Atrioventricular valve repair
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- SHEBA IMPACT LTD
- Filing Date
- 2023-05-19
- Publication Date
- 2026-05-21
AI Technical Summary
Current methods for repairing atrioventricular valves, such as the mitral and tricuspid valves, are limited in their ability to effectively reduce the size of the valve annulus and maintain a leak-free seal, particularly in cases of valve insufficiency due to physical abnormalities or pathological conditions.
The use of a plurality of chordal manipulation arms deployed between the chordae tendineae of the atrioventricular valve, which are then rotated to twist and pull the native valve radially inward, reducing the annulus size. An annuloplasty ring is then implanted into the reduced annulus, with the arms maintaining the size and providing a reaction force during implantation.
This method allows for effective reduction of the atrioventricular valve annulus size, facilitating the secure implantation of an annuloplasty ring, which helps in maintaining a leak-free seal and improving valve function, thereby addressing issues of valve insufficiency.
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Abstract
Description
Technical Field
[0001] (Cross - Reference to Related Applications) This application claims priority to U.S. Provisional Patent Application 63 / 344,590, titled "Atrioventricular valve repair" by Orlov et al., filed on May 22, 2022, which is hereby incorporated by reference in its entirety.
[0002] The present invention relates to medical devices and methods, and more particularly, to devices and methods for repairing atrioventricular valves.
Background Art
[0003] The human heart is a muscular organ that, through the contraction of its four chambers, pumps deoxygenated blood to the lungs to oxygenate the blood and then pumps the oxygenated blood to the rest of the body.
[0004] After circulating through the body, the deoxygenated blood from the body enters the right atrium via the vena cava. In a healthy individual, when the right atrium contracts, the blood is pumped through the tricuspid valve into the right ventricle. When the right ventricle contracts, the blood is pumped through the pulmonary semilunar valve into the pulmonary artery. The pulmonary artery divides into two branches, one for each lung. The blood is oxygenated as it passes through the lungs and re - enters the heart via the left atrium. When the left atrium contracts, the oxygenated blood is pumped through the mitral valve into the left ventricle. When the left ventricle contracts, the oxygenated blood is pumped through the aortic valve into the aorta and distributed to the rest of the body. During the contraction of the right ventricle, the tricuspid valve is closed, preventing the backflow of blood into the right atrium. Similarly, during the contraction of the left ventricle, the mitral valve is closed, preventing the backflow of blood into the left atrium. The mitral valve and the tricuspid valve are known as atrioventricular valves, and these valves control the flow of blood between the atria and the ventricles, respectively.
[0005] In the mitral valve, the mitral annulus defines the mitral valve orifice. The anterior leaflet and the posterior leaflet extend from the mitral annulus. The leaflets are connected to the papillary muscles in the left ventricle by chordae tendineae.
[0006] During ventricular diastole, in a healthy person, the left atrium contracts and blood is pumped into the left ventricle through the mitral valve orifice. The blood flows through the valve orifice, pushing open the valve leaflets and entering the left ventricle with minimal resistance. In a healthy person, the valve leaflets of the aortic valve are in a closed state due to the blood pressure in the aorta.
[0007] During ventricular systole, the left ventricle contracts and blood is pumped into the aorta through the aortic valve, and the valve leaflets of the aortic valve are pushed open by the blood flow. In a healthy person, the mitral annulus contracts, pushing the valve leaflets inward and reducing the area of the mitral valve orifice by about 20% - 30%. The valve leaflets join together to absorb the extra valve leaflet surface area and generate a joining surface for sealing. Since the pressure of the blood in the left ventricle pushes the ventricular surface of the valve leaflets and presses the valve leaflets tightly against each other at the joining surface, a tight and leak - free seal is formed.
[0008] The effective sealing of the mitral valve during ventricular systole depends on the sufficient depth of the joining. Inadequate joining can be caused by numerous physical abnormalities that allow valve leaflet prolapse (e.g., elongated or ruptured chordae tendineae, or weak papillary muscles) or inhibition of joining (e.g., short chordae tendineae, or small valve leaflets). There are also pathological conditions leading to mitral valve insufficiency, including collagen - vascular diseases, ischemic mitral regurgitation (e.g., caused by myocardial infarction, chronic heart failure, or failure / unsuccessful surgical or catheter - based revascularization), myxomatous degeneration of the valve 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 valve leaflets, namely, the septal leaflet, the anterior leaflet, and the posterior leaflet. The valve leaflets are each attached to the tricuspid annulus that defines the tricuspid valve orifice. The valve leaflets are connected to the papillary muscles in the right ventricle by chordae tendineae. In a healthy person, the tricuspid valve controls the direction of blood flow from the right atrium to the right ventricle in the same way as the mitral valve controls the blood flow direction on the left side of the heart. During ventricular diastole, the tricuspid valve opens to allow the blood flow from the right atrium to the right ventricle, and during ventricular systole, the valve leaflets of the tricuspid valve join together to prevent the backflow of blood 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 flow backward from the right ventricle 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 and, as a result, the valve leaflets do not join properly.
[0011] Mammals other than humans affected by mitral regurgitation and tricuspid regurgitation include horses, cats, dogs, cows, sheep, and pigs.
[0012] For example, it is known to use open-heart surgical methods to treat mitral regurgitation and tricuspid regurgitation by modifying subvalvular organs (e.g., lengthening or shortening chordae tendineae) to improve leaflet coaptation and / or implanting an annuloplasty ring to reduce the size of the annulus.
Summary of the Invention
[0013] According to some applications of the present invention, an apparatus and method are provided for facilitating the implantation of an annuloplasty ring into an atrioventricular valve of a subject's heart (e.g., the mitral valve of the subject or the tricuspid valve of the subject). Typically, a plurality of chordal manipulation arms are deployed between the chordae tendineae of the atrioventricular valve. Then, by deflecting the chordae tendineae, the arms are rotated so that the arms twist the native atrioventricular valve and pull the native atrioventricular valve radially inward, causing the arms to reduce the size of the annulus. After rotating the arms, the annuloplasty ring is implanted into 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 their rotated state. In some applications, during implantation of the annuloplasty ring, the arms are used to provide a reaction force against the pressing of the annuloplasty ring by pulling the arms from below the valve leaflets toward the annuloplasty ring.
[0014] Typically, after the annuloplasty ring is implanted, the chord manipulation arm is rotated in a direction opposite to the direction in which it was previously rotated, and the arm is removed from the subject's body. Typically, rotation in the opposite direction of chord manipulation allows the native atrioventricular valve to be untwisted. However, the annuloplasty ring maintains the atrioventricular annulus at a reduced size relative to the expanded size of the annulus prior to ring implantation. In some applications, the annuloplasty ring is fixed to an arm, a portion of the arm, and / or an extension from the arm, and the arm, the portion of the arm, and / or the extension from the arm are left at a predetermined position under the atrioventricular valve leaflets. In some applications, the portion of the arm and / or the extension from the arm are detachable and are configured to remain at a predetermined position under the atrioventricular valve leaflets even after the arm or a portion of the arm has been removed from the subject's ventricle.
[0015] Accordingly, in some applications of the present invention, an apparatus for use with an annuloplasty ring and an atrioventricular valve of a mammalian subject's heart, wherein the atrioventricular valve includes an annulus, valve leaflets, chordae tendineae, and papillary muscles, the apparatus comprising a plurality of chord manipulation arms each comprising a flexible material and a stiffening element, the stiffening element being configured to impart a desired shape to the chord manipulation arm when the chord manipulation arm is disposed in a configuration in which it is non-radially constrained, the chord manipulation arms being deployed between the chordae tendineae of the atrioventricular valve and then rotated to reduce the size of the annulus by causing the chord manipulation arms to deflect the chordae tendineae such that the native atrioventricular valve is twisted and pulled radially inwardly, and a stiffening element configured to be removed from and / or decured from the flexible material of the chord manipulation arm to facilitate removal of the chord manipulation arm from between the chordae tendineae is provided.
[0016] In some application examples, the stiffening element includes a removable stiffening wire disposed within the flexible material of the chordal manipulation arm. After the annuloplasty ring is implanted, the removable stiffening wire is configured to be withdrawn from within the flexible material of the chordal manipulation arm. As a result, the chordal manipulation arm becomes flexible and can be easily removed from between the chords of the native atrioventricular valve.
[0017] In some application examples, the stiffening element includes a stiffening wire coupled to the flexible material of the chordal manipulation arm. After the annuloplasty ring is implanted, the stiffening wire is configured to be detached from the flexible material of the chordal manipulation arm. As a result, the chordal manipulation arm becomes flexible and can be easily removed from between the chords of the native atrioventricular valve.
[0018] In some application examples, after the annuloplasty ring is implanted, the stiffening element is configured to be des stiffened. As a result, the chordal manipulation arm becomes flexible and can be easily removed from between the chords of the native atrioventricular valve.
[0019] In some application examples, the atrioventricular valve includes a mitral valve, and the chordal manipulation arm is configured to be deployed between the chords of the mitral valve.
[0020] In some application examples, the atrioventricular valve includes a tricuspid valve, and the chordal manipulation arm is configured to be deployed between the chords of the tricuspid valve.
[0021] In some application examples, the plurality of chordal manipulation arms includes three or more and less than twelve chordal manipulation arms.
[0022] In some application examples, when the chordal manipulation arms are arranged in a configuration where they are non-radially constrained, at least a portion of the inner edge of each chordal manipulation arm is curved concave in a given circumferential direction, and the chordal manipulation arm is configured to pull the native atrioventricular valve radially inward by rotating in a given circumferential direction.
[0023] In some application examples, the chordal operation arm is sized to expand to a diameter at least equal to the inner diameter of the annuloplasty ring when the chordal operation arm is arranged in a configuration where it is not radially constrained, such that the chordal operation arm is configured to provide a reaction force against which the annuloplasty ring can be pressed during implantation of the annuloplasty ring.
[0024] In some application examples, the chordal operation arm is sized to overlap radially with the annuloplasty ring when the chordal operation arm is arranged in a configuration where it is not radially constrained, such that the chordal operation arm is configured to provide a reaction force against which the annuloplasty ring can be pressed during implantation of the annuloplasty ring.
[0025] In some application examples, at least a portion of the inner edge of each chordal operation arm is curved concave in a given circumferential direction, and the chordal operation arm is configured to pull the atrioventricular valve radially inward by rotating in the given circumferential direction.
[0026] In some application examples, the chordal operation arm, a portion of the chordal operation arm, and / or an extension from the chordal operation arm are configured to be left under the atrioventricular valve leaflet, and the annuloplasty ring is configured to be fixed to the chordal operation arm, a portion of the chordal operation arm, and / or an extension from the chordal operation arm.
[0027] In some application examples, the device further comprises a frame configured to extend from under the atrioventricular valve leaflet to the atrium of the subject's heart, the frame defining holes sized to allow blood to flow from the atrium to the ventricle of the subject's heart through the frame, and the chordal operation arm is coupled to a portion of the frame configured to be disposed within the ventricle.
[0028] In some applications, the device further comprises a strut and a hollow tube defining a hole, the chord operation arm being coupled to the strut, the strut being configured to be disposed within the hollow tube, and the hole within the hollow tube being sized to permit blood to flow from the atrium of the subject's heart through the hollow tube to the ventricle of the subject's heart.
[0029] In some applications, the device further comprises a delivery device configured to deliver the chord operation arm to the ventricle of the subject's heart, the arm being disposed at an angle of 45 degrees to 135 degrees with respect to the longitudinal axis of the most distal portion of the delivery device.
[0030] In some applications, the device further comprises a plurality of support elements, each of the chord operation arms being coupled to a corresponding one of the support elements, the support elements being configured to be grouped together during delivery of the arms to the ventricle of the subject's heart and to be separated from each other during deployment of the arms within the ventricle.
[0031] According to some applications of the present invention, a method for use with an annuloplasty ring and a mitral valve of a mammalian subject's heart, the mitral valve including an annulus, valve leaflets, chordae tendineae, and papillary muscles, the method comprising: delivering a first delivery device through the subject's aorta to the left ventricle of the subject; deploying a plurality of chord operation arms from the first delivery device between the chordae tendineae of the atrioventricular valve; delivering a second delivery device through the atrial septum of the subject to the left atrium of the subject; deploying an annuloplasty ring from the second delivery device into the left atrium of the subject; rotating the arms so that the arms twist the native mitral valve and pull the native mitral valve radially inwardly by deflecting the chordae tendineae, thereby reducing the size of the annulus; and Thereafter, while using the arm, the annuloplasty ring is implanted into the annulus by (a) maintaining the arm in its rotated state to maintain the size of the annulus at its reduced size and (b) pushing the arm from below the valve leaflet toward the annuloplasty ring to provide a reaction force against the annuloplasty ring being pressed, A method including this is further provided.
[0032] The present invention will be more fully understood from the following detailed description of application examples of the present invention, which is to be interpreted together with the drawings.
Brief Description of the Drawings
[0033]
Figure 1A
Figure 1B
Figure 1C
Figure 1D
Figure 1E
Figure 1F
Figure 1G
Figure 2A
Figure 2B
Figure 3
Figure 4
Figure 5A
Figure 5B
Figure 5C
Figure 6A
Figure 6B
Figure 7
Figure 8
DETAILED DESCRIPTION OF THE INVENTION
[0034] Refer to FIGS. 1A, 1B, 1C, 1D, and 1E, which are schematic diagrams of each step of a procedure for implanting an annuloplasty ring 20 (shown in FIGS. 1C to 1E) into the atrioventricular valve 22 of a subject according to some application examples of the present invention. The atrioventricular valve separates the atrium 16 and the ventricle 18 and typically includes an annulus 21, valve leaflets 23, chordae tendineae 25, and papillary muscles 27.
[0035] In the first step of the procedure, a delivery device 24 is delivered to the atrioventricular valve. Then, as shown in FIG. 1A, a plurality of chordae tendineae manipulation arms 26 are released from the delivery device. It should be noted that in the present application, the chordae tendineae manipulation arms 26 deployed between the chordae tendineae of the mitral valve are shown. However, the scope of the present application includes applying the devices and methods described herein to the tricuspid valve by analogy. Further, it should be noted that in some of the figures, a delivery device introduced from above the mitral valve (e.g., by transseptal or transatrial delivery) is shown. However, the scope of the present application includes introducing the delivery device from below the mitral valve (e.g., by transapical delivery or, for example, by aortic delivery as shown in FIG. 7). In application examples 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, for illustrative purposes, it should be noted that some of the figures in the present application show cross-sectional views of the heart (and, where applicable, the annuloplasty ring) in combination with a complete three-dimensional view of the chordae tendineae manipulation arm 26.
[0036] In some applications, to release the arm from the delivery device, the covering sheath 28 of the delivery device is pulled back relative to the chord-operating arm 26, or the arm is pushed forward relative to 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) 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. The arm is typically configured to extend radially outward to a sufficient extent such that, as shown in FIG. 1A, the arm can be deployed between the chordae tendineae 25 of the atrioventricular valve. In some applications, the arm extends radially outward to a sufficient extent such that the arm can be deployed between the primary and / or secondary chordae tendineae. More typically, as shown, the arm is configured such that the arm curves circumferentially. In some applications, the circumferential curvature of each arm is such that at least a portion of the inner edge 29 of the arm (shown in FIG. 1A) curves concavely in a given circumferential direction. For example, as shown in FIG. 1A, at least a portion of the inner edge 29 of the arm curves concavely in the clockwise circumferential direction. In some applications, the inner edge 29 of the arm curves concavely in a given circumferential direction along the entire length of the arm. Typically, at least the 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 first contacts the chordae tendineae) curves concavely in a given circumferential direction.
[0037] In the next step of the procedure, the chord 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 the 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 the counterclockwise direction, in which case the arm is typically rotated in the counterclockwise direction. Typically, rotation of the arm causes the chordae tendineae deployed between them to deflect. Furthermore, the deflection of the chordae tendineae causes at least a portion of the atrioventricular valve (e.g., the valve leaflets and valve annulus of the atrioventricular valve) to twist and be pulled radially inward toward the base of the arm. This is because the chordae tendineae extend between the papillary muscle at the first end of the chordae tendineae and the mitral valve annulus at the second end of the chordae tendineae via the valve leaflets. The deflection of the chordae tendineae pulling the native atrioventricular valve radially inward results in annulus reduction. Thus, in this way, the atrioventricular valve annulus 21 is reduced in size relative to the size of the atrioventricular valve annulus before rotation of the arm. FIG. 1B is a schematic view of the mitral valve after rotating the arm in the above-described manner. FIG. 1B includes a top view of the mitral valve (within the dashed box). As shown, the valve leaflets are twisted by the rotation of the arm. Also, as can be seen by comparing FIG. 1B with FIG. 1A, the mitral valve annulus is pulled radially inward in the direction of arrow 31 by the rotation of the arm.
[0038] In the next step of the procedure, the annuloplasty ring 20 is implanted into the atrioventricular annulus. During implantation of the annuloplasty ring, the arm is maintained in its rotated state so that the arm maintains the atrioventricular annulus at its reduced size. In this way, the annuloplasty ring is implanted into an atrioventricular annulus that is already reduced in size relative to the size of the atrioventricular annulus before the start of annuloplasty. This is in contrast to some other techniques for implanting an annuloplasty ring in which the size of the annulus is not reduced prior to implantation of the annuloplasty ring. Rather, according to such techniques, either 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 then the diameter of the ring is reduced (e.g., by tightening the ring).
[0039] Figures 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 attachable to (or attached to) the delivery device 24, e.g., 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 secure the annuloplasty ring to the annulus by being embedded in the tissue of the annulus. In some applications, as shown by arrow 30 in Figure 1D, the arm (disposed beneath the leaflet) is pulled toward the annuloplasty ring so that the arm provides a reaction force against the annuloplasty ring being pressed (from above the leaflet) during implantation of the annuloplasty ring. Typically, in such applications, the arm is sized to expand to a diameter at least equal to the inner diameter of the annuloplasty ring when the arm is disposed in a configuration where the arm is not radially constrained. Thus, the arm is configured to overlap the annuloplasty ring radially in its non-radially constrained configuration.
[0040] In some application examples, as shown in FIG. 1E, which shows a cross-sectional view of an implanted annuloplasty ring without an arm and a delivery device, after the annuloplasty ring is implanted, the arm 26 is retracted into the delivery device and removed from the subject's body. At this stage, the annuloplasty ring typically maintains the annulus at a reduced size (relative to its expanded size prior to the procedure). Typically, after the annuloplasty ring is implanted, the chord manipulation arm is rotated in a direction opposite to the direction in which it was previously rotated, and the arm is removed from the subject's body. Typically, the rotation in the opposite direction of chord manipulation allows the native atrioventricular valve to be torsion-free. However, the annuloplasty ring maintains the annulus at a reduced size relative to the expanded size of the annulus prior to ring implantation.
[0041] In some application examples, to provide the aforementioned fixation function, the annuloplasty ring is fixed to the arm 26, a portion of the arm, and / or an extension from the arm, and the arm, a portion of the arm, and / or an extension from the arm are left at a predetermined position under the atrioventricular valve leaflets. In some application examples, the portion of the arm and / or the extension from the arm are detachable and are configured to remain at a predetermined position under the atrioventricular valve leaflets even after the arm or a portion of the arm is removed from the subject's ventricle. For example, FIGS. 1F and 1G show embodiments 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 a portion of the anchor element 58 within the plate, as shown in FIG. 1G). In this way, at least a portion of the arm 26 and / or the extension of the arm function as an intraventricular anchor portion to which the annuloplasty ring is fixed.
[0042] Refer to FIGS. 2A and 2B, which are respectively a schematic side view and a schematic bottom view of a series of chordal manipulation arms 26 used during implantation of the annuloplasty ring 20 into the atrioventricular valve of a subject according to some application examples of the present invention. In some application examples, the arm is coupled to a frame 40 configured to extend from below the atrioventricular valve leaflet (i.e., within the ventricle) to the atrium of the subject (e.g., as shown in FIGS. 1A to 1D and 1F). The frame defines a hole sized to allow blood to flow from the atrium to the ventricle through the frame while the above procedure is being performed. This is shown by the arrow 42 indicating blood flow in FIG. 1B.
[0043] Refer to FIG. 3, which is a schematic view of the chordal manipulation arm 26 attached to the frame 40. The arm is typically coupled to the ventricular portion 44 of the frame, and the atrial portion 46 of the frame extends upwardly into the atrium so as to facilitate blood flow from the atrium to the ventricle in the above-described manner. In some application examples, the ventricular portion 44 of the frame is configured to self-expand radially such that the location of the frame to which the arm is coupled has a larger perimeter than the atrial portion of the frame. In some application examples, the expansion of the ventricular portion of the frame facilitates the arm extending radially outwardly to a sufficient extent for the arm to be deployed between the chordae tendineae 25 (e.g., primary chordae tendineae and / or secondary chordae tendineae) of the atrioventricular valve.
[0044] Refer to FIG. 4, which is a schematic view of the chord operation arm 26 coupled to the strut 60 according to some application examples of the present invention. Typically, the strut 60 is disposed within a hollow tube 62, and the hollow tube 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 from the atrium through the hollow tube (as indicated by the blood flow arrow 42) and out of an outflow hole disposed within the ventricle (where the arm typically protrudes). The hole within the hollow tube 62 typically allows blood to flow from the atrium to the ventricle while the above procedure is being performed. In some application examples, 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 to prevent blood flow in the opposite direction.
[0045] Referring back to FIG. 2B, in some application examples, the angle “α” that the arm makes with respect to the frame 40 or the strut 60 (and with respect to the longitudinal axis of the most distal portion of the delivery device) is approximately 90 degrees (e.g., 90 degrees plus / minus 3 degrees, or exactly 90 degrees). Alternatively, this angle may be an acute or obtuse angle. In some application examples, the arm is 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 most distal portion of the delivery device.
[0046] Refer to FIGS. 5A and 5B, which schematically show each view of a series of chordal manipulation arms 26 used during the implantation of the annuloplasty ring 20 into the atrioventricular valve of a subject according to some application examples of the present invention. In some application examples, each arm is coupled to a corresponding support element 50, and the support elements are separable from each other. During the delivery of the arm to the ventricle, the support elements are typically grouped together (e.g., by being constrained within the delivery device) to reduce the delivery profile of the device. Referring now to FIG. 5C, during the deployment of the arm within the ventricle of the subject, the support elements are separated from each other, for example, by pulling back the separation element 52 so as to be disposed between the support elements. Typically, while the above procedure is being performed, the blood flow from the atrium to the ventricle continues through the gap between the support elements, as indicated by the blood flow arrow 42 in FIG. 5C.
[0047] Refer to FIGS. 6A and 6B, which are schematic views of a chordal manipulation arm 26 with a removable stiffening element 70 according to some application examples of the present invention. In some application examples, the arm is made of a flexible material or has a flexible mechanical design. The stiffening element 70 is disposed within and / or coupled to the arm and is shaped to form the arm into the desired shape (as described above). In some application examples, the stiffening element is a wire made of a shape memory material such as nitinol, and the stiffened wire is shaped to give the arm the desired shape.
[0048] As described above, typically, the chord manipulation arm 26 is deployed between the chordae tendineae of the atrioventricular valve. Thereafter, by deflecting the chordae tendineae (and / or the valve leaflets and / or other portions of the subvalvular apparatus), the arm is rotated such that the arm twists the native atrioventricular valve and pulls the native atrioventricular valve radially inwardly to reduce the size of the valve annulus. After rotating the arm, the annuloplasty ring 20 is implanted into the valve annulus. During implantation of the annuloplasty ring, the arm is typically used to maintain the size of the valve annulus at its reduced size by maintaining the arm in its rotated state. In some applications, during implantation of the annuloplasty ring, the arm is used to provide a counterforce against the annuloplasty ring being pressed in by pulling the arm from beneath the valve leaflets toward the annuloplasty ring.
[0049] In some applications, it may be desirable to reduce the stiffness of the chord manipulation arm such that after using the arm to manipulate the chordae tendineae (and / or the valve leaflets and / or other portions of the subvalvular apparatus), the arm can be withdrawn from between the chordae tendineae. Thus, in some applications, after the annuloplasty ring has been implanted, the stiffening wire is withdrawn from within the chord manipulation arm and / or detached from the chord manipulation arm. Alternatively or additionally, the stiffening wire is manipulated and / or treated to be des stiffened (i.e., made more flexible). The stiffening and des stiffening of the arm may be performed by any applicable technical method, including, but not limited to, shape memory alloys (such as nitinol), beads with pull wires therein, application of an electric current or electromagnetic field, application of a temperature change, and / or application of any form of electromagnetic radiation. As a result of the stiffening wire being withdrawn from, detached from, and / or des stiffened from the arm, the chord manipulation arm typically becomes flexible, such that the arm can be easily removed from between the chordae tendineae. Next, as shown in FIG. 6B, the arm is drawn into a hollow tube 62 (and / or another delivery device or portion thereof).
[0050] Refer to FIG. 7, which is a schematic view of a chordal manipulation arm 26 delivered transaortically according to some application examples of the present invention. As described above, in some application examples, the delivery device 24 used to deliver the chordal manipulation arm to the left ventricle is delivered from below the mitral valve. In such some application examples, the delivery device is advanced through the aorta 80 of the subject, through the aortic valve 82 of the subject, and into the left ventricle of the subject. The delivery device 54 used to deliver the annuloplasty ring is typically advanced from above the mitral valve, for example, transseptally (i.e., through the atrial septum of the subject). Alternatively, the delivery device 54 can also be delivered transaortically. The shape and function of the arm are generally substantially the same as those described above.
[0051] Typically, the arm is rotated to deflect the chordae tendineae (and / or leaflets, and / or other parts of the subvalvular apparatus) with the arm deployed. Next, due to the deflection of the chordae tendineae, at least a portion of the atrioventricular valve (e.g., the leaflets and annulus of the atrioventricular valve) is torsionally deflected and pulled radially inward toward the base of the arm. By pulling the native atrioventricular valve radially inward by the deflection of the chordae tendineae, a reduction in the annulus is brought about. Thus, in this way, the atrioventricular valve annulus 21 is reduced in size relative to the size of the atrioventricular valve annulus before rotation of the arm. In the next step of the procedure, as shown in FIG. 7, the annuloplasty ring 20 is implanted into the atrioventricular valve annulus. During implantation of the annuloplasty ring, the arm is maintained in its rotated state so that the arm maintains the atrioventricular valve annulus at its reduced size. In this way, the annuloplasty ring is implanted into the atrioventricular valve annulus that has already been reduced in size relative to the size of the atrioventricular valve annulus before the start of the annuloplasty.
[0052] Typically, during implantation of the annuloplasty ring, the arm 26 is pushed upward toward the annuloplasty ring, such that the arm (disposed beneath the valve leaflet) provides a reaction force against the annuloplasty ring being pressed (from above the valve leaflet). Typically, the arm is sized to expand to a diameter at least equal to the inner diameter of the annuloplasty ring when the arm is disposed in a configuration where it is not radially constrained. Thus, the arm is configured to radially overlap the annuloplasty ring in its non-radially constrained configuration. Typically, by delivering the arm beneath the mitral valve and pushing it upward toward the annuloplasty ring, the arm is configured to provide a strong reaction force against the annuloplasty ring being pressed (from above the valve leaflet).
[0053] Referring now to FIG. 8, a schematic view of an annuloplasty ring 20 deployed in a subject's atrioventricular annulus, according to some applications of the present invention. In some applications, the annuloplasty ring comprises a plurality of anchors 90 (e.g., plates, pads, and / or tubular structures (not shown) as shown in FIG. 8), which are configured to be secured to the annulus via coupling elements (e.g., loops, hooks, sutures, and / or other coupling elements). The plates and / or tubular structures are coupled to each other via flexible strings or wires 94, allowing the plates and / or tubular structures to move relative to each other, enabling the annuloplasty ring to be delivered transcatheterically in a radially constrained (i.e., crimped) configuration, thereby maintaining the flexibility of the atrioventricular annulus when the ring is implanted in the annulus. In some applications, the anchors are coupled to portions of chord manipulation arms that remain at a predetermined location beneath the native valve leaflets in the left ventricle as described above.
[0054] The scope of the present application includes using a chord manipulation arm having any shape that facilitates the use of the chord manipulation arm in the techniques described herein. Typically, three or more arms (e.g., five or more arms) and / or less than twelve arms (e.g., less than ten arms) are used. As described above, according to each application example, the arms are arranged at about 90 degrees (e.g., 90 degrees plus / minus 3 degrees, or exactly 90 degrees) with respect to the longitudinal axis of the most distal portion of the delivery device, define an acute angle with respect to the longitudinal axis of the most distal portion of the delivery device, or define an obtuse angle with respect to the longitudinal axis of the most distal portion of the delivery device. In some application examples, the arms are arranged at 45 to 135 degrees (e.g., 70 to 110 degrees, or 85 to 95 degrees) with respect to the longitudinal axis of the most distal portion of the delivery device.
[0055] According to the above-described apparatus and techniques, the chord manipulation arm 26 may be used to perform any one of a plurality of functions. According to some embodiments, such functions are performed independently of each other or in combination with each other. 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 chords. By rotating the arm, the chords between which the arm is deployed are deflected, and furthermore, due to the deflection of the chords, at least a portion of the atrioventricular valve (e.g., the leaflets and annulus of the atrioventricular valve) is twisted and pulled radially inward toward the base of the arm. According to some application examples of the present invention, a further function provided by the arm is to provide a reaction force against the pressing of the annulus forming ring. According to some application examples 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 function as an intracardiac anchor portion to which the annulus forming ring is fixed, as described above with reference to FIGS. 1F to 1G.
[0056] As described above, according to some application examples of the present invention, the annuloplasty ring is implanted into an atrioventricular annulus that has already been reduced in size relative to the size of the atrioventricular annulus before the start of annuloplasty. Although the scope of the present application is different from the above technology, it uses a technique for reducing the size of the atrioventricular annulus to reduce the size of the atrioventricular annulus before implanting the annuloplasty ring (so that the annuloplasty ring is implanted into the atrioventricular annulus that has already been reduced in size).
[0057] It will be understood by those skilled in the art that the present invention is not limited to what has been particularly shown and described above in this specification. Rather, the scope of the present invention includes both combinations and sub - combinations of the various features described above in this specification, as well as variations and modifications thereof that are not found in the prior art that those skilled in the art would think of upon reading the foregoing description.
Claims
1. An annuloplasty ring and a device for use with the atrioventricular valve of the heart of a mammalian subject, wherein the atrioventricular valve includes an annulus, leaflets, chordae tendineae, and papillary muscles, and the device is A plurality of chordae tendineae manipulating arms, each comprising a flexible material and a hardening element, wherein the hardening element is configured to give the chordae tendineae manipulating arm a desired shape when the chordae tendineae manipulating arm is arranged in a configuration that is constrained in the non-radial direction, The chordae tendineae manipulating arm is deployed between the chordae tendineae of the atrioventricular valve, and thereafter, by bending the chordae tendineae, the chordae tendineae manipulating arm twists the atrioventricular valve and rotates the chordae tendineae manipulating arm so as to pull the atrioventricular valve radially inward, thereby reducing the size of the valve annulus. An apparatus configured such that the hardening element is detached from and / or dehardened from the flexible material of the chordae tendineae manipulating arm in order to facilitate the removal of the chordae tendineae manipulating arm from between the chordae tendineae.
2. The apparatus according to claim 1, wherein the hardening element comprises a removable hardening wire disposed within the flexible material of the chordae tendineae manipulating arm, and after the annulus forming ring is implanted, the removable hardening wire is configured to be pulled back from within the flexible material of the chordae tendineae manipulating arm, thereby making the chordae tendineae manipulating arm flexible and easily removable from between the chordae tendineae of the atrioventricular valve.
3. The apparatus according to claim 1, wherein the hardening element comprises a hardening wire bonded to the flexible material of the chordae tendineae manipulating arm, and the hardening wire is configured to be detached from the flexible material of the chordae tendineae manipulating arm after the annulus forming ring has been implanted, so that the chordae tendineae manipulating arm becomes flexible and can be easily removed from between the chordae tendineae of the atrioventricular valve.
4. The apparatus according to claim 1, wherein the hardening element is configured to deharden after the valve ring forming ring is implanted, and as a result the chordae tendineae manipulating arm becomes flexible and can be easily removed from between the chordae tendineae of the atrioventricular valve.
5. The apparatus according to claim 1, wherein the atrioventricular valve includes a mitral valve, and the chordae tendineae manipulating arm is configured to unfold between the chordae tendineae of the mitral valve.
6. The apparatus according to claim 1, wherein the atrioventricular valve includes a tricuspid valve, and the chordae tendineae manipulating arm is configured to unfold between the chordae tendineae of the tricuspid valve.
7. The apparatus according to claim 1, wherein the plurality of chordae tendineae manipulation arms include three or more chordae tendineae manipulation arms and less than twelve chordae tendineae manipulation arms.
8. The apparatus according to claim 1, wherein, when the chordae tendineae manipulating arms are arranged in a configuration that is constrained in a non-radial direction, at least a portion of the inner edge of each chordae tendineae manipulating arm is curved concavely in a given circumferential direction, and the chordae tendineae manipulating arms are configured to pull the atrioventricular valve radially inward by rotating in the given circumferential direction.
9. The apparatus according to claim 1, wherein the chordae tendineae manipulating arm is sized to expand to a diameter at least equal to the inner diameter of the annular forming ring when the chordae tendineae manipulating arm is arranged in a configuration in which the chordae tendineae manipulating arm is not radially constrained, so as to provide a reaction force against the annular forming ring being pressed during implantation of the annular forming ring.
10. The apparatus according to claim 1, wherein the chordae tendineae manipulating arm is sized to radially overlap the annular forming ring when the chordae tendineae manipulating arm is arranged in a configuration in which it is not radially constrained, so as to provide a reaction force against the annular forming ring being pressed during implantation of the annular forming ring.
11. The apparatus according to claim 1, wherein at least a portion of the inner edge of each chordae tendineae manipulating arm is curved concavely in a given circumferential direction, and the chordae tendineae manipulating arm is configured to pull the atrioventricular valve radially inward by rotating in the given circumferential direction.
12. The apparatus according to claim 1, wherein the chordae tendineae manipulating arm, a portion of the chordae tendineae manipulating arm, and / or an extension from the chordae tendineae manipulating arm are configured to remain below the leaflets of the atrioventricular valve, and the annulus forming ring is configured to be fixed to the chordae tendineae manipulating arm, a portion of the chordae tendineae manipulating arm, and / or an extension from the chordae tendineae arm.
13. The apparatus according to claim 1, further comprising a frame configured to extend from below the leaflets of the atrioventricular valve to the atrium of the subject's heart, wherein the frame defines an opening sized to allow blood to flow from the atrium to the ventricle of the subject's heart through the frame, and the chordae tendineae manipulating arm is coupled to a portion of the frame configured to be positioned within the ventricle.
14. It further comprises a support column and a hollow tube that defines the hole, The chordae tendineae manipulating arm is connected to the support column, and the support column is configured to be disposed within the hollow tube. The apparatus according to claim 1, wherein the hole in the hollow tube is sized to allow blood to flow from the atrium of the subject's heart to the ventricle of the subject's heart through the hollow tube.
15. The apparatus according to claim 1, further comprising a delivery device configured to deliver the chordae tendineae manipulating arm to the ventricle of the subject's heart, wherein the arm is positioned at an angle of 45 to 135 degrees with respect to the longitudinal axis of the most distal part of the delivery device.
16. The apparatus according to claim 1, further comprising a plurality of support elements, wherein each of the chordae tendineae manipulating arms is coupled to a corresponding one of the support elements, the support elements are configured to be brought together during delivery of the arms to the ventricles of the subject's heart, and the support elements are configured to be separated from each other during deployment of the arms within the ventricles.
17. A method for use with an annular formation ring and a mitral valve of the heart of a mammalian subject, wherein the mitral valve includes an annulus, leaflets, chordae tendineae, and papillary muscles, and the method is To deliver the first delivery device to the left ventricle of the subject via the subject's aorta, From the first delivery device, a plurality of chordae tendineae manipulating arms are deployed between the chordae tendineae of the atrioventricular valve. To deliver a second delivery device to the left atrium of the subject via the atrial septum of the subject, The second delivery device deploys the annulus formation ring into the left atrium of the subject. By slackening the chordae tendineae, the arm rotates so that it twists the mitral valve and pulls the mitral valve radially inward, thereby reducing the size of the valve annulus, and Subsequently, the ring-forming ring is implanted into the valve ring using the arm, in order to (a) maintain the arm in its rotated state in order to maintain the size of the valve ring at its reduced size, and (b) push the arm from below the valve leaflets toward the ring-forming ring in order to provide a reaction force against the pressing of the ring-forming ring. A method that includes this.