Prosthetic heart valves and apparatus and methods for delivery of same

Prosthetic heart valve and device and method for delivering it

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application requires US Provisional Application No. 62, entitled Prosthetic Heart Valves and Apparatus and Methods for Delivery of Same, filed on June 30, 2016 /356,828 priority and rights, the entire disclosure of which is incorporated herein by reference.

Technical field

[0003] Embodiments are described herein that relate to devices and methods for delivery and deployment of prosthetic valves, and in particular to devices and methods for prosthetic heart valves, for delivering the prosthetic heart valves in a reverse configuration Into the heart of the patient.

Background technique

[0004] Prosthetic heart valves may present particular challenges for delivery and deployment within the heart. Heart valve disease and especially aortic valve and mitral valve disease are important health issues in the United States (US); approximately 90,000 valve replacements are performed in the United States each year. Traditional valve replacement surgery that involves the replacement of the heart valve in place is considered "open heart" surgery. In short, surgery requires surgery to open the chest cavity, use a heart-lung machine to start extracorporeal circulation, stop and open the heart, remove and replace the diseased valve, and restart the heart. Although for otherwise healthy people, the risk of death from valve replacement surgery is usually 1-4%, but due to the need for extracorporeal circulation, the significantly higher morbidity is largely associated with surgery. In addition, for elderly patients, open heart surgery is often unbearable. Therefore, the elimination of extracorporeal parts of surgery can lead to a reduction in morbidity and can significantly reduce the cost of valve replacement therapy.

[0005] Although transcatheter replacement of the aortic valve is the subject of intensive research, less attention has been paid to the mitral valve. This partly reflects the higher degree of complexity associated with native mitral valve devices, and therefore the higher degree of difficulty in inserting and anchoring the replacement prosthesis. There is a need for delivery devices and methods for transcatheter mitral valve replacement.

[0006] Some known delivery methods include: delivering a prosthetic mitral valve through an apical puncture site. In such an operation, the valve is placed in a compressed configuration in the lumen of a delivery catheter of, for example, 34Fr to 36Fr (ie, about 11mm to 12mm in outer diameter). Delivery of the prosthetic valve to the atrium of the heart can be achieved, for example, via a transfemoral approach transatrially directly into the left atrium of the heart, via a jugular vein approach, or transapically. In many cases, it is desirable for the prosthetic valve to have a small outer circumference or profile to allow insertion through a smaller delivery catheter, such as 28Fr (ie, approximately 9 mm in outer diameter).

[0007] Therefore, there is a need for a prosthetic heart valve that can have a small profile during delivery while still maintaining the size and characteristics required to perform its desired function within the heart.

[0008] There is also a need for devices and methods for the delivery and deployment of prosthetic heart valves in the heart, where the valve is placed in a small diameter delivery sheath and then the valve is moved to an expanded configuration within the heart.

Summary of the invention

[0009] Described herein are devices and methods for various embodiments of prosthetic heart valves, delivery devices, and delivery methods for delivering prosthetic heart valves to the heart of a patient via transvascular and transapical delivery routes . In some implementation

In an example, the prosthetic heart valve includes an outer frame coupled to the inner frame, and the outer frame can move between a first configuration relative to the inner frame and a second reverse configuration relative to the inner frame. The valve can be delivered to the heart using a device that includes a delivery sheath that defines a lumen in which the prosthetic heart valve can be received when the outer frame is in the reverse configuration. The actuation wire is releasably coupled to the outer frame and can be used to help restore the outer frame after the valve is deployed outside the delivery sheath and inside the heart.

Description of the drawings

[0010] FIGS. 1A and 1B are schematic diagrams of a part of a prosthetic heart valve shown in a first configuration and a second configuration, respectively, according to an embodiment.

[0011] FIGS. 1C and 1D are schematic diagrams of a portion of the prosthetic heart valve of FIGS. 1A and 1B shown as being disposed in a delivery sheath, respectively.

[0012] FIGS. 2A and 2B are schematic diagrams of the prosthetic heart valve of FIGS. 1A and 1B shown in a first configuration and a part of a second configuration, respectively.

[0013] FIGS. 3 to 5 are a front view, a bottom view, and a top view of a prosthetic heart valve according to an embodiment.

[0014] FIG. 6 is an open flat view of the inner frame of the prosthetic heart valve of FIGS. 3 to 5 in an unexpanded configuration.

[0015] FIGS. 7 and 8 are a side view and a bottom view of the inner frame of FIG. 6 in an expanded configuration, respectively.

[0016] FIG. 9 is an open flattened view of the outer frame of the valve of FIGS. 3 to 5 in an unexpanded configuration.

[0017] FIGS. 10 and 11 are a side view and a top view of the outer frame of FIG. 9 in an expanded configuration, respectively.

[0018] FIGS. 12 to 14 are side, front, and top views of components of the inner frame of FIGS. 6 to 8 and the outer frame of FIGS. 9 to 11.

[0019] FIG. 15 is a side perspective view showing the assembly of the inner frame and the outer frame in a biased expanded configuration according to an embodiment.

[0020] FIG. 16 is a side perspective view of the assembly of FIG. 15 with the outer frame shown inverted.

[0021] FIG. 17 is a side view of the assembly of FIG. 16 shown in a collapsed configuration within the lumen of the delivery sheath.

[0022] FIG. 18 is a side view of the components of FIG. 17 shown in a first partially deployed configuration.

[0023] FIG. 19 is a side view of the components of FIG. 17 shown in a second partially deployed configuration.

[0024] FIG. 20 is a side view of the assembly of FIG. 17, shown in a third partially deployed configuration, with the inverted outer frame generally deployed outside the delivery sheath.

[0025] FIG. 21 is a side view of the assembly of FIG. 17, shown in a fourth partially deployed configuration, where the outer frame has been restored and assumes a biased expanded configuration.

[0026] FIGS. 22-24 illustrate the steps of a part of a method of delivering the prosthetic valve of FIGS. 15-21 into the atrium of the heart and the natural mitral valve annulus.

[0027] FIG. 25 is a schematic diagram of a delivery device and a prosthetic heart valve according to an embodiment.

[0028] FIG. 26A is a side view of a portion of the prosthetic heart valve of FIG. 25 shown within the delivery sheath and coupled to the valve support.

[0029] FIG. 26B is a side view of the attachment member of the prosthetic valve of FIG. 26A.

[0030] FIG. 26C is an end view of the valve support of FIG. 26A.

[0031] FIG. 27 is a cross-sectional side view of a prosthetic valve in a reverse configuration inside a delivery sheath, according to an embodiment.

[0032] FIG. 28 is a cross-sectional side view of a prosthetic valve in a reverse configuration inside the delivery sheath according to an embodiment

One part includes the dilator.

[0033] FIG. 29A is a cross-sectional side view of a prosthetic heart valve in a reverse configuration inside the lumen of the delivery sheath, according to an embodiment.

[0034] FIG. 29B is a side view of the prosthetic heart valve of FIG. 9A in a reverse configuration and outside the delivery sheath.

[0035] FIGS. 30A and 30B are schematic diagrams of a part of a prosthetic heart valve shown in a first configuration and a second configuration, respectively, according to an embodiment.

[0036] FIGS. 30C and 30D are schematic diagrams of a portion of the prosthetic heart valve of FIGS. 30A and 30B shown as being disposed in a delivery sheath, respectively.

[0037] FIGS. 31A and 31B are schematic diagrams of the prosthetic heart valve of FIGS. 30A and 30B shown in a first configuration and a portion of a second configuration, respectively.

[0038] FIG. 32A is a schematic diagram of a side view of a delivery device and a prosthetic heart valve according to an embodiment.

[0039] FIG. 32B is a schematic diagram of an end view of the elongate member of the delivery device of FIG. 32A.

[0040] FIG. 33A is a cross-sectional side view of a delivery sheath according to an embodiment with the prosthetic valve in a reverse configuration and disposed in the delivery sheath.

[0041] FIG. 33B is an illustration of a side view of the prosthetic heart valve of FIG. 33A in a reverse configuration and outside the delivery sheath.

[0042] FIG. 33C is an illustration of an end view of the elongate member of the delivery device of FIG. 33A.

[0043] FIG. 33D is an illustration of an end view of an elongate member of a conveying device according to an embodiment.

[0044] FIG. 34 is a partial cross-sectional side view of a delivery system and a prosthetic heart valve according to an embodiment.

[0045] FIG. 35 is a cross-sectional view taken along line 35-35 in FIG. 34, showing the actuation wire coupled to the pipe member of the delivery system.

[0046] FIG. 36 is a proximal end view of a tube member of the delivery system of FIG. 34.

[0047] FIG. 37A is a side view of a portion of the pipe member of FIG. 36.

[0048] FIG. 37B is a side view of a multi-lumen tube member according to another embodiment and a portion of a distal retention element according to an embodiment.

[0049] FIG. 37C is a view of a portion of the multi-lumen tube member and distal retention element of FIG. 37B according to another embodiment.

[0050] FIGS. 38A to 38D are each a side view of a different embodiment of an actuation wire.

[0051] FIG. 39 is a partial cross-sectional side view of the delivery system and prosthetic heart valve of FIG. 34 shown in a first partially deployed configuration.

[0052] FIG. 40 is a partial cross-sectional side view of the delivery system and prosthetic heart valve of FIG. 34 shown in a second partially deployed configuration.

[0053] FIG. 41 is a partial cross-sectional side view of the delivery system and prosthetic heart valve of FIG. 34 shown in a third partially deployed configuration.

[0054] FIG. 42 is a cross-sectional view taken along line AA in FIG. 34, showing the actuation wire in a partially released position.

[0055] FIG. 43 illustrates a flowchart of a method of delivering and deploying a prosthetic valve in a heart according to an embodiment.

[0056] FIG. 44 illustrates a flowchart of a method of delivering and deploying a prosthetic valve in a heart according to an embodiment.

Detailed ways

[0057] Described herein are devices and methods for a prosthetic heart valve such as a prosthetic mitral valve, the prosthetic heart

The visceral valve can be configured to move to the reverse configuration for delivery of the prosthetic valve into the patient's heart. As described herein, in some embodiments, the prosthetic valve includes an outer frame, which can be reversed relative to the inner frame when the prosthetic valve is in a biased expanded configuration. The prosthetic mitral valve may be formed of, for example, a shape memory material. After reversing the outer frame, the prosthetic valve can be inserted into the lumen of the delivery sheath, causing the prosthetic valve to move to the contracted configuration.

[0058] The delivery sheath can be used to deliver a prosthetic valve into the heart of a patient using a variety of different delivery routes for the delivery of a prosthetic heart valve (eg, a prosthetic mitral valve), with the reverse prosthetic valve It may enter the heart through the atria of the heart. For example, the prosthetic valve described herein can be used as in PCT International Application No. PCT/US15/14572 "PCT Application No. 572") and/or PCT International Application No. PCT/US16/12305 "PCT Application No. 305") Delivered via the femoral artery delivery route described, the disclosure of each PCT international application is incorporated herein by reference in its entirety; or via a transatrial route (such as the "Apparatus and Methods for Transatrial Delivery of Prosthetic Mitral Valve (apparatus and method for transatrial delivery of a prosthetic mitral valve)" U.S. Provisional Patent Application Serial No. 62/220,704 "Provisional Application No. 704"), which is incorporated by reference in its entirety This article) to deliver. In another example, as each is incorporated herein by reference in its entirety entitled Apparatus and Methods for Delivery of Prosthetic Mitral Valve (Apparatus and Method for Delivery of Prosthetic Mitral Valve)" U.S. Provisional Patent Application Serial No. 62/305,678 "Provisional Application No. 678) and entitled Apparatus and Methods for Delivery of Prosthetic Mitral Valve (for delivery of prosthetic two Cusp device and method)" US Patent Application Publication No. 2017/0079790 "Publication No. 790"), the prosthetic valve described herein (for example, the reverse valve as described herein) can be passed through Delivery via the jugular vein, for example, via the right atrium and through the atrial septum and into the left atrium. If necessary, the prosthetic valve described herein can also be delivered to the apex. Through the transapical approach, the delivery sheath is already placed in the heart After inside the left atrium, the prosthetic mitral valve is moved distally out of the delivery sheath, so that the reverse outer frame is restored and the prosthetic valve assumes its offset expanded configuration. Then, the prosthetic mitral valve can be positioned in the heart Inside the mitral valve annulus.

[0059] In some embodiments, the device includes a delivery sheath, an elongate member that defines a lumen, the elongate member defines a first lumen and a second lumen and is at least partially disposed in the lumen of the delivery sheath Inside. The device also includes a prosthetic heart valve that is at least partially disposed within the lumen of the delivery sheath in a contracted configuration and circumferentially surrounds a portion of the elongate member. The prosthetic heart valve includes an outer frame coupled to the inner frame. The outer frame can be moved between a first configuration relative to the inner frame and a second configuration relative to the inner frame, wherein the outer frame is reversed relative to the inner frame. The prosthetic heart valve is disposed within the lumen of the delivery sheath, and the outer frame is in the second configuration and axially disposed proximal to the inner frame. The device also includes a first actuation wire that is releasably coupled to the first portion of the outer frame and passes through the first lumen of the elongate member from the first portion and from the proximal end of the delivery sheath. Lead out. The device also includes a second actuation wire that is releasably coupled to the second portion of the outer frame and passes through the second lumen of the elongate member from the second portion and from the proximal side of the delivery sheath. The end leads out. The first part and the second part of the outer frame are configured to be placed in the atrium of the heart when implanted in the heart.

[0060] In some embodiments, the method includes inserting the distal end of the delivery sheath through the apical region of the heart and into the atrium of the heart. The delivery sheath has a prosthetic heart valve disposed in the inner cavity of the delivery sheath. The prosthetic heart valve includes an outer frame and an inner frame coupled to the outer frame. The outer frame can move between a first position relative to the inner frame and a second position relative to the inner frame, wherein the outer frame is reversed with respect to the inner frame. The prosthetic heart valve is disposed in the inner cavity of the delivery sheath, and during the insertion of the distal end of the delivery sheath through the apical region of the heart and into the atrium of the heart, the outer frame is in a second position relative to the inner frame. The method also includes: moving the prosthetic heart valve distally out of the delivery sheath. The method also includes:

The outer frame of the prosthetic heart valve is transitioned to a first position relative to the inner frame, so that the prosthetic heart valve at least partially assumes an offset expanded configuration. The method also includes positioning the prosthetic heart valve in the annulus of the heart.

[0061] In some embodiments, the method includes inserting the distal end of the delivery sheath into the atrium of the heart. The delivery sheath has a prosthetic heart valve disposed in the lumen of the delivery sheath. The prosthetic heart valve includes an outer frame and an inner frame coupled to the outer frame. The outer frame can move between a first position relative to the inner frame and a second position relative to the inner frame, wherein the outer frame is reversed with respect to the inner frame. The prosthetic heart valve is arranged in the lumen of the delivery sheath. During the insertion of the distal end of the delivery sheath into the atrium of the heart, the outer frame is in a second position relative to the inner frame and is at least partially axially arranged at The proximal side of the inner frame. The method also includes: moving the prosthetic heart valve distally out of the delivery sheath. The method also includes transitioning the outer frame of the prosthetic heart valve to a first position relative to the inner frame, so that the prosthetic heart valve at least partially assumes an offset expanded configuration. The method also includes positioning the prosthetic heart valve in the annulus of the heart.

[0062] In some embodiments, the device includes an outer sheath, a delivery sheath, and a prosthetic heart valve, the outer sheath defines a lumen, the delivery sheath defines the lumen and is movably disposed within the lumen defined by the outer sheath, The prosthetic heart valve is arranged in the inner cavity of the delivery sheath in the contracted configuration. The prosthetic heart valve includes an outer frame coupled to the inner frame. The inner frame is removably coupled to the distal end of the valve support. The outer frame can move between a first configuration relative to the inner frame and a second configuration relative to the inner frame, wherein the outer frame is reversed relative to the inner frame. The prosthetic heart valve is arranged in the inner cavity of the delivery sheath, and the outer frame is in the second configuration. The device also includes a first actuation wire and a second actuation wire, the first actuation wire is releasably coupled to the first part of the outer frame, and the second actuation wire is releasably coupled to the second part of the outer frame . Each of the first actuating wire and the second actuating wire has (1) a first part and (2) a second part. The first part extends proximally from the outer frame, passes through the inner cavity of the outer sheath, and runs along The outer wall of the delivery sheath and through the first side eyelet defined by the delivery sheath, the second part extends proximally from the outer frame, through the lumen of the outer sheath, along the outside of all delivery sheaths and through the delivery sheath Defined second side eyelet. The first portion and the second portion of each of the first actuation wire and the second actuation wire are configured to be pulled proximally to push the outer frame from the second configuration toward the first configuration relative to the inner frame.

[0063] In some embodiments, the device includes a prosthetic valve that includes an inner frame and an outer frame, the outer frame being coupled to the inner frame at a plurality of coupling joints. The plurality of coupling joints are configured to allow the outer frame to move relative to the inner frame so that the prosthetic valve can move between the first configuration and the second configuration. When the prosthetic valve is in the first configuration, the outer frame and the inner frame jointly define the first length of the prosthetic valve; when the prosthetic valve is in the second configuration, the outer frame and the inner frame jointly define the second length of the prosthetic valve, And the second length is greater than the first length. When the prosthetic valve is in both the first configuration and the second configuration, the inner frame has the same length.

[0064] In some embodiments, the device includes a prosthetic heart valve that includes an inner frame and an outer frame, the outer frame being coupled to the inner frame at a plurality of coupling joints. The prosthetic valve can move between a first configuration and a second configuration. The plurality of coupling joints are configured to allow the outer frame to move between a first position relative to the inner frame and a second position relative to the inner frame, wherein the outer frame is reversed with respect to the inner frame. When the outer frame is in the first position, the prosthetic valve is in the first configuration; when the outer frame is in the second position, the prosthetic valve is in the second configuration.

[0065] In some embodiments, the device includes a prosthetic heart valve that includes an inner frame and an outer frame, the outer frame being coupled to the inner frame at a plurality of coupling joints. The plurality of coupling joints are configured to allow the outer frame to move relative to the inner frame so that the prosthetic valve can move between the first configuration and the second configuration. The outer frame has an outer frame coupling portion and a free end portion of the outer frame, and the outer frame coupling portion is coupled to the inner frame at a plurality of coupling joints. The inner frame has an inner frame coupling portion that is coupled to the outer frame at a plurality of coupling joints. The first end and the free end of the inner frame are on an end of the inner frame opposite to the first end. When the prosthetic valve is in the first configuration, multiple coupling joints are arranged on the outer frame

Between the free end and the first end of the inner frame. When the prosthetic valve is in the second configuration, a plurality of coupling joints are arranged between the free end of the inner frame and the free end of the outer frame.

[0066] In some embodiments, the device includes a prosthetic heart valve that includes an inner frame that is coupled to the outer frame at a plurality of coupling joints. The plurality of coupling joints are configured to allow the outer frame to move relative to the inner frame so that the prosthetic valve can move between the first configuration and the second configuration. The outer frame has an outer frame coupling portion and a free end portion of the outer frame, and the outer frame coupling portion is coupled to the inner frame at a plurality of coupling joints. The inner frame has an inner frame coupling portion and a free end portion of the inner frame, and the inner frame coupling portion is coupled to the outer frame at a plurality of coupling joints. When the prosthetic valve is in the first configuration, the free end of the outer frame and the free end of the inner frame are each opened in the same direction. When the prosthetic valve is in the second configuration, the free end of the outer frame and the free end of the inner frame are opened in opposite directions.

[0067] In some embodiments, the device includes a delivery sheath, a valve support, and a prosthetic heart valve, the delivery sheath defines a lumen, the valve support is movably disposed in the lumen of the delivery sheath, and the prosthetic heart The valve is at least partially disposed within the lumen of the delivery sheath in the contracted configuration. The prosthetic heart valve includes an outer frame coupled to the inner frame, and the inner frame is removably coupled to the distal end of the valve support. The outer frame can be moved between a first configuration relative to the inner frame and a second configuration relative to the inner frame, wherein the outer frame is reversed relative to the inner frame. The prosthetic heart valve is arranged in the inner cavity of the delivery sheath, and the outer frame is in the second configuration. The first actuating wire is releasably coupled to the first part of the open free end of the outer frame, and the second actuating wire is releasably coupled to the second part of the open free end of the outer frame. Each of the first actuation wire and the second actuation wire has a first portion and a second portion, the first portion extending proximally from the outer frame, and the second portion extending proximally from the outer frame. The first portion and the second portion of each of the first actuation wire and the second actuation wire are configured to be pulled proximally to push the outer frame from the second configuration toward the first configuration relative to the inner frame.

[0068] In some embodiments, the device includes an outer sheath, an inner sheath, a tube member, a valve support, and a prosthetic heart valve. The outer sheath defines a lumen, and the inner sheath is movably disposed in the lumen of the outer sheath and Defining a lumen, the tube member is movably disposed in the inner cavity of the outer sheath and defining the inner cavity, and the valve support is movably disposed in the inner cavity of the inner sheath and the inner cavity defined by the tube member, the prosthesis The heart valve is disposed at least partially within the lumen of the outer sheath and at least partially within the lumen of the inner sheath. The prosthetic heart valve includes an outer frame coupled to the inner frame, and the inner frame is removably coupled to the distal end of the valve support. The outer frame can be moved between a first configuration relative to the inner frame and a second configuration relative to the inner frame, wherein the outer frame is reversed relative to the inner frame. The prosthetic heart valve is arranged in the inner cavity of the outer sheath and the inner cavity of the inner sheath, and the outer frame is in the second configuration. The first actuating wire is releasably coupled to the first part of the open free end of the outer frame, and is releasably coupled to the pipe member at a first position on the pipe member. The second actuation wire is releasably coupled to the second portion of the open free end of the outer frame, and is releasably coupled to the pipe member at a second position on the pipe member.

[0069] In some embodiments, the method includes inserting the distal end of the delivery sheath into the left atrium of the heart. The delivery sheath has a prosthetic mitral valve disposed in the lumen of the delivery sheath, and the prosthetic mitral valve has an outer frame coupled to the inner frame, so that the outer frame can be at a first position relative to the inner frame and relative to the inner frame. The frame moves between the second positions, wherein the outer frame is opposite to the inner frame. The prosthetic valve is arranged in the inner cavity of the delivery sheath, and the outer frame is in a second position relative to the inner frame. The prosthetic mitral valve is moved distally out of the delivery sheath, so that the outer frame of the prosthetic mitral valve returns to the first position relative to the inner frame, so that the prosthetic mitral valve at least partially assumes an offset expanded configuration. The prosthetic mitral valve is positioned within the mitral valve annulus of the heart.

[0070] FIGS. 1A and 1B are schematic diagrams showing a part of a prosthetic heart valve 100 in a first configuration and a second configuration, respectively, according to an embodiment, and FIGS. 1C and 1D illustrate the parts of FIGS. 1A and 1B, respectively The prosthetic heart valve 100 is shown as various parts disposed within the lumen of the delivery sheath 126. Figures 2A and 2B illustrate a part of the prosthetic heart valve 100 of Figures 1A and 1B, respectively

Section, and shows the length dimension of the prosthetic heart valve in each of the first configuration and the second configuration. As mentioned above, in some cases, such as when the prosthetic valve is delivered to the heart via the transfemoral artery, transatrial or transjugular route, due to the small size of the lumen of the delivery sheath, the prosthetic valve The size should be constructed accordingly. Therefore, it is desirable to have a prosthetic valve that can be reconfigured between a biased expanded configuration for implantation in the heart (for example, in the natural mitral valve annulus) and a delivery configuration with a smaller outer circumference or profile. Configured to allow delivery within the lumen of the delivery sheath. The prosthetic valve 100 and embodiments of the prosthetic valves described herein can be constructed and formed to achieve these desired functions and features.

[0071] The prosthetic heart valve 100 (also referred to herein as a "prosthetic valve" or "valve") may be, for example, a prosthetic mitral valve. The valve 100 includes an outer frame 120 and an inner frame 150. As described in more detail below with reference to FIGS. 3 to 15, the outer frame 120 and the inner frame 150 are each formed as a tubular structure. As described in more detail below, the outer frame 120 and the inner frame 150 may be coupled together at a plurality of coupling joints 146 arranged around the periphery of the inner frame 150 and the periphery of the outer frame 120. The valve 100 may also include other features, such as those described below with respect to FIGS. 3-15. For illustrative purposes, the inner frame 150 and the outer frame 120 are discussed only with respect to FIGS. 1A to 2B. The various features and characteristics of the valve 100 described with respect to FIGS. 1A to 2B can be applied to any prosthetic valve described herein.

[0072] The outer frame 120 is configured to have a biased expanded or undeformed shape, and can be manipulated and/or deformed (for example compressed or constrained), and when released, returns to its original (expanded or undeformed) shape. For example, the outer frame 120 may be formed of materials such as metal or plastic, which have shape memory properties. Regarding metals, Nitinol 0 has been found to be particularly useful because it can be processed into austenitic, martensitic or superelastic. Other shape memory alloys such as Cu-Zn-Al-Ni alloy and Cu-Al-Ni alloy can also be used. The inner frame 150 may be formed of a laser cut tube of Nitinol®. The inner frame 150 may also have a biased expanded or undeformed shape, and may be manipulated and/or deformed (eg, compressed and/or constrained), and when released, return to its original (expanded or undeformed) shape. Further details regarding the inner frame 150 and the outer frame 120 are described below with respect to the valve 200 and FIGS. 3 to 15.

[0073] The valve 100 can be delivered and deployed in the left atrium of the heart using a variety of different delivery routes, including, for example, as described in PCT Application No. 572 and/or PCT Application No. 305, which are incorporated by reference above. The described transfemoral delivery route, or the transatrial or transjugular route as described in Provisional Application No. 704, Provisional Application No. 678, and Publication No. 790, which are incorporated by reference above. As mentioned above, in some cases, such as when a prosthetic valve is delivered to the heart via a transfemoral or transatrial route, since the size of the lumen of the delivery sheath is small, the size of the prosthetic valve during delivery should be corresponding. Ground structure size. Therefore, it is desirable to have a prosthetic valve that can be reconfigured between a biased expanded configuration for implantation in the heart (for example, in the natural mitral valve annulus) and a delivery configuration with a smaller outer circumference or profile. Configured to allow delivery within the lumen of the delivery sheath. The prosthetic valve 100 and embodiments of the prosthetic valves described herein can be constructed and formed to achieve these desired functions and features.

[0074] More specifically, the valve 100 may have an offset expanded configuration (as shown in FIGS. 1A and 2A), a reverse configuration (as shown in FIGS. 1B and 2B), and a compressed or contracted configuration (as shown in FIGS. 1C and 2A). Shown in 1D). The expanded configuration allows the valve 100 to function when implanted in the heart. The valve 100 can be moved to a reverse configuration and a compressed or contracted configuration for delivery of the valve 100 to the patient's heart.

[0075] To enable the valve 100 to move to the reverse configuration, the outer frame 120 may be coupled to the inner frame 150 in a manner that allows the outer frame 120 to move relative to the inner frame 150. More specifically, the coupling joint 146 may couple the outer frame 120 to the inner frame 150 in a manner that allows the outer frame 120 to move relative to the inner frame 150. For example, in some embodiments, the coupling joint 146 may be configured to allow the outer frame 120 to rotate relative to the inner frame 150 around the coupling joint 146. In some implementation

In an example, the coupling joint can provide a pivotal coupling between the outer frame 120 and the inner frame 150. In some embodiments, the coupling joint may provide a flexible attachment between the outer frame 120 and the inner frame 150. As described herein with reference to various embodiments of the prosthetic valve, the coupling joint 146 may be of various different types and configurations. For example, the coupling joint 146 may include a living hinge, a flexible member, a suture, a suture wound through the opening, a pin or tab inserted through the opening, or any combination thereof.

[0076] In order to move the valve 100 from the expanded configuration (FIG. 1A) to the reverse configuration (FIG. 1B), the outer frame 120 is moved by moving (eg, rotating, pivoting, bending) around the coupling joint 146 To the prolapsed or reverse configuration relative to the inner frame 150, as shown in Figs. 1B, 1D, and 2B. The elastic or superelastic structure of the outer frame 120 of the valve 100 also allows the outer frame 120 to move to and be placed in a prolapsed or reverse configuration relative to the inner frame 150. In order to move the outer frame 120 to a reverse configuration relative to the inner frame 150, the outer frame 120 is folded or reversed distally relative to the inner frame 150 via the coupling joint 146 (to the right in FIG. 1B). As shown in FIGS. 1A and 2A, the outer frame 120 is in a first position relative to the inner frame 150 before being reversed, wherein the opening or free end 116 (also referred to as the atrial portion 116 of the outer frame 120) is provided at the coupling joint The proximal or left side of 146 is in the same direction as the free end 147 of the inner frame 150 (also referred to as the second end of the inner frame). When the outer frame 120 moves to the reverse configuration (ie, the second position relative to the inner frame 150), the free end 116 is disposed on the distal side of the coupling joint 146 (or the right side in FIGS. 1B and 2B), and Opposite to the free end 147 of the inner frame 150 In the direction. In other words, when the valve 100 is in a biased expanded configuration (such as FIG. 1A), the coupling joint 146 is provided at the first end 144 (also referred to as the tether coupling) of the inner frame 150 and the free end of the outer frame 120 116 between. When the valve 100 is in the reverse configuration (for example, FIG. 1B) (that is, the outer frame 120 has moved to the reverse configuration or position), the coupling joint 146 is provided at the free end or the second end 147 of the inner frame 150 and the outer frame 120 Between the free ends 116.

[0077] When in the reverse configuration, the overall length of the valve 100 increases, but the length of the inner frame 150 and the length of the outer frame 120 remain the same (or substantially the same). For example, as shown in Figures 2A and 2B, the total length L1 of the valve 100 in the offset expanded configuration (before the reverse as shown in Figure 2A) is less than the total length L1 of the valve 100 when in the reverse configuration (Figure 2B) Length L2. When the valve 100 is both in the offset expanded configuration and the reverse configuration, the length Li of the inner frame 150 and the length Lo of the outer frame 120 are substantially the same (or the same). In addition, in some examples, depending on the specific configuration of the outer frame, when the valve 100 is in the reverse configuration, the total outer circumference or outer diameter of the valve 100 may be smaller.

[0078] With the valve 100 in the reverse configuration, the valve 100 may be placed in the lumen of the delivery sheath 126 for delivery of the valve 100 to the left atrium of the heart, as shown in FIG. 1D. When placed within the lumen of the delivery sheath 126, the valve 100 moves to a contracted or compressed configuration in which the outer diameter or outer circumference of the valve 100 decreases. Because the valve 100 is in the reverse configuration, the valve 100 can be placed in a smaller delivery sheath 126 than might otherwise be possible. For example, for comparison purposes, Figure 1C illustrates the valve 100 placed within the lumen of the delivery sheath 126', where the valve 100 has not moved to the reverse configuration before being placed within the delivery sheath 126'. As shown in FIG. 1C, when in the reverse configuration, the outer diameter of the valve 100 is reduced, but not as small as the diameter of the valve 100 when placed in the delivery sheath 126. Therefore, in FIG. 1C, the overall outer circumference or outer diameter of the valve 100 is D1, and in FIG. 1D, the overall outer circumference or outer diameter of the valve 100 is D2, which is smaller than D1.

[0079] Therefore, by setting the outer frame 120 in the reverse configuration, the valve 100 can be contracted to a smaller overall diameter, ie, if the valve 100 is only radially contracted, it is placed in the delivery sheath 126 with a smaller diameter. This is because the inner frame 150 is nested within the interior of the outer frame 120 when the valve is in the biased expanded configuration, so the outer frame 120 must contract around the inner frame 150. In some embodiments, the inner frame 150 and the outer frame are arranged concentrically. In the reverse configuration, the inner frame 150 and the outer frame 120 are arranged axially with respect to each other (that is, the inner frame is not nested within the outer frame 150), so that the outer frame 120 can shrink without accommodating all of the inner frame 150 inside. structure. In other words, when the inner frame 150 is mostly disposed inside the outer frame 120 or nested in the outer frame 120, the layers or blocks of the frame structure cannot be compressed to such a diameter.

small. In addition, if the frame is nested, the structure is less flexible, so more force is required to bend the valve, for example to pass through the tortuous vasculature or to make a tight turn in the left atrium after passing through the interatrial septum. For insertion into the mitral valve annulus with proper orientation.

[0080] FIGS. 3 to 14 illustrate another embodiment of a prosthetic heart valve that can be delivered and deployed in the left atrium of the heart using a variety of different delivery routes, including, for example, via Femoral artery delivery route or transatrial delivery route. 3 to 5 are respectively a front view, a bottom view and a top view of a prosthetic heart valve 200 according to an embodiment. The prosthetic heart valve 200 (also referred to herein as a "valve" or "prosthetic valve") is designed to replace a damaged or diseased native heart valve, such as a mitral valve. The valve 200 includes an outer frame assembly 210 and an inner valve assembly 240 coupled to the outer frame assembly 210.

[0081] As shown, the outer frame assembly 210 includes an outer frame 220, which is covered with an outer cover 230 on all or a part of its outer surface, and is covered by an inner cover 232 on its inner surface. All or part of it. The outer frame 220 can provide several functions for the prosthetic heart valve 200, including serving as the main structure, as an anchoring mechanism for anchoring the valve to a native heart valve device, and/or as an attachment point for a separate anchoring mechanism, and carrying internal valve components The support of 240 and/or a seal that inhibits paravalvular leakage between the prosthetic heart valve 200 and the native heart valve device.

[0082] The outer frame 220 has a biased expansion configuration, and can be manipulated and/or deformed (eg, compressed and/or constrained), and when released, returns to its original unconstrained shape. To achieve this, the outer frame 220 may be formed of materials such as metal or plastic, which have shape memory properties. Regarding metals, Nitinol ® has been found to be particularly useful because it can be processed into austenitic, martensitic or superelastic. Other shape memory alloys such as Cu-ZnAl-Ni alloy and Cu-Al-Ni alloy can also be used.

[0083] As best shown in FIG. 3, the outer frame assembly 210 has an upper end (for example, at the atrial portion 216), a lower end (for example, at the ventricular portion 212), and an intermediate portion therebetween (for example, at the annulus portion 214). The upper end or atrial portion 216 (also referred to as the "outer free end") defines the open end of the outer frame assembly 210. The middle or annulus portion 214 of the outer frame assembly 210 has a perimeter that is configured (eg, sized and shaped) to fit into the annulus of the native atrioventricular valve. The circumference of the upper end of the outer frame assembly 210 is greater than the circumference of the middle part. In some embodiments, the circumference of the upper end of the outer frame assembly 210 is substantially greater than the circumference of the middle portion. As best shown in FIG. 5, the upper end and the middle portion of the outer frame assembly 210 have a D-shaped cross section. In this way, the outer frame assembly 210 promotes proper fitting into the body annulus of the native atrioventricular valve.

[0084] The inner valve assembly 240 includes an inner frame 250, an outer cover (not shown), and leaflets 270. As shown, the inner valve assembly 240 includes an upper portion having a periphery formed with a plurality of arches. The inner frame 250 includes six axial columns or frame members that support the outer cover of the inner valve assembly 240 and the leaflets 270. The leaflets 270 are attached along three of the posts shown as commissural posts 252 (best illustrated in Figure 4), and the outer cover of the inner valve assembly 240 is attached to the other three posts 254 (in Figure 4 Best illustrated in ), and optionally attached to the commissure post 252. The inner valve assembly 240 and each outer cover of the leaflet 270 are formed of approximately rectangular material sheets, which are joined together at their upper or atrium ends. The lower ventricular end of the outer cover of the inner valve assembly 240 may be coupled to the inner cover 232 of the outer frame assembly 210, and the lower ventricular end of the leaflet 270 may form a free edge 275, despite being coupled to the lower end of the commissural post 252.

[0085] Although the internal valve assembly 240 is shown as having three leaflets, in other embodiments, the internal valve assembly may include any suitable number of leaflets. The leaflets 270 can be moved between an open configuration and a closed configuration, where the leaflets 270 coapt or contact in the sealing abutment surface.

[0086] The outer cover 230 of the outer frame assembly 210 and the inner cover 232 of the outer frame assembly 210, the outer cover 260 of the inner valve assembly 240, and the leaflets 270 of the inner valve assembly 240 may be made of any suitable material or such as the above That in question

These materials are formed by a combination of materials. In this embodiment, the inner cover 232 of the outer frame assembly 210, the outer cover of the inner valve assembly 240, and the leaflets 270 of the inner valve assembly 240 are at least partially formed by the porcine pericardium. Also, in this embodiment, the outer cover 230 of the outer frame assembly 210 is at least partially formed of polyester.

[0087] The inner frame 250 is shown in more detail in FIGS. 6-8. Specifically, FIGS. 6 to 8 respectively show an inner frame 250 in an undeformed, initial state (FIG. 6), a side view of the inner frame 250 in an expanded configuration (FIG. 7), and an expanded configuration according to an embodiment. A bottom view of the inner frame 250 (Figure 8).

[0088] In this embodiment, the inner frame 250 is formed of a laser cut tube of Nitinol®. FIG. 6 illustrates the inner frame 250 in an undeformed, initial state, that is, cut as a laser but cut and deployed into a flat plate for ease of description. The inner frame 250 can be divided into four parts, corresponding to the functionally different parts of the inner frame 250 in the final form: the atrial part 247, the body part 242, the strut part 243, and the tether clip or connecting part 244. The strut part 243 includes six struts, such as struts 243A, which connect the body part 242 to the tether connection part 244.

[0089] The tether connection portion 244 (also referred to as the first end of the inner frame) includes a longitudinal extension of the strut through a pair of opposed, slightly V-shaped connecting members (or "micro-Vs"). ) Circumferential connection. The tether connecting portion 244 is configured to contract radially by applying a compressive force, which causes the micro-V to become a deeper V-shape, the apexes move closer in the longitudinal direction and the open end of the V-shape moves closer in the circumferential direction. close. Therefore, the tether connecting portion 244 can be configured to compressively clamp or grip one end of the tether, either directly connected to the tether wire (such as a braided filament) or connected to a polymer or metal sheet. In the intermediate structure, the polymer or metal sheet is firmly fixed on the tether wire for a long time.

[0090] In contrast to the tether connection portion 244, the atrial portion 247 (also referred to as the "free end of the inner frame") and the body portion 242 are configured to expand radially. The strut portion 243 forms a longitudinal connection and a radial transition between the expanded body portion and the compressed tether connection portion 244. The body portion 242 provides an inner frame coupling portion 245, which includes six longitudinal pillars, such as pillars 242A. The inner frame coupling portion 245 may be used to attach the leaflets 270 to the inner frame 240 and/or may be used to attach the inner component 240 to the outer component 210, such as by connecting the inner frame 250 to the outer frame 220. In the illustrated embodiment, the post includes an opening through which connecting members (such as suture filaments and/or wires) can pass to couple the post to other structures.

[0091] FIGS. 7 and 8 show the inner frame 250 in a fully deformed (ie, final deployed) configuration in side and bottom views, respectively.

[0092] Figures 9-11 show the outer frame 220 of the valve 200 in more detail. In this embodiment, the outer frame 220 is also formed of a Nitinol® laser cut tube. FIG. 9 illustrates the outer frame 220 in an undeformed initial state (that is, during laser cutting, but cut and unfolded into a flat plate for ease of explanation). The outer frame 220 can be divided into an outer frame coupling part 271, a body part 272, and a cuff part 273 (which includes the atrium or free end 216), as shown in FIG. 9. The outer frame coupling portion 271 includes a plurality of openings or holes, such as 271A, through which the outer frame 220 can be coupled to the inner frame 250, as discussed in more detail below.

[0093] FIGS. 10 and 11 show the outer frame 220 in a fully deformed (ie, final deployed) configuration in a side view and a top view, respectively. As best shown in FIG. 11, the lower end of the outer frame coupling portion 271 forms a substantially circular opening (indicated by "O" in FIG. 11). The diameter of the opening preferably roughly corresponds to the diameter of the body portion 242 of the inner frame 250 to facilitate the coupling of the two components of the valve 200.

[0094] FIGS. 12-14 show the outer frame 220 and the inner frame 250 coupled together in a front view, a side view, and a top view, respectively. The two frames together form a structural support for a prosthetic valve such as valve 200. The frame supports the valve leaflet structure (e.g. leaflet 270) in the desired relationship with the native valve body annulus, and supports the covering for the two frames (e.g.

The outer cover 230, the inner cover 232, the outer cover of the inner valve assembly 240) provide a barrier to blood leakage between the atrium and the ventricle, and are coupled (through the inner frame 250) to a tether (such as the tether assembly 290). ) To help keep the prosthetic valve 200 in place in the annulus of the native valve by tethering to the ventricular wall. The outer frame 220 and the inner frame 250 are connected at six coupling points (representative points are identified as "C"). In this embodiment, the coupling points are realized by mechanical fasteners (such as short-length wires), passing through holes (such as holes 271A) in the outer frame coupling portion 271 and the inner frame coupling in the body portion 242 of the inner frame 250 Corresponding openings in section 245 (for example longitudinal posts, such as posts 242A). Therefore, the inner frame 250 is disposed within the outer frame 220 and is firmly coupled to the outer frame 220.

[0095] FIGS. 15-21 illustrate the reconfiguration of the prosthetic heart valve 300 (for example, the prosthetic Mitral valve) method. The prosthetic heart valve 300 (also referred to herein as a "valve") may be configured to be the same or similar to the valves 100 and 200 described above, and have the same or similar functions. Therefore, some details about the valve 300 are not described below. It should be understood that for features and functions not specifically discussed, those features and functions may be the same as or similar to the valve 200.

[0096] As shown in FIG. 15, the valve 300 has an outer frame 320 and an inner frame 350. As discussed above for the valves 100 and 200, the outer frame 320 and the inner frame 350 of the valve 300 may each be formed of a shape memory material and have an offset expansion configuration. The outer frame 320 and the inner frame 350 can be moved to a contracted configuration for delivery of the valve 300 to the heart. In an exemplary method of preparing a valve 300 for delivery to the heart, the outer frame 320 of the valve 300 is first placed in a prolapsed or reverse configuration as shown in FIG. 16. Specifically, the elastic or superelastic structure of the outer frame 320 of the valve 300 allows the outer frame 320 to be placed in a prolapsed or reverse configuration before the valve 300 is inserted into the lumen of the delivery sheath 326. As shown in FIG. 16, in order to set the outer frame 320 in the reverse configuration, the outer frame 320 is folded or reversed distally (to the right side of FIG. 16) so that the open free end 316 of the outer frame 320 faces away from the inner frame 350 of the open free end 347. As described above for the valve 100, in this reverse configuration, the entire outer circumference or outer diameter of the valve 300 is reduced, and the entire length is increased. For example, the diameter D1 shown in FIG. 15 is greater than the diameter D2 shown in FIG. 16, and the length L1 (of the valve 200 shown in FIG. 12) is less than the length of the valve 300 shown in FIG. Degree L2. With the outer frame 320 in the reverse configuration relative to the inner frame 350, the valve 300 may be placed in the inner cavity of the delivery sheath 326, as shown in FIG. 17, for delivering the valve 300 to the left atrium of the heart. By placing the outer frame 320 in a reverse configuration with respect to the inner frame 350, the valve 300 can be shrunk to a smaller overall diameter, that is, when placed in a configuration other than the valve 300 in the configuration shown in FIG. 15 is radially collapsed And there is no reverse when in the delivery sheath with a smaller diameter. This is because in the configuration shown in FIG. 15, the two frames are concentric or nested, so the outer frame 320 must shrink around the inner frame 350, while in the configuration shown in FIG. 16, the two frames are substantially Coaxial but not concentric or nested. Therefore, in the configuration shown in FIG. 16, the outer frame 320 can be contracted without the need to accommodate the inner frame 350 inside. In other words, when the inner frame 350 is mostly disposed inside the outer frame 320 or nested in the outer frame 320, the layers or blocks of the frame structure cannot be compressed to such a small diameter. In addition, if the frame is nested, the structure is less flexible, so more force is required to bend the valve, for example to pass through the tortuous vasculature or to make a tight turn in the left atrium after passing through the interatrial septum. Use proper orientation for insertion into the mitral valve annulus.

[0097] FIGS. 22-24 illustrate part of a procedure to deliver the valve 300 to the heart. In this example, the valve 300 is shown to be delivered via a transfemoral delivery route such as described in PCT Application No. 572 and/or PCT Application No. 305, which are incorporated by reference above. In the case where the valve 300 is disposed in the lumen of the delivery sheath 326 and is in the reverse configuration as shown in FIG. 17, the delivery sheath 326 can be inserted into the femoral puncture, through the femoral vein, through the inferior vena cava, into the right atrium, Pass through the diaphragm Sp and enter the left atrium LA of the heart. In the case where the distal end of the delivery sheath 326 is disposed in the left atrium of the heart, the valve 300 may be deployed outside the distal end of the delivery sheath 326. For example, in some embodiments, the thruster device 338 may

It is used to move the valve 300 out or push out the distal end of the delivery sheath 326. As shown in Figures 22-24, a tether 336 may be attached to the valve 300 and extend through the mitral valve annulus, through the left ventricle LV, and extend beyond the puncture site at the apex Ap. In some embodiments, the valve 300 can be removed from the delivery sheath 326 by pulling proximally on the tether 336. In some embodiments, the valve 300 can be deployed by pushing with a pusher device and pulling with a tether.

[0098] When the valve 300 leaves the lumen of the delivery sheath 326, the outer frame assembly 310 first leaves in its reverse configuration as shown in the process of FIGS. 18-20 (see also FIG. 22). After the outer frame assembly 310 is completely outside the lumen of the delivery sheath 326, the outer frame 320 can be restored to its expanded or deployed configuration as shown in FIGS. 21, 23, and 24. In some embodiments, due to its shape memory characteristics, the outer frame 320 can automatically recover after leaving the lumen of the delivery sheath completely. In some embodiments, a delivery sheath or a component of another device may be used to assist the recovery of the outer frame assembly 310. In some embodiments, a thruster device and/or tether may be used to help restore the outer frame assembly 310. The valve 300 may continue to be deployed until the inner frame 350 is fully deployed with the left atrium and the valve 300 is in an expanded or deployed configuration (e.g., as shown in Figures 15 and 24). The epicardial cushion device 339 can then be used to secure the valve 300 and tether 336 to the apex of the heart, as shown in Figure 24 and as described in more detail in PCT Application No. 572 and PCT Application No. 305.

[0099] FIG. 25 schematically illustrates another embodiment of a delivery system that can be used to deliver and deploy a prosthetic heart valve in a patient's heart by, for example, a transvascular route. In this embodiment, the delivery system 405 includes a delivery sheath 426, a valve support 438 (also referred to as a "pusher"), and one or more actuation wires 474 and 476. In this schematic diagram, only two actuation wires are shown, but in other embodiments, only one actuation wire or more than two actuation wires may be used.

[0100] The delivery sheath 426 can be used to deliver the valve 400. The valve 400 includes an inner valve assembly 440 and an outer frame assembly 410. The valve assembly 440 includes an inner frame (not labeled in FIG. 25), and the outer frame assembly 410 includes an outer frame (FIG. 25 Not marked in). The valve 400 can be configured to be the same or similar to any prosthetic valve described herein and/or PCT Application No. 305, and to be the same or similar in function, and can be moved between a deployed or expanded configuration and a delivery configuration, where The frame is set in a reverse position relative to the inner frame, as described herein and/or PCT Application No. 305. As shown in FIG. 25, when the valve is in the delivery configuration (ie, the outer frame is reversed relative to the inner frame), the valve 400 may be disposed within the lumen of the delivery sheath 426. In this embodiment, the outer frame assembly 410 is disposed distal to the inner valve assembly 440 when in the delivery configuration and placed within the delivery sheath. The valve support 438 is coupled to the inner valve assembly 440 and the actuation wire is coupled to the outer valve assembly 410. The valve support 438 may be releasably coupled to the inner valve assembly 440 via a coupler 406, which is attached to the inner valve assembly 440, as shown in FIGS. 26A to 26C. In this embodiment, the coupler 406 has a T-shaped rod or hammer shape. It should be understood that couplers having other configurations and shapes can be used.

[0101] As shown in FIG. 26A, the coupler 406 is received in the recess 404, and the valve 400 and the valve support 438 may be disposed in the lumen of the delivery sheath 426. The size of the inner diameter of the delivery sheath 426 is designed so that the coupler 406 cannot leave the recess 404 when the valve support 438 and the valve 400 are disposed therein. In other words, the inner wall of the delivery sheath 426 maintains the coupler 406 within the recess 404. When the valve 400 moves to the outside of the delivery sheath 426, the coupler 406 will be able to freely leave the recess 404, releasing the inner frame 450 from the valve support 438.

[0102] In an alternative embodiment, the valve support 438 may be removably coupled to the valve 400 (such as the inner frame 450 of the valve 400) via wires or sutures, which may be used to deliver the valve 400 to the heart. Cut afterwards. In some cases, the valve support 438 may be uncoupled from the valve 400 when the valve is still disposed within the delivery sheath 426, while in other examples, the valve support 438 may not be coupled until the valve 400 leaves the delivery sheath 426 in the heart. It can be decoupled from the valve 400.

[0103] The actuation wires 474 and 476 may be coupled to the outer frame of the outer frame assembly 410 using various coupling methods. For example, the outer frame 410 may include a ring (as described herein with respect to the outer frame 510, the outer frame 1010, and PCT application Nos. 305) through which the actuation wires 474 and 476 may be received or tightened. The number of loops on the outer frame can vary, and the number of loops through which each actuation wire is connected can vary. For example, in some embodiments, the outer frame includes 12 loops, and the first actuation wire is tightened through 6 loops, and the second actuation wire is tightened through 6 loops. In other embodiments, the outer frame may include 12 loops, and there may be 4 actuation wires, each of which is coupled to 3 loops. In some embodiments, a single actuation wire is coupled through all loops of the outer frame.

[0104] In this embodiment, the delivery sheath 426 may be used to deliver the valve 400 to the left atrium of the heart using a transvascular approach (eg, via the femoral artery, via the atrium, or via the jugular vein). When the distal end of the delivery sheath 426 is set in the left atrium, the actuation wires 474 and 476 are used to move the valve 400 out of the lumen of the delivery sheath 426 to help pull the valve 400 out of the delivery sheath 426. In some cases, the valve support 438 may also be used to push the valve 400 out of the delivery sheath 426. More specifically, the actuation wires 474 and 476 may extend from the outer frame assembly 410 out of the distal end of the delivery sheath and extend toward the proximal end. In some embodiments, the actuation wires 474, 476 extend proximally outside the delivery sheath 426, and then return to the lumen of the delivery sheath 426 through a side eyelet or hole (not shown), and then from the proximal end of the delivery sheath 426. The side ends are extended. Therefore, a user (eg, a doctor) can pull the proximal ends of the actuation wires 474 and 476 to in turn pull the outer frame assembly 410 out of the distal end of the delivery sheath 426. In some embodiments, the actuation wires 474, 476 extend proximally from the outer frame assembly 410, return through the distal end of the delivery sheath 426 (for example, rather than through the lateral eyelet or hole of the delivery sheath), and enter the delivery sheath , Then protrude from the proximal end of the delivery sheath 426. Various embodiments and configurations are described in more detail below.

[0105] When the outer frame assembly 410 leaves the delivery sheath 426, it will still be in a reverse configuration relative to the inner valve assembly 440. When the outer frame assembly 410 is at least partially outside the lumen of the delivery sheath 426, the outer frame assembly 410 may begin to return to its expanded or deployed configuration (not shown in Figure 25). However, in this embodiment, when the valve 400 is delivered to the heart, the actuation wires 474 and 476 may be used to selectively (eg, by an operator) assist and/or control the expansion, deployment, and/or articulation of the valve 400 . In this way, when in use, the proximal ends of the actuation wires 474, 476 can be pulled distally to manipulate the outer frame assembly 410 to assist and control the reversal of the outer frame assembly 410 relative to the inner valve assembly 440 The configuration transitions to its expansion or deployment configuration (not shown). In some embodiments, the actuation wires 474, 476 may be manually grasped by the user to pull the actuation wires proximally. In some embodiments, the actuation wires 474, 476 may be operably coupled to the delivery system 405 so that the user does not have to manually handle the actuation wires. For example, the actuation wire may be coupled to the delivery sheath and/or handle assembly of the delivery system 405 (not shown). Various embodiments of the delivery system are described in more detail below and in PCT Application No. 305. [0106] FIG. 27 illustrates an embodiment of a delivery system 505, which can be used in connection with the other described herein Other embodiments (such as the embodiments shown and described in FIGS. 34 to 42) and the embodiment described in PCT Application No. 305 have similar or identical operations to deliver and deploy a prosthetic heart valve 500 in the heart ( Also called "valve" in this article). Therefore, some details about the valve 500 and the operations performed with it are not described herein. It should be understood that for features and functions not specifically discussed, those features and functions may be the same as or similar to the valves described herein (eg, valve 1000) and/or the valves described in PCT Application No. 305. The valve 500 may be configured to be the same or similar to any valve described herein and/or PCT Application No. 305, and to function the same or similar. For example, the valve 500 includes an outer frame assembly having an outer frame 520, an inner valve assembly 540, and a tether 536, and the inner valve assembly 540 has an inner frame 550 to which the tether 536 is coupled. The delivery system 505 includes an outer delivery sheath 526, an inner sheath 508, a valve support 538 (also called a "pusher"), and a multi-lumen elongated tube member 503 (also called a "tube" or "tube member" or "multiple Inner cavity elongated member"). As shown in FIG. 27, the inner sheath 508 is movably disposed in the inner cavity 582 defined by the outer delivery sheath 526, and the tube member

The 503 is movably disposed in the inner cavity 583 defined by the inner sheath 508. The valve support 538 is movably disposed within the lumen 583 defined by the inner sheath 508.

[0107] As with the other embodiments described herein and the embodiments of PCT Application No. 305, the valve 500 can be moved from the biased expanded configuration to the reverse configuration for delivery of the valve 500 to the heart. More specifically, in order to place the valve 500 in the reverse configuration, the outer frame 520 may be moved to the reverse configuration relative to the inner frame 550. In this embodiment, when the valve 500 is in the reverse configuration, the valve 500 is at least partially placed within the lumen of the inner sheath 508 and disposed near the distal end of the inner sheath 508. The valve support 538 is also provided in the lumen 583 of the inner sheath 508. The inner frame 550 can be releasably coupled to the valve branch using the coupler 506 in the same or similar manner as any of the couplers described above with respect to the coupler 406, coupler 1006, and/or PCT application No. 305. Block 538. Similarly, the outer frame 520 includes a ring 562 through which the actuation wires 574-577 can be tightened in the same or similar manner as described herein (for example with respect to the valve 1000) and/or PCT application No. 305. The inner sheath 508 is movably disposed in the outer delivery sheath 526. As shown in FIG. 6, a portion of the valve 500 is disposed outside the inner sheath 508 and located within the lumen 582 of the outer delivery sheath 526. In some cases, the entire valve 500 may be disposed within the lumen 583 of the inner sheath 508 before performing the surgery to deploy the valve.

[0108] In this embodiment, the inner sheath 508 defines a side eyelet 509 through which the actuation wires 574-577 can pass. More specifically, as shown in FIG. 27, when the valve 500 is disposed in the lumen 583 of the inner sheath 508, the actuation wires 574-577 extend proximally from the outer frame 520, along the outside of the inner sheath 508, and are delivered outside. Inside the inner cavity 582 of the sheath 526, returning through the side eyelet 509 defined by the inner sheath 508, into the inner cavity 583 of the inner sheath 508 and formed by the elongated pinning members 577-1, 578-2, 578-3, 578- 4 (collectively referred to as pinning members 578; pinning members 578-3 and 578-4 are not shown in FIG. 27; for illustrative purposes, it refers to the pinning members shown and described in FIGS. 35 to 37A 1078-3 and 1078-4) are nailed to the pipe member 503. As shown, the first end of the actuation wire 574 and the first end of the actuation wire 575 are pinned by the pinning member 578-2, and the first end of the actuation wire 576 and the first end of the actuation wire 577 The end is pinned by pinning member 577-1. The second end of the actuation wire 574 and the second end of the actuation wire 576 are pinned by a pinning member 578-4 (not shown), and the second end of the actuation wire 575 and the second end of the actuation wire 577 It is pinned by a pinning member 578-3 (not shown).

[0109] The actuation wires 574-577 may be pinned to the tube member 503 by the pinning members 577-1, 578-2, 578-3, 578-4 in the same or similar manner as described below with respect to the delivery system 1005. Therefore, some details regarding, for example, the tube member 503, the pinning members 577-1, 578-2, 578-3, 578-4, and the actuation wires 574-577 and the operations performed with them are not described for this embodiment. . It should be understood that for features and functions not specifically discussed for this embodiment, those features and functions may be the same as or similar to the delivery system described herein (for example, delivery system 1005) and/or the delivery system described in PCT Application No. 305.

[0110] A user (eg, a doctor) may use the tube member 503 to which the actuation wires 574-577 are coupled to control and/or manipulate the movement and/or deployment of the valve 500, such as described for the delivery system 1005. In this embodiment, as shown, at least a portion of the actuation wires 574-577 may be disposed inside the delivery sheath 526, thereby restricting the actuation wires 574-577 from being exposed to the area outside the delivery sheath 526 for At least a portion of the valve 500 is delivered and/or deployed. Although the side eyelet 509 defined by the inner sheath 508 is shown as being provided at or near the distal end of the inner sheath 508, in other embodiments, the side eyelet 509 may be provided along the length of the inner sheath 508 (eg, toward Manage any suitable position in the middle or proximal part of the sheath.

[0111] In this embodiment, in order to deliver the valve 500 to the heart, the distal end of the outer delivery sheath 526 in which the valve 500, the inner sheath 508, the valve support 538, and the tube member 503 are provided is provided in the left atrium of the heart Inside. In the case where the distal end of the delivery sheath 526 is disposed in the left atrium of the heart, the valve 500 may be deployed outside the delivery sheath 526. For example, inner sheath 508, valve

The membrane support 538 and the tube member 503 can move distally relative to the outer sheath 526 to move the valve 500 out of or out of the lumen 582 of the outer sheath 526. Additionally or alternatively, the outer sheath 526 can be moved or pulled proximally, leaving at least a portion of the valve 500 disposed within the heart. In some examples, the tether 536 coupled to the valve 500 can be used to help pull the valve 500 out of the lumen 582 of the outer sheath 526.

[0112] As described in the other embodiments herein and the embodiments of PCT Application No. 305, when the outer frame 520 is not constrained by the outer sheath 526, the outer frame 520 can begin to return to its expanded or unreversed configuration. The actuation wires 575-577 can be used to control the recovery of the outer frame 520. More specifically, after the outer frame 520 is at least partially disposed outside the distal end of the outer sheath 526, the tube member 503 can be pulled proximally, so that the actuation wire (pinned to the tube member 503) proximally (The same or similar to that shown in FIG. 40) The distally disposed part of the outer frame 520 is pulled, and makes it possible to control the outer frame 520 to recover from its reverse configuration relative to the inner frame 550.

[0113] Additionally, in some examples, actuation wires 574-577 can help articulate and place valve 500 into its destination (eg, the native annulus of the atrioventricular valve of the heart). For example, after the valve 500 leaves the outer sheath 526 and is in its restored expanded or partially expanded configuration, the actuation wires 574-577 can also be used to restrain, contract, or otherwise move the valve 500 (eg, radially compress the outer portion of the valve 500). Frame 520). More specifically, in this embodiment, the tube member 503 with the actuation wires 574-577 pinned to it can be manipulated by the user to move or push the outer frame 520 by pulling or moving the tube 503 proximally To a more compressed configuration (similar or identical to the one shown in Figure 41). For example, it may be desirable to reposition the valve 500 within the heart before the valve 500 is fully deployed.

[0114] Where the outer frame 520 of the valve 500 is arranged in its non-reversed and at least partially expanded configuration and in a desired position within the heart, the inner frame 550 may be deployed. As described in PCT Application No. 305 for the valve 2100, in order to decouple the inner frame 550 from the valve support 538, the valve support 538 can be moved distally and/or the inner sheath 508 can be moved proximally so that the valve The support 538 is provided outside the inner cavity 583 of the inner sheath 508. In this manner, the coupler 506 can be released from the recess 504, releasing or decoupling the inner frame 550 from the valve support 538. In some embodiments, the tether 536 can be pulled to help move the inner frame 550 out of the inner sheath 508. When the inner frame 550 is released from the valve support 538 and disposed outside the inner sheath 508, the inner frame 550 may assume its biased expanded configuration.

[0115] Before or after the inner frame 550 is released from the valve support 538, the actuation wires 574-577 may also be released from or uncoupled from the outer frame 520. In order to decouple the actuation wires 574-577 from the outer frame 520, one end of each of the actuation wires 574-577 may be unplugged from the pipe member 503 or decoupled. For example, the pinning member 578-3 can be drawn proximally from the groove of the tube member 503 (the same as or similar to the groove shown in and described with respect to the delivery system 1005), so that the first part of the wire 577 is actuated The two ends and the second end of the actuation wire 575 are each released or unplugged from the tube member 503, but remain pinned by the pinning members 578-2 and 578-1, respectively. Similarly, the pinning member 578-4 can be withdrawn proximally from the groove, so that the second end of the actuation wire 574 and the second end of the actuation wire 576 can be released or unplugged from the tube member 503, but remain separate It is pinned by pinning members 578-2 and 578-1. In the case where one end of each of the actuation wires 575-577 is coupled to the tube member 503 (via pinning members 577-1 and 578-2 in this example), the tube member 503 can be pulled proximally, which turns The opposite ends of the actuation wires 574-577 are pulled out from the ring 562 of the outer frame 520. Therefore, in the actuation wire 574-577 and the outer frame When the 520 is separated, the outer frame can assume a biased expansion or a partially expanded configuration.

[0116] Although in the above example, it is described that the pinning members 578-3 and 578-4 are extracted to release the ends of the actuation wire 574577, alternatively, the pinning members 577-1 and 578- may be withdrawn. 2. The actuation wires 574-577 pinned by the pinning members 578-3 and 578-4 are left. Further, the actuation wires 574-577 can be decoupled from the outer frame 520 in any suitable sequence or time period during the operation. For example, in some examples, the valve 500 at least partially leaves the delivery sheath

After 526 but before the valve 500 is placed within the native annulus of the atrioventricular valve, it may be desirable to release the actuation wires 574-577. In other examples, for example, after the valve 500 has at least partially exited the outer delivery sheath 526 and after the valve 500 is seated within the native annulus of the atrioventricular valve, the actuation wires 574-577 may be released.

[0117] In some examples, such as shown in FIG. 28, the delivery system 505' may include a dilator device or member 511'. The dilator 511' may be, for example, a balloon dilator, and may be configured to expand the opening or channel, for example, during delivery of the prosthetic valve 500'. The dilator device 511' may be the same as or similar to the dilator device 1711, and can be used in the same or similar manner as the manner described in the 305 application with respect to FIGS. 43 to 48 and the delivery method of FIG. 72. The delivery system 505' may include, for example, the same or similar features as the delivery system 505 described herein and/or the delivery system 1005 and/or the delivery system described in PCT Application No. 305, and the functions are also the same or similar.

[0118] In some embodiments, a prosthetic heart valve (such as any prosthetic heart valve described herein and/or PCT Application No. 305) may include an outer frame having multiple rows of rings, any suitable A number of actuator wires can be routed through these loops and/or slidably arranged (for example, to control the recovery profile and timing of the outer frame when deployed and delivered from the delivery sheath). Figures 29A and 29B illustrate such an embodiment of a prosthetic heart valve 600 and a delivery system 605, which can be used to describe other embodiments and the embodiments described in PCT Application No. 305. The procedure is the same or similar to the delivery and deployment of a prosthetic heart valve 600 (also referred to herein as a "valve") in the heart. Therefore, some details about the valve 600 and the operations performed with it will not be described herein. It should be understood that for features and functions not specifically discussed, those features and functions may be the same as or similar to the valve and/or delivery system components described herein and/or PCT Application No. 305. For example, the valve 600 may be configured to be the same or similar to any valve described herein and/or PCT Application No. 305, and to function the same or similarly. For example, the valve 600 includes an outer frame assembly having an outer frame 620 and an inner valve assembly having an inner frame 650. As shown As shown in 29A and 29B, the delivery system 605 includes an outer delivery sheath 626. The delivery system 605 may also include other components and features not shown in FIGS. 29A and 29B, such as, for example, an inner sheath similar to the inner sheath 508, a valve support similar to the valve support 538 described herein, and/or Any other suitable components and/or features described herein and other embodiments of PCT Application No. 305.

[0119] As with the other embodiments described herein and the embodiments of PCT Application No. 305, the valve 600 can be moved from the biased expanded configuration to the reverse configuration for delivery of the valve 600 to the heart, as shown in FIG. 29A. In this embodiment, the valve 600 is positioned for transvascular delivery, similar to that described for the valve 500 above. Therefore, when disposed within the sheath 626 in a reverse configuration, the outer frame is disposed distal to the inner frame. In this embodiment, the outer frame 620 includes a first row of rings 662 and a second row of rings 664. Through these rings, the actuating wires 674-679 can be in accordance with the valve 400 and/or valve 1000 and/or 305 number. The valve 2100 is tightened in the same or similar manner as described in the PCT application.

[0120] In this embodiment, the actuation wire 674-679 extends proximally from the outer frame 620, into the lumen 682 of the outer delivery sheath 626, and protrudes from the proximal end of the outer delivery sheath 626. In an alternative embodiment, the actuator wires 674-679 may be formed by the pinning member in the same or similar manner as described herein with respect to the delivery system 505 and/or delivery system 1005 (not shown in Figures 29A and 29B) Pinned to the pipe member.

[0121] In this embodiment, in order to deliver the valve 600 to the heart, the distal end of the outer delivery sheath 626 in which the valve 600 is provided is provided in the left atrium of the heart. In the case where the distal end of the outer delivery sheath 626 is disposed in the left atrium of the heart, the valve 600 may be deployed outside the outer sheath 626. For example, the valve 600 can move outwardly relative to the outer sheath 626 outside the lumen 600 of the outer sheath 626. Additionally or alternatively, the outer sheath 626 can be moved or pulled proximally, leaving at least a portion of the valve 600 disposed within the heart. In some embodiments, a tether (not shown) coupled to the valve 600 can be used to help

It helps to pull the valve 600 out of the inner cavity 682 of the outer sheath 626.

[0122] As described in the previous embodiment and the embodiment of PCT Application No. 305, when the outer frame 620 is not constrained by the outer sheath 626, the outer frame 620 can begin to return to its expanded or non-reversed configuration. The actuation wires 674-679 can be used to control the recovery of the outer frame 620. More specifically, after the outer frame 620 is at least partially disposed outside the distal end of the outer sheath 626, the proximal end of the actuator wire 674-679 can be pulled proximally, which in turn pulls the open end of the outer frame 620 distally (The actuation wire 674-679 is coupled to the open end) to help restore the outer frame 620. For example, as described with respect to other embodiments herein and in PCT Application No. 305, a user (such as a doctor) can pull the end of the actuator wire 674-679 to in turn move the outer frame 620 to its recovery configuration, As shown in Figure 29B. In the same way, the actuation wire (coupled to the outer frame 620) pulls the distal portion of the outer frame 620 proximally (the same or similar to that shown in FIG. 40) in a controlled manner, and makes it possible to control the outer frame 620 Recovery from its reverse configuration with respect to the inner frame 650. As shown and described with respect to this embodiment, having multiple rows of rings (eg, the first row of rings 662 and the second row of rings 664) provides enhanced control of the recovery of the outer frame 620 from its reverse configuration.

[0123] In this embodiment, the outer frame 620 has two rows of rings, each row has 12 rings. However, in alternative embodiments, the outer frame may have any suitable number of rings and/or row rings so that the outer frame 620 can be restored in a controlled manner. For example, in some alternative embodiments, the outer frame may have 3 or more rows of rings. Further, in some embodiments, the ring may be formed integrally or integrally with the outer frame, while in other embodiments, one or more of the rings may be formed separately from the outer frame and coupled to the outer frame (for example, stitched to the outer frame). Outer frame).

[0124] In addition, in some examples, actuation wires 674-679 can help to engage and place valve 600 into its destination (eg, the native annulus of the atrioventricular valve of the heart). For example, the actuation wire 674-679 may also be used to restrain, contract, or otherwise move the valve 600 after the valve 600 leaves the outer sheath 626 and is in a restored or partially expanded configuration (eg, radially compresses the outer frame 620 of the valve 600) .

[0125] With the outer frame 620 of the valve 600 set in its non-reversed and at least partially expanded configuration (see, for example, FIG. 29B) and in the desired position within the heart, the inner frame 650 may be deployed and allow presentation It has an offset expansion configuration. Before or after the inner frame 650 is deployed, the actuation wires 674-679 may also be released from the outer frame 620 or decoupled from the outer frame 620. To decouple the actuation wires 674-679 from the outer frame 620, one end of each of the actuation wires 674-679 can be pulled proximally, which in turn pulls the opposite end of the actuation wires 674-679 out of the outer frame 620's ring 674. With the actuation wires 674-679 separated from the outer frame 620, the outer frame may assume a biased expanded or partially expanded configuration.

[0126] In some examples, the actuation wires 674-679 may be decoupled from the outer frame 620 in any suitable order or time period during the procedure. For example, in some examples, it may be desirable to release the actuation wires 674-677 after the valve 600 has at least partially exited the delivery sheath 626 but before the valve 600 is seated within the native annulus of the atrioventricular valve. In other examples, for example, after the valve 600 has at least partially exited the outer delivery sheath 626 and after the valve 600 is seated within the native annulus of the atrioventricular valve, the actuation wires 674-679 may be released.

[0127] The embodiments described above and in PCT Application No. 305 are described as being used for delivery via the femoral artery. In other embodiments, similar delivery devices and methods can be used for transapical delivery of prosthetic heart valves. The following devices and methods are described herein for the transapical delivery and deployment of a prosthetic heart valve such as a prosthetic mitral valve, which can be configured to move to a reverse configuration for placing the prosthesis The valve is delivered into the patient's heart. As described herein, in some embodiments, the prosthetic valve includes an outer frame, which can be reversed relative to the inner frame when the prosthetic valve is in a biased expanded configuration. The prosthetic mitral valve may be formed of, for example, a shape memory material. After reversing the outer frame, the prosthetic valve can

Insertion into the lumen of the delivery sheath causes the prosthetic valve to move to the contracted configuration.

[0128] The delivery sheath can be used to deliver a prosthetic valve into the heart of a patient using a variety of different delivery routes for delivery of a prosthetic heart valve (such as a prosthetic mitral valve), where the reverse prosthetic valve will Enter the heart through the ventricle of the heart and into the atrium of the heart. For example, as described in further detail herein with respect to FIGS. 30A to 30D and FIGS. 31A and 31B, the reverse prosthetic valve can be delivered using the apical approach, that is, through the apex of the left ventricle of the heart.

[0129] After the delivery sheath has been placed in the left atrium of the heart (for example via the apical approach), the prosthetic mitral valve is moved distally out of the delivery sheath, so that the reversed outer frame is restored and the prosthetic valve assumes its deviation Set expansion configuration. The prosthetic mitral valve can then be positioned within the mitral valve annulus of the heart.

[0130] FIGS. 30A and 30B are schematic diagrams of a part of a prosthetic heart valve 700 shown in a first configuration and a second configuration, respectively, according to an embodiment. Figures 30C and 30D illustrate the parts of the prosthetic heart valve 700 of Figures 30A and 30B shown as disposed within the lumen of the delivery sheaths 726' and 726, respectively. Figures 31A and 31B illustrate a part of the prosthetic heart valve 700 in the first configuration and the second configuration of Figures 30A and 30B, respectively, and show the prosthesis in each of the first configuration and the second configuration The length dimension of the heart valve. The prosthetic heart valve 700 (also referred to herein as a "prosthetic valve" or "valve") may be, for example, a prosthetic mitral valve. The valve 700 includes an outer frame 720 and an inner frame 750. The outer frame 720 and the inner frame 750 are each formed as a tubular structure similar to the structure described in more detail above with respect to the previous embodiment and/or the prosthetic valve in PCT Application No. 305. The outer frame 720 and the inner frame 750 may be coupled together at a plurality of coupling joints 746 arranged around the circumference of the inner frame 750 and the circumference of the outer frame 720. The valve 700 may also include other features, such as any of those described herein and/or in PCT Application No. 305. For illustrative purposes, only with regard to Figure 30A To FIG. 31B, the inner frame 750 and the outer frame 720 are discussed. The various features and characteristics of the valve 700 described with respect to FIGS. 30A to 31B can be applied to any prosthetic valve described herein.

[0131] The outer frame 720 is configured to have a biased expanded or undeformed shape, and can be manipulated and/or deformed (eg compressed or constrained), and when released, returns to its original (expanded or undeformed) shape . For example, the outer frame 720 may be formed of a material having shape memory characteristics, such as metal or plastic. Regarding metals, Nitinol ® has been found to be particularly useful because it can be processed into austenitic, martensitic or superelastic. Other shape memory alloys such as Cu-Zn-Al-Ni alloy and Cu-Al-Ni alloy can also be used. The inner frame 750 may be formed of a laser cut tube of Nitinol®. The inner frame 750 may also have a biased expanded or undeformed shape, and may be manipulated and/or deformed (eg, compressed and/or constrained), and when released, return to its original (expanded or undeformed) shape.

[0132] A variety of different delivery routes can be used to deliver and deploy the valve 700 in the left atrium of the heart, including, for example, transapical delivery routes as described in more detail below or, for example, transatrium, transjugular vein, or transfemoral artery way. As mentioned above, in some situations, such as when delivering a prosthetic valve to the heart via a transapical approach, it may be desirable to use a delivery sheath with a relatively small lumen, and therefore, the size of the prosthetic valve should be configured accordingly during delivery size. Therefore, it is desirable to have a prosthetic valve that can be used in a biased expansion configuration for implantation in the heart (for example, in a natural mitral valve annulus) and a delivery configuration with a smaller outer circumference or profile. Reconfigured to allow delivery within the lumen of the delivery sheath. The prosthetic valve 700 and embodiments of the prosthetic valves described herein can be constructed and formed to achieve these desired functions and features.

[0133] More specifically, the valve 700 may have an offset expanded configuration (as shown in FIGS. 30A and 31A), a reverse configuration (as shown in FIGS. 30B and 31B), and a compressed or contracted configuration (as shown in FIGS. 30C and 31A). 31D). The expanded configuration allows the valve 700 to function when implanted in the heart. The valve 700 can be moved to a reverse configuration and a compressed or contracted configuration for delivery of the valve 700 to the patient's heart.

[0134] To enable the valve 700 to move to the reverse configuration, the outer frame 720 may be coupled to the inner frame 750 in a manner that allows the outer frame 720 to move relative to the inner frame 750. More specifically, the coupling joint 746 may be coupled to the inner frame 750 in a manner that allows the outer frame 720 to move relative to the inner frame 750. For example, in some embodiments, the coupling joint 746 may be configured to allow the outer frame 720 to rotate about the coupling joint 746 relative to the inner frame 750. In some embodiments, the coupling joint may provide a pivotal coupling between the outer frame 720 and the inner frame 750. In some embodiments, the coupling joint may provide a flexible attachment between the outer frame 720 and the inner frame 750. The coupling joint 746 may be of various different types and configurations as described in Application No. 305, which is incorporated herein with reference to various embodiments of prosthetic valves. For example, the coupling joint 746 may include living hinges, flexible members, sutures, sutures wound through the opening, pins or tabs inserted through the opening, or any combination thereof.

[0135] To move the valve 700 from the expanded configuration (FIG. 30A) to the reverse configuration (FIG. 30B ), the outer frame 720 is moved by moving (eg, rotating, pivoting, bending) around the coupling joint 746 To the prolapsed or reverse configuration with respect to the inner frame 750, as shown in Figs. 30B, 30D, and 31B. The elastic or superelastic structure of the outer frame 720 of the valve 700 also allows the outer frame 720 to move to and be set in a reverse configuration relative to the inner frame 750. In order to move the outer frame 720 to a reverse configuration relative to the inner frame 750, the outer frame 720 is folded or reversed proximally relative to the inner frame 750 via the coupling joint 746 (to the right in FIG. 30B). As shown in FIGS. 30A and 31A, the outer frame 720 is in a first position relative to the inner frame 750 before being reversed, wherein the opening or free end 716 (also referred to as the atrial portion 716 of the outer frame 720) is provided at the coupling joint The distal or left side of 746 is in the same direction as the free end 747 of the inner frame 750 (also referred to as the second end of the inner frame). When the outer frame 720 is moved to the reverse configuration (ie, the second position relative to the inner frame 750), the free end 716 is disposed on the proximal side of the coupling joint 746 (or the right side in FIGS. 30B and 31B) and is in contact with Free end of inner frame 750 747 in the opposite direction. In other words, when the valve 700 is in a biased expanded configuration (for example, FIG. 30A), the coupling joint 746 is provided at the first end 744 (also referred to as the tether coupling) of the inner frame 750 and the free end of the inner frame 720 Between 716. When the valve 700 is in the reverse configuration (for example, FIG. 30B) (that is, the outer frame 720 has moved to the reverse configuration or position), the coupling joint 746 is provided at the free end of the inner frame 750 or the second end 747 and the outer frame 720 Between the free ends 716.

[0136] When in the reverse configuration, the overall length of the valve 700 increases, but the length of the inner frame 750 and the length of the outer frame 720 remain the same (or substantially the same). For example, as shown in Figures 31A and 31B, the overall length L1 of the valve 700 in the offset expanded configuration (before the reverse as shown in Figure 31A) is less than the overall length of the valve 700 in the reverse configuration (Figure 31B) L2. When the valve 700 is in the offset expanded configuration and the reverse configuration, the length Li of the inner frame 750 and the length Lo of the outer frame 720 are substantially the same (or the same). In addition, in some examples, depending on the specific configuration of the outer frame, when the valve 700 is in the reverse configuration, the entire outer circumference or outer diameter of the valve 700 may be smaller.

[0137] With the valve 700 in the reverse configuration, the valve 700 can be placed in the lumen of the delivery sheath 726 for delivery of the valve 700 to the left ventricle and left atrium of the heart, as shown in FIG. 30D. When placed within the lumen of the delivery sheath 726, the valve 700 moves to a contracted or compressed configuration in which the outer diameter or outer circumference of the valve 700 decreases. Because the valve 700 is in a reverse configuration, the valve 700 can be placed in a delivery sheath 726 that is smaller than otherwise possible. For example, for comparison purposes, Figure 30C illustrates the valve 700 placed within the lumen of the delivery sheath 726', where the valve 700 has not moved to the reverse configuration before being placed within the delivery sheath 726. As shown in FIG. 30C, when in the reverse configuration, the outer diameter of the valve 700 is reduced, but when placed in the delivery sheath 726, it is not as small as the diameter of the valve 700. Therefore, in FIG. 30C, the entire outer circumference or outer diameter of the valve 700 is D1, and in FIG. 30D, the entire outer circumference or outer diameter of the valve 700 is D2, which is smaller than D1.

[0138] Therefore, by setting the outer frame 720 in the reverse configuration, the valve 700 can be contracted to a smaller overall diameter, ie, if the valve 700 is only radially contracted, it is placed in the delivery sheath 726 with a smaller diameter. This is because when the valve

In the offset expansion configuration, the inner frame 750 is nested inside the outer frame 720, so the outer frame 720 must contract around the inner frame 750. In some embodiments, the inner frame 750 and the outer frame are arranged concentrically. In the reverse configuration, the inner frame 750 and the outer frame 720 are arranged axially relative to each other (that is, the inner frame is not nested within the outer frame 750), so that the outer frame 720 can be contracted without the need to accommodate the inner frame 750 inside. All structures. In other words, when the inner frame 750 is mostly disposed inside the outer frame 720 or nested in the outer frame 720, the layers or blocks of the frame structure cannot be compressed to such a small diameter. In addition, if the frame is nested, the structure is less flexible, and therefore, more force is required to bend the valve, for example, to pass through a tortuous anatomy or make a turn through the patient to be properly oriented for insertion of the second In the cusp annulus.

[0139] FIG. 32A is a schematic diagram of a side view of a delivery system that can be used, for example, to deliver and deploy a prosthetic heart valve in a patient's heart using a transapical approach. In this embodiment, the delivery system 805 includes a delivery sheath 826, a dilator 870, an elongate member 880, and two actuation wires 874 and 876. FIG. 32B is a schematic diagram of a front view of the elongated member 880. FIG. In this schematic diagram, only two actuation wires are shown, but in other embodiments, only one actuation wire or more than two actuation wires may be used.

[0140] The delivery sheath 826 can be used to deliver the valve 800. The valve 800 includes an inner valve assembly 840 and an outer frame assembly 810. The inner valve assembly 840 includes an inner frame (not labeled in FIGS. 32A and 32B), and the outer frame assembly 810 includes an outer frame. Frame (not labeled in Figure 32A and Figure 32B). The valve 800 can be configured to be the same or similar to the prosthetic valve described herein and/or PCT Application No. 305, and to function the same or similar thereto, and can be in a deployed or expanded configuration and wherein the outer frame is configured as described above. Move between conveying configurations in a reverse position relative to the inner frame. As shown in Figure 32A, when the valve is in the delivery configuration, the valve 800 can be disposed within the lumen of the delivery sheath 826 (ie, the outer frame is reversed relative to the inner frame and positioned proximal to the inner frame when in the delivery sheath) . The actuation wires 874, 876 are releasably coupled to the outer frame assembly 810. In this way, after being delivered to and placed in the autologous annulus of the patient's heart, the actuation wires 874, 876 can be released from the outer frame assembly 810 and removed from the patient, leaving the prosthetic heart valve implanted in the patient's heart, such as Described in more detail in this article.

[0141] The dilator 870 has a fluid delivery portion 872 and a collapsible expansion portion 873 (also referred to herein as an "expansion portion"). The fluid delivery part 872 is configured to receive fluid and deliver the fluid to the expansion part 873 to inflate the expansion part 873. The expanded portion 873 is configured to be inflated so that when inflated, it can expand (eg, expand openings or channels) to one or more portions of the heart as the delivery system 805 is introduced into the patient's heart. For example, when used during a transapical delivery route, the expansion portion 873, when inflated, can extend outside the distal end of the delivery sheath 826 and provide an introducer for the delivery sheath 826 and help open or expand the access opening at the epicardial surface , And it is easy to enter through the mitral valve annulus without tangling the chordae of the valve. With the delivery sheath 826 placed in a desired location within the heart, the dilator portion 873 can be deflated and removed, leaving the delivery sheath 826 in the heart.

[0142] The expansion portion 873 may have any suitable shape or size to expand a portion of the heart (eg, an incision in the apical portion of the heart) to help deliver the valve 800 to the atrium of the heart. For example, in some embodiments, the expanded portion may have a tapered and/or tapered shape with a rounded or blunt distal tip. In other embodiments, the expanded portion may have a circular shape, an oval shape, a triangle shape, or other suitable shapes. Although not shown, in some embodiments, the dilator may define a guide wire lumen therethrough. For example, during delivery of a prosthetic valve, the guide wire may extend through the apical portion of the heart, through the left ventricle of the heart, and into the left atrium. In such an embodiment, the dilator can be screwed over the guide wire for insertion into the heart. The guide wire can be of any suitable size. For example, in some embodiments, the guide wire may range from approximately 0.03" guide wire to 0.04" guide wire (eg, 0.035" guide wire). An exemplary dilator device is described in US Patent Application No. 14,527,382 ("Application No. 382") filed on October 29, 2014, the entire disclosure of which is incorporated herein by reference. As described in more detail herein, the delivery sheath

With 826 placed at a desired location in the heart, the dilator portion 873 can be deflated (by removing fluid from it) and removed along the guide wire, leaving the delivery sheath 826 in the heart.

[0143] The elongate member 880 may be used to flip the outer frame assembly 810 and deliver at least a portion of the dilator 870 to the heart and retract at least a portion of the dilator 870 from the heart. The elongate member 880 defines a dilator lumen 882, which is configured to slidably receive the dilator 870. More specifically, the dilator lumen 882 is configured to slidably receive the delivery portion 872 and the expansion portion 873 when deflated, as described in more detail herein. The elongate member 880 also defines four actuator wire cavities 884 (as shown in FIG. 32B), which are radially spaced from the dilator cavity 882 and are configured to be slidable The actuator wires 874, 876 are received ground. The elongate member 880 is slidably disposed within the delivery catheter 826 and passes through the central portion of both the inner valve assembly 840 and the outer valve assembly 810. Although not shown, in some embodiments, the size of the elongate member 880 may vary, for example, its outer diameter or circumference may increase and/or decrease at various portions of the elongate member 880. For example, in some embodiments, when the elongate member 880 is disposed within the delivery sheath 826 and extends through the central portion of the valve 800, a portion of the elongate member 880 on the proximal side of the valve 800 may have a first diameter; And a portion of the elongate member 880 that extends through the central portion of the valve 800 (for example, between the leaflets of the inner valve assembly 840) may have a second diameter smaller than the first diameter. In this way, the reduction in the diameter of the portion where the elongated member 880 is configured to pass through a portion of the valve 800 can prevent or reduce the undesirable potential interference of the elongated member 880 with the valve 800. Similarly, the portion of the dilator 870 (eg, the fluid delivery portion 872) may vary in size (eg, diameter), which corresponds to the variation in the size of the elongate member 880.

[0144] The actuation wires 874, 876 may be coupled to the outer frame of the outer frame assembly 810 using various coupling methods. For example, the outer frame of the outer frame assembly 810 may include a ring (not shown in FIGS. 32A and 32B) through which the actuation wires 874, 876 may be received or tightened. This outer frame is described in PCT Application No. 305 (see, for example, FIG. 57) and with respect to FIG. 27, which is incorporated herein. The number of loops on the outer frame can vary, and the number of loops connected by each actuation wire can vary. For example, in some embodiments, the outer frame includes 12 loops, and the first actuation wire (for example, actuation wire 874) is screwed through 6 of the loops, and the second actuation wire (for example, actuation wire 876) Tighten through the 6 rings. In other embodiments, the outer frame may include 12 loops, and there may be 4 actuation wires, each of which is coupled to 3 loops. In some embodiments, a single actuation wire is coupled through all loops of the outer frame.

[0145] In order to deliver and deploy the prosthetic valve 800 within the heart, the delivery sheath 826 may be inserted through the epicardial surface of the patient's heart (for example at or near the apex region of the heart) and extend through the left ventricle of the heart and reach Left atrium. Before inserting the delivery sheath 826 into the heart, the expansion portion 873 of the dilator 870 extends to the outside of the distal end of the delivery sheath 826, and fluid can be injected into the fluid delivery portion 872, thereby inflating the expansion portion 873 of the dilator 870. The distal end of the expansion portion 873 (eg, the tapered distal end) can provide an introducer for the delivery sheath 826 and help open or expand the access opening at the epicardial surface and through the mitral valve annulus. When the delivery sheath 826 is placed at a desired position in the heart, fluid can be at least partially withdrawn or removed from the expansion portion 873, thereby deflating the expansion portion 873, and the deflated expansion portion 873 can be removed through the delivery catheter. The delivery sheath 826, inner valve assembly 840, and outer frame assembly 810 are left inside the heart.

[0146] In the case that the distal end of the delivery sheath 826 is set in the left atrium, the valve 800 is pushed out of the distal end of the delivery sheath 826 by drawing the delivery sheath 826 proximally and/or using a pusher device and/or using The elongate member 880 and the actuation wires 874, 876 help to pull the valve 800 out of the distal end of the delivery sheath 826, which can move the valve 800 out of the lumen of the delivery sheath 826. More specifically, in the case where the actuation wires 874, 876 are coupled to the outer frame assembly 810, the ends of the actuation wires 874, 876 may extend distally from the outer frame assembly 810 out of the distal end of the delivery sheath 826, and then pass through Side defined by elongated member 880

An eye or hole 886 (indicated in FIG. 32A) enters the actuation wire lumen 884 of the elongate member 880. In some embodiments, the actuation wire lumen extends out of the opening in the distal end of the elongate member 880, rather than a side opening. In other words, the inner cavity 884 may extend to the distal end of the elongate member 880. The ends of the actuation wires 874, 876 may then extend proximally through the actuation wire lumen 884 of the elongate member 880 and extend beyond the proximal end of the elongate member 880 and the proximal end of the delivery sheath 826. More specifically, each wire 874, 876 has two ends. The first end is held at the proximal end of the elongated member 880, while the second end extends distally through the first actuation wire lumen 884, passes through the ring (not shown) of the outer frame assembly 810, and returns through the second The wire lumen is actuated and the proximal end of the elongate member 880 is extended proximally. Therefore, for an embodiment with two actuation wires and four actuation wire lumens, the four ends of the actuation wires will extend proximal to the distal end of the delivery system 305 or be coupled to a part of the delivery system (such as a catheter Or handle). Therefore, a user (eg, a doctor) can pull the ends of the actuation wires 874, 876 to in turn pull the outer frame assembly 810 out of the distal end of the delivery sheath 826, as described in more detail below. [0147] In some embodiments, the ends of the actuation wires 874, 876 extend proximally from the proximal end of the elongated member 880 and And it is operatively coupled to a handle (not shown). The handle can be manipulated by the user to selectively pull and/or release the actuation wires 874, 876. In some embodiments, the handle may include one or more toggle switches or similar mechanisms to help control the transition of the valve 800. In this way, the user can use the handle to selectively pull the valve 800 distally and out of the delivery sheath 826, and selectively control the flip or transition between the configurations of the outer frame assembly 810. In some embodiments, the end of the actuation wire extends proximally through the actuation wire lumen of the delivery sheath and protrudes from the proximal end of the elongate member, but is still within the delivery sheath. In such an embodiment, a handle or similarly functional actuation wire manipulator is operatively coupled to the actuation wire, and can be actuated and/or manipulated to selectively pull or release the actuation wire for conveying and /Or deploy valve 800, as described above.

[0148] During the delivery of the valve 800, when the inner valve assembly 840 leaves the distal end of the delivery sheath 826, the outer frame assembly 810 will be in an inverted configuration relative to the inner valve assembly 840 (similar to those shown in relation to FIG. 30B and Described). After the inner valve assembly 840 is outside the lumen of the delivery sheath 826, the outer frame assembly 810 may begin to leave the lumen of the delivery sheath 826 and return to its expanded or deployed configuration (similar to, for example, as shown with respect to FIG. 30A). In this embodiment, when the valve 800 is delivered to the heart, the actuation wires 874, 876 may be used to selectively (eg, by an operator) assist and/or control the expansion and restoration of the contour of the valve 800. For example, the distal end of the elongate member 880 can be moved distally out of the delivery sheath 826, and can be pulled proximally (or the handle coupled to it can be manipulated) to actuate the ends of the wires 874, 876 (extend the delivery proximally) Sheath 826), which in turn pulls the open end of the outer frame distally relative to the inner frame to help move the outer frame to its restored expanded configuration. Therefore, the actuation wire and elongate member 880 can be used to help manipulate the outer frame assembly 810 to assist and control the transition of the outer frame assembly 810 from its reverse configuration relative to the inner valve assembly 840 to its expanded or deployed configuration. In this way, the contour of the valve 800 as the outer frame assembly 810 transitions from its reverse configuration to its restored expansion or deployment configuration according to the application. User needs are selectively minimized and/or manipulated in other ways. This control of the contour of the valve 800 throughout this transition between its configurations and during delivery and deployment of the valve 800 can facilitate safer, more repeatable, and efficient valve delivery and deployment procedures. In some embodiments, the actuation wires 874, 876 may be manually grasped by the user to pull the actuation wires proximally. In some embodiments, the actuation wires 874, 876 may be operably coupled to the delivery system 805 so that the user does not have to manually handle the actuation wires. For example, the actuation wire may be coupled to the delivery sheath and/or handle assembly of the delivery system 805 (not shown).

[0149] With the outer frame assembly 810 recovered relative to the inner valve assembly 840 such that the valve 800 is disposed within the annulus of the heart in its deployed configuration, the delivery system 805 can be removed from the heart. For example, the actuation wires 874, 876 can be uncoupled from the outer frame assembly 810 and removed from the heart via the elongated member 880, and the elongated member 880 and the infusion can be withdrawn from the heart.

The sheath 826 is sent, leaving the valve 800 to be implanted in the annulus of the heart. More specifically, in order to decouple the actuation wires 874, 876 from the outer frame assembly 810 and remove the actuation wires 874, 876 from the patient, a single proximal end of the actuation wires 874, 876 can be pulled proximally so that Pull the other proximal end of the actuation wire 874, 876 distally through the actuator wire lumen 884, pull out the hole or hole 886 in the elongated member 880, pass through the ring of the outer frame 820 and be pulled back through The actuator wire lumen 884. Therefore, after the actuation wires 874, 876 are used to facilitate the delivery and deployment of the valve 800 within the heart, the actuation wires 874, 876 can be removed from the elongate member 880, the delivery sheath 826, and the patient.

[0150] FIG. 33A is an illustration of a side view of a delivery system 905 that can be used to deliver and deploy a prosthetic heart valve 900 within the heart of a patient using, for example, a transapical approach. The delivery system 905 may be configured to be the same or similar to, for example, the delivery system 805, and to function the same or similar thereto. Further, the valve 900 may be configured to be the same or similar to any prosthetic valve described herein or any prosthetic valve described in PCT Application No. 305, and to function the same or similar thereto, and as described herein with respect to valve 800 , Can be moved between a deployed or expanded configuration and a delivery configuration in which the outer frame is in a reverse position relative to the inner frame. As shown in Figure 33A, the valve 900 is set in its reverse configuration and is radially constrained within the delivery sheath before being deployed and implanted in the heart, as described in more detail below. Further, as shown in Figure 33B, the valve 900 is placed in a restored deployment configuration after being delivered to the heart and before the actuation wire and delivery sheath are removed. It should be understood that for features and functions not specifically discussed with respect to delivery system 905, those features and functions can be the same as or similar to delivery system 805 or any delivery system described herein. Similarly, it should be understood that for features and functions not specifically discussed with respect to prosthetic valve 900, those features and functions can be the same or similar to any valve described in valve 800 or PCT application No. 305.

[0151] The delivery system 905 includes a delivery sheath 926, a dilator 970, an elongate member 980, and two actuation wires 974 and 976. FIG. 33C is a distal end view of elongate member 980. FIG. The delivery sheath 926 can be used to deliver the valve 900. The valve 900 includes an inner valve assembly 940 and an outer frame assembly 910. The inner valve assembly 940 includes an inner frame (not labeled in FIG. 33A), and the outer frame assembly 910 includes an outer frame (not shown in FIG. 33A). Marked).

[0152] The elongated member 980 may be used to assist in the overturning of the outer frame assembly 910 and to deliver at least a portion of the dilator to and retract the portion from the heart. As shown in FIG. 33C, the elongate member 980 defines a dilator lumen 982, which is configured to slidably receive the dilator 970. More specifically, when the dilator portion 973 is deflated, the dilator lumen 982 is configured to slidably receive the dilator 970. The elongated member 980 also defines four actuator wire cavities 984 (as shown in FIG. 33C), which are radially spaced from the dilator cavity 982 and are configured to receive actuators. Moving wires 974, 976. The elongate member 980 is slidably disposed within the delivery catheter 926 and passes through the central portion of both the inner valve assembly 940 and the outer frame assembly 910. In alternative embodiments, the elongate member may define any suitable number of actuator wire lumens. For example, as shown in Figure 33D, the elongate member 980' can define six actuator wire lumens 984' that are radially spaced from the dilator lumen 982'. Similar to the actuator wire lumens 984 discussed above, six actuator wire lumens 984' may be configured to receive actuator wires (eg, actuator wires 974 and 976). In still other alternative embodiments, the actuator wire lumen may be configured to receive any suitable number of actuator wires. For example, in the delivery system In some embodiments of the elongated member defining six actuator wire cavities (eg, actuator wire cavity 984'), the delivery system may include three actuator wires. In such an embodiment, in some examples, each actuator wire may be routed through two actuator wire cavities. In other words, the first actuator wire can be routed through the first group of two actuator wire cavities; the second actuator wire can be routed through the second group of two actuator wire cavities; third The actuator wires can be routed through the cavities of the third group of two actuator wires. Further, the elongate member may have any suitable shape (for example, circular, elliptical, triangular, etc.). For example, as shown in Figure 33D, the elongated member 980' is circular.

[0153] In this embodiment, as shown, the actuation wires 974, 976 may be releasably coupled to the outer frame of the outer frame assembly 910. For example, as shown in FIGS. 33A and 33B, the actuation wires 974 and 976 may pass through the ring 962, which is disposed around the open end of the outer frame assembly 910. More specifically, as described above, the first end of each actuation wire 974, 976 is held at the proximal end of the elongated member 980, while the second end extends distally through the first actuation wire lumen 984, passing through Pass the loop 962 of the outer frame assembly 910, return through the second actuation wire lumen 984 and extend the proximal end of the elongate member 980 toward the proximal end (see, for example, FIG. 33B).

[0154] In order to deliver and deploy the prosthetic valve 900 within the heart, the delivery sheath 926 may be inserted through the epicardial surface of the patient's heart (for example, at or near the apex region of the heart) and extend through the left ventricle of the heart and reach the left Atrium. Before inserting the delivery sheath 926 into the heart, as the expanded portion of the dilator extends to the outside of the distal end of the delivery sheath 926, fluid may be injected into the fluid delivery portion 972, thereby inflating the expanded portion 973 of the dilator 970. The distal end of the expansion portion 973 (eg, the tapered distal end) may provide an introducer for the delivery sheath 926 and help open or expand the access opening at the epicardial surface and through the mitral valve annulus. When the delivery sheath 926 is placed at a desired position in the heart, fluid can be at least partially drawn or removed from the expansion portion 973, thereby deflating the expansion portion 973, and the deflated expansion portion 973 can be removed through the delivery catheter 926 , Leaving the delivery sheath 926, the inner valve assembly 940 and the outer frame assembly 910 in the heart.

[0155] In the distal end of the delivery sheath 926 is provided in the case of the left atrium, for example, by extracting a delivery sheath 926 and / or the elongate member 980 to move distally and proximally actuation wire using the sheet 974, 976 by Helping to pull the valve 900 out of the distal end of the delivery sheath 926, the valve 900 can be moved out of the lumen of the delivery sheath 926. As described above for the previous embodiment, the inner valve assembly 940 will first exit the delivery sheath 926 and then exit the outer frame assembly 910. Without being constrained by the delivery sheath 926, the inner valve assembly 940 and the outer frame assembly 910 can assume their offset expanded configuration.

[0156] To flip or restore the outer frame assembly 910, the elongate member 980 can be moved distally out of the delivery sheath 926, as shown in FIG. 33B. As the elongate member 980 is moved distally, the proximal ends of the actuation wires 974, 976 can be pulled proximally, which will in turn pull the open ends of the outer frame assembly 910 distally (the actuation wires 974, 976 are coupled To it) to help restore the outer frame. For example, as described above, a user (eg, a doctor) can pull the ends of the actuation wires 974, 976 to in turn move the outer frame assembly 910 to its recovery configuration. In some embodiments, the ends of the actuation wires 974, 976 extend proximally from the proximal end of the elongate member 980 and are operably coupled to a handle (not shown). The handle can be manipulated by the user to selectively pull and/or release the actuation wires 974, 976. In some embodiments, the handle may include one or more toggle switches or similar mechanisms to help control the transition of the valve 900. In this way, the user can use the handle to selectively pull the valve 900 distally and from the delivery sheath 926, and selectively control the flip or transition between the configurations of the outer frame assembly 910. In some embodiments, the end of the actuation wire extends proximally through the actuation wire lumen of the delivery sheath and protrudes from the proximal end of the elongate member, but is still within the delivery sheath. In such an embodiment, a handle or similarly functionally actuated wire manipulator is operably It is coupled to the actuation wire and can be actuated and/or manipulated to selectively pull or release the actuation wire for delivery and/or deployment of the valve 900, as described above.

[0157] As described above, when the valve 900 exits the distal end of the delivery sheath 926, the outer frame assembly 910 will be in a reverse configuration relative to the inner valve assembly 940 (similar to that shown and described with respect to FIG. 30B). After the inner valve assembly 940 is outside the lumen of the delivery sheath 926, the outer frame assembly 910 may begin to leave the lumen of the delivery sheath 926 and return to its expanded or deployed configuration (as shown in Figure 33B). In this embodiment, when the valve 900 is delivered to the heart, the actuation wires 974, 976 may be used to selectively (eg, by an operator) assist and/or control the expansion and restoration of the valve 900. For example, the distal end of the elongate member 980 can be moved distally out of the delivery sheath 926, and can be pulled proximally (or can be manipulated

The handle) actuates the ends of the wires 974, 976 (extending the delivery sheath 926 proximally), which in turn pulls the open end of the outer frame distally relative to the inner frame to help move the outer frame to its restored expansion Configuration. Therefore, the actuation wires 974, 976 and the elongate member 980 can be used to help manipulate the outer frame assembly 910 to assist and control the transition of the outer frame assembly 910 from its reverse configuration relative to the inner valve assembly 940 to its expanded or deployed configuration . In this way, the contour of the valve 900 as the outer frame assembly 910 transitions from its reverse configuration to its restored expanded or deployed configuration can be selectively minimized and/or otherwise manipulated according to the needs of the user. This control of the contour of the valve 900 throughout the transition between its configurations and during delivery and deployment of the valve 900 can facilitate safer, more repeatable, and efficient valve delivery and deployment procedures. In some embodiments, the actuation wires 974, 976 may be manually grasped by the user to pull the actuation wires proximally. In some embodiments, the actuation wires 974, 976 may be operably coupled to the delivery system 905 so that the user does not have to manually handle the actuation wires. For example, the actuation wire may be coupled to the delivery sheath and/or handle assembly of the delivery system 905 (not shown).

[0158] With the outer frame assembly 910 restored relative to the inner valve assembly 940 such that the valve 900 is disposed within the annulus of the heart in its deployed configuration (as shown in FIG. 33B), the delivery system 905 can be removed from the heart. For example, the actuation wires 974, 976 can be uncoupled from the outer frame assembly 910 and removed from the heart via the elongate member 980, and the elongate member 980 and the delivery sheath 926 can be withdrawn from the heart, leaving the valve 900 implanted in the body of the heart Inside the ring. More specifically, in order to decouple the actuation wires 974, 976 from the outer frame assembly 910 and remove the actuation wires 974, 976 from the patient, a single proximal end of the actuation wires 974, 976 can be pulled proximally so that Pull out the other proximal end of the actuating wires 974, 976 through the actuator wire lumen 984, and pass through the side holes or holes 986 in the elongated member 980 (communicating with the corresponding actuator wire lumen 984). Each side eyelet or hole 986) passes through the ring 962 of the outer frame 920 and protrudes backward through the actuator wire lumen 984. In this way, the actuation wires 974, 976 can be removed from the elongate member 980, the delivery sheath 926, and the patient after the actuation wires 974 are used to facilitate delivery and deployment of the valve 900 within the heart.

[0159] In some embodiments, after the valve 900 has been delivered and deployed in the heart, the delivery sheath 926 can be moved distally (after the actuation wire has been removed from the elongated member 980, delivery sheath 926, and/or the patient 974, 976 before and/or after) to at least capture or otherwise engage at least the proximal portion of the valve 900 and at least partially contract the proximal portion of the valve. The delivery sheath 926 can then be used to move and/or reorient (eg, rotate, time, or angle) the valve 900 within the heart. For example, the user can rotate the delivery sheath 926 about its longitudinal axis to in turn rotate the valve 900 about its longitudinal axis. In this way, for example, when the valve 900 is not initially implanted in a proper manner, the user can ensure that the valve 900 is properly implanted in the heart without having to remove the valve 900 from the heart.

[0160] FIGS. 34 to 42 illustrate a delivery system 1005 for delivering and deploying a prosthetic heart valve (such as a prosthetic heart valve 1000) within a heart according to another embodiment. The prosthetic heart valve 1000 (also referred to herein as a "valve") can be configured to be the same or similar to any valve described herein, and to function the same or similar thereto. Therefore, some details about the valve 1000 are not described herein. As shown in FIG. 34, the valve 1000 has an outer frame assembly 1010, an inner valve assembly 1040, and a tether 1036, the outer frame assembly 1010 has an outer frame 1020, and the inner valve assembly 1040 has an inner frame 1050, and the tether 1036 is coupled to the inner frame 1050. As described above for previous embodiments (eg, valves 100, 200, 300, etc.), the outer frame 1020 and the inner frame 1050 of the valve 1000 may each be formed of a shape memory material and have an offset expansion or deployment configuration. The outer frame 1020 and the inner frame 1050 can be moved to a contracted or undeployed configuration for delivery of the valve 1000 to the heart, where the outer frame 1020 is reversed with respect to the inner frame 1050. In order to prepare the valve 1000 for delivery to the heart, the outer frame 1020 of the valve 1000 is first placed in a prolapsed or reverse configuration as shown in FIG. 34. Specifically, the petals The elastic or super-elastic structure of the outer frame 1020 of the membrane 1000 allows the outer frame 1020 to be placed in a prolapsed or reversed configuration with respect to the inner frame 1050 as described above, for example, for the valve 100.

[0161] For example, in order to set the outer frame 1020 in its reverse configuration relative to the inner frame 1050, the outer frame 1020 is folded or reversed distally so that the outer frame 1020 points away from the inner frame 1050. With the outer frame 1020 in the reverse configuration, the valve 1000 can be placed in the lumen of the delivery system 1005, as shown in FIG. 34, for delivering the valve 1000 to the left atrium of the heart. As discussed above, by setting the outer frame 1020 of the valve 1000 in the reverse configuration, the valve 1000 can be shrunk to a smaller overall diameter, that is, placed in a smaller diameter than the valve 1000 when the inner frame 1050 and the outer frame 1020 are arranged concentrically with each other. When radially collapsed in a delivery sheath with a smaller diameter.

[0162] In this embodiment, the delivery system 1005 includes an outer delivery sheath 1026, an inner sheath 1008, a valve support 1038 (also referred to as a "pusher"), and a multi-lumen elongate tube member 1003 (also referred to as a " Tube" or "tube member" or "multi-lumen elongate member"). As shown in FIGS. 34 and 39 to 41, the tube member 1003 is movably disposed in the inner cavity 1082 defined by the outer delivery sheath 1026. The inner sheath 1008 is movably disposed in the inner cavity 1082 and the inner cavity 1080 defined by the tube member 1003. The valve support 1038 is movably disposed in the first lumen 1083 and the second lumen 1085 defined by the inner sheath 1008, and the first lumen 1083 and the second lumen 1085 are in fluid communication with each other.

[0163] In order to deploy the valve 1000 in the heart, the outer frame 1020 of the valve 1000 is first moved or placed in its reverse configuration relative to the inner frame 1050. As shown in FIG. 34, a part of the valve 1000 is placed in the lumen 1082 of the outer sheath, and a part of the valve 1000 is placed in the lumen 1083 of the inner sheath 1008. As described above for the previous embodiment, when the valve 1000 is placed within the delivery system (eg outer sheath 1026 and inner sheath 1008), the valve 1000 can be compressed or contracted into a smaller configuration (eg smaller outer circumference) .

[0164] The inner frame 1050 may be releasably coupled to the valve support 1038 via couplers 1006, which receive in the same manner as described above for the delivery system 405 (see, for example, FIGS. 26A to 26C) Within the corresponding recess 1004 defined by the valve seat 1038. In this way, the valve support 1038 can be used to hold the valve 1000 to help control and manipulate the valve 1000 when it is deployed in the heart. In addition, when the valve 1000 moves within the lumen of the delivery sheath 1026 and during deployment outside the delivery sheath 1026, the valve support 1038 can limit the radial expansion of the inner frame 1050. As described above for the valve 400, the inner diameter 1082 of the inner sheath 1008 can be sized so that the coupler 1006 cannot leave the recess 1004 when the valve support 1038 and the valve 1000 are disposed therein. In other words, the inner wall of the inner sheath 1008 maintains the coupler 1006 within the recess 1004. When the valve 1000 moves to the outside of the inner sheath 1008, the coupler 1006 will be able to freely leave the recess 1004, allowing the inner frame 1050 to be released from the valve support 1038.

[0165] In an alternative embodiment, the valve support 1038 may be removably coupled to the valve 1000 (such as the inner frame 1050 of the valve 1000) via a wire or suture, which may be used to deliver the valve 1000 to the heart Cut afterwards. In some cases, the valve support 1038 can be uncoupled from the valve 1000 while the valve is still disposed within the outer delivery sheath 1026, while in other examples, the valve support 1038 can be after the valve 1000 leaves the delivery sheath 1026 in the heart, Uncoupled from valve 1000.

[0166] Although not shown, in other embodiments, as described for previous embodiments, the valve support 1038 may only contact and push the valve 1000 during deployment, without the need to fix the inner frame 1050 to the valve support 1038 on. In such an embodiment, in some instances, when the inner frame 1050 is disposed in the inner sheath 1008, the radial expansion of the inner frame 1050 may be constrained by the inner sheath 1008.

[0167] In this embodiment, the first actuation wire 1076, the second actuation wire 1074, the third actuation wire 1076, and the fourth actuation wire 1077 are each coupled to the outer frame assembly 1010. More specifically, the outer frame 1020 of the outer frame assembly 1010 includes a ring 1062 through which the actuation wire 1074-1077 can be tightened or received. In this embodiment, the outer frame 1020 includes 12 loops 1062, and each actuation wire 1074-1077 is tightened by three loops 1062 therein. In other embodiments

In the outer frame 1020, different numbers of rings may be provided, and different numbers of actuators may be present. Further, each actuation wire can be tightened or received through a different number of rings than shown for this embodiment.

[0168] When the valve 1000 is placed in the delivery system 1005, for example, as shown in FIG. 34, the actuation wires 1074 to 1077 each extend from the outer frame 1020, within the lumen 1082 of the outer sheath, and approaching along the outer wall of the inner sheath 1008. Side extensions, are folded or placed behind one or more seals 1081 or other holding devices, and are composed of elongated pinning members 1078-1, 1078-2, 1078-3, 1078-4 (collectively referred to as pinning members 1078 ) Pinned to the pipe member 1003. As described in more detail below, the seal 1081 can be configured such that the actuation wire 1074-1077 can slide relative to the seal 1081 during actuation and deployment of the valve 1000.

[0169] As shown in FIGS. 34 and 39 to 41, the first end of the actuation wire 1074 and the first end of the actuation wire 1075 are pinned by the pinning member 1078-2, and the first end of the actuation wire 1076 The end and the first end of the actuation wire 1077 are pinned by the pinning member 1078-1. The second end of the actuation wire 1074 and the second end of the actuation wire 1076 are pinned by the pinning member 1078-4 (not shown in the partial cross-sectional views of FIGS. 34 and 39 to 41), and the actuation wire 1075 The second end and the second end of the actuation wire 1077 are pinned by a pinning member 1078-3 (not shown in the partial cross-sectional views of FIGS. 34 and 39 to 41). For ease of description, the second end of the actuation wire is shown as being separated in FIGS. 34 and 39 to 41.

[0170] FIG. 35 is a cross-sectional view taken along line 35-35 in FIG. 34 and illustrates the pinning of the actuation wire 1074-1077. For illustrative purposes, the actuation wires 1074-1077 are shown not attached to the outer frame. Figure 38A illustrates the actuation wire 1074 and represents the other actuation wires 1075-1077. Figures 38B, 67B, and 67C illustrate alternative embodiments of actuation wires labeled 1074', 1074", and 1074"'. As shown in FIG. 38A, the actuation wires 1074-1077 each include a loop on both ends of the actuation wire, which is pinned by a pinning member 1078. In FIG. 38B, the pinning member may pin a smaller loop on one end of the actuation wire 1074', and pin the end of a larger loop on the opposite end of the actuation wire 1074'. In Figure 38C, the actuation wire 2475" is in a closed loop form, and each end of the loop can be pinned by a pinning member. In Figure 38D, the actuation wire 1074'" includes two elongated rings and a smaller center ring. In this embodiment, the actuation wire 1074'" can be pinned by three pinning members, the first pinning member can pin the end of one of the larger loops, and the second pinning member can pin the other The end of the larger ring and the smaller ring can be pinned by the third pinning member. In each embodiment of Fig. 38B to Fig. 38D In this, the two layers of actuation wire will pass through or be tightened by the ring of the outer frame of the valve. Other alternative configurations can also be used.

[0171] As shown in FIGS. 36 and 37A, the multi-lumen tube member 1003 defines four pinning member lumens 1079-1, 10792, 1079-3, 1079-4 (collectively referred to as pinning member lumens 1079) . The end of the actuating wire 1074-1077 is placed in a circumferential depression or groove 1084 defined by the tube member 1003, wherein the pinning member 1078 is received by a ring on the end of the actuating wire 1074-1077, which will actuate the wire 1074 -1077 is pinned to the pipe member 1003. Therefore, during deployment of the valve 1000 in the heart, a user (eg, a doctor) can use the tube member 1003 to which the actuation wire 1074-1077 is coupled to control and/or manipulate the movement of the valve 1000, as described in more detail below.

[0172] FIGS. 37B and 37C illustrate an alternative embodiment of the multi-lumen tube member 1103, which can be combined with the distal retention element 1186 as shown in FIG. 37B or the distal side as shown in FIG. 37C. Keep element 1286-used together. The distal retention elements 1186 and 1286 may be arranged to abut the distal end of the multi-lumen tube member 1103 and may at least partially define a recessed area to receive the loop end of the actuation wire, and may be used during delivery and deployment of the prosthetic valve Provides the multi-lumen tube member 1103 with enhanced overall strength and durability. The distal retention elements 1186, 1286 may be formed of the same or different material as the multi-lumen tube member 1103. In some embodiments, it is desirable that the distal retention elements 1186, 1286 may be formed of a material with greater strength characteristics than the multi-lumen tube member 1103. For example, the distal retention elements 1186, 1286 may be formed of metal or rigid plastic.

[0173] As shown in FIGS. 37B and 37C, the multi-lumen tube member 1103 (also referred to herein as a "tube member") may define a central lumen 1180 and a plurality of pinning member lumens, including FIGS. 37B and 37B and The pinning member cavities 1179-3 and 1179-4 (collectively referred to as 1179) shown in FIG. 37C can receive pinning members therein, such as pinning members 1078-3 and 1078-4, respectively. Although not shown, the tube member 1103 can also define a pinning member lumen, which can receive pinning members 1078-1 and 1078-2 as shown for the tube member 1003 in FIG. 36.

[0174] As shown in FIG. 37B, the distal retaining element 1186 can be received in the lumen 1180 and can define an lumen 1187 through which the valve seat 1038 can be slidably received. Although not shown, the distal retention element 1186 may be coupled to the tube member 1103 using various different coupling methods. For example, in some embodiments, the distal retention element 1186 may be bonded to the tube member 1103. In some embodiments, the distal retention element 1186 may include one or more features, such as barbs, which allow it to be inserted into the tube member 1103 but not removed. In some embodiments, the distal retention element 1186 can include notches that interlock with corresponding features of the tube member 1103 and/or the tube member 1103 can be reflowed or molded on the retention element 1186. Various other coupling methods and/or combinations of stabilization strategies may be used to couple the distal retention element 1186 to the tube member 1103. In some embodiments, the distal retention element 1186 may extend proximally within the lumen 1180 of the tube member 1103 and be coupled at the proximal end of the tube member 1103.

[0175] The distal retention element 1186 also defines a pinning member lumen 1169 that is aligned with the pinning member lumen 1179 of the multi-lumen tube member 1103 so that the pinning member 1078 can be received therein. The proximal shoulder 1188 may be provided to abut the distal end of the multi-lumen tube member 1103. The distal retention element 1186 also defines a circumferential recessed area 1184 that is defined between the proximal shoulder 1188 and the distal end of the distal retention element 1186. As shown in FIG. 37B, the loop end of the actuation wire 1074-1077 may be received within the recessed area 1184 and pinned by the pinning member 1078 as described above for the multi-lumen tube member 1003.

[0176] FIG. 37C illustrates the distal retention element 1286 disposed to abut the distal end of the multi-lumen tube member 1103. As in the previous embodiment, the distal retention element 1286 may be received within the lumen 1180 and may define an lumen 1287 through which the valve seat 1038 can be slidably received. The distal retention element 1286 may be coupled to the tube member 1103 in the same manner as described above for the distal retention element 1186. The distal retention element 1286 also includes a proximal shoulder 1288 that is configured to abut the distal end of the multi-lumen tube member 1103. The distal retention element 1286 also defines a circumferential recessed area 1284, which can receive the ring ends of the actuation wire 1074"-1077", which can be formed by the pinning member 1078 (shown in FIG. 37). 1078-3 and 1078-4) pinned. In this example, the actuation wire is configured as a closed loop, as shown for the actuation wire 1074" in FIG. 38C.

[0177] The procedure to deliver the valve 1000 to the heart may be the same as or similar to any procedure described in PCT Application No. 572 and/or PCT Application No. 305 herein, incorporated by reference above. For example, a valve 1000 disposed in the delivery system 1005 in a reverse configuration can be delivered to the heart in the same or similar manner as described herein with respect to other embodiments and/or with reference to FIGS. 43 to 48 of PCT Application No. 305 Left atrium. In the case where the distal end of the delivery sheath 1026 is disposed in the left atrium of the heart, the valve 1000 may be deployed outside the delivery sheath 1026. For example, as shown in FIG. 39, the inner sheath 1008, the valve support 1038, and the tube member 1003 can move distally relative to the outer sheath 1026 to move the valve 1000 out of or push out the lumen 1082 of the outer sheath 1026. Additionally or alternatively, the outer sheath 1026 can be moved or pulled proximally, leaving at least a portion of the valve 1000 disposed within the heart. In some cases, the tether 1036 coupled to the valve 1000 can be used to help pull the valve 1000 out of the lumen of the outer sheath 1026.

[0178] As described above for the previous embodiment, when the outer frame 1020 becomes unconstrained by the outer sheath 1026, the outer frame 1020 may begin to return to its expanded or non-reversed configuration. Actuating wire 1075-1077 can be used to control the outer frame 1020

Recovery. More specifically, the tube member 1003 can be pulled proximally, so that the actuation wire (pinned to the tube member 1003) pulls the distal portion of the outer frame 1020 proximally (as shown in FIG. 40) in a controlled manner. , And makes it possible to control the recovery of the outer frame 1020 from its reverse configuration relative to the inner frame 1050.

[0179] Additionally, in some examples, the actuation wire 1074-1077 can assist in engaging and placing the valve 1000 into its destination (eg, the native annulus of the atrioventricular valve of the heart). For example, as shown in Figure 41, after the valve 1000 leaves the outer sheath 1026 and is in its restored expanded or partially expanded configuration, the actuation wire 1074-1077 can also be used to restrain, contract, or otherwise move the valve 1000 (eg, diameter Compress the outer frame 1020 of the valve 1000). More specifically, in this embodiment, the tube member 1003 on which the actuation wire 1074-1077 is pinned can be manipulated by the user to move or push the outer frame to a more compressed by pulling or pushing the tube member 1003 proximally. Configuration (shown in Figure 41). For example, it may be desirable to reposition the valve 1000 within the heart before the valve 1000 is fully deployed.

[0180] Returning to FIG. 40, when the outer frame 1020 of the valve 1000 is placed in its non-reversed and at least partially expanded configuration and in the desired position within the heart, the inner frame 1050 may be deployed. As described above for the valve 400, in order to decouple the inner frame 1050 from the valve support 1038, the valve support 1038 can be moved distally and/or the inner sheath 1008 can be moved proximally, so that the valve support 1038 is disposed at The inner cavity 1083 of the inner sheath 1008 is outside. In this way, the coupler 1006 can be released from the recess 1004, so that the inner frame 1050 is released from the valve support 1038 or decoupled therefrom. In some embodiments, the tether 1036 can be pulled to help move the inner frame 1050 out of the inner sheath 1008. When the inner frame 1050 is released from the valve support 1038 and disposed outside the inner sheath 1008, the inner frame 1050 may assume its biased expanded configuration.

[0181] Before or after the inner frame 1050 is released from the valve support 1038, the actuation wires 1074-1077 may also be released or decoupled from the outer frame 1020. In order to decouple the actuation wires 1074-1077 from the outer frame 1020, one end of each actuation wire 1074-1077 can be unplugged from the tubular member 1003 or decoupled from the tubular member 1003. For example, as shown in Figure 42, The pinning member 1078-3 can be drawn proximally from the groove 1084 (see FIG. 35), so that the second end of the actuation wire 1077 and the second end of the actuation wire 1075 are each released or pulled out of the tube member 1003, but It is still pinned by pinning members 1078-2 and 1078-1, respectively. Similarly, the pinning member 1078-4 can be drawn proximally from the groove 1084 (see FIG. 35), so that the second end of the actuation wire 1074 and the second end of the actuation wire 1076 can be released from the tube member 1003 or Pull out, but still pinned by pinning members 1078-2 and 1078-1, respectively. With one end of each actuation wire 1075-1077 coupled to the tube member 1003 (in this example, via pinning members 1078-1 and 1078-2), the tube member 1003 can be pulled proximally, which in turn Pull the opposite ends of the actuation wires 1074-1077 out of the ring 1062 of the outer frame 1020. Therefore, in the case where the actuation wire 1074-1077 is separated from the outer frame 1020, the outer frame may assume a biased expanded or partially expanded configuration.

[0182] Although in the above example, it is shown that the pinning members 1078-3 and 1078-4 are drawn out to release the ends of the actuation wires 1074-1077, alternatively, the pinning members 1078-1 and 1078 -2 can be withdrawn so that the actuation wires 1074-1077 are pinned by the pinning members 1078-3 and 1078-4. Further, the actuation wires 1074-1077 can be decoupled from the outer frame 1020 in any suitable sequence or time period during the operation. For example, in some examples, it is desirable to release the actuation wire 1074-1077 after the valve 1000 has at least partially exited the delivery sheath 1026 but before the valve 1000 is seated within the native annulus of the atrioventricular valve. In other examples, for example, after the valve 1000 has at least partially exited the outer delivery sheath 1026 and after the valve 1000 is seated within the autologous annulus of the atrioventricular valve, the actuation wires 1074-1077 may be released.

[0183] FIG. 43 is a flowchart illustrating a method of delivering and deploying a prosthetic valve in a heart. The method includes, at 1300, inserting the distal end of the delivery sheath through the apical region of the heart and into the atrium of the heart. The delivery sheath has a prosthetic heart valve, and the prosthetic heart valve is arranged in the inner cavity of the delivery sheath. The prosthetic heart valve includes an outer frame and an inner frame coupled to the outer frame. The outer frame can move between a first position relative to the inner frame and a second position relative to the inner frame.

The frame is opposite to the inner frame. The prosthetic valve is disposed within the lumen of the delivery sheath, wherein the outer frame is in a second position relative to the inner frame during insertion. At 1302, the prosthetic heart valve is moved distally out of the delivery sheath. At 1304, the outer frame of the prosthetic heart valve transitions to a first position relative to the inner frame such that the prosthetic heart valve at least partially assumes an offset expanded configuration. At 1306, the prosthetic heart valve is positioned within the annulus of the heart.

[0184] FIG. 44 is a flowchart illustrating a method of delivering and deploying a prosthetic valve in a heart. At 1400, the distal end of the delivery sheath is inserted into the atrium of the heart. The delivery sheath has a prosthetic heart valve, and the prosthetic heart valve is arranged in the inner cavity of the delivery sheath. The prosthetic heart valve includes an outer frame and an inner frame coupled to the outer frame. The outer frame is movable between a first position relative to the inner frame and a second position relative to the inner frame, the outer frame being reversed relative to the inner frame. The prosthetic heart valve is disposed within the lumen of the delivery sheath, wherein the outer frame is in a second position relative to the inner frame during insertion, and is at least partially axially disposed proximal to the inner frame. At 1402, the prosthetic heart valve is moved distally out of the delivery sheath. At 1404, the outer frame of the prosthetic heart valve transitions to a first position relative to the inner frame, so that the prosthetic heart valve at least partially assumes an offset expanded configuration. At 1406, the prosthetic heart valve is positioned within the annulus of the heart.

[0185] Although various embodiments have been described above, it should be understood that they are presented by way of example only but not limitation. Although the method described above indicates that certain events occur in a specific order, the order of certain events can be modified. Additionally, when possible, certain events can be executed simultaneously in parallel processes, and sequentially as described above.

[0186] Although the schematic diagrams and/or embodiments described above show certain components arranged in certain orientations or positions, the arrangement of the components may be modified. Although the embodiments have been specifically shown and described, it should be understood that various changes in form and details can be made. In addition to mutually exclusive combinations, any part of the devices and/or methods described herein can also be combined in any combination. The embodiments described herein may include various combinations and/or sub-combinations of the functions, components, and/or features of the different embodiments described.

[0187] For example, although not specifically described for each embodiment, any embodiment of the delivery system may include a dilator device or member such as a balloon dilator member. Further, the prosthetic heart valve described herein can be fixed to the heart using the epicardial cushion device as described in Figures 43 to 48 and 72 of PCT Application No. 305. Also, although not shown for every embodiment, any embodiment of the delivery device or system may include a valve support or valve pusher configured to push the valve during delivery of the valve Out of the distal end of the delivery sheath.

[0188] Further, although not shown, any embodiment of the delivery device or system may include a handle or handle assembly to which various delivery sheaths and components are operably coupled, and the user (eg, doctor) The handle or handle assembly can be grasped and used to manipulate the delivery device or system.

[0189] In addition, the systems and methods described herein can also be applied to prosthetic tricuspid valves. For example, in this case, a surgical catheter can be inserted into the right ventricle of the heart, and the delivery sheath can be delivered directly (through the atrium) or via the jugular or femoral vein to the right atrium of the heart.

[0190] Additionally, the systems and methods described herein can also be adapted for use with prosthetic tricuspid valves. For example, in this case, the delivery sheath can be delivered to the heart via the apex.