Patent Application
20240065836
The native heart valves (i.e., the aortic, pulmonary, tricuspid, and mitral valves) serve critical functions in assuring the forward flow of an adequate supply of blood through the cardiovascular system. These heart valves can be damaged, and thus rendered less effective, for example, by congenital malformations, inflammatory processes, infectious conditions, disease, etc. Such damage to the valves may result in serious cardiovascular compromise or death. Damaged valves can be surgically repaired or replaced during open heart surgery. However, open heart surgeries are highly invasive, and complications may occur. Transvascular techniques can be used to introduce and implant devices in a manner that is much less invasive than open heart surgery. As one example, a transvascular technique useable for accessing the native mitral and aortic valves is the trans-septal technique. The trans-septal technique comprises advancing a catheter into the right atrium (e.g., inserting a catheter into the right femoral vein, up the inferior vena cava and into the right atrium). The septum is then punctured, and the catheter passed into the left atrium. A similar transvascular technique can be used to implant a device within the tricuspid valve that begins similarly to the trans-septal technique but stops short of puncturing the septum and instead turns the delivery catheter toward the tricuspid valve in the right atrium.
A healthy heart has a generally conical shape that tapers to a lower apex. The heart is four-chambered and comprises the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall generally referred to as the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomy than other native heart valves. The mitral valve includes an annulus portion, which is an annular portion of the native valve tissue surrounding the mitral valve orifice, and a pair of cusps, or leaflets, extending downward from the annulus into the left ventricle. The mitral valve annulus can form a “D”-shaped, oval, or otherwise out-of-round cross-sectional shape having major and minor axes. The anterior leaflet can be larger than the posterior leaflet, forming a generally “C”-shaped boundary between the abutting sides of the leaflets when they are closed together.
When operating properly, the anterior leaflet and the posterior leaflet function together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle dilates (also referred to as “ventricular diastole” or “diastole”), the oxygenated blood that is collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract (also referred to as “ventricular systole” or “systole”), the increased blood pressure in the left ventricle urges the sides of the two leaflets together, thereby closing the one-way mitral valve so that blood cannot flow back to the left atrium and is instead expelled out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding back through the mitral annulus toward the left atrium, a plurality of fibrous cords called chordae tendineae tether the leaflets to papillary muscles in the left ventricle.
Valvular regurgitation involves the valve improperly allowing some blood to flow in the wrong direction through the valve. For example, mitral regurgitation occurs when the native mitral valve fails to close properly and blood flows into the left atrium from the left ventricle during the systolic phase of heart contraction. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation can have many different causes, such as leaflet prolapse, dysfunctional papillary muscles, stretching of the mitral valve annulus resulting from dilation of the left ventricle, more than one of these, etc. Mitral regurgitation at a central portion of the leaflets can be referred to as central jet mitral regurgitation and mitral regurgitation nearer to one commissure (i.e., location where the leaflets meet) of the leaflets can be referred to as eccentric jet mitral regurgitation. Central jet regurgitation occurs when the edges of the leaflets do not meet in the middle and thus the valve does not close, and regurgitation is present. Tricuspid regurgitation can be similar, but on the right side of the heart.
This summary is meant to provide some examples and is not intended to be limiting of the scope of the invention in any way. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly recite the features. Also, the features, components, steps, concepts, etc. described in examples in this summary and elsewhere in this disclosure can be combined in a variety of ways. Various features and steps as described elsewhere in this disclosure can be included in the examples summarized here.
The present disclosure discloses components for treatment systems (e.g., valve treatment systems). For example, the treatment systems herein can include a delivery system and an implantable device or implant (e.g., a valve repair or replacement device). While not required, these components can make the delivery system easier to use, more ergonomic, more intuitive, and/more accurate than previous delivery systems. One or more of these components can be used with existing delivery systems. Any combination or subcombination of the disclosed components can be used together, but there is no requirement that any of the components disclosed by the present application be used with any other component disclosed by the present application.
In some implementations, a catheter assembly for controlling a transvascular implantable device includes a handle (which can comprise a handle housing) and a sheath or shaft (e.g., a catheter shaft, tube with a lumen, etc.) that extends distally from the handle housing. The catheter assembly can also include an actuation element (e.g., actuation wire, actuation shaft, actuation rod, actuation tube, etc.) and a control element (e.g., a control knob, button, switch, slider, motor, combination of these, etc.) to control, actuate, and/or move the actuation element. The control element can be coupled to the actuation element (e.g., actuation wire, actuation shaft, etc.) directly or indirectly. The actuation element can extend through the sheath and be configured to be coupled to the implantable device.
In some implementations, the control element is a control knob that is rotatable relative to the handle housing. Rotation of the control knob causes axial movement of the actuation element with respect to the handle housing and the sheath.
In some implementations, the catheter assembly includes one or more clasp control lines and one or more clasp control members (e.g., a pair of clasp control lines and a pair of clasp control members, etc.).
In some implementations, the one or more actuation lines (e.g., pair of clasp actuation lines) extend through the sheath. Each clasp actuation line is configured to be coupled to the implantable device. Each clasp control member can be axially and/or slidably movable along the handle housing. Movement (e.g., axial movement) of each clasp control member causes a clasp of the implantable device to be moved between an open configuration and a closed configuration.
In some implementations, a delivery system, such as a delivery system for delivering an implantable device, includes a first catheter assembly (e.g., a steerable catheter assembly, etc.) and a second catheter assembly (e.g., an implant catheter assembly, etc.). The first catheter assembly includes a handle and a sheath or shaft. The sheath or shaft extends from the handle in an axial direction. In some implementations, the sheath or shaft of the first catheter assembly has a distal end portion that is steerable.
In some implementations, the second catheter assembly includes a handle or handle housing and a sheath or shaft (e.g., a catheter shaft, tube with a lumen, etc.) extending distally from the handle or handle housing. The second catheter assembly can further include an actuation element (e.g., actuation wire, actuation shaft, actuation rod, actuation tube, etc.) and a control element (e.g., a control knob, button, switch, slider, motor, combination of these, etc.). The control element can be coupled to the actuation element directly or indirectly. The actuation element can extend through the sheath and can be configured to be coupled to the implantable device.
In some implementations, the control element is a control knob that is rotatable relative to the handle housing. Rotation of the control knob causes axial movement of the actuation element with respect to the handle housing and the sheath.
In some implementations, the second catheter assembly includes one or more clasp control lines (e.g., a pair of clasp control lines, etc.) and one or more clasp control members (e.g., a pair of clasp control members).
In some implementations, the one or more clasp actuation lines (e.g., pair of clasp actuation lines) extend through the sheath or shaft. Each clasp actuation line is configured to be coupled to the implantable device. In some implementations, each clasp control member is configured to be axially and/or slidably movable along the handle housing. Movement (e.g., axial movement) of each clasp control member causes a clasp of the implantable device to be moved between an open configuration and a closed configuration. The sheath of the second catheter assembly (e.g., implant catheter assembly, etc.) can extend through the first catheter assembly (e.g., steerable catheter assembly). In some implementations, the clasp control members are configured to extend around more than half, more than 90%, all, or substantially all of the handle housing, such that they can be readily actuated by an end user in any rotational orientation of the handle housing.
In some implementations, an implantable device is coupled to an actuation element and a pair of clasp actuation lines. The actuation element and the pair of clasp actuation lines extend from a distal end of a sheath or shaft of a first catheter assembly (e.g., an implant catheter assembly, etc.). The sheath or shaft is coupled at a proximal end to a handle of the first catheter assembly. In some methods, the sheath or shaft of the first catheter assembly is advanced through a second catheter assembly (e.g., a steerable catheter assembly, etc.) to position the implantable device at a delivery site.
The method can further comprise actuating a control element (e.g., knob, button, switch, slider, motor, combination of these, etc.) on the handle to cause axial movement of the actuation element to move the implantable device from a fully elongated configuration to an open configuration (e.g., a partially-open configuration as shown in
In some implementations, the control element is a knob, and actuation of the control element comprises rotating the knob with respect to a housing of the handle of the implant catheter assembly. The rotation of the knob causes axial movement of the actuation element to move the implantable device from a fully elongated configuration to an open configuration or capture ready configuration. The method can further include rotating the knob on the handle with respect to the housing of the handle to cause axial movement of the actuation element to move the implantable device from the open configuration or capture-ready configuration to a closed configuration.
In some implementations, rotating the knob to move the implantable device from the fully elongated configuration to the open configuration and rotating the knob to move the implantable device from the open configuration to the closed configuration each comprise rotating the knob in a clockwise direction.
In some implementations, rotating the knob to move the implantable device from the open configuration to the closed configuration comprises rotating the knob until an audible indication is provided by the catheter assembly.
In some implementations, actuating the control element causes axial movement of a release knob from a retracted position to an extended position with respect to the housing of the handle, wherein the release knob is coupled to the actuation element.
In some implementations, decoupling the implantable device comprises rotation of the release knob is effective to rotate the actuation element with respect to the implantable device, thereby decoupling the implantable device from the actuation element.
In some implementations, the method further comprises sliding one or more clasp control members on the handle proximally to cause axial movement of the one or more clasp actuation lines to open one or more clasps (e.g., a pair of clasps) on the implantable device.
In some implementations, the method further comprises sliding one or more clasp control members on the handle distally to cause axial movement of the pair of clasp actuation lines to close a pair of clasps on the implantable device.
In some implementations, sliding the pair of clasp control members on the handle comprises sliding each clasp control member of the pair of clasp control members independent of the other clasp control member of the pair of clasp control members.
The method can further comprise decoupling the implantable device from the actuation element and the pair of clasp actuation lines.
In some implementations, decoupling the implantable device comprises releasing a first end of each of the pair of clasp actuation lines and pulling a second end of each of the pair of clasp actuation lines to cause the first end of each of the pair of clasp actuation lines to be pulled through the sheath of the catheter assembly, thereby decoupling the implantable device from the pair of clasp actuation lines.
The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with body parts, heart, tissue, etc. being simulated), etc.
In some implementations, a delivery system, such as a delivery system for delivering an implantable device, includes one or more catheter assemblies. In some implementations the delivery system includes a first catheter assembly (e.g., an implant catheter assembly, etc.) and a second catheter assembly (e.g., a steerable catheter assembly). The first catheter assembly includes a handle, a nose grip, and a sheath. The handle of the first catheter assembly has a plurality of control members positioned thereon.
In some implementations, a first nose grip having a distal flange is disposed at a distal end of the handle of the first catheter assembly has a passage. The distal flange can be configured to have an outer diameter that is greater than an outer diameter of a central portion of the first nose grip. The sheath of the first catheter assembly extends distally from the handle and through the passage of the first nose grip.
In some implementations, the second catheter assembly includes a handle, a second nose grip, and a sheath. The second nose grip can be configured to have a distal flange at a distal end of the second nose grip. A proximal end of the second nose grip is connected to a distal end of the handle of the second catheter assembly. The second nose grip includes a passage or lumen. The distal flange of the second nose grip has an outer diameter that is greater than an outer diameter of a central portion of the second nose grip. The sheath of the second catheter assembly can extend distally from the handle and through the passage or lumen of the second nose grip. The sheath of the second catheter assembly has a distal end portion comprising a steerable section.
In some implementations, an implantable device is coupled to an adapter at a distal end of a sheath of a first catheter assembly (e.g., an implant catheter assembly, etc.). The sheath is coupled at a proximal end to a handle of the first catheter assembly. The sheath extends through a passage or lumen of a first nose grip. The first nose grip extends between a distal flange at a distal end and a proximal end that is connected to a distal end of the handle. In some methods, the first nose grip is coupled to a first clamp that is slidably coupled to a base plate by positioning the first nose grip within an opening of the first clamp. A second nose grip of a second catheter assembly (e.g., a steerable catheter assembly, etc.) is coupled to a second clamp slidably coupled to the base plate by positioning the second nose grip within an opening of the second clamp.
The method can also include advancing the sheath of the first catheter assembly through the second catheter assembly to position the implantable device at a delivery site. In some implementations, one or more of the first catheter assembly and the second catheter assembly are rotated relative to the base plate to position the implantable device at the delivery site.
In some implementations, the shaft of the first catheter assembly has a friction fit within at least one of a handle of the second catheter assembly and a shaft of the second catheter assembly.
In some implementations, the method includes (i) positioning a first locking knob in an unlocked position in which the first clamp is slidable with respect to the base plate, (ii) positioning a second locking knob in an unlocked position in which the second clamp is slidable with respect to the base plate, and (iii) axially moving the handle of the first catheter assembly effective to cause the first clamp and the second clamp to slide with respect to the base plate.
In some implementations, the method includes positioning the second locking knob in a locked position in which the second clamp is inhibited from sliding with respect to the base plate, and axially moving the handle of the first catheter assembly effective to cause the first clamp to slide with respect to the base plate and to move the shaft of the first catheter assembly axially with respect to the shaft of the second catheter assembly.
In some implementations, the method includes positioning the first locking knob in a locked position in which the first clamp is inhibited from sliding with respect to the base plate.
In some implementations, the first nose grip has a first outer diameter, the second nose grip has a second outer diameter, and the opening of the first clamp and the opening of the second clamp are sized identically. In some implementations, the first outer diameter is different than the second outer diameter.
In some implementations, the second outer diameter is greater than the first outer diameter such that rotating the first catheter assembly relative to the base plate has a different tactile feel as compared to rotating the second catheter assembly relative to the base plate.
In some implementations, the first nose grip is rotatable relative to the first catheter assembly and the second nose grip is rotatable relative to the second catheter assembly, and rotating at least one of the first catheter assembly and the second catheter assembly relative to the base plate to position the implantable device at the delivery site comprises rotating at least one of the first catheter assembly and the second catheter assembly relative to the base plate while the first nose grip and the second nose grip remain unrotated relative to the base plate.
In some implementations, the first catheter assembly is an implant catheter assembly, and the second catheter assembly is a steerable catheter assembly.
The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with body parts, heart, tissue, etc. being simulated), etc.
In some implementations, a catheter assembly for a transvascular delivery system includes a handle housing, and a sheath. The sheath extends longitudinally from the handle. A proximal portion of the sheath is stiffened with respect to the distal portion of the sheath.
In some implementations, a delivery system, such as a delivery system for delivering an implantable device, includes a first catheter assembly (e.g., a steerable catheter assembly, etc.) and a second catheter assembly (e.g., an implant catheter assembly). The first catheter assembly has a handle and a sheath extending from the handle in an axial direction. The sheath comprises a proximal portion and a distal portion comprising a steerable section. The second catheter assembly has a handle and a sheath comprising a proximal portion and a distal portion. The sheath is extendable or configured to extend coaxially through the sheath of the first catheter assembly. At least one of the proximal portion of the sheath of the first catheter assembly and the proximal portion of the sheath of the second catheter assembly is stiffened relative to the distal portion of the sheath of the first catheter assembly or the distal portion of the sheath of the second catheter assembly, respectively.
In some implementations, a catheter assembly for a transvascular delivery system includes a handle housing and a sheath. The sheath extends distally from the handle housing between a proximal end and a distal end. The sheath has a first outer diameter along a first length of the sheath and a second outer diameter along a second length of the sheath.
In some implementations, a catheter assembly for a transvascular delivery system comprises a handle housing and a sheath (e.g., catheter, tube, etc.) extending longitudinally from the handle. The sheath has a proximal portion and a distal portion. The proximal portion of the sheath is configured to have a different stiffness comparted to the distal portion of the sheath.
In some implementations, the proximal portion of the sheath comprises a material having a higher durometer than materials of the distal portion of the sheath.
In some implementations, only the proximal portion of the sheath comprises a braid, mesh, or woven material. In some implementations, only the distal portion of the sheath comprises a braid, mesh, or woven material. In some implementations, both the proximal portion and the distal portion of the sheath comprise a braid, mesh, or woven material.
In some implementations, only the proximal portion of the sheath comprises at least one laser-cut hypotube. In some implementations, only the distal portion of the sheath comprises at least one laser-cut hypotube. In some implementations, both the proximal portion and the distal portion of the sheath comprise at least one laser-cut hypotube.
In some implementations, the at least one laser-cut hypotube extends through an outer jacket of the sheath.
In some implementations, the sheath is a multi-layer sheath, and the at least one laser-cut hypotube comprises a layer of the multi-layer sheath.
In some implementations, the at least one laser-cut hypotube has a stiffness that varies along a length of the at least one laser-cut hypotube.
In some implementations, the sheath comprises a steerable portion. In some implementations, the steerable portion of the sheath is in the distal portion of the sheath. In some implementations, the steerable portion of the sheath comprises one or more of a pull wire, pull ring, pull wire lumen, etc. In some implementations, pull wire, pull ring, pull wire lumen, etc. are radially inside at least one of the braid (or other mesh or woven material) and the at least one laser-cut hypotube. In some implementations, pull wire, pull ring, pull wire lumen, etc. are radially outside of at least one of the braid (or other mesh or woven material) and the at least one laser-cut hypotube.
In some implementations, the sheath is a multi-layer sheath, and the proximal portion of the sheath comprises a first layer comprising at least one laser-cut hypotube and a second layer comprising a braid (or other mesh or woven material). In some implementations, the sheath is a multi-layer sheath, and the distal portion of the sheath comprises a first layer comprising at least one laser-cut hypotube and a second layer comprising a braid (or other mesh or woven material).
In some implementations, the braid, mesh, or woven material is positioned between a lumen extending through the sheath and the at least one laser-cut hypotube.
In some implementations, the proximal portion of the sheath comprises a first laser-cut hypotube along a first length of the sheath and a second laser-cut hypotube along a second length of the sheath, wherein the first laser-cut hypotube and the second laser-cut hypotube have different stiffnesses.
In some implementations, the sheath defines a lumen extending longitudinally through the sheath, and wherein the lumen has a cross-section that transitions from having a circular shape to having a non-circular shape.
The various sheaths described in any of the implementations herein can include any of the features of the sheaths described herein.
In some implementations, a delivery system for an implantable device includes a first catheter assembly (e.g., an implant catheter assembly, etc.) and a second catheter assembly (e.g., a steerable catheter assembly, etc.). The second catheter assembly has a handle and a sheath extending from the handle in an axial direction. The sheath has a steerable section. The first catheter assembly has a handle and a sheath. The sheath of the first catheter assembly extends coaxially through the sheath of the second catheter assembly. The sheath of the first catheter assembly has a first outer diameter along a first length and a second outer diameter along a second length.
In some implementations, an implantable device is coupled to an actuation element extending from a distal end of a sheath of a first catheter assembly (e.g., an implant catheter assembly, etc.). The sheath is coupled at a proximal end to a handle of the first catheter assembly. The sheath has a first outer diameter along a first length of the sheath and a second outer diameter along a second length of the sheath. In some methods, the sheath of the first catheter assembly is advanced through a second catheter assembly (e.g., a steerable catheter assembly, etc.) to position the implantable device at a delivery site.
In some implementations, a position of the implantable device relative to the delivery site is adjusted by extending the distal end of the sheath of the first catheter assembly relative to a distal end of the sheath of the second catheter assembly. During the adjusting, the second length of the sheath is positioned coaxially within the steerable section of the sheath of the second catheter assembly.
The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with body parts, heart, tissue, etc. being simulated), etc.
In some implementations, a method of delivering an implantable device comprises obtaining a first catheter assembly coupled to the implantable device and advancing a sheath (e.g., catheter, tubing, lumen, etc.) of the first catheter assembly through a second catheter assembly to position the implantable device at a delivery site. In some implementations, the first catheter assembly comprises an actuation element extendable from a distal end of the sheath, wherein the actuation element is coupled to the implantable device.
In some implementations, the sheath is coupled at a proximal end to a handle of the first catheter assembly.
In some implementations, the sheath has a first outer diameter along a first length of the sheath and a second outer diameter along a second length of the sheath. In some implementations, the first length is between the second length of the sheath and the proximal end of the sheath of the first catheter assembly.
In some implementations, the sheath of the second catheter assembly comprises a steerable section.
In some implementations, the method includes adjusting a position of the implantable device relative to the delivery site by extending the distal end of the sheath of the first catheter assembly relative to a distal end of the sheath of the second catheter assembly. In some implementations, during the adjusting, the second length of the sheath is positioned coaxially within the steerable section of the sheath of the second catheter assembly.
In some implementations, the method includes decoupling the implantable device from the actuation element.
In some implementations, the second outer diameter is smaller than the first outer diameter. In some implementations, a difference between the first outer diameter and the second outer diameter is from about 0.25 to about 0.76 mm. In some implementations, a transition from the first outer diameter to the second outer diameter forms a smooth taper over a distance of from about 25 mm to about 50 mm.
In some implementations, the sheath includes a lubricated coating on an outer surface of the sheath along the second length of the sheath. In some implementations, the lubricated coating comprises a hydrophilic coating.
In some implementations, the first catheter assembly is an implant catheter assembly, and the second catheter assembly is a steerable catheter assembly.
The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with body parts, heart, tissue, etc. being simulated), etc.
In some implementations, a catheter assembly for controlling an implantable device comprises a handle housing, a sheath (e.g., catheter, tube, etc.) extending distally from the handle housing, and an actuation element extending through the sheath, the actuation element configured to be coupled to the implantable device. In some implementations, the catheter assembly further includes a control element coupled to the actuation element, wherein actuation of the control element causes axial movement of the actuation element with respect to the handle housing and the sheath.
In some implementations, the catheter assembly further comprises a pair of clasp actuation lines (e.g., a first clasp actuation line and a second clasp actuation line) extending through the sheath, each clasp actuation line (e.g., the first clasp actuation line and/or the second clasp actuation line) of the pair of clasp actuation lines is configured to be coupled to the implantable device.
In some implementations, the catheter assembly further comprises a first clasp control member, wherein actuation of the first clasp control member causes a first clasp of the implantable device to be moved between an open configuration and a closed configuration. In some implementation, the first clasp control member is physically or operatively coupled to the first clasp via one of the pair of clasp actuation lines (e.g., a first clasp actuation line) and such that actuation of the first clasp control member can cause axial movement of the clasp actuation line to move the first clasp between the open configuration and the closed configuration. The first clasp control member can be configured in a variety of ways, e.g., as a knob, slider, latch, switch, button, gear, etc. In some implementations, the first clasp control member is configured to extend around between 45-90% of a circumference of the handle housing, between 60-90% of a circumference of the handle housing, between 75-90% of a circumference of the handle housing, between 85-90% of a circumference of the handle housing, or 90% (or substantially 90%) of a circumference of the handle housing. or substantially 90% of a circumference of the handle housing.
In some implementations, the first clasp control member is axially movable relative to the handle housing and the sheath, and axial movement of the first clasp control member causes the first clasp of the implantable device to be moved between the open configuration and the closed configuration. In some implementations, the first clasp control member is axially movable relative to the handle housing and the sheath, and axial movement of the first clasp control member causes axial movement of one of the pair of clasp actuation lines (e.g., the first clasp actuation line) such that the first clasp of the implantable device is moved between the open configuration and the closed configuration.
In some implementations, the catheter assembly further comprises a second clasp control member, wherein actuation of the second clasp control member causes a second clasp of the implantable device to be moved between an open configuration and a closed configuration. In some implementation, the second clasp control member is physically or operatively coupled to the second clasp via one of the pair of clasp actuation lines (e.g., a second clasp actuation line) and such that actuation of the second clasp control member can cause axial movement of the clasp actuation line to move the second clasp between the open configuration and the closed configuration. The second clasp control member can be configured in a variety of ways, e.g., as a knob, slider, latch, switch, button, gear, etc. In some implementations, the second clasp control member is configured to extend around between 45-90% of a circumference of the handle housing, between 60-90% of a circumference of the handle housing, between 75-90% of a circumference of the handle housing, between 85-90% of a circumference of the handle housing, or 90% (or substantially 90%) of a circumference of the handle housing.
In some implementations, both of the first clasp control member and the second clasp control member are configured to extend around between 60-90% of a circumference of the handle housing, between 75-90% of a circumference of the handle housing, between 85-90% of a circumference of the handle housing, or 90% (or substantially 90%) of a circumference of the handle housing such that they can be readily actuated by an end user in any rotational orientation of the handle housing. In some implementations, both of the first clasp control member and the second clasp control member are configured to extend 90% (or substantially 90%) of a circumference of the handle housing such that together they encircle the handle housing such that they can be readily actuated by an end user in any rotational orientation of the handle housing.
In some implementations, the second clasp control member is axially movable relative to the handle housing and the sheath, and wherein axial movement of the second clasp control member causes the second clasp of the implantable device to be moved between the open configuration and the closed configuration. In some implementations, the second clasp control member is axially movable relative to the handle housing and the sheath, and axial movement of the second clasp control member causes axial movement of one of the pair of clasp actuation lines (e.g., the second clasp actuation line) such that the second clasp of the implantable device is moved between the open configuration and the closed configuration.
In some implementations, the catheter assembly includes a slide lock configured to slide between (i) a first position in which the slide lock is not coupled to at least one of the first clasp control member and the second clasp control member, and (ii) a second position in which the slide lock is coupled to both the first clasp control member and the second clasp control member. In some implementations, when the slide lock is in the first position, the first clasp control member is actuatable independently of the second clasp control member, and when the slide lock is in the second position, the first clasp control member and the second clasp control member are coupled such that actuation of the first clasp member also actuates the second clasp member.
In some implementations, the first clasp control member and the second clasp control member are actuatable by axial movement thereof, and wherein when the slide lock is in the first position, the first clasp control member is axially moveable independently of the second clasp control member, and when the slide lock is in the second position, the first clasp control member and the second clasp control member are coupled such that the first clasp member and the second clasp member are configured to move axially together when actuated.
In some implementations, the handle housing comprises a first detent at a first axial position along a path of one of the pair of clasp control members to maintain the one of the pair of clasp control members in a proximal position and a second detent at a second axial position along the path of one of the pair of clasp control members to maintain the one of the pair of clasp control members in a distal position.
In some implementations, the catheter assembly further comprises an externally threaded retractor coupled to the control element and the actuation element, wherein the externally threaded retractor is rotationally fixed with respect to the handle housing, and wherein actuation of the control element advances the externally threaded retractor in an axial direction, thereby causing linear movement of the actuation element.
In some implementations, the catheter assembly further comprises a clutch spring positioned about the externally threaded retractor and configured to bias the externally threaded retractor distally towards threads of an internally threaded tube within the handle housing.
In some implementations, the control element is a control knob and rotation of the control knob causes rotation of the internally threaded tube with respect to the handle housing, which drives the externally threaded retractor to a proximal position in which external threads of the externally threaded retractor and internal threads of the internally threaded tube disengage, and wherein continued rotation of the control knob provides an audible indication.
In some implementations, a catheter assembly includes a handle housing and a sheath. The sheath extends longitudinally from the handle. The sheath comprises a woven layer. A lumen is interwoven into the woven layer. A flex control element extends through the lumen.
In some implementations, the flex control element can comprise a wire. The lumen can comprise a metal tube. The lumen can extend in a direction of a length of the sheath and/or the lumen can have a spiral configuration.
Other features, elements, and components from any of the various implementations and examples herein can also be included in the catheter assembly mutatis mutandis.
A further understanding of the nature and advantages of the present invention are set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts bear like reference numerals.
To further clarify various aspects of implementations of the present disclosure, a more particular description of some examples and implementations will be made by reference to various aspects of the appended drawings. It is appreciated that these drawings depict only example implementations of the present disclosure and are therefore not to be considered limiting of the scope of the disclosure. Moreover, while the figures can be drawn to scale for some examples, the figures are not necessarily drawn to scale for all examples. Examples and other features and advantages of the present disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
The following description refers to the accompanying drawings, which illustrate example implementations of the present disclosure. Other implementations having different structures and operation do not depart from the scope of the present disclosure.
Example implementations of the present disclosure are directed to systems, devices, methods, etc. for repairing a defective heart valve. For example, various implementations of implantable devices, valve repair devices, implants, and systems (including systems for delivery thereof) are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, individual components of the disclosed devices and systems can be combined unless mutually exclusive or otherwise physically impossible. Further, the techniques and methods herein can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc.
As described herein, when one or more components are described as being connected, joined, affixed, coupled, attached, or otherwise interconnected, such interconnection can be direct as between the components or can be indirect such as through the use of one or more intermediary components. Also as described herein, reference to a “member,” “component,” or “portion” shall not be limited to a single structural member, component, or element but can include an assembly of components, members, or elements. Also as described herein, the terms “substantially” and “about” are defined as at least close to (and includes) a given value or state (preferably within 10% of, more preferably within 1% of, and most preferably within 0.1% of).
The left atrium LA receives oxygenated blood from the lungs. During the diastolic phase, or diastole, seen in
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Various disease processes can impair proper function of one or more of the native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow's Disease, fibroelastic deficiency, etc.), inflammatory processes (e.g., Rheumatic Heart Disease), and infectious processes (e.g., endocarditis, etc.). In addition, damage to the left ventricle LV or the right ventricle RV from prior heart attacks (i.e., myocardial infarction secondary to coronary artery disease) or other heart diseases (e.g., cardiomyopathy, etc.) can distort a native valve's geometry, which can cause the native valve to dysfunction. However, the majority of patients undergoing valve surgery, such as surgery to the mitral valve MV, suffer from a degenerative disease that causes a malfunction in a leaflet (e.g., leaflets 20, 22) of a native valve (e.g., the mitral valve MV), which results in prolapse and regurgitation.
Generally, a native valve may malfunction in different ways: including (1) valve stenosis; and (2) valve regurgitation. Valve stenosis occurs when a native valve does not open completely and thereby causes an obstruction of blood flow. Typically, valve stenosis results from buildup of calcified material on the leaflets of a valve, which causes the leaflets to thicken and impairs the ability of the valve to fully open to permit forward blood flow. Valve regurgitation occurs when the leaflets of the valve do not close completely thereby causing blood to leak back into the prior chamber (e.g., causing blood to leak from the left ventricle to the left atrium).
There are three main mechanisms by which a native valve becomes regurgitant or incompetent-which include Carpentier's type I, type II, and type III malfunctions. A Carpentier type I malfunction involves the dilation of the annulus such that normally functioning leaflets are distracted from each other and fail to form a tight seal (i.e., the leaflets do not coapt properly). Included in a type I mechanism malfunction are perforations of the leaflets, as are present in endocarditis. A Carpentier's type II malfunction involves prolapse of one or more leaflets of a native valve above a plane of coaptation. A Carpentier's type III malfunction involves restriction of the motion of one or more leaflets of a native valve such that the leaflets are abnormally constrained below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease (Ma) or dilation of a ventricle (IIIb).
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In any of the above-mentioned situations, a valve repair device or implant is desired that is capable of engaging the anterior leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent or inhibit regurgitation of blood through the mitral valve MV. As can be seen in
Although stenosis or regurgitation can affect any valve, stenosis is predominantly found to affect either the aortic valve AV or the pulmonary valve PV, and regurgitation is predominantly found to affect either the mitral valve MV or the tricuspid valve TV Both valve stenosis and valve regurgitation increase the workload of the heart H and may lead to very serious conditions if left un-treated; such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. Because the left side of the heart (i.e., the left atrium LA, the left ventricle LV, the mitral valve MV, and the aortic valve AV) are primarily responsible for circulating the flow of blood throughout the body. Accordingly, because of the substantially higher pressures on the left side heart dysfunction of the mitral valve MV or the aortic valve AV is particularly problematic and often life threatening.
Malfunctioning native heart valves can either be repaired or replaced. Repair typically involves the preservation and correction of the patient's native valve. Replacement typically involves replacing the patient's native valve with a biological or mechanical substitute. Typically, the aortic valve AV and pulmonary valve PV are more prone to stenosis. Because stenotic damage sustained by the leaflets is irreversible, treatments for a stenotic aortic valve or stenotic pulmonary valve can be removal and replacement of the valve with a surgically implanted heart valve, or displacement of the valve with a transcatheter heart valve. The mitral valve MV and the tricuspid valve TV are more prone to deformation of leaflets and/or surrounding tissue, which, as described above, prevents the mitral valve MV or tricuspid valve TV from closing properly and allows for regurgitation or back flow of blood from the ventricle into the atrium (e.g., a deformed mitral valve MV may allow for regurgitation or back flow from the left ventricle LV to the left atrium LA as shown in
The devices and procedures disclosed herein often make reference to repairing the structure of a mitral valve. However, it should be understood that the devices and concepts provided herein can be used to repair any native valve, as well as any component of a native valve. Such devices can be used between the leaflets 20, 22 of the mitral valve MV to prevent or inhibit regurgitation of blood from the left ventricle into the left atrium. With respect to the tricuspid valve TV (
An example implant or implantable device (e.g., implantable prosthetic device, etc.) can optionally have a coaptation element (e.g., spacer, coaption element, gap filler, etc.) and at least one anchor (e.g., one, two, three, or more). In some implementations, an implantable device or implant can have any combination or sub-combination of the features disclosed herein without a coaptation element. When included, the coaptation element (e.g., coaption element, spacer, etc.) is configured to be positioned within the native heart valve orifice to help fill the space between the leaflets and form a more effective seal, thereby reducing or preventing regurgitation described above. The coaptation element can have a structure that is impervious to blood (or that resists blood flow therethrough) and that allows the native leaflets to close around the coaptation element during ventricular systole to block blood from flowing from the left or right ventricle back into the left or right atrium, respectively. The device or implant can be configured to seal against two or three native valve leaflets; that is, the device can be used in the native mitral (bicuspid) and tricuspid valves. The coaptation element is sometimes referred to herein as a spacer because the coaptation element can fill a space between improperly functioning native leaflets (e.g., mitral valve leaflets 20, 22 or tricuspid valve leaflets 30, 32, 34) that do not close completely.
The optional coaptation element (e.g., spacer, coaption element, etc.) can have various shapes. In some implementations, the coaptation element can have an elongated cylindrical shape having a round cross-sectional shape. In some implementations, the coaptation element can have an oval cross-sectional shape, an ovoid cross-sectional shape, a crescent cross-sectional shape, a rectangular cross-sectional shape, or various other non-cylindrical shapes. In some implementations, the coaptation element can have an atrial portion positioned in or adjacent to the atrium, a ventricular or lower portion positioned in or adjacent to the ventricle, and a side surface that extends between the native leaflets. In some implementations configured for use in the tricuspid valve, the atrial or upper portion is positioned in or adjacent to the right atrium, and the ventricular or lower portion is positioned in or adjacent to the right ventricle, and the side surface that extends between the native tricuspid leaflets.
In some implementations, the anchor can be configured to secure the device to one or both of the native leaflets such that the coaptation element is positioned between the two native leaflets. In some implementations configured for use in the tricuspid valve, the anchor is configured to secure the device to one, two, or three of the tricuspid leaflets such that the coaptation element is positioned between the three native leaflets. In some implementations, the anchor can attach to the coaptation element at a location adjacent the ventricular portion of the coaptation element. In some implementations, the anchor can attach to an actuation element, such as a shaft or actuation wire, to which the coaptation element is also attached. In some implementations, the anchor and the coaptation element can be positioned independently with respect to each other by separately moving each of the anchor and the coaptation element along the longitudinal axis of the actuation element (e.g., actuation shaft, actuation rod, actuation tube, actuation wire, etc.). In some implementations, the anchor and the coaptation element can be positioned simultaneously by moving the anchor and the coaptation element together along the longitudinal axis of the actuation element, e.g., shaft, actuation wire, etc.). The anchor can be configured to be positioned behind a native leaflet when implanted such that the leaflet is grasped by the anchor.
The device or implant can be configured to be implanted via a delivery system or other means for delivery. The delivery system can comprise one or more of a guide/delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, tube, combinations of these, etc. The coaptation element and the anchor can be compressible to a radially compressed state and can be self-expandable to a radially expanded state when compressive pressure is released. The device can be configured for the anchor to be expanded radially away from the still-compressed coaptation element initially in order to create a gap between the coaptation element and the anchor. A native leaflet can then be positioned in the gap. The coaptation element can be expanded radially, closing the gap between the coaptation element and the anchor and capturing the leaflet between the coaptation element and the anchor. In some implementations, the anchor and coaptation element are optionally configured to self-expand. The implantation methods for various implementations can be different and are more fully discussed below with respect to each implementation. Additional information regarding these and other delivery methods can be found in U.S. Pat. No. 8,449,599 and U.S. Patent Application Publication Nos. 2014/0222136, 2014/0067052, 2016/0331523, and PCT patent application publication Nos. WO2020/076898, each of which is incorporated herein by reference in its entirety for all purposes. These method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc. mutatis mutandis.
The disclosed devices or implants can be configured such that the anchor is connected to a leaflet, taking advantage of the tension from native chordae tendineae to resist high systolic pressure urging the device toward the left atrium. During diastole, the devices can rely on the compressive and retention forces exerted on the leaflet that is grasped by the anchor.
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The device or implant 100 is deployed from a delivery system 102 or other means for delivery. The delivery system 102 can comprise one or more of a catheter, a sheath, a guide catheter/sheath, a delivery catheter/sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations of these, etc. The device or implant 100 includes a coaptation portion 104 and an anchor portion 106.
In some implementations, the coaptation portion 104 of the device or implant 100 includes a coaptation element 110 (e.g., spacer, plug, filler, foam, sheet, membrane, coaption element, etc.) that is adapted to be implanted between leaflets of a native valve (e.g., a native mitral valve, native tricuspid valve, etc.) and is slidably attached to an actuation element 112 (e.g., actuation wire, actuation shaft, actuation tube, etc.). The anchor portion 106 includes one or more anchors 108 that are actuatable between open and closed conditions and can take a wide variety of forms, such as, for example, paddles, gripping elements, or the like. Actuation of the means for actuating or actuation element 112 opens and closes the anchor portion 106 of the device 100 to grasp the native valve leaflets during implantation. The means for actuating or actuation element 112 (as well as other means for actuating and actuation elements herein) can take a wide variety of different forms (e.g., as a wire, rod, shaft, tube, screw, suture, line, strip, combination of these, etc.), be made of a variety of different materials, and have a variety of configurations. As one example, the actuation element can be threaded such that rotation of the actuation element moves the anchor portion 106 relative to the coaptation portion 104. Or, the actuation element can be unthreaded, such that pushing or pulling the actuation element 112 moves the anchor portion 106 relative to the coaptation portion 104.
The anchor portion 106 and/or anchors of the device 100 include outer paddles 120 and inner paddles 122 that are, in some implementations, connected between a cap 114 and the means for coapting or coaptation element 110 by portions 124, 126, 128. The portions 124, 126, 128 can be jointed and/or flexible to move between all of the positions described below. The interconnection of the outer paddles 120, the inner paddles 122, the coaptation element 110, and the cap 114 by the portions 124, 126, and 128 can constrain the device to the positions and movements illustrated herein.
In some implementations, the delivery system 102 includes a steerable catheter, implant catheter, and means for actuating or actuation element 112 (e.g., actuation wire, actuation shaft, etc.). These can be configured to extend through a guide catheter/sheath (e.g., a transseptal sheath, etc.). In some implementations, the means for actuating or actuation element 112 extends through a delivery catheter and the means for coapting or coaptation element 110 to the distal end (e.g., a cap 114 or other attachment portion at the distal connection of the anchor portion 106). Extending and retracting the actuation element 112 increases and decreases the spacing between the coaptation element 110 and the distal end of the device (e.g., the cap 114 or other attachment portion), respectively. In some implementations, a collar or other attachment element removably attaches the coaptation element 110 to the delivery system 102, either directly or indirectly, so that the means for actuating or actuation element 112 slides through the collar or other attachment element and, in some implementations, through a means for coapting or coaptation element 110 during actuation to open and close the paddles 120, 122 of the anchor portion 106 and/or anchors 108.
In some implementation, the anchor portion 106 and/or anchors 108 can include attachment portions or gripping members. The illustrated gripping members can comprise clasps 130 that include a base or fixed arm 132, a moveable arm 134, optional barbs, friction-enhancing elements, or other means for securing 136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesive, etc.), and a joint portion 138. The fixed arms 132 are attached to the inner paddles 122. In some implementations, the fixed arms 132 are attached to the inner paddles 122 with the joint portion 138 disposed proximate means for coapting or coaptation element 110. In some implementations, the clasps (e.g., barbed clasps, etc.) have flat surfaces and do not fit in a recess of the inner paddle. Rather, the flat portions of the clasps are disposed against the surface of the inner paddle 122. The joint portion 138 provides a spring force between the fixed and moveable arms 132, 134 of the clasp 130. The joint portion 138 can be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, or the like. In some implementations, the joint portion 138 is a flexible piece of material integrally formed with the fixed and moveable arms 132, 134. The fixed arms 132 are attached to the inner paddles 122 and remain stationary or substantially stationary relative to the inner paddles 122 when the moveable arms 134 are opened to open the clasps 130 and expose the optional barbs, friction-enhancing elements, or means for securing 136.
In some implementations, the clasps 130 are opened by applying tension to actuation lines 116 attached to the moveable arms 134, thereby causing the moveable arms 134 to articulate, flex, or pivot on the joint portions 138. The actuation lines 116 extend through the delivery system 102 (e.g., through a steerable catheter and/or an implant catheter). Other actuation mechanisms are also possible.
The actuation line 116 can take a wide variety of forms, such as, for example, a line, a suture, a wire, a rod, a catheter, or the like. The clasps 130 can be spring loaded so that in the closed position the clasps 130 continue to provide a pinching force on the grasped native leaflet. This pinching force remains constant regardless of the position of the inner paddles 122. Optional barbs, friction-enhancing elements, or other means for securing 136 of the clasps 130 can grab, pinch, and/or pierce the native leaflets to further secure the native leaflets.
During implantation, the paddles 120, 122 can be opened and closed, for example, to grasp the native leaflets (e.g., native mitral valve leaflets, etc.) between the paddles 120, 122 and/or between the paddles 120, 122 and a means for coapting or coaptation element 110. The clasps 130 can be used to grasp and/or further secure the native leaflets by engaging the leaflets with optional barbs, friction-enhancing elements, or means for securing 136 and pinching the leaflets between the moveable and fixed arms 134, 132. The friction-enhancing elements, or other means for securing 136 (e.g., barbs, protrusions, ridges, grooves, textured surfaces, adhesive, etc.) of the clasps 130 increase friction with the leaflets or can partially or completely puncture the leaflets. The actuation lines 116 can be actuated separately so that each clasp 130 can be opened and closed separately. Separate operation allows one leaflet to be grasped at a time, or for the repositioning of a clasp 130 on a leaflet that was insufficiently grasped, without altering a successful grasp on the other leaflet. The clasps 130 can be opened and closed relative to the position of the inner paddle 122 (as long as the inner paddle is in an open or at least partially open position), thereby allowing leaflets to be grasped in a variety of positions as the particular situation requires.
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In some implementations, the implantable device or implant 200 includes a coaptation portion 204, a proximal or attachment portion 209, an anchor portion 206, and a distal portion 207. In some implementations, the coaptation portion 204 of the device optionally includes a coaptation element 210 (e.g., a spacer, coaption element, plug, membrane, sheet, etc.) for implantation between leaflets of a native valve. In some implementations, the anchor portion 206 includes a plurality of anchors 208. The anchors can be configured in a variety of ways. In some implementations, each anchor 208 includes outer paddles 220, inner paddles 222, paddle extension members or paddle frames 224, and clasps 230. In some implementations, the attachment portion 209 includes a first or proximal collar 211 (or other attachment element) for engaging with a capture mechanism 213 (
In some implementations, the coaptation element 210 and paddles 220, 222 are formed from a flexible material that can be a metal fabric, such as a mesh, woven, braided, or formed in any other suitable way or a laser cut or otherwise cut flexible material. The material can be cloth, shape-memory alloy wire-such as Nitinol—to provide shape-setting capability, or any other flexible material suitable for implantation in the human body.
An actuation element 212 (e.g., actuation shaft, actuation rod, actuation tube, actuation wire, actuation line, etc.) extends from the delivery system 202 to engage and enable actuation of the implantable device or implant 200. In some implementations, the actuation element 212 extends through the capture mechanism 213, proximal collar 211, and coaptation element 210 to engage a cap 214 of the distal portion 207. The actuation element 212 can be configured to removably engage the cap 214 with a threaded connection, or the like, so that the actuation element 212 can be disengaged and removed from the device 200 after implantation.
The coaptation element 210 extends from the proximal collar 211 (or other attachment element) to the inner paddles 222. In some implementations, the coaptation element 210 has a generally elongated and round shape, though other shapes and configurations are possible. In some implementations, the coaptation element 210 has an elliptical shape or cross-section when viewed from above (e.g.,
The size and/or shape of the coaptation element 210 can be selected to minimize the number of implants that a single patient will require (preferably one), while at the same time maintaining low transvalvular gradients. In some implementations, the anterior-posterior distance at the top of the coaptation element is about 5 mm, and the medial-lateral distance of the coaptation element at its widest is about 10 mm. In some implementations, the overall geometry of the device 200 can be based on these two dimensions and the overall shape strategy described above. It should be readily apparent that the use of other anterior-posterior distance anterior-posterior distance and medial-lateral distance as starting points for the device will result in a device having different dimensions. Further, using other dimensions and the shape strategy described above will also result in a device having different dimensions.
In some implementations, the outer paddles 220 are jointably attached to the cap 214 of the distal portion 207 by connection portions 221 and to the inner paddles 222 by connection portions 223. The inner paddles 222 are jointably attached to the coaptation element by connection portions 225. In this manner, the anchors 208 are configured similar to legs in that the inner paddles 222 are like upper portions of the legs, the outer paddles 220 are like lower portions of the legs, and the connection portions 223 are like knee portions of the legs.
In some implementations, the inner paddles 222 are stiff, relatively stiff, rigid, have rigid portions and/or are stiffened by a stiffening member or a fixed portion 232 of the clasps 230. The stiffening of the inner paddle allows the device to move to the various different positions shown and described herein. The inner paddle 222, the outer paddle 220, the coaptation can all be interconnected as described herein, such that the device 200 is constrained to the movements and positions shown and described herein.
In some implementations, the paddle frames 224 are attached to the cap 214 at the distal portion 207 and extend to the connection portions 223 between the inner and outer paddles 222, 220. In some implementations, the paddle frames 224 are formed of a material that is more rigid and stiff than the material forming the paddles 222, 220 so that the paddle frames 224 provide support for the paddles 222, 220.
The paddle frames 224 provide additional pinching force between the inner paddles 222 and the coaptation element 210 and assist in wrapping the leaflets around the sides of the coaptation element 210 for a better seal between the coaptation element 210 and the leaflets, as can be seen in
Configuring the paddle frames 224 in this manner provides increased surface area compared to the outer paddles 220 alone. This can, for example, make it easier to grasp and secure the native leaflets. The increased surface area can also distribute the clamping force of the paddles 220 and paddle frames 224 against the native leaflets over a relatively larger surface of the native leaflets in order to further protect the native leaflet tissue. Referring again to
In some implementations the clasps comprise a moveable arm coupled to the anchors. In some implementations, the clasps 230 include a base or fixed arm 232, a moveable arm 234, optional barbs 236, and a joint portion 238. The fixed arms 232 are attached to the inner paddles 222, with the joint portion 238 disposed proximate the coaptation element 210. The joint portion 238 is spring-loaded so that the fixed and moveable arms 232, 234 are biased toward each other when the clasp 230 is in a closed condition. In some implementations, the clasps 230 include friction-enhancing elements or means for securing, such as barbs, protrusions, ridges, grooves, textured surfaces, adhesive, etc.
In some implementations, the fixed arms 232 are attached to the inner paddles 222 through holes or slots 231 with sutures (not shown). The fixed arms 232 can be attached to the inner paddles 222 with any suitable means, such as screws or other fasteners, crimped sleeves, mechanical latches or snaps, welding, adhesive, clamps, latches, or the like. The fixed arms 232 remain substantially stationary relative to the inner paddles 222 when the moveable arms 234 are opened to open the clasps 230 and expose the optional barbs or other friction-enhancing elements 236. The clasps 230 are opened by applying tension to actuation lines 216 (e.g., as shown in
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During implantation, the paddles 220, 222 of the anchors 208 are opened and closed to grasp the native valve leaflets 20, 22 between the paddles 220, 222 and the coaptation element 210. The anchors 208 are moved between a closed position (
As the device 200 is opened and closed, the pair of inner and outer paddles 222, 220 are moved in unison, rather than independently, by a single actuation element 212. Also, the positions of the clasps 230 are dependent on the positions of the paddles 222, 220. For example, the clasps 230 are arranged such that closure of the anchors 208 simultaneously closes the clasps 230. In some implementations, the device 200 can be made to have the paddles 220, 222 be independently controllable in the same manner (e.g., the device 100 illustrated in
In some implementations, the clasps 230 further secure the native leaflets 20, 22 by engaging the leaflets 20, 22 with optional barbs and/or other friction-enhancing elements 236 and pinching the leaflets 20, 22 between the moveable and fixed arms 234, 232. In some implementations, the clasps 230 include barbs that increase friction with and/or can partially or completely puncture the leaflets 20, 22. The actuation lines 216 (
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Configuring the device or implant 200 such that the anchors 208 can extend to a straight or approximately straight configuration (e.g., approximately 120-180 degrees relative to the coaptation element 210) can provide several advantages. For example, this configuration can reduce the radial crimp profile of the device or implant 200. It can also make it easier to grasp the native leaflets 20, 22 by providing a larger opening between the coaptation element 210 and the inner paddles 222 in which to grasp the native leaflets 20, 22. Additionally, the relatively narrow, straight configuration can prevent or reduce the likelihood that the device or implant 200 will become entangled in native anatomy (e.g., chordae tendineae CT shown in
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To adequately fill the gap 26 between the leaflets 20, 22, the device 200 and the components thereof can have a wide variety of different shapes and sizes. For example, the outer paddles 220 and paddle frames 224 can be configured to conform to the shape or geometry of the coaptation element 210 as is shown in
This coaptation of the leaflets 20, 22 against the lateral and medial aspects 201, 203 of the coaptation element 210 (shown from the atrial side in
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The implantable device or implant 300 includes a proximal or attachment portion 305, an anchor portion 306, and a distal portion 307. In some implementations, the device/implant 300 includes a coaptation portion 304, and the coaptation portion 304 can optionally include a coaptation element 310 (e.g., spacer, plug, membrane, sheet, etc.) for implantation between the leaflets 20, 22 of the native valve. In some implementations, the anchor portion 306 includes a plurality of anchors 308. In some implementations, each anchor 308 can include one or more paddles, e.g., outer paddles 320, inner paddles 322, paddle extension members or paddle frames 324. The anchors can also include and/or be coupled to clasps 330. In some implementations, the attachment portion 305 includes a first or proximal collar 311 (or other attachment element) for engaging with a capture mechanism (e.g., a capture mechanism such as the capture mechanism 213 shown in
The anchors 308 can be attached to the other portions of the device and/or to each other in a variety of different ways (e.g., directly, indirectly, welding, sutures, adhesive, links, latches, integrally formed, a combination of some or all of these, etc.). In some implementations, the anchors 308 are attached to a coaptation member or coaptation element 310 by connection portions 325 and to a cap 314 by connection portions 321.
The anchors 308 can comprise first portions or outer paddles 320 and second portions or inner paddles 322 separated by connection portions 323. The connection portions 323 can be attached to paddle frames 324 that are hingeably attached to a cap 314 or other attachment portion. In this manner, the anchors 308 are configured similar to legs in that the inner paddles 322 are like upper portions of the legs, the outer paddles 320 are like lower portions of the legs, and the connection portions 323 are like knee portions of the legs.
In implementations with a coaptation member or coaptation element 310, the coaptation member or coaptation element 310 and the anchors 308 can be coupled together in various ways. For example, as shown in the illustrated example, the coaptation element 310 and the anchors 308 can be coupled together by integrally forming the coaptation element 310 and the anchors 308 as a single, unitary component. This can be accomplished, for example, by forming the coaptation element 310 and the anchors 308 from a continuous strip 301 of a braided or woven material, such as braided or woven nitinol wire. In the illustrated example, the coaptation element 310, the outer paddle portions 320, the inner paddle portions 322, and the connection portions 321, 323, 325 are formed from the continuous strip of fabric 301.
Like the anchors 208 of the implantable device or implant 200 described above, the anchors 308 can be configured to move between various configurations by axially moving the distal end of the device (e.g., cap 314, etc.) relative to the proximal end of the device (e.g., proximal collar 311 or other attachment element, etc.) and thus the anchors 308 move relative to a midpoint of the device. This movement can be along a longitudinal axis extending between the distal end (e.g., cap 314, etc.) and the proximal end (e.g., collar 311 or other attachment element, etc.) of the device. For example, the anchors 308 can be positioned in a fully extended, fully elongated, or straight configuration (e.g., similar to the configuration of device 200 shown in
In some implementations, in the straight configuration, the paddle portions 320, 322 are aligned or straight in the direction of the longitudinal axis of the device. In some implementations, the connection portions 323 of the anchors 308 are adjacent the longitudinal axis of the coaptation element 310 (e.g., similar to the configuration of device 200 shown in
In some implementations, the clasps comprise a moveable arm coupled to an anchor. In some implementations, the clasps 330 (as shown in detail in
The fixed arms 332 are attached to the inner paddles 322 through holes or slots 331 with sutures (not shown). The fixed arms 332 can be attached to the inner paddles 322 with any suitable means, such as screws or other fasteners, crimped sleeves, mechanical latches or snaps, welding, adhesive, or the like. The fixed arms 332 remain substantially stationary relative to the inner paddles 322 when the moveable arms 334 are opened to open the clasps 330 and expose the optional barbs 336. The clasps 330 are opened by applying tension to actuation lines (e.g., the actuation lines 216 shown in
In short, the implantable device or implant 300 is similar in configuration and operation to the implantable device or implant 200 described above, except that the coaptation element 310, outer paddles 320, inner paddles 322, and connection portions 321, 323, 325 are formed from the single strip of material 301. In some implementations, the strip of material 301 is attached to the proximal collar 311, cap 314, and paddle frames 324 by being woven or inserted through openings in the proximal collar 311, cap 314, and paddle frames 324 that are configured to receive the continuous strip of material 301. The continuous strip 301 can be a single layer of material or can include two or more layers. In some implementations, portions of the device 300 have a single layer of the strip of material 301 and other portions are formed from multiple overlapping or overlying layers of the strip of material 301.
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As with the implantable device or implant 200 described above, the size of the coaptation element 310 can be selected to minimize the number of implants that a single patient will require (preferably one), while at the same time maintaining low transvalvular gradients. In particular, forming many components of the device 300 from the strip of material 301 allows the device 300 to be made smaller than the device 200. For example, in some implementations, the anterior-posterior distance at the top of the coaptation element 310 is less than 2 mm, and the medial-lateral distance of the device 300 (i.e., the width of the paddle frames 324 which are wider than the coaptation element 310) at its widest is about 5 mm.
The concepts disclosed by the present application can be used with a wide variety of different valve treatment devices.
The valve repair system 400 includes a delivery system or delivery device 401 and an implant 402 configured as a valve repair device. The implant or valve repair device 402 includes a base assembly 404, a pair of paddles 406, and a pair of gripping members 408. In some implementations, the paddles 406 can be integrally formed with the base assembly. For example, the paddles 406 can be formed as extensions of links of the base assembly. In the illustrated example, the base assembly 404 of the valve repair device 402 has a shaft 403, a coupler 405 configured to move along the shaft, and a lock 407 configured to lock the coupler in a stationary position on the shaft. The coupler 405 is mechanically connected to the paddles 406, such that movement of the coupler 405 along the shaft 403 causes the paddles to move between an open position and a closed position. In this way, the coupler 405 serves as a means for mechanically coupling the paddles 406 to the shaft 403 and, when moving along the shaft 403, for causing the paddles 406 to move between their open and closed positions.
In some implementations, the gripping members 408 are pivotally connected to the base assembly 404 (e.g., the gripping members 408 can be pivotally connected to the shaft 403, or any other suitable member of the base assembly), such that the gripping members can be moved to adjust the width of the opening 414 between the paddles 406 and the gripping members 408. The gripping member 408 can include an optional barbed portion 409 for attaching the gripping members to valve tissue when the implant or valve repair device 402 is attached to the valve tissue. The gripping member 408 forms a means for gripping the valve tissue (in particular tissue of the valve leaflets) with a sticking means or portion such as the barbed portion 409. When the paddles 406 are in the closed position, the paddles engage the gripping members 408, such that, when valve tissue is attached to the barbed portion 409 of the gripping members, the paddles act as holding or securing means to hold the valve tissue at the gripping members and to secure the implant 402 to the valve tissue. In some implementations, the gripping members 408 are configured to engage the paddles 406 such that the barbed portion 409 engages the valve tissue member and the paddles 406 to secure the implant 402 to the valve tissue member. For example, in certain situations, it can be advantageous to have the paddles 406 maintain an open position and have the gripping members 408 move outward toward the paddles 406 to engage valve tissue and the paddles 406.
While the examples shown in
In some implementations, the valve repair system 400 includes a placement shaft 413 that is removably attached to the shaft 403 of the base assembly 404 of the valve repair device 402. After the valve repair device 402 is secured to valve tissue, the placement shaft 413 is removed from the shaft 403 to remove the valve repair device 402 from the remainder of the valve repair system 400, such that the valve repair device 402 can remain attached to the valve tissue, and the delivery device 401 can be removed from a patient's body.
The valve repair system 400 can also include a paddle control mechanism 410, a gripper control mechanism 411, and a lock control mechanism 412. The paddle control mechanism 410 is mechanically attached to the coupler 405 to move the coupler along the shaft, which causes the paddles 406 to move between the open and closed positions. The paddle control mechanism 410 can take any suitable form, such as, for example, a shaft or rod. For example, the paddle control mechanism can comprise a hollow shaft, a catheter tube or a sleeve that fits over the placement shaft 413 and the shaft 403 and is connected to the coupler 405.
The gripper control mechanism 411 is configured to move the gripping members 408 such that the width of the opening 414 between the gripping members and the paddles 406 can be altered. The gripper control mechanism 411 can take any suitable form, such as, for example, a line, a suture or wire, a rod, a catheter, etc.
The lock control mechanism 412 is configured to lock and unlock the lock. The lock 407 serves as a locking means for locking the coupler 405 in a stationary position with respect to the shaft 403 and can take a wide variety of different forms and the type of lock control mechanism 412 may be dictated by the type of lock used. In some implementations, the lock 407 takes the form of locks often used in caulk guns. That is, the lock 407 includes a pivotable plate having a hole, in which the shaft 403 of the valve repair device 402 is disposed within the hole of the pivotable plate. In this example, when the pivotable plate is in the tilted position, the pivotable plate engages the shaft 403 to maintain a position on the shaft 403, but, when the pivotable plate is in a substantially non-tilted position, the pivotable plate can be moved along the shaft (which allows the coupler 405 to move along the shaft 403). In other words, the coupler 405 is prevented from moving in the direction Y (as shown in
In order to move the valve repair device from the open position (as shown in
Referring to
Referring to
Referring to
In order to move the valve repair device 402 from the open position to the closed position, the lock 407 is moved to an unlocked condition (as shown in
Referring to
During implantation of an implantable device or implant in the native heart valve, movement of the device to the implanted position may be impeded or obstructed by the native heart structures. For example, articulable portions of an implantable device or implant (such as paddle portions of anchors used to secure the device to the native heart valve tissue) may rub against, become temporarily caught, or be temporarily blocked by the chordae tendineae CT (shown in
In some implementations, a delivery system or delivery assembly is configured to make it easier to move the implantable device or implant between its various configurations and/or to implant the implantable device or implant in the native heart valve. For example, controls on a handle used in a delivery system/assembly can be configured to enable improved control of the implantable device or implant, as will be described.
In some implementations, as shown in the illustrated example in
In some implementations, the second catheter assembly or steerable catheter assembly 608 extends coaxially through the first catheter assembly or delivery catheter assembly 606, and the third catheter assembly or implant catheter assembly 610 extends coaxially through the second catheter assembly 608 and the first catheter assembly 606. The implantable device 604 can be releasably coupled to a distal portion of the third catheter assembly or implant catheter assembly 610, as further described below. It should be appreciated that the implantable device 604 can be any device described herein.
As shown in
The delivery catheter assembly 606 and the steerable catheter assembly 608 can be used, for example, to access an implantation location (e.g., a native mitral valve region of a heart) and/or to position the implant catheter assembly 610 at the implantation location. Accordingly, in some implementations, the delivery catheter assembly 606 and the steerable catheter assembly 608 are configured to be steerable. The catheter assemblies or features of the catheter assemblies disclosed by U.S. Pat. Nos. 10,653,862 and 10,646,342 can be used as or in the catheter assemblies 606, 608, 610. U.S. Pat. Nos. 10,653,862 and 10,646,342 are hereby incorporated by reference in their entireties.
In some implementations, the outer shaft 611 of the implant catheter assembly 610 can be configured to be steerable. For example, although not shown, the implant catheter assembly 610 can comprise an actuation element, such as a pull wire, and a flexible, axially non-compressible pull wire sleeve (e.g., a helical coil).
As shown in
In the examples of
As shown in
The clasp control members 628 can be configured in a variety of ways. In some implementations, one or more of the clasp control members 628 is an axially-moving control or slider coupled to a corresponding clasp actuation line 624 to axially move the clasp actuation line 624 relative to the outer shaft 611 and the actuation element 112. In some implementations, one or more of the clasp control members 628 comprises a button, switch, latch, gear, etc.
As described above, in some implementations, the actuation element 112 is coupled at a distal end to the cap 114 of the device 604. The actuation element 112 extends axially through the outer shaft 611 to the handle 616 and is coupled at a proximal end portion 112a to the control element or knob 626. Although described with respect to various figures herein as being configured as a knob, it should be appreciated that the actuation element 112 can be coupled to any other type of control element, such as another type of rotational control member that is rotatable about the axis of the handle 616.
As will be described in greater detail, in some implementations, as the knob 626 is rotated about the axis of the handle 616, the rotation is translated to axial movement of the actuation element 112, and is effective to axially advance or retract the actuation element, such a as a rod or wire, to open or close the valve repair device. Optionally, the knob can also drive a paddle release knob 630 (sometimes referred to as an indicator component) between a proximal, or extended, position (as shown in
Turning now to
In some implementations, an optional nose grip 634 extends axially from a distal end of the housing 632 and facilitates removably coupling the implant catheter assembly to a stabilizer (shown in
In some implementations, as shown for example in
In some implementations, the handle 616 further comprises a flush port 638, as shown in
In some implementations, as shown for example in
In some implementations, the marker/indicator 640 can be a marking pin that is removably coupled with the aperture of the housing 632 for storage of the marking pin 640. During use, the marking pin 640 can be removed from the aperture of the housing and inserted into an aperture 641 (shown in
In some implementations, a lock 642 is also included and is configured such that it can be actuated or engaged to selectively physically and/or operatively lock the clasp control members 628 together. The lock can be configured in a variety of ways and take different forms. In some implementations, lock 642 is configured as a slide lock that can be actuated or engaged to slide between a first position, in which the slide lock 642 is coupled to one of the clasp control members 628, to a second position, in which the slide lock 642 is coupled to both of the clasp control members 628. For example, each of the clasp control members 628 can include a flange 643 to which the slide lock 642 is slidably coupled.
In some implementations, the slide lock 642 can be moved to the first position (shown in
In some implementations, each of the clasp control members 628 can include one or more tactile or visual indicators to enable the user to differentiate one clasp control member from the other with improved accuracy. For example, one clasp control member 628 can have a different color and/or texture (e.g., ribbed, smooth) than the other clasp control member 628.
As shown in the figures, in some implementations, each of the clasp control members 628 is wrapped approximately 180 degrees or otherwise in an actuate manner around the circumference of the housing 632 such that together the clasp control members 628 surround and/or encircle (which can include partially encircling) the housing 632. Such an arrangement can, for example, enable the clasp control members 628 to be accessible to the user from any angle with a single hand. Moreover, in the example depicted in
While various configurations and arrangements of clasp control members 628 are possible, having clasp control members that surround, encircle, or are otherwise readily accessible around a significant portion or majority of the handle (or even a full circumference of the handle) provides significant benefits as compared to a handle with clasp control members on only one side or a small portion of the handle. If clasp control members are on only one side of the handle, they may become very difficult to operate and use at various stages of a procedure, for example, when the catheter handle may be rotated to navigate and/or reposition the device appropriately inside the body of a patient and the clasp control members end up on an underside of the handle. Having clasp control members that encircle or are otherwise readily accessible around a significant portion of the handle (or even a full circumference of the handle) makes it significantly easier to continue to operate/actuate the clasp control members when the handle is rotated into any orientation during a procedure.
In some implementations, each clasp control member 628 can further comprise one or more keyed projections or tongues that are configured to be received by and slide along a corresponding groove or slot in the housing 632. As best shown in
Referring to
In the example illustrated by
In some implementations, each clasp control tube 648 can comprise one or more optional keying features 671 at various positions or all along the axial length of the clasp control tube 648. In some implementations, no keying features are included. When included, the optional keying features 671 are complementary to corresponding keying features 675 formed in one or more components of the handle 616, such as in the housing 632 of the handle. These keying features 671, 675 can prevent or inhibit rotation of the clasp control tube 648 in the housing and thereby limit movement of the clasp control tube to linear movement along the length of the housing 632. For example, the optional keying feature 671 of the clasp control tube 648 can comprise a wire welded to the external surface of the clasp control tube 648 (see
The suture lock can take a wide variety of different forms. In the example illustrated by
In some implementations, the suture lock body receptacle 662 includes a central bore that extends from a first end to a second end of the suture lock body receptacle 662. The central bore of the suture lock body receptacle 662 is sized to receive the suture lock body 660 at threaded end of the suture lock body receptacle 662, and is sized to receive and be attached to the clasp control tube 648 at the second end of the suture lock body receptacle 662. An optional sealing member or o-ring 664 is positioned around the suture lock body 660 to form a fluid-tight seal between the suture lock body 660 and the suture lock body receptacle 662.
In some implementations, the clasp actuation line 624 is fixed at one end of the clasp actuation line 624 to the post 658, which is inserted into the suture lock body 660, thereby coupling the clasp actuation line 624 to the suture lock body 660. In some implementations, the clasp actuation line 624 can be welded, adhered, or otherwise fixedly coupled to the post 658.
In some implementations, the clasp actuation line 624 is threaded through the central bore in the suture lock body 660, through the central bore in the suture lock body receptacle 662, and through the clasp control tube 648. The clasp control tube 648 guides and protects the clasp actuation line 624 through the interior of the handle 616. The clasp actuation line 624 exits the clasp control tube 648 near the distal end of the handle 616 and extends through the outer shaft 611 of the implant catheter assembly 610. As described herein, the clasp actuation line 624 exits the outer shaft 611 at the distal end of the outer shaft, and is coupled to the device, such as by passing through one or more holes 235 in the clasp 130 (see, e.g.,
In some implementations, an optional spacer or fixture can be used to position the clasp control tubes 648 and/or suture locks 650 while the effective length of the clasp actuation line 624 is set. That is, the optional spacer or fixture sets a correct position of the clasp actuation line 624 corresponding to the clasps in an open position. The clasp actuation lines 624 can then be pulled taught with the clasps in the open position and the suture locks 650 can be tightened to fix the clasp actuation lines 624 to the clasp control tubes 648. The optional spacer or fixture can take a variety of different forms. Any device that sets the position of the control tubes 648 and/or suture locks 650 relative to the body of the handle can be used.
Referring to
As shown in the example in
In some implementations, the clasp setting spacer 696 has a length extending between the handle supporting end 800 and a proximal end 804 of the clasp setting spacer 696. Although the length of the clasp setting spacer 696 can vary, in some implementations, the length of the clasp setting spacer 696 is selected to provide a pre-determined distance between the suture lock and a proximal end of the handle 616. Accordingly, in use, the clasp setting spacer 696 receives the clasp control tube 648 and suture lock 650 and secures them in a predetermined position relative to the handle 616 such that when the clasp control line is secured in place between the suture lock body and the suture lock receptacle, the distance of the path of the clasp control line is constant. This ensures that the clap control line has a sufficient length to enable the clasps to move through their full range of motion while not being too long.
In some implementations, to release the clasp from the clasp actuation line, the suture lock body 660 can be removed (e.g., by unscrewing) from the suture lock body receptacle 662, freeing the end of the clasp actuation line 624 pinched between the suture lock body 660 and the suture lock body receptacle 662. Once the clasp actuation line 624 is released, the clasp actuation line can be pulled through the clasp control tube 648, the outer shaft 611, the hole 235 of the clasp and back through the outer shaft 611 and clasp control tube 648. As such, the clasp actuation line 624 is no longer connected to the clasp and is removed from the patient.
Returning to
As previously mentioned, in some implementations, the handle 616 can further comprise a control element or knob 626 that can be configured to rotate about an axis of the handle 616 and to control the position of the actuation element 112 relative to the handle 616 and outer shaft 611. As can be seen in the example of
In some implementations, the externally threaded retractor 654 is connected to the actuation element 112 such that linear movement of the externally threaded retractor 654 causes linear movement of the actuation element 112, thereby moving the device between a fully elongated configuration, an open configuration, and a closed configuration, as described herein. The translation of the rotational movement of the knob 626 into linear motion of the actuation element 112 can result in improved control and precision, thereby leading to improved precision during the opening and closing of the device.
In some implementations, the internally threaded tube 652 includes and unthreaded portion 657. A clutch spring 656 is positioned around an unthreaded proximal portion 659 of the retractor 654. The clutch spring presses against a proximal end surface 655 of the threaded portion of the retractor 654. Proximal movement of the actuation element 112 after closure of the device 604 can result in overclosure or compression of the valve repair device. The position of the unthreaded portion 657 is selected to prevent or inhibit over-retraction of the actuation element 112 and thereby prevent or inhibit over-closing of the valve repair device. That is, the externally threaded retractor 654 is no longer driven proximally when the externally threaded nut or retractor 654 reaches the unthreaded portion 657. The clutch spring is configured to bias the externally threaded retractor 654 distally (e.g., toward the threads of the internally threaded tube 652) when the externally threaded retractor 654 has reached the end of the threads of the internally threaded tube 652. Continued rotation of the knob 626 following disengagement of the external threads of the externally threaded retractor 654 and the internal threads of the internally threaded tube 652 results in an audible indication that the device is in a closed position. The biasing of the externally threaded retractor 654 can also reduce slop in the threaded connection, thereby improving stability of the paddle angle. The biasing of the externally threaded retractor 654 towards the internal threads of the internally threaded tube 652 ensures that the externally threaded retractor 654 will be re-engaged by the internally threaded tube 652 when the knob 626 is rotated in an opposite direction that corresponds to advancement of the actuation element 112.
As shown in
In some implementations, in use, the knob 626 is rotated, which rotates the internally threaded tube 652 to rotate with respect to the housing 632, thereby driving the externally threaded retractor 654 axially. The axial movement of the externally threaded retractor 654 causes axial movement of the actuation element 112, which moves the device between a fully elongated configuration, an open configuration, and a closed configuration. Axial movement of the externally threaded retractor 654 also causes axial movement of the release knob 630 between a proximal, or extended, position (shown in
In some implementations, when the device 604 is in a closed configuration (e.g., shown in
As shown in
In some implementations, each of the pawls 678 is in contact with the outer surface of the elongated shaft 673. Accordingly, as the release knob 630 is rotated in the unscrewing or loosening direction, each pawl 678 slides up and over the edge of the tooth 674 with a moderate slope, and springs back into the area between the tooth and an adjacent tooth. In some implementations, the springing back of the pawl into the area between teeth generates an audible indication that a tooth has been cleared. The edge of the tooth 674 with the steeper slope catches the pawl 678 prevents or inhibits the release knob 630 from being rotated in the opposite, tightening direction. Enabling a single direction of rotation of the release knob 630 prevents or inhibits torsion that can build up as a result of the torquing of the actuation element 112 during release of the device 604 from turning the release knob 630 back in the tightening direction.
Once the actuation element 112 is decoupled from the device 604, the actuation element 112 can be withdrawn into the implant catheter assembly 610, and the implant catheter assembly 610 can be withdrawn through the steerable catheter assembly 608 and the delivery catheter assembly 606.
Although not shown in the figures, in some implementations a cap is removably couplable to the proximal end of the handle to cover the release knob 630 and the suture locks 650. Accordingly, the cap can be positioned over the release knob 630 and suture locks 650 to prevent or inhibits the release knob 630 and suture locks 650 from being accidentally contacted or caught on something during manipulation of the implantable device, and removed to access the release knob 630 and suture locks 650.
In some implementations, one or more components of the delivery system are couplable to a stabilizer system to further provide improved control of the delivery system during delivery and implantation of the implantable device. As will be described in greater detail, the stabilizer system generally includes one or more clamps slidable with respect to a base plate that can be fixed relative to the patient. One or more components of the delivery system (e.g., one or more catheter assemblies) are received by the one or more clamps to limit movement of the delivery system or one or more components (e.g., catheter assemblies, etc.) thereof in one or more directions. For example, the stabilizer system can prevent or inhibit the delivery system or component(s) thereof from being moved vertically and from side-to-side while enabling the delivery system or one or more components thereof to be moved axially. In some implementations, the clamps receive a nose grip of one or more of the catheter assemblies of the delivery system.
Turning now to
In some implementations, the nose grip 634 is formed from or as an outer surface that is coated with a rubber or other material with a relatively high coefficient of friction such that the nose grip 634 does not slip when coupled to a clamp 685, such as can be incorporated into a stabilizer. However, in some implementations, the material has a coefficient of friction that allows the nose grip 634 to be rotated about an axis when coupled to the clamp 685, thereby enabling the handle to be rotated during a procedure to rotationally position the implantable device. As shown in
As shown in
In some implementations, the clamp 685 is coupled to a base plate 693 through one or more mounting rails 694 extending from the base plate 693. U.S. Provisional Patent Application Ser. No. 63/073,392 discloses examples of base plates and mounting rails that can be used as the base plate 693 and mounting rails 694, U.S. Provisional Patent Application Ser. No. 63/073,392 and is incorporated by reference herein for all purposes. In some implementations, the one or more mounting rails 694 extend in an axial direction (e.g., proximally and distally) along the base plate 693 and enable the clamp 685 to be moved axially. In some implementations, the clamp 685 is configured to slide with respect to the mounting rails 694 to enable the axial movement of the clamp 685 and, therefore, the steerable catheter assembly when the nose grip 634a is positioned within the opening of the clamp 685. To hold the clamp 685 in a desired location along the mounting rails 694, a locking knob 692 is rotatable between a first, locked position (shown in
In some implementations, the locking knob 692 is connected to a rotating cam portion (not shown) so that rotating the locking knob 692 causes the rotating cam portion to rotate. As the rotating cam portion is rotated, an oblong portion of the rotating camp portion engages a locking foot (not shown), thereby causing the locking foot to move downward to an extended position, which in turn causes the carriage to move upward with respect to the mounting rails 694. Friction generated between the carriage and the mounting rails 694 retains the clamp 685 in the desired location. To reposition the clamp 685, the locking knob 692 is rotated to disengage the locking foot so that the clamp 685 can slide along the mounting rail 694, as shown in
As with the previous example, the clamp 685 can be coupled to a base plate 693 through one or more mounting rails 694 extending from the base plate 693. In some implementations, the one or more mounting rails 694 extend in an axial direction (e.g., proximally and distally) along the base plate 693 and enable the clamp 685 to be moved axially. The clamp 685 is configured to slide with respect to the mounting rails 694 to enable the axial movement of the clamp 685 and, therefore, the implant catheter assembly when the nose grip 634a is positioned within the opening of the clamp 685. To hold the clamp 685 in a desired location along the mounting rails 694, a locking knob 692 is rotatable between a first, locked position (not shown) and a second, unlocked position (shown in
In some implementations, the locking knob 692 is connected to a rotating cam portion (not shown) so that rotating the locking knob 692 causes the rotating cam portion to rotate. As the rotating cam portion is rotated, an oblong portion of the rotating cam portion engages a locking foot (not shown), thereby causing the locking foot to move downward to an extended position, which in turn causes the carriage to move upward with respect to the mounting rails 694. Friction generated between the carriage and the mounting rails 694 retains the clamp 685 in the desired location. To reposition the clamp 685, the locking knob 692 is rotated to disengage the locking foot so that the clamp 685 can slide along the mounting rail 694.
In some implementations, the sheath 611 enters the handle 614 of the steerable catheter assembly and can extend through the handle and into the sheath 609 of the steerable catheter assembly, as described hereinabove. In some implementations, the sheath 611 has a friction fit within the handle 614, the sheath 609, or both. As shown in
As described herein, the nose grip 634 can be incorporated into the handles 614, 616 for a steerable catheter assembly and an implant catheter assembly of a delivery system. It is further contemplated that, in some implementations, any one or more of the catheter assemblies included in a delivery system can comprise the nose grip 634 to enable the catheter assembly to be coupled to a stabilization system. Moreover, it is contemplated that in some implementations in which multiple catheter assemblies in a delivery system comprise the nose grip 634, the nose grip 634 can be the same for each catheter assembly or can differ between catheter assemblies. For example,
In some implementations, the nose grip 634a has an outer diameter OD1, and the nose grip 634b has an outer diameter OD2. In some implementations, the outer diameter OD1 is equal to the outer diameter OD2. In some implementations, the outer diameter OD1 is different than the outer diameter OD2. For example, the outer diameter OD1 can be greater than the outer diameter OD2, or the outer diameter OD1 can be less than the outer diameter OD2. A difference in the outer diameters OD1, OD2 can, for example, enable a different tactile feel upon rotation of the steerable catheter assembly as compared to rotation of the implant catheter assembly. In some implementations, the outer diameter OD1 of the nose grip 634a of the steerable catheter assembly is greater than the outer diameter OD2 of the nose grip 634b of the implant catheter assembly, which can, for example, provide additional friction between the nose grip 634a and the opening 688 of the clamp 685 as compared to an amount of friction between the nose grip 634b and the opening 688 of the clamp 685. This can provide a feeling to the user that it is easier to turn the implant catheter assembly and implant than it is to rotate the steerable catheter assembly in the guide sheath or delivery catheter assembly.
Although the stabilization system can be effective to stabilize the delivery system at proximal locations, in some implementations, one or more of the catheter assemblies comprise features to further improve accuracy of the delivery of the implantable device. For example, movement of the implant catheter assembly through the steerable catheter assembly or while in the steerable catheter assembly (e.g., rotation of the implant catheter shaft to properly orient the implantable device) can alter the trajectory of the steerable catheter sheath, which in turn alters the location of the implantable device coupled to the implant catheter assembly. Accordingly, in some implementations, features can be implemented to reduce friction between the implant catheter shaft and the steerable catheter shaft, to stiffen a proximal portion of the steerable catheter sheath and/or the implant catheter shaft, or both.
Turning now to
In some implementations, the outer shaft or sheath 611 of the implant catheter assembly 610 includes a lumen through which an actuation element 112 (which can be the same as or similar to other actuations elements herein) extends, as described in greater detail above. The actuation element 112 extends in an axial direction through a lumen of the sheath or shaft 611 of the implant catheter assembly 610. In some implementations, the sheath or shaft 611 of the implant catheter assembly has a portion having a first outer diameter OD1. In some implementations, the portion having the first outer diameter OD1 extends distally from the handle 616 (
In some implementations, the portion of the sheath 611 of the implant catheter assembly 610 having the first outer diameter OD1 has a length that is greater than the length L2 of the reduced diameter portion 703 having the second outer diameter OD2. The length L2 of the reduced diameter portion 703 is greater than the length L1 of the steerable portion of the sheath of the steerable catheter assembly 608. Although the length L2 of the reduced diameter portion 703 can vary, in some implementations, the length L2 is greater than or equal to the sum of a stroke distance (i.e., the distance over which the sheath or shaft 611 of the implant catheter assembly 610 is extended from the sheath or shaft 609 of the steerable catheter assembly 608 during delivery of the implantable device) and the length L1 of the steerable portion of the sheath or shaft 609 of the steerable catheter assembly 608. Accordingly, the system can be operated such that only the reduced diameter portion 703 of the sheath or shaft 611 is in the steerable portion of the sheath or shaft 609 during use of the implant catheter assembly 610 and the steerable catheter assembly 608 to position and implant the implant or valve repair device 604. The sheath or shaft 611 of the implant catheter assembly 610 can have a reduced outer diameter over the entire length of the sheath or shaft 611 that will be within the steerable portion of the sheath 609 of the steerable catheter assembly 608, including when the sheath or shaft 611 implant catheter assembly is retracted and extended with respect to the steerable catheter assembly 608, as shown in
The difference between the first outer diameter OD1 and the second outer diameter OD2 can vary depending on the particular implementation and can be, for example, from about 0.25 mm to about 0.76 mm, or any range between 0.25 mm and 0.76 mm. In some implementations, the transition from the first outer diameter OD1 to the second outer diameter OD2 is gradual, and can form a smooth taper from the first outer diameter OD1 to the second outer diameter OD2 over a distance of from about 25 mm to about 50 mm. In some implementations, one or more discrete steps are defined from the first outer diameter OD1 to the second outer diameter OD2. Moreover, as shown in
In some implementations, both of the outer diameters OD1 and OD2 are less than the inner diameter ID1 of the sheath 609 of the steerable catheter assembly 608, and, as described above, the sheath 611 of the implant catheter assembly 610 has the second outer diameter OD2 along the length L1 of the steerable portion of the sheath 609 of the steerable catheter assembly 608. The reduced outer diameter OD2 of the sheath 611 of the implant catheter assembly 610 through the steerable portion of the sheath 609 of the steerable catheter assembly 608 reduces friction between the steerable catheter sheath 609 and the implant catheter sheath 611, which can reduce the amount of cross-talk between the steerable catheter sheath 609 and the implant catheter sheath 611 (e.g. unintended flexing of the steerable catheter sheath 609 and the implant catheter sheath 611 due to friction therebetween), and reduce the need to re-orient the steerable catheter assembly during implant positioning.
As an alternative to reducing the outer diameter of the sheath of the implant catheter assembly over the steerable length, it is contemplated that, in some implementations, the inner diameter of the sheath of the steerable catheter assembly can be increased over the length L1 while the outer diameter of the sheath of the implant catheter assembly remains constant. The inner diameter of the portion of the sheath 609 that flexes can be increased by an amount of from about 0.25 mm to about 0.76 mm (or any subrange thereof), and/or the transition from the first inner diameter to the second inner diameter can be over a distance of about 25 mm to about 50 mm. Moreover, in some implementations, both the inner diameter of the sheath of the steerable catheter assembly can be increased and the outer diameter of the sheath of the implant catheter assembly can be decreased to reduce friction between the steerable catheter assembly and the implant catheter assembly through the steerable portion.
Friction can additionally or alternatively be reduced between the implant catheter shaft and the steerable catheter sheath through the use of a lubricated coating 700, as shown in
The lubricated coating 700 can be a coating made from a wide variety of different materials. Any material that reduces friction can be used. The lubricated coating 700 can be a coating made, for example, from silicone oil, a hydrophilic material, or another material having a low coefficient of friction, such as perfluoropolyether (PFPE) or expanded polytetrafluoroethylene (ePTFE). Accordingly, the lubricated coating 700 can include hydrophilic coatings, coatings of PFPE lubricants, and ePTFE sleeves, such as coatings made from the materials commercially available under the tradenames CHRISTO-LUBE™ (available from Engineered Custom Lubricants) and SURMODICS SERENE™ (available from Surmodics, Inc.).
In some implementations, the lubricated coating 700 reduces a coefficient of friction between the outer surface of the sheath 611 of the implant catheter 610 and an inner surface of the sheath 609 of the steerable catheter assembly 608 through the steerable portion of the sheath 609 of the steerable catheter assembly 608. This reduction in friction can reduce the amount of cross-talk between the steerable catheter sheath 609 and the implant catheter sheath 611 (e.g., unintended flexing of the steerable catheter sheath 609 and the implant catheter sheath 611 due to friction therebetween), and reduce the need to re-orient the steerable catheter sheath during implant orientation.
Use of a liner (e.g., a lubricious liner) within the lumen of the steerable catheter sheath 609 can alternatively or additionally reduce friction between the steerable catheter sheath 609 and the implant catheter sheath 611. In some implementations, such a liner is formed from a polyamide doped with a PTFE powder. The PTFE powder can be incorporated into molten polyamide in an amount of from about 5 wt. % to about 30 wt. %, depending on the particular implementation. For example, the PTFE powder can be incorporated into the polyamide in an amount of from about 5 wt. % to about 30 wt. %, from about 5 wt. % to about 25 wt. %, from about 5 wt. % to about 20 wt. %, from about 5 wt. % to about 15 wt. %, from about 7.5 wt. % to about 30 wt. %, from about 7.5 wt. % to about 25 wt. %, from about 7.5 wt. % to about 20 wt. %, from about 7.5 wt. % to about 15 wt. %, or from about 10 wt. % to about 30 wt. %, from about 10 wt. % to about 25 wt. %, from about 10 wt. % to about 20 wt. %, or from about 10 wt. % to about 15 wt. %, including any ranges and sub-ranges therein.
The polyamide can be a variety of different polyamides. In some implementations, the polyamide is nylon 6,6, nylon 6,12, nylon 4,6, nylon 6, nylon 12, or a combination thereof. In some implementations, the polyamide has a Shore D durometer of 70D or greater. For example, the polyamide can have a Shore D durometer of 70D or greater, 75D or greater, 80D or greater, or 85D or greater. According to various implementations, the PTFE-doped polyamide liner may exhibit a coefficient of friction that is less than that of an otherwise identical polyamide liner, while also exhibiting an improved adhesion to a polymer jacket (e.g., a PEBAX or nylon polymer jacket) bound to the outer surface of the polymer liner. The PTFE-doped polyamide liner can define an interior surface of one or more lumens of the guide sheath, the steerable catheter, and/or the implant catheter of the delivery assemblies described herein, or of any other delivery assembly.
According to some implementations, the inner diameter ID1 of the sheath 609 of the steerable catheter assembly 608 varies along the length of the sheath 609 and, more particularly, can have a larger inner diameter at or near the ends of the sheath 609 than at an inner diameter at a point located closer to the center of the length of the sheath 609. For example, in some implementations, the inner diameter ID1 of the sheath 609 of the steerable catheter assembly 608 is flared at one or both of the proximal end and the distal end of the sheath. The flared inner diameter ID1 of the sheath 609 can be effective to create a smooth transition between the outer diameter of the sheath 611 of the implant catheter assembly 610 and the outer diameter of the sheath 609 of the steerable catheter assembly 608, which in turn can reduce an amount of coating (e.g., the lubricated coating 700) scraped off of the outer surface of the sheath 611 of the implant catheter by the inner surface of the sheath 609 of the steerable catheter assembly 608.
As described above, another method of improve accuracy of the delivery of the implantable device includes stiffening a proximal portion of the sheath 609 of the steerable catheter assembly 608 (as shown in
In
The stiffening material 701 can take a wide variety of different forms. The stiffening material 701 can be, for example, a laser-cut hypotube, a material having a higher durometer than materials in the distal portion(s) of the sheath(s) or shaft(s) of the catheter assembly(s), one or more braids, one or more meshes, one or more woven materials, or the like. The stiffening material 701 can be incorporated into the catheter sheath(s) or shaft(s) as a layer of a multi-layered sheath, as shown in
As shown in
A variable stiffness can be achieved in a variety of different ways. In the example illustrated by
In
The sheath 609 of the steerable catheter assembly 608 illustrated in
Referring to
Referring to
The cut patterns of laser cut hypotubes can take a wide variety of different forms. In the example illustrated by
The stiffness of each laser-cut hypotube 702 (or a segment of a hypotube) can be selected, for example, based on a material from which the hypotube is formed, a pitch of cuts, degrees of the circumference of the laser-cut hypotube that are cut, degrees of the circumference of the laser-cut hypotube that are uncut, and a kerf width of each cut. In some implementations, the hypotube is formed from stainless steel or nitinol, although other materials are suitable and contemplated.
As described above, in some implementations, stiffening materials can be incorporated in the form of a jacket of the sheath 609 of the steerable catheter assembly 608, or the stiffening materials can be incorporated into the structure of the sheath as layers of a multi-layer sheath. Example multi-layer sheaths are shown in
In some implementations, a braid, mesh, or woven material 704 is positioned around the second polymer layer 722 and is positioned within the laser-cut hypotube 702. In some implementations, the first layer of polymer 720 surrounds the laser-cut hypotube 702. Within the second polymer layer 722 and adjacent to the PTFE liner 728, a second liner 730 defines the second lumen, through which the flex control element or flex element 714 (e.g., pull wire, pull suture, tension member, etc.) and compression coil 716 extend. It should be appreciated that other layers and other lumens can be present in some implementations, and the layers can be provided in alternative orders while providing the torque resistance described herein.
In some implementations, the braid 704 (or other mesh or woven material), the laser-cut hypotube 702, and the first layer of polymer 720 that surrounds the laser-cut hypotube 702 do not extend along the proximal length of the multi-layer sheath, enabling the flex element 714 to enter the second lumen of the multi-layer sheath as described above. The lumen 726 has a substantially circular cross-section. In some implementations, a groove in the mandrel used to support the PTFE liner 728 and the second polymer layer 722 is filled at a position corresponding to the proximal end of the multi-layer sheath to enable the lumen 726 illustrated in
In still further implementations, the braid of the multi-layer sheath can be used to facilitate a passage for the flex control element or flex element (e.g., pull wire, pull suture, tension member, etc.). The incorporation of the passage into the braid can enable the separate lumen (lumen 726) under the braid, and, in some implementations, the compression coil 716, to be removed, which can in turn reduce the outer diameter profile of the multi-layer sheath, allow for a more uniform (e.g., circular) profile, allow for a larger inner profile, and/or reduce manufacturing complexity. Various braid patterns incorporating a flex element passage are illustrated in
In
The lumen 730 can be a tube, such as a thin-walled tube, made from any suitable material. In some implementations, the lumen 730 can be a stainless steel or nitinol hypotube. In some other implementations, the lumen 730 can be a polymeric tube, such as a tube made from polyamide, PEEK, or other polymers known and used in the art. The lumen can be made from any material. In the implementations illustrated in
In some implementations, the braid 704 (or other mesh or woven material), the laser-cut hypotube 702, and the first layer of polymer 720 that surrounds the laser-cut hypotube 702 do not extend along the proximal length of the multi-layer sheath, enabling the flex element 714 to enter the lumen 730 of the multi-layer sheath as described above. The lumen 730 can have a substantially circular cross-section. It should be appreciated that other layers and other lumens can be present in some implementations, and the layers can be provided in alternative orders while providing the torque resistance described herein.
In
As above, the lumen 730 can be a tube, such as a thin-walled tube, made from any suitable material. In some implementations, the lumen 730 can be a stainless steel or nitinol hypotube. In some other implementations, the lumen 730 can be a polymeric tube, such as a tube made from polyamide, PEEK, or other polymers known and used in the art. The lumen 730 can be made from any material. In the implementations illustrated in
In some implementations, the braid 704 (or other mesh or woven material), the laser-cut hypotube 702, and the first layer of polymer 720 that surrounds the laser-cut hypotube 702 do not extend along the proximal length of the multi-layer sheath, enabling the flex element 714 to enter the lumen 730 of the multi-layer sheath as described above. In contrast to the lumen illustrated in
While various inventive aspects, concepts and features of the disclosures may be described and illustrated herein as embodied in combination in the example implementations, these various aspects, concepts, and features may be used in many alternative implementations, either individually or in various combinations and sub-combinations thereof. Unless expressly excluded herein all such combinations and sub-combinations are intended to be within the scope covered herein. Still further, while various alternative implementations as to the various aspects, concepts, and features of the disclosures-such as alternative materials, structures, configurations, methods, devices, and components, alternatives as to form, fit, and function, and so on—may be described herein, such descriptions are not intended to be a complete or exhaustive list of available alternative implementations, whether presently known or later developed. One or more of the inventive aspects, concepts, or features can be adapted into additional implementations and uses within the scope of the present application even if such implementations are not expressly disclosed herein.
Additionally, even though some features, concepts, or aspects of the disclosures may be described herein as being a preferred arrangement or method, such description is not intended to suggest that such feature is required or necessary unless expressly so stated. Still further, example or representative values and ranges may be included to assist in understanding the present application, however, such values and ranges are not to be construed in a limiting sense and are intended to be critical values or ranges only if so expressly stated. Moreover, while various aspects, features and concepts may be expressly identified herein as being inventive or forming part of a disclosure, such identification is not intended to be exclusive, but rather there may be inventive aspects, concepts, and features that are fully described herein without being expressly identified as such or as part of a specific disclosure, the disclosures instead being set forth in the appended claims. Descriptions of example methods or processes are not limited to inclusion of all steps as being required in all cases, nor is the order that the steps are presented to be construed as required or necessary unless expressly so stated. Further, the techniques, methods, operations, steps, etc. described or suggested herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, tissue, etc. being simulated), etc. The words used in the claims have their full ordinary meanings and are not limited in any way by the description of the implementations in the specification.
The present application is a continuation of Patent Cooperation Treaty Application No. PCT/US2022/025390, filed on Apr. 19, 2022, which claims the benefit of U.S. Provisional Patent Application No. 63/181,120, filed on Apr. 28, 2021, titled “Delivery Devices for Heart Valve Treatment Devices,” and U.S. Provisional Patent Application No. 63/268,845, filed on Mar. 3, 2022, titled “Delivery Devices for Heart Valve Treatment Devices,” all of which are incorporated herein by reference in their entireties for all purposes.
| Number | Date | Country | |
|---|---|---|---|
| 63268845 | Mar 2022 | US | |
| 63181120 | Apr 2021 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2022/025390 | Apr 2022 | US |
| Child | 18496817 | US |
