Heart valve coaptation device

Abstract

This document relates to heart valve coaptation devices. In one embodiment, a leaflet capture device for improving coaptation of heart valve leaflets is provided. The leaflet capture device can include a first clamping portion having an inner portion and an outer portion. The inner and outer portions can be configured to compress tissue of a first heart valve leaflet therebetween to secure the first clamping portion to the first leaflet. The leaflet capture device can also include a second clamping portion having an inner portion and an outer portion. The inner and outer portions can be configured to compress tissue of a second heart valve leaflet therebetween to secure the second clamping portion to the second leaflet. The first and second clamping portions can be separately deployable onto the first and second leaflets and secured to each other in vivo to bring portions of the first and second leaflets closer to each other to improve coaptation of the first and second leaflets.

Description

[0001] This application is a divisional application. The original application was filed on December 18, 2017, with application number 201780085839.1 and invention title "Heart Valve Closure Device". Technical Field

[0002] This application relates generally to heart valve repair, and more specifically to devices and related methods for improving the occlusion between heart valve leaflets. Background Technology

[0003] Native heart valves (i.e., the aorta, pulmonary artery, tricuspid valve, and mitral valve) play a crucial role in ensuring a unidirectional flow of sufficient blood through the cardiovascular system. These heart valves can become less effective due to congenital malformations, inflammatory processes, infectious conditions, or disease. Such damage to the valves can lead to serious cardiovascular impairment or death.

[0004] For many years, the ultimate treatment for this disease was surgical repair or replacement of the valve during open-heart surgery. However, this surgery is highly invasive and prone to numerous complications. Therefore, older and frail patients with heart valve defects often did not receive treatment. Recently, transcatheter techniques have been developed for the introduction and implantation of prosthetic devices in a less invasive manner than open-heart surgery. This transcatheter technique is gaining increasing popularity due to its high success rate.

[0005] A healthy heart has a roughly cone-shaped form, tapering gradually to a lower apex. The heart has four chambers: the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall commonly called the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle.

[0006] The atrioventricular valves (mitral and tricuspid valves) have very different anatomy from other native heart valves. The mitral valve consists of an annular portion and a pair of cusps or leaflets. The annular portion is the ring-shaped section of native valvular tissue surrounding the mitral orifice, and the cusps or leaflets extend downwards from the annulus into the left ventricle. The mitral annulus can form a "D," elliptical, or other non-circular cross-sectional shape with long and short axes. The anterior leaflet can be larger than the posterior leaflet, forming a roughly "C"-shaped boundary between the adjacent free edges of the leaflets when they are closed together. The leaflets attach to the left ventricular wall via chordae tendineae at the papillary muscles. Similarly, the tricuspid valve consists of an annular portion and three cusps or leaflets extending downwards from the annulus, and attaches to the right ventricular wall via chordae tendineae along the papillary muscles. The chordae tendineae and papillary muscles are called the subvalvular apparatus, which facilitates the opening and closing of the valve during cardiac circulation.

[0007] When the mitral valve functions properly, the anterior and posterior leaflets together act as a one-way valve, allowing blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle dilates (also known as "ventricular diastole" or "cardiac diastole"), the oxygenated blood collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract (also known as "ventricular systole" or "cardiac systole"), the increased blood pressure in the left ventricle causes the two leaflets to come together, closing the one-way mitral valve and preventing blood from flowing back to the left atrium. Instead, blood is expelled from the left ventricle through the aortic valve. To prevent the two leaflets from detaching under pressure and folding back into the left atrium through the mitral annulus, multiple fibrous cords (called chordae tendineae) attach the leaflets to the papillary muscles in the left ventricle.

[0008] Mitral regurgitation occurs when the native mitral valve fails to close properly and blood flows from the left ventricle into the left atrium during the systolic phase of heart contractions. Mitral regurgitation is the most common form of valvular heart disease. There are many different causes of mitral regurgitation. One particular cause is excessive relaxation of at least one native leaflet. This excessive relaxation prevents the native leaflet from closing effectively during the systolic phase of heart contractions, thus allowing mitral regurgitation. In another case, the heart may have a structural defect that causes the leaflets to be too far apart to provide sufficient leaflet occlusion to prevent flow into the left atrium during systole. In yet another case, the ventricle may be enlarged, pulling the occlusal edges of the leaflets too far from the base of the heart below the annular plane, thus preventing proper leaflet occlusion.

[0009] When the tricuspid valve functions properly, the three leaflets work together as a one-way valve to allow blood to flow only from the right atrium to the right ventricle. The right atrium receives deoxygenated blood from the inferior vena cava and superior vena cava. When the muscles of the right atrium contract and the right ventricle dilates (during diastole), the deoxygenated blood collected in the right atrium flows into the right ventricle. When the muscles of the right atrium relax and the muscles of the right ventricle contract (during systole), the increased blood pressure in the right ventricle pushes the leaflets of the tricuspid valve together, thereby closing the one-way tricuspid valve so that blood cannot flow back to the right atrium but is instead pumped out of the right ventricle through the pulmonary artery. Like the mitral valve, the tricuspid valve leaflets are tethered to the papillary muscles in the right ventricle to prevent the leaflets from detaching under pressure and folding back into the right atrium through the tricuspid annulus.

[0010] Tricuspid regurgitation occurs when the native tricuspid valve fails to close properly and blood flows from the right ventricle into the right atrium during the systolic phase of heart contraction. One cause of tricuspid regurgitation is an increase in the size of the right ventricle and dilation of the valvular annulus, which prevents the leaflets from properly engaging to prevent blood from flowing into the right atrium during systole.

[0011] Various devices and methods have been developed for treating valvular regurgitation, including (e.g., implantation of a prosthetic valve within the native mitral or tricuspid valve), surgical removal of a portion of the native heart valve leaflet to reduce excessive laxity, or clamping or otherwise coupling the leaflet to improve occlusion. However, these devices and methods can be highly invasive, requiring lengthy or complex procedures, or necessitating a significant recovery period.

[0012] Therefore, there is a constant need for improved devices and methods to repair native heart valve leaflets. Summary of the Invention

[0013] This article describes embodiments of a leaflet device primarily used for repairing the mitral, aortic, tricuspid, or pulmonary heart valves, and methods for repairing them. This device can be used to improve the occlusion of heart valve leaflets.

[0014] In one representative embodiment, a leaflet capture device may include a first clamping portion having an inner portion and an outer portion. The inner and outer portions may be configured to compress tissue of a first heart valve leaflet therebetween to secure the first clamping portion to the first leaflet. The leaflet capture device may also include a second clamping portion having an inner and outer portion. The inner and outer portions may be configured to compress tissue of a second heart valve leaflet therebetween to secure the second clamping portion to the second leaflet. The first and second clamping portions may be configured to be individually deployable onto the first and second leaflets and to be secured to each other in vivo, thereby bringing portions of the first and second leaflets closer together and improving apposition of the first and second leaflets.

[0015] In some embodiments, the leaflet capturing device may include a strap connecting the first clamping portion and the second clamping portion.

[0016] In some embodiments, the inner portion of the first clamping portion may include a first post. The inner portion of the second clamping portion may include a coupling member for abutting the first post. In a specific example, the coupling member may include an annular base member and a second post. In a more specific example, the first post may be configured to abut the annular base member. In another example, the first post, the second post, the annular base member, or a combination thereof may include an inner cavity for receiving a tether.

[0017] In some embodiments, the outer portion of the first clamping portion or the outer portion of the second clamping portion, or both, may include a frame. When the clamping portion includes a first post or coupling member, the frame may be sufficiently spaced from the first post or coupling member, such that the heart valve leaflet can be securely held between the frame and the first post or coupling member. In some examples, the frame may include an elastic wing member configured to apply compressive force to the heart valve leaflet. In another example, the first clamping portion or the second clamping portion, or both, may include a first post or a second post, and the elastic wing member may be configured to compress the heart valve leaflet against the respective first post or second post.

[0018] In a further embodiment, the device may include a locking member configured to secure the first clamping portion and the second clamping portion to each other. In some examples, when the device includes a strap, the locking device may include an aperture and be used to secure the strap. In a more specific example, the strap can be secured relative to the locking member by reducing the size of the aperture so that the sides of the aperture securely engage the strap. In further examples, the locking member may be coupled to the first clamping portion or the second clamping portion, or both, such as an outer portion.

[0019] In some embodiments, the inner portion of each clamping portion may include a coupling member and an inner frame member extending from the coupling member, and the outer portion of each clamping portion may include an outer frame member biased toward the inner frame member. The outer frame member may include an engagement portion that may include a plurality of retaining members, such as hooks or barbs. A tensioning member may extend through each coupling member and be secured thereto by a locking member on the tensioning member.

[0020] In another embodiment, the clamping portion can be used in conjunction with a delivery assembly that includes an actuation connector coupled to an outer frame member of the clamping portion (e.g., coupled to an engagement portion). The actuation connector can be selectively placed under tension to pull the outer frame member away from the inner frame member, thereby facilitating the placement of the heart valve leaflet between the inner and outer frame members.

[0021] In another embodiment, the device may include two or more clamping portions, for example when the device is to be used to capture more than two leaflets, or when more than one clamping portion is secured to a single leaflet.

[0022] In another aspect, the present invention provides a method for improving the occlusion of heart valve leaflets. The method may include delivering a first clamping portion to the heart. The first clamping portion may include an inner portion and an outer portion. The inner and outer portions may be configured therebetween to compress tissue of a first heart valve leaflet to secure the first clamping portion to the first leaflet. A second clamping portion may be delivered to the heart. The second clamping portion may include an inner portion and an outer portion. The inner and outer portions may be configured therebetween to compress tissue of a second heart valve leaflet to secure the second clamping portion to the second leaflet. The first clamping portion may be secured to the first heart valve leaflet, and the second clamping portion may be secured to the second heart valve leaflet. The first and second clamping portions may be secured to each other to bring portions of the first and second leaflets closer together, thereby improving the occlusion of the first and second leaflets.

[0023] In some embodiments, the first clamping portion and the second clamping portion can be delivered to the heart separately.

[0024] In some embodiments, securing the first clamping portion and the second clamping portion to each other may include engaging locking members.

[0025] In some embodiments, securing the first clamping portion and the second clamping portion to each other may include reducing slack in the straps connecting the first clamping portion and the second clamping portion.

[0026] In some embodiments, the first clamping portion and the second clamping portion are part of the aforementioned leaflet capturing device.

[0027] In some embodiments, the first clamping portion may include a coupling member, the second clamping portion may include a post, and securing the first clamping portion and the second clamping portion to each other may include bringing the post abutting against the coupling member.

[0028] In some embodiments, securing the clamping portion to its corresponding heart valve leaflet may include pulling the outer portion of the clamping portion away from the inner portion and positioning the clamping portion such that the corresponding heart valve leaflet is positioned between the inner and outer portions. In some embodiments, the outer portion may be pulled using elements of an actuation connector coupled to the outer portion and a delivery assembly capable of pulling and releasing the actuation connector. The method may include repeatedly pulling and releasing the outer portion using the actuation connector to achieve the desired placement of the corresponding heart valve leaflet between the inner and outer portions.

[0029] In another aspect, the present invention provides an assembly comprising an elongated delivery catheter having at least one lumen and the aforementioned leaflet capturing device.

[0030] The foregoing and other objects, features and advantages of the present invention will become more apparent from the following detailed description with reference to the accompanying drawings. Attached Figure Description

[0031] Figure 1A This is a perspective view of a representative embodiment of the leaflet capturing device, wherein the locking member of the leaflet capturing device is in an unlocked configuration.

[0032] Figure 1B yes Figure 1A An enlarged perspective view of a portion of the leaf-catching device.

[0033] Figure 2A yes Figure 1A A perspective view of the leaf-catching device, showing the locking member in a locking configuration.

[0034] Figure 2B yes Figure 2A An enlarged perspective view of a portion of the leaf-catching device.

[0035] Figure 3 It shows the state of decomposition. Figure 1A The leaf-catching device includes a perspective view of a first clamping portion and a second clamping portion of the leaf-catching device, and a plan view of a locking member.

[0036] Figure 4 yes Figure 3 Enlarged plan view of the locking component.

[0037] Figure 5 This is a cross-sectional view of the left atrium and left ventricle of the heart, showing them in a decomposed state. Figure 1A The leaflet capture device delivers the lobule to the left ventricle.

[0038] Figure 6 This is a cross-sectional view of the left atrium and left ventricle of the heart, showing... Figure 1A The first clamping part of the leaflet capturing device engages with the rear mitral leaflet and is coupled to the second clamping part via a tension member.

[0039] Figure 7 This is a cross-sectional view of the left atrium and left ventricle of the heart, showing them in an assembled state. Figure 1A The leaflet capturing device, wherein the first clamping portion of the leaflet capturing device engages with the posterior mitral leaflet and the second clamping portion of the leaflet capturing device engages with the anterior mitral leaflet.

[0040] Figure 8 This is a perspective view of another representative embodiment of a leaflet capturing device that can fix heart valve leaflets between external and internal components.

[0041] Figure 9It is implanted on the leaflet of the native mitral valve. Figure 8 A perspective view of multiple leaf-catching devices of the type shown.

[0042] Figure 10A It is used for Figure 8 A perspective view of the delivery mechanism of a leaf-catching device, for example, used in a reverse delivery process.

[0043] Figure 10B It is used for Figure 8 A perspective view of the delivery mechanism of a leaf-catching device, for example, used in a forward delivery process.

[0044] Figure 11 It is a cross-sectional view of the heart, showing multiple catheters inserted into the heart during a retrograde procedure, with a balloon coupled to one of the catheters used to stabilize the catheter in the apex region of the left ventricle. Detailed Implementation

[0045] This document describes embodiments of leaflet capture devices (e.g., leaflet clips) primarily intended for improving leaflet occlusion in mitral, aortic, tricuspid, or pulmonary heart valves, and methods for delivering them. A leaflet capture device may include multiple leaflet capture portions, each independently attachable to one or more native heart valve leaflets. The leaflet capture portions can then be secured to each other. When the leaflet capture portions are secured to each other, their associated native leaflets can remain closer to or in contact with each other, thereby improving leaflet occlusion. By improving occlusion, the leaflet capture device can reduce or improve valvular regurgitation, thereby improving the function of defective heart valves. In some applications, the leaflet capture device may be implanted onto prosthetic leaflets (or a combination of native and prosthetic leaflets), such as leaflets of a prosthetic valve, to improve prosthetic leaflet occlusion.

[0046] In a particular embodiment, the leaflet capture device can be configured to repair native mitral valve leaflets. The leaflet capture device can be accessed from the left ventricle and / or left atrium in a minimally invasive manner (e.g., using catheter techniques). In a further embodiment, the leaflet capture device can be configured to repair native tricuspid valve leaflets. The leaflet capture device can be accessed from the right ventricle and / or right atrium in a minimally invasive manner (e.g., using catheter techniques).

[0047] First refer to Figure 1A and Figure 1BThis illustrates a representative embodiment of a leaflet capture device, manifested as a leaflet clamping assembly 10 for improving the apposition of native or artificial heart valve leaflets. The leaflet clamping assembly 10 may include a first clamping (or leaflet capture) portion 14, a second clamping (or leaflet capture) portion 18, and a locking member 22. The first clamping portion 14 may include an annular base member or ring 30 and a first post 34 fixed to and extending from the base member 30 (e.g., by welding). A tensioning member or tether 38 may be coupled to an end 40 of the first post 34 remote from the annular base member 30. The second clamping portion 18 may include a second post 42 defining an inner cavity 44. The locking member 22 may define a seam or slit 48 for receiving the tensioning member 38.

[0048] The first clamping portion 14 and the second clamping portion 18 can be delivered to the heart as separate components and assembled in the body to produce the leaflet clamping assembly 10. Figure 1A The leaflet clamping assembly 10 in a partially assembled state is shown, wherein the first clamping portion 14 and the second clamping portion 18 are engaged by placing the second post 42 on the annular base member 30 such that the inner cavity 44 of the second post is axially aligned with the inner cavity 50 of the annular base member 30. As further described below, the assembly process can be accomplished by securing the first clamping portion and the second clamping portion to each other to provide the fully assembled leaflet clamping assembly 10.

[0049] Locking member 22 may be coupled to leaflet clamping assembly 10. For example, locking member 22 may include portions of a frame for receiving the first clamping portion 14 (such as...). Figure 1B (As shown) or the openings 56 of some portions of the frame of the second clamping portion 18. See reference. Figure 1B The locking member 22 is shown in the unlocked state, wherein the slit 48 is wide enough to allow the tensioning member 38 to move freely through the slit 48. In an alternative embodiment, the locking member 22 may be secured to the first clamping portion 14 or the second clamping portion 18 by any suitable technique or mechanism (e.g., welding, adhesive, etc.).

[0050] The first clamping part 14 and the second clamping part 18 have been as follows Figure 1A As shown, after being deployed inside the heart and placed against each other, they can be secured together. For example, see reference... Figure 2A and Figure 2BThe tensioning member 38 can be inserted through the cavity 44 of the second post 42, through the cavity 50 of the annular base member 30, and through the slit 48 of the locking member 22. After the tensioning member 38 is placed under the desired level of tension to secure the first clamping portion 14 and the second clamping portion 18 to each other, the width of the slit 48 can be reduced so that the tensioning member is clamped and securely held by the locking member 22, thereby securing the clamping portions to each other and maintaining the assembled state of the clamping assembly 10.

[0051] Figure 3 A first clamping portion 14, a second clamping portion 18, and a locking member 22 in a disassembled state are shown. The first clamping portion 14 may include a frame 60 and a coupling member 64. In some cases, the frame 60 may be part of the outer portion of the first clamping portion 14, and the coupling member 64 may be part of the inner portion of the first clamping portion. The coupling member 64 may include an annular base member 30 and a first post 34. In some cases, the annular base member 30 and the first post 34 may be integrally formed, for example, from a common sheet of material (e.g., metal or plastic). In other cases, the annular base member 30 and the first post 34 may be joined together, for example, by welding, brazing, adhesion, etc.

[0052] As described above, the tensioning member 38 can be coupled to the end 40 of the first post 34 away from the annular base member 30. The tensioning member 38 may comprise, for example, an elongated sheet of flexible material, such as suture, strip, coil, cable, rope, thread, or similar material. In some cases, the tensioning member 38 may be connected to the first post 34 by welding, brazing, adhesion, etc. In other cases, the tensioning member 38 may pass through the cavity of the first post 34, and the proximal end of the tensioning member may be prevented from passing through the proximal end of the cavity. For example, the proximal end of the tensioning member 38 may be knotted to create a clump of material with a diameter larger than the diameter of the cavity of the first post 34, or the tensioning member 38 may be formed at its proximal end with an enlarging member or coupled to an enlarging member.

[0053] The inner cavity 50 of the base member 30 may have a suitably large diameter to receive the tensioning member 38. Additionally, the annular base member 30 may be sized and shaped to accommodate the leaflet clamping assembly 10 during assembly. Figure 2A The second post 42 is supported in the manner shown. The annular base member 30 can be radially offset from the first post 34, allowing the second post 42 to be placed adjacent to the annular base member 30, wherein the first post and the second post are positioned such that... Figure 2A The parallel alignment shown indicates that the elements are positioned adjacent to each other.

[0054] The second clamping portion 18 may include a frame 68 and a second post 42. In some cases, the frame 68 may be part of the outer portion of the second clamping portion 18, and the second post 42 may be part of the inner portion of the second clamping portion. The inner cavity 44 of the second post may have a sufficiently large diameter to receive the tensioning member 38. The second post 42 may have a sufficiently large diameter and / or thickness to abut and abut against the annular base member 30.

[0055] In at least some embodiments, frames 60 and 68 may be at least generally similar. Frames 60, 68 may be formed of filaments 74, such as metal wires or filaments made of biocompatible polymers. In at least some examples, the filaments 74 may be a sufficiently elastic material such that the frames 60, 68 thus constructed can exert compressive holding forces when the heart valve leaflets are inserted between the frame and its corresponding posts 34, 42. Additionally, constructing frames 60, 68 with elastic and / or shape memory materials allows the first and second clamping portions 14, 18 to remain radially compressed during delivery to the heart and to self-expand upon deployment from the delivery device within the patient. In specific examples, the filaments 74 used to form frames 60, 68 may be made of a superelastic shape memory material (e.g., Nitinol or other nickel-titanium alloys). In other examples, the wire 74 may be made of a less elastic metal, such as stainless steel or a cobalt-chromium alloy, which, in wire form, still exhibits sufficient shape memory and / or elasticity to allow the clamping portion to be compressed to a smaller size for easy delivery and to expand on its own when deployed into the body.

[0056] Each of frames 60 and 68 can be configured to be fixed against the outer surface (or lower surface in the case of the mitral valve leaflet) of the heart valve leaflet. In a particular example, frame 60 of the first clamping portion 14 can be configured to be fixed against the lower surface of the anterior mitral valve leaflet. Frame 68 of the second clamping portion 18 can be configured to be fixed against the lower surface of the posterior mitral valve leaflet. If desired, frames 60 and / or 68 may include retaining members, such as inwardly extending hooks or barbs, which can be used to penetrate or otherwise engage the tissue of the heart valve leaflet.

[0057] Each frame 60, 68 may include a central longitudinal section 78 formed by generally straight parallel segments 84 of filament 74. Each frame 60, 68 may include a free end portion 80 having a wing-like element 82 that extends laterally and is located in the atrium away from the corresponding segment 84 of the central longitudinal section 78. The segments of filament 74 forming the free end portions 80 may be shaped (e.g., curved) such that the free end portions are radially outwardly directed relative to the plane of the corresponding central longitudinal section 78. That is, the free end portions 80 may be radially outwardly curved relative to either the first post 34 or the second post 42, respectively.

[0058] Each airfoil 82 may include an inner segment 86 and an outer segment 88. Each of the inner segment 86 and the outer segment 88 may be connected by an arcuate segment 92. The outer segments 88 of each airfoil 82 are connected to each other at a vertex 96. The outer segments 88 may be shaped (e.g., curved) such that they extend toward or away from the corresponding posts 34, 42. For example, in the illustrated embodiment, the outer segment 88 of the first clamping portion 14 may extend downward toward the post 34 to form a recessed portion of the frame or an inwardly curved upper edge, while the outer segment of the second clamping portion 18 may extend upward away from the post 42 to form a convex portion of the second clamping portion 18 or an outwardly curved upper edge.

[0059] The opposite ends of frames 60, 68 may include curved portions 104, each curved portion 104 extending between a corresponding fixed end portion 106 and a corresponding intermediate section 84. The fixed end portion 106 of each frame 60, 68 may extend downwards away from the corresponding posts 34, 42, then transition to the corresponding curved portion 104, which may extend radially outwards away from each other, then turn upwards towards each other, where the curved portion 104 transitions to the intermediate section 84. Figure 2B and Figure 3 As best shown, the fixed end portion 106 of the frame 60 of the first clamping portion 14 can be securely fixed to the base member 30 of the frame, for example by welding, brazing, or using adhesive. Similarly, the fixed end portion 106 of the frame 68 of the second clamping portion 18 can be securely fixed to the lower end portion of the second post 42, for example by welding, brazing, or using adhesive.

[0060] The locking member 22 can be coupled to the fixed end portion 106 of the first frame 60 or the second frame 68. In the illustrated embodiment, for example, as Figure 2B As best shown, the end portion 106 of the frame 60 of the first clamping portion 14 can extend through a corresponding aperture 56 formed in the surface of the locking member 22, which may be disc-shaped. Figure 3As best shown, slit 48 can extend radially to a portion of the diameter of the locking member in order to divide the axial surface of the locking member 22 into a first portion 130 and a second portion 132, such as halves.

[0061] Continue to refer to Figure 3 The locking member 22 may include a locking arm 134 formed along a portion of its periphery. The locking arm 134 may include a radially inwardly extending tab 138 configured to be received by a mating recess 142 formed in an inner surface of the locking member 22. The locking arm 134 may be bent or deformed relative to the remainder of the locking member 22 to allow the tab 138 to engage and disengage from the recess 142. See also... Figure 4 Tongue 146 and groove 148 may be formed on the radial surface of recess 142. Tongue 146 and groove 148 may be received by mating groove 150 and tongue 152 formed on the outer radial surface of tab 138. Tab 138 may be further locked into and engaged with recess 142 by inserting tongues 146, 152 into their respective grooves 148, 150. Tab 138 may include orifice 156 for receiving tools (e.g., components of a delivery device) to assist in bending or deforming locking arm 134 when tab 138 is inserted into or released from recess 142. By inserting tab 138 into recess 142, the width of slit 48 may be reduced, for example, to ensure the length of tensioning member 38, wherein tongues 146, 152 and grooves 148, 150 serve to prevent tab from being accidentally released from recess.

[0062] An opening 160 may be formed in the locking member 22 at the base of the locking arm 134. The opening 160 may help facilitate radial outward bending of the locking arm 134, and allow the first portion 130 and the second portion 132 to move apart from each other, thereby increasing the width of the slit 48. Similarly, an opening 164 may be formed at the opposite end of an arcuate cut or slit 168, which is formed at the end of the slit 48 opposite the notch 142. The opening 164 may help the first portion 130 and the second portion 132 to bend away from or toward each other, depending on whether the width of the slit 48 is to be increased or decreased.

[0063] The slit 48 can be used to secure the tensioning member 38. For example, when the leaflet clamping assembly 10 is implanted in a patient, the tab 138 can disengage from the notch 142, making the slit 48 wide enough to allow the tensioning member 38 to pass freely through the slit 48, such as... Figure 1A and Figure 1BAs shown. When the first clamping portion 14 and the second clamping portion 18 are secured together after the lobule clamping assembly 10 is deployed in the heart, the tab 138 can be inserted into the recess 142, pulling the slit 48 closed and securing the tensioning member 38 therein, as shown. Figure 2A and Figure 2B As shown.

[0064] In use, the first clamping portion 14 and the second clamping portion 18 can be delivered to the heart in a disassembled state. However, both the first clamping portion 14 and the second clamping portion 18 can be connected or coupled to the tensioning member 38 before insertion into the body. For example, the tensioning member 38 can be fixed to the first post 34, pass through the cavity 44 of the second post 42, pass through the cavity 50 of the annular base member 30, and pass through the slit 48 of the locking member 22. The locking member 22 can initially be in an unlocked state, allowing the tensioning member 38 to move freely through the slit 48.

[0065] The first clamping portion 14 and the second clamping portion 18 can be independently implanted onto the leaflets of their respective native valves. Once the first clamping portion 14 and the second clamping portion 18 are attached to their respective leaflets, the leaflet clamping assembly 10 can be assembled within the heart by pulling the tensioning member 38 away from the leaflet clamping assembly 10. As shown in FIG2, as the tensioning member 38 is pulled through the lumen 44, lumen 50 and slit 48, the first clamping portion 14 and the second clamping portion 18 are pulled together and brought into the vicinity, such that the posts 34, 42 are in contact or close to each other. When the first clamping portion 14 and the second clamping portion 18 are sufficiently close to each other, the second post 42 can rest on the annular base member 30. When the desired level of tension has been applied to the tensioning member 38 to secure the first clamping portion 14 and the second clamping portion 18 to each other, the tab 138 of the locking arm 134 can be inserted into the notch 142, thereby reducing the width of the slit 48. The reduced width of the slit 48 causes the opposite longitudinal edges of the slit to engage with the tensioning member 38 and prevents the tensioning member from moving relative to the locking member 22.

[0066] Figures 5-7 An exemplary method is shown for delivering the leaflet clamping assembly 10 to a patient's heart and assembling the leaflet clamping assembly in vivo, including attaching the leaflet clamping assembly 10 to the mitral valve leaflets to improve leaflet synergy and reduce mitral regurgitation. (First refer to...) Figure 5Using transventricular surgery, surgical incisions can be made at bare points in the chest cavity and on the lower anterior ventricular wall. A delivery catheter or guide catheter 210 (also referred to as a "guide") can be advanced through the incision in the anterior ventricular wall and into the left ventricle 208 of the heart 200. A deployment catheter 214 can be advanced within the lumen of the delivery catheter 210 and into the left ventricle 208. The first clamping portion 14 and the second clamping portion 18 of the leaflet clamping assembly 10 can be advanced through the deployment catheter 214 in a disassembled state. For example, a pusher or other advancement mechanism can be used to advance the first clamping portion 14 and the second clamping portion 18. Alternatively, the first clamping portion 14 and the second clamping portion 18 can be preloaded in the distal portion of the delivery catheter and delivered into the heart by advancing the deployment catheter 214 through the guide catheter 210.

[0067] In the example shown, the second clamping portion 18 may be positioned distally within the deployment conduit 214 relative to the first clamping portion 14, such that the second clamping portion is deployed and secured to the leaflet before the first clamping portion. In other embodiments, the first clamping portion 14 may be positioned distally within the deployment conduit 214 relative to the second clamping portion 18, such that the first clamping portion is deployed and secured to the leaflet before the second clamping portion.

[0068] Although the first clamping portion 14 and the second clamping portion 18 can be delivered in a disassembled state, the tensioning member 38 can be positioned relative to the first and second clamping portions to facilitate capture of the anterior mitral leaflet 220 and posterior mitral leaflet 222 of the mitral valve 224 by the first and second clamping portions, and to facilitate subsequent assembly of the leaflet clamping assembly 10. For example, the tensioning member 38 may have a distal end that is secured to the first post 34 of the first clamping portion 14 and extends from the first post through the lumen 44 of the second post 42 of the second clamping portion 18. The tensioning member 38 may also extend through the lumen 50 of the annular base member 30 of the first clamping portion 14, through the slit 48 of the locking member 22, and then proximally through the lumen of the deployment catheter 214. The proximal end of the tensioning member 38 may extend outside the patient for user manipulation.

[0069] Now for reference Figure 6 The first clamping portion 14 and the second clamping portion 18 can be advanced from the distal opening 228 of the deployment catheter 214 and into the left ventricle 208. The second clamping portion 18 can be deployed on the posterior mitral leaflet 222, such that a portion of the posterior mitral leaflet 222 is held between the frame 68 and the second column 42 of the second clamping portion 18. (See also:) Figure 3As described, the upper free end portion 80 of the frame 68 can apply a spring-like compressive force against the lower surface 230 of the posterior mitral leaflet 222, which helps maintain the engagement of the posterior mitral leaflet with the second column 42. The second clamping portion 18 can be configured to clamp or hold the tissue of the native leaflet 222 with sufficient force, such that the second clamping portion can anchor itself to the native leaflet 222 before being secured to the first clamping portion. Additionally, the shape of the frame 68 can enhance the contact between the second clamping portion 18 and the posterior mitral leaflet 222.

[0070] refer to Figure 7 The first clamping portion 14 can be deployed on the anterior mitral leaflet 220. In at least some cases, the tensioning member 38 can be pulled proximally to remove slack in the tensioning member between the locking member 22 and the first post 34. In this way, the first clamping portion 14 and the second clamping portion 18 can be moved to engage, and the first clamping portion 14 can be moved upward to help it engage the anterior mitral leaflet 220.

[0071] A portion of the anterior mitral leaflet 220 is held between the frame 60 and the first post 34. Similar to the second clamping portion 18, the upper free end portion 80 of the frame 60 of the first clamping portion 14 can apply a spring-like compressive force against the lower surface 234 of the anterior mitral leaflet 220, thereby helping to maintain the engagement of the anterior mitral leaflet with the first post 34. The first clamping portion 14 can be configured to clamp or hold the tissue of the native leaflet 220 with sufficient force, such that the first clamping portion can anchor itself to the native leaflet 220 before being secured to the second clamping portion 18. The shape of the frame 60 provides significant contact between the frame and the anterior mitral leaflet 220.

[0072] As the first clamping portion 14 moves upward, the annular base member 30 can be positioned below the second post 42, eventually abutting the base of the second post as the tensioning member 38 is pulled through the inner cavity 44 of the second post, the inner cavity 50 of the annular base member, and the slit 48 of the locking member 22. As the first clamping portion 14 and the second clamping portion 18 engage with each other, the progenitor leaflets 220, 222 become closer together or in contact to improve leaflet apposition. When the desired level of tension has been applied to the tensioning member 38, the tensioning member can be secured by inserting the tab 138 of the locking arm 134 of the locking member 22 into the notch 142. The tensioning member 38 can be cut off at a point in the left ventricle, typically near the lower surface of the locking member 22. The distal end of the cut tensioning member 38 can be retracted into the deployment catheter 214, and the deployment and delivery catheter 210 is removed from the heart 200.

[0073] It should be understood that the leaf clamping assembly 10 can be used with... Figures 5-7The different methods shown are used to deliver the substance to the heart and assemble it within the heart. For example, although... Figures 5-7 The diagram shows a second clamping portion 18 attached to the posterior mitral leaflet 222 before the first clamping portion 14 is attached to the anterior mitral leaflet 220. However, in other cases, the first clamping portion 14 may be attached to the anterior mitral leaflet 220 before the second clamping portion 18 is attached to the posterior mitral leaflet 222. Furthermore, although the first clamping portion 14 and the second clamping portion 18 are described as being coupled to the posterior mitral leaflet 222 and the anterior mitral leaflet 220, respectively, in other respects, the first clamping portion 14 may be implanted on the posterior mitral leaflet and the second clamping portion 18 may be implanted on the anterior mitral leaflet. Alternatively, each of the first clamping portion 14 and the second clamping portion 18 may be implanted on both the anterior and posterior mitral leaflets, for example, positioned near the leaflet suture.

[0074] The locking member 22 may be a suture clip, or other type of fastener that can be deployed from a catheter and secured to a patient. Various suture clips and deployment techniques for suture clips that can be used with the methods disclosed in this application are disclosed in U.S. Publications 2014 / 0031864 and 2008 / 0281356 and U.S. Patent No. 7,628,797. In some embodiments, the locking member 22 may be configured such that when the clamping portions 14, 18 are engaged with each other, the tensioning member 38 can be pulled through a slit 48 of the locking member 22, and portions 130, 132 of the locking member resist the movement of the tensioning member through the slit 48 in opposite directions to maintain tension on the tensioning member.

[0075] In a further embodiment, the tensioning member 38 can be secured in another manner by independently delivering the locking member from the clamping portions 14, 18. For example, as is typically combined Figures 5-7 As described, the leaflet clamping assembly 10 can be secured to the mitral valve 224. Once the desired level of tension is applied to the tensioning member 38, a locking member or similar retaining member, suture clip, or fastener can be advanced along the tensioning member 38 and secured near the lower surface of the annular base member 30. Additionally, although... Figures 5-7 Transventricular procedures have been described, but the leaflet clamping assembly 10 can be delivered to the heart in an alternative manner. For example, the leaflet clamping assembly 10 can be delivered via the left atrium instead of the left ventricle. In some embodiments, the leaflet clamping assembly 10 can be delivered transseptally by advancing a deployment catheter 214 through the inferior or superior vena cava, into the right atrium, across the atrial septum, and into the left ventricle 208. Attaching the first clamping portion 14 and the second clamping portion 18 to the leaflets 220, 222 can be similar to a combination. Figures 5-7 The process is described.

[0076] In other embodiments, the locking member 22 may be omitted, and the clamping portions 14, 18 may have corresponding locking features that engage and lock with each other when they come into contact. For example, a portion of the first post 34 may have a locking feature that forms a snap-fit ​​connection with a corresponding locking feature on the second post 42 when the clamping portions come into contact with each other.

[0077] In other cases, the attachment or assembly procedure can vary. For example, instead of pulling the tensioning member 38 downward toward the bottom of the heart, an upward-pointing force toward the top of the heart can be used to assemble the leaflet clamping assembly 10. In a specific example, the tensioning member 38 can pass through the lumen 44 from the base of the second post 42 and exit from the top of the second post. By applying an upward-pointing force to the tensioning member 38, the annular base member 30 can be pushed below the second post 42. When the desired level of tension has been applied, a locking member 22 or another retaining member or fastener (e.g., a suture clip) can be advanced onto the tensioning member 38 near the top of the second post 42.

[0078] Figure 8 Another embodiment of the leaflet capturing or clamping portion 300 is shown, which can be used with one or more other clamping portions of the same or similar type to form a leaflet repair device or clamping assembly. The clamping portion 300 may include an inner frame member 308 and an outer frame member 312. The inner member 308 and the outer member 312 may each be coupled to a coupling member 316. The coupling member 316 can be used, for example, to attach the clamping portion 300 to another clamping portion.

[0079] In some cases, two or more of the inner member 308, outer member 312, and coupling member 316 may be integral structures, for example, cut or machined from a single piece of material. In other cases, one or more of the inner member 308, outer member 312, and coupling member 316 may be coupled together, for example, by welding, brazing, or using adhesives.

[0080] The coupling member 316 may be tubular or cylindrical, defining an inner cavity 324. The inner cavity 324 may be configured to receive a tensioning member 328 (e.g., Figure 9 (As shown). Tensioning member 328 may include, for example, an elongated sheet of flexible material, such as suture, strip, coil, cable, rope, thread, or similar material. Tensioning member 328 may extend through opposite ends of the cavity 324 and is secured by locking member 332 ( Figure 9The locking member is fixed in place, for example, a suture clip, or another type of fastener that can be deployed from the catheter and secured to a suture within the patient's body. In at least some respects, the locking member 332 can be configured similarly to the locking member 22.

[0081] exist Figure 8 In this embodiment, the outer member 312 is shown as a pair of elongated frame portions 336 extending axially from the bottom of the coupling member 316. The frame portions 336 may be outwardly curved, transitioning from a downward-pointing portion 338 to an upward-pointing portion 340. An engagement section 342 may be formed by the outwardly curved portion of the frame portion 340. The frame portion 340 may connect to the outermost section 346 of the outer member 312. The outermost section 346 may be perpendicular to the frame portion 340 and may include an arcuate recessed portion 350.

[0082] Multiple tissue-engaging members 354 may extend inwardly from the frame portion 340 of the engagement section 342. Members 354 may be, for example, one or more hooks or barbs, configured to engage and / or penetrate the tissue of the heart valve leaflet. The number, size, length, shape, and distribution of the tissue-engaging members 354 can be selected to provide a desired degree of fixation to the heart valve leaflet. For example, longer, sharper, and more numerous tissue-engaging members 354 may provide a stronger engagement with the heart valve leaflet.

[0083] In some aspects, at least a portion of the outer member 312 (e.g., the frame portion 336) may be formed of an elastic material (e.g., a metal, a biocompatible polymer, or other types of biocompatible material). In a specific example, the elastic material may be in the form of filaments. The material constructing the frame portion 336 is typically chosen to be sufficiently elastic such that the outer member 312 (more specifically, the engagement segment 342) can exert a compressive holding force when the heart valve leaflet is inserted between the outer member 312 and the inner member 308.

[0084] Additionally, constructing the frame portion 336 from an elastic and / or shape memory material allows the engagement portion 342 to be pulled or deflected from the inner member 308 during deployment of the clamping portion 300, facilitating the placement of a leaflet between the engagement portion of the inner and outer members 312. The engagement portion 342 can then return to its non-deflected state under its own elasticity to compress the leaflet between the engagement portion and the inner member 308, and optionally engage tissue of the engagement member 354 and the heart valve leaflet. In a specific example, the frame portion 336 may be constructed from a hyperelastic shape memory material (e.g., Nitinol or another nickel-titanium alloy).

[0085] In other examples, the frame portion 336 may be made of a less elastic metal, such as stainless steel or a cobalt-chromium alloy, which still exhibits sufficient shape memory and / or elasticity and / or flexibility to allow the engaging portion 342 to be pulled away from the support member 308 during delivery and then returned to or manipulated to the closed position after leaflet capture. In some cases, the clamping portion 300 may be deployed with the engaging portion 342 in the open position, and the engaging portion may be manipulated (e.g., pushed or pulled) to the closed position or released to return to the closed position after leaflet capture.

[0086] The inner member 308 may include a pair of elongated support frame members 360 extending axially from the bottom of the coupling member 316 and radially outwardly coupled to (or extending from) a portion of the coupling member relative to the frame portion 336 adjoining the coupling member 316. The support frame members 360 may be outwardly curved, transitioning from a downward-pointing portion 362 to an upward-pointing portion 366. The upward-pointing portions 366 of the support frame members 360 may bend inwardly toward each other, thus meeting at the uppermost section 368 (including having a single or continuous structure in at least some cases). In some aspects, the uppermost section 368 may be arcuate, for example, concave.

[0087] The upward-pointing portion 366 of the support frame member 360 may be positioned adjacent to the outer axial surface of the coupling member 316. In some cases, the upward-pointing portion 366 of the support frame member 360 may be coupled to the coupling member 316, for example, by welding, brazing, or using an adhesive. In other cases, the upward-pointing portion 366 of the support frame member 360 may abut the outer axial surface of the coupling member 316.

[0088] The inner member 308 and coupling member 316 may be covered with a biocompatible cover 370. For example, this cover may be a fabric or woven material (e.g., PET fabric). The biocompatible cover 370 can cushion the contact between the leaflet tissue and the support member 308 and increase the surface area of ​​the clamping portion 300 in contact with the leaflet, which can help secure the leaflet to the clamping portion. Similarly, in some cases, the material used for the biocompatible cover 370 may be selected to provide a desired level of friction or other holding force. In some embodiments, the outer member 312 may also be covered with a similar biocompatible fabric or woven cover.

[0089] Figure 9 It shows Figure 8 The leaflet clamping portion 300 can be used with other clamping portions 300 to form a leaflet repair device or clamping assembly 375 to improve the occlusion of heart valve leaflets. Specifically, Figure 9Four clamping portions 300 are shown for forming a clamping assembly 375 to improve the apposition of the anterior mitral leaflet 378 and the posterior mitral leaflet 380. Although four clamping portions 300 are shown in the assembly 375, more or fewer clamping portions may be used to form the assembly. For example, the clamping assembly 375 may include two clamping portions 300, similar to the clamping assembly 10. Typically, although not required, the assembly includes at least one clamping portion 300 for each leaflet 378, 380.

[0090] As further described below, a single clamping portion 300 can be secured to multiple leaflets to improve leaflet alignment, thereby functioning as a leaflet repair device without needing to be secured to additional clamping portions to form an assembly. In some cases, the clamping assembly may include the same number of clamping portions 300 mounted on each leaflet 378, 380 (e.g., two on each leaflet in the illustrated example), while in other cases the number of clamping portions 300 mounted on each leaflet may vary. The number and positioning of the clamping portions 300 on the leaflets 378, 380 can be selected to apply a desired engagement force to the leaflets, which may be symmetrical or asymmetrical depending on the desired result.

[0091] Each clamping portion 300 can be secured to another clamping portion using one or more tensioning members 328 (e.g., suture material), wherein at least one tensioning member is wound around a pair of coupling members 316 of adjacent clamping portions 300, which include front-to-back and inside-outside adjacent clamping portions. The ends of the tensioning members 328 can be collected and retained using a locking device 332 (e.g., a slit 384 of a suture clip 332).

[0092] In some respects, a single clamping portion 300 can be secured to two or more leaflets without needing to be secured to additional clamping portions to improve leaflet alignment. In other words, a single clamping portion 300 can be secured to a leaflet by placing adjacent edges of two or more leaflets between the inner member 308 and the outer member 312. The clamping portion 300 is held in place by the compressive force between the engagement portion 342 of its inner member 308 and its outer member 312, and by the organization of the engagement member 354 of the engagement portion.

[0093] exist Figure 9In the assembly, each clamping portion 300 can hold the tissue of its respective leaflets 378, 380 between the engagement portion 342 of its outer member 312 and its inner member 308. The leaflets 378, 380 can be held at least partially by compressive force by their respective clamping portions 300. Additionally, the clamping portions 300 can be further secured to the leaflets 378, 380 by tissue engagement members 354, which can protrude into the leaflet tissue. Although not described in... Figure 9 As shown, however, the inner member 308, the coupling member 316, and / or the outer member 312 may be made of... Figure 8 The biocompatible covering 370 shown is used for covering.

[0094] Figure 10A A delivery assembly 400 is shown, which can be used to deliver the clamping portion 300 to the heart for deployment, such as using a retrograde approach below the mitral valve (e.g., transfemoral, transventricular, transaortic, or transapical). The delivery assembly 400 may include an external delivery catheter 404. An internal support catheter 408 may be disposed within the lumen of a deployment catheter 416. Furthermore, a guidewire 412 may extend through and axially exceed the internal support catheter 408. The guidewire 412 may pass through the lumen of a coupling member 316 of the clamping portion 300.

[0095] The actuation connector 420 can be coupled to the distal end of the deployment conduit 416 and the engagement portion 342 of the clamping portion 300. The connector 420 can be, for example, a flexible material sheet (e.g., a length of suture material) or a more rigid component (e.g., a metal rod or strut). The delivery conduit 404, the inner support conduit 408, the guidewire 412, and the deployment conduit 416 can be axially movable distally and proximally relative to each other to facilitate the deployment of the clamping portion 300, including capturing the leaflet between the engagement portion 342 and the inner member 308.

[0096] After the delivery catheter 404 is advanced into the left ventricle, the clamping portion 300 can be advanced via guidewire 412 through the distal opening of the delivery catheter to a position below the mitral leaflet. The clamping portion 300 can be advanced distally towards the lower surface of the leaflet using the inner support catheter 408. When the clamping portion 300 is sufficiently close to the leaflet, the engagement portion 342 of the clamping portion can be pulled downward toward the distal end of the delivery catheter 404 by pulling the deployment catheter 416 proximally relative to the inner support catheter 408. This puts the actuation connector 420 into a tensioned state, thereby pulling the engagement portion 342. Pulling the engagement portion 342 toward the distal end of the delivery catheter 404 increases the spacing between the engagement portion 342 and the inner member 308 of the clamping portion 300, thereby facilitating leaflet insertion therebetween.

[0097] When the leaflet is in the desired position between the inner member 308 and the engagement portion 342, the deployment catheter 316 can be moved distally relative to the inner support catheter 408, thereby releasing tension on the actuation connector 420. This release of tension allows the engagement portion 342 to return to its stress-free or unbent configuration under its own elasticity, thereby reducing the gap between the engagement portion and the inner member 308 to secure the leaflet between them. The tissue engagement member 354 of the clamping portion 300 can engage tissue of the heart valve leaflet to help secure the clamping portion to the leaflet.

[0098] During implantation, if the physician wishes to adjust the position of the clamping portion 300 relative to the leaflet, the physician can again move the deployment catheter 416 distally to open the clamping portion, and then move the deployment catheter proximally to close the clamping portion and secure the leaflet. During this process of opening and closing the clamping portion 300 (increasing and decreasing the gap between the engagement portion 342 and the inner member 308), the inner support catheter 408 can have sufficient rigidity to resist the tension exerted by the actuation connector 420, thus allowing the engagement portion 342 to be pulled toward the delivery catheter 404, rather than bending the clamping portion 300, guidewire 412, and inner support catheter 408 outwards.

[0099] The implantation process can be repeated for one or more additional clamping portions 300, wherein at least one additional clamping portion 300 is attached to another heart valve leaflet. After the clamping portion 300 has been secured to the corresponding leaflet, one or more sutures 328 can be used. Figure 9 The coupling member 316, passing through the clamping portion, is placed under desired tension to bring the clamping portions together to form an assembly (e.g., assembly 375) and improve leaflet alignment, and the free suture end is secured by the locking member 332. Figure 9 Alternatively, the suture 328 can be pre-passed through the coupling member 316 of the clamping portion 300 before deployment in the heart. The clamping portions 300 can be secured to their respective leaflets as previously described, the suture 324 is placed under the desired tension, and the free suture ends are secured by the locking member 332. Once the clamping portions 300 have been properly positioned, the actuation connector 420 can be cut or removed, and the delivery assembly 400 can be removed from the patient.

[0100] Figure 10BA delivery assembly 440 is shown, which can be used to deliver the clamping portion 300 to the heart for deployment, such as delivering the clamping portion above the mitral valve using an antegrade approach (e.g., transfemoral or transseptal). The delivery assembly 440 may include an external delivery catheter 444. An internal support catheter 448 may be disposed within the lumen of the delivery catheter 444. An inner shaft or control wire 452 may be disposed within the lumen of the internal support catheter 448. The inner shaft 452 may pass through the lumen of the coupling member 316 of the clamping portion 300. In some embodiments, the inner shaft 452 may have a lumen to receive a guidewire.

[0101] Actuation connector 456 can be coupled to the distal end of inner shaft 452, away from the bottom of coupling member 316. Actuation connector 456 can be coupled to engagement portion 342 of clamping portion 300. Delivery conduit 444, inner support conduit 448, and inner shaft 452 can be axially movable distally and proximally relative to each other to facilitate deployment of clamping portion 300, including capturing a leaflet between engagement portion 342 and support member 308.

[0102] After the delivery catheter 444 is advanced into the left atrium, the clamping portion 300 can be advanced through the distal opening of the delivery catheter to a position below the mitral valve leaflet. This clamping portion 300 can be advanced distally towards the lower part of the left ventricle using the internal support catheter 448. When the clamping portion 300 is sufficiently close to the leaflet, the engaging portion 342 of the clamping portion can be pulled downwards towards the lower surface of the left ventricle and away from the distal end of the delivery catheter 344 by pushing the inner shaft 452 distally relative to the internal support catheter 448.

[0103] The clamping portion 300 can be releasably coupled to the inner support catheter 448 such that the clamping portion 300 does not move axially when the inner shaft 452 moves within the inner support catheter. Pushing the inner shaft 452 pulls the actuating connector 456 under tension, thereby pulling the engagement portion 342 toward the lower surface of the left ventricle and increasing the spacing between the engagement portion and the inner member 308 of the clamping portion. This increased separation facilitates the insertion of a leaflet therebetween.

[0104] The inner support catheter 448 and inner shaft 452 can be pulled proximally to capture the leaflet between the engagement portion 342 and the inner member 308. When the leaflet is in the desired position between the inner member 308 and the engagement portion 342, the inner shaft 452 can be moved proximally relative to the inner support catheter 448 to release tension on the actuating connector 456 and allow the engagement portion 342 to return to its stress-free configuration under its own elasticity. This stress-free configuration can reduce the gap between the engagement portion and the inner member 308, thereby securing the leaflet between them. The retaining member 354 of the clamping portion 300 can engage tissue of the heart valve leaflet to help secure the clamping portion to the leaflet.

[0105] During implantation, if the physician wishes to adjust the position of the clamping portion 300 relative to the leaflet, the physician can again move the inner shaft 452 distally relative to the inner support catheter 448 to open the clamping portion, and then move the inner shaft 452 proximally to close the clamping portion and secure the leaflet. During this process of opening and closing the clamping portion 300, the inner support catheter 448 can have sufficient rigidity to resist the pulling force applied by the actuation connector 456, thereby allowing the engagement portion 342 to be pulled toward the inferior surface of the left ventricle, rather than bending the clamping portion 300, the inner shaft 452, and the inner support catheter 448 outwards.

[0106] This process can be repeated for one or more additional clamping portions 300, wherein at least one additional clamping portion 300 is attached to another heart valve leaflet. After the clamping portion 300 has been secured to the corresponding leaflet, one or more sutures 328 can be applied. Figure 9 The coupling member 316, passing through the clamping portion, is placed under a desired level of tension to bring the clamping portions together to form an assembly (e.g., assembly 375) and improve leaflet alignment, and the free suture end is secured by the locking member 332. Figure 9 Alternatively, the suture 328 may be pre-passed through the coupling member 316 of the clamping portion 300 before deployment in the heart. The clamping portions 300 may be secured to their respective leaflets as previously described, the suture 324 is placed under the desired level of tension, and the free suture ends are secured with locking member 332. Once the clamping portions 300 have been properly positioned, the actuation connector 456 may be cut or removed, and the delivery assembly 440 may be removed from the patient.

[0107] Although delivery assemblies 400 and 440 have been described for use with clamping portion 300, they can be used in a similar manner with leaflet clamping assembly 10. For example, actuation connectors 420 and 456 can be coupled to a portion of frame 60 or 68.

[0108] In some aspects, the delivery assembly for delivering and deploying the leaflet repair device (e.g., leaflet clamping assembly 10 or clamping assembly 375) may include features that help stabilize the delivery assembly in a position within the heart. For example, Figure 11A retrograde deployment procedure is illustrated, in which a delivery assembly 510, which may include an inner catheter 514 and an outer catheter 518, has been guided through the aortic valve into the left ventricle. Once the outer catheter 518 has been guided to the appropriate location, such as near the apex region of the left ventricle (e.g., near the inferior surface of the mitral valve leaflet), a balloon 522 coupled to the outer catheter 518 may inflate near the inferior surface of the left ventricle. The balloon 522 may abut against the inferior ventricular wall, supporting the outer catheter 518 during deployment of the clamping portion (e.g., using the inner catheter 514). In at least some cases, the inner catheter 514 may represent multiple concentric catheters, for example, for use with... Figure 4 The delivery assembly 400 delivers the clamping part 300.

[0109] The repair devices described herein (e.g., leaflet clamping assembly 10 or clamping assembly 375) have already been described in the context of repairing native mitral valve leaflets. However, it should be understood that the disclosed repair devices can be used to repair leaflets of other native heart valves, or artificial heart valves or artificial heart valve components (e.g., artificial leaflets), including using various transcatheter techniques (e.g., transatrial, transventricular, etc.). Leaflet capture assembly 10 and clamping assembly 375 can be used, for example, to reduce or improve valvular regurgitation by improving the occlusion between the leaflets of any native heart valve.

[0110] As will be discussed further, the repair device may include: (1) one or more clamping portions implanted on each leaflet of the heart valve (e.g., clamping portions 14 or 18 similar to leaflet clamping assembly 10, or clamping portion 300); (2) a single clamping portion implanted on multiple leaflets; (3) a single clamping assembly of two or more clamping portions (e.g., clamping assembly 10 or 375); (4) a clamping assembly (e.g., multiple clamping assemblies 10 or 375, or a combination of both); or (5) a combination thereof.

[0111] In some cases, the leaflet clamping assembly may include clamping portions for each native heart valve leaflet in the valve to be repaired (e.g., clamping portion 14 or 18 or clamping portion 300). For example, as Figure 7 As shown, the first leaflet clamping portion 14 of the clamping assembly 10 can be fixed to the anterior mitral leaflet, and the second leaflet clamping portion 18 can be fixed to the posterior mitral leaflet. The first and second clamping portions are fixed to each other after proper positioning to improve leaflet alignment. Similarly, the leaflet clamping portion 300 can be fixed to the anterior mitral leaflet, and the other leaflet clamping portion 300 can be fixed to the posterior leaflet. The two leaflet clamping portions 300 can be fixed to each other after proper positioning to form an assembly to improve leaflet alignment.

[0112] In the case of a heart valve with more than two leaflets (e.g., a tricuspid valve), the leaflet clamping assembly (assembly 10 or 375) may include three or more clamping portions. For example, when the leaflet clamping assembly 10 includes more than two clamping portions, the first clamping portion may include a base member 30, and additional clamping portions may include posts similar to a second post 42, wherein these posts may be axially arranged on top of each other and axially aligned such that a tensioning member 38 may extend through the lumen of each post and the base member 30 to secure the clamping portions to each other. The clamping assembly may be implanted at the center of the native valve such that the clamping assembly brings together the three occlusal edges of the leaflet at the center of the native valve. Similarly, at least one clamping portion 300 may be secured to each leaflet of the tricuspid valve, and the clamping portions may be secured to each other to provide the leaflet clamping assembly.

[0113] In some cases where the clamping assembly is implanted on a native valve with three leaflets, the clamping assembly may be implanted on two of the three native leaflets, for example at the suture defined by the two leaflets. Another clamping assembly may be implanted on another pair of leaflets of the same valve, for example at another suture of the valve.

[0114] The leaflet repair device may include more clamping portions than the leaflet to be fixed, including more clamping portions than the leaflet present in the valve to be repaired. In the case of the mitral valve, multiple clamping portions may be attached and secured together at corresponding locations along the free edges of the posterior and anterior leaflets, as described above. Figure 9 The image shows a leaflet clamping assembly 375 formed by four clamping portions 300. Similarly, for tricuspid, aortic, or pulmonary valves, one or more clamping portions may be implanted on each of the three leaflets of the native valve, wherein each clamping portion is fixed to a clamping portion on an opposite leaflet, and at least one leaflet is fixed to more than one clamping portion.

[0115] In another aspect, at least one clamping portion (e.g., clamping portion 14, 18, or 300) can be secured to multiple leaflets, which may allow the use of fewer clamping portions than the number of leaflets to be secured. For example, portions of two leaflets may be secured between the inner and outer frame members of a single clamping portion (e.g., inner frame member 308 and outer frame member 312 of clamping portion 300, respectively). In some embodiments, only a single clamping portion may be implanted to improve occlusion between the two leaflets. In some embodiments, multiple clamping portions may be secured at corresponding locations along the occlusion line of the two leaflets, wherein each clamping portion receives the opposite edge portions of the two leaflets. In such embodiments, the individual clamping portions may, but are not required to, be secured to each other. In some cases, having clamping portions span multiple leaflets may allow the use of fewer clamping portions than the number of leaflets associated with the valve, or may allow for asymmetric valve repair, which may be useful when asymmetric leaflet misalignment causes regurgitation.

[0116] In one specific embodiment, for example, a single clamping portion can be secured to the posterior and anterior lobules of the native mitral valve such that the opposing edge portions of the native lobules are captured between opposing frame members of the clamping portion (e.g., between the first frame member 308 and the second frame member 312, where clamping portion 300 is used). The clamping portion can be positioned anywhere along the occlusion line of the lobules (e.g., adjacent to the suture or anywhere between the sutures). With the two opposing edge portions of the lobules captured between the opposing frame members of the single clamping portion, the single clamping portion itself serves as a lobule restoration device. In at least some cases, a single clamping portion secured to at least two lobules can be used to improve lobule occlusion and thus can be used as a lobule restoration device without needing to be secured to an additional clamping portion.

[0117] Although this disclosure generally describes the implantation of a single clamping assembly for repairing a heart valve, multiple clamping assemblies can be implanted in a single valve to improve valve function. For example, multiple clamping assemblies 10 or 375 can be attached to the posterior and anterior mitral leaflets at malaligned areas, which can reduce regurgitation more effectively than using a single clamping assembly at a single location. Each clamping assembly 10 or 375 may include the same or different numbers of clamping portions and may be spaced apart from each other along the occlusion line of the two leaflets. In the case of a tricuspid valve or another valve having more than two leaflets, multiple clamping assemblies 10 or 375 may be attached to two or more leaflets, wherein each clamping assembly may include the same or different numbers of clamping portions and may be spaced apart from each other.

[0118] In use, a delivery system (e.g., a delivery system including a delivery device comprising a delivery catheter and a deployment catheter disposed within the delivery catheter) can be introduced into the patient's vascular system (e.g., via the femoral artery or other suitable access point) and percutaneously advanced to the patient's heart using any of a variety of delivery techniques. In transfemoral procedures, the delivery device can be inserted retrogradely into the heart via the femoral artery and aorta (typically, but not only, for deploying one or more clamping portions on the leaflets of the aortic or mitral valve). Similarly, the delivery device can be inserted antegradely into the right side of the heart via the femoral vein and vena cava (typically, but not only, for deploying one or more clamping portions on the leaflets of the pulmonary or tricuspid valve). In transventricular procedures, the delivery device can be inserted through surgical incisions formed at bare points on the inner and lower anterior ventricular walls (typically, but not only, for deploying one or more clamping portions on the leaflets of the aortic or mitral valve). Similarly, the delivery device can be inserted through surgical incisions in the wall of the right ventricle to approach the pulmonary or tricuspid valve. In transatrial procedures, the delivery device can be inserted through a surgical incision formed in the wall of the left or right atrium to access the native valves on the left or right side of the heart, respectively. In transaortic procedures, the delivery device can be inserted through a surgical incision formed in the ascending aorta and advanced toward the heart (typically, but not only, for deploying one or more clamping portions on the leaflets of the aortic or mitral valve). In transseptal procedures, the delivery device can be advanced (e.g., via the femoral vein) into the right atrium and through the septum separating the right and left ventricles (typically, but not only, for deploying one or more clamping portions on the leaflets of the aortic or mitral valve). Further details of delivery techniques for accessing the native valves of the heart are disclosed in U.S. Patent Publication No. 2014 / 0067052.

[0119] It should be noted that the positioning of the disclosed devices (e.g., leaflet clamping assembly 10, leaflet clamping assembly 375, or components thereof) can be visually confirmed using imaging modalities such as fluoroscopy, X-ray, CT, and MR imaging. 2D or 3D echocardiography can also be used to help guide the positioning of the devices.

[0120] General considerations

[0121] For the purposes of this specification, certain aspects, advantages, and novel features of embodiments of this disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as limiting in any way. Rather, this disclosure is directed toward all novel and non-obvious features and aspects of the various disclosed embodiments, as well as various combinations and sub-combinations thereof. The methods, apparatuses, and systems are not limited to any particular aspect or feature or combination thereof, and the disclosed embodiments do not claim to have any one or more particular advantages or solve any one or more problems.

[0122] Features, integers, properties, compounds, chemical parts, or groups described in connection with specific aspects, embodiments, or examples of the invention should be understood to be applicable to any other aspect, embodiment, or example described herein, unless incompatible with it. All features disclosed in this specification (including any appended claims, abstracts, and drawings) and / or all steps of any method or process so disclosed may be combined in any combination, except that at least some such combinations of features and / or steps are mutually exclusive. This disclosure is not limited to the details of any of the foregoing embodiments. This disclosure extends to any novel feature or any novel combination of features disclosed in this specification (including any appended claims, abstracts, and drawings), or any novel step or any novel combination of steps of any method or process so disclosed.

[0123] Although the operations of some of the disclosed methods are described in a specific order for ease of presentation, it should be understood that this description includes rearrangement unless a particular language requires a specific ordering. For example, in some cases, the operations described in sequence can be rearranged or performed simultaneously. Furthermore, for simplicity, the accompanying figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods.

[0124] As used herein, the terms “a,” “an,” and “at least one” include one or more specified elements. That is, if two specific elements exist, then one of those elements also exists, hence the term “a” element. The terms “multiple” and “plural” indicate two or more specified elements.

[0125] As used herein, the term “and / or” used between the last two elements in a list of elements refers to any one or more of the listed elements. For example, the phrase “A, B and / or C” means “A”, “B”, “C”, “A and B”, “A and C”, “B and C”, or “A, B and C”.

[0126] As used in this article, the term “coupled” generally means physical coupling or linking, and does not preclude the existence of intermediate elements between coupled projects in the absence of a specific opposite language.

[0127] As used herein, the term "proximal" refers to the location, orientation, or portion of the device that is closer to the user and further away from the implantation site. As used herein, the term "distal" refers to the location, orientation, or portion of the device that is further away from the user and closer to the implantation site. Thus, for example, proximal movement of the device is movement of the device toward the user, while distal movement of the device is movement of the device away from the user. The terms "longitudinal" and "axial" refer to axes extending along the proximal and distal directions, respectively, unless otherwise explicitly defined.

[0128] As used herein, the terms “monolithic” and “integral structure” refer to a structure that does not include any welded parts, fasteners, or other means for securing individually formed sheets of material together.

[0129] Given the many possible embodiments to which the principles of the disclosed invention can be applied, it should be recognized that the illustrated embodiments are merely preferred embodiments of the invention and should not be considered as limiting the scope of the invention. Rather, the scope of the invention is defined by the appended claims. Therefore, the applicant declares that all of these fall within the scope and spirit of these claims.

Claims

1. A leaflet repair device, the device comprising: A first clamping portion, the first clamping portion including an inner frame member and an outer frame member, wherein the inner frame member and the outer frame member are configured therebetween to compress tissue of a first heart valve leaflet to secure the first clamping portion to the first leaflet. and The second clamping portion includes an inner frame member and an outer frame member, wherein the inner frame member and the outer frame member are configured to compress tissue of the second heart valve leaflet therebetween to secure the second clamping portion to the second leaflet. The inner frame member and the outer frame member of the first clamping portion are coupled to the coupling member; The first clamping portion and the second clamping portion are attached to each other by the coupling member; The coupling member includes a tubular or cylindrical shape that defines an inner cavity; The cavity is configured to receive an inner shaft; The inner shaft passes through the opposite ends of the inner cavity.

2. The device according to claim 1, wherein the inner frame member and outer frame member of the first clamping portion and the second clamping portion and the coupling member are integral structures.

3. The apparatus of claim 1, wherein one or more of the inner frame member and outer frame member of the first clamping portion and the second clamping portion and the coupling member are coupled together.

4. The apparatus of claim 1, wherein the inner cavity is configured to receive a tensioning member.

5. The apparatus of claim 1, wherein the tensioning member comprises an elongated sheet of flexible material.

6. The device of claim 1, wherein the tensioning member extends through the opposite end of the cavity.

7. The device of claim 1, wherein at least a portion of the outer frame member is formed of an elastic material or a biocompatible material.

8. The device of claim 1, wherein at least a portion of the outer frame member is formed of a biocompatible polymer.

9. The apparatus of claim 1, wherein at least one of the first and second clamping portions is configured to be deployed with the engaging portion in an open position, wherein the engaging portion is manipulated to a closed position or releasable to return to a closed position after leaflet capture.

10. The apparatus of claim 1, wherein the inner frame member, the coupling member, and / or the outer frame member are covered with a biocompatible covering.

11. The apparatus of claim 1, wherein the first clamping portion and the second clamping portion are configured to be secured to the respective first and second lobes by tissue-engaging members protruding into the tissue of the lobule.

12. A leaflet repair device, the device comprising: A first clamping portion, the first clamping portion including an inner frame member and an outer frame member, wherein the inner frame member and the outer frame member are configured therebetween to compress tissue of a first heart valve leaflet to secure the first clamping portion to the first leaflet. and The second clamping portion includes an inner frame member and an outer frame member, wherein the inner frame member and the outer frame member are configured to compress tissue of the second heart valve leaflet therebetween to secure the second clamping portion to the second leaflet. The inner frame member and the outer frame member of the first clamping portion are coupled to the coupling member; The first clamping portion and the second clamping portion are attached to each other by the coupling member; The coupling member includes a tubular or cylindrical shape that defines an inner cavity.

13. The apparatus of claim 12, wherein the inner frame member and outer frame member of the first clamping portion and the second clamping portion and the coupling member are integral structures.

14. The apparatus of claim 12, wherein one or more of the inner frame member and outer frame member of the first clamping portion and the second clamping portion and the coupling member are coupled together.

15. The apparatus of claim 12, wherein the inner cavity is configured to receive a tensioning member.

16. The apparatus of claim 12, wherein the tensioning member comprises an elongated sheet of flexible material.

17. The device of claim 12, wherein the tensioning member extends through opposite ends of the cavity.

18. The device of claim 12, wherein at least a portion of the outer frame member is formed of an elastic material or a biocompatible material.

19. The device of claim 12, wherein at least a portion of the outer frame member is formed of a biocompatible polymer.

20. The apparatus of claim 12, wherein at least one of the first clamping portion and the second clamping portion is configured to be deployed with the engaging portion in an open position, wherein the engaging portion is manipulated to a closed position or releasable to return to a closed position after leaflet capture.

21. The apparatus of claim 12, wherein the inner frame member, the coupling member, and / or the outer frame member are covered with a biocompatible covering.

22. The apparatus of claim 12, wherein the first clamping portion and the second clamping portion are configured to be secured to the respective first and second lobes by tissue-engaging members protruding into the tissue of the lobule.

Images