Atrioventricular valve repair

Abstract

To provide apparatus and methods for use with an annuloplasty ring, and an atrioventricular valve of a heart of a mammalian subject.SOLUTION: The atrioventricular valve including a valve annulus, valve leaflets, chords, and papillary muscles. A plurality of chord-manipulation arms (26) are configured to be deployed among the chords of the atrioventricular valve, and to cause a size of the valve annulus to decrease, by the chord-manipulation arms (26) being rotated such as to twist the native atrioventricular valve and pull the native atrioventricular valve radially inwards, by the chord-manipulation arms (26) deflecting the chords. The chord-manipulation arms (26) are configured to subsequently provide a counterforce against which the annuloplasty ring is pushed, during implantation of the annuloplasty ring. Other applications are also described.SELECTED DRAWING: Figure 1A

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 767,018, entitled "Atrioventricular valve repair," filed Nov. 14, 2018, to Raanani, which is incorporated herein by reference.

[0002] Field of the Invention The present invention relates to medical devices and methods, and in particular to devices and methods for repairing atrioventricular valves. [Background technology]

[0003] background The human heart is a four-chambered muscular organ that, by contraction, pumps deoxygenated blood to the lungs to oxygenate the blood, and pumps oxygenated blood to the rest of the body.

[0004] After circulating through the body, deoxygenated blood from the body enters the right atrium via the vena cava. In healthy subjects, when the right atrium contracts, blood is pumped through the tricuspid valve into the right ventricle. When the right ventricle contracts, blood is pumped through the pulmonary semilunar valve into the pulmonary artery. The pulmonary artery splits into two branches, one for each lung. Blood is oxygenated while passing through the lungs and returns to the heart again via the left atrium. When the left atrium contracts, oxygenated blood is pumped through the mitral valve into the left ventricle. When the left ventricle contracts, oxygenated blood is pumped through the aortic valve into the aorta for distribution to the rest of the body. During contraction of the right ventricle, the tricuspid valve is closed, thus preventing the backflow of blood into the right atrium. Similarly, during contraction of the left ventricle, the mitral valve is closed, thus preventing the backflow of blood into the left atrium. The mitral and tricuspid valves are known as the atrioventricular valves and control the flow of blood between the atria and ventricles, respectively.

[0005] In the mitral valve, the mitral annulus defines the mitral orifice. Anterior and posterior leaflets extend from the annulus. The leaflets are connected to the papillary muscles in the left ventricle by chordae tendineae.

[0006] During ventricular diastole, in a healthy subject, the left atrium contracts and blood is pumped through the mitral valve orifice into the left ventricle. Blood flows through the orifice, pushing the leaflets open and entering the left ventricle with minimal resistance. In a healthy subject, the leaflets of the aortic valve are held closed by the aortic blood pressure.

[0007] During ventricular systole, the left ventricle contracts and pumps blood through the aortic valve into the aorta. The leaflets of the aortic valve are forced open by blood flow. In healthy subjects, the mitral annulus contracts, pushing the leaflets inward, reducing the area of ​​the mitral orifice by approximately 20%-30%. The leaflets coapt to absorb the excess leaflet surface area and create a coaptation surface that forms a seal. The pressure of blood in the left ventricle pushes against the ventricular surfaces of the leaflets, forcing them tightly together at the coaptation surface, forming a tight, leak-free seal.

[0008] Effective sealing of the mitral valve during ventricular systole depends on sufficient depth of coaptation. Inadequate coaptation can result from a number of physical abnormalities that allow the leaflets to prolapse (e.g., stretched or torn chordae tendineae, or weak papillary muscles) or inhibit coaptation (e.g., short chordae tendineae or small leaflets). There are also pathologies that lead to mitral valve insufficiency, including collagen vascular disease, ischemic mitral regurgitation (e.g., resulting from myocardial infarction, chronic heart failure, or failed / unsuccessful surgical or catheter revascularization), myxomatous degeneration of the leaflets, and rheumatic heart disease. Mitral regurgitation leads to many 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.

[0009] The tricuspid valve includes three leaflets, namely, the septal leaflet, the anterior leaflet, and the posterior leaflet. Each leaflet is fixed to a tricuspid annulus that defines the orifice of the tricuspid valve. The leaflets are connected to the papillary muscles in 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, similar to the control of the mitral valve on the direction of blood flow in the left side of the heart. During ventricular diastole, the tricuspid valve opens to allow blood flow, for example, from the right atrium to the right ventricle, and during ventricular systole, the leaflets of the tricuspid valve coapt to prevent backflow of blood, for example, from the right ventricle to the right atrium.

[0010] Tricuspid regurgitation occurs when the tricuspid valve does not close properly. This can cause blood to back up into the right atrium when the right ventricle contracts. The most common cause of tricuspid regurgitation is right ventricular dilation, which leads to dilation of the tricuspid annulus, resulting in the leaflets not coapting properly.

[0011] Non-human mammals that suffer from mitral and tricuspid regurgitation include horses, cats, dogs, cows, sheep, and pigs.

[0012] For example, it is known to use open-heart surgical techniques to treat mitral and tricuspid regurgitation by modifying the subvalvular apparatus (e.g., lengthening or shortening the chordae tendineae) to improve leaflet coaptation and / or by implanting annuloplasty rings to reduce the size of the annulus. Summary of the Invention [Means for solving the problem]

[0013] Overview of the embodiment According to some applications of the present invention, devices and methods are provided for facilitating implantation of an annuloplasty ring onto an atrioventricular valve of a subject's heart (e.g., a subject's mitral valve or a subject's tricuspid valve). Typically, multiple chordae tendineae manipulation arms are deployed between the chordae tendineae of the atrioventricular valve. The arms are then rotated such that the arms twist the native atrioventricular valve by deflecting the chordae tendineae and reduce the size of the annulus by pulling the native atrioventricular valve radially inwards. After rotating the arms, the annuloplasty ring is implanted onto the annulus. During implantation of the annuloplasty ring, the arms are typically used to maintain the size of the annulus at its reduced size by maintaining the arms in its rotated state. In some applications, during implantation of the annuloplasty ring, the arms are used to provide a counter force against which the annuloplasty ring is pressed by pulling the arms from under the leaflets towards the annuloplasty ring.

[0014] Typically, after the annuloplasty ring is implanted, the chordae manipulation arms are rotated in the opposite direction to the previous rotation of the chordae manipulation arms, and the arms are removed from the subject's body. Typically, the rotation of the chordae manipulation arms in the opposite direction allows the native atrioventricular valve to untwist. However, the annuloplasty ring maintains the atrioventricular valve annulus at a reduced size relative to the expanded size of the annulus prior to implantation of the ring. In some applications, the annuloplasty ring is secured to the arms, arm portions, and / or arm extensions, and the arms, arm portions, and / or arm extensions are left in place under the atrioventricular valve leaflets. In some applications, the arm portions and / or arm extensions are detachable and configured to remain in place under the atrioventricular valve leaflets even after the arms or arm portions are removed from the subject's ventricle.

[0015] Thus, according to some applications of the present invention, there is provided an apparatus for use with an annuloplasty ring and an atrioventricular valve of a mammalian subject's heart, the atrioventricular valve including an annulus, leaflets, chordae tendineae, and papillary muscles, the apparatus comprising: A plurality of chordae manipulation arms, It is deployed between the chordae of the atrioventricular valves, Thereafter, the size of the annulus is reduced, for example, by rotating the chordae manipulation arms such that the chordae manipulation arms flex the chordae, thereby twisting the native atrioventricular valve and pulling the native atrioventricular valve radially inward; Thereafter, during implantation of the annuloplasty ring, the annuloplasty ring provides a counterforce against which the annuloplasty ring is compressed. a plurality of chordae manipulation arms configured to An apparatus is provided.

[0016] In some applications, the chordae tendineae manipulation arms are configured to allow the native atrioventricular valve to be untwisted after the annuloplasty ring has been implanted by rotating the chordae tendineae manipulation arms in a direction opposite to the direction of rotation of the chordae tendineae manipulation arms that twisted the native atrioventricular valve.

[0017] For some applications, the device further comprises an annuloplasty ring.

[0018] In some applications, the atrioventricular valve includes a mitral valve and the chordae tendineae manipulation arms are configured to be deployed between chordae of the mitral valve.In some applications, the atrioventricular valve includes a tricuspid valve and the chordae tendineae manipulation arms are configured to be deployed between chordae of the tricuspid valve.

[0019] In some applications, the multiple chordae manipulation arms include more than two chordae manipulation arms and less than twelve chordae manipulation arms.

[0020] In some applications, the chorda manipulation arms are sized to span a diameter at least equal to an inner diameter of the annuloplasty ring when the chorda manipulation arms are disposed in a radially unconstrained configuration, such that the chorda manipulation arms are configured to provide a counter force against which the annuloplasty ring may be compressed during implantation of the annuloplasty ring.In some applications, the chorda manipulation arms are sized to be configured to radially overlap the annuloplasty ring when the chorda manipulation arms are disposed in a radially unconstrained configuration, such that the chorda manipulation arms are configured to provide a counter force against which the annuloplasty ring may be compressed during implantation of the annuloplasty ring.

[0021] In some applications, at least a portion of the inner edge of each chorda manipulating arm is concavely curved in the given circumferential direction, and the chorda manipulating arms are configured to rotate in the given circumferential direction to pull the native atrioventricular valve radially inward. In some applications, the inner edge of each chorda manipulating arm is concavely curved in the given circumferential direction along the entire length of the inner edge of the chorda manipulating arm. In some applications, a radially outermost portion of the inner edge of each chorda manipulating arm is concavely curved in the given circumferential direction.

[0022] In some applications, the chordae manipulation arm, a portion of the chordae manipulation arm, and / or an extension from the chordae manipulation arm are configured to remain under the leaflets of the atrioventricular valve, and the annuloplasty ring is configured to be secured to the chordae manipulation arm, a portion of the chordae manipulation arm, and / or an extension from the chordae manipulation arm. In some applications, the chordae manipulation arm includes a first portion and a second portion, and the annuloplasty ring is configured to be secured to the first portion of the chordae manipulation arm, and the first portion of the chordae manipulation arm is configured to be detachable from the second portion of the chordae manipulation arm and configured to remain under the leaflets of the atrioventricular valve even after the second portion of the chordae manipulation arm is removed from the ventricle of the subject. In some applications, the annuloplasty ring is configured to be secured to the extension from the chordae manipulation arm, and the extension from the chordae manipulation arm is configured to be detachable and configured to remain under the leaflets of the atrioventricular valve even after the chordae manipulation arm is removed from the ventricle of the subject. In some applications, a plate is disposed on the ends of at least some of the chordae manipulation arms, the plate configured to remain under the leaflets of the atrioventricular valve, and the annuloplasty ring configured to be secured to the plate. In some applications, the annuloplasty ring includes a plurality of anchor elements, at least some of which are configured to be embedded in the chordae manipulation arms, portions of the chordae manipulation arms, and / or extensions from the chordae manipulation arms.

[0023] In some applications, the device further includes a frame configured to extend beneath the leaflets of the atrioventricular valve into the atrium of the subject's heart, the frame defining a hole sized to, for example, allow blood to flow through the frame from the atrium to the ventricle of the subject's heart, and the chordae tendineae manipulation arms are coupled to a portion of the frame configured to be positioned within the ventricle, in some applications, the portion of the frame configured to be positioned within the ventricle is configured to radially self-expand such that the location of the frame to which the arms are coupled has a greater circumference than the portion of the frame configured to be positioned within the atrium.

[0024] In some applications, The apparatus further includes a post and a hollow tube defining a hole; the chordae manipulation arm is coupled to the post, the post being configured to be disposed within the hollow tube; The holes in the hollow tube are sized to allow blood to flow through the hollow tube, for example, from an atrium of the subject's heart to a ventricle of the subject's heart.

[0025] For some applications, the device further includes a one-way valve disposed within the hollow tube and configured to allow blood flow from the atrium to the ventricle but prevent blood flow in the opposite direction.

[0026] In some applications, the apparatus further includes a delivery device configured to deliver the chordae tendineae manipulation arm to a ventricle of the subject's heart, the arm being disposed at an angle between 45 degrees and 135 degrees relative to a longitudinal axis of a distal-most portion of the delivery device. In some applications, the arm is disposed at an angle between 70 degrees and 110 degrees relative to a longitudinal axis of the distal-most portion of the delivery device. In some applications, the arm is disposed at an angle between 85 degrees and 95 degrees relative to a longitudinal axis of the distal-most portion of the delivery device. In some applications, the arm is disposed at an angle of about 90 degrees relative to a longitudinal axis of the distal-most portion of the delivery device.

[0027] In some applications, the device further includes a plurality of support elements, each chordae manipulation arm coupled to a corresponding one of the support elements, the support elements configured to be brought together during delivery of the arms to a ventricle of the subject's heart, and the support elements configured to be separated from one another during deployment of the arms within the ventricle. In some applications, the device further includes a separation element, the support elements configured to be separated from one another by retracting the separation element such that the separation element is disposed between the support elements. In some applications, the support elements are configured to be separated from one another to allow blood flow from an atrium to a ventricle of the subject's heart.

[0028] According to some applications of the present invention, there is provided an apparatus for use with an atrioventricular valve of a heart of a mammalian subject, the atrioventricular valve including an annulus, leaflets, chordae tendineae, and papillary muscles, the apparatus comprising: an annuloplasty ring defining an inner diameter; a plurality of arms sized to span a diameter at least equal to an inner diameter of the annuloplasty ring when the arms are arranged in a radially unconstrained configuration such that the arms are configured to provide a counter force against the annuloplasty ring during implantation of the annuloplasty ring; An apparatus is further provided, comprising:

[0029] According to some applications of the present invention, there is provided an annuloplasty ring and a method for use with an atrioventricular valve of a heart of a mammalian subject, the atrioventricular valve including an annulus, leaflets, chordae tendineae, and papillary muscles, the method comprising: deploying a plurality of chordae manipulation arms between the chordae of the atrioventricular valve; thereafter, rotating the arms such that the arms twist the native atrioventricular valve by deflecting the chordae tendineae and reduce the size of the annulus by pulling the native atrioventricular valve radially inward; thereafter, implanting the annuloplasty ring over the annulus while using the arms to (a) maintain the size of the annulus at its reduced size by maintaining the arms in its rotated state, and (b) provide a counter force against which the annuloplasty ring is pressed by pulling the arms from beneath the leaflets toward the annuloplasty ring. Further provided is a method comprising:

[0030] According to some applications of the present invention, there is provided an annuloplasty ring and a method for use with an atrioventricular valve of a heart of a mammalian subject, the atrioventricular valve including an annulus, leaflets, chordae tendineae, and papillary muscles, the method comprising: deploying a plurality of arms beneath the leaflets of the native atrioventricular valve; thereafter, implanting the annuloplasty ring onto the annulus while using the arms to provide a counterforce against which the annuloplasty ring is pressed by pulling the arms from beneath the leaflets toward the annuloplasty ring; A method is further provided, comprising:

[0031] The present invention will be more fully understood from the following detailed description of its application, taken in conjunction with the drawings in which: [Brief description of the drawings]

[0032] [Figure 1A] 1A-1C are schematic diagrams of procedural steps for implanting an annuloplasty ring on an atrioventricular valve of a subject, according to some applications of the present invention. [Figure 1B] 1A-1C are schematic diagrams of procedural steps for implanting an annuloplasty ring on an atrioventricular valve of a subject, according to some applications of the present invention. [Figure 1C] 1A-1C are schematic diagrams of procedural steps for implanting an annuloplasty ring on an atrioventricular valve of a subject, according to some applications of the present invention. [Figure 1D] 1A-1C are schematic diagrams of procedural steps for implanting an annuloplasty ring on an atrioventricular valve of a subject, according to some applications of the present invention. [Figure 1E] 1A-1C are schematic diagrams of procedural steps for implanting an annuloplasty ring on an atrioventricular valve of a subject, according to some applications of the present invention. [Figure 1F] 1A-1C are schematic diagrams of the final steps of a procedure for implanting an annuloplasty ring on an atrioventricular valve of a subject, with a portion of the device implanted under the leaflets of the atrioventricular valve in the subject's ventricle, in accordance with some applications of the present invention. [Figure 1G] 1A-1C are schematic diagrams of the final steps of a procedure for implanting an annuloplasty ring on an atrioventricular valve of a subject, with a portion of the device implanted under the leaflets of the atrioventricular valve in the subject's ventricle, in accordance with some applications of the present invention. [Figure 2A] 1 is a schematic diagram of a series of chordae manipulation arms used during implantation of an annuloplasty ring onto an atrioventricular valve of a subject, according to some applications of the present invention. [Figure 2B]1 is a schematic diagram of a series of chordae manipulation arms used during implantation of an annuloplasty ring onto an atrioventricular valve of a subject, according to some applications of the present invention. [Diagram 3] FIG. 1 is a schematic diagram of a chordae manipulation arm attached to a frame including at least a radially self-expandable ventricular portion, according to some applications of the present invention. [Figure 4] 1 is a schematic diagram of a chordae manipulation arm coupled to a strut, according to some applications of the present invention. FIG. [Figure 5A] 1 is a schematic diagram of a series of chordae manipulation arms used during implantation of an annuloplasty ring onto an atrioventricular valve of a subject, according to some applications of the present invention. [Figure 5B] 1 is a schematic diagram of a series of chordae manipulation arms used during implantation of an annuloplasty ring onto an atrioventricular valve of a subject, according to some applications of the present invention. [Figure 5C] 1 is a schematic diagram of a series of chordae manipulation arms used during implantation of an annuloplasty ring onto an atrioventricular valve of a subject, according to some applications of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0033] Detailed Description of the Preferred Embodiments Reference is now made to Figures 1A, 1B, 1C, 1D, and 1E, which are schematic illustrations of steps of a procedure for implanting an annuloplasty ring 20 (shown in Figures 1C-1E) in an atrioventricular valve 22 of a subject, in accordance with some applications of the present invention. The atrioventricular valve is divided between the atrium 16 and the ventricle 18 and typically includes annulus 21, valve cusps 23, chordae tendineae 25, and papillary muscles 27.

[0034] In the first step of the procedure, a delivery device 24 is delivered to the atrioventricular valve. Then, as shown in FIG. 1A, a number of chordae tendineae manipulation arms 26 are released from the delivery device. It is noted that in FIGS. 1A-1G and 5, the chordae tendineae manipulation arms 26 are shown deployed between the chordae tendineae of the mitral valve. However, the scope of the present application includes the application of the devices and methods described herein to the tricuspid valve, mutatis mutandis. It is further noted that in FIGS. 1A-1D, 1F, and 5, the delivery device is shown being introduced from above the mitral valve (e.g., by transseptal or transatrial delivery). However, the scope of the present application includes the introduction of the delivery device from below the mitral valve (e.g., by transapical delivery). In applications where the devices and methods described herein are applied to the tricuspid valve, the delivery device is typically delivered to the tricuspid valve via the jugular vein, the subclavian vein, or the inferior vena cava. Finally, it should be noted that for illustrative purposes, Figures 1A-1D and 5 of the present application show cross-sectional views of the heart (and annuloplasty ring, if applicable) along with a full three-dimensional view of the chordae tendineae manipulation arm 26.

[0035] In some applications, to release the arms from the delivery device, the covering sheath 28 of the delivery device is pulled back against the chordae tendineae manipulation arms 26 or the arms are pushed forward against the delivery device. Typically, the arms are made of a shape memory material (e.g., a shape memory alloy such as Nitinol or copper-aluminum-nickel) that is shaped so that the arms extend radially outward relative to the delivery device when released from the delivery device. Alternatively, the arms are made of a different material. The arms are typically configured to extend radially outward to a sufficient extent for the arms to be deployed between the chordae tendineae 25 of the atrioventricular valves, as shown in FIG. 1A. In some applications, the arms extend radially outward to a sufficient extent for the arms to be deployed between the primary and / or secondary chordae tendineae. More typically, as shown, the arms are shaped so that they are curved in a circumferential direction. In some applications, the circumferential curvature of each arm is such that at least a portion of the inner edge 29 (shown in FIG. 1A) of the arm is curved concavely in a given circumferential direction. For example, as shown in Figure 1A, at least a portion of the inner edge 29 of the arm is concavely curved in a clockwise circumferential direction. In some applications, the inner edge 29 of the arm is concavely curved in a given circumferential direction along the entire length of the arm. Typically, at least a leading portion of the inner edge 29 of the arm (i.e., the radially outermost portion of the inner edge of the arm, which typically contacts the chordae first) is concavely curved in a given circumferential direction.

[0036] In the next step of the procedure, the chordae tendineae manipulation arm 26 is rotated (clockwise or counterclockwise) in the direction of the concave circumferential curvature of the inner edge of the arm. For example, for an arm shaped as shown in FIG. 1A, the arm is rotated in a clockwise direction. Alternatively (not shown), the arm may be shaped such that the concave circumferential curvature of the inner edge of the arm is in a counterclockwise direction, in which case the arm is typically rotated in a counterclockwise direction. Typically, the rotation of the arm deflects the chordae tendineae between which the arm is deployed. Furthermore, the deflection of the chordae tendineae twists and pulls at least a portion of the atrioventricular valve (e.g., the leaflets and annulus of the atrioventricular valve) radially inward toward the base of the arm, since the chordae tendineae extend between the papillary muscles at the first end of the chordae tendineae and, through the leaflets, the mitral annulus at the second end of the chordae tendineae. Pulling the native atrioventricular valve radially inward due to the deflection of the chordae tendineae results in a reduction of the annulus. Thus, in this manner, the atrioventricular valve annulus 21 is reduced in size relative to the size of the atrioventricular valve annulus prior to rotation of the arms. FIG. 1B is a schematic diagram of the mitral valve after the arms have been rotated in the manner described above. FIG. 1B includes a top view of the mitral valve (within the dashed box). As shown, the leaflets have been twisted due to the rotation of the arms. Furthermore, as may be noted by comparing FIG. 1B with FIG. 1A, the mitral valve annulus has been pulled radially inward in the direction of arrow 31 due to the rotation of the arms.

[0037] In the next step of the procedure, the annuloplasty ring 20 is implanted on the atrioventricular valve annulus. The arms are maintained in their rotated position so that they maintain the atrioventricular valve annulus at its reduced size during annuloplasty ring implantation. In this manner, the annuloplasty ring is implanted on the atrioventricular valve annulus that is already reduced in size relative to the size of the atrioventricular valve annulus before the start of the annuloplasty procedure. This is in contrast to some other techniques for annuloplasty ring implantation, in which the size of the annulus is not reduced prior to annuloplasty ring implantation. Rather, according to such techniques, the annuloplasty ring itself is used to reduce the size of the atrioventricular valve annulus during annuloplasty ring implantation, and / or the ring is first attached to the atrioventricular valve annulus and then the diameter of the ring is reduced (e.g., by cinching the ring).

[0038] 1C and 1D show an annuloplasty ring being delivered to the atrial side of the atrioventricular valve using an annuloplasty ring delivery device 54 that is coupleable (or coupled) to a delivery device 24, for example, via an elongate element 56. In some applications, the annuloplasty ring includes a plurality of anchor elements 58 (e.g., barbs, hooks, and / or other anchor elements) configured to be embedded in the tissue of the annulus to secure the annuloplasty ring to the annulus. In some applications, the arms 26 are pulled toward the annuloplasty ring, as shown by arrow 30 in FIG. 1D, such that the arms (located below the leaflets) provide a counterforce against which the annuloplasty ring is pressed (from above the leaflets) during implantation of the annuloplasty ring. Typically, in such applications, the arms are sized to span a diameter at least equal to the inner diameter of the annuloplasty ring when the arms are positioned in a radially unconstrained configuration. Thus, the arms are configured such that in their radially unconstrained configuration, the arms radially overlap the annuloplasty ring.

[0039] In some applications, after the annuloplasty ring is implanted, the arms 26 are retracted back into the delivery device and removed from the subject's body, as shown in FIG. 1E, which shows a cross-sectional view of the implanted annuloplasty ring without the arms and delivery device. At this stage, the annuloplasty ring typically maintains the annulus at a reduced size (relative to its expanded size before the procedure). Typically, after the annuloplasty ring is implanted, the chord-manipulation arms are rotated in the opposite direction to the direction in which they were previously rotated, and the arms are removed from the subject's body. Typically, the rotation of the chord-manipulation in the opposite direction allows the native atrioventricular valve to untwist. However, the annuloplasty ring maintains the annulus at a reduced size relative to the expanded size of the annulus before implantation of the ring.

[0040] In some applications, to provide the above-mentioned fixation function, the annuloplasty ring is fixed to the arm 26, a portion of the arm, and / or an extension of the arm, and the arm, portion of the arm, and / or an extension of the arm are left in place under the leaflets of the atrioventricular valve. In some applications, the portion of the arm and / or an extension of the arm are detachable and configured to remain in place under the leaflets of the atrioventricular valve even after the arm or portion of the arm is removed from the target ventricle. For example, Figures 1F and 1G show an embodiment in which a plate 34 is disposed at the end of the arm and the annuloplasty ring is fixed to the plate (e.g., by embedding at least some of the anchor elements 58 in the plate, as shown in Figure 1G). In this way, at least a portion of the arm 26 and / or an extension of the arm function as an intraventricular anchor to which the annuloplasty ring is fixed.

[0041] Reference is now made to Figures 2A and 2B, which are schematic side and bottom views, respectively, of a series of chordae tendineae manipulation arms 26 used during implantation of an annuloplasty ring 20 in a subject's atrioventricular valve, according to some applications of the present invention. In some applications, the arms are coupled to a frame 40 configured to extend from beneath the leaflets of the atrioventricular valve (i.e., within the ventricle) into the atrium of the subject (e.g., as shown in Figures 1A-1D and 1F). The frame defines holes sized to allow blood to flow through the frame from the atrium to the ventricle while, for example, the procedures described above are being performed. This is indicated in Figure 1B by arrows 42 indicating blood flow.

[0042] Reference is now made to FIG. 3, which is a schematic diagram of chordae manipulation arms 26 attached to a frame 40. The arms are typically coupled to a ventricular portion 44 of the frame, and an atrial portion 46 of the frame extends upward into the atrium, for example, to facilitate blood flow from the atrium to the ventricle in the manner described above. In some applications, the ventricular portion 44 of the frame is configured to self-expand radially, such that the location of the frame to which the arms are coupled has a greater circumference than the atrial portion of the frame. In some applications, the expansion of the ventricular portion of the frame facilitates the arms extending radially outward to a sufficient extent for them to be deployed between the chordae 25 (e.g., primary and / or secondary chordae) of the atrioventricular valve.

[0043] Reference is now made to FIG. 4, which is a schematic illustration of a chordae manipulation arm 26 coupled to a strut 60, according to some applications of the present invention. Typically, the strut 60 is disposed within a hollow tube 62, which defines a hole 64 (e.g., a side hole as shown) configured to be disposed within the atrium. The hole is sized to allow blood to flow, for example, from the atrium to the ventricle through the hollow tube (as indicated by blood flow arrow 42) and out of an outflow hole (the arm typically protrudes from this hole) disposed within the ventricle. The hole in the hollow tube 62 typically allows blood to flow from the atrium to the ventricle while the above-mentioned procedures are being performed. In some applications, a one-way valve (not shown) is disposed within the hollow tube 62. The one-way valve is configured to allow blood flow from the atrium to the ventricle, but prevents blood flow in the opposite direction.

[0044] 2B, in some applications, the angle "α" that the arms make with respect to the frame 40 or post 60 (and with respect to the longitudinal axis of the distal-most portion of the delivery device) is about 90 degrees (e.g., 90 degrees plus / minus 3 degrees, or exactly 90 degrees). Alternatively, the angle may be acute or obtuse. In some applications, the arms are disposed at an angle α of 45 to 135 degrees (e.g., 70 to 110 degrees, or 85 to 95 degrees) with respect to the longitudinal axis of the distal-most portion of the delivery device.

[0045] Reference is now made to Figures 5A and 5B, which show schematic views of a series of chordae tendineae manipulation arms 26 used during implantation of an annuloplasty ring 20 in a subject's atrioventricular valve according to some applications of the present invention. In some applications, each arm is coupled to a corresponding support element 50, which are separable from one another. During delivery of the arms to the ventricle, the support elements are typically grouped together (e.g., by being constrained within a delivery device) to reduce the delivery profile of the device. Now referring to Figure 5C, during deployment of the arms within the subject's ventricle, the support elements are separated from one another, for example, by pulling back a separation element 52 so that it is disposed between the support elements. Typically, while the above-mentioned procedure is being performed, blood flow from the atrium to the ventricle continues due to the separation between the support elements, as indicated by blood flow arrows 42 in Figure 5C.

[0046] The scope of the present application includes the use of chordae manipulation arms having any shape that facilitates their use in the manner described herein. Typically, more than two arms (e.g., more than four arms) and / or less than twelve arms (e.g., less than ten arms) are used. As described herein above, depending on the application, the arms are positioned at about 90 degrees (e.g., 90 degrees plus / minus 3 degrees, or exactly 90 degrees) relative to the longitudinal axis of the most distal part of the delivery device, define an acute angle relative to the longitudinal axis of the most distal part of the delivery device, or define an obtuse angle relative to the longitudinal axis of the most distal part of the delivery device. In some applications, the arms are positioned at 45 to 135 degrees (e.g., 70 to 110 degrees, or 85 to 95 degrees) relative to the longitudinal axis of the most distal part of the delivery device.

[0047] According to the devices and techniques described hereinabove, the chordae tendineae manipulation arms 26 may be used to perform any one of several functions. According to some embodiments, such functions are performed alone or in combination with one another. One such function is to use the arms to reduce the size of the annulus of the atrioventricular valve by rotating the arms while they are deployed between the chordae tendineae. The rotation of the arms deflects the chordae between which the arms are deployed, which in turn twists and pulls at least a portion of the atrioventricular valve (e.g., the leaflets and annulus of the atrioventricular valve) radially inward toward the base of the arms. According to some applications of the invention, a further function provided by the arms is to provide a counter force against which an annuloplasty ring is pressed. According to some applications of the invention, a further function provided by the arms, portions of the arms, and / or extensions of the arms is to act as an intraventricular anchor to which an annuloplasty ring is secured, for example as described hereinabove with reference to Figures 1F-1G.

[0048] As described herein above, according to some applications of the present invention, an annuloplasty ring is implanted on an atrioventricular valve annulus that has already been reduced in size relative to the size of the atrioventricular valve annulus prior to the initiation of an annuloplasty procedure. The scope of the present application differs from the techniques described herein above, but includes using techniques for reducing the size of the atrioventricular valve annulus prior to implanting the annuloplasty ring (such that the annuloplasty ring is implanted on an atrioventricular valve annulus that has already been reduced in size).

[0049] It will be appreciated by those skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove, but rather the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art and that would occur to one skilled in the art upon reading the foregoing description.

Claims

1. 1. An apparatus for use with an annuloplasty ring and an atrioventricular valve of a mammalian subject's heart, the atrioventricular valve including an annulus, leaflets, chordae tendineae, and papillary muscles, the apparatus comprising: A plurality of chordae manipulation arms, deployed between the chordae of the atrioventricular valve; thereafter, reducing the size of the annulus by, for example, rotating the chordae manipulation arms such that the chordae manipulation arms flex the chordae, thereby twisting the native atrioventricular valve and pulling the native atrioventricular valve radially inward; Thereafter, providing a counter force against which the annuloplasty ring is compressed during implantation of the annuloplasty ring. a plurality of chordae manipulation arms configured to Device.

2. 2. The device of claim 1, wherein the chordae tendineae manipulation arms are configured to allow the native atrioventricular valve to be untwisted after the annuloplasty ring has been implanted by rotating the chordae tendineae manipulation arms in a direction opposite to the direction of rotation of the chordae tendineae manipulation arms that twisted the native atrioventricular valve.

3. The device of claim 1 , further comprising the annuloplasty ring.

4. 2. The device of claim 1, wherein the atrioventricular valve includes a mitral valve, and the chordae tendineae manipulation arms are configured to be deployed between the chordae of the mitral valve.

5. 2. The device of claim 1, wherein the atrioventricular valve comprises a tricuspid valve, and the chordae tendineae manipulation arms are configured to be deployed between the chordae tendineae of the tricuspid valve.

6. The apparatus of claim 1 , wherein the plurality of chordae manipulation arms includes more than two chordae manipulation arms and less than twelve chordae manipulation arms.

7. 2. The device of claim 1, wherein the chordae manipulation arms are sized to span a diameter at least equal to an inner diameter of the annuloplasty ring when the chordae manipulation arms are disposed in a radially unconstrained configuration such that the chordae manipulation arms are configured to provide a counter force against which the annuloplasty ring may be compressed during implantation of the annuloplasty ring.

8. 2. The device of claim 1, wherein the chordae manipulation arms are sized to be configured to radially overlap the annuloplasty ring when the chordae manipulation arms are disposed in a radially unconstrained configuration such that the chordae manipulation arms are configured to provide a counter force against which the annuloplasty ring may be compressed during implantation of the annuloplasty ring.

9. The device according to any one of claims 1 to 8, wherein at least a portion of an inner edge of each of the chordae tendineae manipulating arms is concavely curved in a given circumferential direction, and the chordae tendineae manipulating arms are configured to pull the native atrioventricular valve radially inward by rotating in the given circumferential direction.

10. 10. The apparatus of claim 9, wherein the inner edge of each of the tendon manipulation arms is concavely curved in the given circumferential direction along an entire length of the inner edge of the tendon manipulation arm.

11. 10. The apparatus of claim 9, wherein a radially outermost portion of the inner edge of each of the chordae manipulation arms is concavely curved in the given circumferential direction.

12. 9. The device of claim 1, wherein the chordae manipulation arm, portions of the chordae manipulation arm, and / or extensions from the chordae manipulation arm are configured to be left under the leaflets of the atrioventricular valve, and the annuloplasty ring is configured to be secured to the chordae manipulation arm, portions of the chordae manipulation arm, and / or extensions from the chordae manipulation arm.

13. 13. The device of claim 12, wherein the chordae tendineae manipulation arm includes a first portion and a second portion, the annuloplasty ring configured to be secured to the first portion of the chordae tendineae manipulation arm, the first portion of the chordae tendineae manipulation arm configured to be detachable from the second portion of the chordae tendineae manipulation arm and configured to remain under the leaflets of the atrioventricular valve after the second portion of the chordae tendineae manipulation arm is removed from the subject's ventricle.

14. 13. The device of claim 12, wherein the annuloplasty ring is configured to be secured to an extension from the chordae tendineae manipulation arm, the extension of the chordae tendineae manipulation arm being configured to be detachable and to remain under the leaflets of the atrioventricular valve after the chordae tendineae manipulation arm is removed from the subject's ventricle.

15. 13. The device of claim 12, wherein a plate is disposed on the ends of at least some of the chordae manipulation arms, the plate being configured to remain under the leaflets of the atrioventricular valve, and the annuloplasty ring being configured to be secured to the plate.

16. 13. The device of claim 12, wherein the annuloplasty ring includes a plurality of anchor elements, at least some of the anchor elements configured to be embedded in the chordae manipulation arms, portions of the chordae manipulation arms, and / or extensions from the chordae manipulation arms.

17. 9. The device of claim 1, further comprising a frame configured to extend beneath the leaflets of the atrioventricular valve into an atrium of the subject's heart, the frame defining holes sized to allow blood to flow, e.g., through the frame, from the atrium to a ventricle of the subject's heart, and the chordae tendineae manipulation arms are coupled to a portion of the frame configured to be positioned within the ventricle.

18. 18. The device of claim 17, wherein the portion of the frame configured to be positioned in the ventricle is configured to self-expand radially such that the location of the frame to which the arms are coupled has a greater circumference than the portion of the frame configured to be positioned in the atrium.

19. a hollow tube defining a post and a bore; the chordae manipulation arm is coupled to the strut, the strut being configured to be disposed within the hollow tube; The hole in the hollow tube is sized to allow blood to flow through the hollow tube, e.g., from an atrium of the subject's heart to a ventricle of the subject's heart. An apparatus according to any one of claims 1 to 8.

20. 20. The device of claim 19, further comprising a one-way valve disposed within the hollow tube and configured to permit blood flow from the atrium to the ventricle but prevent blood flow in the opposite direction.

21. 9. The apparatus of any one of claims 1 to 8, further comprising a delivery device configured to deliver the chordae manipulation arms to a ventricle of the subject's heart, the arms being positioned at an angle between 45 degrees and 135 degrees relative to a longitudinal axis of a distal-most portion of the delivery device.

22. The apparatus of claim 21 , wherein the arms are disposed at an angle of between 70 degrees and 110 degrees relative to the longitudinal axis of the distal-most portion of the delivery device.

23. The apparatus of claim 22, wherein the arms are disposed at an angle of between 85 degrees and 95 degrees relative to the longitudinal axis of the distal-most portion of the delivery device.

24. 24. The apparatus of claim 23, wherein the arms are disposed at an angle of approximately 90 degrees relative to the longitudinal axis of the distal-most portion of the delivery device.

25. 9. The device of claim 1, further comprising a plurality of support elements, each of the chordae manipulation arms coupled to a corresponding one of the support elements, the support elements configured to be brought together during delivery of the arms to a ventricle of the subject's heart, and the support elements configured to be separated from one another during deployment of the arms within the ventricle.

26. 26. The apparatus of claim 25, further comprising a separation element, the support elements being configured to be separated from one another by pulling back the separation element such that the separation element is disposed between the support elements.

27. 26. The apparatus of claim 25, wherein the support elements are configured to be separated from one another to allow blood flow from an atrium to the ventricle of the subject's heart.

28. 1. An apparatus for use with an atrioventricular valve of a mammalian subject's heart, the atrioventricular valve including an annulus, leaflets, chordae tendineae, and papillary muscles, the apparatus comprising: an annuloplasty ring defining an inner diameter; a plurality of arms sized to span a diameter at least equal to the inner diameter of the annuloplasty ring when the plurality of arms are disposed in a radially unconstrained configuration such that the arms are configured to provide a counter force against which the annuloplasty ring is compressed during implantation of the annuloplasty ring; 13. An apparatus comprising:

29. 1. An annuloplasty ring and a method for use with an atrioventricular valve of a mammalian subject's heart, the atrioventricular valve including an annulus, leaflets, chordae tendineae, and papillary muscles, the method comprising: deploying a plurality of chordae manipulation arms between the chordae of the atrioventricular valve; thereafter, rotating the arms such that the arms twist the native atrioventricular valve by deflecting the chordae tendineae and reduce the size of the annulus by pulling the native atrioventricular valve radially inward; thereafter, implanting the annuloplasty ring onto the annulus while using the arms to (a) maintain the size of the annulus at the reduced size of the annulus by maintaining the arms in their rotated state, and (b) provide a counter force against which the annuloplasty ring is pressed by pulling the arms from beneath the leaflets toward the annuloplasty ring. A method comprising:

30. 30. The method of claim 29, further comprising, subsequent to implanting the annuloplasty ring on the valve annulus, allowing the native atrioventricular valve to untwist by rotating the chordae tendineae manipulation arms in a direction opposite to the direction of rotation of the chordae tendineae manipulation arms that caused the native atrioventricular valve to twist.

31. 30. The method of claim 29, wherein the atrioventricular valve comprises a mitral valve, and deploying the plurality of chordae manipulation arms between the chordae of the atrioventricular valve comprises deploying the plurality of chordae manipulation arms between the chordae of the mitral valve.

32. 30. The method of claim 29, wherein the atrioventricular valve comprises a tricuspid valve, and deploying the plurality of chordae tendineae manipulation arms between the chordae of the atrioventricular valve comprises deploying the plurality of chordae tendineae manipulation arms between the chordae of the tricuspid valve.

33. 30. The method of claim 29, wherein deploying the plurality of chordae manipulation arms between the chordae of the atrioventricular valve comprises deploying more than two and less than twelve chordae manipulation arms between the chordae of the atrioventricular valve.

34. 30. The method of claim 29, wherein deploying the plurality of chordae manipulation arms between the chordae of the atrioventricular valve comprises deploying the arms between the chordae of the atrioventricular valve such that the arms span a diameter at least equal to an inner diameter of the annuloplasty ring such that the arms are configured to provide a counterforce against which the annuloplasty ring is compressed during implantation of the annuloplasty ring.

35. 30. The method of claim 29, wherein deploying the plurality of chordae manipulation arms between the chordae of the atrioventricular valve comprises deploying the arms between the chordae of the atrioventricular valve such that the arms radially overlap the annuloplasty ring such that the arms are configured to provide a counterforce against which the annuloplasty ring is compressed during implantation of the annuloplasty ring.

36. 36. The method of any one of claims 29 to 35, wherein at least a portion of an inner edge of each of the chordae manipulation arms is concavely curved in a given circumferential direction, and rotating the arms comprises rotating the arms in the given circumferential direction.

37. 37. The method of claim 36, wherein the inner edge of each of the tendon manipulation arms is concavely curved in the given circumferential direction along an entire length of the inner edge of the tendon manipulation arm.

38. 37. The method of claim 36, wherein a radially outermost portion of the inner edge of each of the chordae manipulation arms is concavely curved in the given circumferential direction.

39. 36. The method of any one of claims 29 to 35, further comprising leaving the chordae manipulation arms, portions of the chordae manipulation arms, and / or extensions from the chordae manipulation arms under the leaflets of the atrioventricular valve, and wherein implanting the annuloplasty ring on the annulus comprises fixing the annuloplasty ring to the chordae manipulation arms, portions of the chordae manipulation arms, and / or extensions from the chordae manipulation arms.

40. 40. The method of claim 39, wherein fixing the annuloplasty ring to the chordae tendineae manipulation arm, the portion of the chordae tendineae manipulation arm, and / or the extension from the chordae tendineae manipulation arm comprises fixing the annuloplasty ring to a first portion of the chordae tendineae manipulation arm, and leaving the chordae tendineae manipulation arm, the portion of the chordae tendineae manipulation arm, and / or the extension from the chordae tendineae manipulation arm under the leaflets of the atrioventricular valve comprises disengaging the first portion of the arm from the second portion of the arm, and leaving the first portion of the arm under the leaflets of the atrioventricular valve even after the second portion of the chordae tendineae manipulation arm is removed from the subject ventricle.

41. 40. The method of claim 39, wherein fixing the annuloplasty ring to the chordae tendineae manipulation arms, portions of the chordae tendineae manipulation arms, and / or extensions from the chordae tendineae manipulation arms comprises fixing the annuloplasty ring to extensions from the chordae tendineae manipulation arms, and leaving the chordae tendineae manipulation arms, portions of the chordae tendineae manipulation arms, and / or extensions from the chordae tendineae manipulation arms under leaflets of the atrioventricular valve comprises detaching the extensions of the arms from the arms, and leaving the extensions of the arms under leaflets of the atrioventricular valve even after the arms are removed from the subject's ventricle.

42. 40. The method of claim 39, wherein a plate is disposed on ends of at least some of the chordae manipulation arms, and wherein fixing the annuloplasty ring to the chordae manipulation arms, portions of the chordae manipulation arms, and / or extensions from the chordae manipulation arms comprises fixing the annuloplasty ring to the plate.

43. 40. The method of claim 39, wherein the annuloplasty ring includes a plurality of anchor elements, and wherein fixing the annuloplasty ring to the chordae manipulation arms, portions of the chordae manipulation arms, and / or extensions from the chordae manipulation arms includes embedding at least some of the anchor elements in the chordae manipulation arms, portions of the chordae manipulation arms, and / or extensions from the chordae manipulation arms.

44. 36. The method of any one of claims 29 to 35, wherein deploying a plurality of chordae tendineae manipulation arms between the chordae tendineae of the atrioventricular valve comprises deploying the plurality of chordae tendineae manipulation arms between the chordae tendineae of the atrioventricular valve, the arms extending from a portion of a frame positioned within the ventricle, the frame extending beneath the leaflets of the atrioventricular valve into an atrium of the subject's heart, the frame defining a hole sized to, for example, allow blood to flow through the frame from the atrium to a ventricle of the subject's heart.

45. 45. The method of claim 44, wherein deploying the plurality of chordae manipulation arms between the chordae of the atrioventricular valve, the arms extending from a portion of a frame disposed in the ventricle, comprises radially self-expanding the location of the frame to which the arms are coupled such that the location of the frame to which the arms are attached has a greater circumference than the portion of the frame configured to be disposed in the atrium.

46. Deploying the plurality of chordae manipulation arms between the chordae of the atrioventricular valve includes deploying the plurality of chordae manipulation arms between the chordae of the atrioventricular valve, the chordae manipulation arms coupled to struts, the struts disposed within a hollow tube, the hollow tube defining a bore therein; The hole in the hollow tube is sized to allow blood to flow through the hollow tube, e.g., from an atrium of the subject's heart to a ventricle of the subject's heart.

36. The method according to any one of claims 29 to 35.

47. 47. The method of claim 46, wherein a one-way valve is disposed within the hollow tube and configured to permit blood flow from the atrium to the ventricle but prevent blood flow in the opposite direction.

48. 36. The method of any one of claims 29 to 35, further comprising delivering the chordae manipulation arms to a ventricle of the subject's heart using a delivery device, and wherein deploying the plurality of chordae manipulation arms between the chordae of the atrioventricular valve comprises deploying the arms such that they are positioned at an angle between 45 degrees and 135 degrees relative to a longitudinal axis of a distal-most portion of the delivery device.

49. 50. The method of claim 48, wherein deploying the arms such that the arms are disposed at an angle between 45 degrees and 135 degrees relative to the longitudinal axis of the distal-most portion of the delivery device comprises deploying the arms such that the arms are disposed at an angle between 70 degrees and 110 degrees relative to the longitudinal axis of the distal-most portion of the delivery device.

50. 50. The method of claim 49, wherein deploying the arms such that the arms are disposed at an angle between 70 degrees and 110 degrees relative to the longitudinal axis of the distal-most portion of the delivery device comprises deploying the arms such that the arms are disposed at an angle between 85 degrees and 95 degrees relative to the longitudinal axis of the distal-most portion of the delivery device.

51. 51. The method of claim 50, wherein deploying the arms such that the arms are disposed at an angle of between 85 degrees and 95 degrees relative to the longitudinal axis of the distal-most portion of the delivery device comprises deploying the arms such that the arms are disposed at an angle of approximately 90 degrees relative to the longitudinal axis of the distal-most portion of the delivery device.

52. Each of the tendon manipulation arms is coupled to a corresponding support element; The method further includes delivering the chordae tendineae manipulation arms to a ventricle of the subject's heart using a delivery device; the support elements are held together by the delivery device during delivery of the arms to a ventricle of the subject's heart; deploying the plurality of chordae manipulation arms between the chordae of the atrioventricular valve includes separating the support elements from one another.

36. The method according to any one of claims 29 to 35.

53. 53. The method of claim 52, wherein separating the support elements from one another comprises pulling the separation element back so that the separation element is disposed between the support elements.

54. 53. The method of claim 52, wherein separating the support elements from one another comprises separating the support elements from one another to allow blood flow from an atrium to the ventricle of the subject's heart.

55. 1. An annuloplasty ring and a method for use with an atrioventricular valve of a mammalian subject's heart, the atrioventricular valve including an annulus, leaflets, chordae tendineae, and papillary muscles, the method comprising: deploying a plurality of arms beneath the leaflets of the native atrioventricular valve; thereafter, implanting the annuloplasty ring onto the annulus while using the arms to provide a counterforce against which the annuloplasty ring is pressed by pulling the arms from beneath the leaflets towards the annuloplasty ring. A method comprising:

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