Device, system, and method with an adaptive leaflet

Abstract

The present invention relates to a device for transcatheter treatment of mitral valve reflux, in particular a coaptation aid element for implantation across the valve; comprising the apposition aid element and an anchor for implantation; comprising the apposition aid element and a delivery catheter; and methods for transcatheter implantation of involution elements across a heart valve.

Description

(19) State Intellectual Property Office (12) Invention Patent Application (10) Application Publication Number (43) Application Publication Date (21) Application Number 202480030129.9 (22) Application Date 2024.05.01 (30) Priority Data 18 / 312,496 2023.05.04 US (85) PCT International Application Entering National Phase Date 2025.11.03 (86) PCT International Application Application Data PCT / US2024 / 027244 2024.05.01 (87) PCT International Application Publication Data WO2024 / 229113 EN 2024.11.07 (71) Applicant: Baolai Ruis Medical Co., Ltd. Address: USA (72) Inventor: Alexander K. Helhahan Roberto de Filippo (74) Patent Agency: China Patent & Trademark Agency Co., Ltd. 11021 Patent Attorney Wen Jie Sun Jiquan (51) Int.Cl. A61F 2 / 24 (2006.01) (54) Invention Title Device, System and Method with Adaptive Leaflets (57) Abstract This invention relates to a device for transcatheter treatment of mitral regurgitation, particularly for an occlusive aid for transvalvular implantation; a system comprising the occlusive aid and an anchor for implantation; a system comprising the occlusive aid and a delivery catheter; and a method for transcatheter implantation of the occlusive aid across a heart valve. Claims 2 pages, Description 126 pages, Drawings 137 pages, CN 121057564 A 2025.12.02 CN 1 21 05 75 64 A 1. An occlusion aid for treating malalignment of heart valves, the occlusion aid comprising: an annular segment configured to lie in the plane of the annulus of the heart valve; a leaflet segment configured to extend from the annular segment; wherein the leaflet segment includes a leaflet frame; wherein the leaflet segment includes a leaflet-side valve body element configured to be forwardly pushed toward the native leaflet during systole and backwardly pushed away from the native leaflet during diastole. 2. The occlusion aid according to claim 1, wherein the leaflet-side valve body element is configured to be forwardly and backwardly pushed relative to the plane of the leaflet frame. 3. The mating aid element of claim 1, wherein the annular segment includes one or more support members extending from the annular hub. 4. The mating aid element of claim 1, wherein the mating aid element further includes one or more support members, wherein the leaflet frame includes one or more additional support members longer than the one or more support members.5. The occlusion assist element of claim 4, wherein the one or more additional supports are connected. 6. The occlusion assist element of claim 4, wherein the one or more additional supports form a V-shape. 7. The occlusion assist element of claim 4, wherein the one or more additional supports include separate distal ends. 8. The occlusion assist element of claim 4, wherein the one or more additional supports include distal ends connected to a laminated or non-invasive material. 9. The occlusion assist element of claim 1, wherein the annular segment includes one or more laminated layers. 10. The occlusion assist element of claim 1, further comprising at least one polymer material layer. 11. The occlusion assist element of claim 1, further comprising at least one biological tissue layer. 12. The occlusion assist element of claim 1, wherein the leaflet frame includes a plurality of laminated layers to restrict movement of the leaflet frame. 13. An occlusion aid for treating malalignment of heart valves, the occlusion aid comprising: an anchoring portion; a leaflet segment configured to extend between opposing leaflets of the heart valve; wherein the leaflet segment includes a leaflet-side valvular body element, wherein the leaflet-side valvular body element is molded in a predetermined curved configuration. 14. The occlusion aid of claim 13, wherein the leaflet-side valvular body element is molded in a convex configuration. 15. The occlusion aid of claim 13, wherein the leaflet-side valvular body element is molded in a concave configuration. 16. The occlusion aid of claim 13, wherein the leaflet-side valvular body element is molded in a mixed convex-concave configuration. 17. A method for treating malalignment of a heart valve, the method comprising: positioning an occlusion aid relative to the heart valve, the occlusion aid comprising: a leaflet segment configured to extend across a valve plane; wherein the leaflet segment includes a leaflet-side valvular body element; wherein the leaflet-side valvular body element functions as an autologous leaflet during a cardiac cycle. 18. The method of claim 17, wherein the leaflet-side valvular body element includes a predetermined bending configuration to optimize the performance of the leaflet-side valvular body element during the cardiac cycle. 19. The method of claim 17, wherein the leaflet segment provides a non-invasive surface to protect surrounding tissue that can contact the leaflet segment. 20. The method of claim 17, wherein the occlusion aid is provided for anchoring the occlusion aid to one or more sites of tissue.21. The method of claim 17, wherein the occlusion assist element provides a seal between the occlusion assist element and the annulus of the heart valve. 22. An occlusion assist element for treating malalignment of a heart valve, the occlusion assist element comprising: an annular segment including an annular hub; a leaflet segment; an interface between the annular segment and the leaflet segment; wherein the leaflet segment includes a valve body element with leaflets juxtaposed at the interface. 23. The occlusion assist element of claim 22, further comprising a support extending from the annular hub to a lower edge. 24. The occlusion assist element of claim 22, further comprising a support extending from the annular hub to a lateral edge. 25. The occlusion assist element of claim 22, further comprising a support forming a ring from the annular hub to the lower edge and back to the annular hub. 26. The occlusion assist element of claim 22, further comprising one or more supports enclosed in the pericardium. 27. The mating aid of claim 22, further comprising one or more supports wrapped with ePTFE. 28. The mating aid of claim 22, further comprising one or more supports wrapped with tubing. 29. The mating aid of claim 22, further comprising sutures for connecting the supports along the lower edge. 30. The mating aid of claim 22, further comprising sutures for connecting the supports along the interface. 31. The mating aid of claim 22, further comprising an ePTFE laminate only on the annular segment. 32. The mating aid of claim 22, further comprising an ePTFE laminate at the interface. 33. The mating aid of claim 22, further comprising a suture boundary at the interface. Claims 2 / 2 Page 3 CN 121057564 A Device, System, and Method with Adaptive Leaflets

[0001] Cross-Reference to Related Applications

[0002] This application claims priority to U.S. Application No. 18 / 312496, filed May 4, 2023, the entire contents of which are incorporated herein by reference.

[0003] Background Art

[0004] This disclosure generally provides improved medical devices, systems, and methods for treating valvular heart disease and / or for altering the characteristics of one or more valves in the body.

[0005] The human heart receives blood from organs and tissues via veins, pumps the blood through the lungs, where the blood becomes oxygen-rich and propels the oxygenated blood away from the heart to arteries so that the body's organ systems can extract oxygen for appropriate function. The deoxygenated blood flows back to the heart, where it is pumped again to the lungs.

[0006] The heart comprises four chambers: the right atrium (RA), the right ventricle (RV), the left atrium (LA), and the left ventricle (LV). The pumping action of the left and right sides of the heart generally occurs synchronously during the total cardiac cycle.

[0007] The heart has four valves, which are typically configured to selectively deliver blood flow in the correct direction during the cardiac cycle. The valve that separates the atria from the ventricles is called the atrial-ventricular (AV) valve. The AV valve between the left atrium and left ventricle is the mitral valve. The AV valve between the right atrium and right ventricle is the tricuspid valve. The pulmonary valve directs blood flow to the pulmonary artery and from there to the lungs; blood returns to the left atrium via the pulmonary veins. The aortic valve directs blood flow through the aorta and from there to the periphery. There is usually no direct connection between the ventricles or between the atria.

[0008] The mechanical heartbeat is triggered by electrical impulses propagating throughout the heart tissue. The opening and closing of heart valves can occur primarily due to pressure differentials between chambers, generated by passive filling or chamber contraction. For example, the opening and closing of the mitral valve can occur due to pressure differentials between the left atrium and left ventricle.

[0009] At the onset of ventricular filling (diastole), the aortic and pulmonary valves close to prevent backflow from the arteries into the ventricles. Immediately thereafter, the AV valves open to allow unimpeded flow from the atria into the corresponding ventricles. Immediately after the onset of ventricular contraction (i.e., ventricular emptying), the tricuspid and mitral valves normally close, forming a seal that prevents backflow from the ventricles into the corresponding atria.

[0010] Unfortunately, AV valves may be damaged or may not function properly, resulting in abnormal closure. AV valves are complex structures, typically comprising annulus, leaflets, chordae, and supporting structures. Each atrium is connected to its valve via the atrial vestibule. The mitral valve has two leaflets; the tricuspid valve has a similar structure with three leaflets, and the juxtaposition or engagement of the corresponding surfaces of the leaflets facing each other helps to provide closure or sealing of the valve, thereby preventing blood from flowing in the wrong direction. Failure of the leaflets to seal during ventricular systole is called malcoaptation and may allow blood to flow back through the valve (regurgitation). Heart valve regurgitation can have serious consequences for patients, typically leading to heart failure, reduced blood flow, hypotension, and / or reduced oxygen flow to body tissues. Mitral regurgitation can also cause blood to flow back from the left atrium into the pulmonary veins, leading to congestion. Severe valvular regurgitation, if left untreated, can lead to permanent disability or death. [Instructions for Use 1 / 126 pages 4 CN 121057564 A] Background Art

[0011] Various therapies have been applied to treat mitral regurgitation, and other therapies are still being proposed but not yet practically used to treat patients. While several known therapies have been found to provide benefit to at least some patients, further research is still needed.Choices of treatment. For example, medications such as diuretics and vasodilators can be used in patients with mild mitral regurgitation to help reduce the amount of blood returning to the left atrium. However, drug therapy may lack patient adherence. Many patients may occasionally (or even regularly) fail to take medication despite the potential severity of chronic and / or worsening mitral regurgitation. Pharmacological treatment of mitral regurgitation can also be inconvenient, often ineffective (especially as the condition worsens), and may be associated with serious side effects such as hypotension.

[0012] Various surgical options have also been proposed and / or used to treat mitral regurgitation. For example, open-heart surgery can replace or repair a dysfunctional mitral valve. In annuloplasty annulus repair, the posterior mitral annulus can be reduced in size along its circumference, optionally using sutures that pass through the mechanically operated annuloplasty suture ring to provide coaptation. Open surgery may also attempt to reshape the leaflets and / or modify the supporting structures. In any case, open mitral valve surgery is generally a very invasive procedure performed on a cardiopulmonary bypass machine while the patient is under general anesthesia and the chest cavity is opened. Complications can be common, and given the morbidity (and potential mortality) of open-heart surgery, scheduling becomes problematic—more seriously ill patients may desperately need surgery but are less able to withstand it. Successful open mitral valve surgery outcomes can also be highly dependent on surgical skill and experience.

[0013] Given the morbidity and mortality of open-heart surgery, innovators have explored less invasive surgical approaches. Methods using robots or via endoscopy are generally still quite invasive and can also be time-consuming, expensive, and, at least in some cases, highly dependent on the surgeon's skill. It would be ideal to subject these sometimes frail patients to even less trauma, and equally ideal would be to provide such a procedure that can be successfully performed by a large number of physicians using varying techniques. To this end, several techniques and methods that are claimed to be less invasive have been proposed. These include devices that attempt to reshape the mitral valve annulus from within the coronary sinus; devices that attempt to reshape the valve annulus by tightening the autologous valve annulus from top to bottom; devices for fusing the valve leaflets (mimicking the Alfieri suture); devices for reshaping the left ventricle, etc.

[0014] A variety of mitral valve replacement implants have been developed, which typically replace (or substitute) the autologous valve leaflets and rely on surgically implanted structures to control the blood flow path between the heart chambers. While these diverse methods and tools meet varying levels of affirmation, none has yet been widely recognized as the ideal treatment for most or all patients suffering from mitral regurgitation.

[0015] Due to the known challenges and drawbacks of minimally invasive mitral regurgitation therapies and implants, alternative treatments are still being proposed. Some alternative proposals require the implanted structure to remain within the valve annulus throughout the entire cardiac cycle. One group of these proposals includes cylindrical balloons, etc., which are held in place on a cord or rigid bar extending between the atrium and ventricle through the valve opening. Another group relies on arched ring structures, etc., typically combined with an arch (buttress) or structural transverse member extending through the valve to anchor the implant. Unfortunately, sealing between the autologous leaflet and the entire periphery of the balloon or other coaxial body can prove challenging, and significant contraction around the autologous valve annulus during each heartbeat can lead to significant fatigue failure of tissue during long-term implantation if the arch or interlocking transverse member is bent. Furthermore, significant movement of valve tissue can make accurate positioning of the implant difficult, regardless of whether the implant is rigid or flexible.

[0016] In view of the above, it is desirable to provide improved medical devices, systems, and methods. Particularly desirable are new techniques for treating mitral regurgitation and other valvular heart diseases, and / or for altering the characteristics of one or more of the body's other valves. There remains a need for devices that can directly enhance leaflet occlusion (rather than indirectly via the annulus or ventricular reshaping) and without disrupting leaflet anatomy through fusion or other means, yet can be deployed simply and reliably without excessive cost or surgical time. It will be particularly advantageous that these new techniques can be implemented using less invasive methods without requiring cardiac arrest or reliance on a cardiopulmonary bypass machine for deployment, and without relying on the surgeon's exceptional skill, thereby providing improved valve and / or cardiac function. Summary of the Invention

[0017] This disclosure generally provides improved medical devices, systems, and methods. New occlusion assist elements, systems, and methods for treating mitral regurgitation and other valvular diseases are disclosed. The occlusion assist element can be maintained within the blood flow path as the valve moves back and forth between an open valve configuration and a closed valve configuration. The occlusion assist element can be a thin, elongated (along the blood flow path), and / or conforming structure that extends laterally through some, most, or all of the valve opening width, allowing occlusion between at least one of the autologous leaflets and the occlusion assist element. The device described herein can be used with any valve in the human body, including valves with two or three leaflets.

[0018] In some embodiments, an advantage is the ability to retract the occlusion assist element. In some embodiments, the occlusion assist element has a single anchor that can engage or disengage from tissue. In some embodiments, the anchor is captured within an annular hub of the occlusion assist element. In some embodiments, the captured anchor is removed simultaneously with the removal of the occlusion assist element.In some embodiments, the occlusion aid may include a secondary anchor. In some embodiments, the occlusion aid may include a passive anchor. In some embodiments, engagement of the anchor with tissue involves arranging one or more passive anchors to engage with the tissue. In some embodiments, an advantage is the ability to retract the occlusion aid during the procedure. In some embodiments, the occlusion aid may be rearranged during the surgical procedure. In some embodiments, the occlusion aid may be removed from the patient during a subsequent surgical procedure. In some embodiments, the occlusion aid may be replaced by another device during a subsequent surgical procedure. In some embodiments, a single annular anchor facilitates the ability to retract the occlusion aid. In some embodiments, the position of the annular anchor facilitates the ability to retract the occlusion aid. In some embodiments, the ability to collapse the occlusion aid using a purse-string suture, as described herein, facilitates the ability to retract the occlusion aid.

[0019] In some embodiments, an advantage is the connection between the occlusion aid and the delivery catheter. In some embodiments, the occlusion aid includes an annular hub having features for engaging the delivery catheter. In some embodiments, the occlusion aid and the delivery catheter are detachably coupled such that the occlusion aid can be released from the delivery catheter during the procedure. In some embodiments, after the occlusion aid is released from the delivery catheter, one or more substructures connect the occlusion aid and the delivery catheter. In some embodiments, one or more substructures include a purse-shaped drawstring suture as described herein. In some embodiments, one or more substructures facilitate the collapse and / or deployment of the occlusion aid. In some embodiments, the occlusion aid and the delivery catheter are rotated and fixed relative to each other during connection. In some embodiments, relative movement of the delivery catheter causes movement of the occlusion aid.

[0020] In some embodiments, an advantage is that the occlusion aid can be delivered using a hub-guided orientation. In some methods of use, the annular hub can be moved into position relative to the anatomical structure. In some methods of use, the ventricular end of the occlusion aid can be held within the delivery catheter until the annular hub is positioned. In some methods of use, the occlusion aid can be deployed once the annular hub and / or annular anchors engage with the tissue. In some methods of use, the ventricular end of the occlusion aid can be positioned once the annular hub and / or annular anchors engage with the tissue.

[0021] In some embodiments, an advantage is that the occlusion aid can be delivered using a support-guided orientation. In this method of use, one or more of the support members of the mating auxiliary element can be moved to the front end before the arrangement of the annular hub. (See page 3 / 126 of the specification, CN 121057564 A)In the location of the anatomical structure. In some methods of use, the occlusion aid element may be deployed or partially deployed before engagement of the annular anchor. In some methods of use, the annular hub may be held within the delivery conduit until one or more of the supports are arranged. In some methods of use, the annular anchor may engage with the tissue once the supports are arranged.

[0022] In some embodiments, an advantage is that the annular anchor can rotate independently of the occlusion aid element. As described herein, the occlusion aid element is coupled to a portion of the delivery conduit. As described herein, the annular anchor is coupled independently to another portion of the delivery conduit, such as a drive provided with the delivery conduit. The annular anchor can rotate independently of the annular hub. The annular hub can remain fixed when the annular anchor is rotated to engage the tissue. The annular anchor can be driven into the tissue while the delivery conduit holds the position of the annular hub.

[0023] In some embodiments, an advantage is the ability to collapse the occlusion aid element. In some embodiments, the occlusion aid element is fully collapsed. The fully collapsed configuration can be an insertion configuration or a low-profile configuration. In some embodiments, the occlusion aid element is partially collapsed. A partially collapsed configuration can be a partially deployed configuration. A partially collapsed configuration allows for selective deployment of the occlusion aid within the heart. A partially collapsed configuration allows the occlusion aid to be moved to a position within the heart. The configuration of the occlusion aid can be monitored, for example, by imaging, to ensure proper deployment. In some embodiments, one or more pocket-mouth pull cord sutures or portions thereof are tightened to collapse or partially collapse the occlusion aid. In some embodiments, a partially collapsed configuration may allow rotation of the occlusion aid. In some embodiments, a fully collapsed configuration may allow rotation of the occlusion aid. In some embodiments, the occlusion aid may rotate together with the delivery catheter or portions thereof. In some embodiments, the occlusion aid may rotate about a central location, such as an annular hub.

[0024] In some embodiments, an advantage is the ability to deploy the occlusion aid. In some embodiments, one or more pocket-mouth pull cord sutures or portions thereof are loosened to deploy the occlusion aid. In some embodiments, loosening the pocket-mouth pull cord sutures allows one or more supports to take an intermediate configuration. In some embodiments, loosening the pocket-mouth pull cord sutures allows one or more supports to take a pre-shaped curve. In some embodiments, one or more support members comprise NiTi. In some embodiments, the pocket-mouth pull-tab suture can be repeatedly tightened and / or loosened. In some embodiments, the pocket-mouth pull-tab suture is captured within the occlusal aid element. In some embodiments, the pocket-mouth pull-tab suture is tightened to remove the occlusal aid element from the patient. In some embodiments, the pocket-mouth pull-tab suture is loosened to allow...The occlusion assist element is deployed within the patient's heart. In some embodiments, a pocket-shaped suture can be selectively deployed to expand a portion of the occlusion assist element while another portion remains collapsed or partially collapsed.

[0025] In some embodiments, an advantage is the ability to adjust the occlusion assist element. In some embodiments, the occlusion assist element may be supported by a central location. In some embodiments, the central location is an anchor. In some embodiments, the central location is a hub. In some embodiments, the hub and / or anchor are typically located near the midpoint of the diameter of the occlusion assist element. In some embodiments, the hub and / or anchor are typically located near the midpoint and / or central location of the annular segment of the occlusion assist element. In some embodiments, the occlusion assist element may be supported in a central location. In some embodiments, the occlusion assist element can be rotated by rotating a delivery catheter connected to the annular hub. In some embodiments, the occlusion assist element can be moved longitudinally by a corresponding longitudinal movement of the delivery catheter connected to the annular hub.

[0026] In some embodiments, an advantage is that the occlusion assist element can be held in place by the delivery catheter after deployment. In some embodiments, the occlusion assist element may be fully deployed within the mitral valve but still tethered to the delivery catheter. In some embodiments, the occlusive aid element can be adjusted after it is fully deployed within the mitral valve. In some embodiments, the occlusive aid element can be rotated about the hub after it is fully deployed. In some embodiments, the anchor can be detached from and / or re-engaged with the tissue after it is fully deployed. In some embodiments, the purse-mouth pull-off suture can collapse and / or unfold after it is fully deployed. In some embodiments, the occlusive aid element can be recaptured after it is fully deployed. In some embodiments, the occlusive aid element can be removed after it is fully deployed.

[0027] In some embodiments, an advantage is that the occlusive aid element does not require ventricular attachment. In some embodiments, the occlusive aid element only requires annular attachment. In some embodiments, the occlusive aid element only requires annular anchor attachment via annular hub and annular barbs. In some embodiments, the occlusive aid element only requires annular anchor attachment via annular hub and annular barbs. In some embodiments, the mating auxiliary element requires only the attachment of the annular anchor via the annular hub, the petal barb, and / or the mating barb.

[0028] In some embodiments, an advantage is a radially extending frame. In some embodiments, the frame includes an annular hub and one or more struts. In some embodiments, the struts extend radially from the annular hub. In some embodiments, the frame is composed of...The frame is constructed from a single planar sheet of material. In some embodiments, the frame is precisely cut using water jetting, laser etching, or similar techniques. In some embodiments, the frame is constructed by forming an annular hub with the edges of the frame. In some embodiments, the planar sheet of material is formed into a ring, which becomes the annular hub. In some embodiments, the support material is bent into a desired configuration. In some embodiments, the support material is uniformly spaced around the circumference of the annular hub. In some embodiments, the support material is non-uniformly spaced around the circumference of the annular hub. In some embodiments, the support material extending along a portion of the circumference of the annular hub differs from the support material extending along another portion of the circumference of the annular hub. In some embodiments, one or more designated portions of the support material are designed to be placed near the annular region of the heart. In some embodiments, one or more designated portions of the support material are designed to be placed near the commissural region of the heart. In some embodiments, one or more designated portions of the support material are designed to be placed near the ventricular region of the heart. In some embodiments, the radially outward support material of the frame does not intersect. In some embodiments, the radially outward support material of the frame does not form a mesh. In some embodiments, the radially outward support material of the frame extends along a line from the hub to the edge of the commissural auxiliary element. In some embodiments, the radially outward frame support has a sharp edge. In some embodiments, the sharp edge extends along a straight line originating from the edge of the mating auxiliary element. In some embodiments, the sharp edge is integrally formed within the support. In some embodiments, the radially outward frame support has one or more radii of curvature. In some embodiments, the radially outward frame support along the length of the support can be concave or convex or both. In some embodiments, the radially outward frame support has one or more inflection points.

[0029] In some embodiments, an advantage is the curvature of the frame. In some embodiments, the annular hub extends radially. In some embodiments, the annular hub extends away from the valve annulus from the mating auxiliary element. In some embodiments, the annular hub extends above the plane of the support from the surface of the mating auxiliary element. In some embodiments, the edge of the mating auxiliary element is curved. In some embodiments, one or more supports can be laterally curved from the annular hub toward the upper edge. In some embodiments, the upper edge of the mating auxiliary element can be curved upward from the valve annulus. In some embodiments, the upper edge of the mating auxiliary element can be curved upward from the rear valve leaflet. In some embodiments, the upper edge of the mating auxiliary element can be curved downward toward the valve annulus. In some embodiments, the upper edge of the occlusion assist element may be bent downward toward the posterior leaflet. In some embodiments, one or more support members may be bent laterally toward the lower edge from the annular hub. In some embodiments, the lower edge of the occlusion assist element may be bent away from the posterior leaflet. In some embodiments, the lower edge of the occlusion assist element may be bent toward the posterior leaflet.

[0030] In some embodiments, an occlusion assist element is provided for treating malalignment of heart valves. Heart valvesIt has a valve annulus. The occlusion assist element may include a body comprising an annular segment and an occlusion segment. In some embodiments, the annular segment is configured to be implanted in the heart above the valve annulus. In some embodiments, the occlusion segment is configured to be implanted in the heart and traverse the plane of the valve annulus. The occlusion assist element may include a first occlusion surface and an opposite second occlusion surface. In some embodiments, each surface is limited by a first lateral edge, a second lateral edge, a lower edge, and an upper edge. In some embodiments, the upper edge forms a lip and is cup-shaped downward toward the lower edge or cup-shaped upward from the annular segment. The occlusion assist element may include a hub and an anchor connected to the hub and supported by the annular segment. In some embodiments, the anchor may be selectively deployed at a first target location. The occlusion assist element may include a plurality of struts extending radially outward from the hub. In some embodiments, the plurality of supports includes at least a first support located within an annular section and a second support extending from the annular section to an engagement section, wherein the second support has a total length longer than the total length of the first support, such as, for example, about or at least about 110%, 120%, 130%, 140%, 150%, 160%, 170%, 180%, 190%, 200%, 225%, 250% or more of the total length of the first support. In some embodiments, the total length of the second support is about 125% to about 300%, or about 125% to 200% of the total length of the first support.

[0031] In some embodiments, at least one of the plurality of supports has a sharp tip configured to engage the tissue. In some embodiments, the plurality of supports comprises Nitinol. In some embodiments, the anchor is helical. The engagement aid element may include one or more additional anchors. In some embodiments, the one or more additional anchors are active anchors. In some embodiments, the hub includes a cross pin configured to extend through the helix of the anchor. In some embodiments, the hub is configured to mate with a delivery conduit, wherein the delivery conduit is configured to position the hub near the first target location. In some embodiments, the delivery conduit is configured to allow the anchor to rotate independently of the hub. The occlusion aid may include radiopaque markers. The occlusion aid may include a plurality of radiopaque markers near the upper edge. In some embodiments, the upper edge forming the lip is cup-shaped downwards towards the lower edge. In some embodiments, the upper edge forming the lip is cup-shaped upwards from the annular segment. In some embodiments, the hub extends upwards from the annular segment. In some embodiments, the lower edge curves backwards towards the hub.

[0032] In some embodiments, a method for treating malalignment of a patient's heart valves is provided. The heart valves haveThere is a valve annulus. The valve annulus also defines a valve plane that separates the proximal atrium and the distal ventricle. The method includes engaging a delivery catheter with the hub of an occlusion aid. The method may include positioning the hub near the valve annulus. The method may include rotating an anchor through the hub and into cardiac tissue distal to the valve annulus. The method may include deploying the occlusion aid by radially deploying a plurality of supports outward from the hub.

[0033] In some embodiments, the occlusion aid is suspended such that the occlusion surface occludes with a first leaflet, and the leaflet surface of the occlusion aid covers a second leaflet to mitigate malalignment. The method may include engaging the sharp tip of one of the plurality of supports with cardiac tissue distal to the valve annulus. The method may include monitoring the position of the occlusion aid using one or more markers. The method may include monitoring the position of the occlusion aid using a plurality of markers near the upper edge of the occlusion aid. In some embodiments, the tip of the anchor is recessed into the hub during positioning of the hub near the valve annulus.

[0034] In some embodiments, an occlusion assist element is provided for treating malalignment of heart valves. The occlusion assist element may include a first occlusion surface and an opposite second surface. The occlusion assist element may include a first lateral edge, a second lateral edge, a lower edge, and an upper edge. The occlusion assist element may include an upper region and a lower region. In some embodiments, the upper region is configured to lie in the plane of the annulus of the heart valve. In some embodiments, the lower region includes the first occlusion surface and the opposite second surface. In some embodiments, the lower region includes a laminated layer such that the thickness of the lower region is greater than the thickness of a portion of the upper region.

[0035] In some embodiments, the laminated layer includes ePTFE. In some embodiments, the thickness of the lower region is at least about 25% greater than the thickness of a portion of the upper region. In some embodiments, the thickness of the lower region is at least about 50% greater than the thickness of a portion of the upper region. In some embodiments, the peripheral edge of the occlusion assist element includes a non-invasive edge that only partially surrounds a protrusion of the occlusion assist element. In some embodiments, the peripheral edge of the occlusion assist element includes a non-invasive edge that only surrounds a protrusion of the lower region of the occlusion assist element. In some embodiments, the raised edge includes a stitch. In some embodiments, the outer peripheral edge of the mating aid element includes spaced barbs extending radially outward only from the outer peripheral edge of the upper region of the mating aid element. The mating aid element may include hubs spaced inwardly from each of a first lateral edge, a second lateral edge, a lower edge, and an upper edge. The mating aid element may include an active anchor configured to engage with the hub and configured to rotate relative to the hub to selectively deploy the active anchor at a first target location.The occlusion assist element may include a plurality of supports spaced apart around a hub and extending outwardly from the hub, the plurality of supports including at least a first support and a second support, the first support being configured to be implanted in the heart, the second support being configured to be implanted in the heart such that a first occlusion surface engages with a first leaflet of the heart valve, while an opposite second surface covers a second leaflet of the heart valve. In some embodiments, the occlusion assist element includes a mesh layer.

[0036] In some embodiments, an occlusion assist element delivery system for treating malalignment of a heart valve is provided. In some embodiments, the heart valve has a valve annulus. The occlusion assist element delivery system may include an occlusion assist element including a first surface and an opposite second surface. In some embodiments, each surface is defined by a first lateral edge, a second lateral edge, a lower edge, and an upper edge. The occlusion assist element may include a hub. The occlusion assist element delivery system may include a main anchor disposed within a main anchor housing. In some embodiments, the main anchor is configured to extend through the hub to engage the valve annulus. The mating auxiliary component delivery system may include release lines extending through the main anchor housing and configured to be positioned adjacent to the lobe annulus.

[0037] The mating auxiliary component delivery system may include a main anchor actuator disposed within the main anchor housing. In some embodiments, the main anchor actuator is configured to rotate relative to the main anchor housing but not translate. In some embodiments, the main anchor actuator includes two extensions configured to engage a crossbar of the main anchor. The mating auxiliary component delivery system may include two release lines extending through the main anchor housing. In some embodiments, the two release lines are configured to be positioned adjacent to the lobe annulus and extend from the hub in opposite directions. In some embodiments, the two release lines intersect. The mating auxiliary component delivery system may include secondary anchor bolts extending through the mating auxiliary component. In some embodiments, the secondary anchor bolts extend around the release lines. The mating auxiliary component delivery system may include at least two secondary anchor bolts extending through the mating auxiliary component. In some embodiments, at least two secondary anchor bolts extend around the release lines. In some embodiments, at least one secondary anchor bolt member extends about a release line, and at least one secondary anchor bolt member extends about a second release line. The mating auxiliary element delivery system may include a secondary anchor bolt guide. In some embodiments, the secondary anchor bolt guide is configured to lock a secondary anchor bolt driver to a secondary anchor bolt. In some embodiments, the secondary anchor bolt guide is configured to prevent entanglement between the secondary anchor bolt and adjacent secondary anchor bolt members. In some embodiments, the secondary anchor bolt guide is configured to slide along a secondary anchor bolt member to deliver the secondary anchor bolt. The mating auxiliary element delivery system may include a secondary anchor bolt driver. In some embodiments, the secondary anchor bolt driver includes at least one secondary anchor bolt member.One locking tab is missing, and the at least one locking tab is configured to engage the window of the secondary anchor. The mating auxiliary element delivery system may include a secondary anchor. In some embodiments, the secondary anchor is configured to be delivered by causing the secondary anchor along a secondary anchor bolt attached to a release line. In some embodiments, the secondary anchor is configured to rotate to engage the petal ring. In some embodiments, the secondary anchor has a smaller diameter than the primary anchor. In some embodiments, the release line is configured to be retracted after the primary anchor engages the petal ring. In some embodiments, the release line is configured to be retracted after the primary anchor and at least one secondary anchor engage the petal ring. In some embodiments, the primary anchor housing is configured to be retracted after the release line is retracted, wherein the primary anchor driver is retracted together with the primary anchor housing. In some embodiments, the primary anchor's track passes through a hub. In some embodiments, a cross pin of the hub is configured to engage the primary anchor to the mating auxiliary element. In some embodiments, at least one secondary anchor is configured to have two or more tracks. In some embodiments, the track of at least one secondary anchor is determined by the orientation of a corresponding secondary anchor guide. In some embodiments described on page 7 / 126 of document 10 CN 121057564 A, the sub-anchor guide rail includes a curved distal end, wherein the curved distal end defines a trajectory. The mating auxiliary element delivery system may include a proximal assembly configured to lock the sub-anchor guide rail relative to the sub-anchor to prevent entanglement of the sub-anchor tether. The mating auxiliary element delivery system may include a proximal assembly configured to lock the sub-anchor guide rail relative to the sub-anchor driver to facilitate engagement of the sub-anchor driver to the sub-anchor. The mating auxiliary element delivery system may include a proximal assembly configured to lock the position of the sub-anchor tether, wherein the sub-anchor tether is coupled to a release line. The mating auxiliary element delivery system may include a proximal assembly configured to lock the position of the sub-anchor tether to apply tension to the sub-anchor tether, thereby defining the trajectory of the sub-anchor. The mating auxiliary element delivery system may include an anti-rotation feature. In some embodiments, the sub-anchor includes an anti-rotation feature.

[0038] In some embodiments, an occlusion assist element is provided for treating malalignment of heart valves. In some embodiments, the heart valve has a valve annulus. The occlusion assist element may include a first surface and an opposite second surface, each surface being defined by a first lateral edge, a second lateral edge, a lower edge, and an upper edge. The occlusion assist element may include a hub. The occlusion assist element may include a plurality of supports spaced apart around the hub and extending outwardly from the hub, the plurality of supports including at least a first support and a second support, the first support being configured in the valve annulus.The second support is implanted into the heart above, and is configured to be implanted into the heart and pass through the plane of the valve annulus.

[0039] In some embodiments, the occlusion assist element includes at least one layer of ePTFE. In some embodiments, the occlusion assist element includes at least one layer of mesh. In some embodiments, the occlusion assist element includes at least one layer of UHMWPE mesh. In some embodiments, the occlusion assist element includes at least one layer of fabric. In some embodiments, the occlusion assist element includes at least one layer of polyester fabric. In some embodiments, the first surface is reinforced. In some embodiments, the second surface is reinforced. In some embodiments, the ventricular surface is reinforced. In some embodiments, the occlusion surface is reinforced. In some embodiments, the anchoring region is reinforced. In some embodiments, at least one edge includes a raised edge. In some embodiments, the occlusion assist element is configured to minimize contact with the posterior leaflet. In some embodiments, the occlusion assist element is configured to engage the valve and be embedded in the valve annulus.

[0040] In some embodiments, a method of delivering an occlusion assist element is provided. The method may include delivering the occlusion assist element to a patient's heart. In some embodiments, the occlusion assist element is coupled to an occlusion assist element delivery system. In some embodiments, the occlusion assist element delivery system includes a main anchor disposed within a main anchor housing. In some embodiments, the occlusive aid delivery system includes at least one release line. The method may include deploying the occlusive aid within the heart. The method may include anchoring the occlusive aid to the annulus of a heart valve by rotating a primary anchor.

[0041] The method may include rotating a primary anchor driver within a primary anchor housing. In some embodiments, the at least one release line is coupled to the primary anchor housing and extends below the occlusive aid when the occlusive aid is deployed. In some embodiments, when the occlusive aid is deployed, at least one secondary anchor tether extends through the occlusive aid. In some embodiments, when the occlusive aid is deployed, at least one secondary anchor tether surrounds at least one release line. In some embodiments, the occlusive aid is delivered in an inconspicuous configuration. In some embodiments, the at least one release line is configured to maintain the position of the primary anchor housing relative to the occlusive aid. In some embodiments, the at least one release line is configured to maintain the position of at least one secondary anchor tether relative to the occlusive aid. In some embodiments, the occlusive aid is delivered via a delivery catheter. In some embodiments, the telescopic action is configured to position the engagement auxiliary element relative to the position where the main anchor engages the petal annulus. The method may include rotating the main anchor to engage the petal annulus. The method may include rotating a main anchor actuator within the main anchor housing, wherein the main anchor actuator is configured to rotate relative to the main anchor housing but not translate. This method is described on page 8 / 126 of the specification.11 CN 121057564 A includes sliding a secondary anchor assembly along a secondary anchor tether toward the valve annulus. The method may include maintaining engagement between the secondary anchor driver and the secondary anchor with a secondary anchor guide. The method may include preventing entanglement between the secondary anchor and the secondary anchor tether with a secondary anchor guide. The method may include coupling the secondary anchor driver to the secondary anchor. The method may include partially retracting the secondary anchor guide before the secondary anchor engages with tissue. The method may include retracting the secondary anchor guide after the secondary anchor engages with tissue. The method may include retracting the secondary anchor driver after retracting the secondary anchor guide. The method may include retracting the at least one release line.

[0042] In some embodiments, an occlusion aid element is provided for treating malalignment of a heart valve having a valve annulus. The occlusion aid element may include a first occlusion surface and an opposite second surface, each surface being defined by a first lateral edge, a second lateral edge, a lower edge, and an upper edge. The occlusion aid element may include a hub. The occlusion aid may include an anchor attached to the hub and configured to rotate relative to the hub to selectively deploy the anchor at a first target location. The occlusion aid may include a plurality of supports spaced apart from and extending outward from the hub. In some embodiments, the plurality of supports includes at least a first support and a second support, the first support being configured to be implanted in the heart above the valve annulus, and the second support being configured to be implanted in the heart and pass through the plane of the valve annulus.

[0043] In some embodiments, the second support has a total length longer than the total length of the first support. In some embodiments, the hub is radially spaced inward from each of a first lateral edge, a second lateral edge, a lower edge, and an upper edge. In some embodiments, the plurality of supports are spaced apart circumferentially around the hub. In some embodiments, the upper edge forms a lip, the lip being cup-shaped downward toward the lower edge or cup-shaped upward from the lower edge. In some embodiments, at least one of the plurality of supports has a sharp tip configured to engage tissue. In some embodiments, the plurality of supports comprises nitinol. In some embodiments, the anchor is helical. The occlusion aid may include one or more additional anchors. In some embodiments, one or more additional anchors are active anchors. In some embodiments, the hub includes a transverse pin configured to extend through a helical structure of the anchor. In some embodiments, the hub is configured to mate with a delivery conduit, wherein the delivery conduit is configured to position the hub near the first target location. In some embodiments, the delivery conduit is configured to allow the anchor to rotate independently of the hub. The mating aid element may include radiopaque markers. The mating aid element may include a plurality of radiopaque markers near the upper edge. In some embodiments, the lip is oriented downwards toward the lower edge.Cup-shaped. In some embodiments, the lip is cup-shaped from the lower edge upwards. In some embodiments, the hub extends upwards from the first mating surface. In some embodiments, the lower edge bends rearward toward the hub. In some embodiments, the hub is tubular. In some embodiments, the support and the hub are integrally formed. In some embodiments, the mating aid element is configured to collapse relative to the hub. In some embodiments, the active anchor is configured to selectively engage and disengage with tissue.

[0044] In some embodiments, a mating aid element for treating poor mating of a heart valve having a valve annulus is provided. The mating aid element may include a first mating surface and an opposite second surface. In some embodiments, each surface is defined by a first lateral edge, a second lateral edge, a lower edge, and an upper edge. The mating aid element may include a hub. The mating aid element may include an anchor coupled to the hub. In some embodiments, the anchor is configured to rotate in a first direction to selectively deploy an active anchor to engage tissue. In some embodiments, the active anchor is configured to rotate in a second direction opposite to the first direction to selectively disengage from tissue. The mating aid element may include a plurality of supports spaced apart around the hub. In some embodiments, the plurality of supports includes at least a first support and a second support, the first support being configured to be implanted in the heart above the valve annulus, and the second support being configured to be implanted in the heart and pass through the plane of the valve annulus.

[0045] In some embodiments, an occlusion assist element is provided for treating malalignment of heart valves. In some embodiments, the heart valve has a valve annulus, an anterior leaflet, and a posterior leaflet. The occlusion assist element may include a first occlusion surface and an opposite second surface. In some embodiments, each surface is defined by a first lateral edge, a second lateral edge, a lower edge, and an upper edge. The occlusion assist element may include a hub. The occlusion assist element may include an anchor attached to the hub and configured to rotate relative to the hub to selectively deploy the anchor at a first target location. In some embodiments, the anchor is configured to selectively deploy within the annulus. The occlusion assist element may include a plurality of supports spaced apart around the hub. In some embodiments, the plurality of supports includes at least a first support and a second support, the first support being configured to be implanted in the heart above the valve annulus, and the second support being configured to be implanted in the heart and pass through the plane of the valve annulus.

[0046] In some embodiments, an occlusion assist element delivery system is provided for treating malalignment of a heart valve having a valve annulus. The occlusion assist element delivery system may include an occlusion assist element comprising a first surface and an opposite second surface. In some embodiments, each surface is defined by a first lateral edge, a second...Lateral edge, lower edge, and upper edge define the elements. In some embodiments, the mating aid element includes a hub. The mating aid element delivery system may include a first anchor disposed within a first anchor housing. In some embodiments, the first anchor is configured to extend through the hub to engage the petal annulus. The mating aid element delivery system may include a release line extending through the first anchor housing and configured to be positioned adjacent to the petal annulus.

[0047] In some embodiments, the mating aid element delivery system may include a radiopaque marker. In some embodiments, the mating aid element delivery system may include a second anchor fastener extending through the mating aid element and surrounding the release line. In some embodiments, the radiopaque marker is pressed against the second anchor fastener. In some embodiments, the radiopaque marker is configured to visually confirm the anchoring depth of the second anchor. In some embodiments, the mating aid element delivery system may include a second anchor. In some embodiments, the second anchor includes a first helical portion having a first pitch and a second helical portion having a smaller second pitch. In some embodiments, the second helical portion is configured to lock with the mating aid element. In some embodiments, the second anchor includes a locking segment and an anchoring segment, the locking segment having a smaller pitch compared to the anchoring segment. In some embodiments, the second anchor is configured to be conveyed by sliding the second anchor along a second anchor tie member surrounding a release line. In some embodiments, the second anchor is configured to be conveyed by sliding the second anchor along a second anchor guide, wherein the second anchor guide guides the trajectory of the second anchor. In some embodiments, the second anchor is configured to be rotated to engage a flap ring. In some embodiments, the second anchor is configured to have two or more trajectories. In some embodiments, the trajectory of the second anchor is determined by the orientation of a corresponding second anchor guide. In some embodiments, the mating auxiliary element conveying system may include a first anchor driver disposed within a first anchor housing, wherein the first anchor driver is configured to rotate but not translate relative to the first anchor housing. In some embodiments, the mating auxiliary element conveying system may include a second anchor guide. In some embodiments, the second anchor guide is configured to lock the second anchor driver to the second anchor. In some embodiments, the second anchor guide is configured to slide along a second anchor tie member to convey the second anchor. In some embodiments, the second anchor guide rail includes a distal section having a bend between 30 and 90 degrees. In some embodiments, the bend determines the trajectory of the second anchor delivered along the second anchor guide rail.

[0048] In some embodiments, an occlusion aid element is provided for treating malalignment of heart valves in the heart.The occlusion assist element may include an annular segment configured to lie in the plane of the annulus of the heart valve. The occlusion assist element may include a leaflet segment configured to extend from the annular segment. In some embodiments, the leaflet segment includes a leaflet frame. In some embodiments, the leaflet segment includes a leaflet-side valve body element configured to be pushed forward toward the native leaflet during systole and pushed backward away from the native leaflet during diastole. Specification 10 / 126 pages 13 CN 121057564 A

[0049] In some embodiments, the leaflet-side valve body element is configured to be pushed forward and backward relative to the plane of the leaflet frame. In some embodiments, the annular segment includes one or more supports extending from the annular hub. In some embodiments, the occlusion assist element further includes one or more supports, wherein the leaflet frame includes one or more additional supports longer than the one or more supports. In some embodiments, one or more additional supports are connected. In some embodiments, one or more additional support members form a V-shape. In some embodiments, one or more additional support members include separate distal ends. In some embodiments, one or more additional support members include distal ends connected by lamination of them with a polymer and a non-invasive material. In some embodiments, the annular segment includes one or more laminated layers. In some embodiments, the occlusion assist element may include at least one polymer material layer. In some embodiments, the occlusion assist element may include at least one biological tissue layer. In some embodiments, the leaflet frame includes multiple laminated layers to restrict movement of the leaflet frame.

[0050] In some embodiments, an occlusion assist element is provided for treating malalignment of a heart valve. The occlusion assist element may include an anchoring portion. The occlusion assist element may include leaflet segments configured to extend between opposing leaflets of the heart valve. In some embodiments, the leaflet segments include leaflet-side juxtaposed valve body elements. In some embodiments, the leaflet-side juxtaposed valve body elements are molded in a predetermined curved configuration.

[0051] In some embodiments, the leaflet-side juxtaposed valve body elements are molded in a convex configuration. In some embodiments, the leaflet-side valve body element is molded in a concave configuration. In some embodiments, the leaflet-side valve body element is molded in a mixed convex-concave configuration.

[0052] In some embodiments, a method for treating malalignment of heart valves is provided. The method may include positioning an occlusion aid element relative to the heart valve. The occlusion aid element may include a leaflet segment configured to extend across the valve plane. In some embodiments, the leaflet segment includes the leaflet-side valve body element.Body element. In some embodiments, the leaflet-side juxtaposed valve body element serves as an autologous leaflet during the cardiac cycle.

[0053] In some embodiments, the leaflet-side juxtaposed valve body element includes a preset bending configuration to optimize the performance of the leaflet-side juxtaposed valve body element during the cardiac cycle. In some embodiments, leaflet segments create a non-invasive surface to protect surrounding tissue that may come into contact with the leaflet segments. In some embodiments, an occlusion assist element is provided for anchoring the occlusion assist element to one or more sites of tissue. In some embodiments, the occlusion assist element provides a seal between the occlusion assist element and the annulus of the heart valve.

[0054] In some embodiments, an occlusion assist element is provided for treating malalignment of a heart valve. The occlusion assist element may include an anchoring portion. The occlusion assist element may include a first leaflet-side juxtaposed valve body element configured to be pushed toward an opposing autologous leaflet during systole. The occlusion aid may include a second leaflet-side valvular body element configured to be pushed toward the opposing autologous leaflet during systole.

[0055] In some embodiments, the first leaflet-side valvular body element is configured to be pushed forward and backward relative to the plane of the leaflet frame. In some embodiments, the anchoring portion includes an annular hub and one or more secondary anchoring sites. In some embodiments, the first leaflet-side valvular body element is configured to serve as an autologous leaflet. In some embodiments, the first leaflet-side valvular body element is molded into a concave shape. In some embodiments, the second leaflet-side valvular body element provides a seal below the occlusion aid. In some embodiments, the second leaflet-side valvular body element is configured to provide a seal on the posterior side of the occlusion aid. In some embodiments, the second leaflet-side valvular body element is configured to reduce or eliminate periosteal leakage.

[0056] In some embodiments, a occlusion assist element for treating poor occlusion of heart valves is provided (see specification 11 / 126 pages, 14 CN 121057564 A). The occlusion assist element may include a leaflet frame. The occlusion assist element may include a leaflet occlusion valve body element coupled to the leaflet frame. In some embodiments, the leaflet-side valve body element includes a free, unattached edge configured to move.

[0057] In some embodiments, the leaflet-side valve body element includes a free, unattached edge configured to move from one side of the leaflet frame to the other side of the leaflet frame. In some embodiments, a portion of the leaflet-side valve body element is configured to extend from one side of the leaflet frame during systole to the other side of the leaflet frame during diastole. In some embodiments, the occlusion assist element may include an annular hub and one or more extending outward from the annular hub.Multiple support materials. In some embodiments, the occlusion assist element may include an occlusion assist element body cover. In some embodiments, leaflet-side juxtaposed valve body elements are coupled to the occlusion assist element body cover at an interface. In some embodiments, leaflet-side juxtaposed valve body elements are coupled to one or more support materials at an interface.

[0058] In some embodiments, an occlusion assist element is provided for treating malalignment of heart valves. The occlusion assist element may include an annular segment, the annular segment including an annular hub. The occlusion assist element may include leaflet segments. The occlusion assist element may include an interface between the annular segment and the leaflet segment. In some embodiments, the leaflet segment includes leaflet-side juxtaposed valve body elements coupled at the interface.

[0059] In some embodiments, the occlusion assist element may include support materials extending from the annular hub to a lower edge. In some embodiments, the occlusion assist element may include support materials extending from the annular hub to a lateral edge. In some embodiments, the occlusion assist element may include support materials forming a ring from the annular hub to the lower edge and back to the annular hub. In some embodiments, the occlusion assist element may include one or more support materials wrapped with pericardium. In some embodiments, the occlusion aid element may include one or more supports wrapped with ePTFE. In some embodiments, the occlusion aid element may include one or more supports wrapped with tubing. In some embodiments, the occlusion aid element may include sutures connecting the supports along their lower edges. In some embodiments, the occlusion aid element may include sutures for connecting the supports along the interface. In some embodiments, the occlusion aid element may include an ePTFE laminate only on the annular segment. In some embodiments, the occlusion aid element may include an ePTFE laminate at the interface. In some embodiments, the occlusion aid element may include a suture boundary at the interface.

[0060] Figures 1A through 1F schematically illustrate some tissues of the heart and mitral valve, as described in the background section and below, and which may interact with the implants and systems described herein.

[0061] Figure 2A illustrates a simplified cross-section of the heart, schematically illustrating mitral valve function during diastole.

[0062] Figure 2B illustrates a simplified cross-section of the heart, schematically showing mitral valve function during systole.

[0063] Figures 3A and 3B illustrate simplified cross-sections of the heart, schematically illustrating mitral regurgitation during systole in cases of mitral valve leaflet malalignment.

[0064] Figure 4A illustrates a stylized cross-section of the heart, showing mitral valve malalignment in cases of functional mitral regurgitation.

[0065] Figure 4B illustrates a stylized cross-section of the heart, showing mitral valve malalignment in cases of degenerative mitral regurgitation.

[0066] Figure 5A illustrates a perspective view of an embodiment of the occlusion assist element.

[0067] Figure 5B illustrates a top view of the mating aid of Figure 5A.

[0068] Figures 5C to 5D illustrate embodiments of the support material of the mating aid. Specification 12 / 126 pages 15 CN 121057564 A

[0069] Figures 5E to 5G illustrate the mating aid of Figure 5A without the valve ring anchoring portion.

[0070] Figures 5H to 5J illustrate the mating aid of Figure 5A with the valve leaf anchoring portion.

[0071] Figure 5K illustrates the dimensions of the mating aid of Figure 5A.

[0072] Figure 6 illustrates a perspective view of an embodiment of the mating aid.

[0073] Figure 7A illustrates a perspective view of an embodiment of the mating aid, showing a first surface disposed toward the poorly mated autologous valve leaflet.

[0074] Figure 7B illustrates another perspective view of the mating aid of Figure 7A, showing a second surface that may include the mating surface.

[0075] FIG. 7C illustrates a top view of the occlusion aid of FIG. 7A.

[0076] FIG. 7D illustrates the occlusion aid of FIG. 7A implanted in a model of the mitral valve.

[0077] FIG. 7E illustrates a top view of the occlusion aid of FIG. 7A implanted in a model of the mitral valve.

[0078] FIG. 8A schematically illustrates an embodiment of a control handle for a delivery system for transcatheter technology.

[0079] FIG. 8B schematically illustrates a top and side view of the occlusion aid coupled to the delivery system of FIG. 8A.

[0080] FIG. 8C schematically illustrates the connection between the annular hub of the occlusion aid and the tip of the delivery catheter.

[0081] FIG. 9A schematically illustrates the anchoring operation of the delivery system of FIG. 8A.

[0082] FIG. 9B to FIG. 9E schematically illustrate the connection between the annular anchor and the actuator.

[0083] FIG. 10 schematically illustrates a method for transcatheter technology, showing transseptal crossing.

[0084] Figure 11 schematically illustrates a method for transcatheter technology, showing the initial advancement of the occlusion aid.

[0085] Figure 12 schematically illustrates a method for transcatheter technology, showing partial opening of the occlusion aid.

[0086] Figure 13 schematically illustrates a method for transcatheter technology, showing the collapse of the occlusion aid.

[0087] Figure 14 schematically illustrates a method for transcatheter technology, showing a cross-sectional view of the occlusion aid.

[0088] Figure 15 schematically illustrates a method for transcatheter technology, showing placement of the sub-anchor.

[0089] Figure 16 illustrates a method for implant delivery, showing implant loading;

[0090] Figure 17 illustrates a method for inserting a guide.

[0091] Figure 18 illustrates a method for connecting the guide of Figure 17 to the transseptal sheath.

[0092] Figure 19 illustrates a method for advancing the transseptum of Figure 18.

[0093] Figure 20 illustrates a method for positioning the transseptum of Figure 19.

[0094] Figure 21 illustrates a method for delivering the anchor.

[0095] Figures 22A to 22D illustrate methods for deploying the implant.

[0096] Figure 23 illustrates a method for using one or more sub-anchor guidewires.

[0097] Figure 24 illustrates a method for removing the anchor driver.

[0098] Figure 25 illustrates a method for advancing the sub-anchor guide rail.

[0099] Figure 26 illustrates a method for delivering the sub-anchor.

[0100] Figure 27 illustrates a method for inserting the sub-anchor.

[0101] Figure 28 illustrates a method for delivering another sub-anchor.

[0102] Figure 29 illustrates an implant with guidewires that has been anchored. Instruction manual, pages 13 / 126, CN 121057564 A

[0103] Figure 30 illustrates an anchored implant.

[0104] Figures 31A to 31F illustrate methods for removing the implant.

[0105] Figure 32 illustrates a method for inserting a secondary anchor.

[0106] Figure 33 illustrates a method for delivering another secondary anchor.

[0107] Figure 34 illustrates a method for inserting another secondary anchor.

[0108] Figure 35 illustrates an anchored implant.

[0109] Figure 36 illustrates an embodiment of a laminate.

[0110] Figure 37 illustrates an embodiment of a laminate.

[0111] Figure 38 illustrates an embodiment of 3D molding.

[0112] Figure 39 illustrates an embodiment of 3D molding.

[0113] Figure 40 illustrates an implant.

[0114] Figure 41 illustrates an embodiment of a barb.

[0115] Figures 42A to 42I illustrate embodiments of the implant delivery system.

[0116] Figures 43A to 43E illustrate embodiments of the implant delivery system.

[0117] Figures 44A to 44E illustrate embodiments of the implant delivery system.

[0118] Figures 45A to 45K illustrate embodiments of the implant delivery system.

[0119] Figures 46A to 46C illustrate embodiments of the anchor delivery system.

[0120] Figures 47A to 47E illustrate views of embodiments of the mating aid element.

[0121] Figure 48 illustrates an embodiment of the implant construction.

[0122] Figure 49 illustrates an embodiment of the implant delivery system.

[0123] Figure 50 illustrates a delivery method.

[0124] Figure 51 illustrates an embodiment of the main anchor driver.

[0125] Figure 52 illustrates an embodiment of the secondary anchor guide rail.

[0126] Figures 53A and 53B illustrate embodiments of the secondary anchor guide rail for preventing entanglement.

[0127] Figure 54 illustrates an embodiment of a secondary anchor guide rail used to assist the trajectory of the anchor.

[0128] Figures 55A to 55C illustrate embodiments of a proximal assembly.

[0129] Figure 56 illustrates an embodiment of an anti-rotation feature.

[0130] Figures 57A to 57B illustrate embodiments of posterior leaflet augmentation and recovery.

[0131] Figures 58A to 58J illustrate embodiments of an implant delivery system.

[0132] Figures 59A to 59B illustrate embodiments of a secondary anchor.

[0133] Figure 60 illustrates an embodiment of the secondary anchor and implant of Figure 59A.

[0134] Figure 61 illustrates an embodiment of the mitral valve during systole and diastole.

[0135] Figures 62A to 62C illustrate embodiments of the implant.

[0136] Figure 63 illustrates an embodiment of the implant of Figure 62A, positioned in the mitral valve during systole and diastole.

[0137] Figures 64A to 64D illustrate embodiments of the implant.

[0138] Figure 65 illustrates an embodiment of the implant of Figure 64A positioned in the mitral valve during systole and diastole.

[0139] Figures 66A to 66D illustrate embodiments of the implant.

[0140] Figures 67A to 67B illustrate embodiments of the implant of Figure 66A delivered to the mitral valve.

[0141] Figure 68 illustrates an embodiment of the implant of Figure 66A positioned in the mitral valve during systole and diastole. Specification 14 / 126 pages 17 CN 121057564 A

[0142] Figures 69A to 69C illustrate embodiments of the implant.

[0143] Figures 70A to 70K illustrate embodiments of the implant during systole and diastole of Figure 66A.

[0144] Figures 71A to 71D illustrate embodiments of the implant during systole and diastole.

[0145] Figures 72A to 72F illustrate embodiments of the implant.

[0146] Figures 73A to 73C illustrate embodiments of the implant during systole and diastole.

[0147] Figures 74A to 74D illustrate embodiments of the implant during systole and diastole.

[0148] Figures 75A to 75D illustrate embodiments of the implant. Detailed Description

[0149] In some embodiments, the present invention generally provides improved medical devices, systems, and methods typically used for treating mitral regurgitation and other valvular diseases, including tricuspid regurgitation. Although the following description includes references to the anterior leaflet of valves with two leaflets, such as the mitral valve, it should be understood that "anterior leaflet" can refer to one or more leaflets of a valve with multiple leaflets. For example, the tricuspid valve has three leaflets, so "anterior" can refer to one or both of the medial, lateral, and posterior leaflets. The occlusal aids described herein will generally include occlusal aids (sometimes referred to herein as...)The valve body (valve body) typically follows the blood flow path as the valve leaflets move back and forth between an open valve configuration (anterior leaflet separated from the valve body) and a closed valve configuration (anterior leaflet engaging with the opposing valve body surface). The valve body is positioned between the autologous leaflets to close gaps caused by malalignment of the autologous leaflets by providing a surface for occlusion for at least one of the autologous leaflets while effectively replacing a second autologous leaflet in the region of the valve, which would occlude during systole if the valve were functioning normally. The gap can be lateral (e.g., caused by a dilated left ventricle and / or mitral annulus) and / or axial (e.g., when a leaflet prolapses or is pushed out of the annulus by fluid pressure when the valve should close). In some embodiments, the occlusion assist element may fully assist one, two, or more leaflets, or in some embodiments partially assist the leaflets, for example, by covering only one or more of the A1, A2, and / or A3 scallops of the anterior leaflet, and / or one or more of the P1, P2, and / or P3 scallops of the posterior leaflet.

[0150] The occlusion assist elements and methods described herein can be configured to treat functional and / or degenerative mitral regurgitation (MR) by forming at least one sealable artificial or novel occlusion zone in the autologous mitral leaflet therein, and can also be used for other purposes. The structures and methods described herein will be largely tailored to suit this application, although alternative embodiments may be configured for other valves of the heart and / or body, including valves of the tricuspid valve, peripheral vascular system, inferior vena cava, etc.

[0151] Referring to Figures 1A through 1D, the four chambers of the heart are shown: left atrium 10, right atrium 20, left ventricle 30, and right ventricle 40. The mitral valve 60 is positioned between the left atrium 10 and the left ventricle 30. Also shown are the tricuspid valve 50 (which separates the right atrium 20 and right ventricle 40), the aortic valve 80, and the pulmonary valve 70. The mitral valve 60 consists of two leaflets (anterior leaflet 12 and posterior leaflet 14). In a healthy heart, the two leaflets are appose at the occlusal zone 16 during systole.

[0152] A fibrous valve ring 120, as part of the cardiac framework, provides attachment for the two leaflets of the mitral valve, referred to as the anterior leaflet 12 and the posterior leaflet 14. The leaflets are axially supported by attachment to chordae tendineae 32. The chordae tendineae, in turn, are attached to one or both of the papillary muscles 34 and 36 of the left ventricle. In a healthy heart, the chordae tendineae support structure tethers the mitral valve leaflets, allowing the leaflets to open easily during diastole but tolerating the high pressure generated during ventricular systole. In addition to their tethering function as a supporting structure, the shape and tissue consistency of the leaflets contribute to effective sealing or occlusion. The leading edges of the anterior and posterior leaflets meet along a funnel-shaped occlusion zone 16, wherein the lateral section 160 of the three-dimensional occlusion zone (CZ) is schematically illustrated.Page 15 / 126 of the book, CN 121057564 A, is shown in Figure 1E.

[0153] The anterior and posterior leaflets of the mitral valve have different shapes. The anterior leaflet is more firmly attached to the annulus covering the central fibrous body (cardiac frame) and is slightly stiffer than the posterior leaflet, which is attached to the more mobile posterior mitral annulus. Approximately 80% of the closure area is the anterior leaflet. Adjacent to the commissures 110, 114, above or before the annulus 120, there are a left (lateral) fibrous triangular 124 and a right (septal) fibrous triangular 126, which are formed at the fusion of the mitral annulus with the base of the non-coronary cusp of the aorta (Figure 1F). Fiber triangular prisms 124 and 126 form septal and lateral extensions of the central fibrous body 128. In some embodiments, fiber triangular prisms 124 and 126 may have advantages such as providing a secure region for stable engagement with one or more annular anchors or atrial anchors. The occlusal region CL between leaflets 12 and 14 is not a simple line, but a curved, funnel-shaped surface interface. The first commissure 110 (lateral or left-hand) and the second commissure 114 (septal or right-hand) are where the anterior leaflet 12 meets the posterior leaflet 14 at the annulus 120. As most clearly visible in the axial views of the atrium in Figures 1C, 1D, and 1F, the axial section of the occlusal region typically shows a curved line CL that is separated from the centroid CA of the annulus and from the opening through the valve during diastole (CO). Furthermore, the leaflet edges are scalloped, especially the posterior leaflet. Malalignment may occur between one or more of these A-P (anterior-posterior) segments A1 / P1, A2 / P2, and A3 / P3, such that the characteristics of malalignment may vary along the curve of the occlusion zone CL.

[0154] Referring now to FIG2A, a properly functioning mitral valve 60 is open during diastole to allow blood to flow along the flow path FP from the left atrium to the left ventricle 30 and thereby fill the left ventricle. As shown in FIG2B, the functioning mitral valve 60 closes during systole, first passively and then actively, by an increase in ventricular pressure, and effectively separates the left ventricle 30 from the left atrium 10, thereby allowing the cardiac tissue surrounding the left ventricle to contract and propel blood through the vascular system.

[0155] Referring to FIGS3A-3B and FIG4A-4B, there are several conditions or disease states in which the leaflets of the mitral valve are...The leaflets cannot be properly aligned, thus allowing blood to flow from the ventricle back into the atrium during systole. Regardless of the specific etiology of a particular patient, the inability of the leaflets to seal during ventricular systole is called malalignment and causes mitral regurgitation.

[0156] Typically, malalignment can be caused by excessive tethering of the supporting structures of one or both leaflets, or by excessive stretching or tearing of the supporting structures. Other less common causes include valvular infection, congenital abnormalities, and trauma. Valvular dysfunction can be caused by: stretching of the chordae tendineae (known as mitral valve prolapse), and in some cases, tearing of the chordae tendineae 215 or papillary muscles (known as flail leaflets 220), as shown in Figure 3A. Alternatively, if the leaflet tissue itself is superfluous, the valve may prolapse such that the height of occlusion occurs at a higher position in the atrium, opening the valve at a higher position in the atrium during ventricular systole 230. Either leaflet may prolapse or become flail. This condition is sometimes referred to as degenerative mitral regurgitation.

[0157] In the excessive tethering shown in Figure 3B, the leaflets of a structurally normal valve may not function properly due to an enlarged or reshaped annulus (so-called annular dilatation 240). This type of functional mitral regurgitation is usually caused by myocardial failure and associated ventricular dilatation. And the excessive volume load caused by functional mitral regurgitation itself may exacerbate heart failure, ventricular and annular dilatation, and thus worsen mitral regurgitation.

[0158] Figures 4A and 4B illustrate the backflow of blood during systole in functional mitral regurgitation (Figure 4A) and degenerative mitral regurgitation (Figure 4B). In Figure 4A, the increased size of the annulus, coupled with increased tethering due to hypertrophy of the ventricle 320 and papillary muscles 330, prevents the anterior leaflet 312 and posterior leaflet 314 from juxtaposition, thereby preventing occlusion. In Figure 4B, tearing of chordae tendineae 215 (page 16 / 126, CN 121057564 A) causes the posterior leaflet 344 to detach upwards into the left atrium, preventing juxtaposition with the anterior leaflet 342. In either case, the result is blood return to the atrium, which reduces the effectiveness of left ventricular compression.

[0159] Further descriptions of mate assistive elements, tools, anchors, features, systems, and methods that can be utilized in conjunction with the disclosure herein can be found in the following applications, each of which is incorporated herein by reference in its entirety: U.S. Patent Application No. 13 / 099532, filed May 3, 2011; U.S. Patent Application No. 13 / 531407, filed June 22, 2012; U.S. Patent Application No. 14 / 313975, filed June 24, 2014; and U.S. Patent Application No. 14 / 742199, filed June 17, 2015.U.S. Patent Application No. 14 / 749344, filed June 24, 2015; and U.S. Patent Application No. 10 / 419706, filed April 18, 2003.

[0160] In some embodiments, the occlusion assist element described herein may be deployed to cover the posterior leaflet, chordae tendineae, and papillary muscles. In some embodiments, the occlusion assist element is attached superiorly to the posterior side of the valve annulus and inferiorly to the posterior side of the left ventricle via annular anchors and / or ventricular anchors. In other embodiments, more than one annular anchor and / or more than one ventricular anchor may be used to attach the occlusion assist element. In some devices, one or more annular anchors may be replaced by or supplemented by one or more atrial or commissural anchors, which may be annular in some embodiments. The occlusion assist element may be attached to the upper surface of the posterior valve annulus, the posterior atrial wall, or the valve annulus itself. An occlusion zone has been established between the occlusion assist element and the autologous anterior leaflet. Similar occlusion assist elements can be used for both functional and degenerative mitral regurgitation, since leaflet occlusion failure occurs in both, regardless of the underlying mechanism of the dysfunction. In some embodiments, occlusion assist elements of different sizes can be positioned such that the autologous anterior leaflet is opposite the occlusion element at a properly established occlusion point, blocking blood flow during ventricular systole.

[0161] Various sizes of occlusion assist elements can be provided by making the sizes configured for various anatomy. For example, there can be a height measured from the upper annular attachment site of the occlusion assist element to its lowest edge in a plane substantially perpendicular to the plane defined by the valve annulus, a depth between the occlusion point and the upper attachment site, and a protrusion between the posterior wall and the occlusion point at the height of the occlusion point. There are also inner and outer diameters of the occlusion assist element, which are generally larger in functional MR. During diastole, the occlusion assist element can remain in substantially the same position while the movement of the autologous anterior leaflet opens the valve, allowing blood to flow from the left atrium to the left ventricle with minimal restriction. In some embodiments, the surface of the occlusal assist element may balloon or stretch upwards during ventricular systole while the anchor remains stationary. This can be advantageous because it enhances the seal between the anterior or occlusal surface of the device and the autologous leaflet at the occlusal zone during systole. During diastole, the surface may return toward the anterior leaflet to its earlier initial position. This can provide an improved blood flow path between the atrium and ventricle during diastole, thereby improving outflow from the atrium through the occlusal assist element.

[0162] In some methods of use, the autologous posterior leaflet remains in situ, and the occlusal assist element is attached superiorly to the posterior leaflet annulus or adjacent atrial wall. Various possible alternative embodiments may have different attachment mechanisms. In other methods of use, the posterior leaflet is absent, has been surgically removed, or has been removed due to disease. In some methods of use, the autologous leaflet is attached to the occlusal assist element.The posterior surface of the occlusal assist element. In some uses, the occlusal assist element may be attached to the anterior surface of the posterior leaflet, rather than the valve annulus or atrial wall. These are some examples of variations, but other options are still considered. In some uses, an anchoring structure (not shown) may extend from the occlusal assist element through the atrial wall into the coronary sinus, wherein the anchoring structure is attached to a mating structure in the coronary sinus. In some uses, the anchoring structure, which may be a mechanical structure or a simple suture, may extend through the atrial wall and be anchored to the epicardial surface of the heart by a knot or mechanical unit such as a clamp. Similarly, the lower attachment may reach the ventricular myocardium, through the apex into the epicardium or pericardium, and be secured from the outside or at other attachment sites using alternative attachment units.

[0163] The occlusal assist elements described herein may exhibit a variety of desired characteristics. Some embodiments do not rely on mitral annular reshaping (e.g., by thermal shrinkage of the annular tissue, implantation of the annular prosthesis, and / or placement of the holding mechanism above or below the valve plane or in the coronary sinus or related vessels). Advantageously, they also do not need to damage the leaflet structure or rely on the locking or fusion of the mitral leaflets together. Several embodiments can avoid dependence on ventricular reshaping and exhibit a passive implantation device with limited offset after implantation, which can result in a very long fatigue life. Thus, the occlusion aid element can be secured through the posterior leaflet while otherwise keeping the anatomy of the autologous heart (e.g., ventricular, mitral annular, etc.) intact.

[0164] Misalignment of the mitral valve can be effectively relieved regardless of which leaflet segments or segments exhibit malocclusion. The treatment described herein will utilize an occlusion aid element that can be rearranged during the procedure and even removed at full deployment and / or at the start or end of the tissue response, generally without damaging the valve structure. Nevertheless, the occlusion assist element described herein can be combined with one or more therapies that do indeed rely on one or more of the properties excluded above. The occlusion assist element can exhibit benign tissue healing and rapid endothelialization, which inhibits migration, thromboembolism, infection, and / or erosion. In some cases, the occlusion assist element will not exhibit endothelialization, but its surface will remain inert, which can also inhibit migration, thromboembolism, infection, and / or erosion.

[0165] Figures 5A and 5B show two views of an embodiment of the occlusion assist element 500. The occlusion assist element 500 may include a first surface 505 disposed toward a poorly occluded autologous leaflet (in the case of the mitral valve, the posterior leaflet), and a second surface 515 disposed toward the anterior leaflet. The second surface 515 may include an occlusion surface 560. The upper edge 540 of the occlusion assist element 500 may be curved to conform to the overall shape of the valve annulus or adjacent atrial wall, as described herein. The upper edge 540 may be curved downward toward the posterior leaflet.The occlusion assist element 500 may be curved, as shown in Figure 5A, or bend upward toward the atrial wall to conform to the overall shape of the left atrial wall, as shown in Figure 6 and described herein.

[0166] The occlusion assist element 500 may have a geometry that allows it to traverse the valve between attachment sites in the atrium and ventricle. In some embodiments, the attachment site is only in the atrium. In some embodiments, the attachment site is only near the valve annulus and commissure. The occlusion assist element 500 may detach from the attachment near the lower edge 580. The occlusion assist element 500 does not require ventricular attachment. In some embodiments, the geometry of the occlusion assist element 500 helps to maintain the position of the occlusion assist element 500 within the valve. In some embodiments, the occlusion assist element 500 bends to cup the posterior leaflet. In some embodiments, the occlusion assist element 500 bends posteriorly toward the upper edge 540. The occlusion assist element 500 may provide an occlusion surface 560 for anterior leaflet occlusion. Figures 5A and 5B illustrate this geometry.

[0167] In some methods of use, the posterior leaflet may remain intact. The occlusion assist element 500 can be attached to the atrium or valve annulus to effectively close the posterior leaflet. In some methods of use, the posterior leaflet can be removed. In cases where the posterior leaflet has been removed or is already removed, the occlusion assist element 500 can replace the posterior leaflet. In some embodiments, the occlusion assist element 500 requires only valve annulus attachment. In some embodiments, the occlusion assist element 500 requires only attachment at a single point. This single point can be the central location of the occlusion assist element 500, for example, a central hub. In some embodiments, the occlusion assist element 500 can be attached to the atrium or valve annulus along its edges. In some embodiments, the occlusion assist element 500 can be attached to the atrium or valve annulus at a location spaced apart from the edges of the occlusion assist element 500, for example, at a central hub.

[0168] The occlusion assist element 500 may include an annular hub 520 that engages an annular anchor 800. The annular anchor 800 may engage proximally via a actuator as described herein. The annular anchor 800 may include a sharp tip to engage tissue. In some methods of use, the tip of the annular anchor 800 is within the annular hub 520 during delivery of the mating aid 500. In some methods of use, the tip of the annular anchor 800 is above the annular section 510 during delivery. The tip of the annular anchor 800 may remain recessed within the annular hub 520 until the annular anchor 800 is rotated to engage tissue. In some embodiments, the mating aid 500 may be assembled externally, with the annular anchor 800 engaged via the annular hub 520 and the actuator engaged with the annular anchor 800. The actuator may then retract into the delivery conduit, with the mating aid 500 positioned as described on page 18 / 126 of the specification, 21 CN 121057564 A.Collapse position. The actuator can be operated independently by an operator to place the annular anchor 800 in place. Alternatively, the annular anchor 800 can be engaged sequentially with the occlusion aid 500 and / or the actuator before or after deployment via the delivery catheter. After placement, the occlusion aid 500 can completely cover the posterior leaflet so that the occlusion aid 500 occludes with the anterior leaflet during systole and remains in valvular seal at the annular ring together with the autologous anterior leaflet.

[0169] In some embodiments, the annular anchor 800 is an active anchor. The user can selectively engage or disengage the annular anchor 800 from the tissue. Unlike barbs or other passive anchors, the active anchor 800 can be activated, for example, by rotation, to engage the tissue. The annular anchor 800 allows the occlusion aid 500 to be placed prior to engagement of the annular anchor 800. The occlusion aid 500 can contact the tissue without any attachment of the annular anchor 800. In some embodiments, the annular anchor 800 and the corresponding hub 520 are centrally located on the mating auxiliary element 500. The annular anchor 800 and the corresponding hub 520 are spaced apart from any edge of the mating auxiliary element 500. The position of the annular anchor 800 and the corresponding hub 520 can be centrally located to prevent swaying of the mating auxiliary element 500 when supported by the annular hub 520. The corresponding hub 520 provides a convenient position for supporting and moving the mating auxiliary element 500.

[0170] The annular hub 520 may have a built-in or coupled annular anchor 800. In some embodiments, the annular anchor 800 may be held within the annular hub 520 by a cross pin as described herein. The cross pin may pass through a helical structure of the annular anchor 800 to prevent the annular anchor 800 from being dislodged from the annular hub 520 by blunt force. The annular anchor 800 may include a helix rotatable relative to the annular hub 520. In some embodiments, other anchors may be used. The annular anchor 800 may be in the form of a cord or other attachment unit extending from the occlusion aid element 500 through the interventricular septum to the right ventricle. The annular anchor 800 may be in the form of a cord or other attachment unit extending through the apex of the heart to the epicardium or pericardium. The annular anchor 800 may be fastened from outside the heart in a combined endo / epi procedure. When helical anchors are used, they may comprise bioinert materials such as platinum / Ir, nitinol, and / or stainless steel.

[0171] In some embodiments, the occlusion aid element 500 may include a single central annular anchor 800 within the annular hub 520. The occlusion aid element 500 may be delivered percutaneously via attachment of a delivery catheter to the annular hub 520 as described herein.The engagement auxiliary element 500 can be configured to be adjustably arranged by removing and reattaching the annular anchor 800. The engagement auxiliary element 500 can be recaptured by removing the annular anchor 800 and retracting the engagement auxiliary element 500. The engagement auxiliary element 500 may also include secondary anchors, including connecting anchors, ventricular anchors, annular anchors, barbs, ropes, or any other known fastening devices.

[0172] As can be seen in Figures 5A and 5B, the engagement auxiliary element 500 may include a plurality of supports 530. In some embodiments, one or more of the supports 530 have one end terminating at the hub 520 and another end extending radially outward toward one of the upper edge 540, lateral edges 570 and 575, and lower edge 580 of the engagement auxiliary element 500. The supports 530 may extend outward from the hub 520 in various directions and may be spaced apart from adjacent supports 530 at regular or irregular intervals. In some embodiments, adjacent support members 530 extend outward from the hub at an angle of about 5 degrees to about 45 degrees, about 10 degrees to about 30 degrees, or about 5, 10, 15, 20, 25, or 30 degrees relative to adjacent support members 530. Support members 530 may be arranged generally parallel to the longitudinal axis of the occlusion aid 500 to help maintain the shape of the occlusion aid 500 during placement. Support members 530 may allow the occlusion aid 500 to take a reduced configuration for deployment via a catheter. In some embodiments, support members 530 forming a portion of the occlusion region of the implant 500 have a maximum length greater than support members 530 forming only a portion of the annular region of the implant. In some embodiments, support members 530 forming a portion of the occlusion region of the implant may be, for example, at least about 10%, 20%, 30%, 40%, 50%, 75%, 100%, 125%, or 150% longer than support members 530 forming a portion of the annular region of the implant.

[0173] FIG. 5A shows a view of an engagement aid 500 having an annular anchor portion 535. The annular anchor portion 535 may be part of a support 530. The annular anchor portion 535 is shown in FIG. 5A as extending downward from the engagement aid 500. In other embodiments, as described on pages 19 / 126 of the specification 22 CN 121057564 A, the annular anchor portion 535 may extend from the engagement aid 500 in other directions to engage tissue. In some embodiments, the annular anchor portion 535 includes one or more barbs having sharp tips. The annular anchor portion 535 may be a passive anchor.

[0174] In some embodiments, the engagement aid 500 may include one or more retractable barbs. For example, the barbs may be retracted during delivery of the engagement aid 500. For example, the barbs may be advanced after the engagement aid 500 has been positioned relative to an anatomical structure. In some embodiments, the barbs are actively retracted and / or advanced. For example, as described hereinThe delivery catheter may include a mechanism coupled to the barb, designed to retract and / or advance the barb. In other embodiments, the barb is passively advanced and / or retracted. In some embodiments, the occlusion aid 500 is delivered with the barb in the retracted state. In some embodiments, the barb may be covered by a valve body cover as described herein. In some embodiments, the interface between the tissue and the valve body cover pushes the valve body cover backward and exposes the barb. In some embodiments, the tissue dissolves and / or absorbs a portion of the valve body cover and exposes the barb. In some embodiments, movement of the pocket-shaped suture described herein advances the barb. In some embodiments, movement of the pocket-shaped suture causes movement of the valve body cover to expose the barb. Other configurations may be considered.

[0175] The annular anchorage portion 535 may define a diameter D1 as shown in FIG. 5B, which in some embodiments may correspond to the distance between the inner and outer commissures of the autologous valve, or the intracommissural distance (ICD). D1 can be 20-60 mm, and in some embodiments, a length of 35-45 mm is preferred, which most closely corresponds to the widest range of the human mitral valve ICD. In some embodiments, D1 can be the distance from the right fiber triangle to the left fiber triangle.

[0176] The occlusion aid element 500 may include a generally annular segment 510. When the occlusion aid element 500 is deployed, the annular segment 510 may be positioned above the valve leaflet. In some embodiments, the annular segment 510 may be bent toward or away from the valve annulus. The annular segment 510 may be concave. In other embodiments, the annular segment 510 may be substantially flat relative to the valve annulus. One or more of the support members 530 may be laterally bent from the hub 520 toward the upper edge 540 to help maintain the shape of the annular segment 510 of the occlusion aid element 500 during deployment. The occlusion aid element 500 may be bent downward from the hub 520 toward the valve annulus anchorage portion 535. In some embodiments, the occlusion aid element 500 does not protrude toward the posterior valve leaflet. In some embodiments, the annular anchoring portion 535 is the only point of contact between the posterior annular ring of the mitral valve and the mating aid element 500. The upper edge 540 may include an annular radius of curvature. The annular radius of curvature may bend toward the annular ring. The annular radius of curvature may bend toward the mating surface 560. In some embodiments, the annular radius of curvature may be 0mm-5mm, 5mm-10mm, 10mm-15mm, 15mm-20mm, 20mm-25mm, 25mm-30mm, etc.

[0177] The support 530 may be made of a non-transparent material. In some embodiments, the support 530 is made of an elastically deformable material such as a shape memory metal, for example, nitinol or a shape memory polymer. In some embodiments, the material is...Elgiloy. In other embodiments, the support 530 may be made of other materials, including stainless steel, polypropylene, high-density polyethylene (PE), polyester, acellular collagen matrix such as SIS, or other plastics. In other embodiments, the support 530 may be a combination, such as a high-density PE sheath surrounding a core of ePTFE, polyester, and / or polypropylene. The support 530 may have a circular cross-section, an oval cross-section, or a strip shape. In some embodiments, the support 530 is a helical spring or a zigzag shape. The support 530 may have a constant stiffness. In some embodiments, one or more supports 530 may have different stiffnesses along the length of the one or more supports 530. The support 530 may be stiffer at the annular end than at the ventricular end of the occlusal support element 500. The support 530 may be less stiff at the annular end than at the ventricular end of the occlusal support element 500. The support 530 may be stiffer at the midpoint, such as at an inflection point or curve. The support 530, together with one or more other support structures, may form a frame. In some embodiments, one or more support structures may be provided that extend parallel to the upper edge 540 of the occlusion aid 500 and help maintain the shape of the upper edge 540. In some embodiments, the support 530 and / or other support structures of the frame may be laser-cut from a NiTi tube (page 20 / 126, CN 121057564 A).

[0178] The occlusion aid body cover 550 may be made of a material such as ePTFE. Other materials for the occlusion aid body cover 550 include polyester, polyurethane foam, polycarbonate foam, biological tissue (such as porcine pericardium, processed bovine pericardium, pleura, peritoneum), silicone, polyester, acellular collagen matrix, etc. In some embodiments, the occlusion aid body cover 550 may include a foam material surrounded by ePTFE. The use of sponge or foam material enhances the ability of the occlusion aid 500 to fold to a sufficiently small diameter to pass through the conduit. In some embodiments, the occlusion aid body cover 550 is non-porous. In other embodiments, the occlusion aid element body cover 550 may have micropores to enhance endothelialization and cell attachment. The occlusion aid element body cover 550 may also comprise a translucent material or an echo-enhancing material for better visualization. Any support structure of the occlusion aid element 500, including the support member 530 or the support interface including the hub 520, may be coated with a translucent material such as gold or platinum, or impregnated with barium. The occlusion surface 560 may be coated with an echo-enhancing material. The occlusion aid element body cover 550 may be coated with a material that inhibits thrombus formation, such as heparin-bonded compounds or quinoline and quinoxaline compounds, or with a material that accelerates endothelialization, or with an antibiotic that inhibits infection. In some embodiments, the pocket-shaped drawstring suture 1010 described herein may comprise a translucent material or an echo-enhancing material for better visualization.Sound-enhancing material.

[0179] In some embodiments, the support 530 may be sandwiched between layers of the mating auxiliary element body cover 550. The mating auxiliary element body cover 550 may be made of the same material on the first surface 505 and the second surface 515. The mating auxiliary element body cover 550 may be made of different materials on the first surface 505 or a portion thereof and the second surface 515 or a portion thereof. In some embodiments, the support 530 may be attached to or embedded in a single layer of the first surface 505 or the second surface 515 of the mating auxiliary element body cover 550. In some embodiments, the support 530 may be “stitched” through the mating auxiliary element body cover 550. The valve ring anchoring portion 535 may be the exposed end of the support 530 from the mating auxiliary element body cover 550.

[0180] The mating auxiliary element 500 may include a pocket drawstring type stitch 1010. The pocket drawstring type stitch 1010 may extend along a portion of the mating auxiliary element 500. The drawstring suture 1010 may extend along the upper edge 540 or a portion thereof. The drawstring suture 1010 may extend along the lateral edge 570 or a portion thereof. The drawstring suture 1010 may extend along the lateral edge 575 or a portion thereof. The drawstring suture 1010 may extend along the lower edge 580 or a portion thereof. The drawstring suture 1010 may extend along the perimeter of the engagement aid 500 or a portion thereof. The drawstring suture 1010 may extend along one or more supports 530. The drawstring suture 1010 may extend in a straight path, a non-straight path, a curve, a semicircle, or any open or closed shape.

[0181] In some embodiments, the drawstring suture 1010 may be sandwiched between layers of the valve body covering 550. For example, a pocket-shaped drawstring suture 1010 may be disposed in a cavity between layers of the occlusal assist element body cover 550. In some embodiments, the pocket-shaped drawstring suture 1010 may be attached to or embedded in a first surface 505 or a second surface 515 of a single layer of the valve body cover 550. In some embodiments, the pocket-shaped drawstring suture 1010 may be "sewn" through the occlusal assist element body cover 550. The pocket-shaped drawstring suture 1010 may pass through the first surface 505 to the second surface 515 and back to the first surface 505. The pocket-shaped drawstring suture 1010 may include one or more exposed ends from the occlusal assist element body cover 550. In embodiments where the pocket-shaped drawstring suture 1010 is a loop, the pocket-shaped drawstring suture may include a loop from one or more exposed segments of the valve body cover.

[0182] The fitting auxiliary element 500 can be collapsed by tightening the drawstring-type sewing thread 1010 at the opening of the purse. Fitting auxiliary element500 can be unfolded by loosening the drawstring suture 1010. One or more exposed ends or loops can be manipulated by a delivery conduit or other tool to tighten or loosen the drawstring suture 1010. The ability to collapse or unfold the closure aid 500 can facilitate the recapture of the closure aid 500 and / or the rearrangement of the closure aid 500.

[0183] The closure aid 500 can be rotated by tightening one or more drawstring sutures 1010 and / or loosening one or more drawstring sutures 1010. For example, tightening one or more drawstring sutures 1010 on the lateral edge 570 and / or loosening one or more drawstring sutures 1010 on the lateral edge 575 can rotate the closure aid 500. One or more drawstring sutures 1010 can be connected to the engagement aid 500 to enable multi-directional rotation.

[0184] The engagement aid 500 can be unfolded by loosening the drawstring sutures 1010. One or more exposed ends or loops can be manipulated by a delivery conduit or other tool to tighten or loosen the drawstring sutures 1010. The ability to collapse or unfold the engagement aid 500 can facilitate the recapture and / or rearrangement of the engagement aid 500.

[0185] The engagement surface 560 of the engagement aid 500 can be adjusted by moving the drawstring sutures 1010. One or more exposed ends or loops can be manipulated by a delivery conduit or other tool to tighten or loosen the drawstring sutures 1010, thereby changing the curvature of the engagement surface 560 in situ. The ability to adjust the curvature of the occlusion aid 500 can facilitate conforming to the geometry of the heart, including the geometry of the anterior leaflet.

[0186] The annular size of the occlusion aid 500 can be adjusted by moving the pocket-mouth drawstring suture 1010. One or more exposed ends or annexes can be manipulated by a delivery catheter or other tool to tighten or loosen the pocket-mouth drawstring suture 1010, thereby changing one or more dimensions of the occlusion aid 500 in situ. The ability to adjust the size of the occlusion aid 500 can facilitate conforming to the geometry of the heart.

[0187] The occlusion aid 500 may include one or more pocket-mouth drawstring sutures 1010. In some embodiments, the fitting auxiliary element 500 includes one, two, three, four, five, six, seven, eight, or nine drawstring sutures for the purse opening.Threads, ten pocket-shaped drawstring sutures, etc. When multiple pocket-shaped drawstring sutures are provided, the pocket-shaped drawstring sutures 1010 can be used together to change the configuration of the engagement aid 500. When multiple pocket-shaped drawstring sutures are provided, the pocket-shaped drawstring sutures 1010 can be used independently to change the configuration of the engagement aid 500.

[0188] FIG5A further illustrates the engagement element height, which corresponds to the distance between the lower edge 580 and the annular hub 520 measured perpendicular to the plane defined by the valve annulus. The engagement element height in some embodiments may be 10-80 mm, while in some embodiments it is 40-55 mm. The engagement element height may be 10-20 mm, 20-30 mm, 30-40 mm, 40-50 mm, 50-60 mm, 60-70 mm, 70-80 mm, etc.

[0189] FIG5A illustrates the generally triangular shape of the engagement aid 500, such that the engagement aid 500 has an upper edge 540, lateral edges 570 and 575, and a lower edge 580. In some embodiments, the upper edge 540 has a length greater than the lower edge 580, such that the lateral distance between the lateral edges 570 and 575 generally decreases from the upper to the lower part of the engagement aid 500. For example, the length of the upper edge 540 may be in the range of 15-50 mm or 25-35 mm, while the length of the lower edge 580 may be in the range of 1-15 mm or 2-6 mm.

[0190] The annular hub 520 may be a hub, an eyelet, or any other fastening location known in the art. In some embodiments, the annular hub 520 is located at the midpoint of a distance D1. In some embodiments, the annular hub 520 is located at the center to prevent swaying of the engagement aid 500 when supported by the annular hub 520. In other embodiments, the annular hub 520 is located at one of the joints. Although only one annular anchor 800 is shown, in other embodiments, two or more annular hubs 520 may be provided.

[0191] In some embodiments, the support 530 may include a NiTi tube. In some embodiments, the support 530 may be laser-cut from the tube. In some embodiments, a frame including one or more supports 530 and / or one or more support structures may be laser-cut from a single piece of material. In some embodiments, a frame including one or more supports 530, annular hubs 520 and / or one or more support structures may be integrally formed. In some embodiments, the mating auxiliary element body cover 550 includes an ePTFE laminate. The laminate may surround one or more of the supports 530 and / or one or more support structures (e.g., one side, both sides, first side 505, second side 515). Support 530 and / or one or more supportsThe structure may be surrounded by two or more laminated layers. The periphery of the annular segment 510 of the mate auxiliary element 500 may be cupped downwards. The periphery of the annular segment 510 of the mate auxiliary element 500 may be cupped upwards. The periphery of the annular segment 510 of the mate auxiliary element 500 may include a secondary anchor such as a petiole annular anchor portion 535.

[0192] In some embodiments, the annular anchor 800 and the annular hub 520 form a single central anchoring system. In some embodiments, the mate auxiliary element 500 is secured to the tissue by only one annular anchor 800 passing through the hub 520. In other embodiments, additional fixation is included. In some embodiments, the mate auxiliary element 500 is secured to the tissue by the annular anchor 800 passing through the hub 520 and the petiole annular anchor portion 535 as described herein. The system may include features that allow rotational adjustment of the mate auxiliary element 500. For example, the hub 520 and / or the annular anchor 800 may be coupled to a delivery conduit to allow axial movement and / or torque transmission. The engagement aid 500 can be held stationary by the delivery conduit such that rotation of features of the delivery conduit, such as a handle, causes rotation of the engagement aid 500. The engagement aid 500 can be held stationary by the delivery conduit such that axial movement of features of the delivery conduit, such as a drive shaft, causes axial movement of the engagement aid 500.

[0193] In some embodiments, the hub 520 is located at a central position on the engagement aid 500. The central position may be a central position on the annular segment 510. The central position may be between the lateral edges 505, 515. The central position may be between the upper edge 540 and the engagement surface 560. The central position can enhance the stability of the engagement aid 500 when the engagement aid 500 is held at a single position such as the hub 520 and / or the annular anchor 800. The central position may be aligned with the structure of the mitral valve. The central position may be aligned along the engagement region.

[0194] In some embodiments, the engagement aid 500 is delivered percutaneously as described herein. In some embodiments, the mate assist element 500 is adjustable via a delivery conduit. For example, the mate assist element 500 can be deployed and / or collapsed via the delivery conduit. For example, the mate assist element 500 can be rotated about a fixed position of the annular hub 520. For example, the mate assist element 500 can be recaptured. For example, the mate assist element 500 can be engaged and re-engaged via the delivery conduit. For example, the annular anchor 800 can be detached from the tissue, and the delivery conduit can recapture the mate assist element 500.

[0195] Figures 5C to 5D illustrate embodiments of the frame 565 of the mate assist element 500. These figures illustrate the flattened pattern of the frame 565 prior to bending and / or shaping. In some embodiments, the frame 565 is cut from a tubular blank. In other embodimentsIn the example, frame 565 is cut from a flat blank, such as a flat sheet of material. Frame 565, including portions thereof, can be laser-cut. Frame 565 may include one or more support members 530. In the embodiment shown in FIG. 5D, frame 565 includes twenty support members 530, but other configurations are considered (e.g., one support member, two support members, three support members, four support members, five support members, five to ten support members, ten to fifteen support members, fifteen to twenty support members, twenty to twenty-five support members, twenty-five to thirty support members, between twenty-five and thirty support members, between two and thirty support members, between five and thirty support members, etc.). In some embodiments, frame 565 may include approximately, at least approximately, or no more than approximately 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30 or more support members, or a range including any two of the above values. In some embodiments, the length of the support member extending to the upper upward or downward cup-shaped lip is smaller than the longest lower-extending support member, for example less than about 80%, 70%, 60%, 50%, 40%, 30%, 20% of the length of the upper cup-shaped lip, or less than the length of the upper cup-shaped lip.

[0196] In some embodiments, one, two or more support members 530 are coupled to backing 585. In some embodiments, backing 585 is transverse to the direction of the support members 530. In the illustrated embodiment, the backing 585 is vertical or substantially vertical, and the support 530 is horizontal or substantially horizontal. In some embodiments, the backing 585 is an annular hub 520. For example, the two ends of the backing 585 can be joined using methods known in the art to form the annular hub 520. For example, if the frame 565 is cut from a flat blank, the two ends are joined. In other embodiments, the frame 565 is formed from a tubular blank. The backing 585 can be part of an uncut tubular blank. If the frame 565 is formed from a tubular blank, it is not necessary to join the two ends of the backing 585. An uncut tubular blank can form the annular hub 520. The patterns of the frame 565 shown in FIG. 5D can be cut from a tubular blank, thereby eliminating the need to join the two ends of the backing. Other manufacturing methods are considered for forming the frame 565. In other embodiments, the backing 585 forms at least a portion of the annular hub 520. In some embodiments, the backing 585 surrounds at least a portion of the annular hub 520. In some manufacturing methods, the backing 585 may be formed as a circle. In some manufacturing methods, once the backing 585 is formed as a circle, the support 530 extends radially outward from the backing 585. The backing 585 may include one or more openings designed to receive a cross pin, as disclosed herein. In some manufacturing methods, the backing 585 is removed.

[0197] Referring to Figures 5A and 5C, a plurality of supports 530 may extend from the annular hub 520 to a lower end 580. In some embodiments, these supports 530 are longer than other supports 530 of the frame 565. In some embodiments, the supports 530 may include anchors or barbs that interact with subvalvular structures, including the ventricular wall. In some embodiments, these supports engage posterior leaflets or other anatomical structures. In some embodiments, ventricular anchoring is passive.

[0198] Referring to Figures 5A through 5D, a plurality of supports 530 may extend from the annular hub 520 to an upper end 540. In some embodiments, these supports 530 are shorter than other supports 530 of the frame 565. In some embodiments, these supports 530 form atrial anchors and / or annular anchoring portions 535 as described herein. In some embodiments, these supports engage annular structures or other anatomical structures. In some embodiments, annular anchoring is passive.

[0199] Referring to Figures 5A and 5D, a plurality of support members 530 may extend from the annular hub 520 to the lateral edges 570 and 575. In some embodiments, these support members 530 have a moderate length between the ventricular support members and the atrial support members. In some embodiments, these support members engage synapses or other anatomical structures. In some embodiments, the synaptic anchoring is passive.

[0200] The support members 530 may have a variety of lengths based on the desired shape of the synaptic aid element 500. As shown in Figures 5C to 5D, two or more support members 530 have different lengths. As shown in Figures 5C to 5D, two or more support members 530 have the same length. Figure 5C shows a schematic pattern of the frame 565. One or more of the upper three support members may form the synaptic surface 560 and extend to the lower edge. One or more of the lower three support members may form an annular segment and extend to the upper edge. The support members 530 may be laser-cut from the tube. The length may be measured from the annular hub 520 to the edge of the synaptic aid element 500. The length of the support member can range from 1 mm to 50 mm. For the annular section 510, the length of the support member can range from 5 mm to 35 mm. For the annular section 510, the length of the support member can be approximately 15 mm. For the mating surface 560, the length of the support member can range from 20 mm to 35 mm. For the mating surface 560, the length of the support member can be approximately 30 mm. Other configurations considering the range of support member lengths include, for example, 5 mm to 45 mm, 10 mm to 40 mm, 15 mm to 35 mm, approximately 5 mm, approximately 10 mm, approximately 15 mm, approximately 20 mm, approximately 25 mm, approximately 30 mm, approximately 35 mm, approximately 40 mm, approximately 45 mm, approximately 50 mm, approximately 55 mm, approximately 60 mm, 1 mm to 10 mm, 5 mm to 15 mm, 10 mm to 20 mm, 15 mm to 25 mm, 20 mm to 30 mm, 25 mm to 35 mm, 30 mm to 40 mm, etc.

[0201] The width can be measured perpendicular to the length of the support. The width of the support can range from 0.1 mm to 2 mm. One or more supports can have an outer diameter or width of approximately 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2 mm, less than 0.5 mm, less than 1 mm, less than 1.5 mm, less than 2 mm, etc. One or more supports 530 can have a varying width along the length of the support. In some embodiments, one or more supports 530 taper gradually near the edge of the mating auxiliary element 500. In some embodiments, one or more supports 530 taper gradually near the annular hub 520. One or more support members 530 may include a reduced diameter or taper at the connection between one or more support members 530 and the annular hub 520. Tapering near the annular hub 520 may facilitate the collapse of the mating aid element 500. Tapering near the annular hub 520 may facilitate insertion of the mating aid element 500 into the delivery conduit. Tapering may reduce stress and / or strain in the support member 530 during collapse. In some embodiments, tapering may contribute to a longer fatigue life. In some embodiments, one or more support members 530 include a tapered width. The width of the support member 530 may vary along the length of the support member 530. One or more support members 530 may include perforations along the length of the support member 530. In some embodiments, perforations may reduce stress on the support member 530. In some embodiments, perforations may facilitate adhesion between the support member 530 and the valve body cover 550.

[0202] Thickness may be measured perpendicular to the support member length and width. Thickness can be determined by the material thickness of the frame, as described herein. The thickness of the support material can range from 0.2 mm to 0.5 mm. One or more supports can have thicknesses of about 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2 mm, less than 0.5 mm, less than 1 mm, less than 1.5 mm, less than 2 mm, etc.

[0203] One or more supports 530 may include barbs. In some embodiments, the barbs may be configured for placement near the ventricular end of the occlusion aid element 500. In some embodiments, the barbs may be bent out of the plane of the support material 530. In someIn some embodiments, the barbs may have a bayonet configuration. In some embodiments, the barbs may have sharp tips. In some embodiments, one or more support members 530 may be forked. In some embodiments, one or more support members 530 may include one or more zigzag segments. In some embodiments, the zigzag segments reduce stress on the support member 530 and / or increase its flexibility. In some embodiments, the zigzag segments facilitate attachment between the support member 530 and the mating auxiliary element body cover 550.

[0204] In some embodiments, one or more support members 530 may include supplementary barbs. In some embodiments, the supplementary barbs may be bent out of the plane of the support member 530. In some embodiments, one or more portions of the support member length are bent out of the surface of the support member. For example, a portion of the support member may be twisted or bent during manufacturing. In some embodiments, the portion bent out of the plane is shaped to engage tissue. In some embodiments, one or more support members 530 may include an increased width to compensate for electropolishing or other post-manufacturing processes. In some embodiments, the backing 585 may include one or more features for engaging the delivery conduit described herein. In some embodiments, backing 585 may include one or more notches designed to engage with locking tabs or other features of the delivery conduit as described herein. In some embodiments, one or more support members 530 may include a width greater than the other support members 530. In some embodiments, frame 565 includes two or more support members 530 having a width greater than the other support members 530. Two or more support members 530 may facilitate visualization of the mating aid element 500. In some embodiments, two or more support members 530 with a larger width are designed to be placed near the engagement when the mating aid element 500 is deployed. In some embodiments, one or more support members 530 may have a smaller width compared to one or more other support members. In some embodiments, each support member 530 has the same width near the annular hub 520. Backing 585 may be designed to allow independent rotation of the anchor member 800 within the hub of the mating aid element 500.

[0205] Figures 5E, 5F, and 5G illustrate embodiments of the mating aid element 500 without barbs. Figure 5E shows a perspective view of the mating aid element 500. Figure 5F shows a perspective view of the first surface 505 disposed toward the poorly mating self-leaf. Figure 5G shows a cross-sectional view including the anchor 800.

[0206] Figures 5H, 5I, and 5J show embodiments of the mating aid 500 having a leaflet anchoring portion 545. As shown in Figure 5A, the leaflet anchoring portion 535, like a barb, can extend along the edge of the mating aid 500. Figures 5H, 5I, and 5J show the specification of the mating aid 500 having a leaflet anchoring portion 545 extending from the first surface 505 disposed toward the poorly mating self-leaf. Page 25 / 126, 28 CN121057564 A Embodiment.

[0207] FIG5H shows a perspective view of the occlusion aid 500, including an enlarged section showing the leaflet anchoring portion 545. FIG5I shows a perspective view of the first surface 505 toward the poorly occluded autologous leaflet. FIG5J shows a cross-sectional view including the anchor 800.

[0208] In some embodiments, the leaflet anchoring portion 545 includes one or more barbs with sharp tips. The leaflet anchoring portion 545 may be a passive anchor. In some embodiments, the occlusion aid 500 may include one or more retractable barbs. For example, the leaflet anchoring portion 545 may retract during delivery of the occlusion aid 500. For example, the leaflet anchoring portion 545 may advance after the occlusion aid 500 is arranged relative to the anatomical structure. In some embodiments, the leaflet anchoring portion 545 actively retracts and / or advances. For example, the delivery catheter described herein may include a mechanism designed to retract and / or advance the barbs, engaging with the leaflet anchoring portion 545. In other embodiments, the leaflet anchoring portion 545 passively advances and / or retracts. In some embodiments, the leaflet anchoring portion 545 may be covered by a valve body cover as described herein. In some embodiments, the interface between tissue and the valve body cover pushes the valve body cover backward and exposes the leaflet anchoring portion 545. In some embodiments, tissue dissolves and / or absorbs a portion of the valve body cover and exposes the leaflet anchoring portion 545. In some embodiments, movement of the pocket-shaped drawstring suture described herein advances the leaflet anchoring portion 545. In some embodiments, movement of the pocket-shaped drawstring suture causes movement of the valve body cover to expose the leaflet anchoring portion 545. Other configurations may be considered.

[0209] One or more supports 530 may have one or more barbs along the length of the support 530. In the illustrated embodiment, each of the five support members 530 has four leaflet anchoring portions 545 along the length of the support member. Other configurations can be considered, varying the number of support members 530 (e.g., one support member, two support members, three support members, four support members, five support members, six support members, seven support members, eight support members, nine support members, ten support members, etc.) and varying the number of leaflet anchoring portions 545 / support members 530 (e.g., one barb, two barbs, three barbs, four barbs, five barbs, six barbs, seven barbs, eight barbs, nine barbs, ten barbs, etc.). One or more support members 530 may have the same number of leaflet anchoring portions 545. Two or more support members 530 may have different numbers of leaflet anchoring portions 545. The leaflet anchoring portions 545 may be configured to engage the leaflets.

[0210] In some embodiments, the support members 530 may be sandwiched between layers of the valve body covering 550. In some embodiments...In this embodiment, the support 530 may be attached to or embedded in a single layer of the valve body cover 550 on a first surface 505 or a second surface 515. In some embodiments, the support 530 may be “sewn” through the valve body cover 550. The first surface 505 may include one or more openings for leaflet anchoring portions 545. In other embodiments, the leaflet anchoring portions 545 may extend through the valve body cover 550. The leaflet anchoring portions 545 may have a predetermined curve that allows force to be applied to the first surface 505. The leaflet anchoring portions 545 may be sharpened to penetrate the valve body cover 550.

[0211] The frame 565 may have many advantages. The frame 565 may be formed in a flat pattern. The frame 565 may include an edge forming an annular hub 520. The edge may include longitudinal strips or a backing 585. One or more support members 530 may extend from the backing 585. In the illustrated embodiments of Figures 5C and 5D, one or more support members 530 are perpendicular to the longitudinal strips. The support members 530 are generally parallel. In some embodiments, the support members 530 are generally perpendicular to the backing 585 forming the annular hub 520. In some embodiments, the support members 530 form an angle with the backing 585. For example, the longitudinal axis of the support member 530 may form an acute angle with the backing 585. The angle facilitates the collapse of the support member 530 into the delivery conduit.

[0212] The frame 565 may be constructed from a single sheet of planar material. The frame 565 may be precisely cut using water jetting, laser etching, or similar techniques. Details including barbs of the support members 530 may be machined into the support members 530. The frame 565 may be bent and / or shaped to obtain a desired geometry. In some embodiments, the backing 585 is folded to form an annulus. The frame 565 may be rolled into a tubular shape. The backing 585 can be welded or fastened. When fastened end-to-end to form a ring, the backing 565 can be considered as an annular hub 520.

[0213] The support 530 is bent into the desired configuration. The support 530 can form one or more curves. The support 530 can have one or more inflection points. The support 530 can have concave and / or convex portions. One or more supports 530 can include a radially outward taper (flare) starting at the inflection point. In some embodiments, the upper edge 540 bends upward away from the lower edge 580. In some embodiments, the upper edge 540 bends downward toward the lower edge 580. In some embodiments, one or more supports 530 can be substantially flat. The supports 530 near the joint can be substantially flat. In some embodiments, the lower edge 580 bends backward toward the upper edge 540. In some embodiments, the lower edge 580 bends forward away from the upper edge 540.

[0214] Support members 530 may be uniformly spaced around the circumference of annular hub 520. Support members 530 may be non-uniformly spaced around the circumference of annular hub 520. Support members 530 extending along a portion of the circumference of annular hub 520 may differ from support members extending along another portion of the circumference of annular hub 520. One or more designated portions of support members 530 may be designed to be placed near the annular region of the heart. One or more designated portions of support members 530 may be designed to be placed near the commissural region of the heart. One or more designated portions of support members 530 may be designed to be placed near the ventricular region of the heart. The geometry of radially extending support members 530 may be shaped to conform to the geometry of the patient. In some embodiments, the geometry is patient-specific. An operator may shape one or more support members 530 based on the geometry of the heart. An operator may change the shape of one or more support members 530 based on the geometry of the patient.

[0215] FIG5K illustrates the dimensions of commissural aid 500. Commissural aid 500 may include dimension A. Dimension A can be a linear protrusion or a rear protrusion. In some embodiments, dimension A can range from 1 mm to 40 mm. In some embodiments, dimension A can range from 4 mm to 24 mm. Other configurations of the dimension A range are considered, such as 5 mm to 35 mm, 10 mm to 30 mm, 15 mm to 25 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, 1 mm to 10 mm, 5 mm to 15 mm, 10 mm to 20 mm, 15 mm to 25 mm, 20 mm to 30 mm, 25 mm to 35 mm, 30 mm to 40 mm, etc. If there is no rear protrusion, for example if the mating aid 500 is straight, then dimension A can be 0 mm.

[0216] The mating aid 500 can include dimension B. In some embodiments, dimension B can be a radius of curvature. The radius of curvature can be concave or convex, as described herein. In some embodiments, size B may range from 1 / 16 inch to 1 / 2 inch. In some embodiments, size B may range from 1.5 mm to 13 mm. In some embodiments, size B may range from 1 / 4 inch to 3 / 8 inch. In some embodiments, size B may range from 6 mm to 9.5 mm. In some embodiments, size B may range from 1 mm to 15 mm. Other configurations of size B ranges are also considered, such as 2 mm to 14 mm, 3 mm to 13 mm, 4 mm to 12 mm, 5 mm to 11 mm, 6 mm to 10 mm, 7 mm to 9 mm, approximately 1 mm, approximately 2 mm, approximately 3 mm, approximately 4 mm, approximately 5 mm, and approximately...6mm, about 7mm, about 8mm, about 9mm, about 10mm, 1mm to 10mm, 5mm to 15mm, 10mm to 20mm, etc. If there is no curvature, for example if the mating aid 500 is straight, then dimension B can be 0mm.

[0217] The mating aid 500 may include dimension C. In some embodiments, dimension C may be the radius of curvature near the upper edge 540. In some embodiments, dimension C may range from 1mm to 10mm. In some embodiments, dimension C may range from 1mm to 5mm. Other configurations of the dimension C range are considered, such as 2mm to 9mm, 3mm to 8mm, 4mm to 7mm, 5mm to 6mm, about 1mm, about 2mm, about 3mm, about 4mm, about 5mm, about 6mm, about 7mm, about 8mm, about 9mm, about 10mm, 1mm to 15mm, 5mm to 10mm, 3mm to 9mm, etc.

[0218] The mating aid 500 may include dimension D. Dimension D may be the height of the mating element. Dimension D may correspond to the distance between the lower edge 580, measured perpendicular to the plane defined by the valve annulus, and the atrial anchorage or annular hub 520. In some embodiments, dimension D may range from 10 mm to 80 mm. In some embodiments, dimension D may range from 40 mm to 55 mm. Other configurations considering the range of size D include, for example, 5mm to 105mm, 10mm to 100mm, 15mm to 95mm, 20mm to 90mm, 25mm to 85mm, 30mm to 80mm, 35mm to 75mm, 40mm to 70mm, 45mm to 65mm, 50mm to 60mm, approximately 10mm, approximately 20mm, approximately 30mm, approximately 40mm, approximately 50mm, approximately 60mm, approximately 70mm, approximately 80mm, approximately 90mm, approximately 100mm, 10mm to 50mm, 20mm to 60mm, 30mm to 70mm, 40mm to 80mm, 50mm to 90mm, 60mm to 100mm, 70mm to 110mm, etc.

[0219] The mating auxiliary element 500 may include size E. Size E may be a linear protrusion or a forward protrusion. In some embodiments, size E may range from 2mm to 20mm. In some embodiments, dimension E can range from 5 mm to 10 mm. Other configurations of the dimension E range are also considered, such as 0 mm to 25 mm, 5 mm to 20 mm, 10 mm to 15 mm, approximately 1 mm, approximately 2 mm, approximately 3 mm, approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, approximately 8 mm, approximately 9 mm, approximately 10 mm, approximately 11 mm, approximately 12 mm, approximately 13 mm, approximately 14 mm, and approximately...15mm, approximately 16mm, approximately 17mm, approximately 18mm, approximately 19mm, approximately 20mm, 1mm to 10mm, 5mm to 15mm, 10mm to 20mm, 15mm to 25mm, 20mm to 30mm, 25mm to 35mm, 30mm to 40mm, etc. If there is no forward protrusion, dimension E can be 0mm.

[0220] The support 530 of the mating aid 500 can form a back curve of the mating surface 560. The back bend can have a bending length of 30-100% of the distal end of the support. In some embodiments, the back bend can have a bending length of at least 40% of the distal end of the support. The angle of the back bend relative to the longitudinal axis of the mating aid 500 can be in the range of 0 degrees to 90 degrees. In some embodiments, the angle of the back bend can be in the range of 45 degrees to 90 degrees.

[0221] FIG6 illustrates an embodiment of the mating aid 600. The engagement aid 600 may be similar to the engagement aid 500 and include any of the features of the engagement aid 500 described herein, with certain additional features described below.

[0222] The engagement aid 600 may include an annular hub 620 engaging annular anchors (not shown). The annular hub 620 may have built-in or coupled annular anchors, such as the annular anchor 800 described herein. The annular anchors may include a helix rotatable relative to the annular hub 620. In some embodiments, the engagement aid 600 may include a single annular anchor inside the annular hub 620. The engagement aid 600 may be percutaneously delivered via a delivery conduit attached to the annular hub 620 as described herein.

[0223] As can be seen in FIG6, the engagement aid 600 may include a support 630. In some embodiments, one, two, or more support members 630 have one end terminating at an annular hub 620 and another end extending radially outward toward the upper edge 640, lateral edges 670 and 675, and lower edge 680 of the occlusion aid element 600. The support members 630 may extend outward from the hub 620. The support members 630 may be arranged generally parallel to the longitudinal axis of the occlusion aid element 600 to help maintain the shape of the occlusion aid element 600 during placement. The support members 630 may allow the occlusion aid element 600 to take a reduced configuration for deployment via a catheter.

[0224] The occlusion aid element 600 may include an annular segment 610. When the occlusion aid element 600 is deployed, the annular segment 610 may be arranged above the annulus of the autologous leaflet and form a lip as shown. In some embodiments, the annular segment 610 may, for example, bend upward in a direction substantially opposite to and substantially parallel to the occlusion surface 660, and form the uppermost portion of the occlusion aid element 600 upon implantation. The annular segment 610 can be convex. In other embodimentsIn this configuration, the annular segment 610 may be substantially flat relative to the leaflet. One or more of the support members 630 may be laterally bent from the annular hub 620 toward the upper edge 640 to help maintain the shape of the annular segment 610 of the mating aid element 600 during deployment. The mating aid element 600 may be bent upward from the annular segment 620. In some embodiments, the upper edge 640 does not recline toward the rear leaflet. The upper edge 640 may include an annular radius of curvature. The annular radius of curvature may be bent away from the leaflet. The annular radius of curvature may be bent toward the mating surface 660. In some embodiments, the annular radius of curvature may be 0 mm–5 mm, 5 mm–10 mm, 10 mm–15 mm, 15 mm–20 mm, 20 mm–25 mm, 25 mm–30 mm, etc., or a range including any two of the foregoing values. The mating aid element body cover 650 may be similar to the mating aid element body cover 550 described herein.

[0225] In some embodiments, the periphery of the annular segment 610 is upward and cup-shaped in a direction substantially opposite to the longitudinal axis of the occlusal surface 660. In some embodiments, the occlusal aid 600 includes a valve annulus anchoring portion similar to the valve annulus anchoring portion 535. In other embodiments, the occlusal aid 600 does not include the valve annulus anchoring portion shown in FIG. 6.

[0226] FIGS. 7A to 7E illustrate embodiments of the occlusal aid 700. The occlusal aid 700 may be similar to the occlusal aid 500 or 600 and includes any of the features described herein, some of which are described below.

[0227] The occlusal aid 700 may include a first surface 705 and a second surface 715. FIG. 7A illustrates a perspective view of the first surface 705 or lower surface disposed toward a poorly occluded autologous leaflet (in the case of the mitral valve, the posterior leaflet). Figure 7B illustrates a perspective view of a second surface 715 or upper surface that may be positioned anteriorly towards the leaflet. The second surface 715 may include an occlusion surface 760. The upper edge 740 of the occlusion aid element 700 may be bent to conform to the overall shape of the valve annulus or adjacent atrial wall. The upper edge 740 may be bent downward towards the posterior leaflet, as shown in Figure 7B. Figure 7C illustrates a top view of the occlusion aid element 700.

[0228] Figures 7A through 7C show views of the occlusion aid element 700 having an annular hub 720. The occlusion aid element 700 may include an annular hub 720 designed to engage an annular anchor 800. The annular anchor 800 may engage proximally via a actuator as described herein. The annular hub 720 may have a built-in or coupled annular anchor 800. The annular anchor 800 may include a helical structure rotatable relative to the annular hub 720. The occlusion aid element 700 may be delivered percutaneously via an attachment of a delivery catheter to the annular hub 720 as described herein.

[0229] As can be seen in Figures 7A to 7C, the occlusion aid 700 may include a support 730. In some embodiments, one or more supports 730 have one end terminating at an annular hub 720 and another end extending radially outward toward the upper edge 740, lateral edges 770 and 775, and lower edge 780 of the occlusion aid 700 shown in Figure 7B. An annular anchor portion 735 is shown in Figure 7B as extending downward from the body of the occlusion aid 700. The annular anchor 800 may be an active anchor. The annular anchor portion 735 may be a passive anchor, such as a barb. The annular anchor portion 735 may be at the distal end of one or more supports 730.

[0230] When the occlusion aid 700 is deployed, an annular segment 710 may be arranged above the autologous leaflet. In some embodiments, the annular segment 710 may be curved toward the annulus or atrial wall. One or more of the support members 730 may be laterally bent from the hub 720 toward the upper edge 740 to help maintain the shape of the annular segment 710 of the engagement aid element 700 during deployment. The engagement aid element 700 may be bent downward from the annular hub 720 toward the valve annulus anchoring portion 735. The annular segment 710 may be concave. In some embodiments, one or more support structures may be provided extending parallel to the upper edge 740 of the engagement aid element 700 and helping to maintain the shape of the upper edge 740. In some embodiments, the support members 730 and / or other support structures of the frame may be laser-cut from a nitinol tube. The valve body cover 750 may be made of materials as described herein.

[0231] In some embodiments, the engagement aid element 700 includes active anchors such as annular anchors 800. In some embodiments, the engagement aid element 700 includes passive anchors such as valve annulus anchoring portions 735. The valve annulus anchoring portion 735 may include barbs at the tips of one or more support members 730.

[0232] The occlusion aid 700 and the occlusion aids 500, 600 described herein may include one or more markers 900. Markers 900 may be disposed on the occlusion aids 500, 600, 700 or any of their components such as the support members 530, 630, 730, the annular hubs 520, 620, 720, the drawstring suture 1010, and / or any portion of the valve annulus anchoring portions 535, 735. In some embodiments, markers 900 are disposed on the annular anchor 800. In other embodiments, markers 900 are integrally formed with the occlusion aids 500, 600, 700 or the annular anchor 800. Multiple markers 900 may be arranged in a specific pattern on the occlusion aids to provide operators with fluoroscopic visual assistance for accurately orienting and positioning the occlusion aids 500, 600, 700 and / or the annular anchor 800 within the patient's heart.

[0233] In some embodiments, the markers 900 may be radiopaque, or they may be covered by radiographic markers. During the delivery of the occlusion aids 500, 600, 700 and / or the annular anchor 800, the markers 900 can be visualized using a fluoroscope, see page 32, CN 121057564 A, specification 29 / 126. The markers 900 can aid in the placement of the occlusion aids 500, 600, 700 and / or the annular anchor 800 within the patient's heart. In some embodiments, torque may be applied to the annular anchor 800 to drive it into the tissue. To provide feedback on whether the annular anchor 800 is properly secured, the fluorescein markers 900 may be present on the annular anchor 800. The markers may be located proximally. These markers 900 can inform the medical team how far the annular anchor 800 may have traveled toward the annular hubs 520, 620, 720, and provide information about the proper tightening of the annular anchor 800. In some embodiments, to ensure that appropriate torque is applied, the torque level at the handle can rapidly increase as the annular anchor 800 descends to its lowest point on the annular hubs 520, 620, 720. The system described herein may include one or more markers 900 (e.g., one, two, three, four, five, six, seven, eight, nine, ten, more than one, more than two, more than three, more than four, etc.). The system described herein may include more than two different markers 900. Different markers may indicate different components of the system, different portions of the occlusion aids 500, 600, 700, or placement points such as nearest point, farthest point, midline, etc.

[0234] Figures 7D to 7E illustrate embodiments of the occlusion aid 700 deployed within a cardiac mitral valve model. Referring back to Figure 1F, the occlusal zone CL between the leaflets is not a simple line, but a curved funnel-shaped surface interface as shown in Figure 7C. The first 110 (anterior-lateral or left-side) and the second 114 (posterior-medial or right-side) commissures are where the anterior leaflet 12 and the posterior leaflet meet at the occlusal zone, forming the occlusal line (CL). As most clearly visible in the axial view of the atrium in Figure 7D, the axial section of the occlusal zone typically shows a curved line CL that is separated from the centroid of the valve annulus and from the opening through the valve during diastole. Furthermore, the leaflet edges are scalloped, especially the posterior leaflet compared to the anterior leaflet. Malalignment can occur between one or more of these A-P (anterior-posterior) segments A1 / P1, A2 / P2, and A3 / P3, such that the characteristics of malalignment may vary along the curve of the occlusal zone CL, as shown in Figure 1F.

[0235] In some embodiments, the occlusion aid 700 is placed above the posterior leaflet to create a new surface on which the autologous leaflet (here, the anterior leaflet) can occlude. The mitral valve is shown having an anterior leaflet 12. An occlusion zone exists between the anterior leaflet 12 and the occlusion surface 760 of the occlusion aid 700.

[0236] Referring now to FIG8A, aspects of the delivery catheter 1000 are illustrated. The delivery catheter 1000 may include a control handle. The delivery catheter 1000 may include a tip deflection control 1001. The tip deflection control 1001 can deflect a distal segment of the delivery catheter 1000. This can facilitate placement of the occlusion aids 500, 600, 700 within the mitral valve. The delivery catheter 1000 can be inserted into a septal sheath (not shown). The septal sheath allows the delivery catheter to be introduced into the left atrium. The delivery catheter 1000 may also include one or more ports 1002, such as flushing, irrigation, and / or aspiration ports, to remove air from the system and allow fluids such as saline or contrast agents to be injected into the implantation site. The catheter 1000 may include a catheter shaft 1006. The catheter 1000 may include an implant inserter 1007.

[0237] The delivery catheter 1000 may include an implant control handle 1003. The implant control handle 1003 can control the movement of the occlusion aids 500, 600, and 700. The implant control handle 1003 can achieve the collapse of the occlusion aids 500, 600, and 700. The implant control handle 1003 can achieve the deployment of the occlusion aids 500, 600, and 700. Arrow 1003a indicates the direction of movement of the implant control handle 1003 for collapsing and / or unfolding the occlusion aids 500, 600, 700 via the delivery catheter 1000. The implant control handle 1003 can enable rotation of the occlusion aids 500, 600, 700. Arrow 1003b indicates the direction of movement of the implant control handle 1003 for rotating the occlusion aids 500, 600, 700.

[0238] The implant control handle 1003 may be internally connected to the occlusion aids 500, 600, 700 to allow axial movement and / or torque transmission. For example, the implant control handle 1003 of the delivery catheter 1000 may be coupled to annular hubs 520, 620, 720. For example, the implant control handle 1003 can be connected to one or more pocket-shaped drawstring sutures 1010 that can control the deployment of the occlusion aids 500, 600, 700, as described in this specification (page 30 / 126, CN 121057564 A). The pocket-shaped drawstring sutures 1010 can facilitate the collapse and / or deployment of the occlusion aids 500, 600, 700 as described herein.The rotation of the mating auxiliary elements 500, 600, 700. In some embodiments, the delivery conduit 1000 is releasably engaged with the mating auxiliary elements 500, 600, 700 to allow axial movement and torque to be transmitted from the delivery conduit 1000 to the mating auxiliary elements 500, 600, 700.

[0239] In some embodiments, the tip 1300 of the delivery conduit 1000 is releasably coupled to the annular hubs 520, 620, 720. For example, the tip 1300 of the delivery conduit 1000 may be locked onto the annular hubs 520, 620, 720 such that movement of the delivery conduit 1000 causes movement of the mating auxiliary elements 500, 600, 700. In some embodiments, the system includes a release mechanism between the delivery conduit 1000 and the annular hubs 520, 620, 720.

[0240] The annular hubs 520, 620, 720 may have the feature of being lockable using the tip 1300 of the delivery conduit 1000. Referring back to Figures 5A through 7E, the annular hubs 520, 620, and 720 may include one or more features for engaging a portion of the delivery conduit 1000. These features may include one or more notches in the hub 520 of the implant, as shown in Figure 5A. These features may include an internal lip, as shown in Figure 9A. These features may include windows accessible from the outside of the hubs 520, 620, and 720, as shown in Figure 8C. These features may include any structure or mechanism capable of connecting the annular hubs 520, 620, and 720 to a portion of the delivery conduit 1000. In some embodiments, the annular hubs 520, 620, and 720 and the delivery conduit 1000 are connected via a bolted mechanism. For example, the annular hubs 520, 620, and 720 may include female threads and the distal end of the delivery conduit 1000 may include male threads. In some embodiments, the annular hubs 520, 620, and 720 and the delivery conduit 1000 are connected via a lasso and pin configuration. For example, annular hubs 520, 620, and 720 may include pins such as outwardly extending pins, and the distal end of the delivery conduit 1000 may include a ring or sling designed to be tensioned around said pin. Other configurations may be considered.

[0241] FIG8B shows engagement aids 500, 600, and 700 coupled to the delivery conduit 1000. Engagement aids 500, 600, and 700 may collapse or unfold as shown by dashed lines by moving along arrow 1003a. Engagement aids 500, 600, and 700 may rotate as shown by dashed lines by moving along arrow 1003b.

[0242] Referring to FIG8C, the delivery conduit 1000 may include a tip 1300. The distal end of the tip 1300 may include a distal locking tab. In some embodiments, the tip 1300 includes a plurality of pre-bent or shaped locking tabs. In some embodiments, the tip includes two locking tabs, three locking tabs, four locking tabs, five locking tabs, or multiple locking tabs.Numerous locking tabs, etc. The "AT-lock" (axial torsion lock) may include nitinol locking tabs on the tip 1300. In some embodiments, the locking tabs of the tip 1300 can be driven by a sheath 1350. In some embodiments, the sheath 1350 is hollow to allow movement of other components described herein, such as actuators. Movement of the sheath 1350 can force the locking tabs inward to engage with annular hubs 520, 620, 720. In some embodiments, the locking tabs of the tip 1300 engage features such as windows or lips of the annular hubs 520, 620, 720. In some embodiments, movement of the sheath 1350 in the opposite direction can cause the annular hubs 520, 620, 720 to be released from the tip. In other embodiments, the locking tabs of the tip 1300 can be driven by a central pin (not shown) inserted within the tip 1300. In some embodiments, the central pin is hollow to allow movement of other components described herein, such as actuators. Movement of the central pin can force the locking tabs outward to engage with annular hubs 520, 620, 720.

[0243] In some embodiments, the distal end of the tip 1300 may be actuated to lock the delivery conduit 1000 to the annular hubs 520, 620, 720. In some embodiments, the distal end of the tip 1300 may be actuated to unlock the delivery conduit 1000 from the annular hubs 520, 620, 720. As described herein, after the annular hubs 520, 620, 720 are released from the tip 1300, substructures such as pocket drawstring sutures may remain connected to the engagement aids 500, 600, 700. In some embodiments, when the delivery conduit 1000 is unlocked, one or more substructures such as pocket drawstring sutures described herein may remain in their relative positions between the delivery conduit 1000 and the annular hubs 520, 620, 720. The tip 1300 may be repeatedly locked and unlocked during the process. Specification 31 / 126 pages 34 CN 121057564 A

[0244] Referring to Figure 8A, the delivery conduit 1000 may include an anchor control handle 1004. In some embodiments, the anchor control handle 1004 may release the annular anchor 800 and / or engagement aids 500, 600, 700. In some embodiments, the anchor control handle 1004 may engage the annular anchor 800, for example by rotating the annular anchor 800 and / or axially moving the annular anchor 800. In some embodiments, the anchor control handle 1004 may disengage the annular anchor 800. In some embodiments, the anchor control handle 1004 may control a driver 1200 configured to apply torque. In some embodiments, the anchor control handle 1004 may control a driver 1200 configured to apply tension and / or release the engagement aids 500,Actuator 1200 of 600, 700. In some embodiments, anchor control handle 1004 can control actuator 1200 configured to apply tension and torque.

[0245] Anchor control handle 1004 of delivery conduit 1000 can be coupled to annular anchor 800 to allow torque to be transmitted to annular anchor 800. Anchor control handle 1004 can enable simple manipulation of torque or position of annular anchor 800. Arrow 1004a indicates the direction of movement of anchor control handle 1004 for engaging or disengaging annular anchor 800. For example, moving anchor control handle 1004 toward annular anchor 800 can engage actuator 1200 with annular anchor 800. Arrow 1004b indicates the direction of movement of anchor control handle 1004 for transmitting torque to annular anchor 800. In some embodiments, arrow 1004b indicates the direction of release of annular anchor 800. For example, the application of additional torque can twist the actuator 1200 out of engagement with the annular anchor 800.

[0246] An embodiment of the annular anchor 800 is illustrated in detail in FIG. 9A. Other components of the delivery conduit 1000, such as those engaging the annular hubs 520, 620, and 720, are not shown in FIG. 9A. The annular anchor 800 can be coupled to the actuator 1200 in various ways, as described herein. The annular anchor 800 can be coupled to the mating aids 500, 600, and 700 in various ways. In some embodiments, the annular hubs 520, 620, and 720 may have a cross pin 820. The cross pin 820 may provide a portion around which the helical structure 815 of the annular anchor 800, as shown, can be wound. The annular anchor 800 may have a shoulder 805. The shoulder 805 may be mounted around the outside of the actuator 1200 of the delivery conduit 1000.

[0247] In some embodiments, the actuator 1200 is releasably coupled to the annular anchor 800. The actuator 1200 can be coupled and / or controlled via the anchor control handle 1004 described herein. One or more actuators 1200 can deliver torque to drive the annular anchor 800 into tissue. One or more actuators 1200 can deliver tension to support and / or release the annular anchor 800. In some embodiments, a single actuator 1200 delivers torque and tension. In other embodiments, two or more actuators 1200 deliver torque and tension. For example, the actuator 1200 can be locked to the annular anchor 800 such that movement of the actuator 1200 causes movement of the annular anchor 800. In some embodiments, the system includes a release mechanism between the actuator 1200 and the annular anchor 800. In some embodiments, the distal end of the actuator 1200 can be actuated to lock the actuator 1200 to the annular anchor 800. In some embodiments, the distal end of the actuator 1200 can be actuated to lock the actuator 1200 to the annular anchor 800.Unlocking from the annular anchor 800. In some embodiments, when the actuator 1200 is unlocked, one or more substructures, such as a pocket drawstring type suture, may be held in relative position between the delivery conduit 1000 and the annular anchor 800. During the process, the actuator 1200 may be repeatedly locked and unlocked.

[0248] FIG9B illustrates an embodiment of the actuator 1200. The actuator 1200 may include a torque shaft 1205. The torque shaft 1205 may include an annulus 1210. The annulus 1210 may engage a pin 1215, extend and loop around a tension cross pin 1270 and through the anchor 800. Rotation of the torque shaft 1205 may apply torque to the torque cross pin 1275, thereby causing rotation of the annular anchor 800. In some embodiments, the annular anchor 800 may include a torque cross pin and a tension cross pin. Another actuator (not shown) may apply torque to the tension cross pin to apply tension to the annular anchor 800. One or more actuators 1200 may engage annular anchors 800 to deliver torque. One or more actuators 1200 may engage annular anchors 800 to deliver tension. In some embodiments, the delivery of annular anchors 800 is independent of rotation of 500, 600, 700.

[0249] FIG9C illustrates an embodiment of actuator 1200. Actuator 1200 may include torque shaft 1220. Torque shaft 1220 may include anchor docking cap 1225. Anchor docking cap 1225 may engage annular anchors 800 in a single orientation or one of multiple orientations. In some embodiments, annular anchors 800 include protrusions 1230, and anchor docking cap 1225 is designed to receive protrusions 1230. In other embodiments, annular anchors 800 include recesses (not shown) to receive mating protrusions (not shown) on anchor docking cap 1225. Rotation of the torque shaft 1220 can apply torque to the annular anchor 800. Another actuator 1235 can apply tension to the annular anchor 800. In some embodiments, the actuator 1235 may include a release bolt. In other embodiments, an annular and pin release mechanism as described in FIG. 9B can be used. The release bolt can be rotated to release the annular anchor 800. One or more actuators 1200 can engage the annular anchor 800 to deliver torque. One or more actuators 1200 can engage the annular anchor 800 to deliver tension.

[0250] FIG. 9D illustrates an embodiment of the actuator 1200 and the annular anchor 800. The actuator 1200 may include a torque shaft 1220. The torque shaft 1220 may include an anchor butt cap 1225. In some embodiments, the annular anchor 800 includes a protrusionPart 1230, and the anchor butt cap 1225 is designed to receive the protrusion 1230. In other embodiments, the annular anchor 800 includes a recess (not shown) to receive the mating protrusion (not shown) on the anchor butt cap 1225. Two or more wires 1240, 1245 can apply tension to the annular anchor 800. In some embodiments, wire 1240 serves as a pin, and wire 1245 terminates with a ball. In the held state, wires 1240, 1245 are arranged within an opening in the annular anchor 800. The opening is too small to allow the pin and ball ends of wires 1240, 1245 to pass side by side. In some methods of use, wire 1240 is first retracted. The retraction of wire 1240 creates sufficient space to allow wire 1245 to retract. Wires 1240, 1245 can be driven to release the annular anchor 800. One or more actuators 1200 may engage annular anchors 800 to deliver torque. One or more actuators 1200 may engage annular anchors 800 to deliver tension.

[0251] FIG9E illustrates an embodiment of actuator 1200. Actuator 1200 may include torque shaft 1255. Shoulder 805 may have features such as window 810, which may be locked using one or more distal locking tabs 1265 of torque shaft 1255. Distal locking tabs 1265 may include nitinol material such as shaped NiTi clips. Distal locking tabs 1265 may be pushed outward into window 810 by actuator 1260. Actuator 1260 acts as a release mechanism. Longitudinal movement of actuator 1260 toward annular anchors 800 may push distal locking tabs 1265 outward toward window 810. The longitudinal movement of the actuator 1260 away from the annular anchor 800 can restore the distal locking tab 1265 to its intermediate configuration and disengage it from the window 810. The distal locking tab 1265, which engages with the window 810 of the annular anchor 800, can allow axial movement transmission between the torque shaft 1255 and the annular anchor 800. The distal locking tab 1265, which engages with the window 810 of the annular anchor 800, can allow torque transmission between the torque shaft 1255 and the annular anchor 800. In embodiments where the annular anchor 800 is integrated or captured by the annular hubs 520, 620, 720, the distal locking tab 1265, which engages with the window 810, can allow axial movement transmission between the delivery conduit and the mating aids 500, 600, 700.

[0252] In some embodiments, an advantage is that the annular anchor 800 can rotate independently of the mating aids 500, 600, 700. As described herein, the mating auxiliary elements 500, 600, and 700 are connected to the delivery conduit 1000. As described herein, the annular anchor 800 is independently connected to the actuator 1200. The annular anchor 800 can rotate independently of the annular hubs 520, 620, and 720.When the annular anchor 800 is rotated to engage the tissue, the annular hubs 520, 620, and 720 can remain fixed.

[0253] In some methods, the annular anchor 800 may be pre-loaded onto the occlusion aids 500, 600, and 700 and coupled to the actuator 1200 during the process of mounting the occlusion aids 500, 600, and 700 onto the delivery catheter 1000. This can occur before the occlusion aids 500, 600, and 700 are pulled into another portion of the implant sheath and / or the delivery catheter 1000 and are ready for insertion into the femoral vein. As disclosed herein, torque can be applied such that the annular anchor 800 is driven into the tissue. In some embodiments, to ensure that appropriate torque is applied, the torque level at the handle can rise rapidly as the annular anchor 800 is lowered to its lowest point on the annular hubs 520, 620, and 720. The increased torque level can be felt at the handle, providing feedback that the torque has been properly applied. In other embodiments, radiopaque markings can help visually determine the level of anchor engagement within the tissue. In some embodiments, the markings may be located on the annular anchor 800 and / or the engagement aids 500, 600, 700.

[0254] Figures 10 through 15 illustrate various methods that can be performed during the use of the engagement aids 500, 600, 700. The methods may include collapsing the engagement aids 500, 600, 700. The methods may include coupling the engagement aids 500, 600, 700 to the delivery conduit 1000. The methods may include coupling the locking tab 1265 to the annular anchor 800 and / or the engagement aids 500, 600, 700. The methods may include any of the steps disclosed herein for manufacturing the engagement aids 500, 600, 700.

[0255] In some embodiments, an advantage is that the occlusion aids 500, 600, 700 can be delivered using a hub-guided orientation. In this method of use, the annular hubs 520, 620, 720 can be moved into position relative to the anatomical structure before another portion of the occlusion aids 500, 600, 700. In some methods of use, the ventricular end of the occlusion aids 500, 600, 700 can be held within the delivery catheter 1000 until the annular hubs 520, 620, 720 are positioned. In some methods of use, the occlusion aids 500, 600, 700 can be deployed once the annular hubs 520, 620, 720 and / or the annular anchors 800 are engaged with the tissue. In some methods of use, the ventricular end of the occlusion aids 500, 600, 700 can be positioned once the annular hubs 520, 620, 720 and / or the annular anchors 800 are engaged with the tissue.

[0256] In some embodiments, an advantage is that the occlusion aids 500, 600, 700 can be delivered using a support-guided orientation. In this method of use, one or more of the supports 530, 630, 730 of the occlusion aids 500, 600, 700 can be moved into position relative to the anatomical structure before another portion of the occlusion aids 500, 600, 700. In some methods of use, the occlusion aids 500, 600, 700 can be deployed or partially deployed before the arrangement of the annular hubs 520, 620, 720. In some methods of use, the annular hubs 520, 620, 720 can be held within the delivery conduit until one or more of the supports 530, 630, 730 are arranged. In some methods of use, once the supports 530, 630, 730 are arranged, the annular anchor 800 engages with the tissue.

[0257] Figure 10 illustrates an embodiment of transseptal crossing. The method may include femoral vein access. Access can be made via a blood vessel such as the femoral vein to reach a cardiac chamber such as the right atrium 1300. The left ventricle 1380 and its papillary muscles 1360 are also shown. The method may include transseptal puncture and passage into the left atrium 1320 using a standard transseptal kit 1330. The method may include exchanging a custom transseptal sheath and delivery catheter 1000 as described herein. The transseptal puncture kit may be replaced with a transseptal sheath and dilator, and the dilator may be replaced with an implantable delivery catheter, which may be disclosed herein and in U.S. Patent No. 8,888,843 to Khairkhahan et al., which is incorporated herein by reference in its entirety. The method may include removing the dilator. The method may include advancing the delivery catheter 1000. However, other routes such as transapical, transatrial, femoral, brachial, etc., are also within the scope of the invention.

[0258] Figure 11 illustrates the initial advance of the occlusion aids 500, 600, 700. The method may include advancing the occlusion aids 500, 600, 700 within a retraction sheath. The retraction sheath may include a tip having a plurality of petals radiating from a central hub 1420. The retraction sheath may be disposed within a transseptal sheath 1400. The mitral valve is shown at the base of the left atrium 1440. The method may include advancing the annular segments 510, 610, 710 toward the annulus before advancing the occlusion surfaces 560, 660, 760 toward the annulus. The method may include deploying the ventricular end or inferior surface 580 after deploying the annular segment 510.

[0259] Figure 12 illustrates a partial deployment of the occlusion aids 500, 600, 700. The occlusion aids 500, 600, 700 may be advanced toward a target location under imaging guidance such as ultrasound or fluoroscopy. Instruction manual for auxiliary components 500, 600, and 700, page 34 / 126, 37 CN 121057564 AThe annular anchor 800 is engaged in the tissue. The anchor torque axis 1540 can rotate internally and independently of the rotation of the implant torque axis (not shown). Controlled release of the pocket-shaped suture 1010 around the periphery of the occlusion aids 500, 600, 700 can deploy the occlusion aids 500, 600, 700. Before the occlusion aids 500, 600, 700 are fully deployed, rotational adjustments can be made to align the internal (ventricular) segments of the occlusion aids 500, 600, 700 with the valve opening 1580.

[0260] The method may include advancing the occlusion aids 500, 600, 700 toward a target position. The method may include advancing the annular hubs 520, 620, 720 toward a target position. The method may include advancing annular anchors 800 connected to annular hubs 520, 620, 720 toward a target position. The method may include echo- or fluoroscopic guidance of the annular anchors 800, hubs 520, 620, 720, and / or engagement aids 500, 600, 700. The method may include engaging the annular anchors 800 in tissue. The method may include rotating the anchor control handle 1004 to rotate the annular anchors 800. The method may include independent rotation of the valve anchors 800 relative to hubs 520, 620, 720. The method may include holding hubs 520, 620, 720 stationary during rotation of the annular anchors 800. The method may include controlled release of the pocket-shaped drawstring suture 1010. Release may deploy the engagement aids 500, 600, 700. A pocket-shaped drawstring suture 1010 may be provided within and / or around the occlusion aids 500, 600, 700. The pocket-shaped drawstring suture 1010 may facilitate the collapse and / or unfolding of the occlusion aids 500, 600, 700. The method may include rotating and adjusting the occlusion aids 500, 600, 700 so that the lower edges 580, 680, 780 or ventricular segments of the occlusion aids 500, 600, 700 are aligned with the valve openings. The method may include rotating and adjusting the occlusion aids 500, 600, 700 so that the lower edges 580, 680, 780 or ventricular segments are aligned around the posterior leaflet.

[0261] FIG13 illustrates the recapture of the occlusion aids 500, 600, 700. The engaging auxiliary elements 500, 600, and 700 can be recaptured by tightening the drawstring-type stitching 1010 around a portion of the periphery 1620 of the engaging auxiliary elements 500, 600, and 700 to collapse the engaging auxiliary elements 500, 600, and 700. The periphery can include any edge, any combination of edges, or all edges described herein. A recapture sheath and a transect sheath 1600 can be positioned above the collapsed engaging auxiliary elements 500, 600, and 700.Forward. The recapture sheath petals emanating from the central hub can reverse the engagement aids 500, 600, 700, causing them to retract back into the transept. The annular anchor 800 can be unscrewed or released, and the system can be removed. The engagement aids 500, 600, 700, with their petals protruding or partially enclosed by the recapture sheath petals, can be another delivery mode. This enclosed-priority delivery mode can contrast with the hub-priority and support delivery modes described herein.

[0262] In some methods, recapture is optional. The method may include tightening the drawstring-type stitching 1010 at the purse opening. This tightening may collapse the engagement aids 500, 600, 700. The method may include advancing the recapture sheath and / or transept over the collapsed engagement aids 500, 600, 700. The recapture sheath can be folded outward to flip the occlusion aids 500, 600, 700. The method may include retracting the occlusion aids 500, 600, 700 back into the transseptal sheath. The method may include rotating the annular anchor 800 to disengage it from the tissue. The method may include removing the occlusion aids 500, 600, 700 and the annular anchor 800.

[0263] FIG14 illustrates a cross-sectional view of the deployed occlusion aids 500, 600, 700. The method may include releasing the occlusion aids 500, 600, 700. The method may include retracting the delivery catheter 1000.

[0264] FIG15 illustrates the deployment of the secondary anchor. In some methods, the deployment of the secondary anchor is optional. The method may include engaging the valve annulus attachment sites 535, 735 with the valve annulus. The method may include engaging the ventricular anchor. The method may include engaging the commissural anchor 1650. The method may include deploying markers at strategic locations on the mating aids 500, 600, 700 and / or the annular anchor 800. The method may include detecting the markers, such as detecting radiopaque markers. The method may include facilitating the placement of the anchor 800 under fluorescent imaging. The method may include positioning radiopaque markers along the periphery of the mating aids 500, 600, 700 (see page 35 / 126 of the specification of CN 121057564 A) to indicate the shape of the mating aids 500, 600, 700.

[0265] In some embodiments, the manufacturer provides instructions for use of a system including one or more of the steps disclosed herein, or any steps previously described in the drawings or inherent therein.

[0266] Figures 16 through 30 illustrate various methods that may be performed during the use of the mating aids 500, 600, 700. According to some embodiments of the invention, the method may include any steps disclosed herein. This method may include any of the steps disclosed herein for manufacturing and / or deploying mating auxiliary elements 500, 600, 700. The method may include making the mating auxiliary elements...The occlusion aids 500, 600, and 700 are collapsed.

[0267] Figure 16 illustrates a method for implant delivery, showing the loading of the occlusion aids 500, 600, and 700. As described herein, the occlusion aids 500, 600, and 700 can be collapsed. The collapsed occlusion aids 500, 600, and 700 can be loaded into a transseptal sheath introducer 1700. The transseptal sheath introducer 1700 may include a sheath having a lumen to receive the collapsed occlusion aids 500, 600, and 700. The collapsed occlusion aids 500, 600, and 700 can be inverted within the transseptal sheath introducer 1700. Annular hubs 520, 620, and 720 can be positioned near the edge 1705 of the transseptal sheath introducer 1700. The transseptal guide 1700 may include a multilumen catheter 1710 connected to occlusion aids 500, 600, 700. The method may include loading the occlusion aids 500, 600, 700 into the transseptal guide 1700.

[0268] FIG17 illustrates a method for inserting the transseptal guide 1700 into a transseptal sheath 1715. The transseptal guide 1700 may include a multilumen catheter 1710. The multilumen catheter 1710 and / or the transseptal guide 1700 may include a hub 1720. The hub 1720 is capable of connecting to the transseptal sheath 1715. The proximal end of the transseptal sheath 1715 is shown in FIG17. In FIG17, the transseptal guide 1700 is not connected to the transseptal sheath 1715. In FIG18, the transseptal guide 1700 is connected to the transseptal sheath 1715. The method may include connecting a transseptal guide 1700 to a transseptal sheath 1715. The method may include connecting an assembly including engagement aids 500, 600, 700 to the transseptal sheath 1715.

[0269] FIG19 illustrates a method for advancing the transseptal guide 1700. The transseptal guide 1700 may be advanced to the distal end of the transseptal sheath 1715. The engagement aids 500, 600, 700 may be advanced through the transseptal sheath 1715. When advancing through the transseptal sheath 1715, the collapsed engagement aids 500, 600, 700 may be inverted. In FIG19, the engagement aids 500, 600, 700 are located at the distal end of the transseptal sheath 1715.

[0270] FIG20 illustrates a method for positioning the transseptal sheath 1715. During positioning, the occlusion aids 500, 600, and 700 can be located distal to the transseptal sheath 1715. The transseptal sheath 1715 can be positioned within the valve annulus. The transseptal sheath 1715 can be positioned above the posterior leaflet. The transseptal sheath 1715 can be centered on P2 as described herein. The method may include positioning the occlusion aids 500, 600, and 700...Positioning of 600 and 700 to the posterior leaflet. The method may include positioning the occlusal aids 500, 600, and 700 centered on P2. The method may include positioning the occlusal aids 500, 600, and 700 within the valve annulus. The transseptal sheath 1715 can be rotated as indicated by the arrow. The transseptal sheath 1715 can be rotated to position the occlusal aids 500, 600, and 700. The transseptal sheath 1715 can correct the atrium / ventricle orientation. The transseptal sheath 1715 may include one or more markings / marks 1725. Markings 1725 allow the user to guide the rotation of the transseptal sheath 1715. Markings 1725 enable the user to provide correct orientation of the annular portion of the occlusal aids 500, 600, and 700. Markings 1725 enable the user to provide correct orientation of the ventricular segment of the occlusal aids 500, 600, and 700. In some embodiments, the mark 1725 may include a non-transparent mark. Figure 20 shows the mate assist elements 500, 600, 700 and the transseptal sheath 1715 centered at P2 in the annulus of the mitral valve. Figure 20 shows the rotation of the mate assist elements 500, 600, 700 and the transseptal sheath 1715.

[0271] Figure 21 illustrates a method for delivering the anchor 800. The anchor 800 may include any of the features of the anchors described herein. Based on the position of the anchor 800 after deployment, the anchor 800 may be considered the P2 anchor. As described herein on pages 36 / 126, CN 121057564 A, the anchor 800 may extend through the annular hubs 520, 620, 720. The method may include delivering the anchor 800 while the mate assist elements 500, 600, 700 are within the transseptal sheath 1715. In some embodiments, the anchor 800 is coupled to the annular hubs 520, 620, and 720 of the mating aids 500, 600, and 700 before being loaded into the transept 1715. In some embodiments, the anchor 800 is coupled to the annular hubs 520, 620, and 720 of the mating aids 500, 600, and 700 while within the transept 1715. In some embodiments, the anchor 800 is coupled to the annular hubs 520, 620, and 720 of the mating aids 500, 600, and 700 after the transept 1715 has been positioned within the annulus. The method may include delivering the anchor 800 while the mating aids 500, 600, and 700 are within the transept 1715. During the delivery of the anchor 800, the mating aids 500, 600, and 700 may be centered on P2 in the annulus. As described herein, anchor 800 can be inserted by rotating it into the tissue of the annulus.

[0272] Figures 22A to 22D illustrate a method for deploying engagement aids 500, 600, and 700. By retracting...Entrainment aids 500, 600, and 700 can be deployed via diaphragm 1715. Diaphragm 1715 can be retracted by moving it proximally from anchor 800. Entrainment aids 500, 600, and 700 can be inverted within diaphragm 1715. In some embodiments, as shown in FIG22A, the annular segments near the annular hubs 520, 620, and 700 of entrainment aids 500, 600, and 700 can be deployed first. In some embodiments, the ventricular segments of entrainment aids 500, 600, and 700 can then be deployed, as shown in FIG22B. Entrainment aids 500, 600, and 700 can be inverted to extend the ventricular segments proximally from the annular segments. In some embodiments, when entrainment aids 500, 600, and 700 are deployed as shown in FIG22C, the entrainment aids 500, 600, and 700 can be deployed outward from P2. The antagonistic aids 500, 600, and 700 can be inverted to extend the ventricular segment proximally from the annular segment. The antagonistic aids 500, 600, and 700 can also be inverted such that the ventricular segment extends toward the transseptal sheath 1715.

[0273] In some embodiments, the antagonistic aids 500, 600, and 700 can be folded back as shown in FIG22D. The antagonistic aids 500, 600, and 700 can be reversed from the initial deployment configuration such that the ventricular segment extends distally from the annular segment. The antagonistic aids 500, 600, and 700 can be positioned such that the ventricular segment extends away from the transseptal sheath 1715. This method can include deploying the antagonistic aids 500, 600, and 700 by retracting the transseptal sheath 1715. FIG22A through FIG22D illustrate the deployment of the antagonistic aids 500, 600, and 700.

[0274] Figures 23 to 30 illustrate the deployment of one or more sub-anchors 850. Sub-anchors 850 may include any features of anchors 800. Sub-anchors 850 may include helical or spiral structures. Sub-anchors 850 may be designed to engage cardiac tissue, such as the tissue of the valve annulus. Sub-anchors 850 may include bio-inert materials, such as platinum / Ir, Nitinol alloys, and / or stainless steel.

[0275] Figure 23 illustrates a method utilizing one or more sub-anchor guidewires. Occlusion aids 500, 600, 700 may include one or more sub-anchor guidewires. In the illustrated embodiments, occlusion aids 500, 600, 700 may include a first guidewire 1730 and a second guidewire 1735. In some embodiments, occlusion aids 500, 600, 700 may include any number of sub-anchor guidewires (e.g., approximately or at least approximately one, two, three, four, five, etc.). In some embodiments, the number of sub-anchor guide wires corresponds to (or is equal to) the number of sub-anchors (e.g., one sub-anchor uses one...).(Two guide wires are used for two auxiliary anchors, etc.). Figure 23 illustrates an embodiment of the coupling tube 1740. The coupling tube 1740 may include any of the features described herein, including those shown in Figures 42A to 45K.

[0276] Figure 23 illustrates a tethering pattern. The tethering pattern may correspond to one or more methods for evaluating the coupling auxiliary elements 500, 600, 700. The tethering pattern may correspond to one or more methods for evaluating the functionality of the coupling auxiliary elements 500, 600, 700 without one or more delivery systems. In some embodiments, the tethering pattern may correspond to one or more methods for evaluating the functionality of the coupling auxiliary elements 500, 600, 700 without the sheath 1715. The tethering pattern can evaluate functionality without a large number of delivery systems. Figure 23 shows the deployed coupling auxiliary elements 500, 600, 700. Figure 23 shows the occlusion aids 500, 600, and 700 entering the tethered mode by retracting the implant shaft. Figure 23 also shows the occlusion aids 500, 600, and 700 entering the tethered mode by retracting via the diaphragm 1715.

[0277] Figure 24 illustrates a method relating to the coupling tube 1740. The coupling tube 1740 may include internal threads. The coupling tube 1740 may include an internally threaded DS hub for engagement with externally threaded portions 525, 625, and 725 of annular hubs 520, 620, and 720. The coupling tube 1740 may include an internally threaded hub for connection to the occlusion aids 500, 600, and 700. In some methods of use, the coupling tube 1740 is removed for the tethered mode. Figure 24 shows the occlusion aids 500, 600, and 700 entering the tethered mode by retracting the coupling tube 1740.

[0278] FIG24 illustrates a method relating to anchor actuator 1745. Anchor actuator 1745 may be disposed within coupling tube 1740. Anchor actuator 1745 may include any features described herein, including those shown in FIGS. 42A through 45K. During the method shown in FIG21, anchor actuator 1745 may rotate anchor 800. Anchor actuator 1745 may rotate anchor 800 via annular hubs 520, 620, 720. In some methods of use, anchor actuator 1745 is removed for tethering mode. FIG24 shows coupling aids 500, 600, 700 entering tethering mode by retracting anchor actuator 1745.

[0279] Anchor actuator 1745 may include tethering guide 1750. Tethering guide 1750 may include any of the features described herein.Features, including those shown in Figures 42A through 45K. The tethering guide 1750 can be secured to the anchor 800. The tethering guide 1750 allows for a minimum force assessment of the effectiveness of the engagement aids 500, 600, and 700 before releasing them. As an example, the user can verify that the engagement aids 500, 600, and 700 are functioning. As an example, the user can verify that the autologous leaflets are engaging with the engagement aids 500, 600, and 700. As an example, the user can verify that the forces applied to the engagement aids 500, 600, and 700 are within acceptable limits. As an example, the user can verify that the engagement aids 500, 600, and 700 do not deform under the force of the autologous leaflets. As an example, the user can verify that the engagement aids 500, 600, and 700 have been deployed. As an example, a user can verify that the mating auxiliary elements 500, 600, and 700 cross the mitral valve. The mating tube 1740 can be retracted as shown. As shown in Figure 24, during the tethering mode, the tethering guide rail 1750 can remain engaged to the anchor 800.

[0280] Figure 25 illustrates a method for advancing the sub-anchor guide rails. In the illustrated embodiment, the method may include a first guide rail 1755 and a second guide wire 1760. In some embodiments, the mating auxiliary elements 500, 600, and 700 may include any number of sub-anchor guide rails (e.g., one, two, three, four, five, etc.). In some embodiments, the number of sub-anchor guide rails corresponds to the number of sub-guide wires (e.g., one rail for one sub-guide wire, two rails for two sub-guide wires, etc.). The first guide rail 1755 may advance along the first guide wire 1730. The second guide rail 1760 may advance along the second guide wire 1735. The method may include advancing both sub-anchor guide rails 1755 and 1760. In Figure 25, the sub-anchor guides 1755 and 1760 are located on guide wires 1730 and 1735.

[0281] The distal end 1765 of each sub-anchor guide 1755 and 1760 may be threaded. In some embodiments, the distal end 1765 of each sub-anchor guide 1755 and 1760 engages tissue in the valve ring. The distal end 1765 may be threaded to temporarily secure the sub-anchor to the guides 1755 and 1760 during transport. In some embodiments, the distal end 1765 of each sub-anchor guide 1755 and 1760 may reduce the likelihood of the sub-anchor unintentionally detaching from the sub-anchor guide 1755 and 1760. The sub-anchor guides 1755 and 1760 may reduce the likelihood of the sub-anchor becoming entangled with the guide wires 1730 and 1735. In some embodiments, the diameter of the secondary anchor guide rails 1755 and 1760 is greater than or equal to the secondary anchor pitch.

[0282] In some methods of use, the coupling tube 1740 may be attached to the mating auxiliary elements 500, 600, 700. This attachment may allow the anchor 800 to be recessed during the delivery of the mating auxiliary elements 500, 600, 700. In some embodiments, before deploying the anchor 800, the sub-anchor guides 1755, 1760 advance on guide wires 1730, 1735. In some embodiments, after deploying the anchor 800, the sub-anchor guides 1755, 1760 advance on guide wires 1730, 1735. Figure 25 shows the mating auxiliary elements 500, 600, 700 secured to the petiole ring using the anchor 800, wherein the sub-anchor guides advance to the surface of the mating auxiliary elements 500, 600, 700.

[0283] Figure 26 illustrates a method for delivering the sub-anchor 1770. The sub-anchor 1770 advances on the first guide rail 1755. The sub-anchor 1770 can advance toward the mating auxiliary elements 500, 600, 700. The sub-anchor 1770 can be installed by the driver 1775. The driver 1775 can translate the sub-anchor 1770 along the first guide rail 1755.

[0284] FIG27 illustrates a method for inserting the sub-anchor 1770. The driver 1775 can rotate the sub-anchor 1770 along the first guide rail 1755. The sub-anchor 1770 can pass through the mating auxiliary elements 500, 600, 700. The sub-anchor 1770 can be rotated to engage the tissue below the mating auxiliary elements 500, 600, 700. FIG26 shows the mating auxiliary elements 500, 600, 700 secured to the valve rings with anchors 800 when the sub-anchor 1770 is delivered. Figure 26 shows the engagement aids 500, 600, and 700, secured to the annulus by anchors 800, when the sub-anchor 1770 is inserted into the tissue. The actuator 1775 is still attached as shown in Figure 27. The sub-anchor 1770 can be an intermediate anchor. The sub-anchor 1770 can be positioned on the medial side of the anchor 800.

[0285] Figure 28 illustrates a method for delivering the sub-anchor 1780. The sub-anchor 1780 advances on the second guide rail 1760. The sub-anchor 1780 can advance toward the engagement aids 500, 600, and 700. In some applications, the sub-anchor 1780 can be mounted using the actuator 1775. In some applications, the actuator 1775 can be retracted along the first guide rail 1755 before advancing along the second guide rail 1760. In other applications, the secondary anchor 1780 is mounted using a different driver than the secondary anchor 1770. Driver 1775 allows the secondary anchor 1780 to translate along the first guide rail 1760. In some applications,Sub-anchor 1770 can be pre-inserted into the tissue.

[0286] Driver 1775 can rotate sub-anchor 1780 along second guide rail 1760. Sub-anchor 1780 can pass through engagement aids 500, 600, 700. Sub-anchor 1780 can be rotated to engage the tissue below engagement aids 500, 600, 700. Figure 28 shows engagement aids 500, 600, 700 secured to the annulus via anchor 800 and sub-anchor 1770 during delivery of sub-anchor 1780. Figure 26 shows engagement aids 500, 600, 700 secured to the annulus via anchor 800 and sub-anchor 1770 when sub-anchor 1780 is inserted into the tissue. Sub-anchor 1780 can be a lateral anchor. Sub-anchor 1780 can be positioned on the lateral side of anchor 800.

[0287] FIG29 illustrates mating auxiliary elements 500, 600, 700 with sub-anchor guide wires 1730, 1735. The tethering rail 1750 can remain connected to the anchor 800. The sub-anchor guide wires 1730, 1735 remain connected. The delivery system can be reattached. In some uses, one or more rails 1755, 1760 can be reattached. In some uses, the actuator 1775 is reattached. One or more sub-anchors 1770, 1780 can be removed. One or more sub-anchors 1770, 1780 can be repositioned. In some uses, the mating tube 1740 can be reattached. In some uses, the anchor actuator 1745 can be reattached. The anchor 800 can be removed. The anchor 800 can be repositioned. The anchor 800 and sub-anchors 1770, 1780 can be removed. The mating auxiliary elements 500, 600, and 700 can be retracted. Figure 29 shows the mating auxiliary elements 500, 600, and 700 deployed and anchored, with the secondary anchor guide wires 1730 and 1735 and the tethered rail 1750 retained, thus allowing removal.

[0288] Figure 30 illustrates the anchored mating auxiliary elements 500, 600, and 700. The secondary anchor guide wires 1730 and 1735 are removed. The tethered rail 1750 is removed. In some embodiments, the tethered rail 1750 is rotated and retracted. The mating auxiliary elements 500, 600, and 700 are shown as fully deployed and anchored. In some methods of use, removal is no longer possible. In some methods of use, removal by the methods described in Figures 31A to 31F is no longer possible. Instruction manual, pages 39 / 126, CN 121057564 A

[0289] Figures 31A to 31F illustrate methods for removing mating auxiliary elements 500, 600, and 700. Mating auxiliary elements500, 600, and 700 can be removed via sheath 1715. In some methods of use, without the secondary anchors 1770 and 1780, the mating auxiliary elements 500, 600, and 700 can be removed after the anchor 800 is removed. In some methods of use, the mating auxiliary elements 500, 600, and 700 can be removed after the anchor 800 and all secondary anchors 1770 and 1780 have been removed. In Figures 31A to 31F, the mating auxiliary elements 500, 600, and 700 are removed via sheath 1715. In some methods of use, removal is optional. In some methods of use, removal occurs after the method shown in Figure 29 and before the method shown in Figure 30.

[0290] Figures 32 to 35 illustrate a method for installing one or more secondary anchors. One or more methods can be used in conjunction with the methods described herein. One or more methods can be used as alternatives to the methods described herein. As an example, one or more methods shown in Figures 32 to 35 can replace one or more methods shown in Figures 23 to 30. The sub-anchors described herein can be transported using guide wires and / or rails with various different designs. In some embodiments, each sub-anchor may have a dedicated lumen (e.g., two sub-anchors using two lumens; four sub-anchors using four lumens, etc.). In some embodiments, each sub-anchor may have a dedicated guide wire (e.g., two sub-anchors using two guide wires, four sub-anchors using four guide wires, etc.). In some embodiments, two sub-anchors share a lumen (e.g., two sub-anchors in one lumen, four sub-anchors in two lumens; two guide wires in one lumen, four guide wires in two lumens, etc.). The rail can reduce entanglement of the sub-anchors. The rail can reduce entanglement of the sub-anchors with two or more guide wires in the lumen.

[0291] Figure 32 illustrates a method for inserting a sub-anchor. In some methods of use, the sub-anchor 1770 is inserted as described herein. Guide wire 1735 may extend from sub-anchor 1770. Guide wire 1735 may extend into a lumen or a shared lumen. In some methods of use, sub-anchor 1770 is inserted as described herein. One or more sub-anchors 1170, 1780 may be inserted.

[0292] In some embodiments, one guide wire 1735 may be used for two sub-anchors. In some methods of use, guide wire 1735 may be snared and removed to facilitate removal of guide wire 1735 after delivery of the first sub-anchor 1770. In some embodiments, guide wire 1735 forms a loop. In some embodiments, a portion of the loop of guide wire 1735 is received within mating aids 500, 600, 700. In some embodiments, the loop thread-throughs the mating aid.500, 600, 700. In some embodiments, the catcher 1785 may be positioned along the guide wire 1735. In some embodiments, the catcher 1785 forms a loop. In some embodiments, a portion of the loop of the guide wire 1735 is received within the loop of the catcher 1785. The method may include using the catcher 1785. The catcher 1785 may be used to unthreading the guide wire 1735. The catcher 1785 may be retracted. The catcher 1785 may be pulled proximally through the lumen.

[0293] FIG33 illustrates a method for delivering a sub-anchor 1790. The catcher 1785 has been retracted into the lumen. The catcher 1785 has pulled the guide wire 1735 proximally. In some embodiments, an actuator 1775 or another actuator may advance the sub-anchor 1790 along the guide wire 1735. In some embodiments, the sub-anchor 1790 is delivered after the guide wire 1735 has been removed from the anchor 1770 using the catcher 1785.

[0294] FIG34 illustrates a method for inserting the sub-anchor 1790. The sub-anchor 1790 is rotatable. The sub-anchor 1790 can pass through the engagement aids 500, 600, 700. The sub-anchor 1790 can be rotated to engage the tissue beneath the engagement aids 500, 600, 700. FIG34 shows the engagement aids 500, 600, 700 secured to the valve ring by the anchor 800 and the sub-anchor 1770 during delivery of the sub-anchor 1790. The sub-anchor 1790 can be a medial anchor. The sub-anchor 1790 can be positioned on the medial side of the anchor 800. The sub-anchor 1790 can be positioned between the anchor 800 and the sub-anchor 1770. Specification 40 / 126 pages 43 CN 121057564 A

[0295] FIG35 illustrates the anchoring engagement auxiliary elements 500, 600, 700. The method can be repeated to install one or more additional sub-anchors. For example, one or more additional sub-anchors may be located between sub-anchor 1780 and anchor 800, as shown in FIG30. For example, one or more additional sub-anchors may be located between sub-anchor 1770 and anchor 800, as shown in FIG30. For example, one or more additional sub-anchors may be located at any position on the annular segment of engagement auxiliary elements 500, 600, 700.

[0296] FIG36 and FIG37 illustrate embodiments of 2D laminates. FIG38 and FIG39 illustrate embodiments of 3D forming. In some embodiments, engagement auxiliary elements 500, 600, 700 include multiple laminates on the entire engagement auxiliary element or on only a portion of the engagement auxiliary element. In some embodiments, the plurality of laminates may include two or more laminates (e.g.(e.g., two-layer, three-layer, four-layer, five-layer, etc.). Two or more layers in a multilayer laminate may include the same material. Two or more layers in a multilayer laminate may include different materials. Two or more layers in a multilayer laminate may have the same dimensions (e.g., length, width, thickness, diameter, etc.). Two or more layers in a multilayer laminate may include one or more different dimensions. The laminate may be variable depending on the region of the mating auxiliary elements 500, 600, 700. In some embodiments, the mating region may have an additional protective layer. In some embodiments, the mating surfaces 560, 660, 760, relative to another portion of the mating auxiliary elements 500, 600, 700, include one or more additional layers. Figure 38 shows an additional layer 1795 located only in the mating region (e.g., the lower region) of the mating auxiliary elements 500, 600, 700. Thus, the lower occlusion region can be thicker than the upper region of the occlusion aid element located near the annulus of the heart valve, for example, at least about 10%, 25%, 50%, 75%, 100%, 150%, 200%, 250%, 300% or more thicker than the upper region, or a range including any two of the above values.

[0297] The multilayer laminate can be manufactured using a 2D lamination method. In some methods of use, two or more layers are bonded together. These layers can be bonded by heating. These layers can be bonded by adhesives. These layers can be bonded together by any mechanical or chemical change. These layers can be bonded together by any mechanical or chemical change. The occlusion aid elements 500, 600, 700 can have a generally 2D shape. In some embodiments, one or more layers comprise high-density polyethylene (PE), polypropylene, polyester (Dacron), acellular collagen matrix (e.g., SIS) or other plastics.

[0298] The multilayer laminate can be manufactured using a 3D forming method. The occlusion aid elements 500, 600, 700 can be shaped. As described herein, the mating auxiliary elements 500, 600, and 700 may include support members 530, 630, and 730. In some embodiments, the support members 530, 630, and 730 are made of an elastically deformable material, such as a shape memory metal or shape memory polymer, such as nitinol. In some embodiments, the material is Elgiloy. In some embodiments, the support member 530 may be made of other materials, including stainless steel, polypropylene, high-density polyethylene (PE), polyester (Dacron), acellular collagen matrix (e.g., SIS), or other plastics. 3D forming may include shaping the shape memory metal into an appropriate shape. This shape may be set using a suitable mold that bends the support members 530, 630, and 730 into the desired shape. The shaping or shape training may include adjusting the support members...The assembly auxiliary elements 500, 600, and 700 are constrained on a fixing device or within a mold. In some methods of use, when the assembly auxiliary elements 500, 600, and 700 are on a fixing device or within a mold, appropriate heat treatment is applied to the assembly auxiliary elements 500, 600, and 700. In some embodiments, temperature, time, and / or other parameters are adjusted to heat-set the assembly auxiliary elements 500, 600, and 700. In some embodiments, the heat-setting temperature is greater than 300°C, greater than 400°C, greater than 500°C, greater than 600°C, etc. In some embodiments, the heat-setting time is 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 6 minutes, 7 minutes, 8 minutes, 9 minutes, 10 minutes, more than 2 minutes, more than 5 minutes, more than 10 minutes, etc. In some embodiments, the method may include rapid cooling. In some embodiments, the method may include rapid cooling by water or air.

[0299] FIG40 illustrates the assembly auxiliary element 400. The mating aid element 400 may include any of the features of the mating aid elements described herein. The mating aid element 400 may include an annular hub 420 for attachment to a delivery system, similar to the annular hub described herein. The annular hub 425 may include an externally threaded portion 425. The mating aid element 400 may include a support material 430. The support material 430 may be an atrial arm that may be bent in an upward and / or downward direction.

[0300] The mating aid element 400 may include an annular anchoring portion 435. The annular anchoring portion 435 may be part of the support material 430. In some embodiments, the annular anchoring portion 435 includes one or more barbs with sharp tips. The annular anchoring portion 435 may be a passive anchor. The barbs may be fully exposed and shaped as shown in FIG40. In some embodiments, the barbs extend from a multilayer laminate. The barbs may be a free end of the support material 430. In some embodiments, barbs may be located on the surface of the occlusion aid element 400. In some embodiments, tissue may be engaged by the backward push barbs of the lamination. For example, as shown in FIG41, the multilayer lamination may be pushed backward. FIG41 illustrates an embodiment of the barbs. In some methods of use, engagement of the barbs with the tissue may result in the multilayer lamination being pushed backward.

[0301] The occlusion aid element 400 may include a knotless suture edge 455. This edge may reduce trauma to autologous tissue. The occlusion aid element 400 may include one or more rounded edges to reduce trauma. In some embodiments, the lateral edges of the occlusion aid element 400 are rounded. In some embodiments, the occlusion aid elementThe upper edge of 400 is rounded. In some embodiments, the lower edge of the occlusion aid 400 is rounded.

[0302] The occlusion aid 400 may include an occlusion surface 460. The occlusion surface 460 may include an additional protective layer. In some embodiments, the occlusion surface 460 may include one or more additional layers of a multilayer laminate. In some embodiments, the occlusion surface 460 may include one or more different layers of a multilayer laminate. One or more layers of the occlusion surface 460 may be designed to facilitate long-term use of the occlusion aid 400. One or more layers of the occlusion surface 460 may be designed to facilitate occlusion with an autologous leaflet.

[0303] Figures 42A to 45K illustrate embodiments of an implant delivery system. The implant delivery system may include any of the occlusion aids described herein. The implant delivery system may be designed to position the occlusion aid within the heart. The implant delivery system may include any of the anchors described herein. The implant delivery system may be designed to engage the anchors with tissue. The implant delivery system may be designed to allow the anchors to rotate.

[0304] Figures 42A to 42i illustrate embodiments of an implant delivery system 1800. The implant delivery system 1800 may include a coupling tube 1805. The coupling tube 1805 is connected to an implant torque shaft 1810. In some embodiments, the implant torque shaft 1810 may be rigidly coupled to the coupling tube 1805. In some embodiments, the implant torque shaft 1810 is welded or brazed to the coupling tube 1805. The implant torque shaft 1810 may transmit torque to the coupling tube 1805, as described herein. The coupling tube 1805 may be coupled to engagement aids 400, 500, 600, 700. In the illustrated embodiments, only a portion of the supports 430, 530, 630, 730 is illustrated.

[0305] Referring now to Figures 42A to 42B, the coupling tube 1805 may include one or more slots 1815. In the illustrated embodiment, the connector 1805 may include a slot 1815, but other configurations are also considered (e.g., two slots, three slots, four slots, two diametrically opposed slots, four radially spaced slots, etc.). The slot 1815 may extend through the connector 1815. In some embodiments, the connector 1805 may include one or more grooves that do not extend through the connector. The slot 1815 may extend along the length of the connector 1805 or a portion thereof. The slot 1815 may extend between the distal and proximal ends of the connector 1805.

[0306] The connector 1805 may include a pin 1820 disposed within the slot 1815. In some embodiments, the connector 1805 may include a spring 1825 disposed within the slot 1815. The pin 1820 may be coupled to a pull wire 1830. The pull wire 1830 may allow the pin 1820 to...The annular hubs 420, 520, 620, and 720 may include a recess 1835. The recess 1835 in the annular hubs 420, 520, 620, and 720 may be aligned with the recess 1815 in the coupling tube 1805. A pin 1820 may be disposed within the recess 1835.

[0307] The annular hubs 420, 520, 620, and 720 may include externally threaded portions 425, 525, 625, and 725. The coupling tube 1805 may include an internally threaded portion 1840, as described in CN 121057564 A on pages 42 / 126 of the specification. In some methods of use, the coupling tube 1805 is rotated to engage the coupling tube 1805 with the annular hubs 420, 520, 620, and 720. The internal thread portion 1840 engages with the external thread portions 425, 525, 625, and 725. A groove 1835 may be cut out on the outer diameter of the thread on the external thread portions 425, 525, 625, and 725. A slot 1815 may be cut out on the inner diameter of the internal thread portion 1840 of the connecting pipe 1805. The slot 1815 may be aligned with the groove 1835. In some embodiments, the slot 1815 may be aligned with the groove 1835 when the connecting pipe 1805 reaches its lowest point against the mating aids 400, 500, 600, and 700.

[0308] Figures 42A and 42B illustrate the neutral position of the pin 1820. The spring 1825 biases the pin 1820 downwards and engages the pin 1820 with the groove 1835. Pin 1835 spans between connector 1805 and annular hubs 420, 520, 620, and 720. In its natural state, pin 1820 faces forward. In this state, pin 1820 locks the threaded connection between the internal threaded portion 1840 of connector 1805 and the external threaded portions 425, 525, 625, and 725 of annular hubs 420, 520, 620, and 720. Pin 1820 allows the user to rotate mating aids 400, 500, 600, and 700 in both directions via connector 1805 and implant torque shaft 1810. Pin 1820 allows the user to rotate mating aids 400, 500, 600, and 700 clockwise or counterclockwise by rotating connector 1805. In some applications, pin 1820 can be used for movement of mating aids 400, 500, 600, and 700 via connector 1805. When slot 1815 and recess 1835 are aligned, the spring-loaded pin 1820 can slide into recess 1835 and essentially lock into the thread. Figure 42A shows pin 1820 forward so that coupling tube 1805 and mating auxiliary elements 400, 500, 600, 700 are locked together. Figure 42B shows a cross-sectional view of locking pin 1820 in its natural forward position.

[0309] Figures 42C to 42D show the release of pin 1820. Pin 1820 can be pulled back via pull cable 1830. Pin 1820 can compress spring 1825. Pin 1820 can be removed from groove 1835. Pin 1820 slides along groove 1815. In this position, coupling tube 1805 can be unscrewed from mating auxiliary elements 400, 500, 600, 700. Internal threaded portion 1840 can disengage from external threaded portions 425, 525, 625, 725 by rotating coupling tube 1805. Figure 42C shows a cross-sectional view of the retracted pin 1820. With pin 1820 retracted, coupling tube 1805 can be unscrewed from annular hubs 420, 520, 620, 720. Figures 42A to 42D illustrate that the docking hub 1805 can be connected to the mating auxiliary elements 400, 500, 600, and 700 for positioning the mating auxiliary elements 400, 500, 600, and 700. Figures 42A to 42D illustrate that the docking hub 1805 can be connected to the mating auxiliary elements 400, 500, 600, and 700 for rotating the mating auxiliary elements 400, 500, 600, and 700.

[0310] Figures 42E to 42i illustrate the use of the anchor 800 with the implant delivery system 1800. As shown in Figure 42E, the anchor 800 is located within the docking hub 1805. The anchor 800 is in a retracted state within the docking hub 1805. The anchor 800 is internal relative to the locking mechanism or pin 1820. The docking hub 1805 is shown or drawn in line form. For clarity, the docking hub 1805 and implant torque shaft 1810 shown in FIG. 42E are removed in FIG. 42F.

[0311] As described herein, the anchor 800 can be screwed in at the anatomical P2 location on the posterior leaflet. The anchor 800 can be considered as the P2 anchor. The anchor 800 can be driven by the actuator 1845. FIG. 42G shows a close-up view of the actuator 1845. The actuator 1845 has fully driven the anchor 800 into the tissue and down into the annular hubs 420, 520, 620, 720 of the occlusion aids 400, 500, 600, 700. The actuator 1845 is connected to the internal torque shaft 1850. The actuator 1845 and the anchor 800 are fully accommodated within the docking hub 1805, as described herein. The internal torque shaft 1850 can extend through the implant torque shaft 1810, referring to FIG. 42E.

[0312] Figure 42H shows an internal cross-sectional view of the anchor 800. To ensure a secure connection with the actuator 1845, the anchor 800 can be tensioned onto the actuator 1845 via a tethering guide 1855. The tethering guide 1855 may include a guide wire having a small screw or externally threaded portion 1860 at its distal end. The externally threaded portion 1860 of the tethering guide 1855 is configured to engage the anchor.The anchor 800 has an internal threaded portion 1865. Figure 42H shows an internal view of the tethering guide 1855 and the connection between the anchor 800 and the annular hubs 420, 520, 620, and 720.

[0313] Figure 42H also shows a square recess 1870 in the head of the anchor 800. The actuator 1845 may include a square portion (not shown) configured to engage with the square recess 1870 in the head of the anchor 800. Other designs for mating the anchor 800 and the actuator 1845 have also been considered (e.g., any non-circular shape, polygonal, hexagonal, Philips, elliptical, etc.).

[0314] The anchor 800 may include a shoulder 1875. Once the anchor 800 is fully driven into the tissue, the shoulder 1875 of the anchor 800 pushes down the annular hubs 420, 520, 620, 720 to secure the occlusion aids 400, 500, 600, 700. Figure 42i shows a view of the anchored occlusion aids 400, 500, 600, 700.

[0315] Figures 43A to 43E illustrate embodiments of the implant delivery system 1900. The implant delivery system 1900 may include an occlusion manifold 1905. The occlusion manifold 1905 may be cylindrical. The occlusion manifold 1905 is connected to the implant torque shaft 1910. In some embodiments, the implant torque shaft 1910 may be rigidly coupled to the occlusion manifold 1905. In some embodiments, the implant torque shaft 1910 is welded or brazed to the occlusion manifold 1905. The implant torque shaft 1910 may transmit torque to the occlusion manifold 1905 as described herein. The connecting tube 1905 can be coupled to mating auxiliary elements 400, 500, 600, 700. In the illustrated embodiment, only a portion of the support members 430, 530, 630, 730 is shown.

[0316] The connecting tube 1905 may include two or more lower tubes 1915 (hypotubes) embedded in the wall. The lower tubes 1915 may include lumens. The lower tubes 1915 may be diametrically opposed. The lower tubes 1915 may be spaced 180° apart. The lower tubes 1915 may extend within a groove. The lower tubes 1915 may extend along a portion of the length of the connecting tube 1905. In some embodiments, the connecting tube 1905 includes two or more lumens. In some embodiments, the lumens are integrally or integrally formed with the connecting tube 1905. In the illustrated embodiment, the connecting tube 1905 may include two lower tubes 1915, but other configurations are also considered (e.g., four lower tubes, etc.).

[0317] The connecting pipe 1905 may include a fastening element 1920 disposed within the lower pipe 1915. In some embodiments, the fastening element...Component 1920 can loop through the opposing gaps in the mating auxiliary elements 400, 500, 600, and 700. In some embodiments, fastener 1920 can pass between the support members 430, 530, 630, and 730 in the mating auxiliary elements 400, 500, 600, and 700. Fastener 1920 can extend through a lower tube 1915, through the mating auxiliary elements 400, 500, 600, and 700, below the annular hubs 420, 520, 620, and 720, through the mating auxiliary elements 400, 500, 600, and 700, and through another lower tube 1915. Fastener 1920 can loop through the mating auxiliary elements 400, 500, 600, and 700. The tether 1920 can loop through the occlusion aids 400, 500, 600, 700 and return to the proximal or handle end of the system.

[0318] Figures 43A and 43B illustrate the initial position of the tether 1920. In this state, the tether 1920 holds the occlusion aids 400, 500, 600, 700 together. The tether 1920 allows the user to twist the occlusion aids 400, 500, 600, 700 in both directions via the occlusion aid 1905 and the implant torque axis 1910. The tether 1920 allows the user to rotate the occlusion aids 400, 500, 600, 700 clockwise or counterclockwise by rotating the occlusion aid 1905. In some applications, the fastener 1920 can be used for the movement of mating auxiliary elements 400, 500, 600, 700 via the mating connector 1905. The fastener 1920 can be released. With the fastener 1920 released, the mating connector 1905 can be disengaged from the annular hubs 420, 520, 620, 720. Figures 43A and 43B illustrate that the mating hub 1905 can be connected to the mating auxiliary elements 400, 500, 600, 700 for positioning them. Figures 43A and 43B also illustrate that the mating hub 1805 can be connected to the mating auxiliary elements 400, 500, 600, 700 for rotating them.

[0319] Figures 43C to 43E illustrate the use of the anchor 800 with the implant delivery system 1900. As shown in Figure 43C, the anchor 800 is located within the docking hub 1905. The anchor 800 is in a retracted state within the docking hub 1905. The anchor 800 is located internally relative to the locking mechanism or tether 1920. The docking hub 1905 is shown as a line in Figure 43B.

[0320] As described herein, the anchor 800 can be screwed into an anatomical P2 location on the posterior leaflet. The anchor 800 can be considered as the P2 anchor. The anchor 800 can be driven by the actuator 1945. Figure 43D shows a close-up view of the actuator 1945.The actuator has fully driven the anchor 800 into the tissue and down into the annular hubs 420, 520, 620, and 720 of the mating aids 400, 500, 600, and 700. The actuator 1945 is connected to the internal torque shaft 1950. In some embodiments, the internal torque shaft 1950 is welded or brazed to the actuator 1945. The actuator 1945 and the anchor 800 are fully accommodated within the mating hub 1905. The internal torque shaft 1950 may extend through the implant torque shaft 1910. Figure 43C illustrates the advance of the anchor 800 before it is fully positioned. Figure 43D shows the anchor 800 being screwed down into the tissue.

[0321] Figure 43C also shows an internal cross-sectional view of the anchor 800. To ensure a secure connection with the actuator 1945, the anchor 800 can be tensioned onto the actuator 1945 via the tethering guide 1955. The tethering guide 1955 may include a guide wire having a small screw or externally threaded portion 1960 at its distal end. The externally threaded portion 1960 of the tethering guide 1955 is configured to engage the internally threaded portion 1965 of the anchoring device 800. Figure 42C shows an internal view of the tethering guide 1955 and the connection between the anchor 800 and the annular hubs 420, 520, 620, 720. The tethering guide 1955 allows for a minimum force assessment of the effectiveness of the engagement aids 400, 500, 600, 700 before releasing them. The tethering guide 1955 allows for a minimum force assessment of the effectiveness of the engagement aids 400, 500, 600, and 700 before releasing the tethering member 1920. Figure 43C illustrates a cross-sectional view showing the path of the tethering member 1920.

[0322] Figure 43E shows a view of the implanted anchor 800. Figure 42E also shows a square recess 1970 in the head of the anchor 800. The actuator 1945 may include a square portion (not shown) configured to engage with the square recess 1970 within the head of the anchor 800. Other designs for mates between the anchor 800 and the actuator 1945 have also been considered (e.g., any non-circular shape, polygonal, hexagonal, Philips, elliptical, etc.). The anchor 800 may include an anchor hub. The hub may include an internally threaded portion 1965 of the anchor 800 to allow connection to the tethering guide 1955. The anchor 800 may include an anchoring helix. The anchoring helix may include a bottom tip for optimal tissue penetration.

[0323] The engagement aids 400, 500, 600, and 700 may include some cuts to minimize the sliding friction of the bolt 1920.Minimization. Anchor 800 can be screwed into the tissue and lowered to its lowest point on hubs 420, 520, 620, and 720. The user can retract the coupling tube 1905, leaving the two ends of the tether 1920 exposed. The tether can be connected via an internal torque shaft. If the user is satisfied with the performance of the occlusion aids 400, 500, 600, and 700, the user can remove the tether 1920. If the user is not satisfied with the performance of the occlusion aids 400, 500, 600, and 700, the user can re-connect the implant delivery system 1900 to the tether 1920. If the user is not satisfied with the performance of the occlusion aids 400, 500, 600, and 700, the user can pass the tether 1920 through the lower tube 1915. If the user is not satisfied with the performance of the mating aids 400, 500, 600, and 700, the user can remove the anchor 800 and / or completely remove the mating aids 400, 500, 600, and 700.

[0324] Figures 44A to 44E illustrate embodiments of the implant delivery system 2000. The implant delivery system 2000 may include a mating connector 2005. The mating connector 2005 may be of a desired shape, such as a cylindrical shape. The mating connector 2005 is connected to the implant torque shaft 2010. In some embodiments, the implant torque shaft 2010 may be rigidly coupled to the mating connector 2005. In some embodiments, the implant torque shaft 2010 is welded or brazed to the mating connector 2005. The implant torque shaft 2010 may transmit torque to the mating connector 2005, as described herein. The mating connector 2005 may include a mating end cap 2015.

[0325] The coupling tube 2005 may include one, two, or more retaining arms 2020 cut out at its distal end. The one, two, or more retaining arms 2020 may allow the transmission of torque and push / thrust via the implant torque axis 2010 to the engagement aids 400, 500, 600, 700. The coupling tube 2005 may include three retaining arms 2020. The retaining arms 2020 may be equidistantly spaced around the coupling tube 2005. The retaining arms 2020 may be spaced approximately, at least approximately, or no more than approximately 120° or another desired angle. The retaining arms 2020 may extend along a portion of the length of the coupling tube 2005. In some embodiments, the retaining arms 2020 are integrally or integrally formed with the coupling tube 2005. In the illustrated embodiment, the connector 2005 may include three retaining arms 2020, but other configurations are also considered (e.g., one retaining arm, two retaining arms, four retaining arms, five retaining arms, etc.). The retaining arms 2020 may be formed by a U-shaped cutout in the connector 2005.

[0326] Figures 44B and 44C illustrate the initial position of the retaining arm 2020. In this state, the retaining arm 2020 holds the coupling tube 2005 and the engagement aids 400, 500, 600, and 700 together. The retaining arm 2020 allows the user to rotate the engagement aids 400, 500, 600, and 700 in both directions via the coupling tube 2005 and the implant torque axis 2010. The retaining arm 2020 allows the user to rotate the engagement aids 400, 500, 600, and 700 clockwise or counterclockwise by rotating the coupling tube 2005. In some uses, the retaining arm 2020 can be used for movement of the engagement aids 400, 500, 600, and 700 via the coupling tube 2005.

[0327] Referring to Figure 44E, the retaining arm 2020 engages the window 2025 in the head of the anchor 800. In some embodiments, window 2025 is a laser-cut window. In some embodiments, window 2025 extends through annular hubs 420, 520, 620, 720. In some embodiments, window 2025 is a slot or groove. The number of windows 2025 may correspond to the number of retaining arms 2020. In some embodiments, each retaining arm 2020 engages one window 2025. Window 2025 may be shaped to receive a portion of retaining arm 2020, such as tab 2030. In some embodiments, each retaining arm 2020 may include an inwardly facing tab 2030. Tab 2030 may have an increased thickness relative to retaining arm 2020. Tab 2030 may be shaped to engage with window 2025. Tab 2030 may be a distal internal segment of retaining arm 2020.

[0328] Figures 44B to 44D illustrate the use of anchor 800 with implant delivery system 2000. As shown in Figure 44B, the anchor 800 is located within the mating hub 2005. The anchor 800 is in a retracted state within the mating hub 2005. The anchor 800 is located internally relative to the tab 2030 of the locking mechanism or retaining arm 2020. The mating hub 2005 is shown in lines in Figure 44B. Figure 44C shows the advance of the anchor 800. Figure 44C illustrates the advance of the anchor 800 before it is fully positioned and before the retaining arm 2020 bends.

[0329] As described herein, the anchor 800 can be screwed in, for example, at the anatomical P2 position on the posterior leaflet. The anchor 800 can be considered as the P2 anchor. The anchor 800 can be driven by the actuator 2045. Figure 44D shows a close-up view of the actuator 2045. The actuator 2045 has fully driven the anchor 800 into the tissue and downwards onto the annular hubs 420, 520, 620, and 720 of the mating auxiliary elements 400, 500, 600, and 700. The actuator 2045 is connected to the internal torque shaft 2050. In some practical applications...In this embodiment, the internal torque shaft 2050 is welded or brazed to the actuator 2045. The actuator 2045 and the anchor 800 are fully accommodated within the mating hub 2005, as shown in FIG44B. The internal torque shaft 2050 may extend through the implant torque shaft 2010.

[0330] FIG44D shows an internal cross-sectional view of the anchor 800. To ensure a secure connection with the actuator 2045, the anchor 800 can be tensioned onto the actuator 2045 via a tethering guide 2055. The tethering guide 2055 may include a guide wire having a small screw or externally threaded portion 2060 at its distal end. The externally threaded portion 2060 of the tethering guide 2055 is configured to engage the internally threaded portion 2065 of the anchor 800. FIG44D shows an internal view of the tethering guide 2055 and the connection between the anchor 800 and the annular hubs 420, 520, 620, 720. The tethering guide 2055 allows for a minimum force assessment of the effectiveness of the engagement aids 400, 500, 600, and 700 before releasing them. The tethering guide 2055 allows for a minimum force assessment of the effectiveness of the engagement aids 400, 500, 600, and 700 before releasing the retaining arm 2020.

[0331] FIG44D illustrates a cross-sectional view showing the release of the retaining arm 2020. When the anchor 800 is screwed into the tissue, the annular hubs 420, 520, 620, and 720 contact the tabs 2030 of the retaining arm 2020. Due to the distal movement of the annular hubs 420, 520, 620, and 720, the retaining arm 2020 can bend outward from the window 2025 of the anchor 800. The tab 2030 may include an angled surface 2035 that allows the mating tube 2005 to be easily removed from the annular hubs 420, 520, 620, and 720 when the retaining arm 2020 is bent outward. Figure 44D illustrates the advance of the anchor 800, wherein the retaining arm 2020 bends outward when the anchor 800 is fully driven in. Specification 46 / 126 pages 49 CN 121057564 A

[0332] With the retaining arm 2020 bent outward, the mating tube 2005 can be disengaged from the annular hubs 420, 520, 620, and 720. Figure 44D illustrates that the mating hub 2005 can be disengaged from the mating auxiliary elements 400, 500, 600, and 700. Figures 44A to 44C illustrate that the mating hub 2005 can be connected to mating auxiliary elements 400, 500, 600, and 700 for positioning the mating auxiliary elements 400, 500, 600, and 700. Figures 44A to 44C illustrate that the mating hub 2005 can be connected to the mating auxiliary elements 400, 500, 600, and 700 for rotating the mating auxiliary elements 400, 500, 600, and 700.

[0333] Figure 44E shows a view of the implanted anchor 800. Figure 44E also shows a square recess 2070 in the head of the anchor 800. The actuator 2045 may include a square portion (not shown) configured to engage with the square recess 2070 within the head of the anchor 800. Other designs for mating the anchor 800 and the actuator 2045 have also been considered (e.g., any non-circular shape, polygonal, hexagonal, Philips, elliptical, etc.). The anchor 800 may include an anchor hub. The hub may include an internally threaded portion 2065 of the anchor 800 to allow connection to the tethering guide 2055. The anchor 800 may include an anchoring helix. The anchor 800 may include a window 2025. The window 2025 allows the retaining arm 2020 to snap and hold onto the annular hubs 420, 520, 620, and 720. Window 2025 allows the retaining arm 2020 to be held on the annular hubs 420, 520, 620, and 720 under compression, tension, and torsion.

[0334] Figures 45A to 45K illustrate embodiments of the implant delivery system 2100. The implant delivery system 2100 may include a connector 2105. The connector 2105 may be cylindrical. The connector 2105 is connected to the implant torque shaft 2110. In some embodiments, the implant torque shaft 2110 may be rigidly coupled to the connector 2105. In some embodiments, the implant torque shaft 2110 is welded or brazed to the connector 2105. The implant torque shaft 2110 may transmit torque to the connector 2105 as described herein. The connector 2105 may include a mating end cap 2115.

[0335] The connector 2105 may include one or more slots 2120 cut out at the distal end. The slot 2120 may be a bayonet slot. The slot 2120 may have a bayonet configuration. One or more slots 2120 may allow the transmission of torque and push / thrust through the implant torque shaft 2110 to the engagement aids 400, 500, 600, 700. The connector 2105 may include three slots 2120. The slots 2120 may be equidistantly spaced around the connector 2105. The slots 2120 may be spaced 120° apart. The slots 2120 may extend along a portion of the length of the connector 2105. In some embodiments, the slots 2120 are formed integrally or integrally with the connector 2105. In the illustrated embodiment, the connector 2105 may include three slots 2120, but other configurations (e.g., one slot, two slots, four slots, five slots, etc.) are also contemplated. The slots 2120 may be formed by J-shaped cutouts in the connector 2105.

[0336] The connecting pipe 2105 may include a flared ring 2125 as shown in FIG. 45B. The flared ring 2125 can ensure that the groove 2120 will not...The distal end of the connector 2105 is weakened. A flared ring 2125 ensures easy re-interlocking. The flared ring 2125 can be welded or brazed to the distal end of the connector 2105.

[0337] Referring to FIG. 45F, the slot 2120 engages a retaining pin 2030 within the head of the anchor 800. In some embodiments, the retaining pin 2030 protrudes sufficiently to ensure proper engagement with the slot 2120 at the tip of the connector 2105. In some embodiments, the retaining pin 2030 extends radially outward from the annular hubs 420, 520, 620, 720. In some embodiments, the retaining pin 2030 is cylindrical. The number of retaining pins 2030 may correspond to the number of slots 2120. In some embodiments, each slot 2120 engages one retaining pin 2025. The slot 2120 may be shaped to receive and guide the retaining pin 2030.

[0338] Figures 45B and 45C illustrate the initial position of the slot 2120 relative to the retaining pin 2030. In this state, the slot 2120 and retaining pin 2030 hold the coupling tube 2005 and the engagement aids 400, 500, 600, and 700 together. The slot 2120 and retaining pin 2030 allow the user to rotate the engagement aids 400, 500, 600, and 700 in both directions via the coupling tube 2005 and the implant torque shaft 2010. The slot 2120 and retaining pin 2030 allow the user to rotate the engagement aids 400, 500, 600, and 700 clockwise or counterclockwise by rotating the coupling tube 2005. In some applications, the slot 2120 and retaining pin 2030 can be used for movement of the engagement aids 400, 500, 600, 700 via the engagement tube 2105, as described on page 47 / 126 of the specification (CN 121057564 A).

[0339] Figures 45B to 45E illustrate the use of the anchor 800 with the implant delivery system 2100. As shown in Figure 45B, the anchor 800 is located within the engagement hub 2105. The anchor 800 is in a retracted state within the engagement hub 2105. The anchor 800 is located internally relative to the locking mechanism or slot 2120. The engagement hub 2105 is shown as a line in Figure 45B. Figure 45C shows the advance of the anchor 800.

[0340] As described herein, the anchor 800 can be screwed in at the anatomical P2 position on the posterior leaflet. The anchor 800 can be considered as the P2 anchor. Anchor 800 can be driven by actuator 2145. Figure 45D shows a close-up view of actuator 2145. Actuator 2145 is connected to internal torque shaft 2150. In some embodiments, internal torque shaft 2150 is welded or brazed to actuator 2145. Actuator 2145 is connected to internal torque shaft 2150. In some embodiments, internal torque shaft 2150 is welded or brazed to actuator 2145.The anchor 800 is brazed to the actuator 2145. The actuator 2145 and the anchor 800 are fully accommodated within the mating hub 2105, as shown in Figure 45B. An internal torque shaft 2150 may extend through the implant torque shaft 2110.

[0341] Figure 45E shows an internal cross-sectional view of the anchor 800. To ensure a secure connection with the actuator 2145, the anchor 800 can be tensioned onto the actuator 2145 via a tethering guide 2155. The tethering guide 2155 may include a guide wire having a small screw or externally threaded portion 2160 at its distal end. The externally threaded portion 2160 of the tethering guide 2155 is configured to engage the internally threaded portion 2165 of the anchor 800. Figure 45E shows an internal view of the tethering guide 2055 and its connection between the anchor 800 and the annular hubs 420, 520, 620, 720. The tethering guide 2155 allows for a minimum force assessment of the effectiveness of the engagement aids 400, 500, 600, and 700 before releasing them. The tethering guide 2155 allows for a minimum force assessment of the effectiveness of the engagement aids 400, 500, 600, and 700 before releasing the retaining pin 2030.

[0342] When the anchor 800 is screwed into the tissue, the retaining pin 2030 of the annular hubs 420, 520, 620, and 720 moves proximally within the groove 2120. The coupling tube 2005 can be rotated, thereby allowing the retaining pin 2030 of the annular hubs 420, 520, 620, and 720 to move laterally within the groove 2120. The mating hub 2005 can be moved proximally, thereby allowing the retaining pins 2030 of the annular hubs 420, 520, 620, 720 to move distally within the groove 2120. Further proximal movement of the mating hub 2005 can release the mating hub 2105 from the annular hubs 420, 520, 620, 720. Figures 45A to 45C illustrate that the mating hub 2005 can be coupled to the mating aids 400, 500, 600, 700 for positioning the mating aids 400, 500, 600, 700. Figures 45A to 45C illustrate that the mating hub 2105 can be coupled to the mating aids 400, 500, 600, 700 for rotating the mating aids 400, 500, 600, 700.

[0343] Figures 45E to 45F show views of the implanted anchor 800. Figure 45E also shows a square recess 2170 in the head of the anchor 800. The actuator 2145 may include a square portion (not shown) configured to engage with the square recess 2170 within the head of the anchor 800. Other designs for mating the anchor 800 and the actuator 2145 have also been considered (e.g., any non-circular shape, polygon, hexagon, Philips shape, ellipse, etc.). The anchor 800 may include...Anchor hub. The hub may include an internally threaded portion 2165 of anchor 800 to allow connection to tethered guide 2155. Anchor 800 may include an anchoring helix. In some embodiments, annular hubs 420, 520, 620, 720 may include three laser-cut holes for receiving three retaining pins 2130. Retaining pins 2130 may be welded to the holes. In some embodiments, retaining pins 2130 are nitinol. Figures 45G to 45K show additional views.

[0344] Figures 45A to 45C illustrate the deployment of one or more sub-anchors 850, 1770, 1780. Sub-anchors 850, 1770, 1780 may include any feature of anchor 800. Sub-anchors 850, 1770, 1780 may include a helical or spiral structure 852. Sub-anchors 850, 1770, 1780 may be designed to engage tissue of the heart, such as the tissue of the valve annulus. Sub-anchors 850, 1770, and 1780 may include a tip 854, which is designed to engage the structure. The tip 854 may be sharpened. The tip 854 may be ground to achieve optimal penetration. Sub-anchors 850, 1770, and 1780 may include a hub 856. Hub 856 may be an annular hub having any of the features of the annular hubs 420, 520, 620, and 720 described herein. Hub 856 may include one or more mating features 858. Matting feature 858 may be a cut. Matting feature 858 may form two semi-circular portions at different heights. Matting feature 858 may include a first circular portion and a second circular portion. The first circular portion and the second circular portion may be separated by a vertical cut. Matting feature 858 may include any configuration that allows torque transmission to sub-anchors 850, 1770, and 1780.

[0345] Figures 46A to 46C illustrate a delivery catheter 860 designed for deploying one or more sub-anchors 850, 1770, 1780. The distal end of the delivery catheter 860 is shown in the figures. The delivery catheter 860 may include a proximal end outside the patient's body. The proximal end may include one or more controllers for manipulating the delivery catheter 860. The delivery catheter 860 may include a torque shaft 862. In some embodiments, the torque shaft 862 may cause the sub-anchors 850, 1770, 1780 to rotate in any direction. The torque shaft 862 may include a chamber 864. The torque shaft 862 may include a helical or spiral structure 866. The helical or spiral structure 866 of the torque shaft 862 may have the same or similar features as the helical or spiral structure 852 of the one or more sub-anchors 850, 1770, 1780. The helical or spiral structure 866 of the torque shaft 862 may have the same or similar features as the one or more sub-anchors 850, 1770, 1780.The helical or helical structure 852 of the sub-anchors 850, 1770, and 1780 has the same pitch. The helical or helical structure 866 of the torque shaft 862 may have the same diameter as the helical or helical structure 852 of the one or more sub-anchors 850, 1770, and 1780. The helical or helical structure 866 of the torque shaft 862 may have the same wire diameter as the helical or helical structure 852 of the one or more sub-anchors 850, 1770, and 1780.

[0346] The delivery conduit 860 may include a locking hub 868. The locking hub 868 may be an annular hub. The locking hub 868 may include one or more mating features 870. The mating features 870 may be designed to lock with the mating features 858 of the hub 856. The mating features 870 may form two semi-circular portions at different heights. The mating features 870 may include a first circular portion and a second circular portion. The first circular portion and the second circular portion may be separated by a vertical cut. The mating feature 870 may include any configuration that allows torque to be transmitted to the hub 856 of the one or more sub-anchors 850, 1770, 1780. A locking hub 868 may be coupled to a locking shaft 872.

[0347] Figure 46A shows a configuration in which the delivery conduit 860 does not engage with the sub-anchors 850, 1770, 1780. Figure 46B shows a configuration in which the delivery conduit 860 engages with the sub-anchors 850, 1770, 1780. In some embodiments, a helix or helical structure 866 may engage with the helix or helical structure 852 of the sub-anchors 850, 1770, 1780. In some embodiments, the two helices may have the same pitch and diameter. Because the two helices have the same pitch and diameter, the combined profile will be the same as the profile of the sub-anchors 850, 1770, 1780. The helical or helical structure 866 can be interlocked with the helical or helical structure 852 of the secondary anchors 850, 1770, and 1780. The helical or helical structure 866 can be fitted into the gap of the helical or helical structure 852 of the secondary anchors 850, 1770, and 1780. The diameter of the combined structure can be the same as the diameter of the helical or helical structure 852 of the secondary anchors 850, 1770, and 1780. In some embodiments, the torque shaft 862 can be rotated to engage the helical or helical structure 866 with the helical or helical structure 852 of the secondary anchors 850, 1770, and 1780. In some embodiments, the secondary anchors 850, 1770, and 1780 can be rotated to engage the helical or helical structure 852 of the secondary anchors 850, 1770, and 1780 with the helical or helical structure 866. Figure 46B shows the engaged helix.

[0348] In some embodiments, locking hub 868 engages with hub 856 of sub-anchors 850, 1770, and 1780. In some embodiments, locking hub 868 may translate toward sub-anchors 850, 1770, and 1780 within chamber 864 of torque shaft 862. Mating feature 870 of locking hub 868 may interlock with mating feature 858 of hub 565 of sub-anchors 850, 1770, and 1780. Locking hub 868 may engage with sub-anchors 850, 1770, and 1780. Hub 856 of sub-anchors 850, 1770, and 1780 and locking hub 868 are engaged to connect sub-anchors 850, 1770, and 1780 to delivery conduit 860. In some embodiments, locking shaft 872 may advance or retract locking hub 868. Specification page 49 / 126 52 CN 121057564 A

[0349] Figure 46C shows a locking hub 868 engaging with the hub 856 of the sub-anchors 850, 1770, 1780. The locking hub 868 engaging with the hub 856 allows the sub-anchors 850, 1770, 1780 to rotate. In some embodiments, the locking hub 868 engaging with the hub 856 can reduce the likelihood that the delivery conduit 860 will disengage from the sub-anchors 850, 1770, 1780 during delivery. In some embodiments, the locking hub 868 engaging with the hub 856 allows the sub-anchors 850, 1770, 1780 to rotate counterclockwise without disengaging from the delivery conduit 860. The sub-anchors 850, 1770, 1780 can rotate counterclockwise to be driven into the tissue.

[0350] Once the sub-anchors 850, 1770, and 1780 are driven into the tissue, the delivery conduit 860 can disengage from the sub-anchors 850, 1770, and 1780. In some embodiments, the locking hub 868 can disengage from the hub 856 of the sub-anchors 850, 1770, and 1780. The locking hub 868 can translate away from the sub-anchors 850, 1770, and 1780 within the chamber 864 of the torque shaft 862. The locking shaft 872 can retract the locking hub 868. In some embodiments, the torque shaft 862 can be rotated to disengage the helix. In some embodiments, the torque shaft 862 can be rotated to disengage the helix or helical structure 866 from the helix or helical structure 852 of the sub-anchors 850, 1770, and 1780.

[0351] In some embodiments, the occlusion aid elements 400, 500, 600, and 700 may include an annular section configured to be implanted in the heart above the valve annulus. In some embodiments, the occlusion aid elements 400, 500, 600, and 700 may include a plurality of supports, the supports including at least a first support and a second support, the first support being located within the annular section, and the second support having a total length greater than the total length of the first support. In some embodimentsIn this embodiment, the occlusion aids 400, 500, 600, and 700 may include a cup-shaped upper edge with an annular segment. In some embodiments, the occlusion aids 400, 500, 600, and 700 may improve occlusion along the entire length without disrupting anatomical structures. In some embodiments, the occlusion aids 400, 500, 600, and 700 may include a plurality of radial supports. In some embodiments, the occlusion aids 400, 500, 600, and 700 may include a first support and a second support, the first support being located within the annular segment, and the second support having a total length greater than the total length of the first support. In some embodiments, the occlusion aids 400, 500, 600, and 700 include a cup-shaped upper edge. In some embodiments, the occlusion aids 400, 500, 600, and 700 may include a hub positioned near the valve annulus. In some embodiments, the occlusion aids 400, 500, 600, and 700 may include radially extended supports. In some embodiments, the engagement aids 400, 500, 600, 700 may include improved engagement of the support material along its entire length without interfering with the anatomical structure. In some embodiments, the engagement aids 400, 500, 600, 700 may be deployed via the support material.

[0352] In some methods, the method may include positioning the hub near the annulus. In some methods, the support material is radially expanded. In some methods, the method may include improved engagement of the support material along its entire length without disrupting the anatomical structure. In some methods, the method may include deploying the engagement element carried by the radially outward-extending support material. In some methods, the method may include deploying the engagement element carried by the radially outward-extending support material to form an annulus section. In some methods, the method may include deploying the engagement element carried by the support material to form an annulus section.

[0353] In some embodiments, annular hubs 420, 520, 620, and 720 are spaced inwardly from the lateral edges of mating aids 400, 500, 600, and 700. In some embodiments, annular hubs 420, 520, 620, and 720 are spaced inwardly from the upper edges of mating aids 400, 500, 600, and 700. In some embodiments, annular hubs 420, 520, 620, and 720 are spaced inwardly from the lower edges of mating aids 400, 500, 600, and 700. In some embodiments, annular hubs 420, 520, 620, and 720 are not deployable. In some embodiments, annular hubs 420, 520, 620, and 720 have a fixed circumference. In some embodiments...In embodiments, annular hubs 420, 520, 620, and 720 retain their shape during the unfolding of mating auxiliary elements 400, 500, 600, and 700. In some embodiments, annular hubs 420, 520, 620, and 720 are formed of tubes. Supports 430, 530, 630, and 730 can be laser-cut from the tube. The cut can extend from one end of the tube to the other end. The uncut portion of the tube can be annular hubs 420, 520, 620, and 720. In some embodiments, mating auxiliary elements 400, 500, 600, and 700 can be formed of sheet material. The sheet material can be laser-cut to include supports 430, 530, 630, and 730. The sheet material can be rolled to form tubes. The tubes can be welded or otherwise held together. The uncut portion of the sheet can form annular hubs 420, 520, 620, and 720.

[0354] In some embodiments, the anchor 800 is an active anchor. The anchor 800 can be coupled to the annular hubs 420, 520, 620, and 720. The anchor 800 can be coupled to the annular hubs 420, 520, 620, and 720 by interlocking the helix of the anchor 800 with the structure of the annular hubs 420, 520, 620, and 720. The anchor 800 can be configured to rotate relative to the annular hubs 420, 520, 620, and 720. The anchor 800 is configured to rotate relative to the annular hubs 420, 520, 620, and 720 when coupled to them. The anchor 800 is configured to rotate to be selectively deployed. The anchor 800 is configured to rotate to engage tissues. Anchor 800 is configured to rotate to engage the annulus. Anchor 800 is configured to rotate through the annulus. Anchor 800 is configured to rotate relative to the annular hubs 420, 520, 620, and 720 in a first direction. Anchor 800 is configured to rotate in the first direction to selectively deploy anchor 800. Anchor 800 is configured to rotate to deploy anchor 800 at a first target location. Anchor 800 is configured to rotate to engage tissue in the annulus. Anchor 800 can be selectively deployed in the annulus. When anchor 800 rotates to engage tissue, annular hubs 420, 520, 620, and 720 can remain fixed. When anchor 800 rotates to engage tissue, non-deployable annular hubs 420, 520, 620, and 720 can remain fixed.

[0355] In some embodiments, the anchor 800 is configured to rotate relative to the annular hubs 420, 520, 620, 720 in a second direction. The anchor 800 is configured to rotate in the second direction to selectively disengage the anchor 800. The anchor 800 isThe anchor 800 is configured to rotate to disengage from the first target position. The anchor 800 is configured to rotate to disengage from the tissue in the annulus. When the anchor 800 rotates to disengage from the tissue, the annular hubs 420, 520, 620, and 720 can remain fixed. When the anchor 800 rotates to disengage from the tissue, the non-deployable annular hubs 420, 520, 620, and 720 can remain fixed. The second direction can be opposite to the first direction. In some embodiments, the first direction can be clockwise and the second direction can be counterclockwise. In some embodiments, the first direction can be counterclockwise and the second direction can be clockwise.

[0356] In some embodiments, a plurality of support members 430, 530, 630, and 730 are circumferentially spaced around the annular hubs 420, 520, 620, and 720. In some embodiments, a plurality of support members 430, 530, 630, and 730 are uniformly spaced around the annular hubs 420, 520, 620, and 720. In some embodiments, a plurality of support members 430, 530, 630, and 730 are unevenly spaced around annular hubs 420, 520, 620, and 720. In some embodiments, support members 430, 530, 630, and 730, including annular segments, are evenly spaced around annular hubs 420, 520, 620, and 720. In some embodiments, support members 430, 530, 630, and 730, including annular segments, are unevenly spaced around annular hubs 420, 520, 620, and 720. In some embodiments, support members 430, 530, 630, and 730 forming an upper edge are evenly spaced around annular hubs 420, 520, 620, and 720. In some embodiments, support members 430, 530, 630, and 730 forming an upper edge are unevenly spaced around annular hubs 420, 520, 620, and 720. In some embodiments, the support members 430, 530, 630, and 730, including ventricular segments, are uniformly spaced around the annular hub 420, 520, 620, and 720. In some embodiments, the support members 430, 530, 630, and 730, including ventricular segments, are non-uniformly spaced around the annular hub 420, 520, 620, and 720. In some embodiments, the support members 430, 530, 630, and 730 forming the lower edge are uniformly spaced around the annular hub 420, 520, 620, and 720. In some embodiments, the support members 430, 530, 630, and 730 forming the lower edge are non-uniformly spaced around the annular hub 420, 520, 620, and 720. In some embodiments, two or more support members 430, 530, 630, and 730 are uniformly spaced around the annular hub 420, 520, 620, and 720. In some embodiments, two or more support members 430, 530, 630, 730 are unevenly spaced around the annular hub 420, 520, 620, 720.

[0357] In some embodiments, the plurality of support members 430, 530, 630, 730 extend outward from the annular hubs 420, 520, 620, 720. In some embodiments, the plurality of support members 430, 530, 630, 730 have portions adjacent to the annular hubs 420, 520, 620, 720 (see page 51 / 126 of specification CN 121057564 A), wherein said portions are radial. In some embodiments, the plurality of support members 430, 530, 630, 730 are arranged radially. In some embodiments, the plurality of support members 430, 530, 630, 730 diverge from a center. In some embodiments, the plurality of support members 430, 530, 630, 730 diverge from the annular hubs 420, 520, 620, 720. In some embodiments, the plurality of support members 430, 530, 630, 730 are uniformly formed around a central axis. In some embodiments, the plurality of support members 430, 530, 630, 730 are uniformly formed around annular hubs 420, 520, 620, 720. In some embodiments, the plurality of support members 430, 530, 630, 730 are uniformly formed around anchor 800. In some embodiments, the plurality of support members 430, 530, 630, 730 may form spokes. In some embodiments, the plurality of support members 430, 530, 630, 730 extend outward from a center. In some embodiments, the plurality of support members 430, 530, 630, 730 extend inward from the edges of mating auxiliary elements 400, 500, 600, 700. In some embodiments, the plurality of support members 430, 530, 630, 730 are branched. In some embodiments, the plurality of support members 430, 530, 630, 730 are outspread. In some embodiments, the plurality of support members 430, 530, 630, and 730 are radially arranged. In some embodiments, the plurality of support members 430, 530, 630, and 730 extend outward. In some embodiments, the plurality of support members 430, 530, 630, and 730 may include inflection points. In some embodiments, the support members 430, 530, 630, and 730 may include inflection points. In some embodiments, the plurality of support members 430, 530, 630, and 730 may include curved shapes. In some embodiments, the support members 430, 530, 630, and 730 may include curved shapes. In some embodiments, the support members 430, 530, 630, and 730 may include U-shaped curves. In some embodiments, the support members 430, 530, 630, and 730 may include C-shaped curves. In some embodiments, the support members 430, 530, 630, and 730 may include...S-shaped curve. In some embodiments, the support members 430, 530, 630, and 730 may include an L-shaped curve.

[0358] In some embodiments, the plurality of support members 430, 530, 630, and 730 increase the volume of the mating auxiliary elements 400, 500, 600, and 700 during deployment. In some embodiments, the plurality of support members 430, 530, 630, and 730 increase the thickness of the mating auxiliary elements 400, 500, 600, and 700 during deployment. In some embodiments, the plurality of support members 430, 530, 630, and 730 increase the length of the mating auxiliary elements 400, 500, 600, and 700 during deployment. In some embodiments, the plurality of support members 430, 530, 630, and 730 increase the height of the mating auxiliary elements 400, 500, 600, and 700 during deployment. In some embodiments, the plurality of supports 430, 530, 630, 730 increases the width of the occlusion aids 400, 500, 600, 700 during deployment.

[0359] In some embodiments, the plurality of supports 430, 530, 630, 730 may include a first support. The first support may be configured to be implanted in the heart above the valve annulus. The first support may be an annular support. In some embodiments, the plurality of supports 430, 530, 630, 730 may include a second support. The second support may be configured to be implanted in the heart below the valve annulus. The second support may be a ventricular support. The second support may traverse the mitral valve. The second support may traverse the plane of the valve annulus. In some embodiments, the first support and the second support have different lengths. In some embodiments, the second support is longer than the first support.

[0360] In some embodiments, the upper edge of the occlusion aids 400, 500, 600, 700 forms a curve. In some embodiments, the upper edge forms a lip. In some embodiments, the upper edge forms a downward cup shape towards the lower edge. In some embodiments, the upper edge forms an upward cup shape from the lower edge. In some embodiments, the annular hubs 420, 520, 620, and 720 extend upward from the lower edge. In some embodiments, the annular hubs 420, 520, 620, and 720 extend upward from the upper edge. In some embodiments, the annular hubs 420, 520, 620, and 720 extend upward from the annular section of the mating auxiliary elements 400, 500, 600, and 700. In some embodiments, the annular hubs 420, 520, 620, and 720 extend upward from the mating surface of the mating auxiliary elements 400, 500, 600, and 700. In some embodiments, the annular hubs 420, 520, 620, and 720 are tubular. In some embodiments, the annular hubs 420, 520, 620, and 720...Forming a circle. In some embodiments, the annular hubs 420, 520, 620, and 720 have a ring shape. In some embodiments, the hubs 420, 520, 620, and 720 are non-annular. In some embodiments, the hubs 420, 520, 620, and 720 form polygons (e.g., triangles, squares, rectangles, hexagons, octagons, etc.). In some embodiments, the hubs 420, 520, 620, and 720 form non-circular shapes. In some embodiments, the hubs 420, 520, 620, and 720 form elliptical shapes.

[0361] Figures 47A to 47E illustrate embodiments of implant features. Figures 47A to 47E illustrate some non-limiting, potentially clinically relevant aspects of the implant. Although an occlusion aid 400 is illustrated, any occlusion aid described herein may include the features described herein. Additionally, for example, the occlusion aid 400 may include any of the features of the occlusion aid described herein with respect to other embodiments.

[0362] As described herein, the occlusion aid 400 may include an annular hub 420 that can be positioned relatively centrally. The occlusion aid 400 may have a generally elongated shape, but other shapes are also contemplated, such as polygonal, circular, elliptical, rounded, rectangular, triangular, etc. The occlusion aid 400 may have an upper edge 440, lateral edges 470 and 475, and a lower edge 480. In some embodiments, the upper edge 440 has a length greater than the length of the lower edge 480, such that the lateral distance between the lateral edges 470 and 475 generally decreases from the upper to the lower portion of the occlusion aid 400. The upper edge 440 of the occlusion aid 400 may be curved to match the general shape of the valve annulus or adjacent atrial wall.

[0363] The mating aid element 400 may include a first surface 405 and a second surface 415, the first surface 405 being configured to face a misaligned autologous leaflet in use, and the second surface 415 being configured to face the anterior leaflet. The second surface 415 may include a mating surface 460. The mating aid element 400 may include one or more supports 430. The plurality of supports 430 may provide structural support for the mating aid element 400. The plurality of supports 430 may provide a deployment shape for the mating aid element 400. As described herein, the plurality of supports may include shape memory materials, such as shape memory metal or plastic.

[0364] In some embodiments, a first support 430 of the plurality of supports extends from the annular hub 420 to or toward an upper edge 440. In some embodiments, a second support 430 of the plurality of supports extends from the annular hub 420 to or toward a lower edge 480. In some embodiments, a third support 430 of the plurality of supports extends from the annular hub 420.Extending to or toward the lateral edge 470. In some embodiments, a fourth support 430 of the plurality of supports extends from or toward the annular hub 420. Any two or more of the first, second, third, or fourth support may include the same features, including material, length, width, thickness, configuration, preformed bend, curvature, etc. Any two or more of the first, second, third, or fourth support may include different features, including material, length, width, thickness, configuration, preformed bend, curvature, etc. In some embodiments, at least one of the support materials, such as in the upper region of the implant, may extend radially outward from and protrude from the cover 450 of the implant 400 to serve as spaced barbs and may be used for secondary anchoring and / or tissue ingrowth in the valve annulus. In some embodiments, the barbs extend only in the annular region of the implant (e.g., the upper region) but not in the lower (leaflet) occlusion region, which is non-invasive in some embodiments. In some embodiments, the entire peripheral edge of the implant may be non-invasive.

[0365] In some embodiments, the support 430 may be covered with one, two, or more layers of occlusion aid body cover 450. The occlusion aid body cover 450 may include one or more layers (e.g., one, two, three, four, five, or more layers, or a range including any two of the foregoing values). In some embodiments, the first surface 405 may include one or more layers. In some embodiments, the second surface 415 may include one or more layers. In some embodiments, the second surface 1515 may include one or more layers. Any two or more layers may include the same or different features, including material, length, width, thickness, etc. In some embodiments, one or more layers extend along the entire or only a portion of the first surface 405. In some embodiments, one or more layers extend along the entire or only a portion of the second surface 415. The layers may be formed by any of the processes described herein.

[0366] The aligning auxiliary element body cover 450 may include materials such as polymers (e.g., ePTFE). Other materials used for the aligning auxiliary element body cover 450 (page 53 / 126 of the specification, CN 121057564 A) include polyester, polyurethane foam, polycarbonate foam, biological tissues (e.g., porcine pericardium, treated bovine pericardium, pleura, peritoneum), silicone, dacryocystorhinos, acellular collagen matrix, and combinations thereof. In some embodiments, the aligning auxiliary element body cover 450 may include a foam material surrounded by ePTFE.

[0367] In some embodiments, the support 430 may be formed or embedded with one or more layers of occlusion aid body cover 450. In some embodiments, the support 430 may be surrounded or at least partially encapsulated by the occlusion aid body cover 450. In some embodiments, a portion of the support 430 may extend from the occlusion aid body cover 450 to engage tissue, as described elsewhere herein. Figures 47A through 47E illustrate features that may facilitate interaction between the occlusion aid 400 or a portion thereof and autologous anatomical structures.

[0368] Figure 47A illustrates an occlusion surface 460 that may define a relatively inferior region of the implant. The anterior ventricular occlusion surface may be reinforced. As described herein, the occlusion surface 460 may contact the patient's leaflet. The occlusion aid 400 may completely cover the posterior leaflet after placement, such that the anterior leaflet occludes with the occlusion surface 460 during systole. The occlusion aid element 400 and the anterior leaflet can maintain a valve seal at the annular ring.

[0369] In some embodiments, the second surface 415 or a portion thereof is reinforced. In some embodiments, the occlusion surface 460 is reinforced. The second surface 415, including but not limited to the occlusion surface 460, may be reinforced by one or more additional layers. One or more additional layers may extend on the second surface 415 or a portion thereof. One or more additional layers may extend on the occlusion surface 460 or a portion thereof. One or more additional layers may extend on a portion of the second surface 415 including the occlusion surface 460. One or more additional layers may extend on a portion of the second surface 415 larger than the occlusion surface 460.

[0370] The occlusion surface 460 may be reinforced by any material described herein. The occlusion surface 460 may be reinforced by ePTFE. The occlusion surface 460 may be reinforced by any material of the occlusion aid element body cover 450 (e.g., ePTFE, Dacron, and / or polypropylene).

[0371] Figure 47B illustrates a first surface 405. The posterior ventricular occlusion surface may be reinforced. As described herein, the first surface 405 may contact the patient's leaflets. The occlusion aid element 400 may completely cover the posterior leaflets with the first surface 405 after placement. The first surface 405 may be opposite to a second surface 415 including the occlusion surface 460.

[0372] In some embodiments, the first surface 405 or a portion thereof is reinforced. The first surface 405 may be reinforced by one or more additional layers. One or more additional layers may extend on the first surface 405 or a portion thereof. One or more additional layers may be diametrically opposite to one or more additional layers extending on the second surface 415. One or moreMultiple additional layers may extend on a portion of the first surface 405 opposite the occlusion surface 460. One or more additional layers may extend on a portion of the first surface 405 that is larger than the contact area with the posterior leaflet.

[0373] The first surface 405 may be reinforced by any material described herein. The first surface 405 or a portion thereof may be reinforced by ePTFE. The first surface 405 may be reinforced by any material of the occlusion aid element cover 450 (e.g., ePTFE, Dacron, and / or polypropylene), which may advantageously produce a non-traumatic surface, thereby reducing the risk of autologous leaflet trauma due to repeated occlusion against the occlusion surface of the occlusion aid.

[0374] Figures 47C to 47D illustrate the edges of the occlusion aid element 400. As described herein, the occlusion aid element 400 may include reinforced edges with increased thickness, such as knotless suture edges 455. The upper edge 440, lateral edges 470 and 475, and / or lower edge 480 of the occlusion aid element 400 may include raised edges or ridges. In some embodiments, only one, two, or more of the upper edge 440, lateral edges 470 and 475, or lower edge 480 may include raised edges or ridges. In some embodiments, the raised edges or ridges may include Gore-Tex. In some embodiments, the raised edges or ridges surround the periphery of the lower region or the periphery of the entire occlusion aid body in a peripheral direction or at least partially in a peripheral direction.

[0375] The raised edges or ridges may be formed by sutures. Sutures may wrap around the edges to form raised edges or ridges. The raised edges or ridges may have features such as increased thickness and / or softness, for example, reducing trauma to autologous tissue. The raised edges or ridges may reduce contact between the occlusion aid element 400 and the patient's anatomy. In the case of the mitral valve, a raised edge or ridge can reduce contact between the occlusion aid element 400 and the posterior leaflet. In some embodiments, only the first surface 405 includes a raised edge. In some embodiments, both the first surface 405 and the second surface 415 include raised edges. The raised edge or ridge may be located at or near the edge of the first surface 405 or the second surface 415. The raised edge or ridge may be spaced inwardly from the first surface 405 or the second surface 415. Figure 47C illustrates the posterior surface. Figure 47D illustrates the anterior surface.

[0376] The raised edge or ridge may include one or more rounded edges that reduce contact between the occlusion aid element 400 and the underlying patient anatomy. In some embodiments, the occlusion aidThe contact between element 400 and the posterior leaflet is reduced. In some embodiments, the contact between the mating aid element 400 and the annulus is not reduced. In some embodiments, the mating aid element 400 is configured to minimize contact with the posterior leaflet but maximize contact with the annulus. Other configurations may be considered.

[0377] FIG47E illustrates the anchoring region. The mating aid element 400 may include a generally annular upper section 410. The anchoring region may be located within the annular section 410 and may include two sections spaced apart from and extending laterally from the hub 420. When the mating aid element 400 is deployed, the annular section 410 may be positioned relative to the annulus. In some embodiments, the annular section 410 may be bent toward or away from the annulus. In other embodiments, the annular section 410 may be substantially flat relative to the annulus. The annular section 410 may be configured to receive one or more sub-anchors. The sub-anchors may advance on a guide rail which may be coupled to the mating aid element 400 as described herein. The secondary anchor can be rotated to penetrate the annular segment 410. The secondary anchor can engage tissue located below the occlusion aid 400.

[0378] The annular segment 410, such as the anchoring region, can be reinforced to have an increased thickness relative to the remainder of the upper region, and greater than, equal to, or less than the thickness of the lower occlusion region of the implant. The annular segment 410 can be reinforced in a region configured to receive one, two, three, four, or more secondary anchors. As described herein, after the occlusion aid 400 is placed in the patient's heart, a first surface 405 of the occlusion aid 400 can abut against the valve annulus. A second surface 415 can be upward from the valve annulus. In some embodiments, the annular segment 410 or a portion thereof is reinforced. The annular segment 410 can be reinforced by one or more additional layers. One or more additional layers can extend over the annular segment 410 or a portion thereof. One or more additional layers can be diametrically opposed relative to the annular hub 420. One or more additional layers can extend over a portion of the first surface 405. One or more additional layers may extend over a portion of the second surface 415. An anchoring area may be adjacent to the annular hub 420. The anchoring area may include one or more separate regions.

[0379] The annular segment 410 may be reinforced with any material described herein. The annular segment 410 or a portion thereof may be reinforced with ePTFE. The annular segment 410 or a portion thereof may be reinforced with velour. The annular segment 410 may be reinforced with any material of the mating auxiliary element body cover 450 (e.g., ePTFE, Dacron, and / or polypropylene). One or more additional layers may extend outward from the annular hub 420. One or more additional layers may be of any shape sufficient to cover an area larger than the area engaged by one or more sub-anchors.

[0380] In some embodiments, the annular segment 410 may include an edge that is sharper than the other edge of the occlusion aid element 400. In some embodiments, the upper edge 440 is thinner and / or sharper than the other edge of the occlusion aid element 400 (e.g., lateral edge 470, lateral edge 474, or lower edge 480). In some embodiments, the annular segment 410 and / or the upper edge 440 may stimulate or engage with tissue. In some embodiments, the annular segment 410 is configured to be implanted near the valve annulus. Specification 55 / 126 pages 58 CN 121057564 A In some embodiments, the annular segment 410 is configured to promote an immune response. In some embodiments, the annular segment 410 is configured to promote inward growth of tissue.

[0381] FIG48 illustrates an exploded view of an embodiment of the portion surrounding the cover of the implant and includes a lamination. Although the occlusion aid 400 is illustrated, any occlusion aid described herein may include any number of features described herein, or may exclude / omit any features described herein, or may be placed in a different order relative to each other. Additionally, the occlusion aid 400 may include or exclude / omit any features described herein. An exploded view illustrates the thick reinforcing layer for the anterior and posterior ventricular segments. An exploded view illustrates the monofilament anchoring area. Raised edges or ridges are not shown. Raised edges or ridges may be added in the final stage of assembly. The laminate 1100 described herein may form the occlusion aid body cover 450. The laminate 1100 may include one or more layers as described herein. The laminate 1100 may include one or more layers in any order.

[0382] The occlusion aid 400 may include a rear layer 1102. The rear layer may form a first surface 405. In some embodiments, the rear layer 1102 is thin relative to the other layers. In some embodiments, the rear layer 1102 is ePTFE. In some embodiments, the rear layer 1102 has a thickness (e.g., about 0.001'', about 0.0015'', about 0.002'', about 0.0025'', about 0.003'', or any range including two of the foregoing values). The rear layer 1102 may include an opening through which the anchor 800 extends. The rear layer 1102 may be any shape including rectangles, polygons, triangles, circles, and ellipses. In some embodiments, the rear layer 1102 is not the final shape of the mating aid element 400.

[0383] The mating aid element 400 may include a first support structure layer 1104. The first support structure layer 1104 may be a mesh. In some embodiments, the first support structure layer 1104 includes UHMPE. The first support structure layer 1104 may be disposed in the rear layer.On 1102. A first support structure layer 1104 may be disposed on the rear side of the support member 430. The first support structure layer 1104 may include an opening for the anchor 800 to extend through.

[0384] The mating auxiliary element 400 may include a first fabric layer 1106. The first fabric layer 1106 may be relatively thin and in some cases have a thickness (e.g., about 0.001'', about 0.0015'', about 0.002'', about 0.0025'', about 0.003'', about 0.004'', about 0.005'', about 0.01'', or any range including two of the foregoing values). In some embodiments, the first fabric layer 1106 comprises a polyester fabric. The first fabric layer 1106 may be disposed on the first support structure layer 1104. The first fabric layer 1106 may be disposed on the rear side of the support member 430. The first fabric layer 1106 may include an opening for the anchor 800 to extend through. In some embodiments, the first fabric layer 1106 extends only along a portion of the occlusion aid element 400. In some embodiments, the first fabric layer 1106 includes a cut-off portion.

[0385] The occlusion aid element 400 may include a first ventricular layer 1108. The ventricular surface layer 1108 may be a reinforcing layer of the first surface 405. In some embodiments, the first ventricular layer 1108 is thicker than the other layers. In some embodiments, the first ventricular layer 1108 is ePTFE. In some embodiments, the first ventricular layer 1108 has a thickness (e.g., about 0.01'', 0.02'', 0.03'', about 0.035'', about 0.040'', about 0.045'', about 0.05'', about 0.07'', about 0.10'', or any range including two of the foregoing values). The first ventricular layer 1108 may be of any shape, including rectangular, polygonal, triangular, circular, elliptical, etc.

[0386] The mating auxiliary element 400 may include an anchoring layer 1110. The anchoring layer 1110 may be a reinforcing layer for one or more secondary anchors. In some embodiments, the anchoring layer 1110 is thicker than other layers. In some embodiments, the anchoring layer 1110 is ePTFE. In some embodiments, the anchoring layer 1110 is velvet. In some embodiments, the anchoring layer 1110 has a thickness (e.g., about 0.01'', 0.02'', 0.03'', about 0.035'', about 0.040'', about 0.045'', about 0.05'', about 0.07'', about 0.10'', or any range including both of the foregoing values). The anchoring layer 1110 may be of any shape, including rectangular, polygonal, triangular, circular, elliptical, etc. In some embodiments, the mating auxiliary element 400 includes forming the anchoring layer. (See page 56 / 126 of specification, 59 CN 121057564 A)A single anchoring zone of 1110. In some embodiments, the occlusion aid 400 includes two or more separate anchoring zones forming the anchoring layer 1110. The anchoring layer 1110 may be disposed on the rear side of the support 430 as shown. In the illustrated embodiment, the ventricular surface layer 1108 and the anchoring layer 1110 may be sandwiched between two identical adjacent layers. In some embodiments, the ventricular surface layer 1108 and the anchoring layer 1110 are separated by one or more layers.

[0387] The occlusion aid 400 may include a second support structure layer 1112. The second support structure layer 1112 may be a mesh. In some embodiments, the second support structure layer 1112 includes UHMPE. The second support structure layer 1112 may be disposed on the ventricular surface layer 1108. The second support structure layer 1112 may be disposed on the rear side of the support 430. In some embodiments, the second support structure layer 1112 extends only along a portion of the occlusion aid 400. In some embodiments, the second support structure layer 1112 extends only along the ventricular segment of the occlusion aid element 400.

[0388] The occlusion aid element 400 may include a frame 465. In some embodiments, the frame 465 is cut from a tubular blank. The frame 465 may include one or more support members 430. The frame 465 may be constructed from a single integral piece of material. The frame 465 including the support members 430 may be formed using any of the methods described herein, including water jet, laser etching, or similar techniques. Details including barbs of the support members 430 may be machined into the support members 430. The frame 465 may be bent and / or shaped to obtain a desired geometry. The frame 465 including the support members 430 may include an elastically deformable material, such as a shape memory metal (e.g., nitinol) or a shape memory polymer. In some embodiments, the material is Elgiloy. In some embodiments, the frame 465 may be composed of other materials, including stainless steel, polypropylene, high-density polyethylene (PE), polyester (Dacron), acellular collagen matrix (e.g., SIS), or other plastics. In some embodiments, the support 430 may include a shape memory material and a support cover. The support cover may be any material described herein and may cover the entire support 430 or a portion thereof. In some embodiments, the support 430 may include nitinol and LDPE tubing or covers on each support 430. In some embodiments, the frame 465 may be considered as a layer.

[0389] The occlusion aid element 400 may include a second ventricular layer 1114. The second ventricular layer 1114 may be a reinforcing layer of the second surface 415. In some embodiments, the second ventricular layer 1114 is thicker than the other layers. In some embodiments, the second ventricular layer 1114 is ePTFE. In some embodiments, the second ventricular layer 1114 has a thickness (e.g., about 0.03'', about...).0.035'', about 0.040'', about 0.045'', about 0.05'', or any range including two of the foregoing values ​​or other thickness values ​​as described with respect to other layers herein). In some embodiments, the second ventricular layer 1114 extends only along a portion of the occlusal support element 400. In some embodiments, the second ventricular layer 1114 extends only along a ventricular segment of the occlusal support element 400. In some embodiments, the first ventricular layer 1108 and the second ventricular layer 1114 have the same shape.

[0390] The occlusal support element 400 may include a third support structure layer 1116. The third support structure layer 1116 may be a mesh. In some embodiments, the third support structure layer 1116 may include a UHMPE. The third support structure layer 1116 may be disposed on the second ventricular layer 1114. The third support structure layer 1116 may be disposed on the front side of the support 430. In some embodiments, the third support structure layer 1116 extends only along a portion of the occlusal support element 400. In some embodiments, the third support structure layer 1116 extends only along the ventricular segment of the occlusion aid element 400.

[0391] The occlusion aid element 400 may include a second fabric layer 1118. The second fabric layer 1118 may be thinner than the other layers. In some embodiments, the second fabric layer 1118 has a thickness (e.g., about 0.001'', about 0.0015'', about 0.002'', about 0.0025'', about 0.003'', or any range including two of the foregoing values). In some embodiments, the second fabric layer 1118 comprises a polyester fabric. The second fabric layer 1118 may be disposed on the third support structure layer 1116. The second fabric layer 1118 may be disposed on the front side of the support 430. The second fabric layer 1118 may include an opening through which the anchor 800 extends.

[0392] The occlusion aid element 400 may include a fourth support structure layer 1120. The fourth support structure layer 1120 may be a mesh. Specification page 57 / 126 60 CN 121057564 A In some embodiments, the fourth support structure layer 1120 may include UHMPE. The fourth support structure layer 1120 may be disposed on the second fabric layer 1118. The fourth support structure layer 1120 may be disposed on the front side of the support 430. The fourth support structure layer 1120 may include an opening for the anchor 800 to extend through. In some embodiments, the first support structure layer 1104 and the fourth support structure layer 1120 have the same shape.

[0393] The mating auxiliary element 400 may include a front layer 1122. The front layer 1122 may form a second surface 415. In some embodiments, the front layer 1122 is thinner than the other layers. In some embodiments, the front layer 1122 is ePTFE. In some embodimentsIn this embodiment, the front layer 1122 has a thickness (e.g., about 0.001'', about 0.0015'', about 0.002'', about 0.0025'', about 0.003'', or any range including two of the foregoing values, or other thickness values ​​as described herein with respect to other layers). The front layer 1122 may include an opening through which the anchor 800 extends. The front layer 1122 may be of any shape, including rectangular, polygonal, triangular, circular, and elliptical. In some embodiments, the front layer 1122 is not the final shape of the mating aid element 400. In some embodiments, the rear layer 1102 and the front layer 1122 have the same shape.

[0394] FIG49 illustrates an embodiment of the implant delivery system 2200. The implant delivery system 2200 may include any features of the implant delivery system described herein. The implant delivery system 2200 may include a main anchor housing 2202. In some embodiments, the main anchor housing 2202 is a docking tube. The main anchor housing 2202 may be cylindrical. The main anchor housing 2202 may include a central chamber. The main anchor housing 2202 may be disposed around an annular hub 420, 520, 620, 720 of the engagement aids 400, 500, 600, 700.

[0395] The implant delivery system 2200 may include a main anchor driver 2204. The main anchor housing 2202 may be sized to mate with the main anchor driver 2204. In some embodiments, the main anchor driver 2204 is a torque shaft. In some embodiments, the main anchor driver 2204 is configured to rotate relative to the main anchor housing 2202. In some embodiments, the main anchor driver 2204 is not configured to translate relative to the main anchor housing 2202. As described herein, the main anchor driver 2204 may be considered a main anchor fork driver. The main anchor driver 2204 may be designed to engage the anchor 800 and rotate the anchor 800. Anchor 800 can be considered as primary anchor 800 to distinguish it from one or more secondary anchors.

[0396] Implant delivery system 2200 may include one or more release lines 2206, 2208. In the illustrated embodiment, implant delivery system 2200 may include two release lines 2206, 2208, but other configurations are also contemplated (e.g., one release line, two release lines, three release lines, four release lines, five release lines, six release lines, etc.). Release lines 2206, 2208 may extend proximally from primary anchor housing 2202. In some embodiments, release lines 2206, 2208 may extend beyond the implant surface. Release lines 2206, 2208 may extend through at least a portion of primary anchor housing 2202.Release lines 2206 and 2208 may extend through one or more channels or tubes within the main anchor housing 2202. Release lines 2206 and 2208 may be diametrically opposed within the main anchor housing 2202.

[0397] Release lines 2206 and 2208 may extend to the outside of the main anchor housing 2202. The main anchor housing 2202 may include slots 2210 and 2212 through which release lines 2206 and 2208 extend. Release lines 2206 and 2208 may extend from the inside of the main anchor housing 2202 to the outside of the main anchor housing 2202 through slots 2210 and 2212 (e.g., release line 2206 may extend through slot 2210, and release line 2208 may extend through slot 2212).

[0398] Release lines 2206 and 2208 may extend back into the main anchor housing 2202. The main anchor housing 2202 may include slots 2214 and 2216 through which release lines 2206 and 2208 extend. Release lines 2206 and 2208 may extend from the outside of the main anchor housing 2202 to the inside of the main anchor housing 2202 through slots 2214 and 2216 (e.g., release line 2206 may extend through slot 2214, and release line 2208 may extend through slot 2216). Release lines 2206 and 2208 may enter and exit the main anchor housing 2202. Release lines 2206 and 2208 may be coupled to the main anchor housing 2202. Release lines 2206 and 2208 may extend through anchor 800. Release lines 2206 and 2208 may cross.

[0399] Release lines 2206 and 2208 may extend along engagement aids 400, 500, 600, and 700. Release lines 2206 and 2208 may extend along annular surfaces 410, 510, 610, and 710. Release lines 2206 and 2208 may extend below engagement aids 400, 500, 600, and 700. Release lines 2206 and 2208 may extend in opposite directions. Release lines 2206 and 2208 may be diametrically opposed. Release lines 2206 and 2208 may be coaxial. Release lines 2206 and 2208 may be generally along a single line. Release lines 2206 and 2208 may be adjacent to an annulus. Release lines 2206 and 2208 may contact an annulus. Release lines 2206 and 2208 facilitate the connection between the implant delivery system 2200 and the engagement aids 400, 500, 600, and 700. Release lines 2206 and 2208 rigidly hold the main anchor housing 2202 against the annulus of the engagement aids 400, 500, 600, and 700.On hubs 420, 520, 620, and 720. Release lines 2206 and 2208 can extend from the front to the rear of the engagement aids 400, 500, 600, and 700. In some embodiments, the ends of the release lines 2206 and 2208 wrap around the engagement aids 400, 500, 600, and 700. In some embodiments, the ends of the release lines 2206 and 2208 are bent or formed in a C-shape configuration.

[0400] The implant delivery system 2200 may include one or more sub-anchors 2220, 2222, 2224, and 2226 (e.g., one sub-anchor, two sub-anchors, three sub-anchors, four sub-anchors (as shown), five sub-anchors, six sub-anchors, seven sub-anchors, eight sub-anchors, etc.). In some embodiments, two or more sub-anchors 2220, 2222, 2224, and 2226 are identical. In some embodiments, two or more secondary anchors 2220, 2222, 2224, 2226 are different (e.g., different pitch, different diameter, different material, different shoulder, different window, etc.). In some embodiments, secondary anchors 2220, 2222, 2224, 2226 may be helical anchors. Secondary anchors 2220, 2222, 2224, 2226 may have a smaller diameter than the primary anchor 800. Secondary anchors 2220, 2222, 2224, 2226 may have a smaller pitch than the primary anchor 800. Secondary anchors 2220, 2222, 2224, 2226 may be configured to engage tissue in the valve annulus by rotation.

[0401] The implant delivery system 2200 may include one or more sub-anchor drivers 2230, 2232, 2234, 2236 (e.g., one sub-anchor driver, two sub-anchor drivers, three sub-anchor drivers, four sub-anchor drivers (as shown), five sub-anchor drivers, six sub-anchor drivers, seven sub-anchor drivers, eight sub-anchor drivers, etc.). In some embodiments, two or more sub-anchor drivers 2230, 2232, 2234, 2236 are identical. In some embodiments, two or more sub-anchor drivers 2230, 2232, 2234, 2236 are different (e.g., different configurations, mirror images, different anchors coupled thereto, etc.). In some embodiments, the sub-anchor drivers 2230, 2232, 2234, 2236 are torque shafts. In some embodiments, the sub-anchor drivers 2230, 2232, 2234, and 2236 are configured to rotate the respective sub-anchors 2220, 2222, 2224, and 2226. In some embodiments,Sub-anchor drivers 2230, 2232, 2234, and 2236 are configured to translate corresponding sub-anchors 2220, 2222, 2224, and 2226.

[0402] In some embodiments, sub-anchor drivers 2230, 2232, 2234, and 2236 may be coupled to corresponding sub-anchors 2220, 2222, 2224, and 2226 according to any embodiment described herein. In some embodiments, each sub-anchor driver 2230, 2232, 2234, and 2236 is coupled to a corresponding sub-anchor 2220, 2222, 2224, and 2226. In some embodiments, each sub-anchor driver 2230, 2232, 2234, and 2236 is coupled to two or more sub-anchors 2220, 2222, 2224, and 2226. In some embodiments, a single sub-anchor driver (e.g., sub-anchor driver 2230) is coupled to all sub-anchors 2220, 2222, 2224, 2226.

[0403] The implant delivery system 2200 may include one or more sub-anchor rails 2240, 2242, 2244, 2246 (e.g., one sub-anchor rail, two sub-anchor rails, three sub-anchor rails, four sub-anchor rails (as shown), five sub-anchor rails, six sub-anchor rails, seven sub-anchor rails, eight sub-anchor rails, etc.). The number of sub-anchor rails 2240, 2242, 2244, 2246 may correspond to the number of sub-anchors 2220, 2222, 2224, 2226. Sub-anchors 2220, 2222, 2224, and 2226 may include channels passing through them. The channels may extend through the middle of the helix of the sub-anchors 2220, 2222, 2224, and 2226. Sub-anchor guides 2240, 2242, 2244, and 2246 may be configured to extend through the respective channels.

[0404] The implant delivery system 2200 may include one or more sub-anchor fasteners 2250, 2252, 2254, and 2256 (e.g., one sub-anchor fastener, two sub-anchor fasteners, three sub-anchor fasteners, four sub-anchor fasteners (as shown), five sub-anchor fasteners, six sub-anchor fasteners, seven sub-anchor fasteners, eight sub-anchor fasteners, etc.). The number of secondary anchor bolts 2250, 2252, 2254, and 2256 can correspond to the number of secondary anchors 2220, 2222, 2224, and 2226. The secondary anchor bolts 2250, 2252, 2254, and 2256 can form a loop. Each secondary anchor bolt 2250, 2252, 2254, and 2256 may include a first thread, a second thread, and...The arcuate portion between the first strand and the second strand. Each sub-anchor bolt 2250, 2252, 2254, 2256 may loop around the corresponding release line 2206, 2208 as described herein. Sub-anchor bolts 2250, 2252, 2254, 2256 may extend through mating aids 400, 500, 600, 700. Mating aids 400, 500, 600, 700 may include one or more channels through which sub-anchor bolts 2250, 2252, 2254, 2256 pass.

[0405] Sub-anchor rails 2240, 2242, 2244, 2246 may include channels passing through them. The channels may extend through the middle of the sub-anchor rails 2240, 2242, 2244, 2246. Sub-anchor fasteners 2250, 2252, 2254, and 2256 can be configured to extend through channels in sub-anchor guides 2240, 2242, 2244, and 2246. In some embodiments, each sub-anchor fastener 2250, 2252, 2254, and 2256 extends through the corresponding sub-anchor guide 2240, 2242, 2244, and 2246. Sub-anchor drivers 2230, 2232, 2234, and 2236 may include channels therethrough. These channels may extend through the middle of the sub-anchor drivers 2230, 2232, 2234, and 2236. Sub-anchor fasteners 2250, 2252, 2254, and 2256 can be configured to extend through channels in the sub-anchor drivers 2230, 2232, 2234, and 2236.

[0406] Release lines 2206 and 2208 can maintain connections to mating auxiliary elements 400, 500, 600, and 700. Release lines 2206 and 2208 can maintain connections between mating auxiliary elements 400, 500, 600, and 700 and the main anchor 800. Release lines 2206 and 2208 can maintain connections between mating auxiliary elements 400, 500, 600, and 700 and the main anchor driver 2204. Release lines 2206 and 2208 can maintain connections between mating auxiliary elements 400, 500, 600, and 700 and the secondary anchor fasteners 2250, 2252, 2254, and 2256.

[0407] FIG50 illustrates a telescoping action for accessing the position of the main anchor according to some embodiments of the present invention. The main anchor 800 can be positioned near the leaflet. The main anchor 800 can be positioned near the valve annulus. In some methods, access is achieved using a transseptal sheath 1400. The transseptal sheath 1400 may include a chamber for the passage of one or more additional catheters. The occlusion aid 400 described herein...500, 600, and 700 can be conveyed via delivery conduit 1402. The mating auxiliary elements 400, 500, 600, and 700 can be located within delivery conduit 1402. Delivery conduit 1402 is telescopic relative to transect 1400. For conveying mating auxiliary elements 400, 500, 600, and 700, delivery conduit 1402 is telescopic relative to transect 1400 to extend outward relative to transect 1400. For conveying mating auxiliary elements 400, 500, 600, and 700, mating auxiliary elements 400, 500, 600, and 700 are telescopic relative to delivery conduit 1402 to extend outward relative to delivery conduit 1402.

[0408] FIG51 illustrates the rotation of the main anchor actuator 2204 according to some embodiments of the invention. FIG51 illustrates the process of engaging the main anchor 800. On the left, the initial positions of the main anchor driver 2204 and the main anchor 800 are illustrated. The main anchor 800 may be in a proximal position close to the tissue. In the middle, the main anchor driver 2204 rotates to rotate the main anchor 800. The main anchor 800 rotates relative to the main anchor driver 2204 and moves. The main anchor 800 engages the tissue. On the right, the main anchor 800 is further rotated to engage the tissue. The main anchor 800 may be reversible. The main anchor 800 may be rotated in one direction to engage the tissue and may be rotated in the opposite second direction to disengage from the tissue.

[0409] The main anchor driver 2204 may engage and rotate the main anchor 800. The main anchor driver 2204 may be disposed within the main anchor housing 2202. The main anchor 800 may be disposed within the main anchor housing 2202. Release lines 2206 and 2208 may extend through at least a portion of the main anchor housing 2202. As the main anchor 800 rotates, the helixes of the main anchor pass around release lines 2206 and 2208. Release lines 2206 and 2208 maintain their position as the main anchor 800 rotates. The main anchor 800 can be advanced to engage tissues when the engagement aids 400, 500, 600, and 700 are adjacent to the annulus. The main anchor actuator 2204 may include a hub 2260 and one or more extensions 2262 and 2264. The main anchor actuator 2204 may include two extensions 2262 and 2264, but other configurations are also contemplated. Extensions 2262 and 2264 may extend perpendicular to the hub 2260 or at other angles. The main anchor actuator 2204 may be a fork-shaped actuator. The main anchor 800 may include a crossbar 802. The crossbar 802 can form the proximal section of the main anchor 800. The crossbar 802 can form a self-helical anchor.The two extensions 2262, 2264 can be configured to slide within the channel of the main anchor 800 on either side of the crossbar 802. The crossbar 802 can be disposed between the extensions 2262, 2264. Other configurations for coupling the main anchor driver 2204 to the main anchor 800 have also been conceived, including any mating configurations described herein.

[0410] In some embodiments, the main anchor driver 2204 rotates but does not move in the axial direction. In some embodiments, the main anchor driver 2204 rotates but does not translate relative to the main anchor housing 2202. The fork of the main anchor driver 2204 rotates to drive the main anchor 800. In some embodiments, the main anchor driver 2204 does not advance axially. In some embodiments, the main anchor driver 2204 is held within the main anchor housing 2202. In some embodiments, it is advantageous to limit the translation of the main anchor driver 2204. Restrictions associated with the axial movement of the primary anchor driver 2204 can reduce or prevent unintentional interaction between the primary anchor driver 2204 and the tissue. Restrictions associated with the axial movement of the primary anchor driver 2204 can reduce or prevent unintentional interaction between the primary anchor driver 2204 and release lines 2206, 2208.

[0411] FIG52 illustrates the connection between a secondary anchor driver 2230 and a corresponding secondary anchor 2220 according to some embodiments. Although secondary anchor drivers 2230 and secondary anchors 2220 are illustrated, each secondary anchor driver 2230, 2232, 2234, 2236 can be coupled to a corresponding secondary anchor 2220, 2222, 2224, 2226.

[0412] The secondary anchor 2220 may include a helix 2270. The secondary anchor 2220 may include a shoulder 2272. The shoulder 2272 may be configured to engage the secondary anchor driver 2230. The should...

Claims

1. An occlusion assist element for treating misalignment of heart valves, the occlusion assist element comprising: An annular segment, the annular segment being configured to lie in the plane of the valve annulus of the heart valve; Leaflet segment, the leaflet segment being configured to extend from the annular segment; The leaflet segment includes a leaflet frame; The leaflet segment includes a leaflet-side valve body element configured to be pushed forward toward the native leaflet during systole and backward away from the native leaflet during diastole.

2. The mating auxiliary element according to claim 1, wherein, The valve body element, with its leaflets juxtaposed, is configured to be pushed forward and backward relative to the plane of the leaflet frame.

3. The mating auxiliary element according to claim 1, wherein, The annular section includes one or more support members extending from the annular hub.

4. The mating auxiliary element according to claim 1, wherein, The mating auxiliary element also includes one or more support members, wherein the leaflet frame includes one or more additional support members that are longer than the one or more support members.

5. The mating auxiliary element according to claim 4, wherein, The one or more additional support members are connected.

6. The mating auxiliary element according to claim 4, wherein, The one or more additional support members form a V-shape.

7. The mating auxiliary element according to claim 4, wherein, The one or more additional support members include separate distal ends.

8. The mating auxiliary element according to claim 4, wherein, The one or more additional support members include a distal end connected to a laminated or non-invasive material.

9. The mating auxiliary element according to claim 1, wherein, The annular section comprises one or more laminated layers.

10. The mating auxiliary element according to claim 1, further comprising at least one polymer material layer.

11. The pairing aid element according to claim 1, further comprising at least one biological tissue layer.

12. The mating auxiliary element according to claim 1, wherein, The leaflet frame includes multiple laminated layers to restrict the movement of the leaflet frame.

13. An occlusion assist element for treating misalignment of heart valves, the occlusion assist element comprising: Anchoring section; Leaflet segments, the leaflet segments being configured to extend between opposing leaflets of the heart valve; The leaflet segment includes a leaflet-side valve body element, wherein the leaflet-side valve body element is molded into a predetermined curved configuration.

14. The mating auxiliary element according to claim 13, wherein, The valve body element with juxtaposed leaflets is molded into a convex configuration.

15. The mating auxiliary element according to claim 13, wherein, The valve body element with juxtaposed leaflets is molded into a concave configuration.

16. The mating auxiliary element according to claim 13, wherein, The valve body element with juxtaposed leaflets is molded into a hybrid convex-concave configuration.

17. A method for treating misalignment of heart valves in the heart, the method comprising: Relative to the heart valve positioning and occlusion assist element, the occlusion assist element includes: Leaflet segment, the leaflet segment being configured to extend across the valve plane; The leaflet segment includes a valve body element with leaflets arranged side by side; The valve body element with the leaflets arranged in parallel functions as an autologous leaflet during the cardiac cycle.

18. The method according to claim 17, wherein, The leaflet-side valvular body element includes a preset bending configuration to optimize the performance of the leaflet-side valvular body element during the cardiac cycle.

19. The method of claim 17, wherein, The leaflet segment creates a non-invasive surface to protect surrounding tissues that can come into contact with the leaflet segment.

20. The method of claim 17, wherein, The aligning aid is provided for anchoring the aligning aid to one or more sites of tissue.

21. The method according to claim 17, wherein, The occlusion aid provides a seal between the occlusion aid and the annulus of the heart valve.

22. An occlusion assist element for treating misalignment of heart valves, the occlusion assist element comprising: An annular section, the annular section including an annular hub; Leaflet segment; The interface between the annular segment and the leaflet segment; The leaflet segment includes a valve body element with leaflets juxtaposed at the interface.

23. The mating auxiliary element according to claim 22, further comprising a support extending from the annular hub to the lower edge.

24. The mating auxiliary element of claim 22, further comprising a support extending from the annular hub to the lateral edge.

25. The mating auxiliary element of claim 22, further comprising a support material forming a ring extending from the annular hub to the lower edge and back to the annular hub.

26. The mating auxiliary element according to claim 22, further comprising one or more support members wrapped in a pericardium.

27. The mating auxiliary element of claim 22, further comprising one or more support members wrapped with ePTFE.

28. The mating auxiliary element according to claim 22, further comprising one or more support members wrapped in a tube.

29. The mating auxiliary element according to claim 22, further comprising a stitch for connecting the support material along the lower edge.

30. The mating auxiliary element according to claim 22, further comprising a stitch for connecting the support material along the interface.

31. The mating aid element of claim 22, further comprising an ePTFE laminate only on the annular segment.

32. The mating aid element of claim 22, further comprising an ePTFE laminate at the interface.

33. The mating aid element according to claim 22, further comprising a seam boundary at the interface.

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