Arioventricular valve repair
Through the combined technology of the chondrup manipulation arm and annulus shaping ring, the problem of mitral valve and tricuspid valve regurgitation is solved, effective valve repair is achieved, and surgical complexity and complication risk are reduced.
Patent Information
- Application Number
- CN202380041826.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2022-05-22
- Filing Date
- 2023-05-19
- Publication Date
- 2024-12-27
AI Technical Summary
The prior art is difficult to effectively solve the problem of mitral and tricuspid valve regurgitation, leading to the occurrence of cardiac complications. The traditional intracardiac direct vision surgical methods are complex and highly invasive.
Multiple cherry manipulation arms are used to rotate the cherry to shrink the annulus, and maintain the shrinking state after the annulus forming ring is implanted. Structures such as reinforcement elements and frames ensure the stability and effectiveness of the annulus forming ring.
By reducing the size of the valve annulus, the sealing of the valve is improved, the reflux phenomenon is reduced, the complexity and invasiveness of the surgery are reduced, and the treatment effect is improved.
Smart Images
Figure CN119212649A_ABST
Abstract
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 344,590, filed by Orlov et al. on May 22, 2022, entitled “Atrioventricular valve repair,” which is incorporated herein by reference. Field of Embodiments of the Invention
[0002] The present invention relates to medical devices and methods, and in particular to devices and methods for repairing atrioventricular valves. background
[0003] 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.
[0004] 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 the flow of blood between the atria and ventricles.
[0005] In the mitral valve, the mitral annulus defines the mitral valve orifice. Anterior and posterior leaflets extend from the mitral annulus. The leaflets are connected to the papillary muscles within the left ventricle by chordae tendineae.
[0006] 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 minimal resistance. In a healthy subject, the leaflets of the aortic valve are held closed by the blood pressure in the aorta.
[0007] 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 forms a seal. Blood pressure in the left ventricle pushes against the ventricular surface of the leaflets, pressing the leaflets tightly together at the coaptation surface, creating a tight, leak-proof seal.
[0008] The effective sealing of the mitral valve during ventricular systole depends on adequate depth of coaptation. Abnormal coaptation may result from any number of physical abnormalities that may prolapse the leaflets (e.g., elongated or ruptured chordae tendineae, or weakened papillary muscles) or prevent coaptation (e.g., short chordae tendineae, or small leaflets). Several other pathologies 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.
[0009] The tricuspid valve consists of three leaflets: the septal leaflet, the anterior leaflet, and the posterior leaflet. Each 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.
[0010] 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 right ventricular dilation, which causes the tricuspid annulus to dilate, resulting in the valve leaflets not coapting properly.
[0011] In addition to humans, mammals that suffer from mitral regurgitation and tricuspid regurgitation include horses, cats, dogs, cattle, sheep, and pigs.
[0012] It is known to treat mitral and tricuspid regurgitation using an open-heart surgical approach, such as by modifying subvalvular structures (eg, lengthening or shortening chordae tendineae) to improve leaflet coaptation, and / or by implanting an annuloplasty ring to reduce the size of the annulus. Overview of Embodiments
[0013] 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, a plurality of chord-manipulation arms are deployed between the chords of the atrioventricular valve. Subsequently, the arms are rotated so that the arms cause the annulus to be reduced in size by deflecting the chords to twist the native atrioventricular valve through the arms and pull the native atrioventricular valve radially inward. After the arms have been rotated, 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 in its reduced size by maintaining the arms in their rotated state. For some applications, during implantation of the annuloplasty ring, the arms are used to provide a reaction force against which the annuloplasty ring is pushed by pulling the arms from beneath the leaflets toward the annuloplasty ring.
[0014] Typically, after the annuloplasty ring has been implanted, the chord manipulation arms are rotated in a direction opposite to the direction in which they were previously rotated, and the arms are removed from the subject. Typically, rotation of the chord manipulation in the opposite direction allows the native atrioventricular valve to become untwisted. However, the annuloplasty ring maintains the atrioventricular valve annulus at a reduced size relative to the expanded size of the ring prior to implantation of the ring. For some applications, the annuloplasty ring is anchored to the arms, portions of the arms, and / or extensions from the arms, and the arms, portions of the arms, and / or extensions from the arms are retained in place beneath the atrioventricular valve leaflets. For some applications, portions of the arms and / or extensions from the arms are configured to be removable and to be retained in place beneath the atrioventricular valve leaflets even after the arms or portions of the arms are removed from the subject's ventricle.
[0015] Thus, according to some applications of the present invention, there is provided a device for use with an annuloplasty ring and an atrioventricular valve of a heart of a mammalian subject, the atrioventricular valve comprising an annulus, leaflets, chordae tendineae and papillary muscles, the device comprising: A plurality of chord manipulator arms, each chord manipulator arm comprising a flexible material and a stiffening element configured to provide a desired shape to the chord manipulator arm when the chord manipulator arm is disposed in a non-radially constrained configuration, wherein: The chord manipulator arms are configured to be deployed between chords of the atrioventricular valve and then deflect the chords by rotating the chord manipulator arms to twist the native atrioventricular valve and pull the native atrioventricular valve radially inward to reduce the size of the valve annulus, and The stiffening element is configured to be removed and / or de-stiffened from the flexible material of the chord manipulator arm in order to facilitate removal of the chord manipulator arm from between the chords.
[0016] In some applications, the reinforcement element includes a removable reinforcement wire that is disposed within a flexible material of the chord manipulator arms, and wherein, after the annuloplasty ring has been implanted, the removable reinforcement wire is configured to be retracted from within the flexible material of the chord manipulator arms so that the chord manipulator arms become flexible and can be easily removed from between the chordae of the native atrioventricular valve.
[0017] In some applications, the reinforcement element includes a reinforcement wire that is connected to the flexible material of the chord manipulation arms, and wherein, after the annuloplasty ring has been implanted, the reinforcement wire is configured to decouple from the flexible material of the chord manipulation arms so that the chord manipulation arms become flexible and can be easily removed from between the chordae of the native atrioventricular valve.
[0018] In some applications, after the annuloplasty ring has been implanted, the reinforcement element is configured to remove reinforcement such that the chord manipulation arms become flexible and can be easily removed from between the chordae of the native atrioventricular valve.
[0019] In some applications, the atrioventricular valve includes a mitral valve, and the chord manipulator arm is configured to be deployed between chordae tendineae of the mitral valve.
[0020] In some applications, the atrioventricular valve includes a tricuspid valve, and the chord manipulator arm is configured to be deployed between chordae tendineae of the tricuspid valve.
[0021] In some applications, the plurality of chord manipulator arms includes more than two chord manipulator arms and less than twelve chord manipulator arms.
[0022] In some applications, when the chord manipulator arms are configured in a non-radially constrained configuration, at least a portion of an inner edge of each of the chord manipulator arms is concavely curved in a given circumferential direction, and the chord manipulator arms are configured to pull the native atrioventricular valve radially inward by rotating in the given circumferential direction.
[0023] In some applications, the chord manipulator arms are sized such that when disposed in a radially unconstrained configuration, the chord manipulator arms span a diameter at least equal to an inner diameter of the annuloplasty ring such that the chord manipulator arms are configured to provide a reaction force during annuloplasty ring implantation against which the annuloplasty ring can be urged.
[0024] In some applications, the chord manipulator arms are sized such that when disposed in a radially unconstrained configuration, the chord manipulator arms are configured to radially overlap the annuloplasty ring such that the chord manipulator arms are configured to provide a reaction force during annuloplasty ring implantation against which the annuloplasty ring can be urged.
[0025] In some applications, at least a portion of an inner edge of each of the chord manipulator arms is concavely curved in a given circumferential direction, and wherein the chord manipulator arms are configured to pull the native atrioventricular valve radially inward by rotating in the given circumferential direction.
[0026] In some applications, the chord manipulator arms, portions of the chord manipulator arms, and / or extensions therefrom are configured to be retained beneath the atrioventricular valve leaflets, and the annuloplasty ring is configured to be anchored to the chord manipulator arms, portions of the chord manipulator arms, and / or extensions therefrom.
[0027] In some applications, the device also includes a frame configured to extend from beneath the atrioventricular valve leaflets into an atrium of the subject's heart, the frame defining an aperture sized to allow blood to flow from the atrium to a ventricle of the subject's heart via the frame, and wherein the chord manipulator arm is coupled to a portion of the frame configured to be disposed within the ventricle.
[0028] In some applications, the device also includes a support rod and a hollow tube defining a hole, the tendon manipulation arm is connected to the support rod, and the support rod is configured to be disposed within the hollow tube, and the size of the hole within the hollow tube is set to allow blood to flow from the atrium of the subject's heart to the ventricle of the subject's heart via the hollow tube.
[0029] In some applications, the apparatus also includes a delivery device configured to deliver the chord manipulator arm to a ventricle of a heart of a subject, with the arm disposed at an angle between 45 and 135 degrees relative to a longitudinal axis of a distal-most portion of the delivery device.
[0030] In some applications, the device also includes multiple support elements, wherein each of the chord manipulation arms is coupled to a respective one of the support elements, the support elements being configured to remain together with one another during delivery of the arms to a ventricle of the subject's heart, and the support elements being configured to separate from one another during deployment of the arms within the ventricle.
[0031] According to some applications of the present invention, there is also provided a method for use with an annuloplasty ring and a mitral valve of a heart of a mammalian subject, the mitral valve comprising a valve ring, leaflets, chordae tendineae, and papillary muscles, the method comprising: delivering a first delivery device to a left ventricle of the subject via an aorta of the subject; deploying a plurality of chord manipulator arms from a first delivery device between chordae tendineae of an atrioventricular valve; delivering a second delivery device to the left atrium of the subject via the atrial septum of the subject; deploying an annuloplasty ring from a second delivery device into the left atrium of the subject; rotating the arms so that the arms cause the annulus to decrease in size by deflecting the chordae tendineae to twist the native mitral valve through the arms and pull the native mitral valve radially inward; and Subsequently, an annuloplasty ring is implanted over the annulus while using the arms to (a) maintain the size of the annulus in its reduced size by maintaining the arms in their rotated state, and (b) provide a counterforce by pushing the arms from beneath the leaflets toward the annuloplasty ring, against which the annuloplasty ring is pushed.
[0032] The present invention will be more fully understood from the following detailed description of its application taken in conjunction with the accompanying drawings, which are as follows. BRIEF DESCRIPTION OF THE DRAWINGS
[0033] Figure 1A , Figure 1B , Figure 1C , Figure 1D and Figure 1E is a schematic diagram of respective steps of a procedure for implanting an annuloplasty ring on an atrioventricular valve of a subject in accordance with some applications of the present invention; Figure 1F and Figure 1G is a schematic diagram of the final steps of a procedure for implanting an annuloplasty ring on an atrioventricular valve of a subject according to some applications of the present invention, wherein a portion of the device is implanted beneath the atrioventricular valve leaflets within a ventricle of the subject, Figure 2A and Figure 2B is a schematic diagram of respective views of a set of chord manipulator arms for use during implantation of an annuloplasty ring on an atrioventricular valve of a subject in accordance with some applications of the present invention; Figure 3 is a schematic diagram of a chord manipulator arm attached to a frame including at least a radially self-expandable ventricular portion according to some applications of the present invention; Figure 4 is a schematic diagram of a tendon manipulation arm coupled to a support rod according to some applications of the present invention; Figure 5A , Figure 5B and Figure 5C is a schematic diagram of respective views of a set of chord manipulator arms for use during implantation of an annuloplasty ring on an atrioventricular valve of a subject in accordance with some applications of the present invention; Fig. 6A and Figure 6B is a schematic diagram of a chord manipulator arm including a removable reinforcing wire according to some applications of the present invention; Figure 7 is a schematic diagram of a chord manipulator arm for transaortic delivery according to some applications of the present invention; and Figure 8is a schematic diagram of an annuloplasty ring deployed at an atrioventricular valve annulus of a subject, according to some applications of the present invention. DETAILED DESCRIPTION
[0035] Reference now Figure 1A , Figure 1B , Figure 1C , Figure 1D and Figure 1E , these figures are diagrams of a method for inserting an annuloplasty ring 20 (in Figure 1C to Figure 1E ) is a schematic diagram of the corresponding steps of the procedure of implanting an atrioventricular valve 22 on a subject. The atrioventricular valve separates the atria 16 and the ventricles 18 between them, and the atrioventricular valve generally includes a valve ring 21, leaflets 23, chordae tendineae 25, and papillary muscles 27.
[0036] In the first step of the procedure, a delivery device 24 is delivered to the atrioventricular valve. A plurality of chord manipulator arms 26 are then released from the delivery device, such as Figure 1A It should be noted that in the present application, the chord manipulator arms 26 are shown as being deployed between the chordae of the mitral valve. However, the scope of the present application includes applying the apparatus and methods described herein (mutatis mutandis) to the tricuspid valve. It should also be noted that in several of the figures, the delivery device is shown as being introduced from above the mitral valve (e.g., via trans-septal delivery or trans-atrial delivery). However, the scope of the present application includes introducing the delivery device from below the mitral valve (e.g., via trans-apical delivery or trans-aortic delivery, for example, as Figure 7 For 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, subclavian vein, or inferior vena cava. Finally, it should be noted that for illustrative purposes, in a portion of the drawings of the present application, a cross-sectional view of the heart (and, where relevant, a cross-sectional view of an annuloplasty ring) is shown in conjunction with a full three-dimensional view of the chord manipulator arm 26.
[0037] For some applications, the covering sheath 28 of the delivery device is retracted relative to the chord manipulation arm 26 or the arm is pushed forward relative to the delivery device to release the arm from the delivery device. Typically, the arm is made of a shape memory material (e.g., a shape memory alloy such as Nitinol or copper-aluminum-nickel) that is configured such that when released from the delivery device, the arm extends radially outward relative to the delivery device. Alternatively, the arm is made of a different material. For example, Figure 1AAs shown, the arms are generally configured to extend radially outward to a sufficient extent to allow the arms to be deployed between the chordae tendineae 25 of the atrioventricular valve. For some applications, the arms extend radially outward to a sufficient extent to allow the arms to be deployed between the primary chordae tendineae and / or between the secondary chordae tendineae. Also generally, as shown, the arms are configured to be shaped such that the arms are circumferentially curved. For some applications, the circumferential curvature of each of the arms is such that the inner edge 29 (e.g., Figure 1A At least a portion of the circumferential direction is concavely curved in a given circumferential direction. Figure 1A As shown, at least a portion of the inner edge 29 of the arm is concavely curved in a clockwise circumferential direction. For 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 the front portion of the inner edge 29 of the arm (i.e., the radially outermost portion of the inner edge of the arm, which typically first encounters the chordae tendineae) is concavely curved in a given circumferential direction.
[0038] In a subsequent step of the procedure, the chord manipulation arm 26 is rotated (either clockwise or counterclockwise) in the direction of the concave circumferential curvature of the inner edge of the arm. Figure 1A The arms are shaped as shown, with the arms rotated in a clockwise direction. Alternatively (not shown), the arms can be shaped so that the concave circumferential curvature of the inner edge of the arms is in a counterclockwise direction, in which case the arms are typically rotated in a counterclockwise direction. Typically, rotation of the arms causes the chordae tendineae (between which the arms are deployed) to become deflected. In turn, the deflection of the chordae tendineae causes at least a portion of the atrioventricular valve (e.g., the leaflets and annulus of the atrioventricular valve) to become twisted and pulled radially inward toward the base of the arms. This is because the chordae tendineae extend between the papillary muscles at their first end and the mitral annulus to which they extend via the leaflets at their second end. The deflection of the chordae tendineae pulls the native atrioventricular valve radially inward, thereby providing annular reduction. Thus, in this manner, the size of the atrioventricular valve annulus 21 becomes reduced relative to the size of the atrioventricular valve annulus prior to rotation of the arms. Figure 1B is a schematic illustration of the mitral valve after the arms have been rotated in the manner described above. Figure 1B Included is a view from the top of the mitral valve (in the dashed box). As shown, the leaflets have become twisted due to the rotation of the arms. In addition, as can be seen by comparing Figure 1B and Figure 1A It will be noted that due to the rotation of the arms, the mitral annulus has been pulled radially inwardly in the direction of arrow 31 .
[0039] In a subsequent step of the procedure, the annuloplasty ring 20 is implanted onto the atrioventricular annulus. During implantation of the annuloplasty ring, the arms are maintained in their rotated state so that the arms maintain the atrioventricular annulus in its reduced size. In this manner, the annuloplasty ring is implanted onto the atrioventricular annulus, the size of which has been reduced relative to its size prior to the initiation of the annuloplasty procedure. This is in contrast to some other techniques for implanting annuloplasty rings, in which the ring is not reduced in size prior to implantation of the annuloplasty ring. Rather, according to such techniques, during implantation of the annuloplasty ring, the annuloplasty ring itself is used to reduce the size of the atrioventricular annulus, and / or the ring is first attached to the atrioventricular annulus and the diameter of the ring is subsequently reduced (e.g., by tightening the ring).
[0040] Figure 1C and Figure 1D An annuloplasty ring is shown being delivered to the atrial side of the atrioventricular valve using an annuloplasty ring delivery device 54 that is coupleable to (or coupled to) delivery device 24 (e.g., via elongated member 56). For some applications, the annuloplasty ring includes a plurality of anchoring elements 58 (e.g., barbs, hooks, and / or other anchoring elements) that are configured to anchor the annuloplasty ring to the annulus by embedding into tissue of the annulus. For some applications, during implantation of the annuloplasty ring, arms 26 are pulled toward the annuloplasty ring such that the arms (which are disposed below the leaflets) provide a counterforce against which the annuloplasty ring is pushed (from above the leaflets), e.g., Figure 1D 30 in the annuloplasty ring. Typically, for such applications, the arms are sized so that when disposed in a radially non-constrained configuration, the arms span a diameter at least equal to the inner diameter of the annuloplasty ring. Thus, the arms are configured so that in their radially non-constrained configuration, the arms radially overlap the annuloplasty ring.
[0041] For some applications, after the annuloplasty ring is implanted, arms 26 are retracted into the delivery device and removed from the subject, such as Figure 1E As shown, Figure 1E A cross-sectional view of an annuloplasty ring implanted in the absence of the arms and delivery device is shown. At this stage, the annuloplasty ring typically maintains the ring at a reduced size (relative to its expanded size prior to the procedure). Typically, after the annuloplasty ring has been implanted, the chord manipulation arms are rotated in a direction opposite to the direction in which they were previously rotated, and the arms are removed from the subject. Typically, rotation of the chord manipulation in the opposite direction allows the native atrioventricular valve to become untwisted. However, the annuloplasty ring maintains the annulus at a reduced size relative to the expanded size of the annulus prior to implantation of the ring.
[0042] For some applications, the annuloplasty ring is anchored to arms 26, portions of the arms, and / or extensions therefrom, and the arms, portions of the arms, and / or extensions therefrom are retained in place beneath the atrioventricular valve leaflets to provide the anchoring function described above. For some applications, portions of the arms, and / or extensions therefrom are configured to be removable and to be retained in place beneath the atrioventricular valve leaflets even after the arms, or portions thereof, are removed from the subject's ventricle. For example, Figure 1F and Figure 1G An embodiment is shown in which a plate 34 is disposed at the end of the arm and the annuloplasty ring is anchored to the plate (e.g., by at least some of the anchoring elements 58 being embedded within the plate, such as Figure 1G ). In this manner, at least a portion of the arms 26 and / or extensions of the arms serve as an intraventricular anchoring portion to which the annuloplasty ring is anchored.
[0043] Reference now Figure 2A and Figure 2B , Figure 2A and Figure 2B Schematic diagrams of side and bottom views, respectively, of a set of chord manipulation arms 26 for use during implantation of annuloplasty ring 20 on an atrioventricular valve of a subject according to some applications of the present invention. For some applications, the arms are coupled to a frame 40 that is configured to extend from beneath the atrioventricular valve leaflets (i.e., within the ventricle) into the atrium of the subject (e.g., as Figures 1A to 1D and Figure 1F ). The frame defines an aperture that is sized to allow blood to flow from the atrium to the ventricle via the frame when the above-described procedure is performed. Figure 1B Indicated by arrows 42 indicating blood flow.
[0044] Reference now Figure 3 , Figure 3 is a schematic diagram of a chord manipulation arm 26 attached to a frame 40. The arm is typically coupled to a ventricular portion 44 of the frame, and an atrial portion 46 of the frame extends upwardly into the atrium to facilitate blood flow from the atrium to the ventricle in the manner described above. For some applications, the ventricular portion 44 of the frame is configured to self-expand radially so that the location on the frame to which the arm is coupled has a greater circumference than the atrial portion of the frame. For some applications, expansion of the ventricular portion of the frame facilitates radial outward extension of the arm to an extent sufficient to enable the arm to be deployed between chordae tendineae 25 (e.g., primary and / or secondary chordae tendineae) of an atrioventricular valve.
[0045] Reference now Figure 4 , Figure 4is a schematic diagram of a chord manipulation arm 26 coupled to a support rod 60 according to some applications of the present invention. Typically, the support rod 60 is disposed within a hollow tube 62, which defines an aperture 64 (e.g., a lateral aperture as shown), the aperture 64 being configured to be disposed within the atrium. The aperture is sized to allow blood to flow from the atrium to the ventricle via the hollow tube (as indicated by the blood flow arrow 42), and out of an outflow aperture disposed within the ventricle (the arm typically protrudes from the outflow aperture). The aperture through the hollow tube 62 typically allows blood to flow from the atrium to the ventricle when performing the above-described procedure. For some applications, a one-way valve (not shown) is disposed within the hollow tube 62. The one-way valve is configured to allow blood to flow from the atrium to the ventricle, but to prevent blood from flowing in the opposite direction.
[0046] Reference again Figure 2B For some applications, the angle "α (alpha)" formed by the arm relative to the frame 40 or support rod 60 (and the angle formed relative to the longitudinal axis of the distal-most portion of the delivery device) is approximately 90 degrees (e.g., 90 degrees plus / minus 3 degrees, or exactly 90 degrees). Alternatively, the angle can be acute or obtuse. For some applications, the arm is set at an angle α of 45 degrees to 135 degrees (e.g., 70 degrees to 110 degrees or 85 degrees to 95 degrees) relative to the longitudinal axis of the distal-most portion of the delivery device.
[0047] Reference now Figure 5A and Figure 5B , Figure 5A and Figure 5B 2 is a schematic diagram of respective views of a set of chord manipulation arms 26 used during implantation of annuloplasty ring 20 over an atrioventricular valve of a subject in accordance with some applications of the present invention. For some applications, each of the arms is coupled to a respective support element 50, and the support elements are separable from one another. During delivery of the arms to the ventricle, the support elements are typically held together with one another (e.g., by being constrained within a delivery device) in order to reduce the delivery profile of the device. Reference is now made to Figure 5C During deployment of the arm within the subject's ventricle, the support elements are separated from each other, for example by retracting the separation element 52 so that the separation element 52 is disposed between the support elements. Typically, while the above-described procedure is performed, blood flow from the atrium to the ventricle continues to flow through the separation between the support elements, such as Figure 5C Indicated by the blood flow arrow 42 in FIG.
[0048] Reference now Fig. 6A and Figure 6B , Fig. 6A and Figure 6Bis a schematic diagram of a chord manipulation arm 26 according to some applications of the present invention, the arm including a removable reinforcing element 70. For some applications, the arm is made of a flexible material or has a flexible mechanical design. The reinforcing element 70 is disposed within the arm and / or coupled to the arm and is shaped so that the arm is formed into a desired shape (as described above). For some applications, the reinforcing element is a wire made of a shape memory material (such as Nitinol), and the reinforcing wire is shaped to provide the arm with the desired shape.
[0049] As described above, typically, the chord manipulation arms 26 are deployed between the chordae of the atrioventricular valve. The arms are then rotated so that the arms cause the annulus to decrease in size by deflecting the chordae (and / or leaflets, and / or other portions of the subvalvular structure) by twisting the native atrioventricular valve and pulling the native atrioventricular valve radially inward. After the arms have been rotated, the annuloplasty ring 20 is implanted over the annulus. During implantation of the annuloplasty ring, the arms are typically used to maintain the size of the annulus in its reduced size by maintaining the arms in their rotated state. For some applications, during implantation of the annuloplasty ring, the arms are used to provide a reaction force against which the annuloplasty ring is urged by pulling the arms from beneath the leaflets toward the annuloplasty ring.
[0050] For some applications, after using the arm to manipulate the chordae (and / or leaflets, and / or other portions of the subvalvular structures), it is desirable to reduce the stiffness of the arm so as to allow the arm to be withdrawn from between the chordae. Thus, for some applications, after the annuloplasty ring has been implanted, the reinforcing wires are retracted from within and / or decoupled from the chord manipulation arms. Alternatively or additionally, the reinforcing wires are manipulated and / or processed so that the reinforcing wires become de-reinforced (i.e., more flexible). Reinforcement and de-reinforcement of the arms may be performed by any applicable technical method, including (but not limited to): using shape memory alloys (such as, Nitinol), beads with pull wires inside, applying an electric current or electromagnetic field, applying varying temperatures, and / or applying any form of electromagnetic radiation. Because the reinforcing wires have been retracted from within, decoupled from, and / or de-reinforced the arms, the chord manipulation arms typically become flexible so that the arms can be easily removed from between the chordae. As described herein, the reinforcing wires are retracted from within, decoupled from, and / or de-reinforced the arms. Figure 6B As shown, the arm is then retracted into the hollow tube 62 (and / or a different delivery device or portion thereof).
[0051] Reference now Figure 7 , Figure 7is a schematic diagram of a chord manipulator arm 26 for transaortic delivery according to some applications of the present invention. As described above, for some applications, a delivery device 24 for delivering a chord manipulator arm to the left ventricle is delivered from below the mitral valve. For some such applications, the delivery device is advanced through the subject's aorta 80 and through the subject's aortic valve 82 into the subject's left ventricle. A delivery device 54 for delivering an annuloplasty ring is typically advanced from above the mitral valve, such as through the septum (i.e., through the subject's atrial septum). Alternatively, the delivery device 54 is also delivered transaortically. The shape and function of the arm are generally substantially similar to those described above.
[0052] Typically, the arms are rotated such that the arms cause the chordae tendineae (and / or leaflets, and / or other portions of the subvalvular structures) between which the arms are deployed to become deflected. In turn, the deflection of the chordae tendineae causes at least a portion of the atrioventricular valve (e.g., the leaflets and annulus of the atrioventricular valve) to become twisted and pulled radially inward toward the base of the arms. The deflection of the chordae tendineae pulls the native atrioventricular valve radially inward, thereby providing annular reduction. Thus, in this manner, the size of the atrioventricular valve annulus 21 becomes reduced relative to the size of the atrioventricular valve annulus prior to rotation of the arms. In a subsequent step of the procedure, the annuloplasty ring 20 is implanted onto the atrioventricular valve annulus, such as Figure 7 During implantation of the annuloplasty ring, the arms are maintained in their rotated state so that the arms maintain the atrioventricular valve annulus in its reduced size. In this manner, the annuloplasty ring is implanted onto the atrioventricular valve annulus, the size of which has been reduced relative to its size prior to the initiation of the annuloplasty procedure.
[0053] Typically, during implantation of the annuloplasty ring, the arms 26 are pushed upward toward the annuloplasty ring so that the arms (which are disposed below the leaflets) provide a reaction force against which the annuloplasty ring is pushed (from above the leaflets). Typically, the arms are sized so that when disposed in a radially non-constrained configuration, the arms span a diameter at least equal to the inner diameter of the annuloplasty ring. Thus, the arms are configured so that in their radially non-constrained configuration, the arms radially overlap the annuloplasty ring. Typically, by delivering the arms below the mitral valve and pushing the arms upward toward the annuloplasty ring, the arms are configured to provide a strong reaction force against which the annuloplasty ring is pushed (from above the leaflets).
[0054] Reference now Figure 8 , Figure 8 2 is a schematic diagram of an annuloplasty ring 20 deployed at the atrioventricular annulus of a subject according to some applications of the present invention. For some applications, the annuloplasty ring includes a plurality of anchors 90 (e.g., disks (e.g., Figure 8The plurality of anchors 90 are configured to be anchored to the annulus via coupling elements (e.g., via barbs, hooks, sutures, and / or other coupling elements) such that the discs and / or tubular structures are coupled to one another via flexible cords or wires 94 such that the discs and / or tubular structures can move relative to one another, thereby allowing the annuloplasty ring to be delivered via a catheter in a radially constrained (i.e., crimped) configuration and thereby maintaining flexibility of the atrioventricular annulus when the ring is implanted at the atrioventricular annulus. For some applications, the anchors are coupled to portions of chord manipulator arms that remain in position within the left ventricle beneath the native valve leaflets, as described above.
[0055] The scope of the present application includes the use of chord manipulation arms having any shape that will facilitate the use of the chord manipulation arms in the manner described herein. Typically, more than two arms (e.g., more than 4 arms) and / or less than 12 arms (e.g., less than 10 arms) are used. As described above, depending on the respective application, the arms are disposed at approximately 90 degrees (e.g., 90 degrees plus / minus 3 degrees, or exactly 90 degrees) relative to the longitudinal axis of the distal-most portion of the delivery device, define an acute angle relative to the longitudinal axis of the distal-most portion of the delivery device, or define an obtuse angle relative to the longitudinal axis of the distal-most portion of the delivery device. For some applications, the arms are disposed at 45 to 135 degrees (e.g., 70 to 110 degrees or 85 to 95 degrees) relative to the longitudinal axis of the distal-most portion of the delivery device.
[0056] In accordance with the devices and techniques described above, the chord manipulation arm 26 can be used to perform any of a number of functions. In accordance with some embodiments, these functions are performed in isolation from one another or in combination with one another. One such function is to use the arm to reduce the size of the atrioventricular valve annulus by rotating the arm while the arm is deployed between the chordae tendineae. Rotation of the arm causes the chordae tendineae in which the arm is deployed to become deflected, and in turn, the deflection of the chordae tendineae causes at least a portion of the atrioventricular valve (e.g., the leaflets and annulus of the atrioventricular valve) to become twisted and pulled radially inward toward the base of the arm. In accordance with some applications of the present invention, another function provided by the arm is to provide a reaction force against which the annuloplasty ring is urged. In accordance with some applications of the present invention, yet another function provided by the arm, a portion of the arm, and / or an extension of the arm is to serve as an intraventricular anchoring portion to which the annuloplasty ring is anchored, for example, as described above with reference to the Figure 1F to Figure 1G described.
[0057] As described above, according to some applications of the present invention, an annuloplasty ring is implanted onto an atrioventricular valve annulus that has been reduced in size relative to the size prior to the initiation of the annuloplasty procedure. The scope of the present application includes reducing the size of the atrioventricular valve annulus prior to implanting the annuloplasty ring (such that the annuloplasty ring is implanted onto an atrioventricular valve annulus that has been reduced in size), but using different techniques for reducing the size of the atrioventricular valve annulus to the size of the atrioventricular valve annulus described above.
[0058] Those skilled in the art will recognize that the present invention is not limited to what is specifically shown and described above. Rather, the scope of the present invention includes the combinations and sub-combinations of the various features described above, as well as changes and modifications to the combinations and sub-combinations of the various features that will occur to those skilled in the art upon reading the foregoing description and that are not in the prior art.
Claims
1. A device for use with an annuloplasty ring and an atrioventricular valve of a heart of a mammalian subject, the atrioventricular valve comprising an annulus, leaflets, chordae tendineae and papillary muscles, the device comprising: a plurality of chord manipulator arms, each of the chord manipulator arms comprising a flexible material and a stiffening element, the stiffening element being configured to provide a desired shape to the chord manipulator arms when the chord manipulator arms are disposed in a non-radially constrained configuration, wherein: The chord manipulator arm is configured to be deployed between the chordae of the atrioventricular valve, and then the chord manipulator arm is rotated so that the chordae are deflected by the chord manipulator arm to twist the native atrioventricular valve and pull the native atrioventricular valve radially inward, thereby reducing the size of the valve annulus, and The reinforcement element is configured to be removed and / or to remove reinforcement from the flexible material of the chord manipulator arm so as to facilitate removal of the chord manipulator arm from between the chords.
2. The device according to any one of the preceding claims, wherein: The reinforcement element comprises a removable reinforcement wire disposed within the flexible material of the chord manipulator arm, and wherein, after the annuloplasty ring has been implanted, the removable reinforcement wire is configured to be retracted from within the flexible material of the chord manipulator arm so that the chord manipulator arm becomes flexible and can be easily removed from between the chordae of the native atrioventricular valve.
3. A device according to any one of the preceding claims, wherein: The reinforcement element includes a reinforcement wire connected to the flexible material of the chord manipulation arm, and wherein, after the annuloplasty ring has been implanted, the reinforcement wire is configured to be decoupled from the flexible material of the chord manipulation arm so that the chord manipulation arm becomes flexible and can be easily removed from between the chordae of the native atrioventricular valve.
4. A device according to any one of the preceding claims, wherein: After the annuloplasty ring has been implanted, the reinforcement element is configured to remove reinforcement such that the chord manipulation arms become flexible and can be easily removed from between the chordae of the native atrioventricular valve.
5. A device according to any one of the preceding claims, wherein: The atrioventricular valve includes a mitral valve, and the chord manipulator arm is configured to be deployed between chordae tendineae of the mitral valve.
6. A device according to any one of the preceding claims, wherein: The atrioventricular valve includes a tricuspid valve, and the chord manipulator arm is configured to be deployed between chordae of the tricuspid valve.
7. A device according to any one of the preceding claims, wherein: The plurality of chord manipulator arms includes more than two chord manipulator arms and less than 12 chord manipulator arms.
8. A device according to any one of the preceding claims, wherein: When the chord manipulation arms are set in a non-radially constrained configuration, at least a portion of the inner edge of each of the chord manipulation arms is concavely curved in a given circumferential direction, and the chord manipulation arms are configured to pull the natural atrioventricular valve radially inward by rotating in the given circumferential direction.
9. The device according to any one of the preceding claims, wherein: The chord manipulator arms are sized such that when disposed in a radially unconstrained configuration, the chord manipulator arms span a diameter at least equal to an inner diameter of the annuloplasty ring such that the chord manipulator arms are configured to provide a reaction force during implantation of the annuloplasty ring against which the annuloplasty ring can be urged.
10. The device according to any one of the preceding claims, wherein: The chord manipulator arms are sized such that when disposed in a radially non-constrained configuration, the chord manipulator arms are configured to radially overlap the annuloplasty ring such that the chord manipulator arms are configured to provide a counterforce during implantation of the annuloplasty ring against which the annuloplasty ring can be urged.
11. The device according to any one of the preceding claims, wherein: At least a portion of an inner edge of each of the chord manipulator arms is concavely curved in a given circumferential direction, and wherein the chord manipulator arms are configured to pull the native atrioventricular valve radially inward by rotating in the given circumferential direction.
12. The device according to any one of the preceding claims, wherein: The chord manipulator arms, portions of the chord manipulator arms, and / or extensions therefrom are configured to remain beneath the atrioventricular valve leaflets, and the annuloplasty ring is configured to be anchored to the chord manipulator arms, portions of the chord manipulator arms, and / or extensions therefrom.
13. The device of any of the preceding claims, further comprising a frame configured to extend from beneath the atrioventricular valve leaflets into an atrium of the subject's heart, the frame defining an aperture sized to allow blood to flow from the atrium to the ventricle of the subject's heart via the frame, and wherein, The chord manipulator arm is coupled to a portion of the frame configured to be disposed within the ventricle.
14. The device according to any one of the preceding claims, Also included is a support rod and a hollow tube defining a hole, in, The chord manipulation arm is coupled to the support rod, and the support rod is configured to be disposed within the hollow tube, and Wherein the hole in the hollow tube is sized to allow blood to flow from an atrium of the subject's heart to a ventricle of the subject's heart via the hollow tube.
15. The apparatus of any of the preceding claims, further comprising a delivery device configured to deliver the chord manipulator arm to a ventricle of a subject's heart, wherein The arms are disposed at an angle between 45 and 135 degrees relative to a longitudinal axis of a distal-most portion of the delivery device.
16. The device according to any one of the preceding claims, further comprising a plurality of support elements, wherein: Each of the chord manipulation arms is coupled to a respective one of the support elements, wherein the support elements are configured to remain together with one another during delivery of the arms to a ventricle of a heart of a subject, and wherein the support elements are configured to separate from one another during deployment of the arms within the ventricle.
17. A method for use with an annuloplasty ring and a mitral valve of a heart of a mammalian subject, the mitral valve comprising an annulus, leaflets, chordae tendineae, and papillary muscles, the method comprising: delivering a first delivery device to a left ventricle of the subject via an aorta of the subject; deploying a plurality of chord manipulator arms from the first delivery device between the chordae of the atrioventricular valve; delivering a second delivery device to the left atrium of the subject via the atrial septum of the subject; deploying the annuloplasty ring from the second delivery device into the left atrium of the subject; rotating the arms so that the arms cause the annulus to decrease in size by deflecting the chordae tendineae to twist the native mitral valve through the arms and pull the native mitral valve radially inward; and The annuloplasty ring is then implanted over the annulus while using the arms to (a) maintain the size of the annulus in its reduced size by maintaining the arms in their rotated state, and (b) provide a counterforce by pushing the arms from beneath the leaflets toward the annuloplasty ring, the annuloplasty ring being pushed against the counterforce.