Implantable frame

Abstract

Described herein are apparatuses and methods comprising placing an implantable frame (20) comprising struts (98, 99) defining cells (93) into a delivery device (40) to transition the frame (20) from a non-radially constrained configuration of the frame (20) to a radially constrained configuration of the frame (20) to elongate and bend at least a portion of the cells (93) circumferentially about a longitudinal axis of the frame (20), the portion of the cells (93) is configured such that for each of the cells (93) of the portion, an end (94) of the cell (93) becomes circumferentially misaligned with a base (96) of the cell (93). The implantable frame (40) is released from the delivery device (40), thereby transitioning the frame (20) from a radially constrained configuration of the frame (20) to a non-radially constrained configuration of the frame (20). Other applications are also described herein.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 405,966, filed by Karni on September 13, 2022, entitled “Atrioventricular valve replacement,” which is incorporated herein by reference.

[0003] Field of Embodiments of the Invention

[0004] The present invention relates to medical devices and methods, and in particular to devices and methods for implanting a framework into a subject.

[0005] background

[0006] The human heart is a muscular organ that pumps oxygen-depleted blood through the lungs through the contraction of its four chambers to oxygenate the blood and pumps the oxygenated blood to the rest of the body.

[0007] After circulating through the body, deoxygenated blood in the body enters the right atrium through the vena cava. In a healthy subject, the right atrium contracts, pumping blood through the tricuspid valve into the right ventricle. The right ventricle contracts, pumping blood through the pulmonary semilunar valve into the pulmonary artery, which divides into two branches, one for each lung. The blood is oxygenated as it passes through the lungs and re-enters the heart through 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 for distribution to the rest of the body. The tricuspid valve closes during right ventricular contraction, preventing blood from flowing back into the right atrium. Similarly, the mitral valve closes during left ventricular contraction, preventing blood from flowing back into the left atrium. The mitral and tricuspid valves are called atrioventricular valves, and each of these valves controls blood flow between the atria and ventricles.

[0008] In the mitral valve, the mitral annulus defines the mitral valve orifice. The anterior and posterior leaflets extend from the mitral annulus. The leaflets are connected to the papillary muscles in the left ventricle by chordae tendineae.

[0009] During ventricular diastole, in a healthy subject, the left atrium contracts to pump blood through the mitral valve orifice into the left ventricle. 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 held closed by the blood pressure in the aorta.

[0010] During ventricular systole, the left ventricle contracts to pump blood through the aortic valve into the aorta, and the leaflets of the aortic valve are pushed open by the blood flow. In healthy subjects, the mitral annulus contracts to push the leaflets inward and reduce the area of ​​the mitral valve orifice by approximately 20% to 30%. The leaflets coapt to accommodate the excess leaflet surface area, creating a coaptation surface that constitutes the seal. Blood pressure in the left ventricle pushes on the ventricular surface of the leaflets, pressing the leaflets tightly together at the coaptation surface, creating a tight, leak-proof seal.

[0011] Effective sealing of the mitral valve during ventricular systole depends on an adequate degree of coaptation. Improper coaptation can be caused by a number of physical abnormalities that allow leaflet prolapse (e.g., elongated or ruptured chordae tendineae, or weak papillary muscles) or prevent coaptation (e.g., short chordae tendineae, or small leaflets). There are also several pathologies that can lead to mitral regurgitation, including collagen vascular disease, ischemic mitral regurgitation (e.g., caused by myocardial infarction, chronic heart failure, or failed / unsuccessful surgical or catheter revascularization), leaflet myxomatous degeneration, and rheumatic heart disease. Mitral regurgitation leads to numerous complications, including arrhythmias, atrial fibrillation, palpitations, chest pain, congestive heart failure, syncope, fatigue, low cardiac output, orthopnea, paroxysmal nocturnal dyspnea, pulmonary edema, shortness of breath, and sudden death.

[0012] The tricuspid valve consists of three leaflets: the septal leaflet, the anterior leaflet, and the posterior leaflet. Each valve leaflet is attached to the tricuspid annulus, which defines the tricuspid valve orifice. The leaflets are connected to the papillary muscles within the right ventricle by chordae tendineae. In healthy subjects, the tricuspid valve controls the direction of blood flow from the right atrium to the right ventricle in a manner similar to how the mitral valve controls the direction of blood flow on the left side of the heart. During ventricular diastole, the tricuspid valve opens to allow blood to flow from the right atrium to the right ventricle, and during ventricular systole, the leaflets of the tricuspid valve coapt to prevent blood from flowing back from the right ventricle to the right atrium.

[0013] Tricuspid regurgitation occurs when the tricuspid valve does not close properly. This causes blood to flow back into the right atrium when the right ventricle contracts. The most common cause of tricuspid regurgitation is dilation of the right ventricle, which causes the tricuspid annulus to dilate, preventing the valve leaflets from coapting properly.

[0014] Overview of Embodiments

[0015] According to some applications of the present invention, an implantable framework includes struts that define a pore. The pore is shaped to define a non-radial constraint configuration, and the framework is configured to be delivered to a subject's body when the framework is held in a delivery device in a radial constraint configuration. When transitioning from the non-radial constraint configuration of the framework to the radial constraint configuration of the framework, at least a portion of the pores are configured to elongate and bend circumferentially around the longitudinal axis of the framework so that for each pore in the pores of the portion, the end of the pore becomes circumferentially misaligned with the base of the pore. Typically, in the radial constraint configuration of the framework, each pore belonging to the pore of the portion is configured to have an axial length that is less than the axial length of the pore if the pore of the portion is configured so that the end of the pore is circumferentially aligned with the base of the pore. This is because in addition to the axial extension of the pore, the pore is also circumferentially bent around the axis of the valve frame. Subsequently, this typically reduces the total length of the valve frame when the valve frame is in its curled configuration. In some cases, this is beneficial because the valve frame is relatively rigid when it is in its crimped configuration, but during its delivery, the valve frame typically must be traversed through a bend, such as within a blood vessel and / or within the left atrium. The relatively short axial length of the lattice of the portion is configured to facilitate delivery of the implantable frame through a bend in the anatomy, such as a bend in a blood vessel, and / or within a chamber of the heart, such as the left atrium.

[0016] For some applications of the present invention, the implantable framework includes a strut that defines a pore. At the end of the framework, the first group of pores includes a coupling portion for connecting the framework to a delivery device, and the second group of pores does not include a coupling portion. Typically, the first group of pores is shaped so that in the radial non-constrained configuration of the framework, the length of the first group of pores is the same as the length of the second group of pores, so that the coupling portion does not protrude from the end of the framework. Therefore, when the framework is deployed in the body of the subject (for example, in the heart of the subject), the coupling portion will not protrude from the end of the framework, and protruding from the end of the framework may cause damage to the tissue of the subject. More typically, the struts that define the first group of pores are longer than the struts that define the second group of pores, so that in the radial constraint configuration of the framework, the length of the first group of pores is greater than the length of the second group of pores, so that the coupling portion protrudes from the end of the framework. Therefore, during the delivery of the device, the coupling portion can be connected to a part of the delivery device, for example, connected to an anchoring element, such as a clip or a protruding portion in the delivery device (for example, an anchoring element in the front cone of the delivery device).

[0017] For some applications of the present invention, the implantable frame is a valve frame for use with an artificial valve that is configured to be deployed within a native atrioventricular valve (e.g., a mitral valve or a tricuspid valve). For some such applications, the valve frame includes a valve frame body that includes a cylindrical section and an atrial section. Typically, the cylindrical section is configured to support the artificial valve within the native atrioventricular valve. For example, the leaflets of the artificial valve can be sutured to the cylindrical section, and / or can be otherwise connected to the cylindrical section. Typically, the atrial section is configured to be at least partially deployed within the atrium of the subject. Furthermore, typically, the cylindrical section is configured to be at least partially deployed within the ventricle of the subject.

[0018] For some applications, the atrial section includes a disc-shaped portion (also referred to herein as a flange) and a frustoconical portion. Typically, the disc-shaped portion of the atrial section is configured to seal the valve frame relative to tissue on the atrial side of the native atrial-ventricular annulus, and is also configured to prevent the valve frame from migrating into the ventricle. The frustoconical portion typically extends from the disc-shaped portion of the atrial section to the outer surface of the cylindrical section. For some applications, including the frustoconical portion between the disc-shaped portion and the cylindrical section (rather than directly coupling the disc-shaped portion to the cylindrical section) reduces the likelihood of backflow around the outside of the cylindrical section.

[0019] For some applications, a plurality of chord-recruiting arms (e.g., more than two and / or less than twelve arms) extend from a portion of the valve frame body that is configured to be placed within a ventricle of a subject. For example, four chord-recruiting arms or six chord-recruiting arms may extend from the valve frame body. For some applications, a single chord-recruiting arm extends from a portion of the valve frame body that is configured to be placed within a ventricle of a subject. Typically, the chord-recruiting arms extend from a cylindrical portion of the valve frame body. Furthermore, typically, the chord-recruiting arms extend from a ventricular end of the cylindrical portion (i.e., an end of the valve frame body that is configured to be placed within the ventricle). Typically, in addition to extending axially from the ventricular end of the valve frame body toward an atrial end of the valve frame body (i.e., an end of the valve frame body that is configured to be placed within the atrium), the arms also extend radially from the valve frame body. Furthermore, typically, the arms bend around the outside of the valve frame body in a given circumferential bending direction.

[0020] It should be noted that although the lattice design has been described herein in the context of a particular type of implantable valve frame, the scope of the present disclosure includes applying such designs, mutatis mutandis, to frames of other medical devices, such as stents and / or frames of other types of implantable valves.

[0021] Thus, according to some embodiments of the present invention, there is provided an apparatus for use with a delivery device, the apparatus comprising:

[0022] an implantable framework comprising struts defining a lattice,

[0023] wherein the lattice is shaped to define a non-radially constrained configuration, and wherein the frame is configured to be delivered into the body of a subject while the frame is retained within the delivery device in the radially constrained configuration,

[0024] Wherein, when transitioning from a non-radially constrained configuration of the frame to a radially constrained configuration of the frame, at least a portion of the cells are configured to elongate and bend circumferentially around the longitudinal axis of the frame so that for each of the cells in the portion, the end of the cell becomes circumferentially misaligned with the base of the cell.

[0025] In some embodiments, the implantable frame is made of a shape memory material and the pores of the portion are shaped so as to elongate and bend circumferentially about the longitudinal axis of the frame when transitioning from a non-radially constrained configuration of the frame to a radially constrained configuration of the frame.

[0026] In some embodiments, within each of the cells belonging to the portion, the struts on one side of the cell are longer than the struts on the other side of the cell so as to allow the cell to stretch and bend circumferentially around the longitudinal axis of the frame when transitioning from the non-radially constrained configuration of the frame to the radially constrained configuration of the frame.

[0027] In some embodiments, in the radially constrained configuration of the frame, each of the cells belonging to the portion is configured to have an axial length that is less than the axial length of the cell if the cells of the portion are configured so that the ends of the cells are circumferentially aligned with the base of the cells.

[0028] In some embodiments, the implantable framework is configured to be delivered through one or more tortuous vessels, and the axial length of the lattice of cells of the portion is configured to facilitate delivery of the implantable framework through the one or more tortuous vessels.

[0029] In some embodiments, the implantable frame is configured to be delivered through a chamber of the heart, and the axial length of the lattice of cells of the portion is configured to facilitate delivery of the implantable frame through the chamber of the heart.

[0030] In some embodiments, the implantable framework comprises an implantable stent.

[0031] In some embodiments, the implantable frame includes an implantable valve frame configured to be implanted at a native valve of a subject, and the device further includes a plurality of prosthetic valve leaflets coupled to the implantable valve frame.

[0032] In some embodiments, the implantable valve holder comprises an implantable valve holder configured to be implanted at a native atrioventricular valve of a subject.

[0033] In some embodiments, the implantable valve frame comprises:

[0034] an atrial region comprising a disk-shaped portion and a frustoconical portion, the disk-shaped portion being configured to be deployed on the atrial side of an annulus of an atrioventricular valve; and

[0035] a cylindrical section to which the prosthetic valve leaflets are coupled, the cylindrical section being configured to be deployed such that a ventricular end of the cylindrical section is disposed within a ventricle of the subject, and

[0036] The lattice configured as a portion of the lattice configured to be elongated and circumferentially curved about the longitudinal axis of the frame includes the lattice of the disc-shaped portion of the atrial region of the frame.

[0037] In some embodiments, the frustoconical portion of the atrial portion is coupled to the cylindrical portion such that there is an axial overlap between at least the frustoconical portion of the atrial portion and the cylindrical portion.

[0038] In some embodiments, the frustoconical portion of the atrial portion is coupled to the cylindrical portion such that the frustoconical portion of the atrial portion extends from an axial position along the cylindrical portion that is at a lowest 50% of the height of the cylindrical portion.

[0039] In some embodiments, the valve frame further comprises a plurality of chord recruitment arms configured to extend radially from at least the ventricular end of the cylindrical section.

[0040] In some embodiments:

[0041] The valve holder is configured to be delivered to the atrioventricular valve,

[0042] Subsequently, a plurality of chordal recruitment arms are configured to be deployed between the chordae of the native atrioventricular valve, and

[0043] Subsequently, at least a portion of the valve frame is configured to be rotated by the delivery device to cause the plurality of chord recruitment arms 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 chordae tendineae.

[0044] According to some embodiments of the present invention, a method is further provided, the method comprising:

[0045] placing an implantable frame including struts defining a lattice of cells into a delivery device to transition the frame from a non-radially constrained configuration of the frame to a radially constrained configuration of the frame, thereby causing at least a portion of the lattice of cells to elongate and circumferentially bend about a longitudinal axis of the frame such that, for each of the portion of the lattice of cells, a distal end of the lattice of cells becomes circumferentially misaligned with a base of the lattice of cells;

[0046] delivering the implantable frame to a deployment site within the body of a subject; and

[0047] The implantable frame is released from the delivery device, thereby transitioning the frame from a radially constrained configuration of the frame to a non-radially constrained configuration of the frame.

[0048] According to some embodiments of the present invention, there is also provided an apparatus for use with a delivery device, the apparatus comprising:

[0049] an implantable framework comprising struts defining a lattice,

[0050] At the ends of the frame, a first set of wells includes coupling portions for coupling the frame to a delivery device, and a second set of wells does not include coupling portions.

[0051] The first set of holes is shaped such that in a radially unconstrained configuration of the frame, the length of the first set of holes is the same as the length of the second set of holes so that the coupling portion does not protrude from an end of the frame, and

[0052] The struts defining the first set of cells are longer than the struts defining the second set of cells so that in the radially constrained configuration of the frame the length of the first set of cells is greater than the length of the second set of cells so that the coupling portions protrude from the ends of the frame.

[0053] In some embodiments, the frame is configured to assume its radially unconstrained configuration when deployed within the body of a subject, and the connecting portion does not protrude from the end of the frame when the frame assumes its radially unconstrained configuration, thereby reducing the risk of the connecting portion causing damage to the subject's tissue relative to if the connecting portion protruded from the end of the frame.

[0054] In some embodiments, the implantable framework comprises an implantable stent.

[0055] In some embodiments, the delivery device includes an anchoring element, the connecting portion is configured to be connected to the anchoring element, the implantable frame is configured to be delivered into the body of a subject when disposed in a radially constrained configuration within the delivery device, and the connecting portion is configured to protrude from an end of the frame to facilitate connecting the connecting portion to the anchoring element of the delivery device.

[0056] In some embodiments, the delivery device includes a distal nose cone including an anchoring element, and the coupling portion is configured to protrude from an end of the frame to facilitate coupling of the coupling portion to the anchoring element of the distal nose cone of the delivery device.

[0057] In some embodiments, when transitioning from a non-radially constrained configuration of the frame to a radially constrained configuration of the frame, at least a portion of the pores of the frame at a second end of the frame are configured to elongate and bend circumferentially about the longitudinal axis of the frame such that for each pore in the portion of the pores, the end of the pore becomes circumferentially misaligned with the base of the pore.

[0058] In some embodiments, in the radially constrained configuration of the frame, each of the cells belonging to the portion is configured to have an axial length that is less than the axial length of the cells if the cells of the portion are configured so that the ends of the cells are circumferentially aligned with the bases of the cells.

[0059] In some embodiments, the implantable framework is configured to be delivered via one or more tortuous vessels, and the axial length of the lattice of the portion is configured to facilitate delivery of the implantable framework through the one or more tortuous vessels.

[0060] In some embodiments, the implantable frame is configured to be delivered via a chamber of the heart, and the axial length of the lattice of cells of the portion is configured to facilitate delivery of the implantable frame through the chamber of the heart.

[0061] In some embodiments, the implantable frame includes an implantable valve holder configured to be implanted at a native valve of a subject, and the device further includes a plurality of prosthetic valve leaflets coupled to the implantable valve holder.

[0062] In some embodiments, the implantable valve holder comprises an implantable valve holder configured to be implanted at a native atrioventricular valve of a subject.

[0063] In some embodiments, the implantable valve frame comprises:

[0064] an atrial region comprising a disk-shaped portion and a frustoconical portion, the disk-shaped portion being configured to be deployed on the atrial side of an annulus of an atrioventricular valve; and

[0065] a cylindrical section to which the prosthetic valve leaflets are coupled, the cylindrical section being configured to be deployed such that a ventricular end of the cylindrical section is disposed within a ventricle of the subject, and

[0066] The first and second groups of wells are disposed at the ventricular end of the cylindrical section of the implantable valve frame.

[0067] In some embodiments, the frustoconical portion of the atrial portion is coupled to the cylindrical portion such that there is an axial overlap between at least the frustoconical portion of the atrial portion and the cylindrical portion.

[0068] In some embodiments, the frustoconical portion of the atrial portion is coupled to the cylindrical portion such that the frustoconical portion of the atrial portion extends from an axial position along the cylindrical portion that is at a lowest 90% of the height of the cylindrical portion.

[0069] In some embodiments, the implantable valve frame further comprises a plurality of chord recruitment arms configured to extend radially from at least the ventricular end of the cylindrical section.

[0070] In some embodiments:

[0071] The valve holder is configured to be delivered to the atrioventricular valve,

[0072] Subsequently, a plurality of chordal recruitment arms are configured to be deployed between the chordae of the native atrioventricular valve, and

[0073] Subsequently, at least a portion of the valve frame is configured to be rotated by the delivery device to cause the plurality of chord recruitment arms 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 chordae tendineae.

[0074] According to some embodiments of the present invention, a method is further provided, the method comprising:

[0075] placing an implantable frame including struts defining a lattice into a delivery device to transition the frame from a non-radially constrained configuration of the frame to a radially constrained configuration of the frame,

[0076] The frame is configured such that at an end of the frame, a first set of cells includes a coupling portion for coupling the frame to a delivery device and a second set of cells does not include a coupling portion, and struts defining the first set of cells are longer than struts defining the second set of cells, such that in a radially constrained configuration of the frame, the length of the first set of cells is greater than the length of the second set of cells, such that the coupling portion protrudes from the end of the frame;

[0077] delivering the implantable frame to a deployment site within the body of a subject; and

[0078] The implantable frame is released from the delivery device, thereby transitioning the frame from a radially constrained configuration of the frame to a non-radially constrained configuration of the frame, and the first group of pores is shaped so that in the radially non-constrained configuration of the frame, the length of the first group of pores is the same as the length of the second group of pores so that the connecting portion does not protrude from the end of the frame.

[0079] A more complete understanding of the present invention will be obtained from the following detailed description of the application of the present invention taken together with the accompanying drawings, in which: BRIEF DESCRIPTION OF THE DRAWINGS

[0081] Figure 1A , Figure 1B and Figure 1C are schematic diagrams of respective views of a valve holder configured to support a prosthetic valve within a subject's native atrioventricular valve according to some applications of the present invention, the figures showing the valve holder disposed in a non-radially constrained configuration;

[0082] Figure 1D is in a non-radially constrained configuration according to some applications of the present invention Figure 1A , Figure 1B and Figure 1C Schematic diagram of a valve frame showing valve leaflets and covering material attached to the valve frame;

[0083] Figure 2A and 2B According to some applications of the present invention, it is completely arranged in the delivery device ( Figure 2A ) and the chordae tendineae of the valve frame are in a "rotated configuration" ( Figure 2B )of Figure 1A , Figure 1B and Figure 1C Schematic diagram of the valve frame;

[0084] Figure 3A and Figure 3B is a schematic diagram of corresponding views of an atrial region of a valve frame according to some applications of the present invention;

[0085] Figure 4A and Figure 4B is a schematic diagram of a top view of an atrial region and a cylindrical region of a valve frame according to a corresponding application of the present invention;

[0086] Figure 5A is a schematic diagram of a side view of a cylindrical region of a valve frame according to some applications of the present invention;

[0087] Figure 5B is a schematic diagram of an atrial region of a valve frame coupled to a cylindrical region of the valve frame according to some applications of the present invention;

[0088] Fig. 6A is a schematic diagram of a chord-recruiting arm of a valve frame according to some applications of the present invention;

[0089] Figure 6B is a cylindrical region coupled to the valve frame according to some applications of the present invention Fig. 6A Schematic diagram of the chordae tendineae recruiting arm;

[0090] Fig. 7A and Figure 7B is arranged in a non-radially constrained configuration ( Fig. 7A ) and when the lower end of the arm remains in the delivery device but the upper end of the arm has been released from the delivery device ( Figure 7B) is a schematic diagram of the chordal recruitment arm of the valve frame;

[0091] Fig. 8A , Figure 8B and Figure 8C is a schematic diagram of corresponding views of a valve frame in its non-radially constrained configuration according to some applications of the present invention;

[0092] Fig. 9A and Fig. 9B is a schematic diagram of corresponding views of a valve frame body of a valve frame according to some applications of the present invention;

[0093] Fig. 10A and Fig. 10B is a schematic diagram of an atrial region of a valve frame and a strut with a wavy pattern in the atrial region according to some applications of the present invention;

[0094] Fig. 10C , Fig. 10D , Fig.10E and Fig.10F is a schematic diagram of an atrial region undergoing curling according to some applications of the present invention;

[0095] Figure 10G , Fig. 10H , Fig.10I and Fig.10J is a schematic diagram of an atrial region of a valve frame undergoing crimping according to some applications of the present invention;

[0096] Figure 10K Yes Figure 10G-10J A schematic diagram of a single repeating structure (i.e., a structure that repeats itself) of the atrial region of a valve frame of the illustrated configuration;

[0097] Fig.11A , Fig. 11B , Fig. 11C , Fig.11D , Fig.11E and Fig.11F is a schematic diagram of corresponding steps for deploying a prosthetic mitral valve via a transseptal approach according to some applications of the present invention; and

[0098] Fig. 12A , Fig. 12B and Fig. 12C is a schematic diagram of a grid of wells at the distal end of a cylindrical section of a valve frame in a corresponding configuration according to some applications of the present invention. DETAILED DESCRIPTION

[0099] Reference now Figure 1A , Figure 1B and Figure 1C , which are schematic diagrams of corresponding views of a valve frame 20 according to some applications of the present invention, showing the valve frame in its non-radially constrained configuration. Figure 1AA side view of the valve frame is shown, Figure 1B A bottom view (i.e., a view from the ventricular end of the valve frame) is shown, and Figure 1C A top view (ie, a view from the atrial end of the valve frame) is shown. Figure 1D , which is a schematic diagram of valve frame 20 with valve leaflets 23 coupled to the valve frame, according to some applications of the present invention.

[0100] Typically, the valve frame includes a valve frame body 21. For some applications, the valve frame body 21 includes a cylindrical section 22 and an atrial section 26. Typically, the cylindrical section is configured to support the artificial valve within the native atrioventricular valve. For example, the leaflets 23 of the artificial valve can be sutured to the cylindrical section, and / or can be connected to the cylindrical section in other ways, such as Figure 1D Typically, atrial section 26 is configured to be at least partially deployed within an atrium of a subject. For some applications, atrial section 26 includes a disc-shaped portion 28 (also referred to herein as a flange) and a frustoconical portion 30.

[0101] Typically, the disc-shaped portion of the atrial section is configured to seal the valve shelf relative to tissue on the atrial side of the mitral annulus and is also configured to prevent migration of the valve shelf into the left ventricle. The frustoconical portion typically extends from the disc-shaped portion of the atrial section to the outer surface of the cylindrical section. For some applications, including the frustoconical portion between the disc-shaped portion and the cylindrical section (as opposed to coupling the disc-shaped portion directly to the cylindrical section) reduces the likelihood of regurgitation around the outside of the cylindrical section.

[0102] For some applications, the cylindrical section and the atrial section are formed as separate pieces from each other and are coupled to each other, for example, by suturing, gluing, welding, and / or other methods. Optionally, the cylindrical section and the atrial section are part of a single integrally formed piece, for example, as described below with reference to Figure 8A-8C described.

[0103] Typically, the valve frame 20 is made of a shape memory material (e.g., a shape memory alloy such as Nitinol and / or copper-aluminum-nickel) covered on one or both sides with a covering material 32 (e.g., Figure 1D Typically, the shape memory material of the cylindrical section 22 and the atrial section 26 is formed into a stent-like structure that includes struts and / or pores of the shape memory material. The covering material is typically secured by sutures 34 (e.g., Figure 1D ) is coupled to a shape memory material. Note that for illustration purposes, Figure 1A-Figure 1C (as well as Figure 3A-Figure 10B) shows the valve frame 20 without the valve leaflets 23 and the covering material 32. However, the valve leaflets 23 and the covering material 32 may be Figure 1D Observed in.

[0104] For some applications, a plurality of chord recruitment arms 24 (e.g., more than two and / or less than twelve arms) extend from a portion of the valve frame body 21 that is configured to be placed within a ventricle of a subject. For example, four chord recruitment arms or six chord recruitment arms may extend from the valve frame body. For some applications, a single chord recruitment arm 24 extends from a portion of the valve frame body 21 that is configured to be placed within a ventricle of a subject. Typically, the chord recruitment arms extend from the cylindrical section 22 of the valve frame body 21. Furthermore, typically, the chord recruitment arms extend from the ventricular end of the cylindrical section (i.e., the end of the valve frame body that is configured to be placed within the ventricle). Typically, in a non-radially constrained configuration of the valve frame (a configuration in which the valve frame typically assumes when neither the valve frame body nor the chord recruitment arms are constrained by a delivery device), the arms extend radially from the valve frame body in addition to extending axially from the ventricular end of the valve frame body toward the atrial end of the valve frame body (i.e., the end of the valve frame body that is configured to be placed within the atrium). Furthermore, the arms typically bend around the outside of the valve holder body in a given circumferential bending direction.

[0105] It should be noted that descriptions herein of arms extending from the valve frame body in a given direction should not be interpreted as excluding the arms from being oriented in other directions. Conversely, arms described (or claimed) as extending radially from the valve frame body should be interpreted as meaning that the orientation of the arms relative to the valve frame body includes a radial component. Typically, in addition to extending radially from the valve frame body, the arms are also circumferentially curved, and in some cases, the orientation of the arms includes an axial component. For some applications, at least along a portion of the arms, and at least in certain configurations of the arms, the arms are disposed tangentially relative to the valve frame body.

[0106] Typically, the valve frame 20 with the artificial valve leaflets 23 disposed therein is delivered to the native atrioventricular valve by a delivery device 40 (e.g., a delivery catheter, as shown in FIG. 2 ), and the delivery device is configured to maintain the valve frame and the artificial valve in a radially constrained configuration (i.e., a “crimped” configuration) during delivery. Depending on the respective application, the valve frame is delivered transapically (i.e., via the apex of the left ventricle), transseptally (i.e., via the vena cava, right atrium, and atrial septum, as shown in reference Figures 11A-11FDetailed description) and / or delivered via different delivery pathways. For some applications, when the distal end of the delivery device is positioned within the ventricle of the subject, the chord recruitment arms 24 are deployed within the chords of the native atrioventricular valve. Typically, the chord recruitment arms are deployed within the chords of the native atrioventricular valve by releasing the chord recruitment arms from the delivery device, the chord recruitment arms being shaped to extend from the valve frame body when released from the delivery device. For some applications, additional techniques are used to enable the chord recruitment arms to be deployed within the chords of the native atrioventricular valve by releasing the chord recruitment arms from the delivery device. For example, the valve frame may include a lever element that is configured to cause the chord recruitment arms to extend radially (e.g., as described below with reference to Figure 7A-7B As described above). Optionally or additionally, the arm is connected to the cylindrical section of the valve frame by a suture, and the suture acts as a hinge so that the arm pivots about the suture relative to the cylindrical section, as described below. Typically, the chord recruitment arm is released from the delivery device while the valve frame body is still held in an at least partially radially constrained configuration by the delivery device. Typically, when the chord recruitment arm and the valve frame body are configured in the aforementioned configuration, the valve frame rotates. Therefore, in the present application, the configuration of the chord recruitment arm when the valve frame body is still held in an at least partially radially constrained configuration by the delivery device but the chord recruitment arm has been released from the delivery device is referred to as the "rotational configuration" of the chord recruitment arm.

[0107] Reference now Figure 2A and 2B . Figure 2A is a schematic diagram of valve holder 20 fully disposed within a delivery device 40, which typically includes a proximal sleeve 41 and a nose cone 43, according to some applications of the present invention. Figure 2B is a schematic diagram of a valve frame 20 according to some applications of the present invention when the chord recruitment arms are arranged in their rotational configuration (i.e., when the chord recruitment arms 24 of the valve frame have been released from the delivery device 40, while the valve frame body 21 of the valve frame is still held by the delivery device in an at least partially radially constrained configuration). Note that Figure 2B A delivery device and arm configured for insertion from below the mitral valve (e.g., via transapical insertion) are shown. For some such applications, in its rotated configuration, the arm extends axially from a distal end of the delivery device in a distal direction (i.e., the end of the delivery device that is distal from the insertion point of the delivery device into the subject), as shown. For insertion of the delivery device from above the mitral valve (e.g., via transseptal insertion, as described below with reference to Figures 11A-11FFor some applications (described in detail in the foregoing), in their rotated configuration, the arms extend axially in a proximal direction from the distal end of the delivery device (i.e., back toward the proximal end of the delivery device). For some applications, in their rotated configuration, the chord recruitment arms are configured to extend radially from the valve frame and bend circumferentially around the valve frame, but do not extend axially in the proximal or distal directions. In contrast, for such applications, in their rotated configuration, the arms extend in a radial direction from the valve frame, and the arms are axially disposed in a single plane.

[0108] After the chord recruitment arms 24 are deployed within the chordae of the native atrioventricular valve (and typically while the valve frame body 21 is still held in an at least partially radially constrained configuration by the delivery device, as shown in FIG. 2 ), at least a portion of the valve frame 20 is rotated, thereby causing the chord recruitment arms 24 to (a) pull the native atrioventricular valve radially inward toward the valve frame by recruiting and deflecting at least a portion of the chordae, and (b) twist the native atrioventricular valve about the valve frame. For some applications, the valve frame is rotated during ventricular systole, when the native atrioventricular valve is closed, such that the rotation occurs when the chordae are closest to the valve frame. Optionally, the valve frame rotation is independent of the phase of the subject's cardiac cycle (i.e., no attempt is made to synchronize the rotation with a particular phase of the subject's cardiac cycle).

[0109] After the valve frame is rotated, the cylindrical section 22 and the atrial section 26 are typically allowed to expand radially, for example by releasing the cylindrical section and the atrial section from the delivery device, so that the valve frame assumes its non-radially constrained configuration. Typically, the valve frame is configured to thereby capture the native valve leaflets in a partially closed and twisted configuration, thereby at least partially sealing the space between the native atrioventricular valve and the artificial valve. For example, the cylindrical section can be configured to expand radially to capture the native valve leaflets between the cylindrical section and the chordal recruitment arms, and / or the atrial section can be configured to expand radially to capture the native valve leaflets between the atrial section and the chordal recruitment arms.

[0110] Typically, the chord-recruiting arms 24 are configured to bend in a given circumferential direction relative to the longitudinal axis of the valve frame when the arms are deployed within the chordae (i.e., when the arms are disposed in their rotated configurations), and when the cylindrical and atrial sectors 22, 26 are allowed to expand radially (i.e., the valve frame assumes its non-radially constrained configurations), as described in further detail below. For example, the arms may bend in a clockwise or counterclockwise direction relative to the longitudinal axis of the valve frame. Typically, after the chord recruitment arms 24 are deployed within the chordae of the native atrioventricular valve (and typically, while the valve frame body 21 is still maintained by the delivery device in an at least partially radially constrained configuration (i.e., when the arms are set in their rotated configuration, as shown in FIG. 2 ), the valve frame is rotated in a circumferential direction that is the same as the circumferential bending direction of the arms. For some applications, the valve frame is rotated in an opposite circumferential direction before rotating the valve frame in that direction. For example, if the arms are bent in a clockwise circumferential direction, then, after the arms are deployed within the chordae, the valve frame can first be rotated in a counterclockwise direction and can subsequently be rotated in a clockwise direction. For some applications, rotating the valve frame in this manner is more conducive to recruiting a larger portion of the chordae than rotating the valve frame only in the circumferential bending direction of the arms.

[0111] As described in the previous paragraph, for some applications, the valve frame is rotated in an opposite circumferential direction before rotating the valve frame in the same circumferential direction as the circumferential bending direction of the arms. For some applications, the delivery device is configured to perform an initial rotation of the valve frame against the circumferential bending direction of the arms by a given angle, and then rotate the valve frame through a predetermined angle in the circumferential bending direction of the arms. For some applications, in a rotational configuration of the chord-recruiting arms, the outer surface of each arm has a smooth convex curvature extending substantially along the entire length of the arm, so that during the initial rotation (against the circumferential bending direction of the arms), the chordae slide on the outer surface of the arms without being recruited or captured by the arms. For some applications, because the arms are shaped in this manner, the initial rotation of the valve frame results in a relatively large number of chordae being positioned so as to be recruited by each arm in a subsequent rotation step. During subsequent rotations of the valve frame (in the circumferential bending direction of the arms), the chordae are recruited and deflected by the arms. Typically, in the rotated configuration of the chord recruitment arms, the inner surface of each arm has a concave curvature, and during subsequent rotation of the valve frame, the chords are recruited within the space defined by the concave curvature.

[0112] Reference again Figure 1D, for some applications, covering material 32 defines slits 42. Typically, when valve frame 20 is disposed in a delivery device in its radially constrained configuration, the pores of the valve frame become axially elongated. For some applications, slits 42 are configured to allow the pores of the valve frame to elongate axially without tearing the covering material by extending the axially elongated pores through the slits. Typically, when the valve frame is released from the delivery device and assumes its non-radially constrained configuration, the pores are reinserted into the slits so as to be covered by the covering material. Note that for purposes of illustration, in Figure 1D In the figure, the ends of the wells are shown extending from the slits even in the non-radially constrained configuration of the valve frame.

[0113] Reference now Figure 3A and Figure 3B , Figure 3A and Figure 3B is a schematic diagram of a corresponding view of the atrial sector 26 according to some applications of the present invention. Figure 3A A three-dimensional side view is shown, and Figure 3B A top view is shown. As described above, typically, the atrial section 26 is configured to be at least partially deployed within the atrium of a subject. For some applications, the atrial section 26 includes a disc-shaped portion 28 (also referred to herein as a flange) and a frustoconical portion 30. The disc-shaped portion is typically configured to be placed on a native mitral valve annulus, and the frustoconical portion extends from the disc-shaped portion of the atrial section to the cylindrical section 22. Typically, the disc-shaped portion of the atrial section is configured to seal the valve frame relative to tissue on the atrial side of the mitral valve annulus, and is also configured to prevent the valve frame from migrating into the left ventricle. For some applications, the pores of the flange include a spring portion 44. The spring portion is configured to provide flexibility to the pores so that during cardiac movement, the flange can adjust its shape to accommodate changes in the shape of the atrial tissue contacted by the flange. Optionally or additionally, the pores of the flange provide flexibility due to the struts of the pores themselves having a wavy pattern, as described below with reference to Figure 10A-10B Detailed description further. For some applications, including a frustoconical portion between the disc-shaped portion and the cylindrical portion (as opposed to coupling the disc-shaped portion directly to the cylindrical portion) reduces the likelihood of backflow around the outside of the cylindrical portion. Note that the flange is disposed in a plane perpendicular to the longitudinal axis defined by the cylindrical portion, or is disposed at an angle to the plane, depending on the respective application. For example, the flange can define an upward angle or a downward angle relative to a plane perpendicular to the longitudinal axis defined by the cylindrical portion to best match different anatomical structures surrounding the native atrioventricular valve in the atrium or ventricle.

[0114] For some applications, the frustoconical portion defines holes 50 at the bottom of at least some of the pores of the frustoconical portion. Typically, the holes are configured to facilitate suturing the atrial section to the cylindrical section of the valve frame. For some applications, pairs 52 of struts 54 extend from corresponding pores of the disc-shaped portion 28 of the atrial section. The paired struts converge to a point 56. For some applications, the paired strut pairs are configured to pierce tissue of the subject's heart (e.g., tissue of the annulus) at point 56. As described above, typically, the valve frame is rotated to recruit the chordae tendineae of the autologous valve, and then the valve frame body is allowed to expand radially. In some cases, the valve frame tends to experience recoil and rotate in a direction opposite to its rotation direction. Typically, by piercing tissue of the subject's heart at point 56 (and then becoming embedded in the tissue), the paired struts are configured to act as an anti-recoil element by preventing the valve frame from rotating in a direction opposite to its rotation direction.

[0115] Reference now Figure 4A and Figure 4B , which are top views of the atrial sector 26 and the cylindrical sector 22 according to the corresponding application of the present invention. Figure 3A and Figure 3B As described, for some applications, the pair 52 of struts 54 extend from corresponding cells of the disc-shaped portion 28 of the atrial region. Typically, the paired struts are configured to act as anti-recoil elements by preventing the valve frame from rotating in a direction opposite to its rotational direction. For some applications, the paired struts additionally help anchor the atrial region to the autologous tissue.

[0116] like Figure 4A As shown, for some applications, the paired struts are bent in a circumferential direction relative to the axis of the valve frame. Typically, the bending of the paired struts is configured to promote anti-recoil function by bending the struts to face the direction in which the valve frame has a rotational tendency. For example, in Figure 4A In the example shown, the valve frame is configured to initially rotate in a clockwise direction (when viewed from the top, as shown in FIG. Figure 4A ). In some cases, the valve frame thus has a tendency to recoil and rotate in a counterclockwise direction. The bending of the pair 52 of struts 54 is such that when the valve frame begins to rotate in a counterclockwise direction, points 56 of the pair 52 of struts 54 pierce the tissue of the subject's heart (and become at least partially embedded in the tissue), thereby preventing further rotation of the valve frame.

[0117] Typically, each strut 54 of a given pair 52 is configured to extend from a strut on a corresponding side (ie, left or right) of the aperture grid of the disc-shaped portion 28 of the atrial region. Figure 4A As shown, for some applications, each strut 54 of a given pair 52 is configured to extend from a strut on a corresponding side of the outer half of the aperture grid of the disc-shaped portion 28 of the atrial region. Figure 4BAs shown, each strut 54 of a given pair 52 is configured to extend from a strut on a corresponding side (ie, left or right) of the inner half of the lattice of the disc-shaped portion 28 of the atrial region.

[0118] For some applications, in addition to being curved (as in reference Figure 4A As described above, the pairs 52 of struts 54 are twisted relative to the cells from which they extend. For example, Figure 4B As shown, strut 58 is connected to strut 60, which is located on the left inner side of the pores of the disc-shaped portion 28 of the atrial portion. Strut 62 is connected to strut 64, which is on the right inner side of the pores of the disc-shaped portion 28 of the atrial portion. Struts 60 and 64 form a joint 66 with each other. Strut 58 is connected to strut 60 at a position closer to joint 66 than the connection between struts 62 and struts 64. This causes the pair 52 of struts 58 and 62 to twist relative to the disc-shaped portion 28 of the atrial portion. For some applications, the twisting of the pair 52 of struts is configured to promote the anti-recoil function of the strut pair by causing the struts to become more deeply embedded in the tissue of the subject's heart (in response to the valve frame beginning to experience recoil) than when the struts do not have a twisted configuration. For some applications, the valve frame 20 does not include reference Figure 4A-4B The anti-recoil element.

[0119] Reference now Figure 5A , Figure 5A is a schematic diagram of a side view of a cylindrical section 22 according to some applications of the present invention. Figure 5B , Figure 5B is a schematic diagram of an atrial section 26 coupled to a cylindrical section 22 according to some applications of the present invention. For some applications, a plurality of struts 61 extend from the outside of the cylindrical section 22. For some applications, the struts extend from the outside of the cylindrical section 22 such that the orientation of the struts relative to the cylindrical section has radial and axial components. For some applications, along at least a portion of the struts, the struts are disposed tangentially relative to the cylindrical section. Typically, the atrial section is coupled to the cylindrical section by coupling the atrial section to the extended struts 61. For example, as described above, the frustoconical portion 30 of the atrial section 26 can define holes 50 at the bottom of at least some of the cells of the frustoconical portion. For some applications, the extended struts 61 also define holes 65, and the atrial section is coupled to the cylindrical section by suturing through the holes 50 defined by the atrial section and the corresponding holes 65 defined by the extended struts 61 of the cylindrical section 22. Alternatively or additionally, the atrial sector is coupled to the protruding struts by other means, for example by welding (such as laser welding), gluing and / or a different method.

[0120] Note that typically during crimping of the valve frame, there is a lot of strain on the junctions where the extended struts 61 extend from the cylindrical section because the struts pivot about these junctions. If the atrial section was directly connected to the cylindrical section at these junctions, then this would mean that these points on the valve frame where there are relatively large strains are also the points where the two pieces are connected to each other, which would make the frame susceptible to fatigue at these points. In contrast, because the cylindrical section includes the extended struts 61 and the atrial section is connected to the cylindrical section through the struts, there is a separation between the points of high strain and the points where the atrial section is connected to the cylindrical section.

[0121] It should also be noted that, typically, the extended struts extend from an axial position along the cylindrical section that is at a minimum 90% (e.g., minimum 70%, or minimum 50%) of the height of the cylindrical section. Typically, the cylindrical section has a height of at least 15 mm to accommodate the connection of the valve leaflets to the cylindrical section. If the extended struts extend from the top of the cylindrical section (or if the atrial section is directly connected to the cylindrical section at the top of the cylindrical section), then the entire height of the cylindrical section will be set below the atrial section. In contrast, because the extended struts extend from the minimum 90% (e.g., minimum 70%, or minimum 50%) of the height of the cylindrical section, there is typically an axial overlap between the atrial section and the cylindrical section of the valve frame along the height of the cylindrical section. Typically, then, if there is no axial overlap between the atrial and cylindrical portions of the valve frame (which creates less restriction on the ventricle by reducing the ventricular presence of the cylindrical portion), this results in a smaller portion of the height of the cylindrical portion extending into the subject's ventricle. In turn (when the valve frame 20 is configured to be placed within the subject's left ventricle), this typically reduces obstruction of the left ventricular outflow tract relative to if a larger portion of the height of the cylindrical portion extends into the subject's ventricle. In this context, it is noted that, as described above, by recruiting and deflecting at least a portion of the chordae tendineae of the native atrioventricular valve, the chord recruitment arms 24 are typically configured to (a) pull the native atrioventricular valve radially inwardly toward the valve frame, and (b) twist the native atrioventricular valve around the valve frame. Typically, recruiting and deflecting the chordae tendineae in this manner serves to prevent partial obstruction of the left ventricular outflow tract by the native mitral valve device.

[0122] For some applications (not shown), the atrial section is directly coupled to the cylindrical section (i.e., not coupled via extended struts). For example, the atrial section can be directly coupled to the pores and / or pore joints of the cylindrical section. For some applications, the atrial section is directly coupled to the cylindrical section using sutures. For some such applications, the sutures act as hinges, allowing the atrial section to move relative to the cylindrical section. Optionally, a different method is used, such as welding, gluing, or a different method to directly couple the atrial section to the cylindrical section. Typically, in this case, as described above, the coupling is such that there is an axial overlap between the atrial section and the cylindrical section of the valve frame along the height of the cylindrical section. That is, typically, the truncated conical portion of the atrial section is coupled to the cylindrical section so that the truncated conical portion of the atrial section extends from an axial position along the cylindrical section that is at the lowest 90% (e.g., the lowest 70%, or the lowest 50%) of the height of the cylindrical section.

[0123] Reference now Fig. 6A , Fig. 6A is a schematic diagram of the chord-recruiting arm 24 of the valve frame 20 according to some applications of the present invention. Figure 6B , which is a schematic diagram of a chord recruitment arm coupled to a cylindrical section 22 of a valve frame. As described above, for some applications, a plurality of chord recruitment arms 24 (e.g., more than two and / or less than twelve arms) extend from a portion of the valve frame body 21 that is configured to be placed within a ventricle of a subject. For example, four chord recruitment arms or six chord recruitment arms may extend from the valve frame body. For some applications, a single chord recruitment arm 24 extends from a portion of the valve frame body 21 that is configured to be placed within a ventricle of a subject. Typically, as Figure 6B As shown, the chord recruitment arms extend from the cylindrical section 22 of the valve frame body 21.

[0124] For some applications, each chord recruitment arm 24 is defined by a pair 70 of struts 72 extending from corresponding joints at the ventricular end of the cylindrical section 22. Typically, the struts are bent so as to intersect each other and form a joint at the distal end 74 of the arm. For some applications, all of the chord recruitment arms are cut from a single piece 76 of shape memory material (e.g., a shape memory alloy such as nitinol and / or copper aluminum nickel). The shape memory material piece defining the arm is typically coupled to the cylindrical section of the valve frame, as described in further detail below. Typically, the arms are covered by a covering material 32 (shown in FIG. 2 ), such as a fabric and / or a polymer (e.g., expanded polytetrafluoroethylene (ePTFE) and / or polyester).

[0125] Typically, the chord recruitment arms 24 of the valve frame are configured to be released from the delivery device 40 while the valve frame body 21 of the valve frame is still maintained by the delivery device in an at least partially radially constrained configuration, as described above with reference to FIG2. In this first configuration of the chord recruitment arms (referred to herein as the rotational configuration of the chord recruitment arms), the arms are configured to be deployed among the chords of the native atrioventricular valve, and then by recruiting and deflecting at least a portion of the chords, the arms 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. Subsequently, by releasing the valve frame body from the delivery device, the valve frame body is allowed to assume its non-radially constrained configuration. Typically, the non-radially constrained configuration assumed by the valve frame body causes the configuration of the chord recruitment arms to change from their first configuration (i.e., their rotational configuration) to a second configuration different from the first configuration. In this second configuration, the chord-recruiting arms 24 are configured to capture the chords and / or native valve leaflets between the arms and a portion of the valve frame body. Typically, the second configuration of the arms ensures a secure anchoring of the captured chords and / or native valve leaflets relative to the valve frame body and the artificial valve leaflets.

[0126] Typically, the first strut of the pair 70 of struts 72 that includes the chord-recruiting arms is longer than the second strut of the pair of struts. The pair of struts is configured such that when the bases of the struts are held together (when the arms are in their rotated configuration), the arms are relatively long and thin, so that the arms are deployed among a relatively large number of chordae, and subsequently recruit and deflect a relatively large number of chordae. For some applications, in this configuration, each arm has a length measured along the axis of the arm that is greater than 10 mm (e.g., greater than 20 mm, or greater than 25 mm). Typically, the arms are configured such that when the arms are in the rotated configuration, (a) the arms extend radially from the valve frame body, (b) the arms extend axially from the ventricular end of the valve frame body (i.e., the end of the valve frame body that is configured to be placed within the ventricle) toward the atrial end of the valve frame body (i.e., the end of the valve frame body that is configured to be placed within the atrium), and (c) the arms bend around the outside of the cylindrical region in a given circumferential bending direction. As described above, for some applications, in their rotational configuration, the chordal recruitment arms are configured to extend radially from the valve frame and bend circumferentially around the valve frame, but not extend axially in the proximal or distal directions. In contrast, for such applications, in their rotational configuration, the arms extend radially from the valve frame and the arms are axially disposed in a single plane.

[0127] In addition, as described above, for some applications, in the rotational configuration of the chord-recruiting arms, the outer surface of each arm has a smooth convex curvature extending along substantially the entire length of the arm, so that during the initial rotation of the valve frame (against the circumferential bending direction of the arms), the chords slide on the outer surface of the arms without being recruited or caught by the arms and without being damaged by the arms. For some applications, because the arms are formed in this manner, the initial rotation of the valve frame results in a relatively large number of chords being positioned so as to be recruited by each arm during a subsequent rotation step. During subsequent rotation of the valve frame (in the circumferential bending direction of the arms), the chords are recruited and deflected by the arms. Typically, in the rotational configuration of the chord-recruiting arms, the inner surface of the arms has a concave curvature, and during subsequent rotation of the valve frame, the chords are recruited within the space defined by the concave curvature.

[0128] Typically, the arm is configured such that in a second configuration of the arm (i.e., in a non-radially constrained configuration of the valve frame), the arm becomes shorter and (at least at the base of the arm) becomes wider due to the separation of the bases of the struts from each other. Typically, the arm defines the above-mentioned three bends in the second configuration. That is, when the arm assumes the second configuration, (a) the arm extends radially from the valve frame body, (b) the arm extends axially from the ventricular end of the valve frame body (i.e., the end of the valve frame body that is configured to be placed in the ventricle) toward the atrial end of the valve frame body (i.e., the end of the valve frame body that is configured to be placed in the atrium), and (c) the arm bends around the outside of the cylindrical region in a given circumferential bending direction.

[0129] Typically, the piece of shape memory material 76 defining the tendon recruitment arm 24 is coupled to the cylindrical section of the valve frame by suturing. For some applications, one of the struts of each arm intersects one of the struts of the adjacent arm at a junction 78. For some applications, the shape memory material defines a hole 79 at the junction through which a suture is inserted, and the suture is used to create a suture 82 that sews the shape memory material to the cylindrical section of the valve frame body.

[0130] As described above with reference to Figure 2, typically, the chord recruitment arms 24 of the valve frame are configured to be released from the delivery device 40 while the valve frame body 21 of the valve frame is still maintained in an at least partially radially constrained configuration by the delivery device. For some applications, the arms are sutured to the cylindrical section at an axial position for release from the delivery device, even at this stage. For some such applications, the suture acts as a hinge such that the arms pivot about the suture relative to the cylindrical section. For some applications, this allows the arms to extend radially to a greater distance than if the suture did not provide the aforementioned hinge function. Optionally or additionally, the valve frame includes a lever element configured to cause the chord recruitment arms to extend radially, as described below with reference to Figure 7A-7B described.

[0131] like Fig. 6A and Figure 6B As shown, typically, the end 74 of the tendon chord collecting arm 24 is rounded. Optionally or additionally, the thickened layer ( Figure 6A-6B (not shown) is disposed on the end 74 of the tendon collecting arm so that the end of the arm is cushioned. Figure 2B , a lining 75 is shown at the end 74 of the chord recruitment arm. Typically, the rounding of the end and / or the lining of the end renders the end of the arm atraumatic. Additionally, typically, this facilitates movement and rotation of the arm within the subject's chordae tendineae and allows the arm to recruit and deflect the chordae tendineae without causing damage to the chordae tendineae or other surrounding tissue. For some applications, the rounding of the end and / or the lining allows the chordae tendineae to be guided around the end during rotation of the valve frame (e.g., the bidirectional rotation of the valve frame described above). For some applications, the use of a thickened layer of covering material 32 on the end of the arm (i.e., providing a lining 75) helps secure the captured chordae tendineae and native leaflets after the valve frame body is released from the delivery device.

[0132] For some applications, the cover material 32 (e.g. Figure 1D ) are configured to provide different functions to various areas of the valve frame. For example, areas of the valve frame that typically contact the chordae (such as the ventricular edges of the chordae recruitment arms and the cylindrical section) are typically covered with a low-friction fabric (e.g., PTFE) to provide low friction relative to the chordae and allow these parts to move relative to the chordae without damaging the tissue. Typically, one or both of the inner and outer surfaces of the chordae recruitment arms are covered with a low-friction fabric (e.g., PTFE) to provide low friction relative to the chordae and allow these parts to move relative to the chordae without damaging the tissue. Other areas of the valve frame can be covered with a fabric that induces tissue ingrowth (e.g., a porous fabric) so as to anchor these areas to the subject's tissue. These areas typically include portions of the atrial section 26 and / or cylindrical section 22 that contact the native atrioventricular valve leaflets.

[0133] In general, the chord recruitment arm typically defines (a) a radially constrained configuration when the arm is maintained in a curled configuration within a delivery device, and (b) a rotated configuration when the arm is released from the delivery device but the cylindrical section is maintained by the delivery device in an at least partially radially constrained configuration, and (c) a fully deployed configuration when the entire valve frame body including the cylindrical section and the atrial section is released from the delivery device. In the rotated configuration, the arm is configured to recruit and deflect the chordae. For some applications, in the rotated configuration, the arm is configured to pivot outwardly relative to the cylindrical section (e.g., via suture 82, lever element 80) so that the arm covers a relatively large span, thereby enabling the recruitment of a large number of chordae during rotation of the valve frame. Typically, in this configuration, because the arm pivots outwardly relative to the cylindrical section, there is a relatively large gap between the end of the arm and the valve frame body. Furthermore, typically, in the fully deployed configuration (when the entire valve frame body including the cylindrical section and the atrial section is released from the delivery device), the chord-recruiting arms are configured to be arranged to define a relatively small gap G (hereinafter referred to as the gap G) between the distal end of the arm and the outer surface of the valve frame body (e.g., the outer surface of the cylindrical section). Figure 8C The chord-recruiting arm is configured to define a spatial recess P (e.g., a concave curvature) between the chord-recruiting arm itself and the valve frame body (e.g., the outer surface of the cylindrical section) in the fully deployed configuration. Figure 8B Typically, chordae tendineae, which are drawn together by tissue of the arms and / or native valve leaflets, are held in these spatial recesses.

[0134] Reference now Figure 7A-7B , Figure 7A-7B is a schematic diagram of a chord-recruiting arm 24 arranged in a non-radially constrained configuration according to some applications of the present invention ( Fig. 7A ), and a schematic diagram of the chord recruitment arm 24 when the lower end of the arm is retained within the delivery device 40 and the upper end of the arm has been released from the delivery device ( Figure 7B ). As with many other figures, for illustrative purposes, Figure 7A-7B The chord recruitment arm 24 is shown without the cover material 32. For some applications, the shape memory alloy member 76 defining the chord recruitment arm 24 defines a lever element 80. The lever element is configured to be retained within the delivery device 40 when the arm is disposed in its rotated configuration (wherein the arm is configured to be deployed among the chords and then recruit and deflect the chords). Fig. 7A As shown, typically, when the valve frame is arranged in its non-radially constrained configuration, the lever element is configured to extend at an angle from the base of the arm 24. Figure 7B As shown, by being retained within the delivery device, the lever element is configured to pivot the arm radially outward. Fig. 7A 86 and 88. As shown, by moving (or holding) the lever element in the direction of arrow 86, the end 74 of the arm is configured to pivot radially outward in the direction of arrow 88.

[0135] Reference now Fig. 8A , Figure 8B and Figure 8C , which are schematic diagrams of corresponding views of the valve frame 20 according to some applications of the present invention, showing the valve frame in its non-radially constrained configuration. Figure 8A-8C The valve frame 20 shown in FIG. Figure 9A-9B Certain features of the valve frame shown in Figure 1A-Figure 7B The valve frame 20 described herein will be described below. In all other respects, such as Figure 8A-8C The valve frame 20 shown in FIG. Figure 9A-9B The valve frame shown in Figure 1A-Figure 7B The valve frame 20. Figure 8A-8C and Figure 9A-9B The valve frame 20 shown in FIG. 1 depicts certain dimensions of the valve frame 20. Typically, similar dimensions generally apply, mutatis mutandis, to the valve frame 20 of FIG. Figure 1A-Figure 7B The valve holder 20 is shown.

[0136] For some applications, the cylindrical section 22 and the atrial section 26 of the valve frame 20 are made of a single integrally formed piece of shape memory material, such as Figure 8A-8C shown.

[0137] refer to Figure 8A-8C For some applications, the valve frame 20 is configured such that in the absence of any forces acting on the valve frame (e.g., in a non-radially constrained configuration of the valve frame), the height H1 of each chord-recruiting arm 24 is greater than 5 mm (e.g., greater than 7 mm) and / or less than 20 mm (e.g., less than 15 mm), such as 5-20 mm or 7-15 mm. For some applications, in this configuration of the valve frame, the total height H2 of the valve frame is greater than 10 mm (e.g., greater than 15 mm) and / or less than 30 mm (e.g., less than 25 mm), such as 10-30 mm or 15-25 mm.

[0138] refer to Fig. 8A and Figure 8BFor some applications, the valve frame 20 is configured such that in the absence of any forces acting on the valve frame (e.g., in a non-radially constrained configuration of the valve frame), the diameter D1 of the cylindrical section 22 of the valve frame body 21 is greater than 20 mm (e.g., greater than 25 mm) and / or less than 40 mm (e.g., less than 35 mm), such as 20-40 mm or 25-35 mm. For some applications, in this configuration of the valve frame, the span S1 defined by the chord recruitment arms is greater than 22 mm (e.g., greater than 26 mm) and / or less than 45 mm (e.g., less than 40 mm), such as 22-45 mm or 26-40 mm. For some applications, in this configuration of the valve frame, the gap G between the end 74 of each chord recruitment arm 24 and the outer surface of the valve frame body is greater than 0.1 mm (e.g., greater than 0.5 mm) and / or less than 6 mm (e.g., less than 5 mm), such as 0.1-6 mm or 0.5-5 mm. For some applications, the gap G is located between the distal end of the chordal recruitment arm and the cylindrical section. Alternatively or additionally, the gap G is located between the distal end of the chordal recruitment arm and the atrial section 26 (e.g., the frustoconical portion 30 of the atrial section 26). Figure 8B Typically, in the non-radially constrained configuration of the valve frame, the chord recruitment arms are configured such that spatial pockets P are defined between the chord recruitment arms themselves and the valve frame body (e.g., the outer surface of the cylindrical section) due to the concave curvature of the inner surface of the arms. Typically, the chords recruited by the arms and / or tissue of the native valve leaflets are retained in these spatial pockets. For some applications, the shape of the valve frame is set so that in the non-radially constrained configuration of the valve frame, there is no gap between the end 74 of each chord recruitment arm 24 and the outer surface of the valve frame body. For some applications, the arms are preloaded so that the arms exert a force on the outer surface of the valve frame body, for example by the shape of the arms (such that in these applications, the gap G would be less than zero if the frame did not block the ends of the arms).

[0139] Referring again to Figure 2, for some applications, when the chord recruitment arms 24 of the valve frame have been released from the delivery device 40 and the valve frame body 21 of the valve frame is still held by the delivery device in an at least partially radially constrained configuration (i.e., when the chord recruitment arms are set in their rotational configuration), the chord recruitment arms 24 are configured to define a span S2, and the span S2 is greater than 20 mm (e.g., greater than 25 mm), and / or less than 40 mm (e.g., less than 35 mm), for example 20-40 mm or 25-35 mm.

[0140] Reference now Fig. 9A and Fig. 9B , Fig. 9A and Fig. 9B 2 is a schematic diagram of a corresponding view of a valve frame body 21 of a valve frame 20 according to some applications of the present invention. For illustrative purposes, Figure 9A-9BThe valve frame body is shown without the chord recruitment arms 24 of the valve frame.

[0141] As described above, typically, the valve frame body 21 is a stent-like structure that includes struts of shape memory material and is formed to define a generally cylindrical shape. For some applications, a plurality of extensions 90 extend radially from a portion of the valve frame body that is configured to extend into the atrium. Typically, the extensions are configured to prevent the artificial valve and / or valve frame from migrating into the subject's ventricle. Optionally or additionally, the extensions are configured so that when the valve frame body is radially expanded, the native valve leaflets are captured between the extensions and the chordal recruitment arms. For some applications, the extensions are flexible (e.g., the extensions can be formed as springs, as shown) and are configured to adapt to the shape of the tissue of the mitral valve annulus on the atrial side of the mitral valve.

[0142] For some applications, valve frame 20 is configured such that in the absence of any forces acting on the valve frame (e.g., in a non-radially constrained configuration of the valve frame), atrial segment 26 encompasses a radial distance D2 greater than 5 mm (e.g., greater than 10 mm) and / or less than 25 mm (e.g., less than 20 mm) from the outer surface of cylindrical segment 22, e.g., a radial distance D2 of 5-25 mm or 10-20 mm. Referring again to Figure 8B For some applications, in this configuration of the valve frame, the atrial region 26 is configured to define a span S3 greater than 30 mm (e.g., greater than 35 mm) and / or less than 80 mm (e.g., less than 70 mm), for example, a span S3 of 30-80 mm or 35-70 mm.

[0143] Reference now Fig. 10A and Fig. 10B , which are schematic illustrations of the atrial region 26 of a valve frame 20 according to some applications of the present invention, with struts 92 having a wavy pattern. Fig. 10A Only the atrial region of the valve frame is shown. Fig. 10BA top view of the atrial section coupled to the cylindrical section 22 and the chordal recruitment arms 24 is shown. For some applications, the struts of the disc-shaped portion (i.e., flange) 28 of the atrial section have a wavy pattern as shown. Typically, the wavy struts are configured to provide flexibility to the pores 93 of the flange so that the flange can adjust its shape to accommodate changes in the shape of the tissue of the mitral annulus on the atrial side of the mitral valve in contact with the flange. For some applications, the wavy struts are configured to provide better stress and strain distribution to the pores when bent relative to straight struts. For some applications, the pores of the flange have a circumferential bend so that the outer ends 94 of the pores point in a given circumferential direction. Typically, the circumferential bend of the pores is in a direction opposite to the circumferential bend of the chordal recruitment arms. For some applications, by limiting the circumferential bend, the pores of the flange are configured to act as an anti-recoil element and prevent the valve frame from rotating in a direction opposite to its rotation direction.

[0144] Reference now Fig. 10C , Fig. 10D , Fig.10E and Fig.10F , which are schematic illustrations of the atrial region 26 of the valve frame 20 undergoing crimping (ie, radial constraint and axial elongation) according to some applications of the present invention. Figure 10G , Fig. 10H , Fig.10I and Fig.10J , which are schematic diagrams of the atrial region 26 of the valve frame 20 undergoing crimping according to some alternative applications of the present invention. As described above, typically, the valve frame 20 with the artificial valve leaflets 23 disposed therein is delivered to the native atrioventricular valve via a delivery device 40 (e.g., a delivery catheter as shown in FIG. 2 ), and the delivery device is configured to maintain the valve frame and the artificial valve in a radially constrained configuration (i.e., a “crimped” configuration) during delivery.

[0145] like Figure 10C-10F As shown, for some applications, during crimping of the atrial portion of the valve frame, the pores 93 of the atrial portion of the valve frame are elongated and extend substantially in the axial direction so that the tip 94 of each pore is substantially circumferentially aligned with the base 96 of the pore. Figure 10G-10J As shown, for some applications, during crimping of the atrial portion of the valve frame, the pores 93 of the atrial portion of the valve frame are elongated but are configured to bend circumferentially about the longitudinal axis of the valve frame so that the tip 94 of each pore is not circumferentially aligned with the base 96 of the pore. Typically, assuming that the pores of the atrial portion (i.e., the flange) have a given length when the atrial portion is in its radially unconstrained configuration, the axial length of the atrial portion in its crimped configuration is 1 / 2 of the length of the atrial portion. Figure 10G-10J The configuration shown is better than Figure 10C-10FThe axial length of the valve frame is small in the configuration shown. This is because, in addition to the axially extending pores, the pores are also circumferentially curved around the axis of the valve frame. In turn, this typically reduces the overall length of the valve frame when the valve frame is in its crimped configuration. In some cases, this is beneficial because the valve frame is relatively rigid when the valve frame is in its crimped configuration, but during its delivery, the valve frame typically must pass through a bend, such as within a curved blood vessel and / or within a chamber of the heart (such as the left atrium).

[0146] Reference now Figure 10K , which is Figure 10G-10J Schematic diagram of a single repeating structure (i.e., a structure that repeats itself) of the atrial region 26 of the valve frame 20 in the configuration shown. Typically, the pores of the atrial region 26 of the valve frame 20 (similar to the pores of the rest of the valve frame) are made of a shape memory material (e.g., a shape memory alloy such as nitinol and / or copper-aluminum-nickel). For some applications, the pores are configured as described in reference to Figure 10G-10J Alternatively or additionally, in each cell, the struts 98 on one side of the cell are longer than the struts 99 on the other side of the cell, which causes the cell to bend circumferentially about the longitudinal axis of the valve frame as the cell becomes axially elongated during crimping.

[0147] It should be noted that although reference has been described in the context of a particular type of implantable valve frame Figure 10G-10J The lattice designs described herein are for use with other medical devices, but the scope of the present disclosure includes applying such designs mutatis mutandis to frames for other medical devices, such as stents and / or frames for other types of implantable valves.

[0148] Reference now Fig.11A , Fig. 11B , Fig. 11C , Fig.11D , Fig.11E and Fig.11F , which are schematic diagrams of various steps of delivering and deploying a prosthetic mitral valve via a transseptal approach according to some applications of the present invention. Typically, the prosthetic mitral valve includes a valve frame body as described above, with the prosthetic valve leaflets 23 sutured to the cylindrical section, and / or otherwise coupled to the cylindrical section 22 of the valve frame, such as Figure 1D As described above, the prosthetic mitral valve is delivered transseptally (ie, through the vena cava, right atrium and atrial septum), transapically (ie, via the apex of the left ventricle) and / or via different delivery routes, depending on the respective application. Figures 11A-11F The steps of delivering and deploying a prosthetic mitral valve via a transseptal approach are shown by way of illustration and not limitation.

[0149] Typically, a delivery device 40 (eg, a delivery catheter) is guided over a guidewire 102 toward the subject's native mitral valve 100. Fig.11A As shown, the distal end of the delivery device 40 typically enters the left atrium 104 of the subject via the atrial septum 106. Fig. 11B As shown, the distal end of the delivery device is advanced toward the native mitral valve and through the leaflets 108 of the native mitral valve and into the left ventricle 110. When the distal end of the delivery device is disposed within the left ventricle, the chordal recruitment arms 24 are allowed to at least partially radially expand and assume their rotated configuration, such as Fig. 11C As shown. For some applications, the arm is allowed to assume a non-radially constrained configuration by releasing the arm from radial constraint of the delivery device, such as by partially retracting the proximal sleeve 41, and / or by partially advancing the distal front cone 43. Typically, when the chord recruitment arm assumes a rotational configuration, the chord recruitment arm is shaped to extend radially from the valve frame body 21 and bend circumferentially around the valve frame body (e.g., in a clockwise direction as shown). For some applications, the chord recruitment arm is also configured to extend axially toward the atrium of the subject. Typically, the chord recruitment arm is configured to be deployed within the chordae 112 of the native mitral valve when released from the delivery device.

[0150] like Fig.11D As shown, after the chord recruitment arms 24 are deployed in the chords of the native mitral valve, at least a portion of the valve frame 20 is rotated in the direction of arrow 114, thereby causing the chord recruitment arms 24 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. Typically, the chord recruitment arms 24 are configured to bend in a given circumferential direction relative to the longitudinal axis of the valve frame. For example, the arms can bend in a clockwise or counterclockwise direction relative to the longitudinal axis of the valve frame. Typically, after the chord recruitment arms 24 are deployed in the chords of the native mitral valve, the valve frame is rotated in a circumferential direction that is the same as the circumferential bending direction of the arms. Fig.11D In the example shown, the arms are bent in a clockwise circumferential direction (as viewed from the left atrium 104), and the valve frame is rotated in that direction.

[0151] As described above, for some applications, before rotating the valve frame in the circumferential direction that is the same as the circumferential bending direction of the arms, the valve frame is rotated in the opposite circumferential direction. For some applications, delivery device 40 is configured to automatically perform an initial rotation of the valve frame against the circumferential bending direction of the arms by a given angle, and then rotate the valve frame through a predetermined angle along the circumferential bending direction of the arms. For some applications, in the rotated configuration of the arms (e.g., Figure 11C-Figure 11DThe outer surface of each arm has a smooth convex curvature extending along substantially the entire length of the arm, so that during initial rotation (opposite to the circumferential bending direction of the arms), the chordae tendineae slide on the outer surface of the arms without being recruited or caught by the arms. For some applications, because the arms are shaped in this manner, initial rotation of the valve frame results in a relatively large number of chordae tendineae being positioned so as to be recruited by each arm during subsequent rotation steps. During subsequent rotation of the valve frame (in the direction of the circumferential bending of the arms, e.g. Fig.11D Typically, in a rotational configuration of the arm (e.g., in the direction of arrow 114 shown), the chordae tendineae are attracted and deflected by the arm. Figure 11C-Figure 11D As shown), the inner surface of the arm has a concave curvature, and during subsequent rotation of the valve frame, the chordae tendineae are gathered in the space defined by the concave curvature.

[0152] After the chordae recruitment arms 24 have been released and the valve frame 20 has been rotated, the valve frame body 21 (i.e., the cylindrical section 22 and the atrial section 26 of the valve frame) are allowed to assume their non-radially constrained configuration. For some applications, the atrial section is allowed to assume its non-radially constrained configuration by releasing the atrial section from the delivery device, such as by retracting the proximal sleeve 41. For some applications, the cylindrical section is allowed to assume its non-radially constrained configuration by releasing the cylindrical section from the delivery device, such as by advancing the distal nose cone 43. Fig.11E Both the cylindrical section 22 and the atrial section 26 are shown in their non-radially constrained (i.e., radially expanded) configurations. Typically, with the valve frame body assuming its non-radially constrained configuration, the valve frame body is configured to capture the native valve leaflets 108 in a partially closed and twisted configuration, thereby at least partially sealing the space between the native mitral valve and the artificial valve. For example, the cylindrical section may be configured to expand radially so as to capture the native valve leaflets between the cylindrical section and the chordal recruitment arms, and / or the atrial section may be configured to expand radially so as to capture the native valve leaflets between the atrial section and the chordal recruitment arms. For some applications, capturing the native valve leaflets 108 in a partially closed and twisted configuration is achieved by capturing the chordae (which are attached to the leaflets) in a twisted configuration. After performing the above steps, the delivery device 40 will typically then be fully retracted from the left atrium of the subject, as shown. Fig.11F As shown by arrow 120 in FIG.

[0153] Reference now Fig. 12A , Fig. 12B and Fig. 12C, which are schematic diagrams of pores 130A and 130B at the distal end of the cylindrical section 22 of the valve frame 20 in corresponding configurations according to some applications of the present invention. Typically, the pores of the cylindrical section 22 of the valve frame 20 (like the pores of the rest of the valve frame) are made of a shape memory material (e.g., a shape memory alloy such as nitinol and / or copper-aluminum-nickel). As described above, for some applications, during delivery of the valve frame to the mitral valve of a subject, the distal end of the cylindrical section is maintained in a radially constrained configuration within a delivery device (e.g., within the distal nose cone 43)).

[0154] Fig. 12A is a schematic diagram of the pores as configured when the frame is cut from the shape memory material, Fig. 12B is a schematic diagram of the lattice as configured when the shape of the frame is set in its radially unconstrained configuration. Fig. 12C is a schematic diagram of a lattice of cells as configured when the cylindrical sections are retained in a radially constrained configuration within a delivery device.

[0155] For some applications, at the distal end of the cylindrical section of the frame, some cells (cells 130A) include a coupling portion 132 (e.g., an annular coupling portion) for coupling the distal end of the cylindrical section to a delivery device, while other cells (cells 130B) do not include such a coupling portion. Fig. 12A As shown, for some applications, wells 130A are initially cut longer than wells 130B. For some applications, as shown, the widths of wells 130A and wells 130B are similar or identical to each other. Fig. 12A In the configuration shown, the end of the well 130A (which includes the coupling portion) protrudes from the distal end of the cylindrical section of the valve frame relative to the end of the well 130B. Fig. 12B As shown, the shape of the well 130A is set so that the end of the well 130A does not protrude from the distal end of the cylindrical section of the valve frame relative to the end of the well 130B. Typically, this is accomplished by introducing curvature to the struts of the well 130A, for example to reduce the length of the well 130A to be equal to the length of the well 130B. For example, the struts can be shaped so that the well defines an omega shape or a heart shape. Typically, when the cylindrical section of the valve frame is in its non-radially constrained configuration when deployed at the mitral valve of a subject, the wells present a Fig. 12B Thus, although the struts defining pores 130A are longer than the struts defining pores 130B, the struts defining pores 130A are shaped so that pores 130A are not longer than pores 130B. In this way, when the frame is deployed, the coupling portions do not protrude from the ends of the frame, which could cause damage to the subject's tissue.

[0156] refer to Fig. 12C, in a radially constrained (i.e., curled) configuration of the cylindrical portion of the valve frame, both pores 130A and 130B are axially elongated. Because the struts defining pores 130A are longer than the struts defining pores 130B, the distal end of pores 130A protrudes from the distal end of the cylindrical portion of the valve frame relative to the end of pores 130B. Because the connecting portion 132 is disposed at the end of pores 130A, the connecting portion protrudes from the distal end of the cylindrical portion of the valve frame, thereby allowing the connecting portion to be connected to a delivery device. Therefore, during delivery of the device, the connecting portion can be connected to a portion of the delivery device, for example, to an anchoring element 46 (in Figure 2B ) (eg, an anchoring element within a distal nose cone of a delivery device). For some applications, the anchoring element includes a clip, a protrusion, a notch, a snap-fit ​​element, and / or other types of anchoring elements.

[0157] For some applications (not shown), sutures are tied to the distal end of the valve frame as an alternative or in addition to coupling portion 132, and the sutures are used to couple the distal end of the valve frame to the delivery device.

[0158] It should be noted that although reference has been described in the context of a particular type of implantable valve frame Figure 12A-12C The lattice designs described herein are for use with other medical devices, but the scope of the present disclosure includes applying such designs mutatis mutandis to frames for other medical devices, such as stents and / or frames for other types of implantable valves.

[0159] The devices and methods described herein are typically performed on a subject's mitral valve and / or a subject's tricuspid valve. Although some embodiments of the devices and methods have been described primarily with respect to the mitral valve, the scope of the invention includes applying any of the devices and methods described above, mutatis mutandis, to the tricuspid valve.

[0160] For some applications, the devices and methods described herein are performed in conjunction with the devices and methods described in US 2015 / 0173897 to Raanani and / or WO 21 / 028867 to Agian, both of which are incorporated herein by reference.

[0161] Those skilled in the art will recognize that the present invention is not limited to what has been particularly shown and described above. Rather, the scope of protection of the present invention includes the combination and sub-combination of the various features described above, as well as changes and modifications of the present invention that do not belong to the prior art that will occur to those skilled in the art when reading the foregoing description.

Claims

1. An apparatus for use with a delivery device, the apparatus comprising: an implantable framework comprising struts defining a lattice, wherein the lattice is shaped to define a non-radially constrained configuration, and wherein the frame is configured to be delivered into a body of a subject while the frame is retained within the delivery device in the radially constrained configuration, Wherein, when transitioning from the non-radially constrained configuration of the frame to the radially constrained configuration of the frame, at least a portion of the pores are configured to elongate and bend circumferentially around the longitudinal axis of the frame so that for each pore in the portion of pores, the end of the pore becomes circumferentially misaligned with the base of the pore.

2. The device according to claim 1, wherein: The implantable frame is made of a shape memory material, and wherein the pores of the portion are shaped so as to elongate and bend circumferentially about a longitudinal axis of the frame when transitioning from the non-radially constrained configuration of the frame to the radially constrained configuration of the frame.

3. The device according to claim 1, wherein: Within each of the cells belonging to the portion, the struts on one side of the cell are longer than the struts on the other side of the cell so as to allow the cell to stretch and bend circumferentially around the longitudinal axis of the frame when transitioning from the non-radially constrained configuration of the frame to the radially constrained configuration of the frame.

4. The device according to claim 1, wherein: In the radially constrained configuration of the frame, each of the cells belonging to the portion is configured to have an axial length that is less than the axial length of the cell if the cells of the portion are configured so that the ends of the cells are circumferentially aligned with the bases of the cells.

5. The device according to claim 1, wherein: The implantable framework is configured to be delivered through one or more tortuous vessels, and wherein the axial length of the lattice of cells of the portion is configured to facilitate delivery of the implantable framework through the one or more tortuous vessels.

6. The device according to claim 1, wherein: The implantable frame is configured to be delivered through a chamber of the heart, and wherein the axial length of the lattice of cells of the portion is configured to facilitate delivery of the implantable frame through the chamber of the heart.

7. The device according to claim 1, wherein: The implantable framework includes an implantable stent.

8. The device according to any one of claims 1 to 6, wherein: The implantable frame includes an implantable valve frame configured to be implanted at a native valve of a subject, and the device further includes a plurality of prosthetic valve leaflets coupled to the implantable valve frame.

9. The device according to claim 8, wherein: The implantable valve holder includes an implantable valve holder configured to be implanted at a native atrioventricular valve of a subject.

10. The device according to claim 9, wherein: The implantable valve frame comprises: an atrial region comprising a disk-shaped portion and a frustoconical portion, the disk-shaped portion being configured to be deployed on the atrial side of an annulus of an atrioventricular valve; and a cylindrical section to which the prosthetic valve leaflets are coupled, the cylindrical section being configured to be deployed such that a ventricular end of the cylindrical section is disposed within a ventricle of a subject, Wherein, the portion of the pores configured to be elongated and circumferentially curved about the longitudinal axis of the frame that is configured as a portion of the pores includes the pores of the disc-shaped portion of the atrial region of the frame.

11. The device according to claim 10, wherein: The frustoconical portion of the atrial sector is coupled to the cylindrical sector such that there is an axial overlap between at least the frustoconical portion of the atrial sector and the cylindrical sector.

12. The device according to claim 11, wherein The frustoconical portion of the atrial portion is coupled to the cylindrical portion such that the frustoconical portion of the atrial portion extends from an axial position along the cylindrical portion that is at a lowest 50% of the height of the cylindrical portion.

13. The device according to claim 9, wherein: The implantable valve frame also includes a plurality of chord recruitment arms configured to extend radially from at least the ventricular end of the cylindrical section.

14. The device according to claim 13, wherein: The valve holder is configured to be delivered to an atrioventricular valve, Subsequently, the plurality of chord recruitment arms are configured to be deployed between the chordae tendineae of the native atrioventricular valve, and Subsequently, at least a portion of the valve frame is configured to be rotated by the delivery device to cause the plurality of chord recruitment arms 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 chordae tendineae.

15. A method comprising: placing an implantable frame including struts defining a lattice of cells into a delivery device to transition the frame from a non-radially constrained configuration of the frame to a radially constrained configuration of the frame, thereby causing at least a portion of the lattice of cells to elongate and circumferentially bend about a longitudinal axis of the frame such that, for each of the cells in the portion of the lattice of cells, a distal end of the lattice of cells becomes circumferentially misaligned with a base of the lattice of cells; delivering the implantable frame to a deployment site within a body of a subject; as well as The implantable frame is released from the delivery device, thereby transitioning the frame from the radially constrained configuration of the frame to the non-radially constrained configuration of the frame.

16. An apparatus for use with a delivery device, the apparatus comprising: an implantable framework comprising struts defining a lattice, wherein, at an end of the frame, a first set of wells comprises a coupling portion for coupling the frame to the delivery device, and a second set of wells does not comprise the coupling portion, wherein the first set of cells are shaped such that in a radially unconstrained configuration of the frame, the length of the first set of cells is the same as the length of the second set of cells such that the coupling portion does not protrude from the end of the frame, and Wherein, the struts defining the first group of holes are longer than the struts defining the second group of holes, so that in the radial constraint configuration of the frame, the length of the first group of holes is greater than the length of the second group of holes, so that the connecting part protrudes from the end of the frame.

17. The device according to claim 16, wherein: The frame is configured to assume its radially non-constrained configuration when deployed within the body of a subject, and wherein the connecting portion does not protrude from the end of the frame when the frame assumes its radially non-constrained configuration, thereby reducing the risk of the connecting portion causing damage to the subject's tissue relative to if the connecting portion protrudes from the end of the frame.

18. The device according to claim 16, wherein: The implantable framework includes an implantable stent.

19. The device according to any one of claims 16 to 18, wherein: The delivery device includes an anchoring element, the connecting portion is configured to be connected to the anchoring element, wherein the implantable frame is configured to be delivered into the body of a subject when disposed in the delivery device in the radially constrained configuration, and wherein the connecting portion is configured to protrude from the end of the frame to facilitate connecting the connecting portion to the anchoring element of the delivery device.

20. The device according to claim 19, wherein The delivery device comprises a distal nose cone including the anchoring element, and wherein the coupling portion is configured to protrude from the end of the frame to facilitate coupling the coupling portion to the anchoring element of the distal nose cone of the delivery device.

21. The device according to any one of claims 16 to 18, wherein When transitioning from the non-radially constrained configuration of the frame to the radially constrained configuration of the frame, the pores of at least a portion of the frame at the second end of the frame are configured to elongate and bend circumferentially around the longitudinal axis of the frame so that for each pore in the portion of the pores, the end of the pore becomes circumferentially misaligned with the base of the pore.

22. The device according to claim 21, wherein In the radially constrained configuration of the frame, each of the cells belonging to the portion is configured to have an axial length that is less than the axial length of the cell if the cells of the portion are configured so that the ends of the cells are circumferentially aligned with the bases of the cells.

23. The device according to claim 22, wherein: The implantable framework is configured to be delivered through one or more tortuous vessels, and wherein the axial length of the portion of the lattice is configured to facilitate delivery of the implantable framework through the one or more tortuous vessels.

24. The device according to claim 22, wherein: The implantable frame is configured to be delivered through a chamber of the heart, and wherein the axial length of the lattice of cells of the portion is configured to facilitate delivery of the implantable frame through the chamber of the heart.

25. The apparatus of claim 16 or claim 17, wherein: The implantable frame includes an implantable valve frame configured to be implanted at a subject's native valve, and the device also includes a plurality of prosthetic valve leaflets coupled to the implantable valve frame.

26. The device according to claim 25, wherein The implantable valve holder includes an implantable valve holder configured to be implanted at a native atrioventricular valve of a subject.

27. The device according to claim 26, wherein: The implantable valve frame comprises: an atrial region comprising a disk-shaped portion and a frustoconical portion, the disk-shaped portion being configured to be deployed on the atrial side of an annulus of an atrioventricular valve; and a cylindrical section to which the prosthetic valve leaflets are coupled, the cylindrical section being configured to be deployed such that a ventricular end of the cylindrical section is disposed within a ventricle of the subject, Wherein, the first group of wells and the second group of wells are arranged at the ventricular end of the cylindrical section of the implantable valve frame.

28. The device according to claim 27, wherein The frustoconical portion of the atrial sector is coupled to the cylindrical sector such that there is an axial overlap between at least the frustoconical portion of the atrial sector and the cylindrical sector.

29. The device according to claim 28, wherein The frustoconical portion of the atrial portion is coupled to the cylindrical portion such that the frustoconical portion of the atrial portion extends from an axial position along the cylindrical portion that is at a lowest 50% of the height of the cylindrical portion.

30. The device according to claim 26, wherein: The implantable valve frame also includes a plurality of chord recruitment arms configured to extend radially from at least the ventricular end of the cylindrical section.

31. The apparatus of claim 30, wherein: The valve holder is configured to be delivered to an atrioventricular valve, Subsequently, the plurality of chord recruitment arms are configured to be deployed between the chordae tendineae of the native atrioventricular valve, and Subsequently, at least a portion of the valve frame is configured to be rotated by the delivery device to cause the plurality of chord recruitment arms 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 chordae tendineae.

32. A method comprising: placing an implantable frame including struts defining a lattice into a delivery device to transition the frame from a non-radially constrained configuration of the frame to a radially constrained configuration of the frame, The frame is configured such that at an end of the frame, a first set of cells includes a coupling portion for coupling the frame to the delivery device and a second set of cells does not include the coupling portion, and struts defining the first set of cells are longer than struts defining the second set of cells, such that in the radially constrained configuration of the frame, the length of the first set of cells is greater than the length of the second set of cells, such that the coupling portion protrudes from the end of the frame; delivering the implantable frame to a deployment site within a body of a subject; and The implantable frame is released from the delivery device, thereby transitioning the frame from the radially constrained configuration of the frame to the non-radially constrained configuration of the frame, wherein the first group of pores is shaped so that in the radially non-constrained configuration of the frame, the length of the first group of pores is the same as the length of the second group of pores so that the connecting portion does not protrude from the end of the frame.

Images