Valve frame for artificial tricuspid valve

Abstract

The present invention provides an apparatus and method for use with the native tricuspid valve of a mammalian subject's heart. SOLUTION: The valve frame (22) includes a valve frame body (32) configured to support the prosthetic valve leaflets (20) within the native tricuspid valve. The chordae recruiting arms (30) are configured to extend from the valve frame body at circumferential regions corresponding to the anterior and posterior leaflets of the native tricuspid valve. The anchoring arms (28) are configured to extend from the valve frame body at circumferential regions corresponding to the septal leaflet of the native tricuspid valve. The anchoring arms (28) are longer than each of the chordae recruiting arms (30). Other uses are also described.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Patent Application No. 63 / 211,602, entitled "Valve frame for prosthetic tricuspid valve," filed June 17, 2021, to Orlov, which is incorporated herein by reference in its entirety.

[0002] The present invention relates to medical devices and methods, and in particular to devices and methods for implanting a prosthetic valve in a tricuspid valve. [Background technology]

[0003] The human heart is a muscular organ that, by contraction of four chambers, pumps deoxygenated blood to the lungs where it is oxygenated, and pumps oxygenated blood to the rest of the body.

[0004] After circulating through the body, deoxygenated blood from the body enters the right atrium via one or more large veins. In healthy subjects, the right atrium contracts and pumps blood into the right ventricle via the tricuspid valve. The right ventricle contracts and pumps blood into the pulmonary artery via the pulmonary semilunar valve. The pulmonary artery splits into two branches, one for each lung. As the blood passes through the lungs, it becomes oxygenated and re-enters the heart through the left atrium. The left atrium contracts and pumps oxygenated blood into the left ventricle via the mitral valve. The left ventricle contracts and pumps oxygenated blood into the aorta via the aortic valve for distribution to the rest of the body. The tricuspid valve is closed during right ventricular contraction, thus preventing blood from flowing back into the right atrium. Similarly, the mitral valve is closed during left ventricular contraction, thus preventing blood from flowing back into the left atrium. The mitral and tricuspid valves are known as atrioventricular valves, and these valves control blood flow between the atria and ventricles, respectively.

[0005] The tricuspid valve includes three leaflets, the septal leaflet, the anterior leaflet, and the posterior leaflet. Each leaflet is attached to a tricuspid annulus that defines the tricuspid orifice. The leaflets are connected by chords to the right ventricle and / or papillary muscles in the right ventricular wall. In healthy subjects, the tricuspid valve controls the direction of blood flow from the right atrium to the right ventricle, as described above. Tricuspid regurgitation occurs when the tricuspid valve does not close properly, which can allow blood to flow backward into the right atrium as the right ventricle contracts. The most common cause of tricuspid regurgitation is right ventricular dilation, which causes the tricuspid annulus to dilate, resulting in improper coaptation of the leaflets. Summary of the Invention

[0006] According to some applications of the present invention, the leaflets of a prosthetic tricuspid valve are positioned within a prosthetic tricuspid valve frame. The prosthetic tricuspid valve frame is typically delivered to the subject's native tricuspid valve via the subject's inferior or superior vena cava. Typically, the tricuspid valve frame includes an anchoring arm in a circumferential region corresponding to the septal leaflet of the native tricuspid valve, and multiple chord-recruiting arms in circumferential regions corresponding to the anterior and posterior leaflets of the native tricuspid valve. In some applications, the prosthetic tricuspid valve frame includes a valve frame body defining a ventricular portion (configured to be positioned within the subject's right ventricle upon deployment) and an atrial portion (configured to be positioned within the subject's right atrium upon deployment). The prosthetic tricuspid valve frame typically supports multiple prosthetic tricuspid valve leaflets (e.g., two leaflets, or three leaflets as shown) that are sutured or otherwise coupled to the valve frame body.

[0007] Typically, in an unconstrained configuration of the prosthetic tricuspid valve frame, the chordae recruiting arms extend radially from a portion of the valve frame body configured to be disposed within a subject's ventricle. In some applications, in a radially unconstrained configuration of the valve frame, the chordae recruiting arms encircle more than 40 percent of the circumference of the valve frame body (e.g., more than 60 percent of the circumference of the valve frame body) and / or less than 80 percent of the circumference of the valve frame body (e.g., less than 70 percent of the circumference of the valve frame body). Typically, the chordae recruiting arms are configured to be disposed in circumferential regions corresponding to the anterior and posterior leaflets of the native tricuspid valve and are configured to recruit the chordae of the aforementioned leaflets, as described in more detail below. Typically, the chordae recruit arms are configured to extend radially from the valve frame body in addition to extending axially from the ventricular end of the valve frame body (i.e., the end of the valve frame body configured to be placed in the ventricle) towards the atrial end of the valve frame body (i.e., the end of the valve frame body configured to be placed in the atrium). More typically, the chordae recruit arms are curved in a circumferential direction of a given curvature (i.e., in a clockwise or counterclockwise direction) around the outside of the valve frame body. In some applications, the chordae recruit arms are configured to have opposing concave rounded tips in a given circumferential direction.

[0008] Typically, the chordae recruiting arms are not located in the circumferential region of the valve frame corresponding to the septal leaflet of the native tricuspid valve. For example, in the radially unconstrained configuration of the valve frame, the valve frame may not include chordae recruiting arms (or a portion thereof) in at least 20 percent (or at least 30 percent) of the circumference of the valve frame body. In some applications, in the radially unconstrained configuration of the valve frame, the valve frame does not include arms (or a portion thereof) in at least 20 percent (or at least 30 percent) of the circumference of the valve frame body. In some applications, in the circumferential region of the valve frame corresponding to the septal leaflet of the native tricuspid valve, the anchoring arms extend radially from a portion of the valve frame body configured to be placed in the subject's ventricle. Typically, the anchoring arms have a different shape and / or length and a different function than the chordae recruiting arms, as described in more detail below. In some applications, the valve frame does not include arms (i.e., does not include anchoring arms or chordae recruiting arms) in the circumferential region of the valve frame corresponding to the septal leaflet of the native tricuspid valve.

[0009] In some applications, the tricuspid valve frame includes a coronary sinus anchor configured to be secured within the subject's coronary sinus. Typically, the coronary sinus anchor is an elongated anchor configured to extend radially from the atrial portion of the valve frame body in an unconstrained configuration. More typically, the anchor is configured to curve circumferentially relative to the atrial portion of the valve frame body, e.g., to match the curved shape of the coronary sinus. The coronary sinus anchor is configured to be inserted into a coronary sinus ostium in the right atrium and then advanced into the coronary sinus by rotation of the valve frame. The coronary sinus is typically located near the septal cusp. Thus, the coronary sinus anchor typically provides fixation of the valve frame to the native tricuspid valve in a circumferential region corresponding to the septal cusp. Typically, coronary sinus anchors are constructed from a shape memory material (e.g., a shape memory alloy such as Nitinol and / or copper aluminum nickel) covered with a covering material such as a fabric and / or polymer (e.g., expanded polytetrafluoroethylene (ePTFE), or polyester woven, knitted, and / or braided, etc.).

[0010] Thus, in accordance with some applications of the present invention, there is provided an apparatus for use with a native tricuspid valve of a mammalian subject's heart. The native tricuspid valve includes an anterior leaflet, a posterior leaflet, a septal leaflet, and chordae tendineae extending to each of the leaflets. The apparatus includes: An artificial valve leaflet; 1. A valve frame, comprising: a valve frame body configured to support prosthetic leaflets within a native tricuspid valve; chordae recruit arms configured to extend from the valve frame body at circumferential regions corresponding to the anterior and posterior leaflets of the native tricuspid valve; a fixation arm configured to extend from the valve frame body in a circumferential region corresponding to the septal leaflet of the native tricuspid valve, the fixation arm being longer than each of the chordae recruit arms; a valve frame including: Includes.

[0011] In some applications, the valve frame body further includes an atrial portion configured to be deployed within the right atrium of the subject, and the valve frame further includes a coronary sinus anchor extending radially from the atrial portion of the valve frame body, the coronary sinus anchor configured to be inserted into the coronary sinus of the subject, thereby securing the valve frame relative to the native tricuspid valve.

[0012] In some applications, the device further comprises a delivery catheter, the delivery catheter comprising: Delivering the valve frame to the native tricuspid valve; deploying the chordae recruit arms such that the chordae recruit arms deploy between the chordae extending to each of the anterior and posterior leaflets and curve circumferentially around the valve frame body in a given circumferential direction; deploying the fixation arms such that the fixation arms deploy between the chordae tendineae extending to the septal cusp and curve circumferentially around the valve frame body in a given circumferential direction; Rotating at least a portion of the valve frame in a given circumferential direction; recruiting and deflecting at least a portion of the chordae extending to the anterior and posterior leaflets, such that the chordae recruiting arms (a) pull the anterior and posterior leaflets radially inward toward the valve frame and (b) twist the anterior and posterior leaflets about the valve frame; The fixation arms are fixed within the chordae tendineae extending toward the septal cusp; It is structured as follows.

[0013] In some applications, the delivery catheter is configured to radially expand the valve frame body to trap the anterior and posterior leaflets in a partially closed, twisted configuration, thereby at least partially sealing the space between the native tricuspid valve and the valve frame.

[0014] In some applications, the fixation arms are not configured to manipulate the shape of the septal leaflet in the manner in which the chordae recruit arms are configured to manipulate the shape of the anterior and posterior leaflets by rotation of a portion of the valve frame.

[0015] In some applications, in a radially unconstrained configuration of the valve frame, the chordae recruit arms encircle less than 80 percent of the circumference of the valve frame body.

[0016] In some applications, in a radially unconstrained configuration of the valve frame, the chordae recruit arms encircle greater than 40 percent of the circumference of the valve frame body.

[0017] In some applications, the fixation arms and chordae recruit arms are configured to assume a chordae deployed configuration by releasing them from a radially constrained configuration while the portion of the valve frame from which they extend is still in the radially constrained configuration, the fixation arms are configured to be deployed between the chordae extending to the septal cusp by assuming their chordae deployed configuration, and the chordae recruit arms are configured to be deployed between the chordae extending to the anterior cusp and between the chordae extending to the posterior cusp by assuming their chordae deployed configuration.

[0018] In some applications, in the chordae-deployed configuration of the arms, the ratio of the length of the fixed arm to the length of each of the chordae-recruiting arms measured along the center of each of the arms from the base of the arm to the tip of the arm is greater than 4:3.

[0019] In some applications, in the chordae-deployed configuration of the arms, the ratio of the length of the anchoring arm to the length of each of the chordae-recruiting arms measured along the center of each of the arms from the base of the arm to the tip of the arm is greater than 2:1.

[0020] Further, in accordance with some applications of the present invention, there is provided an apparatus for use with a native tricuspid valve of a mammalian subject's heart. The native tricuspid valve includes an anterior leaflet, a posterior leaflet, a septal leaflet, and chordae tendineae extending to each of the leaflets. The apparatus includes: An artificial valve leaflet; 1. A valve frame, comprising: a valve frame body configured to support prosthetic leaflets within a native tricuspid valve; chordae recruit arms configured to extend from the valve frame body at circumferential regions corresponding to the anterior and posterior leaflets of the native tricuspid valve; a valve frame including: wherein the valve frame does not include an arm extending from the valve frame body in a circumferential region corresponding to the septal leaflet of the native tricuspid valve.

[0021] In some applications, the valve frame body includes an atrial portion configured to be deployed within the right atrium of a subject, and the valve frame further includes a coronary sinus anchor extending radially from the atrial portion of the valve frame body, the coronary sinus anchor configured to be inserted into the coronary sinus of the subject, thereby securing the valve frame relative to the native tricuspid valve.

[0022] In some applications, the apparatus further comprises a delivery catheter, the delivery catheter comprising: Delivering the valve frame to the native tricuspid valve; deploying the chordae recruit arms such that the chordae recruit arms deploy between the chordae extending to each of the anterior and posterior leaflets and curve circumferentially around the valve frame body in a given circumferential direction; rotating at least a portion of the valve frame in a given circumferential direction to recruit and deflect at least a portion of the chordae extending to the anterior and posterior leaflets, such that the chordae recruiting arms (a) pull the anterior and posterior leaflets radially inward toward the valve frame and (b) twist the anterior and posterior leaflets about the valve frame; It is structured as follows.

[0023] In some applications, in a radially unconstrained configuration of the valve frame, the chordae recruit arms encircle less than 80 percent of the circumference of the valve frame body.

[0024] In some applications, in a radially unconstrained configuration of the valve frame, the chordae recruit arms encircle greater than 40 percent of the circumference of the valve frame body.

[0025] In some applications, in the radially unconstrained configuration of the valve frame, the valve frame does not include chordae recruit arms that extend from the valve frame body around at least 20 percent of the circumference of the valve frame body.

[0026] In some applications, in the radially unconstrained configuration of the valve frame, the valve frame does not include chordae recruit arms that extend from the valve frame body around at least 30 percent of the circumference of the valve frame body.

[0027] In some applications, the chordae recruit arms are configured to extend from a longitudinal position along the valve frame body such that in a radially unconstrained configuration of the valve frame, at a longitudinal position along the valve frame body, the valve frame does not include chordae recruit arms around at least 20 percent of the circumference of the valve frame body.

[0028] In some applications, in the radially unconstrained configuration of the valve frame, at a longitudinal position along the valve frame body, the valve frame does not include chordae recruit arms around at least 30 percent of the circumference of the valve frame body.

[0029] In some applications, the valve frame body includes a ventricular portion configured to be deployed within a right ventricle of a subject, and the chordae recruit arms are configured to extend from a distal end of the ventricular portion of the valve frame body.

[0030] Further, in accordance with some applications of the present invention, there is provided an apparatus for use with a native tricuspid valve of a mammalian subject's heart. The native tricuspid valve includes an anterior leaflet, a posterior leaflet, a septal leaflet, and chordae tendineae extending to each of the leaflets. The apparatus includes: An artificial valve leaflet; 1. A valve frame, comprising: a valve frame body configured to support prosthetic valve leaflets in a native tricuspid valve, the valve frame body including an atrial portion configured to be positioned within a right atrium of a subject; a coronary sinus anchor extending radially from the atrial portion of the valve frame body, the coronary sinus anchor configured to be inserted into the subject's coronary sinus, thereby securing the valve frame relative to the native tricuspid valve; a valve frame including: Includes.

[0031] In some applications, the valve frame further comprises: chordae recruit arms configured to extend from the valve frame body at circumferential regions corresponding to the anterior and posterior leaflets of the native tricuspid valve; a fixation arm configured to extend from the valve frame body in a circumferential region corresponding to the septal leaflet of the native tricuspid valve, the fixation arm being longer than each of the chordae recruit arms; Includes.

[0032] In some applications, in a radially unconstrained configuration of the valve frame, the chordae recruit arms encircle less than 80 percent of the circumference of the valve frame body.

[0033] In some applications, in a radially unconstrained configuration of the valve frame, the chordae recruit arms encircle greater than 40 percent of the circumference of the valve frame body.

[0034] In some applications, the fixation arms and chordae recruit arms are configured to assume a chordae deployed configuration by releasing them from a radially constrained configuration while the portion of the valve frame from which they extend is still in the radially constrained configuration, the fixation arms are configured to be deployed between the chordae extending to the septal cusp by assuming their chordae deployed configuration, and the chordae recruit arms are configured to be deployed between the chordae extending to the anterior cusp and between the chordae extending to the posterior cusp by assuming their chordae deployed configuration.

[0035] In some applications, in the chordae-deployed configuration of the arms, the ratio of the length of the fixed arm to the length of each of the chordae-recruiting arms measured along the center of each of the arms from the base of the arm to the tip of the arm is greater than 4:3.

[0036] In some applications, in the chordae-deployed configuration of the arms, the ratio of the length of the anchoring arm to the length of each of the chordae-recruiting arms measured along the center of each of the arms from the base of the arm to the tip of the arm is greater than 2:1.

[0037] In some applications, the valve frame further includes chordae recruit arms configured to extend from the valve frame body at circumferential regions corresponding to the anterior and posterior leaflets of the native tricuspid valve, and the valve frame does not include arms extending from the valve frame body at a circumferential region corresponding to the septal leaflet of the native tricuspid valve.

[0038] In some applications, in a radially unconstrained configuration of the valve frame, the chordae recruit arms encircle less than 80 percent of the circumference of the valve frame body.

[0039] In some applications, in a radially unconstrained configuration of the valve frame, the chordae recruit arms encircle greater than 40 percent of the circumference of the valve frame body.

[0040] In some applications, in the radially unconstrained configuration of the valve frame, the valve frame does not include chordae recruit arms that extend from the valve frame body around at least 20 percent of the circumference of the valve frame body.

[0041] In some applications, in the radially unconstrained configuration of the valve frame, the valve frame does not include chordae recruit arms that extend from the valve frame body around at least 30 percent of the circumference of the valve frame body.

[0042] In some applications, the chordae recruit arms are configured to extend from a longitudinal position along the valve frame body such that in a radially unconstrained configuration of the valve frame, at a longitudinal position along the valve frame body, the valve frame does not include chordae recruit arms around at least 20 percent of the circumference of the valve frame body.

[0043] In some applications, in the radially unconstrained configuration of the valve frame, at a longitudinal position along the valve frame body, the valve frame does not include chordae recruit arms around at least 30 percent of the circumference of the valve frame body.

[0044] In some applications, the valve frame body includes a ventricular portion configured to be deployed within a right ventricle of a subject, and the chordae recruit arms are configured to extend from a distal end of the ventricular portion of the valve frame body.

[0045] The invention will be more fully understood from the following detailed description of its application, taken together with the drawings, in which: [Brief description of the drawings]

[0046] [Figure 1] FIG. 1 is a schematic diagram of a prosthetic tricuspid valve frame supporting prosthetic valve leaflets delivered via a subject's vena cava towards a subject's native tricuspid valve, in accordance with some applications of the present invention. [Diagram 2] 1A-1D are schematic diagrams of steps for deployment of a prosthetic tricuspid frame in a subject's native tricuspid valve, in accordance with some applications of the present invention. [Diagram 3] 1A-1D are schematic diagrams of steps for deployment of a prosthetic tricuspid frame in a subject's native tricuspid valve, in accordance with some applications of the present invention. [Figure 4] 1A-1D are schematic diagrams of steps for deployment of a prosthetic tricuspid frame in a subject's native tricuspid valve, in accordance with some applications of the present invention. [Diagram 5]1A-1D are schematic diagrams of steps for deployment of a prosthetic tricuspid frame in a subject's native tricuspid valve, in accordance with some applications of the present invention. [Figure 6] 1A-1D are schematic diagrams of steps for deployment of a prosthetic tricuspid frame in a subject's native tricuspid valve, in accordance with some applications of the present invention. [Figure 7] 1A-1D are schematic diagrams of steps for deployment of a prosthetic tricuspid frame in a subject's native tricuspid valve, in accordance with some applications of the present invention. [Figure 8] FIG. 1 is a schematic diagram of a tricuspid valve frame including a coronary sinus anchor configured to be secured within the coronary sinus of a subject, in accordance with some applications of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0047] Reference is now made to FIG. 1, which is a schematic illustration of a prosthetic valve leaflet 20 and a prosthetic tricuspid valve frame 22 delivered via a subject's vena cava 24 toward a subject's native tricuspid valve 26. The prosthetic tricuspid valve frame 22 is typically delivered via the subject's inferior or superior vena cava. Typically, the tricuspid valve frame includes a fixation arm 28 at a circumferential region corresponding to the septal leaflet of the native tricuspid valve and a plurality of chordae tendineae recruiting arms 30 at circumferential regions corresponding to the anterior and posterior leaflets of the native tricuspid valve. In some applications, the prosthetic tricuspid valve frame includes a valve frame body 32 that defines a ventricular portion 34 (configured to be disposed within the subject's right ventricle upon deployment) and an atrial portion 36 (configured to be disposed within the subject's right atrium upon deployment). In some applications, the atrial portion includes a flange configured to contact the atrial side of the native valve annulus. The tricuspid valve frame 22 typically supports a number of tricuspid valve leaflets 20 (eg, two leaflets, or three leaflets as shown) that are sutured or otherwise attached to the valve frame body.

[0048] Typically, the tricuspid valve frame 22 is made of a shape memory material 40 (e.g., a shape memory alloy such as Nitinol and / or copper aluminum nickel) covered on one or both sides with a covering material 42, such as a fabric and / or polymer (e.g., expanded polytetrafluoroethylene (ePTFE), or polyester woven, knitted, and / or braided, etc.). Typically, the shape memory material of the valve frame is shaped into a stent-like structure that includes struts and / or cells of shape memory material. The covering material is typically attached to the shape memory material by stitching.

[0049] Typically, in an unconstrained configuration of the prosthetic tricuspid valve frame 22, the chordae recruiting arms 30 extend radially from a portion of the valve frame body 32 configured to be disposed within a subject's ventricle. In some applications, in a radially unconstrained configuration of the valve frame, the chordae recruiting arms encircle more than 40 percent of the circumference of the valve frame body (e.g., more than 60 percent of the circumference of the valve frame body) and / or less than 80 percent of the circumference of the valve frame body (e.g., less than 70 percent of the circumference of the valve frame body). Typically, the chordae recruiting arms are configured to be disposed in circumferential regions corresponding to the anterior and posterior leaflets of the native tricuspid valve and are configured to recruit the chordae of said leaflets, as described in more detail below. Typically, the chordae recruit arms are configured to extend radially from the valve frame body in addition to extending axially from the ventricular end of the valve frame body (i.e., the end of the valve frame body configured to be placed in the ventricle) towards the atrial end of the valve frame body (i.e., the end of the valve frame body configured to be placed in the atrium). More typically, the chordae recruit arms are curved in a circumferential direction of a given curvature (i.e., in a clockwise or counterclockwise direction) around the outside of the valve frame body. In some applications, the chordae recruit arms are configured to have opposing concave rounded tips in a given circumferential direction.

[0050] Typically, the chordae recruit arms are not located in the circumferential region of the valve frame that corresponds to the septal leaflet of the native tricuspid valve. For example, in a radially unconstrained configuration of the valve frame, the valve frame may not include chordae recruit arms (or portions thereof) around at least 20 percent (or at least 30 percent) of the circumference of the valve frame body. In some applications, in a radially unconstrained configuration of the valve frame, the valve frame may not include arms (or portions thereof) around at least 20 percent (or at least 30 percent) of the circumference of the valve frame body. (As noted above, the chordae recruit arms are typically curved around the outside of the valve frame body. In some applications, at a longitudinal location along the valve frame body where the chordae recruit arms extend from the valve frame body (e.g., at the distal end of the ventricular portion of the valve frame body), the valve frame does not include the chordae recruit arms (or any arms, or portions thereof) around at least 20 percent (or at least 30 percent) of the circumference of the valve frame body. However, due to the curvature of the chordae recruit arms around the outside of the valve frame body, at different locations along the valve frame body, the chordae recruit arms may extend around a greater portion of the circumference of the valve frame body.) In some applications, as shown in FIGS. 1-5 , anchoring arms 28 extend radially from a portion of the valve frame body 32 configured to be positioned within a target ventricle in a circumferential region of the valve frame corresponding to the septal leaflet of the native tricuspid valve. Typically, the anchoring arms 28 have a different shape and / or length and a different function than the chordae recruiting arms 30, as described in more detail below. In some applications, as shown in Figures 6-7, the valve frame does not include arms (i.e., does not include anchoring arms or chordae recruiting arms) in the circumferential region of the valve frame that corresponds to the septal leaflet of the native tricuspid valve.

[0051] Typically, the prosthetic tricuspid frame 22 is delivered to the native tricuspid valve using a delivery catheter 50 (e.g., shown in FIG. 2 ) inserted over a guidewire 52. The delivery catheter is configured to maintain the prosthetic tricuspid frame 22 in a radially constrained configuration (i.e., a “crimped” configuration) during delivery. In some applications, the delivery catheter includes a capsule 54 configured to house the prosthetic tricuspid frame 22 in the radially constrained configuration. In some applications, the capsule includes a proximal capsule portion 56 (configured to cover a proximal portion of the prosthetic tricuspid frame to maintain the proximal portion in the radially constrained configuration) and a distal capsule portion 58 (configured to cover a distal portion of the prosthetic tricuspid frame to maintain the distal portion in the radially constrained configuration). Alternatively, the delivery catheter includes different housing components configured to house the prosthetic tricuspid frame 22 in the radially constrained configuration. For example, the delivery catheter may include an integrated capsule and / or different housing elements.

[0052] It should be noted that the term "distal" and related terms, when used in connection with a device or portion thereof, should be interpreted to mean the end of the device or portion thereof that is typically furthest from a location of insertion into a subject's body when the device is inserted into the body of a subject. The term "proximal" and related terms, when used in connection with a device or portion thereof, should be interpreted to mean the end of the device or portion thereof that is typically closer to a location of insertion into a subject's body when the device is inserted into the body of a subject. It should be noted that the blown-up portion of FIG. 1 shows views of the prosthetic tricuspid valve frame in a radially unconstrained configuration for purposes of illustration.

[0053] Reference is now made to Figures 2, 3, 4, and 5, which are schematic illustrations of steps in the deployment of the prosthetic tricuspid valve leaflets 20 and prosthetic tricuspid valve frame 22 in a subject's native tricuspid valve 26, according to some applications of the present invention. As shown in Figure 2, a delivery catheter 50 is typically advanced into the subject's right atrium 60 and then into the subject's right ventricle 62 such that the delivery catheter capsule 54 crosses the subject's native tricuspid valve 26. In some applications, the anchoring arms 28 and chordae recruiting arms 30 are then released from their radially constrained configuration. The anchoring arms 28 and chordae recruiting arms 30 can then be released from their radially constrained configuration by distally advancing the distal capsule portion 58 and / or proximal capsule portion retracting proximally, as shown by the arrows in Figure 3. Alternatively, the prosthetic tricuspid valve frame may be housed in a delivery catheter having a different housing element (e.g., an integrated capsule) and the release of the anchoring arms 28 and chordae recruiting arms 30 from their radially constrained configurations may be altered accordingly. The transition from Figure 3 to Figure 4 diagrammatically illustrates the release of the anchoring arms 28 and chordae recruiting arms 30 from their radially constrained configurations.

[0054] Typically, as shown in FIG. 4, the anchoring arms 28 and the chord recruiting arms 30 are released from the radially constrained configuration while the portion of the valve frame from which they extend (typically the ventricular portion 34) is still in the radially constrained configuration. In some applications, in this configuration (referred to herein as the "chord-deployment configuration" of the anchoring arms 28 and the chord recruiting arms 30), the anchoring arms 28 and the chord recruiting arms 30 extend radially from the valve frame body and are shaped to curve in a given circumferential direction (i.e., clockwise or counterclockwise) around the valve frame. Typically, the length of the anchoring arms is greater than the length of the chord recruiting arms. For example, the ratio of the length of the anchoring arms to the length of each chord recruiting arm (measured along the center of each arm from the base of the arm (i.e., where the arm is attached to the valve frame) to the tip of the arm) is typically greater than 4:3, greater than 3:2, or greater than 2:1.

[0055] As described in the Background section, the tricuspid valve includes three leaflets: the septal leaflet, the anterior leaflet, and the posterior leaflet. Each leaflet is attached to a tricuspid annulus that defines the tricuspid orifice. The leaflets are connected to the papillary muscles in the right ventricle by chordae tendineae. Typically, the native tricuspid valve apparatus is constructed such that the chordae tendineae 70 extending from the anterior papillary muscle to the anterior leaflet and the chordae tendineae 72 extending from the posterior papillary muscle to the posterior leaflet are relatively long and flexible, while the chordae tendineae 74 extending from the septal papillary muscle (or from the right ventricular wall) to the septal leaflet are relatively short and stiff. As described above, the chordae recruit arms 30 are configured to be positioned in circumferential regions corresponding to the anterior and posterior leaflets of the native tricuspid valve. Typically, when released from the radially constrained configuration (i.e., the stage of deployment shown in FIG. 4), the chordae recruiting arms assume a chordae-deployed configuration and are deployed between chordae 70 (extending from the anterior papillary muscles to the anterior leaflet) and chordae 72 (extending from the posterior papillary muscles to the posterior leaflet). In a circumferential region of the valve frame corresponding to the septal leaflet of the native tricuspid valve, the fixation arms 28 assume a chordae-deployed configuration and extend radially from a portion of the valve frame body 32. Because the chordae 74 (extending from the septal papillary muscles or from the right ventricular wall to the septal leaflet) are short, in order to deploy the fixation arms between these chordae, the fixation arms are typically made longer than the chordae recruiting arms, as described above.

[0056] Typically, after the anchoring arms 28 and the chordae recruiting arms 30 are deployed between each set of chordae (and while the anchoring arms 28 and the chordae recruiting arms 30 are still in the chordae deployed configuration), at least a portion of the valve frame is rotated. In some applications, the valve frame is rotated in a circumferential direction in which the anchoring arms 28 and the chordae recruiting arms 30 are curved circumferentially around the valve frame. Typically, the rotation of the valve frame recruits and deflects at least a portion of the chordae 70 and 72, causing the chordae recruiting arms 30 to (a) pull the anterior and posterior leaflets radially inward toward the valve frame and (b) twist the anterior and posterior leaflets around the valve frame. More typically, the rotation of the valve frame fixes the anchoring arms 28 relative to the chordae 74. Note that the septal leaflet is typically less flexible and smaller than the anterior and posterior leaflets. Thus, the fixation arms are typically not used to manipulate the shape of the septal leaflet in the manner in which the chordae recruiting arms are configured to manipulate the shape of the anterior and posterior leaflets.

[0057] After the fixation arms 28 and chordae recruiting arms 30 are deployed between each set of chordae and the valve frame is rotated, the valve frame body 32 (i.e., the ventricular and atrial portions 34 and 36 of the valve frame body) assume a radially unconstrained configuration. In some applications, the atrial portion is released from the delivery catheter by, for example, further retracting the proximal capsule portion 56, thereby assuming the radially unconstrained configuration. In some applications, the ventricular portion is released from the delivery catheter by, for example, further advancing the distal capsule portion 58, thereby assuming the radially unconstrained configuration. Alternatively, the valve frame may be housed within a delivery catheter having a different housing component (e.g., an integral capsule) and the release of the ventricular and atrial portions 34 and 36 of the valve frame body from the radially constrained configuration may be altered accordingly.

[0058] 5 illustrates both the ventricular and atrial portions 34, 36 of the valve frame body 32 in a radially unconstrained (i.e., radially stretched) configuration. Typically, with the valve frame body in a radially unconstrained configuration, the valve frame body is configured to trap the anterior and posterior leaflets in a partially closed, twisted configuration, thereby at least partially sealing the space between the native tricuspid valve and the valve frame. More typically, the valve frame is typically secured to the native tricuspid valve by (a) retaining chordae 70 and 72 between the chordae recruit arms 30 and the valve frame body, and / or (b) retaining chordae 74 between the anchoring arms 28 and the valve frame body, as shown.

[0059] In some applications, release of the valve frame body changes the shape of the anchoring arms and / or chordae recruiting arms from a chordae deployed configuration to what is referred to herein as the "deployed configuration" of the anchoring arms 28 and chordae recruiting arms 30. (Note that the deployed configuration of the anchoring arms and chordae recruiting arms is typically the same as the radially unconstrained configuration.) For example, as shown in the transition from FIG. 4 to FIG. 5, the base of the anchoring arms and / or chordae recruiting arms may be flared. Alternatively or additionally, the anchoring arms and / or chordae recruiting arms may be more axially oriented. Typically, even in the deployed configuration, the anchoring arms and / or chordae recruiting arms extend radially from the valve frame body and curve circumferentially around the valve frame body. After performing the above steps, the delivery catheter 50 is typically generally retracted from the right atrium of the subject.

[0060] Reference is now made to Figures 6 and 7, which are schematic illustrations of steps of deployment of a prosthetic tricuspid valve leaflet 20 and a prosthetic tricuspid valve frame 22 in a subject's native tricuspid valve, according to some applications of the present invention. The prosthetic tricuspid valve frame 22 shown in Figures 6 and 7 is generally similar to that shown in Figures 1-5. However, according to some applications of the present invention, the valve frame does not have chordae recruiting arms or anchoring arms in the circumferential region corresponding to the septal leaflet. As shown in Figure 7, the valve frame typically includes chordae recruiting arms 30 in the circumferential region corresponding to the anterior and posterior leaflets. The size, structure, and function of the chordae recruiting arms are typically generally similar to those described above with reference to Figures 1-5. For example, the chordae recruiting arms 30 are typically configured such that rotation of the valve frame recruits and deflects at least a portion of the chordae 70 and 72 such that the chordae recruiting arms (a) pull the anterior and posterior leaflets radially inward toward the valve frame and (b) twist the anterior and posterior leaflets around the valve frame. Alternatively or additionally, as shown in FIG. 7, the valve frame is secured to the native tricuspid valve by retaining the chordae 70 and 72 between the chordae recruiting arms and the valve frame body. In such applications, there are no arms extending from the ventricular portion of the valve frame configured to secure the valve frame to the septal leaflet and / or chordae 74 in a circumferential region corresponding to the septal leaflet. In some applications, an alternative fixation mechanism is used to secure the valve frame in a circumferential region corresponding to the septal leaflet, as described below with reference to FIG. 8, for example.

[0061] Reference is now made to FIG. 8, which is a schematic diagram of a superior view of the native tricuspid valve 26 aligned with a tricuspid valve frame 22 including a coronary sinus anchor 80 configured to be anchored within a subject's coronary sinus 82, according to some alternative applications of the present invention. Typically, the coronary sinus anchor 80 is an elongated anchor configured to extend radially from the atrial portion 36 of the valve frame body 32 in an unconstrained configuration. More typically, the anchor is configured to curve circumferentially relative to the atrial portion 36 of the valve frame body 32, e.g., to match the curved shape of the coronary sinus. The coronary sinus anchor is configured to be inserted into the coronary sinus ostium in the right atrium and then advanced into the coronary sinus by rotation of the valve frame. As shown in FIG. 8, the coronary sinus is typically located near the septal cusp. Thus, the coronary sinus anchor typically provides fixation of the valve frame to the native tricuspid valve in a circumferential region corresponding to the septal cusp. Typically, coronary sinus anchors are constructed from a shape memory material (e.g., a shape memory alloy such as Nitinol and / or copper aluminum nickel) covered with a covering material such as a fabric and / or polymer (e.g., expanded polytetrafluoroethylene (ePTFE), or polyester woven, knitted, and / or braided, etc.).

[0062] As discussed above with reference to FIG. 1, in some applications, the atrial portion 36 includes a flange configured to contact the atrial side of the native valve annulus. In some applications (not shown), a coronary sinus anchor 80 is used in conjunction with the atrial portion that includes a flange. In some applications (as shown in FIG. 8), the atrial portion includes a plurality of atrial anchors 84 configured to contact the atrial side of the native valve annulus. In some such applications, the coronary sinus anchor 80 is disposed between two of the atrial anchors shown in FIG. 8.

[0063] Those skilled in the art will recognize that the present invention is not limited to what has been specifically shown and described above, and the scope of the present invention includes both combinations and subcombinations of the various features described above, as well as variations and modifications that would occur to those skilled in the art upon reading the foregoing description and that do not exist in the prior art.

Claims

1. An apparatus for use with the native tricuspid valve of the heart of a mammalian subject, the native tricuspid valve including an anterior leaflet, a posterior leaflet, a septal leaflet, and chordae tendineae extending to each of the valve leaflets, the apparatus comprising: an artificial leaflet; a valve frame, comprising: a valve frame body configured to support the artificial leaflet within the native tricuspid valve; chordae recruit arms configured to extend from the valve frame body in circumferential regions corresponding to the anterior and posterior leaflets of the native tricuspid valve; fixing arms, each longer than each of the chordae recruit arms, configured to extend from the valve frame body in a circumferential region corresponding to the septal leaflet of the native tricuspid valve; a valve frame including the same; an apparatus comprising the same.

2. The apparatus of claim 1, wherein the valve frame body further includes an atrial portion configured to be deployed within the right atrium of the subject, and the valve frame further includes a coronary sinus anchor extending radially from the atrial portion of the valve frame body, the coronary sinus anchor being configured to be inserted into the coronary sinus of the subject, thereby fixing the valve frame relative to the native tricuspid valve.

3. The apparatus of claim 1 or claim 2, further comprising a delivery catheter configured to: deliver the valve frame to the native tricuspid valve; deploy the chordae recruit arms such that the chordae recruit arms deploy between chordae tendineae extending to each of the anterior and posterior leaflets and curve circumferentially around the valve frame body in a given circumferential direction; deploy the fixing arms such that the fixing arms deploy between chordae tendineae extending to the septal leaflet and curve circumferentially around the valve frame body in the given circumferential direction; rotate at least a portion of the valve frame in the given circumferential direction; recruit and deflect at least a portion of the chordae tendineae extending to the anterior and posterior leaflets such that the chordae recruit arms (a) radially inwardly pull the anterior and posterior leaflets toward the valve frame and (b) twist the anterior and posterior leaflets around the valve frame; fix the fixing arms within the chordae tendineae extending to the septal leaflet.

4. ​ The delivery catheter is configured to radially expand the valve frame body, confine the anterior and posterior leaflets in a twisted configuration with the leaflets partially closed, thereby at least partially sealing the space between the native tricuspid valve and the valve frame, the apparatus of claim 3.

5. The fixed arm is not configured to manipulate the shape of the septal leaflet in a manner such that the chordal recruitment arm manipulates the shape of the anterior and posterior leaflets by rotation of the part of the valve frame, the apparatus of claim 3.

6. In a configuration where the valve frame is not radially constrained, the chordal recruitment arm surrounds less than 80 percent of the circumference of the valve frame body, the apparatus of claim 1 or claim 2.

7. In a configuration where the valve frame is not radially constrained, the chordal recruitment arm surrounds more than 40 percent of the circumference of the valve frame body, the apparatus of claim 6.

8. While a part of the valve frame from which the fixed arm and the chordal recruitment arm extend is still in a radially constrained configuration, the fixed arm and the chordal recruitment arm are configured to assume a chordal deployment configuration by releasing from the radially constrained configuration, the fixed arm is configured to be deployed between the chords extending to the septal leaflet by assuming its chordal deployment configuration, and the chordal recruitment arm is configured to be deployed between the chords extending to the anterior leaflet and between the chords extending to the posterior leaflet by assuming their chordal deployment configurations, the apparatus of claim 1 or claim 2.

9. In the chordal deployment configuration of the arms, the ratio of the length of the fixed arm measured along the center of each of the arms from the base of the arm to the tip of the arm to the length of each of the chordal recruitment arms is greater than 4:3, the apparatus of claim 8.

10. In the chordal deployment configuration of the arms, the ratio of the length of the fixed arm measured along the center of each of the arms from the base of the arm to the tip of the arm to the length of each of the chordal recruitment arms is greater than 2:1, the apparatus of claim 9.

11. An apparatus for use with the native tricuspid valve of a mammalian subject's heart, the native tricuspid valve including an anterior leaflet, a posterior leaflet, a septal leaflet, and chordae tendineae extending to each of the valve leaflets, the apparatus comprising: an artificial leaflet; a valve frame comprising: a valve frame body configured to support the artificial leaflet within the native tricuspid valve; a chordae recruitment arm configured to extend from the valve frame body in a circumferential region corresponding to the anterior and posterior leaflets of the native tricuspid valve; the valve frame including; and being configured such that the valve frame does not include an arm extending from the valve frame body in a circumferential region corresponding to the septal leaflet of the native tricuspid valve. **Claim 12** The apparatus of claim 11, wherein the valve frame body includes an atrial portion configured to be deployed within the right atrium of the subject, and the valve frame further includes a coronary sinus anchor extending radially from the atrial portion of the valve frame body, the coronary sinus anchor being configured to be inserted into the coronary sinus of the subject, thereby fixing the valve frame relative to the native tricuspid valve. **Claim 13** The apparatus of claim 11, further comprising a delivery catheter, the delivery catheter being configured to: deliver the valve frame to the native tricuspid valve; deploy the chordae recruitment arm such that the chordae recruitment arm deploys between chordae tendineae extending to each of the anterior and posterior leaflets and curves circumferentially around the valve frame body in a given circumferential direction; rotate at least a portion of the valve frame in the given circumferential direction to recruit and deflect at least a portion of the chordae tendineae extending to the anterior and posterior leaflets, such that the chordae recruitment arm: (a) radially inwardly pulls the anterior and posterior leaflets toward the valve frame; and (b) twists the anterior and posterior leaflets around the valve frame. **Claim 14** The apparatus according to any one of claims 11 to 13, wherein in a configuration where the valve frame is not radially constrained, the chordae recruitment arm surrounds less than 80 percent of the circumference of the valve frame body. **Claim 15** The apparatus of claim 14, wherein in a configuration where the valve frame is not radially constrained, the chordae recruitment arm surrounds more than 40 percent of the circumference of the valve frame body. ​

16. In the configuration where the valve frame is not radially constrained, the valve frame does not include a chordal recruitment arm extending from the valve frame body at at least 20 percent of the circumference of the valve frame body, and the device according to any one of claims 11 to 13.

17. In the configuration where the valve frame is not radially constrained, the valve frame does not include a chordal recruitment arm extending from the valve frame body at at least 30 percent of the circumference of the valve frame body, and the device according to claim 16.

18. The chordal recruitment arm is configured to extend from a longitudinal position along the valve frame body. In the configuration where the valve frame is not radially constrained, at the longitudinal position along the valve frame body, the valve frame does not include a chordal recruitment arm at at least 20 percent of the circumference of the valve frame body, and the device according to any one of claims 11 to 13.

19. In the configuration where the valve frame is not radially constrained, at the longitudinal position along the valve frame body, the valve frame does not include a chordal recruitment arm at at least 30 percent of the circumference of the valve frame body, and the device according to claim 18.

20. The valve frame body includes a ventricular portion configured to be deployed within the right ventricle of the subject, and the chordal recruitment arm is configured to extend from the distal end of the ventricular portion of the valve frame body, and the device according to claim 18.

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