Tissue grasping devices and related methods

Abstract

A clip for immobilizing the cusps of a cardiac or venous valve includes a hub having a pair of tangle-resistant, spring-biased outer arms coupled to the lower end of the hub and a pair of tangle-resistant, spring-biased inner arms adjacent to the outer arms and coupled to the upper end of the hub. A delivery catheter with a stiffening member is configured to position the valve clip adjacent to a target valve, while the outer and inner arms are biased in an open position relative to each other. The delivery catheter or clip includes a suture to assist bailout. After the valve leaflets are positioned between the open outer and inner arms, the biasing force can be released, allowing the clip to self-close over the leaflets, atraumatically and effectively clamping and coapting the leaflets. An expandable spacer is configured to fill any gaps between the leaflets. A prosthetic valve may include either or both of such leaflet gripping arms and spacer.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of Provisional Application No. 62 / 994,575, filed March 25, 2020, Provisional Application No. 63 / 051,737, filed July 14, 2020, and Provisional Application No. 63 / 127,935, filed December 18, 2020, the entire disclosures of which are incorporated herein by reference.

[0002]

[0001] This disclosure relates to the following patent publications, which have common inventorship with the present specification, namely, U.S. Application No. 2019 / 0142589, filed January 14, 2019; PCT Publication No. WO2019143726A1, filed January 16, 2019; and PCT Publication No. WO2019143726A1, filed July 6, 2018, which are referred to herein as commonly owned prior patent applications, the entire disclosures of which are incorporated herein by reference. This application is directed to the disclosures of PCT Publication Nos. WO / 2019 / 010370A1, filed January 16, 2019, WO / 2019 / 143726A1, filed July 13, 2017, and PCT Publication Nos. WO2019209871A1, filed April 23, 2019, and WO201801856A1, filed July 13, 2017.

[0003] The present invention relates generally to medical methods, devices, and systems. Specifically, the present invention relates to methods, devices, and systems for structural cardiac, endovascular, percutaneous, or minimally invasive surgical treatment of body tissues, such as tissue approximation or valve repair. More specifically, the present invention relates to methods and devices for repair of mitral and tricuspid heart valves, venous valves, and other tissue structures through minimally invasive and other procedures. Summary of the Invention [Means for solving the problem]

[0004] The present invention provides devices, systems, and methods for tissue access and repair at a treatment site. The devices, systems, and methods of the present invention find use in a variety of therapeutic procedures, including structural cardiac, endovascular, minimally invasive, and open surgical procedures, and can be used in a variety of anatomical regions, including the abdomen, thorax, cardiovascular system, heart, intestinal tract, stomach, urinary tract, bladder, lungs, and other organs, vessels, and tissues. The present invention is particularly useful in those procedures requiring minimally invasive or endovascular access to remote tissue locations, especially those in which the instruments utilized must navigate long, narrow, and tortuous paths to the treatment site. In addition, many of the devices and systems of the present invention are reversible and adapted to be removable from the patient at any point without interference with or trauma to internal tissues.

[0005] The present invention allows two or more leaflets to be coapted using an "incisal" or "bow-tie" technique to reduce regurgitation, but does not require open surgery through the chest and heart wall as in traditional approaches. Additionally, leaflet position can vary in an affected mitral valve depending on the type and extent of disease, such as calcification, prolapse, or flailiness. These types of disease can result in one leaflet being more mobile (e.g., more difficult to capture) than the other, and therefore more difficult to grasp symmetrically in the same grasp as the other leaflet. Features of the present invention allow the fixation device to be adapted to meet the challenges of unpredictable target tissue geometries and provide a more robust grip on the tissue once it is captured. Additionally, the present invention optionally incorporates visualization techniques, allowing the device placement procedure to be performed without the use of general anesthesia.

[0006] Leaflet coaptation, annular cinching, and thromboembolization. The most prevalent incisal repair device is the MitraClip®, sold by Abbott Vascular (Santa Clara, California, USA). Although marketed as an incisal device, the MitraClip® design has a wide gap between the opposing arms. Therefore, the device does not fully coapt the leaflets at the tip, thereby completely clamping the annulus. Incomplete coaptation of the leaflets results in suboptimal effectiveness in reducing mitral regurgitation (MR). On the other hand, suboptimal clamping of the annulus results in suboptimal reverse remodeling of the heart.

[0007] Furthermore, according to the MitraClip® IFU, the MitraClip® device typically closes only in a V-shape, which causes further separation between the leaflets at the tip.

[0008] Because the MitraClip® device has exposed metal components between the arms, the wide gaps expose them to circulating blood, thereby posing a risk of thromboembolism.

[0009] In summary, the key drawbacks of the MitraClip® device include suboptimal coaptation due to the wide gap between the arm tips, suboptimal clamping of the annulus due to the wide gap and V-shaped closure of the arms, and the risk of thromboembolization due to exposed bare metal components.

[0010] Another device, PASCAL, sold by Edwards Lifesciences Corp. (Irvine, California, USA), is essentially a hybrid of the incisal and spacer techniques. This spacer-based design fills the wide gaps between the leaflets, thus reducing the risk of thromboembolization, but it suffers from suboptimal coaptation due to the wide gaps between the paddles. This suboptimal coaptation results in suboptimal or no annular cinching, thereby resulting in suboptimal or no reverse remodeling of the heart.

[0011] One particular advantage of the present invention is the robust coaptation force that results in complete coaptation of the autogenous cusps.

[0012] One particular advantage of the present invention is the robust clamping force that results in optimal reverse remodeling of the heart.

[0013] One particular advantage of the present invention is the robust coaptation that results in perfect coaptation of the autogenous cusps.

[0014] One particular advantage of the present invention is the robust fastening that results in optimal reverse remodeling of the heart.

[0015] One particular advantage of the present invention is that there are minimal or no exposed metal components exposed to the circulating blood, reducing potential thromboembolic risks.

[0016] Dynamic and / or gradual tightening of the annulus

[0017] There may be a patient condition where acutely cinching the annulus may result in tearing of the leaflets. One advantage of the present invention is the incorporation of an adjustable or dynamic spacer 690 between the two grippers that gradually coapts the leaflets, thereby gradually (chronically) cinching the annulus over a period of time.

[0018] Bail-out sutures and wider apical grasp

[0019] Bailout using sutures has been described in previously referenced and commonly owned applications such as WO201801856A1 and WO / 2019 / 143726A1, which reduces the risk of having complex implant designs.

[0020] In the present invention, an additional method of bailout using a bailout suture is described.

[0021] One exemplary embodiment of the present invention is a bail-out suture method that interacts only with delivery catheter components and has no direct attachment to the implant.

[0022] One alternative exemplary embodiment of the present invention is a bail-out suture method that interacts with both the delivery catheter components and the implant.

[0023] One alternative exemplary embodiment of the present invention is a simplified bailout system in which the bailout suture is part of the implant.

[0024] Remotely controlled steerability of catheters and actuation of implants

[0025] Exemplary embodiments of the present invention include automatic, remote, electrical, microprocessor-based, electronic, software-controlled, remotely controlled actuation of implants and / or catheters before, during, and / or after the procedure.

[0026] Exemplary embodiments of the present invention include automatic, remote, electrical, microprocessor-based, electronic, software-controlled, remotely controlled steering of a delivery system or catheter before, during, and / or after the procedure.

[0027] Exemplary embodiments of the present invention include automatic, remote, electrical, microprocessor-based, electronic, software-controlled, remotely controlled actuation of implants and / or catheters pre-, during, and / or post-procedure using nitinol motors or similar actuators.

[0028] An exemplary embodiment of the present invention comprises a transcatheter end-to-end repair (TEER) system for treating mitral valve regurgitation via femoral and / or jugular venous access.

[0029] An exemplary embodiment of the present invention comprises a TEER system for treating tricuspid regurgitation via femoral and / or jugular venous access.

[0030] Adjustable, static and dynamic spacers

[0031] Exemplary embodiments of the present invention include automatic, remote, electrical, microprocessor-based, electronic, software-controlled, remote-controlled, manual spacer extension or retraction before, during, and / or after the procedure using self-sealing seals and removable tethers.

[0032] Exemplary embodiments of the present invention include automatic, remote, electrical, microprocessor-based, electronic, software-controlled, remotely controlled, manual dynamic spacer expansion or contraction before, during, and / or after the procedure using external and / or implantable pumps.

[0033] Exemplary embodiments of the invention include pre-, intra-, and / or post-procedural expansion or contraction of a dynamic spacer using automated, remote, electrical, microprocessor-based, electronic, software-controlled, remotely controlled, manual external and / or implantable pumps.

[0034] Exemplary embodiments of the present invention include various methods of spacers that are configured to reduce thromboembolization risk.

[0035] Exemplary embodiments of the present invention include various methods of spacers configured to reduce valvular regurgitation.

[0036] Exemplary embodiments of the present invention include various methods of spacers that are configured to reduce valve regurgitation when attached to both leaflets.

[0037] Exemplary embodiments of the present invention include various methods of spacers that are configured to reduce valve regurgitation when attached to a single leaflet.

[0038] Atraumatic barbs, friction elements and grippers

[0039] Exemplary embodiments of the present invention include various barb designs configured to reduce the risk of trauma and / or tearing of the tip.

[0040] Exemplary embodiments of the present invention include various barb designs configured to reduce the risk of trauma, tearing, severing, and / or entanglement of the cord.

[0041] Valve replacement device with leaflet grasping arms and / or gripper with bailout

[0042] Current solutions for valve replacement systems do not have dynamically or manually actuable leaflet grasping features. Typically, they are either passive barbs or, at times, extendable barbs that can be actively controlled to engage or disengage the leaflets. Thus, once engaged, they cannot be easily disengaged to bail out or retract the device. This is because the need to detach often requires the entire device to be retracted into the catheter; A much earlier "point of no return" in the implant procedure, necessitating suboptimal deployment; This leads to problems such as:

[0043] An exemplary embodiment of the present invention involves incorporating the proven method of leaflet grasping arms and / or grippers, similar to TEER devices, into a valve replacement device.

[0044] One particular advantage of the present hybrid system is the robust "point of no return" that allows for multiple grasping or leaflet engagement attempts during prosthetic valve implantation.

[0045] One particular advantage of the present hybrid system is the robust grip or leaflet engagement that reduces migration of the valve replacement device.

[0046] One particular advantage of the present hybrid system is the robust grasping or leaflet engagement, which results in a smaller or less intrusive valve replacement device design.

[0047] Ergonomic, single-user, small-profile two- or three-catheter delivery system

[0048] The MitraClip® is delivered via a 25 French, three-catheter system, which is unergonomic, difficult to use, and has a long learning curve. Similarly, the Pascal is delivered via a 22 French, three-catheter system. According to literature, 22 French catheters have a sustained iatrogenic atrial septal defect (iASD) rate of approximately 50%. Outer sizes of 14 to 20 French catheters have an iASD rate of approximately 23%, while 12 French catheters have a rate of approximately 6.8%.

[0049] One particular advantage of the present invention is a simple, intuitive, easy-to-use 12 or 14 French two-catheter system for delivering a TEER device via the femoral or jugular vein.

[0050] One particular advantage of the present invention is a TEER delivery system that can be implanted by a single user / operator.

[0051] In one exemplary embodiment, complex multi-planar bends are achieved using a combination of stiffening members and wires.

[0052] In one exemplary embodiment, the proximal curve in the right atrium / SVC is constrained to a single plane by using stiffening members that prevent out-of-plane bending while allowing in-plane flexion.

[0053] In one exemplary embodiment, the proximal curve in the right atrium / SVC is constrained to a single plane by using a stiffening member that may be made from rectangular flat wire that bends easily through its thickness, but resists bending through its width due to its anisotropic moment of inertia.

[0054] In one exemplary embodiment, the proximal curve in the right atrium / SVC is constrained to a single plane by using a stiffening member that may be made from rectangular flat wire that bends easily through its thickness, but resists bending through its width due to its anisotropic moment of inertia.

[0055] In one exemplary embodiment, the proximal curve in the right atrium / SVC is steered using a flat rectangular wire to provide both steering and function as a stiffening member.

[0056] In one exemplary embodiment, the proximal curve in the right atrium / SVC is steered using a flat rectangular wire to provide both steering and function as a stiffening member.

[0057] In one exemplary embodiment, one- or two-way in-plane steering within the right atrium / SVC (proximal steerable segment) is achieved using a flat rectangular wire to provide both steering and function as a stiffening member, while three- or four-way steering in orthogonal planes is achieved using a rounded wire within the left atrium (distal steerable segment).

[0058] One advantage of the present invention is the flat plane of the delivery catheter handle that matches the flat plane of the implant, so that each pair of actuator rod arms 597 and actuator rod grippers 598 intuitively aligns with their corresponding pair of implant arms and grippers.

[0059] Recovery, bailout, funnel, coil, fan, guide

[0060] One problem with large devices such as the MitraClip® is that it is often not easy to retract the device into the guide catheter during bailout. One advantage of the present invention is the expandable funnel, which helps direct the device inside the guide catheter.

[0061] In one exemplary embodiment, the expandable funnel is part of the guide catheter.

[0062] In one exemplary embodiment, the expandable funnel is part of the delivery catheter.

[0063] In one exemplary embodiment, the expandable funnel is part of a rescue catheter.

[0064] As in some exemplary embodiments, the directing function for safely retracting and removing the implant from the body during bailout is achieved through the use of a funnel, coil, fan, and / or balloon feature at the distal tip of the catheter and / or balloon feature in close proximity to the implant.

[0065] One advantage of the present invention is that the expandable implant retraction feature allows for an unrestricted distal delivery catheter section 615 for easy insertion / passage of the device across a cusp or obstruction. For example, the present invention provides the following: (Item 1) 1. An endovascular heart valve repair system comprising: a delivery catheter having a distal end configured to be introduced into a heart chamber adjacent the pair of coapted heart valve leaflets; a valve repair leaflet grasping device attached to a distal region of the delivery catheter, the valve repair leaflet grasping device comprising a first pair of leaflet capture arms including a first inner arm and a first outer arm, and a second pair of leaflet capture arms including a second inner arm and a second outer arm; an inverter bar positioned on the delivery catheter distal to the valve repair leaflet device, the inverter bar oriented transverse to the longitudinal axis of the delivery catheter; a bail-out suture that passes outside the distal region of the delivery catheter and is looped through opposite ends of the retroversion bar, whereby the two ends of the bail-out suture can be drawn proximally to create a triangular cage for expelling the leaflets from the valve repair leaflet grasping device; and 1. An endovascular heart valve repair system comprising: (Item 2) Item 1. The endovascular heart valve repair device of item 1, further comprising a secondary suture loop positioned through the bail-out suture loop, the secondary suture loop configured to be pulled proximally to fasten the bail-out suture toward the delivery catheter and enable the valve repair leaflet grasping device to grasp the valve leaflet. (Item 3) 4. The endovascular heart valve repair device of claim 3, wherein the secondary suture is constrained within a secondary structure and a free loop end passes out of the secondary structure and captures a distal loop segment of the bail-out loop. (Item 4) 1. A method for expelling a valve leaflet from a valve repair leaflet grasping device, comprising: deploying a first length of bail-out suture across a first inner arm and a first outer arm of a first pair of leaflet capture arms; and deploying a second length of bail-out suture across a second inner arm and a second outer arm of a second pair of leaflet capture arms, the suture lengths excluding the leaflet from a space between each pair of arms. (Item 5) 5. The method of claim 4, further comprising deploying a secondary suture loop to radially constrain the bail-out suture so that at least one of the pair of first and second leaflet capture arms can capture a leaflet. (Item 6) 6. The method of claim 5, wherein deploying the secondary suture loop radially constrains the bail-out suture such that both of the first and second pairs of leaflet capture arms can capture a leaflet. (Item 7) 1. An endovascular heart valve repair system comprising: a delivery catheter having a distal end configured to be introduced into a heart chamber adjacent the pair of coapted heart valve leaflets; a valve repair leaflet grasping device comprising: a hub configured to be removably attached to the delivery catheter; a first pair of leaflet capture arms having a first inner arm and a first outer arm coupled to the hub; and a second pair of leaflet capture arms having a second inner arm and a second outer arm coupled to the hub, the first and second pairs of leaflet capture arms together forming a gap on their atrial sides above the hub; a spacer disposed over the fissure to inhibit thrombus formation; 1. An endovascular heart valve repair system comprising: (Item 8) 8. The endovascular heart valve repair device of item 7, wherein the spacer comprises one or more of an expandable sponge, a compressible sponge, a mesh, a balloon, or a non-thrombogenic fabric. (Item 9) 9. The endovascular heart valve repair device of item 7 or 8, wherein the spacer is secured to the atrial side of the hub and / or pair of leaflet capture arms using sutures, adhesives, welding, glue, or fasteners. (Item 10) 10. The endovascular heart valve repair device according to items 7-9, comprising two spacers, each spacer fastened to a pair of leaflet capture arms. (Item 11) 11. The endovascular heart valve repair device according to items 7 to 10, further comprising a spacer attached to the ventricular side of each pair of leaflet capture arms. (Item 12) 1. An endovascular heart valve prosthesis comprising: a peripheral scaffold configured to be expanded within the annulus of the patient's native heart valve; one or more arms disposed on a circumferential surface of the peripheral scaffold, the arms configured to be clipped over free ends of leaflets of the patient's heart valve; prosthetic leaflets coupled to an inner surface of the peripheral scaffold; 1. An endovascular heart valve prosthesis comprising: (Item 13) Item 13. The endovascular heart valve prosthesis according to item 12, comprising at least two arms positioned on the peripheral scaffold to engage anterior and posterior leaflets on the patient's mitral valve. (Item 14) 14. The endovascular heart valve prosthesis of claim 12 or 13, wherein at least some of the arms comprise pairs of leaflet capture arms including an inner arm configured to engage an atrial side of the leaflet and an outer arm configured to engage a ventricular side of the leaflet. (Item 15) 15. The endovascular heart valve prosthesis according to items 12 to 14, wherein the peripheral scaffold is self-expanding. (Item 16) 16. The endovascular heart valve prosthesis according to items 12 to 15, wherein the peripheral scaffold is balloon expandable. (Item 17) 1. A method for deploying an endovascular heart valve within a patient's native heart valve annulus, comprising: positioning a peripheral scaffold within the annulus of the patient's native heart valve in a radially collapsed configuration; attaching one or more arms disposed on a circumferential surface of the peripheral scaffold over free ends of one or more leaflets of the patient's heart valve; expanding the peripheral scaffold within the annulus of the patient's native heart valve to a radially expanded configuration; A method comprising: (Item 18) 20. The method of claim 17, wherein positioning comprises transseptally advancing a delivery catheter into the patient's left atrium and advancing the endovascular heart valve through the cusp toward the patient's ventricle. (Item 19) 19. The method of items 17 and 18, wherein attaching one or more arms comprises releasing one or more resiliently mounted arms on the peripheral scaffold and allowing the arms to self-close and capture the valve leaflets. (Item 20) 20. The method of claim 19, wherein at least some of the arms comprise leaflet capture arm pairs including an inner arm configured to engage an atrial side of a leaflet and an outer arm configured to engage a ventricular side of a leaflet, the inner arm and the outer arm being independently opened and closed over the valve leaflets.

[0066] The following numbered clauses describe other examples, aspects, and embodiments of the invention described herein. 1. Leaflet Coaptation, Annular Tightening, and Thromboembolization 2. A method for clipping an anatomical valve, comprising: advancing a valve clip having a plurality of expandable spacers, a pair of outer arms, and a pair of inner arms adjacent to the anatomical valve; biasing at least one of (1) the pair of outer arms and (2) the pair of inner arms to open a leaflet capture space between adjacent outer and inner arms; positioning the valve clip so that one leaflet is positioned within the leaflet capture space between the left outer and inner arms and another leaflet is positioned within the leaflet capture space between the right outer and inner arms; releasing the bias on at least one pair of outer or inner arms and expanding the spacer so that the left outer and inner arms and the right outer and inner arms self-close over the valve leaflets and anchor them; A method comprising: 3. The method of claim 2, wherein the spacer is expanded within a gap between the cusp, the device, and / or the tissue. 4. The method of claim 2, wherein the spacer volume can be dynamically controlled by an electromechanical pump. 5. The method of claim 2, wherein the spacer volume can be adjustable during or after the procedure using a removable tether. 6. The method of any one of claims 2 to 5, wherein the spacer is expanded to fill the gap and prevent thromboembolism. 7. The method of any one of claims 2 to 5, wherein the spacer is expanded and supports the cusp. 8. The method of any one of claims 2 to 5, wherein the spacer is expanded to fill the reflux gap between the cusps. 9. The method of any one of claims 2 to 8, wherein the outer arm is angled or bent at the tip, as in exemplary Figures 54 and 55, to join the cusps with or without minimal gap. 10. The method of any one of claims 2 to 9, wherein the outer arm is elastically flexible at the tip, as in exemplary Figure 56, to coapt the cusps using a robust force. 11. The method of any one of claims 2 to 9, wherein the outer arm is bent at the tip, as in exemplary Figures 54 and 55, to bring the cusps together using a robust force. 12. The method of any of the preceding or following clauses, wherein the intercusp gap is preferably <1 mm or 0 to 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, ..., 19.5, and / or 20 mm. 13. The method of any of the preceding or following Clauses, wherein the robust intercusp coaptation force is preferably <0.5 lbf or 0 to 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, ..., 49.75, and / or 50 lbf. 14. The method described in any of the preceding or following addenda, wherein the thickness of the outer arm is preferably about 0.33 mm or 0.01 to 0.1, 0.12, 0.14, 0.16, 0.18, 0.2, 0.22, 0.24, 0.26, 0.28, 0.3, 0.32, 0.34, 0.36, 0.38, 0.4, 0.42, ..., 9.8, and / or 10 mm. 15. The method described in any of the preceding or following addenda, wherein the thickness of the inner arm is preferably about 0.20 mm or 0.01 to 0.1, 0.12, 0.14, 0.16, 0.18, 0.2, 0.22, 0.24, 0.26, 0.28, 0.3, 0.32, 0.34, 0.36, 0.38, 0.4, 0.42, ..., 9.8, and / or 10 mm. 16. The method described in any of the above or below appendices, wherein the width of the outer arm is preferably about 2.1 mm or 0 to 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, ... 19.5, and / or 20 mm. 17. The method described in any of the above or below appendices, wherein the width of the inner arm is preferably about 2.1 mm or 0 to 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, ...19.5, and / or 20 mm. 18. The method described in any of the above or below appendices, wherein the maximum length of the cusp captured between the pair of outer and inner arms is preferably 5 mm to 20 mm or 0.25 to 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, ...59.5, and / or 60 mm. 19. An endovascular heart valve repair system comprising: a delivery catheter having a distal end configured to be introduced into a heart chamber adjacent a pair of coapting heart valve leaflets, the delivery catheter including a release bar having a pair of retroversion tools; a valve repair leaflet grasping device comprising: a hub configured to be removably attached to a release bar of a delivery catheter; a first pair of leaflet capture arms comprising a first inner arm and a first outer arm coupled to the hub; and a second pair of leaflet capture arms comprising a second inner arm and a second outer arm coupled to the hub; a first set of control tethers positioned on or through the delivery catheter and coupled to the outer arms and configured to selectively bias the outer arms into a leaflet capture position; a second set of tethers positioned on or through the delivery catheter and coupled to the inner arms and configured to selectively bias the inner arms into a leaflet capturing position; wherein a first set of control tethers are threaded through laterally spaced locations on the retroversion tool such that pulling proximal portions of the first set of control tethers proximally causes distal portions of the first set of control tethers to pull outer segments of the outer arms distally into a leaflet capturing position. 20. The device of claim 19, comprising a single pair of inner and outer arms and a corresponding single inverting tool. 21. The device of claims 19 and 20, comprising an expandable / compressible spacer. 22. The device of claim 19 and 20, wherein the device is configured to fill a gap and / or provide support to a cusp. 23. A device according to any preceding or following clause, wherein the spacer is expanded within the gap between the cusp, the device, and / or the tissue. 24. A device described in any of the above or following supplementary notes, wherein the spacer volume can be dynamically controlled by an electromechanical pump. 25. A device described in any of the above or below supplementary notes, wherein the spacer volume may be adjustable during or after the procedure using a removable tether. 26. A device as described in any preceding or following appendix, wherein the spacer expands to fill the gap and prevent thromboembolism. 27. A device as described in any of the above or following appendices, wherein the spacer is expanded and supports the cusp. 28. A device as described in any preceding or following note, wherein the spacer expands to fill the reflux gap between the leaflets. 29. A device as described in any of the above or following notes, wherein the outer arm is angled or bent at the tip, as in illustrative Figures 54 and 55, to join the cusps with or without minimal gap. 30. A device as described in any of the preceding or following notes, wherein the outer arm is resiliently flexible at the tip, as in exemplary FIG. 56, to coapt the cusps with a robust force. 31. A device as described in any of the above or following notes, wherein the outer arm is bent at the tip, as in illustrative Figures 54 and 55, to bring the cusps together with a robust force. 32. A device according to any preceding or following clause, wherein the intercusp gap is preferably <1 mm or 0 to 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, ...19.5, and / or 20 mm. 33. A device as described in any preceding or following clause, wherein the robust intercusp coaptation force is preferably <0.5 lbf or 0 to 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, ...49.75, and / or 50 lbf. 34. A device described in any of the preceding or following addenda, wherein the thickness of the outer arm is preferably about 0.33 mm or 0.01 to 0.1, 0.12, 0.14, 0.16, 0.18, 0.2, 0.22, 0.24, 0.26, 0.28, 0.3, 0.32, 0.34, 0.36, 0.38, 0.4, 0.42, ..., 9.8, and / or 10 mm. 35. A device described in any of the preceding or following addenda, wherein the thickness of the inner arm is preferably about 0.20 mm or 0.01 to 0.1, 0.12, 0.14, 0.16, 0.18, 0.2, 0.22, 0.24, 0.26, 0.28, 0.3, 0.32, 0.34, 0.36, 0.38, 0.4, 0.42, ..., 9.8, and / or 10 mm. 36. A device described in any of the above or below clauses, wherein the width of the outer arm is preferably about 2.1 mm or 0 to 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, ...19.5, and / or 20 mm. 37. A device described in any of the above or below clauses, wherein the width of the inner arm is preferably about 2.1 mm or 0 to 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, ...19.5, and / or 20 mm. 38. A device described in any of the above or below clauses, wherein the width of the inner or outer arm preferably expands to increase the width of the leaflet capture portion by about 3 mm or 0 to 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, ...19.5, and / or 20 mm. 39. A device described in any of the above or below appendices, wherein the maximum length of the cusp captured between the pair of outer and inner arms is preferably 5 mm to 20 mm or 0.25 to 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, ...59.5, and / or 60 mm. 40. A variation of the device described in any of the above or below clauses, comprising a single pair of outer and inner arms, with a single cusp captured between the arms. 41. A variation of the device described in any of the above or below clauses, comprising at least one pair of outer arms only (and no inner arms), wherein the pair of outer arms are configured to be biased apart to create a tissue capture space therebetween and to resiliently self-close over the cusps when unbiased after the cusps have been captured / grasped. 42. A variation of the device described in any of the above or below clauses, including at least one pair of outer arms only (and no inner arms), wherein the pair of outer arms are biased apart to create a leaflet capture space therebetween and are configured to resiliently self-close over at least two leaflets when unbiased after the leaflets have been captured / grasped. 43. A device as described in any preceding or following clause, wherein the device robustly coapts the cusps with a force greater than the opposing in vivo force. 44. A device as described in any of the above or following appendices, wherein the device fastens the valve annulus. 45. A device as described in any of the above or below appendices, wherein the device preferably tightens the annulus by 1 mm to 6 mm or 0 to 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, ..., 59.5, and / or 60 mm. 46. ​​Valve replacement 47. An expandable valve replacement device comprising: a first pair of tissue grasping arms coupled to the device, the first pair comprising a first inner arm and a first outer arm; a second pair of tissue grasping arms coupled to the device, the second pair comprising a second inner arm and a second outer arm; a scaffold comprising a prosthetic valve, the scaffold configured to expand from a crimped configuration to an expanded configuration; wherein each pair of outer and inner arms is configured to be biased apart to create a tissue capture space therebetween and to resiliently self-close over the tissue when unbiased after the tissue has been captured / grasped, and wherein the scaffold is expanded after the tissue has been captured by each pair of arms. 48. An endovascular heart valve replacement system comprising: a delivery catheter having a distal end configured to be introduced into a heart chamber adjacent a pair of coapting heart valve leaflets, the delivery catheter including a release bar having a pair of retroversion tools; a valve repair leaflet grasping device comprising: a hub configured to be removably attached to a release bar of a delivery catheter; a first pair of leaflet capture arms comprising a first inner arm and a first outer arm coupled to the hub; and a second pair of leaflet capture arms comprising a second inner arm and a second outer arm coupled to the hub; a first set of control tethers positioned on or through the delivery catheter and coupled to the outer arms and configured to selectively bias the outer arms into a leaflet capture position; a second set of tethers positioned on or through the delivery catheter and coupled to the inner arms and configured to selectively bias the inner arms into a leaflet capturing position; wherein the first set of control tethers are threaded through laterally spaced locations on the inverting tool such that pulling the proximal portions of the first set of control tethers proximally causes the distal portions of the first set of control tethers to pull the outer segments of the outer arms distally into a leaflet-capturing position, and further pulling proximally draws the outer segments of the arms into an inverted position. 49. A method for replacing an anatomical valve with a prosthetic valve, comprising: advancing a prosthetic valve device having at least one pair of outer arms and a pair of inner arms adjacent to the anatomical valve; biasing at least one of (1) the pair of outer arms and (2) the pair of inner arms to open a leaflet capture space between adjacent outer and inner arms; positioning the valve clip such that one leaflet is positioned within a leaflet capture space between a first pair of outer and inner arms and another leaflet is positioned within a leaflet capture space between a second pair of outer and inner arms; Releasing the bias on at least one pair of outer arms or inner arms such that the first pair of outer arms and inner arms and the second pair of outer arms and inner arms self-close over the native valve leaflets to anchor them; repeating the native leaflet capture sequence if needed; After the leaflets are captured, expanding the prosthetic valve device A method comprising: 50. A variation of any of the above or below Devices and Methods Appendixes of a valve replacement device comprising a single pair of inner and outer arms. 51. A variation of a valve replacement device described in the above or below Devices and Methods Appendix, comprising multiple pairs of inner and outer arms to capture more leaflets. 52. A variation of a valve replacement device described in the above or below Devices and Methods Appendix, comprising at least one outer arm, wherein the tissue / leaflet is captured within a space between the arm and the prosthetic valve device. 53. A variation of any of the above or below device and method appendices of a valve replacement device comprising at least one expandable spacer for preventing perivalvular leakage. 54. A variation of the valve replacement device described in the above or below Device and Method Appendix, comprising at least one spacer with an adjustable volume. 55. A variation of any of the above or below Device and Method Appendixes of a valve replacement device comprising at least one spacer that can be adjusted dynamically, remotely, electronically, manually, or automatically. 56. A device described in any of the above or below appendices, wherein the thickness of the outer arm is preferably about 0.33 mm or 0.01 to 0.1, 0.12, 0.14, 0.16, 0.18, 0.2, 0.22, 0.24, 0.26, 0.28, 0.3, 0.32, 0.34, 0.36, 0.38, 0.4, 0.42, ..., 9.8, and / or 10 mm. 57. A device described in any of the above or below appendices, wherein the thickness of the inner arm is preferably about 0.20 mm or 0.01 to 0.1, 0.12, 0.14, 0.16, 0.18, 0.2, 0.22, 0.24, 0.26, 0.28, 0.3, 0.32, 0.34, 0.36, 0.38, 0.4, 0.42, ..., 9.8, and / or 10 mm. 58. A device described in any of the above or below appendices, wherein the width of the outer arm is preferably about 2.1 mm or 0 to 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, ...19.5, and / or 20 mm. 59. A device described in any of the above or below appendices, wherein the width of the inner arm is preferably about 2.1 mm or 0 to 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, ...19.5, and / or 20 mm. 60. A device described in any of the above or below appendices, wherein the maximum length of the cusp captured between the pair of outer and inner arms is preferably 5 mm to 20 mm or 0.25 to 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, ...59.5, and / or 60 mm. 61. A device according to any of the preceding or following appendices, wherein the maximum length of the cusp captured by the arms is preferably between 5mm and 20mm or between 0.25 and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, ... 59.5, and / or 60mm. 62. General Notes 63. A device or method as shown in any of the figures herein. 64. A device or method that can be derived from any combination of the figures of the present application. 65. A device or method as described or illustrated in this application. 66. A device or method that can be derived from any combination of the descriptions or teachings of this application. 67. An extendable arm, as shown in or derived from any of Figures 1A-7B. 68. A release bar as shown in or derived from any of Figures 8A-8B. 69. A bailout system or method as shown in or derived from any of Figures 9A-12G. 70. A bailout system or method, as shown in FIG. 9B. 71. A bailout system or method, as shown in FIG. 10B. 72. A bailout system or method as shown in FIG. 12D. 73. A spacer device or method, as shown in FIG. 27. 74. A spacer device or method, as shown in FIG. 28. 75. A spacer device or method, as shown in FIG. 29. 76. A spacer device or method, as shown in FIG. 77. A spacer device or method, as shown in FIG. 78. A spacer device or method as shown in Figures 32, 33, 34, 35, 36, and / or 37. 79. A spacer device or method as shown in or derived from any of Figures 27-27. 80. A device or method, as shown in FIG. 38, configured to provide robust tissue coaptation and / or annular cerclage. 81. A device or method as shown in Figures 38, 39, 40, 41, 42, 43, and / or 44. 82. A cusp grasping device or method, comprising a spacer, as shown in FIG. 53. 83. A tissue grasping device or method as shown in Figures 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, and / or 65. 84. A tissue grasping device or method as shown in Figures 66, 67, 68, 69, 70, and / or 71. 85. A tissue grasping device or method as shown in FIGS. 72, 74, 75, and / or 76. 86. A tissue grasping device or method as shown in Figures 78 and / or 79. 87. A tissue grasping device comprising pointed grasping arms with atraumatic barbs, as shown in FIGS. 81, 82, and / or 83. 88. A tissue grasping device or method as shown in FIG. 84 and / or 85. 89. A release bar, as shown in FIG. 90. A tissue grasping device or method as shown in FIGS. 87, 88, 89, 90, 91, 92, 93, 94, 95, and / or 96. 91. A tissue grasping system or method as shown in FIGS. 97, 98, and / or 99. 92. A release bar, as shown in FIG. 100. 93. A valve replacement device or method as shown in Figures 102, 103, 104, 105, 106, 107, and / or 108. 94. A valve replacement device or method, as shown in FIGS. 102, 103, 104, 105, 106, 107, and / or 108, comprising an expandable spacer configured to seal paravalvular leaks. 95. A catheter delivery system for a valve repair or replacement device or method, as shown in Figures 109A, 109B, 109C, and / or 109D. 96. A steerable guide catheter for a valve repair or replacement device or method, the steerable guide catheter comprising a stiffening member or stiffening pull wire as shown in FIGS. 110, 111, 112, 113, and / or 114. 97. A delivery catheter handle for a valve repair or replacement device or method, as shown in FIGS. 115, 116, 117, 118, and / or 119. 98. A valve repair or replacement implant retraction or retrieval feature / component or method as shown in FIGS. 120, 121, 123, 124, and / or 125. 99. A valve repair or replacement implant retraction or retrieval feature / component or method as shown in FIGS. 126 and / or 127. 100. A delivery catheter, the delivery catheter comprising an external spring 625 configured to reduce friction and maintain straightness as it is advanced into the distal section and out of the guide catheter, as shown in FIG. 128. 101. A rescue catheter or method as shown in Figures 129A, 129B, 129C, and / or 129D. 102. A tissue grasping device or method as shown in Figures 130A and / or 130B. 103. Supplement to Provisional Application No. 62 / 994,575 104. A tissue grasping device comprising: a hub configured to be removably attached to a deployment shaft; a first pair of tissue grasping arms comprising a first inner arm and a first outer arm coupled to the hub; and a second pair of tissue grasping arms comprising a second inner arm and a second outer arm coupled to the hub, wherein each pair of outer and inner arms is biased apart to create a tissue capture space therebetween and configured to resiliently self-close over the tissue when unbiased after the tissue has been captured / grasped. The deployment shaft or tissue grasping device has an actuation feature configured to expel the cusps and enable bailout. 105. The tissue grasping device of claim 1, wherein the hub is a metal tube, the actuatable feature comprises an implantable and / or removable suture (wire, leaf spring, fabric, and / or rope), and actuation includes manual, electrical, thermal, chemical, and / or mechanical. 106. The tissue grasping device described in Appendix 1, wherein the outer arm and the inner arm are made of metal wire. 107. The tissue grasping device of claim 1, wherein the pair of tissue grasping arms is a single component such that the inner arm is part of the outer arm. 108. A tissue grasping device as described in Appendix 4, wherein the tissue grasping arms are produced from metal strips, metal tubes, sheet metal, and / or any other flexible material suitable for implantation within the human body. 109. The tissue grasping device of claim 4, wherein the inner arm is configured to be biased away from the outer arm. 110. The tissue grasping device of claim 4, wherein the outer arm is configured to bend 270 degrees. 111. The tissue grasping device described in Appendix 5, wherein the width of the inner arm can be modified within the circumference of the metal tube. 112. The tissue grasping device of claim 8, wherein the inner arm is made of a thin, expandable metal sheet with a strength pattern that forms a folded fan-like design. 113. The tissue grasping device of claim 8, wherein the hub may be comprised of a stent pattern such as peak-to-valley, mid-strut connector, peak-to-peak, and / or offset peak-to-peak, and / or a strength pattern such as linear, grid, triangular, chevron, high-speed honeycomb, and / or full honeycomb. 114. The tissue grasping device of claim 9, wherein the inner arm and / or the outer arm may have a stent pattern such as peak-to-valley, mid-strut connector, peak-to-peak, and / or offset peak-to-peak, and / or a strength pattern such as linear, grid, triangular, wiggle, high-speed honeycomb, and / or full honeycomb. 115. The tissue grasping device of claim 9, wherein the inner arm may be formed from a flexible material, which may be a metal fabric such as a mesh, woven, braided, or formed in any suitable manner, or a laser cut or otherwise cut flexible material. The flexible material may be a fabric, a shape memory alloy wire that provides shape setting capabilities, or any other flexible material suitable for implantation within the human body. 116. The tissue grasping device of claim 9, wherein the inner arms can be biased inward. 117. The tissue grasping device of claim 9, wherein the inner arm can be biased outward. 118. A tissue grasping device, further comprising: a hub configured to be removably attached to a deployment shaft; a first pair of tissue grasping arms comprising a first fixed inner arm connected to a first movable outer arm coupled to the hub; and a second pair of tissue grasping arms comprising a second fixed inner arm connected to a second movable outer arm coupled to the hub, wherein each pair of outer and inner arms is biased apart to create a tissue capture space therebetween and is configured to resiliently self-close over the tissue when not biased after the tissue has been captured / grasped, and wherein the movable outer arm is movable between an open position and a closed position relative to the fixed inner arm. 119. The tissue grasping device of claim 15, wherein the outer arm is configured with a leaflet ejection feature that releases the mitral valve leaflets without inversion. 120. The tissue grasping device of claim 15, wherein the outer arm is coupled to the spring-loaded base by a metal wire and / or suture. 121. The tissue grasping device of claim 17, wherein the suture extends from the catheter, passes through the small hole, and is attached along the periphery of the movable outer arm. 122. The tissue grasping device of claim 17, wherein the suture extends from the catheter and is attached to a tether line along the circumference of the outer arm. 123. The tissue grasping device of claim 17, wherein the suture extends from the catheter and is attached to a pulling / pushing mechanism coupled to the base of the movable outer arm. 124. The tissue grasping device of claim 17, wherein the spring-loaded base can be actuated by a metal wire / mandrel and / or suture to retract the outer arms upward and release the mitral valve leaflets. 125. The tissue grasping device of claim 17, wherein the suture may be part of the implant or part of the delivery system. 126. The tissue grasping device of claim 15, wherein the base does not need to be spring loaded. 127. The tissue grasping device of claim 15, wherein the fixation arm comprises a plurality of barbs. 128. The tissue grasping device of claim 24, wherein the barb can be at an angle of 10 degrees to 75 degrees relative to the fixed inner arm. 129. The tissue grasping device of claim 24, wherein the barbs are angled away from the movable outer arm to prevent excessive pinching or clipping force on the apex. 130. The tissue grasping device of claim 15, wherein the fixed inner arm can be biased inward from the movable outer arm at an angle between 10 degrees and 350 degrees. 131. The tissue grasping device of claim 15, wherein the movable outer arm can be biased outward at an angle between 10 degrees and 350 degrees from the movable outer arm. 132. A method for releasing and repositioning a patient's mitral valve leaflets for bailout without inversion, the method comprising: applying tension to a release suture in a pulling motion to retract a movable outer arm upward, thereby moving a fixed inner arm; releasing barbs from the mitral valve leaflets; retracting a delivery system; and actuating the release suture to move the outer arm to an open or closed position. 133. The method of claim 29, wherein the release suture may be a metal wire, a metal shaft, a metal rod, a polymer suture, or the like. 134. The method of claim 29, wherein the release suture is coupled to a hub. 135. The method of claim 29, wherein the release suture is not attached to the hub. 136. The method of claim 29, wherein the release suture is coupled to a movable outer arm. 137. The method of claim 29, wherein the release suture is not attached to the movable outer arm. 138. The method of claim 29, wherein the release suture is coupled to a pulling / pushing mechanism attached to the base of the movable outer arm. 139. The method of claim 29, wherein the release suture is attached to the base of the movable outer arm and is not coupled to a pulling / pushing mechanism. 140. The method of claim 29, wherein applying tension to the release suture in a pulling motion will retract the movable outer arm and move the fixed inner arm, thereby releasing the barbs from the valve leaflets. 141. A tissue grasping device, further comprising: a hub configured to be removably attached to a deployment shaft; a first pair of tissue grasping arms comprising a first fixed inner arm connected to a first movable outer arm coupled to the hub; and a second pair of tissue grasping arms comprising a second fixed inner arm connected to a second movable outer arm coupled to the hub, each pair of outer and inner arms configured to include an automatic bailout feature. 142. The tissue grasping device of claim 38, wherein the automatic bail-out feature is looped and / or threaded through the inner and outer arms, thereby creating a suture between the arms that is pulled taut when the outer arm is inverted during leaflet capture, obliterating any captured tissue and / or cords. 143. The tissue grasping device of claim 39, wherein the bail-out suture is made of polyester thread, elastic material, and / or wire. 144. A system for delivering a tissue grasping device to a cardiac or venous valve, the device comprising: a tissue grasping device; and a deployment shaft configured to be removably attached to a hub of the tissue grasping device. 145. The system of claim 41, wherein the deployment shaft comprises a bailout feature. 146. The system of claim 42, wherein the bailout feature comprises a bailout suture and a secondary suture. 147. The system of claim 42, wherein the bail-out feature is designed such that retraction of the secondary suture relaxes the bail-out suture, thereby enabling leaflet capture. 148. The system of claim 42, wherein the bailout feature is designed such that retraction of the bailout suture relaxes the secondary suture, thereby obliterating the captured tissue and / or cord from the tissue grasping arms. 149. The system of claim 42, wherein the bail-out feature is designed such that retraction of the bail-out suture relaxes the secondary suture, thereby releasing the leaflet from the tissue-grasping arm without everting the outer arm. 150. The system of claim 42, wherein the bailout suture and secondary suture are made from polyester thread, elastic material, and / or wire. 151. The system of claim 43, wherein the bailout suture is threaded through a suture loop positioned in the reversal tool and / or a suture loop positioned in the first opening of the release bar. 152. The system of claim 43, wherein the secondary suture is configured to loop through any and / or all of the openings on the release bar. 153. The tissue grasping device of any one of claims 1 to 49, wherein the device is made of a polyester fabric coated with a polymer. 154. A tissue grasping device according to any one of claims 1 to 49, wherein the device is made of polyester fabric that is not coated with a polymer. 155. The tissue grasping device of any one of claims 1 to 49, wherein the device is made of fabric, which may be polyester or any biocompatible material suitable for implantation in the human body. 156. The tissue grasping device of any one of claims 1 to 49, wherein the device is made of fabric, which may be woven, braided, and / or knitted. 157. A tissue grasping device as described in appendix 1 to 49, wherein the device may comprise external attachments on the inner and / or outer arms, such as rings, loops, leaf springs, sensors, and actuators, and / or wires, for the purpose of increasing mechanical strength. 158. The tissue grasping device of any one of claims 1 to 49, wherein the device can be actuated manually, electrically, chemically, and / or mechanically. 159. The tissue grasping device of any one of claims 1 to 49, wherein the delivery system can be manually, electrically, chemically, and / or mechanically actuated. 160. The tissue grasping device of any one of claims 1 to 49, wherein the device may consist of a single unit or multiple units. 161. The tissue grasping device of any one of claims 1 to 49, wherein the device may consist of a single or multiple statically expandable balloons expanded by an expansion tube connected to a delivery catheter. 162. The tissue grasping device of any one of claims 1 to 49, wherein the device may comprise a single or multiple statically expandable balloons stretched by stretch ports controlled by a microprocessor, microcontroller, sensor, and / or actuator. 163. The tissue grasping device of any one of claims 1 to 49, wherein the device may comprise a single or multiple dynamically expandable balloons expanded by an expansion tube connected to a delivery catheter. 164. The tissue grasping device of any one of claims 1 to 49, wherein the device may comprise a single or multiple dynamically expandable balloons stretched by stretch ports controlled by a microprocessor, microcontroller, sensor, and / or actuator. 165. The tissue grasping device of any one of claims 1 to 49, wherein the first outer arm can be 0.25 mm, 0.5 mm, 0.75 mm, 1 mm, 1.25 mm, etc. longer than the second outer arm. 166. The tissue grasping device of any one of claims 1 to 49, wherein the first inner arm can be 0.25 mm, 0.5 mm, 0.75 mm, 1 mm, 1.25 mm, etc. longer than the second inner arm. 167. The tissue grasping device of any one of claims 1 to 49, wherein the first outer arm can be 0.25 mm, 0.5 mm, 0.75 mm, 1 mm, 1.25 mm, etc. longer than the first inner arm. 168. The tissue grasping device of any one of claims 1 to 49, wherein the second outer arm can be 0.25 mm, 0.5 mm, 0.75 mm, 1 mm, 1.25 mm, etc. longer than the second inner arm. 169. The tissue grasping device of any one of claims 1 to 49, wherein the first outer arm can be 0.25%, 0.5%, 0.75%, 1%, 5%, 10%, etc. thicker than the second outer arm. 170. The tissue grasping device of any one of claims 1 to 49, wherein the first inner arm can be 0.25%, 0.5%, 0.75%, 1%, 5%, 10%, etc. thicker than the second inner arm. 171. The tissue grasping device of any one of claims 1 to 49, wherein the first outer arm can be 0.25%, 0.5%, 0.75%, 1%, 5%, 10%, etc. thicker than the first inner arm. 172. The tissue grasping device of any one of claims 1 to 49, wherein the second outer arm can be 0.25%, 0.5%, 0.75%, 1%, 5%, 10%, etc. thicker than the second inner arm. 173. A catheter handle comprising a retractable rod, an o-ring, a suture, and a suture tensioner, wherein the retractable rod is slidable over the compressed o-ring, and the rod is attached to the suture and / or is attached with the suture in addition to the suture tensioner. 174. The handle of claim 70, wherein the rod is actuated manually or robotically. 175. The handle of claim 70, wherein the suture is actuated manually, electrically, mechanically, chemically, and / or robotically. 176. A catheter, such as one manufactured by ASAHI INTECC USA INC., that is flexible and torquable, comprising a cable and a shaft. 177. A valve repair system, the valve repair system comprising audio, visual, tactile, rf, and wireless feedback. 178. Attachment to Provisional Application No. 63 / 051,737 179. A tissue grasping device comprising: a first pair of tissue grasping arms comprising a first inner arm and a first outer arm coupled to a hub; and a second pair of tissue grasping arms comprising a second inner arm and a second outer arm coupled to a hub, wherein each pair of outer and inner arms is biased apart to create a tissue capture space therebetween and are configured to resiliently self-close over the tissue when unbiased after the tissue has been captured / grasped. When the arms are parallel, a fully closed MitraClip® implant has an inherent gap between the tips of the arms. Having an inherent gap allows blood elements to be trapped within this area, and exposure to high shear stress over a long period of time can lead to thrombus formation and thromboembolism. The inherent gap can be filled with a spacer to reduce the risk of thrombus formation. 180. A tissue grasping device as described in Appendix 1, wherein the inherent gap between the tips of the arms is filled with a biocompatible sponge, which reduces the blood recirculation area and results in a reduced risk of thrombus formation. 181. A tissue grasping device as described in Appendix 1, wherein the inherent gap between the tips of the arms is filled with a biocompatible expandable mesh, which reduces the blood recirculation area and results in a reduced risk of thrombus formation. 182. A tissue grasping device as described in Appendix 1, wherein the inherent gap between the tips of the arms is filled with a biocompatible balloon, which reduces the blood recirculation area and results in a reduced risk of thrombus formation. 183. The sponge described in Appendix 2 is attached between the arms to fill the inherent gap that forms after closing the arms. 184. The expandable mesh described in Appendix 3 is attached between the arms to fill the inherent gap that forms after the arms are closed. 185. The balloon described in Appendix 4 is attached between the arms to fill the inherent gap that is formed after closing the arms. 186. In the Medfree system, the inherent gap filling described in Supplementary Notes 5, 6, and 7 allows for gaps of less than 1 mm to be formed, and the tissue bridge formed between the implant and the spacer eliminates the risk of thrombus formation. 187. The sponge described in Appendix 2 is attached to the atrial side of the lateral arm to increase apical support from directly below. 188. The expandable mesh described in Appendix 3 is attached to the atrial side of the outer arm to increase apical support from directly below. 189. The balloon described in Appendix 4 is attached to the atrial side of the outer arm to increase apical support from directly below. 190. The tissue grasping device of claim 1, wherein the inherent gap 52 between the tips of the arms is secured to the atrial side of one gripper using sutures, adhesives, welding, glue, and / or fasteners. 191. A tissue grasping device as described in appendix 1, wherein the unique packet is filled with two small spacers 68, each spacer fastened to one arm and reducing the gap 12, as shown in Figures 13 and 17. 192. When one arm is lowered (deflected) to assume the gripping position, the second arm also tends to move towards the actuated side. 193. Movement of one of the arms during gripping as described in Appendix 12, wherein a central post on the release bar keeps the arms centered and prevents passage of one of the arms in the opposite direction during actuation of the other arm. 194. The tissue grasping device of claim 1, wherein the arm has redundant pivoting that provides various degrees of freedom within the arm. 195. The redundant pivot of claim 12, wherein the stiffness of the arm is improved by increasing the number of pins, providing better grip. 196. The flexible arm provides better retention and flexibility, redundant pivoting as described in Appendix 12. 197. The flexible arm provides a constant elastic spring force, and the redundant pivoting described in Appendix 12. 198. The gripper design incorporates a unique, blunt-shaped friction element (FE) that is midline-located. 199. A blunt barb as described in claim 16, wherein the blunt laser flattening pattern reduces tearing of the apical tissue. 200. The barbs of the laser flat pattern described in Appendix 17 can be W-shaped, V-shaped, or curved. 201. The gripper design described in Appendix 18 does not provide any tearing, perforation, or loss of grip of the cusp. 202. The pivot arm of claim 12, wherein there is limited movement due to the short distance between the pivot and the retaining pin. 203. The redundant pivot arm of claim 12, wherein the U-spring is mounted in a neutral position to provide greater mobility of the screw over a wider range of motion. 204. A redundant pivot arm as described in claim 12, wherein a higher ratio of spring retaining pins results in a tighter grip across the arm. 205.240. The tissue grasping device of claim 1. 206. The removable portion of the delivery system described in Appendix 24 can create an inherent gap when removed. 207. The inherent gaps described in Appendix 25 can be filled with sponges, expandable meshes, and balloons, as in Appendixes 5, 6, and 7. 208. The filler spacer described in Appendix 26 can replace the permanently widened inherent gap 241 as in Figures 24 and 25 to fill the inherent gap between the arms. 209. The tissue grasping device of claim 1, wherein the angle between the outer arms can be -90, -60, -45, -30, -15, -10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, and / or 90 degrees. 210. The outer arm angle of claim 28, wherein the preferred angle may be between -10 and 30 degrees. 211. The tissue grasping device of claim 1, wherein the base width is greater than the top width. 212. Base width and top width as described in Appendix 30, which may also be the case where base width = top width. 213. The base width and top width as set forth in Appendix 30 may also be such that the base width < the top width. 214. The base width is greater than .1%, 1%, 10%, 25%, 50%, 75%, 100%, 150%, 200%, 500%, 1,000%, and / or 10,000% of the base width described in notes 30, 31, and 32. 215. The base width and top width of claim 30, wherein the base width and / or top width is 0.01 mm, 0.1 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 4 mm, 5 mm, 6 mm, 10 mm, 20 mm, 30 mm, 50 mm, 100 mm, and / or 300 mm. 216. A tissue fixation system configured for transvascular delivery and for use in joining mitral valve tissue during mitral valve repair, comprising: The main body and Each of them, a first end pivotally connected to the body and extending to a second end; a tissue engaging surface between the first end and the second end, the tissue engaging surface configured to approximate and engage a portion of a leaflet of a mitral valve; a first distal element and a second distal element formed from a material comprising: a tissue grasping device formed from a shape memory material, the tissue grasping device including a base section; a first arm and a second arm, each arm having a distal end coupled to the base section by an arm bending feature, a proximal end extending laterally from the base section, a bifurcated section having an opening with a rounded distal end formed with a first radius in the arm bending feature, and a tapered distal proximal end formed with a second radius in the first arm, the second radius being smaller than the first radius, an intermediate portion having a cross section larger than both the distal end and the tapered distal proximal end, the first arm and the second arm being disposed opposite one another, each arm configured to cooperate with one of the first distal element or the second distal element to form a space therebetween for receiving and retaining a portion of mitral valve tissue; A system comprising: 217. The tissue fixation system of claim 38, wherein the first distal element and the second distal element are made from either a CP titanium material or an alloy of a titanium material, such as Grade 1, Grade 2, Grade 3, Grade 4, Grade 5, Grade 6, Grade 23, Ti-6Al-7Nb, Ti-3Al-2.5V, Ti Beta 3 / Ti 11.5Mo-6Zr-4.5Sn, Ti Beta C / Ti-3Al-8V-6Cr-4Zr-4Mo, or any other titanium alloy that may be implanted. 218. The tissue fixation system of claim 38, wherein the first distal element and the second distal element are made from any of a non-ferromagnetic material, such as titanium or a titanium alloy or any other non-ferromagnetic biomaterial (metal, polymer, and / or ceramic), that can be implanted. 219. A tissue fixation system configured for transvascular delivery and for use in joining mitral valve tissue during mitral valve repair, comprising: The main body and A base and Each of them, a first end coupled to the body and extending to a second end; a tissue engaging surface between the first end and the second end, the tissue engaging surface configured to approximate and engage a portion of a leaflet of a mitral valve; a first distal element and a second distal element formed from a shape memory material, A plurality of friction elements; a base compartment; a tissue grasping device formed from a shape memory material comprising: wherein the distal element is self-biased toward the gripper, and vice versa, and is configured to deflect against the biasing force to form a space therebetween for receiving and retaining a portion of the leaflet by self-closing the space upon removal of the external force. 220. The tissue fixation system of notes 38 and 41, wherein the tissue engaging surfaces of the distal elements are angled approximately 90 degrees or more apart when positioned in the open configuration, the first and second arms of the tissue grasping device are configured to transition from the pre-deployed configuration towards the deployed configuration by moving towards the tissue engaging surfaces, and the first and second arms are angled approximately 90 degrees or more apart when positioned in the deployed configuration. 221. The tissue fixation system of claims 38 and 41, wherein the tissue engaging surfaces of the distal element are angled approximately 120 degrees apart or more when positioned in the pre-deployed configuration, and the first and second arms of the tissue grasping device are configured to transition from the pre-deployed configuration to the deployed configuration by moving toward the tissue engaging surfaces, and the first and second arms are angled approximately 120 degrees apart or more when positioned in the deployed configuration. 222. The tissue fixation system of claims 38 and 41, wherein the shape memory material of the tissue grasping device is a nickel-titanium alloy. 223. The tissue fixation system of claims 38 and 41, wherein the nickel-titanium alloy of the tissue grasping device has a transformation temperature of -40, -30, -20, -10, -5 to about 37 degrees Celsius. 224. The tissue fixation system of claims 38 and 41, wherein the nickel-titanium alloy of the tissue grasping device has a transformation temperature of about -10 to about 10 degrees Celsius. 225. The tissue fixation system of clauses 38 and 41, wherein, in response to the tissue gripping device being positioned in the deployed state against the leaflets of the mitral valve, the arms of the tissue gripping device are configured to apply a force of approximately 0.10, 0.11, 0.12, 0.13, 0.14, 0.15, 0.20, 0.25, 0.35, 0.4, 0.45, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 9.0, 10, 12, 15, 20, 30, 50, and / or 100 pounds against the leaflets. 226. The tissue fixation system of claims 38 and 41, wherein the arms of the tissue grasping device, in response to transitioning from the pre-deployed configuration to the deployed configuration, deploy while the distal elements are in the open configuration without any proximal movement of the distal elements, to engage mitral valve tissue against the tissue engaging surfaces of the distal elements. 227. The tissue fixation system of claims 38 and 41, wherein the overall length of the arms of the tissue grasping device engages mitral valve tissue against the tissue engaging surfaces of the distal elements while the distal elements are in the open configuration in response to transitioning from the pre-deployed configuration to the deployed configuration. 228. The tissue fixation system of claims 38 and 41, wherein the tissue grasping device formed from a shape memory material is expandable in width and / or thickness. 229. The tissue fixation system of any one of claims 38 and 41, wherein the tissue grasping device is molded from a material having a thickness greater than 0.006 inches, preferably between 0.0063 inches and 0.201 inches. 230. The tissue fixation system of claims 38 and 41, wherein the tissue gripping device is configured such that, in response to being positioned in the deployed state against the mitral valve leaflets, the arms of the tissue gripping device apply a force of greater than 0.10 pounds, preferably between about 0.11 and about 30 pounds, against the leaflets. 231. The tissue fixation system of claim 41, wherein the self-biasing force of the distal element exceeds the self-biasing force of the proximal gripper element by about 0.10, 0.11, 0.12, 0.13, 0.14, 0.15, 0.20, 0.25, 0.35, 0.4, 0.45, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 9.0, 10, 12, 15, 20, 30, 50, and / or 100 pounds against the cusp. 232. The tissue fixation system of claims 38 and 41, wherein the distal arms are close together to reduce a gap therebetween, the gap being less than 0.1, 0.15, 0.2, 0.25, 0.3, 0.4, 0.5, 1, 2, 3, 4, 5, 6, 10, 15, 20, 30, 50, and / or 100 mm. 233. The tissue fixation system of claims 38 and 41, wherein the distal arms are approximated to reduce a gap therebetween, and the distal arms, grippers, and cusps therebetween are in near apposition, as shown in FIG. 32. 234. The tissue fixation system of claims 38 and 41, wherein the distal arms flex when tightly closed. 235. The tissue fixation system of claims 38 and 41, wherein the distal arms flex and apply a resilient closing force on the cusps when tightly closed. 236. The tissue fixation system of claims 38 and 41, wherein the distal arms, which flex when closed, do not have any substantial gaps that create pocket-like portions between the tines or grippers at the tips. 237. The tissue fixation system of any one of claims 38 and 41, wherein the base is fastened together with the distal element and the proximal element. 238. The tissue fixation system of claims 38 and 41, wherein the base is fastened together with the distal and proximal elements using screws, rivets, clamps, and / or ropes. 239. The tissue fixation system of claims 38 and 41, wherein the base is bonded together with and between the distal and proximal elements. 240. The tissue fixation system of claims 38 and 41, wherein the base is welded together with the distal element and the proximal element. 241. The tissue fixation system of claims 38 and 41, wherein all component materials are non-ferromagnetic. 242. The tissue fixation system of any of these appendices, wherein the distal element self-expands laterally and / or radially when unconstrained. 243. The tissue fixation system of any of these appendices, wherein the proximal gripper element self-expands laterally and / or radially when unconstrained. 244. The tissue fixation system of any of these appendices, wherein the expandable element self-expands to completely or partially fill any pocket-like areas between the distal arms, grippers, and / or leaflets. 245. The tissue fixation system of any of these appendices, wherein the expandable element can be remotely configured to self-expand to completely or partially fill any pocket-like areas between the distal arms, the grippers, and / or the leaflets. 246. The tissue fixation system of any of these clauses, configured to receive an expandable element to completely or partially fill any pocket-like portion between the distal arms, the grippers, and / or the leaflets. 247. The tissue fixation system of any of these clauses, configured to receive a variably expandable element to completely or partially fill any adjacent gaps within the leaflet. 248. The tissue fixation system of claim 69, wherein the expandable member can be remotely configured to receive a variably expandable element to completely or partially fill any adjacent gaps within the leaflet. 249. A tissue fixation system according to any of the preceding or following clauses, which may be delivered using a 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, and / or 0.1 French luminal guide / introducer catheter system. Preferably, the guide / introducer luminal catheter system is 18 French to 9 French, and / or preferably 12 French. 250. A tissue grasping device comprising: a hub configured to be removably attached to a deployment shaft; a first pair of tissue grasping arms comprising a first inner arm and a first outer arm coupled to the hub; and a second pair of tissue grasping arms comprising a second inner arm and a second outer arm coupled to the hub, wherein each pair of outer and inner arms is configured to be biased apart to create a tissue capture space therebetween and to resiliently self-close over the tissue when unbiased after the tissue has been captured / grasped. The deployment shaft or tissue grasping device comprises a suture configured to expel the leaflets to enable bailout. A catheter with a stiffening member is configured to steer in a desired direction. An expandable element is configured to fill any gaps between the leaflets. 251. A steerable catheter shaft having one or more stiffening members incorporated within or across the catheter to allow for specific steerability in particular curves or directions. 252. A stiffening member of a catheter according to any of the preceding or following clauses made from laser-cut tubing, small sections, laser-cut strips, wire, suture, fiber, polymer, ceramic, metal, and / or composite. 253. A steerable catheter shaft according to any of the preceding or following clauses, comprising a stiffening member either continuously or intermittently along the length of the shaft. 254. A steerable catheter shaft as described in any preceding or following clause, comprising stiffening members formed by adding or removing material in a given pattern to assist in directional steering. 255. A steerable catheter shaft according to any preceding or following clause, comprising a stiffening member in the proximal 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10%, 5%, or 1% of the shaft. 256. A steerable catheter shaft according to any preceding or following clause, comprising a stiffening member in the distal 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10%, 5%, or 1% of the shaft. 257. A steerable catheter shaft according to any one of the preceding or following clauses, comprising a stiffening member at 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10%, 5%, or 1% of the center of the shaft. 258. A steerable catheter shaft as described in any of the preceding or following clauses, comprising a stiffening member configured to enable preferred steerability for accessing heart valves from the femoral vein and IVC. 259. A steerable catheter shaft as described in any preceding or following clause, comprising a stiffening member configured to allow preferred steerability for accessing a heart valve from the jugular vein and SVC. 260. A steerable catheter shaft as described in any preceding or following clause, comprising a stiffening member configured to enable preferred steerability for accessing a heart valve via the femoral artery and the aorta. 261. A steerable catheter shaft as described in any preceding clause, comprising a stiffening member configured to enable preferred steerability for accessing a heart valve via the carotid artery and through the aorta. 262. A steerable catheter shaft as described in any preceding clause, comprising a stiffening member configured to allow preferred steerability for accessing a heart valve. 263. The steerable catheter shaft of any preceding clause, comprising a stiffening member configured to provide enhanced tracking, torqueability, steering, pullability, and / or pushability. 264. Supplement to Provisional Application No. 63 / 127,935 265. A prosthetic treatment device for treating a native mitral valve having a native annulus and native cusps, comprising: an expandable support having a downstream end configured to be positioned toward the left ventricle, an upstream end configured to be positioned toward the left atrium, and an interior; a prosthetic valve having at least one leaflet assembly mounted on an expandable support and adapted to allow blood flow in a downstream direction and block blood flow in an upstream direction, wherein a flow portion of the support and at least one elongated member or members extend outward from the support in an upstream direction, the elongated members having sufficient flexibility to deflect inward or outward relative to the support and accommodate dilation or distortion of the native annulus, and the elongated members are configured to inhibit movement of the support toward the left atrium; at least one skirt coupled to a downstream portion of the support and extending around the support, the skirt oriented on the device to obstruct blood flow between the prosthetic treatment device and the native valve; at least one suture or sutures coupled to a downstream elongate member and feature and configured to tension or relax the suture to deflect the elongate member, wherein deflection of the elongate member can be configured to various positions to allow repeated stabilization, grasping, and / or release of the self-cusps; A prosthetic treatment device comprising: 266. A prosthetic treatment device for treating a native mitral valve having a native annulus and native cusps, comprising: an expandable support having a downstream end configured to be positioned toward the left ventricle, an upstream end configured to be positioned toward the left atrium, and an interior; a prosthetic valve having at least one cusp assembly mounted on an expandable support and adapted to allow blood flow in a downstream direction and block blood flow in an upstream direction, wherein a flow portion of the support and at least one elongated member or members extend outward from the support in an upstream direction, the elongated members having sufficient flexibility to deflect inward or outward relative to the support and accommodate expansion or distortion of the native valve annulus, and the elongated members are configured to grasp the native cusps from the atrial and ventricular sides and inhibit movement of the support toward the left atrium; at least one skirt coupled to a downstream portion of the support and extending around the support, the skirt oriented on the device to obstruct blood flow between the prosthetic treatment device and the native valve; A prosthetic treatment device comprising: 267. At least one suture or a plurality of sutures coupled to at least one suture or a plurality of elongate members and configured to deflect the elongate members by tensioning or relaxing the suture, wherein deflection of the elongate members can be configured to various positions that allow repeated stabilization, grasping, and / or release of the self-cusps. 268. The device of claims 1 and 2, wherein the elongate member is made from elastic, superelastic, shape memory, nitinol, metal, alloy, plastic, and / or ceramic. 269. A device as described in appendix 1 and 2, wherein the atrial extension member is designed to atraumatically grasp or release the native cusp. 270. The device of clauses 1 and 2, wherein at least some of the elongated members include atraumatic barbs. 271. The device of notes 1 and 2, wherein the ventricular extension member is designed to atraumatically grasp or release the native cusp. 272. The device of appendix 1 and 2, wherein at least one elongate member is covered with a fabric, mesh, coating, and / or surface feature that enables or promotes tissue encapsulation. 273. The device of claim 1 and 2, wherein at least one elongate member is releasably attached to the suture. 274. The device of claim 1 and 2, wherein at least one suture is configured to lift the autogenous cusp from the elongate member. 275. The device of appendix 1 and 2, wherein at least one suture is configured with an inversion tool. 276. The device of appendix 1 and 2, wherein the extension member is a pair of inner and outer arms on the ventricular side, and / or the extension member is a gripper on the atrial side, as in prior co-owned patent applications US20200383782A1, PCT / US2017 / 042003, and / or PCT / 0S2019 / 013853. 277. A capture device for fixation of a cardiac valve leaflet, comprising: at least one distal element adapted to extend radially outward from a center of the capture device after the capture device has been advanced to a location in the heart near a heart valve, the at least one distal element configured to be positioned atraumatically against at least one cusp of the heart valve, the at least one distal element having a biasing portion configured to expand outward from the center of the capture device and, optionally, invert when the suture is pulled to a tensioned condition to allow release of at least one cusp previously captured between the at least one proximal element and the at least one distal element; at least one proximal element held proximally and upwardly by the suture in a tensioned condition, the at least one proximal element having a biasing portion configured to extend radially outward from a center of the capture device when the suture is relaxed toward a relaxed condition to enable capture of the at least one leaflet between the at least one proximal element and the at least one distal element; A capture device comprising: 278. A capture device for fixation of a cardiac valve leaflet, comprising: at least one distal element held distally in an outwardly expanded or everted configuration by a suture in a tensioned condition, the at least one distal element having a biasing portion configured to contract radially inward toward a center of the capture device when the suture is relaxed toward a relaxed condition to allow capture of the at least one leaflet between the at least one proximal element and the at least one distal element; at least one proximal element held proximally and upwardly by the suture in a tensioned condition, the at least one proximal element having a biasing portion configured to extend radially outward from a center of the capture device when the suture is relaxed toward a relaxed condition to enable capture of the at least one leaflet between the at least one proximal element and the at least one distal element; A capture device comprising: 279. The device of claims 11 and 12, wherein the outward bias of the proximal element is less resilient than the inward bias of the distal element. 280. The device of claims 11 and 12, wherein the at least one distal element comprises a pair of distal elements and the at least one proximal element comprises a pair of proximal elements. 281. The device of claims 11 and 12, wherein at least one distal element comprises a loop. 282. The device of claims 11 and 12, wherein at least one distal element comprises a wire. 283. The device of notes 11 and 12, wherein at least one distal element has a petal shape. 284. The device of claims 11 and 12, wherein at least one proximal element is biased toward at least one distal element. 285. The device of notes 11 and 12, wherein at least one proximal element comprises nitinol. 286. The device of notes 11 and 12, wherein at least one proximal element includes at least one frictional appendage extending therefrom. 287. The device of notes 11 and 12, wherein at least one frictional attachment comprises at least one barb. 288. The device of notes 11 and 12, wherein at least one frictional attachment comprises a plurality of barbs. 289. The device of claims 11 and 12, wherein at least one frictional attachment comprises a tissue penetration depth limiting feature in the barb. 290. The device of clauses 11 and 12, wherein at least one frictional attachment comprises a tissue penetration depth limiting feature in the barb. 291. The device of claims 11 and 12, wherein at least one proximal element has a shorter length relative to the distal element. 292. The device of claims 11 and 12, wherein at least one proximal element has a greater length than the distal element. 293. The device of claims 11 and 12, wherein at least one proximal element is equal in length to the distal element. 294. The device of claims 23, 24 and / or Figures 23, 24, and 25, wherein at least one proximal element exceeds the length of the proximal element by 0, 0.1, 0.3, 0.6, 0.9, 1.2, 1.5, 1.8, 2.1, 2.4, 5, 10, 20, 30, and / or 100 mm. 295. The device of claims 23, 24 and / or Figures 23, 24, and 25, wherein at least one proximal element is 0, 0.1, 0.3, 0.6, 0.9, 1.2, 1.5, 1.8, 2.1, 2.4, 5, 10, 20, 30, and / or 100 mm shorter than the length of the proximal element. 296. The device of notes 11 and 12, wherein at least one pair of proximal and distal elements is configured to complement a cusp and is 0, 0.1, 0.3, 0.6, 0.9, 1.2, 1.5, 1.8, 2.1, 2.4, 5, 10, 20, 30, and / or 100 mm longer than the length of an adjacent pair of proximal and distal elements. 297. The device of claims 11 and 12, wherein at least one pair of proximal and distal elements is configured to complement the cusp, and the biasing force of the proximal element is significantly less than that of an adjacent pair of proximal and distal elements. 298. The device of notes 11 and 12, wherein at least one pair of proximal and distal elements is configured to complement the cusp, and the biasing force of the proximal element significantly exceeds that of an adjacent pair of proximal and distal elements. 299. The device of notes 11 and 12, wherein at least one pair of proximal and distal elements is configured to complement a cusp, and the biasing force of the proximal element is approximately the same as that of an adjacent pair of proximal and distal elements. 300. The device of notes 11 and 12, and / or FIGS. 23, 24, and 25, wherein the distal element is configured with a biasing force greater than the proximal element. 301. The device of claims 11 and 12 and / or Figures 23, 24, and 25, wherein the distal element is configured with a biasing force that exceeds the biasing force of the proximal element by 0, 0.14, 0.3, 0.6, 0.9, 1.2, 1.5, 1.8, 2.1, 2.4, 5, 10, 20, 30, and / or 100 pounds-force. 302. The device of claims 11 and 12 and / or Figures 23, 24, and 25, wherein the distal element is configured with a biasing force that is 0, 0.14, 0.3, 0.6, 0.9, 1.2, 1.5, 1.8, 2.1, 2.4, 5, 10, 20, 30, and / or 100 pounds-force less than the biasing force of the proximal element. 303. An endovascular heart valve repair system comprising: a delivery catheter having a distal end configured to be introduced into a heart chamber adjacent a pair of coapting heart valve leaflets, the delivery catheter including a release bar having a pair of retroflex devices; a valve repair leaflet grasping device comprising: a hub configured to be removably attached to a release bar of a delivery catheter; a first pair of leaflet capture arms comprising an inner arm and an outer arm coupled to the hub; and a second pair of leaflet capture arms comprising a second inner arm and a second outer arm coupled to the hub; a first set of control tethers positioned on or through the delivery catheter and coupled to the outer arms and configured to selectively bias the outer arms into a leaflet capture position; a second set of tethers positioned on or through the delivery catheter and coupled to the inner arms and configured to selectively bias the inner arms into a leaflet capturing position; Equipped with the first set of control tethers are threaded through laterally spaced locations on the retroversion tool such that pulling the proximal portions of the first set of control tethers proximally causes the distal portions of the first set of control tethers to pull the outer segments of the outer arms distally into a leaflet capture, stabilize, or release position; The second set of control tethers are threaded through laterally spaced locations on the retroversion tool such that pulling the proximal portions of the second set of control tethers proximally causes the distal portions of the first set of control tethers to pull the outer segments of the outer arms distally into a leaflet capture, stabilize, or release position. Endovascular heart valve repair system. 304. An endovascular heart valve repair system comprising: a delivery catheter having a distal end configured to be introduced into a heart chamber adjacent a pair of coapting heart valve leaflets, the delivery catheter including a release bar having at least one retroflex device; a valve repair leaflet grasping device comprising: a hub configured to be removably attached to a release bar of a delivery catheter; and at least one pair of leaflet capture arms comprising an inner arm and an outer arm coupled to the hub; at least one pair of control tethers, a first tether positioned on or through the delivery catheter and coupled to the outer arm and configured to selectively bias the outer arm into a leaflet capturing position, and a second tether positioned on or through the delivery catheter and coupled to the inner arm and configured to selectively bias the inner arm into a leaflet capturing position; Equipped with at least one pair of control tethers are threaded through laterally spaced locations on the retroversion tool such that pulling the proximal portions of the control tethers proximally causes the distal portions of the control tethers to pull the outer segments of the outer arms distally into a leaflet capture, stabilize, or release position; At least one set of control tethers is threaded through laterally spaced locations on the inverter and release bar and / or through the device such that pulling on a proximal portion of the control tether causes the tethers to assist in bailout by releasing and / or removing any leaflets caught between the gaps of the medial and lateral arms in the leaflet release configuration; Endovascular heart valve repair system. 305. The endovascular heart valve repair device of any one of claims 36 and 37, comprising an expandable spacer configured to prevent retrograde blood / fluid flow. 306. The endovascular heart valve repair device of claims 36 and 37, wherein the pair of retroflex devices includes a first retroflex device extending laterally in a first direction from the distal tip of the delivery catheter and a second retroflex device extending laterally in a second direction from the distal tip of the delivery catheter. 307. The endovascular heart valve repair device of claims 36 and 37, wherein the first direction and the second direction are opposite each other. 308. The endovascular heart valve repair device of claims 36 and 37, wherein the first and second inverting tools are each pivotally attached to a distal tip of the delivery catheter. 309. The endovascular heart valve repair device of claims 36 and 37, wherein the pivotal attachment is configured such that when the first anchor is pulled proximally and an opening force is applied to the retroflex tool, the retroflex tool deploys laterally but is capable of axially collapsing in alignment with the delivery catheter in the absence of the opening force. 310. The endovascular heart valve repair device of claims 36 and 37, wherein a first set of tethers passes from the distal end of the release bar, is slidably coupled to each of the inverting tool and outer arm, and is fixedly attached to the release bar. 311. The endovascular heart valve repair device of claims 36 and 37, wherein a second set of tethers pass from the distal end of the delivery catheter, are slidably coupled to each of the inner arms, and are fixedly attached to the release bar. 312. The endovascular heart valve repair device of claims 36 and 37, wherein the inner and outer arms comprise inner and outer leaf springs. 313. The endovascular heart valve repair device of claims 36 and 37, wherein the inner leaf spring is biased to open laterally and outwardly, away from the release bar, and the outer leaf spring is biased to close laterally and inwardly, toward the release bar, thereby allowing the leaflets to be trapped therebetween when the leaf springs are not biased. 314. The endovascular heart valve repair device of claims 36 and 37, wherein the outward opening bias of the inner leaf spring is less than the inward closing bias of the outer leaf spring. 315. The endovascular heart valve repair device of claims 36 and 37, wherein the outer leaf springs are generally straight and closely spaced across the release bar when unbiased, such that the outer leaf springs will laterally close the inner leaf springs when all leaf springs are in an unbiased state. 316. A valve repair leaflet grasping device comprising: a hub removably attached to a deployment shaft; two pairs of outer and inner arms configured to be biased apart to create a leaflet capture space; a spacer expandable member, typically an expandable balloon or mesh to act as a spacer; an inverting tool for unclasping an incorrectly grasped leaflet; barbs in the inner arms for a non-slip grip; and a removable tether for stretching or retracting the spacer. 317. The apex grasping device of claim 49, wherein the retroflex tool releases the distal arm from the apex and repositions the distal arm. Active movement of the arm within the left ventricle is achieved with the aid of the ventricular suture and the retroflex tool after the arm is deployed and grasps the apex. 318. The embodiment described in Appendix 49, further comprising a gripper that, in addition to the arms on the ventricular side, can be used on the atrial side to facilitate better positioning, engaging, repositioning, and manipulating the leaflets from the top and bottom planes of the heart valve. 319. The cusp grasping device of claim 49, wherein when actuated, the atrial suture releases the arms from the cusp without the use of a reversal tool. 320. The valve repair leaflet grasping device of claim 49, wherein the spacer engages one leaflet while one set of the inner and outer arms engages the other leaflet. 321. A valve repair leaflet grasping device, wherein the expandable member or balloon has a lesser compliance and is rigid to engage one leaflet while the other leaflet is engaged by one set of the inner arms and the outer arms. 322. A method for a valve repair leaflet grasping device as described in claim 49, wherein the expandable member or balloon has a higher compliance, causing the expandable member to conform to one leaflet based on pressure exerted on the expandable member while the other leaflet is engaged by one set of the inner arms and the outer arms. 323. A method for a valve repair leaflet grasping device as described in Appendix 49, wherein the removable anchoring tube, as in Obalon's US20180185185, can be employed to adjust the expandable member to the size and shape of the space during the procedure and after implantation. 324. The valve repair leaflet grasping device of claim 49, wherein the barb is attached to the inner arm and, once grasped, enables a tight, non-slip grip of the leaflet. 325. The valve repair leaflet grasping device of claim 49, wherein the pair of inner arms are longer than the outer arms, with a distance of less than 1 mm between the leaflets after grasping. 326. The valve repair leaflet grasping device of claim 49, wherein the pair of inner arms are coplanar with the outer arms, with a distance between the leaflets of less than 1 mm after grasping. The inner arms and the outer arms are the same height. 327. The valve repair leaflet grasping device of claim 49, comprising a pair of inner arms that are shorter than the outer arms, which allows the leaflets to contact each other and form tissue therebetween because there is no space between them. 328. The expandable member, further comprising a funnel-shaped expandable mesh that resiliently and elastically assumes the shape of a funnel when pushed out of the guide catheter to either partially or completely contain the implant, and that assumes the shape of a tube and fits completely inside the delivery catheter when the implant is retracted back into the guide catheter. 329. The method of claim 49, as in FIG. 31, wherein the distances indicated by 315 are 0 to 1, 2, 3, 4, ..., 24, and / or 25 cm, and the distances indicated by 313 are 0 to 1, 2, 3, ..., 99 and / or 100 cm. 330. A retractor device comprising a member for capturing a previously deployed implant, a steerable guide catheter, and a delivery catheter. 331. The feature of Clause 64, wherein the member is a coiled leaf spring that uncoils when pushed to capture and contain the implant. The member is encapsulated by the guide catheter and uses a single arm to bail out the implant. 332. The feature of claim 64, wherein the member has two coiled leaf springs that uncoil when pushed to capture the implant and are contained by the guide catheter, using two arms to bail out the implant. 333. The feature of claim 64, wherein the member is a fan-shaped structure that captures an implant, is contained by the guide catheter, and bails out an implant. 334. The embodiment of clause 64, further comprising a spring coil made from laser-cut nitinol tubing that encapsulates the delivery catheter and allows for easy steering around sharp curves. The spring coil also positions the catheter in a straight manner at all times. 335. A rescue catheter comprising a shaft and a distal end with a slit for retrieval of the delivery catheter and implant. 336. The method of claim 69, wherein the rescue catheter, in addition to the delivery catheter, captures and completely contains the implant, allowing for bailout of the implant through the guide catheter. 337. The method of claim 69, wherein the rescue catheter is inserted over the guide catheter. 338. An implant capture rescue catheter, 339. An implant delivery catheter; 340. Guide catheter and 341. An implant capture rescue catheter comprising: a rescue catheter having a cylindrical cross-section with a slit and / or a "c" shaped cross-section and a long shaft extending the length and proximally of the delivery catheter and / or guide catheter. 342. The rescue catheter of claim 72, wherein the rescue catheter is configured to be inserted within the guide catheter and over the delivery catheter. 343. The rescue catheter of claim 72, wherein the cylindrical cross-section is expandable and configured to expand when extended beyond the distal tip of the guide catheter and to facilitate retracting the implant delivery catheter within the guide catheter when retracted. 344. The rescue catheter of claim 72, wherein the cylindrical cross-section is configured to slide atraumatically over the guide catheter. 345. A device as illustrated in exemplary FIG. 42, wherein the thickness of the outer arm is preferably about 0.33 mm. 346. A device as described in exemplary FIG. 42, wherein the thickness of the outer arm is 0.12, 0.16, 0.20, ...., 3.12, and / or 3.15 mm. 347. A device as described in exemplary FIG. 42 and / or FIGS. 46-50, wherein the thickness of the gripper is preferably about 0.20 mm. 348. A device as described in exemplary FIG. 42 and / or FIGS. 46-50, wherein the gripper thickness is 0.12-0.16, 0.20, ...., 3.12, and / or 3.15 mm. 349. A device as described in exemplary FIG. 42 and / or FIGS. 46-50, wherein the cross section at the bending region of the outer arm exceeds the gripper bending cross section by 0, 1, 2, 3, ..., 999, and / or 1,000%. 350.F Coapt 42 and / or 50, where ρ is 0 to 0.1, 0.2, 0.3, ..., 19.9, and / or 20 lbf. 351. A device as described in exemplary FIG. 42 and / or FIG. 50, wherein the distance between the cusps at the tip of the device is about 0, 0.1, 0.2, 0.3, ..., 4.9, and / or 5.0 mm, or between 0 and 0.1, 0.2, 0.3, ..., 4.9, and / or 5.0 mm, preferably less than 1 mm. 352. The arm and / or gripper may be configured to have a self-energizing strain of approximately 0, 0.1, 0.2, 0.3, ..., 19.9, and / or 20%, preferably 1% to 6%, in a device as described in exemplary FIG. 42 and / or FIG. 50. 353. A device as described in exemplary FIG. 42 and / or FIG. 50, wherein the outer arm is bent at the tip in a configuration that maximizes leaflet coaptation, as in FIG. 49. [Brief explanation of the drawings]

[0067] [Figure 1A] FIG. 1A shows an exemplary embodiment of an outer arm component of a tissue fixation device with a compressible spring-based single ring and / or loop with a slit made of compressible wire, with the proximal portion of the ring secured onto the outer arm.

[0068] [Figure 1B] FIG. 1B shows the same outer arm with a continuous ring and / or loop, the proximal portion of the ring being secured onto the outer arm at one or two and / or more ends.

[0069] [Figure 1C] 1C shows the same arm with a continuous ring and / or loop with a fixed proximal portion and a free-standing distal portion. The ring may be circular, oval, rectangular, Z-shaped, S-shaped, V-shaped, U-shaped, W-shaped, zigzag-shaped, and / or any compressible shape.

[0070] [Figure 2]FIG. 2 shows an exemplary embodiment of an outer arm consisting of expandable tines.

[0071] [Figure 3] FIG. 3 shows an exemplary embodiment of an outer arm made of expandable stent material that shortens in length as it expands radially and / or laterally.

[0072] [Figure 4A] FIG. 4A shows an exemplary embodiment of an outer arm consisting of an elongated slot of compound geometry.

[0073] [Figure 4B] FIG. 4B shows the outer arms as they expand laterally into a diamond-shaped configuration.

[0074] [Figure 5A] FIG. 5A shows an exemplary embodiment of a split outer arm.

[0075] [Figure 5B] FIG. 5B shows the outer arms of FIG. 5A expanded laterally into a V-shaped configuration.

[0076] [Figure 6A] FIG. 6A shows an exemplary embodiment of an outer arm comprising an expandable stent pattern.

[0077] [Figure 6B] FIG. 6B illustrates an exemplary expandable wire profile that can be attached to the outer arm.

[0078] [Figure 7A] FIG. 7A illustrates a side view of an exemplary embodiment of a tissue fixation device in which the outer arm components of the tissue fixation device expand into a folding (Japanese style) fan-like design.

[0079] [Figure 7B] FIG. 7B shows an alternative view of the FIG. 7A device.

[0080] [Figure 8A] FIG. 8A shows a top-down view of the proximal portion of the release bar, which includes multiple small openings 60 for the actuation sutures / wires and multiple smaller openings 62 for the guidewire / release mandrel.

[0081] [Figure 8B] FIG. 8B shows a release bar with multiple openings for anchoring suture loops.

[0082] [Figure 8C] FIG. 8C shows an opening 78 on the release bar that can be used to form a suture loop.

[0083] [Figure 8D] FIG. 8D shows an exemplary bailout suture 93 looped through the opening shown in FIG. 8C.

[0084] [Figure 9A] FIG. 9A shows a schematic diagram of the bail-out suture as part of a delivery catheter, with the bail-out suture undeployed.

[0085] [Figure 9B] FIG. 9B illustrates the schematic of FIG. 9A with the bail-out suture deployed.

[0086] [Figure 10] 10A and 10B show an alternative configuration of the bail-out suture that uses additional constraining suture loops 120, 122.

[0087] [Figure 11] 11A and 11B illustrate an exemplary embodiment with an automatic bailout feature as part of the implant.

[0088] [Figure 12-1]12A-12D illustrate an exemplary embodiment with a manually actuable bail-out suture that is part of the implant and interacts with both the outer and inner arms.

[0089] [Figure 12-2] 12E-12G illustrate an exemplary embodiment with a manually actuable bail-out suture that is part of the implant and interacts with the outer arm.

[0090] [Figure 13A] 13A-13C illustrate an exemplary method using Nitinol (or shape memory or superelastic material) based motors and actuators. [Figure 13B] 13A-13C illustrate an exemplary method using Nitinol (or shape memory or superelastic material) based motors and actuators. [Figure 13C] 13A-13C illustrate an exemplary method using Nitinol (or shape memory or superelastic material) based motors and actuators.

[0091] [Figure 14] 14A and 14B illustrate an exemplary embodiment of a tissue fixation device in which the outer arms are electrically actuated via nitinol wire, strips, sheet metal, and / or sutures.

[0092] [Figure 15] 15A and 15B illustrate an alternative embodiment of a device constructed in accordance with the principles of the present invention.

[0093] [Figure 16] 16A-16C show exemplary schematic diagrams of electrically actuated steerable catheters that use various configurations of actuator wires within the catheter shaft for steering.

[0094] [Figure 17A]17A illustrates a mitral valve secured within a dual orifice using an exemplary embodiment of the device with an expanding balloon that can be either variably expanded during the procedure or remotely adjusted after the procedure.

[0095] [Figure 17B] 17B shows an exemplary embodiment of the device with a dynamically (volume adjusted based on patient activity or other vital signs such as heart rate or blood pressure) expanding balloon anchored over a mitral valve with an anatomical defect. One or more balloons may be used. The balloons may be remotely anchored / stretched. Variable balloon attachment locations for implants with various numbers of balloons may be configured based on the disease or target mitral valve (or for the tricuspid valve).

[0096] [Figure 18] 18-21 show the wide gap between the opposing leaflets in the MitraClip® device. [Figure 19] 18-21 show the wide gap between the opposing leaflets in the MitraClip® device. [Figure 20] 18-21 show the wide gap between the opposing leaflets in the MitraClip® device. [Figure 21] 18-21 show the wide gap between the opposing leaflets in the MitraClip® device.

[0097] [Figure 22] FIG. 22 shows an x-ray image of an exemplary linear device 255 after implantation.

[0098] [Figure 23] FIG. 23 shows that a straight device 255 has a smooth and continuous tissue bridge 257 after implantation.

[0099] [Figure 24]FIG. 24 shows a curved device 260 and its narrow gap 263.

[0100] [Figure 25] 25 and 26 show an exemplary device with wide spacer-filled gaps between apposing leaflets. [Figure 26] 25 and 26 show an exemplary device with wide spacer-filled gaps between apposing leaflets.

[0101] [Figure 27] 27-30 show various embodiments of support portions and spacers for filling the gap between apposing leaflets. [Figure 28] 27-30 show various embodiments of support portions and spacers for filling the gap between apposing leaflets. [Figure 29] 27-30 show various embodiments of support portions and spacers for filling the gap between apposing leaflets. [Figure 30] 27-30 show various embodiments of support portions and spacers for filling the gap between apposing leaflets.

[0102] [Figure 31] 31-37 show various embodiments of support portions and spacers for filling the gap between apposing leaflets in exemplary devices. [Figure 32] 31-37 show various embodiments of support portions and spacers for filling the gap between apposing leaflets in exemplary devices. [Figure 33] 31-37 show various embodiments of support portions and spacers for filling the gap between apposing leaflets in exemplary devices. [Figure 34] 31-37 show various embodiments of support portions and spacers for filling the gap between apposing leaflets in exemplary devices. [Figure 35]31-37 show various embodiments of support portions and spacers for filling the gap between apposing leaflets in exemplary devices. [Figure 36] 31-37 show various embodiments of support portions and spacers for filling the gap between apposing leaflets in exemplary devices. [Figure 37] 31-37 show various embodiments of support portions and spacers for filling the gap between apposing leaflets in exemplary devices.

[0103] [Figure 38] 38-41 show an exemplary device previously described in commonly owned patent application US20200383782A1. These figures highlight the self-biasing and joining / fastening forces of the leaf springs when assembled. [Figure 39] 38-41 show an exemplary device previously described in commonly owned patent application US20200383782A1. These figures highlight the self-biasing and joining / fastening forces of the leaf springs when assembled. [Figure 40] 38-41 show an exemplary device previously described in commonly owned patent application US20200383782A1. These figures highlight the self-biasing and joining / fastening forces of the leaf springs when assembled. [Figure 41] 38-41 show an exemplary device previously described in commonly owned patent application US20200383782A1. These figures highlight the self-biasing and joining / fastening forces of the leaf springs when assembled.

[0104] [Figure 42] 42A-44C show various exemplary embodiments depicting the size variation of the inner versus outer arms at the tip of the device. [Figure 43] 42A-44C show various exemplary embodiments depicting the size variation of the inner versus outer arms at the tip of the device. [Figure 44] 42A-44C show various exemplary embodiments depicting the size variation of the inner versus outer arms at the tip of the device.

[0105] [Figure 45] FIG. 45 shows a schematic diagram of a normal mitral valve in systole.

[0106] [Figure 46] FIG. 46 shows an exemplary schematic diagram of the mitral valve in systole with an interval representing MR.

[0107] [Figure 47] FIG. 47 shows a longer annular distance with an exemplary V-shaped device.

[0108] [Figure 48] FIG. 48 shows the length of the annular distance that causes insufficient fastening, resulting in a residual gap and thereby a suboptimal reduction in MR.

[0109] [Figure 49] FIG. 49 shows an exemplary device that coapts and clamps the annulus better than the V-shaped device of FIG.

[0110] [Figure 50] FIG. 50 shows that a good fastening results in an optimal reduction in MR.

[0111] [Figure 51] FIG. 51 shows an exemplary schematic diagram of a mitral valve in systole with a very wide gap, indicative of severe MR.

[0112] [Figure 52] FIG. 52 shows the reduction of MR using an exemplary tissue sealing device.

[0113] [Figure 53]FIG. 53 shows the reduction of MR using an exemplary tissue sealing device with side expansion spacers.

[0114] [Figure 54] 54-65 show an alternative embodiment for improving leaflet coaptation and fastening. [Figure 55] 54-65 show an alternative embodiment for improving leaflet coaptation and fastening. [Figure 56] 54-65 show an alternative embodiment for improving leaflet coaptation and fastening. [Figure 57] 54-65 show an alternative embodiment for improving leaflet coaptation and fastening. [Figure 58] 54-65 show an alternative embodiment for improving leaflet coaptation and fastening. [Figure 59] 54-65 show an alternative embodiment for improving leaflet coaptation and fastening. [Figure 60] 54-65 show an alternative embodiment for improving leaflet coaptation and fastening. [Figure 61] 54-65 show an alternative embodiment for improving leaflet coaptation and fastening. [Figure 62] 54-65 show an alternative embodiment for improving leaflet coaptation and fastening. [Figure 63] 54-65 show an alternative embodiment for improving leaflet coaptation and fastening. [Figure 64] 54-65 show an alternative embodiment for improving leaflet coaptation and fastening. [Figure 65] 54-65 show an alternative embodiment for improving leaflet coaptation and fastening.

[0115] [Figure 66] 66A and 66B show an exemplary embodiment of a tissue grasping device with outer arms made of differently sized leaf springs with multiple layers for additional mechanical strength.

[0116] [Figure 67] 67A and 67B illustrate an exemplary embodiment of an outer arm with an inner arm as part of the outer arm.

[0117] [Figure 68] 68A and 68B illustrate schematic views of an exemplary embodiment of a tissue fixation device in which the inner and outer arms are constructed as a single piece.

[0118] [Figure 69] 69A and 69B illustrate an exemplary embodiment of a tissue fixation device with spring-loaded outer arms that are actuated using a wire or suture.

[0119] [Figure 70] 70A-70C illustrate an exemplary embodiment of a tissue fixation device based on a general umbrella design, with discrete inner arms attached to outer arms.

[0120] [Figure 71A] FIG. 71A shows a schematic top view of an exemplary embodiment of a tissue fixation device constructed from coaxial metal tubes.

[0121] [Figure 71B] FIG. 71B shows a side view of the same device.

[0122] [Figure 71C] FIG. 71C shows an alternative configuration of the device as shown in FIG. 71B with the outer arms biased outward.

[0123] [Figure 72] 72-76 show an exemplary embodiment of an alternative self-closing, self-actuating valve repair system. [Figure 73] 72-76 show an exemplary embodiment of an alternative self-closing, self-actuating valve repair system. [Figure 74]72-76 show an exemplary embodiment of an alternative self-closing, self-actuating valve repair system. [Figure 75] 72-76 show an exemplary embodiment of an alternative self-closing, self-actuating valve repair system. [Figure 76] 72-76 show an exemplary embodiment of an alternative self-closing, self-actuating valve repair system.

[0124] [Figure 77] FIG. 77 shows an exemplary isometric view of the gripper of the MitraClip® device.

[0125] [Figure 78] FIG. 78 shows the arm angles at the base and tip of an exemplary embodiment.

[0126] [Figure 79] FIG. 79 shows the distance between the arms at the tip and the widest distance between the arms of an exemplary embodiment.

[0127] [Figure 80] FIG. 80 shows the present MitraClip® barb design with a sharp point 523.

[0128] [Figure 81] 81-83 show various embodiments of exemplary blunt or rounded barb points. [Figure 82] 81-83 show various embodiments of exemplary blunt or rounded barb points. [Figure 83] 81-83 show various embodiments of exemplary blunt or rounded barb points.

[0129] [Figure 84] FIG. 84 illustrates an exemplary device with an expandable stent, mesh, and / or balloon acting as a spacer positioned between the leaflets.

[0130] [Figure 85] FIG. 85 illustrates an alternative configuration with three separate inflatable or self-expandable stents, meshes, and / or balloons acting as spacers positioned between the leaflets, designed to completely fill the inter-leaflet gaps (referenced in FIG. 87 of PCT / 0S2019 / 013853).

[0131] [Figure 86] FIG. 86 is an exemplary delivery catheter interface as described in commonly owned U.S. Application No. US20200383782A1 with one inverting tool attached with a release bar.

[0132] [Figure 87] FIG. 87 illustrates an exemplary embodiment of the implant mounted on the delivery system shown in FIG.

[0133] [Figure 88] FIG. 88 is an exemplary embodiment of an implant with a single pair of grippers and outer arms.

[0134] [Figure 89] FIG. 89 shows the outer arm of the implant biased towards a gripping angle.

[0135] [Figure 90] 90-97 show exemplary embodiments of a single pair of grippers and arms with expandable spacers of various configurations. [Figure 91] 90-97 show exemplary embodiments of a single pair of grippers and arms with expandable spacers of various configurations. [Figure 92] 90-97 show exemplary embodiments of a single pair of grippers and arms with expandable spacers of various configurations. [Figure 93]90-97 show exemplary embodiments of a single pair of grippers and arms with expandable spacers of various configurations. [Figure 94] 90-97 show exemplary embodiments of a single pair of grippers and arms with expandable spacers of various configurations. [Figure 95] 90-97 show exemplary embodiments of a single pair of grippers and arms with expandable spacers of various configurations. [Figure 96] 90-97 show exemplary embodiments of a single pair of grippers and arms with expandable spacers of various configurations. [Figure 97] 90-97 show exemplary embodiments of a single pair of grippers and arms with expandable spacers of various configurations.

[0136] [Figure 97] FIG. 97 illustrates an anatomical cross section of the heart showing the right atrium (RA) and right ventricle (RV).

[0137] [Figure 98] Figure 98 illustrates the heart of Figure 97 with a catheter inserted through the inferior vena cava (IVC) via femoral vein access. Note the sharp U-turn the catheter must make to reach the tricuspid valve.

[0138] [Figure 99] FIG. 99 illustrates the heart of FIG. 97 with a catheter inserted through the superior vena cava (SVC) via jugular vein access.

[0139] [Figure 100] 100 and 101 show an exemplary embodiment of a release bar with a central post. [Figure 101] 100 and 101 show an exemplary embodiment of a release bar with a central post.

[0140] [Figure 102]102-108 show exemplary embodiments of mitral valve replacement devices with actuatable grippers and / or arms for superior anchoring. [Figure 103] 102-108 show exemplary embodiments of mitral valve replacement devices with actuatable grippers and / or arms for superior anchoring. [Figure 104] 102-108 show exemplary embodiments of mitral valve replacement devices with actuatable grippers and / or arms for superior anchoring. [Figure 105] 102-108 show exemplary embodiments of mitral valve replacement devices with actuatable grippers and / or arms for superior anchoring. [Figure 106] 102-108 show exemplary embodiments of mitral valve replacement devices with actuatable grippers and / or arms for superior anchoring. [Figure 107] 102-108 show exemplary embodiments of mitral valve replacement devices with actuatable grippers and / or arms for superior anchoring. [Figure 108] 102-108 show exemplary embodiments of mitral valve replacement devices with actuatable grippers and / or arms for superior anchoring.

[0141] [Figure 109A] FIG. 109A shows an exemplary steerable guide catheter mounted on a stabilizer.

[0142] [Figure 109B] FIG. 109B shows a device delivery catheter co-mounted in addition to the steerable guide and stabilizer shown in FIG. 28A.

[0143] [Figure 109C] FIG. 109C shows an exemplary distal section of a steerable guide shaft and device delivery catheter.

[0144] [Figure 109D] FIG. 109D shows an exemplary device delivery catheter with a fluid delivery port (and / or manual bailout actuation rod).

[0145] [Figure 110] FIG. 110 shows an exemplary steerable guide catheter design incorporating stiffeners.

[0146] [Figure 111] 111-119D show an exemplary delivery system for a tissue grasping device. [Figure 112] 111-119D show an exemplary delivery system for a tissue grasping device. [Figure 113] 111-119D show an exemplary delivery system for a tissue grasping device. [Figure 114] 111-119D show an exemplary delivery system for a tissue grasping device. [Figure 115] 111-119D show an exemplary delivery system for a tissue grasping device. [Figure 116] 111-119D show an exemplary delivery system for a tissue grasping device. [Figure 117] 111-119D show an exemplary delivery system for a tissue grasping device. [Figure 118] 111-119D show an exemplary delivery system for a tissue grasping device. [Figure 119] 111-119D show an exemplary delivery system for a tissue grasping device.

[0147] [Figure 120] 120-125 show various exemplary embodiment configurations of a delivery system as well as an implant and a funnel-shaped mesh for retracting the implant into a delivery catheter. [Figure 121] 120-125 show various exemplary embodiment configurations of a delivery system as well as an implant and a funnel-shaped mesh for retracting the implant into a delivery catheter. [Figure 122] 120-125 show various exemplary embodiment configurations of a delivery system as well as an implant and a funnel-shaped mesh for retracting the implant into a delivery catheter. [Figure 123] 120-125 show various exemplary embodiment configurations of a delivery system as well as an implant and a funnel-shaped mesh for retracting the implant into a delivery catheter. [Figure 124] 120-125 show various exemplary embodiment configurations of a delivery system as well as an implant and a funnel-shaped mesh for retracting the implant into a delivery catheter. [Figure 125] 120-125 show various exemplary embodiment configurations of a delivery system as well as an implant and a funnel-shaped mesh for retracting the implant into a delivery catheter.

[0148] [Figure 126] 126A-126D show an exemplary embodiment with a retractable steel or plastic coil feature across the delivery catheter that aids in retracting the device into the delivery catheter.

[0149] [Figure 127] 127A and 127B show an exemplary embodiment with a retractable fan or cone shaped feature that aids in retracting the device into the delivery catheter. [Figure 128] The delivery catheter includes an external spring 625 in the distal section that is configured to reduce friction and maintain straightness as the delivery catheter is advanced out of the guide catheter, as shown in FIG.

[0150] [Figure 129]Figures 129A and 129B show an exemplary embodiment of a rescue catheter with a slit to aid in retraction of the device into the guide catheter, and Figures 129C and 129D show a rescue catheter having a slit 670 on the proximal portion of its shaft 650.

[0151] [Figure 130A] FIG. 130A shows a cross-sectional view of a balloon spacer placed between the two inner arms of the device between the leaflets.

[0152] [Figure 130B] 130B shows an alternative cross-sectional view of a balloon placed between the two inner arms. The adjustable spacer balloon can be stretched and / or deflated after gripping the leaflet.

[0153] Below is a list of reference numbers used in this application: [Table 1-1] [Table 1-2] [Table 1-3] [Table 1-4] [Table 1-5] [Table 1-6] [Table 1-7] [Table 1-8] DETAILED DESCRIPTION OF THE INVENTION

[0154] Detailed Description of the Invention 1A-1C show an exemplary embodiment of outer arm 1, comprising a nitinol wire fashioned into ring 5 located behind the outer arm. Ring 5 is attached to outer arm 1 via screw 3; however, ring 5 may also be attached to outer arm 1 by sutures or welded. The ring can be compressed while in the delivery catheter. When outside the delivery catheter, the expanded ring provides additional surface area for gripping and / or mechanical strength. The ring can be a single round wire, such as rings 7 and 9, with a section secured on the proximal end of the outer arm and a separate section secured on the distal end of the outer arm. Rings 7 and 9 can also be made from multiple coils, patterns, and shapes.

[0155] 2 illustrates an alternative configuration of outer arm 11 with tines 13, 15, 19. The tines 13, 15, 19 can be actuated and / or configured to elastically self-expand (using a superelastic material such as Nitinol) in multiple combinations, such as in pairs or singly, or in different directions and orientations to provide additional support and strength.

[0156] 3 shows alternative configurations of the outer arms 21, along with stent patterns and properties. Like a nitinol stent, the outer arms 21 can be configured to self-expand, thus shortening in length (arrow 25), as they exit the guide catheter, as indicated by arrows 23, 27. The stent-like outer arms can have an open and / or closed-cell design, and the same can be applied to the inner arms.

[0157] Similarly, Figure 4A illustrates the outer arm 30 with an elongated slot that expands laterally. Figure 4B shows an exemplary direction in which the outer arm self-expands (arrows 32, 34). The lateral expansion (of the outer arm 30) increases the surface area that grips the leaflets, providing additional mechanical support.

[0158] Figure 5A shows a split outer arm 36 that can be configured to self-expand laterally to increase the amount of tissue that is grasped, and Figure 5B shows the direction in which the outer arms self-expand (arrows 38, 40).

[0159] FIG. 6A shows an exemplary embodiment of an outer arm 46 comprising a stent pattern, e.g., a honeycomb pattern 44. The stent pattern may be planar, 3D, linear, grid-like, triangular, S-shaped, Z-shaped, V-shaped, W-shaped, partial honeycomb, and / or full honeycomb. The addition of the stent pattern 44 allows additional area for gripping the cusps. Furthermore, these patterns allow for laterally and / or radially expanding arms, which may be fabricated from strip metal, sheet metal, tubing, and / or wire materials. A stent pattern may also be applied to the inner arm. FIG. 6B shows additional features / coatings added to the outer arm 42 to improve its mechanical, chemical, biological, and / or electrical properties, such as wires, drug-eluting polymers, sensors, and / or actuators, stent-pattern-like features 44. For example, spring wires 48 may be attached to the outer arm 46 to increase mechanical properties and surface area. Thus, the outer arms 42, 46 may be constructed from various combinations of stent patterns, components, and multiple outer and / or inner arm layers.

[0160] For example, Figure 7A shows an alternative embodiment of the device, including outer bases 52, 50 and inner arms 54 in a folding fan-like (hinged Japanese fan) configuration, in which outer arms 42, 46 can also be used. An alternative exemplary stacked leaf spring configuration can resemble a track leaf spring. Figure 7B shows a front view of the device of Figure 7A.

[0161] FIG. 8A shows a top view of the proximal portion 64 of the release bar 86, which includes multiple openings 60 for insertion of actuating sutures / wires and multiple openings 62 for insertion of guidewires / release mandrels. Accordingly, the bailout suture 118 (not shown) and / or secondary suture 93 (not shown) utilize the two middle openings of feature 60 to facilitate access and reduce tension and strain applied to the sutures actuating the inner and outer arms. FIG. 8B shows multiple openings 66-84 on the release bar 86, and a suture loop can be anchored in any of the openings. FIG. 8C illustrates a schematic diagram of the release bar 86, depicting openings 80, 68 through which the secondary suture 93 (not shown) is looped. Referring to FIG. 8D, a schematic diagram shows the secondary suture 93 looped through the openings shown in FIG. 8C and placement of an exemplary device 5. Therefore, the secondary sutures 93 do not interfere with the implanted device during leaflet capture. The secondary sutures 93 can be inserted through any of the openings on the release bar. Figure 8D demonstrates the secondary sutures 93 through the third opening 78.

[0162] 9A shows a schematic diagram of an exemplary bailout feature as part of a delivery system. A bailout suture 118 (not shown) is threaded through suture loops 108, 114 of reversing tools 110, 112, respectively. A secondary suture 93 is threaded through release bar 86 and looped around bailout suture 118. As secondary suture 93 is retracted, as demonstrated by arrow 91, bailout suture segments (106, 97, 104, 95) of suture 118 are pulled / cinched toward release bar 86, thus moving suture segments 97, 95 of bailout suture 118 away from the implantation device and preventing interference from the bailout suture during leaflet capture. Very little tension may be applied on suture 118 to prevent accidental capture of tissue and / or cord. 9B, however, when bailout suture 118 is retracted as demonstrated by arrow 126 while simultaneously allowing secondary bailout suture 93 to relax, suture segments 97, 106, 116, 104, 95 of bailout suture 118 are pulled taut, obliterating any tissue and / or cord captured between the arms / grippers of the implantation device or between the implantation device and the retroversion tools 110, 112 during leaflet capture. Obviously, this action should be paired with raising the inner arm (gripper) and lowering (opening) or retroversion of the outer arm.

[0163] In the different configuration shown in Figure 10A, the suture segments 116, 124 may be attached to the release bar 86 via suture loops 120, 122 to provide additional clearance distance between the implanted device and the bail-out suture. Figure 10B therefore illustrates that retraction of the bail-out suture 118 causes the suture loops 120, 122 to maintain the suture segments 116, 124 of the bail-out suture 118 in a lower position, further preventing interference with the implanted device.

[0164] The bail-out suture 118 and secondary suture 93 may be coupled with a spring system such that actuating the bail-out suture 118 via a pull rod will stretch the spring and slacken the secondary suture 93 without the need for a secondary pull rod.

[0165] FIG. 11A illustrates a schematic of the automatic bailout feature as part of the implant device. Bailout suture 132 is looped through inner arm 128 and outer arm 136, while bailout suture 134 is looped through inner arm 130 and outer arm 138 of the implant device. When inner arms 128, 130 and outer arms 136, 138 are in the grasping position, bailout sutures 132, 134 are relaxed, so the leaflet can be captured without interference from the bailout suture. Referring to FIG. 11B, when outer arm 138 is lowered to inverted position 140, as indicated by arrow 144, bailout suture 134 is automatically pulled taut to position 142. Thus, any tissue and / or cord captured between inner arm 130 and outer arm 138 will be obliterated. Additionally, if inversion and / or repositioning is required, the leaflet can be easily released due to the bail-out suture. Figures 12A-12D show alternative exemplary steps for performing capture and / or bail-out.

[0166] FIG. 12E illustrates an exemplary embodiment of an automatic bailout suture as part of the implant. The bailout suture segments 148, 154, 156 are continuous sutures threaded and / or passed through the fabric of the inner and outer arms and configured to remain relaxed unless the actuating suture 146 is retracted. The actuating suture 146 is designed to be part of the delivery system, which is configured to loop around the apex of the bailout suture segment 148. When the outer arm of the implant device is everted and the actuating suture 146 is retracted, the bailout suture segments 148, 154, 156 are pulled taut into a triangular formation such that trapped cords and / or tissue are expelled from between the inner and outer arms (FIG. 12F). FIG. 12G shows an exemplary configuration in which the bailout suture 146 is significantly retracted, drawing the outer arms together. NOTE: The inner arm / gripper is not shown in all of Figures 12E-12G for simplicity.

[0167] 13A-13C show a general method of using a nitinol actuator or motor.

[0168] 14A shows an exemplary embodiment of a tissue fixation device in which the nitinol outer arms 173, 175 are actuated using nitinol motor / actuator strips and / or wire 181. When electrical current or heat is applied to the wire 181, it shortens, drawing the self-closing nitinol outer arms 173, 175 to a grasping position, as shown in FIG. 14B. Similarly, when the wire 181 is allowed to cool, it lengthens, causing the outer arms 173, 175 to reposition back to their original closed shape.

[0169] In another configuration of an electrically actuated device, FIG. 15A demonstrates a device with a pair of nitinol leaf springs 187, 189 positioned at a base 183 and tethered to nitinol outer arms 173, 175 via wires and / or sutures 181. The leaf springs 187, 189 can be made of any superelastic or shape-memory material, such as nitinol. Applying current or heat through the leaf springs 187, 189 will bend them, thus retracting the outer arms into the gripping position, as shown in FIG. 15B. The extent of the stroke will depend on the heat applied to precisely position the leaf springs in various configurations (i.e., gripping position and bailout).

[0170] FIG. 16A shows a schematic diagram of an electrically operated actuator wire 195 embedded within a flexible, incompressible material 197 within a bend adjustment structure. The actuator wire 195 can have a stroke of 0-110%. The actuator wire functions by contracting upon heating and relaxing upon cooling. FIG. 16B illustrates a front view of multiple actuator wires 213, 211, 223, 205, 217, 203, 201, 215 embedded within an electrically driven catheter 209. Depending on the function of the catheter 209, the actuator wires 195 can vary in size, geometry, and plurality. Additionally, the actuator wires 195 can be embedded and / or positioned anywhere within the inner and / or outer diameter of the catheter and / or catheter lumen. Electrically heating a specific actuator wire will move the wire to a specific position. For example, electrically stimulating actuator wires 223 and 205 or actuator wires 201 and 215 will move catheter 209 laterally (arrows 207 and 219, respectively). Similarly, electrically heating actuator wires 213 and 211 or actuator wires 217 and 203 will move the catheter in a vertical or downward direction (arrows 225 and 221, respectively). Thus, heating certain combinations of actuator wires will move the catheter in the respective planes of the wires. Thus, a simple circuit is used to contract the catheter and maintain the desired position. The actuator wires are used in conjunction with non-conductive, temperature-resistant materials such as silicone rubber, PTFE, FPA, polyimide, and / or PEEK to overcome the high temperatures and forces of the wires during actuation.

[0171] FIG. 16C shows a longitudinal view of catheter 209 with actuator wires 195 in a parallel configuration. As discussed in FIG. 16B, actuation of specific wires will cause movement within the catheter along the wire's individual plane. FIG. 16C shows actuator wires 195 and 227 in a cross configuration, allowing catheter 209 to twist and bend with activated actuation wires. For example, the actuator wires will contract at an austenite finish (Af) temperature of about 45°C to about 50°C and lengthen at 37°C to 40°C. Catheter 209 can consist solely of parallel actuator wires, cross wires, or a combination of both configurations in any permutation and design. Additionally, the wires can be any size, geometry, and multiple. Using a microprocessor controller, nitinol motor-based catheters can be operated similarly to the fluid catheters described in U.S. Pat. No. 10,500,373 (and related patents, including all patent applications from the assignee of that patent), which are incorporated by reference in their entireties.

[0172] The actuator wire can be utilized to move the delivery system or implant's reversing tool. Using a leaf spring biasing mechanism can actuate the inner and outer arms with a stroke of about 7% or more, depending on the biasing force. For the reversing tool, a simple lever or clasp mechanism can provide a stroke of about 120% or about 90%, respectively. The stroke of these mechanisms can be improved using designs with a counter-biasing force.

[0173] FIG. 17A illustrates a mitral valve with a clip secured over the leaflets to form a double orifice. The clip has one or more, e.g., two, balloon features 235, 237 that are removable and expandable. The balloons 235, 237 are expanded via tubes connected and controlled by a delivery catheter. Once the balloons 235, 237 are expanded to their recommended volume, the expansion tubes are detached from the delivery catheter and will gradually detach themselves from the balloons 235, 237. The delivery catheter can also manually expand or deflate the balloons individually and / or simultaneously. In the case of FIG. 16A, the balloons 235, 237 are static, i.e., they maintain their volume after the expansion tubes are removed. However, FIG. 17B illustrates a similar clip with dynamic balloons 239, 241, which can be controlled via mechanical and / or electrical stimulation (e.g., heartbeat) or remote control (e.g., smartphone). Ideally, this system would be used for high-risk patients with mitral valve deformities, in which the mitral valve does not close completely. For these patients, current practice involves the use of multiple clips, which may not be recommended. Thus, the balloons 239, 241 would use actuators and / or sensors 243, 245 to expand during systole and contract during diastole, i.e., synchronized with the heartbeat. Alternatively, the extent of expansion and contraction could be variable and adjusted to the patient's real-time needs, e.g., during sleep, walking, rest, or exertion. Data would be recorded on the clip via microelectronics, actuators, and / or sensors 243, 245, and relayed to an external source (i.e., smart electronics). Unlike the clip of FIG. 17A, this clip could have an embedded expansion mechanism located anywhere on the clip's exterior. The expansion and / or contraction of these balloons could be triggered by mitral valve movement, a microprocessor, a microcontroller, or the like.Balloons 235, 237 and balloons 239, 241 can be positioned at the proximal portion of the clip's base or anywhere along the clip. All embodiments of the present clip and its features are claimed and extended from referenced Applications Nos. PCT / US2018 / 041016 and PCT / US2017 / 042003. Additionally, balloon features may include features recited in patents such as US7854745B2, US9173758B2, and / or US9351862B2.

[0174] Figure 18 illustrates a histopathological cross-section of a MitraClip® device 251, showing a wide inherent gap 249 between the arms and exposed bare metal components 247. Figures 19 and 20 show photographs of a fully closed MitraClip® device, showing the wide inherent gap 249 and exposed bare metal components 247. Blood can clot (253) within the pocket and across the metal components 247, as shown in Figure 21. On the other hand, implants 255 have very narrow (<1 mm) or nearly no gaps between the arms, tightly joining the cusps at the tips, as shown in Figures 22 and 23, allowing for the formation of a well-endothelialized, smooth tissue bridge 257.

[0175] FIG. 24 shows an exemplary curved implant 260 with pockets 263 between curved grippers 262.

[0176] Figures 25 and 26 show the slow Pascal implant, which is essentially a spacer concept rather than an incision technique. Unlike MitraClip®, the spacer fills the wide gap between the cusps, as seen in Figures 25 and 26, reducing the risk of thromboembolism. However, like MitraClip®, there is suboptimal cuspation and coaptation of the cusps by design. Therefore, the long-term benefits regarding aggressive reverse remodeling of the heart remain to be evaluated. This is because effective cusp occlusion is known to be a major contributing factor for long-term aggressive reverse remodeling of the heart.

[0177] 27, 28, and 29 illustrate various exemplary embodiments of the present patent for reducing the pocket-like area between the grippers using spacers 264, 268, 270, 272, 274, and 276. The grippers join together across the hub, forming gaps or cavities that are susceptible to clotting and thrombus formation. The spacers 264, 268, 270, 272, 274, and 276 can be expandable and / or compressible sponges, meshes, balloons, non-thrombogenic fabrics, etc., as would be apparent to one skilled in the art. These spacers can be attached to the atrial side of the grippers or the ventricular side of the arms to capture the bridging suture between the arms. Having a spacer between the arms reduces the risk of thrombus formation by reducing the recirculation area where blood elements can become trapped and experience high shear stress over long periods, potentially leading to thrombus formation and thromboembolism.

[0178] Figures 31-36 depict exemplary embodiments of the present patent for reducing the inherent gap between the tips of the arms 282. In Figures 31, 33, and 35, a large exemplary spacer 264 is secured to the atrial side of the central post or gripper using sutures, adhesives, welding, glue, and / or fasteners. Figures 32 and 36 show an inherent pocket filled with two small spacers 270, each secured to an individual gripper, reducing the gap 249. Figures 34 and 37 show an exemplary embodiment with an atrial apex support spacer 264 and a ventricular apex support spacer 272, 274. Figure 37 shows an exemplary embodiment with a spacer 264 that can replace the central spacer. In addition, an embodiment shows a ventricular spacer.

[0179] One of the problems with these competing devices is that the leaflets are not properly coapted. Furthermore, some of them are also configured with spacers or spaces between the leaflets that keep them apart. This contrasts with the principles of the Alfieri technique of surgery. Additionally, the coaptation of the leaflets contributes to positive remodeling of the heart. Figure 38 shows an exemplary embodiment of the device described in co-owned patent application US20200383782A1. Specifically, the coaptation force F exerted by the outer arm 307 is Coapt is the in vivo force F exerted by the cusps and annulus in-vivo and gripper force F Gripper.The bias must be significantly overcome. This is achieved by making the outer arm 307 much stronger than the gripper 309 in bending by enlarging either the thickness and / or cross-section of the outer arm 307 compared to the gripper 309. Additionally, high bias is achieved by over-curving both the outer arm 307 and the gripper 309, as shown in FIGS. 39, 40, and 41. In some embodiments, the thickness of the outer arm is preferably about 0.33 mm. In some embodiments, the thickness of the outer arm is 0.03 to 0.06, 0.12, 0.16, 0.20, ..., 3.12, and / or 10 mm. In some embodiments, the thickness of the gripper is preferably about 0.20 mm. In some embodiments, the thickness of the gripper is 0.003, 0.06, 0.12, 0.16, 0.20, ..., 3.12, ..., and / or 10 mm. In some embodiments, the cross section of the outer arm in the bending region exceeds the gripper bending cross section by 0, 1, 2, 3, ..., 999, and / or 1,000%. Coapt is preferably about 0.15 lb force. In some embodiments, F Coapt is between 0, 0.1, 0.2, 0.3, ..., 19.9, ..., and / or 60 lbf. In some embodiments, the distance between the cusps at the tip of the device is about 0, 0.1, 0.2, 0.3, ..., 4.9, ..., 9.9, and / or 10.0 mm, or 0, 0.1, 0.2, 0.3, ..., 4.9, ..., 9.9, and / or 10.0 mm, preferably less than 1 mm. In some embodiments, when assembled, the arms and / or grippers may be configured to have a self-energizing strain of about 0, 0.1, 0.2, 0.3, ..., 19.9, and / or 20%, preferably 1% to 6%. In some exemplary embodiments, the outer arms are bent at the tip in a configuration that maximizes cusp coaptation, as in FIG. 55.

[0180] 42A-44C show various exemplary embodiments of tissue grasping devices with different lengths of the inner arm 309 versus the outer arm 307 that can be used to achieve a desired coaptation configuration of the leaflets.

[0181] In FIG. 42A, the inner arm is slightly longer than the outer arm, which facilitates a smaller space between the two cusps.

[0182] Figure 42B depicts the space between the leaflets defined by the two inner arms, which is equal to or less than the thickness of the leaflets themselves.

[0183] FIG. 42C shows an enlarged area between the leaflets where the leaflets and inner arms are coplanar and there is no pocket.

[0184] In FIG. 43A, the inner and outer arms are the same height.

[0185] Figure 43B depicts the space between the cusps. The angle formed by the cusps is a result of the same height of the inner and outer arms. The space between the cusps is less than or equal to the thickness of the cusps themselves.

[0186] Figure 43C shows the enlarged area between the leaflets. Complete cerclage of the leaflets is achieved with very little pocketing. Tissue encapsulation can occur between the leaflets.

[0187] In Figure 44A, the inner arms are lower than the outer arms, which are touching each other in this configuration.

[0188] In FIG. 44B, both of the grasped cusps are in contact with each other because there is no inner arm at the tip separating them.

[0189] In Figure 44C, complete fusion of the leaflets has been achieved. There is zero gap between the leaflets. The leaflets are touching each other. Tissue growth and healing tissue formation can occur between the leaflets.

[0190] In some embodiments, the spacing between the cusps is preferably <1 mm, hi some embodiments, the gap width is 0.0, 0.01, 0.06, 0.12, 0.16, 0.20, ..., 3.12, ..., and / or 10 mm.

[0191] In some embodiments, the dips / potholes / grooves between the cusps are preferably <1 mm, hi some embodiments, the dip / pothole / groove depth is 0.0, 0.003, 0.06, 0.12, 0.16, 0.20, ..., 3.12, ..., and / or 10 mm.

[0192] Figure 45 shows a schematic diagram of a normal mitral valve during systole, while Figure 46 shows a mitral valve suffering from regurgitation. Figure 47 shows a representative schematic diagram of a MitraClip® closed and deployed in a typical V-shape, thereby having a longer diametric annular distance 346 due to suboptimal cerclage and coaptation of the leaflets. Figure 48 shows that suboptimal cerclage and coaptation results in suboptimal reduction of MR due to ineffective coaptation, as depicted by gap 348.

[0193] In contrast, Figure 49 shows an implant with a fully closed clip 350 with a shorter diametric annular distance 354. Figure 50 depicts superior fastening and coaptation of the leaflets, resulting in superior apposition of the leaflets throughout the mitral valve, thereby resulting in improved reduction of MR or improved efficacy over the MitraClip® device.

[0194] FIG. 51 shows a schematic diagram of mitral regurgitation with a wide gap 342 between the leaflets.

[0195] Figure 52 shows an exemplary scenario in which, despite fully fastened and coapted leaflets, some gap 348 exists. Figure 53 shows a mitigating exemplary configuration of the present invention in which an additional laterally or laterally protruding spacer 352 is deployed to fill the gap 348, thereby reducing the MR. In this case, the size of the spacer is not limited to the width of the implant. The spacer 352 can be expandable, compressible, flexible, and remotely adjustable after deployment to reduce the MR, using engineering design solutions available to those skilled in the art (POSA).

[0196] FIG. 54 illustrates an exemplary implant 280 angled and configured to achieve a narrower gap between the arm tips 360 when fully closed. FIGS. 55 and 56 show two exemplary embodiments of the present invention for reducing the gap by having a secondary bend in the arm within a continuous rigid system or by using a spring / elastic hinge 372. Using a hinge with spring or elastic arms 362 would generate a coaptation spring force that, when closed, acutely or gradually coapts the leaflets over time due to potential leaflet remodeling after deployment. FIGS. 57A-C depict schematic diagrams of elastic or superelastic flexible arms 362 made from sheet metal. The entire arm can be configured to be flexible, or the distal and proximal ends of the arm can be semi-rigid or have U-shaped channels, with only the center being flexible.

[0197] In FIG. 58, when the removable portion of the delivery system 364 is removed, a natural gap is created. In this configuration, the U-spring 370 applies a constant elastic joining / clamping force on the arms 360, clamping and joining the cusps at their tips. In FIGS. 59 and 60, the natural pocket can be fully or partially filled with the implantable portion of the actuation rod 368. FIGS. 58, 59, and 60 show different configurations of the U-spring 370 with the arms 360, 366, and 362. Variations in each ratio have a mechanical advantage, and any combination of these ratios can be used to hold the arms together. Additionally, any remaining pocket can be filled with a compressible / expandable spacer, as described above. Additionally, each of these configurations has a different lever arm 371, 369, and 367.

[0198] Figures 61, 62, and 63 show different configurations of two leaf springs instead of a single U-spring as featured in Figures 58, 59, and 60. The problem with a single U-spring is that the physical design does not allow the tips of the spring to extend beyond the centerline or point where both tips meet. As shown in Figures 64 and 65, the individual / separate halves of the spring do not have this limitation and can therefore be loaded with higher strains / forces, which is a particular advantage of the present invention.

[0199] 66A shows an exemplary embodiment of a tissue fixation device with nested leaf springs 384, 382, ​​390, 392 of various lengths. The nested design of the leaf springs provides additional strength / force configuration and mitigates high strain values. The leaf springs may be coated with Teflon or lubricants, or current typical techniques, as would be apparent to one skilled in the art, to reduce friction as they are actuated / flexed. Along their length, the leaf springs are spaced such that A=B, A=C, and B=D.<BまたはA> B, and C = D, C<DまたはC> D and A=C, A<CまたはA> C, and any other permutation. The thickness of the leaf springs can similarly vary between the outer arms 384, 382, ​​390, 392. Similarly, the inner arms can also have multiple leaf springs of various lengths and / or thicknesses. FIG. 66B illustrates leaf springs 384, 382 actuated into a gripping position, as demonstrated by directional arrow 394. As can be inferred, leaf spring 382 presses against leaf spring 384, providing additional strength and functioning as a unit outer arm, cooperating with gripper 386, similar in function to those previously discussed herein and in the referenced commonly owned patents. Thus, one particular advantage of the present invention is that individual leaf springs can be configured with various lengths, thicknesses, and curves to achieve a desired bonding force.

[0200] FIG. 67A illustrates an exemplary embodiment of an outer arm 400 with an inner arm 396 with a midline barb as part of the outer arm. The inner arm 396 is fabricated to be biased away from the outer arm 400 to grasp the mitral valve leaflet without the use of sutures for actuation in the closed or open position. The inner arm 396 has multiple barbs configured toward the outer arm 400. The barbs are configured to grasp the mitral valve leaflet within the space between the outer arm 400 and the inner arm 396. FIG. 67B illustrates a side view of the outer arm 400 in a closed position with multiple midline barbs 398 on the inner arm 396. The inner arm 396 is biased away from the outer arm 400, allowing for capture of the leaflet with an atraumatic and more robust gripping force. The barbs 398 are angled 15 to 150 degrees (preferably 60 degrees) from the inner arm 396 surface to allow for grasping of tissue but allowing release of the cusps during re-grasp attempts or bailout.

[0201] FIG. 68A illustrates a schematic diagram of an exemplary embodiment of a tissue fixation device in which the inner arm 396 and outer arm 400 are constructed as a single piece and are resiliently biased toward one another. The outer arms 400, 408 are coupled to an outer base 380. FIG. 68B illustrates the device with the outer arm 400 actuated 410 to an open position 402. Note the position of the inner arm 396, which remains steady so as to compress the inner arm 396 and grip the leaflet, when the outer arm 400 is actuated to a closed position. Alternatively, the inner arm or gripper and outer arm or arms can function similarly to the embodiments of the referenced and commonly owned patents.

[0202] FIG. 69A illustrates an exemplary embodiment of a tissue fixation device in which the base 420 is spring-loaded and provides the compressive force needed to grip the leaflets. The outer arms 414, 428 are actuated via sutures 418, 422 that extend from eyelets 416, 424 configured in the arcs of the outer arms to the base 420. The sutures 418, 422 can be one continuous or multiple sutures or metal wires. The outer arms 414 and 428 can be one or more components that are continuous, hinged, welded, and / or fastened at the base. The sutures 418, 422 are not only constrained by the eyelets 416, 424, but can also be attached anywhere along the length of the outer arms. Pulling the leaflet release rod 430 in a retracting direction will lift the outer arms 414, 428, thereby releasing the leaflets from the barbs. In contrast, advancing the leaflet release rod 100 will lower the inner arm. Additionally, the base can also be a pulley mechanism, so that pulling or loosening the sutures 418 and 422, either simultaneously or independently / individually, can raise or lower or invert the corresponding outer arm, as shown in FIG. 69B (similar to the configuration described in the referenced patent).

[0203] FIG. 70A shows an exemplary embodiment of a tissue grasping device in which the grippers 439, 441 and outer arms 443, 445 are one piece. The grippers 439, 441 can be threaded, welded, or disconnected from the outer arms and actuated as in the referenced patents. The outer arms are actuated via a suture 435, mandrel, or wire, similar to that of a typical umbrella. Advancement (arrow 455) or retraction (arrow 451) of the suture / mandrel / wire 435 occurs through a delivery shaft 437. Secondary struts (or beams or sutures) 447, 449 permanently or removably connect the outer arms 443, 445 and actuation suture / mandrel / wire 435 to enable positioning of the grippers as well as the outer arms. Retracting the suture / mandrel / wire collapses the outer arms to a closed position (FIG. 70B), and advancing the suture / mandrel / wire moves the gripper and outer arms to a gripping position (FIG. 70C). Note that, although not shown, mechanisms for raising or lowering the gripper can be inferred from the above-referenced and commonly owned patents.

[0204] Figure 71A shows a top-down schematic view of an exemplary embodiment of a tissue fixation device constructed from two or more coaxial metal tubes that also serve as the outer base 482. The outer arms (452, 456) are cut from the same tube so that the device is one continuous device. Figure 71B shows a side view of the device. The inner arms (475, 479) are similarly formed from thinner OD tubes. Figure 71C shows an alternative configuration of the same device, in which the inner and outer arms are biased outward.

[0205] 72-76 show an alternative exemplary embodiment of the tissue-grasping valve repair device. The outer arms 505, 507 are fastened or glued to a base mandrel 509, which is removably attached to a mandrel 494. The tips of the outer arms 505, 507 are connected to the tip of a pusher rod 501 via sutures, fabric, or any hinge configuration. At the other end of the pusher rod, a gripper may be fastened, glued, or riveted. The entire pusher rod and gripper subassembly is then connected to a sliding collar 492 using sutures, fabric, or a hinge. The sliding collar 492 is removably attached to a delivery shaft 496 over the mandrel 494.

[0206] As in the previous embodiment of Figures 122-125, the outer arms 505, 507 are configured to apply a significant coaptation force over the cusp. As shown in Figure 76, the coaptation force F applied by the outer arms 505, 507 Coapt is the force exerted by the inner arms and the in vivo forces F exerted by the leaflets, including the annular fastening, as described in the previous embodiment. in-vivo This is achieved by making the outer arms 505, 507 much stronger in bending.

[0207] One problem with the PASCAL device is that it is essentially a spacer and the paddles are weak. It is not designed to coapt or clamp the cusps. One advantage of the present invention is superior clamping of the cusps in addition to close coaptation (preferably <1 mm gap).

[0208] By retracting the mandrel 494 relative to the delivery catheter 496, the outer arms 505, 507 can be spread apart to a leaflet grasping position, as shown in Figure 72. Additional configurations are shown in Figures 73-76.

[0209] For example, as shown in FIG. 74, the device may be loaded onto a release bar using a base mandrel 509, an inverter 524 may be used to spread the outer arms 505, 507, and the gripper 498 may be raised or lowered (513) in a similar mechanism using a suture, as described in commonly owned patent application US20200383782A1, which is incorporated herein by reference in its entirety.

[0210] The device 490 may be coaxially loaded relative to the delivery catheter 496, mandrel 494, and base mandrel 509. Alternatively, the device 450 may be side-mounted onto the release bar 520, as in commonly owned Patent Application No. US20200383782A1.

[0211] Figure 77 shows a MitraClip® gripper 287 with sharp and exposed barbs 523 that are susceptible to leaflet tearing, perforation, and / or single leaflet device attachment (SLDA). The exemplary embodiments of Figures 80-83 show various versions of atraumatic designs with blunt points 523, 533, 535, 537 to mitigate leaflet trauma. These innovative barb designs may include other leaflet trauma mitigators, such as tissue penetration-limiting features, evident in POSA, to prevent leaflet tearing, perforation, and / or single leaflet device attachment (SLDA).

[0212] Figure 78 illustrates the angle between the outer arms at the base 527 and tip 525 of the device. This is needed to ensure a smooth, pocket-free interface of the cusp at the tip.

[0213] Figure 79 shows the widths at the base 531 and top 529 of the clip. A wider base width is needed to accommodate thicker cusps, and a narrower width is needed to ensure a smooth, pocket-free interface at the tip.

[0214] The following lists various exemplary configurations of the present invention, where there are potential configuration variations in arm angle and width, as in Figures 78 and 79.

[0215] The angle between the tips of the outer arms can be -90, -60, -45, -30, -15, -10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, and / or 90 degrees. A preferred angle is between -10 and 30 degrees.

[0216] The angle at the base of the outer arm can be -90, -60, -45, -30, -15, -10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, and / or 90 degrees. Preferred angles are between -10 and 30 degrees.

[0217] The base (or arm and / or gripper) width is equal to or greater than the top width, base width=top width, and base width is equal to or less than the top width.

[0218] The base (or arm and / or gripper) width is 0.0, 0.1%, 1%, 10%, 25%, 50%, 75%, 100%, 150%, 200%, 500%, 1,000%, and / or 10,000% greater than or less than the top width.

[0219] The base (or arm and / or gripper) width and / or top width is 0.0, 0.01 mm, 0.1 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 4 mm, 5 mm, 6 mm, 10 mm, 20 mm, 30 mm, 50 mm, 100 mm, and / or 300 mm.

[0220] Expandable member 544, as seen in FIG. 84, fills the gap between the leaflets, sealing the gap and reducing reflux.

[0221] In an alternative embodiment, three or more spacers or expandable balloons 550, 552, 548 can be fitted within the inter-cusp (LF) space 542, as depicted in FIG.

[0222] As described in the commonly owned and referenced application (No. PCT / US2017 / 042003), the fixation device is adaptable for deployment in both a reverse and a forward configuration.

[0223] 86 is an exemplary embodiment of an opening bar with a flipper 524 (FIG. 23 of the referenced commonly owned patent and PCT / 0S2019 / 013853). The flipper is hinged to the opening bar and can therefore pivot to allow for ease of maneuvering through the aisle, in addition to the combination of configurations that can be used to manipulate the arms.

[0224] An exemplary expandable member 544 mounted on the release bar assembly 520, along with the inner arm 309 and outer arm 307 fastened to the base 311, is shown in FIG. 87. The implant itself is shown in FIG. 88. In this exemplary embodiment, the inner arm 309 includes atraumatic barbs 305. The grasping prong mechanism of FIGS. 90-105C is similar to that described in commonly owned Patent No. US20200383782A1.

[0225] Figure 89 shows the outer arm 307 at a gripping angle. The cusp is gripped between the outer and inner arms in Figure 90. In Figure 91, the inner arm 309 grips the cusp, and the cusp is engaged by both arms 307 and 309.

[0226] The expandable member 544 is stretched in Fig. 92. In an exemplary embodiment, the expandable member in Fig. 92 is rigid and not very compliant. In an alternative exemplary embodiment, Fig. 93 shows an expandable member 544 that is more compliant and elastic in nature, dynamically changing shape to accommodate and engage the opposing cusps.

[0227] FIG. 94 illustrates a removable tether connected to a balloon or expandable member 544 via port 535. Once the leaflet is grasped and the implant is implanted, tube 532 remains attached to the implant and can be used to externally / remotely stretch expandable member 544. Balloon stretching can be increased or decreased to optimize MR reduction, as shown in FIG. 95. Once optimized, tube 532 can be removed from self-sealing port 535, as shown in FIG. 96. US20180185185 (incorporated herein by reference in its entirety) describes exemplary self-sealing port designs and how the tether can be removed.

[0228] Figure 97 illustrates an anatomical cross-section of the heart showing the right atrium (RA) and right ventricle (RV). Figure 98 illustrates the heart of Figure 97 with a catheter inserted through the inferior vena cava (IVC) via femoral vein access. Note the sharp U-turn the catheter must make to reach the tricuspid valve. Figure 99 illustrates the heart of Figure 97 with a catheter inserted through the superior vena cava (SVC) via jugular vein access. Note the direct and less tortuous path from the SVC to the tricuspid valve.

[0229] An exemplary embodiment of the present invention can be configured to deliver the device via the SVC using jugular vein access.

[0230] An exemplary embodiment of the present invention can be configured to deliver the device via the IVC using femoral access.

[0231] FIG. 100 shows an exemplary embodiment of a release bar with a central post 550 .

[0232] FIG. 101 shows an exemplary embodiment of a release bar component of a delivery system that includes a post 550 that helps partition each of the pairs of grippers 262 and arms 266 on their respective sides of the post.

[0233] 102-108 show an exemplary embodiment of a heart valve replacement device 564 with actuatable arm 565, 567 and / or gripper (not shown) features similar to devices such as 260, 350, etc., described in this patent and the referenced commonly owned patents.

[0234] In one exemplary method, a heart valve replacement device 564 is inserted into a human heart using a guide catheter 557, which is passed from the right atrium into the left atrium LA through a puncture in the atrial septum. As shown in Fig. 102, the steerable guide catheter 557 penetrates the interatrial septum and enters the left atrium LA. A delivery catheter 561 positions the heart valve replacement device 564 through the valve leaflet LF and into the upper region of the left ventricle, as shown in Fig. 103.

[0235] Distal advancement of device cover 563 exposes device arms 567 and 565 from a lateral position of the stent in FIG. 103. The arms can be configured to be radially self-expanding or self-closing. The number of arms depends on the number of cusps in the heart valve and / or the number of arms required to engage a single cusp (LF).

[0236] The heart valve replacement device 564 is lowered to position the device arms 567 and 565 below the mitral valve plane. The arms 567 and 565 are then drawn by the suture 569 to a grasping angle, as depicted in FIG.

[0237] The leaflet LF is first stabilized by arms 567 and 565, as shown in FIG. 105, and then captured or grasped when the arms are closed, as shown in FIG.

[0238] If necessary, leaflet LF may be disengaged as shown in Figure 107. The left leaflet is disengaged from arm 565 with the aid of suture 573 and left ventricular suture 563. In an alternative embodiment, right arm 567 is inverted with the aid of a ventricular suture attached to inversion tool 112.

[0239] Once leaflet capture is achieved, the expandable member of heart valve replacement device 564 may be released within the mitral annulus, with arms 565 and 567 anchoring the device in place, as shown in Figure 108. As POSA will understand, the valve replacement device may be configured to minimize obstruction to blood flow.

[0240] One particular advantage of the present invention is that the method of gripping the leaflets in the exemplary valve replacement device embodiment shown in Figures 102-108 can be similar to that described in US20200383782A1. Additionally, although not shown, yet another alternative embodiment of the leaflet gripping mechanism may include a gripper in addition to the arms, as in US20200383782A1 and as would be apparent to any person skilled in the art.

[0241] 109A-109D show an exemplary embodiment of a valve repair system including a stabilizer, steerable guide catheter, device, and device delivery catheter, built upon commonly owned and referenced patents, including WO2019143726A. While the exemplary handle in FIG. 109D shows only a delivery port in addition to the arm, a gripper actuator rod, i.e., a separate actuator rod dedicated to bailout, could easily be incorporated. Furthermore, each actuator rod may perform more than one function, manually, semi-automatically, automatically, and / or robotically.

[0242] FIG. 110 illustrates an exemplary embodiment of a steerable guide catheter. In particular, it shows exemplary straight stiffening members located at diametrically opposed ends, thereby stiffening the catheter in its orthogonal plane while allowing the catheter to bend along that plane as controlled by the pull wire. While straight stiffening members are shown in this example, it will be readily apparent to POSA that stiffening members can be placed in curved, helical, or any other pattern—direct, parallel, intermittent, or continuous stent-like patterned cuts in the tube—to achieve desired steering or bending characteristics in a given cross-section or length of the catheter. Furthermore, stiffening members of the same or varying stiffness may be formed from metals, polymers, ceramics, composites, fibers, and / or simply by adding or removing material from the shaft wall. The pull wire can be rectangular, square, rounded, or any other shape known to POSA.

[0243] In one exemplary embodiment as shown in FIG. 111, the pull wire in the proximal curve region is provided with a rectangular stiffener / strip 585 so that it can also act as a stiffener.

[0244] In one exemplary embodiment as shown in FIG. 111, the pull wire in the proximal curve region is provided with a rectangular stiffener / strip 585 so that it can also act as a stiffener.

[0245] In one exemplary embodiment as shown in FIG. 112, the pull wires in the distal curved region comprise pull wires 581 that are round in all four directions to allow for four-way steering.

[0246] FIG. 113 shows an exemplary embodiment of a steerable guide catheter (SGC) 590 mounted on an exemplary stabilizer. The proximal knob 594 is configured to provide two-way steering of the proximal curve section using a rectangular pull wire, as in FIG. 111. As shown in FIG. 112, the middle knob 595 is configured to provide two-way steering in the anterior / posterior direction, while the distal knob 596 provides two-way steering in the medial / lateral direction.

[0247] FIG. 114 shows an exemplary configuration of a valve repair system comprising an SGC 593 and a delivery catheter (DC) 592 mounted on a stabilizer.

[0248] Figure 115 shows an exemplary embodiment of a DC handle. As can be seen in Figure 109D, the plane of the implant matches the plane of the handle. Furthermore, due to the torsional stiffness of the delivery catheter, each pair of actuator rod arms 597 and actuator rod grippers 598 matches their respective implant arm and gripper pairs for intuitive operation and ease of use.

[0249] 116A-116H show various views of the DC handle without the actuator rod, delivery port, or release knob.

[0250] 117A-117D show various views of the actuator rod arm 597.

[0251] 118A-117C show various views of actuator rod gripper 597.

[0252] 119A-119D show various views of the DC handle. The release knobs are attached to the release mandrel, while the actuation sutures are connected to their corresponding actuator rods, similar to the descriptions provided in the referenced and commonly owned patents.

[0253] In the exemplary embodiment shown in FIG. 120 , a funnel-shaped mesh 605 is made from nitinol wire or laser-cut tubing. It is configured to expand into a funnel or any other shape with a larger diameter than the protruding guide catheter 603. The larger diameter aids in capturing the implant arms within the guide catheter 603. This therefore allows for full retrieval of the implant and alleviates the problem of the implant arms getting stuck within the distal tip of the guide catheter 603, a common issue with competing devices such as MitraClip®. The mesh 609 is adhered to the delivery catheter 611 at a site 607 proximal to the implant.

[0254] 121 shows a side view of the funnel-shaped mesh in a configuration completely outside of the catheter 603. The funnel-shaped mesh expands as it is pushed outside of the guide catheter 603 and contracts as it is retracted into the guide catheter 603. The funnel-shaped mesh is configured to expand and contract to reside proximal to the implant, avoiding interference with the valve leaflets and the implant.

[0255] FIG. 122 illustrates a funnel-shaped mesh 605 that captures an implant 609 .

[0256] Figure 123 shows a funnel-shaped mesh that completely covers the implant while inside the guide catheter 603, and Figure 124 shows a funnel-shaped mesh that partially covers the implant. The implant can be either completely or partially covered by the mesh 605, but in either case, the mesh 605 encompasses, at a minimum, the arms of the implant. That is, on the broadest free side of the implant, the tips of the arms of the implant are completely encapsulated by the covering 605.

[0257] The distance shown as 615 in FIG. 125 represents a possible distance between the implant and the fully expanded funnel 605. Distance 615 is preferably 7.5 cm and can be configured to be 0, 1, 2, 3, 4, 5, 6, ..., 199, and / or 200 cm. Distance 613 represents a possible distance between the implant 609 and the attachment point 607 between the funnel 605 and delivery catheter 611. It can be configured to be approximately 0, 1, 2, 3, 4, 5, 6, ..., 198, 199, and / or 200 cm.

[0258] FIG. 126A illustrates an exemplary embodiment of the invention comprising a coiled leaf spring instead of the funnel-shaped mesh described in FIGS. 120-125. A 360-degree funnel would not be required for an implant with only two laterally mounted arms. The primary function of 621 is identical to funnel 605: to guide the protruding arms back into the guide catheter for complete retrieval and bailout. A coiled elastic or superelastic strip can be used in place of the funnel in such cases. Distance 623 represents the distance between the implant and the coiled leaf spring. This can be approximately 0, 1, 2, 3, 4, 5, 6, ..., 199, and / or 200 cm (preferably 7.5 cm). FIG. 126B illustrates an orthogonal cross-sectional view of FIG. 126A with only one coiled leaf spring 621. If the implant has only one arm, a single coiled leaf spring is sufficient to withdraw the device. Figure 126C illustrates an orthogonal cross section of Figure 126A with both coiled leaf springs. If the implant has two arms, two coiled leaf springs would be required to withdraw the device.

[0259] FIG. 126D shows the coiled leaf spring 621 almost fully uncoiled and ready to grasp the implant 609. Once the implant is grasped, it can be retracted into the guide catheter and fully retrieved. FIG. 127A shows a fan-shaped mesh 606 instead of a funnel 605 for implant retrieval. A full 360-degree fan 605 resembles a cone, which may also be used depending on the type of implant. FIG. 127B shows an orthogonal view of FIG. 121 with the funnel-shaped mesh 605 fully expanded and the implant 609 in the middle.

[0260] One advantage of the exemplary expandable funnel, coil, and / or fan features is that once expanded after transseptal crossing of the guide catheter, they provide safety protection against accidental withdrawal of the guide catheter.

[0261] The delivery catheter has a coiled spring attached to it in the distal section, directly adjacent to the implant attachment, as shown in Figure 128. The coiled spring facilitates easy steering of the implant 609 through sharp curves and helps maintain the straightness of the shaft as it exits the guide catheter, improving ease of use. The coiled spring can be fabricated from wire or laser-cut tubing.

[0262] 129A shows an exemplary rescue catheter 700 with a slit 670. The rescue catheter can be used to capture an implant as described above in the co-owned applications.

[0263] FIG. 129B shows an alternative embodiment of a cross-sectional view of an exemplary rescue catheter 700.

[0264] In FIG. 129C, the slit ends of 640 overlap one another and are configured to ride snugly over the guide catheter.

[0265] Alternatively, a rescue catheter can be configured to ride over the delivery catheter and inside the guide, and further configured to expand in response to exiting the guide catheter to capture the implant.

[0266] FIG. 130A shows an atrial view of a schematic mitral valve with an exemplary implant, as shown in FIG. 130B, comprising a pair of inner and outer arms and an expandable feature 690 between the two inner arms. The expandable feature 690 may be a balloon placed between the two inner arms and connected to one or both of the inner arms or the outer base. The balloon may be configured as a spacer to reduce regurgitation. Furthermore, the spacer balloon size may be remotely adjustable via controlled expansion or contraction using the removable tube 532, as previously described in FIGS. 94, 95, and 96. After the balloon engages the cusps over a period of time, the balloon may be configured to slowly contract. This slow and gradual clenching over a period of time is advantageous because aggressive, acute clenching of the cusps can cause cusp tearing, a problem with the competing MitraClip® device. Gradual shrinkage of the spacer for controlled fastening over time can be achieved via diffusion, degradation, displacement, and remotely via the removable tube 532. Additionally, the entire expandable feature 690 may be removably attached to the implant.

Claims

1. 1. An endovascular heart valve repair system comprising: a delivery catheter having a distal end configured to be introduced into a heart chamber adjacent the pair of coapted heart valve leaflets; a valve repair leaflet grasping device attached to a distal region of the delivery catheter, the valve repair leaflet grasping device comprising a first pair of leaflet capture arms including a first inner arm and a first outer arm, and a second pair of leaflet capture arms including a second inner arm and a second outer arm; an inverter bar configured to inverter the first outer arm and the second outer arm, the inverter bar being positioned on the delivery catheter distal to the valve repair leaflet grasping device, the inverter bar being oriented transverse to a longitudinal axis of the delivery catheter; a bailout suture passing outside the distal region of the delivery catheter, the bailout suture being threaded through a suture loop passing through the lateral ends of the everter bar, the bailout suture being configured into a triangular formation such that when the two ends of the bailout suture are drawn proximally, the bailout suture is under tension and the bailout suture is configured into a triangular formation such that captured heart valve leaflets are expelled from between the first inner arm and the first outer arm and from between the second inner arm and the second outer arm; 1. An endovascular heart valve repair system comprising:

2. The endovascular heart valve repair device of claim 1, wherein the endovascular heart valve repair system further comprises a secondary suture loop looped around the bailout suture.

3. The endovascular heart valve repair system of claim 1 or claim 2, further comprising a spacer positioned over a gap formed by the first pair of leaflet capture arms and the second pair of leaflet capture arms to inhibit thrombus formation.

4. An endovascular heart valve repair system as described in claim 3, wherein the spacer is secured to at least one of the leaflet capture arms using sutures, adhesives, welding, or glue.

5. An endovascular heart valve repair system as described in claim 3 or claim 4, wherein the spacer is an inflatable or deflatable balloon configured for gradual tightening of the valve leaflets.

6. An intravascular heart valve repair system as described in claim 5, wherein the balloon is connected to a detachable tether to allow for volume adjustment remotely or after implantation.

7. An endovascular heart valve repair system as described in claim 1 or claim 3, wherein the first pair of leaflet capture arms and the second pair of leaflet capture arms are expandable or stackable, and the first pair of leaflet capture arms and the second pair of leaflet capture arms include one or more of rings, teeth, stents, slots, clefts, diamond shapes, or folded patterns.

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