WO2025221671A1

WO2025221671A1 - Prosthetic heart valve

Info

Publication number: WO2025221671A1
Application number: PCT/US2025/024554
Authority: WO
Inventors: Hannah Reed BETTENCOURT; Evan T. SCHWARTZ; Darshin S. PATEL
Original assignee: Edwards Lifesciences Corp
Current assignee: Edwards Lifesciences Corp
Priority date: 2024-04-17
Filing date: 2025-04-14
Publication date: 2025-10-23
Anticipated expiration: 2026-10-17

Abstract

A prosthetic heart valve can include a frame and a valve cover disposed around an outer surface of the frame. The frame can include a first plurality of apices disposed at a first end of the frame and a second plurality of apices disposed at a second end of the frame. The valve cover can include an outer fabric layer and an inner film layer. The outer fabric layer and the inner film layer can be folded to cover the first plurality of apices of the frame, and can further be folded to cover the second plurality of apices of the frame. In some examples, axial end portions of the inner film layer can be folded to cover respective axial end portions of the outer fabric layer. In this way, the valve cover can provide padding between the frame's apices and a subject's native anatomy.

Description

PROSTHETIC HEART VALVE

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63/635,461, filed on April 17, 2024, which is incorporated by reference herein in its entirety.

FIELD

[0002] The present disclosure relates to prosthetic heart valves.

BACKGROUND

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (for example, stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery apparatus and advanced through the patient’s vasculature (for example, through a femoral artery and the aorta) until the prosthetic heart valve reaches the implantation site in the heart. The prosthetic heart valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of the delivery apparatus so that the prosthetic heart valve can self-expand to its functional size.

[0004] Despite recent advances in transcatheter heart valve technology, a need exists for a prosthetic heart valve that can be easily advanced through the patient’s vasculature and/or easily deployed from the sheath of the delivery apparatus and for techniques that simplify the assembly process of a prosthetic heart valve. SUMMARY

[0005] Described herein are prosthetic heart valves and outer coverings for prosthetic heart valves that can, for example, provide for improved delivery and/or simplify the assembly process of such prosthetic valves. As such, the disclosed devices herein can, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves and their delivery apparatus.

[0006] A prosthetic heart valve can include a frame.

[0007] In some examples, the frame can include a plurality of apices disposed at an end of the frame.

[0008] In some examples, the frame can include a valve cover disposed around an outer surface of the frame.

[0009] In some examples, the valve cover can include an outer fabric layer and an inner film layer.

[0010] In some examples, the outer fabric layer and the inner film layer can be folded over the plurality of apices of the frame.

[0011] In some examples, the outer fabric layer and the inner film layer can be folded in a first, radially inwards-facing fold over the plurality of apices of the frame.

[0012] In some examples, the inner film layer can be folded in a second, radially outwards-facing fold over the outer fabric layer and the plurality of apices of the frame.

[0013] In some examples, only the outer fabric layer and the inner film layer cover the plurality of apices of the frame.

[0014] In some examples, the inner film layer can be a non-woven layer.

[0015] In some examples, the inner film layer can be formed from one of TPU and ePTFE.

[0016] In some examples, the valve cover can further include at least one suture securing the outer fabric layer and the inner film layer to the frame.

[0017] A method can include wrapping a valve cover around a prosthetic heart valve frame. [0018] In some examples, the valve cover can include an outer fabric layer and an inner film layer.

[0019] In some examples, the method can include forming a first fold by folding both the outer fabric layer and the inner film layer over a plurality of apices of the prosthetic heart valve frame.

[0020] In some examples, the method can include forming a second fold by folding the inner film layer over the first fold.

[0021] In some examples, the method can further include, prior to wrapping the valve cover around the prosthetic heart valve frame, forming the inner film layer by applying a polymer coating to an inner surface of the outer fabric layer.

[0022] In some examples, a prosthetic heart valve can include a frame with a plurality of apices disposed at an end of the frame and a valve cover disposed around an outer surface of the frame. The valve cover can include an outer fabric layer and an inner film layer. The outer fabric layer and the inner film layer can be folded over the plurality of apices of the frame.

[0023] In some examples, a radially compressible and expandable prosthetic valve can include: a frame including a plurality of apices disposed at an end of the frame and an outer covering disposed around the frame. The outer covering can include a fabric layer and a film layer. The fabric layer and the film layer can be folded in a first fold over the plurality of apices. The film layer can be folded in a second fold over the fabric layer.

[0024] In some examples, a method can include wrapping a valve cover around a prosthetic heart valve frame, wherein the valve cover can include an outer fabric layer and an inner film layer, and forming a first fold by folding both the outer fabric layer and the inner film layer over a plurality of apices of the prosthetic heart valve frame.

[0025] In some examples, a prosthetic heart valve or a method of fabricating a prosthetic heart valve comprises one or more of the features recited in Examples 1-23 below.

[0026] The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

[0027] FIG. 1 schematically illustrates a stage in an example mitral valve replacement procedure, according to an example, where a guide catheter and a guidewire are inserted into a blood vessel of a patient and navigated through the blood vessel and into a heart of the patient, towards a native mitral valve of the heart.

[0028] FIG. 2A schematically illustrates another stage in the example mitral valve replacement procedure where a docking device delivery apparatus extending through the guide catheter is implanting a docking device for a prosthetic heart valve at the native mitral valve.

[0029] FIG. 2B schematically illustrates another stage in the example mitral valve replacement procedure where the docking device of FIG. 2A is fully implanted at the native mitral valve of the patient and the docking device delivery apparatus has been removed from the patient.

[0030] FIG. 3A schematically illustrates another stage in the example mitral valve replacement procedure where a prosthetic heart valve delivery apparatus extending through the guide catheter is implanting a prosthetic heart valve in the implanted docking device at the native mitral valve.

[0031] FIG. 3B schematically illustrates another stage in the example mitral valve replacement procedure where the prosthetic heart valve is fully implanted within the docking device at the native mitral valve and the prosthetic heart valve delivery apparatus has been removed from the patient.

[0032] FIG. 4 schematically illustrates another stage in the example mitral valve replacement procedure where the guide catheter and the guidewire have been removed from the patient.

[0033] FIG. 5 is a perspective view of a prosthetic heart valve, according to an example.

[0034] FIG. 6 is a perspective view of the prosthetic heart valve of FIG. 5 with the prosthetic heart valve’s plurality of leaflets removed for purposes of illustration. [0035] FIG. 7 is a side view of a portion of a frame of the prosthetic heart valve of FIG. 5, wherein the frame is in a flattened configuration.

[0036] FIG. 8 is a cross-sectional view of a portion of the prosthetic heart valve of FIG. 5.

[0037] FIG. 9 is a side view of a flattened portion of a valve cover for the prosthetic heart valve of FIG. 5.

[0038] FIG. 10 is a perspective view of a prosthetic heart valve delivery apparatus, according to an example.

DETAILED DESCRIPTION

General Considerations

[0039] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[0040] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art. [0041] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and/or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.

[0042] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (for example, out of the patient’ s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (for example, into the patient’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0043] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.”

Overview of the Disclosed Technology

[0044] Prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valves can be crimped on or retained by an implant delivery apparatus in the radially compressed state during delivery, and then expanded to the radially expanded state once the prosthetic valve reaches the implantation site. It is understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses and can be implanted via various delivery procedures, examples of which will be discussed in more detail later.

[0045] A typical prosthetic heart valve can include a radially compressible and expandable frame that includes a plurality of inflow apices disposed at an inflow end of the frame and a plurality of outflow apices disposed at an outflow end of the frame. One type of prosthetic heart valve can further include an outer liner disposed around the frame, an outer cloth cover disposed around the outer liner, and inflow and outflow apex covers that cover the frame’s inflow and outflow apices, respectively. The apex covers can provide padding between the frame’s apices and a subject’s native anatomy. The outer liner, outer cloth cover, and apex covers are separate components.

[0046] Disclosed herein are examples of an improved prosthetic heart valve that includes a frame and a valve cover (which is also referred to herein as an “outer cover” and/or “an outer covering”) disposed around an outer surface of the frame. The valve cover can include an outer fabric layer and an inner film layer. The outer fabric layer and the inner film layer can be folded over the plurality of inflow apices and/or the plurality of outflow apices to provide padding between the frame’s apices and the subject’s native anatomy. In some examples, the inner film layer can be folded over an inflow end portion and/or an outflow end portion of the outer fabric layer to provide further additional padding. In this way, the valve cover can beneficially provide padding between the frame’s apices and the subject’s native anatomy without the use of separate apex covers. Omitting separate apex covers from the prosthetic heart valve design can beneficially streamline the prosthetic heart valve assembly process by reducing overall component count. Additionally or alternatively, omitting separate apex covers from the prosthetic heart valve design can further reduce the crimped profile of the prosthetic heart valve, thereby beneficially reducing the amount of force exerted by the prosthetic heart valve on a delivery apparatus’s sheath during a surgical procedure.

Examples of the Disclosed Technology

[0047] FIGS. 1-4 depict an example of a transcatheter heart valve replacement procedure (such as a mitral valve replacement procedure) which utilizes a docking device 52 and a prosthetic heart valve 62, according to one example. During the procedure, a user first creates a pathway to a patient’s native heart valve using a guide catheter 30 (FIG. 1). The user then delivers and implants the docking device 52 at the patient’s native heart valve using a delivery apparatus 50 (FIG. 2A) and then removes the delivery apparatus 50 from the patient 10 after implanting the docking device 52 (FIG. 2B). The user then implants the prosthetic heart valve 62 within the implanted docking device 52 using a prosthetic valve delivery apparatus 60 (FIG. 3A). Thereafter, the user removes the prosthetic valve delivery apparatus 60 from the patient 10 (FIG. 3B), as well as the guide catheter 30 (FIG. 4). [0048] FIG. 1 depicts a stage in a mitral valve replacement procedure, according to one example, where the guide catheter 30 and a guidewire 40 are inserted into a blood vessel 12 of a patient 10 and navigated through the blood vessel 12, into a heart 14 of the patient 10, and toward the native mitral valve 16. Together, the guide catheter 30 and the guidewire 40 can provide a path for the delivery apparatus 50 and the prosthetic valve delivery apparatus 60 to be navigated through and along, to the implantation site (the native mitral valve 16 or native mitral valve annulus). As shown, the heart 14 is illustrated schematically. For example, the anterior leaflet and chordae of the native mitral valve 16 are omitted for illustration purposes, such that only a portion of the posterior leaflet of the native mitral valve 16 is illustrated.

[0049] Initially, the user may first make an incision in the patient’ s body to access the blood vessel 12. For example, in the example illustrated in FIG. 1 , the user may make an incision in the patient’ s groin to access a femoral vein. Thus, in such examples, the blood vessel 12 may be a femoral vein.

[0050] After making the incision at the blood vessel 12, the user may insert the guide catheter 30, the guidewire 40, and/or additional devices (such as an introducer device or transseptal puncture device) through the incision and into the blood vessel 12. The guide catheter 30 (which can also be referred to as an “introducer device,” “introducer,” or “guide sheath”) is configured to facilitate the percutaneous introduction of various implant delivery devices (such as the delivery apparatus 50 and the prosthetic valve delivery apparatus 60) into and through the blood vessel 12 and may extend through the blood vessel 12 and into the heart 14 but may stop short of the native mitral valve 16. The guide catheter 30 can comprise a handle 32 and a shaft 34 (which may also be referred to as a catheter shaft 34) extending distally from the handle 32. The shaft 34 can extend through the blood vessel 12 and into the heart 14 while the handle 32 remains outside the body of the patient 10 and can be operated by the user in order to manipulate the shaft 34 (FIG. 1).

[0051] The guidewire 40 is configured to guide the delivery apparatuses (such as the guide catheter 30, the delivery apparatus 50, the prosthetic valve delivery apparatus 60, additional catheters, or the like) and their associated devices (such as docking device, prosthetic heart valve, and the like) to the implantation site within the heart 14, and thus may extend all the way through the blood vessel 12 and into a left atrium 18 of the heart 14 (FIG. 1) and in some examples, through the native mitral valve 16 and into a left ventricle 26 of the heart 14.

[0052] In some instances, a transseptal puncture device or catheter can be used to initially access the left atrium 18, prior to inserting the guidewire 40 and the guide catheter 30. For example, after making the incision to the blood vessel 12, the user may insert a transseptal puncture device through the incision and into the blood vessel 12. The user may guide the transseptal puncture device through the blood vessel 12 and into the heart 14 (such as through the femoral vein and into the right atrium 20). The user can then make a small incision in an atrial septum 22 of the heart 14 to allow access to the left atrium 18 from the right atrium 20. The user can then insert and advance the guidewire 40 through the transseptal puncture device within the blood vessel 12 and through the incision in the atrial septum 22 into the left atrium 18. Once the guidewire 40 is positioned within the left atrium 18 and/or the left ventricle 26, the transseptal puncture device can be removed from the patient 10. The user can then insert the guide catheter 30 into the blood vessel 12 and advance the guide catheter 30 into the left atrium 18 over the guidewire 40 (FIG. 1).

[0053] In some instances, an introducer device can be inserted through a lumen of the guide catheter 30 prior to inserting the guide catheter 30 into the blood vessel 12. In some instances, the introducer device can include a tapered end that extends out a distal tip of the guide catheter 30 and that is configured to guide the guide catheter 30 into the left atrium 18 over the guidewire 40. Additionally, in some instances the introducer device can include a proximal end portion that extends out a proximal end of the guide catheter 30. Once the guide catheter 30 reaches the left atrium 18, the user can remove the introducer device from inside the guide catheter 30 and the patient 10. Thus, only the guide catheter 30 and the guidewire 40 remain inside the patient 10. The guide catheter 30 is then in position to receive an implant delivery apparatus and help guide it to the left atrium 18, as described further below.

[0054] FIG. 2A depicts another stage in the example mitral valve replacement procedure where a docking device 52 is being implanted at the native mitral valve 16 of the heart 14 of the patient 10 using a delivery apparatus 50 (which is referred to herein as an “implant catheter,” a dock delivery system,” a “docking device delivery apparatus,” and/or a “docking device delivery device”). [0055] In general, the delivery apparatus 50 comprises a delivery shaft 54 (which may also be referred to as a “dock delivery system shaft”), a handle 56 (which may also be referred to as a “dock delivery system handle”), and a pusher assembly 58. The delivery shaft 54 is configured to be advanced through the patient’s vasculature (blood vessel 12) and to the implantation site (such as native mitral valve 16) by the user and may be configured to retain the docking device 52 in a distal end portion 53 of the delivery shaft 54. In some examples, the distal end portion 53 of the delivery shaft 54 retains the docking device 52 therein in a straightened delivery configuration.

[0056] The handle 56 of the delivery apparatus 50 is configured to be gripped and/or otherwise held by the user, outside the body of the patient 10, to advance the delivery shaft 54 through the patient’s vasculature (such as the blood vessel 12).

[0057] In some examples, the handle 56 can comprise one or more articulation members 57 (or rotatable knobs) that are configured to aid in navigating the delivery shaft 54 through the blood vessel 12. For example, the one or more articulation members 57 can comprise one or more of knobs, buttons, wheels, and/or other types of physically adjustable control members that are configured to be adjusted by the user to flex, bend, twist, turn, and/or otherwise articulate a distal end portion 53 of the delivery shaft 54 to aid in navigating the delivery shaft 54 through the blood vessel 12 and within the heart 14.

[0058] The pusher assembly 58 can be configured to deploy and/or implant the docking device 52 at the implantation site (such as the native mitral valve 16). For example, the pusher assembly 58 is configured to be adjusted by the user to push the docking device 52 out of the distal end portion 53 of the delivery shaft 54. A shaft (which may also be referred to as a “pusher shaft”) of the pusher assembly 58 can extend through the delivery shaft 54 and can be disposed adjacent to the docking device 52 within the delivery shaft 54. In some examples, the docking device 52 can be releasably coupled to the shaft of the pusher assembly 58 via a connection mechanism of the delivery apparatus 50 such that the docking device 52 can be released after being deployed at the native mitral valve 16. [0059] Further details of the docking device delivery apparatus and its variants are described in International Publication Nos. W02020/247907, W02023/205076, and WO2024/091366, each of which are incorporated by reference herein in their entirety.

[0060] Referring again to FIG. 2A, after the guide catheter 30 is positioned within the left atrium 18, the user may insert the delivery apparatus 50 (such as the delivery shaft 54) into the patient 10 by advancing the delivery shaft 54 of the delivery apparatus 50 through the guide catheter 30 and over the guidewire 40. In some examples, the guidewire 40 can be at least partially retracted away from the left atrium 18 and into the guide catheter 30. The user may then continue to advance the delivery shaft 54 of the delivery apparatus 50 through the blood vessel 12 along the guidewire 40 until the delivery shaft 54 reaches the left atrium 18, as illustrated in FIG. 2A. Specifically, the user may advance the delivery shaft 54 of the delivery apparatus 50 by gripping and exerting a force on (for example, by pushing) the handle 56 of the delivery apparatus 50 toward the patient 10. While advancing the delivery shaft 54 through the blood vessel 12 and the heart 14, the user may adjust the one or more articulation members 57 of the handle 56 to navigate the various turns, comers, constrictions, and/or other obstacles in the blood vessel 12 and the heart 14.

[0061] Once the delivery shaft 54 reaches the left atrium 18 and extends out of a distal end of the guide catheter 30, the user can position the distal end portion 53 of the delivery shaft 54 at and/or near the posteromedial commissure of the native mitral valve 16 using the handle 56 (such as the articulation members 57). The user may then push the docking device 52 out of the distal end portion 53 of the delivery shaft 54 with the shaft of the pusher assembly 58 to deploy and/or implant the docking device 52 within the annulus of the native mitral valve 16.

[0062] In some examples, the docking device 52 may be constructed from, formed of, and/or comprise a shape memory material, and as such, may return to its original, pre-formed shape when it exits the delivery shaft 54 and is no longer constrained by the delivery shaft 54. As one example, the docking device 52 may originally be formed as a coil, and thus may wrap around leaflets 24 of the native mitral valve 16 as it exits the delivery shaft 54 and returns to its original coiled configuration. [0063] After pushing a ventricular portion of the docking device 52 (such as the portion of the docking device 52 shown in FIG. 2A that is configured to be positioned within the left ventricle 26 and/or on the ventricular side of the native mitral valve 16), the user may then deploy the remaining portion of the docking device 52 (such as an atrial portion of the docking device 52) from the delivery shaft 54 within the left atrium 18 by retracting the delivery shaft 54 away from the posteromedial commissure of the native mitral valve 16.

[0064] After deploying and implanting the docking device 52 at the native mitral valve 16, the user may disconnect the delivery apparatus 50 from the docking device 52. Once the docking device 52 is disconnected from the delivery apparatus 50, the user may retract the delivery apparatus 50 out of the blood vessel 12 and away from the patient 10 so that the user can deliver and implant a prosthetic heart valve 62 within the implanted docking device 52 at the native mitral valve 16.

[0065] FIG. 2B depicts this stage in the mitral valve replacement procedure, where the docking device 52 has been fully deployed and implanted at the native mitral valve 16 and the delivery apparatus 50 (including the delivery shaft 54) has been removed from the patient 10 such that only the guidewire 40 and the guide catheter 30 remain inside the patient 10. In some examples, after removing the delivery apparatus 50, the guidewire 40 can be advanced out of the guide catheter 30, through the implanted docking device 52 at the native mitral valve 16, and into the left ventricle 26 (FIG. 2A). As such, the guidewire 40 can help to guide the prosthetic valve delivery apparatus 60 through the annulus of the native mitral valve 16 and at least partially into the left ventricle 26.

[0066] As illustrated in FIG. 2B, the docking device 52 can comprise a plurality of turns (or coils) that wrap around the leaflets 24 of the native mitral valve 16 (within the left ventricle 26). The implanted docking device 52 has a more cylindrical shape than the annulus of the native mitral valve 16, thereby providing a geometry that more closely matches the shape or profile of the prosthetic heart valve to be implanted. As a result, the docking device 52 can provide a tighter fit, and thus a better seal, between the prosthetic heart valve and the native mitral valve 16, as described further below. [0067] FIG. 3A depicts another stage in the mitral valve replacement procedure where the user is delivering and/or implanting a prosthetic heart valve 62 (which can also be referred to herein as a “transcatheter heart valve” or “THV” for short, “replacement heart valve,” and/or “prosthetic mitral valve”) within the docking device 52 using a prosthetic valve delivery apparatus 60.

[0068] As shown in FIG. 3A, the prosthetic valve delivery apparatus 60 can comprise a delivery shaft 64 and a handle 66, the delivery shaft 64 extending distally from the handle 66. The delivery shaft 64 is configured to extend into the patient’s vasculature to deliver, implant, expand, and/or otherwise deploy the prosthetic heart valve 62 within the docking device 52 at the native mitral valve 16. The handle 66 is configured to be gripped and/or otherwise held by the user to advance the delivery shaft 64 through the patient’s vasculature.

[0069] In some examples, the handle 66 can comprise one or more articulation members 68 that are configured to aid in navigating the delivery shaft 64 through the blood vessel 12 and the heart 14. Specifically, the articulation member(s) 68 can comprise one or more of knobs, buttons, wheels, and/or other types of physically adjustable control members that are configured to be adjusted by the user to flex, bend, twist, turn, and/or otherwise articulate a distal end portion of the delivery shaft 64 to aid in navigating the delivery shaft 64 through the blood vessel 12 and into the left atrium 18 and left ventricle 26 of the heart 14.

[0070] In some examples, the prosthetic valve delivery apparatus 60 can include an expansion mechanism 65 that is configured to radially expand and deploy the prosthetic heart valve 62 at the implantation site. In some instances, as shown in FIG. 3A, the expansion mechanism 65 can comprise an inflatable balloon that is configured to be inflated to radially expand the prosthetic heart valve 62 within the docking device 52. The inflatable balloon can be coupled to the distal end portion of the delivery shaft 64.

[0071] In other examples, the prosthetic heart valve 62 can be self-expanding and can be configured to radially expand on its own upon removable of a sheath or capsule covering the radially compressed prosthetic heart valve 62 on the distal end portion of the delivery shaft 64. In still other examples, the prosthetic heart valve 62 can be mechanically expandable and the prosthetic valve delivery apparatus 60 can include one or more mechanical actuators (such as the expansion mechanism) configured to radially expand the prosthetic heart valve 62.

[0072] As shown in FIG. 3A, the prosthetic heart valve 62 is mounted around the expansion mechanism 65 (the inflatable balloon) on the distal end portion of the delivery shaft 64, in a radially compressed configuration.

[0073] To navigate the distal end portion of the delivery shaft 64 to the implantation site, the user can insert the prosthetic valve delivery apparatus 60 (the delivery shaft 64) into the patient 10 through the guide catheter 30 and over the guidewire 40. The user can continue to advance the prosthetic valve delivery apparatus 60 along the guidewire 40 (through the blood vessel 12) until the distal end portion of the delivery shaft 64 reaches the native mitral valve 16, as illustrated in FIG. 3A. More specifically, the user can advance the delivery shaft 64 of the prosthetic valve delivery apparatus 60 by gripping and exerting a force on (for example, by pushing) the handle 66. While advancing the delivery shaft 64 through the blood vessel 12 and the heart 14, the user can adjust the one or more articulation members 68 of the handle 66 to navigate the various turns, comers, constrictions, and/or other obstacles in the blood vessel 12 and heart 14.

[0074] The user can advance the delivery shaft 64 along the guidewire 40 until the radially compressed prosthetic heart valve 62 mounted around the distal end portion of the delivery shaft 64 is positioned within the docking device 52 and the native mitral valve 16. In some examples, as shown in FIG. 3A, a distal end of the delivery shaft 64 and a least a portion of the radially compressed prosthetic heart valve 62 can be positioned within the left ventricle 26.

[0075] Once the radially compressed prosthetic heart valve 62 is appropriately positioned within the docking device 52 (FIG. 3A), the user can manipulate one or more actuation mechanisms of the handle 66 of the prosthetic valve delivery apparatus 60 to actuate the expansion mechanism 65 (for example, by inflating the inflatable balloon), thereby radially expanding the prosthetic heart valve 62 within the docking device 52.

[0076] FIG. 3B shows another stage in the mitral valve replacement procedure where the prosthetic heart valve 62 in its radially expanded configuration and implanted within the docking device 52 in the native mitral valve 16. As shown in FIG. 3B, the prosthetic heart valve 62 is received and retained within the docking device 52. Thus, the docking device 52 aids in anchoring the prosthetic heart valve 62 within the native mitral valve 16. The docking device 52 can enable better sealing between the prosthetic heart valve 62 and the leaflets 24 of the native mitral valve 16 to reduce paravalvular leakage around the prosthetic heart valve 62.

[0077] As also shown in FIG. 3B, after the prosthetic heart valve 62 has been fully deployed and implanted within the docking device 52 at the native mitral valve 16, the prosthetic valve delivery apparatus 60 (including the delivery shaft 64) is removed from the patient 10 such that only the guidewire 40 and the guide catheter 30 remain inside the patient 10.

[0078] FIG. 4 depicts another stage in the mitral valve replacement procedure, where the guidewire 40 and the guide catheter 30 have been removed from the patient 10.

[0079] Although FIGS. 1-4 specifically depict a mitral valve replacement procedure, it should be appreciated that the same and/or similar’ procedure may be utilized to replace other heart valves (such as tricuspid, pulmonary, and/or aortic valves). Further, the same and/or similar’ delivery apparatuses (such as the delivery apparatus 50, prosthetic valve delivery apparatus 60, guide catheter 30, and/or guidewire 40), docking devices (such as the docking device 52), replacement heart valves (such as the prosthetic heart valve 62), and/or components thereof may be utilized for replacing these other heart valves.

[0080] For example, when replacing a native tricuspid valve, the user may also access the right atrium 20 via a femoral vein but may not need to cross the atrial septum 22 into the left atrium 18. Instead, the user may leave the guidewire 40 in the right atrium 20 and perform the same and/or similar docking device implantation process at the tricuspid valve. Specifically, the user may push the docking device 52 out of the delivery shaft 54 around the ventricular side of the tricuspid valve leaflets, release the remaining portion of the docking device 52 from the delivery shaft 54 within the right atrium 20, and then remove the delivery shaft 54 of the delivery apparatus 50 from the patient 10. The user may then advance the guidewire 40 through the tricuspid valve into the right ventricle and perform the same and/or similar prosthetic heart valve implantation process at the tricuspid valve, within the docking device 52. Specifically, the user may advance the delivery shaft 64 of the prosthetic valve delivery apparatus 60 through the patient’ s vasculature along the guidewire 40 until the prosthetic heart valve 62 is positioned/disposed within the docking device 52 and the tricuspid valve. The user may then expand the prosthetic heart valve 62 within the docking device 52 before removing the prosthetic valve delivery apparatus 60 from the patient 10. In another example, the user may perform the same and/or similar’ process to replace the aortic valve but may access the aortic valve from the outflow side of the aortic valve via a femoral artery.

[0081] Further, although FIGS. 1-4 depict a mitral valve replacement procedure that accesses the native mitral valve 16 from the left atrium 18 via the right atrium 20 and femoral vein, it should be appreciated that the native mitral valve 16 may alternatively be accessed from the left ventricle 26. For example, the user may access the native mitral valve 16 from the left ventricle 26 via the aortic valve by advancing one or more delivery apparatuses through an artery to the aortic valve, and then through the aortic valve into the left ventricle 26.

[0082] FIG. 5 is a perspective view of a prosthetic heart valve 100, according to an example. The prosthetic valve 100 can be used as the prosthetic heart valve 62 in a prosthetic valve implantation procedure, as described above with reference to FIGS. 1-4. As shown in FIG. 5, the prosthetic valve 100 can include a frame 102 and a plurality of leaflets 104 can be situated at least partially within the frame 102. The prosthetic valve 100 can also include valve cover 106 disposed around the frame 102. As shown in FIG. 5, the prosthetic valve 100 includes an inflow end and an outflow end (which respectively correspond to an inflow end 108 and an outflow end 110 of the frame 102). The terms “inflow” and “outflow” are related to the normal direction of blood flow (for example, antegrade blood flow) through the prosthetic valve 100. For example, the leaflets 104 can allow blood flow through the valve 100 in a direction from the inflow end to the outflow end 110 and prevent the reverse flow (for example, prevent flow in a direction from the outflow end 110 to the inflow end). FIG. 5 also shows an outer fabric layer 134, a portion of an inner film layer 142, and two sutures 150 of the valve cover 106, each of which are also described in greater detail with respect to FIG. 8.

[0083] FIG. 6 is a perspective view of the prosthetic heart valve 100 with the plurality of leaflets 104 removed for clarity. In particular, the plurality of leaflets 104 have been removed to more clearly show an inner film layer 142 of the valve cover 106, which is described in greater detail with respect to FIG. 8. FIG. 6 also shows the outer fabric layer 134, the inner film layer 142, and the suture 150 of the valve cover 106, each of which are described in greater detail with respect to FIG. 8.

[0084] As further shown in FIG. 6, the prosthetic heart valve 100 optionally includes an inner skirt 112. The inner skirt 112 can be used for supporting the leaflets 104 within the frame. The cusp edge portions of the leaflets 104 can be stitched to the inner skirt 112. The leaflets 104 can form a plurality of commissures that are connected to respective commissure supports of the frame 102. In the depicted example, the commissures are connected to commissure supports in the form of commissure window frame portions 1 14 of the frame 102. The inner skirt 112 can be coupled (for example, sutured) to an inner surface of the frame 102. Further details regarding the attachment of the leaflets 104 to the inner skirt 112 and the frame 102 as well as the attachment of the inner skirt 112 to the frame 102 are disclosed in U.S. Patent No. 9,393,110, which is incorporated by reference herein in its entirety.

[0085] The inner skirt 112 can extend in an axial direction of the prosthetic heart valve 100 from the inflow end 108 of the frame 102 and towards the outflow end 110 of the frame 102. As shown, the inner skirt 112 extends a partial axial length of the frame 102. In some examples, the inner skirt 112 can extend the entire axial length of the frame 102. Although the illustrated prosthetic heart valve 100 is shown to include the inner skirt 112, it should be understood that the inner skirt 112 can be omitted from some examples of the prosthetic heart valve 100.

[0086] The inner skirt 112 can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof. In some examples, the inner skirt 112 can comprise a fabric having interlaced yams or fibers, such as in the form of a woven, braided, or knitted fabric. In some examples, the fabric can have a plush nap or pile. Exemplary fabrics having a plus nap or pile include velour, velvet, velveteen, corduroy, terrycloth, fleece, etc. In some examples, the inner skirt 112 can comprise a fabric without interlaced yarns or fibers or randomly interlaced yams or fibers, such as felt or an electrospun fabric. Exemplary materials that can be used for forming such fabrics (with or without interlaced yams or fibers) include, without limitation, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc. In some examples, the inner skirt 112 can comprise a non-textile or nonfabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU )), etc. In some examples, the inner skirt 112 can comprise a sponge material or foam, such as polyurethane foam. In some examples, the inner skirt 112 can comprise natural tissue, such as pericardium (for example, bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0087] FIG. 7 is a side view of a portion of the frame 102 in a flattened configuration. The frame 102 can comprise a plurality of struts 116. The plurality of struts 116 can be arranged to form a plurality of open cells 118. Additionally or alternatively, the plurality of struts 116 can be arranged end-to-end to form a plurality of rows that extend circumferentially around the frame 102. For example, the frame 102 can comprise a first row 120 (which is also referred to herein as a “lower row” and/or an “inflow row”) of angled struts 116 that define the inflow end 108 of the frame 102; a second row 122 of struts 116 distally disposed relative to the first row 120; a third row 124 of struts 116 distally disposed relative to the second row 122; a fourth row 126 of struts 116 distally disposed relative to the third row 124, and a fifth row 128 (which is also referred to herein as an “upper row” and/or an “outflow row”) of struts 116 above the fourth row 126 and forming the outflow end 110 of the frame 102.

[0088] At the inflow end 108 of the frame 102, adjacent struts 116 of the first row 120 can be joined to form a plurality of inflow apices 130 at the inflow end 108 of the frame 102. At the outflow end 110 of the frame 102, adjacent stmts 116 of the fifth row 128 can be joined to form a plurality of outflow apices 132.

[0089] The frame 102 can be made of any of various suitable plastically-expandable materials (for example, stainless steel, etc.) or self-expanding materials (for example, Nitinol) as known in the art. When constructed of a plastically-expandable material, the frame 102 (and thus the valve 100) can be crimped to a radially compressed state on a delivery catheter and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self- expandable material, the frame 102 (and thus the valve 100) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the valve 100 can be advanced from the delivery sheath, which allows the valve 100 to expand to its functional size.

[0090] Suitable plastically-expandable materials that can be used to form the frames disclosed herein (for example, the frame 102) include metal alloys, polymers, or combinations thereof. Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the frame 102 can comprise stainless steel. In some examples, the frame 102 can comprise cobalt-chromium. In some examples, the frame 102 can comprise nickel-cobalt-chromium. In some examples, the frame 102 can comprise a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562- 02). MP35N™/UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0091] Additional structures and characteristics of the frame 102 are described in greater detail in U.S. Pat. No. 9,393,110, which is incorporated by reference herein in its entirety.

[0092] FIG. 8 is a cross-sectional view of a portion of the prosthetic heart valve 100. The view illustrated in FIG. 8 shows a cross-section of a portion of the frame 102, a cross-section of one of the plurality of leaflets 104 coupled to the frame 102, and a cross-section of a portion of the valve cover 106 that is disposed around an outer surface 103 of the frame 102.

[0093] As shown, the valve cover 106 includes an outer fabric layer 134 (which is also referred to herein as a “fabric portion,” an “outer layer,” a “cloth layer,” a “cloth portion,” and/or an “outer cloth”) comprising an outflow end portion 136, an intermediate portion 138, and an inflow end portion 140. As further shown, the valve cover 106 includes an inner film layer 142 (which is also referred to herein as an “inner portion,” an “inner layer,” a “film portion,” a “film,” a “membrane,” a “coating,” and/or a “coating portion”) comprising an outflow end portion 144, an intermediate portion 146, and an inflow end portion 148. As shown, the intermediate portion 146 of the inner film layer 142 is disposed radially between (in other words, sandwiched between) the outer surface 103 of the frame 102 and the intermediate portion 138 of the outer fabric layer 134.

[0094] In some examples, the outer fabric layer 134 can be a sheet of fabric material and the inner film layer 142 can be a separate sheet of nonwoven material (for example, an ePTFE layer). In some examples, at least a portion of the inner film layer 142 can be coupled (for example, bonded, adhered, ultrasonically welded, fastened, and/or sutured) to a portion of the separate outer fabric layer 134. In some examples, the outer fabric layer 134 and the inner film layer 142 can be bonded together to form a laminate.

[0095] The valve cover 106 (more specifically, an inflow end portion of the valve cover 106) can be folded over the plurality of inflow apices 130 and/or the plurality of outflow apices 132 to provide padding between these apices 130, 132 and the subject’s native anatomy. For example, the valve cover 106 (more specifically, the inflow end portion 140 of the outer fabric layer 134 and the inflow end portion 148 of the inner film layer 142) can be folded over one or more of the plurality of inflow apices 130 to form multiple layers of material that provide padding between the inflow apices 130 and the subject’s native anatomy. The inflow end portion 140 of the outer fabric layer 134 can be folded over the inflow apices 130 to form an outer layer 140a and an inner layer 140b. The inner film layer 142 can be folded to form a first outer layer 148a on the outside of the frame 102, a first inner layer 148b on the inside of the frame 102, a second inner layer 148c radially inwards of the first inner layer 148b, and a second outer layer 148d radially outwards of the first outer layer 148a. As shown, the outer layer 140a of the outer fabric layer 134 is disposed radially between the first outer layer 148a and the second outer layer 148c of the inner film layer 142. As further shown, the inner layer 140b of the outer fabric layer 134 is disposed radially between the first inner layer 148b and the second inner layer 148c of the inner fabric layer 142. In this way, there can be three layers of material covering the inflow apices 130 of the frame 102, three layers of material on the outside of the frame 102, and three layers of material on the inside of the frame 102 that all provide padding between the inflow end portion 108 of the frame 102 (specifically, the plurality of apices 130) and the subject’s native anatomy. [0096] In some examples, the second outer layer 148d of the inner fabric layer 142 can be omitted. In some examples, both the second outer layer 148d and the second inner layer 148c of the inner fabric layer 142 can be omitted. In this way, there can be two layers of material covering the inflow apices 130 of the frame 102, two layers of material on the outside of the frame 102, and two layers of material on the inside of the frame 102.

[0097] Similarly, the valve cover 106 (more specifically, the outflow end portion 136 of the outer fabric layer 134 and the outflow end portion 144 of the inner film layer 142) can be folded over one or more of the outflow apices 132 to form multiple layers of material providing padding for the outflow apices 132. The outflow end portion 144 of the inner film layer 142 can be folded over the apices 132 to form a first outer layer 144a on the outside of the frame 102, a first inner layer 144b on the inside of the frame 102, a second inner layer 144c radially inwards of the first inner layer 144b, and a second outer layer 144d radially outwards of the first outer layer 144a. The outflow end portion 136 of the fabric layer 134 can be folded over the outflow apices 132 to form an outer layer 136a and an inner layer 136b. The outer layer 136a can be radially disposed between the first and second outer layers 144a, 144d of the inner film layer 142. The inner layer 136b can be radially disposed between the first and second inner layers 144d, 144c of the inner film layer 142. In this manner, there can be three layers of material at the outflow end portion 110 of the frame 102, three layers of material on the outside of the frame 102, and three layers of material on the inside of the frame 102 adjacent the outflow apices 132. In some examples, the second outer layer 144d of the inner film layer 142 can be omitted. In some examples, the second outer layer 144d and the second inner layer 144c of the inner film layer can be omitted.

[0098] During assembly, the valve cover 106 can be first folded in a radially inwards facing direction to form the outer layer 140a and the inner layer 140b of the inflow end portion 140 of the outer fabric layer 134 and the first outer layer 148a and the first inner layer 148b of the inflow end portion 148 of the inner film layer 142. In some examples, the valve cover 106 can be subsequently folded in a radially outwards facing direction to form the second inner layer 148c and the second outer layer 148d of the inflow end portion 148 of the inner film layer 142. The outflow end portions of the outer fabric layer 134 and the inner film layer 142 can be folded in a similar manner to form the various layers at the outflow end of the prosthetic heart valve 100. [0099] As shown in FIG. 8, the inflow and outflow apices 130, 132 of the frame 102 can be covered by only the end portions of the outer fabric layer 134 (for example, end portions 136 and 140) and the end portions of the inner film layer 142 (for example, end portions 144 and 148). In this way, the valve cover 106 can provide padding between the apices 130, 132 of the frame 102 and the subject’s native anatomy without the use of separate apex covers. In some examples, omitting separate apex covers from the valve cover 106 and the prosthetic heart valve 100 can beneficially streamline a prosthetic heart valve assembly process by reducing the number of components that need to be attached to the frame 102 during the prosthetic heart valve assembly process.

[0100] Additionally or alternatively, omitting separate apex covers from the valve cover 106 and the prosthetic heart valve 100 can further reduce the overall crimped profile of the prosthetic heart valve 100. This can beneficially reduce the amount of force exerted by the prosthetic heart valve 100 on a delivery apparatus’s sheath during a surgical procedure. In some examples, the prosthetic heart valve 100 lacking separate apex covers can have a diameter in the radially compressed state of less than 8.2 mm (for example, in a range from 8.1 mm to 8.2 mm), less than 7.7 mm (for example, in a range from 7.6 mm to 7.7 mm), and/or less than 7.5 mm (for example, in a range from 7.4 mm to 7.5 mm).

[0101] As shown, the valve cover 106 can additionally include sutures 150 for securing the axial end portions of the valve cover 106 to the frame 102. For example, the valve cover 106 can include at least one first suture 150a that secures the inflow end portion 140 of the outer fabric layer 134 and the inflow end portion 148 of the inner film layer 142 to the frame 102. The first suture 150a can form a plurality of stitches (for example, in-and-out stitches) that extend, starting on the outside of the frame 102, through the outer layer 148d, the outer layer 140a, the outer layer 148a, a cell 118 of the frame 102, the inner layer 148b, the inner layer 140b, the inner layer 148c, and then back through all six layers of material and the frame in the opposite direction. Similarly, the valve cover 106 can include a second suture 150b that can form a plurality of stitches (for example, in- and-out stitches) extending, starling on the outside of the frame 102, through the outer layer 144d, the outer layer 136a, the outer layer 144a, a cell 118 of the frame 102, the inner layer 144b, the inner layer 136b, the inner layer 144c, and then back through all six layers of material and the frame in the opposite direction. Thus, in some examples, the valve cover 106 can consist or consist substantially of the outer fabric layer 134, the inner film layer 142, and the one or more sutures 150. However, it should be understood that in some examples, the valve cover 106 can include additional components not shown in FIG. 8. Although the illustrated valve cover 106 includes the sutures 150, it should be understood that the valve cover 106 can be secured to the frame 102 using any method (for example, adhesives, ultrasonic welds, mechanical fasteners, etc.).

[0102] The outer fabric layer 134 can comprise a fabric having interlaced yarns or fibers, such as in the form of a woven, braided, or knitted fabric. In some examples, the fabric can have a plush nap or pile. Exemplary fabrics having a plus nap or pile include velour, velvet, velveteen, corduroy, terrycloth, fleece, etc. In some examples, the fabric can comprise yarns or fibers knitted in any of a satin weave, a twill weave, a leno weave, or any other weave pattern. In some examples, the outer fabric layer 134 can comprise a fabric without interlaced yarns or fibers or having randomly interlaced yams or fibers, such as felt or an electrospun fabric. Exemplary materials that can be used for forming the material of the outer fabric layer 134 (with or without interlaced yarns or fibers) include, without limitation, PET, UHMWPE, PTFE, ePTFE, polyamide, etc.

[0103] The inner film layer 142 can be a layer of a non-woven material. As used herein, “nonwoven” materials generally refers to non-woven, non-braided and non-knitted materials. Nonwoven materials can include, for example, non-woven fabrics (such as electro-spun fabrics) or a non-textile material, such as a polymer layer formed by extrusion, molding spraying, dip coating, and/or various other techniques. In some examples, the inner film layer 142 can comprise a film made from any combination of polymeric materials, such as PfFE, ePTFE, PET, polypropylene, polyamide, PEEK, polyurethane (such as TPU), etc. In some examples, the inner film layer 142 can comprise a sponge material or foam, such as polyurethane foam. In some examples, the inner film layer 142 can be a layer of natural tissue, such as pericardial tissue.

[0104] Additional structures and characteristics of the outer fabric layer 134 and the inner film layer 142 are described in greater detail in PCT Publication No. WO 2021/202636, which is incorporated by reference herein in its entirety. [0105] FIG. 9 is a side view of a flattened portion of the valve cover 206 for a prosthetic heart valve, according to an example. One exemplary difference between the valve cover 206 and the valve cover 106 illustrated in FIG. 8 is that the valve cover 206 can include an inner film layer 242 comprising a polymer coating (for example, a TPU coating) applied to an inner surface of the outer fabric layer 134. In some examples, the coating that forms the inner film layer 242 can be disposed over the entirety of the inner surface of the outer fabric layer 134. In some examples, the coating that forms the inner film layer 242 can be disposed over only a portion of the inner surface of the outer fabric layer 134. In some examples, the coating that forms the inner film layer 242 can additionally be disposed over a portion of an outer surface of the outer fabric layer 134 (for example, outer surfaces of the outflow and inflow end portions 136, 140 of the outer fabric layer 134).

[0106] The coating that forms the inner film layer 242 can be formed from any polymer material (for example, any combination of PTFE, ePTFE, PET, polypropylene, polyamide, PEEK, and/or polyurethane (such as TPU)). However, the inner film layer 142 can be formed from any suitable non-textile, non-woven, non-braided, non-knitted material.

[0107] Further details of the prosthetic heart valve 100 and its variants are described in U.S. Patent No. 11,185,406, which is incorporated by reference herein in its entirety.

Example Delivery Apparatus

[0108] FIG. 10 is a perspective view of a delivery apparatus 300 (which can also be referred to here as an “implant catheter” and/or a “prosthetic heart valve delivery apparatus”) that can be used to implant an expandable prosthetic heart valve, according to an example. In some examples, the delivery apparatus 300 is specifically adapted for use in introducing a prosthetic heart valve into a heart. For example, the delivery apparatus 300 can be used as the prosthetic valve delivery apparatus 60 in a prosthetic valve implantation procedure, as described above with reference to FIG. 3A.

[0109] The delivery apparatus 300 in the illustrated example of FIG. 10 is a balloon catheter comprising a handle 302 and a steerable, outer shaft 304 extending distally from the handle 302. The delivery apparatus 300 can further comprise an intermediate shaft 306 (which also may be referred to as a balloon shaft) that extends proximally from the handle 302 and distally from the handle 302, the portion extending distally from the handle 302 also extending coaxially through the outer shaft 304. In some examples, the delivery apparatus 300 can further comprise an inner shaft extending distally from the handle 302 coaxially through the intermediate shaft 306 and the outer shaft 304 and proximally from the handle 302 coaxially through the intermediate shaft.

[0110] The outer shaft 304 and the intermediate shaft 306 can be configured to translate (for example, move) longitudinally, along a central longitudinal axis 320 of the delivery apparatus 300, relative to one another to facilitate delivery and positioning of a prosthetic valve at an implantation site in a patient’s body.

[0111] The intermediate shaft 306 can include a proximal end portion that extends proximally from a proximal end of the handle 302, to an adaptor 312. The adaptor 312 can include a first port 338 configured to receive a guidewire therethrough and a second port 340 configured to receive fluid (for example, inflation fluid) from a fluid source. The second port 340 can be fluidly coupled to an inner lumen of the intermediate shaft 306.

[0112] In some examples, the intermediate shaft 306 can further include a distal end portion that extends distally beyond a distal end of the outer shaft 304 when a distal end of the outer shaft 304 is positioned away from an inflatable balloon 318 of the delivery apparatus 300. A distal end portion of the inner shaft can extend distally beyond the distal end portion of the intermediate shaft 306 toward or to a nose cone 322 at a distal end of the delivery apparatus 300.

[0113] In some examples, a distal end of the balloon 318 can be coupled to a distal end of the delivery apparatus 300, such as to the nose cone 322 (as shown in FIG. 10), or to an alternate component at the distal end of the delivery apparatus 300 (for example, a distal shoulder). An intermediate portion of the balloon 318 can overlay a valve mounting portion 324 of a distal end portion of the del i very apparatus 300 and a distal end portion of the balloon 318 can overly a distal shoulder of the delivery apparatus 300. As shown in FIG. 10, a prosthetic heart valve 350 (which in some examples can be any one of prosthetic heart valves 62, 100) can be mounted around the balloon 318, at the valve mounting portion 324 of the delivery apparatus 300, in a radially compressed state. The prosthetic heart valve 350 can be configured to be radially expanded by inflation of the balloon 318 at a native valve annulus, as described above with reference to FIG. 3A.

[0114] A balloon shoulder assembly of the delivery apparatus 300, which includes the distal shoulder, is configured to maintain the prosthetic heart valve 350 (or other medical device) at a fixed position on the balloon 318 during delivery through the patient’s vasculature.

[0115] The outer shaft 304 can include a distal tip portion 328 mounted on its distal end. In some examples, the outer shaft 304 and the intermediate shaft 306 can be translated axially relative to one another to position the distal tip portion 328 adjacent to a proximal end of the valve mounting portion 324, when the prosthetic valve 350 is mounted in the radially compressed state on the valve mounting portion 324 (as shown in FIG. 10) and during delivery of the prosthetic valve to the target implantation site. As such, the distal tip portion 328 can be configured to resist movement of the prosthetic valve 350 relative to the balloon 318 proximally, in the axial direction, relative to the balloon 318, when the distal tip portion 328 is arranged adjacent to a proximal side of the valve mounting portion 324.

[0116] An annular space can be defined between an outer surface of the inner shaft and an inner surface of the intermediate shaft 306 and can be configured to receive fluid from a fluid source via the second port 340 of the adaptor 312. The annular space can be fluidly coupled to a fluid passageway formed between the outer surface of the distal end portion of the inner shaft and an inner surface of the balloon 318. As such, fluid from the fluid source can flow to the fluid passageway from the annular space to inflate the balloon 318 and radially expand and deploy the prosthetic valve 350.

[0117] An inner lumen of the inner shaft can be configured to receive a guidewire therethrough, for navigating the distal end portion of the delivery apparatus 300 to the target implantation site.

[0118] The handle 302 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery apparatus 300. In the illustrated example, for example, the handle 302 includes an adjustment member, such as the illustrated rotatable knob 360, which in turn is operatively coupled to the proximal end portion of a pull wire. The pull wire can extend distally from the handle 302 through the outer shaft 304 and has a distal end portion affixed to the outer shaft 304 at or near the distal end of the outer shaft 304. Rotating the knob 360 can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 300. Further details on steering or flex mechanisms for the delivery apparatus can be found in U.S. Patent No. 9,339,384, which is incorporated by reference herein in its entirety.

[0119] The handle 302 can further include an adjustment mechanism 361 including an adjustment member, such as the illustrated rotatable knob 362, and an associated locking mechanism including another adjustment member, configured as a rotatable knob 378. The adjustment mechanism 361 is configured to adjust the axial position of the intermediate shaft 306 relative to the outer shaft 304 (for example, for fine positioning at the implantation site).

Example Delivery Techniques

[0120] For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (for example, by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve. Alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-stemotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0121] For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.

[0122] For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar- approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve/pulmonary artery.

[0123] Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0124] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art.

Sterilization

[0125] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat/thermal, pressure, steam, radiation, and/or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat/thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example.

Additional Examples of the Disclosed Technology

[0126] In view of the above-described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.

[0127] Example 1. A prosthetic heart valve can include a frame with a plurality of apices disposed at an end of the frame and a valve cover disposed around an outer surface of the frame. The valve cover can include an outer fabric layer and an inner film layer. The outer fabric layer and the inner film layer can be folded over the plurality of apices of the frame.

[0128] Example 2. The prosthetic heart valve of any example herein, particularly Example 1, wherein the outer fabric layer and the inner film layer can be folded in a first, radially inwards- facing fold over the plurality of apices of the frame. [0129] Example 3. The prosthetic heart valve of any example herein, particularly Example 2, wherein the inner film layer can be folded in a second, radially outwards-facing fold over the outer fabric layer and the plurality of apices of the frame.

[0130] Example 4. The prosthetic heart valve of any example herein, particularly any one of Examples 1-3, wherein an end portion of the outer fabric layer can define an outer layer and an inner layer when folded over the plurality of apices.

[0131] Example 5. The prosthetic heart valve of any example herein, particularly Example 4, wherein the inner film layer can be folded to define a first outer layer and a first inner layer, the outer layer of the outer fabric layer can be disposed radially outwards of the first outer layer of the inner film layer, and the inner layer of the outer fabric layer can be disposed radially inwards of the first inner layer of the inner film layer.

[0132] Example 6. The prosthetic heart valve of any example herein, particularly Example 5, wherein the inner fabric layer can be folded to define a second outer layer and a second inner layer, the outer layer of the outer fabric layer can be disposed radially inwards of the second outer layer of the inner fabric layer, and the inner layer of the outer fabric layer can be disposed radially outwards of the second inner layer of the inner fabric layer.

[0133] Example 7. The prosthetic heart valve of any example herein, particularly any one of Examples 1-6, wherein only the outer fabric layer and the inner film layer cover the plurality of apices of the frame.

[0134] Example 8. The prosthetic heart valve of any example herein, particularly any one of Examples 1-7, wherein the inner film layer can be a non-woven layer.

[0135] Example 9. The prosthetic heart valve of any example herein, particularly any one of Examples 1-8, wherein the prosthetic heart valve does not include a separate apex cover component.

[0136] Example 10. A radially compressible and expandable prosthetic valve can include: a frame including a plurality of apices disposed at an end of the frame and an outer covering disposed around the frame. The outer covering can include a fabric layer and a film layer. The fabric layer and the film layer can be folded in a first fold over the plurality of apices. The film layer can be folded in a second fold over the fabric layer.

[0137] Example 11. The radially compressible and expandable prosthetic valve of any example herein, particularly Example 10, wherein the film layer can be folded in the second fold over both an end portion of the fabric layer and the plurality of apices of the frame.

[0138] Example 12. The radially compressible and expandable prosthetic valve of any example herein, particularly any one of Examples 10-11, wherein the first fold can be in a radially inwards facing direction.

[0139] Example 13. The radially compressible and expandable prosthetic valve of any example herein, particularly any one of Examples 10-12, wherein the second fold can be in a radially outwards facing direction.

[0140] Example 14. The radially compressible and expandable prosthetic valve of any example herein, particularly any one of Examples 10-13, wherein the film layer cam include a non-woven material.

[0141] Example 15. The radially compressible and expandable prosthetic valve of any example herein, particularly Example 14, wherein the film layer can be formed from one of TPU and ePTFE.

[0142] Example 16. The radially compressible and expandable prosthetic valve of any example herein, particularly any one of Examples 10-15, wherein the outer covering can further include at least one suture securing the fabric layer and the film layer to the frame.

[0143] Example 17. The radially compressible and expandable prosthetic valve of any example herein, particularly Example 16, wherein the outer covering can consist of the fabric layer, the film layer, and at least one suture.

[0144] Example 18. A method can include: wrapping a valve cover around a prosthetic heart valve frame, wherein the valve cover can include an outer fabric layer and an inner film layer, and forming a first fold by folding both the outer fabric layer and the inner film layer over a plurality of apices of the prosthetic heart valve frame. [0145] Example 19. The method of any example herein, particularly Example 18, can further include forming a second fold by folding the inner film layer over the first fold.

[0146] Example 20. The method of any example herein, particularly Example 19, wherein the second fold can cover both an end portion of the outer fabric layer and the plurality of apices of the prosthetic heart valve frame.

[0147] Example 21. The method of any example herein, particularly Example 18, can further include, prior to wrapping the valve cover around the prosthetic heart valve frame, forming the inner film layer by applying a polymer coating to an inner surface of the outer fabric layer.

[0148] Example 22. The method of any example herein, particularly Example 21, wherein the polymer coating can be applied to an entirety of the inner surface of the outer fabric layer.

[0149] Examples 23. The prosthetic heart valve of any example herein, wherein the prosthetic heart valve is sterilized.

[0150] The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more of the features of prosthetic heart valve can be combined with any one or more features of another prosthetic heart valve. As another example, any one or more features of one valve cover can be combined with any one or more features of another valve cover.

[0151] In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

Claims:

1. A prosthetic heart valve comprising: a frame comprising: a plurality of apices disposed at an end of the frame; and a valve cover disposed around an outer surface of the frame, wherein: the valve cover comprises an outer fabric layer and an inner film layer, and the outer fabric layer and the inner film layer are folded over the plurality of apices of the frame.

2. The prosthetic heart valve of claim 1, wherein the outer fabric layer and the inner film layer are folded in a first, radially inwards-facing fold over the plurality of apices of the frame.

3. The prosthetic heart valve of claim 2, wherein the inner film layer is folded in a second, radially outwards-facing fold over the outer fabric layer and the plurality of apices of the frame.

4. The prosthetic heart valve of any one of claims 1-3, wherein an end portion of the outer fabric layer defines an outer layer and an inner layer when folded over the plurality of apices.

5. The prosthetic heart valve of claim 4, wherein: the inner film layer is folded to define a first outer layer and a first inner layer, the outer layer of the outer fabric layer is disposed radially outwards of the first outer layer of the inner film layer, and the inner layer of the outer fabric layer is disposed radially inwards of the first inner layer of the inner film layer.

6. The prosthetic heart valve of claim 5, wherein: the inner fabric layer is folded to define a second outer layer and a second inner layer, the outer layer of the outer fabric layer is disposed radially inwards of the second outer layer of the inner fabric layer, and the inner layer of the outer fabric layer is disposed radially outwards of the second inner layer of the inner fabric layer.

7. The prosthetic heart valve of any one of claims 1-6, wherein only the outer fabric layer and the inner film layer cover the plurality of apices of the frame.

8. The prosthetic heart valve of any one of claims 1-7, wherein the inner film layer is a non-woven layer.

9. The prosthetic heart valve of any one of claims 1-8, wherein the prosthetic heart valve does not include a separate apex cover component.

10. A radially compressible and expandable prosthetic valve comprising: a frame including a plurality of apices disposed at an end of the frame; and an outer covering disposed around the frame, wherein: the outer covering comprises a fabric layer and a film layer, the fabric layer and the film layer are folded in a first fold over the plurality of apices, and the film layer is folded in a second fold over the fabric layer.

11. The radially compressible and expandable prosthetic valve of claim 10, wherein the film layer is folded in the second fold over both an end portion of the fabric layer and the plurality of apices of the frame.

12. The radially compressible and expandable prosthetic valve of any one of claims 10-11, wherein the first fold is in a radially inwards facing direction.

13. The radially compressible and expandable prosthetic valve of any one of claims 10-12, wherein the second fold is in a radially outwards facing direction.

14. The radially compressible and expandable prosthetic valve of any one of claims 10-13, wherein the outer covering further comprises at least one suture securing the fabric layer and the film layer to the frame.

15. The radially compressible and expandable prosthetic valve of claim 14, wherein the outer covering consists of the fabric layer, the film layer, and at least one suture.

16. A method comprising: wrapping a valve cover around a prosthetic heart valve frame, wherein the valve cover includes an outer fabric layer and an inner film layer; and forming a first fold by folding both the outer fabric layer and the inner film layer over a plurality of apices of the prosthetic heart valve frame.

17. The method of claim 16, further comprising: forming a second fold by folding the inner film layer over the first fold.

18. The method of claim 17, wherein the second fold covers both an end portion of the outer fabric layer and the plurality of apices of the prosthetic heart valve frame.

19. The method of claim 18, further comprising, prior to wrapping the valve cover around the prosthetic heart valve frame: forming the inner film layer by applying a polymer coating to an inner surface of the outer fabric layer.

20. The method of claim 19, wherein the polymer coating is applied to an entirety of the inner surface of the outer fabric layer.