Two-stage tricuspid valve implant

Abstract

A prosthetic tricuspid heart valve system features a collapsible anchor frame and a collapsible prosthetic heart valve. The anchor comprises a support structure with a waisted central portion and atrial and ventricular dilated sections sized to enclose a native valve annulus. Atrial and ventricular covers are connected to the atrial and ventricular dilated sections, each featuring a central opening. A generally cylindrical, tissue-like valve receptacle has an inlet end connected to the atrial cover and an outlet end connected to the ventricular cover to create a passage through the valve receptacle between the atrial and ventricular covers.The heart valve prosthesis can include a stent and multiple prosthetic valve leaflets, with the heart valve prosthesis being configured to expand into and be received within the valve-receiving element of the anchor frame.

Description

Cross-reference to related applications

[0001] This application claims priority to the filing date of U.S. Provisional Patent Application No. 63 / 315,144, filed March 1, 2022, the disclosure of which is hereby incorporated by reference. Background of the Revelation

[0002] The heart has four natural valves, including the aortic valve, the pulmonary valve, the mitral valve (also called the left atrial valve), and the tricuspid valve (also called the right atrial valve). When these valves begin to fail, for example, by no longer contracting fully and allowing backward blood flow (or regurgitation) across the valve, it may be desirable to repair or replace the valve. Prosthetic heart valves can be implanted through open-heart surgery while the patient is on cardiopulmonary bypass. However, such procedures are highly invasive, and frail patients, who are most likely to need a prosthetic heart valve, may not survive. Recently, the trend in prosthetic heart valves has been toward less invasive procedures, such ascollapsible and expandable heart valves that can be implanted through the vascular system using a transcatheter procedure.

[0003] Unless otherwise stated, the term "tricuspid valve" refers to the right atrioventricular valve and is not just a general term for a valve with three leaflets. Initial human trials of replacing the native tricuspid valve using a transcatheter procedure (e.g., via the femoral vein) have shown promising results, with patients' quality of life significantly improved after valve implantation. Important features of a successful transcatheter tricuspid valve replacement are believed to include not only a good clinical outcome for the patient, but also ease of handling of the tricuspid valve, which, for example, is small enough to avoid a surgical incision in the patient's femoral vein for insertion. Brief summary of Revelation

[0004] According to one aspect of the disclosure, a prosthetic heart valve system for replacing a native right atrioventricular valve may include a collapsible and expandable anchor frame and a collapsible and expandable prosthetic heart valve. The anchor may include a support structure that, in an expanded state, has a tapered central portion and atrial and ventricular sections that each expand radially outward from the central portion. The atrial and ventricular sections may be sized to sandwich an annulus of the right atrioventricular valve between them. It should be understood that the term "clamping" as used herein does not require active mechanical action but also encompasses sandwiching and similar concepts. An atrial cover may be connected to the atrial portion of the support structure and extend radially inward to a central opening in the atrial cover.A ventricular cover may be connected to the ventricular portion of the support structure and extend radially inward to a central opening in the ventricular cover. A valve-receiving member may be fabric-made and generally cylindrical. An inlet end of the valve-receiving member may be connected to the atrial cover, and an outlet end of the valve-receiving member may be connected to the ventricular cover to provide a passageway from the central opening in the atrial cover to the central opening in the ventricular plate through the valve-receiving member. The prosthetic heart valve may include a stent and a plurality of prosthetic valves, the prosthetic heart valve configured to expand into and be received within the valve-receiving member of the anchor frame.

[0005] Another aspect of the disclosure relates to a method for replacing a patient's native right atrioventricular valve. The method includes deploying a collapsible and expandable anchor frame into the native right atrioventricular valve while the anchor frame is in a collapsed state within a first delivery sheath. The anchor frame is deployed from the delivery sheath, and the anchor frame is expanded within the native right atrioventricular valve such that an annulus of the native right atrioventricular valve is sandwiched between an atrial portion of the anchor frame and a ventricular portion of the anchor frame. After deployment of the anchor frame, blood can flow through a passageway of the anchor frame. The passageway is formed by a valve-receiving fabric member having an inlet end and an outlet end.The inlet end of the valve-receiving element is connected to an atrial cover, which is connected to the atrial portion of the anchor frame. The outlet end of the valve-receiving element is connected to a ventricular cover, which is connected to the ventricular portion of the anchor frame. After blood has flowed through the passage of the anchor frame, a collapsible and expandable prosthetic heart valve is brought to the anchor frame. The prosthetic heart valve is expanded into contact with the valve-receiving element, with the valve-receiving element holding the prosthetic heart valve within the native right atrioventricular valve. Brief description of the drawings Fig. Figure 1 is a schematic representation of the right atrioventricular valve. Fig. Figure 2 is a side view of an example of an outer or anchoring frame that may be used as part of a prosthetic tricuspid valve. Fig. 3 is a cross-section through an anchor frame according to one aspect of the disclosure. Fig. 4 is a plan view of the anchor frame of Fig. 3. Fig. Figure 5 is a side view of a flap component connected to the anchor frame(s) of the Fig. 2-4 can be used. Fig. 6 is a cross-sectional view of an anchor frame according to another aspect of the disclosure. Fig. 7 is a plan view of the anchor frame of Fig. 6. Fig. 8A-B are side and front views of a support arm for use with an anchor frame. Fig. 8C is a plan view of an anchor frame with the support arms of the Fig. 8A-B. Fig. 8D is a cross section through the anchor frame of Fig. 8C. Fig. 9A is a front view of a support arm for use with an anchor frame according to another embodiment of the disclosure, showing the stabilizers of the support arm in a folded state. Fig. 9B is a front view of the support arm of Fig. 9A, wherein the stabilizers of the support arm are shown in an extended state. Fig. Figure 9C is a plan view of an anchoring frame that supports the support arms of the Fig. 9A-B contains. Fig. 10A is a front view of a support arm for use with an anchor frame according to another embodiment of the disclosure, the support arm being shown in a partially extended condition. Fig. 10B is a front view of the support arm of Fig. 10A when unfolded. Fig. 10C is a side view of a plurality of support arms of Fig. 10A connected to a flap-receiving member according to another aspect of the disclosure in an expanded state. Fig. 10D is a side view of the configuration of Fig. 10C when folded. Fig. 10E is a side view of a plurality of support arms of Fig. 10A, which are connected to a flap-receiving element in an expanded state according to another aspect of the disclosure. Fig. 10F is a side view of the configuration of Fig. 10E in a folded state. Fig. 10G is a side view of a plurality of support arms of Fig. 10A connected to a valve receiving part according to another aspect of the disclosure, in an expanded state. Fig. 10H is a side view of the configuration of Fig. 10G in a folded state. Fig. 11 is a cross-section of the anchoring frame of Fig. 6 with a plurality of flaps connected to the flap-receiving element of the anchoring frame. Fig. 12 is a plan view of the anchor frame of Fig. 11. Fig. 13A-B are schematic views of the anchor frame of Fig. 3, before or after the blood has coagulated between the atrial and ventricular coverings. Fig. 14A-B are views of the flap-receiving element which is welded via radial seams into the anchor frame of Fig. 3 is mounted. Fig. 15A-C are views of the flap receiving element mounted within the anchor frame of Fig. 3 is suspended via continuous seam loops extending in the circumferential direction. Detailed description of the revelation

[0006] Fig. Figure 1 is a schematic representation of the right atrioventricular valve (commonly called the tricuspid valve). The tricuspid valve separates the right atrium from the right ventricle and typically consists of three leaflets, including a posterior leaflet, an anterior leaflet, and a septal leaflet. The septal leaflet is closest to the interventricular septum (“IVS”). The annulus of the tricuspid valve may contain conduction nodes near the junction between the annulus and the leaflet, such as the atrioventricular node (“AV node”). Electrical impulses can be conducted from the AV node via the bundle of His to the Purkinje fibers, which provide electrical conduction to the ventricles.The papillary muscles along the right ventricular wall ("RVW") can support chordae tendineae, which are connected to the leaflets of the tricuspid valve, to prevent inversion of the leaflets during normal physiological operation. The left atrioventricular valve (commonly called the mitral valve) is generally similar in structure to the tricuspid valve, although there are many differences—for example, the mitral valve typically has two leaflets (an anterior and a posterior leaflet) and a general shape of a hyperbolic paraboloid, or "saddle." Both the annulus of the mitral valve and the annulus of the tricuspid valve can be very large compared to the aortic and pulmonary valves.For example, the tricuspid valve may have a diameter of 45-50 mm in a patient with moderate tricuspid valve disease, while a diameter of 50-60 mm in a patient with severe tricuspid valve disease may be present. Diameters of up to 67 mm have been observed in diseased tricuspid valves, although larger annuli can also occur.

[0007] Although the tricuspid valve typically has three leaflets, the number of leaflets in a given patient is unpredictable, particularly in patients with tricuspid valve problems such as severe or torrential regurgitation, and it is not uncommon for a given patient to have between two and eight (or even more) leaflets. One consequence of this unpredictability is that prosthetic tricuspid valves that rely on anchorage to the native tricuspid valve leaflets can encounter difficulties. At least one transcatheter-delivered prosthetic tricuspid valve, for example, includes a plurality of "arms" designed to hook around the native tricuspid valve leaflets to properly position and anchor the prosthesis in the native tricuspid valve annulus. Visualization (e.g.,Visualization (e.g., by echocardiography) of the native tricuspid valve leaflets in these patients, including confirmation of the desired positioning and anchorage of a prosthetic tricuspid valve with anchoring arms, can be extremely difficult. Although the term "arms" is used above, visualization to confirm leaflet anchorage by other mechanisms (e.g., clips or pinching of the leaflets) can be similarly difficult. This difficulty can lead to a relatively long procedure time and suboptimal positioning and anchorage of this type of prosthetic tricuspid valve. It should be understood that good positioning and anchorage of a prosthetic tricuspid valve within the native tricuspid valve is an important aspect of achieving good patient outcomes with prosthetic tricuspid valves.Ease of use and duration of the procedure is another important parameter for both good patient outcomes and successful physician acceptance. Therefore, it would be desirable for a transcatheter prosthetic tricuspid valve to be able to achieve good anchorage, preferably without significant reliance on imaging to achieve this anchorage.

[0008] Another important aspect of transcatheter tricuspid valve implantation is the size of the components introduced into the patient's body. For example, it may be desirable for the transcatheter tricuspid valve delivery device to be small enough to be inserted through the femoral vein without requiring a surgical incision in the vein. A desirable size example is approximately 30 French (10 mm) or less. Because a transcatheter valve must be inserted through the patient's vasculature, the components of the system must be small enough to safely traverse the patient's vasculature. This goal of size may, in some respects, conflict with the goal of anchoring.In other words, incorporating a relatively large number of anchoring structures into a prosthetic tricuspid valve may contribute to better anchoring, but at the cost of increasing the overall size of the device (and thus of the components, such as a delivery device that houses the prosthetic heart valve).

[0009] Although the goal of size can sometimes conflict with the goal of anchoring, prosthetic tricuspid valves are described here that at least partially address this problem through the use of a two-piece prosthetic heart valve system that includes an anchoring component that can be delivered separately from the valve component. For example, by allowing an anchoring component to be delivered and deployed at a first time and the valve component to be delivered and deployed at a second time later than the first, the two components do not "stack" on top of each other while housed in the delivery device, allowing for a smaller delivery device compared to a system in which the anchoring and valve components are connected during delivery.

[0010] Fig. Figure 2 is a side view of an exemplary anchoring or outer frame that may be used as part of the prosthetic tricuspid heart valve system described herein. The anchoring frame 101 is shown in Fig. 2 in an expanded state. The anchor frame 101 may, in one example, be formed by laser cutting a tube of a shape memory material, such as a nickel-titanium alloy, including nitinol, to form a stent or stent-like structure. After forming, the anchor frame 101 may be formed into the expanded state, and the anchor frame 101 also has a collapsed state in which the stent is collapsed to a smaller size than its expanded state for transcatheter delivery into the patient. The anchor frame 101 may include an atrial portion or anchor 102, a ventricular portion or anchor 104, and a central portion 103 connecting the atrial portion to the ventricular portion. The central portion 103, which may also be referred to herein as the waist or central waist, may be located between the atrial portion 102 and the ventricular portion 104.The atrial portion 102 may be configured and adapted to be disposed on an atrial side of the tricuspid valve annulus and may extend radially outward from the central portion 103. The ventricular portion 104 may be configured and adapted to be disposed on a ventricular side of the native tricuspid valve annulus and may also extend radially outward from the central portion 103. This shape may help self-center the anchor frame 101 during deployment, with the native tricuspid valve annulus being "pinched" or otherwise compressed between the atrial portion 102 and the ventricular portion 104.The term "clamped" does not require any mechanical action or other active compression and may imply that the atrial portion 102 and the ventricular portion 104 are simply positioned on opposite sides of the annulus and are in contact with the annulus.

[0011] The atrial portion 102 may be formed as part of a stent or other support structure comprising or consisting of a plurality of generally diamond-shaped cells, although other suitable cell shapes, such as triangular, quadrangular, or polygonal, may also be suitable. In some examples, the atrial portion 102 may be formed as a braided mesh, as part of a unitary stent, or a combination thereof. According to one example, the stent containing the atrial portion 102 may be laser cut from a nitinol tube and cured into the desired shape so that the stent, including the atrial portion 102, is collapsible for delivery and can be expanded back to the adjusted shape during deployment.The atrial portion 102 may be hardened into a suitable shape to conform to the native anatomy of the tricuspid valve annulus to enable sealing and / or anchoring between the atrial portion 102 and the native tricuspid valve annulus.

[0012] The atrial portion 102 may include features for connecting the atrial portion to a delivery system. For example, the atrial portion 102 may include pins or tabs 122 around which suture material (or suture loops) of the delivery system may wrap, allowing the anchor frame 101 to maintain a connection to the delivery device while the suture loops are wrapped around the pins or tabs 122. However, in some embodiments, these pins or tabs 122 may be omitted.

[0013] The ventricular portion 104 may also be formed as part of a stent or other support structure containing or consisting of a plurality of diamond-shaped cells, although other suitable cell shapes, such as triangular, quadrangular, or polygonal, may also be suitable. In some examples, the ventricular portion 104 may be formed as a braided mesh, as part of a unitary stent, or a combination thereof. According to one example, the stent containing the ventricular portion 104 may be laser cut from a nitinol tube and heat treated to the desired shape so that the ventricular portion 104 is collapsible for delivery and can be returned to the adjusted shape during deployment. It is understood that the atrial portion 102 and the ventricular portion 104 may be formed as parts of a single support structure, such as a stent.a single stent or a braided mesh. However, in other embodiments, the atrial portion 102 and the ventricular portion 104 may be formed separately and connected to each other. It should also be understood that the atrial portion 102 (which may be referred to as a disc) and the ventricular portion 104 (which may also be referred to as a disc) may each be substantially symmetrical or asymmetrical. For example, minimal ring structure is present near the atrial septum, so that smaller stent cells and / or a smaller disc diameter may preferably be provided in this region of the atrial disc, resulting in an asymmetric atrial disc.This may also mean that the anchoring stent 101 should be inserted into the delivery device in a specific orientation, or that the anchoring stent 101 can be rotated or self-aligns so that the anchoring stent 101 is deployed in the desired rotational orientation relative to the patient's anatomy. And even if the atrial or ventricular discs are cut in a symmetrical pattern, it might be desirable to heat-set one or both structures so that the discs are asymmetrical in their preset shape, e.g., more curved upwards or downwards compared to the rest of the structure. Furthermore, it may be desirable for the cells in the atrial disc that are to be positioned closest to the atrial septum to be softer to avoid damaging the septum.

[0014] The anchor frame 101 may be configured to expand circumferentially (and radially) and contract axially as the anchor frame 101 expands from the collapsed delivery configuration to the expanded deployed configuration. In the illustrated example, the anchor frame 101 includes or defines a plurality of atrial cells 111a in one circumferential row and a plurality of ventricular cells 111b in two circumferential rows. Each of the plurality of cells 111a, 111b may be configured to expand circumferentially and contract axially as the anchor frame 101 expands. As illustrated, the cells 111a-b may each be diamond-shaped. In addition, a third plurality of cells 111c may be provided in additional circumferential rows, in this embodiment, three additional central rows, forming the central portion 103, also referred to as the waist.

[0015] As in Fig. 2, a pin or tab 122 may extend from an apex of each atrial cell 111a toward the outlet end of the anchor frame 101. Although a pin or tab 122 is illustrated in each atrial cell 111a, in other embodiments, fewer than all atrial cells may have a pin or tab, and in some embodiments, the pins or tabs 122 may be omitted entirely. Furthermore, each ventricular cell 111b may have a prong or barb 108 extending therefrom. In the illustrated embodiment, each prong extends from a point where two adjacent ventricular cells 111b meet in the terminal outflow row of cells, or otherwise from the outflow tip of a ventricular cell 111b in the second row of ventricular cells (e.g.,the row of ventricular cells that directly borders the terminal outflow row of ventricular cells 111b in the inflow direction). However, fewer than all cells of the ventricular cells 111b may have such prongs or barbs. In the expanded state of the anchoring frame 101, as shown in . Fig. 2, the barbs 108 are capable of outwardly hooking, with the barbs being configured to pierce native tissue of the tricuspid valve annulus, such as the native valve leaflets, to prevent the prosthetic heart valve from migrating under pressure during heartbeat. Typically, the term "prong" may refer to a structure configured to penetrate the tissue, while the term "barb" may refer to a prong that also has a barb-like structure to prevent the barb from being withdrawn from the tissue once it has pierced it. However, the term "barb" as used herein also includes prongs with or without barb-like structures that prevent withdrawal from the tissue, unless expressly stated otherwise. Further, it is to be understood that the barbs and / or prongs, orProngs do not need to actually pierce the tissue to prevent migration—rather, the barbs and / or prongs can come into direct contact with the tissue without actually piercing it. Both piercing and direct contact without piercing can serve to increase the valve's resistance to migration. However, it should be understood that the prongs 108 on the anchor frame 101 can be omitted entirely without compromising the ability of the anchor frame 101 to properly anchor the valve component (described in more detail below) without causing migration toward the right atrium. While prongs or barbs have been used in mitral valve prostheses to prevent migration toward the right atrium, such prongs or barbs can be omitted if desired due to the relatively low pressure in the right heart.It goes without saying that . Fig. 2 shows only the metal framework forming the anchoring frame 201 (which may be referred to as a stent), but other features, including tissue wrappings, may also be included, such as those used in conjunction with the Fig. 3-4 below. Although the tines 108 are illustrated as being generally evenly distributed around the ventricular disc, the tines 108 need not be evenly distributed. For example, to avoid interference with the conduction system of the patient's heart, it may be desirable to omit the tines 108 in the region of the AV node or the bundle of His, or to have a different shape or structure for the tines 108 at that location to avoid electrical interference with the conduction system of the heart. Although the tines 108 are illustrated as extending from the point where two adjacent diamond-shaped cells meet, in some embodiments, where tines are included, they may extend from the outflow apexes of the diamond-shaped cells in the outflow row of cells.

[0016] Fig. 3 is a cross-section of an anchor frame 201 according to another aspect of the disclosure. As in Fig. 3, the anchor frame 201 includes a flared atrial disc or portion 202, a flared ventricular disc or portion 204, and a narrow, waisted midsection 203. The overall shape and structure of the anchor frame 201 may be generally similar to that of the anchor frame 101 and will therefore not be described again here, except that the anchor frame 201 may be made of a shape memory material, such as Nitinol, and may be formed with a braided mesh or laser cut from a Nitinol tube, for example, with generally diamond-shaped cells shaped to, in the absence of applied forces, retain the Fig. 3. In other words, the anchor frame 101 and the anchor frame 201 may be part of the same structure, but the illustration and description of the anchor frame 101 focuses on the stent or scaffold component, while the illustration and description of the anchor frame 201 focuses on the other components that may be incorporated with the stent or scaffold. As will be apparent, the anchor frames 101, 201 are not intended for direct connection to an internal valve component, but rather are intended to serve as a first-stage implant to which a valve component is later attached. In this respect, the anchor frames 101, 201 can be considered a "dock" for a prosthetic valve component.

[0017] The anchoring frame 201 may include one or more fabric components that can perform one or more functions, such as a seal. In the illustrated embodiment, the anchoring frame 201 may have a sealing skirt 220 on its luminal and / or abluminal surface. This sealing skirt 220 may generally be similar to other sealing skirts provided on stents or frames of transcatheter heart valve prostheses. This luminal and / or abluminal sealing skirt 220 may be made of any suitable material, including biomaterials such as bovine pericardium, biocompatible polymers such as ultra-high molecular weight polyethylene, woven polyethylene terephthalate ("PET"), or expanded polytetrafluoroethylene ("ePTFE"), or combinations thereof.The sealing skirt 220, particularly when positioned on the abluminal surface of the echo frame 201, may include a "bump" (or gasket or ring) to enhance the seal, similar to that described in U.S. Patent Application No. 17 / 548,984, the disclosure of which is hereby incorporated by reference. In addition to the sealing skirt 220, the anchor frame 201 may include an atrial cover 230 and a ventricular cover 240. In some embodiments, any combination of the sealing skirt 220, atrial cover 230, and ventricular cover 240 may be formed as an integral member, although in other embodiments, the atrial cover 230 and ventricular cover 240 are formed of different materials that provide different functions and are not formed as integral members.

[0018] As in Fig. 3, the atrial cover 230 may include a radially outer portion (e.g., an outer peripheral region) connected to the atrial portion 202, e.g., by suturing, and extending radially inward toward a central longitudinal axis where a central opening is formed in the atrial cover 230. Except for the central opening, the atrial cover 230 can be thought of as a membrane not unlike the head or skin of a drum. The ventricular cover 240 may also include a radially outer portion (e.g., an outer peripheral region) connected to the ventricular portion 204, e.g., by suturing, and extending radially inward toward a central longitudinal axis where a central opening is formed in the ventricular cover 240.In other words, the atrial cover 230 and the ventricular cover 240 may have substantially similar constructions, although they may be formed from different materials to provide different functionalities, preferably with the central openings being substantially coaxial with each other when the anchoring frame 201 is in the expanded or deployed state.

[0019] A valve-receiving member 250, which may be generally cylindrical, may have a first inflow end connected to the atrial cover 230 such that the first inflow end substantially coincides with the central opening of the atrial cover 230, and a second outflow end connected to the ventricular cover 240 such that the second outflow end substantially coincides with the central opening of the ventricular cover 240. The valve-receiving member 250 is preferably made of a fabric, such as PTFE, UHMWPE, Kevlar braid, Dacron, or biomaterials such as fabric. In some embodiments, the valve-receiving member 250 may be made of thin wires of Nitinol, stainless steel, or other biocompatible metals or metal alloys formed into a braided, knitted, or woven structure.The inlet and outlet ends of the valve-receiving member 250 may be connected to the atrial covering 230 and the ventricular covering 240, respectively, by any suitable means, including sutures. For example, in some embodiments, an inflow end of the valve-receiving member 250 may be suspended via sutures extending radially outward and connected to the atrial portion 202, and the outflow end of the valve-receiving member 250 may be suspended via sutures extending radially outward and connected to the ventricular portion 204. In this embodiment, the suspension sutures may have a "spoke" configuration, or in other embodiments, one or more layers of continuous suture loops may be used.Further examples of suspending an inner valve portion (or valve-receiving portion) in an anchor frame are described in U.S. Provisional Patent Application No. 63 / 376,496, entitled "Prosthetic Tricuspid Heart Valve," filed September 21, 2022, the disclosure of which is hereby incorporated by reference.

[0020] An example of this “spoke” configuration described above can be found in the Fig. 14A-B. Fig. 14A schematically shows a plurality of individual radially extending seams S, each having a first end connected to the flap-receiving member 250 and a second end connected to the anchoring frame. Fig. Figure 14B shows a view from the ventricular end showing the sutures S extending radially between the valve-receiving member 250 and the ventricular portion 204 of the anchor frame 201. Although Fig. 14A shows individual seams S, groups of seams S can also be provided, as in Fig. 14B. For example, Fig. 14B shows a group of radially extending sutures extending from each cell in the ventricular portion 204 to the valve-receiving member 250 to suspend the valve-receiving member 250 within the frame. These sutures S can be tied to the stent frame and can provide a significant amount of axial support to the valve-receiving member 250.

[0021] An example of the continuous seam loop configuration described above is shown in the Fig. 15A-C. Fig. 15A is a schematic view showing a single continuous seam S extending from the flap-receiving member 250 to the frame and then looping back to the flap-receiving member 250, with the looping continuing around the circumference of the anchor frame 201. Preferably, a number of continuous seams S are provided at different axial heights of the anchor frame 201. For example, as shown in FIGS. Fig. 15B-C, five continuous seam loops S1-S5 are used, with each continuous seam loop being arranged at a different axial height. However, it goes without saying that more or fewer than five continuous seam loops S1-S5 can also be used. In the Fig. In the embodiment illustrated in Figures 15B-C, two suture loops S1-S2 are provided at or adjacent to the atrial portion 202, one suture loop S3 at the central waist 203, and two suture loops S4-5 are provided at or adjacent to the ventricular portion 204. As with the radially extending sutures S, the circumferentially continuous sutures may allow the valve-receiving member 250 to be securely suspended within the frame and minimize axial movement of the valve-receiving member relative to the frame as the heart cycles between systole and diastole.

[0022] Preferably, a support wire 260 is provided around the circumference of the flap-receiving element 250 at its outlet end, with a further support wire (in Fig. 3 not labeled) is provided around the circumference of the valve-receiving member 250 at its inlet end. Although the term "support wire" is used, it is to be understood that the term "wire" does not require a specific material, and a support wire may be a loop, and the loop may be formed from any suitable material, including metal wires, flexible cables, sutures, monofilaments, multifilaments, etc. The support wires 260 may, for example, each be a strong suture (e.g., 2-0 suture) or a flexible metal cable that can be woven circumferentially into the valve-receiving member 250. As described in more detail below, the support wires 260 can assist in anchoring a valve component that is expanded (e.g., balloon-expanded or self-expanded) into the valve-receiving member 250 after the anchor frame 201 has been deployed in the native tricuspid valve.At least in part because the valve-receiving member 250 is suspended within the anchor frame 201 via the atrial cover 230 and the ventricular cover 240, the valve component ultimately received within the valve-receiving member 250 maintains its shape even if the native tricuspid valve deforms the shape of the anchor frame 201, e.g., due to forces during heartbeat. In other words, the shape of the valve component within the valve-receiving member 250 is substantially independent of the shape of the anchor frame 201. This may be desirable because the valve component typically has a circular shape or profile, and it is desirable to maintain this circular shape or profile to ensure that the prosthetic leaflets of the valve component are able to abut one another to prevent regurgitation across the prosthetic leaflets.When forces on the anchor frame 201 are transferred to the valve component in the valve-receiving member 250 and the valve component is deformed, the prosthetic valve leaflets of the valve component may not coapt properly.

[0023] Although not required, it may be desirable to place radiopaque markers 270 on both the inlet end of the valve-receiving member 250 and the outflow end of the valve-receiving member 250. These radiopaque markers 270 may be made of any biocompatible substance that is readily visible during imaging and may have any desired configuration. For example, the radiopaque markers 270 may be small pieces of biocompatible metal bonded to the valve-receiving member, or they may be radiopaque threads sewn into the valve-receiving member 250, although other configurations may also be suitable.These radiopaque markers 270 can easily show, during imaging, where the ends of the valve-receiving member 250 are located so that the valve component can be reliably and conveniently positioned within the valve-receiving member 250 prior to expansion of the valve component.

[0024] It may be desirable for the valve-receiving element 250 not to "knot" or deform during insertion of the anchor frame 201 into the native tricuspid valve annulus. This can be a problem, particularly when the valve-receiving element 250 is made of a fabric. Rather, it is preferable for the valve-receiving element 250 to be smooth and fully axially expanded, hanging between the atrial covering 230 and the ventricular covering 240 upon deployment of the anchor frame 201. To facilitate this, stretching or stiffening elements 280 may be provided in or on the valve-receiving element 250, although such features are not required in all embodiments. In the illustrated embodiment, a metal structure, such asNitinol, either woven into or sewn onto the fabric forming the valve-receiving member 250, with the expansion element(s) 280 extending generally axially from the inlet end of the valve-receiving member 250 to the outlet end of the valve-receiving member 250. By extending axially, the expansion element(s) help ensure that the valve-receiving member 250 does not axially expand, or at least does not bunch, during deployment of the anchor frame 201. Furthermore, this axial positioning helps ensure that no (or no significant) increase in force is required to bring the anchor frame 201 into the collapsed state for deployment. It should be understood that other materials may also be suitable for the expansion or stiffening elements 280, such as, for example, E.g. polymeric materials, small carbon tubes, metals, plastics, ceramics, etc.When these elements are aligned parallel to the longitudinal axis, they need not lengthen or shorten when the anchor frame 201 is compressed or otherwise collapsed. Other features, such as the support arms 500 and the support arms 600, described further below in connection with the . Fig. 8A-9C, may have a similar functionality to the stretching or stiffening elements 280.

[0025] Compared to a typical prosthetic heart valve frame, which requires (1) structures to directly support prosthetic valve leaflets, such as commissure attachment features, and / or (2) structures to directly connect to an internal valve, the anchor frame 201 (which requires neither) can be constructed of significantly less metal and thus have a significantly smaller folded profile when collapsed. For example, the size of the anchor frame 201 when collapsed can be approximately 30 French (10 mm) or less.

[0026] Fig. 4 is a top view (from the atrial side) of the anchor frame 201 in the expanded state. As illustrated, the valve-receiving member 250 results in an open axial passageway through the anchor frame 201. As described in more detail below, this results in no valve function the entire time the valve-receiving member 250 is open (e.g., without a valve component deployed therein). The diameter D1 of the valve-receiving member 250 is preferably between about 20 mm and about 40 mm, including between about 25 mm and 35 mm, and preferably between about 27 mm and about 33 mm, including about 28 mm, about 29 mm, about 30 mm, about 31 mm, and about 32 mm. The diameter D2 of the central waist 203 can be determined based on the size of the patient's tricuspid valve annulus.In some examples, the diameter D2 of the central waist 203 may be between about 30 mm and about 70 mm, including between about 36 mm and about 60 mm. The diameter D3 of the atrial portion 202 and the ventricular portion 204 may also depend on the size of the diseased tricuspid valve, and different sizes may be provided. For example, the diameter D3 of the atrial portion 202 and the ventricular portion 204 may be about 50 mm or more, including up to about 65 mm, or in extreme cases even up to about 75 mm. Although multiple anchoring frames 201 with different diameters D2 and D3 may be provided (see, e.g., FIG. Fig. 3-4) so ​​that a specific size combination can be selected for a particular patient's anatomy, it is generally preferable that only a single diameter D1 of the valve-receiving member 250 be provided, as the valve-receiving member 250 can be configured to receive a single size valve component that is not dependent on the size of the patient's tricuspid valve annulus. It should also be understood that, although the term "diameter" is used, in some embodiments, the atrial and ventricular coverings may be non-circular and may be asymmetrical as described above.

[0027] In an exemplary use of the anchoring frame 201, it may first be collapsed and placed within a sleeve of a delivery device, with the sleeve holding the anchoring frame in the collapsed state. The sleeve of the delivery device may have an outer diameter of about 30 French (10 mm) or less, including about 28 French (9.333 mm), and may be inserted into the femoral vein without requiring a surgical incision in the femoral vein. However, in some embodiments, the sleeve may have a diameter between 18 French (6 mm) and about 28 French (9.333 mm), less than 18 French (6 mm), or greater than 30 French (10 mm). The delivery device may be advanced through the patient's vasculature, through the inferior vena cava, into the right atrium, and (e.g.,via a control mechanism) such that the distal end of the sleeve is within or near the native tricuspid valve annulus. The distal end of the sleeve can be retracted relative to the anchoring frame 201, thereby releasing the constraint of the anchoring frame 201 and allowing the anchoring frame 201 to begin expanding itself into the native tricuspid valve annulus, with the ventricular portion 204 abutting the ventricular side of the valve annulus, the atrial portion 202 abutting the atrial side of the valve annulus, and the valve annulus being received within the waisted central portion 203.When deployed, the anchor frame 201 can provide reliable anchoring by (i) pinching the native tricuspid valve annulus by the atrial portion 202 and the ventricular portion 204; (ii) oversizing the central waisted portion 203 relative to the native tricuspid valve annulus; and / or (iii) anchoring tines or barbs, if present. During the anchor frame 201 deployment and before the valve component is deployed into the valve-receiving member 250 (which may be referred to as the first stage of implantation), the valve-receiving member 250 presents an open passageway between the right ventricle and the right atrium.

[0028] Before describing the second phase or stage of implantation, in which a valve component is inserted into the anchor frame 201, certain concepts and features related to the presence of the patent passageway (after the first stage of implantation) will be described. Although two-stage prosthetic valve implantations utilizing docking stations have been described in the past in the context of aortic valves and mitral valves, these two-stage prosthetic valve implantations generally involve (1) temporary valve leaflets that ensure valve functionality between the two stages; (2) a very short period of time between the completion of the first stage and the second stage, on the order of seconds (e.g., one minute or less); and / or (3) preservation of the function of the native valve leaflets.The reasoning behind the above points is that while a patent connection is created between the left atrium and the left ventricle (or between the left ventricle and the aorta), the lack of valve function can lead to patient death if the duration is longer than one or two minutes, although even one or two minutes may be an unacceptably long time. For example, the lack of valve function between the left and right atria after only 10 to 15 seconds may pose an unacceptable risk. Simply put, the heart will not pump blood if the aortic or mitral valve cannot close. And while secondary mechanisms (e.g., an interaortic balloon pump) can be used to pump blood while the natural valves are not functioning, such additional components can make the procedure more complicated, expensive, and / or risky.However, this problem does not occur with the tricuspid valve, at least not to the same extent. Although the purpose of implanting the prosthetic tricuspid valve system is to reduce or eliminate backflow between the right atrium and the right ventricle, leaving the anchor frame 201 in the native tricuspid valve for an extended period without completing the second stage of implantation may not be a major problem. It may even prove advantageous to delay the second stage of tricuspid valve prosthesis implantation for several minutes, hours, or even days after the first stage is completed and there is virtually no valve function between the right atrium and the right ventricle. This is due, at least in part, to the different hemodynamics between the relatively low-pressure right heart and the relatively high-pressure left heart.For example, a relatively healthy left heart, despite the tricuspid valve being opened by the anchor frame 201, can pump blood through the vascular system to reach the right side of the heart and then the lungs with the help of the pulmonary valve, even though tricuspid regurgitation is very severe due to the lack of tricuspid valve function. Although the heart's efficiency may be very poor in this condition, the patient can survive for days or even weeks, whereas they might only survive for a minute or two if the mitral or aortic valves were non-functioning.

[0029] As previously mentioned, it may even be advantageous to intentionally extend the time between the completion of the first implantation phase and the second implantation phase. One such advantage may be an increase in the stability of the anchoring frame 201, e.g., through tissue ingrowth. In one example, the atrial cover 230 may be formed from a permeable or porous fabric, such as a polyester, while the ventricular cover 240 may be formed from a substantially non-porous or liquid-impermeable material, such as a tightly woven and / or coated PTFE. The pores in the atrial cover 230 may be sized to allow blood to pass through the atrial cover 230, but when blood clots in the space between the atrial cover 230 and the ventricular cover 240, the pores are too small to allow thrombi to pass through the atrial cover 230.While liquid blood can permeate the atrial cover 230, it cannot permeate the ventricular cover 240 in the configuration described above because the ventricular cover 240 is not porous or impermeable to liquids. After implantation of the anchor frame 201, the blood may tend to coagulate between the atrial cover 230 and the ventricular cover 240, and the blood may also effectively coagulate on the atrial cover 230 itself. The coagulated blood may provide a semi-rigid support for the prosthetic heart valve later implanted within the valve-receiving member 250. If this process continues over an extended period of time, the anchor frame 201 may become more stable over time, with at least some additional stability provided by tissue ingrowth.In other words, if the second phase of implantation is intentionally delayed, the anchor frame 201 may be more stable when it is time to actually complete the second phase and implant, or "dock," the valve component into the anchor frame 201. The aforementioned stability may include a reduction in the axial movement of the valve-receiving member 250 relative to the anchor carrier after the prosthetic heart valve is implanted into the valve-receiving member 250 and the heart cycles between systole and diastole. Fig. show such an embodiment with a permeable atrial cover 230 and an impermeable ventricular cover 240. Fig. Figure 13A shows the configuration before blood clotting in the volume between the two covers, and Fig. Figure 13B shows the configuration after the blood has clotted in the volume between the two covers. It should be understood that, although in some embodiments, the atrial cover 230 may be formed from a porous fabric and the ventricular cover 240 may be formed from a fluid-impermeable material, in some embodiments, the atrial cover 230 may be formed from a fluid-impermeable material and the ventricular cover 240 may be formed from a porous fabric.

[0030] Another potential advantage of intentionally delaying the time between the completion of the first and second phases of implantation is to allow the heart to adapt to the new flow dynamics over time. For example, in patients with severe or torrential tricuspid regurgitation, there may be a risk that the transition from extreme tricuspid regurgitation to minimal or no regurgitation occurs essentially immediately after implantation of a tricuspid valve prosthesis. This potential danger arises, at least in part, from the fact that flow dynamics change almost instantaneously, while the heart muscle cannot acclimate immediately. For example, a patient with severe or torrential tricuspid regurgitation may have a relatively thin right ventricle due to dilation from heart failure.However, after tricuspid regurgitation is corrected, right ventricular pressure may rise, putting the patient at risk of right ventricular rupture or further dilation. This can lead to excessive stress on the right ventricle. In some cases, particularly in torrential tricuspid regurgitation, the orifice of the native tricuspid valve is large even when it should be closed—even larger than the diameter D1 of the valve-receiving element 250 of approximately 28 mm to approximately 32 mm. In other words, even before the completion of the second implantation phase, simply inserting the anchor frame 201 can reduce tricuspid valve regurgitation.This reduction in regurgitation increases the resistance to contraction of the right ventricle, which may allow the right ventricle to strengthen and / or thicken over a period of several days prior to completion of the second implantation phase. During this time between the two phases, the right ventricle can become accustomed to the new hemodynamic conditions so that, by the time the second implantation phase is completed, it is already strengthened and better "equipped" for the changed hemodynamic conditions that occur after completion of the second implantation phase. Although the size of the patent passageway of the valve-receiving element 250 is unlikely to result in a reduction in the patient's tricuspid regurgitation, other mechanisms, such asthe temporary valves described below, can be used to achieve a gradual reduction of tricuspid regurgitation by delaying the time between the first and second stages of implantation.

[0031] Continuing the exemplary application description above, the first phase of implantation is completed, and the anchoring frame 201 is deployed within the native tricuspid valve annulus, with the valve-receiving element 250 forming an open passageway between the right atrium and the right ventricle. At some point after this first phase, the second phase of implantation may begin. As previously mentioned, the timing may vary between the completion of the first phase and the beginning of the second phase. Under certain circumstances, it may be desirable to complete the first phase of implantation, remove all devices from the patient, and allow several hours, days, or even a week or more to elapse before beginning the second phase of implantation, which is virtually a completely separate procedure.Under other circumstances, there may be little or no delay between the completion of the first phase of implantation and the start of the second phase of implantation. Even if the anchor frame 201 is implanted and allows a patent passage between the right atrium and ventricle for a period of time (even hours, days, or weeks), no assistive device (e.g., a mechanical pump) may be used during the time the patent passage remains in place.

[0032] In the second phase of implantation, a valve component 300 is inserted into the anchor frame 201. Fig. 5 shows an exemplary flap component 300, but it is understood that other configurations of flap components may be used in a similar or identical manner. Fig. 5 shows a valve component 300 similar to the Navitor™ heart valve prosthesis offered by Abbot Labs. Generally, the valve component 300 extends from an inlet end 302 to an outlet end 304 and includes a stent 320, a plurality of prosthetic valve leaflets 340 (in this embodiment, three prosthetic valve leaflets 340, preferably made of pericardial tissue or synthetic biocompatible materials), an inner skirt or cuff 360 on a luminal surface of the stent 320, and an outer skirt or cuff 380 on an abluminal surface of the stent 320. In this particular example, the stent 320 has a generally cylindrical annular portion proximate the inlet end 302 and an outwardly flared outlet portion proximate the outlet end 304. In this particular example, the stent 320 is made of a shape memory material, e.g.a nickel-titanium alloy such as nitinol, so that the valve component 300 is self-expanding. However, in other embodiments, the stent 320 may have other shapes, including a generally cylindrical shape. In other embodiments, the stent 320 may be made of a plastically expandable material, such as stainless steel, cobalt-chromium, or other metals or metal alloys that are plastically expandable, so that the valve component 300 is balloon-expandable.

[0033] The prosthetic valve leaflets 340 may have a generally cylindrical profile with a total of three leaflets, each leaflet being connected to an adjacent leaflet at a commissure of the stent 320. However, more or fewer prosthetic valve leaflets 340 may be provided as desired. The inner cuff 360 may be made of biocompatible fabric or synthetic material, such as PTFE, PET, or ultra-high molecular weight polyethylene (UHMWPE). The outer cuff 308 may also be made of biocompatible fabric or synthetic material, such as PTFE, PET, or UHMWPE. In the illustrated configuration, the outer cuff 308 has an inlet rim that (e.g.,by suturing) to the inner cuff 360 and / or the stent 320, with an outlet rim connected to the inner cuff 360 and / or the stent 320 at spaced circumferential locations to create one or more openings between the outer cuff 380 and the inner cuff 360 into which blood can flow. When blood flows into these openings, e.g., during retrograde blood flow, the outer cuff 380 can bulge outward to ensure that there is no regurgitation around the exterior of the valve component 300. Additional details that may be relevant for use with the valve component 300 are further described in U.S. Patent No. 10,548,722, the disclosure of which is hereby incorporated by reference.

[0034] The valve component 300 can be collapsed to a small diameter and positioned within the sheath of a delivery device and delivered into the right heart via any suitable means and route of introduction. For example, the valve component 300 can be delivered via the femoral vein, similar to the anchor frame 201, via a transapical approach through the chest and through the right ventricle, via a transjugular approach and through the superior vena cava, or via any other desired route of introduction leading to the tricuspid valve. Under certain circumstances, particularly when the second stage of implantation is performed immediately after the first stage, even the same catheter can be used for each stage of implantation, although this is not required.

[0035] Regardless of the delivery route, the distal end of the delivery catheter containing the collapsed valve component 300 is positioned adjacent to or within the valve-receiving element 250 of the anchor frame 201.

[0036] If the valve component 300 is self-expandable, the catheter sheath can be retracted or advanced to expose the valve component 300, thereby releasing the constriction holding the valve component 300 in the collapsed state, allowing the valve component 300 to self-expand into the valve-receiving member 250. After self-expansion, one or both of the support wires 260 contribute to anchoring the valve component 300 within the anchor frame 201. If the stent 320 of the valve component 300 includes the outwardly flared outlet portion, the outward flare can extend beyond the outlet end of the valve-receiving member 250 and provide additional anchoring force to resist migration toward the right atrium. However, in other embodiments, the outwardly expanding outlet portion may be omitted, with the stent being generally cylindrical.

[0037] If the valve component 300 is balloon-expandable, the valve component 300 can be crimped over a deflated balloon when the valve component 300 is in a collapsed state within the delivery catheter. Examples of balloon-expandable valves that can be used as a second-stage implant are described in more detail in U.S. Provisional Patent Application No. 17 / 381,358, the disclosure of which is hereby incorporated by reference. However, if the valve component 300 is balloon-expandable, it may or may not be covered by a catheter sheath during the second stage of implantation. Instead of retracting a sheath to allow the valve component 300 to expand itself, the balloon is inflated (e.g., by forcing saline through the introducer into the balloon) to force the valve component 300 to expand into the valve-receiving member 250 of the anchor frame 201.Regardless of whether the valve component 300 is self-expanding or balloon-expandable, the radiopaque markers 270 at the inflow and / or outflow end of the valve-receiving member 250 (if present) can be referenced using imaging to confirm that the valve component 300 is in the desired position relative to the valve-receiving member 250 prior to expansion of the valve component 300. As the balloon inflates to force the valve component 300 to expand into the valve-receiving member 250 of the anchor frame 201, one or both of the support wires (or sutures) 260 provide some resistance to the forces and help prevent the forces from simply causing the valve-receiving member 250 to expand and potentially tear, rupture, or otherwise damage.The support wires 260, each of which may have a generally circular profile, may also help ensure that upon expansion of the valve component 300, the valve component is generally cylindrical (e.g., having a circular profile). The support wires 260 contribute, at least in part, to preventing the valve component 300 from becoming "ovalized" upon expansion. If the support wires 260 are made of a material that exhibits low elongation, such as the 2-0 suture mentioned above, the support wire 260 may stretch slightly while the valve component 300 remains in the desired cylindrical or circular shape. However, it should be understood that the tubular fabric forming the valve-receiving member 250 may be strong enough to adequately retain the valve component 300 therein even without the use of support wires 260.And while one or both (or more) of the 260 support wires or loops are optional, the loop(s) may provide some benefit, particularly when the valve-receiving element can be stretched by the implanted valve. In this case, the loop may prevent overexpansion and even allow the inlet and outlet portions of the balloon-expandable stent to expand outward, thereby improving anchoring.

[0038] Regardless of whether it is a self-expanding or a balloon-expanding component, it is preferable that the valve component have a diameter (at least at the portion that houses the prosthetic valve leaflets 340) between about 25 mm and about 35 mm, including between about 28 mm and about 32 mm, including about 29 mm, about 30 mm, and about 31 mm.

[0039] After the valve component 300 has been inserted into the anchor frame 201, the prosthetic valve leaflets 340 can assume the function of the previously failed native tricuspid valve leaflets. At this point, any catheters or other accessories remaining in the patient can be removed and the procedure completed.

[0040] As is evident from the above description, the use of anchor frame 201 can help reduce the need for (or significant reliance on) imaging to confirm anchorage after deployment within the native tricuspid valve annulus. Because the native tricuspid valve leaflets are not used to achieve the desired fixation of anchor frame 201 within the native tricuspid valve annulus, uncertainty regarding the number and particular configuration of a patient's native tricuspid valve leaflets does not negatively impact the procedure. Because anchor frame 201 and valve component 300 can be delivered at different times (seconds or weeks apart), the delivery device used to deliver each component can be small, e.g., less than 30 French (10 mm), which, among other things, offers the possibility of avoiding a surgical incision in the femoral vein.

[0041] As mentioned above, the atrial cover 230 and the ventricular cover 240, when attached to the stent or scaffold of the anchor frame 201, may have a configuration resembling the head or skin of a drum. This may help the valve component 300 maintain a circular profile or cylindrical shape within the valve-receiving member 250 even if the anchor frame 201 deforms, but this "drum" configuration may result in some instability of the valve component 300. For example, with each heartbeat (e.g., with each contraction of the right ventricle), pressure against the closed prosthetic valve leaflets 340 of the valve component 300 may cause the valve component 300 and the valve-receiving member 250 to temporarily move toward the right atrium before the pressure is released and the valve component 300 moves back to a neutral position.In other words, due to a relatively "soft" connection between the stent or the scaffold of the anchor frame 201 and the valve component 300, the valve component 300 may rock up and down as the heart beats. Furthermore, there is a possibility that the valve component 300 may temporarily tilt away from the central longitudinal axis of the native tricuspid valve annulus during the heartbeat and / or temporarily experience lateral movement as other forms of "rocking."

[0042] One way to minimize or eliminate the likelihood of wobble of the valve component 300 is to provide one or more support arms that directly connect the stent or scaffold of the anchor frame 201 to the tissue valve-receiving member 250. Fig. 6 shows a cross section and Fig. 7 is a top view (atrial) of an anchor frame 401 having one or more support arms 490 according to another aspect of the invention. It should be understood that the anchor frame 401, like the anchor frame 201, may include a stent or scaffold structure similar or identical to the anchor frame 101. Also, the anchor frame 401 has many similar or identical components to the anchor frame 201, with these similar or identical components being designated by part numbers incremented by 200. Therefore, only the differences of the anchor frame 401 compared to the anchor frame 201 will be described below, and the remaining components of the anchor frame 401 may be similar or identical to those of the anchor frame 201. It should further be understood that the description of the exemplary use of the anchor frame 201 with the valve component 300 may apply substantially equally to an exemplary use of the anchor frame 401 with the valve component 300.

[0043] As in Fig. 6, the anchor frame 401 may include an atrial section 402, a central waist section 403, and a ventricular section 404 that are similar or identical to the corresponding components of the anchor frame 201. The anchor frame 401 may also include a sealing skirt 420, an atrial cover 430, and a ventricular cover 440 that are similar or identical to the corresponding components of the anchor frame 201. The anchor frame 401 may also include support wires 460 that are similar or identical to the corresponding components of the anchor frame 201. Expansion or stiffening elements similar to the elements 280 of the anchor frame 201 may or may not be included in similar configurations as described in connection with the anchor frame 201.However, it should be understood that the support arms 490 described below may have a similar effect by maintaining the fabric flap-receiving member 450 in a stretched state, eliminating the need for additional stretching or stiffening elements similar to the elements 280 of the anchor frame 201. Radiopaque markers 470 similar or identical to those described in connection with the anchor frame 201 may also be included in the anchor frame 401.

[0044] As can be seen from the above description and a comparison of the Fig. 3 and Fig. As can be seen in Figure 6, the main difference between the anchor frame 201 and the anchor frame 401 is that the anchor frame has a plurality of support arms 490. Each support arm 490 is preferably formed from a shape memory alloy such as a nickel-titanium alloy (including Nitinol). However, the support arms 490 may also be formed from other metals or metal alloys, or from biocompatible polymers instead of Nitinol. In the embodiment shown in the Fig. 6-7, each support arm 490 has a first end directly connected (e.g., via sutures or other attachment means) to (or formed integrally with) the stent or the framework of the anchor frame 401, and a second free end connected to either the inflow or outflow end of the valve-receiving member 450. For example, in the illustrated embodiment, each support arm 490 has a free end with an eyelet or opening formed therein, with the support wire 460 extending through the eyelet or opening to connect the valve-receiving member 450 to the support arm 490. The support arms 490 can, as in Fig. 7, be arranged at intervals around the inner circumference of the stent or scaffold of the anchor frame 401. While three or more support arms 490 are preferable, one or two support arms 490 may also perform the desired function. In the illustrated embodiment, the support arms 490 are arranged in pairs, with one support arm 490 connected to the inlet end of the valve-receiving member 450 and one support arm 490 connected to the outlet end of the valve-receiving member 450. However, this one-to-one correspondence is not required, and in some embodiments, all support arms 490 may be coupled to the inlet end of the valve-receiving member 450 with no support arms 490 coupled to the outflow end of the valve-receiving member 450, or vice versa.In embodiments where the support arms 490 are connected to both the inlet and outlet ends of the flap-receiving member 450, the support arms 490 may perform an additional function similar to the stiffening or stretching elements 280 of the anchor frame 201. If the support arms 490 are provided only at the inlet or only at the outlet end of the flap-receiving member 450, it may be desirable (but not required) to incorporate similar stiffening elements as the elements 280 into the flap-receiving member 450.

[0045] As described above, the anchor frame 401 provides very secure anchoring to the native tricuspid valve annulus, so that the stent or scaffold of the anchor frame 401 does not shift upward or downward relative to the tricuspid valve annulus after deployment. Consequently, the direct coupling of the support arms 490 between the stent or scaffold of the anchor frame 401 and the valve-receiving member 450 (e.g., via the support wires 460) prevents or limits any bouncing or lateral tilting of the valve component 300 after deployment within the anchor frame 401 during heartbeat.

[0046] In the Fig. In the embodiment shown in Figure 6, each support arm 490 is illustrated with a first end connected to an area where the central waist portion 403 transitions into the ventricular portion 404. However, this is only exemplary, and the support arms 490 may be connected to the atrial portion 402, the ventricular portion 404, the central waist portion 403, or anywhere in between.

[0047] Although the support arms 490 are generally shown as individual pieces of metal, such as Nitinol, with eyelets at one end for connection to a support wire 460, the support arms 490 may have other configurations. For example, Fig. 8A-B show side and front views of a particular configuration of a support arm 500 that can be used in place of the support arms 490. Each support arm 500 can be individually cut and shaped and can be formed as a single integral element. For example, if the stent or the scaffold of the anchor frame 401 is made of Nitinol, the support arms 500 are preferably formed of Nitinol. However, other metals, metal alloys, or polymers can also be used to fabricate the support arms 500. The support arms 500 can be cut from a flat cover or flat component, or from a tube and formed into a shape (e.g., by heat setting) that corresponds to the Fig. 8A. For example, each support arm 500 may include an atrial extension 510, a ventricular extension 520, and a central portion 530 between the two. The atrial extension 510 and the ventricular extension 520 may each have a concave shape, with the concavity facing the valve-receiving element 450 when assembled, as shown in Fig. 8D. The central portion 530 may have a concave shape, with the concavity facing away from the valve-receiving member 450 or otherwise toward the stent or the scaffold of the anchor frame 401. In particular, the central portion 530 may be shaped to have a contour complementary to a contour of the central waist 403 where the central portion 530 attaches to the central waist 403. With this configuration, each support arm 500 may form a tight fit with the stent of the anchor frame 401 at the connection points between the two.

[0048] With general reference to the Fig. 8A-D, a plurality of openings or eyelets may be formed in the support arm 500 to assist in connecting the support arm 500 to the stent, anchor frame 401, and valve-receiving member 450. For example, the atrial extension 510 may have an atrial opening 512 near its end, and the ventricular extension 520 may have a ventricular opening 522 near its end. The support wire 460 at the inlet end of the valve-receiving member 450 can be passed through the atrial opening 512 and the support wire 460 at the outlet end of the valve-receiving member 450 can be passed through the ventricular opening 522, similar to the description of the support arms 490 above. In other embodiments, the atrial opening 512 and the ventricular opening 522 can simply be used to suture or otherwise attach to the valve-receiving member 550 without necessarily threading the support wires 460 through the openings 512, 522.When the support wires 460 are threaded through the openings 512, 522, which is the generally preferred attachment method, the terminal ends of the atrial and ventricular extensions 510, 520 can be twisted relative to the rest of the support arm (e.g., approximately 90 degrees) so that the openings 512, 522 are generally aligned with the periphery of the valve-receiving member 450. In other words, when the ends of the extensions 510, 520 are twisted, it may be easier to guide the support wires 460 through the openings 512, 522.

[0049] As in the Fig. 8A and Fig. As best illustrated in Figure 8D, the central portion 530 of the support arm 500, in the expanded state of the anchor frame 401, may have a generally complementary profile to the central waisted portion 403 of the stent or scaffold forming the anchor frame 401. The central portion 530 may have one or more central openings 532, 534 having a generally similar configuration to the atrial opening 512 and the ventricular opening 522 (without any twisting of the openings). The central openings 532, 534 can be used to connect the central portion 530 of the support arm 530 to the stent or the scaffold of the anchor frame 401, for example, at the central waisted portion 403. Any suitable fastening means such as sutures, rivets, clips, etc. can be used to connect the central portion 530 of the support arm 530 to the central waisted portion 403.

[0050] Because each support arm 500 has its central portion 530 directly connected to the stent or scaffold of the anchor frame 401, its atrial extension 510 connected to the inlet end of the valve-receiving member 450 (e.g., via a first support wire 460), and its ventricular extension 520 connected to the outlet end of the valve-receiving member 450 (e.g., via a second support wire 460), the valve-receiving member 450 and the valve component 300 received therein are prevented from rocking up and down as the heart beats. Although any number (e.g., 1, 2, 3, 4, 5, 6, etc.) of support arms 500 may be used to stabilize the valve component 300 received in the valve-receiving member 450, as best shown in Fig. 8C, at least three such support arms 500 are preferred, with it being preferred that the support arms 500 be spaced at substantially equal intervals around the circumference of the central waisted portion 403, although other spacings may be acceptable.

[0051] Support arms 500 are merely one example of an alternative structure to support arms 490. A potential disadvantage of the specific configuration of support arms 500 is that each individual support arm 500 has the potential to tilt sideways (e.g., in a direction tangential to flap-receiving member 450 where support arms 500 are connected to flap-receiving member 450). Other support arm configurations may be used to achieve different results, including reducing the likelihood of such tilting.

[0052] The Fig. show another example of a support arm 600 that can be used instead of the support arms 500, 490. The support arm 600 can have the entire structure of the support arm 500, but with additional features. For example, the support arm can have an atrial extension with an opening 612, a ventricular extension 620 with an opening 622, and a middle section 630 with two openings 632, 634. In some embodiments, as in Fig. 9B, the central openings 632, 634 may be omitted. All of the above statements regarding the support arm 500 apply equally to the support arm 600 and are therefore not repeated here. However, the support arm 600 may have additional stabilizing sections. For example, the support arm 600 may have two lateral stabilizers 640, 650 extending from either side of the central section 630. Each stabilizer 640, 650 may comprise an expandable and collapsible cell, which may be diamond-shaped, with each cell having a strut connected to the central section 630 and extending from a lateral vertex of the cell, and a strut extending to an opening 642, 652 connected to the opposite lateral vertex of the cell.The cells of the stabilizers 640, 650 can expand and collapse to move the openings away from each other and away from the central portion 630, or toward each other and toward the central portion 630. Preferably, the shape of the cells of each stabilizer 640, 650, which can be diamond-shaped, has a size and shape that generally conforms to the corresponding collapsible and expandable cells of the stent or the support structure of the anchor frame 401. For example, if the stent is made of . Fig. 2 were the stent used with the anchor frame 401, each cell of each stabilizer 640, 650 may have a shape and size corresponding to the shape and size of one of the center cells 111c on the waist portion 103. In this configuration, the center openings 632, 634 (if present) may be connected to the anchor frame 401 (e.g., by sutures or rivets), with the cells of each stabilizer 640, 650 overlapping correspondingly shaped cells of the stent of the anchor frame 401, and the openings 642, 652 of the stabilizers being connected to the stent of the anchor frame 401, again, for example, by sutures or rivets. With this configuration, the stabilizers 640, 650 can provide resistance to tilting at the atrial process 610 and the ventricular process 620, with the stabilizers 640, 650 being able to expand or collapse with the stent of the anchor frame 401.It should be understood that while the various support arms described herein may be separate structures attached to the anchor frame, in other embodiments, the support arms may be part of the frame structure itself. This is an option for the support arms described both above and below.

[0053] As with the support arms 500, any number of support arms 600 may be provided to directly connect the stent of the anchor frame 401 to the valve-receiving element 450, e.g., 1, 2, 3 (as in Fig. 9C) or more. Again, it is advantageous, although not required, that the support arms 600 be arranged at substantially equal intervals around the circumference of the stent of the anchor frame 401. As with the support arms 500, the support arms 600 may be made of a shape memory material and cut from a flat cover or tube and then shaped to have the desired contours. The atrial extension 610, the ventricular extension 620, and the central portion 630 may be shaped (e.g., by heat setting) to obtain similar or identical contours as described in connection with the support arm 500. The stabilizers 640, 650 may each be brought into the expanded state (e.g., as in Fig. 9B), having a contour that generally follows the circumferential contours of the stent of the anchor frame 401 at or near the central portion 403, as shown in Fig. 9C. Each support arm 600 can be positioned so that the atrial extension 610 and the ventricular extension 620 lie radially inward of the stent of the anchor frame 401. However, the stabilizers 640, 650 can be positioned either radially inward or radially outward of the stent of the anchor frame 401. For example, if the stabilizers 640, 650 are positioned radially outward of the stent of the anchor frame 401, the atrial extension 610 and the ventricular extension 620 can pass through an open cell of the stent of the anchor frame 401, allowing the atrial and ventricular extensions 610, 620 to be connected to the valve-receiving member 450.

[0054] The Fig. 10A-B show another embodiment of a support arm 700 that can be used instead of the support arms 490, 500, 600. In general, the support arm 700 can be configured as shown in Fig. 10A-B, may be formed as a collapsible and expandable diamond-shaped cell, which may be made of a shape-memory material such as nitinol. The support arm 700 may have an atrial extension 710 at one apex defining an opening 712, and a ventricular extension 720 at the opposite apex defining an opening 722. As with the atrial and ventricular extensions and openings of the support arms 500, 600, the openings 712, 722 can be used to connect the support arm 700 to the inlet and outlet ends of the valve-receiving member 450, for example, to the support wires 460. The support arm 700 can include two side struts 630a, 630b extending between the atrial extension 710 and the ventricular extension 720, although the side struts 630a, 630b can alternatively be thought of as two side struts each to form four diamond-shaped struts.Each of the side struts 630a, 630b may have one or more openings defined therein. In the examples shown, strut 630a includes two openings 632a, 634a, and strut 630b includes two openings 632b, 634b, with the openings formed at or near the lateral vertices that form the diamond shape. Although in the . Fig. 10A-B, the atrial extension 710 and the ventricular extension 720 may be formed (e.g., by heat setting) to curve or otherwise extend toward the inlet and outlet ends of the valve-receiving member 450, generally similar to the curvature of the support arm 500. The one or more apertures 632a-b, 634a-b may be used to couple the support arm 700 to the stent of the anchor frame 401 in a manner similar to that described above for the support arms 500, 600.

[0055] Fig. Figure 10A shows the support arm 700 in a partially expanded state (e.g., not fully collapsed, but not as expanded as in Fig. 10B shown) and Fig. Figure 10B shows the support arm 700 in a more expanded state compared to Fig. 10A. When the support arm 700 is coupled to the stent of the anchor frame 401, the diamond shape of the cell preferably matches the diamond shape of a corresponding cell of the stent of the anchor frame 401, although the match need not be perfect. For example, it may be sufficient for the side struts 630a, 630b to expand and collapse to similar widths as the struts of the stent of the anchor frame 401 to which the side struts 630a, 630b are attached. As can be seen from the Fig. 10A-B, the axial process (e.g., between the vertices defined by the atrial process 710 and the ventricular process 720) in a collapsed state has a relatively large length L1 compared to the length L2 of the axial process in the expanded state, as shown in Fig. 10B. The circumferential extent (in a direction transverse to the axial extension), however, increases from the collapsed state to the expanded state. In some examples, the support arms 700 may be cut (e.g., laser cut) from individual sections of material. However, in other examples, the support arms 700 may be cut (e.g., laser cut) from a single tube (e.g., a tube made of nitinol). For example, three support arms 700 may be cut from a nitinol tube having an expanded state with the same diameter as the waist 403 of the anchor frame 401. In some embodiments, depending on the shape of the support arms 700, a central portion of the fabric tube 450 may be shaped to narrow slightly in the central region to intentionally reduce blood flow through the tube 450. This narrow portion, if present, may be fully opened when the secondary implant is deployed.

[0056] Advantages of the support arm 700 may include that it is a relatively simple construction that is easy to manufacture and connect to the stent of the anchor frame 401, and that the connection at two side struts 630a, 630b may help prevent tilting of the valve-receiving member 450 and the valve component 300 received therein when the heart beats. However, a potential disadvantage is that the axial extension decreases as the support arm 700 expands. If the valve-receiving member 450 is unable to change its axial length, this may be a problem, since the inlet and outlet ends of the valve-receiving member 450 are preferably attached to the atrial extension 710 and the ventricular extension 720. Various modifications to the valve-receiving member 450 that address this potential disadvantage are described below.

[0057] The Fig. show a plurality of support arms 700 connected to a flap receiving element 450', which is similar to the flap receiving element 450 with one exception. The remainder of the anchor frame 401 is shown in the Fig. 10C-D, but it is understood that the support arms 700 are connected to the stent of the anchor frame 401, e.g., at the waisted portion 403, and that the various fabrics or coverings described in connection with the anchor frame 401 can be used in substantially the same manner as in connection with the anchor frame 401. The primary difference in the valve-receiving member 450' is that it includes an elastic material that can stretch and return to its original shape. As shown in Fig. 10C, for example, the support arms 700, in the expanded state, can be connected to the inlet and outlet ends of the valve-receiving element 450', which can be made of an elastic material, while the elastic material is in a relaxed state. When the anchor frame 401 is collapsed and the support arms 700 increase their axial length, the valve-receiving element 450' can stretch axially due to its elastic nature. As can be seen, when the support arms 700 are collapsed, each end of the valve-receiving element 450' can stretch by a length of Δx, which corresponds to a total length change of Δ2x. Once the anchor frame 401 is detached from the delivery catheter and inserted into the native tricuspid valve annulus, the arms 700 shorten again, and the valve-receiving element 450' "shrinks" back to its relaxed state of Fig. 10C.

[0058] Fig. 10E-F show a configuration similar to Fig. 10C-D, but instead of a flap-receiving member 450' being elastic, the flap-receiving member 450" may be elastic or non-elastic, with a plurality of bellows or folds formed along the length of the flap-receiving member 450". In other words, in the Fig. 10E, the bellows or folds may be present in the flap-receiving member 450", for example, at spaced intervals along the axial extent of the flap-receiving member 450". When the anchor frame 401 collapses and the support arms 700 collapse and increase in axial length, the bellows or folds unfold to correspondingly increase the axial length of the flap-receiving member 450". The bellows or folds may be shaped such that the bellows or folds reform when the anchor frame 401 expands again, as shown in Fig. 10E. In some embodiments, the valve-receiving member 450' may be formed as a braided material with a maximum outer diameter. Braids are typically longer when folded and shorter when expanded. Depending on the manufacturing angle of the individual fibers, a braid expands when a balloon is expanded inside the tube. The expansion is limited when further shortening of the braided tube is limited, e.g., by the action of the support arms 700. However, the valve-receiving member 450'' need not be formed from a braid. And, as described in other embodiments above, radial loops (e.g.,Suture or other support wire may be provided to prevent the valve-receiving member 450'' from opening excessively during valve expansion within the valve-receiving member 450''. It may even be advantageous to have a bulge in the valve-receiving member 450'' between the upper and lower support wires to further securely hold the valve prosthesis therein or therebetween. Such retention loops or wires may be radiopaque to facilitate visualization during deployment.

[0059] Fig. 10G-H show a similar configuration to Fig. 10E-F, but instead of a flap-receiving member 450'' including bellows or pleats, the flap-receiving member 450''' may be inelastic and include a plurality of pleats (e.g., vertical pleats) formed when the support arms shorten, as in Fig. 10G. These folds may be acceptable because the replacement valve (e.g., valve component 300), which is expanded within valve-receiving member 450, seals at its atrial and ventricular portions. Even if some blood enters the space, it will clot over time and be trapped within this defined space.

[0060] Although the anchoring frames described above, and in particular the valve-receiving elements described therewith, have generally been described as intentionally not including valves or other structures that act as a temporary valve to bridge the time between the completion of the first implantation phase and the second implantation phase, temporary valves may be desirable in some embodiments.

[0061] Fig. 11 shows, for example, the anchoring frame 401 of Fig. 6, except that the anchoring frame 401 includes a plurality of prosthetic valve leaflets 495 connected to the tissue forming the valve-receiving element 450. Although the prosthetic valve leaflets 495 are used in conjunction with the anchoring frame 401 of Fig. 6, the prosthetic valve leaflets 495 may instead be used in the valve-receiving member of any other embodiment disclosed herein, whether or not support arms are included. Rather than being coupled to a metal scaffold or stent structure, as is typically the case, the prosthetic valve leaflets 495 may be sutured directly to the tissue of the valve-receiving member 450. This allows the anchoring frame 401 to remain small in the collapsed state (e.g., because no additional metal structure is used to support the prosthetic valve leaflets 495), so that the anchoring frame 401 can be squeezed to a small profile, e.g., 30 French (10 mm) or smaller. However, even if the prosthetic valve leaflets 495 are sutured directly to the tissue of the valve-receiving member 450, some degree of support structure may be added, e.g., B.Three individual commissures, which may be relatively rigid rods with holes through which sutures are passed to attach the prosthetic valve leaflets 495 to the valve-receiving element 450. As with the leaflets 340 of the valve component 300, the prosthetic valve leaflets 495 may be made of bioprosthetic tissue, such as pericardial tissue, or of synthetic material, such as fabric. Any number of prosthetic valve leaflets 495 may be provided, although three are preferred.

[0062] The prosthetic valve leaflets 495 can act like typical prosthetic valve leaflets, allowing blood flow in the antegrade direction (toward the ventricular segment 404) and restricting blood flow in the retrograde direction (toward the atrial segment 402). The prosthetic valve leaflets 495 are in the two Fig.shown in the closed or coapted state. The use of the anchoring frame 401 with the prosthetic valve leaflets 495 can be essentially identical to that described above for the other anchoring frames without prosthetic valve leaflets. The only difference is that the prosthetic valve leaflets 495 provide valve functionality between the first and second implantation phases. Then, when the valve component 300 (or a similar valve component) is balloon-expanded or self-expanded into the valve-receiving element 450, the provisional prosthetic valve leaflets 495 are pushed aside, and the prosthetic valve leaflets 340 of the valve component 300 assume valve functionality on the tricuspid valve.

[0063] It is understood that the prosthetic valve leaflets 495 are not strictly required, but may be useful as a bridging function between the first and second implantation phases, particularly if it is determined that the patient may suffer excessively from an open passageway between the right atrium and the right ventricle during the time between the first and second implantation phases. Typically, it would be desirable for the prosthetic valve leaflets 495 to alternate between closed and open, similar to healthy prosthetic valve leaflets. However, in some embodiments, the prosthetic valve leaflets 495 may be modified to intentionally exhibit poor coaptation. As described above, it may be desirable for the patient's heart to acclimate to the new hemodynamic conditions after implantation of the anchor frame 401 but before implantation of the valve component 300.Although the valve-receiving element 450 can be left open as an open passageway between the two implantation phases to allow the heart some time to acclimate to the new hemodynamic conditions, the size of this passageway may be too large for some patients. However, as previously mentioned, it may not be desirable for the prosthetic valve leaflets 495 to function normally, as this can result in a virtually immediate change in hemodynamics. Therefore, in some embodiments, the prosthetic valve leaflets 495 can be modified to allow a desired degree of regurgitation while the anchor frame 401 is deployed. With this controlled regurgitation, the heart has time to acclimate to the new hemodynamic conditions before the valve component 300 is inserted into the anchor frame 401, but the regurgitation may not be so severe as to pose a significant problem to the patient.Any suitable mechanism may be used to create intentional regurgitation with the temporary prosthetic valve leaflets 495. For example, one or more of the provisional valve leaflets 495 may be clipped on. One way to achieve such anchoring is to attach one or more connectors (e.g., sutures) to the free edge of the one or more provisional valve leaflets 495, with these sutures also being attached to the structure of the anchoring frame 401, such as the stent portion forming the ventricular segment, the support arms, etc. The length of the sutures may be selected such that the provisional valve leaflets 495 cannot move far enough to establish complete coaptation between the provisional valve leaflets 495.The degree of regurgitation can be fine-tuned depending on the length of the sutures and the number of temporary leaflets 495 connected to those sutures. If intentional regurgitation is created, it may be desirable for all temporary leaflets 495 to be confined by sutures or other connectors, as the sutures or connectors may also prevent inversion of the leaflets (e.g., similar to the function of the chordae tendineae). In some embodiments, permanent leaflets may be provided instead of temporary leaflets. More detailed examples of permanent leaflets are described in U.S. Provisional Patent Application No. 63 / 376,496, entitled "Prosthetic Tricuspid Heart Valve," filed September 21, 2022, the disclosure of which is hereby incorporated by reference.

[0064] It should be understood that while the above-described embodiments include both atrial covers / fabrics and ventricular covers / fabrics for suspending the valve-receiving element within the outer anchor, in some embodiments, one of these covers / fabrics may be omitted. In such cases, it would be preferable to support the valve-receiving element via other mechanisms, such as support arms, including the embodiments described herein.

[0065] According to one aspect of the disclosure, a prosthetic heart valve system for replacing a native right atrioventricular valve comprises: a foldable and expandable anchor frame comprising: a support structure having, in an expanded state, a waisted central portion and atrial and ventricular sections each extending radially outwardly from the central portion, the atrial and ventricular sections being sized to sandwich an annulus of the right atrioventricular valve therebetween; an atrial cover connected to the atrial portion of the support structure and extending radially inward to a central opening in the atrial cover; a ventricular cover connected to the ventricular portion of the support structure and extending radially inward to a central opening in the ventricular cover; and a valve-receiving member formed of fabric and generally cylindrical, an inlet end of the valve-receiving member being connected to the atrial cover and an outlet end of the valve-receiving member being connected to the ventricular cover to provide a passage from the central opening in the atrial cover to the central opening in the ventricular cover through the valve-receiving member; and a collapsible and expandable heart valve prosthesis comprising a stent and a plurality of prosthetic valve leaflets, wherein the heart valve prosthesis is configured to be expanded into and received in the valve-receiving element of the anchor frame; and / or one of the atrial and ventricular coverings is made of a porous fabric and the other of the atrial and ventricular coverings is made of a substantially liquid-impermeable fabric; and / or at least one radiopaque marker connected to the valve-receiving element at the inlet end of the valve-receiving element or at the outlet end of the valve-receiving element; and / or an expansion element coupled to the flap-receiving element, wherein the expansion element is a rigid material extending in a longitudinal direction of the flap-receiving element, wherein the rigid material is configured to reduce the passage in the flap-receiving element when the support structure of the anchor frame is in the expanded state; and / or a support wire connected to the valve-receiving element and extending along a circumference of the valve-receiving element; and / or the support wire consists of a metal cable; and / or the support wire consists of a suture; and / or the support wire comprises a first support wire at the inlet end of the flap-receiving element and a second support wire at the outlet end of the flap-receiving element; and / or a support arm, the first end of which is directly connected to the support structure of the anchor frame and the second end of which is directly connected to the flap-receiving element; and / or the support arm is made of a nickel-titanium alloy; and / or the support arm has an atrial extension coupled to the inlet end of the valve-receiving element and a ventricular extension coupled to the outlet end of the valve-receiving element, wherein a central portion of the support arm is directly coupled to the central portion of the support structure of the anchor frame; and / or the atrial process contains an opening, and the ventricular process contains an opening; and / or a first support wire coupled to the valve-receiving element at the inlet end of the valve-receiving element and extending along a circumference of the valve-receiving element, and a second support wire coupled to the valve-receiving element at the outlet end of the valve-receiving element and extending along a circumference of the valve-receiving element, wherein the first support wire extends through the opening in the atrial extension of the support arm and the second support wire extends through the opening in the ventricular extension of the support arm; and / or the support arm comprises a first lateral stabilizer and a second lateral stabilizer, the first and second lateral stabilizers extending in opposite directions on opposite sides of the central portion of the support arm; and / or the first and second lateral stabilizers each comprise an expandable cell that can expand and collapse to move the respective lateral stabilizer toward or away from the central portion of the support arm; and / or the support arm is a diamond-shaped structure, the central portion having two side struts each connecting the atrial process to the ventricular process; and / or the tissue forming the valve-receiving element is elastic; and / or the fabric forming the valve-receiving element is inelastic and has a plurality of folds or wrinkles that can unfold to increase an axial length of the valve-receiving element when the support structure of the anchor frame transitions from the expanded state to a collapsed state; and / or the anchoring frame does not have any temporary prosthetic valve leaflets within the valve-receiving element; and / or the anchoring frame contains a plurality of temporary prosthetic heart valve leaflets within the valve-receiving element.

[0066] According to another aspect of the disclosure, a method for replacing a native right atrioventricular valve of a patient is disclosed, the method comprising the steps of: Delivering a collapsible and expandable anchor frame into the native right atrioventricular valve while the anchor frame is in a collapsed state within a first delivery sheath; Unfolding the anchor frame from the delivery sheath and expanding the anchor frame within the native right atrioventricular valve such that an annulus of the native right atrioventricular valve is clamped between an atrial portion of the anchor frame and a ventricular portion of the anchor frame; after deploying the anchor frame, allowing blood to flow through a passageway of the anchor frame, the passageway being formed by a fabric valve-receiving member having an inlet end and an outlet end, the inlet end of the valve-receiving member being connected to an atrial cover connected to the atrial portion of the anchor frame, the outlet end of the valve-receiving member being connected to a ventricular cover connected to the ventricular portion of the anchor frame; and after allowing blood to flow through the passageway of the anchor frame, delivering a collapsible and expandable prosthetic heart valve to the anchor frame and causing the prosthetic heart valve to expand to contact the valve-receiving member, wherein the valve-receiving member retains the prosthetic heart valve within the native right atrioventricular valve; and / or the valve-receiving element does not have any provisional prosthetic valve leaflets; and / or the expansion of the heart valve prosthesis in contact with the valve-receiving element is carried out at least two minutes after the deployment of the anchoring frame, so that the blood can flow through the passage of the anchoring frame for at least two minutes; and / or the expansion of the heart valve prosthesis in contact with the valve-receiving element is carried out at least one day after the deployment of the anchoring frame, so that the blood can flow through the passage of the anchoring frame for at least one day; and / or the expansion of the heart valve prosthesis in contact with the valve-receiving element is carried out at least one week after the deployment of the anchoring frame, so that the blood can flow through the passage of the anchoring frame for at least one week; and / or the valve-receiving element comprises a plurality of temporary prosthetic valve leaflets connected to the valve-receiving element; and / or the provisional prosthetic valve leaflets are designed to allow regurgitation of blood from the outlet end of the passageway to the inflow end of the passageway; and / or the expansion of the prosthetic heart valve in contact with the valve-receiving element is carried out at least two minutes after the deployment of the anchoring frame, so that the regurgitation of blood through the temporary prosthetic valve leaflets is permitted for at least two minutes; and / or the expansion of the prosthetic heart valve in contact with the valve-receiving element is carried out at least one day after the deployment of the anchoring frame, so that the regurgitation of blood through the temporary prosthetic valve leaflets is possible for at least one day; and / or the expansion of the prosthetic heart valve in contact with the valve-receiving element takes place at least one week after deployment of the anchor frame, so that regurgitation of blood through the temporary prosthetic valve leaflets is possible for at least one week.

[0067] Although the invention has been described herein with reference to specific embodiments, these embodiments are intended merely to illustrate the principles and applications of the present invention. It is therefore to be understood that numerous changes may be made to the illustrated embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims. QUOTES CONTAINED IN THE DESCRIPTION

[0000] This list of documents submitted by the applicant was generated automatically and is included solely for the convenience of the reader. This list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions. Cited patent literature

[0000] US 63 / 315,144

[0001] US 13"?>17 / 548,984

[0017] US 63 / 376,496 [0019, 0063] US 10.548.722

[0033] US 17 / 381,358

[0037]

Claims

[1] A heart valve prosthesis system for replacing a native right atrioventricular valve, the system comprising: a collapsible and expandable anchor frame comprising: a support structure having, in an expanded state, a waisted central portion and atrial and ventricular sections each extending radially outwardly from the central portion, the atrial and ventricular sections being sized to sandwich an annulus of the right atrioventricular valve therebetween; an atrial cover connected to the atrial portion of the support structure and extending radially inward to a central opening in the atrial cover; a ventricular cover connected to the ventricular portion of the support structure and extending radially inward to a central opening in the ventricular cover; and a valve-receiving member formed of fabric and generally cylindrical, an inlet end of the valve-receiving member being connected to the atrial cover and an outlet end of the valve-receiving member being connected to the ventricular cover to provide a passage from the central opening in the atrial cover to the central opening in the ventricular cover through the valve-receiving member; and a collapsible and expandable heart valve prosthesis including a stent and a plurality of prosthetic valve leaflets, the heart valve prosthesis configured to be expandable and receivable into the valve-receiving member of the anchor frame. [2] The heart valve prosthesis system of claim 1, wherein one of the atrial and ventricular coverings is formed from a porous fabric and the other of the atrial and ventricular coverings is formed from a substantially fluid-impermeable fabric. [3] The prosthetic heart valve system of claim 1, further comprising at least one radiopaque marker connected to the valve-receiving member at the inlet end of the valve-receiving member or at the outlet end of the valve-receiving member. [4] The heart valve prosthesis system of claim 1, further comprising an expansion member connected to the valve-receiving member, wherein the expansion member is made of a rigid material extending in a longitudinal direction of the valve-receiving member, and the rigid material is configured to reduce the passage in the valve-receiving member when the support structure of the anchor frame is in the expanded state. [5] The prosthetic heart valve system of claim 1, further comprising a support wire connected to the valve-receiving member and extending along a circumference of the valve-receiving member. [6] A heart valve prosthesis system according to claim 5, wherein the support wire is formed from a metal cable. [7] A heart valve prosthesis system according to claim 5, wherein the support wire is formed from a suture. [8] The heart valve prosthesis system of claim 5, wherein the support wire comprises a first support wire at the inlet end of the valve-receiving member and a second support wire at the outlet end of the valve-receiving member. [9] The heart valve prosthesis system of claim 1, further comprising a support arm having a first end directly connected to the support structure of the anchor frame and a second end directly connected to the valve-receiving member. [10] A heart valve prosthesis system according to claim 9, wherein the support arm is formed from a nickel-titanium alloy. [11] The prosthetic heart valve system of claim 9, wherein the support arm includes an atrial extension coupled to the inlet end of the valve-receiving member and a ventricular extension coupled to the outflow end of the valve-receiving member, a central portion of the support arm being directly coupled to the central portion of the support structure of the anchor frame. [12] The prosthetic heart valve system of claim 11, wherein the atrial process has an opening therein and the ventricular process has an opening therein. [13] The prosthetic heart valve system of claim 12, further comprising a first support wire coupled to the valve-receiving member at the inlet end of the valve-receiving member and extending along a periphery of the valve-receiving member, and a second support wire coupled to the valve-receiving member at the outlet end of the valve-receiving member and extending along a periphery of the valve-receiving member, wherein the first support wire extends through the opening in the atrial extension of the support arm and the second support wire extends through the opening in the ventricular extension of the support arm. [14] The heart valve prosthesis system of claim 11, wherein the support arm includes a first lateral stabilizer and a second lateral stabilizer, the first and second lateral stabilizers extending in opposite directions on opposite sides of the central portion of the support arm. [15] The prosthetic heart valve system of claim 14, wherein the first and second lateral stabilizers each comprise an expandable cell that is expandable and collapsible to move the corresponding lateral stabilizer toward or away from the central portion of the support arm. [16] A heart valve prosthesis system according to claim 11, wherein the support arm is a diamond-shaped structure, the central portion having two side struts each connecting the atrial process to the ventricular process. [17] A heart valve prosthesis system according to claim 11, wherein the tissue forming the valve-receiving element is elastic. [18] The heart valve prosthesis system of claim 11, wherein the fabric forming the valve-receiving member is inelastic and has a plurality of folds or wrinkles that can unfold to increase an axial length of the valve-receiving member when the support structure of the anchor frame transitions from an expanded state to a collapsed state. [19] The prosthetic heart valve system of claim 1, wherein the anchor frame does not include temporary prosthetic heart valve leaflets within the valve-receiving member. [20] The prosthetic heart valve system of claim 1, wherein the anchor frame includes a plurality of temporary prosthetic heart valve leaflets within the valve-receiving member. [21] The heart valve prosthesis system of claim 1, wherein the valve-receiving member is suspended within the support structure via a plurality of sutures, each of the sutures being connected to and extending radially between the valve-receiving member and the support structure. [22] The prosthetic heart valve system of claim 1, wherein the valve-receiving member is suspended within the support structure via a plurality of sutures, each of the sutures extending circumferentially around the anchor frame and forming a loop between the valve-receiving member and the support structure. [23] A method for replacing a native right atrioventricular valve of a patient, the method comprising: Inserting a collapsible and expandable anchor frame into the native right atrioventricular valve while the anchor frame is in a collapsed state within a first introducer sheath; Unfolding the anchor frame from the introducer sheath and expanding the anchor frame within the native right atrioventricular valve such that an annulus of the native right atrioventricular valve is clamped between an atrial portion of the anchor frame and a ventricular portion of the anchor frame; after deploying the anchor frame, allowing blood to flow through a passageway of the anchor frame, the passageway being formed by a fabric valve-receiving member having an inlet end and an outlet end, the inlet end of the valve-receiving member being connected to an atrial cover connected to the atrial portion of the anchor frame, the outlet end of the valve-receiving member being connected to a ventricular cover connected to the ventricular portion of the anchor frame; and after allowing blood to flow through the passageway of the anchor frame, delivering a collapsible and expandable prosthetic heart valve to the anchor frame and causing the prosthetic heart valve to expand to come into contact with the valve-receiving member, the valve-receiving member retaining the prosthetic heart valve within the native right atrioventricular valve. [24] The method of claim 23, wherein the valve-receiving member does not comprise temporary prosthetic valve leaflets. [25] The method of claim 24, wherein expanding the prosthetic heart valve in contact with the valve-receiving member is performed at least two minutes after deploying the anchor frame so that blood can flow through the passageway of the anchor frame for at least two minutes. [26] The method of claim 24, wherein expanding the prosthetic heart valve in contact with the valve-receiving member is performed at least one day after deploying the anchor frame so that blood can flow through the passageway of the anchor frame for at least one day. [27] The method of claim 24, wherein expanding the prosthetic heart valve in contact with the valve-receiving member is performed at least one week after deployment of the anchor frame so that blood can flow through the passageway of the anchor frame for at least one week. [28] The method of claim 23, wherein the valve-receiving member comprises a plurality of temporary prosthetic valve leaflets connected to the valve-receiving member. [29] The method of claim 28, wherein the temporary prosthetic valve leaflets are configured to allow regurgitation of blood from the outlet end of the conduit to the inflow end of the conduit. [30] The method of claim 29, wherein expanding the heart valve prosthesis in contact with the valve-receiving element is performed at least two minutes after deployment of the anchoring frame, so that regurgitation of blood through the temporary prosthetic valve leaflets is possible for at least two minutes. [31] The method of claim 29, wherein expanding the prosthetic heart valve in contact with the valve-receiving element is performed at least one day after deploying the anchoring frame, so that regurgitation of blood through the temporary prosthetic valve leaflets is possible for at least one day. [32] The method of claim 29, wherein expanding the prosthetic heart valve in contact with the valve-receiving element is performed at least one week after deployment of the anchoring frame, so as to allow regurgitation of blood through the temporary prosthetic valve leaflets for at least one week.

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