Heart valve prosthesis comprising a torque anchoring mechanism and delivery device for a heart valve prosthesis

Abstract

A delivery device for delivering and deploying a heart valve prosthesis having a torque anchoring mechanism includes a balloon having a shaped surface configured to mate with a corresponding shaped surface of the heart valve prosthesis. The balloon is configured to rotate about a central longitudinal axis of the delivery device to rotate the heart valve prosthesis.

Description

[0001] This invention patent application is a divisional application of the invention patent application with international application number PCT / US2018 / 016232, international application date of January 31, 2018, and Chinese national phase application number 201880006267.8, entitled "Heart valve prosthesis including torque anchoring mechanism and delivery device for heart valve prosthesis". Invention Field

[0002] This invention relates to systems and methods for percutaneous implantation of prosthetic heart valves. More specifically, the invention relates to systems and methods for anchoring stent-supported prosthetic heart valves via transcatheter implantation. background

[0003] Heart valves can sometimes be damaged due to disease or aging, causing them to malfunction. Surgical replacement of heart valves is commonly used for patients with valvular dysfunction. Traditional open surgery is highly invasive and uncomfortable for patients, requires a long recovery time, and can lead to life-threatening complications.

[0004] To address these issues, efforts have been made to perform heart valve replacement using minimally invasive techniques. In these methods, laparoscopic instruments are used to create a small incision through the patient's ribcage to establish access to the heart. While considerable effort has been made towards these techniques, their widespread adoption remains limited by the surgeon's ability to access only certain areas of the heart using laparoscopic instruments.

[0005] Other efforts have focused on percutaneous transcatheter (or transluminal) delivery of replacement heart valves to address the problems associated with traditional open surgery and minimally invasive surgical approaches. In these approaches, the heart valve prosthesis is compressed to be delivered within a delivery device, also known as a delivery catheter, and then advanced to the heart, for example, through an opening in the natural vascular system, where the heart valve prosthesis is deployed in the valve annulus (e.g., the mitral valve annulus).

[0006] Various types and constructions of prosthetic heart valves are available for percutaneous valve replacement surgery. Typically, prosthetic heart valves are designed to replicate the function of the replaced valve and thus include leaflet-like structures. Heart valve prostheses are usually formed by attaching a bioprosthetic valve to a framework made of sutures or a mesh of sutures. Such prostheses can be radially constricted to allow percutaneous insertion into the patient via a delivery device (catheter). Once positioned at the desired target site, the prosthesis can be deployed by radial expansion.

[0007] It is important that the heart valve prosthesis is properly anchored at the intended implantation site. In some cases, such as with a non-restrictive natural mitral valve, it may be difficult to properly anchor the heart valve prosthesis. This can lead to undesirable migration of the heart valve prosthesis and / or paravalvular leak (PVL).

[0008] Therefore, there is a need for improved anchoring mechanisms for heart valve prostheses, as well as methods for more securely anchoring implanted heart valve prostheses via transcatheter delivery devices. Invention Overview

[0009] Embodiments of the present invention relate to a delivery device for delivering and deploying a heart valve prosthesis to a site of a damaged or diseased natural valve, the delivery device having a torque anchoring mechanism. The delivery device includes a balloon having a first uninflated configuration and a second inflated configuration. The balloon includes a shaped end configured to mate with a corresponding shaped end of the heart valve prosthesis and configured to rotate about a central longitudinal axis of the delivery device. The balloon is configured to rotate the corresponding shaped end of the heart valve prosthesis.

[0010] Embodiments of the invention also relate to a delivery device for delivering and deploying a heart valve prosthesis to the site of a damaged or diseased natural valve. The delivery device includes an inner shaft coupled to a handle and a tether shaft disposed above the inner shaft. The tether shaft includes a proximal shaft portion and multiple tethers extending from a distal portion of the proximal shaft portion. These tethers are configured to engage the proximal shaft portion of the tether shaft with an end of the heart valve prosthesis. The tether shaft is rotatable about the inner shaft and configured to cause corresponding rotation of the tethers and at least a portion of the heart valve prosthesis.

[0011] Embodiments of the present invention also relate to a method for deploying and anchoring a heart valve prosthesis at a desired implantation site using a torque anchoring mechanism. The method includes delivering a heart valve, including the torque anchoring mechanism, located in a delivery device in a radially compressed configuration to the desired implantation site. The heart valve prosthesis expands to a radially expanded configuration at the desired location. The delivery device is rotated, thereby rotating at least a portion of the heart valve prosthesis and embedding the torque anchoring mechanism into the tissue at the desired implantation site. Attached Figures

[0012] Figure 1 This is a perspective view of an embodiment of a heart valve prosthesis with a torque anchoring mechanism according to an embodiment of the present invention.

[0013] Figure 2 This is a side view of an embodiment of the delivery device according to an embodiment of the present invention.

[0014] Figure 3 yes Figure 2 An exploded perspective view of the delivery device shown.

[0015] Figure 4 yes Figure 2 A side sectional view of the delivery device shown.

[0016] Figure 5 It is along Figure 4 Line 5-5 was taken from the middle. Figure 2 A cross-sectional view of the delivery device shown.

[0017] Figure 6A It is in the delivery structure Figure 2 A side sectional view of the delivery device shown.

[0018] Figure 6B yes Figure 2 The side sectional view of the delivery device shown shows the sac retracted and the balloon in an inflated configuration.

[0019] Figure 7A This is a side sectional view of another embodiment of the delivery device in the delivery configuration.

[0020] Figure 7B yes Figure 7A The side sectional view of the delivery device shown shows the sac retracted and the balloon in an inflated configuration.

[0021] Figure 8A This is a side sectional view of another embodiment of a delivery device in a delivery configuration, the delivery device including a second balloon in an uninflated configuration.

[0022] Figure 8B yes Figure 8A The side sectional view of the delivery device shown shows the sac retracted and the balloon in an inflated configuration.

[0023] Figure 9A This is a side sectional view of another embodiment of the delivery device in the delivery configuration, wherein the delivery device includes a dumbbell-shaped balloon.

[0024] Figure 9B yes Figure 9A The side sectional view of the delivery device shown shows the sac retracted and the dumbbell-shaped balloon in an inflated configuration.

[0025] Figure 10A This is a side sectional view of another embodiment of a delivery device in a delivery configuration, wherein the delivery device includes a balloon.

[0026] Figure 10B yes Figure 10A The side sectional view of the delivery device shown shows the sac retracted and the balloon in an inflated configuration.

[0027] Figure 10C yes Figure 10BThe end view of the balloon shown.

[0028] Figure 11A-11D This is an illustration of another embodiment of a heart valve prosthesis that includes a torque anchoring mechanism.

[0029] Figure 12A-12B It is in the pre-deployment configuration and the deployed configuration. Figures 10A-10C The end view of the heart valve prosthesis shown.

[0030] Figure 12C yes Figure 11A-11C End view of an alternative embodiment of the heart valve prosthesis shown.

[0031] Figure 13 This is a perspective view of a heart valve prosthesis with a torque anchoring mechanism according to another embodiment of the present invention.

[0032] Figure 14 This is an exploded perspective view of an embodiment of a delivery device according to an embodiment of the present invention.

[0033] Figure 15 yes Figure 14 Side view of the delivery device shown.

[0034] Figure 16 yes Figure 14 The delivery device shown and Figure 13 The side view of the heart valve prosthesis shown.

[0035] Figure 17 This is an exploded perspective view of an embodiment of a delivery device according to an embodiment of the present invention.

[0036] Figure 18 yes Figure 17 Side view of the delivery device shown.

[0037] Figure 19 yes Figure 17 The delivery device shown and Figure 13 The side view of the heart valve prosthesis shown.

[0038] Figure 20-24 This is a schematic diagram of a method for delivering a heart valve prosthesis.

[0039] Figure 25-29 This is a schematic diagram of another method for delivering a heart valve prosthesis.

[0040] Figures 30-34 This is a schematic diagram of another method for delivering a heart valve prosthesis.

[0041] Figure 35 This is an illustration of another embodiment of a heart valve prosthesis that includes a torque anchoring mechanism.

[0042] Figure 36 yes Figure 35 A schematic cross-sectional view of a variant of a heart valve prosthesis.

[0043] Detailed Explanation

[0044] Specific embodiments of the invention are now described with reference to the accompanying drawings, wherein similar reference numerals indicate the same or functionally similar elements. The terms "distal" and "proximal" are used in the following description when referring to catheters or delivery devices, relative to the position or orientation of the treating physician. Thus, "distal" or "distal" refers to a position away from the treating physician or in a direction away from the treating physician, while "proximal" and "proximal" refer to a position closer to the physician or in a direction toward the physician. When the terms "distal" and "proximal" are used in the following description when referring to devices implanted in blood vessels, such as heart valve prostheses, they are used with reference to the direction of blood flow. Thus, "distal" or "distal" refers to a position in the downstream direction relative to the direction of blood flow, and "proximal" and "proximal" refer to the upstream direction relative to the direction of blood flow.

[0045] The following detailed description is exemplary in nature only and is not intended to limit the invention or its application or use. Furthermore, it is not intended to be bound by any express or implied theory presented in the foregoing description of the technical field, background art, summary of the invention, or the following detailed description.

[0046] As mentioned herein, the various systems, apparatuses, and methods according to this disclosure and / or the heart valve prostheses used as part of the various systems, apparatuses, and methods may include a variety of different constructions, such as biological prosthetic heart valves with tissue leaflets or synthetic heart valves with polymer, metal, or tissue-engineered leaflets, and may be specifically configured for replacing any heart valve.

[0047] Generally, the heart valve prostheses of this disclosure, or sometimes referred to as stented prosthetic heart valves, include a frame supporting the valve structure (tissue or synthetic), wherein the frame has a normal radially expandable configuration that can be folded into a radially compressible configuration for loading within or onto a delivery device. When released from the delivery device, the stent may be configured to self-deploy or expand, or may be balloon-expandable.

[0048] Figure 1 An embodiment of the heart valve prosthesis 10 is shown. Figure 1A heart valve prosthesis 10 in a radially expanded configuration is shown. The heart valve prosthesis 10 includes a frame 14 and a prosthetic valve 12 connected to the frame 14. The heart valve prosthesis 10 includes a radially collapsed configuration and a radially expanded configuration. The heart valve prosthesis 10 also includes a first end 26 and a second end 32 opposite to the first end 26. The frame 14 is generally tubular and defines a central channel 24, and includes a first end 34 and a second end 36. Figure 1 In the illustrated embodiment, the first end 34 of the frame 14 defines the first end 26 of the heart valve prosthesis 10. Similarly, the second end 36 of the frame 14 defines the second end 32 of the heart valve prosthesis 10. Those skilled in the art will recognize that other features, such as a skirt or arm, may be included as part of the heart valve prosthesis 10. In the illustrated embodiment, the first end 26 of the heart valve prosthesis 10 is the proximal or inflow end, and the second end 32 of the heart valve prosthesis 10 is the distal or outflow end. Furthermore, as... Figure 1 As shown, the first end 34 of the frame 14 flares outward. This outward flare at the first end 34 forms an inflow edge 15, which is configured to contact the atrial side of the natural mitral valve annulus. Further, although the inflow edge 15 is shown as generally circular, it can be other shapes that conform to the anatomy adjacent to the natural mitral valve, such as, but not limited to, a D-shape. A portion of the frame 14 can also be described as an outflow portion 25. The outflow portion 25 is generally tubular and configured to extend through the leaflets of the natural valve complex. Although the heart valve prosthesis 10 shown is configured for placement at the site of the natural mitral valve, the heart valve prosthesis 10 can also be used at other implantation sites, such as, but not limited to, other natural heart valve sites.

[0049] Frame 14 is a support structure comprising struts 16 arranged relative to each other, with a plurality of openings 17 between the struts. Frame 14 provides the desired compressibility and expansion force at the desired implantation site. Frame 14 also provides support for the prosthetic valve 12. The prosthetic valve 12 is coupled to and disposed within frame 14. Figure 1 In the illustrated embodiment, the radially outward portion of the inflow edge 15 is curved such that this radially outward portion of the inflow edge 15 extends substantially longitudinally away from the second end 36 of the frame 14. The support 16 of the inflow edge 15 is curved and forms a plurality of peaks 18 and valleys 20 at the first end of the inflow edge 15.

[0050] Multiple torque anchoring mechanisms 22 are connected to the inflow edge 15. Figure 1In the illustrated embodiment, the torque anchoring mechanism 22 is coupled to the valley 20 of the inflow edge 15, but may be coupled to other portions of the inflow edge 15. The torque anchoring mechanism 22 is configured such that when the heart valve prosthesis 10 is in a radially expanded configuration at the desired implantation site, and at least a portion of the heart valve prosthesis 10 is rotated, the torque anchoring mechanism 22 embeds into the tissue at the desired implantation site. Figure 1 As shown, the torque anchoring mechanism 22 extends clockwise. However, it may extend counterclockwise or partially at an angle in either direction. Further, the torque anchoring mechanism 22 may typically extend from the lower side 19 of the inflow edge 15. The lower side 19 of the inflow edge 15 is the surface facing the natural mitral valve annulus (i.e., the outflow-facing surface of the inflow edge) when the heart valve prosthesis 10 is deployed together with the inflow edge 15 on the atrial side of the natural mitral valve annulus. The torque anchoring mechanism 22 may be a barb, clamp, hook, arrow, or similar device configured to embed into the tissue at the desired implantation site. Although Figure 1 Each torque anchoring mechanism 22 is shown as a single wire, but this is not limiting, and other configurations of the torque anchoring mechanism may also be used.

[0051] Frame 14 may be constructed, for example but not limited to, of a nickel-titanium alloy (e.g., Nitinol), a nickel-cobalt-chromium-molybdenum alloy (e.g., MP35N), a cobalt-chromium-tungsten-nickel alloy (L605), stainless steel, high-spring tempered steel, or any other metal suitable for the purposes of this disclosure. Torque anchoring mechanism 22 may be formed of the same type of material as frame 14. Torque anchoring mechanism 22 may be an extension of strut 16, or may be attached to frame 14, for example but not limited to, by fusion, welding, adhesive, stitching, snap fitting, interference fit, other mechanical fit, or other methods suitable for the purposes described herein.

[0052] Considering the above understanding of the heart valve prosthesis 10, in Figure 2-5 The diagram illustrates a delivery device 100 consistent with the components, methods, and procedures of this disclosure. In embodiments, the delivery device 100 typically includes a handle 140, an outer shaft assembly 110 having a bladder-like element 107, an inner shaft assembly 104, and a balloon 150. Figure 2(Not shown in the image). The delivery device 100 can be any standard construction delivery device, such as, but not limited to, multi-lumen or coaxial construction delivery devices. In other embodiments, such as when using a balloon-expandable heart valve prosthesis or a self-expanding heart valve prosthesis with other devices to maintain the heart valve prosthesis in a radially collapsed configuration, the balloon 107 is not required. The guidewire lumen 123 is configured to pass through the inner shaft assembly 104 such that the delivery device 100 can advance on a guidewire (not shown) disposed within the guidewire lumen 123. The delivery device 100 can be made of any suitable material, such as, but not limited to, polyethylene (PE), polyethylene terephthalate (PET), polyether block amide (PEBA, e.g., ... Hypo tubes are made of materials such as nylon, polyurethane, polyvinyl chloride (PVC), and metals such as stainless steel.

[0053] According to an embodiment of the present invention, the delivery device 100 is used for percutaneous delivery, implantation and anchoring of a heart valve prosthesis 10 having a torque anchoring mechanism 22. Figure 2 An embodiment of the delivery device 100 is shown, wherein a heart valve prosthesis 10 in a radially collapsed configuration is disposed within a sac-like element 107 of an outer shaft assembly 110. In other embodiments, the heart valve prosthesis 10 may be mounted on a balloon without a sac-like element, or a self-expanding heart valve prosthesis may be mounted together with other devices to hold the heart valve prosthesis in a radially collapsed configuration. The delivery device 100 and the heart valve prosthesis 10 are configured such that when the heart valve prosthesis 10 is positioned at the desired implantation site and in a radially expanded configuration, rotation of the delivery device 100 causes at least a portion of the heart valve prosthesis 10 to rotate, and a torque anchoring mechanism 22 engages with the tissue at the implantation site, as will be described in more detail herein.

[0054] according to Figure 2 and Figure 3 The components of the exemplary embodiment of the delivery device 100 shown are in Figure 3-6B It is presented in more detail in [the text]. Reflected in [the text]. Figure 2-6B Furthermore, various features of the components of the delivery device 100 described below can be modified or replaced with different structures and / or mechanisms. The components of the delivery device 100 can take on different forms and configurations. Therefore, the following detailed description is not intended to be limiting. Moreover, the systems and functions described below can be implemented in many different hardware embodiments. Any actual components described are not intended to be limiting. The operation and performance of the presented systems and methods are described by understanding that modifications and variations of the embodiments are possible given the level of detail presented.

[0055] exist Figure 3-4In the embodiment shown schematically, the handle 140 may include a housing 142 and an actuator mechanism 144. More specifically, the handle 140 includes a cavity 143. Figure 4 The cavity 143 is defined by the housing 142 and configured to receive portions of the actuator mechanism 144. Figure 2-4 In the illustrated embodiment, the housing 140 may include a longitudinal slot 146 through which an actuator mechanism 144 extends for user interaction. The handle 140 provides a surface for easy user operation and gripping and may have a generally cylindrical shape as shown. Although Figure 2-4 The handle 140 shown is depicted as having a cylindrical shape, but this is not intended to limit the design, and other shapes and sizes are conceivable depending on application requirements. The actuator mechanism 144 is generally configured to provide selective retraction / advancement of the outer shaft assembly 110. Although shown as a sliding mechanism, other configurations and / or devices can be used to retract / advance the outer shaft assembly 110, such as, but not limited to, rotary mechanisms, sliding mechanisms coaxially disposed on the inner shaft assembly 104, combinations of rotary and sliding mechanisms, and other advance / retraction mechanisms known to those skilled in the art.

[0056] The outer shaft assembly 110 is slidably mounted on the inner shaft assembly 104. (See reference...) Figure 3-4In an embodiment, the outer shaft assembly 110 includes a proximal shaft 118 and a capsule 107, and defines an inner cavity 112 extending from a proximal end 130 of the proximal shaft 118 to a distal end 132 of the capsule 107. Although the outer shaft 110 is described herein as including a capsule 107 and a proximal shaft 118, the capsule 107 may simply be an extension of the proximal shaft 118. Further, the outer shaft 110 may be referred to as a sheath or outer sleeve. The proximal shaft 118 is configured to be securely connected to the capsule 107 at a connection point 116 at a proximal end 109 of the capsule 107 by fusion, welding, adhesive, sutures, or other means suitable for the purposes described herein. Alternatively, the proximal shaft 118 and the capsule 107 may be integral. The proximal shaft 118 extends proximally from the capsule 107 and is configured for connection to a handle 140. More specifically, the proximal shaft 118 extends proximally into the housing 142 of the handle 140, and the proximal portion 131 of the proximal shaft 118 is connected to the actuator mechanism 144 of the handle 140. The proximal portion 131 is connected to the actuator mechanism 144 such that movement of the actuator mechanism 144 causes the outer shaft assembly 110 to move relative to the inner shaft assembly 104. The proximal shaft 118 may, for example and not limited to, be connected to the actuator mechanism 144 by adhesives, welding, clamping, and other suitable coupling means. Thus, the outer shaft assembly 110 can move relative to the handle 140 and the inner shaft assembly 104 via the actuator mechanism 144. However, if the actuator mechanism 144 is not moving and the handle 140 is moving, the outer shaft assembly 110 moves with the handle 140, rather than relative to the handle 140.

[0057] Such as at least in Figure 4 As shown, the inner shaft assembly 104 extends within the lumen 112 of the outer shaft assembly 110. The inner shaft assembly 104 includes an inner shaft 114, a distal end 122, and a balloon 150, which will be described in more detail below. The inner shaft 114 extends from a proximal end 134 to a distal end 136. The distal end 136 of the inner shaft 114 is attached to the distal end 122. The components of the inner shaft assembly 104 are combined to define a guidewire lumen 123, which is dimensioned to receive auxiliary components such as a guidewire (not shown) and an expansion lumen 192, which will be described in more detail below. In the illustrated embodiment, the delivery device 100 includes an on-the-line (OTW), multi-lumen configuration in which the guidewire lumen 123 extends substantially along the entire length of the inner shaft assembly 104. However, other configurations, such as a quick-change configuration, may also be used. The proximal end 134 of the inner shaft 114 may be attached to the handle 140, or to another device such as an interface. The inner shaft 114 may be attached to the handle 140, for example, but not limited to, by adhesives, welding, clamping, and other suitable coupling means. During sliding or longitudinal movement of the outer shaft assembly 110 relative to the inner shaft assembly 104, the inner shaft 114 may be fixed relative to the handle 140.

[0058] As previously described, the inner shaft assembly 114 includes an expansion cavity 192 and a guidewire cavity 123 extending through the inner shaft assembly. Figure 5 A cross-sectional view of the inner shaft 114 disposed within the outer shaft assembly 110 is shown. (See figure) Figure 5 As shown, the guidewire lumen 123 and the expansion lumen 192 extend through the inner shaft 114. In the illustrated embodiment, the expansion lumen 192 and the guidewire lumen 123 are two cavities extending through a single shaft. Of course, other structures can also be used.

[0059] Figure 6A and 6B The distal portion of the delivery device 100 is shown, in which the heart valve prosthesis 10 is disposed in a delivery configuration. The heart valve prosthesis 10 is disposed within the sac-like element 107 of the outer axis assembly 110 and on the inner axis 114. A balloon 150 is disposed proximally to the heart valve prosthesis 10 and coupled to the inner axis 114. Figure 6A In the delivery configuration shown, the balloon 150 is disposed within the outer shaft assembly 110. Figure 6A and 6B In the illustrated embodiment, the proximal end 154 of the balloon 150 is attached to the inner shaft 114 at a proximal junction 155. Similarly, the distal end 156 of the balloon 150 is attached to the inner shaft 114 at a distal junction (not shown). The inner shaft 114 extends distally beyond the distal junction of the balloon 150 / inner shaft 114. The inflatable lumen 192 includes an inflatable port 196 that opens into the interior 151 of the balloon 150.

[0060] The distal end 156 of the balloon 150 can also be described as a shaping end 152. The shaping end 152 is shaped to form a first end 34 of the frame 14 that fits the heart valve prosthesis 10. In an embodiment, the shaping end 152 includes a plurality of distally extending peaks 158 and proximally extending valleys 160. The peaks 158 and valleys 160 extend from the central longitudinal axis LA. C Radially spaced apart. Peaks 158 and valleys 160 can be arranged opposite peaks 18 and valleys 20 of the first end 34 of frame 14; specifically, Figure 1 The radially outer portion of the inflow edge 15 shown. For example... Figure 6A As shown, the balloon 150 is in an uninflated configuration and is disposed within the outer shaft assembly 110 for delivery, and as Figure 6BAs shown, it inflates to an inflated configuration to fit and rotate the frame 14. The balloon 150 can be a compliant, high-friction balloon made of any suitable material such as, but not limited to, polyethylene terephthalate (PET), nylon, or polyurethane. Furthermore, the balloon 150 may include a three-dimensional pattern or texture on its outer surface to increase the fit (frictional contact) with the heart valve prosthesis 10 when the balloon is in the second (inflated) configuration.

[0061] Based on the above understanding of the components, the operation and interaction of the components of this disclosure can be explained herein. For example... Figure 6A As shown, the heart valve prosthesis 10 is disposed within the sac 107 of the external shaft assembly 110 in a radially compressible configuration. The balloon 150 is also uninflated. The delivery device 100 is delivered to the implantation site, such as the site of a natural mitral valve. Upon arrival at the implantation site, the external shaft assembly 110 retracts proximally, thereby retracting the sac 107 proximally. The sac 107 retracts sufficiently proximally to expose the heart valve prosthesis 10. In the illustrated embodiment, the heart valve prosthesis 10 is self-expanding. Therefore, the retraction of the sac 107 allows the heart valve prosthesis 10 to self-expand to a radially expandable configuration. The sac 107 may retract further proximally, or may have initially retracted further so that the balloon 150 is not covered by the sac 107. Figure 6B As shown, an expanding fluid, such as but not limited to saline, is injected through the expanding cavity 192 into the expanding port 196 and into the interior 151 of the balloon 150, thereby inflating the balloon 150. If necessary, the delivery device 100 can be rotated to align the shaped end 152 of the balloon 150 with the shaped first end 34 of the frame 14 of the heart valve prosthesis 10. Figure 6B As shown, if necessary, the delivery device 100 can also be advanced longitudinally such that the shaping end 152 of the balloon 150 engages with the first shaping end 34 of the frame 14 of the heart valve prosthesis 10. In the engagement embodiment, the peak 158 of the balloon 150 engages with the corresponding valley 20 of the heart valve prosthesis 10, and the valley 160 of the balloon 150 engages with the corresponding peak 18 of the heart valve prosthesis 10.

[0062] With the shaped end 152 of the balloon 150 engaging with the shaped first end 24 of the frame 14 of the heart valve prosthesis 10, the delivery device 100 can be positioned relative to the central longitudinal axis LA. C Along direction R r Rotation causes the shaped end 152 of the balloon 150 to rotate along direction R. r Rotation causes the forming end 152 to rotate along direction R. r A rotational torque is applied to the corresponding shaped first end 34 of the frame 14. This rotational torque causes the heart valve prosthesis 10 to move along the direction R. rRotation causes the torque anchoring mechanism 22 to embed into the tissue at the desired implantation site. In other words, with the balloon 150 inflated, the heart valve prosthesis 10 in a radially expanded configuration, and the shaped end 152 of the balloon 150 engaging with the shaped first end 26 of the heart valve prosthesis 10, the delivery device 100 moves along the direction R... r Rotation is used to embed the torque anchoring mechanism 22 into the tissue, thereby anchoring the heart valve prosthesis 10 to the tissue at the desired implantation site. The balloon 150 can then be deflated and the delivery device 100 can be withdrawn from the patient, leaving the heart valve prosthesis 10 implanted at the desired implantation site.

[0063] Figures 6A-6B Specific embodiments of the balloon 150 and the heart valve prosthesis 10 are shown. As explained above, this specific embodiment is not intended to limit the design. Thus, for example, but not in a limiting sense, the shaped end 152 of the balloon 150 may be located at the proximal end 154 instead of the distal end 156, and the heart valve prosthesis 10 may be positioned proximal to the balloon 150 such that the proximal end 154 of the balloon 150 can mate with the shaped distal end of the heart valve prosthesis 10. Further, Figure 6A and 6B The specific number of peaks 158 and valleys 160 in the balloon 150 shown is merely an example, and these numbers may be increased or decreased to match the corresponding number of peaks and valleys in the shaped end of the heart valve prosthesis 10.

[0064] Figures 7A-7B The distal portion of another embodiment of a delivery device 100' for delivering and deploying a heart valve prosthesis 10 is shown. The delivery device 100' is similar to... Figures 6A-6B The embodiments shown are for illustrative purposes only; therefore, only the differences between these embodiments will be described in detail here. Features not specifically described may be found in the references. Figures 6A-6B The features described in the illustrated embodiments, or other embodiments described herein, are the same. Figures 7A-7B In the illustrated embodiment, as an alternative to the inner shaft having a guidewire lumen 123 and an expansion lumen 192 as described above, the inner shaft assembly 104' includes a guidewire shaft 114' having an expansion shaft 190 coaxially disposed on the guidewire shaft 114'. The guidewire lumen 123' extends through the guidewire shaft 114', and the expansion lumen 192' is defined between the outer surface of the guidewire shaft 114' and the inner surface of the expansion shaft 190.

[0065] exist Figures 7A-7BIn the illustrated embodiment, the proximal end 154 of the balloon 150 is attached to the expansion shaft 190 at a proximal junction 155'. The expansion shaft 190 terminates before the distal end 156 of the balloon 150, such that an expansion port 196' is formed between the distal end 194 of the expansion shaft and the guidewire shaft 114'. The distal end 156 of the balloon 150 is attached to the guidewire shaft 114' at a distal junction (not shown). Figure 7B As shown, when the expansion fluid is injected into the expansion cavity 192', the expansion fluid leaves the expansion cavity 192' through the expansion port 196' and enters the interior 151 of the balloon 150, thereby inflating the balloon 150.

[0066] Figures 8A-8B The distal portion of another embodiment of the delivery device 100” is shown. The delivery device 100” includes a first balloon 150 and a second balloon 162. Figure 8A A delivery device 100 with a heart valve prosthesis 10 is shown, the heart valve prosthesis 10 including a torque anchoring mechanism 22 disposed therein. Figure 8A A delivery device 100” in a delivery configuration is shown, the delivery device 100” having a first balloon 150, a second balloon 162 and a heart valve prosthesis 10 disposed within an outer shaft assembly 110 such that the first balloon 150 and the second balloon 162 are not inflated and the heart valve prosthesis 10 is in a radially compressed configuration.

[0067] Delivery device 100” is similar to delivery device 100, except that a second balloon 162 is added and an inflatable cavity 192” extends distally to the second balloon 162. Therefore, except for the differences specifically noted below, the components of delivery device 100” are comparable to those of delivery device 100”. Figure 2-6B The corresponding elements shown are the same or similar. Specifically, the proximal portion of the delivery device 100” is not described in detail, but may be similar to the following reference. Figure 2-4 The proximal portion of the described delivery device 100.

[0068] like Figures 8A-8B As shown, the second balloon 162 includes a proximal end 164 attached to the inner shaft 114 at a proximal junction 163 and a distal end 166 attached to the inner shaft 114 at a distal junction 165. The second balloon 162 is positioned distal to the heart valve prosthesis such that the proximal end 164 of the second balloon is adjacent to the second end 32 of the heart valve prosthesis 10. The first balloon 150 is positioned proximal to the heart valve prosthesis 10 and connected to the inner shaft 114. Figure 8A In the delivery configuration shown, the balloon 150 is disposed within the outer shaft assembly 110. For example... Figures 8A-8BIn the illustrated embodiment, the proximal end 154 of the first balloon 150 is attached to the inner shaft 114 at the proximal junction 155, and the distal end 156 of the balloon 150 is attached to the inner shaft 114 at the distal junction 157. The inner shaft 114 extends distally beyond the distal junction 155.

[0069] The expansion cavity 192” of the inner shaft 114 extends distally to a second expansion port 208, which opens into the interior of the second balloon 162. The second expansion port 208 is located between the proximal end 164 and the distal end 166 of the second balloon 162, allowing expansion fluid injected through the expansion cavity 192” to exit the second expansion portion 208 and enter the interior of the second balloon 162, thereby inflating the second balloon 162. (As in...) Figures 6A-6B As shown in the embodiment, the expansion fluid injected into the expansion cavity 192” enters the interior 151 of the first balloon 150 from the expansion portion 196”, thereby inflating the first balloon 150.

[0070] As in Figures 6A-6B As shown in the embodiment, the distal end 154 of the balloon 150 is a shaped end 152, which is shaped to fit the first end 34 of the frame 14 of the heart valve prosthesis 10. In this embodiment, the shaped end 152 includes a plurality of distally extending peaks 158 and proximally extending valleys 160. The peaks 158 and valleys 160 extend from the central longitudinal axis LA. C They are radially spaced apart. Peaks 158 and valleys 160 are arranged opposite peaks 18 and valleys 20 at the first end 34 of frame 14. (As shown) Figure 8A As shown, the first balloon 150 is in an uninflated configuration and is disposed within the outer shaft assembly 110 for delivery, and as Figure 8B As shown, it inflates to its inflated configuration to fit and rotate the frame 14. The first balloon 150 can be a compliant, high-friction balloon made of any suitable material such as, but not limited to, polyethylene terephthalate (PET), nylon, or polyurethane.

[0071] Based on the above understanding of the components, the operation and interaction of the components of this disclosure can be explained herein. For example... Figure 8AAs shown, the heart valve prosthesis 10 is disposed within the sac 107 of the external shaft assembly 110 in a radially compressible configuration. The first balloon 150 and the second balloon 162 are not inflated. The delivery device 100” is delivered to the implantation site, such as the site of a natural mitral valve. Upon arrival at the implantation site, the external shaft assembly 110 retracts proximally, thereby retracting the sac 107 proximally. The sac 107 retracts sufficiently proximally to expose the heart valve prosthesis 10. In the illustrated embodiment, the heart valve prosthesis 10 is self-expanding. Therefore, the retraction of the sac 107 allows the heart valve prosthesis 10 to self-expand to a radially expandable configuration. The sac 107 may retract further proximally, or may have initially retracted further so that the first balloon 150 is not covered by the sac 107. Figure 8B As shown, an expanding fluid, such as but not limited to saline, is injected through the expanding cavity 192”, exits from the expanding ports 196’ and 206, and enters the interiors 151 of the first balloon 150 and the interiors of the first balloon 162, thereby inflating the first balloon 150 and the second balloon 162. If necessary, the delivery device 100” can be rotated to align the shaped end 152 of the first balloon 150 with the shaped first end 34 of the frame 14 of the heart valve prosthesis 10. Figure 8B As shown, if necessary, the delivery device 100 can also be advanced longitudinally such that the shaped end 152 of the first balloon 150 engages with the shaped first end 34 of the frame 14 of the heart valve prosthesis 10. In the engagement embodiment, the peak 158 of the first balloon 150 engages with the corresponding valley 20 of the heart valve prosthesis 10, and the valley 160 of the first balloon 150 engages with the corresponding peak 18 of the heart valve prosthesis 10. Specifically, the shaped end 152 of the first balloon 150 engages with the peak and valley of the radially outwardly curved portion of the inflow edge 15 of the heart valve prosthesis 10.

[0072] like Figure 8B As shown, when the second balloon 162 inflates, the proximal end 164 can engage the distal end 32 of the heart valve prosthesis 10 when the heart valve prosthesis 10 is in a radially expanded configuration. The second balloon 162 is configured to, relative to the delivery device 100” along the central longitudinal axis LA, when the heart valve prosthesis 10 rotates and the torque anchoring mechanism 22 is embedded in the tissue at the desired implantation site. C Provides longitudinal stability for the heart valve prosthesis 10. The second balloon 162 may be a compliant, high-friction balloon made of any suitable material such as, but not limited to, polyethylene terephthalate (PET), nylon, or polyurethane.

[0073] With the shaped end 152 of the first balloon 150 engaging with the shaped first end 24 of the frame 14 of the heart valve prosthesis 10 and the second balloon 162 abutting the second end 36 of the frame 14, the delivery device 100” can be positioned relative to the central longitudinal axis LA. CAlong direction R r Rotation causes the shaped end 152 of the first balloon 150 to rotate along direction R. r Rotation causes the forming end 152 to rotate along direction R. r A rotational torque is applied to the corresponding shaped first end 34 of the frame 14. This rotational torque causes the heart valve prosthesis 10 to move along the direction R. r Rotation causes the torque anchoring mechanism 22 to embed into the tissue at the desired implantation site. In other words, with the first balloon 150 and the second balloon 162 inflated, the heart valve prosthesis 10 in a radially expanded configuration, and the shaped end 152 of the balloon 150 engaging with the shaped first end 26 of the heart valve prosthesis 10, the delivery device 100" moves along the direction R... r Rotation is used to embed the torque anchoring mechanism 22 into the tissue, thereby anchoring the heart valve prosthesis 10 to the tissue at the desired implantation site. Then, the first balloon 150 and the second balloon 162 can be deflated and the delivery device 100 can be withdrawn from the patient, leaving the heart valve prosthesis 10 implanted at the desired implantation site.

[0074] Figures 8A-8B The expansion cavity 192” extending through the inner shaft 114 and the guidewire cavity 123 are shown, similar to Figures 6A-6B The embodiment shown. However, as an alternative to a single inflatable cavity 192", two inflatable cavities may exist; one for the first balloon 150 and the other for the second balloon 162. Furthermore, as an alternative to multiple cavities passing through the inner shaft, multiple coaxial inner shafts having one or more annular cavities can be used, similar to... Figures 7A-7B The illustrated embodiment. In this embodiment, a single expansion shaft can be used in conjunction with an expansion lumen between the guidewire shaft and the expansion shaft. The expansion shaft extends to a second balloon, with an expansion port passing through the expansion shaft at the first balloon and the expansion port opening at the second balloon. Alternatively, two annular expansion shafts can be used, one terminating at the first balloon and the second at the second balloon. Other arrangements of the guidewire lumen and expansion lumen are possible, as will be understood by those skilled in the art.

[0075] Figures 9A-9B The distal portion of another embodiment of the delivery device 100”' is shown. The delivery device 100”' includes a dumbbell-shaped balloon 170. Figure 9A A delivery device 100”' with a heart valve prosthesis 10 is shown, the heart valve prosthesis 10 including a torque anchoring mechanism 22 disposed therein. Figure 9A A delivery device 100”' in a delivery configuration is shown, the delivery device 100”' having a dumbbell-shaped balloon 170 and a heart valve prosthesis disposed within an external shaft assembly 110, wherein the dumbbell-shaped balloon 170 is not inflated and the heart valve prosthesis 10 is in a radially compressed configuration.

[0076] Delivery device 100”' is similar to Figure 2-6B The delivery device 100 shown is modified except that the dumbbell-shaped balloon 170 replaces... Figures 9A-9B The balloon 150 shown and Figures 9A-9B The expansion cavity 210 shown is... Figure 2-6B The expansion cavity 192 shown is different. Therefore, apart from the differences specifically pointed out below, the elements of the delivery device 100”’ are different. Figure 2-6B The corresponding elements shown are the same or similar. Specifically, the proximal portion of the delivery device 100”’ is not described in detail, but may be similar to the following reference. Figure 2-4 The proximal portion of the described delivery device 100.

[0077] like Figure 9B As shown, the dumbbell-shaped balloon 170 includes a first portion 172, a second portion 180, and a third portion 186 disposed between the first portion 172 and the second portion 180. Figure 9A As shown, the proximal end 176 of the first portion 172 is attached to the inner shaft 114 at the proximal junction 175, and the distal end 184 of the second portion 180 is attached to the inner shaft 114 at the distal junction 185. The first portion 172 of the balloon 170 is positioned proximal to the heart valve prosthesis 10, and the second portion 180 is positioned distal to the heart valve prosthesis 10. The third portion 186 of the dumbbell-shaped balloon 170 is positioned below the heart valve prosthesis 10. In other words, the heart valve prosthesis 10 is positioned on the third (middle) portion 186 of the dumbbell-shaped balloon 170. Figure 9A In the delivery configuration shown, a dumbbell-shaped balloon 170 is disposed within the outer shaft assembly 110. Figures 9A-9B In the illustrated embodiment, the dumbbell-shaped balloon 170 is a single balloon whose shape forms the aforementioned portions and is described in more detail below. However, the dumbbell-shaped balloon 170 may alternatively be three separate balloons. Alternatively, the dumbbell-shaped balloon 170 may be a single balloon, and the three portions described above may be separate compartments of the balloon.

[0078] Figures 9A-9B The inner shaft assembly 104 shown is similar to Figures 6A-6B The illustrated inner shaft assembly 104 includes an inner shaft 114 having a guidewire lumen 123 extending therethrough and an inflatable lumen 210. The inflatable lumen 210 is in fluid communication with a dumbbell-shaped balloon 170. Figures 9A-9BIn the illustrated embodiment, the inflatable cavity includes a first inflatable portion 216 in fluid communication with a first portion 172, a second inflatable port 218 in fluid communication with a second portion 180, and a third inflatable portion 220 in fluid communication with an opening in a third portion 186. However, if the dumbbell-shaped balloon 170 is a single balloon with a single interior, as described above, an inflatable portion for each portion is not required. If each portion of the dumbbell-shaped balloon 170 is a separate balloon or these portions are separate compartments, at least three inflatable ports are required, one for each balloon / compartment.

[0079] like Figure 9B As shown, the distal end 178 of the first portion 172 of the dumbbell-shaped balloon 172 is a shaped end 174, which is shaped to fit the first end 34 of the frame 14 of the heart valve prosthesis 10. In an embodiment, the shaped end 174 includes a plurality of peaks 175 extending distally and a plurality of valleys 177 extending proximally. The peaks 175 and valleys 177 are located from the central longitudinal axis LA. C They are radially spaced apart. Peaks 175 and valleys 177 are arranged opposite peaks 18 and valleys 20 at the first end 34 of frame 14. (As shown) Figure 9A As shown, the dumbbell-shaped balloon 170 is in an uninflated configuration and is disposed within the outer shaft assembly 110 for delivery, and as... Figure 9B As shown, it inflates to its inflated configuration to fit and rotate the frame 14. The dumbbell-shaped balloon 170 can be a compliant, high-friction balloon made of any suitable material such as, but not limited to, polyethylene terephthalate (PET), nylon, or polyurethane.

[0080] Figure 9B A dumbbell-shaped balloon 170 in its inflated configuration is shown. A first portion 172 of the dumbbell-shaped balloon 170 has a first expansion diameter Df in its inflated configuration. A second portion 180 of the dumbbell-shaped balloon 170 has a second expansion diameter D in its inflated configuration. S The proximal end 182 of the second portion 180 is configured such that it abuts the second end 32 of the heart valve prosthesis 10. The second portion 180 is configured such that, when the heart valve prosthesis 10 is rotated and the torque anchoring mechanism 22 is embedded in the tissue at the desired implantation site, it moves relative to the delivery device 100 along the central longitudinal axis LA. CProvides longitudinal stability for the heart valve prosthesis 10. In other words, when the second portion 180 of the dumbbell-shaped balloon 170 is in the inflated configuration, the second portion 180 is configured to prevent the shaped end 26 of the heart valve prosthesis 10 from disengaging from the shaped end 174 of the first portion 172 of the dumbbell-shaped balloon 170. When in the inflated configuration, the third portion 186 of the dumbbell-shaped balloon 170 has a third expansion diameter Dt. The third portion 186 is configured such that when the third portion 186 is in the inflated configuration, its outer surface 189 engages with the inner surface of the heart valve prosthesis 10. In other words, when the third portion 186 of the dumbbell-shaped balloon 170 is in the inflated configuration, the third portion 186 extends from the central longitudinal axis LA. C A radial force is provided outward to support the frame 14 of the heart valve prosthesis 10. When the first portion 172, the second portion 180, and the third portion 186 are all in the inflated configuration, the third expansion diameter Dt is smaller than the first expansion diameter Df and the second expansion diameter D. S .

[0081] Based on the above understanding of the components, the operation and interaction of the components of this disclosure can be explained herein. For example... Figure 9A As shown, the heart valve prosthesis 10 is disposed within the sac-like portion 107 of the outer shaft assembly 110 in a radially compressible configuration. The dumbbell-shaped balloon 170 is uninflated. In other embodiments, specifically in embodiments where the third portion 186 of the dumbbell-shaped balloon 170 mates with the inner surface of the heart valve prosthesis 10, the sac-like portion 107 may be excluded. Specifically, the heart valve prosthesis 10 may be balloon-expandable. The delivery device 100”’ is delivered to the implantation site, such as the site of a natural mitral valve. Upon arrival at the implantation site, the outer shaft assembly 110 retracts proximally, thereby retracting the sac 107 proximally. The sac 107 retracts sufficiently proximally to expose the heart valve prosthesis 10. In the illustrated embodiment, the heart valve prosthesis 10 is self-expanding. Therefore, the retraction of the sac 107 allows the heart valve prosthesis 10 to self-expand to a radially expanded configuration. The sac 107 may retract further proximally, or may have initially retracted further, such that the first portion 172 of the dumbbell-shaped balloon 170 is not covered by the sac 107. Figure 9BAs shown, an expanding fluid, such as, but not limited to, saline, is injected through the expanding cavity 210, exits from the expanding ports 216, 218, and 220, and enters the first portion 172, the second portion 180, and the third portion 186 of the dumbbell-shaped balloon 170, thereby inflating the dumbbell-shaped balloon 170. In other embodiments, the heart valve prosthesis 10 may be balloon-expandable and the balloon 107 may be removable. When such a delivery device is at the implantation site, the dumbbell-shaped balloon 170 inflates, thereby expanding the heart valve prosthesis 10. The shaped end 174 of the first portion 172 is aligned with the shaped first end 34 of the frame 14 of the heart valve prosthesis 10. In an embodiment, the peak 175 of the first portion 172 of the dumbbell-shaped balloon 170 mates with the corresponding valley 20 of the heart valve prosthesis 10, and the valley 177 of the dumbbell-shaped balloon 170 mates with the corresponding peak 18 of the heart valve prosthesis 10. Furthermore, the proximal end 182 of the second portion 180 of the dumbbell-shaped balloon 170 is adjacent to the second end 34 of the heart valve prosthesis 10. In an embodiment, when the balloon 170 is in the second (inflated) configuration, the heart valve prosthesis 10 is compressibly held between the first portion 172 and the third portion 186 of the balloon 170.

[0082] With the shaped end 174 of the first portion 172 of the dumbbell-shaped balloon 170 engaging with the shaped first end 24 of the frame 14 of the heart valve prosthesis 10 and the second portion 180 of the dumbbell-shaped balloon 170 abutting the second end 36 of the frame 14, the delivery device 100”’ can be positioned relative to the central longitudinal axis LA. C Along direction R r Rotation causes the dumbbell-shaped balloon 170 to rotate along direction R. r Rotation causes the forming end 174 to rotate along direction R. r A rotational torque is applied to the corresponding shaped first end 34 of the frame 14. This rotational torque causes the heart valve prosthesis 10 to rotate in the direction Rr, causing the torque anchoring mechanism 22 to embed into the tissue at the desired implantation site. In other words, with the dumbbell-shaped balloon 170 inflated, the heart valve prosthesis 10 in a radially expanded configuration, and the shaped end 174 of the first portion 172 of the dumbbell-shaped balloon 170 engaging with the shaped first end 26 of the heart valve prosthesis 10, the delivery device 100" moves in the direction Rr. r Rotation is used to embed the torque anchoring mechanism 22 into the tissue, thereby anchoring the heart valve prosthesis 10 to the tissue at the desired implantation site. The dumbbell-shaped balloon 170 can then be deflated and the delivery device 100”’ can be withdrawn from the patient, leaving the heart valve prosthesis 10 implanted at the desired implantation site.

[0083] Figures 10A-10C The distal portion of another embodiment of the delivery device 100”” is shown. The delivery device 100”” includes a balloon 250. Figure 10A A delivery device 100” with a heart valve prosthesis 10 is shown, the heart valve prosthesis 10 including a torque anchoring mechanism 22 disposed therein. Figure 10B ). Figure 10A A delivery device 100”””””””””””””””””””””””””””””””””””””. 250”””””””””””””””””””””””””””””" ...

[0084] Delivery device 100” is similar to Figure 2-6B The delivery device 100 shown is an alternative to balloon 150, except that balloon 250 replaces balloon 150 and is disposed within the heart valve prosthesis 10. Therefore, except for the differences specifically pointed out below, the components of the delivery device 100 are similar to... Figure 2-6B The corresponding elements shown are the same or similar. Specifically, the proximal portion of the delivery device 100” is not described in detail, but may be similar to the following reference. Figure 2-4 The proximal portion of the described delivery device 100.

[0085] like Figure 10A As shown, the proximal end 254 of the balloon 255 is attached to the inner shaft 114 at the proximal junction 254, and the distal end 166 is attached to the inner shaft 114 at the distal junction 256. The balloon 250 is positioned below (within) the heart valve prosthesis 10. In other words, the heart valve prosthesis 10 is positioned on the balloon 250. Figure 10A In the delivery configuration shown, the balloon 250 is therefore disposed within the outer shaft assembly 110.

[0086] Figures 10A-10B The inner shaft assembly 104 shown is similar to Figures 6A-6B The inner shaft assembly 104 shown includes an inner shaft 114 having a guidewire lumen 123 extending therethrough and an inflatable lumen 192. The inflatable lumen 192 is in fluid communication with a balloon 250. Figures 10A-10B In the illustrated embodiment, the inflatable cavity 192 includes an inflatable port 196 in fluid communication with the balloon 250.

[0087] like Figure 10B As shown, and as Figure 10C As shown in more detail, the outer surface 253 of the balloon 250 includes a shaped portion 252. In an embodiment, the shaped portion 252 is configured to extend into the opening space 17 and engage with the frame 14 of the heart valve prosthesis 10 when the balloon 250 is inflated. In an embodiment, the shaped portion 252 includes a plurality of protrusions 258 extending radially outward from the outer surface 253 of the balloon 250. The heart valve prosthesis 10 is loaded onto the balloon 250 such that the protrusions 258 are arranged relative to corresponding opening spaces 17 of the frame 14. Figure 10AAs shown, the balloon 250 is in an uninflated configuration and is disposed within the outer shaft assembly 110 for delivery, and inflates to an inflated configuration such that each protrusion 258 extends radially through the corresponding opening space 17. Figure 10B As shown, when in the inflated configuration, the outer surface of each protrusion 258 engages with the adjacent strut 16, causing the balloon 250 to rotate within the frame 14 and rotate the frame 14. The balloon 250 can be a compliant, high-friction balloon made of any suitable material such as, but not limited to, polyethylene terephthalate (PET), nylon, or polyurethane.

[0088] Figure 10B The balloon 250 in its inflated configuration is shown. The balloon 250 is further configured such that, when in its inflated configuration, the outer surface 253 of the balloon 250 engages with the inner surface of the heart valve prosthesis. Therefore, when in its inflated configuration, the balloon 250 extends from its central longitudinal axis LA. C A radial force is provided outward to support the frame 14 of the heart valve prosthesis 10 and to be configured to engage the frame 14 and allow the frame 14 to rotate.

[0089] Based on the above understanding of the components, the operation and interaction of the components of this disclosure can be explained herein. For example... Figure 10A As shown, the heart valve prosthesis 10 is disposed within the sac 107 of the external shaft assembly 110 in a radially compressible configuration. The balloon 250 is in an uninflated configuration and disposed within the heart valve prosthesis 10. In other embodiments, as described above, the sac 107 may be excluded. The delivery device 100 is delivered to the implantation site, such as the site of a natural mitral valve. Upon arrival at the implantation site, the external shaft assembly 110 retracts proximally, thereby retracting the sac 107 proximally. The sac 107 retracts sufficiently proximally to expose the heart valve prosthesis 10 and the balloon 250 therein. In the illustrated embodiment, the heart valve prosthesis 10 is self-expanding. Therefore, the retraction of the sac 107 allows the heart valve prosthesis 10 to self-expand into a radially expandable configuration. Figure 10B As shown, an expanding fluid, such as, but not limited to, saline, is injected through the expanding lumen 192 into the expanding port 196 and into the interior of the balloon 250, thereby inflating the balloon 250 (transforming it from an uninflated configuration to an inflated configuration). In other embodiments, the heart valve prosthesis 10 may be balloon-expandable and the balloon 107 may be removable. When such a delivery device is at the implantation site, the balloon 250 inflates, thereby expanding the heart valve prosthesis 10. The protrusion 258 of the shaped portion 252 of the balloon 250 is aligned with the opening space 17 between the adjacent struts 16 of the frame 14 of the heart valve prosthesis 10.

[0090] With the shaped portion 252 of the balloon 250 engaging with the strut 16 and opening space 17 of the frame 14 of the heart valve prosthesis 10, the delivery device 100”” can be positioned relative to the central longitudinal axis LA. C Along direction R r Rotation, thereby causing the balloon 250 to rotate in direction R r Rotation causes the forming portion 252 to apply a rotational torque along the direction Rr to the corresponding forming frame 14 that it mates with. This rotational torque causes the heart valve prosthesis 10 to rotate along the direction Rr. r Rotation causes the torque anchoring mechanism 22 to embed into the tissue at the desired implantation site. In other words, with the balloon 250 inflated, the heart valve prosthesis 10 in a radially expanded configuration, and the shaped portion 252 of the balloon 250 engaging with the frame 14 of the heart valve prosthesis 10, the delivery device 100 moves along the direction R... r Rotation is used to embed the torque anchoring mechanism 22 into the tissue, thereby anchoring the heart valve prosthesis 10 to the tissue at the desired implantation site. The balloon 250 can then be deflated and the delivery device 100”” can be withdrawn from the patient, leaving the heart valve prosthesis 10 implanted at the desired implantation site.

[0091] Features of any of the above embodiments can be used in conjunction with any of the other embodiments described above. Furthermore, the number of balloons, inflatable lumens, inflatable ports, and similar objects can be varied within the scope of the invention. For example, and not limited to, the delivery device described above and below may also include an external stabilizing shaft disposed outside the external shaft assembly 110. Further details of the delivery device can be found as described in U.S. Patent Nos. 8,414,645, 8,876,893, and 8,926,692 to Dwork, each of which is incorporated herein by reference in its entirety. Other materials besides those described above may also be used within the scope of the invention.

[0092] Figure 11A-11D Figures 12A-12B illustrate another embodiment of a heart valve prosthesis 500 including a torque anchoring mechanism 530. The heart valve prosthesis 500 includes a frame 502 and a prosthetic heart valve 504 attached to the frame 502 (see Figure 12A-12B). Figure 11C-11DThe prosthetic heart valve 504 can be any suitable prosthetic heart valve known to those skilled in the art, and can be bileaf, trileaf (shown), or any other suitable design. The frame 502 may include an inflow edge 510 and an outflow tube 520. The inflow edge 510 and the outflow tube 520 need not be separate components and can generally be integral, wherein the inflow edge 510 flares radially outward from the outflow tube 520. The frame 502 including the inflow edge 510 and the outflow tube 520 may be formed from a plurality of struts 512, with spaces or openings 513 formed between the struts, as known to those skilled in the art. The frame 502 can be radially compressed for delivery and radially expanded for deployment at the treatment site. Figure 11A-11D Figures 12A-12B show a frame 502 in a radially expanding configuration. The frame 502 may be self-expanding or balloon-expandable. The frame 502 may be made of, but is not limited to, nickel-titanium alloys (e.g., Nitinol), nickel-cobalt-chromium-molybdenum alloys (e.g., MP35N), stainless steel, high-spring tempered steel, or any other metal or other material suitable for the purposes of this disclosure.

[0093] Frame 502 defines a first or inflow end 506 and a second or outflow end 508 of the heart valve prosthesis 500. Frame 502 is generally tubular and defines a central channel 524 through which it passes. Figure 11C and 11D As shown, the prosthetic valve 504 is disposed in the central channel 504.

[0094] like Figure 11A-11D As shown in 12A-12B, the torque anchoring mechanism 530 of the heart valve prosthesis 500 includes a ring 532 having a plurality of barbs 534 extending radially outward from the ring 532. In the illustrated embodiment, the ring 532 is disposed on (around) the outflow tube 520 such that the inner surface of the ring 532 surrounds the outer surface of the outflow tube 520. The ring 532 is rotatable relative to the outflow tube 520 and the inflow ring 510, as will be described in more detail below. The ring 532 is also radially compressible and expandable, such that the ring 532 is radially compressible for transcavitary delivery and radially expandable at the treatment site for deployment. The ring 532 may be self-expanding or balloon-expandable.

[0095] Each barb 534 includes a distal end 536 at the end opposite to the loop 532. The distal end 536 may be a pointed end to assist in tissue engagement. Each barb 534 may be formed separately from and attached to the loop 532, or may be formed integrally with the loop 532. The barbs 534 are shown as being directly from... Figure 11A-11D And ring 532 in 12A extends radially outward. However, as Figure 12B As shown, in the illustrated embodiment, the barb 534 is angled. Specifically, as... Figure 12B As shown, each barb 534 includes a first portion 535 extending radially outward from the ring 532, a bend 533, and a portion relative to the radial direction R. d The second portion 537 extends at an angle α, in the radial direction R d The extension passes through the first portion of the same barb 534. Angle α can be 10-90 degrees. In the illustrated embodiment, barb 534 is preset to... Figure 12B The bending shape shown, and along the external force Figure 11A-11C And maintain the radially outward direction as shown in 12A, as described below. Therefore, when the external force is removed, the barb 534 returns to Figure 12B The preset curved shape shown. Although... Figure 12B The specific shape of the barb 534 is shown, but this is not a limitation. Other shapes, angles, and bends may be used to maintain consistency with this disclosure. To give the barbs 534 a predetermined bend, these barbs 534 may be formed of shape memory materials, including but not limited to nickel-titanium alloys (e.g., nitinol), nickel-cobalt-chromium-molybdenum alloys (e.g., MP35N), stainless steel, high-spring tempered steel, or any other metal or other material suitable for the purposes of this disclosure.

[0096] like Figure 11A-11D As shown in 12A, the barb 534 can be confined in a straight, radially outward direction for delivery and pre-deployment. Specifically, as Figure 11B As shown, certain struts 512 of the inflow portion 510 may each include a lip 514 that restricts the barb 534 in a radially outward configuration. The lip 514 may be configured as an extension of the corresponding strut 512 of the inflow portion. The lip 514 may extend in a direction generally parallel to the longitudinal axis LA of the heart valve prosthesis 500, and when the barb 534 is in the restricted, generally radially outward direction, the lip 514 is generally perpendicular to the longitudinal axis of the corresponding barb 534. Alternatively, the lip 514 may be configured as a groove in the corresponding strut 512 such that the barb 534 is at least partially located in the groove, thereby restricting the barb 534 from returning to its predetermined curved configuration. The lip 514 also prevents the ring 532 from rotating about the central longitudinal axis LA until a force is applied to overcome the restricting force of the lip 514, thereby causing the ring 532 to rotate and allowing the barb 534 to return to its predetermined curved configuration, as explained in more detail below.

[0097] It can also restrict the longitudinal movement of ring 532 along the outflow portion 520. Ring 532 can be restricted by a lip, groove, or any other means to prevent ring 532 from sliding longitudinally along the outflow portion 520, while still allowing ring 532 to rotate about the central longitudinal axis LA. Figure 11CIn the non-limiting embodiment shown, the groove 522 is circumferentially disposed around a portion of the outflow pipe 520. A ring 532 is disposed in the groove 522 such that the ring 532 is positioned between a shoulder 524 and an inflow ring 510, the shoulder 524 preventing longitudinal movement toward the second (outflow) end 508, and the inflow ring 510 preventing longitudinal movement toward the first (inflow) end 506. Figure 11D In another non-limiting example shown, the lip 526 may extend radially outward from the distal outflow portion 520 of the ring 532. Thus, the ring 532 is disposed between the lip 526 and the inflow ring 510 such that the lip 526 prevents longitudinal movement of the ring 532 in the distal (outflow) direction, and the inflow portion 510 prevents longitudinal movement of the ring 532 in the proximal (inflow) direction. The lip 526 may be a continuous lip disposed around the periphery of the outflow portion 520, or multiple lips 526 may be disposed intermittently around the periphery of the outflow portion 520 (i.e., spaced apart from each other).

[0098] The torque anchoring mechanism 530 is configured such that the delivery device (examples of which are described below) can interact with the torque anchoring mechanism 530 to rotate the ring 532, allowing the barb 534 to embed into the tissue at the desired implantation site. Figure 11A-11D In the embodiments shown in 12A-12B, the ring 532 of the torque anchoring mechanism 530 includes a plurality of connection points 538 for the delivery system. In these embodiments, the connection points 538 are openings configured to pass through the ring 532 for connecting a tether or pole of the delivery system, as described in more detail below. Figure 12A-12B In the illustrated embodiment, three (3) connection points 538 are shown. However, more or fewer connection points 538 may be used as long as the delivery system is configured to rotate the ring 532 to overcome the restraining force of the lip 514.

[0099] Considering the components of the aforementioned heart valve prosthesis 500, the delivery and deployment of the heart valve prosthesis 500 are explained. The heart valve prosthesis 500 is compressed into a radially compressed configuration for delivery. In the radially compressed configuration, the outflow conduit 520 is radially compressed. The inflow portion 510 and the torque anchoring mechanism 530 are rotatable such that they extend longitudinally away from the outflow portion 520 and can be radially compressed. The heart valve prosthesis 500, located in the delivery device, is delivered in a radially compressed configuration to a treatment site such as a natural mitral valve. When at the treatment site, the capsule or sheath of the delivery device can retract, thereby allowing the heart valve prosthesis 500 to self-expand to... Figure 11A and 12A The radial expansion structure is shown. (As in...) Figure 11A and 12AAs can be seen, the barb 534 extends radially outward. The delivery system is maintained attached to the heart valve prosthesis 500 via a tether that interacts with the connection point 538 of the ring 532. When the heart valve prosthesis 500 is in the desired position and in a radially expanded configuration, rotation of the delivery device or a portion thereof causes rotation of the portion of the delivery device attached to the ring 532, thereby rotating the ring 532. This rotation overcomes the restraining force of the lip 514. Figure 12B As shown, since the barbs 534 are no longer restricted by the lip 514, the barbs 534 return to their pre-defined curved structure. Furthermore, due to the rotation of the ring 532, the angled barbs 534 embed into the tissue at the implantation site, thereby anchoring the heart valve prosthesis 500 at the implantation site.

[0100] Although specific embodiments of the heart valve prosthesis 500 have been disclosed, modifications may be made to maintain consistency with this disclosure. For example, and not limitingly, the barbs 534 need not be straightened by the lip 514 and then returned to their predetermined curved configuration. Instead, the barbs 534 may be bent or flexed before the ring 532 rotates. In this embodiment, the lip 514 may be removed or may still be used so that the ring 534 does not rotate during delivery and initial deployment of the heart valve prosthesis 500. In this embodiment, as Figure 12C As shown, when the heart valve prosthesis is initially deployed from the delivery system, the heart valve prosthesis 500 expands radially. It can be seen that the barbs 534 have been bent or kinked. However, as described above, each barb 534 is held in place by the lip 514. Therefore, Figure 12C A portion of each barb 534 is concealed by a corresponding support rod 512. As explained above, the delivery system is maintained connected to the following tether, which interacts with the connection point 538 of the ring 532. Figure 12C The heart valve prosthesis 500 is shown. With the heart valve prosthesis 500 in the desired position and in a radially expanded configuration, the delivery device or a portion thereof rotates, causing the portion of the delivery device connected to the ring 532 to rotate, thereby rotating the ring 532. This rotation overcomes the restraining force of the lip 514. Therefore, the ring 532 rotates, and the angled barbs 534 engage with the tissue at the implantation site, thereby anchoring the heart valve prosthesis 500 at the implantation site.

[0101] Other variations of the heart valve prosthesis 500 may be used. For example, and not limited to, a clamp or arm at the second (outflow) end 208 may be used with the heart valve prosthesis 500 to fit the natural leaflet of a natural valve. Furthermore, elements of the other embodiments described above and below may be used with the heart valve prosthesis 500.

[0102] Figure 13Another embodiment of the heart valve prosthesis 310 is shown. Figure 13 A heart valve prosthesis 310 in a radially expanded configuration is shown. The heart valve prosthesis 310 includes a frame 314 and a prosthetic valve 312 connected to the frame 314. The heart valve prosthesis 310 includes both radially collapsed and radially expanded configurations. The heart valve prosthesis 310 also includes a first end 326 and a second end 332 opposite to the first end 326. The frame 314 is generally tubular and defines a central channel 324, and includes a first end 334 and a second end 336. Figure 13 In the illustrated embodiment, the first end 334 of the frame 314 defines the first end 326 of the heart valve prosthesis 310. Similarly, the second end 336 of the frame 314 defines the second end 332 of the heart valve prosthesis 310. Those skilled in the art will recognize that other features, such as a skirt or arm, may be included as part of the heart valve prosthesis 310. In the illustrated embodiment, the first end 326 of the heart valve prosthesis 310 is the proximal or inflow end, and the second end 332 of the heart valve prosthesis is the distal or outflow end. Furthermore, as... Figure 13 As shown, the first end 334 of the frame 314 flares radially outward. This outward flare at the first end 334 forms an inflow edge 315, which is configured to contact the atrial side of the natural mitral valve annulus. Further, although the inflow edge 315 is shown as generally circular, it can be other shapes that conform to the anatomy adjacent to the natural mitral valve, such as, but not limited to, a D-shape. A portion of the frame 314 can also be described as an outflow portion 325. The outflow portion 325 is generally tubular and configured to extend through the leaflets of the natural valve complex. Although the heart valve prosthesis 310 shown is configured for placement at the site of the natural mitral valve, the heart valve prosthesis 310 can be used at other implantation sites, such as, but not limited to, other natural heart valve sites.

[0103] Frame 314 is a support structure comprising struts 316 arranged relative to each other, with a plurality of openings 317 between the struts. Frame 314 provides the desired compressibility and resistance to the expansion forces of the natural valve annulus at the desired implantation site. Frame 314 also provides support for the prosthetic valve 312. The prosthetic valve 312 is coupled to and disposed within frame 314. Although Figure 13 The illustrated embodiment does not show the radially outward portion of the inflow edge 315 as shown. Figure 1 It bends in that way to extend longitudinally, but this is not restrictive, and Figure 13 The heart valve prosthesis 310 shown may include such a bend. The strut 316 of the inflow edge 315 forms a plurality of peaks 318 and valleys 320 at the first end of the inflow edge 315.

[0104] Multiple torque anchoring mechanisms 322 are connected to the inflow edge 315. The torque anchoring mechanisms 322 are configured such that when the heart valve prosthesis 310 is in a radially expanded configuration at the desired implantation site, and at least a portion of the heart valve prosthesis 310 is rotated, the torque anchoring mechanisms 322 embed into the tissue at the desired implantation site. Figure 13 As shown, the torque anchoring mechanism 322 extends clockwise. However, it may extend counterclockwise or partially at an angle in either direction. Further, the torque anchoring mechanism 322 typically extends from the lower side 319 of the inflow edge 315. The lower side 319 of the inflow edge 315 is the surface facing the natural mitral valve annulus (i.e., the outflow-facing surface of the inflow edge) when the heart valve prosthesis 310 is deployed together with the inflow edge 315 on the atrial side of the natural mitral valve annulus. The torque anchoring mechanism 322 may be a barb, clamp, hook, arrow, or similar device configured to embed into the tissue at the desired implantation site. Although Figure 13 Each torque anchoring mechanism 322 is shown as a single wire, but this is not limiting and other configurations of the torque anchoring mechanism may be used.

[0105] Frame 314 may be constructed, for example but not limited to, of nickel-titanium alloy, nitinol, nickel-cobalt-chromium-molybdenum alloy (MP35N), stainless steel, high-spring tempered steel, or any other metal suitable for the purposes of this disclosure. Torque anchoring mechanism 322 may be formed of the same type of material as frame 314. Torque anchoring mechanism 322 may be an extension of strut 316, or may be attached to frame 314, for example but not limited to, by fusion, welding, adhesive, stitching, or other methods suitable for the purposes described herein.

[0106] Figure 13 The illustrated frame 314 also includes a plurality of tether connection points 338. In the illustrated embodiment, the tether connection points 338 are shown at the valley 320, but they may be located at other locations on the inflow edge 315. In the illustrated embodiment, the tether connection points 338 are openings that allow the tethers of the delivery system to be connected to the heart valve prosthesis 310 by direct coupling or looping or wrapping, so that the heart valve prosthesis 310 or a portion thereof can be rotated to embed the torque anchoring mechanism 322 into the tissue at the implantation site, as described in more detail below.

[0107] Based on the above understanding of the 310 heart valve prosthesis, it can be used Figure 14-16The delivery device 400 shown is for delivering and deploying heart valve prostheses, such as heart valve prosthesis 310. In embodiments, the delivery device 400 typically includes a handle 440, an outer shaft assembly 410, an inner shaft assembly 404, a tether shaft 450, and multiple tethers 460. The delivery device 400 can be made of any suitable material, such as, but not limited to, polyethylene (PE), polyethylene terephthalate (PET), and polyvinyl chloride (PVC). Figure 14-16 The various features of the components of the delivery device 400 reflected in and described below can be modified or replaced with different structures and / or mechanisms. The components of the delivery device 400 can take on different forms and configurations. Therefore, the following detailed description is not intended to be limiting. Furthermore, the systems and functions described below can be implemented in many different component embodiments. Any actual component described is not intended to be limiting. The operation and performance of the presented systems and methods are described by understanding that modifications and variations of the embodiments can be made given the level of detail presented.

[0108] exist Figure 14-15 In the embodiment shown schematically, the handle 440 may include a housing 442 having an actuator mechanism 444 and a rotator mechanism 470 retained therein. More specifically, the handle 440 includes a cavity 443 defined by the housing 142 and configured to receive portions of the actuator mechanism 444 and the rotator mechanism 470. Figure 14-15 In the illustrated embodiment, housing 420 forms a longitudinal slot 446 and a rotation slot 472, actuator mechanism 444 extending through longitudinal slot 446 for user interaction, and rotator mechanism 470 extending through rotation slot 472 for user interaction. Handle 440 provides a surface for user operation and gripping and may have a generally cylindrical shape as shown or other shapes. Actuator mechanism 444 is generally configured to provide selective retraction / advancement of outer shaft assembly 410 and may have various structures and / or means capable of providing a desired user interface. Although shown as a sliding mechanism, other structures and / or means may be used to retract / advance outer shaft assembly 410, such as, but not limited to, rotation mechanisms, combinations of sliding and rotation mechanisms coaxially disposed on inner shaft assembly 404, and other advance / retraction mechanisms known to those skilled in the art. Similarly, rotator mechanism 470 may be any mechanism for rotating tether 460.

[0109] The outer shaft assembly 410 is slidably mounted on the inner shaft assembly 404. (Refer to...) Figure 14-15In an embodiment, the outer shaft assembly 410 includes a proximal shaft 418 and a capsule 407, and defines an inner cavity 412 extending from the proximal end 430 of the proximal shaft 418 to the distal end 432 of the capsule 407. Although the outer shaft assembly 410 is described herein as including a capsule 407 and a proximal shaft 418, the capsule 407 may simply be an extension of the proximal shaft 418. Further, the outer shaft assembly 410 may be referred to as a sheath or outer sleeve. The proximal shaft 418 is configured to be connected to the capsule 407 at a connection point 416 at the proximal end 409 of the capsule 407 by fusion, welding, adhesive, suture, or other means suitable for the purposes described herein. Alternatively, the proximal shaft 418 and the capsule 407 may be integral. The proximal shaft 418 extends proximally from the capsule 407 and is configured to connect to a handle 440. More specifically, the proximal shaft 418 extends proximally into the housing 442 of the handle 440, and the proximal portion 431 of the proximal shaft 418 is connected to the actuator mechanism 444 of the handle 440. The proximal portion 431 is connected to the actuator mechanism 444 such that movement of the actuator mechanism 444 causes the outer shaft assembly 410 to move relative to the inner shaft assembly 404. The proximal shaft 418 may, for example and not limited to, be connected to the actuator mechanism 444 by adhesives, welding, clamping, and other suitable coupling means. Thus, the outer shaft assembly 410 can move relative to the handle 440 and the inner shaft assembly 404 via the actuator mechanism 444. However, if the actuator mechanism 444 is not moving and the handle 440 is moving, the outer shaft assembly 410 moves with the handle 440, rather than relative to the handle 440.

[0110] The inner shaft assembly 404 is similar to the previously described inner shaft assembly 104. As will be described in more detail below, and as... Figure 14-15As shown, the inner shaft assembly 404 extends within the cavity 456 of the tether shaft 450. The inner shaft assembly 404 includes an inner shaft 414 and a distal end 422. The inner shaft 414 extends from its proximal end 434 to its distal end 436. The distal end 436 of the inner shaft 414 is attached to the distal end 422. The components of the inner shaft assembly 404 are combined to define a continuous guidewire cavity 423, which is sized to receive auxiliary components such as a guidewire (not shown). Although the inner shaft assembly 404 is described herein as including an inner shaft 414 and a distal end 422, the distal end 422 may simply be an extension of the inner shaft 414. Furthermore, the inner shaft may be multiple components attached together rather than a single component. The inner shaft 414 extends proximally into the housing 442 of the handle 440 and is connected to the handle 440 such that the guidewire cavity 423 provides access to auxiliary components therein (e.g., the guidewire). The inner shaft 414 may, for example and not limited to, be connected to the handle 440 by adhesives, welding, clamping, and other suitable coupling means. During sliding or longitudinal movement of the outer shaft assembly 410, the inner shaft assembly 404 is fixed relative to the handle 440. However, in other embodiments, the inner shaft assembly may be configured to move relative to the handle 440, such as by another actuator mechanism.

[0111] In one embodiment, the tether shaft 450 is coaxially disposed between the inner shaft 404 and the outer shaft assembly 410. The tether shaft 450 is rotatable relative to the inner shaft assembly 404 and the outer shaft assembly 410. (See reference...) Figure 14-15 The tether shaft 450 includes a proximal shaft portion 466 and a distal shaft portion 468, and defines an inner cavity 456 extending from a proximal end 452 to a distal end 454 of the tether shaft 450. The proximal shaft portion 466 is configured to connect to a handle 440. The proximal shaft portion 466 of the tether shaft 450 extends proximally into the housing 442 of the handle 440 and is connected to a rotator mechanism 470 of the handle 440. The proximal shaft portion 466 is coupled to the rotator mechanism 470 such that movement of the rotator mechanism 470 causes the tether shaft 450 to rotate relative to the outer shaft assembly 410 and the inner shaft assembly 404 about a central longitudinal axis LAc. The proximal shaft portion 466 may, for example and not limited to, be coupled to the rotator mechanism 470 by adhesives, welding, clamping, and other suitable coupling means. Thus, the tether shaft 450 can be rotatably moved relative to the housing 442, the inner shaft assembly 404, and the outer shaft assembly 410 via the rotator mechanism 470. However, if the rotator mechanism 470 is not moving and the housing 442 is moving, the tether shaft 450 moves with the housing 442, rather than relative to it. A plurality of tether connection points 458 are located at the distal shaft portion 468 of the tether shaft 450, proximal to the distal end 464. The tether connection points 458 are configured to connect the distal shaft portion 468 of the tether shaft 450 to the tether 460, as described below. Although Figure 16A tether connection point 458 arranged circumferentially around the tether axis 450 is shown, but this is not intended to limit the design, and other configurations can be envisioned depending on the application. Non-limiting examples of the connection between the tether 460 and the tether connection point 458 include configurations such as retaining posts and knot / ball retaining holes that can be released by manipulating the outer axis 410, configurations that can be released by cutting / splitting the tether, and other configurations suitable for the purposes described herein.

[0112] like Figure 15 As shown, in this embodiment, the tether 460 includes a first end 462 connected to a corresponding tether connection point 338 of the heart valve prosthesis 310, and a second end 464 connected to a tether connection point 458 of the tether shaft 450.

[0113] The tether 460 is an elongated component such as a wire. The tether 460 is relatively rigid, such that rotation of the tether 460 increases its tension, such that when tensioned, the rotational torque applied to the tether 460 is transmitted to the heart valve prosthesis 310, causing the heart valve prosthesis 310 to rotate. The tether 460 may be attached to the tether shaft 450 by means such as, but not limited to, fusion, welding, or mechanical connection. Alternatively, the tether 460 may extend through the tether shaft 450 to a drive mechanism (not shown) such as, but not limited to, a slider, button, knob, and similar mechanism, to rotate the tether 460 and release it from the heart valve prosthesis 310. The tether 460 may be releasably attached to the connection point 338 and the tether connection point 458 in any manner suitable for the purposes of this document; that is, a sufficiently rigid connection that transmits rotation of the tether 460 to the heart valve prosthesis 310 and a removable connection. In an alternative embodiment, a first end 462 of the tether 460 may be connected to a corresponding tether connection point 458 of the tether shaft 450, and a second end 464 of the tether 460 may be releasably connected to a corresponding tether connection point 458 of the tether shaft 450. In this embodiment, a portion of each tether 460 passes through the opening space 17 at the corresponding tether connection point 338 and loops around the support rod 16 of the frame 14.

[0114] Based on the above understanding of the components, the operation and interaction of the components of this disclosure can be explained herein. For example... Figure 15 As shown, the heart valve prosthesis 310 is disposed within the sac 407 of the external shaft assembly 410 in a radially compressed configuration. In this delivery configuration, a tether 460 is connected to the heart valve prosthesis 310 and the connection point 338. The delivery device 400 is delivered to the implantation site, such as the site of a natural mitral valve. Upon arrival at the implantation site, the external shaft assembly 410 retracts proximally, thereby retracting the sac 407 proximally. The sac 407 retracts sufficiently proximally to expose the heart valve prosthesis 310. In the illustrated embodiment, the heart valve prosthesis 310 is self-expanding. Therefore, as... Figure 16As shown, the retraction of the sac-like element 407 allows the heart valve prosthesis 310 to self-expand into a radially expanding configuration. The rotation mechanism 470 is relative to the central longitudinal axis LA. C Along direction R r The user actuates the tether shaft 450 along direction R. r Rotate so that the tether 460° along direction R r Rotation. The tether rotates 460 degrees along the direction R on the inflow edge 315 of the heart valve prosthesis 310. r Apply a rotational force so that at least a portion of the heart valve prosthesis 310 moves along direction R. r Rotation causes the torque anchoring mechanism 322 to embed into the tissue at the desired implantation site. In other words, a heart valve prosthesis 310 with a radially expanded configuration is present at the desired implantation site, with the tether 460 along the direction R. r Rotation is used to embed the anchoring mechanism 322 into the tissue, thereby anchoring the heart valve prosthesis 310 at the desired implantation site. In an alternative embodiment, the tether 460 loops around the connection point 338 through the heart valve prosthesis 310. Once the heart valve prosthesis 310 is anchored, the outer shaft 410 is further retracted proximally, thereby releasing the second end 464 of the tether 460 from the tether shaft 450, allowing the tether 460 to be removed together with the delivery device 400. In other embodiments, the tether 460 may be released from the tether shaft 450 and retained within the heart valve prosthesis 310. In yet another embodiment, the tether 460 may be cut, and the portion attached to the tether shaft 450 is removed together with the delivery device 400, while the portion attached to the heart valve prosthesis 310 remains with the heart valve prosthesis 310.

[0115] Figure 17-19 Another embodiment of a delivery device 400' for delivering and deploying a heart valve prosthesis 10 is shown. The delivery device 400' is similar to... Figure 14-16 The embodiments shown are for illustrative purposes only; therefore, only the differences between these embodiments will be described in detail here. Features not specifically described may be found in the references. Figure 14-16 The features described in the illustrated embodiments, or other embodiments described herein, are the same. Figure 17-19 In the illustrated embodiment, as an alternative to the tether shaft 450 and tether 460 as described above, the delivery device 400' includes a rod shaft 450' and a rod 460'.

[0116] In one embodiment, the rod shaft 450' is coaxially disposed between the inner shaft 404 and the outer shaft assembly 410. The rod shaft 450' is rotatable relative to the inner shaft assembly 404 and the outer shaft assembly 410. (See reference...) Figure 17-18The lever 450' includes a proximal shaft portion 466' and a distal shaft portion 468', and defines an inner cavity 456' extending from a proximal end 452' to a distal end 454' of the lever 450'. The proximal shaft portion 466' is configured to connect to a handle 440. The proximal shaft portion 466' of the lever 450' extends proximally into a housing 442 of the handle 440 and is connected to a rotator mechanism 470 of the handle 440. The proximal shaft portion 466' is coupled to the rotator mechanism 470 such that movement of the rotator mechanism 470 causes the lever 450' to revolve about a central longitudinal axis LA relative to the outer shaft assembly 410 and the inner shaft assembly 404. C Rotation. The proximal shaft portion 466' may, for example and not limited to, be coupled to the rotator mechanism 470 by adhesives, welding, clamping, and other suitable coupling means. Thus, the rod shaft 450' can be rotatably moved relative to the housing 442, the inner shaft assembly 404, and the outer shaft assembly 410 via the rotator mechanism 470. However, if the rotator mechanism 470 is not moving and the housing 442 is moving, the rod shaft 450' moves with the housing 442, rather than relative to the housing 442. A plurality of rod connection points 458' are located at the distal shaft portion 468 of the rod shaft 450'. The rod connection points 458' are configured to pivotally connect the distal shaft portion 468' of the rod shaft 450' to the rod 460', as described below. Although Figure 19 The shaft connection point 458' is shown circumferentially arranged around the shaft axis 450', but this does not imply a limitation on the design, and other configurations can be envisioned based on the application.

[0117] In an embodiment, each rod 460' includes a first end 462' and a second end 464' designed for wound protection. Figure 17 As shown, each second end 464' is pivotally connected to a corresponding rod connection point 458' of the rod shaft 450'. The rod 460' is an elongated rigid member such as a wire. The rod 460' includes a pivotally collapsible configuration when disposed within the outer shaft assembly 410, and a pivotally expanding configuration, wherein a first end 462' expands radially outward from the inner shaft 414 and a second end 464' is pivotally connected to the rod shaft 450', as... Figure 19As shown. Unless compressed into a pivotally collapsible configuration when held within the capsule 407 and outer shaft 410, the rod 460' is self-expanding while held in a pivotally expandable configuration. In the pivotally expandable configuration, the first end 462' expands radially to a first diameter D1. The first diameter D1 is equal to the diameter of the connection point 338', such that distal advance of the delivery device 400' selectively engages the first end 462' with the connection point 338' on the torque portion 350 of the heart valve prosthesis 310. The first end 462' will remain selectively engaged with the connection point 338', wherein a continuous distal force is present on the delivery device 400'. When selectively engaged, rotation of the rod shaft 450' and the pivotally engaged rod 460' is transmitted to the heart valve prosthesis 310 to cause rotation of the heart valve prosthesis 310. The rod 460' may be pivotally connected to the rod shaft 450' by means such as, but not limited to, fusion, welding, flexible joining, or mechanisms suitable for the purposes described herein. The rod 460' may be selectively connected to the connection point 338' by various methods, such as, but not limited to, a rod cup mechanism, a rod groove mechanism, a friction fit mechanism, or other methods suitable for the purposes described herein.

[0118] Based on the above understanding of the components, the operation and interaction of the components of this disclosure can be explained herein. For example... Figure 18 As shown, the heart valve prosthesis 310 is disposed within the sac 407 of the outer shaft assembly 410 in a radially compressible configuration. In this delivery configuration, a rod 460' is held within the sac 407 and the outer shaft 410 in a pivotally collapsible configuration, wherein a first end 462 is selectively coupled to the heart valve prosthesis 310 at a rod connection point 338'. The delivery device 400' is delivered to the implantation site, such as the site of a natural mitral valve. Upon arrival at the implantation site, the outer shaft assembly 410 retracts proximally, thereby retracting the sac 407 proximally. The sac 407 retracts sufficiently proximally to expose the heart valve prosthesis 310. In the illustrated embodiment, the heart valve prosthesis 310 is self-expanding. Therefore, the retraction of the sac 407 allows the heart valve prosthesis 310 to self-expand into a radially expandable configuration. Once the heart valve prosthesis is in a radially expanded configuration, the outer shaft assembly 410 retracts further proximally, thereby retracting the sac 407 proximally. The sac 407 retracts sufficiently proximally to expose the rod 460'. In the illustrated embodiment, the rod 460' is self-expanding. Therefore, as Figure 19 As shown, the retraction of the sac-like member 407 allows the rod 460' to self-expand into a pivotable expansion configuration. With the rod 460' in the pivotable expansion configuration, the delivery device 400' advances distally until each first end 462' is selectively engaged with its corresponding connection point 338' on the heart valve prosthesis 310. Once selectively engaged with the delivery device 400' by distal force, the rotating mechanism 470 rotates relative to the central longitudinal axis LA.C Along direction R r The user actuation causes the rod shaft 450' to move in the direction R r Rotate so that rod 460' moves along direction R r Rotation. The rotation of lever 460' along direction R r A rotational force is applied to the heart valve prosthesis 310, causing at least a portion of the heart valve prosthesis 310 to move along the direction R. r Rotation causes the torque anchoring mechanism 322 to embed into the tissue at the desired implantation site. Once the heart valve prosthesis 310 is anchored, the delivery device 400' retracts proximally, causing the rod 460' to selectively disengage from the connection point 338'. As the rod 460' selectively disengages from the connection point 338, the outer shaft assembly 410 advances distally, thereby advancing the capsule 407 distally. The capsule 407 advances distally sufficiently to radially compress the rod 460' into a pivotable, collapsible configuration. The delivery device 400' can then be retracted proximally for removal from the implantation site. While the rod shaft 450' and the rod 460' are described herein as part of the delivery device 400', this is not intended to limit the design, and in other embodiments, the rod shaft 450' and the rod 460' may be separate devices that advance to the implantation site as the heart valve prosthesis 310 expands and the delivery device 400' is removed.

[0119] Features of any of the above embodiments can be used in conjunction with any of the other embodiments described above. Furthermore, the quantity and type of ropes, rods, shafts, actuating mechanisms, and similar objects can be varied within the scope of this invention. Other materials besides those described above can also be used within the scope of this invention.

[0120] exist Figure 20-24 The diagram schematically illustrates a method for deploying and anchoring a heart valve prosthesis at a desired implantation site using a delivery device according to an embodiment of the invention. Figure 20-24 The method steps shown are described with respect to a delivery device 100 including a dumbbell-shaped balloon 170. However, this embodiment can be used with other delivery devices described herein. Figure 20 As shown, using an established percutaneous transcatheter delivery procedure, the delivery device 100”’ is introduced into the patient’s vascular system, advanced over a guidewire, and positioned at the treatment site of the damaged or diseased natural valve, in this embodiment the natural mitral valve 730 of the heart 700.

[0121] With the delivery device 100” in place, the actuator mechanism 144 of the operating handle 140 is operated proximally to the outer shaft assembly 110. For example... Figure 21 As shown, as the sac-like part 107 of the outer shaft assembly 110 retracts proximally, the heart valve prosthesis 10 changes from a radially collapsed structure to a radially expanded structure.

[0122] like Figure 22 As shown, once the heart valve prosthesis 10 is in a radially expanded configuration, expansion fluid is injected into the dumbbell-shaped balloon 170, causing the dumbbell-shaped balloon 170 to change from an unexpanded configuration to an inflated configuration. The balloon 170 is configured such that, when in the inflated configuration, the shaped end 174 of the first portion 172 of the dumbbell-shaped balloon 170 mates with the corresponding shaped end 26 of the heart valve prosthesis 10, the proximal end 182 of the second portion 180 of the dumbbell-shaped balloon 170 abuts the proximal end 34 of the heart valve prosthesis 10, and the outer surface 189 of the third portion 186 of the dumbbell-shaped balloon 170 (… Figure 20-24 (Not shown) The inner surface of the frame 14 that mates with the heart valve prosthesis 10.

[0123] Next, the delivery device 100”’ rotates around the central longitudinal axis LA C Along direction R r Rotation. (e.g.) Figure 23 As shown, the delivery device 100”’ is arranged around the central longitudinal axis LA C Along direction R r The rotation causes the dumbbell-shaped balloon 170 to rotate along direction R. r Rotation causes at least a portion of the heart valve prosthesis 10 to rotate along direction R. r The device rotates and the torque anchoring mechanism 22 is embedded in the tissue at the desired implantation site.

[0124] Then, the inflated fluid is discharged from the dumbbell-shaped balloon 170, causing the dumbbell-shaped balloon 170 to change from an inflated configuration to a first uninflated configuration. Figure 24 As shown, the delivery device 100”” retracts through the patient’s vascular system, thereby leaving the heart valve prosthesis 10 anchored at the site of the natural mitral valve.

[0125] Reference Figure 20-24 The described methods can be used in conjunction with other devices and features described herein. Furthermore, as those skilled in the art will understand, variations, additional steps, and fewer steps may be used.

[0126] exist Figure 25-29 The diagram schematically illustrates another method for deploying and anchoring a heart valve prosthesis at a desired implantation site using a delivery device according to an embodiment of the invention. Figure 25-29 The method steps shown are described with respect to the aforementioned delivery device 400 and the heart valve prosthesis 310. For example... Figure 25 As shown, using an established percutaneous transcatheter delivery procedure, the delivery device 400 is introduced into the patient's vascular system, advanced over a guidewire, and positioned at the treatment site of a damaged or diseased natural valve, in this embodiment the natural mitral valve 730 of the heart 700.

[0127] The actuator mechanism 444 of the proximal operating handle 440 retracts the outer shaft assembly 410. For example... Figure 26 As shown, as the sac-like part 407 of the outer shaft assembly 410 retracts proximally, the heart valve prosthesis 310 changes from a radially collapsed structure to a radially expanded structure.

[0128] like Figure 27 As shown, when the heart valve prosthesis 310 is in a radially expanded configuration, the rotator mechanism 470 of the handle 440 rotates around the central longitudinal axis LA. C Along direction R r Rotation. The rotation of the rotator mechanism 470 causes the tether shaft 450 and the tether 460 attached thereto to rotate in the direction R. r Rotation Figure 28 As shown, the rotation of the tether 460 causes at least a portion of the heart valve prosthesis 310 to move along the direction R. r Rotation thereby embeds the torque anchoring mechanism 322 of the heart valve prosthesis 310 into the tissue at the desired implantation site.

[0129] The tether 460 can then be released from the heart valve prosthesis 310, as described above. Figure 29 As shown, the delivery device 400 can then be removed from the patient, leaving the heart valve prosthesis 310 anchored in the heart 700.

[0130] Reference Figure 25-29 The described method can be used in conjunction with other devices and features described herein. Furthermore, as those skilled in the art will understand, variations, additional steps, and fewer steps may be used. For example, and not limitingly, the delivery device 400 may be used in conjunction with those described above. Figure 10A-11D The heart valve prosthesis described below, or in conjunction with the following Figure 35 The heart valve prosthesis described is used together.

[0131] exist Figures 30-34 The diagram schematically illustrates another method for deploying and anchoring a heart valve prosthesis at a desired implantation site using a delivery device according to an embodiment of the invention. Figures 30-34 The method steps shown are described with respect to the aforementioned delivery device 400' and the heart valve prosthesis 310. For example... Figure 30 As shown, using an established percutaneous transcatheter delivery procedure, the delivery device 400' is introduced into the patient's vascular system, advanced over a guidewire, and positioned at the treatment site of a damaged or diseased natural valve, in this embodiment the natural mitral valve 730 of the heart 700.

[0132] The actuator mechanism 444 of the proximal operating handle 440 retracts the outer shaft assembly 410. As the sac-like part 407 of the outer shaft assembly 410 retracts proximally, the heart valve prosthesis 310 changes from a radially collapsed configuration to a radially expanded configuration. With the heart valve prosthesis 310 in the radially expanded configuration, the delivery device 400' advances distally. The actuator mechanism 444 of the proximal operating handle 440 retracts the outer shaft assembly 410. As the sac-like part 407 of the outer shaft assembly 410 retracts proximally, the rod 460' of the rod shaft 450' changes from a pivotable collapsed configuration to a pivotable expanded configuration. Figure 31 As shown, the delivery device 400' advances distally and the rod 460' engages with the connection point 338' of the heart valve prosthesis 310.

[0133] like Figure 32 As shown, when the heart valve prosthesis 310, which mates with the lever 460', is in a radially expanded configuration, the rotator mechanism 470 of the handle 440 rotates around the central longitudinal axis LA. C Along direction R r Rotation. The rotation of the rotator mechanism 470 causes the rod shaft 450' and the rod 460' attached thereto to rotate in the direction R. r Rotation Figure 33 As shown, rotation of lever 460' causes at least a portion of the heart valve prosthesis 310 to move along direction R. r Rotation thereby embeds the torque anchoring mechanism 322 of the heart valve prosthesis 310 into the tissue at the desired implantation site.

[0134] Then, the delivery device 400' can retract proximally, causing the rod 460' to disengage from and be released from the connection point 338' of the heart valve prosthesis 310. The outer shaft 410 (including the sac-like element 407) advances distally, and the rod 460' is radially compressed from a pivotally expandable configuration into a pivotally collapseable configuration. Figure 34 As shown, the delivery device 400' can then be removed from the patient's body, leaving the heart valve prosthesis 310 anchored in the heart 700.

[0135] Reference Figures 30-34 The described methods can be used in conjunction with other devices and features described herein. Furthermore, as those skilled in the art will understand, variations, additional steps, and fewer steps may be used.

[0136] Figures 35-36Another embodiment of a heart valve prosthesis 600 is illustrated schematically. The heart valve prosthesis 600 is similar to the heart valve prosthesis described above and will not be described in detail again. The heart valve prosthesis 600 includes a frame 614 and a prosthetic valve 612. The frame 614 defines a central channel 624 in which the prosthetic valve 612 is disposed. The frame 614 also defines an inflow edge 615 and an outflow tube 625. As described above, the inflow edge 615 includes a plurality of torque anchoring mechanisms 622 coupled thereto. The heart valve prosthesis 600 also includes a plurality of arms 650 coupled to the outflow tube 625. The arms 650 are shown folded rearward such that they are positioned outside the outer surface of the outflow tube 625. Each arm 650 may be configured to capture the natural leaflet of the natural valve between the arm and the outer surface of the outflow tube 625. When in the radial compression delivery configuration, arm 650 can extend longitudinally away from the outlet end of outlet pipe 625, and then fold back when radially expanding. Figure 35 The location is shown in the figure. A heart valve prosthesis with arm 650 is used to capture the natural leaflet between arm 650 and outflow tube 625. It is not desirable to rotate such a heart valve prosthesis to embed the torque anchoring mechanism 622 into the tissue adjacent to the natural valve, because such torque is transferred to arm 650 and natural valve leaflet.

[0137] Therefore, in Figure 35 In the illustrated embodiment, the inflow edge 615 is separated from the outflow tube 625. "Separation" means that the inflow edge 615 can rotate at least partially without causing the outflow tube 625 to rotate. Figure 35 In the illustrated embodiment, a connector 640 is used to separate the inflow edge 615 from the outflow tube 625. The connector 640 can be a flexible material such as, but not limited to, fabric materials (e.g., polyester, nylon, etc.). A first end 642 of the connector 640 is attached to the inflow edge 615 and a second end 644 of the connector 640 is attached to the outflow tube 625. The connector 640 can be joined to the inflow edge 615 and the outflow tube 625 by sutures, adhesives, and other connections suitable for the purposes described herein. After the heart valve prosthesis has expanded radially at the treatment site, wherein the natural valve leaflet is captured between the arm 650 and the outflow tube 625, the inflow edge 615 can be rotated using a heart valve prosthesis 600 with the connector 640 to engage the torque anchoring mechanism 622 without rotating the outflow tube 625. Conversely, the connector 640 is twisted to absorb rotation of the inflow edge 615. The inflow edge 615 can be rotated by any of the aforementioned means and methods.

[0138] In another embodiment, a flexible material is used instead of connector 640, allowing the inflow edge 615 and outflow tube 625 to be connected to each other in a manner that allows them to rotate relative to each other, but not to be separated longitudinally. Figure 36An example of this connector 670 is shown. In the illustrated embodiment, the inflow edge 615 includes a tubular portion 680 extending toward the outflow tube 625. The end of the tubular portion 680 opposite the inflow edge 615 includes a lip 574. The outflow tube 625 includes an end opposite the outflow end, having a groove 672. The lip 672 is disposed in the groove 674. This connection allows the inflow edge 615 to rotate relative to the outflow tube 625 while maintaining the inflow edge 615 and the outflow tube 625 connected to each other.

[0139] After the heart valve prosthesis is radially expanded at the treatment site, wherein the natural valve leaflet is captured between the arm 650 and the outflow tube 625, the inflow edge 615 can be rotated to engage the torque anchoring mechanism 622 using the heart valve prosthesis 600 with the connector 670 without rotating the outflow tube 625. The inflow edge 615 can be rotated by any of the aforementioned means and methods.

[0140] While only a few embodiments are described herein, it should be understood that they are presented as illustrative and exemplary rather than as limiting. Various changes in form and detail may be made herein without departing from the spirit and scope of the invention, and each feature of the embodiments discussed herein and each reference cited herein may be used in combination with features of any other embodiment. Furthermore, features of any embodiment described herein may be used in conjunction with any other embodiment described herein. All patents and published documents discussed herein are incorporated herein by reference in their entirety.

Claims

1. A heart valve prosthesis comprising: a frame comprising an inflow edge and an outflow portion, wherein the inflow edge flares radially outward from the outflow portion, and wherein the frame is radially compressible and radially expandable; a ring disposed about an outer surface of the outflow portion of the frame; and a prosthetic heart valve coupled to an inner surface of the outflow portion of the frame; wherein the ring is rotatable relative to the frame, further comprising a plurality of barbs extending outwardly from the ring, and the inflow edge is connected to the outflow portion. Each of the barbs comprises a distal tip at an end of the barb opposite the ring.

2. The cardiac valve prosthesis of claim 1, wherein, The distal tip of each of the barbs is a sharp tip configured to engage heart tissue.

3. The cardiac valve prosthesis of claim 2, wherein, Each of the barbs is disposed at a non-zero angle relative to a radial direction of the ring.

4. The cardiac valve prosthesis of claim 1, wherein, Each of the barbs comprises a first portion extending radially outward from the ring and a second portion disposed at a non-zero angle relative to a radial direction extending through the first portion of the respective barb.

5. The cardiac valve prosthesis of claim 1, wherein, The angle is in a range of 10 degrees to 90 degrees.

6. The cardiac valve prosthesis of claim 5, wherein, Each of the barbs comprises a delivery configuration in which the barb is disposed radially outward relative to the ring and an expanded configuration in which at least a portion of the barb is disposed at a non-zero angle relative to a radial direction extending through the first portion of the barb.

7. The cardiac valve prosthesis of claim 5, wherein, Further comprising a plurality of lips, each of the lips configured to retain a barb of the plurality of barbs in the delivery configuration until a force is applied to overcome a retention force of the lips.

8. The cardiac valve prosthesis of claim 7, wherein, The plurality of lips is configured to prevent rotation of the ring until the force is applied to overcome the retention force of the lips.

9. The cardiac valve prosthesis of claim 8, wherein, The heart valve prosthesis is configured to limit longitudinal movement of the ring along the outflow portion of the frame.

10. The cardiac valve prosthesis of claim 1, wherein, The outflow portion of the frame comprises a groove in which the ring is disposed to limit longitudinal movement of the ring along the outflow portion of the frame.

11. The cardiac valve prosthesis of claim 10, wherein, The outflow portion of the frame further comprises a lip that limits longitudinal movement of the ring in a longitudinal direction.

12. The cardiac valve prosthesis of claim 10, wherein, 13. A heart valve prosthesis comprising: a frame comprising: an inflow edge; and an outflow portion, wherein the inflow edge flares radially outward from the outflow portion, and wherein the inflow edge and the outflow portion are rotatable relative to one another; and a prosthetic heart valve coupled to an inner surface of the outflow portion of the frame; wherein further comprising a plurality of barbs extending from the inflow edge, the plurality of barbs configured to embed into tissue by rotation of the inflow edge relative to the outflow portion, and the inflow edge is connected to the outflow portion. Further comprising a joint disposed between the inflow edge and the outflow portion, wherein the joint enables the inflow edge and the outflow portion to rotate relative to one another.

14. The cardiac valve prosthesis of claim 13, wherein, The joint comprises a flexible material that enables the inflow edge and the outflow portion to rotate relative to one another.

15. The cardiac valve prosthesis of claim 14, wherein, The flexible material comprises a fabric material.

16. The cardiac valve prosthesis of claim 15, wherein, ​ 17. The cardiac valve prosthesis of claim 14, wherein, The joint includes a groove in one of the inflow edge or the outflow portion and a lip in the other of the inflow edge or the outflow portion, wherein the lip is disposed in the groove to enable the inflow edge and the outflow portion to rotate relative to one another and limit longitudinal movement of the inflow edge and the outflow portion relative to one another.

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