TW202224648A - Systems and methods for heart valve leaflet repair - Google Patents

Abstract

An implant includes an interface, and a wing that is coupled to the interface and has a contact face. A catheter is transluminally advanceable to a chamber of a heart of a subject and houses the implant. A delivery tool comprises a shaft and a driver. Via engagement with the interface, the shaft is configured to (i) deploy the implant out of the catheter such that, within the chamber, the wing extends away from the interface; and (ii) position the implant in a position in which the interface is at a site in the heart, the wing extends over the first leaflet toward the opposing leaflet, and the contact face faces the first leaflet. The driver is configured to secure the implant in the position by using an anchor to anchor the interface. Other embodiments are also described.

Description

System and method for heart valve leaflet repair

The present invention relates to systems and methods for heart valve leaflet repair. CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims U.S. Provisional Patent Application 63/046,638 to Chau et al. (filed June 30, 2020) and U.S. Provisional Patent Application 63/124,704 to Chau et al. (filed December 2020) 11th filing) priority.

Each of the above-cited applications is hereby incorporated by reference in its entirety for all purposes.

Background of the Invention

The native heart valves (ie, the aortic, pulmonary, tricuspid, and mitral valves) provide key functions in ensuring the forward flow of a proper supply of one of the blood through the cardiovascular system. Congenital malformations, inflammatory processes, infectious conditions or diseases may render these heart valves less effective. Such damage to these valves can lead to serious cardiovascular compromise or death. Treatment of such disorders may be accomplished using surgical repair or replacement of the valve during open-heart surgery, or using transcatheter transvascular techniques in a less invasive procedure than open-heart surgery method for introduction and implantation of prosthetic devices.

A healthy heart has a generally conical shape that tapers to a lower apex. The heart has 4 chambers: left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall commonly called the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve includes: an annulus portion, which is an annular portion of the native valve tissue surrounding the mitral valve orifice; and extending from the annulus down into the left ventricle A pair of valve leaflets (called cusps). The mitral valve annulus may form a "D" shape with a major axis and a minor axis, oval or other non-circular cross-sectional shape. The anterior leaflets may be larger than the posterior leaflets, forming a generally "C" shaped boundary between adjacent free edges of the leaflets when they are closed together.

When functioning properly, the anterior and posterior lobes function together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle expands, oxygenated blood collected in the left atrium flows into the left ventricle. When the muscle of the left atrium relaxes and the muscle of the left ventricle contracts, the increased blood pressure in the left ventricle pushes the two valve leaflets together, thus closing the one-way mitral valve, so blood cannot flow back To the left atrium, it is instead expelled out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapse or flail under pressure and fold back towards the left atrium through the mitral annulus, bundles of fibers called chordae tendineae The iso-valve leaflets are tethered to the mastoid muscle of the left ventricle.

Valve regurgitation occurs when the native valve fails to close properly and blood flows from the left ventricle into the left atrium during the systolic phase of systole. Valvular insufficiency, particularly mitral valve regurgitation, is the most common form of valvular heart disease. Mitral regurgitation has different etiologies, including leaflet prolapse or flail, restricted leaflet motion [eg, due to leaflet rigidity] / leaflet calcification (leaflet calcification)] and/or dysfunctional papillary muscles stretching (dysfunctional papillary muscles stretching).

Certain techniques for the treatment of leaflet valve insufficiency due to flail and prolapse involve directly suturing or otherwise coupling portions of the natural valve leaflets to each other, but are intended for use in the treatment of leaflets. There is a continuing need for improved devices and methods for flail, prolapse, and limited leaflet movement.

Outline of Invention

Many of the examples herein are directed to systems, apparatus, devices, methods, etc. that can alleviate leaflet flail, prolapse, abnormal leaflet motion, and/or other problems. For example, various embodiments of systems, devices, etc. provide contact pressure on flailed, prolapsed or restricted areas of the leaflet. Certain embodiments of the systems, devices, etc. herein are anchored within adjacent vasculature. Certain embodiments of the systems, devices, etc. herein are anchored directly to the annulus and/or a leaflet. Instances of certain systems, devices, etc. are compressed over the leaflet to be repaired.

In certain applications, a system [eg, a leaflet repair system, an arrestor system, a prolapse repair system, a flail repair system, a repair system, etc.] is provided for use with a heart valve middle. The system may include a device (eg, a repair device, a leaflet repair device, a stopper, etc.) that includes a contact surface that conforms to the contour of an inflow surface of a heart valve leaflet and is capable of The inflow surface provides contact pressure (eg, on the atrial side of an atrioventricular valve). The system contains an anchor capable of anchoring within the vasculature. Also the system includes a connector or an anchor receiver connecting the device and the anchor.

In some applications, the device is an implant that includes a flexible wing and an interface, and the system includes a delivery tool that engages the interface and can be used to position and anchor the interface to tissue of the heart (eg, to an annulus of the valve being treated) such that the wings extend beyond a first leaflet of the valve (eg, beyond a prolapsed or flail portion of the leaflet) ), towards an opposing leaflet of the valve. For some such applications, the wing is curved, and the tether is positioned and anchored so that the wing is curved downstream between the leaflets, eg, such that a tip (eg, a free end of the wing) ) is disposed within the ventricle downstream of the valve under treatment.

In certain applications, the contact surface of the device has a length and a width to cover a prolapse or a flail of the heart valve leaflets.

In certain applications, the contact surface of the device can provide contact pressure over a prolapse or a flail of the heart valve leaflets.

In certain applications, the system further includes a coaptation portion extending from the contact surface, the coaptation portion being capable of extending the length of the device into the coaptation region of the valve.

In certain applications, the coaptation portion can help promote coaptation between the leaflets of the valve.

In some applications, the device is a wire form.

In some applications, the wire forming systems are Nitinol, Cobalt-Chromium (CoCr), Stainless Steel, Titanium, Polyglycolic Acid (PGA), Polylactic Acid (PLA), Poly-D-Lactic Acid (PDLA), Polyamine-based Formate (PU), Poly-4-hydroxybutyrate (P4HB), Polycaprolactone (PCL), Polyetheretherketone (PEEK), Cyclic Olefin Copolymers (COCs), Polyethylene Vinyl Acetate ( EVA), polytetrafluoroethylene (PTFE), perfluoroether (PFA) or fluorinated ethylene propylene copolymer (FEP).

In some applications, the wire form is compressible to fit within a delivery catheter.

In some applications, the wire form is self-expanding.

In certain applications, the system further includes a sheet material attached over the wire form, the sheet material forming the contact surface.

In certain applications, the sheet has a length and a width to cover a prolapse or a flail of the heart valve leaflets.

In certain applications, the sheet system can provide contact pressure over a prolapse or a flail of the heart valve leaflets.

In certain applications, the sheet is permeable, semi-permeable or impermeable.

In some applications, the sheet is a mesh.

In some applications, the sheet system is lactic acid-glycolic acid copolymer (PLGA), polyvinyl chloride (PVC), polyethylene (PE), polypropylene (PP), polytetrafluoroethylene (PTFE), poly Urethane (PU), polyethylene terephthalate (PET), polyether selenium (PES), polyglycolic acid (PGA), polylactic acid (PLA), poly-D-lactic acid (PDLA), poly- 4-hydroxybutyrate (P4HB) or polycaprolactone (PCL).

In certain applications, the system further comprises a latch or a hook capable of latching or hooking within a heart valve leaflet commissure or cleft.

In some applications, the system consists of a static part and a dynamic part. The dynamic part can be repositioned or resized.

In some applications, the anchor is a wire stent.

In some applications, the anchor is a pin fastener.

In some applications, the anchor is a wire fastener that fastens the wire.

In certain applications, the connector or anchor receptacle includes one or more of the following: rivets, sutures, staples, wires, pins, shafts, sheets, meshes, housings, tubing , crossbars, etc.

In certain applications, the system further comprises a clamp capable of clamping the device (eg, prosthetic device, leaflet repair device, actuator, etc.) to the valve leaflets.

In certain applications, a tether extends from the device and can extend to a fixation site on the outflow side of the valve (eg, on the ventricular side of an atrioventricular valve).

In some applications, the device incorporates an internal gap in the engagement region of the device. This internal gap does not contain wire forming.

In some applications, the device incorporates a joint element, spacer, gap filler, and the like.

In some applications, the engagement element/spacer/filler comprises foam, hydrogel or silicone.

In some applications, the engagement element/spacer/filler incorporates a scissor mechanism or a coil.

In some applications, the device incorporates an expandable stent.

In certain applications, the device is configured to be implanted within a mitral valve, a tricuspid valve, an aortic valve, or a pulmonic valve.

In certain applications, the anchor is configured to be implanted within the vasculature adjacent the valve, and wherein the connector traverses a chamber wall.

In certain applications, the device is configured to be implanted within the mitral valve, the anchor is configured to be implanted within the coronary sinus, and the connector traverses the left atrial wall.

In certain applications, the system further comprises a delivery catheter. The device, the connector and the anchor are each compressible within the delivery catheter.

In certain applications, the delivery catheter is configured to be passed through a transfemoral, subclavian, transapical, transseptal, or transaortic ) to be delivered.

The methods herein, eg, the delivery of the systems/devices herein, can be on a live animal or on a simulation, such as on a cadaver, cadaver heart, simulator (eg, with simulated body parts, hearts, tissues, etc.), etc., to execute.

In some applications, a compression element is provided for use in a heart valve. The compression element includes an inflow portion, an outflow portion, and an engagement portion. The inflow portion can sit on the inflow surface of a heart valve leaflet. The outflow portion can sit on the outflow surface of a heart valve leaflet. In some applications, the joint portion connects the inflow portion and the outflow portion. The inflow portion and the outflow portion are compressed together such that the stent can be stabilized over a heart valve leaflet when implanted. The stent is contoured to the shape of the heart valve leaflets.

In certain applications, the inflow portion can provide contact pressure against a prolapsed heart valve leaflet or flail.

In some applications, the compression element is a wire form.

In some applications, the wire forming systems are Nitinol, Cobalt-Chromium (CoCr), Stainless Steel, Titanium, Polyglycolic Acid (PGA), Polylactic Acid (PLA), Poly-D-Lactic Acid (PDLA), Polyamine-based Formate (PU), Poly-4-hydroxybutyrate (P4HB), Polycaprolactone (PCL), Polyetheretherketone (PEEK), Cyclic Olefin Copolymers (COCs), Polyethylene Vinyl Acetate ( EVA), polytetrafluoroethylene (PTFE), perfluoroether (PFA) or fluorinated ethylene propylene copolymer (FEP).

In some applications, the wire form is compressible to fit within a delivery catheter.

In some applications, the wire form is self-expanding.

In certain applications, the compression element further includes a sheet attached over the inflow portion of the wireform.

In certain applications, the sheet has a length and a width to cover a prolapse or a flail of the heart valve leaflets.

In certain applications, the sheet system can provide contact pressure over a prolapse or a flail of the heart valve leaflets.

In certain applications, the sheet is permeable, semi-permeable or impermeable.

In some applications, the sheet is a mesh.

In certain applications, the sheet system is lactic acid-glycolic acid copolymer (PLGA), polyvinyl chloride (PVC), polyethylene (PE), polypropylene (PP), polytetrafluoroethylene (PTFE), Polyurethane (PU), Polyethylene terephthalate (PET), Polyether terephthalate (PES), Polyglycolic acid (PGA), Polylactic acid (PLA), Poly-D-lactic acid (PDLA), Poly -4-hydroxybutyrate (P4HB) or polycaprolactone (PCL).

In certain applications, the compression element further includes an extended coaptation portion capable of extending beyond a leaflet edge. The extended joint portion incorporates an impermeable sheet.

In some applications, the extended engagement portion incorporates a thickened material. The impermeable sheet covers the thickened material capable of filling a gap in the orifice of a heart valve when the valve is closed.

In some applications, the extended engagement portion includes a corner.

In certain applications, the compression element further comprises: an anchor capable of anchoring within the vasculature, and a connector or an anchor receptacle connecting the compression element and the anchor.

In some applications, the anchor is a wire support.

In some applications, the anchor is a pin fastener.

In some applications, the anchor is a wire fastener that fastens the wire.

In certain applications, the connector or anchor receptacle includes one or more of the following: rivets, sutures, staples, wires, pins, shafts, sheets, meshes, housings, tubing , crossbars, etc.

In certain applications, the compression element is configured to be implanted within a mitral valve, a tricuspid valve, an aortic valve, or a pulmonary valve.

In certain applications, the anchor is configured to be implanted within the vasculature adjacent the valve, and wherein the connector traverses a chamber wall.

In certain applications, the compression element is configured to be implanted within the mitral valve, the anchor is configured to be implanted within the coronary sinus, and the connector traverses the left atrial wall .

In certain applications, the compression element further comprises a delivery catheter and the compression element is compressed within the delivery catheter.

In certain applications, the delivery catheter is configured to be delivered via a transfemoral, subclavian, transapical, transseptal, or transaortic approach.

The methods herein, eg, the delivery of the systems/devices herein, can be on a live animal or on a simulation, such as on a cadaver, cadaver heart, simulator (eg, with a simulated body parts, hearts, tissues, etc.), etc., to perform.

In some applications, a rod element is provided for use in a heart mitral valve. The rod element contains an arched rod. The rod element includes a hook or latch on each of the two distal ends of the arcuate rod capable of hooking or latching within the commissure of a mitral valve. The rod element contains an anchor capable of being anchored within the vasculature. Also the rod element includes a connector connecting the arched rod and the anchor.

In some applications, the anchor is a wire support.

In some applications, the anchor is a pin fastener.

In some applications, the anchor is a wire fastener that fastens the wire.

In certain applications, the connector or anchor receptacle includes one or more of the following: rivets, sutures, staples, wires, pins, shafts, sheets, meshes, housings, tubing , crossbars, etc.

In some applications, a sheet of material extends from the arched rod.

In some applications, a gap filler/spacer/engaging element extends from the arched rod.

In some applications, the arched rod is a telescopic rod comprising an inner rod and an outer rod. The inner rod is slidable within the outer rod so that the length of the telescopic rod is adjustable.

In certain applications, a method is provided to deliver a system (eg, a leaflet repair system, a brake system, a prolapse repair system, a flail repair system, a repair system, etc.) via transcatheter delivery to a native valve (eg, mitral valve, tricuspid valve, etc.). In certain applications, the method includes directing a puncture catheter or other puncturing device (eg, via a first guide wire, etc.) to a chamber of the heart (eg, an atrium, a ventricle, etc.) ) adjoining the vasculature of the heart (eg, coronary sinus, coronary arteries, etc.). The method includes puncturing the vasculature (eg, coronary sinus, etc.) luminal wall and the chamber wall (eg, atrial wall, etc.). The method includes guiding a delivery catheter (eg, via a second guide) through the vascular system (eg, coronary sinus, etc.) lumen wall and puncture holes in the chamber wall (eg, atrial wall, etc.) wire, etc.) into the chamber (eg, atrium, etc.).

In certain applications, the method comprises releasing a device (eg, a repair device, a leaflet repair device, a stopper) from the delivery catheter within the chamber (eg, within the atrium, etc.) and many more). The method includes using the delivery catheter to seat the device on a portion of the natural valve (eg, mitral valve, tricuspid valve, etc.) that is undergoing prolapse or flail (eg, a posterior leaflet, etc.) above.

In certain applications, the method includes releasing a connector or an interface and an anchor from the delivery system such that the anchor resides within the vasculature (eg, coronary sinus, etc.), and the connection A device or interface connects the device to the anchor across the lumen wall of the vasculature (eg, coronary sinus, etc.) and the chamber wall (eg, atrial wall, etc.).

In certain applications, the delivery catheter reaches the vasculature (eg, coronary sinus, etc.) via a transfemoral, a subclavian, a transapical, a transseptal, or a transaortic approach ).

The method(s) above can be on a live animal or on a simulation, such as on a cadaver, cadaver heart, simulator (eg, with simulated body parts, heart, tissue, etc.), etc. above, to be implemented.

In some applications, a method involves delivering a compression element (eg, stent, clasp, form, etc.) to a native valve (eg, mitral valve, etc.) via transcatheter delivery ). In certain applications, the method includes directing a puncture catheter or other puncturing device (eg, via a first guide wire, etc.) to a chamber of the heart (eg, an atrium, a ventricle, etc.) ) adjoining the vasculature of the heart (eg, coronary sinus, coronary arteries, etc.). In certain applications, the method comprises puncturing the vasculature lumen wall (eg, coronary sinus lumen wall, coronary artery lumen wall, etc.) and the chamber wall (eg, atrial wall, ventricular wall, etc.) .

In certain applications, the method includes directing a delivery catheter (eg, via a second guide wire, etc.) to the lumen (eg, via a second guidewire, etc.) through the vasculature lumen wall and a puncture hole in the lumen wall , atrium, ventricle, left atrium, left ventricle, etc.).

In certain applications, the method involves releasing a compression element from the delivery catheter within the chamber (eg, within the atrium or ventricle).

In certain applications, the method includes using the delivery catheter (eg, an actuator in combination therewith) to compress the compression element to one of the native valves (eg, mitral valve, etc.) undergoing prolapse or over a portion of the posterior leaflet or other leaflet of the flail.

In certain applications, the method further includes releasing a connector or an interface and an anchor from the delivery system such that the anchor resides within the vasculature (eg, coronary sinus, etc.), and the A connector or interface connects the compression element to the anchor across the lumen wall of the vasculature (eg, coronary sinus, etc.) and the chamber wall (eg, atrial wall, etc.).

In certain applications, the delivery catheter reaches the vasculature (eg, coronary sinus, etc.) via a transfemoral, a subclavian, a transapical, a transseptal, or a transaortic approach ).

In certain applications, a gap filler/coaptation element/spacer system is configured for use within a heart valve. The gap filler/coaptation element/spacer system comprises a gap filler, coaptation element or spacer capable of expanding within the space of the orifice of a heart valve when the valve is closed to fill the space in the valve any gap and prevent or inhibit valvular insufficiency. The gap filler/engagement element/spacer system includes an anchor capable of anchoring within the vasculature. The gap filler/engagement element/spacer system includes a connector or anchor receiver connecting the gap filler/engagement element/spacer and the anchor.

In certain applications, the gap filler/engagement element/spacer comprises lactic acid-glycolic acid (PLGA), polyvinyl chloride (PVC), polyethylene (PE), polypropylene (PP), poly Tetrafluoroethylene (PTFE), Polyurethane (PU), Polyethylene terephthalate (PET), Polyether terephthalate (PES), Polyglycolic acid (PGA), Polylactic acid (PLA), Polypropylene Spiral lactic acid (PDLA), poly-4-hydroxybutyrate (P4HB) or polycaprolactone (PCL).

In some applications, the anchor is a wire support.

In some applications, the anchor is a pin fastener.

In some applications, the anchor is a wire fastener that fastens the wire.

In certain applications, the connector or anchor receptacle includes one or more of the following: rivets, sutures, staples, wires, pins, shafts, sheets, meshes, housings, tubing , crossbars, etc.

In certain applications, the gap filler/commissure element/spacer is configured to be implanted within a mitral valve, a tricuspid valve, an aortic valve, or a pulmonary valve.

In certain applications, the anchor is configured to be implanted within the vasculature adjacent the valve, and wherein the connector traverses a chamber wall.

In certain applications, the device (eg, repair device, leaflet repair device, actuator, etc.) is configured to be implanted within the mitral valve and the anchor is configured to be implanted in the coronary within the sinus, and the connector traverses the left atrium wall.

In certain applications, the gap filler/engagement element/spacer system further comprises a delivery catheter. The gap filler/engaging element/spacer, the connector and the anchor are each compressible and/or otherwise configured to fit within the delivery catheter.

In certain applications, the delivery catheter is configured to be delivered via a transfemoral, subclavian, transapical, transseptal, or transaortic approach.

The method(s) above can be on a live animal or on a simulation, such as on a cadaver, cadaver heart, simulator (eg, with simulated body parts, heart, tissue, etc.), etc. above, to be implemented.

In certain applications, a system (eg, a leaflet repair system, a brake system, a prolapse repair system, a flail repair system, a repair system, etc.) is provided for use within a heart valve for Contact pressure is provided over one leaflet. The system includes a device (eg, a repair device, a leaflet repair device, a stopper, etc.) having a contact surface capable of providing contact pressure over an inflow surface of a heart valve leaflet. The system includes an anchor attached to the device capable of anchoring within tissue of the leaflet, the annulus or the chamber wall.

In some applications, the contact surface may be contoured to help provide the proper contact pressure.

In certain applications, the contact surface of the device has a length and a width to cover a prolapse or a flail of the heart valve leaflets.

In certain applications, the contact surface of the device can provide contact pressure over a prolapse or a flail of the heart valve leaflets.

In some applications, the system includes a joint extending from the contact surface. The coaptation portion is capable of extending the length of the device into the coaptation region of the valve.

In certain applications, the coaptation portion can help promote coaptation between the leaflets of the valve.

In some applications, the device is a wire forming.

In some applications, the wire forming systems are Nitinol, Cobalt-Chromium (CoCr), Stainless Steel, Titanium, Polyglycolic Acid (PGA), Polylactic Acid (PLA), Poly-D-Lactic Acid (PDLA), Polyamine-based Formate (PU), Poly-4-hydroxybutyrate (P4HB), Polycaprolactone (PCL), Polyetheretherketone (PEEK), Cyclic Olefin Copolymers (COCs), Polyethylene Vinyl Acetate ( EVA), polytetrafluoroethylene (PTFE), perfluoroether (PFA) or fluorinated ethylene propylene copolymer (FEP).

In some applications, the wire form is compressible to fit within a delivery catheter.

In some applications, the wire form is self-expanding.

In certain applications, the system includes corrugated or crossed wires to provide contact pressure over a prolapse or a flail of the heart valve leaflets.

In some applications, the system includes a sheet attached over the wireform. The sheet forms the contact surface.

In certain applications, the sheet has a length and a width to cover a prolapse or a flail of the heart valve leaflets.

In certain applications, the sheet system can provide contact pressure over a prolapse or a flail of the heart valve leaflets.

In certain applications, the device contains an impermeable engaging portion and a permeable non- engaging portion.

In some applications, the impermeable joint portion is thickened.

In some applications, the impermeable joint can be thickened at the site of implantation.

In certain applications, the sheet system is lactic acid-glycolic acid copolymer (PLGA), polyvinyl chloride (PVC), polyethylene (PE), polypropylene (PP), polytetrafluoroethylene (PTFE), Polyurethane (PU), Polyethylene terephthalate (PET), Polyether terephthalate (PES), Polyglycolic acid (PGA), Polylactic acid (PLA), Poly-D-lactic acid (PDLA), Poly -4-hydroxybutyrate (P4HB) or polycaprolactone (PCL).

In some applications, the system includes a reaction force support relative to the joint area.

In certain applications, the reaction force support is configured to engage a heart chamber wall.

In some applications, the anchor is a helical anchor, a W-shaped anchor, a T-shaped anchor, or a single-turn helix.

In certain applications, the anchorage is one or more helical anchors located within a tubular compartment housing. The tubular compartment housing is attached to the device.

In certain applications, the one or more helical anchors are a single helical anchor wrapped within itself compressed within the tubular compartment housing.

In certain applications, the one or more helical anchors are two or more helical anchors stacked on top of one another in series and compressed in the tubular septum inside the chamber enclosure.

In certain applications, the one or more helical anchors are two or more helical anchors comprising an inner helix (or inner helical anchor portion) and an outer helix (or outer helical anchor portion) and compressed within the tubular compartment housing.

In certain applications, the two or more helical anchors are configured to be embedded within the tissue at two oblique angles to each other.

In some applications, the system includes a fulcrum attached to the tubular compartment housing such that the plane of the device interface is adjustable.

In some applications, the system includes a sliding mechanism incorporated on the edge of the tubular compartment housing such that the plane of the device interface is adjustable.

In some applications, the system includes a swing hinge or a soft hinge that is attached to the device.

In some applications, the device incorporates an internal gap in the engagement region of the device. This internal gap does not contain wire forming.

In some applications, the device incorporates a gap filler, engagement element or spacer.

In certain applications, the gap filler/bonding element/spacer comprises a material selected from the group consisting of foam, hydrogel or silicone.

In some applications, the gap filler/engagement element/spacer incorporates a scissor mechanism or a coil.

In some applications, the device incorporates an expandable stent.

In certain applications, the device is configured to be implanted within the mitral valve.

In certain applications, the system includes a delivery catheter, wherein the device and the anchor are each compressible within the delivery catheter.

In certain applications, the delivery catheter is configured to be delivered via a transfemoral, subclavian, transapical, transseptal, or transaortic approach.

In certain applications, the device and the anchor are configured to be delivered to a mitral valve through a coronary sinus via a transcatheter procedure.

In some applications, a netting system is intended for use within a heart valve. The netting system includes a netting device having a netting with a contact surface capable of providing contact pressure over an inflow surface of a heart valve leaflet. The side edges of the netting device can be seated within a heart valve cleft. The netting system includes an anchor attached to the netting and capable of anchoring within the tissue of the leaflet, annulus, or chamber wall.

In certain applications, the netting system is lactic acid-glycolic acid (PLGA), polyvinyl chloride (PVC), polyethylene (PE), polypropylene (PP), polytetrafluoroethylene (PTFE), Polyurethane (PU), Polyethylene terephthalate (PET), Polyether terephthalate (PES), Polyglycolic acid (PGA), Polylactic acid (PLA), Poly-D-lactic acid (PDLA), Poly -4-hydroxybutyrate (P4HB) or polycaprolactone (PCL).

In some applications, the anchor is a helical anchor configured to be received within a tubular compartment connected to the netting device.

In some applications, the netting system includes a tether extending from an engagement portion of the netting device.

In certain applications, the netting system includes a wire form that outlines the netting.

In certain applications, the netting device is configured to be implanted within a mitral valve, a tricuspid valve, an aortic valve, or a pulmonary valve.

In certain applications, the netting system includes a delivery catheter. The netting device and the anchor are each compressible within the delivery catheter.

In certain applications, a method for repairing a native heart valve of a heart comprises transvascularly advancing a delivery catheter to the native heart valve, attaching an anchor (which may be the same as or similar to the delivery catheter) to the native heart valve advance of any of the anchors or anchoring features described herein) into the tissue of the heart, thereby placing a leaflet repair implant/device (which may be the same as or similar to any implant described herein) (device/device) anchoring to the tissue, and releasing the leaflet repair implant/device from the delivery catheter so that the leaflet repair implant/device is along a portion of a leaflet of the native heart valve to extend.

In certain applications, the anchor is advanced from the delivery catheter into the tissue of the heart, thereby anchoring the leaflet repair implant/device to the tissue, tied to release the valve from the delivery catheter The leaflet repair implant is previously completed such that the leaflet repair implant extends along a portion of a leaflet of the native heart valve.

In certain applications, the anchor is advanced from the delivery catheter into the tissue of the heart, thereby anchoring the leaflet repair implant to the tissue, tethering the leaflet repair from the delivery catheter The implant is then completed such that the leaflet repair implant extends along a portion of a leaflet of the native heart valve.

In certain applications, transvascularly advancing a delivery catheter to the native heart valve is accomplished via a transfemoral, subclavian, transapical, transseptal, or transaortic approach.

In certain applications, transvascularly advancing a delivery catheter to the native heart valve is accomplished via a transseptal approach across an atrial septum, and wherein the native heart valve is a mitral valve.

In certain applications, the anchor is a helical anchor, and the anchor is advanced from the delivery catheter into tissue of the heart, thereby anchoring the leaflet repair implant/device to the tissue, comprising The helical anchor is rotated into the tissue. Other types of anchors are also possible.

In certain applications, the tissue is part of an annulus of the native heart valve, and wherein rotating the helical anchor into the tissue comprises rotating the helical anchor into the annulus of the native heart valve.

In certain applications, the leaflet repair implant/device is released from the delivery catheter such that the leaflet repair implant/device extends along the portion of the leaflets of the native heart valve, comprising releasing the leaflet repair implant/device from the delivery catheter such that the leaflet repair implant/device is along a prolapsed portion of the leaflet and a flail portion of the leaflet. at least one of them to extend and apply a contact pressure to it.

In certain applications, releasing the leaflet repair implant/device from the delivery catheter includes converting the leaflet repair implant/device from a compressed delivery configuration inside the delivery catheter to an expanded configuration that is external to the delivery catheter.

In certain applications, the leaflet repair implant/device is a contact pressure implant configured to apply a contact pressure to a native leaflet. The implant/device can be the same as or similar to any of the implants/devices described anywhere herein that apply a contact pressure to a native leaflet of a native valve.

In certain applications, the leaflet repair implant/device is a compression implant/device, and releasing the leaflet repair implant from the delivery catheter comprises the compression implant The device is attached to the leaflet such that a portion of the leaflet experiencing prolapse, flail or stiffness is on an inflow side of the compression element (eg, one is attached to or in contact with an inflow side of the leaflet). is compressed between the side of the outflow side) and an outflow side (eg, a side attached to or in contact with an outflow side of the leaflet). The compressive implant/device may be the same as or similar to implants that apply a compressive force to or compress a native leaflet of a native valve as described anywhere herein any of the objects/devices.

In certain applications, the leaflet repair implant/device is a rod-type implant/device, and wherein releasing the leaflet repair implant from the delivery catheter comprises securing the distal end of the rod element Anchored within the commissures of the native heart valve. The rod-type implant/device may be the same as or similar to any of the implants/devices described anywhere herein that include a rod, elongated extension, arch, arched rod, etc. one.

In certain applications, the leaflet repair implant/device is a netting implant/device, and releasing the leaflet repair implant/device from the delivery catheter includes releasing from the delivery catheter The netting implant/device. The netting implant/device can be the same as or similar to any of the implants/devices comprising a netting described anywhere herein.

According to certain applications, further provided herein is a system and/or for use with a valve (eg, a native valve, mitral valve, tricuspid valve, other valve, etc.) of one of the hearts of an individual A device having a chamber upstream of the valve and the system/device comprising an implant, an anchor, a catheter, and a delivery tool. The implant may contain an interface and/or a flexible wing. The wing can be coupled to the interface. The wing may have a contact surface and an opposing surface with respect to the contact surface. The catheter is typically advanced transluminally into the chamber and is configured to receive the implant.

The delivery tool may include a shaft that engages the interface. Through engagement with the interface, the shaft can be configured to deploy the implant out of the catheter such that within the chamber, the wings extend away from the interface. Alternatively or additionally, the shaft may be configured to position the implant in a position in which the interface is tethered at an address in the heart, the wings extending beyond the A first leaflet of the heart faces at least one opposing leaflet (eg, an opposing leaflet portion) of the heart, and the contact surface faces the first leaflet.

The delivery tool may include a driver engaged with the anchor and configured to anchor the implant in the position by using the anchor to anchor the interface to tissue of the heart .

In some applications, the implant does not contain a downstream anchor.

In some applications, the implant contains exactly one anchor.

In some applications, the contact surface is concave.

In some applications, the catheter is configured to receive the implant and the wings are constrained within the catheter.

In some applications, the driver is configured to anchor the implant in the location by using the anchor to anchor the interface at the location.

In certain applications, the site is located over an annulus of the valve, and the delivery tool is configured to position the implant in the location in which the interface is located at at the location on the ring, and the driver is configured to anchor the implant in that location by using the anchor to anchor the interface to tissue of the ring.

In some applications, the address is on a wall of the chamber, and the delivery tool is configured to position the implant in the position where the interface is in the position at the location on the wall of the chamber, and the driver is configured to anchor the implant at that location by using the anchor to anchor the interface to the tissue of the wall of the chamber middle.

In certain applications, the chamber is an upstream chamber, the heart has a downstream chamber downstream of the valve, the delivery tool is configured to compress the interface against the first valve leaflet, such that the first leaflet becomes sandwiched between the delivery tool and a wall of the downstream chamber, and the driver is configured to drive the anchor through the first leaflet and to the downstream chamber within the wall to anchor the interface.

In certain applications, the driver is configured to anchor the implant in the position by driving the anchor through the first leaflet and into the tissue of the heart.

In some applications, the shaft is configured, via engagement with the interface, to deploy the wings entirely out of the catheter, and the driver is configured to deploy the wings entirely on the shaft The implant is anchored in this position after deployment out of the catheter.

In some applications, the shaft is configured, via engagement with the interface, to deploy the implant entirely out of the catheter, and the driver is configured to deploy the implant on the shaft The implant is anchored in this position after deployment entirely out of the catheter.

In some applications, the driver extends through the shaft.

In some applications, the shaft is configured via engagement with the interface to deploy the implant out of the catheter when the driver is disposed within the shaft.

In some applications, the shaft is configured via engagement with the interface to deploy the implant out of the catheter when the anchor is disposed within the shaft.

In some applications, the implant is configured to be received within the catheter with the wings attached distal to the interface.

In some applications, the shaft is configured to deploy the implant out of the catheter such that the wings become exposed from the catheter prior to the interface.

In some applications, the implant includes an anchor receptor at the interface (eg, the interface may include an anchor receptor), and the driver is configured to use the anchor to The anchor receptor is anchored to the tissue and the interface is anchored to the tissue.

In some applications, the interface defines a space within which the anchor receptor is disposed.

In certain applications, the implant includes a housing that defines at least a portion of the interface and at least a portion of the anchor receptor.

In some applications, the housing includes a sidewall that defines an aperture, and the sidewall defines the interface.

In some applications, the housing defines an obstruction that protrudes at least partially through the aperture, and the driver is configured to drive the anchor through the housing until the anchor presses the obstruction Anchor the interface to the organization to the organization.

In some applications, the side wall and the shaft define respective engagement elements, and the shaft engages the interface via engagement between the engagement elements of the shaft and the engagement elements of the side wall.

In certain applications, the driver is configured to anchor the anchor receptor to the tissue by anchoring the anchor to the anchor receptor and to the tissue.

In some applications, the driver is configured to anchor the anchor to the receptacle by driving the anchor through the anchor receptacle.

In certain applications, the anchor includes a tissue-engaging element and a head, the anchor receptacle defining an aperture therethrough, and an obstruction body in a manner that facilitates passage of the tissue-engaging element through the aperture But restraint protrudes medially into the orifice in a way that prevents the head from passing through the orifice, and the driver is configured to drive the tissue-engaging element through the anchor receptacle until the head of the anchor Becoming blocked by the blocking body anchors the anchor to the anchor receptacle.

In some applications, the blocking body includes a crossbar that traverses the aperture.

In some applications, the blocking body includes a collar.

In certain applications, the barrier comprises a sheet that is penetrable by the tissue engaging element.

In certain applications, the tissue engaging element is a helical tissue engaging element and the driver is configured to drive the tissue engaging element through the anchor receiver by tightening the tissue engaging element through the anchor receiver device.

In some applications, the position is a first position, the address is a first address, and the shaft is configured, via engagement with the interface, to place the implant in the first position in position, repositioning the implant into a second position in which the interface is tethered at a second site in the heart with the wings extending beyond the first valve The leaflet faces the opposing leaflet and the contact surface faces the first leaflet, the second position is different from the first position, and the second address is different from the first address.

In certain applications, the shaft is configured to reposition the implant into the second position while the wings remain entirely outside the catheter.

In some applications, the shaft is configured to reposition the implant into the second position while the implant remains entirely outside the catheter.

In some applications, the wing includes a frame and a sheet overlaid on the frame.

In certain applications, the frame comprises at least one frame material selected from the group consisting of: Nitinol, Cobalt-Chromium (CoCr), stainless steel, titanium, polyglycolic acid, polylactic acid, polyright Spiral lactic acid, polyurethane, poly-4-hydroxybutyrate, polycaprolactone, polyether ether ketone, a cyclic olefin copolymer, polyethylene vinyl acetate, polytetrafluoroethylene, a perfluoro ethers and fluorinated ethylene propylene copolymers.

In some applications, the frame is compressible to fit within the conduit.

In some applications, the framework is self-extending.

In some applications, the frame is attached to the interface.

In certain applications, the sheet comprises at least one sheet material selected from the group consisting of lactic acid-glycolic acid copolymers, polyvinyl chloride, polyethylene, polypropylene, polytetrafluoroethylene Ethylene, polyurethane, polyethylene terephthalate, polyether, polyglycolic acid, polylactic acid, poly-D-lactic acid, poly-4-hydroxybutyrate, and polycaprolactone.

In certain applications, the wing has a root coupled to the interface, a tip at an end of one of the wings relative to the root, and two sides extending from the root to the tip side.

In certain applications, the chamber is an upstream chamber, the heart has a downstream chamber downstream of the valve, and the angled arrangement of the wings relative to the interface allows the implant to utilize The tip is positioned within the downstream chamber by the positioning of the shaft in this position.

In some applications, the first leaflet has a lip, and an angular arrangement of the wing relative to the interface enables the implant to position the tip at the Downstream of the lip of the first leaflet.

In some applications, the frame defines two rings extending side by side from the root.

In some applications, the two rings extend side by side from the root to the tip.

In some applications, the frame only connects the two rings to each other at the interface.

In some applications, the sheet material is laid over the frame such that the sheet material extends over and between the two rings.

In some applications, each of the rings defines a space that is substantially free of frame components.

In certain applications, each of the annular members is substantially teardrop shaped. In certain applications, each of the rings is substantially oval, oval, or triangular in shape.

In certain applications, the wings are curved in the direction of the valve leaflets. In some applications, the wings bend in one direction from the interface and then bend in the opposite direction moving toward the end.

In some applications, the frame defines an elongated space between the two rings extending from the root towards the tip, and the sheet is laid over the frame such that the sheet extends across the Two rings and the space.

In some applications, the elongated space runs along a reflective symmetry plane of the wing.

In some applications, the elongated space extends from the root to the tip such that the frame does not bridge the two rings at the tip.

In some applications, the sheet has holes therethrough.

In some applications, the holes are polygonal and tessellated.

In some applications, the holes are hexagonal.

In some applications, a curvature of the wing is such that in a cross-section of one of the implants through the interface and the wing, the contact surface is concave.

In certain applications, the curvature of the wings increases with distance from the interface in the cross-section of the implant.

In some applications, the cross-section lies in a reflective symmetry plane of the implant.

In some applications, the implant further includes a reaction force support extending from the interface and away from the wing.

In some applications, the reaction force support is shaped such that in this position the reaction force support rests against a wall of the chamber.

In certain applications, the catheter has a distal opening and is configured to receive the implant with the wings disposed away from the interface and the interface disposed away from the reaction force support.

In some applications, the reaction force support includes a wire loop.

In some applications, the shaft is configured to engage the interface within the catheter such that within the catheter, the shaft extends proximally away from the interface and is supported by the reaction force.

In some applications, the anchor is a first anchor, and the system/device further includes a second anchor configured to anchor the interface to the tissue.

In some applications, the driver is configured to anchor the implant in the position by using the second anchor to anchor the interface to the tissue.

In some applications, the driver is a first driver, and the delivery tool further includes a second driver engaged with the second anchor and configured to use the second anchor to The interface is anchored to the tissue to anchor the implant in the position.

In certain applications, the anchor includes a helical tissue engaging element and the driver is configured to anchor the implant in the position by tightening the tissue engaging element into the tissue.

In certain applications, the tissue engaging element is a first tissue engaging element and the anchor further comprises a second helical tissue engaging element, the first tissue engaging element and the second tissue engaging element being arranged as a double spiral.

In certain applications, the anchor has a proximal end and a distal end, and each of the first tissue engaging element and the second tissue engaging element has a sharpened tip at the distal end of the anchor The tip is shaped as a conical helix that widens towards the distal end of the anchor.

In some applications, the first tissue-engaging element is defined by a first wire and the second tissue-engaging element is defined by a second wire.

In certain applications, along a longitudinal axis of the anchor, the anchor has: a tissue-engaging region in which a first wire defines the first tissue-engaging element and a second wire defines the first tissue-engaging element Two tissue-engaging elements, and the first wire and the second wire each have a tissue-engaging pitch such that within the double helix, the turns of the first wire and the turns of the second wire are axially oriented spaced apart.

In some applications, the anchor also has a head region in which the first wire and the second wire each have a head pitch such that within the double helix, the first wire The turns of the second helix abut the turns of the second helix. The head region may also be aligned along the longitudinal axis of the anchor.

In certain applications, the tissue engagement pitch of the first wire is at least 4 times greater than a thickness of the first wire.

In some applications, the anchor includes a wire system with a sharp distal tip. In certain applications, the wire has: a first helical portion having a first pitch and defining a head portion of the anchor; and a second helical portion having a greater than the first helical portion A second pitch of pitches, defines the tissue engaging element and terminates at the sharp distal tip. In certain applications, the first pitch configures the first helical portion to resist being screwed into the tissue.

In certain applications, the contact surface is shaped to define a leaflet thickening element configured to induce thickening of the first leaflet where the wing extends beyond the first leaflet.

In certain applications, the leaflet thickening elements include protruding formations.

In certain applications, the leaflet thickening elements include concave portions.

According to certain applications, further provided herein is a method for use with a valve (eg, a native valve, mitral valve, tricuspid valve, other valve, etc.) of one of the hearts of an individual, the heart Having a chamber located upstream of the valve and the method comprising within a catheter, advancing the following to the chamber: (1) an implant comprising an interface and a flexible wing coupled to the chamber An interface, the wing has a contact surface and an opposite surface relative to the contact surface; and (2) an axis connected to the interface.

In certain applications, the method further includes deploying the implant out of the catheter using the shaft such that within the catheter, the wings extend away from the interface.

In certain applications, the method further includes subsequently using the shaft to position the implant at a location where the interface is tethered at a site in the heart with the wings extending beyond the valve A first leaflet of the valve faces at least one opposing leaflet (eg, an opposing leaflet portion) of the valve, and the contact surface faces the first leaflet.

In certain applications, the method further includes subsequently positioning the implant in the location by anchoring the interface to tissue of the heart.

In certain applications, advancing the implant to the chamber includes advancing the implant to the chamber while the wings are constrained within the catheter.

In certain applications, the wing has a root coupled to the interface, and a tip at an end of one of the wings relative to the root, the chamber is an upstream chamber, the heart has A downstream chamber located downstream of the valve, and positioning the implant in the position includes positioning the implant such that the tip is disposed within the downstream chamber.

In some applications, the wings have a root coupled to the interface, and a tip at an end of one of the wings relative to the root. In certain applications, the first leaflet of the valve has a lip, and positioning the implant in the position includes positioning the implant such that the tip is disposed on the first leaflet downstream of the lip.

In some applications, the contact surface is concave, and positioning the implant in the position includes positioning the implant such that the concave contact surface contacts the first leaflet.

In certain applications, positioning the implant in the position includes positioning the implant such that the opposing faces contact the opposing leaflets.

In certain applications, the valve is a mitral valve of the heart, the chamber is a left atrium of the heart, and advancing the implant into the chamber comprises advancing the implant into the left atrium .

In certain applications, the valve is a tricuspid valve of the heart, the chamber is a right atrium of the heart, and advancing the implant into the chamber comprises advancing the implant into the right atrium .

In certain applications, the valve is an aortic valve of the heart, the chamber is a left ventricle of the heart, and advancing the implant to the chamber comprises advancing the implant to the left ventricle .

In certain applications, the valve is a pulmonary valve of the heart, the chamber is a right ventricle of the heart, and advancing the implant to the chamber includes advancing the implant to the right ventricle.

In some applications, the address is located on an annulus of the valve, and anchoring the interface to tissue of the heart includes anchoring the interface to tissue of the annulus.

In some applications, the address is located on a wall of the chamber, and anchoring the interface to the tissue of the heart includes anchoring the interface to the tissue of the wall of the chamber.

In certain applications, anchoring the interface to the tissue of the heart includes securing the first leaflet to the tissue of the heart.

In certain applications, the chamber is an upstream chamber, the heart has a downstream chamber downstream of the valve, and positioning the implant in that position includes pressing the interface against the first leaflets such that the first leaflet is sandwiched between the delivery tool and a wall of the downstream chamber, and anchoring the implant in the position comprises driving an anchor through the first leaflet and into the wall of the downstream chamber.

In some applications, anchoring the interface to the tissue includes using a driver to drive an anchor into the tissue.

In certain applications, the anchor includes a tissue-engaging element, and using the driver to drive the anchor into the tissue includes using the driver to tighten the tissue-engaging element into the tissue.

In some applications, the implant includes an anchor receptor located at the interface, and the method further includes using the driver to anchor the anchor to the anchor receptor.

In certain applications, anchoring the interface to the tissue includes using the driver to drive the anchor through the anchor receptor and into the tissue.

In certain applications, the anchor includes a tissue engaging element and a head, the anchor receptacle defines a port therethrough, and includes a blocking body projecting medially into the port, and the use of the The driver to drive the anchor through the anchor receptacle and into the tissue includes using the driver to drive the tissue engaging element past the obstruction body until the head of the anchor becomes obstructed by the obstruction body.

In some applications, the obstructing body includes a rail that traverses the orifice, and the driver is used to drive the tissue engaging element beyond the obstructing body until the head of the anchor becomes contained by the obstructing body. The driver is used to drive the tissue engaging element past the rail until the head of the anchor becomes obstructed by the rail.

In some applications, the blocking body includes a collar, and using the driver to drive the tissue engaging element past the blocking body until the head of the anchor becomes blocked by the blocking body includes using the driver to drive the The tissue engaging element passes over the collar until the head of the anchor becomes obstructed by the collar.

In certain applications, the obstruction body comprises a flexible sheet, and using the driver to drive the tissue engaging element beyond the obstruction body until the head of the anchor becomes obstructed by the obstruction body involves using the driver to pierce the sheet with the tissue engaging element and drive the tissue engaging element through the sheet until the head of the anchor becomes obstructed by the sheet.

In certain applications, the implant includes a housing including a sidewall defining an aperture, the sidewall defining at least a portion of the interface, and positioning the implant in the position includes using the shaft to The implant is positioned in this position with the shaft engaging the sidewall.

In certain applications, the implant defines a barrier that protrudes at least partially through the orifice, and anchoring the interface to the tissue includes driving the anchor through the housing by using the driver until the anchor The barrier is pressed against the tissue to anchor the shell to the tissue.

In certain applications, the implant further includes a reaction force support, and deploying the implant out of the catheter includes deploying the implant out of the catheter such that the reaction force support is removed from the catheter. The interface extends away from the wing.

In certain applications, the position is a position in which the reaction force support rests against a wall of the chamber, and positioning the implant in the position includes positioning the implant in the The reaction force support rests in the position of the wall of the chamber.

In some applications, deploying the implant out of the catheter includes deploying the following out of the catheter: the wings, followed by the interface, followed by the reaction force support.

In certain applications, deploying the implant out of the catheter includes deploying the wings out of the catheter while the shaft extends proximally within the catheter away from the interface and by the reaction force support.

In certain applications, positioning the implant in the position includes positioning the implant in the position after the wings are fully deployed out of the catheter.

In certain applications, positioning the implant in the position includes positioning the implant in the position after the implant has been fully deployed out of the catheter.

In some applications, the location is a first location, the address is a first location, and the method further comprises: after placing the implant in the first location, the implant repositioning into a second position in which the interface is located at a second location in the heart, the wing extending beyond the first leaflet towards the opposing leaflet, And the contact surface faces the first leaflet, the second position is different from the first position, and the second address is different from the first address.

In some applications, the first address is a first address on a ring of the valve and the second address is a second address on the ring of the valve.

In some applications, repositioning the implant into the second position includes sliding the interface along the ring using the shaft.

In some applications, repositioning the implant into the second location includes using the shaft to lift the interface away from the ring at the first location, and to return the interface at the second location. Reposition the interface against the ring.

In certain applications, repositioning the implant into the second position includes repositioning the implant into the second position prior to anchoring the interface to the tissue.

In certain applications, the method further includes unanchoring the interface from the organization after anchoring the interface to the organization, repositioning the interface to the second location includes unanchoring the interface from the organization The implant is then repositioned into the second position, and the method further includes re-anchoring the interface to the tissue after repositioning the implant into the second position.

In certain applications, the method further comprises: receiving a message indicative of regurgitation through the valve while the implant is positioned at the first position, and repositioning the implant to the second position Within includes repositioning the implant into the second position in response to receiving the message.

In some applications, the message is an electrocardiogram message, and repositioning the implant into the second position includes repositioning the implant into the second position in response to receiving the electrocardiogram message.

In certain applications, repositioning the implant into the second position includes repositioning the implant into the second position while the wings remain entirely outside the catheter.

In certain applications, repositioning the implant into the second position includes repositioning the implant into the second position while the implant remains entirely outside the catheter .

In some applications, deploying the implant out of the catheter includes deploying the implant out of the catheter when the driver is disposed within the shaft.

In certain applications, deploying the implant out of the catheter includes deploying the implant out of the catheter when the anchor is disposed within the shaft.

The method(s) above can be on a live animal or on a simulation, such as on a cadaver, cadaver heart, simulator (eg, with simulated body parts, heart, tissue, etc.), etc. above, to be implemented.

The present invention will be more fully understood from the following detailed description of its application, together with the drawings, wherein:

Detailed description

Systems, apparatus, devices, methods, etc. for alleviating heart valve insufficiency are described herein. In certain applications, systems, devices, devices, methods, etc., comprise implants/devices tethered within a valvular annulus and anchored within the annulus and/or adjacent vasculature. Such systems, apparatus, devices, methods, etc. may be configured to provide contact pressure onto and/or support leaflet regions experiencing flail, prolapse, rigidity, and the like. In certain applications, systems, devices, devices, methods capable of compressing over a leaflet and providing contact pressure over and/or supporting the region of the leaflet subject to flail, prolapse, rigidity, etc. etc. are described, such as compression elements, clasps, splints, templates, and the like. In certain applications, systems, devices, devices, etc. are described that are further anchored within the leaflet annulus or an adjacent vasculature, which provide contact pressure to withstand flail, Provide support over and/or to the leaflet region of prolapse, stiffness, etc. Various examples of methods for delivering and implanting systems, devices, devices, etc. to the site of flail, prolapse, rigidity, etc. are described. An example of a situation where these may be helpful is when used at the posterior leaflet of a mitral valve that suffers from flail, prolapse, stiffness and/or other problems.

The systems, apparatus, devices, methods, etc. described are not to be construed as limiting in any way. Rather, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed implementations and applications, individually and in various combinations and subcombinations with each other. The disclosed systems, apparatus, apparatus, methods, etc. are not limited to any particular aspect, feature, or combination thereof, nor do the disclosed systems, apparatus, apparatus, methods, etc. require: any one or more A particular advantage exists or a problem is solved. Furthermore, the techniques, methods, operations, steps, etc. described or suggested herein may be on a living animal (eg, humans, other mammals, etc.) or on an inanimate simulation, such as on A cadaver, cadaveric heart, simulator (eg, with simulated body parts, tissue, etc.), anthropomorphic phantom, etc., to execute.

Various implementations of systems, devices, examples of prosthetic implants, etc. are disclosed herein, and any combination of the described features, components and options may be made unless specifically excluded. For example, the variously described anchors may be used with any suitable prosthetic device and/or delivered and implanted by any suitable method, even if a particular combination is not expressly described. Likewise, different configurations and features of devices and systems may be mixed and matched, such as by combining any implant device type/feature, attachment type/feature, location of repair, etc., even if not expressly reveal. In short, the individual components of the disclosed system can be combined unless mutually exclusive or physically impossible.

Although the operation of certain disclosed methods has been described in a particular sequential order for ease of presentation, it should be understood that this description encompasses rearrangements unless a particular ordering is in the particular language set forth below Required. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Furthermore, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed systems, devices, devices, methods, etc. may be used in conjunction with other systems, devices, devices, methods, etc. Way.

Figure 1 is a coronal plan view within the left chambers cut through the coaptation region of the mitral valve, and Figure 2 is a transverse plan view within the left atrium above the mitral valve. The left ventricle (LV) and the left atrium (LA) are separated by the mitral valve (MV). Each of the four valves of the heart has flexible leaflets that extend inwardly through respective orifices, which come together or "coapt" in the blood flow to form a one-way fluid barrier surface. Thus, referring back to the left chambers, oxygenated blood is brought from the pulmonary vein (not shown) to the left atrium and then diverted across the mitral valve into the left ventricle. The left ventricle pumps oxygenated blood through the aortic valve, into the aorta, and throughout the body.

Also shown in Figure 1 is the mastoid muscle (PM), which is attached to the left ventricular wall via the chordae tendineae (CT) and connected to the mitral valve (MV) leaflets . These muscles and cords assist the function of the mitral valve (MV) to open the leaflets to form an orifice, to engage the leaflets to close the orifice, and to maintain leaflet shape and position.

Figure 1 also shows the coronary sinus (CS), a vasculature surrounding the left ventricle. Throughout the present disclosure, the coronary sinus is used as an example to serve as an adjacent vasculature site for docking anchors for the various implementations described.

Figure 3 provides an example of a leaflet flail, while Figure 4 provides an example of leaflet prolapse. Leaflet flail occurs when the coapted portion of the leaflet flips backwards against blood flow. Likewise, leaflet prolapse occurs when a portion of the leaflet bulges posteriorly. Flails and prolapses can occur due to a variety of different conditions including, but not limited to, mastoid muscle (PM) and/or chordae tendineae (CT) dysfunction. In the examples provided in Figures 3 and 4, ruptures in the chordae tendineae (CT) result in leaflet flail and prolapse, respectively. Leaflet flail and prolapse may also occur due to stretch of the chordae tendineae (CT). Leaflet flail, prolapse, stiffness, and/or leaflet problems may cause one of the coaptations to fail, resulting in regurgitation of blood flow.

Throughout this document, descriptions and drawings refer generally to the left chambers, and in particular to the mitral valve (MV) and coronary sinus (CS), as an example for the various implementations described example. It is to be noted, however, that the various implementations and applications described may be applied mutatis mutandis to other valves (eg, tricuspid, pulmonary, aortic, valve, etc.) and other vasculature (eg, coronary arteries, etc.).

Several implementations and applications herein are directed to systems, devices, devices, etc. (eg, leaflet repair systems, brakes, etc.) that are directed toward immobilizing or otherwise treating valve leaflet problems (such as flail, prolapse, stiffness, etc.). system, prolapse repair system, flail repair system, repair system, etc.). In certain applications, a system, apparatus, device, etc. herein can be seated on the inflow side of a valve such that it can exert contact over an area of flail, prolapse, rigidity, etc. pressure or support. The contact pressure or support provided by various implementations can help to flatten and/or reshape the flail, prolapse, rigidity and/or abnormality, which assists in coapting a leaflet when in a closed position The edge extends rearwardly towards the junction area. Normal coaptation resulting in a fully closed valve prevents valve insufficiency. In certain applications, the system, apparatus, device, etc. is configured to support, brake and/or depress a leaflet to prevent flailing or inversion of the leaflet towards the inflow side of the valve. Likewise, in certain applications, the system, apparatus, device, etc. is configured to support, brake and/or depress a leaflet to prevent prolapse or bulge of the leaflet towards the inflow side of the valve .

In certain applications, a system, device, device, etc. herein (eg, leaflet repair system, brake system, prolapse repair system, flail repair system, repair system, etc.) includes (but is not limited to) a facet Tie to come in direct contact with the face of a leaflet experiencing a leaflet problem (eg, flail, prolapse, stiffness, etc.). Typically, the inflow face of a leaflet is the face that experiences flail, prolapse, stiffness and/or problems. In some applications, the contact surface of the device conforms to the profile of the inflow surface of a leaflet, which may be a hyperbolic paraboloid-like profile. In certain applications, the contact surface of the system/device provides contact pressure over a leaflet flail, prolapse, rigidity and/or abnormality. In certain applications, the contact surface has a width and a length such that it can cover the area of the leaflet that experiences flail, prolapse, rigidity, and/or abnormalities. In certain applications, the length of the system/device extends into the coaptation region of the leaflet. In certain applications, the coaptation portion of the system/device helps facilitate coaptation of the leaflets when closed.

In certain applications, the system, apparatus, device, etc. herein contain an anchor to stabilize the system/device at the implanted site. In some applications, a system/apparatus includes a portion connected to the anchor. In certain applications, the anchor attachment point (eg, an anchor receiver) is tied adjacent to or in contact with the valve annulus or a ventricular or atrial wall. In some applications, an anchor point includes a hinge that can adjust the plane of the interface of the system/device relative to the anchor point. In some applications, a swing hinge is used. In some applications, a hinge is made of soft compliant material (eg, cloth or mesh) such that the plane of the system/device interface is adjustable relative to the anchor point. In some applications, a fulcrum is incorporated at the anchor point such that the plane of the contact surface is adjustable relative to the anchor point. In some applications, sliding mechanisms are incorporated at the edges of the anchor point such that the plane of the contact surface is adjustable relative to the anchor point.

In some applications, the anchor attachment point or anchor receiver is configured as an interface. The interface can be connected to a catheter or shaft for delivery and positioning of the system/device.

In certain applications, an anchor is seated adjacent to or in contact with the valve annulus, leaflet region, or atrial/ventricular wall. In some applications, an anchor is a helical anchor, screw or other feature that can be screwed/rotated or embedded within the valve annulus, leaflet or atrial/ventricular wall.

In some applications, a helical anchor is housed within a tubular compartment connected to or to be anchored to a portion of the device. In certain applications, the tubular compartment contains one, two or more helical or helical anchor portions within it to anchor the device. In certain applications, the helical or helical anchor portion(s) is pushed through the tubular compartment to screw or rotate into the tissue at the anchoring site. In certain applications, the helical or helical anchor(s) may be compressible (eg, like a spring) within the tubular compartment such that the tubular compartment maintains a low profile; when the(s) The helical or helical anchor portion(s) is decompressed when the helical or helical anchor portion is screwed or rotated into position within the tissue at the anchoring site. In certain applications with a single helical or helical anchor portion located within the housing, the helical or helical anchor portion is coiled within itself to maintain a very low profile. In certain applications where two or more helical or helical anchors are located within the housing, the helical or helical anchor(s) are stacked on top of one another in series. In certain applications having two or more helical or helical anchor portions located within the housing, one helical or helical anchor portion is positioned radially within the other helical or helical anchor portion, Rather, there is at least one inner helical or inner helical anchor portion and at least one outer helical or outer helical anchor portion. In certain applications having two or more helical or helical anchor portions located within the housing, the helical or helical anchor portion(s) are configured to be embedded at two oblique angles to each other to the within the organization at the anchor address.

In certain applications, an anchor is positioned adjacent to or in contact with the ventricular or atrial wall on the opposite side of the wall of the anchor attachment point (eg, within the adjacent vasculature). In some applications, a connector is applied to connect the anchor, the connector traversing through the ventricle or atrial wall. Any suitable connector may be used, such as, for example, a screw, rivet, suture, staple, wire, pin or shaft. In some applications, a connector wire is applied such that the wire tension between the device and the anchor is taut.

In some applications, an anchor is seated within the vasculature on opposite sides of the walls of a chamber (ie, ventricle or atrium). For example, various implant or device implementations herein are configured to alleviate leaflet problems (such as flail, prolapse, and/or stiffness) of the mitral valve and thus sit within the left atrium . In these various implementations, a device can be connected to an anchor that is seated in the coronary sinus using a connector traversing through the atrial wall. Any suitable anchor can be applied. In some applications, an anchor is a wire stent or wire molding capable of expanding within the vasculature. In some applications, an anchor is a pin fastener (eg, R-pin, etc.) or wire fastener capable of securing a device to the ventricle or atrial wall via a connector. In some applications, a pin or wire fastener is applied to the opposite side of a ventricle or atrial wall, and the connector traverses the wall. In some applications, a pin fastener is applied within the vasculature on the opposite side of a ventricle or atrial wall. In some applications, a wire fastener system can pinch a connecting wire to hold the wire in place and create tension between the wire fastener anchor and the device.

In certain applications, a system and/or device is anchored using a T-anchor that fits within and adheres to a cleft (eg, cleft or commissure) within the heart valve. In some applications, a T-anchor has two arms (ie, the transverse portion of the T-shape) and a connecting portion (ie, the vertical portion of the T-shape). In some applications, the connecting portion is connected to a device to hold the device at the deployed site. In some applications, the two arms can be retracted and expanded; in a retracted state, the two arms are parallel (or nearly parallel) to the connecting portion, and in an extended state, the two The arms are orthogonal (or nearly orthogonal) to the connecting portion. In certain applications, when the anchor is deployed, the two arms enter into the cleft in a retracted state and are captured in the cleft within the heart valve and below the leaflet expand so that it is anchored within the fissure.

In certain applications, one of the systems, implants and/or devices herein is otherwise anchored or secured directly to the leaflets that are experiencing problems (eg, flail, prolapse, stiffness, and/or other problems). In some applications, an anchor is a pin fastener (eg, R-pin, R-key, etc.) or wire fastener that can secure a device to the leaflet via a connector. In some applications, a pin or wire fastener is applied on the outflow side of a leaflet (eg, one of the ventricular sides of an atrioventricular valve leaflet) and the connector traverses through the leaflet. In some applications, an anchored system/device has a length extending from the anchor to the coaptation edge of a leaflet, where a clamp is applied by pinching the device edge and the leaflet edge The system/device is anchored to the leaflet edge by shrinking or compressing it together.

In certain applications, a system and/or device herein incorporates a tether or artificial chord for further stabilization at the implanted site. In some applications, a tether or string extends from the engagement portion of a device to a securing site on the outflow side of the valve where the tether is secured. The fixation site may be any sturdy feature, such as, for example, a ventricular wall, atrial wall, mastoid muscle, and/or adjacent vasculature.

In certain applications, a system and/or device herein (eg, leaflet repair system/device, brake system/device, prolapse repair system/device, flail repair system/device, repair system/device, etc.) Contains a wire forming frame and/or a wire forming element (eg, an element that contains a wire forming frame). Any suitable material used to create a wire form may be used, including (but not limited to): Nitinol, Cobalt-Chromium (CoCr), Stainless Steel, Titanium, Polyglycolic Acid (PGA), Polylactic Acid (PLA), Poly-D-Lactic Acid (PDLA), Polyurethane (PU), Poly-4-hydroxybutyrate (P4HB), Polycaprolactone (PCL), Polyetheretherketone (PEEK), Cyclic Olefin Copolymerization compounds (COCs), polyethylene vinyl acetate (EVA), polytetrafluoroethylene (PTFE), perfluoroethers (PFA), fluorinated ethylene propylene copolymers (FEP), their additives, and derivatives of these . In certain applications, a wire forming element or wire forming frame is collapsible for fitting into a catheter in a tighter or folded configuration for less invasive catheter delivery methodologies, This is useful. In certain applications, nitinol systems are used for their self-expanding properties, which may be useful for implanting the device in a less invasive catheter delivery methodology.

Various shapes of wire forming elements or wire forming frames can be used in a wide variety of different implementations and applications. In certain applications, a wireformed frame/element is formed with the wireformed portion to provide contact pressure or support for the leaflet problem (eg, flail, prolapse, and/or stiffness for a leaflet) . In certain applications, a wire forming frame/element has a length and width to surround an area of flail or prolapse and applies a sheet extending across the area to provide contact over the flail, prolapse, rigidity, etc. pressure. In some applications, a wire forming frame or wire forming element has a length and width to surround a flail or prolapse area and a wire that undulates or crosses across the area is applied to prevent the flail, prolapse, stiffness, etc. provide contact pressure. In some applications, a wire forming frame or wire frame element is tied wire-free at an inner portion of one of the joint regions that lacks wire, so that any future procedures that may be required at some later time can still be found at (eg, an edge-to-edge repair, such as suturing or clamping the leaflet edges together) is performed over the native leaflet coaptation area. In certain applications, a wire-forming frame or wire-forming element includes a support or reaction force support extending from the portion of the wire-forming element relative to the engagement region, which assists the wire-forming element in the flail, prolapse , stiffness, etc. to provide contact pressure. In certain applications, the support or reaction force support is configured to contact a heart chamber wall (eg, an atrium or ventricle wall). In some applications, a wire forming element includes an indentation or hook formed through the wire, which aids in or hooks by fitting within the commissures, slits or other similar valve regions On top of these the device is anchored within the implanted site.

In certain applications, a system and/or device herein (eg, leaflet repair system/device, brake system/device, prolapse repair system/device, flail repair system/device, repair system/device, etc.) Incorporation A sheet is attached over a wire form capable of forming a contact surface. In certain applications, a sheet provides a surface capable of providing contact pressure or support over a leaflet that is experiencing problems such as flail, prolapse and/or stiffness. A sheet can be impermeable, semi-permeable, or permeable to fluids (eg, blood or plasma). In some applications, the sheet is a mesh. In some applications, a mesh system is formed using overlapping and intersecting staggered strands. A mesh or permeable sheet can beneficially provide contact pressure/support without restricting the flow of blood or plasma, which may be important in a variety of applications. For example, an impermeable sheet can trap blood or plasma between the device and the valve leaflets, which may in turn create undesired pressure on the valve and/or create displacement or alteration of the device position pressure. In some applications, the sheet is partly an impermeable material and partly a permeable mesh. For example, in some applications, a system/device herein employs an impermeable material for an engaging portion and a permeable mesh for a non-engaging portion of the device. In certain applications, when coapted, the impermeable coaptation portion helps promote normal closure of a native valve. In some applications, a mesh is formed using a mesh sheet. For a sheet and/or mesh, any suitable material may be applied, including (but not limited to): lactic acid-glycolic acid copolymer (PLGA), polyvinyl chloride (PVC), polyethylene (PE) , Polypropylene (PP), Polytetrafluoroethylene (PTFE), Polyurethane (PU), Polyethylene terephthalate (PET), Polyether (PES), Polyglycolic acid (PGA), Polylactic acid (PLA), poly-D-lactic acid (PDLA), poly-4-hydroxybutyrate (P4HB) or polycaprolactone (PCL). Any suitable means for attaching a sheet and/or mesh to a wire form may be applied, including but not limited to: stitching, staples, and glue. Optionally, in certain applications, the sheet is a form-fit cover that extends across the wireform or wireform frame.

In some applications, a wire forming element or a system/device with a wire forming frame has a static part and a dynamic part. In certain applications, the static portion can be seated within the valve and may contain indents and/or hooks to be fitted by fitting within the commissures or other similar leaflet areas or hooking on these to anchor the device within the implanted site. In some applications, the dynamic portion includes a sheet to help provide contact pressure and/or support over a leaflet, eg, to address flail, prolapse, stiffness, and the like. In certain applications, the dynamic portion can be repositioned or resized during the implantation procedure so that it can properly cover the leaflet area that suffers from the flail, prolapse, stiffness, and/or other problems .

In certain applications, the system/device is configured to help facilitate coaptation of the leaflets when closed. In some applications, a gap filler, engagement element or spacer is incorporated into the system/device. In certain applications, the gap filler, engagement element or spacer extends from or within the engagement portion, which can help fill the gap within the valve orifice. In certain applications, the system/device includes an extension with an impermeable sheet extending from the leaflet lip into the orifice, which may assist in forming coaptation with other leaflets. In certain applications, the system/device includes a thickened extension that acts as a gap filler or spacer to help fill the gap within the valve orifice. Having a gap filler, engagement element or spacer is expected to beneficially assist the system/device to better manage functional mitral insufficiency by filling a gap within the valve.

In certain applications, the systems/devices herein include an expandable gap filler, expandable engagement element, or expandable spacer. The gap filler/engaging element/spacer may be expandable in various ways, eg, via inflation, injection, filling, balloon dilation, self-expanding (eg, using a shape memory material), mechanical expansion, etc. . The mechanism used to expand the expandable gap filler/bond element/spacer herein can include any of the expansion mechanisms described herein, including but not limited to: the use of a material (eg, foam , hydrogel or silicone) to fill, inflate, self-expand, balloon dilation, mechanical expansion, expansion via a stent (eg, self-expanding, balloon, mechanical), via a scissor mechanism or scissor-like mechanism to expand (eg, using a hinged joint), to expand via twisting a coil, and/or any combination of these.

In certain applications, the systems/devices herein include a gap filler/engagement element/spacer that is filled or can be filled with a material at the site of the implant, which may be when the device is This is done either at the time of implantation or in a subsequent procedure (eg, immediately after or after a certain period of time has elapsed, such as days, weeks, or months). Thus, in these applications, a material is delivered via a catheter to the device at the site of the implant, and the device is then filled, injected, inflated, etc. with the material, and thus Increase the size of the gap filler/engagement element/spacer in vivo. A variety of different materials can be applied, such as, for example, a foam, hydrogel, or silicone. In some applications, a system/device with a gap filler/engagement element/spacer includes a stent enclosing the gap filler portion of the device. Thus, a stent can be expanded at the implanted site, which can be self-expanding (eg, Nitinol), mechanically expanded, or expanded via a balloon. The system/device may have a guide or guide wire to help advance the catheter to the correct site over the gap filler/bond element/spacer to inject the material between the gap filler/bond element/spacer Inside.

In some applications, a system/device with a gap filler, engagement element or spacer is expanded at the implanted site using mechanical expansion. For example, an expansion mechanism configured as a scissors or scissor-like mechanism (or mechanism with pivoting struts) within the gap filler/engagement element/spacer portion can be used to cause the mechanical Expansion, which can be done when the device is implanted or in a subsequent procedure. Thus, in these applications, the scissors or scissor-like mechanism (or mechanism with pivoting struts) can be extended hydraulically, pneumatically, mechanically or magnetically, thereby increasing the gap filler/engagement element/spacer size of. In some applications, a catheter is delivered to the implant/device and provides a hydraulic, pneumatic, mechanical or magnetic force to expand the expansion mechanism. In some applications, a magnetic force is applied outside the body to expand the expansion mechanism. In some applications, a series of struts may be connected at a joint and hinged from a radially expanded configuration by various different struts articulating or moving at the joints (eg, in a scissors-like movement) Or move to a radially compressed configuration.

In some applications, a system/device with a gap filler/bond element/spacer uses a coil located within the gap filler/bond element/spacer portion at the site of the implant Expanded mechanically, this can be done when the device is implanted or in a subsequent procedure. Thus, in some applications, the circumference of the coil can be increased by twisting the coil, thereby increasing the gap filler/engagement element/spacer size. Various means can be used to relieve tension when the coil is twisted, such as, for example, the coil containing a number of slits or furrows on the inner portion of the coil.

In certain applications, the systems/devices herein incorporate or contain an impermeable engaging portion and a permeable and/or open non-engaging portion. In certain applications, the impermeable coaptation portion extends into the coaptation region of the leaflet. In certain applications, the impermeable coaptation portion is elongated to reach the outflow side of one or both of the opposing leaflets to aid in coaptation of the leaflets. In certain applications, the impermeable coaptation portion contains or can be injected with a filler material that thickens the coaptation portion, which can help fill the gap within the valve orifice. In some applications, the impermeable junction is extended at the site of the implant. The mechanism used to expand the impermeable joint can include any of the expansion mechanisms described herein, including but not limited to: the use of a material (eg, foam, hydrogel, or silicone) to fill, inflate, self-expand, balloon dilation, mechanically expand, expand via a stent (e.g., self-expanding, balloon, mechanical), expand via a scissor mechanism or scissor-like mechanism (e.g., using a hinge joint), expansion via twisting a coil, and/or any combination of these.

Various implementations and applications of the devices herein are intended to be used on any leaflet that suffers from flail or prolapse. Thus, in certain applications, a device can be applied over a leaflet of a mitral valve, a tricuspid valve, an aortic valve, and/or a pulmonary valve. Likewise, various implementations and applications of the device can be applied over any area of the leaflet that experiences flail or prolapse. In certain applications, a device can be applied over or adjacent to a leaflet commissure and/or any region between the commissures of a leaflet.

To reach the site of implantation, any suitable surgical, minimally invasive, or percutaneous technique can be used, including (but not limited to): a transcatheter delivery system that uses a transfemoral, clavicle Inferior, transapical, transseptal, or transaortic approaches. In certain applications, a delivery catheter is applied to incorporate a device, which is then delivered to the site of deployment via a guidewire and applied to anchor the device at the site of implantation.

Certain applications are directed to methods for delivering a device to an expanded address. The various techniques, methods, procedures, steps, etc. described or suggested anywhere herein (including in the documents incorporated herein by reference) may be other animals, etc.) or on an inanimate simulation, such as on a cadaver, cadaver heart, simulator (eg, with simulated body parts, tissue, etc.), etc., to perform. Thus, methods of delivery include methods of treatment (eg, treatment of a human subject) as well as methods of training and/or practice (eg, applying an anthropomorphic prosthesis that mimics the human vasculature to perform the method).

Figures 5 and 6 provide an exemplary depiction of an implant or device 501 with a stent anchor 503 positioned at an implanted site. As shown here, the device is positioned over the mitral valve 505 for illustration. In this example, one or more chordae tendineae 507 of the valve are ruptured resulting in leaflet flail and/or prolapse in the P2 region 509 of the posterior leaflet 511 of the valve 505 . The contact surface 513 of the device 501 is seated within the left atrium 517 on the inflow surface 515 of the posterior leaflet 511 at the site of a leaflet problem (eg, flail, prolapse and/or rigidity). or on the atrial side). The contact surface 513 may provide contact pressure on the leaflet (eg, a portion of one of the leaflets with flail, prolapse, and/or stiffness) to help flatten the leaflet [eg, its protruding configuration, bulge] (bulge), etc.] and to reduce backflow.

In some applications, the device 501 includes an engagement portion 519 that extends beyond the edge of the posterior leaflet 511 into the left ventricle 521 . The coaptation portion 519 may engage the anterior leaflet to help facilitate coaptation when the valve is closed. The device 501 has a covering or sheet 523 to help provide contact pressure over the leaflets to resolve a problem (eg, such as flail, prolapse and/or rigidity) and to aid in coaptation of the leaflets . The engaging portion may be configured as a wing or wing portion or as part of a wing or wing portion.

In some applications, the anchor 503 is a stent [eg, a wire stent, stent with alternating struts, laser-cut stent, braided stent) , balloon-expandable stent, self-expanding stent, etc.], is expanded within the coronary sinus 525 adjacent the left atrium 517. The anchor 503 is connected to the connection point 527 of the device 501 via a connector 529 that traverses through the atrial wall 531 (eg, an anchor receptacle, etc.). Thus, the anchor 503 stabilizes the device 501 at the mitral valve 505 . In some applications, a different type of anchor [eg, helical anchor, T-anchor, clamp anchor, sutured anchor, etc.] may alternatively or additionally be used, eg, An anchor can be used to anchor the device/system directly to the annulus or other adjacent tissue.

In some applications, the anchor attachment point or anchor receiver is configured as an interface. The interface can be connected to a catheter or shaft for delivery and positioning of the system/device.

Figures 7, 8 and 9 show examples of implants or devices (eg, prosthetic devices, leaflet repair devices, prolapse/flail repair devices, contact pressure devices, support devices, etc.) comprising There is a tether to further stabilize the device at an implanted site. As shown here, the device is implantable at a native valve. The implant/devices may be anchored in the coronary sinus, at the annulus, over the leaflets and/or any other channel described herein. The implant/devices may be configured to apply a contact pressure or increased support to the leaflet (eg, a portion of the leaflet, etc.).

In Figure 7, an implant/device 701 is shown seated and implanted over a native valve 703, depicted as a mitral valve for illustration. Extending from the engaging portion 705 of the device 701 is a tether 707 that extends to and connects (eg, anchors, clamps, attaches, attaches, joins, etc.) to a region of the ventricular wall 709 .

In FIG. 8, an implant/device 801 is seated and implanted over the native valve 803. Extending from the engagement portion 805 of the device 801 is a tether 807 that extends to and connects (eg, anchors, clamps, attaches, attaches, links, etc.) to a mastoid muscle 809 .

In FIG. 9, an implant/device 901 is seated and implanted over the native valve 903. Extending from the engaging portion 905 of the device 901 is a tether 907 that extends to and connects (eg, anchors, clamps, attaches, attaches, links, etc.) to the apex 909 of the ventricle.

Figures 10A, 10B and 10C show implants or devices (eg, prosthetic devices, leaflet repair devices, prolapse/flail repairs) seated in various implantation sites along the posterior leaflet of the mitral valve device, contact pressure device, support device, etc.). The implant/devices may be configured to apply a contact pressure or increased support to the leaflet (eg, a portion of the leaflet, etc.).

In Figure 10A, an implant/device 1001 is seated and implanted at the tip of the fissure between P2 1003 and P3 1005 of the posterior lobe. The device can be anchored in a variety of different ways. In some applications, the device 1001 is anchored within the coronary sinus. In some applications, the device 1001 is anchored to the ring.

In Figure 10B, an implant/device 1011 is seated and implanted at the tip of the commissure between the posterior lobe 1013 and the anterior lobe (not shown). The device can be anchored in a variety of different ways. In some applications, the device 1011 is anchored within the coronary sinus. In some applications, the device 1011 is anchored to the ring.

In Figure 1OC, an implant/device 1021 is configured to span most of the posterior lobe 1023, including Pl of the covering, all of P2, and part of P3. The device can be anchored in a variety of different ways. In some applications, the device 1021 is anchored within the coronary sinus. In some applications, the device 1021 is anchored to the ring.

Although the exemplary implantation site is depicted along the posterior leaflet of the mitral valve, it should be understood that various implementations and applications may be applied on other leaflets or within other valves .

Figures 11 and 12 show an exemplary implant or device 1101 with an anchor (eg, a repair device, a leaflet repair device, a prolapse/flail repair device, a contact pressure device, a support device, etc.). The implant/device can be anchored in a variety of different ways. In certain applications, the implant/device 1101 is anchorable within the coronary sinus. In certain applications, the implant/device is anchorable to a valve annulus at an implanted site, eg, as shown in FIG. 12 . The implant/devices may be configured to apply a contact pressure or increased support to the leaflet (eg, a portion of the leaflet, etc.).

As shown in Figures 11 and 12, the device is implantable in place of a native valve 1103 (eg, a mitral valve, tricuspid valve, etc.). The contact surface of the device 1101 is seated within the atrium 1109 of a native leaflet 1107 (shown as a posterior leaflet) at the site of flail, prolapse, rigidity and/or other leaflet abnormalities Above the inflow surface 1105 (or the atrial side). The contact surface can provide contact pressure and/or support over the flail, prolapse, rigidity, etc. to help flatten and/or reshape the bulge, protrusion, flail, etc., as well as reduce backflow blood flow. The device 1101 includes an engagement portion 1111 . The coaptation portion 1111 can be configured to cover some or all of the native leaflets. In certain applications, the coaptation portion 1111 is configured to extend beyond a lower edge of the native leaflet 1107. The engaging portion may be configured as a wing or wing portion or as part of a wing or wing portion.

In certain applications, the device 1101 has a cover layer that spans the contact surface and can help provide contact pressure and/or support over the flail, prolapse, stiffness, leaflet abnormalities, etc. and can aid in coaptation. In some applications, the cover layer is a mesh sheet. In some applications, the cover layer is one or more of the following: a cloth sheet, a polymeric sheet, a pericardium sheet, and the like. The contact surface and/or cover layer may be configured to allow blood and plasma to flow therethrough without pressure from the blood damaging, deflecting or displacing the device. A mesh cover may be particularly useful to allow blood and plasma to flow therethrough without disrupting device function.

In some applications, the device 1101 includes a selective support 1113 [eg, a reaction force support, atrial support, etc.]. The support 1113 can be configured to press against or against a wall of the heart (eg, the wall of the atrium 1109) to help orient and/or maintain the position of the device, which can help the device in a Contact pressure and/or support is provided over the native leaflets [eg, to reduce or eliminate flail, prolapse, stiffness problems and/or leaflet abnormalities]. The support 1113 may also be configured to help prevent the contact surface and/or a covering thereon from flailing or otherwise moving back to or toward the atrium in an undesired manner. For some applications, and as shown, support 1113 includes (eg, consists of): a wire loop.

In certain applications, the device 1101 further comprises an anchor 1115 to anchor the device 1101 to the valve annulus 1117. The anchor may be the same as or similar to any other anchor or anchoring mechanism described herein. In some applications, the anchor 1115 is a helical anchor that can be screwed or rotated into tissue (eg, as shown in Figure 12). A helical anchor that is rotated into annulus tissue can be particularly good at anchoring and retaining the device at the native valve because the annulus tissue is strong, and the helical design allows a large amount of contact with the tissue. Contact and articulation.

Figure 13 shows an exemplary implant or device 1301 (eg, prosthetic device, leaflet prosthetic device, prosthetic device, contact pressure device) including a stent anchor (not shown) at the site of an implant , support device, etc.) is further clamped over a native leaflet 1303 of a native valve. In certain applications, as shown here, the device is implantable at the mitral valve. The contact surface of the device 1301 is seated within the atrium 1309 of the native leaflet 1307 (eg, a posterior leaflet, etc.) at the site of flail, prolapse, stiffness problems, and/or other leaflet abnormalities on the inflow surface 1305 (or atrial side). The contact surface may provide contact pressure and/or support on flail, prolapse, etc. to help flatten and/or reshape the leaflet (eg, a protruding feature, bulge, etc.) and relieve or eliminate backflow. The device 1301 includes an engagement portion 1311. The engagement portion can be configured to extend to the edge of the leaflet 1307 . A clip 1313 can be attached at the leaflet edge to help anchor the coaptation portion 1311 and/or the contact surface to the leaflet 1307 edge. The clamp 1313 anchors the device 1301 to the posterior leaflet 1307, which allows the device 1301 to move with the posterior leaflet 1307 as it opens and closes.

In some applications, the device 1301 has a cover layer 1315. The cover layer 1315 may be the same or similar to other cover layers described herein. In certain applications, the cover layer spans the contact surface and can help provide contact pressure over the flail, prolapse, stiffness, etc. and can assist in bonding.

14 and 15 show an exemplary system or implant/device with a gap filler/engagement element/spacer 1401 and an anchor. The anchor may be the same or similar to other anchors described herein. In some applications, the system/device includes a stent anchor 1403 at an implanted site and/or within a blood vessel of the heart (eg, coronary sinus, etc.). As shown here, the gap filler/commissure element/spacer is implantable 1405 at a native valve (eg, a mitral valve, a tricuspid valve, etc.). In certain applications, the gap filler/coaptation element/spacer 1401 is a loose substance capable of filling gaps that may occur at the leaflet coaptation region 1407 when the native valve 1405 is closed. In some applications, the anchor 1403 is a stent that is extended within a blood vessel, such as the coronary sinus 1409 adjacent the left atrium 1411. In certain applications, the anchor 1403 is connected to the connection point 1413 of the gap filler/engagement element/spacer 1401 via a connector 1415 that traverses through the atrial wall 1417. Thus, the anchor 1403 stabilizes the gap filler/coaptation element/spacer 1401 at the native valve 1405.

16A and 16B show an example of an expandable stent anchor 1601 with a connector 1603. The anchor 1601 can be extended to the wall 1605 of the vasculature (eg, coronary sinus, circumflex artery, etc.) within the vasculature. The connector 1603 (eg, tether, suture, thread, wire, etc.) can extend from the anchor 1601 and traverse through the vasculature wall 1605 to connect or couple an implanted device to the anchor, Rather, the implanted device is anchored, eg, via tension.

16C and 16D show an exemplary anchor 1611 with a connector 1613 (eg, tether, suture, thread, wire, etc.). The anchor 1611 can be seated proximate the wall 1615 of the vasculature. The connector 1613 can extend from the anchor 1611 and traverse through the vasculature wall 1615 to connect or couple the anchor to the implanted device to anchor the implanted device, such as by attaching to the anchor 1611 A tensile force is created between the implanted device and the anchor 1611 to anchor the device in place.

17A, 17B, and 17C each illustrate an example of an anchor that can be anchored (eg, embedded, snapped, screwed, etc.) into native tissue. 17A illustrates an example of a curved or annular anchor 1701 with an upper portion 1703 and lower portion 1705 and a central ring 1707. The superior portion 1703 and inferior portion 1705 can be embedded in the tissue, and the central ring 1707 can be interconnected with a device to anchor it to the tissue at the site of the implant.

17B illustrates an example of an anchor 1711 with two distal ends 1713 and 1715 and an inner spine 1717. The two distal ends 1713 and 1715 can be embedded in the tissue, and the inner spine 1717 can be interconnected with a device to anchor it to the tissue at the site of the implant.

Figure 17C illustrates an example of a helical anchor 1721 that can be screwed or rotated into tissue at the lower end 1723 and attached to a device at its upper end 1725 to allow the device anchored to the tissue at the site of the implant.

17D and 17E illustrate an example of a T-anchor 1731 capable of anchoring a cleft within the heart valve (eg, within a cleft and/or commissure). The T-anchor 1731 includes two arms 1733 and 1735 and a connecting portion 1737 . While the T-anchor 1731 is being deployed into a slit, the two arms 1733 and 1735 may remain in a retracted position (see Figure 17D). To anchor the anchor 1731, the two arms 1733 and 1735 can expand outward within a slit and under the leaflet so that it can be anchored within the slit (see Figure 17E). The connecting portion 1737 connects the anchor to an implant or device.

Figures 18A and 18B illustrate cross-sectional views of one example of a double helix anchor within its housing. In some applications, the shell is the anchor head. The anchor 1801 comprises two helical or helical anchor portions 1803 and 1805 which are stacked, nested or arranged within a tubular compartment or housing 1807 in a first configuration. The two helical/anchor portions 1803 and 1805 can be configured to transition to a second configuration in which the helical/anchor portions are skewed from the housing 1807 or are not identical to each other Angle down to extend (see Figure 18B). The two helical/anchor portions 1803 and 1805 may be configured to extend into the housing in different directions or at different angles when the helical/anchor portions are pushed or rotated 1809 out of the tubular compartment/housing 1807 Beyond 1807. Depending on the patient's anatomy and/or other factors, the helical or helical anchor portions 1803 and 1805 may advantageously be extended from the housing by varying amounts or lengths. For example, in some cases, a user may want to extend the helical/anchor portions more (or a longer length from the housing) to increase penetration depth and retention strength, and in In other cases, the user may want to extend the helical anchor portions less (or a shorter length from the housing) to avoid damage to a blood vessel of the heart or the like.

Figures 18C and 18D illustrate cross-sectional views of an example of a low profile double helix anchor compressed or compressible within its housing. The anchor 1811 comprises two spring-like compressible helical or helical anchor portions 1813 and 1815 that are stacked, nested or arranged within a tubular compartment or housing 1817 in a first configuration. In the first configuration, the two helical/anchor portions 1813 and 1815 are compressed (eg, axially compressed to a smaller height) within the tubular compartment/housing 1817 . The helical/anchor portions 1813 and 1815 are configured to decompress or extend axially as they extend from the compartment/housing or are pushed or rotated out. The two helical/anchor portions 1813 and 1815 can be configured to transition to a second configuration in which the helical/anchor portions are skewed from the housing 1817 or are not identical to each other Angle down to extend (see Figure 18D). The two helical/anchor portions 1813 and 1815 can be configured to extend into the housing 1817 in different directions or at different angles when the helical/anchor portions are pushed or rotated out of the tubular compartment/housing 1817 outside. Depending on the patient's anatomy and/or other factors, the anchors or anchor portions 1813 and 1815 may beneficially be extended from the housing by different amounts or lengths, eg, as discussed above for anchor 1801 .

Figures 18E and 18F provide a cross-sectional view of an exemplary example of a low profile double helix anchor compressed or compressible within its housing. The anchor 1821 comprises an inner spring-like compressible helical or helical-type anchor portion 1823 and an outer spring-like compressible helical or helical-type anchor portion 1825 tethered within a tubular compartment or housing 1827 in a first configuration The inner ones are stacked, nested, or aligned together with the inner helix/anchor portion 1823 radially inside the outer helix/anchor portion 1825 (eg, the inner helix/anchor portion 1823 may have a larger The outer helix/anchor portion 1825 is of small diameter). In the first configuration, the inner and outer helical/anchor portions 1823 and 1825 are compressed (eg, axially compressed to a smaller height) within the tubular compartment/housing 1827 . The helical/anchor portions 1823 and 1825 are configured to decompress or extend axially as they extend from the compartment/housing or are pushed or rotated out. The inner and outer helix/anchor portions 1823 and 1825 can be configured to transition to a second configuration in which the helix/anchor portions are skewed from the housing 1827 or different from each other angle down to extend (see Figure 18F). The inner and outer helical/anchor portions 1823 and 1825 can be configured to extend into the housing in different directions or at different angles when the helical/anchor portions are pushed or rotated out of the tubular compartment/housing 1827 Beyond 1827. Depending on the patient's anatomy and/or other factors, the anchors or anchor portions 1823 and 1825 may beneficially be extended from the housing by different amounts or lengths, eg, as discussed above for anchors 1801 and 1811.

Figures 18G and 18H provide cross-sectional views of an exemplary example of a low profile single helix anchor compressed and coiled within its housing. The anchor 1831 comprises a single spring-like compressible helical anchor or anchor portion 1833 that is coiled within a tubular compartment/housing 1835 in a first configuration. In the first configuration, the helical anchor/anchor portion 1833 is compressed within the tubular compartment/housing 1835. The anchor/anchor portion 1833 is configured to decompress or extend axially as it extends from the compartment/housing or is pushed or rotated out. The anchor/anchor portion 1833 can thus be converted to a second configuration in which the anchor/anchor portion extends from the housing 1837. In some applications, the anchor/anchor portion 1833 is arranged within the housing such that each turn or loop of the coil has the same or a similar diameter, such that each turn/turn of the coil has the same or a similar diameter Loops are stacked over one of the coils adjacent turns/loops to the end, eg in the form of a spiral. In some applications, and as shown, the anchor/anchor portion 1833 is arranged or configured such that in the housing, the helical anchor/anchor portion is tied in a single plane (eg, having a relatively The large outer turn/loop and each subsequent turn/loop of the coil having a slightly smaller diameter is located radially inside an adjacent larger turn/loop), for example, as In the form of a flat spiral.

19A illustrates a cross-sectional view of an example of a system with an anchor 1901 and an implant/device 1903 with an adjustable contact surface angle. There are a number of potential mechanisms that can be used to adjust the interface angle of the implant/device while the implant/device is being anchored into tissue. In some applications, the implant/device 1903 incorporates a fulcrum 1905 that is connected to the anchor housing 1907. A deployment tool 1909 is applied to anchor the anchor into the tissue. In some applications, the deployment tool 1909 includes a cable 1911 extending to the front of the device 1903. The cable 1911 together with the fulcrum 1905 can adjust the angle of the contact surface of the implant/device 1903 to match the angle of the native tissue. Once anastomosed, the deployment tool 1909 can anchor the anchor 1901 into the native tissue. The anchor 1901 is shown as a helical anchor, but other anchor configurations are possible.

19B and 19C illustrate a cross-sectional view of an example consisting of an anchor 1921 and an implant/device 1923 with an adjustable contact surface angle. This example describes a mechanism to adjust the interface angle of the device while the device is being anchored into tissue. The implant/device 1923 incorporates two sliding mechanisms 1925 and 1927 on respective sides (eg, opposite sides) of the anchor housing 1929. A deployment tool 1931 is applied to anchor the helical anchor into tissue. The sliding mechanisms 1925 and 1927 can adjust the angle of the interface of the implant/device 1923 to match the angle of the native tissue. Once anastomotic, the deployment tool 1931 can anchor the helical anchor 1921 into the native tissue. The anchor 1921 is shown as a helical anchor, but other anchor configurations are possible.

Figure 20A illustrates an example depicting an implant/device 2001 (eg, prosthetic device, leaflet repair device, prosthetic device, contact pressure device, support device, etc.) that includes a device for providing contact to a valve leaflet Wire forming for pressure and/or support. The implant/device 2001 includes a contact surface formed by corrugated wire 2003 to provide contact pressure and/or support over a leaflet (eg, to address flail, prolapse, stiffness and/or leaflet abnormalities). The implant/device 2001 includes a coaptation portion 2005 that extends into the coaptation region of a leaflet and helps promote coaptation between the leaflets. The implant/device 2001 includes a connector 2007 which can be connected to an anchor. In certain applications, the implant/device 2001 may optionally comprise a permeable, semi-permeable or impermeable cover or sheet (not shown) which may be attached to a leaflet flail, Provide contact pressure over and/or support prolapse, stiffness, and/or leaflet abnormalities. Alternatively, the cover or sheet may be a mesh sheet or mesh cover (not shown).

Figure 20B illustrates an example implant or device 2011 (eg, repair device, leaflet repair device, prosthetic device, contact pressure device, support device, etc.) comprising a device for providing contact pressure to a valve leaflet and / or supported wire forming. The implant/device 2001 includes a contact surface formed by 3 cross-section wireforms 2013, 2015 and 2017 that intersect or overlap each other and are capable of a leaflet flail, prolapse, rigidity and/or leaflet abnormalities provide contact pressure and/or support it. The 3-section wireforms 2013, 2015, and 2017 can be laterally expanded or contracted 2019 (eg, fanned out to various degrees) to accommodate the native leaflet flail, prolapse, rigidity, and/or valve Anomalous characteristics of leaves. The implant/device 2011 includes a coaptation portion 2021 that extends into the coaptation region of a leaflet and helps promote coaptation between the leaflets. The implant/device 2101 includes a connector or attachment point 2023 that can be connected to an anchor. In certain applications, the implant/device 2101 may optionally comprise a permeable, semi-permeable or impermeable cover or sheet (not shown) which may be attached to a leaflet flail, Provide contact pressure over and/or support prolapse, stiffness, and/or leaflet abnormalities. Alternatively, the cover or sheet may be a mesh sheet or cover (not shown). The connector or connection point may contain an anchor receptacle and/or an interface.

Figures 21A and 21B illustrate an example implant or device 2101 (eg, repair device, leaflet repair device, prosthetic device, contact pressure device, support device, etc.) comprising a device for providing contact to a valve leaflet Wire forming for pressure and/or support. The implant/device 2101 includes a contact surface 2103 capable of providing contact pressure and/or support over a leaflet flail, prolapse, rigidity and/or abnormality. The implant/device 2101 includes a coaptation portion 2105 that can extend into the coaptation region of a leaflet and help facilitate coaptation between the leaflets. The device 2101 includes an anchor attachment point 2107 to which an anchor can be attached. The anchor attachment point may contain an anchor receiver. In some applications, the anchor attachment point or anchor receiver includes or is configured as an interface. The interface may be connected to a catheter or shaft for delivery and positioning of the system/device and may be the same or similar to other interfaces herein. The portion extending below the anchor attachment point may be considered a wing or wing portion containing the contact surface 2103 and the engagement portion 2105. The implant or device 2101 can be configured to be anchored in any of the ways described herein to any of the sites described herein, eg, to a vessel located within a coronary vessel, etc. the ring.

In certain applications, the engagement portion 2105 may include an optional clip, fastener or other anchoring mechanism to be attached or clamped over a leaflet edge, which may allow the device 2101 to be positioned on the leaflet Move with it as it opens and closes.

In some applications, the device includes a reaction force support 2109 that can be compressed against an atrial wall to help the device provide contact pressure over a leaflet flail, prolapse, rigidity, and/or abnormality.

In certain applications, the device 2001 (eg, the wing portion of the device) includes a permeable non-engaging portion 2111 that may be made of mesh or otherwise include apertures to allow for contact pressure over leaflet flail, prolapse, rigidity, and/or abnormalities), and includes an impermeable coaptation portion 2113 that can help promote coaptation. It is noted that various examples may include an elongated impermeable coaptation portion 2113 capable of reaching the outflow side (or ventricular side) of one or both opposing native valve leaflets to assist in valve closure. In various examples, the impermeable coaptation portion 2113 is thickened such that it can fill the gap within the valve orifice, eg, acting as a gap filler/coaptation element/spacer. In some applications, the junction portion 2113 may be filled and/or expanded at the implanted location.

In certain applications, as shown in FIG. 21A , the device 2101 (eg, the wing portion of the device) includes a open or exposed areas. In some applications, this open or exposed area allows blood to flow freely therethrough without any tissue ingrowth, which can help prevent blood from moving the device in an unintended manner. In some applications, the permeable non-joint portion 2111 may be omitted such that the entire area (eg, the area between the impermeable joint portion 2113 and the anchor attachment point 2107) is open, Blood can flow through it. The frame and engagement portion 2113 provide systolic pressure, while the open or exposed area allows blood flow and avoids undue pressure on the device, as well as tissue ingrowth within the exposed area. The frame of the device can be of various sizes and shapes (including, with respect to any example, any of the other frame shapes, sizes, configurations described herein or depicted in the Figures, and One or more anchor attachment points and/or interfaces may be included), such as teardrops, ovals, ovals, triangles, and the like. The open or exposed area, permeable non-joint portion 2111 (if included), and impermeable joint portion 2113 can be of various sizes and shapes other than those depicted in Figure 21A. For example, the device may include an impermeable joint portion 2113 covering between 20%-80% of the area within the frame, while having an open portion covering between 10% within the frame An area between -80% and/or optionally a permeable non-joint portion occupies between 10%-80% of the area within the framework. In some applications, the device 2101 includes an impermeable joint portion 2113 covering between 40%-70% of the area within the frame and an area between 30%-60% of the area within the frame open/exposed areas. In some applications, the impermeable joint portion 2113 can be omitted, and a permeable portion 2111 (which can be used in the joint region) and an open/exposed portion are used and can be aligned or Designed to be similar to the above.

22A and 22B illustrate an exemplary implant or device 2201 (eg, repair device, leaflet repair device, prosthetic device, contact pressure device, support device, etc.) that incorporates a wire forming. The device 2201 includes a contact surface 2203 capable of providing contact pressure and/or support over a leaflet flail, prolapse, rigidity and/or abnormality. The device 2201 includes a coaptation portion 2205 that extends into the coaptation region of a leaflet and helps facilitate coaptation between the leaflets. The engagement portion 2205 can be clamped onto a leaflet edge, which will allow the device 2201 to move with the leaflet as it opens and closes. The device 2201 includes an anchor attachment point 2207 (which may include an anchor receptor) that can be connected to an anchor. In certain applications, the device 2201 includes a permeable, semi-permeable or impermeable cover or sheet 2209 which can help provide contact pressure over a leaflet flail, prolapse, rigidity and/or abnormality and/or provide support for it. Alternatively, the cover or sheet may be a mesh sheet or mesh cover (such as that shown in Figure 22C).

Figure 23A illustrates an exemplary implant or device 2301 incorporating a wire formation for providing contact pressure and/or support to a valve leaflet. The device 2301 includes a contact surface system capable of providing contact pressure and/or support over a leaflet flail, prolapse, rigidity and/or abnormality. The device 2301 includes a coaptation portion 2303 that extends into the coaptation region of a leaflet and helps facilitate coaptation between the leaflets. The coaptation portion 2303 contains an inner portion 2305 that lacks wire molding, allowing various procedures to be performed over the native leaflet coaptation area. The device 2301 includes an anchor attachment point 2307 (which may include an anchor receptor) to which an anchor, eg, any of the various anchors described herein, may be attached. In certain applications, the device includes a selective reaction force support 2309 that can be pressed against an atrial wall to help the device provide contact pressure over a leaflet flail, prolapse, rigidity and/or abnormality. In certain applications, the device 2301 includes a permeable mesh 2311 to help provide contact pressure and/or support over a leaflet problem (eg, flail, prolapse, stiffness, etc.). In some applications, the anchor attachment point or anchor receiver includes or is configured as an interface. The interface can be connected to a catheter or shaft for delivery and positioning of the system/device. The portion extending below the anchor attachment point or interface may be considered a wing or wing portion containing the joint portion or the like.

Illustrated in Figure 23B is an exemplary implant or device 2301 that incorporates a wire forming for providing contact pressure and/or support to a leaflet. The example depicted in Figure 23B is identical to the example of Figure 23A with an added anchor receptacle at the interface or anchor connection point, which may be configured as a housing or tubular compartment 2313, Used to receive and/or connect a helical anchor to the implant/device. For some applications, the anchor receptor or housing or tubular compartment 2313 is connected to the implant/device 2301 at the interface or anchor connection point 2307. Figure 23C is an enlarged cross-sectional view of one of the wire formations of the housing/tubular compartment 2313 and the anchor connection point 2307 intersected therethrough. The anchor connection point wire molding 2307 anchors the housing/tubular compartment 2313 to the device 2301 through a guide tube 2315 (eg, defined by the housing 2313). As shown in Figure 23D, the housing/tubular compartment 2313 includes an orifice 2317 through which a helical anchor 2319 can pass. Guide tube 2315 and/or wire form 2307 may act as a crossbar across port hole 2317. The helical anchor 2319 anchors the housing/tubular compartment 2313 and thus the implant/device 2301 to an anchoring portion (eg, the ring) of tissue at the deployed site. In some applications, this is accomplished by the helical anchor 2319 (ie, a helical tissue engaging element of the anchor) being screwed around and across a crossbar (eg, guide tube 2315, The wire is formed and/or another rail element defined by the shell 2313) and enters into the tissue until a head of the anchor abuts the rail. The housing/tubular compartment 2313 is depicted with a circular recess 2321 that can precisely mate with a tool (eg, a cloaked screwdriver, anchor driver, etc.) with a complementary circular projection configuration etc.) connection.

Methods for delivering implant/device 2301, as well as other implants/devices herein (eg, implant/device 2421, etc.), can include: transvascularly (eg, via a transfemoral catheter) , a subclavian, a transapical, a transseptal, or a transaortic approach) to the native heart valve, the anchor (which may be the same as or similar to any anchor or anchor feature described herein) component) from the delivery catheter into the tissue of the heart, thereby anchoring the implant/device to the tissue, and releasing the implant/device from the delivery catheter such that the implant/device The device extends along a portion of a leaflet of the native heart valve. Advancing the anchor from the delivery catheter into the tissue of the heart and releasing the leaflet implant/device from the delivery catheter can be done in either order.

Where the anchor is a helical anchor, advancing the anchor may include rotating the helical anchor into the tissue (eg, into the annulus or into a wall of the heart).

The implant/device can be converted from a compressed delivery configuration within the delivery catheter (for a smaller delivery profile) to an expanded configuration outside the delivery catheter to Better coverage of the leaflet or problematic portion of the leaflet.

This method can be on a live animal or on a simulation, such as on a cadaver, cadaver heart, simulator (eg, with simulated body parts, heart, tissue, etc.), etc., to be implemented.

Figure 24A illustrates an example implant or device 2401 comprising a wire molding with a swinging hinge to adjust the angle of the contact surface. The device 2401 includes a contact surface capable of providing contact pressure and/or support over a leaflet, eg, to address leaflet flail, prolapse, stiffness and/or abnormalities. The device 2401 includes an engagement portion 2403, a selective reaction force support 2405, and a permeable mesh 2407. The device 2401 further includes a swing hinge 2409 connecting the device 2401 to a W-anchor 2411. The swing hinge 2409 can adjust the angle of the W-shaped anchor 2411 relative to the angle of the contact surface of the device 2401 to match the angle of the natural tissue. A detailed close-up image of one of the hinges is provided in Figure 24B.

Figure 24C illustrates an example implant or device 2421 comprising a wire molding with a soft compliant hinge to adjust the contact surface angle. The device 2421 includes a contact surface capable of providing contact pressure over and/or supporting a leaflet, eg, to address leaflet flail, prolapse, stiffness, and/or other problems. The device 2421 includes a joint portion 2423 and a permeable mesh 2425. The device 2421 further includes an interface or hinge 2427 made of a soft pliable material (eg, PTFE) that allows a helical anchor to anchor the device 2421 to tissue. Regardless of the deployment angle of the helical anchor, the flexibility of the soft hinge 2427 is adjusted to allow the angle of the contact surface of the device 2421 to conform to the angle of the native tissue. A detailed close-up image of one of the hinges is provided in Figure 24D. The portion extending below the interface or hinge may be considered a wing or wing portion.

25 and 26 illustrate an exemplary implant or device 2501 comprising a wire form with a gap filler, engagement element or spacer 2503. FIG. 26 is a cross-sectional view of one of the device 2501 provided in FIG. 25 . The device 2501 includes a sheet 2505 formed around the wire 2507 and an engagement element, spacer or filler 2503. The device also includes a contact surface 2503 that can provide contact pressure and/or support over a leaflet, eg, to address leaflet flail, prolapse, stiffness, and/or other problems. The device 2501 includes a coaptation portion 2509 that can extend into the coaptation region of a leaflet and help facilitate coaptation between the leaflets. The gap filler/coaptation element/spacer 2503 expands the thickness within the coaptation portion 2509 so that the coaptation portion 2509 can fill a gap within the coaptation region of a valve to help it close and/or prevent or inhibit Valvular insufficiency. The device 2501 includes an anchor attachment point 2511 which can be connected to an anchor via a connector or an anchor receptacle. A permeable, semi-permeable, impermeable or mesh sheet can be applied. The engagement element or spacer 2503 may contain a material (eg, shape memory material, foam, etc.) or a mechanism to expand the device, eg, via balloon dilation, self-expansion, mechanical expansion, and the like. For example, the bonding element or spacer 2503 may comprise a foam, a hydrogel or a silicone material. Optionally, the engagement element or spacer 2503 may incorporate a scissor mechanism or an expandable coil. Furthermore, the device may include an expandable stent within or on the sheet 2505. The anchor connection point may contain an interface, which may be the same as or similar to other interfaces herein.

Figure 27 illustrates an example implant or device 2701 comprising a wire formed with a small anchor configured to hook into a cleft (eg, cleft or commissure) within a valve 2703 . The device 2701 includes a sheet 2705 extending between the hooks 2703 capable of applying contact pressure over a leaflet flail, prolapse, rigidity and/or abnormality. The sheet may be permeable, semi-permeable, impermeable, or a mesh. The device 2701 includes an anchor connector 2707 capable of connecting to an additional anchor, but optionally using an anchor attachment point as described in relation to FIG. 20 . The anchor connector or anchor connection point may include an interface, which may be the same as or similar to other interfaces herein.

Figure 28 illustrates an exemplary implant or device 2801 comprising a wire form with depressions 2803 that can be anchored into a fissure (eg, fissure or commissure) within a valve. The device 2801 includes a sheet 2805 extending between the depressions 2803 capable of applying contact pressure over a leaflet flail, prolapse, rigidity and/or abnormality. The sheet may be permeable, semi-permeable, impermeable, or a mesh. An anchor connector 2807 of the device 2801 can be connected to an anchor, but may optionally employ an anchor connection point as described in relation to FIG. 20 . The anchor connector or anchor connection point may include an interface, which may be the same as or similar to other interfaces herein.

29 illustrates an exemplary implant or device 2901 comprising a wire molding with a static portion 2903 and a dynamic portion 2905. The static portion 2903 is used to seat and anchor the device 2901 and contains depressions 2907 that can anchor into a cleft (eg, fissure or commissure) within a valve. The dynamic portion 2905 can be adjusted so that it can be seated over a leaflet flail, prolapse, rigidity and/or abnormality. The dynamic portion 2905 incorporates a sheet 2909 capable of applying contact pressure over a leaflet flail, prolapse, rigidity and/or abnormality. The sheet may be permeable, semi-permeable, impermeable, or a mesh. The device 2901 includes an anchor connector 2911 that can be attached to an anchor, but may optionally employ an anchor attachment point as described in relation to FIG. 20 . The anchor connector or anchor connection point may include an interface, which may be the same as or similar to other interfaces herein.

30 illustrates an example implant or device 3001 comprising a wire form with a static portion 3003 and a dynamic portion 3005. The static portion 3003 is used to seat and anchor the device 3001 and contains depressions 3007 that can be anchored into a cleft (eg, fissure or commissure) within a valve. The dynamic portion 3005 can be adjusted to be widened or elongated to sit over a leaflet flail, prolapse, rigidity and/or abnormality. The dynamic portion 3005 incorporating a sheet 3009 is capable of applying contact pressure and/or supporting a leaflet flail, prolapse, rigidity and/or abnormality. The sheet may be permeable, semi-permeable, impermeable, or a mesh. The device 3001 includes an anchor connector 3011 capable of being connected to an anchor, but optionally using an anchor connection point as described in relation to FIG. 20 . The anchor connector or anchor connection point may include an interface, which may be the same as or similar to other interfaces herein.

31A-31L are schematic diagrams of exemplary steps that may be used to deliver an implant or prosthetic device to a mitral using a connector traversing through the coronary sinus and a wall of the left atrium The flap and the implant are anchored with an anchor disposed in the coronary sinus. To aid in understanding the delivery process, several figures provide a transverse plan view within the left atrium above the mitral valve, and several other figures provide a cut through the coaptation region of the mitral valve in the Wait for a coronal plan view inside the left chamber. Although described with respect to the coronary sinus and mitral valve, the systems, devices, methods, steps, etc. are equally applicable to other vasculature and other valves of the heart.

Figure 31A shows a guide wire 3101 being advanced from the right atrium through the ostium or opening of the coronary sinus into the coronary sinus. As seen in FIG. 31B, a puncture catheter 3103 is then advanced over the guide wire 3101. The puncture catheter 3103 is introduced into the body through a proximal end of an introducer sheath (not shown). An introducer sheath provides access to a specific vascular access (eg, jugular vein or subclavian vein) and may have a hemostatic valve therein. With the introducer sheath held at a fixation site, the puncture catheter 3103 is guided to a site of the coronary sinus/left atrium wall to be traversed.

At least one distal end of the puncture catheter 3103 preferably has a slight curvature built into it, with a radially inner side and a radially outer side, to conform to the curved coronary sinus. An expandable anchor member 3105 is exposed along the radially outer side of one of the catheters 3103 adjacent a distal segment 3107, which may be thinner than the proximal extent of the catheter or extend from the catheter 3103. The proximal extent of the catheter is tapered to be narrower. For desired placement of the anchoring member 3105 within the coronary sinus, radiopaque markers 3109 located on the catheter 3103 help determine the precise advancement distance.

Figure 31C shows the radially outward deployment of the expandable anchoring member 3105, which in the illustrated example is a spherical balloon but could also be a woven mesh. One of the advantages of a mesh is that it avoids excessive blockage of blood flow through the coronary sinus during the procedure. Other possible anchoring structures include, but are not limited to, nitinol wire forming stent-like structures. The expansion of the anchoring member 3105 flexes the radially inner portion of the catheter against the luminal wall of the coronary sinus. The expandable anchoring member 3105 is positioned adjacent the distal segment 3107 of the puncture catheter 3103 and expands opposite a needle port 3111 formed in the radially inner sidewall of the catheter. The needle port 3111 abuts the lumen wall and faces toward a tissue wall 3113 between the coronary sinus and the left atrium. The catheter 3103 is advanced so that the needle port 3111 is properly positioned to traverse the tissue wall 3113, which can be guided by visualizing the radiopaque markers 3109. For example, the needle port 3111 can be positioned approximately above the P2 segment of the posterior leaflet of the mitral valve as shown. The anchoring member 3105 may be centered radially across the catheter 3103 from the needle port 3111, or may be slightly offset from the needle port 3111 in a proximal direction as shown to improve leverage.

The curvature at the distal end of the puncture catheter 3103 aligns with anatomy adjacent the coronary sinus and orients the needle port 3111 inwardly while the anchoring member 3105 holds the catheter 3103 relative to the coronary sinus. proper location of the sinus. Subsequently, as seen in Figure 31D, a piercing sheath 3115 (having a piercing needle 3117 with a sharp tip) is advanced along the catheter 3103 such that it exits the catheter at an angle to the longitudinal direction of the catheter Needle port 3111 and penetrate through the wall 3113 into the left atrium. The anchoring member 3105 provides rigidity to the system and holds the needle port 3111 against the wall 3113. The puncture needle 3117 is retracted from within the puncture sheath 3115 and completely removed from the catheter 3113.

Figures 31E and 31F then show the advancement of a second guide wire 3119 through the lumen of the puncture sheath 3115, through the left atrium, the mitral valve orifice, and into the left ventricle. Figure 31F further illustrates the removal of the puncture sheath 3115 from the left atrium and into the puncture catheter 3113, leaving only the guide wire 3119 extending through the coronary sinus and into the left chambers . During these steps, the anchoring member 3105 remains expanded against the lumen wall of the opposite coronary sinus for stability, but is then removed along with the puncture catheter 3103 to allow a delivery catheter 3121 to into the left chambers.

Figures 31G and 31H show a delivery catheter 3121 being advanced along the guide wire 3119 and through the tissue wall 3113 into the left atrium. Located within the delivery catheter 3121 is a compressed device 3123 to be implanted within the left chambers and located within a flail, flail, detachment of the P2 segment of the posterior lobe. sagging, rigidity and/or other abnormalities.

31I then shows advancement of the device 3123 into the left chambers and retraction while the delivery catheter 3121 is retracted through the atrial tissue wall 3113. As the device 3123 advances, it expands into shape. Figure 31J shows a fully expanded device 3123 at the site of the implant, which is the P2 segment of the posterior lobe. Figures 31J and 31K show that as the delivery catheter 3121 is retracted through the atrial tissue wall 3113 and retracted into the coronary sinus, a connector 3125 of the device 3123 is released, allowing the connector to traverse the tissue wall 3113. The connector 3125 connects the expanded and released device 3123 and a condensed wire stent anchor 3127 still within the delivery catheter 3121.

Figures 31K and 31L show further retraction of the delivery catheter 3121, which results in the advance and release of the wire stent anchor 3127 expanded and anchored within the coronary sinus. Subsequently, the entire delivery catheter 3121 is removed from the body along the guide wire 3119, which is then removed from the body. The delivery procedure results in the device 3123 being implanted over the P2 segment of the posterior leaflet of the mitral valve, which is anchored using a wire stent anchor 3127 expanded within the coronary sinus.

Certain examples herein are directed toward compression elements (eg, compression stents, compression clamps, compression splints, compression molding, etc.) for relief of heart valve leaflet flail, prolapse, stiffness, and/or other abnormalities. In certain applications, a compression element can be clamped over a leaflet, maintaining its position on the leaflet while providing compression and contact pressure on an area of flail, prolapse, rigidity and/or abnormality . Compression and contact pressure provided by various stent implementations help to flatten and/or reshape the flail, prolapse, rigidity and/or abnormality, which helps to rearward the coaptation edge of a leaflet when in a closed position extends towards the junction area. Normal coaptation resulting in a fully closed valve prevents valve insufficiency.

In some applications, a compression element has an outflow portion and an inflow portion that are compressed together via compressive force. When attached over the leaflet, the outflow portion sits on the outflow surface of the leaflet and the inflow portion sits on the inflow surface of the leaflet, the two parts are connected to each other. Thus, in certain applications, the inflow portion of a stent provides contact pressure over and/or supports a leaflet, for example, to address flail, prolapse, rigidity, and/or another abnormality. In some applications, the outflow portion and the inflow portion are compressed together to generate a force to hold to maintain its position on the leaflet. In some applications, a torsion spring is applied to provide the compressive force. In some applications, a compression element is contoured to the shape of the leaflet. In some applications, a compression element is textured on its surface with a roughened surface, depressions, notches, protruding features and/or barbs to provide further grip to hold the stent in place Location. In some applications, a compression element is incorporated into an undulating wire to provide further grip (like a hairpin grip).

In some applications, a compression element contains a wire-formed stent. Any suitable material used to create a wire form can be used, including but not limited to the use of Nitinol, Cobalt-Chromium (CoCr), Stainless Steel, Titanium, Polyglycolic Acid (PGA), Polylactic Acid (PLA), Poly-D-Lactic Acid (PDLA), Polyurethane (PU), Poly-4-hydroxybutyrate (P4HB), Polycaprolactone (PCL), Polyetheretherketone (PEEK), Cyclic Olefin Copolymerization Compounds (COCs), polyethylene vinyl acetate (EVA), polytetrafluoroethylene (PTFE), perfluoroether (PFA) or fluorinated ethylene propylene copolymer (FEP), their additives, and derivatives of these . In certain applications, a compression element is collapsible, which may be useful for fitting into a catheter device for a less invasive catheter delivery methodology. In certain applications, nitinol systems are used for their self-expanding properties, which may be useful for implanting the compression element via a less invasive catheter delivery methodology.

A wide variety of shapes of wire forming compression elements can be used in a variety of different implementations. In certain applications, a compressed wire-formed stent is formed with the wire-formed portion to provide contact pressure over and/or support the flail, prolapse, stiffness and/or abnormality. In certain applications, a compressed wire-formed stent has a length and width to surround a flail or prolapsed region and a sheet extending across the region is applied to provide over the flail, prolapse, rigidity and/or abnormality Contact pressure and/or support it.

In some applications, a compression implant or compression element incorporates a sheet over a wire form. In certain applications, a sheet or cover is provided over the inflow portion of a compression element and provides a surface that can be provided to a leaflet that suffers from flail, prolapse, stiffness, and/or another problem Contact pressure and/or support it. A sheet or cover may be impermeable, semi-permeable, or permeable to fluids (eg, blood or plasma). In some applications, the sheet or cover is a mesh. In some applications, a mesh is formed using a mesh sheet. In some applications, a mesh system is formed using overlapping and intersecting staggered strands. A mesh or permeable sheet can provide contact pressure without restricting the flow of blood or plasma, which can be important in a variety of applications. For example, an impermeable sheet or covering can trap blood within the compression element, which in turn may create undesired pressure within the valve or potentially cause the implant/ The pressure with which the device displaces or changes its position. A sheet, cover and/or mesh herein may comprise any one or more of the following: lactic acid-glycolic acid copolymer (PLGA), polyvinyl chloride (PVC), polyvinyl chloride Ethylene (PE), Polypropylene (PP), Polytetrafluoroethylene (PTFE), Polyurethane (PU), Polyethylene terephthalate (PET), Polyether (PES), Polyglycolic acid (PGA), polylactic acid (PLA), poly-d-lactic acid (PDLA), poly-4-hydroxybutyrate (P4HB), and polycaprolactone (PCL).

Various implementations of the compression elements help facilitate coaptation of the leaflets when closed. In some applications, a gap filler/engaging element/spacer is incorporated with the compression element, which can help fill the gap within the valve orifice. In some applications, a compressive element includes an extension with an impermeable sheet extending from the leaflet lip into the orifice, which may assist in forming coaptation with other leaflets. In certain applications, a compression element includes an extension that extends to the outflow surface of the other valve leaflet to contact the other valve leaflet when the valve is closed such that it assists the relative The leaflets of the stent come together and engage with the stented leaflets. In certain applications, the extension of the outflow surface one to the other valve leaflet has a curvature toward the other valve leaflet (eg, to reach a tricuspid valve, aortic valve, or pulmonary artery) the other leaflet in the valve).

In some applications, a compression element contains an anchor to stabilize the stent at the implanted site. In some applications, the inflow portion of a compression element includes a portion connected to the anchor. In certain applications, the anchor attachment point is adjacent to or in contact with the valve annulus or a ventricular or atrial wall. In some applications, an anchor is seated adjacent to or in contact with the valve annulus. In certain applications, an anchor is positioned adjacent to or in contact with the ventricular or atrial wall on the opposite side of the wall to the anchor attachment point. In some applications, a connector is applied to connect the anchor, the connector traversing through the ventricle or atrial wall. Any suitable connector may be used, such as, for example, a screw, rivet, suture, staple, wire, pin, shaft, strip, sheet, and the like.

In some applications, an anchor is seated within the vasculature on opposite sides of a ventricle or atrial wall. For example, various compression element implementations relieve flail, prolapse, rigidity, and/or other abnormalities of the mitral valve and thus sit within the left atrium. In these various implementations, a compression element can be connected to an anchor that is seated in the coronary sinus using a connector traversing through the atrial wall. Any suitable anchor can be applied. In some applications, an anchor is a wire stent that can be expanded within the vasculature. In some applications, an anchor is a pin, pin clamp (eg, R-clamp, R-pin, R-key) or wire capable of securing a compression element to the ventricle or atrial wall via a connector. In some applications, a pin or wire fastener is applied to the opposite side of a ventricle or atrial wall, and the connector traverses the wall. In some applications, a pin or wire fastener is applied within the vasculature on the opposite side of a ventricle or atrial wall. In some applications, a wire fastener system can pinch a connecting wire to hold the wire in place and create tension between the wire fastener or wire anchor and the compression element. In certain applications, an anchor comprises a screw, helical or helical anchor anchored within the valve annulus or within the wall of an atrium or a ventricle.

In some applications, a compression element is designed to contain spaces and/or features that permit further medical intervention at a subsequent point in time. In some applications, a wire-formed stent contains space within the junction area (configured as a space between the wire-formed wires) so that, if required at some point in the future If so, a percutaneous edge-to-edge mitral valve repair device can still be implanted without the implant/device interference.

Various implementations of compression elements are to be used over any leaflet that suffers from flail or prolapse. Thus, in certain applications, a compression element system can be applied over a leaflet of a mitral valve, a tricuspid valve, an aortic valve and/or a pulmonary valve. Likewise, various implementations of compression elements can be applied over any area of the leaflet that experiences flail or prolapse. In certain applications, a compression element can be applied over or adjacent to a leaflet commissure and/or any region between the commissures of a leaflet.

To reach the site of the implant, any suitable surgical technique can be used, including but not limited to a transcatheter delivery system that can employ a transfemoral, subclavian, transapical, transseptal or trans-aortic approach. In certain applications, a delivery catheter is applied to incorporate a compression element, then delivered to the deployed site via a guide wire and applied to attach the stent to a leaflet.

Certain applications are directed to methods for delivering a compressed element to the expanded address. The various methods described or suggested anywhere in this document (including the documents incorporated herein by reference) can be performed on or on a living animal (eg, human, mammal, other animal, etc.) Executed on an inanimate simulation, such as on a cadaver, cadaver heart, simulator (eg, with simulated body parts, tissue, etc.), etc. Thus, methods of delivery include methods of treatment (eg, treatment of a human subject) as well as methods of training and/or practice (eg, applying an anthropomorphic prosthesis that mimics the human vasculature to perform the method).

32 and 33 illustrate an exemplary implant or device 3201 (eg, a compression element, prosthetic device, prosthetic implant, etc.) being implanted and/or compressed at an implanted site above leaflet 3203. As shown here, the implant/device is tethered over the native valve 3205 (eg, mitral valve, tricuspid valve, etc.). In this example, the valve chordae tendineae ruptured 3207 causing leaflet flail and/or prolapse in the P2 region 3209 of the posterior leaflet 3203 of the valve 3205. The implant/device 3201 has an inflow portion 3211 and an outflow portion 3213. The inflow portion 3211 is seated on and in contact with the inflow surface 3215 of the posterior lobe 3203 within the atrium 3217 at the site of the flail and/or prolapse. The outflow portion 3213 is seated within the ventricle 3221 and in contact with the outflow surface 3219 of the posterior lobe 3203 at the site of the flail and/or prolapse. The implant/device acts as a compressive element, wherein the inflow portion 3211 and the outflow portion 3213 are configured to apply a compressive force over the flail, prolapse and/or other abnormalities to aid in flattening and/or The leaflets are reshaped (eg, a protruding feature, bulge, etc.) and regurgitated blood flow is relieved. The implant/device 3201 includes an engagement portion 3223 extending beyond the edge of the posterior leaflet 3203 and connecting the inflow portion 3211 and the outflow portion 3213.

Figure 34 illustrates an exemplary implant or device 3401 (eg, a compression element, prosthetic device, prosthetic implant, etc.) with an expanded inflow portion 3403 having multiple rings implanted Or compressed over a leaflet 3405 at a site of implantation. As shown here, the implant/device is tethered over the native valve 3407 (eg, a mitral valve, tricuspid valve, etc.). The implant/device also includes an outflow portion 3409 (indicated in phantom). The inflow portion 3403 is seated on and in contact with the inflow surface 3411 of the posterior lobe 3405 within the atrium 3413 at the site of flail, prolapse, rigidity and/or abnormality. The outflow portion 3409 is seated and in contact with the outflow surface of the posterior lobe 3405 within the ventricle 3415 at the site of flail, prolapse, rigidity and/or abnormality. The implant/device acts as a compression element, wherein the inflow portion 3403 and the outflow portion 3409 are configured to apply a compressive force over the flail, prolapse, rigidity and/or abnormality to aid in flattening and/or abnormality Or reshape the leaflets (eg, a protrusion, bulge, flail, etc.) and/or relieve backflow. In addition, the expanded inflow portion 3403 with annular members increases contact compared to the inflow portion of the device 3201 and thus may be at the site of leaflet flail, prolapse, rigidity and/or abnormalities Provide additional contact pressure and/or support. Thus, various element shapes or stent shapes can increase the contact pressure on a leaflet flail, prolapse, stiffness and/or abnormalities by increasing the amount of contact between the stent and the leaflets. The device 3401 includes two engaging portions 3419 extending beyond the edge of the trailing leaf 3405 and connecting the inflow portion 3403 and the outflow portion 3409. The two coaptation portions are spaced apart to provide an area 3421 for further medical intervention of the valve leaflets at a later point in time (eg, subsequent edge-to-edge repair, such as implanting a device to hold the leaflets together) installation).

Figure 35 illustrates an exemplary implant or device 3501 (eg, compression element, prosthetic device, etc.) system containing a wire stent anchor (not shown) at an implanted site. As shown here, the implant/device is tethered over the native valve 3505 (eg, mitral valve, tricuspid valve, etc.). The implant/device 3501 has an inflow portion 3507 and an outflow portion 3509 (indicated in phantom). The inflow portion 3507 is seated on and in contact with the inflow surface 3511 of the posterior lobe 3513 within the atrium 3515 at the site of flail, prolapse, rigidity and/or abnormality. The outflow portion 3509 is seated and in contact with the outflow surface of the posterior lobe 3513 within the ventricle 3517 at the site of flail, prolapse, rigidity and/or abnormality. The implant/device acts as a compressive element, wherein the inflow portion 3507 and the outflow portion 3509 are configured to apply a compressive force over the flail, prolapse, rigidity and/or abnormality to assist in flattening and/or abnormality Or reshape the leaflets (eg, a protruding feature, bulge, flail, etc.) and relieve backflow blood flow. The implant/device 3501 can include an engagement portion 3519 extending beyond the edge of the posterior leaflet 3513 and connecting the inflow portion 3507 and the outflow portion 3509.

In certain applications, the anchor is a wire formed within the coronary sinus 3521 adjacent the left atrium 3515 (or within another blood vessel at or near another chamber of the heart) is expanded. The anchorage 3503 is connected to the compression element 3501 via a connector 3523 traversing through the atrial wall 3525. Thus, the anchor helps stabilize the implant/device 3501 at the native valve 3505.

36-44 illustrate examples of implants or devices configured as compression elements (eg, compression wire moldings and/or stents). In these examples, for simplicity, a first portion of the compression element represents an inflow portion, and a second portion represents an outflow portion. However, it is to be understood that an outflow portion can be the inflow portion, and an inflow portion can be the outflow portion, since the sides of the leaflets that contact the portions are interchangeable.

36 illustrates an example implant or device configured as a compression element or compression wire forming stent 3601. The device or wire form stent includes an inflow portion 3603 and an outflow portion 3605 connected via a joint portion 3607.

Figure 37 illustrates an implant or device configured as a compression element or compression wire forming stent 3701 as a single wire with no wire endpoints. The wire forming stent includes an inflow portion 3703 and an outflow portion 3705 connected via a joint portion 3707 .

Figure 38 illustrates an implant or device configured as a compression element or compression wire forming stent 3801 with additional curvature to increase wire contact with a leaflet prolapse and/or flail. The device or wire-formed stent includes an inflow portion 3803 and an outflow portion 3805 that are connected via a joint portion 3807. The inflow portion 3803 includes two rings 3809, 3811 as additional curvatures that increase the point of contact of the inflow portion 3803 with the inflow surface of a leaflet. The coaptation portions 3807 are spaced apart to allow further subsequent medical intervention on the valve leaflets (eg, subsequent edge-to-edge repair).

Figure 39 illustrates an implant or device configured as a compression element or compression wire forming stent 3901 with additional curvature to increase wire contact with a leaflet prolapse and/or flail. The device or wire-formed stent includes an inflow portion 3903 and an outflow portion 3905 that are connected via joint portions 3907. The inlet portion 3903 includes outer wing-like rings 3909, 3911 and a large inner ring 3913 as additional curvature that increases the point of contact of the inlet portion 3903 with the inlet surface of a leaflet. The coaptation portions 3907 are spaced apart to leave a space to allow further medical intervention on the valve leaflets at some later point in time (eg, subsequent edge-to-edge repair) without the implant from the implant /device interference.

40 and 41 illustrate an implant or device configured as a compression element or compression wire forming stent 4001 with a torsion spring. The device or wire-formed stent comprises an inflow portion 4003 and an outflow portion 4005 connected via a joint portion. The engagement portion includes a torsion spring 4007 to increase the compressive force provided between the inflow portion 4003 and the outflow portion 4005. The torsion spring 4007 can be seated within an open region on the outflow side of the valve (eg, within the left ventricular region if used on the mitral valve).

Figure 42 illustrates an implant or device configured as a compression element or compression wire forming stent 4201 with a connector to connect with an anchor. The wire forming stent includes an inflow portion 4203 and an outflow portion 4205 connected via a joint portion 4207 . A connector 4209 extends from the inlet portion 4203 and connects with an anchor (not shown). In certain applications, the connector 4209 is capable of traversing tissue through the heart or vasculature. The connector may also be an anchor attachment point and/or anchor receptacle similar to those described elsewhere herein. For example, in some applications, the compression element or stent 4201 may include an anchor receptor at a configured anchor attachment point such that the device 4201 is anchored to the ring.

Figure 43 illustrates an implant or device configured as a compression element or compression wire forming stent 4301 with a connector and additional curvature to increase contact with a leaflet prolapse and/or flail wire. The device or wire-formed stent includes an inflow portion 4303 and an outflow portion 4305 that are connected via joint portions 4307 . A connector 4309 extends from the inlet portion 4303 and connects with an anchor (not shown). In certain applications, the connector is capable of traversing tissue through the heart or vasculature. The inflow portion 4303 includes two annular members 4311, 4313 as additional curvatures that increase the point of contact of the inflow portion 4303 with the inflow surface of a leaflet. The coaptation portions 4307 are spaced apart to allow further medical intervention (eg, subsequent edge-to-edge repair) on the valve leaflets at a later point in time. The connector may also be an anchor attachment point and/or anchor receptacle similar to those described elsewhere herein. For example, in some applications, the compression element or stent may include an anchor receptor at a configured anchor attachment point such that the device is anchored to the ring.

Figure 44 illustrates an implant or device configured as a compression element or compression wire forming stent 4401 with a connector and additional curvature to increase wire contact with a leaflet prolapse and/or flail. The device or wire-formed stent includes an inflow portion 4403 and an outflow portion 4405 that are connected via a joint portion 4407 . A connector 4409 extends from the inlet portion 4403 and connects with an anchor (not shown). In certain applications, the connector is capable of traversing tissue through the heart or vasculature. The inflow portion 4403 includes a back-and-forth pattern as an additional curvature that increases the point of contact of the inflow portion 4403 with the inflow surface of a leaflet. The connector may also be an anchor attachment point and/or anchor receptacle similar to those described elsewhere herein. For example, in some applications, the compression element or stent may include an anchor receptor at a configured anchor attachment point such that the device is anchored to the ring.

Figures 45 and 46 illustrate an implant or device configured as a compression element or compression wire forming stent 4501 with a sheet positioned over an inflow portion to increase contact with a leaflet prolapse and/or Wire contacts of the flail. The device or wire-formed stent includes an inflow portion 4503 and an outflow portion 4505 connected via a joint portion 4507. The inflow portion 4503 includes a sheet or cover 4509 to increase the point of contact of the inflow portion 4503 with the inflow surface of a leaflet. The sheet or cover may be permeable (eg, as a mesh, etc.), semi-permeable, or impermeable.

Figures 47 and 48 illustrate an implant or device configured as a compression element or compression wire forming stent 4701 with a sheet or covering over an inflow portion to prolapse with a leaflet and / or flail surface contact. The implant/device may also have an extended coaptation region to aid in coaptation of the leaflets when the valve is closed. The device or wire form stent includes an inflow portion 4703 and an outflow portion 4705 connected via a joint portion 4707. The inflow portion 4703 includes a sheet or cover 4709 to increase the point of contact of the inflow portion 4703 with the inflow surface of a leaflet. The engaging portion 4707 may also contain the sheet or covering 4709, but the engaging portion 4707 with the sheet or covering is extended 4711 so that it can extend when it is seated over the leaflet edge beyond the leaflet edge.

Figure 49 illustrates an implant or device configured as a compression element or compression wire forming stent 4901 with a sheet positioned over an inflow portion for contact with a leaflet prolapse and/or flail surface . This exemplary application is described and shown in Figure 38 for the same basic wire form, but thus includes additional curvature to increase wire contact with one leaflet prolapse and/or flail. The device or wire form stent includes an inflow portion 4903 and an outflow portion 4905 connected via a joint portion 4907. The inflow portion 4903 includes two rings 4909, 4911 as additional curvatures that increase the point of contact of the inflow portion 4903 with the inflow surface of a leaflet. The inflow portion 4903 also includes a sheet or cover 4913 to increase the point of contact of the inflow portion 4903 with the inflow surface of a leaflet. The sheet or cover may be permeable, semi-permeable or impermeable. An example containing a permeable mesh sheet is depicted in FIG. 50 .

Figure 51 illustrates an implant or device configured as a compression element or compression wire forming stent 5101 with a sheet positioned over an inflow portion for contact with a leaflet prolapse and/or flail surface . This example applies the same basic wire form and connector described and shown in Figure 42, and thus includes a connector to connect with an anchor. The device or wire-formed stent comprises an inflow portion 5103 and an outflow portion 5105 connected via a joint portion 5107 . A connector 5109 extends from the inflow portion 5103 and connects to an anchor (not shown) and can traverse through cardiac or vasculature tissue. The inflow portion 5103 also includes a sheet or cover 5111 to increase the point of contact of the inflow portion 5103 with the inflow surface of a leaflet. The sheet or cover may be permeable, semi-permeable or impermeable. An example with a permeable mesh sheet or cover is depicted in FIG. 52 .

Figure 53 illustrates an implant or device configured as a compression element or compression wire forming stent 5301 with a sheet positioned over an inflow portion for contact with a leaflet prolapse and/or flail surface . This example application is the same basic wire form and connector described and shown in Figure 44, but thus includes a connector and additional curvature to increase wire contact with a leaflet prolapse and/or flail. The wire forming stent includes an inflow portion 5303 and an outflow portion 5305 that are connected via joint portions 5307 . A connector 5309 extends from the inflow portion 5303 and connects to an anchor (not shown) and can traverse through the heart or vasculature tissue. The inflow portion 5303 includes a back-and-forth pattern as an additional curvature that increases the point of contact of the inflow portion 5303 with the inflow surface of a leaflet. The inflow portion 5303 also includes a sheet or cover 5311 to increase the point of contact of the inflow portion 5303 with the inflow surface of a leaflet. The sheet or cover may be permeable (eg, a mesh, etc.), semi-permeable, or impermeable.

Figures 54 and 55 illustrate an implant or device configured as a compression implant/device comprising a compression wire forming stent 5401 with an extended and contoured coaptation portion to aid in leaflet coaptation. The implant/device or wire-formed stent includes an inflow portion 5403 and an outflow portion 5405 connected by an engagement portion 5407. The coaptation portion 5407 is extended beyond the edge of a leaflet experiencing a problem (eg, flail, prolapse, stiffness and/or abnormality). The coaptation portion 5407 is also contoured to be able to reach a leaflet opposite the leaflet experiencing the problem (eg, flail, prolapse, stiffness and/or abnormality). The contoured portion lifts and pulls the opposing leaflet towards the problem leaflet to help the leaflets close.

Figure 56 shows the implant/device depicted in Figures 54 and 55 positioned over a posterior leaflet 5409 of a mitral valve 5411. The engaging portion 5407 extends beyond the edge of the posterior leaflet 5413 and into the left ventricle. The coaptation portion 5407 is also contoured such that when the valve is closed, the distal edge of the coaptation portion 5407 contacts the outflow surface of the anterior leaflet 5413 to assist in bringing the anterior and posterior leaflets together and coapting.

Figures 57 and 58 illustrate an implant or device configured as a compression implant/device comprising a compression wire forming stent 5701 with an attached gap filler, engagement element or spacer . The implant/device or wire-formed stent includes an inflow portion 5703 and an outflow portion 5705 connected via a joint portion 5707. The outflow portion 5705 contains a loose gap filler/engagement element/spacer 5709 that is seated adjacent the engagement portion 5707. The gap filler/engagement element/spacer 5709 has a loose configuration such that it fits within a valve orifice and fills the gap when the valve is closed.

Figure 59 shows the implant/device depicted in Figures 57 and 58 positioned over a posterior leaflet 5711 of a mitral valve 5713. When the valve is closed, the gap filler/coaptation element/spacer 5709 sits between the posterior leaflet 5711 and the anterior leaflet 5715 to fill any gap that may exist.

60A-60D are schematic diagrams of exemplary steps in delivering an implant/device to a native valve via a blood vessel of the heart, as described herein for delivering an implant/device via the coronary sinus. The device to a mitral valve is used for illustration (but similar steps can be used mutatis mutandis at other sites). For example, the steps may include entering the vessel or coronary sinus, and traversing through the coronary sinus and a wall of the left atrium. The initial steps to reach the left chambers via the coronary sinus are similar to those shown in Figures 31A-31F and described in the accompanying text. To aid in understanding the delivery process, several figures provide a coronal plan view within the left chambers cut through the coaptation region of the mitral valve.

After a puncture catheter is removed from the left side chambers (see Figure 31F), a delivery catheter is advanced into the left side chambers via a guide wire.

Figure 60A shows a guide wire 6001 and a delivery catheter 6003 that has been advanced along the guide wire 6001 and through the tissue wall 6005 into the left side chambers. A collapsed compression splint device 6007 is being released and expanded within the left ventricle such that the compression splint device 6007 is to be implanted into a flail, prolapse, rigidity and/or abnormality of the posterior lobe.

Figure 65B then shows full advancement of the compression splint device 6007 within the left ventricle and simultaneous retraction of the delivery catheter 6003. The delivery catheter contains an actuator to actuate the compression splint device 6007 by opening the device by distancing an inflow portion 6009 from an outflow portion 6011 of the device. Figure 60C shows the delivery catheter 6003 retracted back toward the coronary sinus while the actuator positions the inflow portion 6009 over the inflow surface of the mitral valve leaflets and the outflow portion 6011 over the inflow surface of the mitral valve leaflets on the outflow surface of the valve leaflets. An engaging portion 6013 of the compression splint device 6007 is pulled towards the mitral valve leaflet edge such that the compression splint device 6007 is seated over a leaflet flail, prolapse, rigidity and/or abnormality.

Figure 60D shows further retraction of the delivery catheter 6003. Subsequently, the entire delivery catheter 6003 is removed from the body along the guide wire 6001, which is then removed from the body. The delivery process results in the compression splint device 6007 being implanted over the P2 segment of the posterior leaflet of the mitral valve.

Many of the examples herein are directed toward valve implants or devices for alleviating heart valve leaflet flail, prolapse, stiffness, and/or other abnormalities, the valve implants or devices comprising a rod or elongated extension Ties may span between parts or commissures of a native valve. In certain applications, a valve device can be seated within the outflow side of a valve, the rod or elongated extension holding its position on the leaflet while in a flail, prolapse, rigidity and/or abnormality provide contact pressure over the area. The contact pressure provided by the various rod or extension implants/devices helps to flatten and/or reshape the flail, prolapse, rigidity and/or abnormality, which helps when in a closed position Extend the coaptation edge of one leaflet rearwardly towards the coaptation area. Normal coaptation resulting in a fully closed valve prevents valve insufficiency.

In some applications, a rod/elongate extension is configured as an elongated arch having two distal ends, each end having a bar for hooking, latching, Anchor or member for anchoring, securing, etc. In some applications, each of the distal ends of the rod/extension includes a depression or hook, which can assist in securing the rod/extension by latching or hooking over the commissures Anchoring is within the site of the implant. In some applications, the rod/extension is telescopic so that there is an inner rod and an outer rod, allowing the rod to be shortened and elongated between various sizes or lengths. Thus, in certain applications, the telescoping rod/extension can be shortened or elongated to extend beyond a leaflet problem (eg, flail or prolapse) and provide contact pressure on the leaflet tissue.

In some applications, a rod/extension/arch includes an anchor for stabilizing the rod/extension/arch at the site of implantation beyond the commissure of the two leaflets Such anchors or members that hook, latch, anchor, secure, etc. within (although in some cases, to hook, latch, anchor, secure, etc., within the commissure of two leaflets The anchors or members, etc. may be sufficient to anchor the implant/device within the native valve without the need for an additional anchor). In some applications, a rod/extension/arch contains a portion connected to the anchor. In some applications, an anchor attachment point extends from the rod/extension/arch and towards a ventricle or atrial wall. In some applications, an anchor is seated adjacent to or in contact with the ventricular or atrial wall on the opposite side of the wall at the rod/extension/arch junction. In some applications, a connector is applied to connect the anchor to the anchor attachment point, the connector traversing through the ventricle or atrial wall. Any suitable connector may be used, such as, for example, a screw, rivet, suture, staple, wire, pin, shaft, sheet, mesh, and the like.

In some applications, an anchor is seated within the vasculature on opposite sides of a ventricle or atrial wall. For example, various rod or elongated extension examples alleviate leaflet problems (eg, flail, prolapse, rigidity, and/or abnormalities) of the mitral valve and thus sit within the left atrium. In these various implementations, a rod/extension can be connected with an anchor seated within the coronary sinus using a connector traversing through the atrial wall. Any suitable anchor can be applied. In some applications, an anchor is a wire stent that can be expanded within the vasculature. In some applications, an anchor is a pin (eg, R-pin) or wire fastener capable of securing an arcuate telescopic rod to the ventricle or atrial wall via a connector. In some applications, a pin or wire fastener is applied to the opposite side of a ventricle or atrial wall, and the connector traverses the wall. In some applications, a pin or wire fastener is applied within the vasculature on the opposite side of a ventricle or atrial wall. In some applications, a wire fastener system can pinch a connecting wire to hold the wire in place and create tension between the wire anchor or wire fastener and the telescoping rod. In certain applications, an anchor is a screw, helical or helical anchor anchored within the valve annulus or the wall of an atrium or ventricle.

Various implementations of rods, elongated extensions, arches, or arched rods help facilitate coaptation of the leaflets when closed. In some applications, a gap filler, engagement element or spacer is incorporated to extend from the stem/extension/arch and into the valve orifice, which can help fill the valve orifice gap within. In some applications, a rod/extension/arch comprises a sheet extension with an impermeable sheet tie hanging from the rod/extension/arch along the leaflet engagement area out of the valve and into the orifice of the valve, which can help to form coaptation with the other leaflets. In certain applications, the sheet includes wire shaping along the border to help maintain the sheet within the orifice of a valve when implanted.

Any suitable material for creating a rod shape, elongated extension, arch or an arched rod shape may be used. In some applications, the rod/extension/arch comprises one or more of the following: Nitinol, Cobalt-Chromium (CoCr), Stainless Steel, Titanium, Polyglycolic Acid (PGA), Polylactic acid (PLA), Poly-D-Lactic acid (PDLA), Polyurethane (PU), Poly-4-hydroxybutyrate (P4HB), Polycaprolactone (PCL), Polyetheretherketone (PEEK) ), cyclic olefin copolymers (COCs), polyethylene vinyl acetate (EVA), polytetrafluoroethylene (PTFE), perfluoroether (PFA), fluorinated ethylene propylene copolymer (FEP), their additives, and derivatives of these.

Figure 61 illustrates an example telescoping rod/extension or telescoping arch rod 6101 that can sit within a valve and provide contact pressure over a leaflet flail, prolapse, stiffness and/or leaflet abnormalities. The telescopic rod/extension or arched rod 6101 has an inner rod/extension 6103 and an outer rod/extension 6105. The inner rod/extension 6103 is slidable within the outer rod/extension 6105 so that the length and arc angle of the rod/extension can be adjusted. In some applications, the rod/extension or arched rod 6101 includes a connector 6107 to connect the rod/extension or arched rod 6101 to an anchor for the rod/extension or arched rod Provides added stability. In some applications, the rod/extension or arcuate rod 6101 contains hooks 6109 that can be anchored within a leaflet commissure or cleft.

Figure 62 illustrates an example rod/extension device comprising an arch or arcuate rod 6201 with a sheet extension capable of extending a leaflet edge so that it can better engage. The stem/extension or arcuate stem 6201 is a single stem/extension that can be seated within the orifice of a valve. In some applications, the stem/extension or arched stem 6201 includes hooks 6203 that can be anchored within a leaflet commissure or cleft. A sheet 6205 hangs down from the stem/extension or arcuate stem 6201 to reach and extend beyond a leaflet edge, thus extending the leaflet to provide more area for engagement. In some applications, the sheet includes a wire 6207 along its border, which can help retain the sheet within the joint area when implanted.

Figure 63 illustrates an example rod/extension device or an arched rod 6301 with a gap filler, coaptation element or spacer capable of filling one(s) within a valve coaptation region when the valve is closed gap. In some applications, the stem/extension or arcuate stem 6301 is a single stem/extension that can be seated within the orifice of a valve. In some applications, the rod/extension or arcuate rod 6301 contains hooks 6303 that can be anchored within a leaflet commissure or cleft. Gap fillers, coaptation elements or spacers 6305 hang down from the stem/extension or arched stem 6301 to sit within the valve coaptation area, helping by filling into any gaps when the valve leaflets are closed The leaflets are coapted.

Certain examples herein are directed towards containing netting (eg, meshes, sheets, coverings) for alleviating heart valve leaflet problems (such as flail, prolapse, stiffness, and/or other abnormalities) etc.) implants or devices. In certain applications, a netting implant/device can be seated on the outflow side of a valve with the lateral edges seated in a fissure (eg, fissure or commissure) within the heart valve , while providing contact pressure and/or support for a flail, prolapse, rigidity and/or abnormality. The contact pressure provided by the various netting devices/implants helps to flatten and/or reshape the leaflet or the flail, prolapse, stiffness and/or abnormalities of the leaflet, which helps when in A closed position extends the coaptation edge of a leaflet rearwardly towards the coaptation region. Normal coaptation resulting in a fully closed valve prevents valve insufficiency.

In certain applications, a netting implant/device includes, but is not limited to, a surface configured to directly contact the surface of a leaflet suffering from flail, prolapse, stiffness, and/or other problems. Typically, the inflow surface of a leaflet is the surface that experiences flail, prolapse, stiffness, and/or other problems. In some applications, the contact surface of the netting device is flexible and thus conforms to the profile of the inflow surface of a leaflet, which may be a hyperbolic paraboloid-like profile. In certain applications, the contact surface of the netting device provides contact pressure over a leaflet flail, prolapse, rigidity and/or abnormality. In certain applications, the interface of the netting implant/device has a width and a length such that it can cover the area of the leaflet that experiences flail, prolapse, rigidity and/or abnormalities. In certain applications, the length of an implant/device extends just beyond the coaptation region of the leaflet.

In certain applications, a netting implant/device contains an anchor to stabilize the device at the implanted site. In certain applications, an anchor is seated adjacent to or in contact with the valve annulus, leaflet region, or atrial/ventricular wall. In some applications, an anchor is a screw, helix, helical anchor, or other feature that can be screwed or embedded within the valve annulus, valve leaflets, or atrial/ventricular wall. In certain applications, a helical anchor is housed within a tubular compartment that is connected to or to be anchored to a portion of the netting implant/device.

In certain applications, an anchored netting implant/device incorporates a tether for further stabilization at the site of the implant. In some applications, a tether extends from the engagement portion of a netting implant/device to a fixation site on the outflow side of the valve, where the tether is stapled. The fixation site can be any solid feature, such as, for example, the wall of the ventricle, the wall of the atrium, the mastoid muscle, and/or the adjacent vasculature.

The netting of a netting device may be impermeable, semi-permeable, or permeable to fluids (eg, blood or plasma). In some applications, the netting is a mesh. In some applications, a mesh system is formed using overlapping and intersecting staggered strands. In some applications, a mesh is formed using a mesh sheet. Any suitable material can be applied to a netting, for example, a netting can contain one or more of the following: lactic acid-glycolic acid (PLGA), polyvinyl chloride (PVC) ), polyethylene (PE), polypropylene (PP), polytetrafluoroethylene (PTFE), polyurethane (PU), polyethylene terephthalate (PET), polyether sintered (PES), Polyglycolic acid (PGA), polylactic acid (PLA), poly-d-lactic acid (PDLA), poly-4-hydroxybutyrate (P4HB) and polycaprolactone (PCL). Any suitable means for attaching a netting to an anchor(s) may be applied, including but not limited to: stitching, staples, and glue.

In certain applications, a netting device includes a wire form that outlines the netting or a portion of the netting. Any suitable material used to create a wireform may be used, for example, the wireform may comprise one or more of the following: Nitinol, Cobalt-Chromium (CoCr), Stainless Steel, Titanium , Polyglycolic acid (PGA), Polylactic acid (PLA), Poly-D-lactic acid (PDLA), Polyurethane (PU), Poly-4-hydroxybutyrate (P4HB), Polycaprolactone (PCL) ), polyetheretherketone (PEEK), cyclic olefin copolymers (COCs), polyethylene vinyl acetate (EVA), polytetrafluoroethylene (PTFE), perfluoroether (PFA), fluorinated ethylene propylene copolymer ( FEP), their additives, and derivatives of these.

In some applications, a netting device is collapsible, which may be useful for fitting into a catheter device for a less invasive catheter delivery methodology. In certain applications, nitinol systems are used for their self-expanding properties, which may be useful for implanting the device in a less invasive catheter delivery methodology.

Certain applications of netting devices are configured to be used over any leaflet that suffers from flail or prolapse. Thus, in certain applications, a netting device can be applied over a leaflet of a mitral valve, a tricuspid valve, an aortic valve, and/or a pulmonary valve. Likewise, various devices/implants can be applied over any area of the leaflet that suffers from flail or prolapse. In certain applications, a netting device can be applied over any area between the fissures (eg, commissures and fissures) of a leaflet.

To reach the site of the implant, any suitable surgical technique can be used, including but not limited to a transcatheter delivery system that can employ a transfemoral, subclavian, transapical, transseptal or trans-aortic approach. In certain applications, a delivery catheter is applied to incorporate a device, then delivered via a guidewire to the deployed site and applied to anchor the device at the implanted site .

Certain examples herein are directed to methods for delivering a networked device to the expanded address. The various methods described or suggested anywhere in this document (including the documents incorporated herein by reference) can be performed on or on a living animal (eg, human, mammal, other animal, etc.) Executed on an inanimate simulation, such as on a cadaver, cadaver heart, simulator (eg, with the body part, tissue, etc. being simulated), etc. Thus, methods of delivery include methods of treatment (eg, treatment of a human subject) as well as methods of training and/or practice (eg, applying an anthropomorphic prosthesis that mimics the human vasculature to perform the method).

64 illustrates an exemplary netting implant or netting device 6401 with a helical anchor 6403. The netting implant/device 6401 is shown with a mesh material 6405 extending from the anchoring portion 6407. The side edges 6409 and 6411 of the netting implant/device 6401 can be positioned into a cleft (eg, commissure or fissure) of the heart valve, while the mesh material 6405 can be positioned over a leaflet And provide contact pressure over the leaflets to address flail, prolapse, stiffness, and/or other problems. The side edges 6409 and 6411 can optionally incorporate a wire form. The engagement portion 6413 may optionally contain a tether or hammer to further stabilize the netting device at the implanted site.

Figures 65 and 66 show an exemplary depiction of the netting implant/device 6401 with a helical anchor 6403 positioned at an implanted site. As shown here, the netting implant/device is positioned over the mitral valve 6415. The contact surface of the netting implant/device 6401 is seated within the left atrium 6419 on the inflow surface of the posterior lobe at the site of flail, prolapse, rigidity and/or abnormality. The contact surface may provide contact pressure on and/or support the leaflet to address flail, prolapse, stiffness and/or abnormalities and to help flatten and/or reshape the leaflet or the leaflet A protruding structure, bulge, flail, etc., and a relief of backflow of blood flow. The implant/device 6401 includes an engagement portion 6413 extending beyond the edge of the posterior lobe (eg, below the edge) into the left ventricle 6417.

The lateral edges 6409 and 6411 of the netting implant/device 6401 can be positioned within the slit 6419 between P1 and P2 and the slit 6421 between P2 and P3. Any of the anchors described herein may be used. In certain applications, the anchor 6403 is a helical anchor configured to be anchored within the valve annulus 6423. The anchor 6403 stabilizes the netting device 6401 at the native valve 6415.

67A-B, 68A-G, and 69-75, which are schematic diagrams of a system 20 for use with a valve of a heart 4 of an individual, according to certain applications. The system 20 is shown being used on a mitral valve 10 of the heart, the heart chamber upstream of the mitral valve is the left atrium 6, and the heart chamber downstream of the mitral valve is the left ventricle 8. However, the system 20 may also be adapted for use with another atrioventricular valve (the tricuspid valve), upstream of the atrioventricular valve is another atrium (the right atrium), and downstream of the atrioventricular valve is the other ventricle (the right ventricle). System 20 can also be used with the aortic valve or the pulmonary valve, upstream of which is a ventricle (the left ventricle and the ventricle, respectively).

System 20 includes an implant 100 , an anchor 30 , a catheter 40 and a delivery tool 50 . Implant 100 includes an interface 110 and a flexible wing 120 coupled to the interface. Wing 120 may include a contact surface or surface 122 and an opposing surface or surface 123 relative to the contact surface. For certain applications, implant 100 may be adapted to have features or elements similar to those described with respect to implant 1101, implant 2101, 2301, and/or 2421 described above.

The delivery tool 50 may include a shaft 60 and a driver 70 . The shaft 60 is configured to engage the interface 110, and via this engagement, to deploy and position the implant 100, eg, as described in more detail below. This engagement may be achieved by the shaft 60 having a shaft head 62 containing one or more couplers 64 such as latches or arms that engage one or more couplers of the interface 110 114 (eg, recesses, grooves, notches, or sockets).

The driver 70 is configured to engage the anchor 30 (eg, a head 32 thereof) and is configured to anchor the implant 100 to the tissue by using the anchor to anchor the interface 110 to the tissue. tissue of the heart. In some applications, the driver 70 includes a flexible shaft 74 and a drive portion 72 at a distal end of the shaft that engages the anchor 30 .

For some applications, and as shown, the wing 120 includes a frame 124 (eg, a wire frame) and a sheet 126 overlaid on the frame. For some applications, the wings 120 have a root 130 coupled to the interface 110, and a tip 132 at the end of one of the wings relative to the root. Tip 132 represents a free end of wing 120 .

For some applications, frame 124 is attached to interface 110 . For example, and as shown, at root 130 , frame 124 may define a loop 128 that mates with interface 110 . The wings 120 may define two sides 134 (eg, a first side 134a and a second side 134b) extending from the root to the tip.

For some applications, and as shown, the frame 124 defines two rings 136 (eg, a first ring 136a and a second ring 136b ) extending side by side from the root 130 , eg, all the way to the tip 132. It is to be noted that, as shown, the rings 136 may be discrete rings rather than a grid of cells or lattice structures. For example, rings 136 are unconnected to each other and/or to any other metallic components of implant 100 except at root 130 (eg, at ring 128 and/or interface 110 ). Furthermore, each of the rings 136 may be configured to define a space 137 substantially free of frame components. For some applications, and as shown, each of the rings 136 is substantially teardrop shaped.

For certain applications where the frame 124 defines the ring 136, the frame 124 defines an elongated space 138 between the two rings. The space 138 may extend from the root 130 toward the tip 132, eg, all the way to the tip (eg, such that the frame 124 does not bridge the two rings at the tip). For some applications, and as shown, space 138 runs along a reflective symmetry plane of wing 120 .

For certain applications in which the frame 124 defines the rings 136 , the sheet 126 may be configured to extend across and between the rings, eg, across both the rings and the space 138 .

For some applications, the sheet 126 has several holes 140 therethrough. For some such applications, and as shown, the holes 140 are polygonal and checkerboard with each other. For example, and as shown, the holes 140 may be hexagonal. As shown, some of the holes 140 may be arranged above the spaces 137 . Alternatively or additionally, certain apertures 140 may be disposed over space 138 . For some applications, and as shown, the apertures or holes 140 are sized and numbered such that the wings 120 as a whole are more than 20 percent open and/or less than 80 percent open, eg, 20-80 percent open , such as 20-70 percent open (eg, 30-70 percent open, such as 30-60 percent open or 40-70 percent open) or 30-80 percent open (eg, 40-80 percent open) .

In some applications, the wings 120 are curved such that the contact surface 122 is concave. That is, the curvature of the wings 120 is such that in a cross-section of one of the implants 100 through the interface 110 and the wings, the contact surface 122 is concave. FIG. 67B is a schematic illustration of this cross-section, while in FIG. 67A the position of the cross-section is shown by index A. FIG. However, Figure 67B shows the implant 100 with anchor 30 in place, eg, as if the implant had been implanted. As shown, this cross-section may be in a reflective symmetry plane of the implant, such as in space 138, between rings 136. For some applications, and as shown, the curvature of the wings 120 increases with distance from the interface 110 , eg, such that the curvature is greatest at the tip 132 . For example, and as shown in FIG. 67B , at the tip 132 , after anchoring of the implant 100 by the anchor 30 , the tangent ax2 of the curvature of the wings 120 is relative to an anchor axis of the anchor 30 ax1 may be below 60 degrees (eg, below 45 degrees, such as below 35 degrees). This angle between tangent ax2 and axis ax1 may depend, at least in part, on the geometry of interface 110 and/or an anchor receptor 150 (described below) located at the interface, eg, relative to anchor 30 geometry.

For certain applications, and as described in more detail below, the angular arrangement of one of the wings 120 relative to the interface 110 and/or anchor receptor 150 is such that the interface is positioned against tissue in an atrium of the heart ( For example, abutting an annulus of an atrioventricular valve of the heart, or abutting a wall of the atrium) positions the tip 132 within the ventricle downstream of the atrium and the atrioventricular valve.

68A-G show at least some steps in the implantation of implant 100, according to certain applications. Within catheter 40, implant 100 is advanced to a heart chamber located upstream of the heart valve to be treated (FIG. 68A). For example, catheter 40 may be advanced to the chamber prior to advancing implant 100 through the catheter, or the catheter may be advanced to the chamber with the implant already deployed therein. In the illustrated example, the mitral valve 10 of the heart 4 is being treated, and thus the implant 100 is advanced into the left atrium 6 of the heart. The mitral valve 10 has a first leaflet (eg, a posterior leaflet) 12 and an opposing leaflet (eg, an anterior leaflet) 14 . In the illustrated example, the posterior leaflet is the leaflet that is being flailed. The flailing part of the latter is indicated by the numeral 16 . It is to be noted that the system 20 can be similarly used to treat flails in the anterior lobe 14 , mutatis mutandis.

In the example shown, catheter 40 is advanced transluminally to the heart chamber. However, a transatrial approach also falls within the scope of the disclosure in this case. Likewise, although a transfemoral approach is shown, the scope of the present disclosure includes advancement via the superior vena cava. It is to be noted that although a transseptal approach is shown from the right atrium 5 into the left atrium 6, the atrial septum is not shown as it is behind the aorta 7. A portion of the catheter 40 is shown in phantom in order to illustrate that it is tied behind the aorta 7.

As shown, advancement of the implant 100 within the catheter 40 is performed while the shaft 60 (eg, its head 62) engages the interface 110 of the implant. In certain applications, the implant 100 is advanced within the catheter 40 while the wings 120 are constrained (eg, compressed, folded, and/or rolled up) within the catheter.

Using the shaft 60, the implant 100 is deployed out of the catheter 40 such that within the atrium 6, the wings 120 extend away from the interface 110 (FIGS. 68B-C). For some applications, once deployed, the wings 120 automatically expand toward the shape described with reference to FIGS. 67A-B, eg, due to the elasticity and/or shape memory of the frame 124.

Subsequently, using the shaft 60 again, the implant 100 is positioned in a position in which the interface 110 is tethered at a location 18 in the heart and the wings 120 extend beyond the first leaflet 12 toward the opposite leaflet 14, and the contact surface 122 faces the first leaflet (Fig. 68D). For some applications, and as shown, the wings 120 extend beyond the first leaflet 12 such that the tip 132 is disposed beyond the lip (eg, downstream) of the first leaflet, eg, on the left Inside the ventricle 8 , for example, with the opposing face 123 facing the opposing leaflets 14 . Typically, this is due at least in part to the geometry and dimensions of the implant 100 and/or at least in part to the location 18 . The location 18 may be, but need not be, over the annulus of the valve being treated, eg, at the root of the leaflet being flailed. Thus, in the example shown, the wings 120 extend from the interface 110 at the address 18 above the mitral annulus 11 at the root of the posterior leaflet 12 across the posterior leaflet 12 toward the opposing leaflet 14 , and bend downstream between the leaflets 12 and 14 , beyond the lip of the leaflet 12 , so that the tip 132 is disposed within the ventricle 8 .

For some applications, and as shown, the wings 120 (and optionally the entire implant 100 ) are fully deployed (ie, exposed) from the catheter 40 before being positioned against the tissue.

The wings 120 can be configured to be at various angles relative to the catheter shaft and/or relative to the native anatomy (eg, the annulus and/or leaflets) during delivery to is positioned for anchoring to properly restore the function of the native leaflet, for example, in certain applications, the device is relative to an axis of the tip of the catheter (and/or relative to the annulus) during delivery A plane) is at an angle between 20-160 degrees, between 30-150 degrees, between 40-140 degrees, between 50-130 degrees, between 60-120 degrees between, between 70-110 degrees, etc.

The optimum for a given location of the implant 100 can be determined during the implantation procedure, eg, prior to anchoring the implant to the tissue. For example, suitability can be determined using blood pressure sensing techniques and/or imaging techniques such as fluoroscopy and cardiac ultrasound. For example, Doppler echocardiography can be used to determine the degree to which regurgitation through the valve has remained or has been reduced. To illustrate one advantage of the system 20, FIG. 68D shows that the implant 100 is initially positioned suboptimally, eg, with the wings 120 positioned away from the flail 16. FIG. That is, address 18 is the initial address 18a at which an interface 110 has been located. At this point, the implant 100 has not been anchored to the tissue, and the interface 110 can simply be moved to another location 18, eg, a second location 18b (FIG. 68E). For example, the interface 110 can simply be slid along the ring 11 . Optionally, the interface can be lifted away from the tissue at the first site and then repositioned against the tissue at the second site. As shown, this repositioning can be performed without withdrawal (eg, even a partial withdrawal) of the implant 100 into the catheter 40 . In the illustrated example, this second position of the implant 100 is more appropriate (eg, optimal) than the first position, eg, the wings 120 are disposed over the flails 18 and valve insufficiency be minimized or eliminated.

Once it is determined that the implant 100 is properly positioned (eg, optimally), the implant is anchored in its position by anchoring the interface 110 to the tissue of the heart, eg, at the current at address 18 (FIG. 68F). This can be accomplished by using the driver 70 to distally advance the anchor 30 while maintaining the position of the implant 100 . Subsequently, the driver 70 (eg, its driver portion 72) is disengaged from the anchor 30, the shaft 60 (eg, its shaft head 62) is disengaged from the interface 110, and the tool 50 is removed to disengage the implant 100 left in place.

It is to be noted that the tip 132, which is a free end of the wing 120, is typically not anchored to tissue during the implantation process. It is further to be noted that, at least for applications in which the interface 110 is anchored to the annulus 11, the implant 100 is typically not anchored downstream of the valves being treated (eg, at the within the ventricle downstream of the valve), eg, implant 100 does not contain a downstream anchor (eg, a ventricular anchor). For example, and as shown, at least for applications in which the interface 110 is anchored to the annulus 11, any anchoring of the implant 100 to the tissue of the heart is typically tethered to the valve under treatment. within the atrium upstream.

For some applications, the implant 100 can be repositioned even after anchoring, with the driver 70 being used to unanchor the interface 110 from the tissue (eg, by loosening the anchor 30).

68G shows the implant 100 after its implantation, and the subsequent disengagement of the tool 50 from the implant (eg, the disengagement of the driver 70 from the anchor 30, and the disengagement of the shaft 60 from the interface 110), and The tool is extracted from the individual.

It is assumed that the simplicity of repositioning the implant 100 is due, at least in part, to the simplicity and parsimonious nature of the implant itself and/or to the simplicity of its anchoring (eg, via a single anchor). It is further assumed that because the shaft 60 holds the implant 100 in various locations within which the implant would likely be anchored [eg, because the shaft holds (eg, against) the interface 110 [18], and because subsequent anchoring of the implant causes minimal (eg, no) change in the position of the implant, the positional optima described above The determination, advantageously, is particularly accurate and reliable for the system 20 . It is further hypothesized that this advantage may additionally be facilitated by complete deployment of the wings 120 (eg, the entire implant 100) prior to placing the implant into various locations.

Furthermore, if it is decided to interrupt the implant 100 after it has been deployed in the atrium, it is possible to simply withdraw the implant by retracting the shaft 60 into the catheter. into the catheter 40 and outside the subject. The shape and flexibility of the wing 120 causes it to be recompressed by its re-entry into the conduit. If the interface 110 has been anchored before the decision to interrupt is made, the actuator 70 may be used to un-anchor the anchor 30 prior to retraction of the shaft 60 .

Further to the simplicity of implant 100, for some applications, implant 100 consists essentially of the following: interface 110 and wings 120 (ie, frame 124 and sheet 126).

For some applications, and as shown, the driver 70 is disposed within the shaft 60 and through which the anchor 30 can be advanced. For some such applications, and as shown, driver 70 and anchor 30 may exist within shaft 60 throughout the procedure. In certain applications, driver 70 and anchor 30 may be introduced into shaft 60 after implant 100 has been introduced into the heart.

The anchor 30 can include a tissue engaging element 34, and the driver 70 can anchor the interface 110 to the tissue by driving the tissue engaging element into the tissue. Tissue engaging element 34 may take one of a variety of different shapes known in the art, such as helical, target, staple, and the like. In the example shown, tissue engaging element 34 is a helical tissue engaging element that driver 70 tightens into the tissue.

For some applications, implant 100 includes an anchor receptor 150 at interface 110 (or interface 110 includes an anchor receptor 150) such that anchoring of the interface to the tissue is accomplished by the receptor is achieved by anchoring the device to the tissue. This may itself be accomplished by using driver 70 to anchor anchor 30 to receptacle 150 (eg, by driving the anchor through the receptacle into the tissue).

For some applications, and as shown, the receptacle 150 defines an aperture therethrough and includes a blocking body 152 that projects medially into or across the aperture. For such applications, anchor 30 and driver 70 can be configured such that the driver can drive tissue engaging element 34 past obstructing body 152 until head 32 becomes obstructed by the obstructing body.

For some applications, receptacle 150 may be similar to and/or may be substituted for an anchor attachment point described above, such as anchor attachment point 2107, mutatis mutandis.

69, 70, and 71, which are schematic illustrations of valve 10 during one of the transitions from ventricular diastole to ventricular systole, according to certain applications. In Boxes B-D of each of these figures, a series of small upward pointing arrows represent the pressure from the contraction of the ventricle 8 during ventricular systole. Figure 69 shows the valve 10 as a healthy valve 10, while Figures 70-71 show the valve 10 as a damaged valve 10 in which the leaflets 12 are experiencing flail (eg, as described above for the valve 10) . According to certain applications, Figure 70 shows the damaged valve 10 prior to implantation of the implant 100, while Figure 71 shows the valve after implantation of the implant. In each of Figures 69-71, frames A-D represent sequential snapshots during the transition from ventricular diastole to ventricular systole. When viewed in reverse order, frames D-A can be considered to represent sequential snapshots during the return transition from ventricular systole to ventricular diastole.

In a healthy valve 10 , the leaflets 12 and 14 close synchronously during ventricular systole, thus coapting and preventing retrograde flow into the atrium 6 . In a damaged valve 10 , the flail 16 occurs at one site of the leaflets 12 (eg, due to one or more damaged chordae tendineae), thereby allowing retrograde leakage into the atrium 6 . The previously described treatment for flails is based on inhibiting movement of the valve leaflets in an atrial direction (eg, along an atrioventricular valve axis ax3), such as by implanting a restraint device (eg, a artificial chordae) implants in or in the atrium a restraint device (eg, a blocking frame) that resists (eg, directly resists) the flail's ventricle-atrial movement and thus requires substantial strength to resist The force exerted by ventricular pressure on this leaflet. It is hypothesized that the implant 100 favorably manipulates the force of the ventricular pressure, deflecting the original ventricular-atrial movement of the leaflets 12 toward the opposing leaflets 14, so that the portion of the leaflets 12 that would otherwise flail comes with the Leaflets 14 are coapted - albeit with wings 120 sandwiched in between.

It is hypothesized that this guided coaptation mimics the physiological coaptation in a healthy valve, allowing the leaflets to cooperatively resist ventricular pressure. That is, due to this guided coaptation, the leaflets 14 provide support to the leaflets 12 against the flail. It is further assumed that because of this, the implant 100 advantageously does not need the substantial strength that would be required to resist the force exerted by the ventricular pressure. Instead, the implant 100 may advantageously be anchored by a single anchor (although multiple anchors may be used), implanted using a single and highly steerable delivery system, and the wings 120 Can be highly flexible. For certain applications, the implant 100 and/or its anchors may in fact not be strong enough to directly resist (eg, obstruct) the flapping of the leaflets 12 in response to forces from ventricular pressure - but can still be (Re)directing the leaflet towards the opposing leaflet lowers or eliminates the flail.

A comparison of Figures 70 and 71 further illustrates an example of this hypothetical behavior, although this example should not be construed as limiting the scope of the present disclosure. In Figure 70, frames B-D show the undamaged leaflet 14 swinging toward the leaflet 12 in response to ventricular pressure. That is, while the ventricular pressure is directed broadly toward the atrium (eg, along axis ax3 ), and while leaflet 14 moves toward the atrium in response to this pressure, it also swings/deflects toward leaflet 12 . In a healthy valve, the two leaflets behave in this manner and thus coapt (Figure 69). In contrast, in Figure 70, the damaged leaflet 12 (eg, its flail portion 16) has relatively little movement toward the leaflet 14 and is therefore able to slip through the lips and flail of the leaflet 14 to the atrium within 6. In FIG. 71 , implant 100 (eg, its wings 120 redirect leaflet 12 toward leaflet 14 , facilitates closure of valve 10 .

In many applications, a portion of the native leaflet being treated (eg, leaflet 12) still engages directly against another native leaflet. In certain instances, more than 20%, more than 30%, more than 40%, more than 50%, more than 60%, or more than 70% of the native leaflet (or the native leaflet being treated) one of the engagement surfaces) directly engages against the other native leaflet. Again, typically, the native leaflet being treated (leaflet 12 in this case) is separated from wing 120 (FIG. 71), typically during at least part of the cardiac cycle (eg, ventricular diastole). , frame A), while during another portion of the cardiac cycle (eg, ventricular systole), the valve leaflets become pushed against the wings 120 by ventricular pressure. Thus, wing 120 does not act as a prosthetic leaflet, but rather guides and/or supports one of the native leaflets, helping the native leaflet to assume an appropriate configuration for engagement with the opposing leaflet. It is assumed that, at least for some applications, the shape of the wings 120 and/or the position and orientation in which the implant 100 is implanted is such that during systole, the native leaflets become molded or The shape of the wing 120 is followed or conformed as the contact between the native leaflet and the wing widens toward the lip of the leaflet and the tip 132 of the wing, eg, as shown.

Implant/device 100 (and any of the implants/devices herein) may be beneficially configured to extend beyond (and/or below) the edge of the native leaflet (eg, when when the valve is closed). It is hypothesized that this may beneficially help ensure that the leaflet assumes the correct shape without requiring the tip of the implant/device 100 to be anchored within the ventricle or clipped to the edge of the native leaflet.

It is hypothesized that the hole 140 [or other opening(s)] contributes to the natural leaflet becoming molded into or following or conforming to the shape of the wing 120 by allowing blood to flow during diastole Flow downstream through the wing 120 (eg, pushes the leaflet 12 away from the wing) and allows blood to escape from between the leaflet and the wing during the first moment of systole, thereby allowing the valve The leaflet quickly flattens against the wing and engages the opposing leaflet, thus contributing to a small amount of backflow. A similar permeable portion and/or open/exposed portion to that described with respect to FIG. 21A may provide similar benefits, and it is possible for this device to contain or be used and shown and described with respect to FIG. 21A those similar covered parts and/or exposed parts. The hole(s), open portion and/or permeable portion may also help facilitate implantation in a beating heart and allow earlier positioning of the device without circulating blood trapping like a sail the wing and cause excessive movement of the wing or device. This also helps to avoid undesired device/implant migration after implantation.

Typically, and as shown, the wings 120 beat or move during the cardiac cycle, eg, by the manner in which the implant 100 is anchored and/or the flexibility of the wings (eg, frame 124 ) induced by sex. For example, as the leaflet being treated is pushed upstream by ventricular pressure, it pushes the wings 120 upstream. The transition from frame A to frame B of FIG. 71 represents that the entire implant 100 pivots about the anchor 30 in response to the leaflets 12 being pushed against the wings 120, eg, since the implant 100 is only anchored It is set at interface 110. The transition from frame B to frame C of FIG. 71 represents the deflection of the wing 120 relative to the interface 110 and anchor 30 as the wing is pushed further by the leaflet 12, eg, due to the wing (eg, frame 124) ) because of its flexibility.

Figure 72A schematically illustrates an implant 100a, Figure 72B schematically illustrates an implant 100b, and Figure 72C schematically illustrates an implant 100c. Implants 100a, 100b and 100c are variants of implant 100. Implants 100a, 100b, and 100c may be identical to each other, except that implant example 100a includes anchor receptor 150 or one of interface 110 receptors 150a, and implant example 100b includes anchor receptors 150 or a receptacle 150b of the interface 110, and the implant example 100c includes the anchor receptacle 150 or a receptacle 150c of the interface 110.

Receptacle 150a includes an exemplary barrier element 152a of barrier 152 . Barrier element 152a is defined by the portion of sheet 126 that extends beyond the aperture defined by the anchor receptacle. During anchoring, tissue engaging elements 34 are driven through and past the sheet (eg, pierce the sheet) until the head 32 becomes obstructed (eg, abuts) by the sheet, eg, presses /sandwich the sheet towards/against the tissue. For some applications, the receptacle 150a is adapted to have the same features as those described with reference to Figures 24C-D. For example, the portion of sheet 126 that defines barrier element 152a may define a hinge similar to hinge 2427 described with reference to Figures 24C-D.

Receptacle 150b includes an exemplary barrier element 152b of barrier 152 . Barrier element 152b includes a crossbar (or is defined by the crossbar) across the aperture defined by the anchor receptacle. During anchoring, the tissue engaging element 34 is driven beyond the crossbar until the head 32 becomes obstructed (eg, abutted) by the crossbar, eg, pressing/sanding the crossbar toward/against the tissue . For some applications, the receptacle 150b is adapted to have the same features as those described with reference to Figures 23B-C. For example, the crossbar that defines barrier element 152b may correspond to or be similar to the crossbar that traverses aperture 2317. For certain applications, the crossbar defining the barrier element 152b may be adapted to correspond to or be similar to the fulcrum 1905 described with reference to Figure 19A.

Receptacle 150c includes an exemplary barrier element 152c of barrier 152 . Barrier element 152c includes (or is bounded by) a collar. During anchoring, the tissue engaging element 34 is driven past the collar until the head 32 becomes obstructed (eg, abutted) by the collar, eg, pressing/sanding the collar toward/against the tissue .

A wide variety of different types of barrier elements are also possible, for example, a sheet(s), a cloth(s), a fabric(s), a panel(s), a metal (e.g. , metal sheet, metal cloth, metal structure, etc., configured to interconnect with the anchor), one or more holes [e.g., sized to allow passage of the tissue-penetrating portion of the anchor but not the anchor head one (more) holes], one (more) crossbar, one (more) collar, one (more) hub, one (more) polymer layer, mesh, one (more) screw A cap, a threaded portion(s) (eg, with threads that interact with the anchor to allow tissue penetration but keep the anchor attached to the device), stop(s), and the like.

For some applications, the implant 100 includes a side wall (eg, a tube wall) 112 that defines at least a portion of the interface 110, and a coupler 114 may be defined in the side wall. For example, implant 100 may include a housing 108 that includes or defines interface 110 (eg, wall 112 and its coupler 114) and receptacle 150 (eg, its barrier 152). The housing 108 may be formed from a single piece stock incorporating all of these elements. Housing 108 may be adapted to have the same features as housing 2313 described above.

For some applications, implant 100 incorporates a reaction force support, such as support 1113 and/or support 2309 described above. For some such applications, the reactive force support is disposed proximally from interface 110 and/or receptacle 150 while tethered within catheter 40 during delivery. For example, only after an optimal location for implant 100 has been identified and/or only after interface 110 has been anchored to the tissue (eg, such that when wings 120 are being deployed out of the catheter , shaft 60 extends proximally within the catheter away from the interface and is supported by the reaction force) that can be deployed from catheter 40. Optionally, although the reaction force support is disposed proximally from interface 110, it may be deployed from catheter 40 prior to placement of interface 110 against the tissue. For some applications, during delivery, the reaction force support is disposed away from the interface 110 and/or the receptacle 150 (eg, alongside the wings 120) while being tethered within the catheter 40, and can be coupled with the The wings are simultaneously deployed from the catheter.

Once deployed, the reaction force support extends from interface 110 and away from wings 120, and after implantation, implant 100 typically rests against the wall of the chamber in which the implant has been implanted, eg , similar to as described with reference to Figures 11-12, mutatis mutandis.

73, which is a schematic illustration of one of a plurality of implants 100 that have been implanted at a single heart valve, according to certain applications. Advantageously, and at least in part because of the simplicity of the implant 100, the implant typically allows for the implantation of multiple implants 100 at the same valve. It is assumed that the simplicity of the implant 100 and/or the flexibility of the wings 120 allow such multiple implants to be implanted without preventing the underlying leaflet from engaging the opposing leaflet - Even the wings 120 of the implants overlap, eg, as shown.

Although all three implants 100 are shown attached to the same leaflet in Figure 73, it is to be understood that the scope of the present disclosure includes implanting one or more implants 100 within the valve over one leaflet, and one or more implants 100 over the other leaflet of the valve.

Furthermore, implant 100 is compatible with the implantation of other implants, either before or after implantation of implant 100. For example, because the implant 100 has a relatively small footprint on the annulus, an annuloplasty structure can also be implanted, if desired. Likewise, because wings 120 are flexible, if it is subsequently determined that the individual requires implantation of a prosthetic valve at the heart valve (eg, due to further deterioration of the condition to be treated), a transluminal The delivered prosthetic valve can be implanted without removal of the implant 100, eg by simply pushing/deflecting laterally by the wings 120 being expanded by the prosthetic valve. It is assumed that the size and simple design of the wings 120 will mean that the wings will not conceal the outflow of an implanted prosthetic valve without removal of the implant.

Furthermore, it may be possible to implant implant 100 with wings 120 over a portion of a leaflet and perform an edge-to-edge repair (eg, by implanting a leaflet that holds the edge of the leaflet in place) together with the leaflet clamp). The edge-to-edge repair may be accomplished at another portion of the leaflet that is not covered by the implant, or in some applications may be performed over or through a portion of the implant 100 .

Referring to Figures 74-75, Figures 74-75 are schematic illustrations of implant 100 that has been implanted at a different location than that shown above, according to certain applications.

In Figures 68A-G and 71, the interface 110 is anchored to the annulus 11, which is more outboard relative to the valve 10 than the root 13 of the leaflet (in this case, the leaflet 12). In contrast, in Figure 74, the interface 110 has been anchored medially from the root of the leaflet, with the tissue engaging elements 34 of the anchor 30 penetrating entirely through the leaflet and into the wall 9 of the ventricle 8 . For the ventricular wall 9, this fixes the portion of the leaflet closest to the root 13, thus actually reducing the effective length of the leaflet. It is hypothesized that, in addition to the advantages of the implant 100 described above, such an anchoring site may be particularly useful in the case of leaflet prolapse.

Typically, for applications where this anchoring site is used, the interface 110 is pressed against the leaflet prior to anchoring such that the leaflet is sandwiched between the delivery tool 50 (eg, its shaft 60) and the ventricle 8 between the walls.

68A-G and 71, the implant 100 therein is shown being implanted medially over the leaflets 12 [eg, at the P2 sector]. In contrast, in FIG. 75 , the implant 100 has been implanted more laterally over the leaflet, eg, near or at a commissure 15 of the valve 10 . It is hypothesized that the flexibility of the wings 120 allows it to conform to the anatomy while improving coaptation. Again, it is further hypothesized that the flexibility and configuration themselves may make the implant 100 particularly suitable for implantation at such sites, for example, as compared to one that might inhibit the first valve. The leaflets move towards the opposing leaflets and engage the more rigid implant with the opposing leaflets. In the example shown, implant 100 has been implanted at a site and in an orientation in which one wing 120 is asymmetrically deflected, contributing to the P3 sector of leaflet 12 at commissure 15 and leaflet 14 The junction between the A3 sector structures. For such applications, the double-ring configuration of the wing 120 may facilitate such asymmetric deflection, for example, allowing the wing to deflect along a central longitudinal axis of the wing (the transverse axis indicated by index A in FIG. 67A ). The cross section is located on the central longitudinal axis) to fold.

76, which is a schematic illustration of an implant 100d, according to certain applications. Implant 100d is a variant of implant 100 and, mutatis mutandis, may be the same as or similar to implant 100 as described above, with the exception that implant 100d is secured by multiple anchors. be anchored. In some applications, the implant 100d may contain multiple discrete anchor receptors 150, or multiple anchors may be received by a single anchor receptor or interface.

In some applications, and as shown, the implant 100d may have a single anchor receiver 150 that accepts a single anchor 30 along with additional anchors that are driven through the sheet 126 located adjacent to the interface 110 30a. For some applications, the implant 100d includes multiple interfaces 110, each of which may include an anchor receptor. For some applications, implant 100d (eg, one of its anchor interfaces) is configured to accept multiple anchors at different angular arrangements such that the anchors cooperate to provide improved anchoring.

Having an anchor point provides the benefit of easier and faster implantation, which makes it very easy to locate the device, confirm normal functioning (eg, using fluoroscopy and/or echocardiography), and simply Anchor in place. Having multiple anchors and anchor attachment points may allow for greater stability and redundancy to ensure that the implant is securely and permanently anchored in place. Where multiple anchor attachment points and anchors are used, one delivery device can be used that is configured to deliver multiple (eg, 2, 3, 4, etc.) anchors simultaneously to assist Provides greater stability and redundancy while maintaining a fast and secure delivery.

Referring to Figures 77A-B, the figures are schematic illustrations of an implant 100e, according to certain applications. Implant 100e is a variant of implant 100, and mutatis mutandis may be identical to implant 100 described above, except that it includes a wing 120e that is one of wings 120 variant. Contact surface 122e of wing 120e (corresponding to contact surface 122 of wing 120) defines a leaflet configured to capture blood cells and cell fragments and/or induce localized thickening of the underlying leaflet (referred to at 17 ). Protruding structures (eg, cilia or flanges) 160 and/or concave portions (eg, dimples or pockets) 162 for tissue growth and/or mild inflammation. It is hypothesized that this thickening further contributes to a reduction in regurgitation, eg, by increasing local stiffness and/or reach of the underlying leaflet, thereby improving coaptation with the opposing leaflet.

As shown, the protruding features and/or recessed portions may be defined by the sheet 126e, eg, by the sheet being textured. For some applications, the protruding features and/or recessed portions may be defined by discrete elements attached to the sheet.

Referring now to Figures 78A-B and 79, which are schematic illustrations of an anchor 30b and an anchor 30c, according to certain applications. Anchors 30b and 30c may be used mutatis mutandis in place of any of the other anchors described above. Anchors 30b and 30c may be considered variants of anchor 30 for some applications. Furthermore, the features of anchors 30b and 30c may be combined with each other and/or with the features of other anchors described herein.

While anchor 30 has a single helical tissue engaging element 34, each of anchors 30b and 30c has two tissue engaging elements arranged as a double helix, each of the tissue engaging elements having a sharp distal tip . Anchor 30b includes two tissue-engaging elements 34b (ie, a first tissue-engaging element 34b' and a second tissue-engaging element 34b''), and anchor 30c includes two tissue-engaging elements 34c (ie, a first tissue-engaging element 34b''). tissue engaging element 34c' and a second tissue engaging element 34c").

It is hypothesized that such use of two tissue engaging elements may provide greater stability during initial penetration of the anchor into the tissue, and/or greater anchor strength.

Although anchors 30b and 30c are shown with the two tissue engaging elements being the same length, for some applications one tissue engaging element may be longer than the other, eg, such that one penetrates the tissue first, in The other provides stability when penetrated into the tissue.

For some applications, and as shown, each of the tissue engaging elements is defined by a separate wire. This is shown as wire 36b for anchor 30b, with a first wire 36b' bounding tissue engaging element 34b', and a second wire 36b"' bounding tissue engaging element 34b".

For some applications, anchor 30b or 30c may include a discrete component 32b that acts as an anchor head and/or the portion of the anchor that is engaged by the anchor driver. Assembly 32b is shown in Figures 78A-B as a rod transversely spanning a central longitudinal axis of the anchor located between wires 36b' and 36b". For certain applications, anchor 30b or 30c may comprise a single wire system defining (i) the two tissue engaging elements, and (ii) a head 32c and/or the portion of the anchor that is engaged by the anchor driver. This is shown in Figure 79. Other anchor head designs are also possible.

Anchor 30b has a tissue engagement region 38 and a head region 39 . For some applications, and as shown, (i) in the tissue-engaging region 38, each wire 36b defines its respective tissue-engaging element and has a tissue-engaging pitch d1 such that in the double helix, each The turns of the wire are axially spaced apart from the turns of the other wire, however (ii) in the head region 39 each wire 36b has a head pitch d2 such that in the double helix, the first The turns of the wire abut the turns of the second wire.

For some applications, pitch d1 facilitates screwing of tissue engaging region 38 within tissue, whereas pitch d2 configures head region 39 to resist being screwed into the tissue, eg, such that head region 39 acts as a An anchor head.

As shown with respect to anchor 30c, tissue engaging elements 34c may be individually and/or collectively shaped as a conical helix that widens toward the distal end of the anchor. For some applications, such tissue engaging elements are delivered in a radially compressed state and expand to become conical (or more conical) during deployment.

While the above description contains many specific embodiments of the invention, these should not be construed as limitations on the scope of the invention, but rather as a exemplification of one of the other embodiments. Thus, the scope of the present invention should be determined not by the specific examples exemplified, but by the scope of the claims and their equivalents attached herewith. Features of one specific example may be combined with features of other specific examples herein. In particular, features of a given variant of implant 100 may be combined with features of another variant of implant 100, mutatis mutandis.

CS, 525, 1409, 3521: Coronary Sinus CT, 507: chordae tendineae LA, 517: Left Atrium LV, 521, 6417: Left ventricle MV, 10, 505, 5411, 5713: Mitral Valve PM, 809: Mastoid muscle A-A: Indicators ax1: anchor axis ax2: Tangent ax3: atrioventricular valve axis d1: tissue cohesion pitch d2: head pitch 4: Heart 6: Left atrium, atrium 7: Aorta 8: Left ventricle, ventricle 9,709: Ventricular wall 10: Valves 11: Mitral valve annulus, annulus 12: First leaflet, posterior leaflet, leaflet 13: Roots 14: Opposite leaflets, anterior leaflets, leaflets 15: Combination 16: The flail part of the latter leaves, flail, flail part 17: Lower leaflet 18: address 18a: initial address 18b: Second address 20: System 30, 30a, 30b, 30c, 1115, 1611, 1711, 1801, 1901, 1921, 3503: Anchor 32, 32b, 32c: Anchor head 34,34b,34c: Tissue engaging elements 34b', 34c': first tissue engagement element 34b", 34c": Second tissue engaging element 36b, 6207: Wire 36b': first wire 36b": 2nd wire 38: Tissue articulation zone 39: Head area 40: Catheter 50: Delivery Tool 60,74: Shaft 62: Shaft head 64,114: Couplings 70: Drive 72: Drive Department 100, 100a, 100b, 100c, 100d, 100e: Implants 108: Shell 110:Interface 112: Sidewall (eg pipe wall) 114: Coupler 120, 120e: Wings 122: Contact surface or surface, contact surface 122e: Contact surface 123: Opposite face or surface 124: Frame 126, 126e: Sheet 128: Ring 130: roots 132: tip 134: Side 134a: First side 134b: Second side 136, 3809, 3811, 4311, 4313, 4909, 4911: Rings 136a: first ring 136b: Second ring 137, 138: Space 140: Holes, openings 150: Anchor Receiver 150a, 150b, 150c: Receivers 152: Obstructing body 152a, 152b, 152c: Barrier elements 160: Prominent Construct 162: Recessed part 501, 701, 801, 901, 1001, 1011, 1021, 1101, 1301, 1903, 1923: Implants or devices 2001, 2011, 2101, 2201, 2301, 2401, 2421, 2501, 2701, 2801: Implants or devices 3401: Implants or devices 3501: Implants or devices, compression elements 2901, 3001, 3201: Implants or devices 503, 1403: Bracket anchor 509:P2 area 511, 1013, 1023, 3513, 5409, 5711: posterior leaf 513, 2103, 2203: Contact surface 515, 1105, 1305, 3215, 3411, 3511: Inflow surface 519, 705, 805, 905, 1111, 1311, 2005, 2021, 2105, 2205, 2303: Joint parts 2403, 2423, 2509, 3223, 3419, 3519, 3607, 3707, 3807, 3907: Joint parts 4207, 4307, 4407, 4507, 4707, 4907, 5107, 5307, 5407, 5707: Joint parts 6013, 6413: Splice parts 523, 2209, 4509, 4709, 5111. 5311: Covers or sheets 527, 1413: Connection point 529, 1415, 1603, 1613, 2007, 3125, 3523, 4209, 4309, 4409, 5109: Connectors 5309, 6107: Connectors 531, 1417, 3525: Atrial wall 703, 803, 903, 1103, 1107, 1303, 1405, 3205, 3407, 3505: Natural Valves 707,807,907: Tether 909: Apex of the ventricle 1003: P2 of the posterior lobe 1005: P3 of the back leaf 1109, 1309, 3217, 3413: Atrium 1113: Support 1117,6423: valve annulus 1307: Natural leaflet, posterior leaflet 1313: Fixtures 1315: Overlay 1401, 5709, 6305: Gap Fillers/Joint Elements/Spacers 1407: Leaflet Coaptation Area 1601: Expandable Bracket Anchor 1605, 1615: Walls of the vasculature 1701: Curved or Ring Anchors 1703: Upper part 1705: The lower part 1707: Central Ring 1713, 1715: Remote 1717: Inner Ridge 1721, 2319, 6403: Spiral Anchor 1723: Bottom end 1725: Upper end 1731: T-Anchor 1733, 1735: Arm 1737: Connection part 1803, 1805: Helical or helical anchor sections 1807, 1817, 1827, 1835: Tubular compartments or enclosures 1809: Push or Rotate 1811, 1821, 1831: Low Profile Double Helix Anchor 1813, 1815: Spring-like compressible helical or helical anchor sections 1823: Internal spring-like compressible helical or helical anchor sections, internal helical/anchor sections 1825: External spring-like compressible helical or helical anchor sections, external helical/anchor sections 1833: Spring-like compressible helical anchors or anchor parts 1905: Pivot 1907, 1929: Anchor Housing 1909, 1931: Unfolding tools 1911: Cable 1925, 1927: Sliding mechanism 1929: Anchor Shell 2003: Corrugated wire 2013, 2015, 2017: Cross-section wire forming 2019: Expand or contract laterally 2023: Connectors or Connection Points 2107, 2207, 2511: Anchor connection points 2109, 2309, 2405: Reaction force support 2111: Permeable non-joint parts, permeable parts 2113: Impermeable joint part 2305, 2507: Wire forming 2307: Wire Forming for Anchor Connections, Interfaces, Anchor Connections 2311, 2407, 2425: Permeable mesh 2313: Tubular Compartments, Housings, Anchor Receptacles 2315: Guide tube 2317: Orifice 2321: Circular groove 2409: Swing hinge 2411: W Anchor 2427: Interface or hinge 2503: Joining elements, spacers or fillers, contact surfaces 2505, 2705, 2805, 2909, 3009, 6205: Sheet 2703, 6109, 6203, 6303: hooks 2707, 2807, 2911, 3011: Anchor Connectors 2803, 2907, 3007: low concave 2903, 3003: Static part 2905, 3005: Dynamic section 3101, 6001: Guide wire 3103: Puncture catheter 3105: Anchor Member 3107: Distal segment 3109: Radiopaque Markers 3111: pin port 3113: Tissue Wall 3115: Piercing Sheath 3117: Puncture Needle 3119: Second guide wire, guide wire 3121,6003: Delivery catheter 3123: Compressed device 3127: Condensed Wire Bracket Anchor 3203, 3405: valve leaflets, posterior leaflets 3207: The valve chordae tendineae is ruptured 3209: P2 area 3211, 3403, 3507, 3603, 3703, 3803, 3903, 4003, 4203, 4303: Inflow part 4403, 4503, 4703, 4903, 5103, 5303, 5403, 5703, 6009: Inflow part 3219: Outflow Surface 3221, 3415, 3517: Ventricle 3213, 3409, 3509, 3605, 3705, 3805, 3905, 4005, 4205, 4305: Outflow part 4405, 4505, 4705, 4905, 5105, 5305, 5405, 5705, 6011: Outflow part 3421: Area 3515: Atrium, left atrium 3601, 3701, 3801, 3901, 4001: Implants or devices, compression elements or compression wire forming stents 4201, 4301, 4401, 4501, 4701: Implants or devices, compression elements or compression wire forming stents 4901, 5101, 5301: Implants or devices, compression elements or compression wire forming stents 3909, 3911: External Wing Rings 3913: Large Internal Ring 4007: Torsion Spring 4711: The joined portion 4707 with the sheet or cover is extended 5401, 5701: Implants or devices, compression wire forming stents 5413: Front Leaf 5715: Front Leaf 6005: Tissue Wall 6007: Compression splint device 6101: Telescopic poles/extensions or telescopic arch poles 6103: Inner Rod/Extension 6105: Outer Rod/Extension 6201: Rod/extension device, arch or arched rod, rod/extension or arched rod 6301: Rod/Extension Device or Arched Rod, Rod/Extension or Arched Rod 6401: Netting implants or netting devices 6405: Mesh material 6507: Anchor Section 6409, 6411: Lateral edge 6415: Mitral valve, natural valve 6419: Left atrium, cleft between P1 and P2 6421: Crack between P2 and P3

1 is a schematic illustration of the left ventricle of a heart referenced as one of various embodiments;

Figure 2 is a schematic diagram of a mitral valve referenced as one of various embodiments;

Figures 3 and 4 are schematic illustrations of a heart valve leaflet flail and a heart valve leaflet prolapse, respectively, referenced as one of various embodiments;

Figures 5-9, 10A-C, and 11-13 are schematic illustrations of various exemplary devices implanted on a native valve;

14 and 15 are schematic illustrations of an exemplary gap filler, coaptation element or spacer element implanted on a native valve;

16A-D are schematic diagrams of exemplary anchors for use within the vasculature;

17A-E are schematic illustrations of exemplary anchors for use within a visceral valve;

18A-H are schematic diagrams of exemplary helical anchors;

19A-C are schematic diagrams of an exemplary system having a device with an adjustable contact surface angle;

20A-B, 21A-B, 22A-C, 23A-D, 24A-D, and 25-30 are schematic diagrams of example devices according to certain applications;

31A-31L are schematic illustrations of an exemplary method for delivering a device to a native valve via a transcatheter procedure;

32-35 are schematic illustrations of exemplary compression elements implanted on a native valve;

36-59 are schematic diagrams of exemplary compression elements;

60A-60D are schematic illustrations of an exemplary method for delivering a compression element to a native valve via a transcatheter procedure;

61-63 are schematic diagrams of an example prosthetic device including a rod;

64-66 are schematic diagrams of an exemplary repair device including a netting or mesh;

67A-B, 68A-G, 69-71, 72A-C, and 73-75 are schematic diagrams of a system for use with a valve in an individual's heart, according to certain applications;

Figure 76 is a schematic illustration of one of the implants according to certain applications;

77A-B are schematic diagrams of an implant according to certain applications; and

78A-B and 79 are schematic illustrations of anchors according to certain applications.

6: Left atrium

10: Mitral Valve

11: Mitral annulus

12: First leaflet, posterior leaflet

14: Opposite leaflets, anterior leaflets

16: The flail part of the latter leaves

30: Anchor

40: Catheter

50: Delivery Tool

60: Shaft

70: Drive

100: Implants

110:Interface

120: Wings

150: Anchor Receiver

Claims (249)

A system for use with a valve of a heart of an individual, the valve having a first leaflet and at least one opposing leaflet, the heart having a chamber upstream of the valve, and the system comprising Have: An implant containing: an interface, and a flexible wing coupled to the interface and having a contact surface and an opposite surface relative to the contact surface; an anchor; a catheter penetrably advanced into the chamber and configured to receive the implant; and A delivery tool that includes: an axis, interfaced with the interface, and configured through the interface with the interface to: deploying the implant out of the catheter such that within the chamber the wings extend away from the interface, and positioning the implant in a position in which the interface is tethered at a site in the heart, the wing extends beyond the first leaflet toward the opposing leaflet, and the contact surface facing the first leaflet, and A driver is engaged with the anchor and is configured to anchor the implant in the position by using the anchor to anchor the interface to tissue of the heart. The system of claim 1, wherein the implant does not contain a downstream anchor. A system according to any of claims 1-2, wherein the implant contains exactly one anchor. A system according to any of claims 1-3, wherein the contact surface is concave. The system of any one of claims 1-4, wherein the catheter is configured to receive the implant and the wings are constrained within the catheter. The system of any of claims 1-5, wherein the driver is configured to anchor the implant in the location by using the anchor to anchor the interface at the location . The system of any one of claims 1-6, wherein the address is located on an annulus of the valve, the delivery tool is configured to position the implant in the position, in the in position, the interface is at the site on the ring, and the driver is configured to anchor the implant by using the anchor to anchor the interface to tissue of the ring in that location. The system of any one of claims 1-6, wherein the address is on a wall of the chamber, the delivery tool is configured to position the implant in the position, at the position , the interface is at the location on the wall of the chamber, and the driver is configured to anchor the interface to tissue of the wall of the chamber by using the anchor The implant is anchored in this position. A system according to any of claims 1-6, wherein: The chamber is an upstream chamber, The heart has a downstream chamber located downstream of the valve, The delivery tool is configured to press the interface against the first leaflet such that the first leaflet becomes sandwiched between the delivery tool and a wall of the downstream chamber, and The driver is configured to anchor the interface by driving the anchor through the first leaflet and into the wall of the downstream chamber. The system of any of claims 1-6, wherein the driver is configured to anchor the implant by driving the anchor through the first leaflet and into the tissue of the heart in that location. The system of any one of claims 1-10, wherein the shaft is configured, via engagement with the interface, to deploy the wings entirely out of the catheter, and the driver is configured to deploy The implant is anchored in this position after the shaft fully deploys the wings out of the catheter. The system of claim 11, wherein the shaft is configured, via engagement with the interface, to deploy the implant entirely out of the catheter, and the driver is configured to deploy the implant at the shaft The implant is anchored in this position after the implant is deployed entirely out of the catheter. The system of any of claims 1-12, wherein the driver extends through the shaft. The system of claim 13, wherein the shaft is configured via engagement with the interface to deploy the implant out of the catheter when the driver is disposed within the shaft. The system of claim 14, wherein the shaft is configured via engagement with the interface to deploy the implant out of the catheter when the anchor is disposed within the shaft. The system of any one of claims 1-15, wherein the implant is configured to be received within the catheter, with the wings tethered distal to the interface. The system of claim 16, wherein the shaft is configured to deploy the implant out of the catheter such that the wings become exposed from the catheter prior to the interface. The system of any one of claims 1-17, wherein the implant includes an anchor receiver at the interface, and the driver is configured to accept the anchor by using the anchor The device is anchored to the tissue and the interface is anchored to the tissue. The system of claim 18, wherein the interface defines a space within which the anchor receptor is disposed. The system of claim 18, wherein the implant includes a housing defining at least a portion of the interface and at least a portion of the anchor receptor. The system of claim 20, wherein the housing includes a side wall defining an aperture, and the side wall defines the interface. The system of claim 21, wherein the housing defines an obstruction that protrudes at least partially through the aperture, and wherein the driver is configured to drive the anchor through the housing until the anchor presses the obstruction Anchor the interface to the organization to the organization. The system of claim 21, wherein the side wall and the shaft define respective engagement elements, the shaft being engaged with the interface via engagement between the engagement elements of the shaft and the engagement elements of the side wall. The system of claim 18, wherein the driver is configured to anchor the anchor receptor to the tissue by anchoring the anchor to the anchor receptor and to the tissue. The system of claim 24, wherein the driver is configured to anchor the anchor to the receptacle by driving the anchor through the anchor receptacle. A system according to claim 25, wherein: The anchor includes a tissue engaging element and a head, The anchor receptacle defines a port therethrough and includes an obstructing body projecting medially in a manner that facilitates passage of the tissue engaging element through the port but inhibits impeding passage of the head through the port into the orifice, and The driver is configured to anchor the anchor to the anchor receptacle by driving the tissue engaging element through the anchor receptacle until the head of the anchor becomes obstructed by the obstructing body. The system of claim 26, wherein the obstructing body includes a rail that traverses the aperture. The system of claim 26, wherein the blocking body includes a collar. The system of claim 26, wherein the obstructing body comprises a sheet penetrable by the tissue engaging element. The system of claim 26, wherein the tissue engaging element is a helical tissue engaging element and the driver is configured to drive the tissue engaging element through the anchor receiver by screwing the tissue engaging element through the anchor receiver Anchor receiver. A system according to any of claims 1-30, wherein: The position is a first position, the address is a first address, and via engagement with the interface, the shaft is configured, after placing the implant in the first position, to reposition the implant into a second position in which , the interface is located at a second location in the heart, the wing extends beyond the first leaflet toward the opposite leaflet, and the contact surface faces the first leaflet, the second location is Different from the first location, and the second address is different from the first address. The system of claim 31, wherein the shaft is configured to reposition the implant into the second position while the wings remain entirely outside the catheter. The system of claim 32, wherein the shaft is configured to reposition the implant into the second position while the implant remains entirely outside the catheter. The system of any one of claims 1-33, wherein the wing includes a frame and a sheet overlying the frame. The system of claim 34, wherein the frame comprises at least one frame material selected from the group consisting of: Nitinol, Cobalt-Chromium (CoCr), stainless steel, titanium, polyglycolic acid, polylactic acid , poly-D-lactic acid, polyurethane, poly-4-hydroxybutyrate, polycaprolactone, polyether ether ketone, a cyclic olefin copolymer, polyethylene vinyl acetate, polytetrafluoroethylene, A perfluoroether and fluorinated ethylene propylene copolymer. The system of claim 34, wherein the frame is compressible to fit within the conduit. The system of claim 34, wherein the framework is self-extending. The system of claim 34, wherein the frame is attached to the interface. The system of claim 34, wherein the sheet comprises at least one sheet material selected from the group consisting of lactic acid-glycolic acid copolymers, polyvinyl chloride, polyethylene, polypropylene, Polytetrafluoroethylene, polyurethane, polyethylene terephthalate, polyether, polyglycolic acid, polylactic acid, polyd-lactic acid, poly-4-hydroxybutyrate, and polycaprolactone. The system of claim 34, wherein the wing has a root coupled to the interface, a tip at an end of one of the wings relative to the root, and two extending from the root to the tip side. The system of claim 40, wherein: The chamber is an upstream chamber, the heart has a downstream chamber located downstream of the valve, and An angular arrangement of the wings relative to the interface enables the implant to position the tip within the downstream chamber with the positioning of the shaft in that position. The system of claim 40, wherein: the first leaflet has a lip, and An angular arrangement of the wings relative to the interface is such that the implant is positioned downstream of the lip of the first leaflet with the tip positioned by the shaft in that position. The system of claim 40, wherein the frame defines two rings extending from the root alongside each other. The system of claim 43, wherein the two annular members extend from the root to the tip side by side with each other. The system of claim 43, wherein the frame connects the two rings to each other only at the interface. The system of claim 43, wherein the sheet material is laid over the frame such that the sheet material extends across and between the two rings. The system of claim 43, wherein each of the rings defines a space that is substantially free of the frame assembly. The system of claim 43, wherein each of the annular members is substantially teardrop shaped. The system of claim 43, wherein the frame defines an elongated space between the two annular members extending from the root towards the tip, and the sheet material is laid over the frame such that the sheet material extends spans the two rings and the space. The system of claim 49, wherein the elongated space runs along a reflective symmetry plane of the wing. The system of claim 49, wherein the elongated space extends from the root to the tip such that the frame does not bridge the two rings at the tip. The system of claim 34, wherein the sheet has a plurality of holes therethrough. The system of claim 52, wherein the holes are polygonal and checkerboard-like. The system of claim 53, wherein the holes are hexagonal. A system according to any of claims 1-54, wherein a curvature of the wing is such that in a cross-section of one of the implants through the interface and the wing, the contact surface is concave . The system of claim 55, wherein the curvature of the wings increases with distance from the interface in the cross-section of the implant. The system of claim 55, wherein the cross-section lies in a reflective symmetry plane of the implant. The system of any of claims 1-57, wherein the implant further includes a reaction force support extending from the interface and away from the wings. The system of claim 58, wherein the reaction force support is shaped such that in the position the reaction force support rests against a wall of the chamber. The system of claim 58, wherein the catheter has a distal opening and is configured to receive the implant, the implant with the wings disposed away from the interface and the interface disposed away from the interface The reaction force supports. The system of claim 58, wherein the reaction force support includes a wire loop. The system of claim 58, wherein the shaft is configured to engage the interface within the catheter such that within the catheter, the shaft extends proximally away from the interface and is supported by the reaction force. The system of any of claims 1-62, wherein the anchor is a first anchor, and the system further includes a second anchor configured to anchor the interface to the tissue. The system of claim 63, wherein the driver is configured to anchor the implant in the position by using the second anchor to anchor the interface to the tissue. The system of claim 63, wherein the driver is a first driver, and the delivery tool further includes a second driver engaged with the second anchor and configured to use the second anchor to Anchoring the interface to the tissue anchors the implant in the position. The system of any one of claims 1-65, wherein the anchor comprises a helical tissue engaging element, and the driver is configured to tighten the implant by tightening the tissue engaging element into the tissue The incoming object is anchored in this position. The system of claim 66, wherein the tissue engaging element is a first tissue engaging element, and the anchor further comprises a second helical tissue engaging element, the first tissue engaging element and the second tissue engaging element being aligned become a double helix. The system of claim 67, wherein: the anchor has a proximal end and a distal end, and Each of the first tissue engaging element and the second tissue engaging element has a sharpened distal tip at the distal end of the anchor and is shaped to widen toward the distal end of the anchor Conical spiral. The system of claim 67, wherein: The first tissue engagement element is defined by a first wire, The second tissue engagement element is defined by a second wire, Along one of the longitudinal axes of the anchor, the anchor has: An organizational interface in which: a first wire defines the first tissue engaging element, a second wire defining the second tissue engaging element, and The first wire and the second wire each have a tissue engagement pitch such that the turns of the first wire are axially spaced apart from the turns of the second wire within the double helix, and a head region in which the first wire and the second wire each have a head pitch such that within the double helix the turns of the first wire abut the second wire The turns of the spiral. The system of claim 69, wherein the tissue engagement pitch of the first wire is at least 4 times greater than a thickness of the first wire. The system of claim 66, wherein: The anchor consists of a wire with a sharp distal tip, This wire has: a first helical portion having a first pitch and defining a head of the anchor, and a second helical portion having a second pitch greater than the pitch, defining the tissue engaging element and terminating at the sharp distal tip, and The first pitch configures the first helical portion to resist being screwed into the tissue. The system of any one of claims 1-71, wherein the contact surface is shaped to define a leaflet thickening element, etc. configured to induce the wing where the wing extends beyond the first leaflet Thickening of the first leaflet. The system of claim 72, wherein the leaflet thickening elements comprise protruding formations. The system of claim 72, wherein the leaflet thickening elements comprise concave portions. A simulation method for a simulated valve for a heart having a first leaflet and an opposing leaflet, the heart having a chamber located upstream of the valve, and the method comprising: Within a catheter, advance the following to the chamber: an implant comprising an interface and a flexible wing coupled to the interface, the wing having a contact surface and an opposing surface relative to the contact surface; and an axis connected to the interface, deploying the implant out of the catheter using the shaft such that within the catheter the wings extend away from the interface; The shaft is then used to position the implant in a position where the interface is tethered at a site in the heart with the wings extending beyond the first leaflet towards the opposing leaflet , and the contact surface faces the first leaflet; and The implant is then positioned in this position by anchoring the interface to the tissue of the heart. The method of claim 75, wherein advancing the implant into the chamber comprises advancing the implant into the chamber while the wings are constrained within the catheter. A method according to any of claims 75-76, wherein: The wing has a root coupled to the interface, and a tip at an end of one of the wings opposite the root, The chamber is an upstream chamber, the heart has a downstream chamber located downstream of the valve, and Positioning the implant in the position includes positioning the implant such that the tip is disposed within the downstream chamber. A method according to any of claims 75-77, wherein: The wing has a root coupled to the interface, and a tip at an end of one of the wings opposite the root, the first leaflet has a lip, and Positioning the implant in the position includes positioning the implant such that the tip is disposed downstream of the lip of the first leaflet. The method of any one of claims 75-78, wherein the contact surface is concave, and wherein positioning the implant in the position includes positioning the implant such that the contact surface of the concave surface contacts the first leaflet. The method of any of claims 75-79, wherein positioning the implant in the position includes positioning the implant such that the opposing face contacts the opposing leaflets. The method of any one of claims 75-80, wherein the valve is a mitral valve of the heart, the chamber is a left atrium of the heart, and advancing the implant to the chamber comprises moving the The implant is advanced into the left atrium. The method of any one of claims 75-80, wherein the valve is a tricuspid valve of the heart, the chamber is a right atrium of the heart, and advancing the implant to the chamber comprises moving the The implant is advanced into the right atrium. The method of any one of claims 75-80, wherein the valve is an aortic valve of the heart, the chamber is a left ventricle of the heart, and advancing the implant into the chamber comprises placing the implant into the chamber The implant is advanced into the left ventricle. The method of any of claims 75-80, wherein the valve is a pulmonary valve of the heart, the chamber is a right ventricle of the heart, and advancing the implant to the chamber comprises the The implant is advanced into the right ventricle. The method of any one of claims 75-84, wherein the address is located on an annulus of the valve, and wherein anchoring the interface to the tissue of the heart comprises anchoring the interface to the annulus organize. The method of any of claims 75-84, wherein the address is located on a wall of the chamber, and wherein anchoring the interface to the tissue of the heart comprises anchoring the interface to the chamber The tissue of the wall of the chamber. The method of any of claims 75-84, wherein anchoring the interface to the tissue of the heart comprises securing the first leaflet to the tissue of the heart. A method according to any of claims 75-84, wherein: The chamber is an upstream chamber, The heart has a downstream chamber located downstream of the valve, Positioning the implant in the position includes pressing the interface against the first leaflet such that the first leaflet becomes sandwiched between the delivery tool and a wall of the downstream chamber, and Anchoring the implant in the position includes driving an anchor through the first leaflet and into the wall of the downstream chamber. The method of any of claims 75-88, wherein anchoring the interface to the tissue comprises using a driver to drive an anchor into the tissue. The method of claim 89, wherein the anchor comprises a tissue-engaging element, and wherein using the driver to drive the anchor into the tissue includes using the driver to tighten the tissue-engaging element into the tissue. A method according to claim 89, wherein: the implant includes an anchor receptor located at the interface, and The method further includes using the driver to anchor the anchor to the anchor receptor. The method of claim 91, wherein anchoring the interface to the tissue comprises using the driver to drive the anchor through the anchor receptor and into the tissue. A method according to claim 92, wherein: The anchor contains a tissue engaging element and a head, the anchor receptacle defines an aperture therethrough and includes a blocking body projecting medially into the aperture, and Using the driver to drive the anchor through the anchor receptacle and into the tissue includes using the driver to drive the tissue engaging element past the blocking body until the head of the anchor becomes blocked by the blocking body. The method of claim 93, wherein the obstructing body comprises a crossbar that traverses the orifice, and wherein the driver is used to drive the tissue engaging element past the obstructing body until the head of the anchor becomes caught by the obstructing body Obstructing includes using the driver to drive the tissue engaging element past the rail until the head of the anchor becomes blocked by the rail. The method of claim 93, wherein the obstructing body comprises a collar, and wherein using the driver to drive the tissue engaging element beyond the obstructing body until the head of the anchor becomes obstructed by the obstructing body comprises using the driver to drive the tissue engaging element beyond the collar until the head of the anchor becomes obstructed by the collar. The method of claim 93, wherein the obstructing body comprises a flexible sheet, and wherein using the driver to drive the tissue engaging element past the obstructing body until the head of the anchor becomes obstructed by the obstructing body comprises comprising The driver is used to pierce the sheet with the tissue engaging element and drive the tissue engaging element through the sheet until the head of the anchor becomes obstructed by the sheet. The method of claim 89, wherein the implant includes a housing including a sidewall defining an aperture, the sidewall defining at least a portion of the interface, and wherein positioning the implant in the position includes using the a shaft to position the implant in this position while the shaft engages the side wall. The method of claim 97, wherein the implant defines a barrier that protrudes at least partially through the orifice, and wherein anchoring the interface to the tissue comprises driving the anchor through the housing by using the driver Until the anchor presses the blocking body against the tissue to anchor the shell to the tissue. The method of any of claims 75-98, wherein the implant further comprises a reaction force support, and wherein deploying the implant out of the catheter comprises deploying the implant into the catheter outside, so that the reaction force support extends from the interface and away from the wing. The method of claim 99, wherein the position is a position in which the reaction force support rests against a wall of the chamber, and wherein positioning the implant in the position comprises positioning the implant In the position where the reaction force support rests against the wall of the chamber. The method of claim 99, wherein deploying the implant out of the catheter comprises deploying the following out of the catheter: the wings, followed by the interface, followed by the reaction force support. The method of claim 99, wherein deploying the implant out of the catheter comprises deploying the wings out of the catheter while the shaft extends proximally within the catheter away from the interface and through the catheter Reaction force support. The method of any of claims 75-102, wherein positioning the implant in the position comprises positioning the implant in the position after fully deploying the wings out of the catheter middle. The method of claim 103, wherein positioning the implant in the position comprises positioning the implant in the position after deploying the implant entirely out of the catheter. A method according to any of claims 75-104, wherein: The position is a first position, the address is a first address, and The method further includes: after placing the implant in the first position, repositioning the implant into a second position in which the interface is tethered in the heart at a second location of the wing extending beyond the first leaflet toward the opposing leaflet, and the contact surface facing the first leaflet, the second position is different from the first position, and the The second address is different from the first address. The method of claim 105, wherein the first address is a first address on a ring of the valve and the second address is a second address on the ring of the valve . The method of claim 106, wherein repositioning the implant into the second position comprises sliding the interface along the ring using the shaft. The method of claim 106, wherein repositioning the implant into the second position comprises using the shaft to lift the interface away from the ring at the first location, and at the second location to reposition the interface against the ring. The method of claim 105, wherein repositioning the implant into the second position comprises repositioning the implant into the second position prior to anchoring the interface to the tissue. A method according to claim 105, wherein: The method further includes unanchoring the interface from the tissue after anchoring the interface to the tissue, Repositioning the interface into the second position includes repositioning the implant into the second position after deanchoring the interface from the tissue, and The method further includes re-anchoring the interface to the tissue after repositioning the implant within the second location. The method of claim 105, further comprising receiving a message indicating regurgitation through the valve while the implant is positioned at the first position, wherein the implant is repositioned to the second position The internal system includes repositioning the implant into the second position in response to receiving the message. The method of claim 111, wherein the message is an electrocardiogram message, and wherein repositioning the implant into the second position comprises repositioning the implant to the second position in response to receiving the electrocardiogram message within. The method of claim 105, wherein repositioning the implant into the second position comprises repositioning the implant into the second position while the wings remain entirely within the catheter outside. The method of claim 113, wherein repositioning the implant into the second position comprises repositioning the implant into the second position while the implant remains fully seated in the catheter outside. The method of any of claims 75-114, wherein deploying the implant out of the catheter comprises simultaneously deploying the implant into the catheter while the driver is disposed within the shaft outside. The method of claim 115, wherein deploying the implant out of the catheter comprises deploying the implant out of the catheter when the anchor is disposed within the shaft. A system for use within a heart valve to provide contact pressure over a leaflet, comprising: a device comprising a contact surface contoured to an inflow surface of a heart valve leaflet and capable of providing contact pressure over the inflow surface; an anchor capable of anchoring within the vasculature; and A connector connecting the device and the anchor. The system of claim 117, wherein the contact surface of the device has a length and a width to cover a prolapse or a flail of the heart valve leaflets. The system of any of claims 117-118, wherein the contact surface of the device is capable of providing contact pressure over a prolapse or a flail of the heart valve leaflets. The system of any of claims 117-119, further comprising a coaptation portion extending from the contact surface, the coaptation portion capable of extending the length of the device into a coaptation region of a heart valve. The system of claim 120, wherein the coaptation portion is capable of helping to facilitate coaptation between leaflets of a heart valve. A system according to any of claims 117-121, wherein the device includes a wire form. The system of claim 122, wherein the wire form comprises at least one material selected from the group consisting of: Nitinol, Cobalt-Chromium (CoCr), Stainless Steel, Titanium, Polyglycolic Acid (PGA) , polylactic acid (PLA), poly-d-lactic acid (PDLA), polyurethane (PU), poly-4-hydroxybutyrate (P4HB), polycaprolactone (PCL), polyetheretherketone ( PEEK), cyclic olefin copolymers (COCs), polyethylene vinyl acetate (EVA), polytetrafluoroethylene (PTFE), perfluoroether (PFA) and fluorinated ethylene propylene copolymer (FEP). A system according to any of claims 122-123, wherein the wire is shaped to be compressible to fit within a delivery catheter. The system of any of claims 122-124, wherein the wire forming is self-expanding. The system of any of claims 122-125, further comprising a sheet material attached over the wire form, the sheet material forming the contact surface. The system of claim 126, wherein the sheet has a length and a width to cover a prolapse or a flail of the heart valve leaflets. The system of any of claims 126-127, wherein the sheet system is capable of providing contact pressure over a prolapse or a flail of the heart valve leaflets. A system according to any of claims 126-128, wherein the sheet is permeable, semi-permeable or impermeable. The system of any of claims 126-129, wherein the sheet includes a mesh. A system according to any of claims 126-130, wherein the sheet comprises at least one material selected from the group consisting of lactic acid-glycolic acid (PLGA), polychlorinated Ethylene (PVC), Polyethylene (PE), Polypropylene (PP), Polytetrafluoroethylene (PTFE), Polyurethane (PU), Polyethylene terephthalate (PET), Polyether ( PES), polyglycolic acid (PGA), polylactic acid (PLA), poly-d-lactic acid (PDLA), poly-4-hydroxybutyrate (P4HB), and polycaprolactone (PCL). The system of any of claims 117-131, further comprising a latch or a hook capable of latching or hooking within a heart valve leaflet commissure or slit. The system of any of claims 117-132, further comprising a static portion and a dynamic portion, wherein the dynamic portion is capable of being repositioned or resized. The system of any of claims 117-133, wherein the anchor includes a wire support. The system of any of claims 117-133, wherein the anchor includes a pin fastener. The system of any one of claims 117-133, wherein the anchor includes a wire fastener that fastens the wire. The system of any of claims 117-136, wherein the connector includes at least one connector selected from the group consisting of: rivets, sutures, staples, wires, pins, and shafts . The system of any of claims 117-137, further comprising a clamp capable of clamping the device to the leaflet. The system of any of claims 117-138, further comprising a tether extending from the device and capable of extending to a fixation site on the outflow side of a heart valve. The system of any one of claims 121-139, wherein the device incorporates an internal gap in the joint region of the device, wherein the internal gap is free of wire forming. The system of any of claims 117-140, wherein the device incorporates a gap filler. The system of claim 141, wherein the gap filler comprises foam, hydrogel or silicone. The system of claim 141, wherein the gap filler includes a mechanical expansion mechanism or a coil. The system of any of claims 117-143, wherein the apparatus incorporates an expandable stand. The system of any of claims 117-144, wherein the device is configured to be implanted within a mitral valve, a tricuspid valve, an aortic valve, or a pulmonary valve. The system of claim 145, wherein the anchor is configured to be implanted within the vasculature adjacent the valve, and wherein the connector traverses a chamber wall. The system of claim 146, wherein the device is configured to be implanted within the mitral valve, the anchor is configured to be implanted within the coronary sinus, and the connector traverses the left atrial wall . The system of any of claims 117-147, further comprising a delivery catheter, wherein the device, the connector and the anchor are each compressible within the delivery catheter. The system of claim 148, wherein the delivery catheter is configured to be delivered via a transfemoral, subclavian, transapical, transseptal, or transaortic approach. The system of any of claims 117-149, wherein the device, the connector and the anchor are configured to be delivered to a mitral valve through a coronary sinus via a transcatheter procedure. A device for use within a heart valve, comprising: a compression element comprising an inflow portion, an outflow portion and an engagement portion; wherein the inflow portion is capable of seating over an inflow surface of a heart valve leaflet, the outflow portion is capable of seating over an outflow surface of a heart valve leaflet, and the joint portion connects the inflow portion and the the outflow portion, and the inflow portion and the outflow portion can be compressed together such that the compression element can be stabilized over a heart valve leaflet when implanted; and Wherein the compression element is contoured to the shape of a heart valve leaflet. The device of claim 151 wherein the inflow portion is capable of providing contact pressure onto a prolapsed heart valve leaflet or flail. A device according to any of claims 151-152, wherein the compression element comprises a wire form. The device of claim 153, wherein the wire form comprises one or more of the following: nitinol, cobalt-chromium (CoCr), stainless steel, titanium, polyglycolic acid (PGA), polylactic acid (PLA) ), poly-D-lactic acid (PDLA), polyurethane (PU), poly-4-hydroxybutyrate (P4HB), polycaprolactone (PCL), polyetheretherketone (PEEK), cyclic Olefin copolymers (COCs), polyethylene vinyl acetate (EVA), polytetrafluoroethylene (PTFE), perfluoroethers (PFA) or fluorinated ethylene propylene copolymers (FEP). A device according to any of claims 153-154, wherein the wire is shaped to be compressible to fit within a delivery catheter. An apparatus according to any of claims 153-155, wherein the wire forming is self-expanding. The apparatus of any of claims 153-156, further comprising a sheet attached over the inflow portion of the wire form. The device of claim 157, wherein the sheet has a length and a width to cover a prolapse or a flail of the heart valve leaflets. A device according to any of claims 157-158, wherein the sheet is capable of providing contact pressure over a prolapse or a flail of the heart valve leaflets. A device according to any of claims 157-159, wherein the sheet is permeable, semi-permeable or impermeable. An apparatus according to any of claims 157-160, wherein the sheet is a mesh. A device according to any of claims 157-161, wherein the sheet comprises at least one material selected from the group consisting of lactic acid-glycolic acid (PLGA), polychlorinated Ethylene (PVC), Polyethylene (PE), Polypropylene (PP), Polytetrafluoroethylene (PTFE), Polyurethane (PU), Polyethylene terephthalate (PET), Polyether ( PES), polyglycolic acid (PGA), polylactic acid (PLA), poly-d-lactic acid (PDLA), poly-4-hydroxybutyrate (P4HB), and polycaprolactone (PCL). The device of any of claims 151-162, further comprising an extended engagement portion capable of extending beyond a leaflet edge, and wherein the extended engagement portion incorporates an impermeable sheet. The device of claim 163, wherein the extended engagement portion incorporates a thickened material, wherein the impermeable sheet covers the thickened material, and wherein the thickened material is capable of being closed at a heart valve filling a gap in the orifice of the heart valve. A device according to any of claims 163-164, wherein the extended engagement portion comprises a bend. The apparatus of any one of claims 151-165, further comprising: an anchor capable of anchoring within the vasculature, and a connector connecting the compression element and the anchor. The device of claim 166, wherein the anchor includes a wire support. The device of claim 166, wherein the anchor includes a pin fastener. The device of claim 166, wherein the anchor includes a wire fastener for securing the wire. The device of any of claims 166-169, wherein the connector comprises at least one connector selected from the group consisting of: rivets, sutures, staples, wires, pins, or shafts . The device of any of claims 151-170, wherein the compression element is configured to be implanted within a heart valve selected from the group consisting of: a mitral valve, a The tricuspid valve, one aortic valve, and one pulmonary valve. The device of claim 171, wherein the anchor is configured to be implanted within the vasculature adjacent the valve, and wherein the connector is configured to traverse a chamber wall. The device of claim 172, wherein the compression element is configured to be implanted within the mitral valve, the anchor is configured to be implanted within the coronary sinus, and the connector is configured to be implanted with to traverse the left atrium wall. The device of any of claims 151-173, further comprising a delivery catheter, wherein the compression element is compressed within the delivery catheter. The device of claim 174, wherein the delivery catheter is configured to be advanced via a transfemoral, subclavian, transapical, transseptal, or transaortic approach. A device for use within a heart valve, comprising: a rod; and A hook or latch is located on each of the two distal ends of the rod, which hook or latch is capable of hooking or latching within the commissure of a native valve. The device of claim 176, further comprising an anchor capable of being anchored within the vasculature and a connector connecting the rod and the anchor. The device of claim 177, wherein the anchor includes a wire support. 177. The device of claim 177 wherein the anchor includes a pin or wire fastener for securing the wire. The device of any of claims 177-179, wherein the connector comprises a rivet, suture, staple, wire, pin or shaft. A device according to any of claims 176-180, wherein a sheet extends from the rod. An apparatus according to any of claims 176-180, wherein a gap filling system extends from the rod. The device of any one of claims 176-182, wherein the rod tie is a telescopic rod comprising an inner rod and an outer rod, the inner rod tie being slidable within the outer rod such that the The length of the telescopic rod is adjustable. An apparatus according to any of claims 176-183, wherein the rod is an arched rod. A method of delivering a system to a native valve via transcatheter delivery, the method comprising: directing a puncture catheter into the vasculature of a heart adjacent a chamber of the heart; puncturing a lumen wall of the vasculature and a chamber wall of the chamber of the heart; directing a delivery catheter into the chamber through the lumen wall and the puncture hole in the chamber wall; releasing a device from the delivery catheter into the chamber; using the delivery catheter to seat the device over a portion of a leaflet of the native valve that is undergoing prolapse or flail; and A connector and an anchor are released from the delivery system such that the anchor resides within the vasculature, and the connector connects the device to the anchor across the lumen wall and the lumen wall . The method of claim 185, wherein directing the delivery catheter comprises directing the delivery catheter to the delivery catheter via a transfemoral, a subclavian, a transapical, a transseptal, or a transaortic approach Chamber. A method according to any of claims 185-186, wherein the method is performed on a simulation. A method of delivering a compression element to a native valve via transcatheter delivery, the method comprising: directing a puncture catheter into the vasculature of a heart adjacent a chamber of the heart; puncturing a lumen wall of the vasculature and a chamber wall of the chamber of the heart; directing a delivery catheter into the chamber through the lumen wall and the puncture hole in the chamber wall; releasing a compression element from the delivery catheter within the left atrium or left ventricle; and The compression element is compressed over a portion of a leaflet of the native valve that is undergoing prolapse or flail. The method of claim 188, wherein compressing the compression element over the portion of the leaflet comprises using the delivery catheter to compress the compression element over the portion of the leaflet. The method of claim 189, wherein the delivery catheter includes an actuator, and wherein compressing the compression element over the portion of the leaflet comprises using the actuator to compress the compression element to the valve over that part of the leaf. The method of claim 188, further comprising releasing a connector and an anchor from the delivery system such that the anchor resides within the vasculature, and the connector connects the compression element to traverse the the lumen wall and the anchor of the lumen wall. The method of any one of claims 188-191, wherein directing the delivery catheter comprises delivering via a transfemoral, a subclavian, a transapical, a transseptal, or a transaortic approach The delivery catheter is guided to the chamber. A method according to any of claims 188-192, wherein the method is performed on a simulation. A system for use within a heart valve, comprising: a gap filler capable of expanding within the gap of the orifice of a heart valve when the valve is closed; an anchor capable of anchoring within the vasculature; and a connector connecting the gap filler and the anchor. The system of claim 194, wherein the gap filler comprises at least one material selected from the group consisting of lactic acid-glycolic acid (PLGA), polyvinyl chloride (PVC), polyvinyl chloride Ethylene (PE), Polypropylene (PP), Polytetrafluoroethylene (PTFE), Polyurethane (PU), Polyethylene terephthalate (PET), Polyether (PES), Polyglycolic acid (PGA), polylactic acid (PLA), poly-d-lactic acid (PDLA), poly-4-hydroxybutyrate (P4HB), and polycaprolactone (PCL). A system according to any of claims 194-195, wherein the anchor includes a wire support. The system of any of claims 194-195, wherein the anchor includes a pin fastener. A system according to any of claims 194-195, wherein the anchor includes a wire fastener for fastening the wire. A system according to any of claims 194-198, wherein the connector comprises a wire, pin or shaft. The system of any of claims 194-199, wherein the gap filler is configured to be implanted within a mitral valve, a tricuspid valve, an aortic valve, or a pulmonary valve. The system of claim 200, wherein the anchor is configured to be implanted within the vasculature adjacent the valve, and wherein the connector is configured to traverse a chamber wall. The system of claim 201, wherein the device is configured to be implanted within the mitral valve and the anchor is configured to be implanted within the coronary sinus with the connector traversing the left Atrial wall. The system of any of claims 194-202, further comprising a delivery catheter, wherein the gap filler, the connector, and the anchor are each compressible within the delivery catheter. A system for use within a heart valve for the treatment of a leaflet, comprising: a device comprising a contact surface contoured to an inflow surface of a heart valve leaflet and capable of providing contact pressure over the inflow surface; and An anchor attached to the device can be anchored within the tissue of the leaflet, annulus, or chamber wall. The system of claim 204, wherein the contact surface of the device has a length and a width to cover a prolapse or a flail of the heart valve leaflets. The system of any of claims 204-205, wherein the contact surface of the device is capable of providing contact pressure over a prolapse or a flail of the heart valve leaflets. The system of any of claims 204-206, further comprising a coaptation portion extending from the contact surface, the coaptation portion capable of extending the length of the device into the coaptation region of the valve. The system of claim 207, wherein the coaptation portion is capable of helping to promote coaptation between the leaflets of the valve. The system of any of claims 204-208, wherein the apparatus includes a wire forming. The system of claim 209, wherein the wire form comprises at least one material selected from the group consisting of: Nitinol, Cobalt-Chromium (CoCr), Stainless Steel, Titanium, Polyglycolic Acid (PGA) , polylactic acid (PLA), poly-d-lactic acid (PDLA), polyurethane (PU), poly-4-hydroxybutyrate (P4HB), polycaprolactone (PCL), polyetheretherketone ( PEEK), cyclic olefin copolymers (COCs), polyethylene vinyl acetate (EVA), polytetrafluoroethylene (PTFE), perfluoroether (PFA) and fluorinated ethylene propylene copolymer (FEP). The system of any one of claims 209-210, wherein the wire is shaped to be compressible to fit within a delivery catheter. The system of any of claims 209-211, wherein the wire forming is self-expanding. The system of any of claims 204-212, further comprising a corrugated wire or a crossed wire to provide contact pressure over a prolapse or a flail of the heart valve leaflets. The system of any of claims 209-213, further comprising a sheet attached over the wire form, the sheet forming the contact surface. The system of claim 214, wherein the sheet has a length and a width to cover a prolapse or a flail of the heart valve leaflets. The system of any of claims 214-215, wherein the sheet system is capable of providing contact pressure over a prolapse or a flail of the heart valve leaflets. The system of any of claims 214-216, wherein the device contains an impermeable engagement portion and a permeable non-engaged portion. The system of claim 217, wherein the impermeable engagement portion is thickened. The system of claim 218, wherein the impermeable joint is capable of being thickened at the site of implantation. The system according to any one of claims 214-219, wherein the sheet comprises at least one material selected from the group consisting of lactic acid-glycolic acid (PLGA), polychlorinated Ethylene (PVC), Polyethylene (PE), Polypropylene (PP), Polytetrafluoroethylene (PTFE), Polyurethane (PU), Polyethylene terephthalate (PET), Polyether ( PES), polyglycolic acid (PGA), polylactic acid (PLA), poly-d-lactic acid (PDLA), poly-4-hydroxybutyrate (P4HB), and polycaprolactone (PCL). The system of any of claims 214-220, further comprising a reaction force support relative to the engagement region. The system of claim 221, wherein the reaction force support is configured to engage a heart chamber wall. The system of any of claims 204-222, wherein the anchor is a helical anchor, a W-shaped anchor, a T-shaped anchor, or a single-turn helix. The system of any of claims 204-223, wherein the anchorage is one or more helical anchors located within a tubular compartment housing, and wherein the tubular compartment housing connects the device. The system of claim 224, wherein the one or more helical anchors are a single helical anchor wrapped within itself compressed within the tubular compartment housing. The system of claim 224, wherein the one or more helical anchors are two or more helical anchors stacked on top of the other in series and compressed on the Inside the tubular compartment housing. The system of claim 224, wherein the one or more helical anchors are two or more helical anchors comprising an inner helix and an outer helix and compressed in the tubular inside the compartment shell. The system of any of claims 226-227, wherein the two or more helical anchors are configured to be embedded within the tissue at two oblique angles to each other. The system of any of claims 224-228, further comprising a fulcrum coupled to the tubular compartment housing such that the plane of the device interface is adjustable. The system of any of claims 224-228, further comprising a sliding mechanism incorporated on the edge of the tubular compartment housing such that the plane of the device contact surface is adjustable. The system of any of claims 204-230, further comprising a swing hinge or a soft hinge connected to the device. The system of any one of claims 209-231, wherein the device incorporates an internal gap in the engagement region of the device, wherein the internal gap is free of wire forming. The system of any of claims 204-232, wherein the device incorporates a gap filler. The system of claim 233, wherein the gap filler comprises a material selected from the group consisting of a foam, a hydrogel, and a silicone. The system of claim 233, wherein the gap filler includes an expansion mechanism or a coil. The system of any of claims 204-235, wherein the apparatus incorporates an expandable stand. The system of any of claims 204-236, wherein the device is configured to be implanted within the mitral valve. The system of any of claims 204-237, further comprising a delivery catheter, wherein the device and the anchor are each compressible within the delivery catheter. The system of claim 238, wherein the delivery catheter is configured to be delivered via a transfemoral, subclavian, transapical, transseptal, or transaortic approach. The system of any of claims 204-239, wherein the device and the anchor are configured to be delivered to a mitral valve through a coronary sinus via a transcatheter procedure. A system for use within a heart valve, comprising: A netting device having a netting with a contact surface capable of providing contact pressure over an inflow surface of a heart valve leaflet, wherein the side edges of the netting device are capable of seating on within a heart valve cleft; and An anchor attached to the netting and capable of anchoring within the tissue of the leaflet, annulus, or chamber wall. The system of claim 241, wherein the netting comprises at least one material selected from the group consisting of lactic acid-glycolic acid copolymer (PLGA), polyvinyl chloride (PVC), polyethylene (PE), polypropylene (PP), polytetrafluoroethylene (PTFE), polyurethane (PU), polyethylene terephthalate (PET), polyether (PES), polyglycolic acid ( PGA), polylactic acid (PLA), poly-d-lactic acid (PDLA), poly-4-hydroxybutyrate (P4HB), and polycaprolactone (PCL). A system according to any of claims 241-242, wherein the anchor is a helical anchor configured to be received within a tubular compartment connected to the netting device. The system of any of claims 241-243, further comprising a tether extending from an engagement portion of the netting device. The system of any of claims 241-244, further comprising a wire form that outlines the netting. The system of any of claims 241-245, wherein the netting device is configured to be implanted within a mitral valve, a tricuspid valve, an aortic valve, or a pulmonary valve. The system of any of claims 241-246, further comprising a delivery catheter, wherein the netting device and the anchor are each compressible within the delivery catheter. A method for repairing a native heart valve of a heart, the method comprising: advancing a delivery catheter transvascularly to the native heart valve; advancing an anchor from the delivery catheter into tissue of the heart, thereby anchoring a leaflet repair implant to the tissue; and The leaflet repair implant is released from the delivery catheter such that the leaflet repair implant extends along a portion of a leaflet of the native heart valve. The method of claim 248, wherein releasing the leaflet repair implant from the delivery catheter such that the leaflet repair implant extends along the portion of the leaflets of the native heart valve comprises: from The delivery catheter releases the leaflet repair implant such that the leaflet repair implant extends along at least one of a prolapsed portion of the leaflet and a flail portion of the leaflet and Apply a contact pressure to it.

Images