Retrievable tissue gripping devices, spacers, prosthetic valves, and related methods

Abstract

A clip for securing leaflets of a heart or vein valve includes a hub having a pair of anti-tangling spring-biased outer arms coupled to a lower end of the hub. A pair of anti-entanglement spring-biased inner arms are adjacent to the outer arms and coupled to the upper end of the hub. The clip may incorporate an adjustable spacer and may be retrieved after implantation. When the outer arm and the inner arm are biased relative to each other in an open position, a delivery catheter is used to position the valve clip proximate a target valve. After the valve leaflet is located between the open outer and inner arms, the biasing force may be released to allow the clip to self-close on the valve leaflet.

Description

[0001] This application is a divisional application of the Chinese patent application with the application date of April 23, 2019, application number 201980042866.X, and invention name “Retrievable tissue grasping device, spacer, artificial valve and related methods” (the corresponding PCT application with the application date of April 23, 2019 and application number PCT / US2019 / 028788).

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 662,152, filed on April 24, 2018, the entire disclosure of which is incorporated herein by reference. Background Art

[0004] The present disclosure generally relates to medical devices and related methods that use retrievable tissue grasping devices, spacers, annular remodeling devices, artificial valves to help seal native heart valves and / or enhance and / or replace their function to prevent or reduce regurgitation therethrough, and delivery devices and related methods for implanting these prosthetic devices. More specifically, the present invention relates to methods and devices for repairing mitral and tricuspid valves, venous valves, and other tissue structures through minimally invasive and other procedures.

[0005] The natural heart valves (i.e., the aortic valve, pulmonary valve, tricuspid valve, and mitral valve) play a key role in ensuring that an adequate blood supply flows forward through the cardiovascular system. Congenital malformations, inflammatory processes, infectious conditions, or diseases can reduce the effectiveness of these heart valves. Such damage to the valves can lead to severe cardiovascular damage or death. For many years, the ultimate treatment for this disease has been surgical repair or replacement of the valves in open heart surgery. However, such surgeries are very invasive and prone to many complications. Therefore, elderly and frail patients with heart valve defects often go untreated. Recently, transvascular techniques have been developed that introduce and implant prosthetic devices in a much less invasive manner than open heart surgery. Due to the high success rate, such transvascular techniques have become widely popular.

[0006] A healthy heart is typically conical in shape, tapering to a lower apex. The heart is a four-chambered heart consisting of a left atrium, a right atrium, a left ventricle, and a right ventricle. The left and right sides of the heart are usually separated by a wall called the septum. The native mitral valve of the human heart connects the left atrium and the left ventricle. The mitral valve has an anatomical structure that is very different from other native heart valves. The mitral valve includes an annulus, which is a ring-shaped portion of native valve tissue surrounding the mitral valve orifice, and a pair of cusps or leaflets extending from the annulus downward to the left ventricle. The mitral valve annulus can form a "D" shape, an elliptical shape, or other non-circular cross-sectional shape having a major axis and a minor axis. The anterior leaflet can be larger than the posterior leaflet, forming a roughly "C"-shaped border between their adjacent free edges when the leaflets are closed together.

[0007] When functioning properly, the anterior and posterior leaflets work together as a one-way valve, allowing blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle expands, the oxygenated blood that collects in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract, the increased blood pressure in the left ventricle pushes the two leaflets together, closing the one-way mitral valve so that blood cannot flow back into the left atrium and is instead expelled out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding through the mitral annulus toward the left atrium, multiple fibrous cords called chordae tendineae tether the leaflets to the papillary muscles of the left ventricle.

[0008] Mitral regurgitation occurs when the native mitral valve fails to close properly during the systolic phase of the heart's contraction, allowing blood to flow from the left ventricle into the left atrium. Mitral regurgitation is the most common valvular heart disease. Mitral regurgitation has different causes, such as leaflet prolapse, papillary muscle dysfunction, and / or left ventricular dilation leading to stretching of the mitral annulus. Mitral regurgitation in the central portion of the leaflet may be referred to as central jet mitral regurgitation, and mitral regurgitation near one of the commissures of the leaflet (i.e., where the leaflets meet) may be referred to as eccentric jet mitral regurgitation. Some existing technologies for treating mitral regurgitation include suturing one portion of the native mitral valve leaflet directly to another portion. The most common treatment for mitral regurgitation relies on valve replacement or repair, including leaflet and annular remodeling. Due to its complex design and multiple components, the only FDA-approved catheter-based device (Abbott's MitraClip) is large (24Fr) and is also complex to use / operate. Despite these existing technologies, there remains a need for improved devices and methods for treating mitral regurgitation. Summary of the invention

[0009] The present disclosure generally relates to prosthetic devices and related methods for helping to seal native heart valves and prevent or reduce regurgitation therethrough, as well as devices and related methods for implanting such prosthetic devices.

[0010] The present invention provides devices, systems and methods for tissue approximation and repair at a treatment site. The devices, systems and methods of the present invention will be useful for a variety of treatment procedures, including intravascular procedures, minimally invasive procedures and open surgical procedures, and can be used in various anatomical regions, including the abdomen, chest, cardiovascular system, heart, intestines, stomach, urethra, bladder, lungs and other organs, blood vessels and tissues. The present invention is particularly useful in those procedures that require minimally invasive or intravascular access to distal tissue locations, particularly those procedures in which the instruments used must traverse long, narrow and tortuous paths to reach the treatment site. In addition, many of the devices and systems of the present invention are adapted to be able to be retrieved and removed from a patient at any location without disturbing or harming internal tissues.

[0011] In a preferred embodiment, the devices, systems and methods of the present invention are suitable for fixing tissue at a treatment site. Exemplary tissue fixation applications include heart valve repair, septal defect repair, vascular ligation and clamping, laceration repair and wound closure, but the present invention can be used in a variety of tissue approximation and repair procedures. In a particularly preferred embodiment, the devices, systems and methods of the present invention are suitable for repairing heart valves, particularly the mitral valve, as a regurgitation therapy. The present invention can use an "edge-to-edge" or "bow tie" technique to close two or more valve leaflets to reduce regurgitation without the need for open heart surgery through the chest cavity and heart wall as in traditional methods. In addition, in a diseased mitral valve, the position of the leaflets may vary depending on the type and degree of disease (such as calcification, prolapse or flail). These types of disease can cause one leaflet to be more mobile (e.g., more difficult to capture) than another leaflet, and therefore it will be more difficult to grasp symmetrically when grasping the same as another leaflet. Features of the present invention enable the fixation device to adapt to the challenges of unpredictable target tissue geometry and provide a more powerful grasp of the tissue after it is captured. Furthermore, the present invention optionally incorporates visualization techniques to enable the device placement procedure to be performed without the use of general anesthesia.

[0012] The devices, systems and methods of the present invention focus on a variety of devices that can be used alone or in combination to form an interventional system. In a preferred embodiment, the interventional system includes a multi-catheter guide system, a delivery catheter and an interventional device. Each of these components will be discussed herein.

[0013] In one exemplary embodiment, the present invention provides a fixation device having a pair of outer arms (or fixation elements), each outer arm having a free end and an engagement surface for engaging tissue, wherein the outer arms are movable between a first position for capturing the tissue and a second position for fixing the tissue. Preferably, the engagement surfaces are spaced apart at a distance in the first position and are close to each other and generally facing each other in the second position. The fixation device is preferably delivered to a target location in the patient's body by a delivery catheter having an elongated shaft, a proximal end, and a distal end, the delivery catheter being configured to be positioned at the target location from a remote access point such as a vascular puncture or incision or surgical penetration. In a preferred embodiment, the target location is a valve in the heart.

[0014] A particular advantage of the present invention is its ability to occlude the leaflets of the mitral valve (or any other tissue used therewith) in a parallel or perpendicular relationship and to capture the leaflets along their anatomical contours. In other words, even with little or no occlusion depth, the leaflets can be captured, brought together and secured so that their proximal upstream surfaces lie parallel to each other and are roughly aligned with the direction of flow through the valve at the occlusion point. In some embodiments of the fixation device, the leaflets are captured in a spaced-apart relationship and then drawn together in a occluded relationship using a sufficiently rigid outer arm, a high friction and compression inner arm, and a passive closure mechanism, while maintaining the leaflets perpendicular (aligned with the blood flow) to achieve an optimal occlusion configuration.

[0015] A particular advantage of the present invention is its ability to occlude the leaflets of the mitral valve (or any other tissue used therewith) in a close anatomical relationship of the leaflet shape while being captured along with the anatomical contours of the leaflets. In other words, the leaflets can be captured, drawn together, and secured to maintain their natural anatomical shape. In some embodiments of the fixation device, the leaflets are captured in a spaced-apart relationship and then drawn together in an occluded relationship while maintaining the leaflets vertical (aligned with the blood flow) using sufficiently flexible outer arms, high friction and compression inner arms, and a passive closure mechanism to achieve an optimal occluded configuration.

[0016] The fixation device is preferably delivered with the outer arm to a delivery position configured to minimize the profile of the device. When approaching the mitral valve from the atrial side, some embodiments of the fixation device allow the device to be delivered with the free end of the outer arm pointing in a generally proximal direction forming an angle of less than about 180°, typically less than 90°, and preferably less than about 40° relative to the longitudinal axis of the delivery device shaft. In this position, the engagement surfaces are generally opposite to each other, generally arranged at an angle of less than about 180° and preferably less than about 40° relative to each other. For a ventricular approach, in the delivery position, the free end of the outer arm points and forms an angle of less than about 90°, preferably less than about 40° relative to the longitudinal axis of the delivery device shaft. In this position, the engagement surfaces are generally opposite to each other, generally arranged at an angle of less than about 180° and preferably less than about 90° relative to each other. Optionally, in some ventricular approaches, it is preferred to point the free end of the fixation element in a generally proximal direction and the engagement surfaces are away from each other in the delivery position.

[0017] In order to provide reversibility and removability of the devices and systems of the present invention, the leaflets are lifted from the sufficiently flexible arms using sutures or wires. This is particularly important in applications for mitral valve repair because of the presence of chordae tendineae, valve leaflets and other tissues that may become entangled with the device. For an approach from the atrial side of the mitral valve (in an inverted position), the free end will point in a generally distal direction relative to the catheter shaft and the engagement surfaces will generally be opposed to each other, typically arranged at an angle greater than about 180° and preferably greater than about 270° relative to each other. For a ventricular approach to the valve in a simulated inverted position, the free end will point in a distal direction relative to the catheter shaft and the engagement surfaces will generally face each other, typically arranged at an angle less than about 180° and preferably less than about 90° relative to each other.

[0018] In the open position, the engagement surfaces of the outer arms preferably form an angle of up to 180° relative to each other to maximize the area of ​​capture of the valve leaflets or other target tissue. The outer arms are preferably flexible to a closed position in which the engagement surfaces engage each other or form an angle as small as 0° relative to each other, and in some cases less than 0° relative to each other, such as -10° relative to each other. The distal arm is configured to be flexible and permanently retained in various positions while applying a compressive force relative to the proximal arm to allow fixation of tissues of various thicknesses, various geometries, and various spacings.

[0019] A particular advantage of the present invention is that both the outer arm and the inner arm are sufficiently superelastic and flexible to exert a persistent yet gentle relative force on the tissue while allowing small movements to conform to a) the anatomical shape of the leaflet and b) the physiological forces on the leaflet.

[0020] Another particular advantage of the present invention is that the partially non-invasive friction elements (barbs) are placed along the inner side of the long axis of the arm and are enclosed by continuous and solid sides. Unlike the MitraClip device, the barbs are not exposed along the sides. This is advantageous because it significantly reduces the risk of entanglement of chordae tendineae, valve leaflets and other tissues that may become entangled with the device. In addition, this feature reduces the risk of entanglement or sutures or wires or other such delivery catheter elements that may come into contact with the fixture.

[0021] One aspect of the present invention provides a tissue shaping device that is suitable for being deployed in a blood vessel to reshape tissue adjacent to the blood vessel. In an exemplary embodiment, the device includes juxtaposed features in the form of leaf springs for engaging leaflets from the atrial and ventricular sides. Two such leaf spring features can be connected to a base to capture the posterior leaflet and the anterior leaflet of the mitral valve. In some embodiments, the leaf springs can be made of metal plates and / or metal wires and / or ribbons and / or any other suitable material form. In some embodiments, the leaf springs can have anchors and / or barbs to capture and / or restrain the captured tissue / leaflets.

[0022] In some embodiments, in addition to restraining the leaflets, the leaf springs are configured to tighten the ring to better mitigate regurgitation.

[0023] In some embodiments, the opposing leaf springs may be formed from a combination of wire and / or sheet metal and / or strip and / or solid and / or hollow shapes with or without cut patterns.

[0024] In some embodiments, leaf springs can be expandable and / or compressible such that they can be in a compressed configuration within the delivery system as well as deployed in an expanded configuration.

[0025] In some embodiments, the catheter shaft can be used to manipulate features of the leaf spring to capture the leaflets.

[0026] In some embodiments, the catheter can manipulate the leaf spring to capture both leaflets simultaneously or sequentially using sutures or wires or any other common technique commonly used in interventional catheter technology.

[0027] In some embodiments, only one juxtaposed leaf spring may be used instead of a pair of opposing leaf springs. In this way, only one leaflet (the anterior leaflet or the posterior leaflet) is captured, while the other leaflet is free.

[0028] In some embodiments, when the prosthetic sealing device is implanted at the native mitral valve, the uncaptured valve leaflet of one of the anterior mitral leaflet and the posterior mitral leaflet is not secured to the sealing device.

[0029] In some embodiments, advancing the delivery device via the left ventricle to the native mitral valve region comprises inserting the delivery device into the left ventricle through an incision in the apex of the left ventricle.

[0030] In some embodiments, advancing the delivery system from the left ventricle to the native mitral valve region includes inserting the delivery device into the left ventricle through an incision at the apex of the left ventricle.

[0031] In some embodiments, as the delivery system is advanced to the native mitral valve region of the heart, the anchor is maintained in a generally straightened position within a delivery catheter extending distally along one side of the body of the prosthetic sealing device.

[0032] In some embodiments, a method of implanting a prosthetic sealing device in a native mitral valve of a heart includes advancing a delivery system from the left atrium of the heart to the native mitral valve region of the heart, the delivery system housing the prosthetic sealing device, proximally retracting an outer sheath of the delivery system such that an anchor of the prosthetic sealing device is not confined within the delivery system, retracting the delivery system toward the left atrium of the heart such that a native mitral valve leaflet is positioned between the anchor of the prosthetic sealing device and the delivery system, proximally retracting an inner sheath of the delivery system such that a body of the prosthetic sealing device is not confined within the delivery system, wherein the body is configured to prevent blood from flowing through the body during systole and diastole, and removing the delivery system from the native mitral valve region of the heart.

[0033] In some embodiments, advancing the delivery system from the left atrium to the native mitral valve region includes advancing the delivery system through an incision in a portion of the septum between the left atrium and the right atrium. In some embodiments, when the delivery system is advanced to the native mitral valve region of the heart, the device is maintained in a generally straightened position extending proximally from the body of the prosthetic sealing device within the delivery catheter.

[0034] In some embodiments, the device can be retrieved immediately after deployment. In some embodiments, the device can be retrieved within 24 hours after deployment. In some embodiments, the device can be retrieved within 30 days after deployment. In some embodiments, the device can be retrieved after 30 days after deployment. In some embodiments, the device can be retrieved within 6 months after deployment. In some embodiments, the device can be retrieved after 6 months after deployment.

[0035] In some embodiments, the device has a spacer feature to mitigate reflux. In some embodiments, the spacer feature can be adjusted during the procedure and / or after recovery and / or at a later time post-surgery.

[0036] In some embodiments, the device has a leaflet tightening feature to reduce regurgitation. In some embodiments, the tightening feature can be adjusted during the procedure and / or after recovery and / or at a later time after surgery.

[0037] In some embodiments, the device can be configured for veterinary applications to treat valvular regurgitation in animals / pets.

[0038] Different aspects of the invention are further described in the following numbered clauses:

[0039] Item 1. A method for implanting a prosthetic sealing device into a native mitral valve of a heart, the method comprising: advancing a delivery catheter from the left atrium of the heart to the native mitral valve region of the heart, the delivery catheter accommodating the prosthetic sealing device in a compressed and / or extended configuration; advancing the prosthetic sealing device distally relative to the delivery catheter so that the prosthetic sealing device moves out of the catheter and forms a leaflet engagement structure, the leaflet engagement structure being capable of capturing or grasping the leaflets from the ventricular and atrial sides sequentially (one leaflet at a time) or simultaneously (two leaflets at a time), and being configured to reduce or eliminate or alleviate valve regurgitation, similar to the Afieri edge-to-edge repair technique.

[0040] Clause 2. The method of Clause 1, wherein advancing the delivery catheter from the left atrium through the native mitral valve comprises advancing the delivery catheter through an incision in a portion of a septum between the left atrium and the right atrium.

[0041] Clause 3. The method of clause 1, wherein advancing the delivery catheter from the left ventricle through the native mitral valve comprises advancing the delivery catheter through an incision in a portion of a septum between the left ventricle and the right ventricle.

[0042] Clause 4. The method of Clause 1, wherein advancing the delivery catheter from the left ventricle through the native mitral valve comprises advancing the delivery catheter through the aortic valve.

[0043] Clause 5. A method according to clause 1, wherein advancing a delivery catheter through the left ventricle to the native mitral valve region comprises inserting the delivery device into the left ventricle through an incision at the apex of the left ventricle. Clause 6. A method of implanting a prosthetic sealing device into the native mitral valve of a heart, the method comprising: advancing a delivery catheter from the left atrium of the heart to the native mitral valve region of the heart, the delivery catheter containing the prosthetic sealing device in a compressed and / or extended configuration; advancing the prosthetic sealing device distally relative to the delivery catheter so that the prosthetic sealing device moves out of the catheter and forms a leaflet engagement structure capable of capturing or grabbing a single leaflet from the ventricular and atrial sides, wherein the device is configured to prevent regurgitation of blood during systole and diastole, wherein when the prosthetic sealing device is implanted into the native mitral valve for its intended use, one of the uncaptured anterior leaflet and posterior leaflet is not fixed to the prosthetic sealing device.

[0044] Clause 7. The method of Clause 2, wherein advancing the delivery catheter from the left atrium through the native mitral valve comprises advancing the delivery catheter through an incision in a portion of a septum between the left atrium and the right atrium.

[0045] Clause 8. The method of Clause 2, wherein advancing the delivery catheter from the left ventricle through the native mitral valve comprises advancing the delivery catheter through an incision in a portion of a septum between the left ventricle and the right ventricle.

[0046] Clause 9. The method of Clause 2, wherein advancing the delivery catheter from the left ventricle through the native mitral valve comprises advancing the delivery catheter through the aortic valve.

[0047] Clause 10. A method according to clause 2, wherein advancing a delivery catheter through the left ventricle to the native mitral valve region comprises inserting the delivery device into the left ventricle through an incision in the apex of the left ventricle. Clause 11. A method of implanting a prosthetic sealing device into the native mitral valve of a heart, the method comprising: advancing a delivery catheter from the left atrium of the heart to the native mitral valve region of the heart, the delivery catheter containing the prosthetic sealing device in a compressed and / or extended configuration; advancing the prosthetic sealing device distally relative to the delivery catheter so that the prosthetic sealing device is displaced from the catheter and forms a leaflet engagement structure, the leaflet engagement structure being capable of sequentially (one leaflet at a time) or simultaneously (two leaflets at a time) capturing or grasping the leaflets from the ventricular and atrial sides, configured to reduce or eliminate or mitigate valvular regurgitation, similar to the Afieri edge-to-edge repair technique; wherein the prosthetic sealing device has a capture feature that allows the device to be retrieved.

[0048] Clause 12. The method of Clause 11, wherein advancing the delivery catheter from the left atrium through the native mitral valve comprises advancing the delivery catheter through an incision in a portion of a septum between the left atrium and the right atrium.

[0049] Clause 13. The method of Clause 11, wherein advancing the delivery catheter from the left ventricle through the native mitral valve comprises advancing the delivery catheter through an incision in a portion of a septum between the left ventricle and the right ventricle.

[0050] Clause 14. The method of Clause 11, wherein advancing the delivery catheter from the left ventricle through the native mitral valve comprises advancing the delivery catheter through the aortic valve.

[0051] Clause 15. The method of clause 11, wherein advancing a delivery catheter through the left ventricle to the native mitral valve region comprises inserting the delivery device into the left ventricle through an incision in the apex of the left ventricle. Clause 16. A method of implanting a prosthetic sealing device into a native mitral valve of a heart, the method comprising: advancing a delivery catheter from the left atrium of the heart to the native mitral valve region of the heart, the delivery catheter containing the prosthetic sealing device in a compressed and / or extended configuration; advancing the prosthetic sealing device distally relative to the delivery catheter so that the prosthetic sealing device is displaced from the catheter and forms a leaflet engagement structure capable of capturing or grabbing a single leaflet from the ventricular and atrial sides, wherein the device is configured to prevent regurgitation of blood during systole and diastole, wherein when the prosthetic sealing device is implanted into the native mitral valve for its intended use, one of the uncaptured anterior leaflet and the posterior leaflet is not secured to the prosthetic sealing device; wherein the prosthetic sealing device has a capture feature that allows the device to be retrieved.

[0052] Clause 17. The method of Clause 16, wherein advancing the delivery catheter from the left atrium through the native mitral valve comprises advancing the delivery catheter through an incision in a portion of a septum between the left atrium and the right atrium.

[0053] Clause 18. The method of Clause 16, wherein advancing the delivery catheter from the left ventricle through the native mitral valve comprises advancing the delivery catheter through an incision in a portion of a septum between the left ventricle and the right ventricle.

[0054] Clause 19. The method of Clause 16, wherein advancing the delivery catheter from the left ventricle through the native mitral valve comprises advancing the delivery catheter through the aortic valve.

[0055] Clause 20. The method of clause 16, wherein advancing a delivery catheter through the left ventricle to the region of the native mitral valve comprises inserting the delivery device into the left ventricle through an incision in the apex of the left ventricle. Clause 21. A method of implanting a prosthetic sealing device into the native mitral valve of a heart, the method comprising: advancing a delivery catheter from the left atrium of the heart to the region of the native mitral valve of the heart, the delivery catheter containing the prosthetic sealing device in a compressed and / or extended configuration; advancing the prosthetic sealing device distally relative to the delivery catheter such that the prosthetic sealing device is displaced from the catheter and forms a leaflet engagement structure capable of sequentially (one leaflet at a time) or simultaneously (two leaflets at a time) capturing or grabbing the leaflets from the ventricular and atrial sides and having a spacer feature configured to reduce or eliminate or mitigate valve regurgitation. Clause 22. The method of clause 21, wherein advancing a delivery catheter from the left atrium through the native mitral valve comprises advancing the delivery catheter through an incision in a portion of the septum between the left atrium and the right atrium.

[0056] Clause 23. The method of Clause 21, wherein advancing the delivery catheter from the left ventricle through the native mitral valve comprises advancing the delivery catheter through an incision in a portion of a septum between the left ventricle and the right ventricle.

[0057] Clause 24. The method of Clause 21, wherein advancing the delivery catheter from the left ventricle through the native mitral valve comprises advancing the delivery catheter through the aortic valve.

[0058] Clause 25. The method of Clause 21, wherein advancing the delivery catheter through the left ventricle to the native mitral valve region comprises inserting the delivery device into the left ventricle through an incision in the apex of the left ventricle. Clause 26. The method of Clause 21, wherein the spacer is expandable.

[0059] Clause 27. The method of Clause 21, wherein the spacer is foldable.

[0060] Clause 28. The method of Clause 21, wherein the spacer is compressible.

[0061] Clause 29. The method of Clause 21, wherein the spacer is expandable.

[0062] Clause 30. The method of Clause 21, wherein the spacer is solid.

[0063] Clause 31. The method of Clause 21, wherein the spacer is hollow.

[0064] Clause 32. The method of Clause 21, wherein the spacer is porous.

[0065] Clause 33. The method of Clause 21, wherein the spacer is non-porous.

[0066] Clause 34. The method of clause 21, wherein the spacer is non-compressible. Clause 35. A method of implanting a prosthetic sealing device into a native mitral valve of a heart, the method comprising: advancing a delivery catheter from the left atrium of the heart to the native mitral valve region of the heart, the delivery catheter containing the prosthetic sealing device in a compressed and / or extended configuration; advancing the prosthetic sealing device distally relative to the delivery catheter so that the prosthetic sealing device is displaced from the catheter and forms a leaflet engagement structure capable of capturing or grabbing a single leaflet from the ventricular and atrial sides, wherein the device is configured to prevent regurgitant flow of blood during systole and diastole, wherein when the prosthetic sealing device is implanted into the native mitral valve for its intended use, one of the uncaptured anterior leaflet and posterior leaflet is not secured to the prosthetic sealing device; and having a spacer feature configured to reduce or eliminate or mitigate valve regurgitation.

[0067] Clause 36. The method of Clause 35, wherein advancing the delivery catheter from the left atrium through the native mitral valve comprises advancing the delivery catheter through an incision in a portion of a septum between the left atrium and the right atrium.

[0068] Clause 37. The method of Clause 35, wherein advancing the delivery catheter from the left ventricle through the native mitral valve comprises advancing the delivery catheter through an incision in a portion of a septum between the left ventricle and the right ventricle.

[0069] Clause 38. The method of Clause 35, wherein advancing the delivery catheter from the left ventricle through the native mitral valve comprises advancing the delivery catheter through the aortic valve.

[0070] Clause 39. The method of Clause 35, wherein advancing the delivery catheter through the left ventricle to the native mitral valve region comprises inserting the delivery device into the left ventricle through an incision in the apex of the left ventricle. Clause 40. The method of Clause 35, wherein the spacer is expandable.

[0071] Clause 41. The method of Clause 35, wherein the spacer is foldable.

[0072] Clause 42. The method of Clause 35, wherein the spacer is compressible.

[0073] Clause 43. The method of Clause 35, wherein the spacer is expandable.

[0074] Clause 44. The method of Clause 35, wherein the spacer is solid.

[0075] Clause 45. The method of Clause 35, wherein the spacer is hollow.

[0076] Clause 46. The method of Clause 35, wherein the spacer is porous.

[0077] Clause 47. The method of Clause 35, wherein the spacer is non-porous.

[0078] Clause 48. The method of clause 35, wherein the spacer is incompressible. Clause 49. The method of any of the preceding clauses, comprising a capture feature that allows for retrieval of the device during and / or after deployment.

[0079] Clause 50. The method of Clause 49, wherein the capture feature can be used to actuate at least one component of the prosthetic sealing device during and / or after implantation.

[0080] Clause 51. A method according to any of the preceding clauses, wherein the prosthetic device can be retrieved within 1 day, 1 week, 1 month, 1 year, 10 years, 20 years, 30 years, 50 years, 100 years and / or 120 years after implantation.

[0081] Clause 52. A method according to any of the preceding clauses, wherein the prosthetic device can be retrieved 0 days, 1 week, 1 month, 1 year, 10 years, 20 years, 30 years, 50 years, 100 years and / or 120 years after implantation.

[0082] Clause 53. A method according to any of the preceding clauses, comprising sensors, transducers, actuators and / or one or more imaging features for assisting, adjusting, implanting, retrieving and / or monitoring the functionality, safety and / or effectiveness of the prosthetic device.

[0083] Clause 54. A method according to any of the preceding clauses, including any combination of claims, clauses or embodiments described in the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0084] Figure 1 Exemplary embodiments of devices configured for capturing either the anterior leaflet or the posterior leaflet are shown.

[0085] Figure 2 Shows Figure 3 A perspective view of an exemplary embodiment is shown.

[0086] Figure 3 Shows Figure 1 Laser cut flat pattern (of metal sheet) of the exemplary embodiment shown.

[0087] Figure 4 Shown by combining Figure 1 The exemplary embodiment of the device is formed by two of the exemplary embodiments shown. This is to capture each of the anterior mitral valve leaflet and the posterior mitral valve leaflet.

[0088] Figure 5 An exemplary embodiment of a device 1090 is shown in a straightened configuration within a delivery catheter 1050 having a delivery lumen 1050a, wherein each capture spring of the device is in a constrained straightened configuration.

[0089] Figure 6 An exemplary embodiment is shown where the device 1090 is deployed by pushing the device distally relative to the delivery catheter 1050, or vice versa by retracting the delivery catheter proximally relative to the delivery catheter.

[0090] Figure 7 The device is shown pushed out in an exemplary leaflet grabbing configuration. The leaflets can be grabbed in gaps 1053, 1054.

[0091] Figure 8 An exemplary embodiment of a deployed device 1090 is shown. For simplicity, leaflets are not shown within the gaps 1047 and 1048. It also shows a retrieval suture 1091 with a radiopaque marker 1093.

[0092] Figures 9 to 13 A method of deploying 1090 an exemplary device embodiment from a stepped delivery sheath is shown, which allows for sequential coaptation of the leaflets.

[0093] Fig.14 An exemplary embodiment 1090 is shown as deployed in the mitral valve of a heart.

[0094] Figures 15 to 22 A method of retrieving an exemplary device embodiment 1090 after implantation is shown.

[0095] Figure 23 to Figure 24 An exemplary embodiment of an implant device 1130 is shown.

[0096] Figure 25 to Figure 26 An exemplary embodiment of an implant device 1150 is shown.

[0097] Figures 27 to 30 The deployment steps of an exemplary embodiment of implant device 1155 are shown.

[0098] Fig.31 An exemplary embodiment 1155 is shown with an expanded balloon 1157 when implanted in the mitral valve of a heart.

[0099] Fig.32 A schematic diagram of an exemplary embodiment 1150 implanted in a mitral valve during systole is shown, and Fig.33 A schematic diagram of the diastolic phase is shown.

[0100] Fig.34 A schematic diagram of an exemplary embodiment 1155 of a mitral valve implanted during systole is shown, and Fig.35 A schematic diagram of the diastolic phase is shown.

[0101] Figure 36 to Figure 37 Shown with Figure 1 to Figure 2 The illustrated embodiment 1030 is similar to exemplary embodiment 1175 . However, the inner and outer elements are separate components that are connected together by base bracket 1180 .

[0102] Figure 38 to Figure 39 Retrieval suture 1197 is shown attached to embodiment 1175.

[0103] Fig.40 A schematic diagram of an embodiment 1175 implanted inside a mitral valve is shown.

[0104] Fig.41 Shows Fig.38 The illustrated embodiment 1175 incorporates a spacer balloon 1257 .

[0105] Fig.42 Shows Fig.38 The embodiment 117 shown incorporates a spacer stent-like structure 1267. The structure can be self-expandable, balloon expandable or non-expandable. In addition, it can be hollow, porous, covered or uncovered, coated or uncoated.

[0106] Fig.43 It shows that previously Fig.41 Schematic diagram of embodiment 1175 implanted within a mitral valve.

[0107] Fig.44 It shows that previously Fig.42 Schematic diagram of embodiment 1175 implanted within a mitral valve.

[0108] Fig.45 An exemplary mitral valve is shown with regurgitant area / orifice during systole.

[0109] Fig.46 Shows the Fig.45 An exemplary mitral valve.

[0110] Fig.47 An exemplary schematic diagram of a mitral valve implanted with balloon 1257 during systole is shown.

[0111] Fig.48 An exemplary embodiment 1175 is shown in which a balloon 1257 is implanted in the same exemplary mitral valve during diastole.

[0112] Fig.49 An exemplary embodiment is shown in which two devices 1175 are connected to one spacer 1257.

[0113] Fig.50 An exemplary embodiment is shown in which two devices 1175 are looped together using sutures 1257. The sutures can be cinched after deployment during the procedure, or remotely cinched after the procedure. DETAILED DESCRIPTION

[0114] Embodiments of prosthetic devices primarily for implantation in one of the mitral, aortic, tricuspid, or pulmonary valve regions of a human heart, as well as apparatus and methods for implanting the prosthetic devices are described herein. The prosthetic device can be used to help restore and / or replace the function of a defective native mitral valve. The disclosed embodiments should not be construed as limiting in any way. On the contrary, the present disclosure is intended to address all novel and non-obvious features and aspects of the various disclosed embodiments, individually and in various combinations and sub-combinations with each other. In addition, although the subject matter is for use in humans, the disclosed embodiments can also be configured for use in animals.

[0115] The grasping will preferably be non-traumatic, which provides a number of benefits. Non-traumatic means that the device and method of the present invention can be applied to the valve leaflet, which can then be removed without causing any significant clinical damage to the leaflet structure or function. The leaflet and valve continue to perform essentially the same function as before the application of the present invention. Therefore, some slight penetration or leaflet depression may occur using the present invention, but it still meets the definition of "non-traumatic". This allows the device of the present invention to be applied to diseased valves and, if necessary, can be removed or repositioned without negatively affecting valve function. In addition, it will be understood that in some cases, it may be necessary or desirable to puncture or permanently affect the leaflet when grasping, fixing, or both. In some of these cases, grasping and fixing can be accomplished by a single device. Although multiple embodiments are provided to achieve these results, the basic features will be generally outlined herein. These features are not intended to limit the scope of the present invention, and their purpose is to provide a basis for describing the various embodiments proposed later in this application.

[0116] The apparatus and methods of the present invention rely on the use of minimally invasive tools and / or interventional tools that are located near the desired treatment site and used to grasp the target tissue. In intravascular applications, the interventional tool is typically an interventional catheter. In surgical applications, the interventional tool is typically an interventional instrument. In a preferred embodiment, fixation of the grasped tissue is accomplished by maintaining the grasp with a portion of the interventional tool left as an implant. Although the present invention can have a variety of applications in tissue approximation and fixation throughout the body, it is particularly suitable for the repair of valves, especially heart valves, such as the mitral valve and tricuspid valve.

[0117] The prosthetic device can be configured to be implanted via a delivery sheath. The body and anchor can be solid or hollow, compressible or incompressible, and rigid or flexible. The device can be configured to allow the anchor to initially self-expand from the body in a radial or transverse direction to form a gap between the body and the anchor. The leaflet can then be placed in the gap. The body can then be allowed to contact the leaflet, closing the gap between the body and the anchor, and capturing the leaflet between the body and the anchor. The implantation methods of different embodiments can be different, and will be discussed more fully below with respect to each embodiment.

[0118] Some embodiments disclosed herein are generally configured to be secured to only one of the native mitral valve leaflets. However, other embodiments include more than one anchor, and the anchor may be configured for securing to both mitral valve leaflets. Additionally, there are other embodiments of anchors that allow for retrieval of the implanted subject at a later date. Unless otherwise noted, any of the embodiments disclosed herein that include a single anchor may optionally be secured to the anterior mitral valve leaflet or to the posterior mitral valve leaflet, or to both, regardless of whether a particular embodiment is shown as being secured to a particular one of the leaflets.

[0119] Some embodiments disclosed herein are generally configured with an anchor or anchor-like support structure having a coating or covering to promote tissue incorporation in chronic conditions. However, other embodiments include a biocompatible coating or covering that can promote minimal or no tissue ingrowth - so that the device can be retrieved / removed later. Unless otherwise specified, any embodiment can be configured to: a) fully incorporate into tissue, b) partially incorporate into tissue, or c) minimal to no tissue incorporation, or a combination of tissue incorporation at various locations on the device, regardless of whether the specific embodiment is shown as a covering or coating.

[0120] Some embodiments disclosed herein include spacer features that can be used to fill regurgitant holes to further reduce and / or eliminate valve regurgitation. Unless otherwise stated, any embodiment disclosed herein may optionally include a spacer, regardless of whether the particular embodiment shows a spacer.

[0121] In addition, some embodiments may also optionally include one or more atrial and / or ventricular anchors to provide additional stability. Unless otherwise specified, any embodiment disclosed herein may optionally include an atrial (and / or ventricular) anchor, or may not include an atrial (and / or ventricular) anchor, regardless of whether a particular embodiment is shown with an atrial (and / or ventricular) anchor.

[0122] Figure 1 and Figure 2 1041 and 1042. The atrial leaf spring 1041 and / or the ventricular leaf spring 1042 may have an anchor or barb or friction element (an exemplary atrial friction element 1046 is shown). Figure 1 and Figure 2 ). These anchors can be configured to be atraumatic and designed to release or constrain tissue depending on the gap between the two leaf springs 1041, 1042. The gap between leaf springs 1041 and 1042 can be manipulated using common interventional catheter techniques, such as pulling the atrial leaf spring 1041 with sutures or wires while constraining the ventricular leaf spring 1042 with a catheter shaft and / or sutures / wires and / or a custom delivery mechanism. Figure 2 Shows Figure 1 The perspective view of the exemplary embodiment further illustrates a hole feature 1049 at the top of the atrial leaf spring 1041 that may be used to attach a retrieval suture loop 1091 as described below.

[0123] Figure 3 The prosthetic device 1030 is shown in a straightened form prior to being bent into a final spring form. The blank or strip may be cut into Figure 3 The pattern shown is usually obtained from a piece of superelastic nickel-titanium alloy or other alloy (such as ) laser cut. In other embodiments, the device 1030 can be made of an elastic polymer, metal, ceramic, or a combination thereof.

[0124] Figure 4 An exemplary embodiment of an apparatus 1090 is shown, which uses two apparatuses 1030 (such as Figure 1 1041 ) are formed by fastening / bonding / welding / pressing the two devices 1030 together at the base, in which case a tubular or rectangular fastening member 1045 is used to tie or otherwise secure the two devices 1030 together in a face-to-face manner. By securing the devices 1030 near their respective bases, the atrial leaf spring 1041 can bend freely to capture and / or release the leaflets. In addition, this embodiment can include a retrieval suture loop 1091 with a radiopaque marker 1093.

[0125] Figures 5 to 8An exemplary method of deploying device 1090 from delivery catheter 1050 is shown. Figure 5 1, device 1090 is shown primarily within catheter 1050 with atrial leaf springs 1041, 1043 extending proximally while ventricular leaf springs 1042, 1044 extend distally in a straightened or unfolded state. Pusher member 1051 may be used to push device 1090 distally relative to catheter 1050, or to stabilize device 1090 when the catheter is retracted. Device 1090 will typically be removably attached to pusher member 1051 by retrieval of suture loops 1091 and 1092.

[0126] exist Figure 6 In the embodiment, the device 1090 is deployed by pushing distally relative to the catheter 1050 so that the ventricular leaf springs 1042, 1044 begin to extend out of the distal end 1056 of the catheter 1050. Figure 7 As shown, the ventricular leaf springs 1042, 1044 are fully exposed from the distal end 1056 and elastically return to their predetermined shape.

[0127] Mitral valve leaflets 1074, 1077 may initially be captured within large gaps 1053, 1054 between the inner surfaces of ventricular leaf springs 1042, 1044 and the outer surface of the distal region of delivery catheter 1050 formed after the ventricular leaf springs emerge from the delivery catheter, as shown in FIG. Figure 7 After the entire device 1090 has emerged from the catheter 1050, as shown. Figure 8 As shown, when the atrial leaf spring returns to its unconstrained shape, the atrial leaf springs 1041, 1042 close on the atrial surface of the mitral valve leaflets 1074, 1077. In this way, the leaflets 1074, 1077 are captured / anchored within the small gaps 1047, 1048.

[0128] like Figure 8 As shown, the device 1090 is completely separated from the delivery catheter 1050, and once the device is fully released from the constraints of the delivery catheter 1050, the ventricular leaf springs 1042, 1044 elastically return to their pre-deformed shape.

[0129] Figures 9 to 11 An exemplary method of deploying the device 1090 from the delivery catheter 1057 is illustrated, wherein the user may sequentially grasp and / or constrain one leaflet at a time. This method is as previously described in Figures 5 to 8 A slightly modified form of the method shown and described in , in which all components except the distal end of the catheter shaft 1057 are stepped, i.e., as Fig.12 As shown, there is a front distal edge 1056 and a trailing edge 1055. Fig. 9, the device 1040 is shown primarily within the catheter 1057, with the atrial leaf springs 1041, 1043 extending proximally and the ventricular leaf springs 1042, 1044 extending distally in a straightened or unfolded state. The pusher member 1051 can be used to push the device 1090 distally relative to the catheter 1057, or to keep the device 1090 stable when the catheter is retracted. Fig.10 In the embodiment, the catheter 1057 is retracted proximally from the device 1090 and / or the device 1090 is advanced distally from the catheter 1050, so that due to the offset 1055, the leaf spring 1044 first elastically rebounds, while the leaf spring 1090 is still constrained in a straight position by the distal portion 1056 of the shaft 1057. Thus, the user is allowed to selectively grasp and / or constrain a leaflet in the interval 1053. Fig.11 1090, the user then retracts and / or pushes the device 1090 further outward toward the catheter 1057, causing the second ventricular leaf spring 1042 to also elastically recoil, allowing the user to grasp and / or constrain the second leaflet at this time. Once both leaflets are grasped and / or constrained, the user can then fully deploy the device 1090, constraining the leaflets within the septum 1047 and septum 1048 of the device.

[0130] Fig.13 An exemplary embodiment is shown when fully deployed (eg Figure 8 Note that the leaflets are not shown for simplicity.

[0131] Fig.14 An example of a device 1090 deployed within a mitral valve leaflet is shown.

[0132] Figures 15 to 22 A method of retrieving an exemplary device embodiment 1090 after implantation is shown. Fig.15 An exemplary rat tooth grasper 1100 is shown being advanced toward an implanted exemplary device 1090. Fig.16 The retrieval suture 1093 is shown grasped by the grasper 1100. Figure 17 to Figure 18 The grabber 1100 is shown retracted into the interior of the inner conduit 1051, thereby raising the inner arm 1041 and the inner arm 1043 together, as shown in FIG. Fig.19 shown. Fig. 20 Inner arm 1041 and inner arm 1043 are shown retracted into guide catheter shaft 1050. Further retraction of implant 1090 into guide catheter 1050 inverts outer arm 1042 and outer arm 1044. Raising the inner arm and / or inverting the outer arm releases the leaflets from implant 1090. Fig. 22 The implant is shown fully retracted into the guide catheter 1050, at which point the entire system and implant 1090 can be completely removed.

[0133] Fig.23 and Fig.24 An exemplary embodiment 1125 is shown in which the inner arms 1126, 1128 and outer arms 1127, 1129 are made from separate components. All four components are then fastened together using a base bracket 1130 and screws 1131.

[0134] Fig.25 and Fig.26 An exemplary embodiment 1150 is shown with a retrieval suture 1091. As with embodiment 1125, it is made of separate inner arms 1126, 1128 and outer arms 1127, 1129. All four components are then fastened together using base brackets 1130 and screws 1131.

[0135] Fig. 27 and Fig.28 An exemplary embodiment 1155 is shown with an expandable balloon attached thereto. During deployment, the balloon is tethered to the catheter and can be inflated to reduce or alleviate valve regurgitation.

[0136] like Fig.29 As shown, if the balloon is made of a low-compliance material, it can be inflated to a set pressure, or if the balloon material is compliant, it can be gradually expanded under fluoroscopic or ultrasound guidance until reflux can be alleviated.

[0137] like Fig.30 As shown, the balloon with the implant can be completely separated from the catheter during the procedure. Any obvious and known technique for remotely inflating and implanting the balloon can be used. For example, a technique similar to that explained in U.S. Pat. No. 9,351,862 B2 can be used. In addition, the balloon can have a remote tether attached thereto permanently or temporarily for continuous or intermittent adjustment of the volume of the balloon, thereby controlling reflux.

[0138] Fig.31 A schematic diagram of an implant embodiment 1155 is shown in which a balloon 1157 is implanted in the mitral valve.

[0139] Fig.32 A schematic diagram of an exemplary embodiment 1150 implanted in a mitral valve during systole is shown, and Fig.33 A schematic diagram of the diastolic phase is shown.

[0140] Fig.34 A schematic diagram of an exemplary embodiment 1155 of a mitral valve implanted during systole is shown, and Fig.35 A schematic diagram of the diastolic phase is shown.

[0141] Figure 36 to Figure 37 Shown with Figure 1 to Figure 2The illustrated embodiment 1030 is similar to exemplary embodiment 1175. However, the inner and outer components are separate components that are connected together by base bracket 1180. An advantage of the present invention is having separate inner and outer components to allow for increased closure bias between the two components.

[0142] Figure 38 to Figure 39 A retrieval suture 1197 with a radiopaque marker 1093 attached to embodiment 1175 is shown.

[0143] Fig.40 A schematic diagram of an embodiment 1175 implanted inside a mitral valve is shown.

[0144] Fig.41 Shows Fig.38 Embodiment 1175 is shown in combination with an exemplary spacer balloon 1257 .

[0145] Fig.42 Shows Fig.38 The embodiment 117 shown incorporates a spacer stent-like structure 1267. The structure can be self-expandable, balloon expandable or non-expandable. In addition, it can be hollow, porous, covered or uncovered, coated or uncoated.

[0146] Fig.43 It shows that previously Fig.41 Schematic diagram of embodiment 1175 implanted within a mitral valve.

[0147] Fig.44 It shows that previously Fig.42 Schematic diagram of embodiment 1175 implanted within a mitral valve.

[0148] Fig.45 An exemplary schematic diagram of a mitral valve with regurgitant area / orifice during systole is shown.

[0149] Fig.46 Shows the Fig.45 An exemplary schematic diagram of the mitral valve.

[0150] Fig.47 An exemplary embodiment 1175 is shown in which a balloon 1257 is implanted in an exemplary mitral valve during systole.

[0151] Fig.48 An exemplary embodiment 1175 is shown in which a balloon 1257 is implanted in the Fig.46 in the same exemplary mitral valve.

[0152] Fig.49An exemplary embodiment is shown in which two devices 1175 are connected to one spacer 1257.

[0153] Fig.50 An exemplary embodiment is shown in which two devices 1175 are looped together using sutures 1257. The sutures can be cinched after deployment during the procedure, or remotely cinched after the procedure.

[0154] The unique concepts shown in this patent, such as the retrieval concept, can be applied directly or with obvious modifications to other designs, for example, the structural heart designs disclosed in co-owned PCT WIPO patent applications WO / 2018 / 013856 and / or WO / 2019 / 010370. Vice versa, the unique concepts taught in other co-owned patent applications can also be applied to the present invention, for example, the sensors, transducers, actuators and / or imaging systems described in WO / 2018 / 013856 can also be applied to the present invention.

[0155] General Considerations

[0156] Any device can be deployed using known invasive and minimally invasive techniques. For example, some approaches can be transseptal, transapical, transatrial, and transaortic.

[0157] For the purpose of description, certain aspects, advantages and novel features of the embodiments of the present disclosure are described herein. The disclosed methods, devices and systems should not be interpreted as limiting in any way. On the contrary, the present disclosure is only directed to all novel and non-obvious features and aspects of each disclosed embodiment (whether individually or in various combinations and sub-combinations with each other). The methods, devices and systems are not limited to any particular aspect or feature or combination thereof, and the disclosed embodiments do not require the presence of any one or more specific advantages or solutions to problems.

[0158] Although the operations of some disclosed methods are described in a particular order for convenience of presentation, it should be understood that this description includes rearrangement unless a specific language requires a specific order. For example, in some cases, the operations described in sequence can be rearranged or performed simultaneously. Moreover, for simplicity, the accompanying drawings may not show the various ways in which the disclosed methods can be used in combination with other methods. As used herein, the terms "one", "one" and "at least one" cover one or more specified elements. That is, if there are two specific elements, one of these elements is also present, so there is a "one" element. The terms "multiple" and "plural" refer to two or more specified elements.

[0159] As used herein, the term "and / or" used between the last two elements listed refers to any one or more of the listed elements. For example, the phrase "A, B, and / or C" means "A," "B," "C," "A and B," "A and C," "B and C," or "A, B, and C."

[0160] As used herein, the term "coupled" generally refers to being physically coupled or connected, and does not exclude the presence of intervening elements between the coupled items unless there is specific language to the contrary.

[0161] All implant embodiments described herein may optionally be coated to improve biocompatibility and tissue interface.

[0162] The coating can be metallic or polymeric. Examples of metallic coatings are: Titanium, TiN, Tantalum, Gold, Platinum. Examples of polymeric coatings are: Fluoropolymers: PTFE, PFA, FEP, ECTFE, ETFE, Parylene, Polyester, PET, Polypropylene, PEEK, PVDF, HDPE, LDPE, UHMWPE, Phosphorylcholine, Hydroxyapatite, THV, CaP Biodegradable: Poly(lactic acid), Poly(glycolic acid).

[0163] All implant embodiments may optionally be covered to improve biocompatibility and tissue interface. The covering may be metallic or polymeric. Additionally, the covering may be a fabric, mesh, fiber, braid, woven or nonwoven. Examples of metal coverings are: titanium, tantalum, gold, platinum. Examples of polymer coatings are: Fluoropolymers: PTFE, PFA, FEP, ECTFE, ETFE, parylene, polyester, PET, polypropylene, PEEK, PVDF, HDPE, LDPE, UHMWPE, phosphorylcholine, hydroxyapatite, CaP, THV Biodegradable: poly(lactic acid), poly(glycolic acid).

[0164] The following is a list of reference numbers used in this application:

[0165] H Heart

[0166] MV Mitral valve

[0167] 1030 Exemplary Embodiments of Implant Devices

[0168] 1041 Inner arm of a preferred embodiment for capturing a leaflet

[0169] 1042 Outer arm of a preferred embodiment for capturing a leaflet

[0170] 1043 Inner arm of a preferred embodiment for capturing a leaflet

[0171] 1044 Outer arm of a preferred embodiment for capturing a leaflet

[0172] 1045 Base bracket of the fixing device in the preferred embodiment

[0173] 1046 Non-invasive friction element of inner arms 1041, 1043

[0174] 1047 Gap between inner arm 1041, 1126 and outer arm 1042, 1127 for capturing leaflets 1048 Gap between inner arm 1043, 1128 and outer arm 1044, 1129 for capturing leaflets 1049 Hole feature

[0175] 1050 catheter outer shaft (guide catheter)

[0176] 1050a The inner lumen of the outer shaft of the catheter

[0177] 1051 Catheter shaft (delivery catheter)

[0178] 1053 The gap between the guide catheter 1050 and the outer arm 1044

[0179] 1054 guides the gap between the catheter 1050 and the outer arm 1042

[0180] 1056 Distal edge of the outer guide catheter shaft

[0181] 1057 The trailing (proximal) edge of the stepped guide catheter shaft

[0182] 1074 Anterior lobule

[0183] 1077 Posterior leaflet

[0184] 1090 Exemplary Embodiments of Implant Devices

[0185] 1091 Retrieving Sutures

[0186] 1092 Suture loop with knot

[0187] 1093 Radiopaque markers

[0188] 1100 Example Rat Tooth Grasper

[0189] 1101 Rat Tooth Gripper Shaft

[0190] 1102 Rat Tooth Grasper Pliers

[0191] 1125 Exemplary Alternative Embodiments of Implant Device 1900

[0192] 1126 Inner arm of a preferred embodiment for capturing a leaflet

[0193] 1127 Outer arm of a preferred embodiment for capturing a leaflet

[0194] 1128 Inner arm of a preferred embodiment for capturing a leaflet

[0195] 1129 Outer arm of a preferred embodiment for capturing a leaflet

[0196] 1136 Non-invasive friction element of inner arm 1126

[0197] 1138 Non-invasive friction element of inner arm 1128

[0198] 1130 Base bracket of the fixing device in exemplary embodiment 1125

[0199] 1131 Exemplary Fasteners for Base Bracket Assemblies

[0200] 1137 Suture hole in outer arm 1127

[0201] 1139 Suture hole in outer arm 1129

[0202] 1146 Suture hole in inner arm 1126

[0203] 1148 Suture hole in inner arm 1128

[0204] 1150 Exemplary Embodiment of Implant Device 1125 with Retrieval Suture / Tether

[0205] 1155 Exemplary Embodiment of Implant Device 1125 with Spacer Balloon

[0206] 1156 Proximal portion of tube connected to exemplary spacer balloon 1157

[0207] 1157Exemplary Spacer Balloon

[0208] 1159 Distal portion of the tether between the spacer balloon 1157 and the base bracket 1130

[0209] 1175 Exemplary Embodiment of an Implant Device Capturing a Leaflet

[0210] 1176 Inner arm of a preferred embodiment for capturing a leaflet

[0211] 1177 Outer arm of a preferred embodiment for capturing a leaflet

[0212] 1176 Non-invasive friction element of inner arm 1126

[0213] 1180 Base bracket of the fixing device in exemplary embodiment 1125

[0214] 1197 Retrieve Sutures

[0215] 1257Exemplary spacer: balloon

[0216] 1267 Exemplary spacer: expandable covered stent

[0217] 1293 Exemplary Suture Fastener

[0218] 1297 Closing suture loop

[0219] The present invention provides embodiments including but not limited to the following:

[0220] 1. A method for implanting a closure device on a mitral valve of a patient, the method comprising:

[0221] providing a closure device comprising at least a first pair of capture springs, the at least first pair of capture springs comprising an atrial capture spring and an opposing ventricular capture spring, wherein the capture springs each have a base end and a free end, and wherein when unconstrained, the base ends are coupled together and the free ends are close together, and resiliently separate in response to a separation force;

[0222] constraining the closure device within the lumen of a delivery catheter so that the atrial capture spring and the posterior capture spring are straightened;

[0223] positioning a distal end of the delivery catheter adjacent a mitral valve of the patient;

[0224] releasing the ventricular capture spring from the lumen of the delivery catheter to engage a ventricular surface of a mitral valve leaflet; and

[0225] releasing the atrial capture spring from the lumen of the delivery catheter to engage an atrial surface of the mitral valve leaflet;

[0226] The atrial capture spring and the ventricular capture spring are self-sealing over the mitral valve leaflets to adhere to the leaflets.

[0227] 2. A method according to embodiment 1, wherein the closing device further comprises a second pair of capture springs, the second pair of capture springs comprising an atrial capture spring and an opposing ventricular capture spring, wherein the capture springs in the second pair of capture springs each have a base end and a free end, and wherein when unconstrained, the base ends are coupled together and the free ends are close together, and elastically separate in response to a separation force.

[0228] 3. A method according to embodiment 2, wherein before the closure device is constrained in the inner cavity of the delivery catheter, the first pair of capture springs and the second pair of capture springs are fixed together at their respective bases, so that before release, the atrial capture springs and the rear capture springs in the two pairs of capture springs are straightened and close to each other in the lumen.

[0229] 4. A method according to embodiment 2, wherein the release includes releasing the first pair of capture springs to capture the first mitral valve leaflet, releasing the second pair of capture springs to capture the second mitral valve leaflet, and coupling together at their respective bases after each pair of capture springs is fixed to its respective mitral valve leaflet.

[0230] 5. The method of embodiment 1, wherein the delivery catheter is positioned through the septum from the right atrium to the left atrium and through the mitral valve.

[0231] 6. A method according to embodiment 1, wherein the delivery catheter is positioned from the right ventricle to the left ventricle through the septum and through the mitral valve.

[0232] 7. A method according to embodiment 1, wherein the delivery catheter is positioned into the left ventricle through the aortic valve and through the mitral valve.

[0233] 8. The method of embodiment 1, wherein the delivery catheter is positioned into the left ventricle through the apex of the left ventricle and through the mitral valve.

[0234] 9. A method according to embodiment 1, wherein the closure device consists essentially of only the first pair of capture springs and only a single mitral valve leaflet is captured, wherein the closure device prevents regurgitant flow of blood during systole and diastole.

[0235] 10. The method of embodiment 2, wherein the first pair of capture springs and the second pair of capture springs are released sequentially to capture the first and second mitral valve leaflets.

[0236] 12. The method of embodiment 2, wherein the first pair of capture springs and the second pair of capture springs are released simultaneously to capture the first and second mitral valve leaflets.

[0237] 13. The method of embodiment 1 further comprises capturing a capturable feature on the closure device and retrieving the closure device using the capturable feature.

[0238] 14. The method according to embodiment 1 also includes deploying a spacer to reduce, eliminate or alleviate valve regurgitation.

[0239] 15. A method according to embodiment 14, wherein the spacer is at least one of expandable, foldable, compressible, expandable, solid, hollow, porous, non-porous and incompressible.

[0240] 16. A closure device comprising:

[0241] at least a first pair of capture springs, the at least first pair of capture springs comprising an atrial capture spring and an opposing ventricular capture spring;

[0242] Wherein the capture springs each have a base end and a free end, and wherein when unconstrained, the base ends are coupled together and the free ends are close together and resiliently separate in response to a separation force.

[0243] 17. The closing device according to embodiment 16 further includes a second pair of capture springs, the second pair of capture springs including an atrial capture spring and an opposing ventricular capture spring, wherein the capture springs in the second pair each have a base end and a free end, and wherein when unconstrained, the base ends are configured to be coupled together and the free ends are configured to be close together and elastically separate in response to a separation force.

[0244] 18. The closure device of embodiment 17, wherein the first pair of capture springs and the second pair of capture springs are secured together at their respective bases.

[0245] 19. The closure device of embodiment 17, wherein the first pair of capture springs and the second pair of capture springs are separate but configured to be secured together at their respective bases.

[0246] 20. The closure device of any one of embodiments 16-19, wherein the atrial capture spring and the opposing ventricular capture spring are each curved along their lengths such that they nest together when unconstrained.

[0247] 21. A system for delivering a closure device to a mitral valve of a patient, the system comprising:

[0248] The closure device of any one of embodiments 16-20; and

[0249] A delivery catheter having a central lumen, wherein the closure device has at least a pair of capture springs constrained in the delivery lumen, wherein the atrial capture spring and the posterior capture spring are arranged in a straightened configuration.

[0250] 22. The closure device of embodiment 17, wherein the closure device comprises a first pair of capture springs and a second pair of capture springs arranged adjacent to each other in the inner cavity, with respective atrial and posterior capture springs arranged in a straightened configuration.

[0251] 23. A system according to embodiment 22, wherein the delivery catheter has a straight-cut distal end, and the straight-cut distal end is configured to simultaneously release the first pair of capture springs to capture the first mitral valve leaflet and release the second pair of capture springs to capture the second mitral valve leaflet.

[0252] 24. A system according to embodiment 22, wherein the delivery catheter has a chamfered distal end, and the chamfered distal end is configured to sequentially release the first pair of capture springs to capture the first mitral valve leaflet and release the second pair of capture springs to capture the second mitral valve leaflet.

[0253] 25. The system of embodiment 16, wherein the closure device consists essentially of only the first pair of capture springs, wherein the closure device prevents reverse flow of blood during systole and diastole.

[0254] 26. The system of embodiment 16 further comprises a spacer configured to reduce, eliminate or mitigate valve regurgitation.

[0255] 27. A system according to embodiment 26, wherein the spacer is at least one of expandable, foldable, compressible, inflatable, solid, hollow, porous, non-porous and incompressible.

[0256] Although many embodiments of the present disclosure have been described in detail, some changes and modifications will be readily understood by those skilled in the art, including embodiments that do not provide all the features and benefits described herein. It will be understood by those skilled in the art that the present disclosure extends to other alternative or additional embodiments and / or uses and obvious modifications and equivalents thereof beyond the specifically disclosed embodiments. In addition, although many changes have been shown and described in different details, based on the present disclosure, other modifications within the scope of the present disclosure will be readily understood by those skilled in the art. It is also contemplated that various combinations or sub-combinations may be made to the specific features and aspects of the embodiments, and still fall within the scope of the present disclosure. Therefore, it should be understood that the various features and aspects of the disclosed embodiments may be combined or substituted with each other to form different modes of the present disclosure. Therefore, it is intended that the scope of the present disclosure disclosed herein should not be limited by the above-mentioned specifically disclosed embodiments. For all the above-mentioned embodiments, the steps of any method do not need to be performed sequentially. Therefore, we advocate the content within the spirit and scope of all these embodiments.

Claims

1. A method for implanting a closure device on a mitral valve of a patient, the method comprising: providing a closure device comprising at least a first pair of capture springs, the at least first pair of capture springs comprising an atrial capture spring and an opposing ventricular capture spring, wherein the capture springs each have a base end and a free end, and wherein when unconstrained, the base ends are coupled together and the free ends are close together, and resiliently separate in response to a separation force; constraining the closure device within the lumen of a delivery catheter so that the atrial capture spring and the posterior capture spring are straightened; positioning a distal end of the delivery catheter adjacent a mitral valve of the patient; releasing the ventricular capture spring from the lumen of the delivery catheter to engage a ventricular surface of a mitral valve leaflet; as well as releasing the atrial capture spring from the lumen of the delivery catheter to engage an atrial surface of the mitral valve leaflet; The atrial capture spring and the ventricular capture spring are self-sealing over the mitral valve leaflets to adhere to the leaflets.

2. A method according to claim 1, wherein the closing device further includes a second pair of capture springs, the second pair of capture springs including an atrial capture spring and an opposing ventricular capture spring, wherein the capture springs in the second pair of capture springs each have a base end and a free end, and wherein when unconstrained, the base ends are coupled together and the free ends are close together, and elastically separate in response to a separation force.

3. A method according to claim 2, wherein before constraining the closure device in the inner cavity of the delivery catheter, the first pair of capture springs and the second pair of capture springs are fixed together at their respective bases, so that before release, the atrial capture springs and the rear capture springs of the two pairs of capture springs are straightened and close to each other in the lumen.

4. A method according to claim 2, wherein releasing includes releasing the first pair of capture springs to capture the first mitral valve leaflet, releasing the second pair of capture springs to capture the second mitral valve leaflet, and coupling together at their respective bases after each pair of capture springs is fixed to its respective mitral valve leaflet.

5. The method of claim 1, wherein the delivery catheter is positioned through the septum from the right atrium to the left atrium and through the mitral valve.

6. The method of claim 1, wherein the delivery catheter is positioned through the septum from the right ventricle to the left ventricle and through the mitral valve.

7. The method of claim 1, wherein the delivery catheter is positioned through the aortic valve into the left ventricle and through the mitral valve.

8. The method of claim 1, wherein the delivery catheter is positioned into the left ventricle through the left ventricular apex and through the mitral valve.

9. A closing device comprising: at least a first pair of capture springs, the at least first pair of capture springs comprising an atrial capture spring and an opposing ventricular capture spring; Wherein the capture springs each have a base end and a free end, and wherein when unconstrained, the base ends are coupled together and the free ends are close together and resiliently separate in response to a separation force.

10. A system for delivering a closure device to a mitral valve of a patient, the system comprising: The closure device according to claim 9; as well as A delivery catheter having a central lumen, wherein the closure device has at least a pair of capture springs constrained in the delivery lumen, wherein the atrial capture spring and the posterior capture spring are arranged in a straightened configuration.

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