PROSTHETIC HEART VALVE DELIVERY ASSEMBLY

A transcatheter heart valve delivery assembly includes a first shaft portion including a first wall surrounding a first chamber. A second shaft portion is attached to a distal end of the first shaft portion and includes a second wall surrounding a second chamber. A funnel portion is attached to a distal end of the second shaft portion and includes a funnel wall surrounding a funnel chamber. The funnel portion moves between a radially-compressed position, in which the funnel chamber includes a first diameter that is less than or equal to a diameter of the second chamber, and a radially-expanded position, in which the funnel chamber includes a second diameter that is greater than the first diameter. The funnel portion is biased into the radially-compressed position. Methods of recapturing a heart valve prosthesis are provided.

FIELD

The present disclosure relates generally to a prosthetic heart valve assembly and, more particularly, to a delivery assembly for delivering a heart valve prosthesis.

BACKGROUND

It is known to provide a prosthetic heart valve assembly for implanting a heart valve prosthesis within a target site of the vasculature of a patient. The heart valve prosthesis can be moved from a radially-collapsed position to a radially-expanded position. However, recapture of the heart valve prosthesis can be difficult.

SUMMARY

The following presents a simplified summary of the disclosure to provide a basic understanding of some aspects described in the detailed description.

In aspects, a transcatheter heart valve delivery assembly is provided for delivering a heart valve prosthesis to a treatment site. The transcatheter heart valve delivery assembly comprises a first shaft portion comprising a first wall surrounding a first chamber and extending along an axis. The first wall comprises a first durometer value. The transcatheter heart valve delivery assembly comprises a second shaft portion attached to a distal end of the first shaft portion and comprising a second wall surrounding a second chamber. The second shaft portion extends along the axis. The second wall comprises a second durometer value that is less than the first durometer value. The transcatheter heart valve delivery assembly comprises a funnel portion attached to a distal end of the second shaft portion and comprising a funnel wall surrounding a funnel chamber. The funnel portion extends along the axis and can move between a radially-compressed position, in which the funnel chamber comprises a first diameter that is less than or equal to a diameter of the second chamber, and a radially-expanded position, in which the funnel chamber comprises a second diameter that is greater than the first diameter. The funnel wall comprises a third durometer value that is less than the second durometer value. The funnel portion is biased into the radially-compressed position and configured to receive and compress the heart valve prosthesis within the funnel chamber.

In aspects, the funnel portion comprises one or more of a polyether-based thermoplastic polyurethane material or a thermoplastic elastomer material.

In aspects, the funnel wall comprises a funnel wall thickness within a range from about 0.3 millimeters to about 0.6 millimeters.

In aspects, the first diameter is within a range from about 5 millimeters to about 10 millimeters and the second diameter is within a range from about 12 millimeters to about 20 millimeters.

In aspects, the funnel portion comprises a length between a distal funnel end of the funnel portion and a proximal funnel end of the funnel portion that is within a range from about 5 millimeters to about 10 millimeters.

In aspects, the second shaft portion is reinforced with one or more of a frame or a coil.

In aspects, the second wall comprises a second wall thickness within a range from about 0.4 millimeters to about 0.8 millimeters.

In aspects, the second chamber comprises a second chamber diameter within a range from about 5 millimeters to about 10 millimeters.

In aspects, the first shaft portion is reinforced with one or more of a frame, a braid, or a coil.

In aspects, the first chamber, the second chamber, and the funnel chamber extend coaxially and contiguously through the first shaft portion, the second shaft portion, and the funnel portion, the first chamber, the second chamber, and the funnel chamber configured to receive at least a portion of the delivery assembly through the first shaft portion, the second shaft portion, and the funnel portion.

In aspects, a transcatheter heart valve delivery assembly is provided for delivering a heart valve prosthesis to a treatment site. The transcatheter heart valve delivery assembly comprises a first shaft portion comprising a first wall surrounding a first chamber. The first wall comprises a first durometer value. The first shaft portion is configured to receive a first portion of the delivery assembly within the first chamber. The transcatheter heart valve delivery assembly comprises a second shaft portion attached to a distal end of the first shaft portion and comprising a second wall surrounding a second chamber. The second wall comprises a second durometer value that is less than the first durometer value. The second shaft portion is configured to receive a second portion of the delivery assembly within the second chamber. The transcatheter heart valve delivery assembly comprises a funnel portion attached to a distal end of the second shaft portion and comprising a funnel wall surrounding a funnel chamber. The funnel portion is configured to move between a radially-compressed position, in which a distal end of the funnel portion comprises a first diameter, and a radially-expanded position, in which the distal end of the funnel portion comprises a second diameter that is greater than the first diameter. The funnel wall comprises a third durometer value that is less than the second durometer value. The funnel portion is biased into the radially-compressed position.

In aspects, the funnel portion comprises one or more of a polyether-based thermoplastic polyurethane material or a thermoplastic elastomer material.

In aspects, the funnel wall comprises a funnel wall thickness within a range from about 0.3 millimeters to about 0.6 millimeters.

In aspects, the second shaft portion comprises one or more of a thermoplastic elastomer material or a thermoplastic polyurethane elastomer.

In aspects, the second wall comprises a second wall thickness within a range from about 0.4 millimeters to about 0.8 millimeters.

In aspects, methods of recapturing a heart valve prosthesis comprise deploying the heart valve prosthesis at a treatment site. Methods comprise positioning a funnel portion of a heart valve implant recapture apparatus adjacent to a valve end of the heart valve prosthesis with the funnel portion in a radially-compressed position. Methods comprise moving one or more of the funnel portion relative to the heart valve prosthesis or the heart valve prosthesis relative to the funnel portion such that the funnel portion receives the heart valve prosthesis within the funnel chamber and the funnel portion moves from the radially-compressed position to a radially-expanded position. Methods comprise applying a radial force from the funnel portion to the heart valve prosthesis to radially compress the heart valve prosthesis.

In aspects, moving the funnel portion comprises applying an axial force to the funnel portion by a second shaft portion that is attached to the funnel portion. The funnel portion comprises a durometer value that is less than the second shaft portion.

In aspects, methods can comprise applying an outward radial force from the heart valve prosthesis to the funnel portion to move the funnel portion from the radially-compressed position to a radially-expanded position.

In aspects, a diameter of the funnel chamber changes from the radially-compressed position to the radially-expanded position.

In aspects, the funnel portion is attached to a shaft portion that comprises a different material than the funnel portion.

Additional features and advantages of the aspects disclosed herein will be set forth in the detailed description that follows, and in part will be clear to those skilled in the art from that description or recognized by practicing the aspects described herein, including the detailed description which follows, the claims, as well as the appended drawings. It is to be understood that both the foregoing general description and the following detailed description present aspects intended to provide an overview or framework for understanding the nature and character of the aspects disclosed herein. The accompanying drawings are included to provide further understanding and are incorporated into and constitute a part of this specification. The drawings illustrate various aspects of the disclosure, and together with the description explain the principles and operations thereof.

DETAILED DESCRIPTION

Aspects will now be described more fully hereinafter with reference to the accompanying drawings in which example aspects are shown. Whenever possible, the same reference numerals are used throughout the drawings to refer to the same or like parts. However, this disclosure may be embodied in many different forms and should not be construed as limited to the aspects set forth herein.

As used herein, the term “about” means that amounts, sizes, formulations, parameters, and other quantities and characteristics are not, and need not be, exact, but may be approximate and/or larger or smaller, as desired, reflecting tolerances, conversion factors, rounding off, measurement error and the like, and other factors known to those of skill in the art.

Ranges can be expressed herein as from “about” one value, and/or to “about” another value. When such a range is expressed, aspects include from the one value to the other value. Similarly, when values are expressed as approximations by use of the antecedent “about,” it will be understood that the value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.

Directional terms as used herein—for example up, down, right, left, front, back, top, bottom, upper, lower, etc.—are made only with reference to the figures as drawn and are not intended to imply absolute orientation.

Unless otherwise expressly stated, it is in no way intended that any methods set forth herein be construed as requiring that its steps be performed in a specific order, nor that with any apparatus, specific orientations be required. Accordingly, where a method claim does not actually recite an order to be followed by its steps, or that any apparatus claim does not actually recite an order or orientation to individual components, or it is not otherwise specifically stated in the claims or description that the steps are to be limited to a specific order, or that a specific order or orientation to components of an apparatus is not recited, it is in no way intended that an order or orientation be inferred in any respect. This holds for any possible non-express basis for interpretation, including matters of logic relative to arrangement of steps, operational flow, order of components, or orientation of components; plain meaning derived from grammatical organization or punctuation, and; the number or type of aspects described in the specification.

As used herein, the terms “comprising,” “including,” and variations thereof shall be construed as synonymous and open-ended, unless otherwise indicated. A list of elements following the transitional phrases comprising or including is a non-exclusive list, such that elements in addition to those specifically recited in the list may also be present.

Modifications may be made to the instant disclosure without departing from the scope or spirit of the claimed subject matter. Unless specified otherwise, “first,” “second,” or the like are not intended to imply a temporal aspect, a spatial aspect, an ordering, etc. Rather, such terms are merely used as identifiers, names, etc. for features, elements, items, etc. For example, a first end and a second end generally correspond to end A and end B or two different ends.

Unless otherwise indicated, the terms “distal” and “proximal” are used in the following description with respect to a position or direction relative to the treating clinician. “Distal” and “distally” are positions distant from or in a direction away from the clinician, and “proximal” and “proximally” are positions near or in a direction toward the clinician. In addition, the term “self-expanding” may be used in the following description with reference to one or more valve or stent structures of the prostheses hereof and is intended to convey that the structures are shaped or formed from a material that can be provided with a mechanical memory to return the structure from a compressed, collapsed, or constricted delivery configuration to an expanded deployed configuration or vice versa. Non-exhaustive exemplary self-expanding materials include stainless steel, a pseudo-clastic metal such as a nickel titanium alloy or nitinol, various polymers, or a so-called super alloy, which may have a base metal of nickel, cobalt, chromium, or other metal. Mechanical memory may be imparted to a wire or stent structure by thermal treatment to achieve a spring temper in stainless steel, for example, or to set a shape memory in a susceptible metal alloy, such as nitinol. Various polymers that can be made to have shape memory characteristics may also be suitable for use in aspects hereof to include polymers such as polynorborene, trans-polyisoprene, styrene-butadiene, and polyurethane. As well poly L-D lactic copolymer, oligo caprylactone copolymer and poly cyclo-octine can be used separately or in conjunction with other shape memory polymers.

Diseases associated with heart valves, such as those caused by damage or a defect, can include stenosis and valvular insufficiency or regurgitation. For example, valvular stenosis causes the valve to become narrowed and hardened which can prevent blood flow to a downstream heart chamber from occurring at the proper flow rate and may cause the heart to work harder to pump the blood through the diseased valve. Valvular insufficiency or regurgitation occurs when the valve does not close completely, allowing blood to flow backwards, thereby causing the heart to be less efficient. A diseased or damaged valve, which can be congenital, age-related, drug-induced, or in some instances, caused by infection, can result in an enlarged, thickened heart that loses elasticity and efficiency. Some symptoms of heart valve diseases can include weakness, shortness of breath, dizziness, fainting, palpitations, anemia and edema, and blood clots which can increase the likelihood of stroke or pulmonary embolism. Symptoms can often be severe enough to be debilitating and/or life threatening.

Heart valve prostheses have been developed for repair and replacement of diseased and/or damaged heart valves. Such heart valve prostheses can be percutaneously delivered and deployed at the site of the diseased heart valve through catheter-based delivery systems. Such heart valve prostheses generally include a frame or stent and a prosthetic valve mounted within the frame. Such heart valve prostheses are delivered in a radially collapsed or crimped configuration so that the heart valve prosthesis can be advanced through the patient's vasculature. Once positioned at the treatment site, the heart valve prosthesis is expanded to engage tissue at the diseased heart valve region to, for instance, hold the heart valve prosthesis in position.

FIGS.1and2illustrate an example transcatheter heart valve prosthesis10. The delivery assemblies described herein may be used with the transcatheter heart valve prosthesis10and/or other transcatheter heart valve prostheses. The transcatheter heart valve prosthesis10is illustrated to facilitate description of the disclosure. The following description of the transcatheter heart valve prosthesis10is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention.

FIGS.1and2illustrate a side view and a top/end view, respectively, of the transcatheter heart valve prosthesis10. The transcatheter heart valve prosthesis10includes a radially-expandable frame or stent15and a prosthetic valve20. The frame15of the transcatheter heart valve prosthesis10supports the prosthetic valve20within an interior of the frame15. In the example transcatheter heart valve prosthesis10shown inFIGS.1and2, the frame15is self-expandable. However, this is not meant to be limiting, and the frame15can be balloon-expandable or mechanically expandable in other embodiments. In some embodiments, the transcatheter heart valve prosthesis10may be delivered to and implanted at a treatment site within a patient to replace any of an aortic valve, a pulmonic valve, a mitral valve, and a tricuspid valve. The valve to be replaced may be a native valve or a previously-implanted prosthetic valve, such as a failed surgical replacement valve or a failed transcatheter valve.

The prosthetic valve20includes at least one leaflet21disposed within and secured to the frame15. In the embodiment shown inFIGS.1and2, the prosthetic valve20includes exactly three leaflets21, as shown inFIG.2. However, this is not meant to be limiting, as the prosthetic valve20may include more or fewer leaflets21. The valve leaflets21open and close to regulate flow through the transcatheter heart valve prosthesis10.

As shown inFIG.1, the transcatheter heart valve prosthesis10includes an inflow end11and an outflow end12. The prosthetic leaflets21are attached to the frame15at commissures25such that when pressure at the inflow end11exceeds pressure at the outflow end12, the prosthetic leaflets21open to allow blood flow through the heart valve prosthesis10from the inflow end11to the outflow end12. When the pressure at the outflow end12exceeds pressure at the inflow end11, the prosthetic leaflets21close to prevent blood flow from the outflow end12to the inflow end11. Accordingly, the at least one leaflet (e.g., the prosthetic leaflets21) can be attached to the plurality of struts16, for example, by being directly attached to the plurality of struts16at the commissures25, or by being indirectly attached to the plurality of struts16, for example, by being attached to a skirt, a commissure bracket, or other structure (e.g., mechanical actuator) that is attached to the plurality of struts16.

The frame15of the transcatheter heart valve prosthesis10further includes a plurality of struts16that are arranged to form a plurality of openings or cells18arranged circumferentially around a longitudinal axis LA of the transcatheter heart valve prosthesis10and longitudinally to form a tubular structure defining a central lumen of the transcatheter heart valve prosthesis10. For example, the frame15can extend along the longitudinal axis LA between the inflow end11and the outflow end12. The frame15is configured to secure the prosthetic valve20within the central lumen of the frame15and to secure the transcatheter heart valve prosthesis10in place in the vasculature of the patient. The struts16are defined herein as the elongated wire segments of the frame15. Struts16come together to form crowns17or nodes19, as can be seen inFIG.1. In aspects, attachment members26(e.g., loops) can be located at the inflow end11of the heart valve prosthesis10, for example, at the crowns. The frame15of the heart valve prosthesis10includes a plurality of cells18defined as the spaces between the plurality of crowns17, the plurality of nodes19, and the plurality of struts16. The frame15, and, thus, the plurality of struts16, can be adjustable between a radially-collapsed position and a radially-expanded position.

In the example embodiment shown inFIG.1, the plurality of cells18may be diamond-shaped. In the example embodiment shown, the plurality of cells include a plurality of first cells18and, in aspects, access cells. In particular, the access cells may be larger than the first cells18and can provide access to one or more coronary arteries when the transcatheter heart valve prosthesis10is implanted in the patient. The access cells can have an enlarged area relative or compared to the first cells18. Although not shown, in some embodiments the transcatheter heart valve prosthesis10may include an outer skirt extending circumferentially around an outer circumference of the stent15at or near the inflow end11to prevent paravalvular leakage of blood around the outside of the transcatheter heart valve prosthesis10once implanted in the patient.

FIG.3illustrates an example delivery assembly30for a transcatheter heart valve implant apparatus having and extending between a distal end102and a proximal end104. The distal end102can be used to load and deliver the heart valve prosthesis10(e.g., illustrated inFIG.4). The proximal end104can comprise components, for example, those found in other catheter delivery systems for controlling transcatheter delivery of the heart valve prosthesis10through the vasculature of the patient and for controlling deployment of the heart valve prosthesis10at the target site. In aspects, the components at the proximal end104may comprise, for example, a first rotating homeostasis valve106, a side access port108, a second rotating homeostasis valve110, and a guide member112. The first rotating homeostasis valve106can comprise latex and can form a fluid seal to limit blood or other fluid from leaking out of the delivery assembly30at the proximal end104or entry site into a patient. The side access port108is provided to inject contrast media or saline, for example, into the delivery assembly30. The second rotating homeostasis valve110may be similar to the first rotating homeostasis valve106and can limit blood or other fluid from leaking back through the delivery assembly30. In addition, the second rotating homeostasis valve110can allow wires, devices, and fluid to pass through to aid in the preparation, delivery, and deployment of the heart valve prosthesis10. Furthermore, the second rotating homeostasis valve110can control the components of the distal end102. For example, by manipulating (e.g., rotating) a portion of the second rotating homeostasis valve110, a physician can control components of the distal end102. The first and second homeostasis valves106,110can be compatible with catheter-laboratory components and, unless otherwise noted, the delivery assembly30is not intended to be limited to the specific components and features disclosed.

In aspects, the transcatheter delivery assembly30can be inserted into a vessel or artery of a patient, for example, the femoral artery. The proximal end104can extend outside of the patient, for example, in the groin area, while the distal end102may be delivered intravascularly to an area at or near a pulmonary valve inside the body. However, insertion of the transcatheter delivery assembly30in other areas of the body are also contemplated. The transcatheter delivery assembly30can include one or more axial lumens to pass items (e.g., guidewires, valve prosthesis, contrast media, other catheters, etc.) through the transcatheter delivery assembly30.

In aspects, the delivery assembly30can comprise an inner shaft member36comprising at least one guidewire lumen. As used herein, a lumen comprises a cavity or hollow bore that extends through a structure, for example, the inner shaft member36. The guide member112can be attached to a proximal shaft portion114of the the inner shaft member36at the proximal end104. In aspects, the inner shaft member36can extend partially or completely along an entire length of the transcatheter delivery assembly30and may be slid or moved through other components of the transcatheter delivery assembly30. As explained herein, a plurality of guidewires can extend through the inner shaft member36and can be used to guide the heart valve prosthesis10to a desired location. The transcatheter delivery assembly30can comprise an outer shaft116that is located between the distal end102and the proximal end104, with the inner shaft member36extending through the outer shaft116. The outer shaft116can limit blood from leaking around the transcatheter delivery assembly30and provides a relatively smooth, flexible length to enable the delivery assembly30to traverse through the vasculature of the patient.

In aspects, a tapered tip37can be attached to the inner shaft member36at the distal end102. The tip37comprises a tapered shape to case the passage of the delivery assembly30into and through the vasculature. In aspects, a holding catheter34can be attached to the heart valve prosthesis10. The holding catheter34can comprise a centrally located lumen surrounding the inner shaft member36. The holding catheter34can slide relative to the inner shaft member36and may be controlled by the second rotating homeostasis valve110at the proximal end104of the delivery assembly30. In aspects, a portion of the second rotating homeostasis valve110can be rotated or otherwise manipulated in order to rotate the holding catheter34or move the holding catheter34proximally and distally as desired. In aspects, a coil701can be attached to the distal end of the holding catheter34. In this way, movement of the holding catheter34, as controlled by the second rotating homeostasis valve110, can control movement or rotation of the coil701. In aspects, the holding catheter34can be surrounded by a reinforcement layer124, which can be attached or otherwise bonded to the holding catheter34and can serve to reinforce the holding catheter34. The coil701can be removably attached to the valve prosthesis10, for example, by engaging the attachment members26(e.g., illustrated inFIG.1). As such, the coil701can allow for loading of the valve prosthesis10, holding of the valve prosthesis10during delivery, and release of the valve prosthesis10upon reaching a treatment site. In aspects, rotation of the coil701can cause the valve prosthesis10to detach from the coil701. The delivery assembly30can further comprise an outer sheath126that may comprise a low friction and flexible material, such as polytetrafluoroethylene (PTFE), polyurethane, silicone, or polyethylene. The outer sheath126can be sized and shaped to receive components near the distal end102, for example, the inner shaft member36, the coil701, the valve prosthesis10, etc.

FIG.4illustrates the distal end102of the delivery assembly30. In aspects, the valve prosthesis10can be in a radially-compressed position during intraluminal delivery to a treatment site. In the radially-compressed position, the valve prosthesis10can be removably attached to the coil701and circumferentially surrounded by the outer sheath126. The valve prosthesis10can extend coaxially with the inner shaft member36, for example, with the inner shaft member36extending through a center of the valve prosthesis10. The outer sheath126comprises a cross-sectional size (e.g., diameter) that is less than a cross-sectional size of the valve prosthesis10when the valve prosthesis10is in a radially-expanded position (e.g., illustrated inFIG.1). As such, the outer sheath126, along with the coil701, can maintain the valve prosthesis10in the radially-compressed position during delivery.

Minimally invasive percutaneous interventional procedures, including endovascular procedures, require access to the venous or arterial system. In general, it is desirable to make the smallest incision point with the shortest tissue contact time when entering the body. Small incisions and short tissue contact time generally lead to improved patient outcomes, less complications, and less trauma to the vessels or organs being accessed, as well as less trauma to the skin and tissue through which the access point is created. Access is required for various medical procedures that deliver or implant structural elements (such as heart valves, heart valve repair devices, occluders, grafts, electrical stimulators, leads, etc.) percutaneously. Some procedures employ relatively large devices that require relatively large sheaths to deliver the devices to the intended site within the body. With such procedures, access site trauma can occur, often resulting in vessel damage, excessive bleeding, increased case time, increased risk of infection, and increased hospitalization time. To reduce access trauma, physicians try to use the smallest devices possible and place the smallest sheath size. This can be problematic, however, if during the procedure the physician discovers a larger device is needed. This leads to a need to upsize the sheath, which is a lengthy procedure and leads to increased risk to the patient. Expandable sheaths can be expanded within the body and thus do not require removal to upsize.

Expandable sheath designs may be regionally or locally expansive to selectively and temporarily expand when the device is passing through a region of the sheath and to retract or recover when the device is not passing or has already passed through the sheath. Embodiments disclosed herein may be employed with an expandable introducer sheath that may solve these and other issues that contribute to vascular trauma. The expandable introducer sheath is described with respect to percutaneous access for transcatheter heart valve repair or replacement, and it should be understood that one or more features of the expandable introducer sheath may be employed alone or in combination for other medical procedures requiring percutaneous access, including but not limited to placement of stents, angioplasty, removal of arterial or venous calcification, and pre-dilatation or post-dilatation.

Various embodiments disclosed herein may include an introducer sheath that has a selectively expandable diameter to allow for the passage of a relatively larger device therethrough and further is configured to return to its original diameter upon passage of the device. The various embodiments may reduce damage to surrounding tissues by reducing contact with those tissues and by eliminating the need to exchange sheaths of different sizes. As a result, these embodiments can reduce procedure time, vascular trauma, bleeding, and the resulting risk of infection and other complications.

FIG.5depicts one embodiment of an introducer sheath50positioned through an incision60in the skin of a patient and into a vessel40(e.g., for example, a femoral vein) surrounded by a vessel wall65of a patient. The sheath50has a tubular shaft55and a proximal hub56with a hemostatic seal and a luer lock57.FIG.5shows the sheath50positioned in the vessel40in its normal, unexpanded state. The shaft55can expand as a device passes through and then can retract or recover to its original diameter after the device moves past or is removed from the shaft55. Thus, the tubular shaft55is configured to be expandable and retractable.

In certain embodiments, the expandability of the shaft55(and any shaft described according to any embodiment set forth herein) can be achieved via the elasticity of the shaft55, which can result in the shaft55being either expandable or expanding or mechanically expandable or mechanically expanding. For purposes of this application, expandable means that the shaft55is configured to expand to a predetermined or nominal diameter. Further, for purposes of this application, mechanically expandable means that the shaft55is configured to expand when a positionable medical device is positioned through the shaft55. That is, the device itself that is being passed through the shaft55causes the expansion of the shaft55. In this way, the expandable and/or mechanically expandable shaft55can expand in response to a component or structure being pushed through the shaft55. Further, in the alternative, while an expandable introducer sheath can be used, in aspects, the transcatheter heart valve prosthesis10may be delivered via a non-expandable introducer sheath.

After passage of the device, the shaft55is configured to be contractable, retractable, or recoverable to its original, unexpanded state as depicted inFIG.5. The retractability can be, in certain embodiments, achieved by the elasticity of the shaft55, which can result in the shaft55being either self-retractable or self-retracting, self-recoverable, or self-contractable, or mechanically retractable or mechanically retracting, mechanically recoverable, or mechanically contractable. For purposes of this application, self-retractable means that the shaft55is configured to retract to a predetermined or nominal diameter automatically (without any type of actuation, mechanical or otherwise). Further, for purposes of this application, mechanically retractable means that the shaft55is configured to retract when a device or component is used to cause the shaft55to retract or recover. Alternatively, the retractable characteristics of the shaft55can be caused by something other than elasticity.

For purposes of this application, any device that can be positioned through an introducer sheath according to any embodiment disclosed or contemplated herein can be referred to as a positionable medical device or insertable medical device. Such devices include guidewires, dilators, delivery devices (for delivery and/or placement of structural elements such as heart valves, heart valve repair devices, occluders, grafts, electrical stimulators, leads, etc.), guide catheters, guiding sheaths, diagnostic catheters, stent delivery systems, balloon catheters, and other known vascular devices. Other devices can include non-vascular devices such as scopes and other common surgical instruments. Further, the introducer sheath is configured to receive tissues or organs. Thus, as one non-limiting example, the introducer sheath50is described as being an expandable introducer sheath50for introduction of a delivery assembly30including a transcatheter heart valve prosthesis10.

FIG.6illustrates a side view of an embodiment of the heart valve prosthesis10and a portion of an embodiment of the delivery assembly30, for example, an inflow capture device701, the distal tip37, retractable sheath(s), shaft(s)34,36, etc. In aspects, the inflow capture device701can comprise a coil that can engage with attachment members26(e.g., illustrated inFIG.1) at the inflow end11of the heart valve prosthesis10, and, thus, support the inflow end11in a radially-compressed position.FIG.6illustrates the valve prosthesis10in the process of deployment, wherein the the outflow end12moves from the radially-compressed position to a radially-expanded position. As illustrated inFIG.6, the inflow capture device701is still attached to the inflow end11, such that the inflow end11is in the radially-compressed position. Accordingly, methods of recapturing the heart valve prosthesis10can comprise deploying the heart valve prosthesis10at the treatment site, wherein the deployment can comprise partial or complete deployment.

In aspects, due to an undesirable position of the valve prosthesis10at the treatment site, it may be beneficial to recapture the valve prosthesis10, for example, by radially-compressing the valve prosthesis10from the radially-expanded position to the radially-compressed position. As used herein, the term “recapture” can refer to the process of radially-compressing the valve prosthesis10from a partially or completely radially-expanded position to a radially-compressed position, and maintaining the valve prosthesis10in the radially-compressed position while repositioning the valve prosthesis10. As illustrated inFIG.6, the delivery assembly30can comprise a recapture apparatus711that is provided to recapture the valve prosthesis10. In aspects, the recapture apparatus711can circumferentially surround portions of the delivery assembly30, for example, one or more of the inner shaft36, the holding catheter34, etc. In this way, while circumferentially surrounding portions of the delivery assembly30, the recapture apparatus711is movable relative to the aforementioned portions of the delivery assembly30. That is, the recapture apparatus711may not be permanently fixed or attached to the delivery assembly30, such that relative movement between the recapture apparatus711and the delivery assembly30is provided.

FIG.7illustrates a side view of the recapture apparatus711, wherein portions of the delivery assembly30are omitted from view inFIG.7so as to more clearly illustrate the recapture apparatus711. In aspects, the recapture apparatus711can comprise a first shaft portion801, a second shaft portion803, and a funnel portion805positioned end-to-end. For example, the first shaft portion801can extend along an axis809between a proximal end811and a distal end813. It will be understood that the first shaft portion801, the second shaft portion803, and the funnel portion805are not limited to extending linearly along the axis809, and, in operation, one or more of the first shaft portion801, the second shaft portion803, and the funnel portion805may be bent, curved, or otherwise oriented to extend non-linearly to accommodate for the tortuous anatomy of a patient's vasculature. At least a portion of the first shaft portion801can be positioned at an exterior of the patient's vasculature (e.g., outside of the incision60as illustrated inFIG.5). For example, the proximal end811, and some or all of the length of the first shaft portion801from the proximal end811toward the distal end813can be positioned at the exterior of the patient's vasculature.

The first shaft portion801can comprise a first wall817surrounding a first chamber819. In this way, the first shaft portion801is substantially hollow, with the first chamber819extending along the length of the first shaft portion801between the proximal end811and the distal end813. The first chamber819can comprise a first chamber diameter823that is a distance between an inner surface of the first wall817measured in a direction substantially perpendicular to the axis809. In aspects, the first chamber diameter823may be within a range from about 5 millimeters to about 10 millimeters. In aspects, the first chamber diameter823may be substantially constant along the length of the first shaft portion801between the proximal end811and the distal end813. In this way, portions of the delivery assembly30can be received within the first chamber819. That is, the first shaft portion801can receive a first portion of the delivery assembly30within the first chamber819. In aspects, the first wall817of the first shaft portion801can comprise a first wall thickness825that is within a range from about 0.4 millimeters to about 0.8 millimeters. The first wall thickness825can be measured in a radial direction between an inner surface of the first wall817and an outer surface of the first wall817. In aspects, the first wall thickness825can be substantially constant along the length of the first shaft portion801between the proximal end811and the distal end813.

The first shaft portion801can comprise several materials, for example, a thermoplastic elastomer such as polyether block amide, a thermoplastic polyurethane elastomer, etc. The first wall817can comprise a first durometer value (e.g., shore durometer) that is a measure of the hardness of the first wall817. In aspects, the first wall817can comprise a higher durometer value (e.g., a harder and less flexible material) than the second shaft portion803and/or the funnel portion805. For example, the first durometer of the first wall817allows the first shaft portion801to be moved in an axial direction along the axis809(e.g., toward and away from the incision60), such that the first shaft portion801can apply a pushing force to the second shaft portion803. In aspects, the first shaft portion801can comprise a first length827measured between the proximal end811and the distal end813, wherein the first length827may be greater than 50 centimeters, or greater than 100 centimeters, or greater than 100 centimeters. In aspects, the first shaft portion801can further comprise one or more structures to provide additional reinforcement to enhance the ability to move axially (e.g., pushability) at a minimal dimensional increase. For example, the first shaft portion801can be reinforced with one or more of a frame (e.g., a nitinol frame, for example), a braid (e.g., braided sheath, sleeve, etc.), or a coil (e.g., a nitinol coil, for example). In aspects, when the first shaft portion801is reinforced with one of these structures, the structure (e.g., frame, braid, coil, etc.) may be embedded within and/or surrounded by the thermoplastic elastomer material described above.

The second shaft portion803can be attached to the first shaft portion801and, in aspects, can extend along the axis809between a proximal end831and a distal end833. The proximal end831of the second shaft portion803can be attached to the distal end813of the first shaft portion801such that the first shaft portion801and the second shaft portion803can be attached and positioned in an end-to-end configuration. In aspects, some, or all, of the second shaft portion803can be positioned within the patient's vasculature, for example, with the distal end833and some, or all, of the length of the second shaft portion803from the distal end833toward the proximal end831positioned within the patient's vasculature.

The second shaft portion803can comprise a second wall837surrounding a second chamber839. In this way, the second shaft portion803is substantially hollow, with the second chamber839extending along the length of the second shaft portion803between the proximal end831and the distal end833. In aspects, the second chamber839is contiguous and coaxial with the first chamber819. The second chamber839can comprise a second chamber diameter843that is a distance between an inner surface of the second wall837measured in a direction substantially perpendicular to the axis809. In aspects, the second chamber diameter843may be within a range from about 5 millimeters to about 10 millimeters. In aspects, the second chamber diameter843may be substantially constant along the length of the second shaft portion803between the proximal end831and the distal end833. In this way, portions of the delivery assembly30can be received within the second chamber839. That is, the second shaft portion803can receive a second portion of the delivery assembly30within the second chamber839. In aspects, the second wall837of the second shaft portion803can comprise a second wall thickness845that is within a range from about 0.4 millimeters to about 0.8 millimeters. The second wall thickness845can be measured in a radial direction between an inner surface of the second wall837and an outer surface of the second wall837. In aspects, the second wall thickness845can be substantially constant along the length of the second shaft portion803between the proximal end831and the distal end833.

The second shaft portion803can comprise several materials, for example, one or more of a thermoplastic elastomer material or a thermoplastic polyurethane elastomer. In aspects, the second shaft portion803can be reinforced with a nitinol frame or coil while still being capable of a relatively tight bend radius. The second shaft portion803can comprise a mid-durometer polymer material. The second wall837can comprise a second durometer value (e.g., shore durometer) that is a measure of the hardness of the second wall837. In aspects, the second durometer value of the second shaft portion803is less than the first durometer value of the first shaft portion801, such that the second wall837comprises a softer and more clastic or flexible material than the first wall817. In this way, the second durometer value of the second shaft portion803may be chosen to allow for the second shaft portion803to bend and flex while moving through tortuous sections of the patient's vasculature. The second durometer value of the second shaft portion803can also allow for the second shaft portion803to maintain sufficient axial strength and rigidity to allow for the first shaft portion801to apply an axial pushing force upon the second shaft portion803, thus allowing for the second shaft portion803to move axially through the patient's vasculature. In aspects, the second shaft portion803can comprise a second length847measured between the proximal end831and the distal end833, wherein the second length847may be greater than 50 centimeters, or greater than 100 centimeters, or greater than 100 centimeters. In aspects, the second shaft portion803can be reinforced with a structure, such that the second shaft portion803may, for example, be reinforced with one or more of a frame or a coil comprising nitinol. Reinforcing the second shaft portion803(e.g., with the nitinol frame or coil, etc.) can further accommodate for the relatively tight bends within a patient's anatomy. In aspects, when the second shaft portion803is reinforced with the nitinol frame or coil, the nitinol frame or coil may be embedded within and/or surrounded by the mid-durometer polymer material described above.

The funnel portion805can be attached to the second shaft portion803such that the second shaft portion803is positioned axially between the first shaft portion801and the funnel portion805. The first shaft portion801, the second shaft portion803, and the funnel portion805can be attached to one another in several ways, for example, with adhesives or the like. The funnel portion805can be attached to the second shaft portion803and, in aspects, can extend along the axis809between a proximal funnel end851and a distal funnel end853. For example, the proximal funnel end851can be attached to the distal end833of the second shaft portion803such that the funnel portion805and the second shaft portion803can be attached and positioned in an end-to-end configuration.

The funnel portion805can comprise a funnel wall855surrounding a funnel chamber859. In this way, the funnel portion805is substantially hollow, with the funnel chamber859extending along the length of the funnel portion805between the proximal funnel end851and the distal funnel end853. In aspects, the funnel chamber859is contiguous and coaxial with the second chamber839. For example, the first chamber819, the second chamber839, and the funnel chamber859can extend coaxially and contiguously through the first shaft portion801, the second shaft portion803, and the funnel portion805. In this way, the first chamber819, the second chamber839, and the funnel chamber859can receive at least a portion of the delivery assembly30(e.g., shafts34,36, etc.) through the chambers819,839,859of the first shaft portion801, the second shaft portion803, and the funnel portion805. The funnel portion805can move between a radially-compressed position (e.g., as illustrated inFIG.7), in which the funnel chamber859comprises a first diameter863that is less than or equal to the second chamber diameter843of the second chamber839, and a radially-expanded position (e.g., as illustrated inFIG.8). The funnel portion805may be biased into the radially-compressed position and is configured to receive and compress the heart valve prosthesis10within the funnel chamber859. In aspects, the first diameter863is the distance between an inner surface of the funnel wall855measured in a direction substantially perpendicular to the axis809. The first diameter863(e.g., the cross-sectional size of the funnel chamber859) may, in aspects, be substantially constant along the length of the funnel portion805between the ends851,853when the funnel portion805is in the radially-compressed position. In aspects, the first diameter863may be within a range from about 5 millimeters to about 10 millimeters. In aspects, the funnel wall855can comprise a funnel wall thickness865that is within a range from about 0.3 millimeters to about 0.6 millimeters. The funnel wall thickness865can be measured in a radial direction between an inner surface of the funnel wall855and an outer surface of the funnel wall855. In aspects, the funnel wall thickness865may be substantially constant along the length of the funnel portion805between the ends851,853.

The funnel portion805can comprise, for example, one or more of a polyether-based thermoplastic polyurethane material or a thermoplastic elastomer material. In aspects, the funnel portion805can comprise a super-elastic material that can reversibly deform to a high strain in response to a high stress. The funnel wall855can comprise a third durometer value (e.g., shore durometer) that is a measure of the hardness of the funnel wall855. In aspects, the third durometer value of the funnel portion805is less than the second durometer value of the second shaft portion803. As such, the funnel wall855comprises a softer and more clastic or flexible material than the first wall817and the second wall837. The funnel portion805can therefore be attached to the shaft portions801,803, with the funnel portion805comprising a different, and softer more flexible material than the shaft portions801,803. In this way, the third durometer value of the funnel portion805can be chosen to allow for the funnel portion805to flex and move between the radially-compressed position and the radially-expanded position. The third durometer value can also allow for the funnel portion805to maintain sufficient axial strength and rigidity to allow for the second shaft portion803to apply an axial pushing force upon the funnel portion805, thus allowing for the funnel portion805to move axially through the patient's vasculature. In aspects, the funnel portion805can comprise a funnel length867measured between the proximal funnel end851and the distal funnel end853, wherein the funnel length867is within a range from about 5 millimeters to about 10 millimeters.

FIG.8illustrates the funnel portion805in the radially-expanded position, wherein the funnel chamber859comprises a second diameter901that is greater than the first diameter863. In aspects, the second diameter901is measured at the distal funnel end853, which can represent a location of a maximum cross-sectional size (e.g., diameter) of the funnel chamber859. In aspects, the second diameter901may be within a range from about 12 millimeters to about 20 millimeters. When the funnel portion805is in the radially-expanded position, the funnel portion805may comprise a non-constant and increasing cross-sectional size (e.g., diameter) from the proximal funnel end851to the distal funnel end853. In aspects, the funnel chamber859at the proximal funnel end851may comprise the first diameter863while the funnel chamber859at the distal funnel end853may comprise the second diameter901.

As mentioned above, the funnel portion805may be biased into the radially-compressed position. As used herein, the term ‘biased’ can refer to the funnel portion805reverting back to the radially-compressed position illustrated inFIG.7in the absence of other forces acting upon the funnel portion805, and remaining in the radially-compressed position. However, in response to an outward radial force acting upon the inner surface of the funnel wall855, the funnel portion805can move from the radially-compressed position to the radially-expanded position. In aspects, the outward radial force can occur when the heart valve prosthesis10is received within the funnel chamber859and contacts the inner surface of the funnel wall855. In the radially-compressed position, the funnel portion805can comprise a minimum cross-sectional size (e.g., diameter) and in the radially-expanded position, the funnel portion805can comprise a maximum cross-sectional size. While in the radially-compressed position, the funnel portion805can comprise an outer diameter (e.g., a diameter measured at the outer surface of the funnel wall855) that can substantially match an outer diameter of the second shaft portion803. In this way, the junction between the second shaft portion803and the funnel portion805may be relatively smooth to limit the likelihood of negatively affecting the patient's vasculature during movement of the recapture apparatus711. However, in the radially-expanded position, the outer diameter of the funnel portion805may be greater than an outer diameter of the second shaft portion803, with the outer diameter of the funnel portion805increasing from the proximal funnel end851to the distal funnel end853.

Referring toFIGS.6and9, the operation of the recapture apparatus711relative to the heart valve prosthesis10is illustrated. Initially, as illustrated inFIG.6, the heart valve prosthesis10may be at least partially deployed, for example, with the outflow end12in a radially-expanded position and the inflow end11in the radially-compressed position (e.g., attached to the inflow capture device701). However, a physician may determine that the heart valve prosthesis10is in an undesirable position relative to the treatment site of the patient. Accordingly, the recapture apparatus711can receive and radially compress the heart valve prosthesis10, allowing for the heart valve prosthesis10to be moved and re-deployed. For example, the recapture apparatus711may be moved relative to the delivery assembly30and the heart valve prosthesis10such that the distal funnel end853of the funnel portion805can be positioned adjacent to the inflow end11of the heart valve prosthesis10(e.g., as illustrated inFIG.6). In aspects, movement of the recapture apparatus711relative to the delivery assembly30can comprise axial movement of the recapture apparatus711and/or rotational movement of the recapture apparatus711. Accordingly, methods can comprise positioning the funnel portion805of the heart valve implant recapture apparatus711adjacent to the valve end (e.g., inflow end11) of the heart valve prosthesis10with the funnel portion805in the radially-compressed position (e.g., illustrated inFIG.6).

Referring toFIG.9, the recapture apparatus711can be moved from the position illustrated inFIG.6in a first movement direction1001toward the heart valve prosthesis10. The recapture apparatus711can be moved in the first movement direction1001, for example, by a physician applying an axial pushing force to the first shaft portion801, which can likewise cause the second shaft portion803and the funnel portion805to move axially in the first movement direction1001. In addition, or in the alternative, the heart valve prosthesis10can be moved in a second movement direction1003toward the recapture apparatus711, wherein the second movement direction1003is opposite the first movement direction1001. The recapture apparatus711and/or the heart valve prosthesis10can be moved relative to one another such that the heart valve prosthesis10can be received within the funnel chamber859.

In aspects, the heart valve prosthesis10can contact the inner surface of the funnel wall855and apply an outward radial force1005(e.g., illustrated with a directional arrow) to the funnel wall855, thus causing the funnel portion805to radially expand from the radially-compressed position. Likewise, the funnel wall855can apply an inward radial force1007(e.g., illustrated with a directional arrow) to the heart valve prosthesis10, thus causing the heart valve prosthesis10to radially contract and move from the radially-expanded position to a radially-compressed position. Methods can therefore comprise moving one or more of the funnel portion805(e.g., in the first movement direction1001) relative to the heart valve prosthesis10or the heart valve prosthesis10(e.g., in the second movement direction1003) relative to the funnel portion805such that the funnel portion805receives the heart valve prosthesis10within the funnel chamber859and the funnel portion805moves from the radially-compressed position to the radially-expanded position. Moving the funnel portion805can comprise applying the axial force to the funnel portion805by the second shaft portion803that is attached to the funnel portion805, with the funnel portion805comprising the durometer value that is less than the durometer value of the second shaft portion803. Methods can further comprise applying the outward radial force1005from the valve prosthesis10to the funnel portion805to move the funnel portion805from the radially-compressed position to the radially-expanded position. The diameter of the funnel chamber859can therefore change from the radially-compressed position to the radially-expanded position to accommodate the heart valve prosthesis10. The recapture apparatus711can continue moving in the first movement direction1001and/or the heart valve prosthesis10can continue moving in the second movement direction1003at least until the heart valve prosthesis10is received within the funnel chamber859(e.g., as illustrated inFIGS.9-10).

FIG.10illustrates the heart valve prosthesis10fully received within the funnel chamber859, such that the length of the heart valve prosthesis10is circumferentially surrounded by the funnel wall855. In this way, the funnel portion805can apply the inward radial force1007to the heart valve prosthesis10, thus maintaining the heart valve prosthesis10in the radially-compressed position illustrated inFIG.10. Accordingly, the heart valve prosthesis10can be fully recaptured and repositioned, for example, by moving the delivery assembly30. Methods can therefore comprise applying a radial force (e.g., the inward radial force1007) from the funnel portion805to the heart valve prosthesis10to radially compress the heart valve prosthesis10. The recapture apparatus711can provide several benefits. For example, the recapture apparatus711can be moved relative to the delivery assembly30, such that modifications to an existing delivery assembly30may be avoided. Further, the recapture apparatus711can be used to recapture the heart valve prosthesis10and allow for a more desirable positioning of the heart valve prosthesis10within the patient's vasculature.

Aspect 1. A transcatheter heart valve delivery assembly is provided for delivering a heart valve prosthesis to a treatment site. The transcatheter heart valve delivery assembly comprises a first shaft portion comprising a first wall surrounding a first chamber and extending along an axis. The first wall comprises a first durometer value. The transcatheter heart valve delivery assembly comprises a second shaft portion attached to a distal end of the first shaft portion and comprising a second wall surrounding a second chamber. The second shaft portion extends along the axis. The second wall comprises a second durometer value that is less than the first durometer value. The transcatheter heart valve delivery assembly comprises a funnel portion attached to a distal end of the second shaft portion and comprising a funnel wall surrounding a funnel chamber. The funnel portion extends along the axis and can move between a radially-compressed position, in which the funnel chamber comprises a first diameter that is less than or equal to a diameter of the second chamber, and a radially-expanded position, in which the funnel chamber comprises a second diameter that is greater than the first diameter. The funnel wall comprises a third durometer value that is less than the second durometer value. The funnel portion is biased into the radially-compressed position and configured to receive and compress the heart valve prosthesis within the funnel chamber.

Aspect 2. The transcatheter heart valve delivery assembly of aspect 1, wherein the funnel portion comprises one or more of a polyether-based thermoplastic polyurethane material or a thermoplastic elastomer material.

Aspect 3. The transcatheter heart valve delivery assembly of any one of aspects 1-2, wherein the funnel wall comprises a funnel wall thickness within a range from about 0.3 millimeters to about 0.6 millimeters.

Aspect 4. The transcatheter heart valve delivery assembly of any one of aspects 1-3, wherein the first diameter is within a range from about 5 millimeters to about 10 millimeters and the second diameter is within a range from about 12 millimeters to about 20 millimeters.

Aspect 5. The transcatheter heart valve delivery assembly of any one of aspects 1-4, wherein the funnel portion comprises a length between a distal funnel end of the funnel portion and a proximal funnel end of the funnel portion that is within a range from about 5 millimeters to about 10 millimeters.

Aspect 6. The transcatheter heart valve delivery assembly of any one of aspects 1-5, wherein the second shaft portion is reinforced with one or more of a frame or a coil.

Aspect 7. The transcatheter heart valve delivery assembly of any one of aspects 1-6, wherein the second wall comprises a second wall thickness within a range from about 0.4 millimeters to about 0.8 millimeters.

Aspect 8. The transcatheter heart valve delivery assembly of any one of aspects 1-7, wherein the second chamber comprises a second chamber diameter within a range from about 5 millimeters to about 10 millimeters.

Aspect 9. The transcatheter heart valve delivery assembly of any one of aspects 1-8, wherein the first shaft portion is reinforced with one or more of a frame, a braid, or a coil.

Aspect 10. The transcatheter heart valve delivery assembly of any one of aspects 1-9, wherein the first chamber, the second chamber, and the funnel chamber extend coaxially and contiguously through the first shaft portion, the second shaft portion, and the funnel portion, the first chamber, the second chamber, and the funnel chamber configured to receive at least a portion of the delivery assembly through the first shaft portion, the second shaft portion, and the funnel portion.

Aspect 11. A transcatheter heart valve delivery assembly is provided for delivering a heart valve prosthesis to a treatment site. The transcatheter heart valve delivery assembly comprises a first shaft portion comprising a first wall surrounding a first chamber. The first wall comprises a first durometer value. The first shaft portion is configured to receive a first portion of the delivery assembly within the first chamber. The transcatheter heart valve delivery assembly comprises a second shaft portion attached to a distal end of the first shaft portion and comprising a second wall surrounding a second chamber. The second wall comprises a second durometer value that is less than the first durometer value. The second shaft portion is configured to receive a second portion of the delivery assembly within the second chamber. The transcatheter heart valve delivery assembly comprises a funnel portion attached to a distal end of the second shaft portion and comprising a funnel wall surrounding a funnel chamber. The funnel portion is configured to move between a radially-compressed position, in which a distal end of the funnel portion comprises a first diameter, and a radially-expanded position, in which the distal end of the funnel portion comprises a second diameter that is greater than the first diameter. The funnel wall comprises a third durometer value that is less than the second durometer value. The funnel portion is biased into the radially-compressed position.

Aspect 12. The transcatheter heart valve delivery assembly of aspect 11, wherein the funnel portion comprises one or more of a polyether-based thermoplastic polyurethane material or a thermoplastic elastomer material.

Aspect 13. The transcatheter heart valve delivery assembly of any one of aspects 11-12, wherein the funnel wall comprises a funnel wall thickness within a range from about 0.3 millimeters to about 0.6 millimeters.

Aspect 14. The transcatheter heart valve delivery assembly of any one of aspects 11-13, wherein the second shaft portion comprises one or more of a thermoplastic elastomer material or a thermoplastic polyurethane elastomer.

Aspect 15. The transcatheter heart valve delivery assembly of any one of aspects 11-14, wherein the second wall comprises a second wall thickness within a range from about 0.4 millimeters to about 0.8 millimeters.

Aspect 16. Methods of recapturing a heart valve prosthesis comprise deploying the heart valve prosthesis at a treatment site. Methods comprise positioning a funnel portion of a heart valve implant recapture apparatus adjacent to a valve end of the heart valve prosthesis with the funnel portion in a radially-compressed position. Methods comprise moving one or more of the funnel portion relative to the heart valve prosthesis or the heart valve prosthesis relative to the funnel portion such that the funnel portion receives the heart valve prosthesis within the funnel chamber and the funnel portion moves from the radially-compressed position to a radially-expanded position. Methods comprise applying a radial force from the funnel portion to the heart valve prosthesis to radially compress the heart valve prosthesis.

Aspect 17. The method of aspect 16, wherein the moving the funnel portion comprises applying an axial force to the funnel portion by a second shaft portion that is attached to the funnel portion, the funnel portion comprising a durometer value that is less than the second shaft portion.

Aspect 18. The method of any one of aspects 16-17, further comprising applying an outward radial force from the heart valve prosthesis to the funnel portion to move the funnel portion from the radially-compressed position to a radially-expanded position.

Aspect 19. The method of any one of aspects 16-18, wherein a diameter of the funnel chamber changes from the radially-compressed position to the radially-expanded position.

Aspect 20. The method of any one of aspects 16-19, wherein the funnel portion is attached to a shaft portion that comprises a different material than the funnel portion.

It should be understood that while various aspects have been described in detail relative to certain illustrative and specific examples thereof, the present disclosure should not be considered limited to such, as numerous modifications and combinations of the disclosed features are possible without departing from the scope of the following claims.