Heart valve repair prostheses, delivery devices and methods

Abstract

A heart valve prosthesis is provided that includes a separable ventricular member and an atrial member. The ventricular member has a first hub with a connection feature. At least three arms are each coupled to the first hub at a first end and have a second end opposite the first end. The arms are preloaded toward the location of the leaflets of the heart when the ventricular member is implanted. The atrial member has a second hub coupled to the frame arrangement and has a connection feature configured to connect to the connection feature of the first hub to secure the atrial and ventricular members together. The frame arrangement is preloaded toward the location of the leaflets of the heart when the atrial member is implanted. A recess is formed in a periphery of the frame arrangement to receive the arms of the ventricular member in an engaged configuration. Valve tissue may be captured between the arms and the recess.

Description

[Technical field]

[0001] INCORPORATION BY REFERENCE OF PRIORITY APPLICATIONS Any and all applications for which a claim of foreign or domestic priority is identified in the Application Data Sheet filed with this application are incorporated herein by reference under 37 CFR 1.57. For example, this application claims priority to U.S. Provisional Patent Application No. 63 / 210898, filed June 15, 2021, which is incorporated herein by reference in its entirety.

[0002] The present application is directed to a heart valve prosthesis configured to treat valvular regurgitation, preferably without surgery. [Background technology]

[0003] Heart valve regurgitation is a condition resulting from a variety of causes in which blood flows backward through a valve when the valve should prevent such flow. Regurgitation can occur in several valves of the heart, including the mitral, aortic, pulmonary, and tricuspid valves.

[0004] The tricuspid valve separates the lower right heart chamber (right ventricle) from the right upper heart chamber (right atrium). Tricuspid regurgitation is a condition in which this valve does not close tightly enough. The problem is that when the lower right heart chamber (ventricle) contracts, it allows blood to flow backward into the right upper heart chamber (atrium). Tricuspid regurgitation is the leakage of blood backward through the tricuspid valve every time the right ventricle contracts. Tricuspid regurgitation usually results from an enlargement of the lower heart chambers (called the ventricles) or from any other condition that restricts blood flow from the right ventricle to the lungs. Sometimes long-standing diseases such as emphysema or pulmonary valve stenosis can cause problems that affect the tricuspid valve, which is "upstream" from the lungs. To compensate, the right ventricle enlarges so it can pump harder, which can stretch the opening of the tricuspid valve and cause it to droop.

[0005] Valve repair is the most common surgical treatment for tricuspid valve disease. The procedure can be performed alone or in combination with treatments for other heart problems. Tricuspid valve repair using a prosthetic annulus is a common surgical approach for tricuspid regurgitation and can be performed for primary tricuspid valve disease or in combination with other valve surgeries (mitral, aortic). Traditional tricuspid valve repair is an open-heart procedure performed through a 6-8 inch incision through the sternum.

[0006] Transcatheter systems for tricuspid valve repair have been explored, but such systems provide less than optimal definitive results, are complex to use, lack durability, and pose a very high risk of thrombus formation at the valve if the patient is not anticoagulated. Summary of the Invention [Problem to be solved by the invention]

[0007] For these reasons, a need exists for a minimally invasive method of tricuspid valve repair.The present disclosure is directed to a valve fixation device that can be delivered intravascularly. [Means for solving the problem]

[0008] In one embodiment, a heart valve prosthesis is provided that includes a ventricular member and an atrial member. The ventricular member is configured to be advanced into a ventricle of the heart. The ventricular member has a hub (sometimes referred to as a first hub) that includes one or more slots and an array of arms. The first hub can be configured to be positioned adjacent to a line of coaptation between a first heart valve leaflet and a second heart valve leaflet. The first hub can be positioned on the ventricular side of the line of coaptation, in the line of coaptation, and / or on the atrial side of the line of coaptation. Each arm of the array of arms can have a first end connected to the first hub and a second end opposite the first end. The second end of one or more arms (e.g., each arm) can be biased toward the first hub in a free state. The second ends of adjacent arms are not connected to each other. For example, the second ends of adjacent arms are not connected to each other in a circumferential direction in some embodiments. The arms are not connected to each other along their length between the first and second ends in some embodiments. One or more of the second ends of the arms may be configured to be placed into direct contact with the first heart valve leaflet. One or more of the second ends of the arms may be configured to be placed into direct contact with the second heart valve leaflet. The atrial member is configured to be advanced into the atrium adjacent to the line of coaptation. The atrial member may be positioned across the line of coaptation of the first and second heart valve leaflets (e.g., spanning the gap between the first and second heart valve leaflets). The atrial member may be positioned across the line of coaptation of the first and second heart valve leaflets (e.g., opposite the line of coaptation) from the arms of the ventricular member. The atrial member has a second hub having one or more tangs, e.g., a plurality of tangs, and an arrangement of petals. The tangs can be configured to lock into the slots of the first hub to engage the second hub with the first hub when the atrial and ventricular members are assembled. One or more petals, such as each petal in the array of petals, have a proximal end connected to the second hub and an outer end opposite the proximal end. The outer end of the one or more petals, such as each petal, is biased away from the second hub.One or more adjacent petals, such as each adjacent petal, are bounded by a shared inner strut and a separate outer strut, forming a recess at the junction of the shared inner strut and the separate outer strut. The atrial member is separate from the ventricular member and is movable relative to the ventricular member before the first hub and the second hub are engaged. In the engaged configuration, the arms of the ventricular member are forced into the recesses of the atrial member.

[0009] A ventricular member of a heart valve prosthesis may be provided. The ventricular member or clamping member may have a plurality of arms disposed about a central member. The arms may collectively span two or three heart valve cusps. Each arm of the plurality of arms may have a free end that is biased toward the central member. The second ends of adjacent arms are not connected to each other. For example, the second ends of adjacent arms are not connected to each other in a circumferential direction in some embodiments. The arms are not connected to each other along their length between the first end and the second end in some embodiments. One or more of the second ends of the arms may be configured to be disposed into direct contact with a first heart valve cusp. One or more of the second ends of the arms may be configured to be disposed into direct contact with a second heart valve cusp.

[0010] The ventricular member or the central member of the ventricular clamping portion may include a hub, which may have slots or tangs for engagement with other leaflet capture members, such as the atrial clamping portion.

[0011] An atrial member or atrial clamping portion of a heart valve prosthesis may be provided. The atrial member may be positioned across, e.g., opposite, the first and second heart valve cusps from a matching ventricular member or clamping portion. The atrial member may have a central member and an array of petals. One or more petals, such as each petal of the array of petals, are connected to the central member and have an outer end opposite the central member. The outer end of one or more petals, such as each petal, is biased away from the central member. The petals may be symmetrical and comprise an array of frame members symmetrically arranged around the center of the central member of the atrial member. Non-symmetrical (asymmetrical) frames or symmetrical frames arranged in a non-symmetrical (asymmetrical) manner may be provided in some embodiments.

[0012] One or more adjacent petals, such as each adjacent petal, may be bounded by a radial strut adjacent to the central member. The radial strut may be or may comprise a shared inner strut. The petals may be bounded by separate outer struts. There is a recess at the junction of the shared inner strut and the separate outer strut.

[0013] When provided together in a heart valve prosthesis, the atrial member may be separate from the ventricular member and may be movable relative to the ventricular member prior to ventricular member implantation. The central member of the ventricular member and the central member of the atrial member may be engaged following movement of the ventricular member and the atrial member together. In the engaged configuration, the arms of the ventricular member may be pressed against the atrial member, such as into recesses formed between adjacent petals of the atrial member, such that the leaflets are compressed between the ventricular member and the atrial member. In the engaged configuration, the atrial member may deflect one or more arms such that the leaflets are compressed between the atrial member and the arms. In the engaged configuration, both the petals of the atrial member and the arms of the ventricular member may be deflected such that the leaflets are compressed between the petals and the arms.

[0014] When the ventricular member is engaged with the atrial member, a portion of the ventricular member can be positioned across the line of coaptation of the first and second heart valve leaflets (e.g., spanning the gap between the leaflets). The atrial member can include a slot or a tang to engage with the ventricular member. If the atrial member includes a tang, the tang can be configured to lock into a slot disposed in the central member of the ventricular member when the atrial member and the ventricular member are assembled. If the atrial member includes a slot, the slot can be configured to lock into a tang protruding from the central member of the ventricular member when the atrial member and the ventricular member are assembled.

[0015] In other embodiments, a heart valve prosthesis is provided that includes a ventricular member and an atrial member. The atrial member is separate from the ventricular member and is movable relative to the ventricular member, e.g., prior to assembly. The atrial member and the ventricular member are configured for assembly in the heart in some embodiments. For example, a connection feature of a first hub of the ventricular member and a connection feature of a second hub of the atrial member can be engaged inside the heart. The ventricular member can be configured to be advanced into a ventricle of the heart. The ventricular member can have a first hub with a slot and at least three arms. The first hub can be configured to be positioned adjacent a line of coaptation of the first and second heart valve leaflets. Each arm can have a first end connected to the first hub and a second end opposite the first end, and the second ends of adjacent arms are not connected to each other. One or more of the second ends are configured to be disposed into direct contact with the first heart valve leaflet and one or more of the second ends are configured to be disposed into direct contact with the second heart valve leaflet. The atrial member may be configured to be advanced at least partially into the atrium across a line of coaptation of the first heart valve leaflet and the second heart valve leaflet. The atrial member has a second hub having a tang. The atrial member has a frame arrangement. The tang of the second hub is configured to lock into a slot of the first hub to engage the second hub with the first hub when the atrial member and the ventricular member are assembled. The frame arrangement comprises a plurality of frames. The frames have a base portion connected to the second hub and an outer portion opposite the base portion. Each frame of the frame arrangement has two shared struts and two dedicated strut portions. The two shared struts are connected to the second hub at a first end to form a base portion. Two dedicated strut portions are attached to each second end of the shared strut. One or more frames, e.g., each frame, encloses a roughly rectangular area. Adjacent frames are connected by the shared strut. Adjacent frames form a recess therebetween. In the engaged configuration, the arms of the ventricular member are forced into the recesses of the atrial member.

[0016] In another embodiment, the heart valve prosthesis comprises a ventricular member and an atrial member. The atrial member may be separate from the ventricular member and may be movable relative to the ventricular member, for example, prior to engagement. During engagement of the ventricular member to the atrial member, a centering mechanism of the atrial member guides the arms of the ventricular member to a predetermined position and / or orientation when a connection feature (e.g., a tongue) of one of the ventricular member and the atrial member (e.g., a hub of the atrial member) engages with a connection feature of the other of the ventricular member and the atrial member (e.g., a slot in the first hub of the ventricular member). The ventricular member is configured to be advanced into a ventricle of the heart. The ventricular member may comprise a first hub and at least three arms. The first hub has a slot. The first hub is configured to be positioned adjacent to a line of coaptation of the first heart valve leaflet and the second heart valve leaflet. Each arm of the at least three arms has a first end connected to the first hub and a second end opposite the first end. One or more of the second ends of the arms are configured to be disposed into direct contact with the first heart valve leaflet, and one or more of the second ends are configured to be disposed into direct contact with the second heart valve leaflet. The atrial member is configured to be advanced into the atrium and positioned across the line of coaptation. The atrial member comprises a second hub and at least one centering mechanism. When the atrial member and the ventricular member are assembled, the second hub has a connection feature (e.g., a tongue) for locking into the contact feature (e.g., a slot of the first hub). The at least one centering mechanism is configured to center the at least one arm of the ventricular member. During engagement of the ventricular member to the atrial member, the centering mechanism of the atrial member guides the arm of the ventricular member into a predetermined position and / or orientation when the connection feature (e.g., a tongue) of the second hub engages with the connection feature (e.g., a slot) of the first hub.

[0017] In a variation of the foregoing, one or more extents of the arms adjacent the second end may be configured to be disposed in direct contact with the first heart valve leaflet. One or more extents of the arms adjacent the second end may be configured to be disposed in direct contact with the second heart valve leaflet. One or more extents of the arms extending from the second end may be configured to be disposed in direct contact with the first heart valve leaflet. One or more extents of the arms extending from the second end may be configured to be disposed in direct contact with the second heart valve leaflet. The entirety of one or more extents of the arms may be configured to be disposed in direct contact with the first heart valve leaflet. The entirety of one or more extents of the arms may be configured to be disposed in direct contact with the second heart valve leaflet.

[0018] Further embodiments of the foregoing may provide other connection features on the first hub of the ventricular member and the second hub of the atrial member. For example, the first hub of the ventricular member may be provided with one or more tangs, such as multiple tangs, and the second hub of the atrial member may have one or more slots, such as multiple slots. The tangs of the first hub may be configured to lock into the slots of the second hub to engage the first hub with the second hub when the atrial and ventricular members are assembled. In other embodiments, the first hub of the ventricular member may be configured with one or more tangs, such as multiple tangs, and one or more slots, such as multiple slots. The second hub of the atrial member may be configured with one or more tangs, such as multiple tangs, and one or more slots, such as multiple slots. The slots and tangs may alternate around the circumference of the first hub. The slots and tangs may alternate around the circumference of the second hub. Alternating around the hub in this situation may include providing a first connecting feature followed by providing a second connecting feature of a different type that is spaced apart, such as circumferentially spaced apart from the first connecting feature.

[0019] In another embodiment, a system for delivering a heart valve prosthesis is provided. The system may include a delivery device and a prosthesis. The delivery device may include a delivery handle, a plurality of removable lockouts, a sheath assembly, and a guide handle. The delivery handle may include a housing and a plurality of slides disposed on the housing. The plurality of removable lockouts may be configured to prevent movement of the slides in a first state and allow a range of movement in a second state. The sheath assembly may include an outer sheath and an inner sheath disposed within the outer sheath, the outer sheath being movable relative to the inner sheath. The guide handle may be configured to retract the outer sheath. The prosthesis may include a ventricular member and an atrial member. The ventricular member may include at least three arms, each arm having a first end coupled to a hub. The atrial member may include a hub configured to couple with a hub of the ventricular member and at least one centering mechanism including a recess for centering at least one of the at least three arms of the ventricular member. The delivery handle may be configured to control movement and positioning of the prosthesis within the heart by movement of the sliders and lockout portions.

[0020] In a variation of the foregoing, the system may include one or more of the following features. The system may include a nose cone coupled to a distal end of the outer sheath. The nose cone may include a plurality of slits configured to open the nose cone to allow the prosthesis to exit the outer sheath. The nose cone may include a flexible tip configured to expand to allow the prosthesis to exit the outer sheath. The nose cone may surround the outer sheath and may be configured to be retracted to allow the prosthesis to exit the outer sheath. The system may include an inflation balloon disposed within the outer sheath, the inflation balloon configured to be inflated to prevent the prosthesis from exiting the outer sheath and configured to be deflated to allow the prosthesis to exit the outer sheath. The system may include a source of fluid coupled to the housing and configured to supply fluid to a space disposed between an inner surface of the outer sheath and an outer surface of the inner sheath. The system may include a source of fluid coupled to the housing and configured to supply fluid to a plurality of spaces disposed between an inner surface of the outer sheath and an outer surface of the inner sheath. The system can include a plurality of fluid sources coupled to a plurality of spaces disposed between the inner surface of the outer sheath and the outer surface of the inner sheath, one of the fluid sources supplying fluid to a respective one of the spaces between the inner surface of the outer sheath and the outer surface of the inner sheath.

[0021] In another embodiment, a method for performing a procedure in the heart is provided that may include advancing a delivery catheter into the heart, threading a ventricular member over the delivery catheter into a ventricle of the heart, the ventricular member comprising at least three arms, each arm having a first end coupled to a hub, threading an atrial member over the delivery catheter into an atrium of the heart, the atrial member comprising at least one centering feature comprising an indentation for centering at least one of the at least three arms of the ventricular member, aligning the ventricular member and the atrial member such that tissue is compressed between the ventricular member and the atrial member, inserting the hub of the ventricular member into the hub of the atrial member, and securing the ventricular member to the atrial member.

[0022] In variations on the foregoing, the system may include one or more of the following features: The delivery catheter may be coupled to a delivery handle, the delivery handle including a plurality of slides disposed on the housing and a plurality of removable lockouts configured to prevent movement of the slides in a first state and allow a range of movement in a second state. The slides and lockouts may be configured to pass the ventricular and atrial members through the delivery catheter. The tissue may be a tricuspid valve. The method may include providing fluid to a space disposed within the delivery catheter via a fluid source coupled to a delivery handle coupled to the delivery catheter. The method may include providing fluid to a plurality of spaces disposed within the delivery catheter. The method may include opening a plurality of slits in a nosecone coupled to a distal end of the delivery catheter, the opening of the slits allowing the ventricular and atrial members to pass through the distal end of the delivery catheter.

[0023] In another embodiment, a method for performing a procedure in a heart is provided that may include threading a ventricular member onto a delivery catheter into a right ventricle of the heart, the ventricular member comprising at least three arms, each arm having a first end coupled to a hub, positioning the ventricular member against a first side of a leaflet of a tricuspid valve, threading an atrial member onto a delivery catheter into the right atrium of the heart, the atrial member comprising at least one centering feature comprising an indentation for centering at least one of the at least three arms of the ventricular member, positioning the atrial member against a second side of the leaflet of the tricuspid valve, aligning the ventricular member and the atrial member such that the leaflets of the tricuspid valve are compressed between the ventricular member and the atrial member, inserting a hub of the ventricular member into the hub of the atrial member, and securing the ventricular member to the atrial member.

[0024] In variations on the foregoing, the system may include one or more of the following features: The delivery catheter may be coupled to a delivery handle, the delivery handle including a plurality of slides disposed on the housing and a plurality of removable lockouts configured to prevent movement of the slides in a first state and allow a range of movement in a second state. The slides and lockouts may be configured to pass the ventricular and atrial members through the delivery catheter. The method may include providing fluid to spaces disposed within the delivery catheter via a fluid source coupled to a delivery handle coupled to the delivery catheter. The fluid source may be configured to provide fluid to spaces disposed within the delivery catheter. The method may include opening a plurality of slits in a nosecone coupled to a distal end of the delivery catheter, the slits opening allowing the ventricular and atrial members to pass through the distal end of the delivery catheter. The delivery catheter may be advanced through a femoral vein. The delivery catheter may be advanced through a jugular vein.

[0025] A more complete understanding of the subject matter of the present application, as well as various advantages thereof, may be obtained by reference to the following detailed description, in which reference is made to the accompanying drawings. [Brief description of the drawings]

[0026] [Figure 1] FIG. 1 is a perspective view of a heart valve repair device coupled with a catheter-based delivery system. [Figure 1A] FIG. 1 is a cross-sectional view of a heart during normal diastole. [Figure 1B] FIG. 1 is a cross-sectional view of the heart during normal systole. [Figure 1C] FIG. 1 is a top view of a tricuspid heart valve in systole that is in need of repair due to poor or no coaptation along the edges of the leaflets. [Figure 1D] 1D is a top view of the tricuspid valve of FIG. 1C showing non-limiting options of locations for placement of devices across the leaflets to ameliorate valve disease. [Diagram 2] FIG. 2 is a perspective view of the ventricular member of the heart valve prosthesis of FIG. 1 in a collapsed state. [Diagram 3] FIG. 3 is a perspective view of the ventricular member shown in FIG. 2 in an expanded state. [Figure 3A] FIG. 3 is a schematic diagram showing the angulation of one arm and hub of the ventricular member of FIG. 2 in an expanded state. [Figure 4] FIG. 2 is a perspective view of the atrial member of the heart valve prosthesis of FIG. 1 in a collapsed state. [Diagram 5] FIG. 5 is a perspective view of the atrial member shown in FIG. 4 in an expanded state. [Figure 5A] FIG. 6 is a schematic diagram showing angulation of the frame and hub of one of the atrial members of FIG. 5 in an expanded state. [Figure 5B] 13A-13C are views of additional embodiments of an atrial member. [Figure 5C] 13A-13C are views of additional embodiments of an atrial member. [Figure 6A] FIG. 2 is a diagram of a delivery system in a first delivery state. [Figure 6B]FIG. 6B is a diagram of the delivery system of FIG. 6A in a second delivery state. [Figure 6C] FIG. 6B is a diagram of the delivery system of FIG. 6A in a third delivery state. [Figure 6D] FIG. 6B is a diagram of the delivery system of FIG. 6A in a fourth delivery state. [Figure 6E] FIG. 6B is a diagram of the delivery system of FIG. 6A in a fifth delivery state. [Figure 6F] FIG. 6B is a diagram of the delivery system of FIG. 6A in a sixth delivery state. [Figure 6G] 6B is a diagram of an embodiment of the delivery system of FIG. 6A including a delivery handle with a fluid supply. [Figure 7A] FIG. 2 is a diagram of a heart valve prosthesis secured in the heart, shown from within the atrial chamber. [Figure 7B] FIG. 7B is a view from inside the ventricle of the heart valve prosthesis of FIG. 7A implanted in the heart. [Figure 7C] 7B is a view similar to FIG. 7A showing the heart valve prosthesis secured to heart valve tissue, shown from the atrial member side of the heart valve prosthesis. [Figure 7D] 7B showing the heart valve prosthesis secured to heart valve tissue, shown from the ventricular member side of the heart valve prosthesis. FIG. [Figure 8A] FIG. 13 is a diagram of another embodiment of a heart valve prosthesis in which the plug function provided by a resealable valve is provided on the hub of the ventricular member to control the flow of blood through the heart valve prosthesis. [Figure 8B] FIG. 13 is a diagram of another embodiment of a heart valve prosthesis in which the plug function provided by a resealable valve is provided on the hub of the ventricular member to control the flow of blood through the heart valve prosthesis. [Figure 9A] 13A-13C show another embodiment of a heart valve prosthesis in which the plug function provided by the collapsible member is provided on the hub of the ventricular member to control the flow of blood through the heart valve prosthesis. [Figure 9B] 13A-13C show another embodiment of a heart valve prosthesis in which the plug function provided by the collapsible member is provided on the hub of the ventricular member to control the flow of blood through the heart valve prosthesis. [Figure 10A] 6B-6C are diagrams of various nose cone embodiments that may be provided at or near the distal tip of the delivery system of FIG. 6A. [Figure 10B] 6B-6C are diagrams of various nose cone embodiments that may be provided at or near the distal tip of the delivery system of FIG. 6A. [Figure 10C] 6B-6C are diagrams of various nose cone embodiments that may be provided at or near the distal tip of the delivery system of FIG. 6A. [Figure 10D] 6B-6C are diagrams of various nose cone embodiments that may be provided at or near the distal tip of the delivery system of FIG. 6A. [Figure 10E] 6B-6C are diagrams of various nose cone embodiments that may be provided at or near the distal tip of the delivery system of FIG. 6A. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0027] Set forth below are more detailed descriptions of various embodiments of valve repair devices and methods that are useful for treating patients suffering from valvular regurgitation.

[0028] The present application is directed to a heart valve repair prosthesis, a delivery device, and a method for delivering and implanting the heart valve repair prosthesis. FIG. 1 illustrates one embodiment of a heart valve prosthesis 100 and a delivery system 400. The heart valve prosthesis 100 and other embodiments disclosed herein provide more reliable leaflet capture than in other prior devices and methods. The components and assemblies have less, minimal, or non-invasive device materials and configurations for increased safety. As described further below, the devices and methods disclosed herein provide improved treatment for severe tricuspid valve regurgitation. The heart valve prosthesis 100 includes an atrial member 212 with a cover 223 and a ventricular member 112 configured to avoid tendons in delivery and assembly and to provide a non-invasive interaction with the leaflet tissue. These components and assemblies, described in more detail below, are characterized by a physiological approach to treating tricuspid valve regurgitation that incorporates an understanding of tricuspid valve anatomy.

[0029] I. Heart valve regurgitation and its endovascular treatment As previously mentioned, insufficient coaptation of the valve leaflets is the main problem. Figures 1A-1C illustrate this problem and a technique for correcting this problem. Figure 1A is a schematic depiction of a heart 10 in normal diastole. The heart 10 is four chambered with a tricuspid valve 12 positioned between the right atrium 14 and the right ventricle 16. Figure 1B shows the heart 10 in normal systole, showing the leaflets LF1, LF2, and LF3 of the tricuspid valve 12 contacting each other where they meet. This leaflet contact seals the right atrium 14 from the right ventricle 16 along the length of the leaflets, sometimes referred to as the line of coaptation.

[0030] FIG. 1C shows a schematic of a defective tricuspid valve 12. This view shows the tricuspid valve from above, such as a view from the right atrium. FIG. 1C shows that there is a large gap G between the edges of the leaflets during systole, with a complete lack of coaptation along these leaflets. FIG. 1D shows how the heart valve prosthesis described herein improves the function of the valve during systole. In this view, the heart valve prosthesis 100 is placed within the leaflets of the tricuspid valve and captures the leaflets. Specifically, the heart valve prosthesis 100 is applied such that each leaflet is engaged by a frame member or petal of the atrial member 212 of the heart valve prosthesis 100. Also, each leaflet of the valve is engaged by an arm of the ventricular member 112. The second end 136 of the arm and the frame 222 or petal 236 of the atrial member 212 grip the heart valve leaflets LF1, LF2, LF3 to reduce or eliminate regurgitation through the valve 12. 1D depicts a simplified version of the heart valve prosthesis 100, showing three frames 222 and three arms 124. The heart valve prosthesis 100 may include two frames 222 and two arms 124, or may include more than four frames 222 and more than four arms 124, such as, for example, four, five, six, seven, eight, nine, ten, eleven, twelve, or thirteen or more frames 222 and any number of arms, including four, five, six, seven, eight, nine, ten, eleven, twelve, or thirteen or more arms 124, or any combination of these numbers of frames and arms. In some embodiments, there are more frames 222 than arms 124, e.g., 12 frames 222 and 6 arms 124, or other combinations of frames and arms from the aforementioned numbers of each of these components to form the heart valve prosthesis 100. In some embodiments, there are more arms 124 than frames 222, e.g., 12 arms 124 and 6 frames 222, or other combinations of frames and arms from the aforementioned numbers of each of these components to form the heart valve prosthesis 100. The heart valve prosthesis 100 has a cover 223 that obstructs flow through a substantial portion of the valve 12 even if the uncovered portion of the valve along the line of coaptation does not close.As a result, the amount of reverse flow (regurgitation) is reduced or prevented during systole, and the leaflets can still separate sufficiently during diastole to allow blood to flow from the right atrium to the right ventricle.

[0031] The present disclosure provides for closure of at least the central region of the leak, or forcing the uncovered portion of valve 12 to close during systole. The resulting repaired valve is much more capable of providing healthy blood flow through heart 10.

[0032] II. Heart Valve Repair System Having shown one example of treating a tricuspid valve 12 with an embodiment of a heart valve prosthesis 100, additional details of various embodiments of the heart valve prosthesis 100 and treatment system 50 for treating patients suffering from heart valve regurgitation will now be described. Figure 1 shows a treatment system 50 comprising a heart valve prosthesis 100 coupled with a delivery system 400. The heart valve prosthesis 100, as previously described, is particularly well suited for treating tricuspid valve regurgitation.

[0033] The heart valve prosthesis 100 comprises a ventricular member 112 and an atrial member 212. The ventricular member 112 is configured to be advanced into a ventricle of the heart, such as the right ventricle, by a delivery system 400. The atrial member 212 is configured to be advanced into an atrium of the heart, such as the right atrium, by a delivery system 400. Further discussion of the delivery system 400 is provided below.

[0034] The heart valve prosthesis 100 is further illustrated in Figures 2-5. Figure 2 illustrates a folded configuration of the ventricular member 112. The ventricular member 112 includes a hub 116, sometimes referred to herein as a first hub 116. The ventricular member 112 includes one or more slots 120 formed through the first hub 116. The slots 120 are an example of a connection feature of the ventricular member 112 of the heart valve prosthesis 100. The ventricular member 112 includes an array of arms 124. The ventricular member 112 may include at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 arms 124. The ventricular member 112 may include 2 or less, 3 or less, 4 or less, 5 or less, 6 or less, 7 or less, 8 or less, 9 or less, 10 or less, 11 or less, or 12 or less arms 124. The ventricular member 112 may include only 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 arms 124. The arms 124 have a first end 132 connected to the first hub 116. The arms 124 have a second end 136 opposite the first end 132. FIG. 2 illustrates that in one embodiment, the arrangement of the arms 124 may include some arms 124 that are longer than the other arms. The shorter arms 124 may have a first end 132' and a second end 136'. The second end 136' may be positioned closer to the first hub 116 than the second end 136 of the longer arm 124. Each arm 124 in the array of arms 124 may include an elongated body 130 disposed between the first end 132 and the second end 136.

[0035] 3 and 3A show that the first end 132 of one or more arms, such as each arm of the ventricular member 112, can be biased toward the first hub 116 in the free state 140. For example, the first hub 116 can be disposed along a luminal axis LA1. The luminal axis LA1 can be an axis at the center of the lumen in the first hub 116. FIG. 3A shows the first hub 116 and a single arm 124 for simplicity. The arm 124 has a first end 132 and a second end 136 as previously described and extends along the elongated body 130. The first end 132 can be the end of the elongated body 130 that is coupled or attached to the first hub 116. The first end 132 can be coupled or attached to a distal end of the first hub 116. The elongate body 130 may include a first curved section 130a adjacent to or extending from the first end 132, and a second section 130b adjacent to or extending from the first section 130a. The second section 130b may be a straight section. The second section 130b may be curved. In one embodiment, the second section 130b is curved in the same direction as the first section. If curved, the second section 130b may have a much larger radius of curvature than the first section 130a. The radius of curvature may be about 0.25 mm, about 0.5 mm, about 1 mm, about 1.5 mm, about 2 mm, or about 2.5 mm, or within a range including any of these dimensions as endpoints. The magnitude of the radius of curvature may be a compromise between being as small as possible, but large enough to minimize distortion during manufacture or implementation. An arm axis AA1 may be defined along the elongate body 130. In one embodiment, the arm axis AA1 may be a line aligned or parallel to the longitudinal axis of the second section 130b. In one embodiment, the arm axis AA1 may be a tangent to the second section 130b of the elongate body 130. An angle of deflection α may be defined between the lumen axis LA1 and the arm axis AA1. The angle of deflection α may be about 5 degrees, about 10 degrees, about 15 degrees, about 20 degrees, about 25 degrees, about 30 degrees, about 35 degrees, about 40 degrees, or about 45 degrees, or may be within a range defined between any of these angles.

[0036] The angle of deflection α is such that the projection of the second end 136 of the elongated body 130 towards the first hub 116 is closer to the proximal end of the first hub 116 than the projection of the other portions of the elongated body 130. The projection of the second end 136 of the elongated body 130 towards the first hub 116 may be located closer to the proximal end of the first hub 116 than the end of the second section 130b adjacent to the first section 130a. The projection of the second end 136 of the elongated body 130 towards the first hub 116 may be located closer to the proximal end of the first hub 116 than the first section 130a. The projection of the second end 136 of the elongated body 130 towards the first hub 116 may be located closer to the proximal end of the first hub 116 than the first end 132.

[0037] 3 and 3A show that the slot 120 can be an elongated opening, such as a rectangle, in the side of the first hub 116. The slot 120 can be elongated along the direction of the luminal axis LA1. The slot 120 can have an axial edge aligned with the luminal axis LA1 and a circumferential edge that follows the curvature of the first hub 116. As described further below, the slot 120 can engage a connection feature of the atrial member 212 when the heart valve prosthesis 100 is assembled in the patient's heart.

[0038] The ventricular member 112 may be formed in any suitable manner. In one embodiment, the ventricular member 112 is formed from a tubular body. The elongate body 130 of each of the arms 124 may be formed by cutting or removing material between the elongate body 130 and one or more adjacent elongate bodies 130. FIG. 2 illustrates that the ventricular member 112 may have a tubular configuration when in an unexpanded or compressed state. The outwardly facing surface of the elongate body 130 may be aligned with a protrusion on the outer surface of the first hub 116. The outwardly facing surface of the elongate body 130 may be disposed radially inward of the protrusion on the outer surface of the first hub 116. These configurations facilitate the use of a cylindrical catheter body of the delivery system 400 to keep the arms 124 in an unexpanded or compressed state during delivery, and then extend the ventricular member 112 outwardly from the cylindrical catheter body for expansion in the ventricle, as described further below.

[0039] In one embodiment, the ventricular member 112 may be formed using or may include a shape memory material. Such a material may allow the arms 124 to self-expand from the configuration of FIG. 2 to the configuration of FIG. 3. One such material is a nickel-titanium alloy known as Nitinol. A shape memory material configured to be highly elastic (e.g., superelastic) may allow the configuration of FIG. 3 to be achieved by removing a restraint (e.g., an outer catheter body of the delivery system 400) from a location radially outside the arms 124. When the arms 124 are no longer restrained, they may move from the compressed state of FIG. 2 to the expanded state of FIG. 3. The shape memory material may also be configured to be actuated by ambient temperature. The material used to form the ventricular member 112, such as the arms 124, may be configured such that the compressed state of FIG. 2 is provided at room temperature and the expanded state of FIG. 3 is provided by increasing the temperature of the arms 124 to a higher temperature, such as the patient's body temperature.

[0040] FIG. 2 illustrates that the arms 124 may have an atraumatic configuration. In one embodiment, the atraumatic configuration is provided by configuring the second end 136 of one or at least some (e.g., all) of the arms 124 with an atraumatic tip. The atraumatic tip may have an enlarged portion 136a and a reduced portion 136b. The enlarged portion 136a may be of the same size or width (e.g., dimension transverse to the longitudinal axis of the arms 124) and may be enlarged relative to the reduced portion 136b. The enlarged portion 136a may be larger than the reduced portion 136b dimension transverse to the longitudinal axis of the arms 124. The enlarged portion 136a may spread the contact load on the leaflet on the ventricular side of the leaflet to reduce trauma to the leaflet. The reduced portion 136b and the different lengths of adjacent arms 124 allow for improved packing of the arms. Specifically, the reduced portion 136b may be configured to accommodate the increased width of the expanded portion 136a, as seen in Figure 2. As a result, a greater number of arms 124 may be included in a given diameter of the ventricular member 112 than if the expanded portions 136a of some of the arms 124 were not nested within the reduced portions 136b of the arms 124.

[0041] The ventricular member 112 may be configured such that the second ends 136 of the arms 124 may lie at or adjacent to an arcuate contour, such as a circle C1. The circle C1 may have a diameter of about 10 mm, about 15 mm, about 20 mm, about 25 mm, about 30 mm, or about 35 mm, or may have a diameter in a range including any of these dimensions, such as about 15 mm to about 25 mm. The arcuate contour, such as a circle C1, connecting the second ends 136 of the arms 124 is smaller than the arcuate contour, such as a circle C2 (see FIG. 5) connecting the outer ends of the petals 236 of the atrial member 212. The relative sizes of the circles C1 and C2 can be seen in FIGS. 6D and 6F and are discussed further below.

[0042] In the illustrated embodiment of FIG. 3, the second ends 136 of adjacent arms 124 are not connected to each other. One or more of the second ends 136 are configured to be placed into direct contact with the first heart valve leaflet LF1. One or more of the second ends 136 are configured to be placed into direct contact with the second heart valve leaflet LF2. Optionally, one or more of the second ends 136 are configured to be placed into direct contact with the third heart valve leaflet LF3. In some embodiments, the entire elongated body 130 of adjacent arms 124 remains unconnected to the adjacent arms. The heart leaflets LF1, LF2, LF3 are connected to the cardiac tissue by chordae tendineae or tendons. Tendons are elongated fibrous cords that span the ventricles. The unconnected nature of the arms 124 allows the arms to expand without entanglement between adjacent tendons. More specifically, the arms 124 can transition from extending in a direction aligned with the luminal axis LA1 to an orientation corresponding to a preloaded configuration, which can include swinging through angles greater than 90 degrees. The slender, unconnected configuration of the arms 124 allows them to move between adjacent tendons without intertwining.

[0043] 4 and 5 show additional details of the atrial member 212. The atrial member 212 is configured to be advanced into the atrium and to extend across the line of coaptation LOC of the first heart valve cusp LF1, the second heart valve cusp LF2, and / or the third heart valve cusp LF3. The atrial member 212 is separate from and movable relative to the ventricular member 112 before connecting or engaging the first hub 116 to the second hub 216 of the atrial member 212 to assemble the heart valve prosthesis 100. The engagement of the first hub 116 and the second hub 216 presses the arms 124 of the ventricular member 112 into recesses in the atrial member 212. The recesses may be located around the outer periphery of the atrial member 212.

[0044] The atrial member 212 includes a frame arrangement 220 including a plurality of frames 222 that may be at least partially surrounded, such as entirely surrounded, by a cover 223. The cover 223 may include a membrane formed from a material such as ePTFE or Dacron. By positioning the cover 223 on the atrial side of the valve (in the atrial member 212), the cover 223 does not interfere with the tendons. The cover 223 and frame arrangement 220 provide a closed compartment framework that creates a more consistent load around the circumference of the atrial member 212. The cover 223 may be used to seal the portion of the valve that it extends over. In some cases, the cover 223 promotes endothelialization across the atrial member 212. The cover 223 allows some load to be applied between the tips of the frames 222. The cover 223 can partially cover the recesses between the frames 222 (described later) and can receive the tips of the arms 124 of the ventricular member 112 with valve tissue sandwiched between them in some places upon deployment.

[0045] The frame 222 may be configured as petals 236. The petals 236 may include a repeating pattern of structures around the perimeter. The petals 236 may be positioned edge to edge. The petals 236 may share a common edge or post. The petals 236 may be symmetrical about a radius that bisects each petal. In some embodiments, the petals 236 are symmetrical about a radius that extends from the center of the inner portion of the petal 236 adjacent the second hub 216 to the tip of the petal 236. The tip of the petal 236 may be the radially outermost portion of each petal. If a cover 223 is provided, the cover 223 may extend across several petals or the structure of the petals surrounding each petal. The cover 223 may have an arcuate outer perimeter, such as a circle, as shown in FIG. 1. The cover 223 may extend between the tips of the petals 236 around the perimeter of the atrial member 212.

[0046] 4 and 5 show that each of the frames 222 may have a base portion 224 and an outer portion 226. The base portion 224 of each frame 222 may include one or more shared struts 228. The shared struts 228 may have opposing circumferential edges that bound a portion of an adjacent frame 222. A single frame 222 may be bounded by two adjacent shared struts 228. The single frame 222 may be bounded by a dedicated strut portion 229. The single frame 222 may include a first shared strut 228 and a first dedicated strut portion 229 that extends from an outer end of the first shared strut 228 to a tip of the frame 222. The single frame 222 may be further bounded by a second dedicated strut portion 229. The second dedicated strut portion 229 may extend from the tip of the frame 222 to an outer end of the second shared strut 228. The second shared strut 228 is disposed adjacent to the first shared strut 228 on an opposite radius that extends to the tip of the frame 222. The first and second shared struts 228 may be connected at their inner ends to the second hub 216 or to another frame member that is connected to the second hub 216.

[0047] Each frame 222, in one embodiment, encompasses a generally rectangular area 238. As previously described, adjacent frames are connected by shared struts 228. Adjacent frames 222 form recesses 240 therebetween. The recesses 240 provide an area for receiving or nesting the arms 124 of the atrial member 212. The atrial member 212 is separate from the ventricular member 112 and is movable relative to the ventricular member 112 prior to engagement of the first hub 116 and the second hub 216. The recesses 240, in one embodiment, may be centered on the longitudinal axis of the shared struts 228. In the engaged configuration, the arms 124 of the ventricular member 112 are pressed into the recesses 240 of the atrial member 212. This relationship is illustrated in FIGS. 6D, 6F, and 7B-7D.

[0048] FIG. 5 illustrates that the rectangular region 238 may have a kite shape. For example, in some embodiments, the shared strut 228 may have a length greater than the length of the dedicated strut portion 229. In some embodiments, the shared strut 228 extends away from the central radial axis of the frame 222 at a first angle, and the dedicated strut portion 229 extends away from the central radial axis at a second angle greater than the first angle. The kite shaped region may be defined by a first isosceles triangular region and a second isosceles triangular region. The first isosceles triangular region may be defined by an axis extending between the outer ends of the shared strut 228 and the two shared struts 228 of the individual frames 222. The second isosceles triangular region may be defined by an axis extending between the outer ends of the shared strut 228 and the dedicated strut portion 229 of the individual frames 222. The first isosceles triangle may be disposed between the second isosceles triangle and the second hub 216. The first isosceles triangle region may have a first height greater than a second height of the second isosceles triangle. The first height may range from about 5 mm to about 9 mm. The second height may range from about 2 mm to about 6 mm. The height of the first isosceles triangle region may be about 20 percent, about 30 percent, about 40 percent, about 50 percent, about 60 percent, about 70 percent, about 80 percent, about 90 percent, about 100 percent, about 150 percent, or about 200 percent greater than the height of the second isosceles triangle region, or may be in a range including any two of these recited percentages as endpoints. The height of the first isosceles triangle region may be less than or equal to the height of the second isosceles triangle region. The magnitude of the height of the first isosceles triangle region may be about twice the magnitude of the length of the base of the first isosceles triangle region. The height of the second isosceles triangular area may be approximately the same as the length of the base of the second isosceles triangular area.

[0049] 5A is a schematic diagram showing a preloaded state of the atrial member 212. In the preloaded state, the frame 222 is oriented toward the location of the valve leaflets when the atrial member 212 is positioned or implanted in the heart. The atrial member 212 can provide that the frame 222 extends outwardly and distally from the distal end of the second hub 216. In one embodiment, the magnitude of the extension in the distal direction can be defined by an angle of deflection β. The angle of deflection β can be about 85 degrees, about 80 degrees, about 75 degrees, about 70 degrees, about 65 degrees, about 60 degrees, about 55 degrees, about 50 degrees, or about 45 degrees, or can be within a range defined between any of these angles. The magnitude of the angle of deflection β can be the same as the magnitude of the angle of deflection α of the arm 124. The magnitude of the angle of deflection β can be greater than the angle of deflection α of the arm 124. The magnitude of the angle of deflection β may be less than the angle of deflection α of the arm 124 .

[0050] FIG. 3A shows the arms 124 bent or tilted toward the first hub 116 when the ventricular member 112 is disengaged from the atrial member 212. FIG. 3A shows a preloaded state in which the arms 124 are oriented toward the location of the valve leaflets when the ventricular member 112 is positioned or implanted in the heart. FIG. 5A shows the frame 222 or petals 236 bent or tilted away from the second hub 216 (e.g., toward the location of the valve leaflets) when the atrial member 212 is disengaged from the ventricular member 112. The arms 124 and base portion 224 are each elastic, e.g., formed from a nickel-titanium alloy (e.g., Nitinol) or similar highly elastic material, such that the arms 124 and base portion 224 apply a load when deflected away from the unloaded state of FIGs. 3A and 5A. When the arms 124 are deflected to a larger angle α, they will apply a proximal load to the leaflets of the valve when implanted. When the frame 222 is deflected to a larger angle β, they will apply a distal load. As described further below, the process of assembling the first hub 116 of the ventricular member 112 to the second hub 216 of the atrial member 212 will deflect the arms 124 to a larger angle α and the frame 222 to a larger angle β. Thus, in this embodiment, the arms 124 and the frame 222 will apply a compressive load to one or more of the first heart valve leaflet LF1, the second heart valve leaflet LF2, and the optional third heart valve leaflet LF3 compressed therebetween. In other embodiments, one of the arms 124 and the frame 222 is more deflectable or one of the arms 124 and the frame 222 is non-deflectable under the loads involved in assembling the heart valve prosthesis 100. Thus, the load applied to one side of the leaflets LF1, LF2, LF3 may be different than the load applied to the other side of the leaflets LF1, LF2, LF3.

[0051] 5B and 5C show additional configurations of frames 222A, 222B. Frame 222A has a recess 240A centered on the central radial axis (dashed line) of the frame. Similar to frame 222, frame 222A is formed by a dedicated strut portion 229 extending radially outward. The recess 240A may be formed by an undulating shape of a portion of the dedicated strut portion 229 that is disposed away from the shared strut 228. The recess 240A may be located between adjacent dedicated strut portions 229 of frame 222A. Frame 222B has a recess 240B centered on the central radial axis (dashed line) of frame 222B. Similar to frame 222, frame 222B is formed by a dedicated strut portion 229 extending from an outer end of the shared strut 228. The dedicated strut portion 229 of the frame 222B extends radially inward from the outer end of the shared strut 228 to form a recess 240B along a central radial axis of the frame 222B. The recess 240B may be formed by the dedicated strut portion 229 of the frame 222B extending straight inward.

[0052] 5 shows that the frame 222 of the atrial member 212 may have a tip disposed at an arcuate perimeter, such as a circle C2. The circle C2 may be configured to be larger than the circle C1 that extends between the ends of the arms 124 of the ventricular member 112. The location of the depression 240, depression 240A, or depression 240B may be disposed at a radial location that is smaller than the radius of the circle C1. Thus, the tip of the arms 124 may be disposed in an annular band between the perimeter of the circle C1 and the perimeter of the circle C2. The circle C2 may have a diameter of about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 35 mm, or about 40 mm, or may have a diameter in a range that includes any of these dimensions as endpoints.

[0053] The atrial member 212 may also have connection features. In one embodiment, a tongue (or tongues) 252 is configured to lock into the slot 120 of the first hub 116 to engage the second hub 216 with the first hub 116 when the atrial member 212 and the ventricular member 112 are assembled. The tongue 252 may be configured to engage a connection feature of the ventricular member 112, such as the slot 120. In one embodiment, the first hub 116 is received in the second hub 216. The tongue 252 is inwardly biased and will be biased inwardly into the slot 120 when the tongue 252 is aligned with the slot 120. In another embodiment, the second hub 216 is received in the first hub 116. The tongue 252 is outwardly biased and will be biased outwardly into the slot 120 when the tongue 252 is aligned with the slot 120.

[0054] The heart valve prosthesis 100 preferably has a centering mechanism to align the connection features of the ventricular member 112 and the atrial member 212 with each other during their engagement with each other. In one example, when the arm 124 is moved into the recess 240, the sloping side surfaces of the dedicated strut portion 229 guide the arm 124 to the radially innermost part of the recess 240. This position corresponds to the alignment of the tang 252 with the slot 120. For example, in one embodiment, the delivery system 400 is configured such that the atrial member 212 is held rotationally stationary and the frame 222 or petals 236 can apply a load to the arms 124, thereby applying a moment to the first hub 116 to rotate the first hub 116 relative to (e.g., within or across) the second hub 216 and rotate the slot 120 into rotational alignment with the tang 252. In another embodiment of the delivery system 400, the ventricular member 112 is maintained rotationally stationary and the arms 124 apply a force to the frame 222 or petals 236, thereby applying a moment to the second hub 216 to rotate the second hub 216 relative to (e.g., within or across) the first hub 116, such that the tang 252 moves into rotational alignment with the slot 120. Thus, the arms 124 can act as a centering feature and the recesses 240 can also act as centering features, or the arms 124 and the recesses 240 can act as centering features for the heart valve prosthesis 100 .

[0055] Similar to the ventricular member 112, the atrial member 212 can be compressed into a cylindrical configuration as seen in Figure 4. The cylindrical configuration allows the atrial member 212 to be placed in a catheter body of a delivery system 400, as described below. As previously described, the atrial member 212 can be formed from a resilient material, such as a nickel-titanium material, such as Nitinol, such that it can self-expand into the configuration of Figure 5.

[0056] 8A-9B show additional embodiments of heart valve prostheses that can incorporate bungs or other flow controls for the heart valve prosthesis. The prosthesis can include ventricular member 112A or ventricular member 112B as shown in those figures. Ventricular member 112A and ventricular member 112B can be similar to ventricular member 112 except as described below as different.

[0057] The ventricular member 112A may include a deflectable flow control member 150 disposed within the first hub 116. The deflectable flow control member 150 may be configured as a one-way valve with a deflectable flap 154 ​​configured to span the lumen of the first hub 116. The deflectable flap 154 ​​may be deflected as shown in FIG. 8A to accommodate an inner shaft 404, which may be part of a delivery system 400 as described further below. Deflection of the deflectable flap 154 ​​may position the inner shaft 404 through the ventricular member 112A during delivery. The inner shaft 404 may be removed during or at the end of delivery and assembly of the heart valve prosthesis 100 incorporating the ventricular member 112A. FIG. 8B shows the deflectable flaps 154 extending across the lumen and sealing against each other after the inner shaft 404 has been removed from the lumen of the first hub 116. The pressure distal to the ventricular member 112A (i.e., in the right ventricle) will exceed the pressure proximal to the ventricular member 112A, and when that condition exists, the deflectable flap 154 ​​will remain closed. The deflectable flow control member 150 is advantageous in that the valve allows access through the heart valve prosthesis 100 to reintroduce the inner shaft 404 or to perform other procedures through the heart valve prosthesis 100.

[0058] 9A-9B show the ventricular member 112B in more detail. A compressible flow control member 162 is provided within the lumen of the first hub 116. The compressible flow control member 162 may be a compressible foam material, a woven Dacron material, or other similar material. The compressible flow control member 162 may be provided with a small opening through which the inner shaft 404 can pass. After delivery of the ventricular member 112B, the inner shaft 404 may be removed from the lumen of the first hub 116 of the ventricular member 112B. Pressure in the ventricle will cause the small opening to collapse closed, plugging the lumen of the first hub 116. The compressible flow control member 162 is advantageous in that it provides complete closure of the lumen through the first hub 116 (and through the heart valve prosthesis 100) after the inner shaft 404 is removed, regardless of pressure on either side of the ventricular member 112B. The compressible flow control member 162 may have openings to begin with, e.g., do not completely close when the inner shaft 404 is not deployed through it. The small size of the openings may become blocked by tissue over time. In some cases, the ventricular member 112 may not be provided with a collapsible flow control member, but may still close due to tissue growth over time.

[0059] III. Delivery Systems and Methods 1 and 6A-6F show various embodiments of a delivery system 400 for delivering and assembling a heart valve prosthesis 100 in a patient's heart, for example in the tricuspid valve between the right atrium and the ventricle. The delivery system 400 is configured to be delivered over a guidewire GW, as seen in FIG. 1 and 6A-6E. In some techniques, the guidewire GW can be advanced into the ventricle and held stationary (e.g., stopped) in the ventricle to provide rails for rapid and precise advancement and deployment of the prosthesis 100. In other techniques, a guide catheter (not shown) can be advanced into the ventricle and held stationary in the ventricle to provide rails for rapid and precise advancement and deployment of the prosthesis 100. The guide catheter can be used alone or in combination with a guidewire to facilitate deployment. The delivery system 400 comprises a distal portion 402A and a proximal portion 402B. An outer sheath 406 can extend to a distal tip 410. The proximal portion 402B may include a guide handle 412 and a delivery handle 414. The guide handle 412 may be coupled to a proximal end of the outer sheath 406. The delivery handle 414 may extend through the guide handle 412, through the outer sheath 406, and to components of the heart valve prosthesis 100.

[0060] FIG. 6A illustrates an embodiment of a method of using the delivery system 400 to deliver the heart valve prosthesis 100. The guide handle 412 can be steered to advance the outer sheath 406 over the guidewire through the venous vasculature into the heart. The outer sheath 406 can be advanced into the right atrium. Continued advancement of the outer sheath 406 can move the distal tip 410 beyond the line of coaptation LOC of the patient's tricuspid valve into the right ventricle. This is the position shown in FIG. 6A. The delivery handle 414 controls the movement and relative position of the components of the heart valve prosthesis 100, such as during movement of the guide handle 412 and the outer sheath 406. The delivery handle 414 can be held stationary while the guide handle 412 is pulled back to expose the implant. In various embodiments, the heart valve prosthesis 100 is positioned in one of the peripheral regions of the tricuspid valve.

[0061] FIG. 1D shows that the heart valve prosthesis 100 may be implanted between the first heart valve leaflet LF1 and the second heart valve leaflet LF2. The positioning of the heart valve prosthesis 100 in FIG. 1D may be such that the heart valve prosthesis 100 is not positioned across the gap G between the first heart valve leaflet LF1 and the non-diseased third heart valve leaflet LF3. The positioning of the heart valve prosthesis 100 in FIG. 1D may be such that the heart valve prosthesis 100 is not positioned across the gap G between the second heart valve leaflet LF2 and the non-diseased third heart valve leaflet LF3. In other techniques, the heart valve prosthesis 100 may be positioned between the first heart valve leaflet LF1 and the third heart valve leaflet LF3. In other techniques, the heart valve prosthesis 100 may be positioned between the second heart valve leaflet LF2 and the third heart valve leaflet LF3. The appropriate position of the heart valve prosthesis 100 may be determined before or during the procedure, such as by using an echocardiogram. Proper positioning of the heart valve prosthesis 100 can be achieved by maneuvering the distal tip 410 and the distal length of the outer sheath 406 within the peripheral area of ​​a portion of the tricuspid valve between two of the three leaflets.

[0062] 6B illustrates that relative movement between the outer sheath 406 and the ventricular member 112 can expose the ventricular member in the right ventricle. The outer sheath 406 can be moved proximally by retracting the guide handle 412 as indicated by arrow A1. The delivery handle 414 can, in one technique, be held stationary while the guide handle 412 is moved as indicated by arrow A1. As the outer sheath 406 moves proximally, the distal tip 410 is retracted proximally until it is positioned proximal to the ventricular member 112. The distal tip 410 can be retracted into the right atrium while the delivery system 400 maintains the position of the ventricular member 112, e.g., the ventricular member can be maintained in the same position while the distal tip 410 is moved proximally. In other techniques, the guide handle 412 can remain stationary and the delivery handle 414 can move the ventricular member 112 distally out of the distal tip 410 of the outer sheath 406.

[0063] As previously mentioned, the ventricular member 112 may include arms 124 that may be configured to self-expand into the position or configuration seen in FIG. 6B. The arms 124 may be arranged such that their second ends 136 are not connected to one another. Thus, the arms 124 are slender members that can expand between the network of tendons that traverse the right ventricle to move the leaflets LF1, LF2, LF3 as the heart beats. This configuration of the ventricular member 112 reduces or eliminates the risk of entanglement between the ventricular member 112 and the tendons. In one form of the delivery system 400, the rotational position of the delivery handle 414 may be maintained as the outer sheath 406 is moved relative to the ventricular member 112 such that the ventricular member does not rotate as it is expanded.

[0064] FIG. 6C illustrates a further embodiment of a method of using the delivery system 400. The outer sheath 406 can be moved relative to the inner sheath 408, for example, proximally as indicated by arrow A2, until the distal tip 410 is proximal to the atrial member 212. The atrial member 212 can be positioned distal to the inner sheath 408 such that it can expand within the atrium when exposed. Proximal movement along arrow A2 can be effected by corresponding movement of the guide handle 412, as indicated by arrow A2. FIG. 6C illustrates that the ventricular member 112 and the atrial member 212 can be expanded within the heart before being engaged with one another. The ventricular member 112 can be preloaded, such as with the arms 124 biased or oriented toward the ventricular member first hub 116 as described in connection with FIG. 3A. The frame arrangement 220 may be preloaded, such as with the frame 222 or petals 236 biased or oriented away from the second hub 216 as described in connection with Figure 5A. The angle of deflection or orientation of the arms 124 and frame arrangement 220 may be greater in the state of Figure 6C than when the ventricular member 112 and the atrial member 212 are engaged with one another.

[0065] FIG. 6D illustrates a technique for gripping one or more leaflets, such as two or three. The delivery handle 414 can be modified by removing the first lockout portion 432 from the first slide 436 and the second slide 440. The first lockout portion 432 is configured to prevent movement of the first slide 436 and the second slide 440 before being removed from the delivery handle 414. FIG. 6C illustrates that the first lockout portion 432 can fill a space in the delivery handle 414, and if the first lockout portion 432 cannot be positioned in that space, the first slide 436 and the second slide 440 can move. When the first lockout portion 432 is removed, the first slide 436 and the second slide 440 can be moved together, as indicated by arrow A3. This movement can result in a corresponding movement according to arrow A3 that moves the atrial member 212 toward the ventricular member 112 into engagement with the ventricular member 112. Following the movement of the first slide 436 and the second slide 440, the ventricular member 112 and the atrial member 212 can be engaged and can capture leaflet material therebetween. At least one of the tips (e.g., the second end 136) of the arms 124 can be received in the recess 240 of the frame arrangement 220. The ventricular member 112 and the atrial member 212 can still be connected to the delivery system 400 during this portion of the method of using the delivery system 400. FIG. 6D shows that the second lockout portion 444 can maintain the relative positions of the first slide 436 and the second slide 440 during the movement according to arrow A3. FIG. 6D also shows that a third lockout portion 452 may be provided to maintain the relative position of the third slide portion 456 and the fourth slide portion 460, the operation of which will be described further below.

[0066] As previously mentioned, the tongue 252 may be configured to engage a window, such as the slot 120, of the ventricular member 112. The tongue 252 may be biased inwardly in a free state. Prior to engaging the first hub 116 with the second hub 216 (e.g., prior to advancing the first hub 116 onto the second hub 216), the tongue 252 may be biased inwardly such that the minimum distance between the tongues 252 is less than the outer diameter of the first hub 116. The tongue 252 may be rotationally aligned with the slot 120 such that the tongue 252 may be advanced to the proximal edge of the first hub 116 when movement according to arrow A3 occurs. When the proximal edge engages the inside of the tongue 252, the tongue may be biased outwardly by the first hub 116. Continued relative movement of the first hub 116 and the second hub 216 toward one another may be provided, for example according to arrow A3, until the tang 252 is disposed across the slot 120. When disposed across the slot 120, the tang 252 is no longer held in the radially outwardly altered position but may deflect inwardly into the slot 120 to fixedly connect the ventricular member 112 to the atrial member 212.

[0067] As previously mentioned, the recesses 240 can receive the arms 124 (and in at least some cases have valve tissue therebetween) and can provide at least some rotational movement of the members relative to one another as subsequent movement of the ventricular member 112 and the atrial member 212 together occurs. This rotational movement can reduce or eliminate misalignment of the tangs 252 into the slots 120 that can complicate engagement of these connecting features.

[0068] 6E illustrates a further embodiment of a method of using the delivery system 400. The second lockout portion 444 is removed, allowing relative movement of the first slide 436 with respect to the second slide 440. The first slide 436 can be moved toward the second slide 440 as indicated by arrow A4. Such movement corresponds to retracting a distal portion of the inner sheath 408 to expand the outer grip 407 of the delivery system 400. Prior to expansion of the outer grip 407, the outer grip 407 is engaged with the second hub 216, such as with a window 250 of the second hub 216 disposed about the tang 252. Retracting the inner sheath 408 from the outer grip 407 allows the outer grip 407 to self-expand out of engagement with the window 250.

[0069] 6F is an illustration of disengagement of the heart valve prosthesis 100 from the delivery system 400. Disengagement can be achieved by removing the third lockout portion 452 from the delivery handle 414. The third lockout portion 452 can prevent relative movement of the third slide 456 to the fourth slide 460. When the third lockout portion 452 is removed, the fourth slide 460 can be moved proximally as indicated by arrow A5 to retract the inner shaft 404 to a position proximal to the inner grips 409. Prior to such movement, the inner shaft 404 is positioned in the space between the inner grips 409 to maintain the inner grips 409 in the slots 120 and hold the ventricular member 112 in place in the delivery system 400. Movement along arrow A5 moves the inner shaft 404 out of position between the inner grips 409. Such movement causes the inner grip 409 to self-fold into the configuration shown in FIG. 6F. This configuration provides a maximum dimension of the inner grip 409 that is less than the inner diameter of the first hub 116, or in some embodiments, the maximum dimension of the inner grip 409 that is moved out of the slot 120. In such a configuration, the inner grip 409 does not deflect completely out of the slot 120 when the inner shaft 404 is retracted. In such a configuration, when the inner shaft 404 is retracted, the inner grip 409 may be sufficiently deflectable that the inner grip 409 is deflected by the heart valve prosthesis 100 as the heart valve prosthesis 100 moves out of the delivery system 400. For example, the heart valve prosthesis 100 may be securely engaged with two or more of the valve leaflets LF1, LF2, LF3 such that the leaflets retain the heart valve prosthesis 100 upon proximal movement of the guide handle 412 to retract the delivery system 400 from the heart.

[0070] FIG. 6G illustrates an additional embodiment of the delivery handle 414A. The features described with reference to FIG. 6G are optional. The delivery system 400, and in particular the delivery handle 414A, may include one or more tubes or fluid sources 441 (e.g., tube 441a, tube 441b, tube 441c, tube 441d) configured to act as flushing sources for flushing the catheter body of the system 400. The tubes 441a-441d may allow the delivery system 400 to be flushed with a fluid, such as saline or any other biocompatible fluid. The fluid may flow through the tubes 441a-441d and the delivery device and ultimately into the blood for drainage. The tubes 441a-441d may assist in removing air from the delivery system 400 when pressurized, which may prevent air from entering the bloodstream. The tubes 441a-441d may also prevent / remove blood from entering the area of ​​the delivery device 400 when pressurized. The tubes 441 a - 441 d , when pressurized, can prevent / reduce friction when moving the sliders 436 , 440 , 456 , 460 to move the different catheter bodies of the system 400 .

[0071] Tubes 441a-441d can each be in fluid communication with a different annular space within delivery system 400 that may correspond to the slide to which each tube 441a-441d is connected. For example, tube 441a can be connected to first slide 436. Tube 441b can be connected to second slide 440. Tube 441c can be connected to third slide 456. Tube 441d can be connected to fourth slide 460.

[0072] The first tube 441a may be fluidly connected to a first annular space extending from the first slide 436 towards or to the distal tip 410 of the delivery system 400. The second tube 441b may be fluidly connected to a second annular space extending from the second slide 440 towards or to the distal tip 410 of the delivery system 400. The third tube 441c may be fluidly connected to a third annular space extending from the third slide 456 towards or to the distal tip 410 of the delivery system 400. The fourth tube 441d may be fluidly connected to a fourth annular space extending from the fourth slide 460 towards or to the distal tip 410 of the delivery system 400. The annular spaces may be separated from each other. The annular spaces may be embedded within each other. For example, the fourth annular space may surround the third annular space. The third annular space may surround the second annular space. The second annular space may surround the first annular space. In other embodiments, the fourth annular space may extend through the third annular space. The fourth and third annular spaces may extend through the second annular space. The fourth, third, and second annular spaces may extend through the first annular space. One or more of the annular spaces may be disposed between an inner surface of the outer sheath 406 and an outer surface of the inner sheath 408. One or more of the annular spaces may be disposed between an outer surface of the inner shaft 404 and an inner surface of the inner sheath 408.

[0073] A syringe 442 may be used to push the fluid through the tubes 441a-441d. In some embodiments, more than one syringe 442 may be used. For example, one syringe or separate syringes may be used for each tube 441a-441d. Fluid may be selectively inserted into one or more annular spaces at a time. Fluid may be inserted into two or more or all annular spaces simultaneously. Fluid may exit the syringe 442 and proceed through a manifold 443. The manifold 443 may direct the fluid into the appropriate tubes 441a-441d and corresponding annular spaces. As such, the fluid will proceed through the annular spaces of the delivery system and eventually out the distal end. As previously described, this may flush air out of the delivery system, prevent or remove blood from the system, and / or reduce or eliminate friction when moving the slides 436, 440, 456, 460. If present, manifold 443 may be supplied with a continuous supply of fluid, such as a drip of saline from an elevated saline bag.

[0074] In an embodiment, each tube 441a-441d may be connected to a flow regulator, a manifold 443, and / or an IV fluid source. The IV fluid source may be a gravity-fed IV flow bag, a pressurized bag, and / or a fluid pump. The flow regulator, manifold, and IV fluid source may be configured such that each tube 441a-441d receives a fixed flow rate for flushing. This may be beneficial when all tubes 441a-441d are connected together for flushing, allowing flow to be preferentially directed to the tubes 441a-441d with the least resistance and bypassing the more restricted tubes 441a-441d.

[0075] In other embodiments, a single injection supply tube may be provided, such as by placing one of tubes 441a-441d in fluid communication with an interstitial space between adjacent layers of system 400. This approach has the benefit of simplicity, but may require a higher injection pressure to overcome resistance in a particular interstitial space of system 400.

[0076] 8A-9B were previously described in the context of the ventricular member 112A and the ventricular member 112B configured to occlude the lumen of the first hub 116. The occlusion may be accomplished during the technique illustrated in FIG. 6F. Specifically, when the fourth slide 460 is retracted according to arrow A5, the inner shaft 404 is retracted from within the lumen of the first hub 116 of the ventricular member 112B. This may cause the deflectable flow control member 150, such as the deflectable flap 154 ​​of the ventricular member 112A, to extend into the lumen of the first hub 116. When the fourth slide 460 is retracted according to arrow A5, the inner shaft 404 is retracted from within the lumen of the first hub 116 of the ventricular member 112B. This may cause the compressible flow control member 162 of the first hub 116 of the ventricular member 112B to extend into the lumen of the first hub 116. Flow control in the ventricular member 112A is just when the deflectable flaps 154 contact each other. The ventricular member 112A can again cross the lumen of the first hub 116. The ventricular member 112A can again cross the lumen of the first hub 116 in some techniques. Flow control in the ventricular member 112B can increase over time as the compressible flow control member 162 absorbs blood that may become embedded in the ostia of the member 162.

[0077] 7A shows engagement of the heart valve prosthesis 100 with heart tissue in one experiment. The heart valve prosthesis 100 is depicted from the atrial side of the valve. The second hub 216 is seen disposed about the first hub 116, both of which are on the atrial side of the line of coaptation.

[0078] FIG. 7B shows the same heart valve prosthesis 100 engaged with heart tissue. FIG. 7B shows a view from the ventricular side of the valve to which the prosthesis 100 has been applied, with the chordae tendineae CT in the foreground. The second end 136 is shown engaged with the recess 240. The leaflet tissue is captured between the arms 124 and the frame arrangement 220. In some applications, one or more regions of the heart valve prosthesis 100 may be positioned at the line of coaptation LOC, such as not being engaged with any leaflets, as seen in the 2 o'clock position. For portions of the heart valve prosthesis 100 where the leaflet tissue is not captured between the arms 124 and the recess 240, or other portions of the frame arrangement 220, the atrial member 212 may be covered by a cover 223 as previously described, so that reverse flow may be reduced, minimized, or prevented.

[0079] 7C illustrates that in some applications, a portion of the circumference of the heart valve prosthesis 100 at an angle of about 120 degrees may be provided where direct engagement is provided between the arms 124 and the recesses 240 of the frame arrangement 220. In some embodiments, the arms 124 may be aligned with the center of the recesses 240. In some embodiments, the arms 124 may be displaced from the center of the recesses 240. This may be due to interaction with or interference by tissue or other obstructions. The cover 223 may block reverse flow over the portion of the circumference. In other applications, the extent is about 10 degrees, about 20 degrees, about 30 degrees, about 40 degrees, about 50 degrees, about 60 degrees, about 70 degrees, about 80 degrees, about 90 degrees, about 100 degrees, about 110 degrees, about 130 degrees, about 140 degrees, about 150 degrees, about 160 degrees, about 170 degrees, or about 180 degrees, or a range of angles including any combination of these numbers as endpoints. In some applications, two or more portions of the periphery of the heart valve prosthesis 100 can provide direct engagement between the ventricular member 112 and the atrial member 212 with a portion of the heart valve prosthesis 100 therebetween engaging the valve tissue.

[0080] 10A-10E show an exemplary nose cone coupled or disposed at the distal tip 410 of the delivery system 400. The nose cone allows the delivery system 400 to track over the guidewire GW within the vasculature. The nose cone can preload the heart valve prosthesis 100 at the distal end of the outer sheath 406. The nose cone can provide an atraumatic tip for the delivery system 400 so that it does not snag or damage the vasculature or the valve leaflets as the tip 410 crosses the line of coaptation of the leaflets. The nose cone can be provided in a location to block or protect the heart valve prosthesis 100 while the delivery system 400 is advanced, and can be moved out of the path of the heart valve prosthesis 100, or at least into a second position or configuration that does not block the heart valve prosthesis 100 as much, to allow the heart valve prosthesis 100 to pass over the distal tip 410 of the outer sheath 406.

[0081] 10A-10B illustrate an example embodiment of a nose cone 500. FIG. 10A illustrates the nose cone 500. The nose cone 500 can be coupled to the distal tip 410 of the outer sheath 406. The nose cone 500 can be a distal portion or region of the distal tip 410. The nose cone 500 can have a first portion 501 that extends generally parallel to the outer sheath 406. The nose cone 500 can have a second portion 502 that extends at an angle relative to the outer sheath 406, toward a central axis of the sheath 406, to form a generally conical shape or other distally tapered shape. The second portion 502 can be configured to transition to an open state, as shown in FIG. 10B'.

[0082] The nose cone 500 may have a splitting tip. For example, the nose cone 500 may have one or more seams or clefts 504 that cause the nose cone 500 to open away from the central axis. The nose cone 500 may have multiple seams or clefts 504. For example, there are one, two, three, four, or more seams or clefts 504. The number of clefts 504 may determine the number of sections 505 the nose cone 500 may split into when in the open state. In some embodiments, the cleft 504 may extend along both the first and second portions 501, 502 of the nose cone 500. In some embodiments, the cleft 504 may extend only along the second portion 502 of the nose cone 500.

[0083] The cleft 504 of the nose cone 500 may be secured together with a separation retention device or structure. For example, the separation retention device or structure may include a series of perforations, an area provided with weak adhesive, an area with scratches along the cleft 504, or any other suitable method. The separation retention device or structure may allow the nose cone 500 to be advanced together or as a unit and to separate, split, or open as or when the heart valve prosthesis 100 is advanced through the nose cone 500. In some embodiments, the advancement of the heart valve prosthesis 100 may cause the nose cone 500 to separate at the cleft 504.

[0084] 10B and 10B' show the nosecone 500 transitioning from a closed state, position, or configuration to an open state, position, or configuration. In the closed state, the delivery system 400 is advanced to the delivery site. The nosecone 500 is closed to prevent the heart valve prosthesis 100 from exiting the delivery system 400. In the open state, the delivery system 400 is at the delivery site and the nosecone transitions to the open state to enable delivery of the heart valve prosthesis 100.

[0085] The nose cone 500 may have an interlocking portion 508. The interlocking portion 508 may be configured to hold the nose cone 500 closed during advancement of the delivery system 400. The nose cone 500 may be held in a closed position by pushing the distal tip 410 of the delivery system 400 into the interlocking portion 508. The nose cone 500 may be opened by retracting the distal tip 410 to release the interlocking portion 508 and pushing the heart valve prosthesis 100 through the nose cone 500. The nose cone 500 may be opened away from the central axis as indicated by arrow 2.

[0086] 10C and 10C' show another example embodiment of the nose cone 512. FIG. 10C shows the nose cone 512 in a closed state or configuration, and FIG. 10C' shows the nose cone 512 in an open state or configuration. The nose cone 512 can be coupled to the distal tip 410 of the outer sheath 406. The nose cone 512 can comprise a flexible material. The flexible material can be configured to release or expand as the heart valve prosthesis 100 passes through the nose cone 512. After the heart valve prosthesis 100 is delivered, the nose cone 512 can return to its original closed shape. Although FIG. 10C' shows the elastic expansion of the nose cone 512, some deformation is acceptable given that the nose cone is no longer needed after the heart valve prosthesis 100 is deployed.

[0087] 10D and 10D' show another example embodiment of the nose cone 516. FIG. 10D shows the nose cone 516 in a closed state or configuration, and FIG. 10D' shows the nose cone 516 in an open state or configuration. The nose cone 516 may be configured as an additional outer sheath disposed around the outer sheath 406. The nose cone 516 may have a tip portion and an outer sheath portion. The tip portion and the outer sheath portion may surround the outer sheath 406. The nose cone 516 may slide over the outer sheath 406 to expose the distal tip 410 of the outer sheath 406. The nose cone 516 may be retracted or pulled back by pulling and stretching the nose cone 516 over the outer sheath 406, as indicated by the arrows. In one technique, the outer sheath 406 may be advanced out of the nose cone 516. In another technique, simultaneous movement of the nosecone 516 and the outer sheath 406 can be provided to move the tip of the sheath 406 out of the nosecone 516. The heart valve prosthesis 100 can be delivered through the exposed distal tip 410 of the outer sheath 406.

[0088] FIG. 10E shows an example embodiment of a nose cone 520. The nose cone 520 can be an inflation balloon tip positioned inside or partially coupled to the outer surface of the distal tip 410 of the outer sheath 406. The inflation balloon tip nose cone 520 can be inflated by a lumen positioned inside the distal tip 410 to prevent the heart valve prosthesis 100 from exiting the outer sheath 406. The inflated tip can block a passage inside the distal tip 410 to prevent the prosthesis 100 from exiting. The inflatable tip can have a hemispherical, tapered, or conical profile that can function as a nose cone until delivery of the heart valve prosthesis 100. In some embodiments, the heart valve prosthesis 100 can be advanced along a guidewire GW and the inflation balloon tip can surround the guidewire and can be inflated to prevent the heart valve prosthesis 100 from exiting the delivery system 400. The nose cone 520 on the tip of the dilatation balloon can then be deflated and subsequently pulled back over the heart valve prosthesis 100 to allow the heart valve prosthesis 100 to exit the outer sheath 406. Alternatively, the prosthesis 100 can be advanced over the nose cone 520 as the nose cone 520 on the tip of the dilatation balloon is deflated.

[0089] Common to the advantages of the prostheses, delivery systems, nose cones, and methods disclosed herein is the fact that the procedure can be used to deploy the prosthesis without anticoagulant therapy.

[0090] term As used herein, the relative terms "proximal" and "distal" may be defined from the perspective of the implant, whereby proximal refers to the direction of the portion of the implant that is disposed in the right atrium and distal refers to the portion of the implant that is disposed in the right ventricle.

[0091] Conditional language such as "can," "could," "could," "may," "for example," and the like, unless otherwise expressly stated or otherwise understood within the context as it is used, is generally intended to convey that certain embodiments include certain features, elements, and / or steps, but not other embodiments. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are in any way required for one or more embodiments.

[0092] Terms such as "comprising," "including," "having," and the like are synonymous and are used inclusively in an open-ended manner and do not exclude additional elements, features, acts, operations, etc. Additionally, the term "or," when used, for example, to connect a list of elements, is used in its inclusive sense (and not its exclusive sense) to mean one, some, or all of the elements in the list. Additionally, the articles "a," "an," and "the" as used in this application and the appended claims are intended to mean "one or more" or "at least one," unless expressly stated otherwise.

[0093] Ranges disclosed herein also encompass any and all overlaps, subranges, and combinations thereof. Words such as "up to," "at least," "greater than," "less than," "between," and the like, are inclusive of the number being suggested. Numbers preceded by terms such as "about" or "approximately" are inclusive of the number being suggested and should be interpreted in the context (e.g., as precisely as reasonably possible under the circumstances, e.g., ±5%, ±10%, ±15%). For example, "about 1" includes "1". Words preceded by "substantially," "generally," and the like, are inclusive of the number being suggested and should be interpreted in the context (e.g., as precisely as reasonably possible under the circumstances). For example, "substantially spherical" includes "spherical". Unless otherwise stated, all measurements are at standard conditions, including temperature and pressure.

[0094] As used herein, a phrase referring to "at least one" of a list of items refers to any combination of those items, including single members. By way of example, "at least one of A, B, or C" is intended to cover A, B, C, A and B, A and C, B and C, and A, B, and C. Transitives such as "at least one of X, Y, and Z" are understood otherwise in the context as generally used to convey that an item, term, etc. may be at least one of X, Y, or Z, unless expressly stated otherwise. Thus, such transitives are generally not intended to imply that a particular embodiment requires that at least one of X, at least one of Y, and at least one of Z are each present.

[0095] While specific embodiments and examples are described herein, it should be emphasized that many variations and modifications can be made to the heart valve prosthesis and delivery system shown and described in this disclosure, and it is understood that the elements of the heart valve prosthesis and delivery system can be differently combined and / or modified to form still further embodiments or acceptable examples. All such modifications and variations are intended to be included herein within the scope of this disclosure. A wide variety of designs and approaches are possible. No feature, structure, or step disclosed herein is essential or essential.

[0096] Some embodiments are described in relation to the accompanying drawings. However, it should be understood that the figures are not drawn to scale. Distances, angles, etc. are merely exemplary and do not necessarily bear a precise relationship to the actual dimensions and arrangement of the illustrated devices. Components can be added, removed, and / or rearranged. Furthermore, any specific features, aspects, methods, properties, characteristics, qualities, attributes, elements, etc. disclosed herein in connection with various embodiments can be used in all other embodiments described herein. It is also recognized that any method described herein can be performed using any apparatus suitable for performing the proposed steps.

[0097] For the purpose of this disclosure, certain aspects, advantages, and novel features are described herein. It is understood that not all such advantages may be achieved according to any particular embodiment. Thus, for example, those skilled in the art will recognize that the present disclosure may be embodied or carried out in a manner that achieves one advantage or group of advantages as taught herein, without necessarily achieving other advantages as taught or suggested herein.

[0098] Moreover, while exemplary embodiments are described herein, it will be understood by those skilled in the art that the scope of the present invention extends beyond the specifically disclosed embodiments to any and all embodiments having equivalent elements, improvements, omissions, combinations, or subcombinations of specific features and aspects of the present invention (e.g., aspects across various embodiments), adaptations and / or modifications, and uses as would be understood by those skilled in the art based on this disclosure. The limitations in the claims are to be interpreted broadly and not limited to the examples described herein or during prosecution of this application, based on the language used in the claims, which examples are to be interpreted as non-exclusive. Furthermore, the acts of the disclosed processes and methods may be modified in any manner, including by reordering acts, inserting additional acts, and / or deleting acts. As such, it is intended that the specification and examples be considered as exemplary only, with the true scope and spirit being indicated by the claims and their full scope of equivalents.

[0099] Any methods disclosed herein need not be performed in the order suggested. Methods disclosed herein include specific actions taken by a practitioner, but may include any third-party command of those actions, either explicitly or implicitly. For example, an action such as "insert a delivery catheter into the right internal jugular vein" includes "command the insertion of a delivery catheter into the right internal jugular vein." [Explanation of symbols]

[0100] 10. Heart 12 Tricuspid Valve 14 Right atrium 16 Right ventricle 50 Treatment System 100 Heart valve prostheses 112, 112A, 112B Ventricular members 116 First Hub 120 Slots 124 Arm 130 Long and thin body 130a First curved section 130b Second Area 132, 132' first end 136, 136' second end 136a Enlarged section 136b Reduced part 140 Free State 150 Deflectable flow control member 154 Deflectable Flaps 212 Atrial member 222, 222A, 222B Frames 223 Cover 224 Basic part 226 Outer part 228 Shared Pillar 229 Dedicated support part 236 Petal 238 Quadrilateral Area 240, 240A, 240B recess 250 Windows 252 Tongue 400 Delivery System 402A Distal Part 402B Proximal part 404 Inner Shaft 406 Outer sheath 407 Outer grip 408 Inner sheath 409 Inner grip part 410 Distal tip 412 Guide handle 414, 414A Delivery Handle 432 First Lockout Section 436 First Slide 440 Second Slide 441 Piping, fluid supply source 441a First tube 441b Second tube 441c Third Tube 441d Fourth Tube 442 Syringe 443 Manifold 444 Second Lockout Section 452 Third Lockout Section 456 Third Slide 460 Fourth Slide 500 Nosecone 501 First Part 502 Second Part 504 Joints and cracks 505 classification 508 Interlocking part 512, 516, 520 Nosecone

Claims

**Claim 1** A ventricular member configured to be advanced into a ventricle of the heart, the ventricular member comprising a first hub with a slot, the first hub being configured to be disposed adjacent to a line of junction of a first heart valve cusp and a second heart valve cusp, a first end connected to the first hub, and an array of arms each having a second end opposite the first end, wherein the second end of each arm is deflected toward the first hub in a free state, the second ends of adjacent arms are not connected to each other, one or more of the second ends are configured to be placed in direct contact with the first heart valve cusp, and one or more of the second ends are configured to be placed in direct contact with the second heart valve cusp, and an array of arms. An atrial member configured to be advanced into the atrium adjacent to a line of junction of the first heart valve cusp and the second heart valve cusp, the atrial member comprising a second hub with an array of tangs and petals, the tangs being configured to lock into the slot of the first hub to engage the second hub with the first hub when the atrial member and the ventricular member are assembled, each petal of the array of petals having a proximal end connected to the second hub and a distal end opposite the proximal end, the distal end of each petal being deflected away from the second hub, and adjacent petals bounded by a common inner strut and separate outer struts forming a depression at the junction of the common inner strut and the separate outer struts. Comprising The atrial member is separate from the ventricular member and is movable relative to the ventricular member before the first hub and the second hub are engaged. In an engaged configuration, the arms of the ventricular member are pushed into the depressions of the atrial member. A heart valve prosthesis. **Claim 2** The heart valve prosthesis according to claim 1, wherein the ventricular member and the atrial member are made of a shape memory alloy. **Claim 3** The heart valve prosthesis according to claim 1, wherein the ventricular member and the atrial member comprise nitinol. **Claim 4** The second end of each arm has a tip, the tip having a reduced portion and an enlarged portion, the enlarged portion being distal to the reduced portion. The heart valve prosthesis according to claim 1. **Claim 5** The heart valve prosthesis according to claim 1, wherein a ventricular constriction diameter measured with respect to a circle drawn by the second end of the wrist portion is smaller than an atrial constriction diameter measured with respect to a circle drawn by the outer end of the petal.

6. The heart valve prosthesis according to claim 1, wherein a ventricular constriction diameter measured with respect to a circle drawn by the second end of the wrist portion is about 20 mm.

7. The heart valve prosthesis according to claim 1, wherein an atrial constriction diameter measured with respect to a circle drawn by the outer end of the petal is about 25 mm.

8. A ventricular member configured to be advanced into a ventricle of the heart, the ventricular member comprising a first hub having a slot and at least three wrist portions, the first hub being configured to be disposed adjacent to a line of junction of a first heart valve cusp and a second heart valve cusp, each wrist portion having a first end connected to the first hub and a second end opposite the first end, the second ends of adjacent wrist portions not being connected to each other, one or more of the second ends being configured to be placed in direct contact with the first heart valve cusp, one or more of the second ends being configured to be placed in direct contact with the second heart valve cusp, a ventricular member; An atrial member configured to be advanced into the atrium adjacent to a line of junction of the first heart valve cusp and the second heart valve cusp, the atrial member comprising a second hub having a tongue and a frame arrangement, the tongue being configured to lock into the slot of the first hub for engaging the second hub with the first hub when the atrial member and the ventricular member are assembled, the frame arrangement comprising a plurality of frames having a base portion connected to the second hub and an outer portion opposite the base portion, each frame comprising two common struts and two dedicated strut portions, the two common struts being connected to the second hub at a first end and forming the base portion, the two dedicated strut portions being attached to a second end of each of the common struts, an atrial member comprising Each frame surrounds an approximately quadrilateral area, adjacent frames are connected by common struts, and adjacent frames form a depression therebetween. The atrial member is separate from the ventricular member and is movable relative to the ventricular member before the first hub and the second hub are engaged. In the engaged configuration, the arm portion of the ventricular member is pushed into the recess of the atrial member, a heart valve prosthesis. **Claim 9** The heart valve prosthesis according to claim 8, wherein the rectangular region is substantially kite-shaped. **Claim 10** The region that is kite-shaped has a first isosceles triangle region and a second isosceles triangle region, the first isosceles triangle region is close to the second hub, and the first isosceles triangle region has a first height greater than a second height of the second isosceles triangle region, the heart valve prosthesis according to claim 9. **Claim 11** The heart valve prosthesis according to claim 10, wherein the first height is about 5 to 9 mm. **Claim 12** The heart valve prosthesis according to claim 10, wherein the second height is about 2 to 6 mm. **Claim 13** The heart valve prosthesis according to claim 10, wherein the first height is about twice a first base width of the first isosceles triangle region. **Claim 14** The heart valve prosthesis according to claim 10, wherein the second height is about one times a second base width of the second isosceles triangle region. **Claim 15** The second end of each arm portion bends toward the first hub when the ventricular member and the atrial member are disengaged, the heart valve prosthesis according to claim 8. **Claim 16** At least one of the outer portions of the frame bends away from the second hub when the ventricular member and the atrial member are disengaged, the heart valve prosthesis according to claim 8. **Claim 17** At least one of the second ends of the arm portions transitions from a state of being bent by a first amount toward the first hub to a state of being bent by a second amount toward the first hub when the ventricular member and the atrial member transition from a disengaged state to an engaged state, the heart valve prosthesis according to claim 8. **Claim 18** The force applied by the recess of the atrial member bends the arm portion of the ventricular member from a state of being bent by the first amount to a state of being bent by the second amount, the heart valve prosthesis according to claim 17. **Claim 19** The heart valve prosthesis according to claim 17, wherein the second amount is smaller than the first amount. **Claim 20** When the outer portion of each frame is shifted from a state where the ventricular member and the atrial member are disengaged to a state where they are engaged, it shifts from a state of being bent by a first amount away from the second hub to a state of being bent by a second amount away from the second hub. The heart valve prosthesis according to claim 8.

21. The force applied by the arm portion of the ventricular member bends the frame of the atrial member from a state of being bent by the first amount to a state of being bent by the second amount. The heart valve prosthesis according to claim 20.

22. The first amount is smaller than the second amount. The heart valve prosthesis according to claim 20.

23. The bottom of each recess is aligned with the longitudinal axis of each common strut. The heart valve prosthesis according to claim 8.

24. The bottom of each recess is aligned with the central radial axis of the frame. The heart valve prosthesis according to claim 8.

25. A ventricular member configured to be advanced into the ventricle of the heart, A first hub having a slot, the first hub being configured to be disposed adjacent to the line of junction of the first heart valve leaflet and the second heart valve leaflet, and At least three arm portions each having a first end connected to the first hub and a second end opposite the first end, one or more of the second ends being configured to be placed in direct contact with the first heart valve leaflet, and one or more of the second ends being configured to be placed in direct contact with the second heart valve leaflet. At least three arm portions A ventricular member comprising An atrial member configured to be advanced into the atrium and positioned across the line of junction, A second hub having a tang for locking into the slot of the first hub when the atrial member and the ventricular member are assembled, and At least one centering mechanism for centering at least one arm portion of the ventricular member An atrial member comprising Comprising During engagement of the ventricular member with the atrial member, the centering mechanism of the atrial member guides the arm portion of the ventricular member to a predetermined position and / or orientation when the tang of the second hub engages the slot of the first hub. A heart valve prosthesis.

26. The at least one centering mechanism comprises a recess. The heart valve prosthesis according to claim 25.

27. The heart valve prosthesis according to claim 25, wherein the atrial member includes an alignment mechanism corresponding to each arm portion of the ventricular member.

28. A system for delivering a heart valve prosthesis, comprising: a delivery device and a prosthesis, wherein the delivery device is a delivery handle, including a housing, and a plurality of sliding portions disposed in the housing a delivery handle comprising; a plurality of removable lockout portions configured to prevent movement of the sliding portions in a first state and allow movement within a certain range in a second state; a sheath assembly, including an outer sheath, and an inner sheath disposed within the outer sheath, wherein the outer sheath is movable relative to the inner sheath a sheath assembly comprising, and a guide handle configured to retract the outer sheath comprising, wherein the prosthesis is a ventricular member having at least three arm portions, each arm portion having a first end connected to a hub, a hub configured to connect to the hub of the ventricular member, and an atrial member comprising at least one alignment mechanism having a recess for centering at least one of the at least three arm portions of the ventricular member comprising, The system, wherein the delivery handle is configured to control movement and positioning of the prosthesis within the heart by movement of the sliding portions and the lockout portions.

29. The system according to claim 28, further comprising a nose cone connected to a distal end of the outer sheath.

30. The system according to claim 29, wherein the nose cone comprises a plurality of slits configured to open the nose cone to allow the prosthesis to exit the outer sheath.

31. The system according to claim 29, wherein the nose cone comprises a flexible tip configured to expand to allow the prosthesis to exit the outer sheath.

32. The system according to claim 29, wherein the nose cone surrounds the outer sheath and is configured to be retracted to allow the prosthesis to exit the outer sheath.

33. The system according to claim 28, further comprising an inflatable balloon disposed within the outer sheath, the inflatable balloon being configured to be inflated to prevent the patch from exiting the outer sheath and configured to be deflated to allow the patch to exit the outer sheath.

34. The system according to claim 28, further comprising a fluid supply source configured to be connected to the housing and supply fluid to a space disposed between the inner surface of the outer sheath and the outer surface of the inner sheath.

35. The system according to claim 34, further comprising a fluid supply source configured to be connected to the housing and supply fluid to a plurality of spaces disposed between the inner surface of the outer sheath and the outer surface of the inner sheath.

36. The system according to claim 34, further comprising a plurality of fluid supply sources connected to a plurality of spaces disposed between the inner surface of the outer sheath and the outer surface of the inner sheath, wherein one of the fluid supply sources supplies fluid to each one of the spaces between the inner surface of the outer sheath and the outer surface of the inner sheath.

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