Mitral valve repair and replacement devices and methods

Abstract

The present invention relates to mitral valve repair and replacement devices and methods. An implant and method for repairing and / or replacing the function of a native mitral valve, in various embodiments, is configured to reduce or eliminate mitral regurgitation and residual mitral valve leakage. A coiled anchor with a central turn that reduces in size after implantation is used to approximate the native mitral annulus size and reshape the native mitral annulus to reduce valve leakage. A clip can be further applied to the native valve leaflets to reduce the size of the native mitral annulus and reduce leakage therethrough. An artificial heart valve can be implanted in the coiled anchor to replace and further improve the function of the valve. In some cases, an artificial valve can be implanted in the clipped valve, with the clip detached from one of the native valve leaflets to provide space for the artificial valve to expand.

Description

[0001] This application is a divisional application. The original application was filed on September 11, 2015, with application number 201580047893.8 (the divisional application it addresses has application number 201910383077.4), and the invention title is "Mitral Valve Repair and Replacement Device and Method".

[0002] This application claims priority and benefit to U.S. Provisional Patent Application No. 62 / 049,432, filed September 12, 2014, the contents of which are incorporated herein by reference in their entirety; and also claims priority and benefit to U.S. Provisional Patent Application No. 62 / 073,088, filed October 31, 2014, the contents of which are also incorporated herein by reference in their entirety. Technical Field

[0003] This invention generally relates to medical devices and procedures for mitral valve repair and to artificial heart valves. More specifically, the invention relates to the repair and / or replacement of heart valves with malformations or dysfunctions. Embodiments of the invention relate to devices and methods for reshaping or adjusting the size of a natural mitral valve, for further treatment to reduce residual leakage at the mitral annulus, and, for example, the function of replacing the mitral valve with an artificial heart valve when leakage persists. Background Technology

[0004] First, general reference Figure 1 and Figure 2 The mitral valve controls blood flow between the left atrium and left ventricle of the heart. After the left atrium receives oxygenated blood from the lungs via the pulmonary veins, the mitral valve allows oxygenated blood to flow from the left atrium into the left ventricle. When the left ventricle contracts, the oxygenated blood held in the left ventricle is delivered to the rest of the body through the aortic valve and the aorta. Simultaneously, the mitral valve closes during ventricular contraction to prevent blood from flowing back into the left atrium.

[0005] The mitral valve consists of an anterior leaflet and a posterior leaflet. When the left ventricle contracts, the anterior and posterior leaflets converge, and the blood pressure in the left ventricle increases significantly to cause the mitral valve to close. Due to the large pressure gradient between the left ventricle and left atrium during ventricular systole, there is a possibility that a leaflet of the mitral valve may prolapse or flip back into the atrium. To prevent this, a series of chordae tendineae connect the mitral valve to the papillary muscles along the opposing wall of the left ventricle. Figure 1 Cross-sectional view of the heart and Figure 2 The chordae tendineae are schematically shown in the top view of the mitral valve. Before and during ventricular systole, the papillary muscles also contract and maintain tension in the chordae tendineae to keep the leaflets of the mitral valve in the closed position and prevent them from flipping outward and returning to the atria, thereby also preventing oxygenated blood from flowing back into the atria.

[0006] The overall shape of the mitral valve and its leaflets as seen from the left atrium is as follows: Figure 2 As shown. Mitral valve complications can lead to fatal heart failure. One form of valvular heart disease is mitral leakage, also known as mitral regurgitation, characterized by the abnormal leakage of blood from the left ventricle back into the left atrium through the mitral valve.

[0007] Mitral regurgitation is a common problem, and various options for reducing or preventing mitral regurgitation that can be more easily tolerated or managed by the patient's body have been studied.

[0008] One repair protocol for patients with mitral regurgitation or other mitral valve leakage involves catheter-based surgery in which the free edge of the anterior leaflet is attached to the free edge of the posterior leaflet. The idea for this procedure was proposed by Dr. Ottavio Alfieri, who described a patient with a congenital abnormality where the anterior leaflet edge fused to the posterior leaflet edge and speculated that this might provide a good solution for mitral regurgitation. Dr. Alfieri has performed numerous procedures in which the mitral annulus is repaired by reducing the size of the annulus through annulusoplasty to reshape the natural mitral annulus to make it smaller and / or more rounded or otherwise consistent, and residual leakage is then controlled by bringing the anterior leaflet edge closer together and attaching it to the posterior leaflet edge in the desired arrangement. Utilizing a combination of annulusoplasty to reduce the diameter of the mitral annulus and the proximity of the leaflet edges, the performance of many leaky mitral valves can be repaired and improved through the known Alfieri procedures.

[0009] The Alfieri procedure has led to other catheter-based variations for attaching the edges of the anterior and posterior leaflets to control mitral regurgitation. In one procedure, under echocardiographic and fluorescein guidance, a clamp is introduced at the mitral annulus using a catheter, which secures the free edge of the anterior leaflet to the free edge of the posterior leaflet. The clamp and delivery system are typically introduced into the patient's femoral vein and into the right side of the heart. A transseptal puncture is then performed in the patient's heart, and the clamp is advanced into the left atrium and then into the left ventricle. The leaflet edges are then secured to the clamp, and the delivery system is removed. In other variations of this procedure, the clamp and delivery system may alternatively be introduced into the patient's heart from one of a variety of other entry points or locations on the patient's body.

[0010] Most patients require a clamp during this type of procedure, but additional clamps may be used if leakage is severe and / or the lobules are highly dispersed. Clinical outcomes are satisfactory. Many patients have shown a significant reduction in leakage and substantial symptom improvement compared to before the procedure.

[0011] Another option to further reduce mitral valve leakage is to combine one of the above-mentioned annulusoplasty procedures with or supplement it with edge-to-edge leaflet folding surgery to further enhance the connection or attachment between the natural mitral valve leaflets. Summary of the Invention

[0012] However, even after undergoing one or more of the aforementioned procedures, some patients still have significant mitral valve leakage. This increases the workload on the heart, and the heart can be damaged due to the long-term effects of this residual valvular regurgitation.

[0013] According to embodiments of the invention, a helical anchor or coiled anchor with a different radius of curvature is provided to more effectively reduce and / or reshape the natural mitral valve annulus, thereby reducing leakage at the mitral valve. If leakage is still observed after reshaping the natural mitral valve annulus and / or adjusting its size, additional measures, such as edge-to-edge repair or other reconstructive procedures, can be applied more easily or more effectively to the reconstructed mitral valve annulus.

[0014] In another alternative to remedy continuous leakage following one of the above-described annuloplasty procedures or other similar annulus reduction procedures, an artificial mitral valve can be further implanted into the mitral annulus because the annuloplasty procedure using a coiled anchor according to an embodiment of the invention will result in the formation of a stable anchor or base in which the artificial mitral valve can abut or abut against.

[0015] According to an embodiment of the invention, an implant for reshaping the shape of a natural mitral valve of the heart includes a coiled anchor having a first end, a second end, and a central axis extending between the first and second ends. The coiled anchor defines an internal space coaxial with the central axis and includes a first turn defining a central portion having a first width; a second turn connected at the first end of the coiled anchor to the central turn, the second turn defining a portion of the internal space with a width less than the first width; and a third turn connected at the second end of the coiled anchor to the central turn, the third turn defining another portion of the internal space with a width less than the first width. The coiled anchor can be implanted at a natural mitral valve, wherein at least a portion of the first turn of the coiled anchor is positioned in the left ventricle of the heart and surrounds the leaflet of the natural mitral valve.

[0016] According to another embodiment of the present invention, a method for delivering an implant according to the above embodiments includes: positioning a coiled anchor at the natural mitral valve of a patient's heart, such that at least a portion of a first turn of the coiled anchor is positioned in the left ventricle of the heart and around the leaflet of the natural mitral valve; positioning an expandable stent at the natural mitral valve through the internal space of the coiled anchor when the stent is in a collapsed state; and expanding the stent. When the coiled anchor is not biased, the stent can expand to a width greater than the width of the internal space defined by at least one of a second or third turn, such that radially outward pressure is applied to the stent on at least one of the second or third turns to increase the width of the portion of the internal space defined by at least one of the second or third turns, while reducing the width of the portion of the internal space defined by the first turn to a width less than a first width.

[0017] According to embodiments of the invention, by first using helical or coiled anchors to reshape, adjust the size, and / or otherwise reconstruct the natural mitral valve annulus, the repair and / or replacement of the diseased mitral valve can be achieved more effectively, making it easier or more effective to apply additional devices and methods to reinforced mitral valve locations. Attached Figure Description

[0018] Further features and advantages of the invention will become apparent from the description of embodiments using the accompanying drawings. In the drawings:

[0019] Figure 1 A schematic cross-sectional view of the human heart is shown.

[0020] Figure 2 A schematic top view showing the mitral valve annulus of the heart;

[0021] Figure 3A and Figure 3B Perspective and side views of a coiled anchor for adjusting the size of the natural mitral annulus or reshaping the shape of the natural mitral annulus according to embodiments of the present invention are shown respectively.

[0022] Figures 4A to 4C This schematically illustrates an embodiment of the invention. Figures 3A to 3B The steps of expanding the balloon in the coiled anchoring element to expand the stent;

[0023] Figures 5A to 5C The steps of implanting a coiled anchor and a balloon-expandable stent at the natural mitral valve according to an embodiment of the present invention are shown.

[0024] Figure 6A and Figure 6BThe steps of performing edge-to-edge repair on a mitral valve with an implanted stent using a clamp according to an embodiment of the present invention are illustrated.

[0025] Figure 7A and Figure 7B This illustrates the steps of implanting an artificial mitral valve at a previously performed edge-to-edge repair of the natural mitral valve annulus, according to an embodiment of the invention; and

[0026] Figure 8 An artificial mitral valve is shown, fully implanted in a stent at the site of a previously performed edge-to-edge repair of the natural mitral valve, according to an embodiment of the invention. Detailed Implementation

[0027] This document discloses various implants and other devices for repairing and / or replacing the function of a natural mitral valve, as well as methods for implanting such devices. By providing such devices and methods for implanting them, it is possible to reduce mitral valve leakage and leakage caused by similar types of valvular heart disease, and to improve mitral valve performance.

[0028] In some embodiments, a helical anchor or a coiled anchor can be used to reduce and / or reshape the annulus of the natural mitral valve, preparing for valve repair or further annulusoplasty. In other embodiments, when valve replacement is planned, a helical anchor can be used to reduce the size of the patient's natural mitral annulus and shape the annulus more suitable for anchoring or docking with an artificial heart valve. In these embodiments, one of a variety of artificial valves that can be implanted in a stent can be used in conjunction with a helical anchor that narrows and / or reshapes the natural mitral annulus.

[0029] Figure 3A and Figure 3BEmbodiments of a helical anchoring device or coil anchoring device according to an embodiment of the present invention are shown. The illustrated embodiment shows a helical anchor 10 with three turns. However, in other embodiments, depending on the specific application and the patient's anatomy, other helical anchors can have more or fewer turns. The helical anchor 10 includes an upper first end turn 12, a second center turn 14, and a lower third end turn 16, and defines a space extending through the center of the helical anchor 10. The upper end turn 12 and the lower end turn 16 of the helical anchor 10 are smaller than the center turn 14. In one embodiment, when the helical anchor 10 is not biased, the smaller end turns 12, 16 of the helix have a diameter of approximately 25 mm, while the larger center turn 14 has a diameter of approximately 35 mm. However, in other embodiments, the dimensions of the end turns 12, the center turn 14, and the end turns 16 can be different, as long as the center turn 14 is larger than the end turns 12, 16. In embodiments having more than three turns, the size of more than one center turn can be set to be larger than that of the end turns, or more than one smaller turn can be present at either end of the anchor, or both. Furthermore, in some embodiments, the upper and lower turns of the anchor can have different diameters.

[0030] In one embodiment, the helical anchor 10 is made of a shape memory material such as nitinol, which facilitates the straightening of the helical anchor 10 for easier delivery within the patient. In other embodiments, the helical anchor 10 can be made of or include one of a variety of other biocompatible metals or other biocompatible materials.

[0031] Furthermore, the core material of the helical anchor 10 can be covered with a biocompatible fabric or other biocompatible material to improve the stability, biocompatibility, or other functions of the helical anchor 10 after implantation in a patient. Such fabrics or other coverings can also be used to promote contact or friction between the stent and / or prosthetic valve and the helical anchor 10, reducing expansion of the helical anchor 10 and allowing the helical anchor 10 to grip any expanded or dilated stent or prosthetic valve within it, as discussed in more detail below.

[0032] Figures 4A to 4C The steps of inserting the balloon expandable support into the coiled helical anchor 10 are illustrated schematically. Figure 4A First, a cross-sectional view of the helical anchor 10 is shown before the stent or artificial valve expands inside the anchor. (This is in contrast to the above regarding...) Figure 3A and Figure 3B Similarly discussed, the helical anchor 10 includes three turns, wherein the central turn 14 has a larger diameter than the end turns 12 and 16.

[0033] exist Figure 4BIn this configuration, the balloon 30 is inserted through the central space 18 defined by the helical anchor 10, and then expands within the helical anchor 10 to a size greater than the diameter of at least one of the end turns 12, 16 of the helical anchor 10. Additionally, the balloon 30 carries a stent 20, which is positioned at the center of the helical anchor 10 in front of the balloon 30, and the stent 20 expands on the balloon 30, impacting or otherwise contacting the helical anchor 10.

[0034] Because the balloon is expanded to a size larger than the diameter of the end turns 12, 16 of the helical anchor 10, the expansion of the balloon 30 and the stent 20 within the helical anchor 10 results in an increase in the diameter of the two end turns 12, 16. For example, with the end turns 12, 16 having an unbiased diameter of 25 mm, the balloon 30 and the stent 20 can expand to a width of up to 27 mm, forcing the end turns 12, 16 radially outward, causing the end turns to also expand to approximately 27 mm wide. Simultaneously, as the two end turns 12, 16 expand, they pull on the end of the larger central turn 14 of the helical anchor 10, and conversely, reduce the diameter of the larger central turn 14. Therefore, after the balloon 30 and the stent 20 expand within the helical anchor 10, in one embodiment, all the turns of the helical anchor 10 have approximately the same diameter, which is approximately 27 mm in the example described above.

[0035] After the stent 20 has expanded through the center of the helical anchor 10, the balloon 30 can be deflated and removed. Figure 4C The diagram schematically illustrates the final configuration of the helical anchor 10 with the stent 20 through which expansion has occurred after the balloon 30 has been removed. The stent 20 is held in place within the helical anchor 10 by radial pressure or friction formed between the stent 20 and the turns of the helical anchor 10.

[0036] Figure 4C The stent 20 shown has a fabric cover. The cover can cover the interior or exterior of the stent 20, or both. In other embodiments, the stent does not include a cover or other covering layer. Polyester or one of a variety of other materials can be used for the stent cover. In other embodiments, biological covers, such as pericardium derived from animal or human materials, can also be used.

[0037] Meanwhile, the stent 20 itself can be made of stainless steel or stainless steel alloys commonly used in medical implants, or of a variety of other biocompatible metals or other materials. Various stent designs are compatible with and can be used in conjunction with the helical anchor 10 described above.

[0038] The friction between the support 20 and at least the smaller turns of the helical anchor 10 and / or the underside of the mitral leaflet pressed between the helical anchor 10 and the support 20 holds the support 20 in its proper position within the helical anchor 10. Furthermore, the larger central turn 14 can be pulled closer to the support 20 to the extent that it also abuts against and applies pressure to the outer surface of the support 20. Along these same lines, the larger central turn 14 of the helical anchor 10 can be pulled radially inward more rapidly or effectively as the smaller end turns 12, 16 of the helical anchor 10 remain more firmly against the support 20 during expansion, and as movement or slippage between these surfaces decreases. Therefore, surface coatings and / or other treatments or options that improve the contact or friction between the smaller turns of the helical anchor 10 and the support 20 will increase the rate of reduction in the diameter of the largest turn or multiple turns of the helical anchor 10, resulting in a tighter or more secure fixation between the parts. In one embodiment, one or more smaller turns of the helical anchor 10 have hooks, barbs, or other attachment mechanisms to improve engagement with the bracket 20.

[0039] Figures 5A to 5C The procedure illustrates the implantation of a coiled helical anchor 10 and a stent 20 into the patient's heart 80 at the natural mitral valve annulus 86. The natural mitral valve annulus of patients with mitral regurgitation or other mitral valve leakage can be enlarged, in some cases up to approximately 35 mm. The enlargement size of different diseased mitral valves can vary, and different anchors and / or stents can be used to treat each specific diseased valve according to the patient's natural mitral valve enlargement size or desired size.

[0040] exist Figure 5A In this embodiment, the coiled helical anchor 10 has been delivered intracardiacly, for example via apical or transseptal surgery, endovascular or transcatheter surgery, or one of various other known procedures. When the helical anchor 10 is positioned around the natural mitral annulus 86, the two turns of the helical anchor 10, the lowest smaller end turn 16 and the larger central turn 14, are located below the natural mitral annulus 86 and within the left ventricle 84. Simultaneously, the upper smaller end turn 12 is located within the left atrium 82. In other embodiments, different combinations of turns may be positioned in the left atrium 82 and left ventricle 84 based on the physician's desired application.

[0041] Generally, the larger central turn 14 of the helical anchor 10 can be selected to match the diameter of the patient's enlarged natural mitral annulus 86, allowing the helical anchor 10 to be positioned around the natural mitral annulus 86 without applying excessive pressure to the natural mitral leaflet 88 or other parts of the natural mitral annulus 86 before the stent or artificial valve is introduced. The smaller end turns 12, 16 of the helical anchor 10 can be selected based on the required amount of shortening of the larger central turn 14. In other words, the larger central turn 14 can be selected based on the size of the enlarged natural mitral annulus 86 in the patient, and the sizes of the smaller end turns 12, 16 can be selected to specify the desired size to which the larger central turn 14 of the helical anchor 10 will be reduced, thereby approximating the desired size of the treated natural mitral annulus 86 after implantation. In addition, the size and shape of the end turns 12, center turns 14, and end turns 16 of the coiled helical anchor 10 can be selected to facilitate the placement and positioning of the helical anchor 10 around the natural mitral leaflet 88 and / or chordae tendineae (not shown) when the helical anchor 10 is first unfolded.

[0042] After positioning the helical anchor 10 at the desired location around the natural mitral valve annulus 86, the balloon 30 is used to inflate the helical anchor 10, as... Figure 5B As shown. With Figure 4B Similarly, balloon 30 carries and delivers stent 20, which can be covered with a covering layer, as previously described. The deflated balloon 30 and the uninflated stent 20 first move within the space defined by helical anchor 10 until the stent 20 is positioned at the desired location by the helical anchor 10.

[0043] The balloon 30 is then inflated to expand the stent 20, and this expansion causes radially outward pressure to be applied to at least the smaller end turns 12, 16 abutting the helical anchor 10. Similarly, the inflation of the balloon 30 in the helical anchor 10 and the expansion of the stent 20 in the helical anchor 10 cause the lowest and highest end turns 12, 16 of the helical anchor 10 to expand, and the diameter of the larger central turn 14 of the helical anchor 10 to decrease. The movement of the turns and the amount of reduction in the size / shape of the larger central turn 14 can be adjusted based on the amount of friction or retention between the smaller end turns 12, 16 of the helical anchor 10 and the stent 20.

[0044] from Figure 5B It can also be seen that, since the lower central ring 14 and the end ring 16 are positioned outside the natural mitral leaflet 88, and the support 20 expands within the natural mitral annulus 86, the natural mitral leaflet 88 is captured or pressed in the position between the lower central ring 14, the end ring 16 and the support 20 of the spiral anchor 10.

[0045] After the stent 20 has expanded to its final size within the helical anchor 10, the balloon 30 can be removed. After the balloon 30 is removed, the stent 20 remains fixed in its expanded position within the helical anchor 10.

[0046] The size of the natural mitral annulus 86 has also been reduced by decreasing the size of the larger central turn 14 of the helical anchor 10 through the expansion of the support 20. This reduction in the size of the natural mitral annulus 86 is caused by... Figure 5C The arrows in the diagram illustrate this. For example, the diameter of the diseased or leaking mitral annulus in a patient may be 35 mm before treatment, but after the stent 20 is implanted in the spiral anchor 10 and expanded, the central turn 14 of the spiral anchor 10 is reduced to approximately 27 mm. As the size of the larger central turn 14 of the spiral anchor 10 decreases, the central turn 14 forces the natural mitral leaflet 88 inward, causing the size of the natural mitral annulus 86 to also decrease from approximately 35 mm to approximately 27 mm. By using the spiral anchor 10 and stent 20 or other types of annuloplasty rings in this way to reduce the size of the diseased natural mitral annulus 86 and / or to reshape it, mitral regurgitation can be eliminated or significantly reduced.

[0047] Other mitral annulus variants in other patients or based on other diseases can be paired with helical anchors 10 and / or stents 20 with different diameter combinations to produce optimal results for each patient and his or her needs. In each embodiment, there are one or more larger central turns surrounded by smaller upper and lower turns, wherein the larger one or more turns are used to reduce the diameter of the mitral annulus when the system is activated.

[0048] Furthermore, in the described embodiment, three complete turns are shown in the helical anchor 10. However, anchors may also have upper and lower turns that are not complete turns. For example, in an alternative embodiment, the lower end turn 16 shown in the left ventricle 84 could be half a turn, such that at the end of the procedure, the helical anchor 10 positioned in the left ventricle 84 has fewer than two turns. In some embodiments, the procedure can also be performed with an anchor having only two turns, such as one large turn and one small turn.

[0049] Figures 5A to 5CThe embodiments also show an axial gap between the highest end turn 12 and the central turn 14 of the helical anchor 10. This gap allows for a longer attachment length for the stent 20, providing a larger target for positioning the stent 20 during implantation. The longer length of the helical anchor 10 also provides greater stability to the system after implantation. In some embodiments, the longer helical anchor 10 can also facilitate easier initial positioning of the helical anchor 10 around the natural mitral valve annulus 86. In other embodiments, the helical anchor 10 can have larger or smaller gaps between the turns as needed. In some embodiments, the anchor can have no gaps between the turns. In embodiments with a longer anchor, the longer anchor can also facilitate the implantation of a longer stent. The longer stent, in turn, can provide a larger target for subsequent potential valve implantation.

[0050] In some patients, residual leakage can still exist even after annuloplasty or other mitral valve resizing or reshaping procedures. In some cases, additional measures can still be taken to further reduce leakage or otherwise improve the performance of the natural mitral valve.

[0051] For example, Figure 6A and Figure 6B The steps for further treatment on a stented mitral valve where additional leakage reduction is desired are shown. Figure 6A This illustration shows the beginning of an edge-to-edge repair procedure on a natural mitral valve leaflet 88 using a clamp 40 to eliminate or reduce any residual leakage following the implantation of the helical anchor 10 and stent 20. The clamp 40 is introduced into the left ventricle 84, for example, from the left atrium 82, using one of various known delivery methods and access sites. The clamp 40 can be delivered by a tool 50 and positioned such that the ends of the natural mitral valve leaflet 88 can be clamped together using the clamp 40. The clamp 40 can include one or more inner clamping surfaces 42 and one or more outer clamping surfaces 44 connected via a distal hinge. In the illustrated embodiment, the clamp 40 includes two inner clamping surfaces 42 and two outer clamping surfaces 44. One or both of the clamping surfaces 42, 44 can further include teeth or other surface features to facilitate more secure clamping of the natural mitral valve leaflet 88 by the clamp 40. In other embodiments, other clamping or holding devices can also be applied to the natural mitral valve leaflet 88 to perform an edge-to-edge repair procedure.

[0052] exist Figure 6BIn this embodiment, clamp 40 is closed to attach the free edge of the anterior mitral leaflet to the free edge of the posterior mitral leaflet. In the illustrated example, the outer clamping surface 44 is pushed against the inner clamping surface 42 to close clamp 40, and each natural mitral leaflet 88 can be pressed or clamped between the corresponding inner clamping surface 42 and the corresponding outer clamping surface 44 of clamp 40. In this embodiment, clamp 40 is applied approximately in the middle of the valve foramen (e.g., as shown in the image). Figure 7A (As shown). In other embodiments, the clamp 40 can be applied at any of a variety of different locations on each natural mitral leaflet 88, based on the location of the most severe leakage or the location where the clamp 40 can reduce most of the leakage. In some embodiments, more than one clamp may be applied as needed to further reduce leakage through the natural valve.

[0053] like Figure 6B As can be seen, the final result is similar to the original Alfieri-type procedure, comprising an annuloplasty ring consisting of an anchor and / or stent for reshaping the natural mitral valve annulus and a combination of edge-to-edge repair performed on the natural mitral leaflet. The order discussed above is shown as the initial annuloplasty or natural valve reshaping, followed by edge-to-edge repair performed on the natural valve leaflet. However, in other embodiments, the order can be reversed, where a clamp is applied first (even if it is performed in conjunction with the aforementioned procedure), and then annuloplasty or other reshaping or sizing adjustments of the annulus can be performed. In procedures where edge-to-edge repair is performed first, the subsequent delivery of the stent via an inflatable balloon can be limited by the presence of clamps, forceps, or other devices used for edge-to-edge repair. In these cases, a shorter balloon can be used, or the stent can be positioned more distally on the balloon so that the balloon does not contact the clamp, preventing damage to the clamp as the balloon inflates and the stent expands. It may also have a bifurcated or Y-shaped balloon, allowing the separated ends of the balloon to be positioned around the clamp, wherein a portion of the balloon passes through a valve opening on one side of the clamp, and another portion of the balloon passes through a valve opening on the other side of the clamp. For example, see reference. Figure 7A One end of the bifurcation balloon can pass through the orifice 90 of the natural valve formed by the clamp 40, while the other end of the bifurcation balloon can pass through the orifice 92 on the other side of the clamp 40.

[0054] In some cases, annuloplasty or a combination of natural valve reshaping and edge-to-edge repair is still insufficient to suppress mitral regurgitation or other mitral valve leaks. Even after undergoing these two procedures, patients may still have unacceptable leakage at the mitral valve.

[0055] Figure 7A , Figure 7B and Figure 8This illustrates how the spiral anchor 10 and / or stent 20 discussed above can also be used as ideal anchors for artificial valves used in stent placement. From a regulatory approval and inventory perspective, having many different valve shapes and sizes is expensive. Reducing the size of the natural mitral annulus with the spiral anchor 10 and / or stent 20 allows for the use of smaller-sized artificial stent valves. Furthermore, the spiral anchor 10 and / or stent 20 helps reshape the natural mitral annulus into a more rounded shape, enabling the use of more commercially available conventional valves with rounded or cylindrical outer contours at the mitral valve location. Additionally, the heart can function more efficiently or effectively at the mitral valve location with a smaller annulus diameter because the mitral valve will not stretch as much and can contract more fully. Therefore, mitral valve anchors or stents used to reduce the natural mitral annulus to a more uniform shape and / or size allow for fewer valves or valve deformities, thus saving costs and simplifying manufacturing and implantation procedures.

[0056] Figure 7A The diagram shows a top view of the mitral valve annulus, which has been fitted with a helical anchor 10 and / or a support (not in use). Figure 7A (As shown in the image) The patient underwent reshaping and edge-to-edge surgery using clamp 40 to clamp the distal end of the natural mitral valve leaflet 88. Edge-to-edge repair created two holes 90, 92 at the mitral valve location on either side of clamp 40. In some patients, it cannot be demonstrated that prior surgery was sufficient to inhibit or reduce the passage of... Figure 7A The illustration shows mitral valve leakage. Therefore, the balloon carrying the implantable prosthetic valve 60 can be further positioned across the mitral valve through one of the orifices 90 or 92. The deployed and implanted prosthetic valve 60 can be one of a variety of known valves with sizes and shapes suitable for fitting into the helical anchor 10, such as the Edwards Lifesciences Sapien XT™ valve.

[0057] exist Figure 7B In this process, the artificial valve 60 is expanded, for example, via inflation of a balloon delivery system. The expansion of the artificial valve 60 applies a large radial force or load to the natural mitral valve leaflets 88, which were pre-clamped together using clamps 40 during earlier edge-to-edge repair. Figure 7B As shown, the expansion of the artificial valve 60 begins to displace the clamp 40 and extend the natural mitral valve leaflet 88, and eventually, at least one of the natural mitral valve leaflets 88 is torn off the clamp 40, slides out of the clamp 40, or otherwise separates from the clamp 40.

[0058] To facilitate or promote the cutting or tearing of the natural mitral valve leaflet 88, the aforementioned valve dilation procedure can be performed after a separate balloon for cutting the natural mitral valve leaflet 88 has been inflated at the mitral valve location. Similar cutting balloons have been used, for example, to remove plaque in arteries. Another option is to cut at least one defect in the natural mitral valve leaflet 88 and then advance a stent valve within or near the pre-cut portion of the natural mitral valve leaflet 88. In other embodiments, the stent for implanting the artificial mitral valve can have its own cutting features for cutting the peripheral portion of the natural mitral valve leaflet 88 to further facilitate the dilation of the artificial valve 60.

[0059] In some embodiments, the artificial valve 60 can be repaired from edge to edge with the clamp 40 to maintain its integrity. In this case, it is necessary to ensure that the artificial valve 60 is formed of a sufficiently large size to be positioned within the orifice to allow adequate flow into the left ventricle. If flow obstruction is present, or if the orifice size is insufficient, the clamp 40 can still be subsequently cut from one edge of the natural mitral valve leaflet 88 to form a more suitable orifice or opening for the artificial valve 60.

[0060] In some cases, the clip 40 may detach from the edges of the two natural mitral valve leaflets. This would be highly unusual, as it would mean that the clip 40 would remain almost identical on both leaflets. However, in such cases, the clip 40 can be easily retrieved and removed from the patient.

[0061] Typically, after one of the natural mitral valve leaflets 88 is torn or ripped from the clamp 40, the artificial valve expands freely until it is close to the spiral anchor 10 and / or the stent 20. Figure 8 The artificial valve 60 is shown after it has fully expanded. The valve 60 is securely positioned within an existing annulusoplasty device, which includes a helical anchor 10 and a stent 20. The pre-positioned helical anchor 10 and stent 20 provide excellent targeting for the insertion and expansion of the artificial valve 60. The annulusoplasty device is clearly visible under fluoroscopy.

[0062] As previously discussed, one of the natural mitral valve leaflets 88 has been torn or ripped apart at the fissure 94 or otherwise separated from the clamp 40, and the function of the natural mitral valve leaflet 88 has been replaced by the artificial valve 60. The clamp 40, which has been separated from one of the natural mitral valve leaflets 88, is shown inside the left ventricle 84 and should not affect the function of the artificial valve 60.

[0063] In other embodiments, various features from the different embodiments described above can be combined or modified based on the needs of each individual patient. For example, annuloplasty or mitral annulus remodeling surgery does not need to be performed in conjunction with edge-to-edge surgery. Instead, annuloplasty or mitral remodeling can be a standalone procedure. Furthermore, if annuloplasty is insufficient to salvage the diseased heart and leakage appears too severe to be addressed by implanting one or more clips via edge-to-edge repair, an artificial mitral valve can be implanted directly from the annuloplasty or mitral remodeling shape into the implantation of an artificial mitral valve within the anchor and / or stent used for the annuloplasty or mitral remodeling shape.

[0064] 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 relates to all novel and non-obvious features and aspects of the various disclosed embodiments, which are individual and in various combinations and sub-combinations with each other. The methods, apparatuses, and systems are not limited to any particular aspect or feature or combination thereof, and the disclosed embodiments are not claimed to present any one or more specific advantages or solve any one or more specific problems.

[0065] Although some operations in the disclosed embodiments are described in a particular ordered order for ease of presentation, it should be understood that this descriptive method includes rearrangement unless the specific language used below requires a particular order. For example, in some cases, the ordered operations may be rearranged or performed simultaneously. Furthermore, for simplicity, the accompanying drawings may not show various ways in which the disclosed methods can be combined with other methods. Additionally, the invention sometimes uses terms such as “provide” or “implementation” to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation, and will be readily discernible to those skilled in the art.

[0066] Given the many possible embodiments to which the principles of this disclosure can be applied, it should be understood that the illustrated embodiments are merely preferred examples and should not be considered as limiting the scope of this disclosure. Rather, the scope of this disclosure is defined by the appended claims.

Claims

1. A system comprising: The implant is rolled into a coil, including: The upper turn has the diameter of the upper turn. A center turn connected to the upper turn, the center turn defining a center turn diameter, the center turn diameter being larger than the upper turn diameter, and A lower turn connected to the center turn, the lower turn defining a lower turn diameter smaller than the diameter of the center turn; Includes a support structure with an expandable frame; Inflatable balloon; and One or more clamps configured to hold the respective ends of the leaflets of a natural valve together; The coiled implant comprises multiple turns and is configured to be implanted at the natural valve, wherein at least a portion of the central turn of the coiled implant is located in the ventricle of the heart and surrounds the leaflet of the natural valve. The stent is configured to expand within the internal space of the coiled implant and interact with the plurality of turns of the coiled implant; The inflatable balloon is configured to be inflated such that it expands the inflatable frame without contacting the one or more clamps.

2. The system of claim 1, wherein the inflatable balloon has a short length such that the inflatable balloon does not contact the one or more clamps to prevent damage to the one or more clamps when the inflatable balloon inflates and the stent expands.

3. The system of claim 1, wherein the stent is configured to be positioned at a distal location on the inflatable balloon to avoid contact with the one or more clamps.

4. The system of claim 1, wherein the inflatable balloon is bifurcated and configured such that a first portion of the inflatable balloon can pass through a first opening in the natural valve formed by the one or more clamps, and a second portion of the inflatable balloon can pass through a second opening in the natural valve formed by the one or more clamps.

5. The system according to any one of claims 1-4, wherein the internal space is defined by the upper turn, the central turn, and the lower turn of the coiled implant.

6. The system according to any one of claims 1-4, wherein the center turn, the upper turn, and the lower turn are configured such that when radially outward pressure is applied to at least one of the upper turn or the lower turn, the diameter of the center turn is reduced to a smaller diameter.

7. The system of claim 6, wherein the diameter of the center turn, the diameter of the upper turn, and the diameter of the lower turn become substantially equal to the reduced diameter.

8. The system of claim 7, wherein the maximum expansion diameter of the support is at least the same as or greater than the reduced diameter.

9. The system according to any one of claims 1-4, wherein at least one of the upper and lower turns of the coiled implant is configured to be attached to the outer surface of the stent.

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