Covering materials for prosthetic valve frame

Abstract

Apparatus and methods are described including a frame (20) includes an atrial part (26) that includes a disc-shaped portion (28) configured to be deployed on an atrial side of the valve annulus, and a cylindrical part (22) configured to be deployed such that a ventricular end of the cylindrical part (22) is disposed within the ventricle. The cylindrical part (22) is coupled to the atrial part, via one or more sutures (132), at a plurality of junctions (67) that are disposed around a circumference of the frame (20), and each of the junctions (67) is individually padded with a covering material (32). Other applications are also described.

Description

[0001] COVERING MATERIALS FOR PROSTHETIC VALVE FRAME

[0002] CROSS-REFERENCES TO RELATED APPLICATIONS

[0003] The present application claims priority from US Provisional Patent Application 63 / 664,954 to Kami et al., filed une 27, 2024, entitled "Covering materials for prosthetic valve frame," which is incorporated herein by reference.

[0004] TECHNICAL FIELD

[0005] The present disclosure relates to medical apparatus and methods, including to apparatus and methods for implanting a prosthetic valve.

[0006] BACKGROUND

[0007] The human heart is a muscular organ that pumps deoxygenated blood through the lungs to oxygenate the blood and pumps oxygenated blood to the rest of the body by contractions of four chambers.

[0008] After having circulated in the body, deoxygenated blood from the body enters the right atrium through the vena cava. In a healthy subject, the right atrium contracts, pumping the blood through the tricuspid valve into the right ventricle. The right ventricle contracts, pumping the blood through the pulmonary semi-lunar valve into the pulmonary artery which splits to two branches, one for each lung. The blood is oxygenated while passing through the lungs, and reenters the heart via the left atrium. The left atrium contracts, pumping the oxygenated blood through the mitral valve into the left ventricle. The left ventricle contracts, pumping the oxygenated blood through the aortic valve into the aorta to be distributed to the rest of the body. The tricuspid valve closes during right ventricle contraction, so that backflow of blood into the right atrium is prevented. Similarly, the mitral valve closes during left ventricle contraction, so that backflow of blood into the left atrium is prevented. The mitral valve and the tricuspid valve are known as atrioventricular valves, each of these valves controlling the flow of blood between an atrium and a ventricle.

[0009] In the mitral valve, the mitral annulus defines a mitral valve orifice. An anterior leaflet and a posterior leaflet extend from the mitral annulus. The leaflets are connected by chords to papillary muscles within the left ventricle. During ventricular diastole, in a healthy subject, the left atrium contracts to pump blood into the left ventricle through the mitral valve orifice. The blood flows through the orifice, pushing the leaflets apart and into the left ventricle with little resistance. In a healthy subject, the leaflets of the aortic valve are kept closed by blood pressure in the aorta.

[0010] During ventricular systole, the left ventricle contracts to pump blood into the aorta through the aortic valve, the leaflets of which are pushed open by the blood flow. In a healthy subject, the mitral annulus contracts, pushing the leaflets inwards and reducing the area of the mitral valve orifice by about 20% to 30%. The leaflets coapt to accommodate the excess leaflet surface area, producing a coaptation surface that constitutes a seal. The pressure of blood in the left ventricle pushes against the ventricular surfaces of the leaflets, tightly pressing the leaflets together at the coaptation surface so that a tight, leak-proof seal is formed.

[0011] An effective seal of the mitral valve during ventricular systole depends on a sufficient degree of coaptation. Improper coaptation may be caused by any number of physical anomalies that allow leaflet prolapse (for example, elongated or ruptured chords, or weak papillary muscles) or prevent coaptation (for example, short chords, or small leaflets). There are also pathologies that lead to mitral valve insufficiency, including collagen vascular disease, ischemic mitral regurgitation (resulting, for example, from myocardial infarction, chronic heart failure, or failed / unsuccessful surgical or catheter revascularization), myxomatous degeneration of the leaflets, and rheumatic heart disease. Mitral valve regurgitation leads to many complications including arrhythmia, atrial fibrillation, cardiac palpitations, chest pain, congestive heart failure, fainting, fatigue, low cardiac output, orthopnea, paroxysmal nocturnal dyspnea, pulmonary edema, shortness of breath, and sudden death.

[0012] The tricuspid valve includes three leaflets: the septal leaflet, the anterior leaflet, and the posterior leaflet. Each of the valve leaflets is attached to the tricuspid valve annulus, which defines the tricuspid valve orifice. The leaflets are connected to papillary muscles within the right ventricle, by chords. In a healthy subject the tricuspid valve controls the direction of blood flow from the right atrium to the right ventricular, in a similar manner to the control of the mitral valve over the direction of blood flow on the left side of the heart. During ventricular diastole, the tricuspid valve opens, such as to allow the flow of blood from the right atrium to the right ventricle, and during ventricular systole the leaflets of the tricuspid valve coapt, such as to prevent the backflow of blood from the right ventricle to the right atrium. Tricuspid valve regurgitation occurs when the tricuspid valve fails to close properly. This can cause blood to flow back up into the right atrium when the right ventricle contracts. Tricuspid valve regurgitation is most commonly caused by right ventricle dilation, which leads to the tricuspid valve annulus dilating, resulting in the valve leaflets failing to coapt properly.

[0013] SUMMARY

[0014] This summary is meant to provide some examples and is not intended to be limiting of the scope of the invention in any way. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly recite the features. Also, the features, components, steps, concepts, etc. described in examples in this summary and elsewhere in this disclosure can be combined in a variety of ways. Various features and steps as described elsewhere in this disclosure may be included in the examples summarized here.

[0015] In some implementations of the present disclosure, a frame (e.g., a valve frame, a repair frame, a treatment frame, a stent frame, etc.) is provided that can be used to treat a native heart valve, such as an atrioventricular valve (e.g., the mitral valve, or the tricuspid valve. In some implementations, the frame includes a frame body (e.g., a valve-frame body, a repair frame body, a treatment frame body, a stent frame body, etc.).

[0016] In some implementation, the frame body includes a cylindrical part. In some implementations the frame body additionally or alternatively includes an atrial part or atrial portion.

[0017] In some implementations, the frame is usable and / or configured for use with a prosthetic valve that is configured to be deployed within the native heart valve.

[0018] In some implementations, the cylindrical part is configured to support a prosthetic valve within the native atrioventricular valve. For example, leaflets of the prosthetic valve can be sutured to the cylindrical part, and / or can be otherwise coupled to the cylindrical part.

[0019] In some implementations, the cylindrical part is configured to be deployed at least partially within the subject's ventricle.

[0020] In some implementations, the atrial part or atrial portion is configured to be deployed at least partially within the subject's atrium. In some implementations, the atrial part is optional. In some implementations, the atrial part includes a disc-shaped portion (also referred to herein as a flange) and a frustoconical portion. In some implementations, the disc-shaped portion of the atrial part is configured to seal the frame with respect to tissue on the atrial side of the native atrioventricular annulus. In some implementations, the disc-shaped portion of the atrial part is further configured to prevent migration of the frame into the ventricle.

[0021] In some implementations, the frustoconical portion extends from the disc-shaped portion of the atrial part to the outer surface of the cylindrical part. In some implementations, the inclusion of the frustoconical portion between the disc-shaped portion and the cylindrical part (as opposed to directly coupling the disc-shaped portion to the cylindrical part) reduces a likelihood of regurgitation around the outside of the cylindrical part.

[0022] In some implementations, a plurality of chord-recruiting arms extend from a portion of the frame body that is configured to be placed within the subject's ventricle. In some implementations the plurality of chord-recruiting arms comprise more than one arm. In some implementations the plurality of chord-recruiting arms comprise more than two arms. In some implementations the plurality of chord-recruiting arms comprise less than twelve arms. In some implementations, four chord-recruiting arms extend from the frame body. In some implementations, six chord-recruiting arms extend from the frame body. In some implementations, a single chord-recruiting arm extends from a portion of frame body that is configured to be placed within the subject's ventricle.

[0023] In some implementations, the plurality of chord-recruiting arms extend from the cylindrical part of frame body. In some implementations, the chord-recruiting arms extend from a ventricular region and / or ventricular end of the cylindrical part (e.g., an end of the frame body that is configured to be placed within the ventricle).

[0024] In some implementations, the arms can extend radially from the frame body, in addition to extending axially from the ventricular end of the frame body toward an atrial end of the frame body (e.g., an end of the frame body that is configured to be placed within the atrium).

[0025] In some implementations, the arms curve around outside of the frame body in a given circumferential direction of curvature.

[0026] It is noted that descriptions herein of the arms extending from the frame body in a given direction should not be interpreted as excluding additional directions in which the arms are oriented. Rather, for example, the arms being described (or claimed) as extending radially from the frame body should be interpreted as meaning that the orientation of the arms with respect to the frame body includes a radial component. In some implementations, in addition to extending radially from the frame body, the arms curve circumferentially, and in some cases, the orientation of the arms includes an axial component. In some implementations, at least along a portion of the arms, and at least in some configurations of the arms, the arms are disposed tangentially with respect to the frame body.

[0027] In some implementations, the arms curve around outside of the frame body in a clockwise circumferential direction of curvature. In some implementations, the arms curve around outside of the frame body in a counterclockwise circumferential direction of curvature. In some implementations, some of the arms curve in a first direction and some of the arms curve in a second direction.

[0028] In some implementations, the frame has prosthetic valve leaflets disposed therein.

[0029] In some implementations, the frame is delivered to the native atrioventricular valve, via a delivery device (e.g., a delivery catheter). In some implementations, the delivery device is configured to maintain the frame in a radially-constrained configuration (e.g., "crimped" configuration) during the delivery.

[0030] In some implementations, the delivery device is configured to maintain the prosthetic valve and / or prosthetic valve leaflets in a radially-constrained configuration (e.g., "crimped" configuration) during the delivery.

[0031] In some implementations, the frame is configured to be delivered transapically (e.g., via the apex of the left ventricle). In accordance some implementations, the frame is configured to be delivered transseptally (e.g., via the vena cava, the right atrium, and the interatrial septum). In some implementations, the frame is configured to be delivered via a different delivery path. In some implementations, the frame is configured to be delivered by any or all of the above approaches.

[0032] In some implementations, when a distal end of the delivery device is disposed within the subject's ventricle, the chord-recruiting arms can be deployed among chords of the native atrioventricular valve.

[0033] In some implementations, the chord-recruiting arms can be deployed among chords of the native atrioventricular valve by releasing the chord-recruiting arms from the delivery device. In some implementations, the chord-recruiting arms are shape set to extend from the frame body, upon being released from the delivery device.

[0034] In some implementations, the chord-recruiting arms are coupled to the cylindrical part of the frame via stitches and / or another coupling method. In some implementations, the stitches act as hinges, such that the arms pivot about the stitches with respect to the cylindrical part, as described hereinbelow.

[0035] In some implementations, the chord-recruiting arms can be released from the delivery device while the frame body is still maintained in an at least partially radially-constrained configuration by the delivery device. In some implementations, in this configuration of the frame body (e.g., with the chord-recruiting arms having been released from the delivery device, but with the frame body still maintained in an at least partially radially-constrained configuration by the delivery device), the chord-recruiting arms can assume a configuration that is described herein as the "rotation configuration" of the chord-recruiting arms.

[0036] In some implementations, subsequent to the chord-recruiting arms being deployed among chords of the native atrioventricular valve (and, in some implementations, while the frame body is still maintained in the at least partially radially-constrained configuration by the delivery device), at least a portion of the frame can be rotated, such as to cause the chordrecruiting arms to pull the native atrioventricular valve radially inward toward the frame. In some implementations, at least a portion of the frame can be rotated, such as to cause the chord-recruiting arms to additionally or alternatively twist the native atrioventricular valve around the frame by recruiting and deflecting at least a portion of the chords.

[0037] In some implementations, the cylindrical part is coupled to the atrial part. In some implementations, the cylindrical part is coupled to the atrial part via one or more sutures. In some implementations, the cylindrical part is coupled to the atrial part via one or more of a suture, adhesive, rivet, friction fit, snap, clip, clamp, etc.

[0038] In some implementations, the cylindrical part is coupled to the atrial part (e.g., in any of the ways discussed above) at a plurality of junctions that are disposed around a circumference of the frame. In some implementations, each of the junctions is individually padded with a covering material. In some implementations, at each of the plurality of junctions, a knot is knotted in at least one of the one or more sutures. In some implementations, the set of chord-recruiting arms are coupled to the frame body. In some implementations, the set of chord-recruiting arms are coupled to the frame body via one or more sutures. In some implementations, the set of chord-recruiting arms are coupled to the frame body via one or more of a suture, adhesive, rivet, friction fit, snap, clip, clamp, etc.

[0039] In some implementations, the set of chord-recruiting arms are coupled to the frame body (e.g., in any of the ways discussed above) at a plurality of junctions that are disposed around a circumference of the frame, e.g., at a ventricular end of the frame body. In some implementations, each of the junctions is individually padded with an individual cover. In some implementations, at each of the plurality of junctions, a knot is knotted in the at least one of the one or more sutures.

[0040] In some implementations, one, some, or all of the chord-recruiting arms are configured to curve circumferentially around the frame body so as to define a curved inner edge having a concave curvature and a curved outer edge having a convex curvature.

[0041] In some implementations, one, some, or all of the chord-recruiting arms are covered with the first covering material on its curved inner edge and is covered with a second covering material on its curved outer edge. In some implementations, the first covering material and the second covering materials are different from each other (e.g., comprise different materials).

[0042] In some implementations, the first covering material includes a low-friction fabric configured to provide low friction of the curved inner edges of the chord-recruiting arms with respect to chords disposed within a ventricle of the subject (e.g., a living subject, a simulation, etc.). In some implementations, the second covering material includes a porous fabric configured to provide curved outer edges of the chord-recruiting arms with atraumatic covers and to induce tissue ingrowth to curved outer edges of the chord-recruiting arms.

[0043] In some implementations, the second covering material includes a knitted fabric configured to provide curved outer edges of the chord-recruiting arms with atraumatic covers and to induce tissue ingrowth to curved outer edges of the chord-recruiting arms.

[0044] In accordance with some implementations, a system and / or an apparatus is configured to be deployed at a native atrioventricular valve. In some implementations, the system / apparatus is configured to be disposed within the native atrioventricular valve between an atrium and a ventricle of a heart of a subject (e.g., a living subject, a simulation, etc.). In some implementations, the system / apparatus includes a frame (e.g., a valve frame, a repair frame, a treatment frame, a stent frame, etc.).

[0045] In some implementations, the frame includes an atrial part including a disc-shaped portion configured to be deployed on an atrial side of the valve annulus. In some implementations, the frame includes a cylindrical part configured to be deployed such that a ventricular end of the cylindrical part is disposed within the ventricle.

[0046] In some implementations, the cylindrical part configured to couple to and / or contain prosthetic valve leaflets.

[0047] In some implementations, the cylindrical part is coupled to the atrial part. In some implementations, the cylindrical part is coupled to the atrial part at a plurality of junctions that are disposed around a circumference of the frame. In some implementations, each of the junctions is individually padded with a covering material.

[0048] In some implementations, the padding material includes a knitted fabric. In some implementations, the padding material includes a porous fabric. In some implementations, the padding material includes a material selected from the group consisting of: polyethylene terephthalate, and ethylene polyester. In some implementations, the padding material includes an inner cushioning layer of knitted polyester, which is covered in an outer coating of woven polyester.

[0049] In some implementations, the cylindrical part is coupled to the atrial part via one or more of a suture, a clip, a clamp, a friction fit, a rivet, a tie, an adhesive, etc.

[0050] In some implementations, the atrial part further includes a frustoconical portion extending from the disc-shaped portion to the cylindrical part. In some implementations, the disc-shaped portion is coupled to the cylindrical part via the frustoconical portion.

[0051] In some implementations, the cylindrical part is coupled to the atrial part via one or more sutures. In some implementations, at each of the plurality of junctions a knot is knotted in the at least one of the one or more sutures. In some implementations, the one or more sutures include a single suture that is used to couple the cylindrical part to the atrial part at each of the plurality of the junctions. In some implementations, the suture is sutured through each of the junctions in a figure-of-eight pattern.

[0052] In some implementations, the frame includes a plurality of protruding struts that protrude from the cylindrical part. In some implementations, the plurality of protruding struts also define one or more holes (e.g., a pair of holes, etc.). In some implementations, the atrial part defines one or more corresponding holes (e.g., a corresponding pair of holes, etc.) at each of the junctions. In some implementations, the suture is sutured through the one or more holes (e.g., pair of holes, etc.) in the protruding strut and the corresponding one or more holes (e.g., corresponding pair of holes, etc.) in the atrial part. In some implementations, this is done in the figure-of-eight pattern.

[0053] In some implementations, each of the protruding struts is individually padded, by the covering material being wrapped around the each of the protruding struts individually.

[0054] In some implementations, the frame includes a plurality of protruding struts that protrude from the cylindrical part. In some implementations, the disc-shaped portion is coupled to the cylindrical part via the protruding struts. In some implementations, each of the protruding struts is individually padded, by the covering material being wrapped around the each of the protruding struts individually.

[0055] In some implementations, the protruding struts protrude from an axial location along the cylindrical part that is in the lowest 90 percent of a height of the cylindrical part, such that there is axial overlap between the atrial part and the cylindrical part of the frame.

[0056] In accordance with some implementations, a system and / or an apparatus is configured to be deployed at a native atrioventricular valve. In some implementations, the system / apparatus is configured to be disposed within the native atrioventricular valve between an atrium and a ventricle of a heart of a subject (e.g., a living subject, a simulation, etc.). In some implementations, the system / apparatus includes a frame (e.g., a valve frame, a repair frame, a treatment frame, a stent frame, etc.).

[0057] In some implementations, the frame includes a cylindrical part configured to be deployed such that a ventricular end or ventricular portion of the cylindrical part is disposed within the ventricle.

[0058] In some implementations, the frame optionally includes an atrial part or atrial portion including a disc-shaped portion configured to be deployed on an atrial side of the valve annulus.

[0059] In some implementations, the system / apparatus can comprise prosthetic valve leaflets. In some implementations, the cylindrical part configured to couple to and / or contain the prosthetic valve leaflets. In some implementations, the cylindrical part is coupled to the atrial part. In some implementations, the cylindrical part is coupled to the atrial part at a plurality of junctions that are disposed around a circumference of the frame.

[0060] In some implementations, the cylindrical part is coupled to the atrial part via one or more of a suture, a clamp, a clip, a rivet, a friction fit, an adhesive, etc.

[0061] In some implementations, the atrial part further includes a frustoconical portion extending from the disc-shaped portion to the cylindrical part. In some implementations, the disc-shaped portion is coupled to the cylindrical part via the frustoconical portion.

[0062] In some implementations, the cylindrical part is coupled to the atrial part via one or more sutures. In some implementations, at each of the plurality of junctions, a knot is knotted in the at least one of the one or more sutures.

[0063] In some implementations, the one or more sutures include a single suture that is used to couple the cylindrical part to the atrial part at each of the plurality of the junctions. In some implementations, the suture is sutured through each of the junctions in a figure-of-eight pattern.

[0064] In some implementations, the frame includes a plurality of protruding struts that protrude from the cylindrical part. In some implementations, the plurality of protruding struts also define one or more holes (e.g., a pair of holes, etc.). In some implementations, the atrial part defines one or more corresponding holes (e.g., a corresponding pair of holes, etc.) at each of the junctions. In some implementations, the suture is sutured through the one or more holes (e.g., pair of holes, etc.) in the protruding strut and the corresponding one or more holes (e.g., corresponding pair of holes, etc.) in the atrial part. In some implementations, this is done in the figure-of-eight pattern.

[0065] In some implementations, the frame includes a plurality of protruding struts that protrude from the cylindrical part. In some implementations, the disc-shaped portion is coupled to the cylindrical part via the protruding struts.

[0066] In some implementations, the protruding struts protrude from an axial location along the cylindrical part that is in the lowest 90 percent of a height of the cylindrical part, such that there is axial overlap between the atrial part and the cylindrical part of the frame.

[0067] In some implementations, the system / apparatus further includes a padding material. In some implementations, each of the junctions is individually padded with the covering material. In some implementations, the frame includes a plurality of protruding struts that protrude from the cylindrical part. In some implementations, the disc-shaped portion is coupled to the cylindrical part via the protruding struts.

[0068] In some implementations, each of the protruding struts is individually padded. In some implementations, each of the protruding struts is individually padded by the covering material being wrapped around the each of the protruding struts individually. In some implementations, the padding material includes a knitted fabric. In some implementations, the padding material includes a porous fabric. In some implementations, the padding material includes a material selected from the group consisting of: polyethylene terephthalate, and ethylene polyester. In some implementations, the padding material includes an inner cushioning layer of knitted polyester, which is covered in an outer coating of woven polyester.

[0069] In accordance with some implementations, a system and / or an apparatus is configured to be deployed at a native atrioventricular valve. In some implementations, the system / apparatus is configured to be disposed within the native atrioventricular valve between an atrium and a ventricle of a heart of a subject (e.g., a living subject, a simulation, etc.). In some implementations, the system / apparatus includes a frame (e.g., a valve frame, a repair frame, a treatment frame, a stent frame, etc.). In some implementations, the frame includes a frame body (e.g., a valve-frame body, a repair frame body, a treatment frame body, a stent frame body, etc.).

[0070] In some implementations, the frame body comprises a ventricular end or ventricular portion, which is disposed / disposable on a ventricular side of the native atrioventricular valve.

[0071] In some implementations, the frame body optionally comprises an atrial portion, which is disposed / disposable on an atrial side of the native atrioventricular valve.

[0072] In some implementations, the frame body is configured to extend from an atrial side of the native atrioventricular valve to a ventricular end or ventricular portion of the frame body, which is disposed / disposable on a ventricular side of the native atrioventricular valve.

[0073] In some implementations, the frame includes a set of chord-recruiting arms configured to extend at least radially from the ventricular end or ventricular portion of the frame body.

[0074] In some implementations, the set of chord-recruiting arms are coupled to the frame body. In some implementations, the set of chord-recruiting arms are coupled to the frame body at a plurality of junctions that are disposed around a circumference of the frame at a ventricular end of the frame body. In some implementations, each of the junctions is individually padded with an individual cover.

[0075] In some implementations, the set of chord-recruiting arms are coupled to the frame body via one or more of a suture, a clip, a clamp, a rivet, a friction fit, an adhesive, or other coupling means. In some implementations, the set of chord-recruiting arms are coupled to the frame body via one or more sutures.

[0076] In some implementations, the set of chord-recruiting arms are configured to curve circumferentially around the frame body so as to define a curved inner edge having a concave curvature. In some implementations, the set of chord-recruiting arms are additionally or alternatively configured to curve circumferentially around the frame body so as to define a curved outer edge having a convex curvature.

[0077] In some implementations, the system / apparatus further includes a first covering material and a second covering material. In some implementations the first covering material is different from the second covering material (e.g., comprises a different type of material, etc.). In some implementations, each of the chord-recruiting arms is covered with the first covering material on its curved inner edge. In some implementations, each of the chordrecruiting arms is additionally or alternatively covered with the second covering material on its curved outer edge.

[0078] In some implementations, the individual covers each include a flap of material. In some implementations, the flap of material is folded over the junction (e.g., over each respective junction).

[0079] In some implementations, the system / apparatus further includes an inner lining that lines the inside of the frame. In some implementations, the flaps of material that are folded over the junctions includes flaps of materials that extend from the inner lining.

[0080] In some implementations, the system / apparatus further includes an additional cover that is disposed over the individual covers. In some implementations, the additional cover extends around a full circumference of the ventricular end of the frame body. In some implementations, the additional cover includes a low-friction fabric. In some implementations, the additional cover includes expanded polytetrafluoroethylene. In some implementations, the frame further includes one or more axially-protruding cell junctions configured to protrude axially from the additional cover. In some implementations, the frame body is configured to couple to and / or contain prosthetic valve leaflets. In some implementations, the inner lining is couplable to prosthetic valve leaflets (e.g., to couple to and / or contain within the frame).

[0081] In accordance with some implementations, a system and / or an apparatus is configured to be deployed at a native atrioventricular valve. In some implementations, the system / apparatus is configured to be disposed within the native atrioventricular valve between an atrium and a ventricle of a heart of a subject (e.g., a living subject, a simulation, etc.). In some implementations, the system / apparatus includes a frame (e.g., a valve frame, a repair frame, a treatment frame, a stent frame, etc.). In some implementations, the frame includes a frame body (e.g., a valve-frame body, a repair frame body, a treatment frame body, a stent frame body, etc.).

[0082] In some implementations, the frame body comprises a ventricular end or ventricular portion, which is disposed / disposable on a ventricular side of the native atrioventricular valve.

[0083] In some implementations, the frame body optionally comprises an atrial portion, which is disposed / disposable on an atrial side of the native atrioventricular valve.

[0084] In some implementations, the frame body is configured to extend from an atrial side of the native atrioventricular valve to a ventricular end or ventricular portion of the frame body, which is disposed / disposable on a ventricular side of the native atrioventricular valve.

[0085] In some implementations, the frame includes a set of chord-recruiting arms. In some implementations, the chord-recruiting arms are configured to extend at least radially from the ventricular end or ventricular portion of the frame body. In some implementations, each of the chord-recruiting arms is configured to curve circumferentially around the frame body so as to define a curved inner edge having a concave curvature and a curved outer edge having a convex curvature.

[0086] In some implementations, the frame includes a first covering material. In some implementations, the frame includes a second covering material, which is different from the first covering material (e.g., a different type of material, etc.). In some implementations, each of the chord-recruiting arms is covered with the first covering material on its curved inner edge. In some implementations, each of the chord-recruiting arms is covered with the second covering material on its curved outer edge. In some implementations, the first covering material includes a low-friction fabric configured to provide low friction of the curved inner edges of the chord-recruiting arms with respect to chords disposed within a ventricle of the subject (e.g., a living subject, a simulation, etc.). In some implementations, the first material includes expanded polytetrafluoroethylene.

[0087] In some implementations, the second covering material includes a porous fabric configured to provide curved outer edges of the chord-recruiting arms with atraumatic covers and to induce tissue ingrowth to curved outer edges of the chord-recruiting arms. In some implementations, the second covering material includes a knitted fabric configured to provide curved outer edges of the chord-recruiting arms with atraumatic covers and to induce tissue ingrowth to curved outer edges of the chord-recruiting arms. In some implementations, the second material includes polyester.

[0088] In some implementations, the frame body is configured to be coupled to and / or contain prosthetic valve leaflets.

[0089] In accordance with some implementations, a system and / or an apparatus is configured to be deployed at a native atrioventricular valve. In some implementations, the system / apparatus is configured to be disposed within the native atrioventricular valve between an atrium and a ventricle of a heart of a subject (e.g., a living subject, a simulation, etc.). In some implementations, the system / apparatus includes a frame (e.g., a valve frame, a repair frame, a treatment frame, a stent frame, etc.). In some implementations, the frame includes a frame body (e.g., a valve-frame body, a repair frame body, a treatment frame body, a stent frame body, etc.).

[0090] In some implementations, the frame body comprises a ventricular end or ventricular portion, which is disposed / disposable on a ventricular side of the native atrioventricular valve.

[0091] In some implementations, the frame body optionally comprises an atrial portion, which is disposed / disposable on an atrial side of the native atrioventricular valve.

[0092] In some implementations, the frame body is configured to extend from an atrial side of the native atrioventricular valve to a ventricular end or ventricular portion of the frame body, which is disposed / disposable on a ventricular side of the native atrioventricular valve.

[0093] In some implementations, the frame includes a set of chord-recruiting arms configured to extend at least radially from the ventricular end or ventricular portion of the frame body. In some implementations, the set of chord-recruiting arms are coupled to the frame body. In some implementations, the set of chord-recruiting arms are coupled to the frame body at a plurality of junctions that are disposed around a circumference of the frame at a ventricular end or ventricular portion of the frame body.

[0094] In some implementations, the set of chord-recruiting arms are coupled to the frame body via one or more of a suture, clamp, clip, rivet, friction fit, adhesive, etc.

[0095] In some implementations, the set of chord-recruiting arms are coupled to the frame body via one or more sutures. In some implementations, at each of the plurality of junctions, a knot is knotted in the at least one of the one or more sutures.

[0096] In some implementations, the one or more sutures include a single suture that is used to couple the set of chord-recruiting arms to the frame body at each of the plurality of the junctions.

[0097] In some implementations, each of the junctions is individually padded with an individual cover. In some implementations, the individual covers each include a flap of material, which is folded over the junction. In some implementations, the system / apparatus further includes an inner lining that lines the inside of the frame. In some implementations, the flaps of material that are folded over the junctions includes flaps of materials that extend from the inner lining.

[0098] In some implementations, the frame body is configured to couple to and / or contain prosthetic valve leaflets. In some implementations, the inner lining is couplable to the prosthetic valve leaflets. In some implementations, the inner lining couples the prosthetic valve leaflets to the frame body.

[0099] In some implementations, the system / apparatus further includes an additional cover that is disposed over the individual covers and that extends around a full circumference of the ventricular end of the frame body. In some implementations, the additional cover includes a low-friction fabric. In some implementations, the additional cover includes expanded poly tetrafluoroethyl ene .

[0100] In some implementations, the set of chord-recruiting arms are configured to curve circumferentially around the frame body so as to define a curved inner edge having a concave curvature. In some implementations, the set of chord-recruiting arms are configured to curve circumferentially around the frame body so as to define, additionally or alternatively, a curved outer edge having a convex curvature.

[0101] In some implementations, the system / apparatus further includes a first covering material. In some implementations, the system / apparatus can optionally additionally include a second covering material, which is different from the first covering material (e.g., a different type of material, etc.). In some implementations, each of the chord-recruiting arms is covered with the first covering material on its curved inner edge. In some implementations, each of the chord-recruiting arms is covered with the second covering material on its curved outer edge.

[0102] In some implementations, methods herein can include deploying any of the devices herein to a native heart valve. The devices can include any of the features disclosed herein.

[0103] Any of the above method(s) and any methods of using the systems, assemblies, apparatus, devices, etc. herein can be performed on a living subject (e.g., human or other animal) or on a simulation (e.g., a cadaver, cadaver heart, imaginary person, simulator, etc.). With a simulation, the body parts can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, etc.) and can optionally comprise computerized and / or physical representations.

[0104] Any of the above systems, assemblies, devices, apparatus, components, etc. can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise (or additional methods comprise or consist of) sterilization of one or more systems, devices, apparatuses, components, etc. herein (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0105] The present disclosure will be more fully understood from the following detailed description of applications thereof, taken together with the drawings, in which:

[0106] BRIEF DESCRIPTION OF THE DRAWINGS

[0107] Figs. 1A, IB, and 1C are schematic illustrations of respective views of an example frame that is configured to be used within a subject's native atrioventricular valve, the figures showing the frame disposed in a non-radially-constrained configuration, in accordance with some applications of the present disclosure; Fig. ID is a schematic illustration of the frame of Figs. 1A, IB, and 1C, in a non- radially-constrained configuration, showing valve leaflets within the frame and covering material attached to the frame, in accordance with some applications of the present disclosure;

[0108] Fig. 2A is a schematic illustration of an atrial part of a frame, in accordance with some applications of the present disclosure;

[0109] Fig. 2B is a schematic illustration of a side view of a cylindrical part of a frame in accordance with some applications of the present disclosure;

[0110] Fig. 2C is a schematic illustration of an atrial part of a frame coupled to a cylindrical part of the frame, in accordance with some applications of the present disclosure;

[0111] Fig. 3A is a schematic illustration of chord-recruiting arms of a frame, in accordance with some applications of the present disclosure;

[0112] Fig. 3B is a schematic illustration of the chord-recruiting arms of Fig. 3 A coupled to a cylindrical part of the frame, in accordance with some applications of the present disclosure;

[0113] Fig. 4 is a photograph of parts of a frame being sutured to each other during assembly of the frame, in accordance with some applications of the present disclosure;

[0114] Fig. 5 is a photograph of a knot being knotted at a junction between two portions of the frame during assembly of the frame, in accordance with some applications of the present disclosure;

[0115] Fig 6 is a photograph of a junction of the frame that has been covered, in accordance with some applications of the present disclosure;

[0116] Fig. 7 is a photograph of a chord-recruiting arm of a frame that has been covered, in accordance with some applications of the present disclosure;

[0117] Fig. 8 is a photograph of a tip of chord-recruiting arm of a frame that has been cushioned, in accordance with some applications of the present disclosure;

[0118] Figs. 9A, 9B, 9C, and 9D are photographs of respective steps of a ventricular end of a frame being covered during assembly of the frame, in accordance with some applications of the present disclosure; Fig. 10 is a schematic illustration of a portion of a frame in which the atrial part and the cylindrical part are formed unitarily, from a single frame, in accordance with some applications of the present disclosure; and

[0119] Figs. 11 A, 1 IB, 11C, 1 ID, 1 IE, and 1 IF are schematic illustrations of respective steps of the deployment of a prosthetic mitral valve via a transseptal approach, in accordance with some applications of the present disclosure.

[0120] DETAILED DESCRIPTION

[0121] Reference is now made to Figs. 1A, IB, and 1C, which are schematic illustrations of respective views of a frame 20 (which may be described or depicted by way of example as a valve frame, but can be a variety of types of frames), the figures showing the frame in its non- radially-constrained configuration, in accordance with some applications of the present disclosure. Fig. 1 A shows a side view of the frame, Fig. IB shows a bottom view (i.e., a view from a ventricular end of the frame), and Fig. 1C shows a top view (i.e., a view from an atrial end of the frame). Reference is also made to Fig. ID, which is a schematic illustration of frame 20, with the frame covered with covering material 32 and with valve leaflets 23 coupled to the frame, in accordance with some applications of the present disclosure.

[0122] In some implementations, the frame includes a frame body 21 (e.g., a valve-frame body, a repair frame body, a treatment frame body, a stent frame body, etc.). The frame body is sometimes described and / or depicted for example as a valve-frame body, but other frame body types can be used even when described / depicted as a valve-frame body.

[0123] In some implementations, frame body or valve-frame body 21 includes a cylindrical part 22, as well as an atrial part 26. In some implementations, the cylindrical part is configured to support the prosthetic valve within the native atrioventricular valve. For example, leaflets 23 of the prosthetic valve can be sutured to the cylindrical part, and / or can be otherwise coupled to the cylindrical part, e.g., as shown in Fig. ID. In some implementations, atrial part 26 is configured to be deployed at least partially within the subject's atrium. In some implementations, atrial part 26 includes a disc-shaped portion 28 (also referred to herein as a flange) and a frustoconical portion 30.

[0124] In some implementations, the disc-shaped portion of the atrial part is configured to seal the frame with respect to tissue on the atrial side of the mitral annulus, and is further configured to prevent migration of the frame into the ventricle. In some implementations, the frustoconical portion extends from the disc-shaped portion of the atrial part to the outer surface of the cylindrical part. In some implementations, the inclusion of the frustoconical portion between the disc-shaped portion and the cylindrical part (as opposed to directly coupling the disc-shaped portion to the cylindrical part) reduces a likelihood of regurgitation around the outside of the cylindrical part.

[0125] In some implementations, the cylindrical part and the atrial part are formed as separate pieces from one another and are coupled to each other, for example, via stitching, gluing, welding, and / or an alternative or additional method. In some implementations, the cylindrical part and the atrial part are portions of a single unitarily-formed piece, e.g., as described with reference to Fig. 10.

[0126] In some implementations, frame or valve frame 20 is made of a shape-memory material (e.g., a shape-memory alloy, such as nickel-titanium alloy (e.g., nitinol) and / or copper- aluminum-nickel), which is covered on one or both sides with a covering material 32 (shown in Fig. ID), e.g., a fabric and / or a polymer (such as expanded polytetrafluoroethylene (ePTFE), or woven, knitted, mesh and / or braided polyester). Covering materials that are used within frame 20 are described in further details hereinbelow. In some implementations, the shape-memory material of cylindrical part 22 and atrial part 26 is shaped into a stent-like structure that comprises struts and / or cells of the shape-memory material. In some implementations, the covering material is coupled to the shape-memory material via stitches 34 (shown in Fig. ID).

[0127] It is noted that Figs. 1A-C, as well as Figs. 2A-C, 3A-B, and 10, show frame 20 or portions thereof in the absence of valve leaflets 23 and / or covering material 32 for illustrative purposes. However, valve leaflets 23, and covering material 32 can be observed in Fig. ID, for example.

[0128] In some implementations, a plurality of chord -recruiting arms 24 (e.g., more than two and / or fewer than twelve arms) extend from a portion of frame body 21 that is configured to be placed within the subject's ventricle. For example, four chord-recruiting arms or six chordrecruiting arms can extend from the frame body. In some implementations, a single chordrecruiting arm 24 extends from a portion of frame body 21 that is configured to be placed within the subject's ventricle. In some implementations, chord-recruiting arms 24 extend from cylindrical part 22 of frame body 21. In some implementations, the chord -recruiting arms extend from a ventricular end of the cylindrical part (i.e., the end of the frame body that is configured to be placed within the ventricle). In some implementations, in a non-radially constrained configuration of the valve frame (which the valve frame typically assumes when neither the frame body nor the chord-recruiting arms are constrained by the delivery device), the chord-recruiting arms extend radially from the frame body, in addition to extending axially from the ventricular end of the frame body toward an atrial end of the frame body (i.e., the end of the frame body that is configured to be placed within the atrium). In some implementations, the chord-recruiting arms curve around outside of the frame body in a given circumferential direction of curvature.

[0129] Descriptions herein of the chord-recruiting arms extending from the frame body in a given direction should not be interpreted as excluding additional directions in which the chordrecruiting arms are oriented. Rather, by way of example, the chord-recruiting arms being described (and / or claimed) as extending radially from the frame body should be interpreted as meaning that the orientation of the chord-recruiting arms with respect to the frame body includes a radial component. In some implementations, in addition to extending radially from the frame body, the chord-recruiting arms curve circumferentially, and in some cases the orientation of the chord-recruiting arms includes an axial component. In some implementations, at least along a portion of the chord-recruiting arms, and at least in some configurations of the chord-recruiting arms, the chord-recruiting arms are disposed tangentially with respect to the frame body.

[0130] In some implementations, valve frame 20 with prosthetic valve leaflets 23 coupled thereto is delivered to the native atrioventricular valve, via a delivery device 40 (e.g., a delivery catheter), and the delivery device is configured to maintain the valve frame in a radially- constrained configuration (e.g., "crimped" configurations) during the delivery. In accordance with respective applications, the valve frame is delivered transapically (e.g., via the apex of the left ventricle), transseptally (e.g., via the vena cava, the right atrium, and the interatrial septum, as described in detail with reference to Figs. 11A-F), and / or via a different delivery path.

[0131] In some implementations, when a distal end of the delivery device is disposed within the subject's ventricle, chord-recruiting arms 24 are deployed among chords of the native atrioventricular valve. In some implementations, the chord-recruiting arms are deployed among chords of the native atrioventricular valve by releasing the chord-recruiting arms from the delivery device, the chord-recruiting arms being shape set to extend from the frame body, upon being released from the delivery device.

[0132] In some implementations, the chord-recruiting arms are coupled to the cylindrical part of the frame via stitches, the stitches acting as hinges, such that the arms pivot about the stitches with respect to the cylindrical part. In some implementations, the chord-recruiting arms are released from the delivery device while the frame body is still maintained in an at least partially radially-constrained configuration by the delivery device.

[0133] In some implementations, the frame is rotated while the chord-recruiting arms and the frame body are configured in the aforementioned configuration. Therefore, in the present application, the configuration of the chord-recruiting arms when the frame body is still maintained in an at least partially radially-constrained configuration by the delivery device but the chord-recruiting arms have been released from the delivery device is referred to as the "rotation configuration" of the chord-recruiting arms. The chord-recruiting arms are shown in the rotation configuration in Figs. 11C and 1 ID, for example.

[0134] Subsequent to chord-recruiting arms 24 being deployed among chords of the native atrioventricular valve (and, in some implementations, while frame body 21 is still maintained in the at least partially radially-constrained configuration by the delivery device), at least a portion of frame 20 is rotated, such as to cause chord-recruiting arms 24 to (a) pull the native atrioventricular valve radially inward toward the frame, and (b) twist the native atrioventricular valve around the frame, by recruiting and deflecting at least a portion of the chords.

[0135] In some implementations, subsequent to the rotation of the frame, cylindrical part 22 and atrial part 26 are allowed to radially expand, e.g., by releasing the cylindrical part and the atrial part from the delivery device, such that the frame assumes its non-radially constrained configuration. In some implementations, the frame is configured to thereby trap the native valve leaflets in a partially closed and twisted configuration, to thereby at least partially seal a space between the native atrioventricular valve and the prosthetic valve. For example, the cylindrical part is configured to radially expand such as to trap the native valve leaflets between the cylindrical part and the chord-recruiting arms, and / or the atrial part is configured to radially expand such as to trap the native valve leaflets between the atrial part and the chordrecruiting arms. Referring to Fig. ID, in some implementations, covering material 32 defines slits 42. In some implementations, when frame 20 is arranged in its radially-constrained configuration inside the delivery device, cells of the frame become axially elongated. In some implementations, slits 42 are configured such as to allow the cells of the frame to become axially elongated without tearing the covering material, by the axially-elongated cells extending through the slits. In some implementations, upon the frame being released from the delivery device, and assuming its non-radially constrained configuration, the cells become reinserted into the slits, such as to become covered by the covering material. It is noted that, for illustrative purposes, in Fig. ID, the tip of the cells are shown as protruding from the slits even in the non-radially-constrained configuration of the frame.

[0136] Reference is now made to Fig. 2A, which is a schematic illustration of atrial part 26, in accordance with some applications of the present disclosure. As described hereinabove, in some implementations, atrial part 26 is configured to be deployed at least partially within the subject's atrium. In some implementations, atrial part 26 includes a disc-shaped portion 28 (also referred to herein as a flange) and a frustoconical portion 30.

[0137] In some implementations, the disc-shaped portion is configured to be placed upon the native mitral valve annulus, and the frustoconical portion extends from the disc-shaped portion of the atrial part to cylindrical part 22. In some implementations, the disc-shaped portion of the atrial part is configured to seal the frame with respect to tissue on the atrial side of the mitral annulus, and is further configured to prevent migration of the frame further into the ventricle. In some implementations, the inclusion of the frustoconical portion between the disc-shaped portion and the cylindrical part (as opposed to directly coupling the disc-shaped portion to the cylindrical portion) reduces a likelihood of regurgitation around the outside of the cylindrical part.

[0138] It is noted that, in accordance with respective applications, the flange is disposed within a plane that is perpendicular to the longitudinal axis defined by the cylindrical part, or is disposed at an angle to such a plane. For example, the flange can define an upwards angle or a downwards angle with respect to a plane that is perpendicular to the longitudinal axis defined by the cylindrical part, to best match the different anatomical structures surrounding the native atrioventricular valves, either in the atrium or ventricle.

[0139] In some implementations, the frustoconical portion defines holes 50 at the bottom of at least some of the cells of the frustoconical portion. In some implementations, the holes are configured to facilitate stitching of the atrial part to the cylindrical part of the frame. In some implementations, pairs 52 of struts 54 extend from respective cells of disc-shaped portion 28 of the atrial part. The pairs of struts converge to a point 56. In some implementations, pairs of struts are configured to pierce tissue of the subject's heart (e.g., tissue of the valve annulus) at point 56. In some implementations, the disc-shaped portion of the atrial part does not include the above-described pairs of struts that are configured to pierce tissue.

[0140] Reference is now made to Fig. 2B, which is a schematic illustration of a side view of cylindrical part 22, in accordance with some applications of the present disclosure. Reference is also made to Fig. 2C, which is a schematic illustration of atrial part 26 coupled to cylindrical part 22, in accordance with some applications of the present disclosure. In some implementations, a plurality of struts 61 protrude from the outside of cylindrical part 22. In some implementations, the protrusion of the struts from the outside of cylindrical part 22 is such that the orientation of the struts with respect to the cylindrical part has a radial and an axial component. In some implementations, along at least a portion of the struts, the struts are disposed tangentially with respect to the cylindrical part.

[0141] In some implementations, the atrial part is coupled to the cylindrical part by the atrial part being coupled to protruding struts 61. For example, as described hereinabove, frustoconical portion 30 of atrial part 26 can define holes 50 at the bottom of at least some of the cells of the frustoconical portion. In some implementations, protruding struts 61 also defines holes 65, and the atrial part is coupled to the cylindrical part by stitching a suture through holes 50 defined by the atrial part and corresponding holes 65 defined by protruding struts 61 of cylindrical part 22.

[0142] In some implementations, at each junction 67 (shown in Fig. 2C) at which the protruding struts are coupled to the atrial part, there is a pair of holes in the protruding strut and a corresponding pair of holes in the atrial part. In some implementations, the suture is sutured through each of the junctions in a figure-of-eight pattern. For example, the suture is sutured through the pair of holes in the protruding strut and the corresponding pair of holes in the atrial part a figure-of-eight pattern. Techniques that are performed during suturing of the atrial part to the protruding struts, in some implementations, are described hereinbelow with reference to Figs. 4 and 5. Alternatively or additionally, the atrial part is coupled to the protruding struts via alternative or additional means, e.g., via welding (such as laser welding), gluing, and / or a different method. It is noted that, in some implementations, during the crimping of the frame, there is a lot of strain that is placed on the junctions from which protruding struts 61 protrude from the cylindrical part, since the struts pivot about these junctions. If the atrial part were to be directly coupled to the cylindrical part at these junctions, then this would mean that these points at which there is relatively large strain placed on the frame are also points at which the two pieces are coupled to each other, which would make the frame susceptible to fatigue at these points. By contrast, by virtue of the cylindrical part including protruding struts 61 and the atrial part being coupled to the cylindrical part via the struts, there is a separation between the points of high strain and the points at which atrial part is coupled to the cylindrical part.

[0143] It is further noted that, in some implementations, the protruding struts protrude from an axial location along the cylindrical part that is in the lowest 90 percent (e.g., the lowest 70 percent, or the lowest 50 percent) of the height of the cylindrical part. In some implementations, the cylindrical part has a height of at least 15 mm, in order to accommodate the coupling of the valve leaflets to the cylindrical part. If the protruding struts were to protrude from the top of the cylindrical part (or if the atrial part were to be coupled directly to the cylindrical part at the top of the cylindrical part), then the entire height of the cylindrical part would be disposed below the atrial part. By contrast, since the protruding struts protrude from the lowest 90 percent (e.g., the lowest 70 percent, or the lowest 50 percent) of the height of the cylindrical part, in some implementations, there is axial overlap between the atrial part and the cylindrical part of the frame, along the height of the cylindrical part.

[0144] In some implementations, the axial overlap between the atrial part and the cylindrical part of the frame results in a smaller portion of the height of the cylindrical part protruding into the subject's ventricle, then if there were to be no axial overlap between the atrial part and the cylindrical part of the frame (which poses less restriction on the ventricle, by reducing the ventricular presence of the cylindrical part). In turn (when valve frame 20 is configured for placement within the subject's ventricle), in some implementations, this reduces obstruction of the left ventricular outflow tract, relative to if a larger portion of the height of the cylindrical part were to protrude into the subject's ventricle.

[0145] In this context, it is noted that, as described hereinabove, in some implementations, chord-recruiting arms 24 are configured to (a) pull the native atrioventricular valve radially inward toward the valve frame, and (b) twist the native atrioventricular valve around the valve frame, by recruiting and deflecting at least a portion of the chords of the native atrioventricular valve. In some implementations, the recruitment and deflection of the chords in this manner serves to prevent obstruction of the left ventricular outflow tract by portions of the native mitral valve apparatus.

[0146] Reference is now made to Fig. 3 A, which is a schematic illustration of chord-recruiting arms 24 of frame 20, in accordance with some applications of the present disclosure. Reference is also made to Fig. 3B, which is a schematic illustration of the chord-recruiting arms coupled to cylindrical part 22 of the frame. As described hereinabove, in some implementations, a plurality of chord-recruiting arms 24 (e.g., more than two and / or fewer than twelve arms) extend from a portion of frame body 21 that is configured to be placed within the subject's ventricle. For example, four chord-recruiting arms or six chord-recruiting arms can extend from the frame body. In some implementations, a single chord-recruiting arm 24 extends from a portion of frame body 21 that is configured to be placed within the subject's ventricle. In some implementations, the chord-recruiting arms extend from cylindrical part 22 of frame body 21, as shown in Fig. 3B.

[0147] In some implementations, each of chord-recruiting arms 24 is defined by a pair 70 of struts 72, which extend from respective junctions of the ventricular end of cylindrical part 22. In some implementations, the struts curve such as to meet each other and form a junction at a tip 74 of the arm. In some implementations, all of the chord-recruiting arms are cut from a single piece 76 of a shape memory material (e.g., a shape-memory alloy, such as nickeltitanium alloy (e.g., nitinol) and / or copper-aluminum-nickel). In some implementations, the piece of shape-memory material that defines the arms is coupled to the cylindrical part of the frame, as described in further detail hereinbelow. In some implementations, the arms are covered in covering material 32 (shown in Fig. 2), e.g., a fabric and / or a polymer (such as expanded polytetrafluoroethylene (ePTFE) and / or polyester). Covering materials that are used for the arms are described in further details hereinbelow.

[0148] In some implementations, chord-recruiting arms 24 of the frame are configured to be released from delivery device 40 while frame body or valve-frame body 21 of the valve frame is still maintained in an at least partial radially-constrained configuration by the delivery device, as described hereinabove. In this first configuration of the chord-recruiting arms (referred to herein as the rotation configuration of the chord-recruiting arms), the arms are configured to become deployed among chords of the native atrioventricular valve, and are then configured to (a) pull the native atrioventricular valve radially inward toward the valve frame, and (b) twist the native atrioventricular valve around the valve frame, by recruiting and deflecting at least a portion of the chords. Subsequently, the frame body is allowed to assume its non-radially-constrained configuration, by releasing the frame body from the delivery device.

[0149] In some implementations, the assumption of the non-radially-constrained configuration by the frame body causes the configuration of the chord-recruiting arms to change from their first configuration (i.e., their rotation configuration) to a second configuration that is different from the first configuration. In this second configuration, chordrecruiting arms 24 are configured to cause the chords and / or the native valve leaflets to become trapped between the arms and portions of the frame body. The chord-recruiting arms are shown in the second configuration in Figs. HE and 1 IF, for example. In some implementations, the second configuration of the arms ensures robust anchoring between the trapped chords and / or the native valve leaflets with respect to the frame body and the prosthetic valve leaflets.

[0150] In some implementations, a first one of struts 72 of pair 70 of struts that comprise a chord-recruiting arm is longer than a second strut of the pair. The pair of struts is configured such that, when the bases of the struts are held together (when the arms are in their rotation configuration), the chord-recruiting arms are relatively long and thin, such that the chordrecruiting arms deploy among a relatively large number of chords, and subsequently, recruit and deflect a relatively large number of chords.

[0151] In some implementations, in this configuration (i.e., the rotation configuration), each of the chord-recruiting arms has a length of more than 10 mm (e.g. more than 20 mm, or more than 25 mm), measured along the axis of the chord-recruiting arm. In some implementations, the chord-recruiting arms are configured such that, when the arms are in the rotation configuration, (a) the arms extend radially from the frame body, (b) the arms extend axially from a ventricular end of the frame body (i.e., the end of the frame body that is configured to be placed within the ventricle) toward an atrial end of the frame body (i.e., the end of the frame body that is configured to be placed within the atrium), and / or (c) the arms curve around outside of the cylindrical part in a given direction of circumferential curvature.

[0152] In some implementations, in their rotation configuration, the chord-recruiting arms are configured to extend radially from the frame and to curve circumferentially around the frame, but not to extend axially in either the proximal or the distal direction. Rather, for such applications, in their rotation configuration, the arms extend from the frame in the radial direction with the arms disposed in a single plane along the axial direction.

[0153] In some implementations, piece 76 of shape-memory material that defines chordrecruiting arms 24 is coupled to the cylindrical part of the frame, via stitching or other coupling means. In some implementations, one of the struts of each of the arms meets one of the struts of an adjacent arm at a junction 78. In some implementations, the shape memory material defines a hole 79 at the junction and junctions of cells at the ventricular end of the cylindrical part of the frame body define corresponding holes 82. A suture is inserted through holes 79 of the chord-recruiting arms and holes 82 of the cylindrical part, in order to couple the chordrecruiting arms to the cylindrical part.

[0154] As described hereinabove, in some implementations, chord-recruiting arms 24 of the frame are configured to be released from delivery device 40 while frame body 21 of the frame is still maintained in an at least partial radially-constrained configuration by the delivery device. In some implementations, the chord-recruiting arms are stitched to the cylindrical part at an axial location that is released from the delivery device, even at this stage. For some such applications, the stitches act as hinges, such that the chord-recruiting arms pivot about the stitches, with respect to the cylindrical part. In some implementations, this allows the chordrecruiting arms to extend radially to a greater distance than if the stitches did not provide the aforementioned hinge functionality.

[0155] In some implementations, the chord-recruiting arms define (a) a radially-constrained configuration when the arms are maintained in crimped configurations inside the delivery device, as well as (b) a rotation configuration, when the arms are released from the delivery device, but the cylindrical part is maintained in an at least partially radially-constrained configuration by the delivery device, and (c) a fully deployed configuration, when the entire frame body, including the cylindrical part and the atrial part, is released from the delivery device.

[0156] In the rotation configuration, the chord-recruiting arms are configured to recruit and deflect the chords. In some implementations, in the rotation configuration, the chordrecruiting arms are configured to pivot outwardly with respect to the cylindrical part, such that the chord-recruiting arms encompass a relatively large span and are thereby able to recruit a large number of chords during the rotation of the frame. In some implementations, there is a relatively large gap between the tips of the chord-recruiting arms and the frame body in this configuration, by virtue of the chord-recruiting arms pivoting outwardly with respect to the cylindrical part.

[0157] In some implementations, in the fully deployed configuration (when the entire frame body, including the cylindrical part and the atrial part, is released from the delivery device), the chord-recruiting arms are configured to be disposed such as to define a relatively small gap between the tips of the chord-recruiting arms and the outer surface of the frame body (e.g., the outer surface of the cylindrical part), such that leaflets and or chords of the native atrioventricular valve are trapped between the chord-recruiting arms and the frame body (e.g., the outer surface of the cylindrical part). In some implementations, in the fully deployed configuration, the chord-recruiting arms are configured to define pockets of space between themselves and the frame body (e.g., the outer surface of the cylindrical part), by virtue of the inner surfaces of the arms having a concave curvature. In some implementations, chords that are recruited by the chord-recruiting arms and / or tissue of the native valve leaflets are held within these pockets of space.

[0158] Still referring to Fig. 3B, it is noted that, in some implementations, ventricular end 84 of the cylindrical portion includes one or more axially-protruding cell junctions 86, which protrude axially from the ventricular end or ventricular portion of the cylindrical portion. In some implementations, the axially-protruding cell junctions are used to hold the ventricular end of the frame within the delivery device. For example, as shown, the axially-protruding cell junctions can define holes 88, via which the delivery device (e.g., an anchor (not shown) within the delivery device) is coupled to the axially-protruding cell junctions.

[0159] Reference is now made to Fig. 4, which is a photograph of portions of atrial part 26 and cylindrical part 22 of frame 20 being sutured (or otherwise coupled) to each other, during assembly of the frame, in accordance with some applications of the present disclosure. Reference is also made to Fig. 5, which is a photograph of a knot 130 being knotted in a suture 132, during assembly of the frame, at junction 67 at which a protruding strut 61 of the cylindrical part is coupled to the atrial part, in accordance with some applications of the present disclosure.

[0160] As described hereinabove, in some implementations, the atrial part is coupled to the cylindrical part by the atrial part being coupled to protruding struts 61, which protrude from the outside of cylindrical part 22. For example, as described hereinabove, frustoconical portion 30 of atrial part 26 can define holes 50 at the bottom of at least some of the cells of the frustoconical portion. In some implementations, protruding struts 61 also defines holes 65, and the atrial part is coupled to the cylindrical part by stitching a suture through holes 50 defined by the atrial part and corresponding holes 65 defined by protruding struts 61 of cylindrical part 22. In some implementations, at each junction 67 at which the protruding struts are coupled to the atrial part, there is a pair of holes in the protruding strut and a corresponding pair of holes in the atrial part. In some implementations, the suture is stitched through the pairs of struts in a figure-of-eight pattern.

[0161] In some implementations, a single suture is used to suture a plurality of such junctions 67. For example, a single suture can be used to suture the atrial part to the cylindrical part around the full circumference of the frame. For some such applications, after a given junction has been sutured, knot 130 is knotted in suture 132, before the suture is stitched through the holes at the next junction. In some implementations, this acts as a safeguard against the suture degrading or tearing at a given circumferential location, because the suture is still effective at other location by virtue of the knots at each of the junctions. Thus, the knot at each of the junctions acts as a break in the continuous suturing.

[0162] In some implementations, the atrial part is directly coupled to the cylindrical part in the absence of the protruding struts. In some implementations, similar coupling techniques to those described in the above paragraph are used in the direct coupling of the atrial part to the cylindrical part of the frame.

[0163] As described hereinabove, in some implementations, piece 76 of shape-memory material that defines chord-recruiting arms 24 (shown in Fig. 3 A) is coupled to the cylindrical part of the frame, via suturing or other coupling means. In some implementations, one of the struts of each of the arms meets one of the struts of an adjacent arm at a junction 78. In some implementations, the shape memory material defines a hole 79 at the junction and junctions of cells at the ventricular end or ventricular portion (e.g., junctions need not be at the end, but can be elsewhere in the ventricular region) of the cylindrical part of the frame body define corresponding holes 82. A suture is inserted through holes 79 of the chord-recruiting arms and holes 82 of the cylindrical part, in order to couple the chord-recruiting arms to the cylindrical part.

[0164] For some applications, generally similar techniques to those described with reference to Fig. 5 are used in suturing the chord-recruiting arms 24 to the cylindrical part of the frame. In some implementations, a single suture is used to suture a plurality of junctions. For example, a single suture can be used to suture the chord-recruiting arms to the cylindrical part of the frame around the full circumference of the frame. For some such applications, after a given junction has been sutured, a knot is knotted in the suture, before the suture is stitched through the holes at the next junction. As described hereinabove, in some implementations, this acts as a safeguard against the suture degrading or tearing at a given circumferential location, because the suture is still effective at other location by virtue of the knots at each of the junctions. Thus, the knots at each of the junctions as a break in the continuous suturing.

[0165] Reference is now made to Fig. 6, which is a photograph of junction 67 of frame 20 that has been padded, in accordance with some applications of the present disclosure. In some implementations, in addition to covering material 32, which covers the whole of the frame, padding, which is includes and / or is made of knitted and / or porous fabric (e.g., polyester, also known as PET (polyethylene terephthalate) or ethylene polyester) covers junctions 67, in order to provide additional padding at these regions, to prevent the metal and / or alloy within the junctions from causing damage to adjacent portions of the cylindrical part or the atrial part of the frame, and / or in order to prevent the metal and / or alloy within the junctions from causing damage to the subject’s tissue. Although it is desirable to provide padding at the junctions, the padding adds to the crimp profile of the frame (i.e., the minimum diameter to which the frame can be radially constrained). Therefore, the padding is added to each of the junctions individually (and only around the junctions themselves), rather than padding the entire circumference of the frame at the location of the junctions. For example, the covering material may be individually wrapped around each of protruding struts 61, so as to individually pad each of the protruding struts.

[0166] Reference is now made to Fig. 7, which is a photograph of a chord-recruiting arm 24 of frame 20 that has been covered, in accordance with some applications of the present disclosure. Reference is also made to Fig. 8, which is a photograph of a tip 74 of chordrecruiting arm 24 of frame that has been cushioned, in accordance with some applications of the present disclosure.

[0167] As described in US 2022 / 0296370 to Agian, which is incorporated herein by reference, and as shown in Figs. 3 A and 3B, in some implementations, tips 74 of chord-recruiting arms 24 are rounded. Alternatively or additionally, as shown in Figs. 7-8, a thickened layer of covering material 32 is disposed over tips 74 of the chord-recruiting arms, such that the tips of the arms form a cushion 75. In some implementations, the roundness of the tips and / or the cushioning of the tips is such that the tips of the arms are atraumatic. In some implementations, this facilitates movement and rotation of the arms among the subject's chords and allows recruitment and deflection of the chords by the arms, without causing damage to the chords or to other surrounding tissue. In some implementations, the roundness and / or cushioning of the tips allows the chords to be guided around the tips during the rotation of the frame (e.g., the bidirectional rotation of the frame described hereinabove). In some implementations, using a thickened layer of covering material 32 on the tips of the arms (i.e., providing cushion 75) facilitates securement of the trapped chords and native leaflets, after the release of the frame body from the delivery device, by preventing chords from slipping out from the ends of the arms.

[0168] In some implementations, the cushioning of the tips is provided by knitted polyester, which is covered in an outer coating of woven polyester.

[0169] In some implementations, covering material 32 is configured such as to provide different functionalities to respective regions of the frame. For example, in some implementations, areas of the frame that typically come into contact with the chords (such as the chord-recruiting arms and the ventricular rim of the cylindrical portion) are covered with a low-friction fabric (such as, ePTFE) in order to provide low friction with respect to the chords and to allow the movement of these portions with respect to the chords without damaging the tissue. Other areas of the frame can be covered with fabric that induces tissue ingrowth (e.g., a porous and / or knitted fabric, such as polyester), in order to cause these areas to become anchored to tissue of the subject. In some implementations, such areas include portions of atrial part 26 and / or cylindrical part 22 that contact the native atrioventricular valve leaflets.

[0170] In some implementations, edge 140 of each of the chord-recruiting arms that defines the inside of the curve defined by the respective arm (i.e., the edge having a concave curvature) is covered with a cover 142 made from a low friction fabric (such as, ePTFE) in order to provide low friction with respect to the chords and to allow the movement of these portions with respect to the chords without damaging the tissue. In some implementations, edge 144 of each of the chord-recruiting arms that defines the outside of the curve defined by the respective arm (i.e., the edge having a convex curvature) is covered with a cover 146 made from a porous and / or knitted fabric (such as polyester). In some implementations, cover 146 on the outer edge is configured to provide edge 144 with an atraumatic cover and also to induce tissue ingrowth to edge 144, once the frame is fully deployed. In some implementations, portions that are configured to be cushioned or padded (e.g., junctions 67 and tips 74 of chordrecruiting arms 24) include an inner cushioning layer of knitted polyester, which is covered in an outer coating of woven polyester.

[0171] Reference is now made to Figs. 9A, 9B, 9C, and 9D, which are photographs of respective steps of ventricular end 84 of frame 20 being covered during assembly of the frame, in accordance with some applications of the present disclosure. As described hereinabove, in some implementations, piece 76 of shape-memory material that defines chord-recruiting arms 24 (shown in Fig. 3A) is coupled to the cylindrical part of the frame, via suturing or other coupling means. In some implementations, one of the struts of each of the arms meets one of the struts of an adjacent arm at a junction 78. In some implementations, the shape memory material defines a hole 79 at the junction and junctions of cells at the ventricular end or ventricular portion of the cylindrical part of the frame body define corresponding holes 82. A suture is inserted through holes 79 of the chord-recruiting arms and holes 82 of the cylindrical part, in order to couple the chord-recruiting arms to the cylindrical part.

[0172] In some implementations, in order to prevent the junctions of cells at the ventricular end or ventricular portion of the cylindrical part of the frame body from damaging tissue of the subject’s left ventricle, these junctions are padded with individual covers 92. In some implementations, the covers can include and / or be formed from flaps of material, which are folded over the junctions, as indicated in the transition from Fig. 9A to 9B, and then from Fig. 9B to 9C. In some implementations, the covers can include and / or be formed from polyester. Although it is desirable to provide padding at the junctions, the padding adds to the crimp profile of the frame (i.e., the minimum diameter to which the frame can be radially constrained). Therefore, the padding is added only around the junctions themselves, rather than padding the entire circumference of the frame at the location of the junctions. In some implementations, that flaps of material include flaps of material that extend from an inner lining of the frame (e.g., an inner lining of the cylindrical part). For some applications, the prosthetic valve leaflets are coupled to (e.g., sutured to) the inner lining.

[0173] In some implementations, during the assembly of the frame, covers 92 are first folded over junctions 78, and subsequently thereto, the suture(s) is inserted through holes 79 of the chord-recruiting arms and holes 82 of the cylindrical part, in order to couple the chordrecruiting arms to the cylindrical part. In such implementations, the suture is sutured through cover 92. In some implementations, the suture(s) is inserted through holes 79 of the chordrecruiting arms and holes 82 of the cylindrical part, in order to couple the chord-recruiting arms to the cylindrical part, and subsequently thereto, covers 92 are folded over the junctions 78.

[0174] In some implementations, an additional cover 94 is added over individual covers 92, around the full circumference of the ventricular end of the frame body. In some implementations, the additional cover can include and / or be formed from a low friction fabric (such as ePTFE) in order to provide low friction with respect to the portions of the ventricle which can contact the ventricular end of the frame. In some implementations, even after the additional cover has been added, axially-protruding cell junctions 86, protrude axially from the additional cover, in order to facilitate holding the ventricular end of the frame within a delivery device, as described hereinabove.

[0175] Reference is now made to Fig. 10, which is a schematic illustration of a portion of frame 20, in which the atrial part 26 and cylindrical part 22 are formed unitarily, from a single frame, in accordance with some applications of the present disclosure. As shown in Fig. 10, in some implementations, a single frame is cut and shape set to define cylindrical part 22, frustoconical portion 30 and disc-shaped portion 28. For some such applications, the cylindrical portion is continuous with the frustoconical portion. In some implementations, in order for the frustoconical portion to form the desired angle with respect to the disc-shaped portion, cells that define the frustoconical portion extend through cells that define the discshaped portion, as shown.

[0176] As described hereinabove, in some implementations, the disc-shaped portion of the atrial part is configured to seal the frame with respect to tissue on the atrial side of the mitral annulus, and is further configured to prevent migration of the frame further into the ventricle. In some implementations, the cylindrical part is configured to support the prosthetic valve within the native atrioventricular valve. For example, leaflets 23 of the prosthetic valve can be sutured to the cylindrical part, and / or can be otherwise coupled to the cylindrical part, e.g., as shown in Fig. ID. In some implementations, the frustoconical portion extends from the discshaped portion of the atrial part to the cylindrical part. In some implementations, the inclusion of the frustoconical portion between the disc-shaped portion and the cylindrical part (as opposed to directly coupling the disc-shaped portion to the cylindrical part) reduces a likelihood of regurgitation around the outside of the cylindrical part. Reference is now made to Figs. 11 A, 11B, 11C, 11D, HE, and 1 IF, which are schematic illustrations of respective steps of the delivery and deployment of a prosthetic valve or prosthetic mitral valve, via a transseptal approach, in accordance with some applications of the present disclosure. In some implementations, the prosthetic valve includes valve-frame body as described hereinabove, with prosthetic valve leaflets 23 sutured to the cylindrical part, and / or otherwise coupled to cylindrical part 22 of the valve frame, e.g., as shown in Fig. ID. As described hereinabove, in accordance with respective applications, the prosthetic valve is delivered transseptally (i.e., via the vena cava, the right atrium, and the interatrial septum), transapically (i.e., via the apex of the left ventricle), and / or via a different delivery path. Figs. 11A-F shows steps of delivery and deployment of a prosthetic valve, via the transseptal approach, by way of illustration and not limitation.

[0177] In some implementations, delivery device 40 (e.g., delivery catheter) is guided toward the subject's native valve 100 over a guidewire 102. As shown in Fig. 11 A, in some implementations, the distal end of delivery device 40 is advanced into the subject's left atrium 104, via the interatrial septum 106. The distal end of the delivery device is advanced toward the native valve and is advanced through leaflets 108 of the native mitral valve and into ventricle 110, as shown in Fig. 11B. When the distal end of the delivery device is disposed within the ventricle, chord-recruiting arms 24 are allowed to at least partially radially expand, and assume their rotation configurations, as shown in Fig. 11C. In some implementations, the arms are allowed to assume non-radially-constrained configurations by releasing the arms from being radially constrained by the delivery device, e.g., by partially retracting proximal overtube 41, and / or by partially advancing distal nosecone 43. In some implementations, the chord-recruiting arms are shape set to extend radially from frame body 21 and to curve circumferentially around the frame body (e.g., in the clockwise direction, as shown), upon assuming their rotation configurations. In some implementations, the chord-recruiting arms are further configured to extend axially toward the subject's atrium. In some implementations, the chord-recruiting arms are configured to become deployed among chords 112 of the native mitral valve upon being released from the delivery device.

[0178] As shown in Fig. 1 ID, subsequent to the chord-recruiting arms 24 being deployed among chords of the native mitral valve, at least a portion of frame 20 is rotated in the direction of arrow 114, such as to cause chord -recruiting arms 24 to (a) pull the native atrioventricular valve radially inward toward the frame, and (b) twist the native atrioventricular valve around the frame, by recruiting and deflecting at least a portion of the chords. In some implementations, the chord-recruiting arms 24 are configured to curve in a given circumferential direction with respect to the longitudinal axis of the frame. For example, the arms can curve in a clockwise direction or in a counter-clockwise direction with respect to the longitudinal axis of the frame. In some implementations, subsequent to chord-recruiting arms 24 being deployed among chords of the native mitral valve, the frame is rotated in the same circumferential direction as the direction of the circumferential curvature of the arms. In the example shown in Fig. 1 ID, the arms curve in the clockwise circumferential direction (as viewed from left atrium 104), and the frame is rotated in this direction.

[0179] In some implementations, prior to rotating the frame in the same circumferential direction as the direction of the circumferential curvature of the arms, the frame is rotated in the opposite circumferential direction. In some implementations, the delivery device 40 is configured such as to automatically perform the initial rotation of the frame through a given angle against the direction of circumferential curvature of the arm, and to subsequently rotate the frame though a predetermined angle in the direction of the circumferential curvature of the arms.

[0180] In some implementations, in the rotation configuration of the arms (shown in Figs. 11C-D), the outer surfaces of each of the arms has a smooth, convex curvature that extends along substantially the full length of the arm, such that during the initial rotation (against the direction of circumferential curvature of the arm) the chords slide over the outer surfaces of the arm without be recruited or caught by the arm. In some implementations, by virtue of the arms being shaped in this manner, the initial rotation of the frame causes a relatively large number of chords to be positioned such as to be recruited by each of the arms in the subsequent rotation step. During the subsequent rotation of the frame (in the direction of the circumferential curvature of the arms, e.g., the direction of arrow 114 as shown in Fig. 1 ID), the chords are recruited and deflected by the arms. In some implementations, in the rotation configuration of the arms (shown in Figs. 11C-D), the inner surface of the arm has a concave curvature and the chords are recruited within the space defined by the concave curvature, during the subsequent rotation by the frame.

[0181] As described hereinabove with reference to Fig. 7, in some implementations, edge 140 of each of the chord-recruiting arms that defines the inside of the curve defined by the respective arm is covered with a cover 142 made from a low friction fabric (such as, ePTFE) in order to provide low friction with respect to the chords and to allow the movement of these portions with respect to the chords without damaging the tissue. In some implementations, (a) prior to rotating the frame in the same circumferential direction as the direction of the circumferential curvature of the arms, the frame is rotated in the opposite circumferential direction, and (b) edge 144 of each of the chord-recruiting arms that defines the outside of the curve defined by the respective arm (i.e., the edge having a convex curvature) is also covered with a cover made from a low friction fabric (such as, ePTFE). In some such implementations, this provides low friction between edges 144 of the chord-recruiting arms and the chords, to thereby allow movement of edges 144 of the chord-recruiting arms with respect to the chords without damaging the tissue.

[0182] For some applications, edge 144 of each of the chord -recruiting arms that defines the outside of the curve defined by the respective arm (i.e., the edge having a convex curvature) is covered with a cover 146 made from a porous and / or knitted fabric (such as polyester). In some implementations, cover 146 on the outer edge is configured to provide edge 144 with an atraumatic cover and also to induce tissue ingrowth to edge 144, once the frame is fully deployed.

[0183] Subsequent to chord-recruiting arms 24 having been released and frame 20 having been rotated, frame body 21 (i.e., cylindrical part 22 and atrial part 26 of the frame) is allowed to assume its non-radially-constrained configurations. In some implementations, the atrial part is allowed to assume its non-radially-constrained configuration by releasing the atrial part from the delivery device, e.g., by retracting proximal overtube 41. In some implementations, the cylindrical part is allowed to assume its non-radially-constrained configuration by releasing the cylindrical part from the delivery device, e.g., by advancing distal nosecone 43.

[0184] Fig. HE shows both cylindrical part 22 and atrial part 26 in their non-radially- constrained (i.e., radially-expanded) configurations. In some implementations, by the frame body assuming its non-radially-constrained configuration, the frame body is configured to trap the native valve leaflets 108 partially closed and twisted configurations, to thereby at least partially seal a space between the native mitral valve and the prosthetic valve. For example, the cylindrical part can be configured to radially expand such as to trap the native valve leaflets between the cylindrical part and the chord-recruiting arms, and / or the atrial part can be configured to radially expand such as to trap the native valve leaflets between the atrial portion and the chord-recruiting arms. In some implementations, the trapping of native valve leaflets 108 in a partially closed and twisted configuration is achieved by trapping the chords (which are attached to the leaflets) in twisted configurations. In some implementations, subsequent to the above-described steps being performed, delivery device 40 is then retracted in its entirety from the subject's left atrium, as indicated by arrow 120 in Fig. 1 IF.

[0185] In some implementations, the systems, apparatus, and / or methods described herein are performed with respect to a subject's mitral valve and / or with respect to a subject's tricuspid valve. Although some implementations of the apparatus and methods have been described primarily in relation to a mitral valve, the scope of the present disclosure includes applying any of the apparatus and methods described hereinabove to the tricuspid valve, mutatis mutandis. Although some implementations of the apparatus and methods have been described in relation to an atrioventricular valve, the scope of the present disclosure includes applying any of the apparatus and methods described hereinabove to an aortic or pulmonary valve, mutatis mutandis.

[0186] In some implementations, apparatus and methods described herein are performed in conjunction with apparatus and methods described in US 2015 / 0173897 to Raanani and / or in US 2022 / 0296370 to Agian, both of which are incorporated herein by reference.

[0187] Any of the various systems, assemblies, devices, components, apparatus, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise (or additional methods comprise or consist of) sterilization of the associated system, device, component, apparatus, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0188] The techniques, methods, processes, operations, steps, etc. described or suggested herein or in the references incorporated herein, and any methods of using the systems, assemblies, apparatus, devices, etc. herein, can be performed on a living subject (e.g., human, other animal, etc.) or on a simulation (e.g., a cadaver, cadaver heart, simulator, imaginary person, etc.). When performed on a simulation, the body parts, e.g., heart, tissue, valve, etc., can be assumed to be simulated or can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, simulated valve, etc.) and can optionally comprise computerized and / or physical representations of body parts, tissue, etc. The term “simulation” covers use on a cadaver, computer simulator, imaginary person (e.g., if they are just demonstrating in the air on an imaginary heart), etc.”) It will be appreciated by persons skilled in the art that the present disclosure is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present disclosure includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.

Claims

CLAIMS1. Apparatus configured to be deployed within a native atrioventricular valve disposed between an atrium and a ventricle of a heart of a subject, the apparatus comprising: a frame comprising: an atrial part comprising a disc-shaped portion configured to be deployed on an atrial side of the valve annulus; and a cylindrical part configured to be deployed such that a ventricular end of the cylindrical part is disposed within the ventricle; and one or more sutures, the cylindrical part being coupled to the atrial part, via the one or more sutures, at a plurality of junctions that are disposed around a circumference of the frame, wherein each of the junctions is individually padded with a covering material.

2. The apparatus according to claim 1, wherein the padding material comprises a knitted fabric.

3. The apparatus according to claim 1 or claim 2, wherein the padding material comprises a porous fabric.

4. The apparatus according to any one of claims 1-3, wherein the padding material comprises a material selected from the group consisting of: polyethylene terephthalate, and ethylene polyester.

5. The apparatus according to any one of claims 1-4, wherein the padding material comprises an inner cushioning layer of knitted polyester, which is covered in an outer coating of woven polyester.

6. The apparatus according to any one of claims 1-5, wherein the atrial part further comprises a frustoconical portion extending from the disc-shaped portion to the cylindrical part, and wherein the disc-shaped portion is coupled to the cylindrical part via the frustoconical portion.

7. The apparatus according to any one of claims 1-6, wherein at each of the plurality of junctions a knot is knotted in the at least one of the one or more sutures.

8. The apparatus according to any one of claims 1-7, wherein the one or more sutures comprise a single suture that is used to couple the cylindrical part to the atrial part at each of the plurality of the junctions.

9. The apparatus according to claim 8, wherein the suture is sutured through each of the junctions in a figure-of-eight pattern.

10. The apparatus according to claim 9, wherein the frame comprises a plurality of protruding struts that protrude from the cylindrical part and that define a pair of holes, wherein the atrial part defines a corresponding pair of holes at each of the junctions, and wherein the suture is sutured through the pair of holes in the protruding strut and the corresponding pair of holes in the atrial part in the figure-of-eight pattern.

11. The apparatus according to claim 10, wherein each of the protruding struts is individually padded, by the covering material being wrapped around the each of the protruding struts individually.

12. The apparatus according to any one of claims 1-11, wherein the frame comprises a plurality of protruding struts that protrude from the cylindrical part and wherein the discshaped portion is coupled to the cylindrical part via the protruding struts.

13. The apparatus according to claim 12, wherein each of the protruding struts is individually padded, by the covering material being wrapped around the each of the protruding struts individually.

14. The apparatus according to claim 12, wherein the protruding struts protrude from an axial location along the cylindrical part that is in the lowest 90 percent of a height of the cylindrical part, such that there is axial overlap between the atrial part and the cylindrical part of the frame.

15. Apparatus configured to be deployed within a native atrioventricular valve disposed between an atrium and a ventricle of a heart of a subject, the apparatus comprising: a frame comprising: an atrial part comprising a disc-shaped portion configured to be deployed on an atrial side of the valve annulus; and a cylindrical part configured to be deployed such that a ventricular end of the cylindrical part is disposed within the ventricle; and one or more sutures, the cylindrical part being coupled to the atrial part, via the one or more sutures, at a plurality of junctions that are disposed around a circumference of the frame, wherein at each of the plurality of junctions, a knot is knotted in the at least one of the one or more sutures.

16. The apparatus according to claim 15, wherein the atrial part further comprises a frustoconical portion extending from the disc-shaped portion to the cylindrical part, and wherein the disc-shaped portion is coupled to the cylindrical part via the frustoconical portion.

17. The apparatus according to claim 15 or claim 16, wherein the one or more sutures comprise a single suture that is used to couple the cylindrical part to the atrial part at each of the plurality of the junctions.

18. The apparatus according to claim 17, wherein the suture is sutured through each of the junctions in a figure-of-eight pattern.

19. The apparatus according to claim 18, wherein the frame comprises a plurality of protruding struts that protrude from the cylindrical part and that define a pair of holes, wherein the atrial part defines a corresponding pair of holes at each of the junctions, and wherein the suture is sutured through the pair of holes in the protruding strut and the corresponding pair of holes in the atrial part in the figure-of-eight pattern.

20. The apparatus according to any one of claims 15-19, wherein the frame comprises a plurality of protruding struts that protrude from the cylindrical part and wherein the discshaped portion is coupled to the cylindrical part via the protruding struts.

21. The apparatus according to claim 20, wherein the protruding struts protrude from an axial location along the cylindrical part that is in the lowest 90 percent of a height of the cylindrical part, such that there is axial overlap between the atrial part and the cylindrical part of the frame.

22. The apparatus according to any one of claims 15-21, further comprising a padding material, wherein each of the junctions is individually padded with the covering material.

23. The apparatus according to claim 22, wherein the frame comprises a plurality of protruding struts that protrude from the cylindrical part, wherein the disc-shaped portion is coupled to the cylindrical part via the protruding struts, and wherein each of the protruding struts is individually padded, by the covering material being wrapped around the each of the protruding struts individually.

24. The apparatus according to claim 22 or claim 23, wherein the padding material comprises a knitted fabric.

25. The apparatus according to any one of claims 22-24, wherein the padding material comprises a porous fabric.

26. The apparatus according to any one of claims 22-25, wherein the padding material comprises a material selected from the group consisting of: polyethylene terephthalate, and ethylene polyester.

27. The apparatus according to any one of claims 22-26, wherein the padding material comprises an inner cushioning layer of knitted polyester, which is covered in an outer coating of woven polyester.

28. Apparatus configured to be deployed within a native atrioventricular valve disposed between an atrium and a ventricle of a heart of a subject, the apparatus comprising: a frame comprising: a frame body comprising a ventricular portion that is disposable on a ventricular side of the native atrioventricular valve; and a set of chord-recruiting arms configured to extend at least radially from the ventricular portion of the frame body; and one or more sutures, the set of chord-recruiting arms being coupled to the frame body, via the one or more sutures, at a plurality of junctions that are disposed around a circumference of the frame at the ventricular portion of the frame body, wherein each of the junctions is individually padded with an individual cover.

29. The apparatus according to claim 28, wherein: the set of chord-recruiting arms are configured to curve circumferentially around the frame body so as to define a curved inner edge having a concave curvature and a curved outer edge having a convex curvature; and the apparatus further comprises a first covering material and a second covering material, which is different from the first covering material, each of the chord-recruiting arms being covered with the first covering material on its curved inner edge and is covered with the second covering material on its curved outer edge.

30. The apparatus according to claim 28 or claim 29, wherein the individual covers each comprise a flap of material, which is folded over the junction.

31. The apparatus according to claim 30, further comprising an inner lining that lines the inside of the frame and which is coupled to or is couplable to prosthetic valve leaflets, whereinthe flaps of material that are folded over the junctions comprises flaps of materials that extend from the inner lining.

32. The apparatus according to any one of claims 28-31, further comprising an additional cover that is disposed over the individual covers and that extends around a full circumference of the ventricular portion of the frame body.

33. The apparatus according to claim 32, wherein the additional cover comprises a low- friction fabric.

34. The apparatus according to claim 32 or claim 33, wherein the additional cover comprises expanded polytetrafluoroethylene.

35. The apparatus according to any one of claims 32-34, wherein the frame further comprises one or more axially-protruding cell junctions configured to protrude axially from the additional cover.

36. Apparatus configured to be deployed within a native atrioventricular valve disposed between an atrium and a ventricle of a heart of a subject, the apparatus comprising: a frame comprising: a frame body comprising a ventricular portion that is disposable on a ventricular side of the native atrioventricular valve; and a set of chord-recruiting arms configured to extend at least radially from the ventricular portion of the frame body, each of the chord-recruiting arms being configured to curve circumferentially around the frame body so as to define a curved inner edge having a concave curvature and a curved outer edge having a convex curvature; and a first covering material and a second covering material, which is different from the first covering material, wherein each of the chord-recruiting arms is covered with the first covering material on its curved inner edge and is covered with the second covering material on its curved outer edge.

37. The apparatus according to claim 36, wherein the first covering material comprises a low-friction fabric configured to provide low friction of the curved inner edges of the chordrecruiting arms with respect to chords disposed within the ventricle of the subject.

38. The apparatus according to claim 36 or claim 37, wherein the first material comprises expanded polytetrafluoroethylene.

39. The apparatus according to any one of claims 36-38, wherein the second covering material comprises a porous fabric configured to provide curved outer edges of the chordrecruiting arms with atraumatic covers and to induce tissue ingrowth to curved outer edges of the chord-recruiting arms.

40. The apparatus according to any one of claims 36-39, wherein the second covering material comprises a knitted fabric configured to provide curved outer edges of the chordrecruiting arms with atraumatic covers and to induce tissue ingrowth to curved outer edges of the chord-recruiting arms.

41. The apparatus according to any one of claims 36-40, wherein the second material comprises polyester.

42. Apparatus configured to be deployed within a native atrioventricular valve disposed between an atrium and a ventricle of a heart of a subject, the apparatus comprising: a frame comprising: a frame body comprising a ventricular portion that is disposable on a ventricular side of the native atrioventricular valve; and a set of chord-recruiting arms configured to extend at least radially from the ventricular portion of the frame body; and one or more sutures, the set of chord-recruiting arms being coupled to the frame body, via one or more sutures, at a plurality of junctions that are disposed around a circumference of the frame at the ventricular portion of the frame body, wherein at each of the plurality of junctions a knot is knotted in the at least one of the one or more sutures.

43. The apparatus according to claim 42, wherein the one or more sutures comprise a single suture that is used to couple the set of chord-recruiting arms to the frame body at each of the plurality of the junctions.

44. The apparatus according to claim 42 or claim 43, wherein each of the junctions is individually padded with an individual cover.

45. The apparatus according to claim 44, wherein the individual covers each comprise a flap of material, which is folded over the junction.

46. The apparatus according to claim 45, further comprising an inner lining that lines the inside of the frame and which is coupled to prosthetic valve leaflets, wherein the flaps ofmaterial that are folded over the junctions comprises flaps of materials that extend from the inner lining.

47. The apparatus according to any one of claims 44-46, further comprising an additional cover that is disposed over the individual covers and that extends around a full circumference of the ventricular end of the frame body.

48. The apparatus according to claim 47, wherein the additional cover comprises a low- friction fabric.

49. The apparatus according to claim 47 or claim 48, wherein the additional cover comprises expanded polytetrafluoroethylene.

50. The apparatus according to any one of claims 44-49, wherein: the set of chord-recruiting arms are configured to curve circumferentially around the frame body so as to define a curved inner edge having a concave curvature and a curved outer edge having a convex curvature; and the apparatus further comprises a first covering material and a second covering material, which is different from the first covering material, each of the chord-recruiting arms being covered with the first covering material on its curved inner edge and is covered with the second covering material on its curved outer edge.

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