, be coupled to the one or more axially extending suture posts 142 extending from selected vertical struts 114.
With continued reference to
The skirt can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof. In some examples, the skirt can comprise a fabric having interlaced yarns or fibers, such as in the form of a woven, braided, or knitted fabric. In some examples, the fabric can have a plush nap or pile, Exemplary fabrics having a plus nap or pile include velour, velvet, velveteen, corduroy, terrycloth, fleece, etc. In some examples, the skirt can comprise a fabric without interlaced yarns or fibers, such as felt or an electrospun fabric. Exemplary materials that can be used for forming such fabrics (with or without interlaced yarns or fibers) include, without limitation, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc. In some examples, the skirt can comprise a non-textile or non-fabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)), etc. In some examples, the skirt can comprise a sponge material or foam, such as polyurethane foam. In some examples, the skirt can comprise natural tissue, such as pericardium (for example, bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).
Further details regarding prosthetic heart valves, including the valvular structure 104 and manner in which the valvular structure 104 can be coupled to the frame 102 of the prosthetic heart valve 100, can be found in U.S. Pat. Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, 8,652,202, and 9,393,110, U.S. Publication No. 2018/0325665, and U.S. Application No. 63/138,890, filed Jan. 19, 2021, which are incorporated by reference herein.
The examples of prosthetic heart valves described herein may be configured to be implanted in the vasculature of a patient by a delivery apparatus. A suitable delivery apparatus may comprise an elongated shaft configured to pass through the vasculature of a patient, one or more delivery actuators to manipulate a prosthetic heart valve within the patient's body, and a control mechanism by which a physician may control the actuators. Some examples of a delivery apparatus may further include a restraining mechanism configured to retain the prosthetic heart valve in a compressed configuration.
The prosthetic heart valve 202 can include a distal end 204 (which can be the inlet end of the prosthetic heart valve 202, such as when the prosthetic heart valve 202 is configured to replace a defective aortic valve when delivered transfemorally) and a proximal end 206 (which can be the outlet end of the prosthetic heart valve 202, such as when the prosthetic heart valve 202 is configured to replace a defective aortic valve when delivered transfemorally), wherein the proximal end 206 is positioned closer to a handle 208 of the delivery apparatus 200 than the distal end 204, and wherein the distal end 204 is positioned farther from the handle 208 than the proximal end 206. It is to be understood that in some examples, such as when the prosthetic heart valve 202 is implanted in a different location in the vasculature of the patient, the proximal end 206 can alternatively be an inlet end of the prosthetic heart valve 202 and the distal end 204 can be an outlet end of the prosthetic heart valve 202. The prosthetic heart valve 202 can also include one or more actuators 210, extending from the distal end 204 to the proximal end 206, as has been discussed herein.
The delivery apparatus 200 in the illustrated example generally includes the handle 208, a first shaft 212 (an outer shaft in the illustrated example) extending distally from the handle 208, a second shaft 214 (an inner shaft in the illustrated example) extending distally from the handle 208 through the first shaft 212, one or more delivery system actuators 216 extending distally through the outer shaft 212, and one or more support tubes (sometimes called support members) 218 that can extend distally through the outer shaft 212 and can abut the proximal end 206 of the prosthetic heart valve 202. The delivery apparatus 200 can further include a nose cone 220 connected to the distal end portion of the second shaft 214.
Each delivery system actuator 216 can have a distal end connected to an actuator 210 of the prosthetic heart valve 202. Each of the delivery system actuators 216 can extend through a respective support tube 218 and together can define a respective actuator assembly that can extend through the outer shaft 212 to the handle 208. In alternative examples, the delivery system actuators 216 and the support tubes 218 need not be co-axial with respect to each and instead can extend side-by-side through the shaft.
When the prosthetic heart valve includes linear actuators 210, the delivery system actuators 216 and/or the support tubes 218 can be configured to radially expand the prosthetic heart valve 202 by bringing the ends 204, 206 of the prosthetic heart valve 202 closer together (that is, squeezing the prosthetic heart valve 202 axially) thereby axially foreshortening and radially expanding the prosthetic heart valve 202. As one example, the delivery system actuators 216 can be configured to be actuated to provide a proximally directed (for example, pulling) force to the actuators 210 of the prosthetic heart valve 202 while the one or more support tubes 218 can be configured to provide a countervailing distally directed (for example, pushing) force to the proximal end 206 of the prosthetic heart valve 202. The actuators 210, in turn, may transmit the force to the distal end 204 of the prosthetic heart valve 202. In one such example, a physician can pull the delivery system actuators 216 to provide the proximally directed force to the distal end 204 of the prosthetic heart valve 202, while simultaneously gripping, holding, and/or pushing the handle 208 to provide the countervailing distally directed force to the proximal end 206 of the prosthetic heart valve 202.
When the prosthetic heart valve includes rotationally-driven actuators 210, the delivery system actuators 216 can be configured to apply a rotational force to the actuators 210. In such examples, the actuators 210 may have a first threaded end configured to connect with a corresponding threaded end of a delivery system actuator 216. When the delivery system actuator 216 is rotated in a first rotational direction, the actuator 210 can exert an axial force in the proximal direction on the distal end 204 of the prosthetic heart valve 202, thereby axially foreshortening and radially expanding the prosthetic heart valve 202. When the delivery system actuator 216 is rotated in a second rotational direction opposite to the first rotational direction, the actuator 210 can exert an axial force in the distal direction on the distal end 204 of the prosthetic heart valve 202, thereby axially extending and radially contracting the prosthetic heart valve 202. In such an example, a physician can rotationally manipulate the actuators 210 of the prosthetic heart valve 202 to radially expand or contract the prosthetic heart valve 202 to a desired diameter.
As described herein, the delivery system actuators 216 can cooperate with a locking element on the prosthetic heart valve 202 to retain the prosthetic heart valve in a radially expanded state.
Although two pairs of delivery system actuators 216 and support tubes 218 are shown in
Examples of the delivery apparatus disclosed herein may further include a restraining mechanism configured to retain the prosthetic heart valve in a compressed state. The restraining mechanism may be releasably attached to the prosthetic heart valve while the prosthetic heart valve is being advanced through the vasculature of the patient and/or being positioned at the desired implantation site and may be detached once the prosthetic heart valve has been positioned in the desired location.
In some examples, illustrated in
In lieu of or in addition to a delivery capsule, as illustrated in
Also disclosed herein are various examples of prosthetic heart valves having frame elements configured to reduce the bending or buckling of the actuators, such as actuators 106. When the prosthetic heart valve 100 is in the radially compressed configuration, the frame 102 can tend to compress more at the first end (sometimes called the distal end) 108 and the second end (sometimes called the proximal end) 110 than at the axial midpoint of the frame, in a phenomenon sometimes known as “barreling”, shown in
As shown in
The buckling of actuators can be addressed in several ways in the various examples disclosed herein. In some examples, the frame of the prosthetic heart valve can include actuated vertical struts having one or more apertures. In some examples, the frame of the prosthetic heart valve can include actuated vertical struts that are heat set radially away from the outer circumference of the frame. In yet some examples, the frame of the prosthetic heart valve can include commissure openings that are heat set away from the outer circumference of the frame. In still some examples, the frame can include one or more lateral struts that connect the actuated vertical struts to the cells of the frame. It is to be appreciated that any of these frame elements may be used alone, or in conjunction with any or all of the other frame elements disclosed herein. The various example prosthetic heart valves disclosed herein can, therefore, reduce or eliminate the problems associated with the buckling of the actuators, as will be discussed herein.
In some examples, the actuated vertical strut (such as actuated vertical strut 130 previously described) of a prosthetic heart valve frame (such as frame 102 previously described) can include one or more apertures set in the length of the actuated vertical strut. These apertures can serve to reduce the structural rigidity of the actuated vertical strut (that is, the inclusion of the apertures can reduce the flexural modulus of the actuated vertical strut, increasing its tendency to flex under bending forces). When prosthetic heart valves according to the present disclosure are held in the radially compressed configuration, the barreling of the frame illustrated in
As shown in
With continued reference to
As shown in
In some examples, as shown in
In examples in which the prosthetic heart valve includes actuators 308 configured for rotatable actuation, the actuated vertical strut 306 can further comprise a window 340. The window 340 can have a proximal end 342 and a distal end 344, and can be configured to accommodate a component of the actuator 308, such as an actuation nut 346, which rests within the window 340 and is threadably attached to a portion of the actuator 308. In such examples, because the actuation nut 346 cannot move in the proximal direction (that is, towards the outlet end 318 of the frame 300) past the proximal end 342 or in the distal direction (that is, towards the inlet end 316 of the frame 300) past the distal end 344 of the window 340, and because the nut is threadably attached to the actuator 308, the nut may limit the axial range of motion of the actuator 308.
With continued reference to
In some examples, elements of a frame (such as frame 102) can be plastically deformed or heat set in a deformed configuration suitable for protecting any actuators connected to the frame from bending and/or buckling when the frame is in the compressed configuration. In some examples, the actuated vertical struts can be plastically deformed or heat set to extend radially inwards from the other struts of the frame when the frame is in the radially expanded configuration, resulting in a smaller radial displacement between the actuated vertical struts and the ends of the frame when the frame is in the radially compressed configuration. In some examples, frame struts having commissure openings can be plastically deformed or heat set to extend radially inwards from adjacent struts of the frame when the frame is in the radially expanded configuration, tending to exert force on adjacent actuated struts and reducing the radial displacement between the actuated vertical struts and the ends of the frame when the frame is in the radially compressed configuration.
As shown in
With continued reference to
As shown in
With continued reference to
The frame 400 can also include one or more commissure openings 448, as shown in
Referring now to
In examples of frames having an actuated vertical strut that is heat set inwards relative to the body of the frame, the radially inwards disposition of the free end of the actuated vertical strut while the frame is in the radially expanded configuration can prevent or minimize the bending any actuator connected with the frame when the frame is in the radially compressed configuration. For example, the free end 436 of the actuated vertical strut 406 can have a reduced radial displacement relative to the inlet end 416 and the outlet end 418 of the frame 400 when the frame 400 is in the compressed configuration. In turn, this can reduce the radial displacement between an end portion 444 and a center portion 446 of the actuator 408, illustrated in
As shown in
With continued reference to
As shown in
With continued reference to
As shown in
In some examples, the radially inwards extension of the vertical strut 504 having a commissure window 542 shown in
With continued reference to
In some examples, the actuated vertical struts (for example, the actuated vertical strut 130) of a prosthetic heart valve frame (for example, frame 102) can be mechanically supported at both ends. For example, the frame can include an actuated vertical strut attached at a first end to an apex of an inner cell, and attached to other frame components at a second end by one or more lateral and/or angled struts extending from the second end of the actuated vertical strut to other components of the frame. In alternative examples, the second end of the actuated vertical strut can connect directly to a portion of a cell formed by the interconnected struts of the frame. When the prosthetic heart valves according to such examples are held in the radially compressed configuration, the one or more lateral and/or angled struts extending from the second end of the actuated vertical strut, such as actuated vertical strut, can apply a radially compressive force to the second end of the vertical strut. In turn, this radially compressive force can minimize the radial distance between the second end of the actuated vertical strut and the inlet end and outlet end of the frame (such as inlet end 108 and outlet end 110 of the frame 102). As a result, the corresponding bowing of the actuator, (for example, actuator 106) caused by the radial displacement between the end of the actuated vertical strut when the frame is in the radially compressed configuration.
With continued reference to
As shown in
As shown in
With continued reference to
As shown in
In some examples of a section of a frame 700 having support for the free end of the actuated strut, in a radially compressed configuration is shown in
As shown in
In some examples, such as that shown in
As shown in
With continued reference
In examples such as those illustrated in
It is to be appreciated that any method of reducing the radial distance (that is, distance R as illustrated in
Also disclosed herein are frames for prosthetic heart valves in which the actuated struts are axial posts (sometimes called vertical posts) with a collapsible window or aperture to facilitate a change in the length of the post along the longitudinal axis of the frame. When stresses are imparted on an axial post including such features, the post can deflect (that is, change shape or elastically deform) to accommodate the actuator and/or to relieve the axial forces acting on the actuator and/or the post. In this way, the degree to which the actuator bends with the frame during the radial compression and/or expansion of the frame can be reduced, and the tendency of the actuator to buckle or bend can be mitigated or prevented.
Returning to
With continued reference to
The fixed end portion 810 of the first post 806 with the collapsible aperture 814 is shown in greater detail in
As shown in
In some examples, the legs 820a, 820b can have a thickness ranging from 0.15 mm to 0.3 mm at the maximum thickness points along the first and second end portions 822, 824 of each strut. In a specific example, the legs 820a, 820b can have a thickness of 0.2 mm at the maximum thickness points along the first and second end portions 822, 824 of each strut. The legs 820a, 820b can also have a thickness ranging from 0.12 to 0.15 mm at the minimum thickness point at the joint 826 of each strut. In such examples, the legs 820a, 820b can form a collapsible aperture 814 with a height of 3 mm along the first axis A1 and a width of 1.3 mm along the second axis A2, when the window 816 is in an undeflected and/or neutral state (that is, when there are no axially-directed compressive or tensile forces acting on the first post 806).
It will be appreciated by one of ordinary skill in the art that the relative thicknesses of the points of minimum and maximum thickness can be related to one another, and may be selected to control the reaction of the collapsible aperture 814 to axial (that is, tensile or compressive) forces. For example, when the ratio of minimum thickness to maximum thickness is lower, the collapsible aperture 814 may deflect further or under lighter loads, and when the ratio of minimum thickness to maximum thickness is higher, the collapsible aperture 814 can deflect to a lesser degree or require heavier loads to begin deflecting.
In general, when compressive forces act on the first post 806, the legs 820a, 820b forming the collapsible aperture 814 can bend at the joints 826, bringing the axial vertices 828 closer together and pushing the lateral vertices 830 further apart to axially foreshorten the first post 806, as shown in
In one example, the prosthetic heart valve including frame 800 can be advanced by a delivery device, such as the delivery device 200 described herein and illustrated in
The prosthetic heart valve including the frame 800 can initially be constrained to a crimped state by a delivery sheath such as the delivery capsule 222 or adjustable loop 224 described herein. While constrained to the crimped state, the frame 800 can have a substantially unbowed shape, and the actuator 106 can be substantially straight along the longitudinal axis of the frame 800. Because the actuator 106 is substantially straight along the longitudinal axis of the frame 800, little or no compressive force is imparted to the first post 806 and the collapsible aperture 814 can remain in the axially extended state.
At the desired implantation site, the prosthetic valve including frame 800 can be deployed from the delivery capsule 222 or the adjustable lasso 224, and the frame 800 can radially expand from the crimped state to a radially compressed state (see
The frame 800 can also be mechanically expanded from the radially compressed state to a radially expanded state (see
In some circumstances, such as during post ballooning or a valve-in valve procedure, it may also be necessary to expand the diameter of the frame 800 further than can be accomplished solely by the rotation of the actuators 106 relative to the first post 806 and the second post 808. For example, in a valve in valve procedure, a patient has a first prosthetic heart valve pre-installed. In such examples, it may be necessary to replace the valvular structure of the first prosthetic heart valve with the valvular structure of a second prosthetic heart valve. To do this, a second prosthetic heart valve is advanced to the implantation site of the first prosthetic heart valve, and thereafter expanded to the desired diameter. Typically, the desired diameter of the second prosthetic heart valve is large enough to require expansion of the frame of the first prosthetic heart valve to accommodate the second heart valve, such that the frame of the first prosthetic heart valve provides an anchoring site for the second prosthetic heart valve.
In such cases, the frame 800 can be further radially expanded from the radially expanded state to a radially dilated state by applying a force directed radially outwards to the frame 800, which in some examples can be accomplished by inflating an inflatable balloon positioned radially inwards of the frame 800. As the frame 800 is further radially expanded from the radially expanded state to the radially dilated state, the inflow end portion 108 and the outflow end portion 110 are drawn closer together. This in turn causes the ends of the actuator 106 extending between the first post 806 and the second post 808 to draw closer together, compressing and exerting a bending force on the actuator 106. As the actuator 106 is compressed and/or as the actuator 106 begins to bend, it imparts a compressive force on the free end portion 812 of the first post 806, which can cause the legs 820a, 820b to bend at the joints 826 to axially collapse the aperture 816 and axially foreshorten the first post 806 (see
In some examples, the deflection of the legs 820a, 820b (and therefore the deflection of the first post 806) can occur entirely within the elastic region. For example, the legs 820a, 820b may fold along the joints 826 without exceeding the yield stress of the material used. Thus, the components of the first post 806 can, in such examples, experience no plastic deformation during the radial expansion and/or radial compression of the frame. Therefore, when the axial compressive and/or tensile forces imparted to the first post 806 by the actuator 106 are relieved, the legs 820a, 820b and the first post 806 can return to a “neutral” undeflected state. Advantageously, this may allow such an example frame 800 to be radially adjusted multiple times if needed, without plastically deforming one or more components of the first post 806, which may affect further adjustments.
In this way, the compressible aperture 816 can relieve the bending forces experienced by the actuator 106 through the deployment of the prosthetic heart valve including the frame 800. In turn, this mitigates the tendency of the actuator 106 to buckle as the frame is radially expanded and/or compressed to various diameters.
In one specific example, the frame 800 has a diameter of 7 mm while in the radially crimped state within the delivery capsule 222 or the adjustable loop 224, and the first post 806 is in the axially extended state. In this example, when the frame 800 is deployed from the delivery capsule 222 or the adjustable loop 224, the frame 800 expands to a diameter of 13 mm, and the first post 806 deflects from an axially extended state to an axially compressed state. The actuators 106, 316 can then be rotated to expand the frame 800 to a diameter of 27 mm, which causes the first post 806 to deflect from the axially compressed state to the axially extended state. In such an example, the actuators 106, 316 may be unable to radially expand the frame 800 past a diameter of 27 mm, and the frame 800 can be further expanded, for example up to a diameter of 31 mm, by an inflatable balloon, which causes the first post 806 to deflect from the axially extended state to the axially compressed state.
In some examples, the legs 820a, 820b and the compressible aperture 816 formed thereby can be configured to deflect very little while the compressive forces on the first post 806 are below a given threshold, and to deflect greatly while the compressive forces on the first post 806 exceed the given threshold. For example, the collapsible aperture 814 can be configured to function as a mechanical fuse, changing shape as the legs 820a, 820b deflect if the forces on the first post 806 exceed the load threshold.
In this way, the compressible aperture 816 and the first post 806 can be configured to substantially retain their shape while under lower stresses (for example, compressive stresses), such as those which are unlikely to strain the actuator 106 past the yield point and cause plastic deformation, such as that associated with the buckling of the actuators 106, 316. At the same time, the compressible aperture 816 and the first post 806 can also be configured to rapidly deflect under higher stresses to relieve the stresses on the actuator 106 as they approach the yield point and risk plastic deformation and/or catastrophic buckling of the actuator 106.
In one particular example, illustrated in
In these ways, the frame 800, having a first post 806 with a collapsible aperture 814 can mitigate or prevent the tendency of the actuator 106 of the prosthetic heart valve assemblies described herein from bending or buckling during the expansion and/or compression of the frame 800, by allowing the first post 806 to relieve the compressive stresses experienced by the actuator 106.
The valvular structure 1040 is configured to regulate the flow of blood through the prosthetic valve 1000, from an inflow end 1100 to an outflow end 1120. The valvular structure 1040 can include, for example, a leaflet assembly comprising one or more leaflets 1140 made of flexible material. The leaflets 1140 can be made in whole or part from, biological material, bio-compatible synthetic materials, or other such materials. Suitable biological material can include, for example, bovine pericardium (or pericardium from other sources). The leaflets 1140 can be secured to one another at their adjacent sides to form commissures 1080, each of which can be secured to portions of the frame 1020.
In the illustrated example of
The prosthetic valve 1000 may include one or more skirts mounted around the frame 1020. For example, as shown in
In some examples, the inflow edge portions 1160 (shown in
The inner and outer skirts (for example, the outer skirt 1200 shown in
Further details regarding the assembly of the leaflet assembly and the assembly of the leaflets and the skirts to the frame can be found, for example, in U.S. Provisional Application Nos. 63/209,904, filed Jun. 11, 2021, and 63/224,534, filed Jul. 22, 2021, which are incorporated herein by reference. Further details of the construction and function of the frame 1020 can be found in International Patent Application No. PCT/US2021/052745, filed Sep. 30, 2021, which is incorporated herein by reference.
The frame 1020 includes one or more first frame portions 1400 to which one or more rod actuators 1060 can be coupled. Each first frame portion 1400 can include an inflow actuator portion 1580 (or first post) extending in the axial direction of the frame 1020 and an outflow actuator portion 1600 (or second post) extending in the axial direction of the frame 1020. At the inflow end 1320, an end portion of the inflow actuator portion 1580 forms a first apex 1610 (which can be referred to as “inflow apex”). At the outflow end 1340, an end portion of the second actuator 1600 forms a second apex 1630 (which can be referred to as “outflow apex”). The frame 1020 can include one or more second frame portions 1420 to which the commissures 1080 (shown in
The frame 1020 can include one or more additional support posts 1380. The first frame portions 1400, second frame portions 1420, and support posts 1380 are spaced about a circumference of the frame 1020 and coupled together by a plurality of circumferentially extending struts 1180. For example, the struts 1180 can extend circumferentially between adjacent frame portions/posts to connect all the frame portions/posts together. In the illustrated example, the struts 1180 have curved shapes, which can allow the struts 1180 to deflect more easily in the axial direction (for example, when radially expanding or radially compressing the frame).
The struts 1180 can include a first row of struts 1190 at or near the inflow end 1320 of the frame 1020, a second row of struts 1210 at or near the outflow end 1340, and third and fourth rows of struts 1230, 1250, respectively, positioned axially between the first and second rows of struts 1190, 1210. As illustrated in
Each first cell 1270 can have an axially-extending hexagonal shape. Each second cell 1290 can have a diamond shape. In some examples, the frame 1020 can comprise six first cells 1270 extending circumferentially in a row, six second cells 1290 extending circumferentially in a row within the six first cells 1270, and twelve support posts 1380. However, in other examples, the frame 1020 can have a greater or fewer number of first cells 1270 and a correspondingly greater or fewer number of second cells 1290 and support posts 1380.
The frame 1020 can have any number, arrangement, and configuration of the frame portions 1400, 1420 and posts 1380. For example, the frame 1020 can have three second frame portions 1420 spaced around the circumference of the frame 1020, which can be used to couple up to three commissures 1080 of a valvular structure to the frame 1020. In one example, the frame 1020 can have six first frame portions 1400, which can be used to couple up to six rod actuators 1060 to the frame 1020. In some examples, the first frame portions 1400 can be grouped in pairs that are spaced around the circumference of the frame 1020 (for example, the first frame portions 1400a, 1400b as indicated in
The commissure support 1440 of the second frame portion 1420 can have strut portions defining a commissure window (or commissure opening) 1460. The commissure window 1460 extends radially through a thickness of the commissure support 1440 and can be configured to accept a commissure 1080 (shown in
The commissure windows 1460 are spaced apart about the circumference of frame 1020. The spacing may or may not be uniform. In one example, the proximal ends 1460a (upper ends in
The rod actuator 1060 can include a threaded rod 1620 having a head portion 1640 configured to be releasably coupled to an actuator assembly of a delivery apparatus. The rod actuator 1060 can further include a stopper 1660 (for example, in the form of a nut, washer, collar, or flange) disposed on the threaded rod 1620 such that the stopper 1660 is fixed axially on the threaded rod 1620 and can move in lockstep with the threaded rod 1620 when the threaded rod 1620 is rotated. The stopper 1660 can be integrally formed on the threaded rod or separately formed and coupled to the threaded rod 1620 (for example, by welding, an adhesive, or with a mechanical fastener) such that the stopper 1660 can remain in a fixed axial position on the threaded rod 1620. As will be further described, the stopper 1660 can engage an edge of a stopper window formed in a first frame portion 1400 for radially compressing the frame 1020.
Referring to
The inflow actuator portion 1580 can include a nut window 1670 in which a nut 1690 is mounted. The nut 1690 includes a bore with internal threads. The threaded bore of the nut 1690 can be aligned with the inner bore 1730 of the inflow actuator portion 1580 such that the threaded rod 1620 can extend into the inner bore 1730 of the inflow actuator portion 1580 and through the bore of the nut 1690. The threaded rod 1620 includes external threads that engage the internal threads of the bore of the nut 1690. In some examples, the portions of the inner bore 1730 of the inflow actuator portion 1580 located above and below the nut 1690 can have a smooth and/or non-threaded inner surface to allow the threaded rod 1620 to slide freely within the inner bore 1730 while being threadedly engaged with the nut 1690.
In some examples, the nut 1690 can be held in a fixed position relative to the inflow actuator portion 1580 (for example, fixed to the edges of the nut window 1670). Since the nut 1690 is fixed relative to the inflow actuator portion 1580, rotation of the threaded rod 1620 relative to the nut 1690 moves the threaded rod 1620 axially along the nut 1690. When the threaded rod 1620 is not rotated relative to the nut 1690, the threaded engagement between the threaded rod 1620 and the nut 1690 retains the threaded rod 1620 on the inflow actuator portion 1580. Thus, axial movement of the threaded rod 1620 to radially compress or radially expand the prosthetic valve is only possible when the threaded rod 1620 is rotated relative to the nut 1690.
In other examples, in lieu of using the nut 1690, at least a portion of the inner bore 1730 of the inflow actuator portion 1580 can be threaded. For example, the proximal portion 1730b and/or the distal portion 1730a of the inner bore 1730 of the inflow actuator portion 1580 can comprise inner threads that engage the external threads of the threaded rod 1620 such that rotation of the threaded rod 1620 causes the threaded rod 1620 to move axially relative to the inflow actuator portion 1580.
The threaded rod 1620 extending through the inflow and outflow actuator portions 1580, 1600 and threadedly engaged with the inflow actuator portion 1580 can serve as an expansion and locking mechanism for the frame 1020. Such an expansion and locking mechanism can be formed at each of or some of the first frame portions 1400 on the frame 1020. If an expansion and locking mechanism is not desired at a specific first frame portion 1400, a threaded rod 1620 need not extend through the inflow and outflow actuator portions 1580, 1600 of the specific first frame portion. Thus, the frame 1020 can have one or more expansion and locking mechanisms spaced about the circumference of the frame 1020. In the illustrated example, the external threads of the threaded rod 1620 are shown to extend along the rod within the gap G to the distal end 1600a of the outflow actuator portion 1600, however, this is not required. The external threads need only be present on the portion of the threaded rod 1620 that engages the internal threads of the nut 1690 or the internal threads of the inner bore 1730 when the frame is in the radially compressed state and the radially expanded state.
The threaded rod 1620 can be rotated relative to the nut 1690, the inflow actuator portion 1580, and the outflow actuator portion 1600 to axially foreshorten the frame 1020, thereby radially expanding the frame 1020, or to axially elongate the frame 1020, thereby radially compressing the frame 1020. For example, when the threaded rod 1620 is rotated relative to the nut 1690 in one direction, the inflow actuator portion 1580 and the outflow actuator portion 1600 can move axially relative to one another to increase an axial length of the gap G (or widen the gap G), thereby radially compressing the frame 1020 (or the prosthetic valve in general). When the threaded rod 1620 is rotated relative to the nut 1690 in an opposite direction, the inflow actuator portion 1580 and the outflow actuator portion 1600 can move axially relative to one another to decrease the axial length of the gap G (or narrow the gap G), thereby radially expanding the frame 1020 (or the prosthetic valve in general).
In one example, the rod actuator 1060 can be assembled to the first frame portion 1400 by separating the stopper 1660 from the threaded rod 1620, disposing the stopper 1660 within the stopper window 1700 such that the bore of the stopper 1660 is aligned with the inner bore 1710 of the outflow actuator portion 1600, and then inserting the threaded rod 1620 into the inner bore 1710 (for example, from the outflow apex 1630 or outflow end 1340 of the frame) and through the stopper 1660. The stopper 1660 can then be fixedly coupled to the threaded rod 1620 using various techniques and mechanisms, such as by welding, an adhesive, or a mechanical fastener (for example, a pin or screw extending laterally through the stopper and into the threaded rod). Alternatively, other methods of coupling the stopper 1660 to the threaded bore 1620 such that the stopper 1660 is fixed at a desired axial position on the threaded rod 1620 can be used. For example, the stopper 1660 can be a hinged or split collar that can be mounted around the threaded rod 1620 while the threaded rod 1620 extends through the stopper window 1700. The stopper 1660 is not fixed relative to the stopper window 1700 such that the stopper 1660 can move freely within the stopper window 1700, which would allow the stopper 1660 to move in lockstep with the threaded rod 1620 and remain at a fixed axial position on the threaded rod 1620 as the threaded rod 1620 is rotated (for example, during expansion or compression of the frame 1020).
In one example, the frame 1020 can be radially compressed (or crimped) by rotating the rod actuator 1060 in a direction that causes the threaded rod 1620 to move axially in a proximal direction (for example, in a direction towards the outflow end 1340). Since the stopper 1660 is axially fixed in position relative to the threaded rod 1620, the proximal axial movement of the threaded rod 1620 results in proximal axial movement of the stopper 1660 within the stopper window 1700. The stopper 1660 can move proximally (or towards the outflow end 1340) as the threaded rod 1620 is rotated until the stopper 1660 abuts the proximal edge 1700a of the stopper window 1700, as shown in
Rotating the rod actuator 1060 in the opposite direction causes the head portion 1640 to apply a distally directed force to outflow actuator portion 1600 via contact with an adjacent surface of the frame (for example, surface 1680a), while the nut 1690 and the inflow actuator portion 1580 move proximally along the threaded rod 1620. This causes the inflow actuator portion 1580 to move closer to the outflow actuator portion 1600, thereby axially foreshortening and radially expanding the frame.
The stopper 1660 is fixed axially on the threaded rod 1620 and can be axially offset from the head portion 1640 by a distance d4 (shown in
The distal edge 1700b of the stopper window 1700 is axially offset from the outflow end 1340 by a distance d2 (shown in
The leaflets 1140 (shown in
In some examples, as illustrated in
In one example, a depth d3 of the recess 1680 can be equal to or greater than a height h1 of the head portion 1640 such that the head portion 1640 can be fully disposed (or hidden) within the recess 1680 (that is, the proximal end of the head portion 1640 is flush or recessed relative to the outflow end 1340 as illustrated, for example, in
To radially expand the prosthetic valve, the threaded rod 1620 can be rotated relative to the nut 1690 (shown in
In some examples, after radially expanding the frame 1020 (or prosthetic valve) to a working diameter, the stopper 1660 is at an axial position within the stopper window 1700 that is offset from the proximal edge 1700a of the stopper window 1700 by a distance d5>0 (as illustrated in
As the outflow actuator portion 1600 moves towards the inflow actuator portion 1580, the proximal edge 1700a of the stopper window moves towards the stopper 1660. The frame 1020 can be over-expanded via the expansion tool until the proximal edge 1700a of the stopper window 1700 engages the stopper 1660, at which point the distance d5 is now zero and over-expansion of the frame is no longer possible. Therefore, the stopper 1660 also acts to limit over-expansion of the frame 1020. One practical use of over-expanding the frame 1020 is to allow reshaping or remodeling of the annulus into a more circular shape, thereby allowing the prosthetic valve to be deployed uniformly in a circular shape. When the outward radial force applied by the expansion tool is removed (for example, the inflatable balloon is deflated), the frame 1020 returns to its initial expanded state, and the annulus can relax and form a seal around the prosthetic valve.
The inflow end portion of one or more of the posts 1380, 1440 can include an extension 1800 (shown in
In some examples, the outer skirt 1200 can be mounted around the outer surface of frame 1020 as shown in
The frame 1020 can be a unitary and/or fastener-free frame that can be constructed from a single piece of material (e.g., Nitinol, stainless steel or a cobalt-chromium alloy), such as in the form of a tube. The plurality of cells 1270, 1290 (shown in
In some examples, the frame 1020 can be formed from a plastically-expandable material, such as stainless steel or a cobalt-chromium alloy. When the frame is formed from a plastically-expandable material, the prosthetic valve 1000 can be placed in a radially compressed state along the distal end portion of a delivery apparatus for insertion into a patient's body. When at the desired implantation site, the frame 1020 (and therefore the prosthetic valve 1000) can be radially expanded from the radially compressed state to a radially expanded state via actuation of actuation assemblies of the delivery apparatus (as further described below), which rotate the threaded rods 1620 to produce expansion of the frame 1020. During delivery to the implantation site, the prosthetic valve 1000 can be placed inside of a delivery capsule (sheath) to protect against the prosthetic valve contacting the patient's vasculature, such as when the prosthetic valve is advanced through a femoral artery. The capsule can also retain the prosthetic valve in a compressed state having a slightly smaller diameter and crimp profile than may be otherwise possible without a capsule by preventing any recoil (expansion) of the frame once it is crimped onto the delivery apparatus.
In other examples, the frame 1020 can be formed from a self-expandable material (e.g., Nitinol). When the frame 1020 is formed from a self-expandable material, the prosthetic valve can be radially compressed and placed inside the capsule of the delivery apparatus to maintain the prosthetic valve in the radially compressed state while it is being delivered to the implantation site. When at the desired implantation site, the prosthetic valve is deployed or released from the capsule. In some examples, the frame (and therefore the prosthetic valve) can partially self-expand from the radially compressed state to a partially radially expanded state. The frame 1020 (and therefore the prosthetic valve 1000) can be further radially expanded from the partially expanded state to a further radially expanded state via actuation of actuation assemblies of the delivery apparatus (as further described below), which rotate the rods 1620 to produce expansion of the frame.
In the illustrated example, the delivery apparatus 2000 generally includes a handle 2040, a first elongated shaft 2060 (which comprises an outer shaft) extending distally from the handle 2040, one or more actuator assemblies 2080 extending distally through the first shaft 2060, a second elongated shaft 2090 (which comprises an inner shaft) extending through the first shaft 2060, and a nosecone 2100 coupled to a distal end portion of the second shaft 2090. The second shaft 2090 and the nosecone 2100 can define a guidewire lumen for advancing the delivery apparatus through a patient's vasculature over a guidewire. Each actuator assembly 2080 can be configured to radially expand and/or radially collapse the prosthetic valve 1000 when actuated, such as by one or more knobs 2110, 2120, 2140 of the handle 2040.
Though the illustrated example shows two actuator assemblies 2080 for purposes of illustration, it should be understood that one actuator assembly 2080 can be provided for each actuator (for example, rod actuator 1060/threaded rod 1620) on the prosthetic valve. For example, three actuator assemblies 2080 can be provided for a prosthetic valve having three actuators. In other embodiments, a greater or fewer number of actuator assemblies can be present.
In some examples, a distal end portion 2160 of the shaft 2060 can be sized to house the prosthetic valve in its radially compressed, delivery state during delivery of the prosthetic valve through the patient's vasculature. In this manner, the distal end portion 2160 functions as a delivery sheath or capsule for the prosthetic valve during delivery.
The actuator assemblies 2080 can be releasably coupled to the prosthetic valve 1000. In the illustrated example, each actuator assembly 2080 can be coupled to a respective actuator (for example, rod actuator 1060/threaded rod 1620 in
The handle 2040 of the delivery apparatus 2000 can include one or more control mechanisms (for example, knobs or other actuating mechanisms) for controlling different components of the delivery apparatus 2000 in order to expand and/or deploy the prosthetic valve 1000. In the illustrated example, the handle 2040 includes first, second, and third knobs 2110, 2120, and 2140, respectively.
The first knob 2110 can be a rotatable knob configured to produce axial movement of the first shaft 2060 relative to the prosthetic valve 1000 in the distal and/or proximal directions in order to deploy the prosthetic valve from the delivery sheath 2160 once the prosthetic valve has been advanced to a location at or adjacent the desired implantation location with the patient's body. For example, rotation of the first knob 2110 in a first direction (e.g., clockwise) can retract the sheath 2160 proximally relative to the prosthetic valve 1000 and rotation of the first knob 2110 in a second direction (e.g., counter-clockwise) can advance the sheath 2160 distally. In other embodiments, the first knob 2110 can be actuated by sliding or moving the first knob 2110 axially, such as pulling and/or pushing the knob. In other embodiments, actuation of the first knob 2110 (rotation or sliding movement of the first knob 2110) can produce axial movement of the actuator assemblies 2080 (and therefore the prosthetic valve 1000) relative to the delivery sheath 2160 to advance the prosthetic valve distally from the sheath 2160.
The second knob 2120 can be a rotatable knob configured to produce radial expansion and/or compression of the prosthetic valve 1000. For example, rotation of the second knob 2120 can rotate the threaded rods of the prosthetic valve 1000 via the actuator assemblies 2080. Rotation of the second knob 2120 in a first direction (e.g., clockwise) can radially expand the prosthetic valve 1000 and rotation of the second knob 2120 in a second direction (e.g., counter-clockwise) can radially collapse the prosthetic valve 1000. In other embodiments, the second knob 2120 can be actuated by sliding or moving the second knob 2120 axially, such as pulling and/or pushing the knob.
The third knob 2140 can be a rotatable knob operatively connected to a proximal end portion of each actuator assembly 2080. The third knob 2140 can be configured to retract an outer sleeve or support tube of each actuator assembly 2080 to disconnect the actuator assemblies 2080 from the proximal portions of the actuators of the prosthetic valve (e.g., threaded rod). Once the actuator assemblies 2080 are uncoupled from the prosthetic valve 1000, the delivery apparatus 2000 can be removed from the patient, leaving just the prosthetic valve 1000 in the patient.
In some examples, the head portion 1640 of the threaded rod 1620 is configured to be releasably coupled to a respective actuator assembly 3000 of the delivery apparatus 2000. For example, the head portion 1640 can include first and second protrusions 1900, defining a channel or slot 1920 between them, and one or more shoulders 1940.
Each actuator assembly 3000 can include a first actuation member configured as a support tube or outer sleeve 3020 and a second actuation member configured as a driver 3040. The driver 3040 can extend through the outer sleeve 3020 (the outer sleeve 3020 is shown transparently in
The proximal portions of the outer sleeve 3020 and driver 3040 can be operatively coupled to the handle of a delivery apparatus (for example, the handle 2040 shown in
The distal end portion of the driver 3040 can include a central protrusion 3060 configured to extend into the slot 1920 of the head portion 1640 of the rod actuator 1060. The distal end portion of the driver 3040 can include one or more flexible elongated elements or arms 3080 having protrusions or teeth 3100 configured to be releasably coupled to the shoulders 1940 of the head portion 1640 of the rod actuator 1060. The protrusions 3100 can extend radially inwardly toward a longitudinal axis of the second actuation member 3040. As shown in
As shown in
Because the central protrusion 3060 of the driver 3040 extends into the slot 1920 of the head portion 1640 when the driver 3040 and the rod actuator 1060 are coupled, the driver 3040 and the rod actuator 1060 can be rotationally locked such that they co-rotate. So coupled, the driver 3040 can be rotated (for example, using knob 2120 of the handle of the delivery apparatus 2000 shown in
The outer sleeve 3020 can be advanced distally relative to the driver 3040 past the elongated elements 3080, until the outer sleeve 3020 engages the frame 1020 (for example, an outflow actuator portion 1600 of the frame 1020). The distal end portion of the outer sleeve 3020 also can comprise first and second support extensions 3120 defining gaps or notches 3140 between the extensions 3120. The support extensions 3120 can be oriented such that, when the actuator assembly 3000 is coupled to a respective rod actuator 1060, the support extensions 3120 extend partially over an adjacent end portion (for example, the upper end portion) of a respective outflow actuator portion 1600 on opposite sides of the outflow actuator portion 1600. The engagement of the support extensions 3120 with the frame 1020 in this manner can counteract rotational forces applied to the frame 1020 by the rod actuator 1060 during expansion of the frame 1020. In the absence of a counter-force acting against these rotational forces, the frame can tend to “jerk” or rock in the direction of rotation of the rods when they are actuated to expand the frame. The illustrated configuration is advantageous in that outer sleeves, when engaging the second posts 1600 of the frame 1020, can prevent or mitigate such jerking or rocking motion of the frame 1020 when the frame 1020 is radially expanded.
To decouple the actuator assembly 3000 from the prosthetic device 1000, the sleeve 3020 can be withdrawn proximally relative to the driver 3040 until the sleeve 3020 no longer covers the elongated elements 3080 of the driver 3040. As described above, the sleeve 3020 can be used to hold the elongated elements 3080 against the shoulders 1940 of the head portion 1640 of the rod actuator 1060 since the elongated elements 3080 can be naturally biased to a radial outward position where the elongated elements 3080 do not engage the shoulders 1940 of the head portion 1640. Thus, when the sleeve 3020 is withdrawn such that it no longer covers/constrains the elongated elements 3080, the elongated elements 3080 can naturally and/or passively deflect away from, and thereby release from, the shoulders 1940 of the threaded rod 1620, thereby decoupling the driver 3040 from the rod actuator 1060. The sleeve 3020 can be advanced (moved distally) and/or retracted (moved proximally) relative to the driver 3040 via a control mechanism (for example, knob 2140 shown in
For implanting the prosthetic valve within an anatomy, the prosthetic valve can be delivered to the implantation site in a radially compressed configuration. At the delivery site, the prosthetic valve can be radially expanded to the working diameter. When the frame of the prosthetic valve is expanded to the working diameter, the head portion 1640 of the rod actuator 1060 can be recessed relative to the outflow end of the frame (for example, hidden within a recess formed at an outflow apex 1630 of the frame as illustrated in
For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (for example, by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a delivery capsule to allow the prosthetic valve to self-expand). Alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve. Alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-sternotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.
For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.
For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve/pulmonary artery.
Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.
In all delivery approaches, the delivery apparatus can be advanced over a guidewire and/or an introducer sheath previously inserted into a patient's vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art.
Advantageously, prosthetic heart valves according to the examples previously discussed can reduce the bending stresses on the attached actuators by reducing the radial displacement between the end portions and the center portions of the actuators. In turn, this may mitigate the tendency of the actuators to bend or buckle during the implantation procedure and reduce resulting impairment to the ability of the prosthetic heart valve to be radially expanded or contracted at the desired implantation site.
Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat/thermal, pressure, steam, radiation, and/or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples heat/thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example.
Example 1: A prosthetic valve comprises a frame having an axial direction extending from an inflow end to an outflow end, a first frame portion extending in the axial direction, and a first window formed in the first frame portion. The prosthetic valve comprises a threaded rod coupled to the first frame portion and extending through the first window, wherein rotation of the threaded rod relative to the first frame portion in a first direction radially expands the frame and rotation of the threaded rod relative to the first frame portion in a second direction that is opposite to the first direction radially compresses the frame. The prosthetic valve comprises a stopper disposed within the first window and coupled to the threaded rod, wherein the stopper is fixed in axial position relative to the threaded rod and axially movable within the first window by rotation of the threaded rod, and wherein the stopper can engage a first edge of the window to produce radial compression of the frame.
Example 2: The prosthetic valve of any example herein, particularly Example 210, wherein the first frame portion comprises a first actuator portion and a second actuator portion aligned in the axial direction, wherein an end portion of the first actuator portion forms a first apex at the inflow end, wherein an end portion of the second actuator portion forms a second apex at the outflow end, and wherein the first window is formed in the second actuator portion.
Example 3: The prosthetic valve of any example herein, particularly Example 2, wherein the first actuator portion includes a first end, wherein the second actuator portion includes a second end in opposing relation to the first end and separated from the first end by a gap, and wherein rotation of the threaded rod in the first direction decreases a size of the gap and rotation of the threaded rod in the second direction increases the size of the gap.
Example 4: The prosthetic valve of any example herein, particularly Example 3, wherein the first window is connected to the first end by a first bore formed in the second actuator portion, and wherein a diameter of the stopper is larger than a diameter of the first bore to prevent passage of the stopper through the first bore.
Example 5: The prosthetic valve of any example herein, particularly Example 4, wherein the threaded rod extends through the stopper.
Example 6: The prosthetic valve of any example herein, particularly any one of Examples 4-5, wherein the threaded rod includes a head portion, and further comprising a recess formed in the second apex to receive the head portion.
Example 7: The prosthetic valve of any example herein, particularly Example 6, wherein a depth of the recess is equal to or greater than a height of the head portion.
Example 8: The prosthetic valve of any example herein, particularly any one of Examples 6-7, wherein the recess is connected to the first window by a second bore formed in the second actuator portion, and wherein a diameter of the stopper is larger than a diameter of the second bore to prevent passage of the stopper through the second bore.
Example 9: The prosthetic valve of any example herein, particularly Example 8, wherein the threaded rod extends through the second bore, the first window, and the first bore, and wherein a diameter of the head portion is larger than a diameter of the second bore to prevent passage of the head portion through the second bore.
Example 10: The prosthetic valve of any example herein, particularly Example 2-9, wherein the threaded rod is threadedly engaged with the first actuator portion, and wherein rotation of the threaded rod relative to the first actuator portion radially expands or radially compresses the frame.
Example 11: The prosthetic valve of any example herein, particularly Example 10, wherein the first actuator portion includes a threaded bore or a threaded nut that threadedly engages with the threaded rod.
Example 12: The prosthetic valve of any example herein, particularly any one of Examples 2-11, further comprising a valvular structure disposed inside the frame and having at least one commissure.
Example 13: The prosthetic valve of any example herein, particularly Example 12, wherein the frame comprises a second frame portion spaced from the first frame portion along a circumference of the frame, and wherein the second frame portion comprises a second window configured to receive the at least one commissure.
Example 14: The prosthetic valve of any example herein, particularly Example 13, wherein the first window is positioned between the outflow end and the second window in the axial direction.
Example 15: The prosthetic valve of any example herein, particularly any one of Examples 13-14, wherein the frame comprises a plurality of first struts connecting the first actuator portion to the second frame portion and a plurality of second struts connecting the second actuator portion to the second frame portion.
Example 16: The prosthetic valve of any example herein, particularly any one of Examples 1-15, further comprising a skirt assembly coupled to the frame.
Example 17: The prosthetic valve of any example herein, particularly any one of Examples 1-16, further comprises a plurality of first frame portions extending in the axial direction and spaced along a circumference of the frame and a plurality of first windows formed in the plurality of first frame portions. The prosthetic valve further comprises a plurality of threaded rods coupled to the plurality of first frame portions and extending through the plurality of first windows, wherein rotation of each threaded rod relative to the respective first frame portion in a first direction radially expands the frame and rotation of each threaded rod relative to the respective first frame portion in a second direction that is opposite to the first direction radially compresses the frame. The prosthetic valve further comprises a plurality of stoppers disposed within the plurality of first windows and coupled to the plurality of threaded rods extending through the plurality of first windows, wherein each stopper is fixed in axial position relative to the respective threaded rod and axially movable within the respective first window by rotation of the respective threaded rod, and wherein each stopper can engage a first edge of the respective first window to produce radial compression of the frame.
Example 18: A prosthetic valve comprises a frame having an axial direction extending from an inflow end to an outflow end, a first frame portion extending in the axial direction, a second frame portion extending in the axial direction, a first window formed in the first frame portion, a second window formed in the second frame portion, wherein the first window is positioned axially between the second window and the outflow end in the axial direction. The prosthetic valve comprises a threaded rod coupled to the first frame portion and extending through the first window, wherein rotation of the threaded rod relative to the first frame portion in a first direction radially expands the frame and rotation of the threaded rod relative to the first frame portion in a second direction that is opposite to the first direction radially compresses the frame. The prosthetic valve comprises a stopper fixedly coupled to the threaded rod and disposed within the first window, wherein the stopper can engage a first edge of the first window to produce radial compression of the frame. The prosthetic valve comprises a valvular structure disposed inside the frame and having a commissure received in the second window.
Example 19: The prosthetic valve of any example herein, particularly Example 18, wherein the first frame portion includes a first actuator portion and a second actuator portion aligned in the axial direction, wherein an end portion of the first actuator portion forms a first apex at the inflow end, wherein an end portion of the second actuator portion forms a second apex at the outflow end, and wherein the first window is formed in the second actuator portion.
Example 20: The prosthetic valve of any example herein, particularly Example 19, wherein the first actuator portion has a first end, wherein the second actuator portion has a second end in opposing relation to the first end and separated from the first end by a gap, and wherein the rod actuator extends across the gap.
Example 21: The prosthetic valve of any example herein, particularly any one of Examples 19-20, wherein the threaded rod extends through the stopper.
Example 22: The prosthetic valve of any example herein, particularly any one of Examples 19-21, wherein a recess is formed in the second apex, and wherein the threaded rod includes a head portion received in the recess.
Example 23: The prosthetic valve of any example herein, particularly Example 22, wherein a depth of the recess is equal to or greater than a height of the head portion.
Example 24: The prosthetic valve of any example herein, particularly any one of Examples 19-23, wherein the frame comprises a plurality of first struts connecting the first actuator portion to the second frame portion and a plurality of second struts connecting the second actuator portion to the second frame portion.
Example 25: The prosthetic valve of any example herein, particularly any one of Examples 18-24, further comprising a skirt assembly coupled to the frame.
Example 26: The prosthetic valve of any example herein, particularly any one of Examples 18-25, further comprises a plurality of first frame portions extending in the axial direction and spaced along a circumference of the frame and a plurality of first windows formed in the plurality of first frame portions. The prosthetic valve comprises a plurality of threaded rods coupled to the plurality of first frame portions and extending through the plurality of first windows, wherein rotation of each of the plurality of threaded rods relative to the respective first frame portion in the first direction radially expands the frame and rotation of each of the plurality of threaded rods relative to the respective first frame portion in a second direction that is opposite to the first direction radially compresses the frame. The prosthetic valve comprises a plurality of stoppers fixedly coupled to the plurality of threaded rods and disposed within the plurality of first windows, wherein each of the plurality of stoppers can engage a first edge of the respective first window to produce radial compression of the frame.
Example 27: A prosthetic valve comprises a frame having an axial direction extending from an inflow end to an outflow end, a first frame portion extending in the axial direction, the first frame portion comprising a first actuator portion connected to the inflow end at a first apex, a second actuator portion connected to the outflow end at a second apex, and a recess formed in the second apex. The prosthetic valve comprises a threaded rod including a head portion, the threaded rod extending through the first actuator portion and the second actuator portion and threadedly engaged with the first actuator portion with the head portion received in the recess, wherein a height of the head portion is equal to or less than a depth of the recess, wherein rotation of the threaded rod relative to the first actuator portion in a first direction radially expands the frame and rotation of the threaded rod relative to the first actuator portion in a second direction that is opposite to the first direction radially compresses the frame.
Example 28: The prosthetic valve of any example herein, particularly Example 27, further comprising a first window formed in the second actuator portion and axially displaced from the recess, wherein the threaded rod extends through the first window.
Example 29: The prosthetic valve of any example herein, particularly Example 28, further comprising a stopper fixedly coupled to the threaded rod and disposed within the first window, wherein the stopper can engage a first edge of the first window to produce radial compression of the frame.
Example 30: The prosthetic valve of any example herein, particularly any one of Examples 28-29, further comprising a valvular structure disposed inside the frame and having at least one commissure.
Example 31: The prosthetic valve of any example herein, particularly Example 30, wherein the frame comprises a second frame portion spaced from the first frame portion along a circumference of the frame, and wherein the second frame portion comprises a second window configured to receive the at least one commissure.
Example 32: The prosthetic valve of any example herein, particularly Example 31, wherein the first window is positioned axially between the outflow end and the second window in the axial direction.
Example 33: The prosthetic valve of any example herein, particularly any one of Examples 27-32, further comprises a plurality of first frame portions extending in the axial direction and spaced along a circumference of the frame, the plurality of first frame portions comprising a plurality of first actuator portions connected to the inflow end at a plurality of first apices, a plurality of second actuator portions connected to the output end at a plurality of second apices, and a plurality of recesses formed in the plurality of second apices. The prosthetic valve comprises a plurality of threaded rods extending through the plurality of first actuator portions and the plurality of second actuator portions and threadedly engaged with the plurality of first actuator portions, each of the plurality of threaded rods having a head portion received in a respective recess, wherein rotation of each of the plurality of threaded rods relative to the respective first actuator portion in a first direction radially expands the frame and rotation of each of the plurality of threaded rods relative to the first action actuator in a second direction radially compresses the frame.
Example 34: A prosthetic valve comprises a frame having an axial direction extending from an inflow end to an outflow end, a plurality of first frame portions spaced about a circumference of the frame, and a first window formed in each of the first frame portions. The prosthetic valve comprises a plurality of threaded rods, each threaded rod coupled to one of the first frame portions and extending through the respective first window formed in the one of the first frame portions, wherein rotation of each threaded rod relative to the respective first frame portion in a first direction radially expands the frame and rotation of each threaded rod relative to the respective first frame portion in a second direction that is opposite to the first direction radially compresses the frame. The prosthetic valve comprises at least one stopper fixedly coupled to one of the threaded rods and disposed within the first window receiving the one of the threaded rods, wherein the at least one stopper can engage a first edge of the respective first window to produce radial compression of the frame.
Example 35: The prosthetic valve of any example herein, particularly Example 34, wherein a stopper is fixedly coupled to each of the threaded rods and disposed within the first window receiving the threaded rod.
Example 36: The prosthetic valve of any example herein, particularly any one of Examples 34-35, wherein each first frame portion comprises a first actuator portion and a second actuator portion aligned in the axial direction, wherein the first actuator portion is connected to the inflow end, wherein the second actuator portion is connected to the outflow end, and wherein the first window of the first frame portion is formed in the second actuator portion.
Example 37: The prosthetic valve of any example herein, particularly Example 36, wherein the first actuator portion of each first frame portion has a first end, wherein the second actuator portion of each first frame portion has a second end in opposing relation to the first end and separated from the first end by a gap, and wherein the rod actuator coupled to each first frame portion extends across the respective gap.
Example 38: The prosthetic valve of any example herein, particularly Example 36, wherein the threaded rod extends through the at least one stopper.
Example 39: The prosthetic valve of any example herein, particularly Example 38, wherein the at least one stopper comprises a threaded bore, and wherein the threaded rod is threadedly engaged with the threaded bore.
Example 40: The prosthetic valve of any example herein, particularly any one of
Examples 38-39, further comprising a recess formed in an end portion of the second actuator portion adjacent to the outflow end, and wherein the threaded rod includes a head portion disposed in the recess.
Example 41: The prosthetic valve of any example herein, particularly Example 40, wherein a depth of the recess is equal to or greater than a height of the head portion.
Example 42: The prosthetic valve of any example herein, particularly any one of Examples 34-41, wherein the frame comprises a plurality of second frame portions circumferentially spaced about the circumference of the frame and a second window formed in each of the second frame portions.
Example 43: The prosthetic valve of any example herein, particularly Example 42, wherein the first windows are positioned closer to the outflow end compared to the second windows in the axial direction.
Example 44: The prosthetic valve of any example herein, particularly Example 43, further comprising a valvular structure disposed inside the frame, the valvular structure having at least one commissure received in one of the second windows.
Example 45: The prosthetic valve of any example herein, particularly any one of Examples 34-44, comprising a plurality of stoppers, wherein each stopper is coupled to one of the plurality of threaded rods and disposed within a respective first window receiving the threaded rod, and wherein each stopper can engage a first edge of the respective first window to produce radial compression of the frame.
Example 46: The prosthetic valve of any example herein, particularly any one of Examples 1-45, wherein the prosthetic valve is sterilized.
Example 47: A method comprises coupling a prosthetic valve to a distal end of a delivery apparatus, wherein the prosthetic valve comprises a frame having an axial direction extending from an inflow end to an outflow end and having a first actuator portion and a second actuator portion aligned along the axial direction, a threaded rod coupled to the first actuator portion and extending axially through the second actuator portion, and a stopper fixedly coupled to the threaded rod and disposed within a window formed in the second actuator portion. The method comprises rotating the threaded rod in a first direction to cause the stopper to engage a first edge of the window, thereby causing the first actuator portion to move away from the second actuator portion and radially compress the prosthetic valve.
Example 48: The method of any example herein, particularly Example 47, wherein rotating the threaded rod in the first direction axially displaces the stopper in a direction towards the outflow end.
Example 49: The method of any example herein, particularly any one of Examples 47-48, further comprising rotating the threaded rod in a second direction that is opposite to the first direction to radially expand the prosthetic valve to a first diameter and disengage the stopper from the first edge of the window.
Example 50: The method of any example herein, particularly Example 49, wherein the threaded rod is rotated until a head portion of the threaded rod is fully retracted into a recess formed in an end portion of the second actuator portion connected to the outflow end.
Example 51: The method of any example herein, particularly Example 49, further comprising applying an outward radial force to the frame to over-expand the prosthetic valve to a second diameter that is greater than the first diameter and removing the outward radial force from the frame, wherein the prosthetic valve returns to the first diameter after removing the outward radial force.
Example 52: The method of any example herein, particularly Example 51, wherein applying the outward radial force to the frame displaces the first edge of the window in a direction towards the stopper, and wherein engagement of the first edge of the window with the stopper during applying the outward radial force limits over-expansion of the prosthetic valve.
Example 53: The method of any example herein, particularly any one of Examples 47-52, wherein the frame comprises a plurality of first actuator portions aligned with a plurality of second actuator portions, wherein a plurality of threaded rods are coupled to the first actuator portions and extend axially through the respective second actuator portions, wherein a plurality of stoppers are fixedly coupled to the plurality of threaded rods and disposed in respective windows formed in the plurality of second actuator portions, and wherein each of the plurality of threaded rods is rotated in a first direction to cause the respective stopper to engage an edge of the respective window.
Example 54: The method of any example herein, particularly any one of Examples 47-53, further comprises inserting the prosthetic valve and the distal end of the delivery apparatus into a patient's vasculature and advancing the delivery apparatus through the patient's vasculature to position the prosthetic valve at an implantation site.
In view of the many possible embodiments to which the principles of the disclosed invention may be applied, it should be recognized that the illustrated embodiments are only preferred examples of the invention and should not be taken as limiting the scope of the invention. Rather, the scope of the invention is defined by the following claims. We therefore claim as our invention all that comes within the scope and spirit of these claims.
This application is a continuation of PCT Application No. PCT/US2023/10622, filed on Jan. 11, 2023, which claims the benefit of U.S. Provisional Patent Application No. 63/404,675, filed on Sep. 8, 2022, U.S. Provisional Patent Application No. 63/298,526, filed on Jan. 11, 2022, and U.S. Provisional Patent Application No. 63/409,343, filed on Sep. 23, 2022, each of which is incorporated by reference herein in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63409343 | Sep 2022 | US | |
| 63404675 | Sep 2022 | US | |
| 63298526 | Jan 2022 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2023/010622 | Jan 2023 | WO |
| Child | 18761769 | US |
