TWI893153B - Systems 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

Systems for heart valve leaflet repair

The present invention relates to systems and methods for repairing heart valve leaflets.

Cross-references to related applications

This application claims priority to U.S. Provisional Patent Application No. 63/046,638 (filed on June 30, 2020) issued to Chau et al. and U.S. Provisional Patent Application No. 63/124,704 (filed on December 11, 2020) issued to Chau et al.

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

Invention Background

Natural heart valves (i.e., the aortic, pulmonary, tricuspid, and mitral valves) perform a critical function in ensuring the proper forward flow of blood through the cardiovascular system. Congenital malformations, inflammatory processes, infectious conditions, or disease can render these heart valves less effective. Such damage to the valves can lead to serious cardiovascular compromise or death. Treatment for these disorders can be accomplished through surgical repair or replacement of the valve during open-heart surgery, or through transcatheter transvascular techniques, which allow for the introduction and implantation of a prosthetic device in a less invasive manner than open-heart surgery.

A healthy heart has a roughly conical shape that tapers to a lower apex. The heart has four chambers: the 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 natural mitral valve in the human heart connects the left atrium to the left ventricle. The mitral valve consists of an annulus, a ring-shaped portion of the natural valve tissue surrounding the mitral valve orifice, and a pair of leaflets (called cusps) that extend downward from the annulus into the left ventricle. The mitral valve annulus may have a "D" shape, an oval shape, or other non-circular cross-sectional shape with a major axis and a minor axis. The anterior leaflet may be larger than the posterior leaflet, forming a generally "C"-shaped boundary between the adjacent free edges of the leaflets when they are closed together.

When functioning normally, the anterior and posterior leaflets work together like a one-way valve, allowing blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary vein. When the muscles of the left atrium contract and the left ventricle expands, the oxygenated blood collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract, the increased blood pressure in the left ventricle pushes the two leaflets together, thereby closing the one-way mitral valve. Blood cannot flow back into the left atrium and is instead expelled out of the left ventricle through the aortic valve. To prevent the two valve leaflets from drooping or flailing under pressure and folding back through the mitral annulus toward the left atrium, several fiber bundles called chordae tendineae tether the leaflets to the papillary muscles of the left ventricle.

Valve regurgitation occurs when the natural valve fails to close properly and blood flows from the left ventricle into the left atrium during the systolic phase of the heart's contraction. Valve regurgitation, particularly mitral valve regurgitation, is the most common form of valvular heart disease. Mitral regurgitation has different causes, including leaflet prolapse or flail, restricted leaflet motion (e.g., due to leaflet rigidity/calcification), and/or dysfunctional papillary muscle stretching.

Some techniques for treating leaflet regurgitation due to flail and prolapse involve directly suturing or otherwise coupling portions of the native valve leaflets to one another, but there is an ongoing need for improved devices and methods for treating leaflet flail, prolapse, and restricted leaflet motion.

Summary of the invention

Many examples herein are directed to systems, devices, apparatuses, methods, etc. that can reduce leaflet flail, prolapse, abnormal leaflet motion, and/or other problems. For example, various embodiments of the systems, apparatuses, etc. provide contact pressure on the area of the leaflet that is flail, prolapsed, or restricted. Some embodiments of the systems, apparatuses, etc. herein are anchored within the adjacent vascular system. Some embodiments of the systems, apparatuses, etc. herein are anchored directly to the annulus and/or a leaflet. Some embodiments of the systems, apparatuses, etc. are compressed over the leaflet to be repaired.

In some applications, a system (e.g., a leaflet repair system, an arrestor system, a prolapse repair system, a flail repair system, a repair system, etc.) is for use in a heart valve. The system may include a device (e.g., a repair device, a leaflet repair device, an arrestor, etc.) comprising a contact surface that conforms to the contour of an inlet surface of a heart valve leaflet and is capable of providing contact pressure on the inlet surface (e.g., on the atrial side of an atrioventricular valve). The system includes an anchor capable of anchoring within the vascular system. The system also includes a connector or an anchor receiver connecting the device and the anchor.

In some applications, the device is an implant comprising a flexible wing and an interface, and the system comprises a delivery tool that is attachable to the interface and can be used to position and anchor the interface to tissue of the heart (e.g., to an annulus of a valve being treated) such that the wing extends beyond a first leaflet of the valve (e.g., beyond a prolapsed or flailed portion of the leaflet) toward an opposing leaflet of the valve. For some such applications, the wing is curved, and positioning and anchoring is such that the wing is curved downstream between the leaflets, e.g., such that a tip (e.g., a free end) of the wing is disposed within the ventricle downstream of the valve being treated.

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

In some applications, the contact surface of the device is capable of providing contact pressure on a prolapse or a flail of the heart valve leaflet.

In some applications, the system further comprises a coaptation portion extending from the contact surface, wherein the coaptation portion is capable of extending the length of the device into the coaptation region of the valve.

In some 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 is formed of nickel-titanium alloy, cobalt-chromium (CoCr), stainless steel, titanium, polyglycolic acid (PGA), polylactic acid (PLA), polydextral 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), or fluorinated ethylene propylene copolymer (FEP).

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

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

In some applications, the system further comprises a sheet material attached to the wire form, the sheet material forming the contact surface.

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

In some applications, the sheet is capable of providing contact pressure over a prolapse or a flail of the heart valve leaflet.

In some applications, the sheet is permeable, semipermeable, or impermeable.

In some applications, the sheet is a mesh.

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

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

In some applications, the system includes a static portion and a dynamic portion. The dynamic portion is capable of being 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 secures a wire.

In some applications, the connector or anchor receiver includes one or more of the following: rivets, sutures, clips, wires, pins, shafts, sheets, mesh, housings, tubes, crossbars, and the like.

In some applications, the system further comprises a clamp capable of clamping the device (e.g., a repair device, a leaflet repair device, an actuator, etc.) to the leaflet.

In some applications, a tether extends from the device and is capable of extending to a fixation site on the outflow side of the valve (e.g., on the ventricular side of an atrioventricular valve).

In some applications, the device incorporates an internal gap in the bonding area of the device. The internal gap does not contain wire forming.

In some applications, the device incorporates a joining element, spacer, gap filler, etc.

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

In some applications, the engaging element/spacer/filler comprises a scissor mechanism or a coil.

In some applications, the device incorporates an expandable stand.

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

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

In some 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 is positioned across the left atrial wall.

In some applications, the system further includes a delivery conduit. The device, the connector, and the anchor are each compressible within the delivery conduit.

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

The methods herein, such as the delivery of the systems/devices herein, can be performed on a living animal or on a simulation, such as a cadaver, a cadaver heart, a simulator (e.g., with a simulated body part, heart, tissue, etc.), etc.

In some applications, a compression element is used in a heart valve. The compression element includes an inlet portion, an outlet portion, and a coupling portion. The inlet portion is capable of seating on the inlet surface of a heart valve leaflet. The outlet portion is capable of seating on the outlet surface of a heart valve leaflet. In some applications, the coupling portion connects the inlet and outlet portions. The inlet and outlet portions are compressed together to stabilize the stent on a heart valve leaflet when implanted. The stent conforms to the shape of the heart valve leaflet.

In some applications, the inflow portion is capable of providing contact pressure to a prolapsed or flailed heart valve leaflet.

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

In some applications, the wire is formed of nickel-titanium alloy, cobalt-chromium (CoCr), stainless steel, titanium, polyglycolic acid (PGA), polylactic acid (PLA), polydextrose-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), or fluorinated ethylene propylene copolymer (FEP).

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

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

In some applications, the compression element further comprises a sheet attached to the inlet portion of the wire form.

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

In some applications, the sheet is capable of providing contact pressure over a prolapse or a flail of the heart valve leaflet.

In some applications, the sheet is permeable, semipermeable, or impermeable.

In some applications, the sheet is a mesh.

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

In some applications, the compression element further comprises an extended joint portion capable of extending beyond a leaflet edge. The extended joint portion is incorporated into an impermeable sheet.

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

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

In some applications, the compression element further comprises: an anchor capable of being anchored within the vascular system, and a connector or an anchor receiver 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 secures a wire.

In some applications, the connector or anchor receiver includes one or more of the following: rivets, sutures, clips, wires, pins, shafts, sheets, mesh, housings, tubes, crossbars, and the like.

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

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

In some 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 some applications, the compression element further comprises a delivery conduit and the compression element is compressed within the delivery conduit.

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

The methods herein, such as the delivery of the systems/devices herein, can be performed on a living animal or on a simulator, such as a cadaver, a cadaver heart, a simulator (e.g., with a simulated body part, heart, tissue, etc.), etc.

In some applications, a rod component is for use in a mitral valve of a heart. The rod component includes an arched rod. The rod component includes a hook or latch located on each of two distal ends of the arched rod, the hook or latch capable of hooking or latching within the commissures of a mitral valve. The rod component includes an anchor capable of anchoring within the vascular system. The rod component also 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 secures a wire.

In some applications, the connector or anchor receiver includes one or more of the following: rivets, sutures, clips, wires, pins, shafts, sheets, mesh, housings, tubes, crossbars, and the like.

In some applications, a sheet extends from the arch bar.

In some applications, a gap filler/spacer/joining element extends from the arch bar.

In some applications, the arched rod is a telescopic rod comprising an inner rod and an outer rod. The inner rod is capable of sliding within the outer rod, making the length of the telescopic rod adjustable.

In some applications, a method is provided for delivering a system (e.g., a leaflet repair system, an actuator system, a prolapse repair system, a flail repair system, a repair system, etc.) to a native valve (e.g., a mitral valve, a tricuspid valve, etc.) via transcatheter delivery. In some applications, the method includes introducing a puncture catheter or other puncture device (e.g., via a first guidewire, etc.) into a vascular system (e.g., a coronary sinus, a coronary artery, etc.) of the heart adjacent to a chamber (e.g., an atrium, a ventricle, etc.) of the heart. The method includes puncturing the luminal wall of the vascular system (e.g., a coronary sinus, etc.) and the chamber wall (e.g., an atrial wall, etc.). The method includes guiding a delivery catheter (e.g., via a second guidewire, etc.) into the chamber (e.g., atrium, etc.) through a puncture hole in the vascular system (e.g., coronary sinus, etc.) and the chamber wall (e.g., atrial wall, etc.).

In some applications, the method includes releasing a device (e.g., a repair device, a leaflet repair device, an actuator, etc.) from the delivery catheter within the chamber (e.g., within the atrium, etc.). The method includes using the delivery catheter to position the device over a portion of the leaflet (e.g., a posterior leaflet, etc.) of the native valve (e.g., mitral valve, tricuspid valve, etc.) that is experiencing prolapse or flail.

In some applications, the method includes releasing a connector or an interface and an anchor from the delivery system such that the anchor is located within the vascular system (e.g., coronary sinus, etc.), and the connector or interface connects the device to the anchor across the luminal wall of the vascular system (e.g., coronary sinus, etc.) and the chamber wall (e.g., atrial wall, etc.).

In some applications, the delivery catheter accesses the vascular system (e.g., coronary sinus, etc.) via a transfemoral, a subclavian, a transapical, a transseptal, or a transaortic approach.

The above method(s) may be performed on a living animal or on a simulation, such as a cadaver, a cadaver heart, a simulator (e.g., with simulated body parts, heart, tissue, etc.), etc.

In some applications, a method involves delivering a compression element (e.g., a stent, clasp, form, etc.) to a native valve (e.g., a mitral valve, etc.) via a catheter. In some applications, the method includes introducing a puncture catheter or other puncture device (e.g., via a first guidewire, etc.) into a vascular system (e.g., a coronary sinus, a coronary artery, etc.) of the heart adjacent to a chamber (e.g., an atrium, a ventricle, etc.) of the heart. In some applications, the method includes puncturing a luminal wall of the vascular system (e.g., a coronary sinus luminal wall, a coronary artery luminal wall, etc.) and a chamber wall (e.g., an atrial wall, a ventricular wall, etc.).

In some applications, the method includes guiding a delivery catheter (e.g., via a second guidewire, etc.) through the vascular system lumen wall and the puncture hole in the chamber wall into the chamber (e.g., atrium, ventricle, left atrium, left ventricle, etc.).

In some applications, the method includes releasing a compression element from the delivery catheter within the chamber (e.g., within the atrium or ventricle).

In some applications, the method includes using the delivery catheter (e.g., an actuator coupled thereto) to compress the compression element against a portion of a posterior leaflet or other leaflet of the native valve (e.g., mitral valve, etc.) that is experiencing prolapse or flailment.

In some applications, the method further includes releasing a connector or an interface and an anchor from the delivery system, such that the anchor is located within the vascular system (e.g., coronary sinus, etc.), and the connector or interface connects the compression element to the anchor across the luminal wall of the vascular system (e.g., coronary sinus, etc.) and the chamber wall (e.g., atrial wall, etc.).

In some applications, the delivery catheter accesses the vascular system (e.g., coronary sinus, etc.) via a transfemoral, a subclavian, a transapical, a transseptal, or a transaortic approach.

In some applications, a spacer/joint element/spacer system is configured for use within a heart valve. The spacer/joint element/spacer system includes a spacer, joint element, or spacer capable of expanding within the ostium of a heart valve when the heart valve is closed to fill any gaps in the valve and prevent or inhibit valvular regurgitation. The spacer/joint element/spacer system includes an anchor capable of anchoring within the vascular system. The spacer/joint element/spacer system includes a connector or anchor receiver connecting the spacer/joint element/spacer and the anchor.

In some applications, the gap filler/joining element/spacer comprises poly(lactic-co-glycolic acid) (PLGA), polyvinyl chloride (PVC), polyethylene (PE), polypropylene (PP), polytetrafluoroethylene (PTFE), polyurethane (PU), polyethylene terephthalate (PET), polyether sulfone (PES), polyglycolic acid (PGA), polylactic acid (PLA), poly(dextrose-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 secures a wire.

In some applications, the connector or anchor receiver includes one or more of the following: rivets, sutures, clips, wires, pins, shafts, sheets, mesh, housings, tubes, crossbars, and the like.

In some applications, the space filler/engagement element/spacer is configured to be implanted within a mitral valve, a tricuspid valve, an aortic valve, or a pulmonary valve.

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

In some applications, the device (e.g., a repair device, a leaflet repair device, an actuator, etc.) is configured to be implanted within the mitral valve, the anchor is configured to be implanted within the coronary sinus, and the connector is positioned across the left atrial wall.

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

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

The above method(s) may be performed on a living animal or on a simulation, such as a cadaver, a cadaver heart, a simulator (e.g., with simulated body parts, heart, tissue, etc.), etc.

In some applications, a system (e.g., a leaflet repair system, an actuator system, a prolapse repair system, a flail repair system, a repair system, etc.) is for use within a heart valve to provide contact pressure on a leaflet. The system includes a device (e.g., a repair device, a leaflet repair device, an actuator, etc.) having a contact surface capable of providing contact pressure on 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 a chamber wall.

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

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

In some applications, the contact surface of the device is capable of providing contact pressure on a prolapse or a flail of the heart valve leaflet.

In some applications, the system includes a coaptation portion 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 some applications, the coaptation portion can help promote coaptation between the leaflets of the valve.

In some applications, the device is a wire former.

In some applications, the wire is formed of nickel-titanium alloy, cobalt-chromium (CoCr), stainless steel, titanium, polyglycolic acid (PGA), polylactic acid (PLA), polydextral 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), or fluorinated ethylene propylene copolymer (FEP).

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

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

In some applications, the system includes a corrugated wire or a cross-shaped wire to provide contact pressure on a prolapse or a flail of the heart valve leaflet.

In some applications, the system includes a sheet attached to the wire form. The sheet forms the contact surface.

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

In some applications, the sheet is capable of providing contact pressure over a prolapse or a flail of the heart valve leaflet.

In some applications, the device comprises an impermeable bonding portion and a permeable non-bonding portion.

In some applications, the impermeable joint is thickened.

In some applications, the impermeable junction portion can be thickened at the implantation site.

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

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

In some applications, the reaction force support is configured to anchor to a heart chamber wall.

In some applications, the anchor is a screw anchor, a W-anchor, a T-anchor, or a single-turn screw.

In some applications, the anchor is one or more screw-type anchors located within a tubular compartment housing. The tubular compartment housing is connected to the device.

In some applications, the one or more screw anchors are a single screw anchor that is compressed within the tubular compartment housing and is wound upon itself.

In some applications, the one or more screw anchors are two or more screw anchors, which are stacked one on top of another in series and compressed within the tubular compartment housing.

In some applications, the one or more screw anchors are two or more screw anchors, each of which includes an inner screw (or inner screw anchor portion) and an outer screw (or outer screw anchor portion) and is compressed within the tubular compartment outer casing.

In some applications, the two or more screw anchors are configured to be embedded in the tissue at two angles that are oblique to each other.

In some applications, the system includes a support connected to the outer housing of the tubular compartment so that the plane of the device contact surface is adjustable.

In some applications, the system includes a sliding mechanism incorporated into the edge of the tubular compartment housing so that the plane of the device contact surface is adjustable.

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

In some applications, the device incorporates an internal gap in the bonding area of the device. The internal gap does not contain wire forming.

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

In some applications, the gap filler/joining element/spacer comprises a material selected from the group consisting of foam, hydrogel, and silicone.

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

In some applications, the device incorporates an expandable stand.

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

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

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

In some 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 meshing system is provided for use within a heart valve. The meshing system includes a meshing device having a mesh with a contact surface capable of providing contact pressure on an inflow surface of a heart valve leaflet. The side edge of the meshing device is capable of being seated within a heart valve cleft. The meshing system includes an anchor attached to the mesh and capable of anchoring within the tissue of the leaflet, annulus, or chamber wall.

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

In some applications, the anchor is a screw-type 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 a joint portion of the netting device.

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

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

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

In some applications, a method for repairing a native heart valve in a heart includes: transvascularly advancing a delivery catheter to the native heart valve, advancing an anchor (which may be the same as or similar to any anchor or anchoring feature described herein) from the delivery catheter into tissue of the heart, thereby anchoring a leaflet repair implant/device (which may be the same as or similar to any implant/device described herein) to the tissue, and releasing the leaflet repair implant/device from the delivery catheter such that the leaflet repair implant/device extends along a portion of a leaflet of the native heart valve.

In some applications, advancing the anchor from the delivery catheter into tissue of the heart, thereby anchoring the leaflet repair implant/device to the tissue, is performed prior to releasing the leaflet repair implant from the delivery catheter, such that the leaflet repair implant extends along a portion of a leaflet of the native heart valve.

In some applications, advancing the anchor from the delivery catheter into tissue of the heart, thereby anchoring the leaflet repair implant to the tissue, is performed after releasing the leaflet repair implant from the delivery catheter such that the leaflet repair implant extends along a portion of a leaflet of the native heart valve.

In some applications, transvascular advancement of a delivery catheter to the native heart valve is accomplished via a transfemoral, subclavian, transapical, transseptal, or transaortic approach.

In some applications, transvascular advancement of 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 some applications, the anchor is a helical anchor, and advancing the anchor from the delivery catheter into tissue of the heart, thereby anchoring the leaflet repair implant/device to the tissue, includes rotating the helical anchor into the tissue. Other types of anchors are also possible.

In some 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 some applications, releasing the leaflet repair implant/device from the delivery catheter such that the leaflet repair implant/device extends along the portion of the leaflet of the native heart valve includes releasing the leaflet repair implant/device from the delivery catheter such that the leaflet repair implant/device extends along at least one of a prolapsed portion of the leaflet and a flail portion of the leaflet and applies a contact pressure thereto.

In some applications, releasing the leaflet repair implant/device from the delivery catheter includes transitioning the leaflet repair implant/device from a compressed delivery configuration within the delivery catheter to an expanded configuration outside the delivery catheter.

In some 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 herein for applying a contact pressure to a native leaflet of a native valve.

In some applications, the leaflet repair implant/device is a compression implant/device, and releasing the leaflet repair implant/device from the delivery catheter includes attaching the compression implant/device to the leaflet such that a portion of the leaflet experiencing prolapse, flail, or stiffness is compressed between an inflow side (e.g., a side attached to or in contact with an inflow side of the leaflet) and an outflow side (e.g., a side attached to or in contact with an outflow side of the leaflet) of the compression element. The compression implant/device may be the same as or similar to any of the implants/devices described herein for applying a compressive force to a native leaflet of a native valve or compressing a native leaflet of a native valve.

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

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

According to certain applications, further provided herein is a system and/or device for use with a valve (e.g., a native valve, mitral valve, tricuspid valve, other valve, etc.) in a heart of an individual, the heart having a chamber upstream of the valve, the system/device comprising an implant, an anchor, a catheter, and a delivery tool. The implant may include an interface and/or a flexible wing. The wing may be coupled to the interface. The wing may have a contact surface and an opposing surface opposite the contact surface. The catheter is typically transluminally advanceable into the chamber and configured to receive the implant.

The delivery tool may include a shaft coupled to the interface. Through coupling to the interface, the shaft may be configured to deploy the implant outside the catheter such that the wings extend away from the interface within the chamber. Alternatively or additionally, the shaft may be configured to position the implant in a position in which the interface is located at a location within the heart, the wings extend past a first leaflet of the heart toward at least one opposing leaflet (e.g., an opposing leaflet portion), and the contact surface faces the first leaflet.

The delivery tool may include an actuator coupled to the anchor and configured to anchor the implant in position by using the anchor to anchor the interface to tissue of the heart.

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

In some applications, the implant includes exactly one anchor.

In some applications, the contact surface is concave.

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

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

In some applications, the location is on an annulus of the valve, the delivery tool is configured to position the implant in the location wherein the interface is at the location on the annulus, and the actuator is configured to anchor the implant in the location by anchoring the interface to tissue of the annulus using the anchor.

In some applications, the location is located on a wall of the chamber, the delivery tool is configured to position the implant in the location wherein the interface is at the location on the wall of the chamber, and the actuator is configured to anchor the implant in the location by anchoring the interface to the structure of the wall of the chamber using the anchor.

In some applications, the chamber is an upstream chamber, the heart has a downstream chamber 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 actuator is configured to anchor the interface by driving the anchor through the first leaflet and into the wall of the downstream chamber.

In some applications, the actuator is configured to anchor the implant in place by driving the anchor through the first leaflet and into the tissue of the heart.

In some applications, the shaft is configured to fully deploy the wings out of the catheter via an anchoring engagement with the interface, and the actuator is configured to anchor the implant in position after the shaft fully deploys the wings out of the catheter.

In some applications, the shaft is configured to deploy the implant entirely out of the catheter via an engagement with the interface, and the actuator is configured to anchor the implant in place after the shaft deploys the implant entirely out of the catheter.

In some applications, the driver extends through the shaft.

In some applications, the shaft is configured, via coupling to the interface, to deploy the implant out of the catheter when the actuator is positioned within the shaft.

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

In some applications, the implant is configured to be received within the catheter, with the wing located 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 before the interface.

In some applications, the implant includes an anchor receiver located at the interface (e.g., the interface may include an anchor receiver), and the actuator is configured to anchor the interface to the tissue by anchoring the anchor receiver to the tissue using the anchor.

In some applications, the interface defines a space therein, and the anchor receiver is disposed within the space.

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

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

In some applications, the housing defines an obstruction that projects at least partially through the aperture, and the actuator is configured to anchor the interface to the tissue by driving the anchor through the housing until the anchor presses the obstruction toward the tissue.

In some applications, the sidewall and the shaft define respective anchoring elements, and the shaft is anchored to the interface via an anchoring connection between the anchoring elements of the shaft and the anchoring elements of the sidewall.

In some applications, the actuator is configured to anchor the anchor receiver to the tissue by anchoring the anchor to the anchor receiver and to the tissue.

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

In some applications, the anchor includes a tissue anchoring element and a head, the anchor receiver defines an aperture therethrough, and includes a blocker that projects inwardly into the aperture in a manner that facilitates passage of the tissue anchoring element through the aperture but inhibits passage of the head through the aperture, and the driver is configured to anchor the anchor to the anchor receiver by driving the tissue anchoring element through the anchor receiver until the head of the anchor becomes blocked by the blocker.

In some applications, the obstruction body includes a crossbar extending across the orifice.

In some applications, the baffle body includes a shaft collar.

In some applications, the barrier comprises a sheet of material through which the tissue attachment element can penetrate.

In some applications, the tissue anchor is a screw-type tissue anchor, and the driver is configured to drive the tissue anchor through the anchor receiver by tightening the tissue anchor through the anchor receiver.

In some applications, the position is a first position, the address is a first address, and the shaft, via engagement with the interface, is configured to reposition the implant to a second position after placement of the implant in the first position, wherein the interface is located at a second address in the heart, the wing extends beyond the first leaflet toward the opposite leaflet, and the contact surface faces the first leaflet, the second position being different from the first position, and the second address being different from the first address.

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

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

In some applications, the wing includes a frame and a sheet laid over the frame.

In some applications, the frame comprises at least one frame material selected from the group consisting of nickel-titanium alloy, cobalt-chromium (CoCr), stainless steel, titanium, polyglycolic acid, polylactic acid, polydextrose, polyurethane, poly-4-hydroxybutyrate, polycaprolactone, polyetheretherketone, a cyclic olefin copolymer, polyethylene vinyl acetate, polytetrafluoroethylene, a perfluoroether, and a fluorinated ethylene propylene copolymer.

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

In some applications, the framework is self-extensible.

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

In some applications, the sheet material comprises at least one sheet material selected from the group consisting of lactic acid-glycolic acid copolymer, polyvinyl chloride, polyethylene, polypropylene, polytetrafluoroethylene, polyurethane, polyethylene terephthalate, polyether sulfone, polyglycolic acid, polylactic acid, poly(dextrose), poly(4-hydroxybutyrate), and polycaprolactone.

In some applications, the wing has: a root coupled to the interface, a tip located at an end of the wing opposite the root, and two sides extending from the root to the tip.

In some applications, the chamber is an upstream chamber, the heart has a downstream chamber downstream of the valve, and the wing is arranged at an angle relative to the interface such that the implant, with the shaft positioned in this position, positions the tip within the downstream chamber.

In some applications, the first leaflet has a lip, and the wing is arranged at an angle relative to the interface such that the implant, with the shaft positioned in the position, positions the tip 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 connects the two rings to each other only at the interface.

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

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

In some applications, each of the rings is substantially teardrop-shaped. In some applications, each of the rings is substantially oval, ovoid, or triangular.

In some applications, the wing is bent in the direction of the valve leaflet. In some applications, the wing bends in one direction from the interface and then bends in the opposite direction moving toward the tip.

In some applications, the frame defines an elongated space between the two rings extending from the root toward 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 is along a reflection 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 a plurality of 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 the implant passing through the interface and the wing, the contact surface is concave.

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

In some applications, the cross-section lies in a plane of reflection symmetry 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 so that, in this position, the reaction force support rests against a wall of the chamber.

In some applications, the catheter has a distal opening and is configured to receive the implant, the implant with the wing disposed distally from the interface and the interface disposed distally from the counterforce support.

In some applications, the reaction support consists of a wire loop.

In some applications, the shaft is configured to be anchored to the interface within the conduit, such that within the conduit, 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 organization.

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

In some applications, the actuator is a first actuator, and the delivery tool further includes a second actuator coupled to the second anchor and configured to anchor the implant in position by anchoring the interface to the tissue using the second anchor.

In some applications, the anchor includes a helical tissue anchoring element, and the actuator is configured to anchor the implant in place by tightening the tissue anchoring element into the tissue.

In some applications, the tissue anchor element is a first tissue anchor element, and the anchor further includes a second helical tissue anchor element, wherein the first tissue anchor element and the second tissue anchor element are arranged to form a double helix.

In some applications, the anchor has a proximal end and a distal end, and each of the first and second tissue anchoring elements has a sharp distal tip at the distal end of the anchor and is formed into a conical spiral that widens toward the distal end of the anchor.

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

In some applications, along a longitudinal axis of the anchor, the anchor has: a fabric anchor region, in which: a first wire defines the first fabric anchor element, a second wire defines the second fabric anchor element, and the first wire and the second wire each have a fabric anchor pitch such that within the double helix, turns of the first wire are axially spaced apart from turns of the second wire.

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 turns of the first wire abut the turns of the second helix. The head region can also be aligned along the longitudinal axis of the anchor.

In some applications, the weave joint 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 having a sharp distal tip. In some applications, the 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 first pitch, defining the tissue-anchoring element, and terminating at the sharp distal tip. In some applications, the first pitch configures the first helical portion to resist being squeezed into the tissue.

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

In some applications, the leaflet thickening elements include protrusions.

In some applications, the leaflet thickening elements include recessed portions.

According to certain applications, further provided herein is a method for use with a valve (e.g., a native valve, mitral valve, tricuspid valve, other valve, etc.) of a heart of an individual, the heart having a chamber upstream of the valve, and the method comprising advancing, within a catheter, into the chamber: (1) 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 (2) a shaft articulated to the interface.

In some applications, the method further includes using the shaft to deploy the implant outside the catheter such that, within the catheter, the wings extend away from the interface.

In some applications, the method further includes subsequently using the shaft to position the implant in a position wherein the interface is located at a location in the heart, the wing extends beyond a first leaflet of the valve toward at least one opposing leaflet (e.g., an opposing leaflet portion) of the valve, and the contact surface faces the first leaflet.

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

In some applications, advancing the implant into the cavity includes advancing the implant into the cavity while the wing is constrained within the catheter.

In some applications, the wing has a root coupled to the interface and a tip located at an end of the wing 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 so that the tip is disposed within the downstream chamber.

In some applications, the wing has a root coupled to the interface and a tip located at an end of the wing opposite the root. In some 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 downstream of the lip of the first leaflet.

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 some applications, positioning the implant in the position includes positioning the implant so that the opposing surface contacts the opposing leaflet.

In some 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 includes advancing the implant into the left atrium.

In some 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 includes advancing the implant into the right atrium.

In some applications, 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 includes advancing the implant into the left ventricle.

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

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

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

In some applications, the chamber is an upstream chamber, the heart has a downstream chamber downstream of the valve, positioning the implant in the position includes pressing the interface against the first leaflet 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 includes 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 some applications, the anchor includes a tissue anchor element, and using the actuator to drive the anchor into the tissue includes using the actuator to tighten the tissue anchor element into the tissue.

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

In some applications, anchoring the interface to the tissue includes using the actuator to drive the anchor through the anchor receiver and into the tissue.

In some applications, the anchor includes a tissue-anchoring element and a head, the anchor receiver defines an aperture therethrough and includes a blockage projecting medially into the aperture, and using the driver to drive the anchor through the anchor receiver and into the tissue includes using the driver to drive the tissue-anchoring element past the blockage until the head of the anchor becomes blocked by the blockage.

In some applications, the obstruction body includes a crossbar extending across the aperture, and using the driver to drive the tissue anchor element past the obstruction body until the head of the anchor becomes obstructed by the obstruction body includes using the driver to drive the tissue anchor element past the crossbar until the head of the anchor becomes obstructed by the crossbar.

In some applications, the obstruction body includes a shaft ring, and using the driver to drive the tissue anchor element past the obstruction body until the head of the anchor becomes obstructed by the obstruction body includes using the driver to drive the tissue anchor element past the shaft ring until the head of the anchor becomes obstructed by the shaft ring.

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

In some 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 positioning the implant in the position using the shaft, wherein the shaft is anchored to the sidewall.

In some applications, the implant defines a barrier that projects at least partially through the orifice, and anchoring the interface to the tissue includes anchoring the housing to the tissue by driving the anchor through the housing using the actuator until the anchor presses the barrier toward the tissue.

In some applications, the implant further includes a counterforce support, and deploying the implant outside the catheter includes deploying the implant outside the catheter such that the counterforce support extends from the interface and away from the wing.

In some applications, the position is a position where the counter-force bearing rests against a wall of the chamber, and positioning the implant in the position includes positioning the implant in the position where the counter-force bearing rests against the wall of the chamber.

In some applications, deploying the implant outside the catheter includes deploying the following outside the catheter: the wing, followed by the interface, and followed by the reaction force support.

In some 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 supported by the reaction force.

In some applications, positioning the implant in the location includes positioning the implant in the location after fully deploying the wings out of the catheter.

In some applications, positioning the implant in the location includes positioning the implant in the location after fully deploying the implant outside the catheter.

In some applications, the position is a first position, the address is a first address, and the method further comprises: after placing the implant in the first position, repositioning the implant to a second position, wherein the interface is located at a second address in the heart, the wing extends beyond the first leaflet toward the opposite leaflet, and the contact surface faces the first leaflet, the second position being different from the first position, and the second address being different from the first address.

In some applications, the first address is a first address located on a ring of the valve, and the second address is a second address located 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 repositioning the interface against the ring at the second location.

In some applications, repositioning the implant to the second location includes repositioning the implant to the second location before anchoring the interface to the tissue.

In some applications, the method further comprises unanchoring the interface from the tissue after anchoring the interface to the tissue, repositioning the interface to the second position comprises repositioning the implant to the second position after unanchoring the interface from the tissue, and the method further comprises reanchoring the interface to the tissue after repositioning the implant to the second position.

In some applications, the method further includes receiving a signal indicating regurgitation through the valve while the implant is positioned at the first position, and repositioning the implant to the second position includes repositioning the implant to the second position in response to receiving the signal.

In some applications, the information is an electrocardiogram (ECG) information, and repositioning the implant to the second location includes repositioning the implant to the second location in response to receiving the ECG information.

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

In some applications, repositioning the implant into the second location includes repositioning the implant into the second location while maintaining the implant entirely outside of the catheter.

In some applications, deploying the implant outside the catheter includes deploying the implant outside the catheter while the actuator is positioned within the shaft.

In some applications, deploying the implant out of the catheter includes deploying the implant out of the catheter while the anchor is positioned within the shaft.

The above method(s) may be performed on a living animal or on a simulation, such as a cadaver, a cadaver heart, a simulator (e.g., with simulated body parts, heart, tissue, etc.), etc.

The present invention will be more fully understood from the following detailed description of its applications, together with the accompanying drawings, in which:

CS,525,1409,3521: Coronary sinus

CT, 507: Chordae tendineae

LA,517: left atrium

LV,521,6417: Left ventricle

MV,505,5411,5713:Mitral valve

PM,809: Mastoid muscle

A-A:Indicator

ax1: Anchor

ax2: tangent

ax3: atrioventricular valve axis

d1: tissue joint pitch

d2: Head pitch

4: Heart

6: Left atrium, atrium

7:Aorta

8: Left ventricle, ventricle

9,709: Ventricular wall

10: Valve, mitral valve

11: Mitral valve annulus, annulus

12: First leaflet, posterior leaflet, and petal leaflet

13: Roots

14: Opposite leaflets, anterior leaflets, leaflets

15:Unite

16: The flail portion of the posterior lobe, the flail, the flail portion

17: Lower leaflet

18: Address

18a: Initial address

18b: Second address

20: System

30,30a,30b,30c,1115,1611,1711.1801,1901,1921: Anchor

32,32b,32c: Anchor head

34,34b,34c: Tissue connection components

34b’, 34c’: First tissue connection element

34b”, 34c”: Secondary tissue connection element

36b,6207: Wire

36b’: First Wire

36b”: Second cable

38: Tissue connection area

39: Head area

40: Catheter

50: Delivery Tools

60,74:axis

62: Shaft head

64,114: Connector

70:Driver

72: Drive Department

100, 100a, 100b, 100c, 100d, 100e: Implants

108: Shell

110: Interface

112: Sidewall (e.g., pipe wall)

114: Connector

120,120e: Wing

122: contact surface or surface, contact surface

122e: Contact surface

123: Opposite sides or surfaces

124:Framework

126,126e: Sheet

128: Circle

130: Roots

132: Tip

134: Side

134a: First side

134b: Second side

136,3809,3811,4311,4313,4909,4911: Rings

136a: First ring-shaped member

136b: Second ring

137,138: Space

140: Holes, openings

150: Anchor Receiver

150a, 150b, 150c: Receiver

152: Obstacle

152a, 152b, 152c: Impedance components

160: Prominent structure

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 lobe

513,2103,2203:Contact surface

515,1105,1305,3215,3411,3511: Inlet surface

519,705,805,905,1111,1311,2005,2021,2105,2205,2303: Joints

2403, 2423, 2509, 3223, 3419, 3519, 3607, 3707, 3807, 3907: Joints

4207, 4307, 4407, 4507, 4707, 4907, 5107, 5307, 5407, 5707: Joints

6013,6413: Jointing part

523,2209,4509,4709,5111.5311: Covering or sheet

527,1413:Connection point

529,1415,1603,1613,2007,3125,3523,4209,4309,4409,5109: Connector

5309,6107: Connector

531,1417,3525: Atrial wall

703, 803, 903, 1103, 1107, 1303, 1405, 3205, 3407, 3505: Natural valves

707,807,907: Chain

909: Apex of the ventricle

1003: P2 of the posterior lobe

1005: P3 of the posterior lobe

1109, 1309, 3217, 3413: Atria

1113: Support

1117,6423: Valvular annulus

1307:Natural valve leaflets, posterior leaflets

1313: Clamps

1315: Covering layer

1401,5709,6305: Gap filler/joining element/spacer

1407: Leaflet coaptation area

1601: Expandable bracket anchor

1605,1615: Wall of the vascular system

1701: Curved or ring anchor

1703: Upper part

1705: Lower part

1707: Central Ring Road

1713,1715: Remote

1717: Inner Rib

1721,2319,6403: Screw Anchor

1723: Lower end

1725: Upper end

1731: T-Anchor

1733,1735: Arm

1737: Connection part

1803, 1805: Spiral or spiral anchor part

1807, 1817, 1827, 1835: Tubular compartment or shell

1809: Push or rotate

1811, 1821, 1831: Low-profile double screw anchor

1813,1815: Spring-like compressible spiral or helical anchor portion

1823: Internal spring-loaded compressible helix or spiral anchor portion, internal helix/anchor portion

1825: External spring-loaded compressible helical or spiral anchor portion, external helical/anchor portion

1833: Spring-loaded, compressible spiral anchor or anchor portion

1905: Pivot

1907,1929: Anchor shell

1909,1931: Deployment Tools

1911: Cables

1925, 1927: Sliding mechanism

1929: Anchor Casing

2003: Corrugated Wire

2013, 2015, 2017: Cross-section wire forming

2019: Lateral expansion or contraction

2023: Connector or connection point

2107,2207,2511: Anchor connection point

2109, 2309, 2405: Reaction force support

2111: Permeable non-joint portion, permeable portion

2113: Impermeable joint

2305, 2507: Wire Forming

2307: Anchor connection points, interfaces, and wire forming for anchor connection points

2311, 2407, 2425: Permeable mesh

2313: Tubular compartment, housing, anchor receiver

2315: Guide tube

2317:orifice

2321: Circular Groove

2409: Swinging hinge

2411: W-type anchor

2427: Interface or hinge

2503:Joint elements, spacers or fillers, contact surfaces

2505, 2705, 2805, 2909, 3009, 6205: Sheet

2703,6109,6203,6303: Hooks

2707, 2807, 2911, 3011: Anchor Connector

2803,2907,3007: concave

2903,3003: Static part

2905,3005: Dynamic section

3101.6001: Guide wire

3103:Puncture catheter

3105: Anchoring components

3107: Distal segment

3109: Radiopaque marker

3111: Needle port

3113:Tissue wall

3115:Puncture Sheath

3117:Puncture Needle

3119: Second guide line, guide line

3121,6003: Delivery catheter

3123: Compressed device

3127: Compression Wire Support Anchor

3203,3405: valve leaflets, posterior leaflets

3207: The valve chordae tendineae are ruptured

3209: P2 Area

3211,3403,3507,3603,3703,3803,3903,4003,4203,4303: Inflow section

4403, 4503, 4703, 4903, 5103, 5303, 5403, 5703, 6009: Inflow section

3219: Outflow surface

3221,3415,3517: Ventricles

3213, 3409, 3509, 3605, 3705, 3805, 3905, 4005, 4205, 4305: Outflow

4405, 4505, 4705, 4905, 5105, 5305, 5405, 5705, 6011: Outflow

3421: Area

3515: Atria, Left Atrium

3601, 3701, 3801, 3901, 4001: Implants or devices, compression elements, or compression wire-formed stents

4201, 4301, 4401, 4501, 4701: Implants or devices, compression elements, or compression wire-formed stents

4901, 5101, 5301: Implants or devices, compression elements, or compression wire-formed stents

3909,3911: External wing ring

3913: Large inner ring

4007: Torsion Spring

4711: The joint portion 4707 with the sheet or cover is extended.

5401, 5701: Implants or devices, compressed wire-formed stents

5413: Anterior lobe

5715: Anterior leaf

6005: Tissue wall

6007: Compression Clamp Device

6101: Telescopic rod/extension or telescopic arch rod

6103: Inner rod/extension section

6105: Outer rod/extension section

6201: Rod/extension assembly, arch or arch rod, rod/extension or arch rod

6301: Rod/extension assembly or arched rod, rod/extension or arched rod

6401:Netting implant or device

6405: Mesh material

6507: Anchoring part

6409,6411: Side edge

6415: Mitral valve, natural valve

6419: Left atrium, fissure between P1 and P2

6421: The gap between P2 and P3

FIG. 1 is a schematic diagram of the left ventricle of a heart as one of various specific examples; FIG. 2 is a schematic diagram of a mitral valve as one of various specific examples; FIG. 3 and FIG. 4 are schematic diagrams of a heart valve leaflet flail and a heart valve leaflet prolapse, respectively, as one of various specific examples; FIG. 5-9, 10A-C, and 11-13 are schematic diagrams of various exemplary devices implanted on a native valve; FIG. 14 and FIG. 15 are schematic diagrams of an exemplary intercuspid valve implanted on a native valve. 16A-D are schematic diagrams of an exemplary anchor for use in a vascular system; FIG17A-E are schematic diagrams of an exemplary anchor for use in a vascular valve; FIG18A-H are schematic diagrams of an exemplary spiral anchor; FIG19A-C are schematic diagrams of an exemplary system having a device with an adjustable contact surface angle; FIG20A-B, 21A-B, 22A-C, 23A-D, 24A-D and 25-30 are schematic diagrams of an exemplary system having a device with an adjustable contact surface angle according to certain applications; Figures 31A-31L are schematic diagrams of an exemplary method for delivering a device to a native valve via a transcatheter procedure; Figures 32-35 are schematic diagrams of an exemplary compression element implanted on a native valve; Figures 36-59 are schematic diagrams of exemplary compression elements; Figures 60A-60D are schematic diagrams of an exemplary method for delivering a compression element to a native valve via a transcatheter procedure; Figures 61-63 are schematic diagrams of an exemplary device comprising a rod. Figures 64-66 are schematic diagrams of exemplary repair devices comprising a netting or mesh; Figures 67A-B, 68A-G, 69-71, 72A-C, and 73-75 are schematic diagrams of a system for use with a valve of a heart of an individual according to certain applications; Figure 76 is a schematic diagram of an implant according to certain applications; Figures 77A-B are schematic diagrams of an implant according to certain applications; and Figures 78A-B and 79 are schematic diagrams of anchors according to certain applications.

Detailed description

Systems, apparatuses, devices, methods, etc. for alleviating heart valve regurgitation are described herein. In certain applications, the systems, apparatuses, devices, methods, etc. comprise an implant/device positioned within a valvular annulus and anchored within the annulus and/or adjacent vascular system. The systems, apparatuses, devices, methods, etc. can be configured to provide contact pressure to and/or support valve leaflet regions experiencing flail, prolapse, stiffness, etc. In certain applications, systems, apparatuses, devices, methods, etc. are described, such as compression elements, buckles, splints, templates, etc., that can compress onto a leaflet and provide contact pressure and/or support to a region of the leaflet experiencing flail, prolapse, stiffness, etc. In certain applications, systems, apparatuses, devices, etc. that are further anchored within the leaflet annulus or an adjacent vascular system are described, such systems, apparatuses, devices, etc. providing contact pressure and/or support to a region of the leaflet experiencing flail, prolapse, stiffness, etc. Various examples of methods for delivering and implanting systems, apparatuses, devices, etc. to a site of flail, prolapse, stiffness, etc. are described. One example of a situation where this may be helpful is when used on the posterior leaflet of a mitral valve that is experiencing flail, prolapse, stiffness, and/or other problems.

The described systems, devices, apparatuses, methods, etc. should not be construed as limiting in any way. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed implementations and applications, both individually and in various combinations and subcombinations with each other. The disclosed systems, devices, apparatuses, methods, etc. are not limited to any specific aspects, features, or combinations thereof, nor do the disclosed systems, devices, apparatuses, methods, etc. require that any one or more specific advantages be present or problems be solved. Furthermore, the techniques, methods, operations, steps, etc. described or suggested herein can be performed on a living animal (e.g., a human, other mammal, etc.) or on an inanimate simulation, such as a cadaver, a cadaver heart, a simulator (e.g., with simulated body parts, tissues, etc.), an anthropomorphic phantom, etc.

Various implementations of systems, devices, examples of artificial implants, and the like 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 artificial device and/or delivered and implanted by any suitable method, even if a specific combination is not explicitly described. Similarly, 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, and the like, even if not explicitly disclosed. In short, the individual components of the disclosed systems may be combined unless mutually exclusive or physically impossible.

Although certain disclosed method operations are described in a particular sequential order for ease of presentation, it should be understood that this description encompasses reordering unless a specific ordering is required by the specific language described below. For example, operations described sequentially may in some cases be reordered or performed concurrently. Furthermore, for simplicity, the accompanying figures may not illustrate the various ways in which the disclosed systems, devices, apparatuses, methods, etc. may be used in conjunction with other systems, devices, apparatuses, methods, etc.

FIG1 is a coronal plan view of the left lateral chambers cut through the coaptation region of the mitral valve, and FIG2 is a transverse plan view of 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 inward through respective orifices, which come together or "coapt" in blood flow to form a one-way flow-blocking surface. Then, returning to the left lateral chambers, oxygenated blood is brought from the pulmonary vein (not shown) to the left atrium and then transferred 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 are the mastoid muscles (PM), which are attached to the left ventricular wall via the chordae tendineae (CT) and connected to the mitral valve (MV) leaflets. These muscles and chordae assist in the MV's function of opening the leaflets to form an orifice, coapting the leaflets to close the orifice, and maintaining leaflet shape and position.

FIG1 also shows the coronary sinus (CS), which is a vascular system surrounding the left ventricle. Throughout this disclosure, the coronary sinus is used as an example of a proximal vascular system location for docking anchors for the various implementations described.

Figure 3 provides an example of leaflet flailment, while Figure 4 provides an example of leaflet prolapse. Leaflet flailment occurs when the coapted portion of the leaflet flips backward against blood flow. Similarly, leaflet prolapse occurs when a portion of the leaflet bulges backward. Flail and prolapse can occur due to a variety of conditions, including, but not limited to, dysfunction of the papillary muscles (PM) and/or chordae tendineae (CT). In the examples provided in Figures 3 and 4, a break in the chordae tendineae (CT) causes leaflet flailment and prolapse, respectively. Leaflet flailment and prolapse can also occur due to stretching of the chordae tendineae (CT). Leaflet flailment, prolapse, stiffness, and/or leaflet problems can lead to failure of one of the coaptations, resulting in regurgitant blood flow.

Throughout this document, descriptions and figures generally refer to the left lateral chambers, and in particular, the mitral valve (MV) and coronary sinus (CS), as examples for the various embodiments described. However, it should be noted that, as will be understood by those skilled in the art, the various embodiments and applications described may be applied, by analogy, to other valves (e.g., tricuspid valve, pulmonary valve, aortic valve, etc.) and other vascular systems (e.g., coronary arteries, etc.).

Several embodiments and applications herein are directed to systems, apparatuses, devices, etc. (e.g., leaflet repair systems, actuator systems, prolapse repair systems, flail repair systems, repair systems, etc.) directed toward arresting or otherwise addressing valve leaflet problems (e.g., flail, prolapse, stiffness, etc.). In some applications, a system, apparatus, device, etc. herein can be positioned on the inflow side of a valve so that it can apply contact pressure or support to an area of flail, prolapse, stiffness, etc. The contact pressure or support provided by various implementations can help flatten and/or reshape the flail, prolapse, stiffness, and/or anomaly, which helps extend the coaptation edge of a leaflet posteriorly toward the coaptation region when in a closed position. Normal coaptation resulting in a fully occluded valve prevents valvular insufficiency. In some applications, the systems, apparatus, devices, etc. are configured to support, restrain, and/or depress a leaflet to prevent the leaflet from flailing or flipping toward the inflow side of the valve. Similarly, in some applications, the systems, apparatus, devices, etc. are configured to support, restrain, and/or depress a leaflet to prevent the leaflet from prolapse or bulging toward the inflow side of the valve.

In some applications, a system, apparatus, device, etc. herein (e.g., a leaflet repair system, an actuator system, a prolapse repair system, a flail repair system, a repair system, etc.) includes (but is not limited to) a surface that is intended to directly contact a surface of a leaflet experiencing a leaflet problem (e.g., flail, prolapse, stiffness, etc.). Typically, the inflow surface of a leaflet is the surface experiencing flail, prolapse, stiffness, and/or a problem. In some applications, the contact surface of the device conforms to the contour of the inflow surface of a leaflet, which can be a hyperbolic paraboloid. In some applications, the contact surface of the system/device provides contact pressure above a leaflet that flail, prolapse, stiffness, and/or anomalous. In some applications, the contact surface has a width and a length such that it covers the area of the leaflet experiencing flail, prolapse, stiffness, and/or abnormality. In some applications, the length of the system/device extends into the coaptation region of the leaflet. In some applications, the coaptation portion of the system/device helps promote coaptation of the leaflets when closed.

In some applications, the systems, apparatuses, devices, etc. herein include an anchor to stabilize the system/device at the implant site. In some applications, a system/device includes a portion connected to the anchor. In some applications, the anchor connection point (e.g., an anchor receiver) is adjacent to or contacts the valve annulus or a ventricular or atrial wall. In some applications, an anchor connection point includes a hinge that is capable of adjusting the contact surface of the system/device relative to the plane of the anchor point. In some applications, a swing hinge is used. In some applications, a hinge is made of a soft, compliant material (e.g., cloth or mesh) such that the plane of the system/device contact surface is adjustable relative to the anchor point. In some applications, a support is incorporated at the anchor point such that the plane of the contact surface is adjustable relative to the anchor point. In some applications, a sliding mechanism is 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 connection point or anchor receiver is configured as an interface. The interface can be connected to a conduit or shaft for delivering and positioning the system/device.

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

In some applications, a screw anchor is housed within a tubular compartment that is connected to or anchors a portion of the device. In some applications, the tubular compartment contains one, two, or more screw or screw-type anchor sections within it to anchor the device. In some applications, the screw or screw-type anchor sections are pushed through the tubular compartment to tighten or rotate into the tissue at the anchoring site. In some applications, the helical or spiral anchor portion(s) are compressible (e.g., like a spring) within the tubular compartment, allowing the tubular compartment to maintain a low profile; when the helical or spiral anchor portion(s) are tightened or rotated into the tissue at the anchoring site, the helical or spiral anchor portion(s) are decompressed. In some applications having a single helical or spiral anchor portion within the housing, the helical or spiral anchor portion(s) are coiled within themselves to maintain a very low profile. In some applications having two or more helical or spiral anchor portions within the housing, the helical or spiral anchor portion(s) are stacked one upon another in series. In some applications having two or more helical or spiral-type anchor portions within the housing, one helical or spiral-type anchor portion is radially positioned within another helical or spiral-type anchor portion such that there is at least one inner helical or inner spiral-type anchor portion and at least one outer helical or outer spiral-type anchor portion. In some applications having two or more helical or spiral-type anchor portions within the housing, the helical or spiral-type anchor portion(s) are configured to engage the tissue at the anchoring location at two angles that are oblique to each other.

In some applications, an anchor is positioned adjacent to or in contact with the ventricular or atrial wall on the opposite side of the wall from the anchor connection point (e.g., within the adjacent vascular system). In some applications, a connector is used to connect the anchor, the connector passing across the ventricular or atrial wall. Any suitable connector may be used, such as, for example, a screw, rivet, suture, clip, wire, pin, or shaft. In some applications, a connector wire is used so that the wire tension between the device and the anchor is taut.

In some applications, an anchor is positioned within the vasculature on opposite sides of a chamber wall (i.e., ventricle or atrium). For example, various implant or device embodiments herein are configured to alleviate mitral valve leaflet problems (such as flail, prolapse, and/or stiffness) and are therefore positioned within the left atrium. In these various embodiments, a device can be connected to an anchor positioned within the coronary sinus using a connector that passes across the atrial wall. Any suitable anchor can be used. In some applications, an anchor is a wire stent or wireform capable of expanding within the vasculature. In some applications, an anchor is a pin (e.g., an R-pin, etc.) or wire fastener that secures a device to the ventricular or atrial wall via a connector. In some applications, a pin or wire fastener is applied to opposite sides of a ventricular or atrial wall, with the connector extending across the wall. In some applications, a pin fastener is applied within the vascular system on opposite sides of a ventricular or atrial wall. In some applications, a wire fastener is capable of pinching a connecting wire to hold it in place and generate tension between the wire fastener anchor and the device.

In some applications, a system and/or device is anchored using a T-anchor that fits within and affixes to a cleft (e.g., a cleft or commissure) within the heart valve. In some applications, a T-anchor has two arms (i.e., the horizontal portion of the T) and a connecting portion (i.e., the vertical portion of the T). In some applications, the connecting portion is connected to a device to hold the device in a deployed position. In some applications, the two arms are capable of contracting and expanding; in a contracted state, the two arms are parallel (or nearly parallel) to the connecting portion, and in an expanded state, the two arms are orthogonal (or nearly orthogonal) to the connecting portion. In some applications, when the anchor is deployed, the two arms in a collapsed state enter the cleft and expand within the cleft within the heart valve and beneath the leaflets, thereby anchoring it within the cleft.

In some applications, a system, implant, and/or device herein is otherwise directly anchored or secured to a leaflet experiencing a problem (e.g., flail, prolapse, stiffness, and/or other problems). In some applications, an anchor is a pin fastener (e.g., R-pin, R-key, etc.) or wire fastener that secures a device to the leaflet via a connector. In some applications, a pin or wire fastener is applied to the outflow side of a leaflet (e.g., the ventricular side of a leaflet of an atrioventricular valve), and the connector passes across 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 to anchor the system/device to the leaflet edge by pinching or compressing the device edge and the leaflet edge together.

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

In some applications, a system and/or device herein (e.g., a leaflet repair system/device, an actuator system/device, a prolapse repair system/device, a flail repair system/device, a repair system/device, etc.) includes a wire forming frame and/or a wire forming element (e.g., an element including a wire forming frame). Any suitable material for forming a wire rod may be used, including but not limited to: nickel-titanium alloy, cobalt-chromium (CoCr), stainless steel, titanium, polyglycolic acid (PGA), polylactic acid (PLA), polydextrose-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 their derivatives. In some applications, a wire forming element or wire forming frame is collapsible, which is useful for fitting into a catheter in a more compact or collapsed configuration for less invasive catheter delivery methods. In some applications, nickel-titanium alloys are used for their self-expanding properties, which may be useful for implanting the device in less invasive catheter delivery methods.

Wireformed elements or wireformed frames of various shapes can be used in a variety of different implementations and applications. In some applications, a wireformed frame/element is formed with the wireformed portion to provide contact pressure or support to a leaflet problem (e.g., flail, prolapse, and/or stiffness of a leaflet). In some applications, a wireformed frame/element has a length and width to surround a flail or prolapse area and utilizes a sheet extending across the area to provide contact pressure to the flail, prolapse, stiffness, etc. In some applications, a wire forming frame or wire forming element has a length and width to surround a flail or prolapse area and apply a wire that undulates or crosses across the area to provide contact pressure over the flail, prolapse, stiffness, etc. In some applications, a wire forming frame or wire frame element is wire-free at an interior portion of one of the coaptation areas where wire is absent, so that any future procedure that may be required at some subsequent time can still be performed over the native leaflet coaptation area (e.g., edge-to-edge repair, such as suturing or clamping leaflet edges together). In some applications, a wire-forming frame or wire-forming element includes a support or counterforce support extending from a portion of the wire-forming element opposite the commissure region, which can help the wire-forming element provide contact pressure over the flail, prolapse, stiffness, etc. In some applications, the support or counterforce support is configured to contact a heart chamber wall (e.g., an atrial or ventricular wall). In some applications, a wire-forming element includes an indentation or hook formed through the wire, which can help anchor the device in the implantation site by fitting into or hooking onto the commissures, clefts, or other similar valve regions.

In some applications, a system and/or device herein (e.g., a leaflet repair system/device, an actuator system/device, a prolapse repair system/device, a flail repair system/device, a repair system/device, etc.) incorporates a sheet attached to a wire form capable of forming a contact surface. In some applications, a sheet provides a surface capable of providing contact pressure or support on a leaflet experiencing a problem such as flail, prolapse, and/or stiffness. A sheet can be impermeable, semipermeable, or permeable to fluids (e.g., blood or plasma). In some applications, the sheet is a mesh. In some applications, a mesh is formed using overlapping and intersecting interlaced threads. A mesh or permeable sheet can advantageously provide contact pressure/support without restricting blood or plasma flow, which can be important in various applications. For example, an impermeable sheet can trap blood or plasma between the device and the valve leaflets, which can in turn create undesirable pressure on the valve and/or create pressure that can displace or alter the position of the device. In some applications, the sheet is partially an impermeable material and partially a permeable mesh. For example, in some applications, an articulating portion of a system/device herein utilizes an impermeable material, while a non-articulating portion of the device utilizes a permeable mesh. In some applications, when articulated, the impermeable articulating portion helps promote normal closure of a native valve. In some applications, a mesh is formed using a mesh sheet. Any suitable material may be used for the sheet and/or mesh, including, but not limited to, poly(lactic-co-glycolic acid) (PLGA), polyvinyl chloride (PVC), polyethylene (PE), polypropylene (PP), polytetrafluoroethylene (PTFE), polyurethane (PU), polyethylene terephthalate (PET), polyether sulfone (PES), polyglycolic acid (PGA), polylactic acid (PLA), poly(dextrose-lactic acid) (PDLA), poly-4-hydroxybutyrate (P4HB), or polycaprolactone (PCL). Any suitable means for attaching the sheet and/or mesh to a wire form may be used, including, but not limited to, suturing, staples, and adhesive. Optionally, in some applications, the sheet is a form-fitting cover that extends across the wire form or wire form frame.

In some applications, a wireformed element or a system/device having a wireformed frame has a static portion and a dynamic portion. In some applications, the static portion is capable of seating within the valve and may include indents and/or hooks to anchor the device within the implant site by fitting within or hooking onto the commissures or other similar leaflet regions. In some applications, the dynamic portion includes a sheet to help provide contact pressure and/or support on a leaflet, for example, to address flail, prolapse, stiffness, etc. In some applications, the dynamic portion is capable of being repositioned or resized during the implantation procedure so that it can properly cover the area of the valve leaflet experiencing the flail, prolapse, stiffness, and/or other problems.

In some applications, the system/device is configured to help promote coaptation of the leaflets when closed. In some applications, a spacer, coaptation element, or spacer is incorporated into the system/device. In some applications, the spacer, coaptation element, or spacer extends from or within the coaptation portion to help fill the space within the valve orifice. In some applications, the system/device includes an extension portion with an impermeable sheet extending from the leaflet lip into the orifice to help form coaptation with the other leaflets. In some applications, the system/device includes a thickened extension portion that acts as a spacer or spacer to help fill the space within the valve orifice. Having a space filler, coaptation element, or spacer is expected to beneficially assist the system/device in better managing functional mitral regurgitation by filling a space within the valve.

In some applications, the system/device herein includes an expandable gap filler, expandable joint element, or expandable spacer. The gap filler/joint element/spacer can be expandable in various ways, such as by inflation, injection, filling, balloon dilation, self-expansion (e.g., using a shape-memory material), mechanical expansion, and the like. The mechanism for expanding the expandable gap filler/joining element/spacer herein may include any of the expansion mechanisms described herein, including but not limited to: filling with a material (e.g., foam, hydrogel, or silicone), inflation, self-expansion, balloon dilation, mechanical expansion, expansion via a stent (e.g., self-expanding, balloon, mechanical), expansion via a scissor mechanism or scissor-like mechanism (e.g., using hinged joints), expansion via twisting a coil, and/or any combination thereof.

In some applications, the systems/devices herein include a spacer that is filled or fillable with a material at the implant site, either at the time the device is implanted or in a subsequent procedure (e.g., immediately thereafter or after a certain period of time, such as days, weeks, or months). Thus, in these applications, a material is delivered to the device at the implant site via a catheter, and the device is then filled, injected, inflated, etc. with the material, thereby increasing the size of the spacer/joint element/spacer in vivo. Various materials can be used, such as, for example, a foam, hydrogel, or silicone. In some applications, a system/device with a spacer/joint/spacer includes a stent that encases the spacer portion of the device. A stent can then be expanded at the implant site; it can be self-expanding (e.g., nickel-titanium alloy), mechanically expanded, or expanded via a balloon. The system/device may have a guide or guidewire to help advance the catheter to the correct location over the spacer/joint/spacer for injection of the material into the spacer/joint/spacer.

In certain applications, a system/device with a spacer, joint, or spacer is expanded at the implant site using mechanical expansion. For example, an expansion mechanism configured as a scissors or scissor-like mechanism (or a mechanism with pivoting struts) within the spacer/joint/spacer portion can be used to cause the mechanical expansion, which can be accomplished at the time the device is implanted or in a subsequent procedure. Thus, in these applications, the scissors or scissor-like mechanism (or a mechanism with pivoting struts) can be expanded hydraulically, pneumatically, mechanically, or magnetically, thereby increasing the size of the spacer/joint/spacer. 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 externally to the body to expand the expansion mechanism. In some applications, a series of struts can be connected at a joint and articulated or moved from a radially expanded configuration to a radially compressed configuration by articulating or moving the various struts at the joint (e.g., in a scissor-like motion).

In some applications, systems/devices with gap fillers/joints/spacers are mechanically expanded at the implant site using a coil located within the gap filler/joint/spacer portion, either at the time of device implantation or during a subsequent procedure. Thus, in some applications, the circumference of the coil can be increased by twisting the coil, thereby increasing the size of the gap filler/joint/spacer. Various means can be used to relieve tension when the coil is twisted, such as, for example, having the coil contain a plurality of slits or furrows located within the coil's interior portion.

In some applications, the systems/devices herein incorporate or include an impermeable coaptation portion and a permeable and/or open non-coaptation portion. In some applications, the impermeable coaptation portion extends into the coaptation region of the leaflets. In some applications, the impermeable coaptation portion is elongated to reach the outflow side of one or both of the opposing leaflets to facilitate coaptation of the leaflets. In some applications, the impermeable coaptation portion contains or can be injected with a filler material that thickens the coaptation portion, which can help fill gaps within the valve orifice. In some applications, the impermeable coaptation portion is expanded at the site of implantation. The mechanism for expanding the impermeable joint portion may include any of the expansion mechanisms described herein, including but not limited to: filling with a material (e.g., foam, hydrogel, or silicone), inflation, self-expansion, balloon dilation, mechanical expansion, expansion via a stent (e.g., self-expanding, balloon, mechanical), expansion via a scissor mechanism or scissor-like mechanism (e.g., using hinged joints), expansion via twisting a coil, and/or any combination thereof.

Various implementations and applications of the devices herein are intended to be used on any valve leaflet that is subject to flail or prolapse. Thus, in some applications, a device can be applied to a leaflet of a mitral valve, a tricuspid valve, an aortic valve, and/or a pulmonary valve. Similarly, various implementations and applications of the devices can be applied to any area of the leaflet that is subject to flail or prolapse. In some applications, a device can be applied to or adjacent to a leaflet commissure and/or any area between commissures of a leaflet.

To reach the implantation site, any appropriate surgical, minimally invasive, or percutaneous technique may be used, including, but not limited to, a transcatheter delivery system that may employ a transfemoral, subclavian, transapical, transseptal, or transaortic approach. In some applications, a delivery catheter is used to incorporate a device, which is then delivered to the deployment site over a guidewire and used to anchor the device at the implantation site.

Certain applications are directed to methods for delivering a device to a deployed location. The various techniques, methods, procedures, steps, and the like described or suggested herein (including in documents incorporated herein by reference) can be performed on a living animal (e.g., a human, a mammal, other animals, etc.) or on an inanimate simulation, such as a cadaver, a cadaver heart, a simulator (e.g., with simulated body parts, tissues, etc.), and the like. Thus, methods of delivery include methods of treatment (e.g., treatment of a human subject) and methods of training and/or practice (e.g., performing methods using an anthropomorphic prosthesis that mimics the human vascular system).

Figures 5 and 6 provide an example depiction of an implant or device 501 with a stent anchor 503 at an implantation 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 positioned on the inflow surface 515 (or atrial side) of the posterior leaflet 511 within the left atrium 517 at the site of a leaflet problem (e.g., flail, prolapse, and/or stiffness). The contact surface 513 can provide contact pressure on the leaflet (e.g., a portion of the leaflet that has a flail, prolapse, and/or stiffness) to help flatten the leaflet (e.g., its protrusion, bulge, etc.) and reduce regurgitant blood flow.

In some applications, the device 501 includes a coaptation portion 519 that extends beyond the edge of the posterior leaflet 511 into the left ventricle 521. The coaptation portion 519 can coapt with the anterior leaflet to help promote coaptation when the valve is closed. The device 501 has a cover or sheet 523 that can help provide contact pressure on the leaflets to address a problem (e.g., flail, prolapse, and/or stiffness) and assist in coaptation of the leaflets. The coaptation portion can be configured as a wing, a wing portion, or a portion of a wing or a wing portion.

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

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

Figures 7, 8, and 9 illustrate examples of implants or devices (e.g., repair devices, leaflet repair devices, prolapse/flail repair devices, contact pressure devices, support devices, etc.) that include a tether to further stabilize the device at an implant site. As shown here, the device is implantable at a native valve. The implant/devices can be anchored in the coronary sinus, at the annulus, above the leaflet, and/or any other passageway described herein. The implant/devices can be configured to apply a contact pressure or increased support to the leaflet (e.g., a portion of the leaflet, etc.).

In FIG7 , an implant/device 701 is shown positioned and implanted upon a native valve 703, depicted as a mitral valve for illustration. Extending from the coaptation portion 705 of the device 701 is a tether 707 that extends to and connects (e.g., anchors, clamps, attaches, affixes, links, etc.) to a region of the ventricular wall 709.

In FIG8 , an implant/device 801 is positioned 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 (e.g., anchors, clamps, attaches, affixes, links, etc.) to a mastoid muscle 809.

In FIG9 , an implant/device 901 is positioned and implanted over the native valve 903. Extending from the joint portion 905 of the device 901 is a tether 907 that extends to and connects (e.g., anchors, clamps, attaches, affixes, links, etc.) to the apex 909 of the ventricle.

Figures 10A, 10B, and 10C illustrate examples of implants or devices (e.g., repair devices, leaflet repair devices, prolapse/flail repair devices, contact pressure devices, support devices, etc.) positioned at various implantation sites along the posterior leaflet of the mitral valve. The implants/devices can be configured to apply contact pressure or increased support to the leaflet (e.g., a portion of the leaflet, etc.).

In Figure 10A, an implant/device 1001 is positioned and implanted at the apex of the cleft between P2 1003 and P3 1005 of the posterior leaflet. The device can be anchored in a variety of ways. In some applications, the device 1001 is anchored within the coronary sinus. In some applications, the device 1001 is anchored to the annulus.

In FIG10B , an implant/device 1011 is positioned and implanted at the apex of the commissure between the posterior leaflet 1013 and the anterior leaflet (not shown). The device can be anchored in a variety of ways. In some applications, the device 1011 is anchored within the coronary sinus. In some applications, the device 1011 is anchored to the annulus.

In FIG10C , an implant/device 1021 is configured to span most of the posterior leaflet 1023, including the overlying portion P1, all of P2, and a portion of P3. The device can be anchored in a variety of ways. In some applications, the device 1021 is anchored within the coronary sinus. In some applications, the device 1021 is anchored to the annulus.

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

Figures 11 and 12 show an example implant or device 1101 (e.g., a repair device, a leaflet repair device, a prolapse/flail repair device, a contact pressure device, a support device, etc.) with an anchor. The implant/device can be anchored in a variety of ways. In some applications, the implant/device 1101 is anchored within the coronary sinus. In some applications, the implant/device is anchored to a valve annulus at an implantation site, for example, as shown in Figure 12. The implant/device can be configured to apply contact pressure or increased support to the leaflet (e.g., a portion of the leaflet, etc.).

As shown in Figures 11 and 12, the device is implantable at a native valve 1103 (e.g., a mitral valve, tricuspid valve, etc.). The contact surface of the device 1101 is positioned on the inflow surface 1105 (or atrial side) of a native leaflet 1107 (shown as a posterior leaflet) at the site of a flail, prolapse, ankylosing, and/or other leaflet abnormality within the atrium 1109. The contact surface can provide contact pressure and/or support on the flail, prolapse, ankylosing, etc. to help flatten and/or reshape the bulge, protrusion, flail, etc. and reduce backflow of blood. The device 1101 includes a coaptation portion 1111. The coaptation portion 1111 can be configured to cover some or all of the native leaflet. In some applications, the coaptation portion 1111 is configured to extend beyond a lower edge of the native leaflet 1107. The coaptation portion can be configured as a wing, a wing portion, or a portion of a wing or a wing portion.

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

In some applications, the device 1101 includes an optional support 1113 (e.g., a counterforce support, atrial support, etc.). The support 1113 can be configured to press against or abut a wall of the heart (e.g., the wall of the atrium 1109) to help orient and/or maintain the position of the device, which can help the device provide contact pressure and/or support on a native valve leaflet (e.g., to reduce or eliminate flail, prolapse, stiffness, and/or leaflet abnormalities). The support 1113 can also be configured to help prevent the contact surface and/or a covering thereon from flailing or otherwise moving back toward or toward the atrium in an undesirable manner. For some applications, and as shown, support 1113 includes (e.g., is comprised of): a wire loop.

In some applications, the device 1101 further includes an anchor 1115 that anchors the device 1101 to the valve annulus 1117. The anchor can 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 tightened or rotated into tissue (e.g., as shown in FIG. 12 ). A helical anchor that is rotated into annular tissue can be particularly good at anchoring and retaining the device to the native valve because the annular tissue is strong, and the helical design allows for a large amount of contact surface and articulation with the tissue.

FIG13 shows an exemplary implant or device 1301 (e.g., a repair device, leaflet repair device, prosthetic device, contact pressure device, support device, etc.) comprising a stent anchor (not shown) at an implantation site further clamped onto a native leaflet 1303 of a native valve. In some applications, as shown here, the device is implantable at the mitral valve. The contact surface of the device 1301 is positioned on the inflow surface 1305 (or atrial side) of the native leaflet 1307 (e.g., a posterior leaflet, etc.) at the site of flail, prolapse, stiffness problem, and/or other leaflet abnormality within the atrium 1309. The contact surface can provide contact pressure and/or support on the flail, prolapse, etc. to help flatten and/or reshape the leaflet (e.g., a protruding structure, bulge, etc.) and reduce or eliminate backflow. The device 1301 includes a coaptation portion 1311. The coaptation portion can be configured to extend to the edge of the leaflet 1307. A clip 1313 can be attached to the edge of the leaflet to help anchor the coaptation portion 1311 and/or the contact surface to the edge of the leaflet 1307. The clip 1313 anchors the device 1301 to the posterior leaflet 1307, allowing 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 can be the same as or similar to other covers described herein. In some applications, the cover layer spans the contact surface and can help provide contact pressure on the flail, prolapse, stiffness, etc. and can assist in bonding.

Figures 14 and 15 show an exemplary system or implant/device with a spacer/joint/spacer 1401 and an anchor. The anchor can be the same as or similar to other anchors described herein. In some applications, the system/device includes a stent anchor 1403 positioned at an implantation site and/or within a vessel of the heart (e.g., the coronary sinus, etc.). As shown here, the spacer/joint/spacer is implantable at a native valve (e.g., a mitral valve, a tricuspid valve, etc.) 1405. In some applications, the spacer/coaptation element/spacer 1401 is a loose material capable of filling the space 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 to the left atrium. In some applications, the anchor 1403 is connected to the connection point 1413 of the spacer/coaptation element/spacer 1401 via a connector 1415 that passes through the atrial wall 1417. The anchor 1403 thus stabilizes the spacer/coaptation element/spacer 1401 at the native valve 1405.

Figures 16A and 16B show an example of an expandable stent anchor 1601 with a connector 1603. The anchor 1601 can be expanded within a vascular system (e.g., the coronary sinus, circumflex artery, etc.) to a wall 1605 of the vascular system. The connector 1603 (e.g., a tether, suture, string, wire, etc.) can extend from the anchor 1601 and pass across the vascular system wall 1605 to connect or couple an implanted device to the anchor, thereby anchoring the implanted device, for example, by tension.

Figures 16C and 16D show an example anchor 1611 with a connector 1613 (e.g., a tether, suture, string, wire, etc.). The anchor 1611 can be positioned proximate to a wall 1615 of the vascular system. The connector 1613 can extend from the anchor 1611 and traverse through the vascular system wall 1615 to connect or couple the anchor to the implanted device to anchor the implanted device, for example, by generating a tension between the anchor 1611 and the implanted device that anchors the anchor 1611 to the device in place.

Figures 17A, 17B, and 17C each illustrate an example of an anchor that can be anchored (e.g., embedded, snapped, tightened, etc.) into natural tissue. Figure 17A illustrates an example of a curved or ring-shaped anchor 1701 having an upper portion 1703, a lower portion 1705, and a central ring 1707. The upper portion 1703 and lower portion 1705 can be embedded into the tissue, while the central ring 1707 can be interconnected with a device to anchor it to the tissue at the implantation site.

FIG17B illustrates an example of an anchor 1711 having two distal ends 1713 and 1715 and an internal ridge 1717. The distal ends 1713 and 1715 can be embedded in the tissue, while the internal ridge 1717 can interconnect with a device to anchor it to the tissue at the implantation site.

FIG17C illustrates an example of a screw-type anchor 1721 that can be tightened or rotated into tissue at its lower end 1723 and attached to a device at its upper end 1725 to anchor the device to the tissue at the implantation site.

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

Figures 18A and 18B illustrate cross-sectional views of an exemplary double helix anchor within its housing. In some applications, the housing is the anchor head. The anchor 1801 includes two helical or spiral anchor portions 1803 and 1805 that 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 extend from the housing 1807 skewed or at different angles to each other (see Figure 18B). The two spiral/anchor portions 1803 and 1805 can be configured to extend out of the housing 1807 in different directions or at different angles when the spiral/anchor portions are pushed or rotated 1809 out of the tubular compartment/housing 1807. Depending on the patient's anatomy and/or other factors, the spiral or helical anchor portions 1803 and 1805 may be advantageously extended from the housing by different amounts or lengths. For example, in some cases, the user may want to extend the spiral/anchor portions further (or a longer length from the housing) to increase penetration depth and retention strength, while in other cases, the user may want to extend the spiral anchor portions less (or a shorter length from the housing) to avoid damaging a blood vessel of the heart, etc.

18C and 18D illustrate cross-sectional views of an exemplary low-profile double helix anchor that is compressed or compressible within its housing. The anchor 1811 includes two spring-loaded, compressible helical or spiral 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 (e.g., axially compressed to a smaller height) within the tubular compartment/housing 1817. The screw/anchor portions 1813 and 1815 are configured to decompress or extend axially when they are extended or pushed or rotated out of the compartment/housing. The two screw/anchor portions 1813 and 1815 can be configured to transform into a second configuration in which the screw/anchor portions extend from the housing 1817 skewed or at different angles from each other (see FIG. 18D ). The two screw/anchor portions 1813 and 1815 can be configured to extend out of the housing 1817 in different directions or at different angles when the screw/anchor portions are pushed or rotated out of the tubular compartment/housing 1817. 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, for example, as discussed above with respect to anchor 1801.

Figures 18E and 18F provide cross-sectional views of an exemplary low-profile double helix anchor that is compressed or compressible within its housing. The anchor 1821 includes an inner spring-loaded, compressible helical or spiral anchor portion 1823 and an outer spring-loaded, compressible helical or spiral anchor portion 1825, which, in a first configuration, are stacked, nested, or otherwise arranged within a tubular compartment or housing 1827, with the inner helix/anchor portion 1823 radially positioned within the outer helix/anchor portion 1825 (e.g., the inner helix/anchor portion 1823 may have a smaller diameter than the outer helix/anchor portion 1825). In the first configuration, the inner and outer spiral/anchor portions 1823 and 1825 are compressed (e.g., axially compressed to a smaller height) within the tubular compartment/housing 1827. The spiral/anchor portions 1823 and 1825 are configured to decompress or extend axially when they extend or are pushed or rotated out of the compartment/housing. The inner and outer spiral/anchor portions 1823 and 1825 can be configured to transition to a second configuration in which the spiral/anchor portions extend from the housing 1827 skewed or at different angles from each other (see FIG. 18F ). The inner and outer screw/anchor portions 1823 and 1825 can be configured to extend out of the housing 1827 in different directions or at different angles when the screw/anchor portions are pushed or rotated out of the tubular compartment/housing 1827. Depending on the patient's anatomy and/or other factors, the anchors or anchor portions 1823 and 1825 may be beneficially extended from the housing by different amounts or lengths, for example, as discussed above with respect to anchors 1801 and 1811.

Figures 18G and 18H provide cross-sectional views of an example of a low-profile single helical anchor compressed and wound within its housing. The anchor 1831 includes a single, spring-loaded, compressible helical anchor or anchor portion 1833 wound 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 when it is extended or pushed or rotated out of the compartment/housing. The anchor/anchor portion 1833 can thereby be transformed into 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 so that each turn or loop of the coil has the same or a similar diameter, so that each turn/loop of the coil is stacked on top of an adjacent turn/loop of the coil until the end, for example, in the form of a spiral. In some applications, and as shown, the anchor/anchor portion 1833 is arranged or configured so that within the housing, the helical anchor/anchor portion lies in a single plane (e.g., with one larger outer turn/loop and each subsequent turn/loop of the coil having a slightly smaller diameter lying radially inward of an adjacent larger turn/loop), for example, in the form of a planar helix.

FIG19A illustrates a cross-sectional view of an example of a system having an anchor 1901 and an implant/device 1903 with an adjustable contact angle. There are multiple potential mechanisms that can be used to adjust the contact angle of the implant/device while the implant/device is being anchored into tissue. In some applications, the implant/device 1903 incorporates a support 1905 that is connected to an anchor housing 1907. A deployment tool 1909 is used to anchor the anchor into tissue. In some applications, the deployment tool 1909 includes a cable 1911 extending to the front of the device 1903. The cable 1911, along with the support shaft 1905, allows the angle of the contact surface of the implant/device 1903 to match the angle of the native tissue. Once aligned, the deployment tool 1909 can anchor the anchor 1901 into the native tissue. The anchor 1901 is shown as a screw-type anchor, but other anchor configurations are possible.

Figures 19B and 19C illustrate a cross-sectional view of an example of an anchor 1921 and an implant/device 1923 with an adjustable contact angle. This example depicts a mechanism for adjusting the contact angle of the device while it is being anchored into tissue. The implant/device 1923 incorporates two sliding mechanisms 1925 and 1927 located on respective sides (e.g., opposing sides) of an anchor housing 1929. A deployment tool 1931 is applied to anchor the spiral anchor into tissue. The sliding mechanisms 1925 and 1927 can adjust the angle of the contact surface of the implant/device 1923 to match the angle of the native tissue. Once aligned, 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.

FIG20A illustrates an exemplary implant/device 2001 (e.g., a prosthetic device, leaflet repair device, prosthetic device, contact pressure device, support device, etc.) comprising a wireform for providing contact pressure and/or support to a leaflet. The implant/device 2001 includes a contact surface formed by a corrugated wire 2003 capable of providing contact pressure and/or support to a leaflet (e.g., to address flail, prolapse, stiffness, and/or leaflet abnormality). 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 that can be connected to an anchor. In some applications, the implant/device 2001 can optionally include a permeable, semipermeable, or impermeable covering or sheet (not shown) that can provide contact pressure and/or support over a valve leaflet that flailes, prolapses, stiffness, and/or abnormalities. Optionally, the covering or sheet can be a mesh sheet or mesh covering (not shown).

FIG20B illustrates an exemplary implant or device 2011 (e.g., a repair device, leaflet repair device, prosthetic device, contact pressure device, support device, etc.) comprising a wireform for providing contact pressure and/or support to a valve leaflet. The implant/device 2011 comprises a contact surface formed from three cross-sectional wireforms 2013, 2015, and 2017 that intersect or overlap and are capable of providing contact pressure and/or support to a valve leaflet that flailes, prolapses, stiffens, and/or is abnormal. The three cross-sectional wire forms 2013, 2015, and 2017 can expand or contract laterally 2019 (e.g., fan outward to various degrees) to accommodate the characteristics of the native leaflet flail, prolapse, stiffness, and/or leaflet abnormalities. 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 connection point 2023 that can be connected to an anchor. In some applications, the implant/device 2101 may optionally include a permeable, semipermeable, or impermeable covering or sheet (not shown) that provides contact pressure and/or support over a valve leaflet that flailes, prolapses, stiffness, and/or abnormalities. Optionally, the covering or sheet may be a mesh sheet or covering (not shown). The connector or connection point may include an anchor receiver and/or an interface.

Figures 21A and 21B illustrate an exemplary implant or device 2101 (e.g., a prosthetic device, leaflet repair device, prosthetic device, contact pressure device, support device, etc.) comprising a wireform for providing contact pressure and/or support to a valve leaflet. The implant/device 2101 includes a contact surface 2103 capable of providing contact pressure and/or support to a leaflet that flailes, prolapses, stiffness, and/or is abnormal. The implant/device 2101 includes a coaptation portion 2105 that extends into the coaptation region of a leaflet and helps promote coaptation between the leaflets. The device 2101 includes an anchor point 2107 that can be connected to an anchor. The anchor point can include an anchor receiver. In some applications, the anchor point or anchor receiver includes or is configured as an interface. The interface can be connected to a catheter or shaft used to deliver and position the system/device and can be the same as or similar to other interfaces described herein. The portion extending below the anchor point can be considered a wing or wing portion that includes the contact surface 2103 and the engagement portion 2105. The implant or device 2101 can be configured to be anchored in any of the manners described herein to any of the locations described herein, for example, to the annulus within a coronary vessel, etc.

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

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

In some applications, the device 2001 (e.g., the wing portion of the device) includes a permeable non-coaptation portion 2111 that can be made of mesh or otherwise include openings to provide contact pressure upon a leaflet that flailes, prolapses, stiffness, and/or abnormalities, and an impermeable coaptation portion 2113 that can help promote coaptation. It is noted that various examples can include an elongated impermeable coaptation portion 2113 that can reach the outflow side (or ventricular side) of one or both opposing native leaflets to assist in valve closure. In various examples, the impermeable coaptation portion 2113 is thickened so that it can fill a gap within the valve orifice, for example, acting as a spacer/coaptation element/spacer. In some applications, the junction portion 2113 may be filled and/or expanded at the implant site.

In some applications, as shown in FIG21A , the device 2101 (e.g., the wing portion of the device) includes an open or exposed area between the permeable non-joining portion 2111 and the anchoring point 2107. 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 undesirable manner. In some applications, the permeable non-joining portion 2111 can be omitted, leaving the entire area (e.g., the area between the impermeable joining portion 2113 and the anchoring point 2107) open to allow blood to flow therethrough. The frame and joint portion 2113 provide constriction, while the open or exposed area allows blood flow and avoids undue pressure on the device, as well as prevents tissue ingrowth within the exposed area. The frame of the device can be a variety of 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 can include one or more anchor connection points and/or interfaces), such as teardrop, oval, ovoid, triangular, etc. The open or exposed area, permeable non-joint portion 2111 (if included), and impermeable joint portion 2113 can be a variety of sizes and shapes other than those depicted in FIG21A. For example, the device may include an impermeable junction portion 2113 covering between 20% and 80% of the frame, and an open portion comprising between 10% and 80% of the frame and/or optionally a permeable non-junction portion comprising between 10% and 80% of the frame. In some applications, the device 2101 includes an impermeable junction portion 2113 covering between 40% and 70% of the frame and an open/exposed portion comprising between 30% and 60% of the frame. In some applications, the impermeable joint portion 2113 may be omitted, and a permeable portion 2111 (which may be used within the joint area) and an open/exposed portion may be used and may be arranged or designed similarly to the above.

Figures 22A and 22B illustrate an exemplary implant or device 2201 (e.g., a prosthetic device, leaflet repair device, prosthetic device, contact pressure device, support device, etc.) comprising a wireform. The device 2201 includes a contact surface 2203 capable of providing contact pressure and/or support to a leaflet that flailes, prolapses, stiffness, and/or abnormalities. The device 2201 includes a coaptation portion 2205 that extends into the coaptation region of a leaflet and helps promote coaptation between the leaflets. The coaptation portion 2205 can be clamped onto a leaflet edge, allowing the device 2201 to move with the leaflet as it opens and closes. The device 2201 includes an anchor connection point 2207 that can be connected to an anchor (which can include an anchor receiver). In some applications, the device 2201 includes a permeable, semipermeable, or impermeable cover or sheet 2209 to help provide contact pressure and/or support to a valve leaflet that flailes, prolapses, stiffness, and/or abnormalities. Optionally, the cover or sheet can be a mesh sheet or mesh cover (as shown in FIG. 22C ).

FIG23A illustrates an exemplary implant or device 2301 comprising a wireform for providing contact pressure and/or support to a valve leaflet. The device 2301 comprises a contact surface capable of providing contact pressure and/or support over a valve leaflet that flailes, prolapses, stiffness, and/or abnormalities. The device 2301 comprises a coaptation portion 2303 that extends into the coaptation region of a valve leaflet and helps promote coaptation between the leaflets. The coaptation portion 2303 comprises an inner portion 2305 devoid of wireform, enabling a variety of procedures to be performed over the native leaflet coaptation region. The device 2301 includes an anchor connection point 2307 (which may include an anchor receiver) that can be connected to an anchor, such as any of the various anchors described herein. In some applications, the device includes an optional counterforce support 2309 that can be pressed against an atrial wall to help the device provide contact pressure on a valve leaflet that flailes, prolapses, stiffness, and/or abnormalities. In some applications, the device 2301 includes a permeable mesh 2311 that can help provide contact pressure and/or support on a valve leaflet problem (e.g., flail, prolapse, stiffness, etc.). In some applications, the anchor connection point or anchor receiver includes or is configured as an interface. The interface can be connected to a conduit or shaft for delivering and positioning the system/device. The portion extending below the anchor connection point or interface can be considered a wing or wing portion that includes the engaging portion, etc.

Illustrated in FIG23B is an example implant or device 2301 comprising a wireform for providing contact pressure and/or support to a valve leaflet. The example depicted in FIG23B is identical to the example depicted in FIG23A , with an additional anchor receiver at the interface or anchor connection point. This receiver, which can be configured as a housing or tubular compartment 2313, is used to receive a screw-type anchor and/or connect it to the implant/device. For some applications, the anchor receiver, housing, or tubular compartment 2313 is connected to the implant/device 2301 at the interface or anchor connection point 2307. FIG23C is an enlarged cross-sectional view of the housing/tubular compartment 2313 and one of the wire forms intersecting the anchor connection point 2307 therethrough. The anchor connection point wire form 2307 anchors the housing/tubular compartment 2313 to the device 2301 through a guide tube 2315 (e.g., defined by the housing 2313). As shown in FIG23D , the housing/tubular compartment 2313 includes an orifice 2317 through which a screw-type anchor 2319 can pass. The guide tube 2315 and/or wire form 2307 can act as a crossbar across the orifice 2317. The helical anchor 2319 anchors the housing/tubular compartment 2313, and therefore the implant/device 2301, to an anchor portion of the tissue (e.g., the ring) in the deployed position. In some applications, this is achieved by tightening the helical anchor 2319 (i.e., a helical tissue anchoring element of the anchor) around and across a crossbar (e.g., a guide tube 2315, wire forming, and/or another crossbar element defined by the housing 2313) that extends across the aperture 2317 and into the tissue until a head of the anchor abuts the crossbar. The housing/tubular compartment 2313 is depicted as having a circular recess 2321 that precisely engages a tool having a complementary circular protrusion (e.g., a cloaked screwdriver, anchor driver, etc.).

Methods for delivering implant/device 2301 and other implants/devices described herein (e.g., implant/device 2421, etc.) may include: advancing a delivery catheter transvascularly (e.g., via a transfemoral, a subclavian, a transapical, a transseptal, or a transaortic approach) to the native heart valve, advancing the anchor (which may be the same as or similar to any anchor or anchoring feature described herein) from the delivery catheter into tissue of the heart, thereby anchoring the implant/device to the tissue, and releasing the implant/device from the delivery catheter so that the implant/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 accomplished in either order.

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

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

The method can be performed on a living animal or on a simulation, such as a cadaver, a cadaver heart, a simulator (e.g., with simulated body parts, heart, tissue, etc.), etc.

FIG24A illustrates an exemplary implant or device 2401 comprising a wireformed strip with a pivoting hinge to adjust the contact surface angle. The device 2401 comprises a contact surface capable of providing contact pressure and/or support on a valve leaflet, for example, to address leaflet flail, prolapse, stiffness, and/or abnormality. The device 2401 comprises a coaptation portion 2403, a selective counterforce support 2405, and a permeable mesh 2407. The device 2401 further comprises a pivoting hinge 2409 connecting the device 2401 to a W-anchor 2411. The pivoting hinge 2409 adjusts the angle of the W-anchor 2411 relative to the angle of the contact surface of the device 2401 to match the angle of the native tissue. A detailed close-up image of the hinge is provided in Figure 24B.

Figure 24C illustrates an exemplary implant or device 2421 comprising a wireform with a soft, compliant hinge to adjust the contact surface angle. The device 2421 comprises a contact surface capable of providing contact pressure and/or support on a leaflet, for example, to address leaflet flail, prolapse, stiffness, and/or other issues. The device 2421 comprises a joint portion 2423 and a permeable mesh 2425. The device 2421 further comprises an interface or hinge 2427 made of a soft, pliable material (e.g., PTFE) that allows a screw-type anchor to anchor the device 2421 to tissue. Regardless of the angle of deployment of the screw anchor, the flexible hinge 2427 allows the contact surface of the device 2421 to be angled to match the angle of the native tissue. A detailed close-up image of the hinge is provided in FIG24D . The portion extending below the interface or hinge can be considered a wing or wing portion.

Figures 25 and 26 illustrate an exemplary implant or device 2501 comprising a wireform with a spacer, coaptation element, or spacer 2503. Figure 26 is a cross-sectional view of the device 2501 provided in Figure 25. The device 2501 comprises a sheet 2505 surrounding the wireform 2507 and a coaptation element, spacer, or filler 2503. The device also comprises a contact surface 2503 that is capable of providing contact pressure and/or support to a leaflet, for example, to address leaflet flail, prolapse, stiffness, and/or other issues. The device 2501 comprises a coaptation portion 2509 that extends into the coaptation region of a leaflet and helps promote coaptation between the leaflets. The gap filler/coupling 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 regurgitation. The device 2501 includes an anchor connection point 2511 that can be connected to an anchor via a connector or an anchor receiver. A permeable, semipermeable, impermeable or mesh sheet can be used. The coaptation element or spacer 2503 can include a material (e.g., a shape memory material, a foam, etc.) or a mechanism to expand the device, for example, via balloon inflation, self-expansion, mechanical expansion, etc. For example, the joining element or spacer 2503 may comprise a foam, a hydrogel, or a silicone material. Optionally, the joining element or spacer 2503 may comprise a scissor mechanism or an expandable coil. Furthermore, the device may comprise an expandable bracket within or on the sheet 2505. The anchor connection may comprise an interface that may be the same as or similar to the other interfaces described herein.

FIG27 illustrates an exemplary implant or device 2701 comprising a wireformed hook 2703 with small anchors configured to hook into a cleft (e.g., a cleft or commissure) within a valve. The device 2701 includes a sheet 2705 extending between the hooks 2703, which is capable of applying contact pressure to a valve leaflet that flailed, prolapsed, stiffened, and/or abnormal. The sheet can be permeable, semipermeable, impermeable, or a mesh. The device 2701 includes an anchor connector 2707 capable of connecting to an additional anchor, but optionally employs an anchor connection point as described with respect to FIG20 . The anchor connector or anchor connection point may include an interface that may be the same as or similar to other interfaces described herein.

FIG28 illustrates an exemplary implant or device 2801 comprising a wireform having depressions 2803 capable of anchoring into a cleft (e.g., a cleft or commissure) within a valve. The device 2801 comprises a sheet 2805 extending between the depressions 2803 that is capable of applying contact pressure to a valve leaflet that flailes, prolapses, stiffness, and/or abnormalities. The sheet can be permeable, semipermeable, impermeable, or a mesh. The device 2801 has an anchor connector 2807 capable of connecting to an anchor, but optionally employs an anchor connection point as described with respect to FIG20 . The anchor connector or anchor connection point may include an interface that may be the same as or similar to other interfaces described herein.

FIG29 illustrates an exemplary implant or device 2901 comprising a wireform with a static portion 2903 and a dynamic portion 2905. The static portion 2903 is used to seat and anchor the device 2901 and includes a depression 2907 capable of anchoring into a cleft (e.g., a cleft or commissure) within a valve. The dynamic portion 2905 is adjustable so that it can be seated over a leaflet that flail, prolapse, stiffness, and/or abnormality. The dynamic portion 2905 is incorporated into a sheet 2909 capable of applying contact pressure over a leaflet that flail, prolapse, stiffness, and/or abnormality. The sheet material can be permeable, semi-permeable, impermeable, or a mesh. The device 2901 includes an anchor connector 2911 that can be connected to an anchor, but can optionally utilize an anchor connection point as described with respect to FIG. 20 . The anchor connector or anchor connection point can include an interface that can be the same as or similar to other interfaces described herein.

FIG30 illustrates an exemplary implant or device 3001 comprising a wireform having a static portion 3003 and a dynamic portion 3005. The static portion 3003 is used to seat and anchor the device 3001 and includes a depression 3007 capable of anchoring into a cleft (e.g., a cleft or commissure) within a valve. The dynamic portion 3005 can be adjusted to widen or lengthen to seat over a leaflet that flailed, prolapsed, stiffened, and/or abnormal. The dynamic portion 3005 is incorporated into a sheet 3009 capable of applying contact pressure and/or providing support to a leaflet that flailed, prolapsed, stiffened, and/or abnormal. The sheet material can be permeable, semi-permeable, impermeable, or a mesh. The device 3001 includes an anchor connector 3011 capable of connecting to an anchor, but can optionally utilize an anchor connection point as described with respect to FIG. 20 . The anchor connector or anchor connection point can include an interface that can be the same as or similar to other interfaces described herein.

Figures 31A-31L are schematic diagrams illustrating exemplary steps that may be used to deliver an implant or prosthetic device to a mitral valve and anchor the implant with an anchor positioned in the coronary sinus using a connector that passes transversely through the coronary sinus and a wall of the left atrium. To aid in understanding the delivery process, several figures provide transverse plan views within the left atrium above the mitral valve, and several other figures provide coronal plan views within the left chambers, cut through the coaptation region of the mitral valve. Although described with respect to the coronary sinus and mitral valve, the systems, devices, methods, steps, etc. may be similarly applied to other vascular systems and other valves of the heart.

FIG31A shows a guidewire 3101 being advanced from the right atrium through the ostium or opening of the coronary sinus and into the coronary sinus. As seen in FIG31B , a puncture catheter 3103 is then advanced over the guidewire 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 pathway (e.g., the cervical or subclavian vein) and may have a hemostatic valve therein. While the introducer sheath is held in a fixed position, the puncture catheter 3103 is guided to a location in the coronary sinus/left atrial 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 medial and a radially lateral side to conform to the curvature of the coronary sinus. An expandable anchor member 3105 is exposed radially lateral to the catheter 3103 adjacent a distal segment 3107, which may be thinner than or tapered from the proximal end of the catheter. Radiopaque markers 3109 on the catheter 3103 help determine the precise advancement distance for the anchor member 3105 to be positioned within the coronary sinus.

FIG31C shows the radial outward expansion of the expandable anchoring member 3105, which in the illustrated example is a spherical balloon but could also be a woven mesh. One advantage of a mesh is that it prevents excessive obstruction of blood flow through the coronary sinus during the procedure. Other possible anchoring structures include, but are not limited to, stent-like structures formed from nickel-titanium alloy wire. The expansion of the anchoring member 3105 radially bends the catheter inward against the coronary sinus lumen wall. The expandable anchor member 3105 is positioned adjacent to the distal segment 3107 of the puncture catheter 3103 and expands opposite a needle port 3111 formed in the radially inner wall 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 correctly positioned across the tissue wall 3113, which can be guided by visualizing the radiopaque markers 3109. For example, the port 3111 can be positioned approximately above the P2 segment of the posterior leaflet of the mitral valve as shown. The anchoring member 3105 can be radially centered across the catheter 3103 from the port 3111, or, as shown, can be slightly offset in a proximal direction from the port 3111 to improve leverage.

The curvature at the distal end of the puncture catheter 3103 aligns with the anatomy adjacent to the coronary sinus and orients the needle port 3111 inwardly, while the anchor member 3105 holds the catheter 3103 in place relative to the coronary sinus. Subsequently, as seen in FIG31D , an introducer sheath 3115 (having an introducer needle 3117 with a sharp tip) is advanced along the catheter 3103 such that it angles away from the needle port 3111 and penetrates through the wall 3113 into the left atrium. The anchor member 3105 provides rigidity to the system and holds the needle port 3111 against the wall 3113. The puncture needle 3117 is retracted from the puncture sheath 3115 and completely removed from the catheter 3113.

Figures 31E and 31F then show a second guidewire 3119 being advanced through the lumen of the puncture sheath 3115, through the left atrium, through 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 guidewire 3119 extending through the coronary sinus and into the left ventricles. During these steps, the anchor member 3105 remains expanded against the opposite coronary sinus lumen wall for stability but is subsequently removed along with the puncture catheter 3103 to allow a delivery catheter 3121 to advance into the left ventricles.

Figures 31G and 31H show a delivery catheter 3121 being advanced along the guidewire 3119 and through the tissue wall 3113 into the left atrium. Located within the delivery catheter 3121 is a compressed device 3123 that is to be implanted within the left chambers and positioned over a flail, prolapse, stenosis, and/or other abnormality of the P2 segment of the posterior leaflet.

FIG31I then shows the advancement of the device 3123 into the left lateral chambers and the simultaneous retraction of the delivery catheter 3121 through the atrial tissue wall 3113. As the device 3123 is advanced, it expands into shape. FIG31J shows a fully expanded device 3123 at the implantation site, which is the P2 segment of the posterior leaflet. FIG31J and FIG31K show that as the delivery catheter 3121 is retracted through the atrial tissue wall 3113 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 compression wire support anchor 3127 that remains within the delivery conduit 3121.

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

Certain examples herein are directed to compression elements (e.g., compression stents, compression clips, compression plates, compression molding, etc.) for reducing flail, prolapse, stiffness, and/or other abnormalities of heart valve leaflets. In some applications, a compression element is capable of clamping onto a leaflet, maintaining its position on the leaflet while providing compression and contact pressure to an area of flail, prolapse, stiffness, and/or abnormality. The compression and contact pressure provided by various stent implementations helps flatten and/or reshape the flail, prolapse, stiffness, and/or anomaly, which helps extend the coaptation edge of a leaflet posteriorly toward the coaptation region when in a closed position. This results in normal coaptation of a fully closed valve, preventing valvular insufficiency.

In some applications, a compression element has an outflow portion and an inflow portion that are compressed together by a compressive force. When attached to 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, and the two portions are connected to each other. Thus, in some applications, the inflow portion of a stent provides contact pressure and/or support on a leaflet, for example, to address flail, prolapse, stiffness and/or another abnormality. In some applications, the outflow portion and inflow portion are compressed together to generate a force to hold it in place on the leaflet. In some applications, a torsion spring is used to provide the compressive force. In some applications, a compression element conforms to the shape of the leaflets. In some applications, a compression element is textured on its surface with a roughened surface, depressions, notches, protrusions, and/or hooks to provide additional grip to hold the stent in place. In some applications, a compression element incorporates an undulating wire to provide additional grip (like a hairpin grip).

In some applications, a compression element comprises a wire forming bracket. Any suitable material for forming a wire forming bracket may be used, including but not limited to nickel-titanium alloy, cobalt-chromium (CoCr), stainless steel, titanium, polyglycolic acid (PGA), polylactic acid (PLA), polydextrose-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), or fluorinated ethylene propylene copolymer (FEP), their additives, and derivatives thereof. In some applications, a compression element is retractable, which may be useful for fitting into a catheter device for less invasive catheter delivery methods. In some applications, nickel-titanium alloys are used for their self-expanding properties, which may be useful for implanting the compression element via less invasive catheter delivery methods.

Wire-formed compression elements of various shapes can be used in various implementations. In some applications, a compression wire-formed support is formed with the wire-formed portion to provide contact pressure and/or support over the flail, prolapse, stiffness, and/or anomaly. In some applications, a compression wire-formed support has a length and width to surround a flail or prolapse area and utilizes a sheet extending across the area to provide contact pressure and/or support over the flail, prolapse, stiffness, and/or anomaly.

In some applications, a compression implant or compression element incorporates a sheet over a wire form. In some applications, a sheet or covering is provided over the inflow portion of a compression element and provides a surface capable of providing contact pressure and/or support to a leaflet experiencing flail, prolapse, stiffness, and/or another problem. A sheet or covering can be impermeable, semipermeable, or permeable to fluids (e.g., blood or plasma). In some applications, the sheet or covering is a mesh. In some applications, a mesh is formed using a mesh sheet. In some applications, a mesh is formed using overlapping and intersecting interlaced threads. A mesh or permeable sheet can provide contact pressure without restricting the flow of blood or plasma, which can be important in various applications. For example, an impermeable sheet or cover can trap blood within the compression element, which in turn can create undesirable pressure within the valve or potentially cause the implant/device to shift or change its position. A sheet, cover layer, and/or web herein may comprise any one or more of the following: poly(lactic acid-glycolic acid copolymer) (PLGA), polyvinyl chloride (PVC), polyethylene (PE), polypropylene (PP), polytetrafluoroethylene (PTFE), polyurethane (PU), polyethylene terephthalate (PET), polyether sulphate (PES), polyglycolic acid (PGA), polylactic acid (PLA), poly(dextrose-lactic acid) (PDLA), poly-4-hydroxybutyrate (P4HB), and polycaprolactone (PCL).

Various implementations of compression elements help promote coaptation of the leaflets when closed. In some applications, a spacer is incorporated into the compression element, which helps fill the space within the valve orifice. In some applications, a compression element includes an extension with an impermeable sheet extending from the leaflet lip into the orifice, which helps form coaptation with the other leaflet. In some applications, a compression element includes an extension that extends to the outflow surface of another valve leaflet to contact the other leaflet when the valve closes, such that it helps the opposing leaflet come together and coapt with the stented leaflet. In some applications, an extension of the outflow surface that extends to another valve leaflet has a bend toward the other leaflet (e.g., to reach another leaflet in a tricuspid valve, aortic valve, or pulmonary valve).

In some applications, a compression element includes an anchor to stabilize the stent at the implantation site. In some applications, the inflow portion of a compression element includes a portion connected to the anchor. In some applications, the anchor connection point is adjacent to or in contact with the valve annulus or a ventricular or atrial wall. In some applications, an anchor is located adjacent to or in contact with the valve annulus. In some applications, an anchor is located adjacent to or in contact with the ventricular or atrial wall on the opposite side of the wall located at the anchor connection point. In some applications, a connector is used to connect the anchor, and the connector passes across the ventricular or atrial wall. Any suitable connector may be used, such as (for example) a screw, rivet, suture, clamp, wire, pin, shaft, strap, sheet, etc.

In some applications, an anchor is positioned within the vasculature on opposite sides of a ventricle or atrial wall. For example, various compression element implementations alleviate mitral valve flail, prolapse, stiffness, and/or other abnormalities and are therefore positioned within the left atrium. In these various implementations, a compression element can be connected to an anchor positioned within the coronary sinus using a connector that passes across the atrial wall. Any suitable anchor can be used. In some applications, an anchor is a wire stent capable of expanding within the vasculature. In some applications, an anchor is a pin, pin clamp (e.g., R-clip, R-pin, R-key), or wire that secures a compression element to the ventricular or atrial wall via a connector. In some applications, a pin or wire fastener is applied to opposite sides of a ventricular or atrial wall, with the connector extending across the wall. In some applications, a pin or wire fastener is applied within the vascular system on opposite sides of a ventricular or atrial wall. In some applications, a wire fastener pinches a connecting wire to hold it in place and generate tension between the wire fastener or wire anchor and the compression element. In some applications, an anchor comprises a screw, spiral, or helical anchor that is anchored within the valve annulus or an atrial or ventricular wall.

In some applications, a compression element is designed to contain spaces and/or features that allow for further medical intervention at a later time. In some applications, a wireformed stent contains spaces within the coaptation region (configured as a space between the wires of the wireformed stent) so that, if needed at some time in the future, a percutaneous edge-to-edge mitral valve repair device can still be implanted without interference from the implant/device.

Various implementations of the compression element are intended to be used on any valve leaflet that experiences flail or prolapse. Thus, in some applications, a compression element can be applied to a leaflet of a mitral valve, a tricuspid valve, an aortic valve, and/or a pulmonary valve. Similarly, various implementations of the compression element can be applied to any area of the leaflet that experiences flail or prolapse. In some applications, a compression element can be applied to or adjacent to a leaflet commissure and/or any area between commissures of a leaflet.

To reach the implantation site, any appropriate surgical technique may be used, including, but not limited to, a transcatheter delivery system that may utilize a transfemoral, subclavian, transapical, transseptal, or transaortic approach. In some applications, a delivery catheter is used to incorporate a compression element, which is then delivered over a guidewire to the deployment site and used to attach the stent to a valve leaflet.

Certain applications are directed to methods for delivering a compression element to the expanded location. The various methods described or suggested herein (including in documents incorporated herein by reference) can be performed on a living animal (e.g., a human, a mammal, another animal, etc.) or on an inanimate simulation, such as a cadaver, a cadaver heart, a simulator (e.g., with simulated body parts, tissues, etc.), etc. Thus, methods of delivery include methods of treatment (e.g., treatment of a human subject) and methods of training and/or practice (e.g., performing methods using an anthropomorphic prosthesis that mimics the human vascular system).

32 and 33 illustrate an exemplary implant or device 3201 (e.g., a compression element, prosthetic device, prosthetic implant, etc.) being implanted and/or compressed over a valve leaflet 3203 at an implantation site. As shown here, the implant/device is positioned over a native valve 3205 (e.g., mitral valve, tricuspid valve, etc.). In this example, the valve chordae tendineae rupture 3207, causing the leaflet to 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 inlet portion 3211 is positioned on and in contact with the inlet surface 3215 of the posterior leaflet 3203 at the site of the flail and/or prolapse within the atrium 3217. The outflow portion 3213 is positioned on and in contact with the outflow surface 3219 of the posterior leaflet 3203 at the site of the flail and/or prolapse within the ventricle 3221. The implant/device functions as a compression element, wherein the inlet portion 3211 and the outflow portion 3213 are configured to apply compressive forces over the flail, prolapse, and/or other abnormality to help flatten and/or reshape the leaflet (e.g., a protrusion, bulge, etc.) and reduce regurgitant blood flow. The implant/device 3201 includes a junction portion 3223 that extends beyond the edge of the posterior leaflet 3203 and connects the inflow portion 3211 and the outflow portion 3213.

FIG34 illustrates an exemplary implant or device 3401 (e.g., a compression element, prosthetic device, prosthetic implant, etc.) with an expanded inlet portion 3403 having multiple rings implanted or compressed above a valve leaflet 3405 at an implantation site. As shown here, the implant/device is positioned above the native valve 3407 (e.g., a mitral valve, tricuspid valve, etc.). The implant/device also includes an outflow portion 3409 (indicated by dashed lines). The inlet portion 3403 is positioned within the atrium 3413 on and in contact with the inlet surface 3411 of the posterior leaflet 3405 at the site of flail, prolapse, stiffness, and/or abnormality. The outflow portion 3409 is positioned on and in contact with the outflow surface of the posterior leaflet 3405 at the site of the flail, prolapse, ankylosing, and/or abnormality within the ventricle 3415. 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, ankylosing, and/or abnormality to help flatten and/or reshape the leaflet (e.g., a protruding structure, bulge, flail, etc.) and/or reduce backflow of blood flow. Furthermore, the expanded inlet portion 3403 with multiple rings provides increased contact compared to the inlet portion of device 3201 and can therefore provide additional contact pressure and/or support at sites of leaflet flail, prolapse, stiffness, and/or abnormality. Thus, various element shapes or stent shapes can increase contact pressure at sites of leaflet flail, prolapse, stiffness, and/or abnormality by increasing the amount of contact between the stent and the leaflet. The device 3401 includes two junctions 3419 that extend beyond the edge of the posterior leaflet 3405 and connect the inlet portion 3403 and the outflow portion 3409. The two coapted portions are spaced apart to provide an area 3421 for further medical intervention of the valve leaflets at a later point in time (e.g., subsequent edge-to-edge repair, such as implantation of a device to hold the leaflets together).

FIG35 illustrates an exemplary implant or device 3501 (e.g., a compression element, a prosthetic device, etc.) comprising a wire stent anchor (not shown) at an implantation site. As shown here, the implant/device is positioned over the native valve 3505 (e.g., the mitral valve, the tricuspid valve, etc.). The implant/device 3501 has an inflow portion 3507 and an outflow portion 3509 (indicated by dashed lines). The inflow portion 3507 is positioned on and in contact with the inflow surface 3511 of the posterior leaflet 3513 at the site of flail, prolapse, stiffness, and/or abnormality within the atrium 3515. The outflow portion 3509 is positioned within the ventricle 3517 and contacts the outflow surface of the posterior leaflet 3513 at the site of the flail, prolapse, ankylosing, and/or abnormality. The implant/device functions as a compression element, wherein the inflow portion 3507 and the outflow portion 3509 are configured to apply compression forces above the flail, prolapse, ankylosing, and/or abnormality to help flatten and/or reshape the leaflet (e.g., a protruding structure, bulge, flail, etc.) and reduce regurgitant blood flow. The implant/device 3501 may include a coaptation portion 3519 extending beyond the edge of the posterior leaflet 3513 and connecting the inflow portion 3507 and the outflow portion 3509.

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

Figures 36 to 44 illustrate examples of implants or devices configured as compression elements (e.g., compression wireforms 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 should be understood that an outflow portion can be the inflow portion, and an inflow portion can be the outflow portion, because the sides of the leaflets contacting these portions are interchangeable.

FIG36 illustrates an exemplary implant or device configured as a compression element or compression wireformed stent 3601. The device or wireformed stent includes an inflow portion 3603 and an outflow portion 3605 connected via a junction portion 3607.

FIG37 illustrates an implant or device configured as a compression element or compression wire forming stent 3701 in the form of a single wire without wire ends. The wire forming stent includes an inlet portion 3703 and an outlet portion 3705 connected via a junction portion 3707.

FIG38 illustrates an implant or device configured as a compression element or compression wireformed stent 3801 with additional curvature to enhance wire contact with a prolapsed and/or flailed valve leaflet. The device or wireformed stent comprises an inflow portion 3803 and an outflow portion 3805 connected by a joint 3807. The inflow portion 3803 comprises two rings 3809, 3811 as additional curvature that enhances the contact point between the inflow portion 3803 and the inflow surface of a valve leaflet. The joints 3807 are spaced apart to allow for further subsequent medical intervention on the valve leaflets (e.g., subsequent edge-to-edge repair).

Figure 39 illustrates an implant or device configured as a compression element or compression wireformed stent 3901 with additional curvature to enhance wire contact with a prolapsed and/or flailed leaflet. The device or wireformed stent comprises an inflow portion 3903 and an outflow portion 3905 connected by a joint 3907. The inflow portion 3903 comprises outer wing-shaped rings 3909 and 3911 and a large inner ring 3913 as additional curvature that increases the contact point between the inflow portion 3903 and the inflow 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 a later point in time (e.g., a subsequent edge-to-edge repair) without interference from the implant/device.

Figures 40 and 41 illustrate an implant or device configured as a compression element or compression wireformed stent 4001 with a torsion spring. The device or wireformed stent includes an inflow portion 4003 and an outflow portion 4005 connected via a joint. The joint includes a torsion spring 4007 to increase the compression force provided between the inflow portion 4003 and the outflow portion 4005. The torsion spring 4007 can be located within an open area on the outflow side of the valve (e.g., within the left ventricular region if used on the mitral valve).

FIG42 illustrates an implant or device configured as a compression element or compression wire forming stent 4201 with a connector to connect to 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 inflow portion 4203 and connects to an anchor (not shown). In some applications, the connector 4209 is capable of traversing through heart or vascular system tissue. The connector can also be an anchor connection point and/or anchor receiver similar to those described elsewhere herein. For example, in some applications, the compression element or bracket 4201 may include an anchor receiver at a configured anchor connection point, allowing the device 4201 to be anchored to the ring.

Figure 43 illustrates an implant or device configured as a compression element or compression wireformed stent 4301 with a connector and additional curvature to enhance contact with a prolapsed leaflet and/or flail wire. The device or wireformed stent comprises an inflow portion 4303 and an outflow portion 4305 connected by a joint 4307. A connector 4309 extends from the inflow portion 4303 and is connected to an anchor (not shown). In some applications, the connector is capable of being passed across cardiac or vascular tissue. The inlet portion 4303 includes two annular elements 4311, 4313 as additional curvature that increases the contact point between the inlet portion 4303 and the inlet surface of a valve leaflet. The joints 4307 are spaced apart to allow for further medical intervention on the valve leaflets at a later time (e.g., subsequent edge-to-edge repair). The connector can also be an anchor point and/or anchor receiver similar to those described elsewhere herein. For example, in some applications, the compression element or stent may include an anchor receiver at a configured anchor point, allowing the device to be anchored to the annulus.

FIG44 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 valve leaflet prolapse and/or flail. The device or wire forming stent includes an inflow portion 4403 and an outflow portion 4405 connected via a joint portion 4407. A connector 4409 extends from the inflow portion 4403 and is connected to an anchor (not shown). In some applications, the connector is capable of being passed through heart or vascular tissue. The inlet portion 4403 includes a reciprocating pattern as additional curvature that increases the contact point between the inlet portion 4403 and the inlet surface of a leaflet. The connector may also be an anchor point and/or anchor receiver similar to those described elsewhere herein. For example, in some applications, the compression element or stent may include an anchor receiver at a configured anchor point, allowing the device to be anchored to the ring.

Figures 45 and 46 illustrate an implant or device configured as a compression element or compression wireformed stent 4501 with a sheet positioned over an inflow portion to enhance wire contact with a prolapsed and/or flailed leaflet. The device or wireformed stent comprises an inflow portion 4503 and an outflow portion 4505 connected by a joint 4507. The inflow portion 4503 comprises a sheet or covering 4509 to enhance the contact point between the inflow portion 4503 and the inflow surface of a leaflet. The sheet or covering can be permeable (e.g., such as a mesh, etc.), semipermeable, or impermeable.

Figures 47 and 48 illustrate an implant or device configured as a compression element or compression wireformed stent 4701 with a sheet or cover positioned over an inflow portion to contact a leaflet prolapse and/or flail surface. The implant/device may also have an extended coaptation region to assist in coaptation of the leaflets when the valve is closed. The device or wireformed stent includes an inflow portion 4703 and an outflow portion 4705 connected by a coaptation portion 4707. The inflow portion 4703 includes a sheet or cover 4709 that increases the contact points of the inflow portion 4703 with the inflow surface of a leaflet. The joint portion 4707 may also include the sheet or cover 4709, but the joint portion 4707 with the sheet or cover is extended 4711 so that it extends beyond the leaflet edge when seated over the leaflet edge.

FIG49 illustrates an implant or device configured as a compression element or compression wireformed stent 4901 with a sheet positioned over an inflow portion to contact a leaflet prolapse and/or flail surface. This example utilizes the same basic wireform described and shown in FIG38 , but thus includes additional curvature to enhance wire contact with a leaflet prolapse and/or flail. The device or wireformed stent includes an inflow portion 4903 and an outflow portion 4905 connected by a junction portion 4907. The inlet portion 4903 includes two annular members 4909 and 4911 as additional curvature, which increases the contact points between the inlet portion 4903 and the inlet surface of a leaflet. The inlet portion 4903 also includes a sheet or cover 4913 to increase the contact points between the inlet portion 4903 and the inlet surface of a leaflet. The sheet or cover can be permeable, semipermeable, or impermeable. An example including a permeable mesh sheet is depicted in FIG50.

FIG51 illustrates an implant or device configured as a compression element or compression wireformed stent 5101 with a sheet positioned above an inflow portion for contacting a leaflet prolapse and/or flail surface. This example utilizes the same basic wireform and connector described and shown in FIG42 , and thus includes a connector for connection to an anchor. The device or wireformed stent includes an inflow portion 5103 and an outflow portion 5105 connected via a joint 5107. A connector 5109 extends from the inflow portion 5103 and connects to an anchor (not shown) and is capable of traversing through the heart or vascular tissue. The inlet portion 5103 also includes a sheet or cover 5111 to increase the contact points between the inlet portion 5103 and the inlet surface of a leaflet. The sheet or cover can be permeable, semipermeable, or impermeable. An example of a sheet or cover with a permeable mesh is depicted in FIG52.

FIG53 illustrates an implant or device configured as a compression element or compression wireformed stent 5301 with a sheet positioned over an inflow portion to contact a leaflet prolapse and/or flail surface. This example utilizes the same basic wireform and connector described and shown in FIG44, and thus includes a connector and additional curvature to enhance wire contact with a leaflet prolapse and/or flail. The wireformed stent includes an inflow portion 5303 and an outflow portion 5305 connected via a junction portion 5307. A connector 5309 extends from the inlet portion 5303 and is connected to an anchor (not shown) and is capable of traversing through the heart or vascular system tissue. The inlet portion 5303 includes a reciprocating pattern as additional curvature, which increases the contact points between the inlet portion 5303 and the inlet surface of a valve leaflet. The inlet portion 5303 also includes a sheet or covering 5311 to increase the contact points between the inlet portion 5303 and the inlet surface of a valve leaflet. The sheet or covering can be permeable (e.g., a mesh, etc.), semipermeable, or impermeable.

Figures 54 and 55 illustrate an implant or device configured as a compression implant/device comprising a compression wireformed stent 5401 with an extended and contoured coaptation portion to assist in leaflet coaptation. The implant/device or wireformed stent comprises an inflow portion 5403 and an outflow portion 5405 connected by a coaptation portion 5407. The coaptation portion 5407 extends beyond the edge of a leaflet experiencing a problem (e.g., flail, prolapse, stiffness, and/or abnormality). The coaptation portion 5407 is also contoured to reach the leaflet opposite the leaflet experiencing the problem (e.g., flail, prolapse, stiffness, and/or abnormality). The contoured portion lifts the opposing leaflet and pulls it toward the affected leaflet to help them close.

FIG56 shows the implant/device depicted in FIG54 and FIG55 positioned on a posterior leaflet 5409 of a mitral valve 5411. The coaptation portion 5407 extends beyond the edge of the posterior leaflet 5413 and into the left ventricle. The coaptation portion 5407 is also contoured so that when the valve closes, the distal edge of the coaptation portion 5407 contacts the outflow surface of the anterior leaflet 5413 to help bring the anterior and posterior leaflets together and coapt.

Figures 57 and 58 illustrate an implant or device configured as a compressed implant/device comprising a compressed wireformed stent 5701 with an attached spacer, coaptation element, or spacer. The implant/device or wireformed stent comprises an inflow portion 5703 and an outflow portion 5705 connected via a coaptation portion 5707. The outflow portion 5705 comprises a loose spacer/coaptation element/spacer 5709 located adjacent to the coaptation portion 5707. The spacer/coaptation element/spacer 5709 has a loose configuration that allows it to fit within a valve orifice and fill the space when the valve is closed.

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

Figures 60A-60D are schematic diagrams of exemplary steps in delivering an implant/device to a native valve via a blood vessel of the heart. Described herein is the case of delivering an implant/device to a mitral valve via the coronary sinus (although similar steps may be applied to other locations). For example, the steps may include entering the blood vessel or coronary sinus and traversing the coronary sinus and a wall of the left atrium. The initial steps of reaching the left chambers via the coronary sinus are similar to those shown in Figures 31A-31F and described in the accompanying text. To help understand the delivery process, several figures provide a coronal view of the left lateral chambers through the coaptation region of the mitral valve.

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

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

Figure 65B then shows the full advancement of the compression clip device 6007 within the left ventricle and the simultaneous retraction of the delivery catheter 6003. The delivery catheter includes an actuator to actuate the compression clip 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 being retracted 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 outflow surface of the leaflets. A coaptation portion 6013 of the compression clip device 6007 is pulled toward the edge of the mitral valve leaflet such that the compression clip device 6007 is positioned over a leaflet that flail, prolapse, stiffness, and/or abnormality.

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

Many examples herein are directed to valve implants or devices for alleviating heart valve leaflet flail, prolapse, stiffness, and/or other abnormalities. These valve implants or devices include a stem or elongated extension that spans between portions or commissures of a native valve. In some applications, a valve device can be positioned within the outflow side of a valve, with the stem or elongated extension maintaining its position on the leaflet while providing contact pressure over an area of flail, prolapse, stiffness, and/or abnormality. The contact pressure provided by various stem or extension implants/devices helps flatten and/or reshape the flail, prolapse, stiffness, and/or anomaly, which helps extend the coaptation margins of a leaflet posteriorly toward the coaptation region when in a closed position. This results in normal coaptation of a fully closed valve, preventing valvular insufficiency.

In some applications, a rod/slender extension is configured as an elongated arch with two distal ends, each end having an anchor or member for hooking, latching, anchoring, securing, etc., within the commissures of two leaflets. In some applications, each of the distal ends of the rod/extension includes a depression or hook that helps anchor the rod/extension within the implant site by latching or hooking onto the commissures. In some applications, the rod/extension is telescopic, such that there is an inner rod and an outer rod, allowing the rod to be shortened and lengthened between a variety of different sizes or lengths. Thus, in some applications, the telescoping rod/extension can be shortened or lengthened to extend over a leaflet problem (e.g., 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 implantation site, beyond the anchors or members used to hook, latch, anchor, secure, etc. within the commissure of the two valve leaflets (although in some cases, the anchors or members used to hook, latch, anchor, secure, etc. within the commissure of the two valve leaflets 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 includes a portion connected to the anchor. In some applications, an anchor connection point extends from the rod/extension/arch toward a ventricular or atrial wall. In some applications, an anchor is located adjacent to or in contact with the ventricular or atrial wall on the opposite side of the wall from the rod/extension/arch connection point. In some applications, a connector is used to connect the anchor to the anchor connection point, the connector extending across the ventricular or atrial wall. Any suitable connector may be used, such as, for example, a screw, rivet, suture, clamp, wire, pin, shaft, sheet, mesh, etc.

In some applications, an anchor is positioned within the vasculature on opposite sides of a ventricle or atrial wall. For example, various rods or elongated extensions are positioned within the left atrium to alleviate mitral valve leaflet problems (e.g., flail, prolapse, stiffness, and/or abnormality). In these various implementations, a rod/extension can be connected to an anchor positioned within the coronary sinus using a connector that passes across the atrial wall. Any suitable anchor can be used. In some applications, an anchor is a wire stent capable of expanding within the vasculature. In some applications, an anchor is a pin (e.g., an R-pin) or a wire fastener that secures an arched telescopic rod to the ventricular or atrial wall via a connector. In some applications, a pin or wire fastener is applied on opposite sides of a ventricular or atrial wall, with the connector extending across the wall. In some applications, a pin or wire fastener is applied within vascular system on opposite sides of a ventricular or atrial wall. In some applications, a wire fastener is capable of pinching a connecting wire to hold the wire in place and create tension between the wire anchor or wire fastener and the telescopic rod. In some applications, an anchor is a screw, spiral, or helical anchor that is anchored into 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 spacer, coaptation element, or spacer is incorporated to extend from the rod/extension/arch and into the valve orifice, which can help fill the space within the valve orifice. In some applications, a rod/extension/arch includes a sheet extension with an impermeable sheet that extends beyond the rod/extension/arch along the leaflet coaptation region and into the valve orifice, which can help form coaptation with the other leaflets. In some applications, the sheet includes wire molding along its edges to help maintain the sheet within the orifice of a valve when implanted.

Any suitable material for forming a rod, elongated extension, arch, or arched rod may be used. In some applications, the rod/extension/arch comprises one or more of the following: nickel-titanium alloy, cobalt-chromium (CoCr), stainless steel, titanium, polyglycolic acid (PGA), polylactic acid (PLA), polydextrose-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), additives thereof, and derivatives thereof.

Figure 61 illustrates an example telescopic rod/extension or telescopic arch rod 6101 that can be positioned within a valve and provide contact pressure upon a leaflet flail, prolapse, stiffness, and/or leaflet abnormality. The telescopic rod/extension or arch rod 6101 has an inner rod/extension 6103 and an outer rod/extension 6105. The inner rod/extension 6103 can slide within the outer rod/extension 6105, allowing the length and arc angle of the rod/extension to be adjusted. In some applications, the rod/extension or arch 6101 includes a connector 6107 to connect the rod/extension or arch 6101 to an anchor to provide added stability to the rod/extension or arch. In some applications, the rod/extension or arch 6101 includes a hook 6109 that can be anchored within a leaflet commissure or cleft.

FIG62 illustrates an exemplary rod/extension device comprising an arch or arched rod 6201 with a sheet extension that extends a leaflet edge to allow for better coaptation. The rod/extension or arched rod 6201 is a single rod/extension that can be positioned within the orifice of a valve. In some applications, the rod/extension or arched rod 6201 includes a hook 6203 that can be anchored within a leaflet commissure or cleft. A sheet 6205 descends from the rod/extension or arched rod 6201 to reach and extend beyond a leaflet edge, thereby extending the leaflet to provide more area for coaptation. In some applications, the sheet includes a wire 6207 along its border, which can help hold the sheet within the joint area when implanted.

FIG63 illustrates an exemplary rod/extension device or an arched rod 6301 with a spacer, coaptation element, or spacer capable of filling one or more spaces within a valve coaptation region when the valve is closed. In some applications, the rod/extension or arched rod 6301 is a single rod/extension that can be positioned within the orifice of a valve. In some applications, the rod/extension or arched rod 6301 includes a hook 6303 capable of anchoring within a leaflet commissure or cleft. A plurality of spacer elements, coaptation elements, or spacers 6305 depend from the rod/extension or arched rod 6301 to sit within the valve coaptation region and assist in the coaptation of the leaflets by filling any gaps as they close.

Certain examples herein are directed to implants or devices comprising a mesh (e.g., a mesh, sheet, covering, etc.) for alleviating heart valve leaflet problems, such as flail, prolapse, stiffness, and/or other abnormalities. In some applications, a mesh implant/device is capable of being positioned on the outflow side of a valve, with the edges positioned within a cleft (e.g., a fissure or commissure) within the heart valve, while providing contact pressure and/or support over a flail, prolapse, stiffness, and/or abnormality. The contact pressure provided by various mesh devices/implants helps flatten and/or reshape the leaflets or the flail, prolapse, stiffness, and/or abnormalities of the leaflets, which helps extend the coaptation edge of a leaflet posteriorly toward the coaptation region when in a closed position. This results in normal coaptation of a fully closed valve, preventing valvular insufficiency.

In some applications, a mesh implant/device includes, but is not limited to, a surface configured to directly contact a surface of a valve leaflet experiencing flail, prolapse, stiffness, and/or other issues. Typically, the inflow surface of a valve leaflet is the surface experiencing flail, prolapse, stiffness, and/or other issues. In some applications, the contact surface of the mesh device is pliable and thus conforms to the contour of the inflow surface of a valve leaflet, which can be a hyperbolic paraboloid profile. In some applications, the contact surface of the mesh device provides contact pressure above a valve leaflet that flail, prolapse, stiffness, and/or abnormality. In some applications, the contact surface of the mesh implant/device has a width and a length such that it can cover the area of the valve leaflet experiencing flail, prolapse, stiffness, and/or abnormality. In some applications, the length of an implant/device extends just beyond the coaptation area of the valve leaflet.

In some applications, a mesh implant/device includes an anchor to secure the device at the implant site. In some applications, an anchor is located adjacent to or in contact with the valve annulus, leaflet region, or atrial/ventricular wall. In some applications, an anchor is a screw, spiral, spiral-shaped anchor, or other feature that is capable of tightening or embedding within the valve annulus, leaflet, or atrial/ventricular wall. In some applications, a spiral-shaped anchor is housed within a tubular compartment that is connected to or anchored to a portion of the mesh implant/device.

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

The netting of a netting device can be impermeable, semipermeable, or permeable to fluids (e.g., blood or plasma). In some applications, the netting is a mesh. In some applications, a mesh is formed using overlapping and intersecting crisscross threads. In some applications, a mesh is formed using a mesh sheet. Any suitable material may be used for a netting. For example, a netting may include one or more of the following: poly(lactic-co-glycolic acid) (PLGA), polyvinyl chloride (PVC), polyethylene (PE), polypropylene (PP), polytetrafluoroethylene (PTFE), polyurethane (PU), polyethylene terephthalate (PET), polyether sulphate (PES), polyglycolic acid (PGA), polylactic acid (PLA), poly(dextrose-lactic acid) (PDLA), poly-4-hydroxybutyrate (P4HB), and polycaprolactone (PCL). Any suitable means for attaching a netting to one or more anchors may be used, including but not limited to sutures, staples, and glue.

In some applications, a netting device includes a wire form outlining the netting or a portion of the netting. Any suitable material for forming a wire form can be used. For example, the wire form can include one or more of the following: nickel-titanium alloy, cobalt-chromium (CoCr), stainless steel, titanium, polyglycolic acid (PGA), polylactic acid (PLA), polydextrose-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), additives thereof, and derivatives thereof.

In some applications, a meshing device is collapsible, which may be useful for fitting into a catheter for less invasive catheter delivery methods. In some applications, nickel-titanium alloys are used for their self-expanding properties, which may be useful for implanting the device in less invasive catheter delivery methods.

Some applications of meshing devices are configured to be used on any valve leaflet that is experiencing flail or prolapse. Thus, in some applications, a meshing device can be applied to a leaflet of a mitral valve, a tricuspid valve, an aortic valve, and/or a pulmonary valve. Similarly, various devices/implants can be applied to any area of the valve leaflet that is experiencing flail or prolapse. In some applications, a meshing device can be applied to any area between clefts (e.g., commissures and clefts) of a valve leaflet.

To reach the implantation site, any appropriate surgical technique may be used, including, but not limited to, a transcatheter delivery system that may utilize a transfemoral, subclavian, transapical, transseptal, or transaortic approach. In some applications, a delivery catheter is used to incorporate a device, which is then delivered to the deployment site over a guidewire and used to anchor the device at the implantation site.

Certain examples herein are directed to methods for delivering a networked device to the deployment site. Various methods described or suggested herein (including in documents incorporated herein by reference) can be performed on a living animal (e.g., a human, a mammal, another animal, etc.) or on an inanimate simulation, such as a cadaver, a cadaver heart, a simulator (e.g., with a body part, tissue, etc. being simulated), etc. Thus, methods of delivery include methods of treatment (e.g., treatment of a human subject) and methods of training and/or practice (e.g., performing methods using an anthropomorphic prosthesis that mimics the human vascular system).

FIG64 illustrates an exemplary mesh implant or device 6401 with a helical anchor 6403. The mesh implant/device 6401 is shown with a mesh material 6405 extending from an anchor portion 6407. The side edges 6409 and 6411 of the mesh implant/device 6401 can be positioned within a cleft (e.g., a commissure or fissure) of the heart valve, while the mesh material 6405 can be positioned across a leaflet and provide contact pressure on the leaflet to address flail, prolapse, stiffness, and/or other issues. The side edges 6409 and 6411 can optionally incorporate a wireform. The engagement portion 6413 may optionally include a tether or hammer to further secure the meshing device at the implantation site.

Figures 65 and 66 show an exemplary depiction of the mesh implant/device 6401 with a helical anchor 6403 at an implantation site. As shown here, the mesh implant/device is positioned over the mitral valve 6415. The contact surface of the mesh implant/device 6401 is positioned on the inflow surface of the posterior leaflet within the left atrium 6419 at the site of flail, prolapse, stiffness, and/or anomaly. The contact surface can provide contact pressure and/or support on the leaflet to resolve the flail, prolapse, stiffness, and/or anomaly and help flatten and/or reshape the leaflet or a protrusion, bulge, flail, etc. of the leaflet and reduce regurgitant blood flow. The implant/device 6401 includes a coupling portion 6413 that extends beyond the edge of the posterior leaflet (e.g., below the edge) into the left ventricle 6417.

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

67A-B, 68A-G, and 69-75, these figures are schematic illustrations 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 with a mitral valve 10 of the heart, with the heart chamber upstream of the mitral valve being the left atrium 6 and the heart chamber downstream of the mitral valve being the left ventricle 8. However, the system 20 can also be similarly adapted for use with another atrioventricular valve (the tricuspid valve), with another atrium (the right atrium) upstream of the atrioventricular valve and another ventricle (the right ventricle) downstream of the atrioventricular valve. 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 right 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 122 and an opposing surface 123 opposite the contact surface. For some applications, implant 100 may have features or components similar to those described above for implants 1101, 2101, 2301, and/or 2421.

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

The actuator 70 is configured to couple with the anchor 30 (e.g., a head 32 thereof) and is configured to anchor the implant 100 to the tissue of the heart by using the anchor to anchor the interface 110 to the tissue. In some applications, the actuator 70 includes a flexible shaft 74 and an actuator portion 72 at a distal end of the shaft, the actuator portion being coupled to the anchor 30.

For some applications, and as shown, the wing 120 includes a frame 124 (e.g., a wire frame) and a sheet 126 laid over the frame. For some applications, the wing 120 has a root 130 coupled to the interface 110 and a tip 132 at an end of the wing opposite the root. The tip 132 represents a free end of the wing 120.

For some applications, the frame 124 is attached to the interface 110. For example, and as shown, at the root 130, the frame 124 can define a ring 128 that mates with the interface 110. The wing 120 can define two sides 134 (e.g., 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 (e.g., a first ring 136a and a second ring 136b) extending side by side from the root 130, e.g., to the tip 132. It should be noted that, as shown, the rings 136 can be discrete rings rather than a cellular or lattice-like structure. For example, except at the root 130 (e.g., at the ring 128 and/or the interface 110), the rings 136 are disconnected from each other and/or from any other metal components of the implant 100. Furthermore, each of the rings 136 can be configured to define a space 137 that is substantially free of frame components. For some applications, and as shown, each of the rings 136 is substantially teardrop-shaped.

For some applications where the frame 124 defines the rings 136, the frame 124 defines an elongated space 138 between the two rings. The space 138 can extend from the root 130 toward the tip 132, for example, all the way to the tip (e.g., so that the frame 124 does not bridge the two rings at the tip). For some applications, and as shown, the space 138 runs along a plane of reflection symmetry of the wing 120.

For certain applications where the frame 124 defines rings 136, the sheet 126 can be configured to extend over and between the rings, for example spanning both the rings and the spaces 138.

For some applications, sheet 126 has a plurality of holes 140 therethrough. For some such applications, and as shown, holes 140 are polygonal and arranged in a checkerboard pattern. For example, and as shown, holes 140 can be hexagonal. As shown, some holes 140 can be arranged above spaces 137. Alternatively or additionally, some holes 140 can be arranged above spaces 138. For some applications, and as shown, the size and number of openings or holes 140 are such that the wing 120 as a whole is greater than 20 percent and/or less than 80 percent open, e.g., 20-80 percent open, such as 20-70 percent open (e.g., 30-70 percent open, such as 30-60 percent open or 40-70 percent open), or 30-80 percent open (e.g., 40-80 percent open).

In some applications, wing 120 is curved such that contact surface 122 is concave. That is, the curvature of wing 120 is such that, in a cross-section of implant 100 through interface 110 and the wing, contact surface 122 is concave. Figure 67B is a schematic illustration of this cross-section, while the location of the cross-section is indicated by marker A in Figure 67A. However, Figure 67B shows implant 100 with anchor 30 in place, e.g., as if the implant has already been implanted. As shown, this cross-section may be located in a plane of reflection symmetry of the implant, such as in space 138 between rings 136. For some applications, and as shown, the curvature of the wing 120 increases with distance from the interface 110, for example, such that the curvature is greatest at the tip 132. For example, and as shown in FIG. 67B , at the tip 132, after the implant 100 is anchored by the anchor 30, a tangent line ax2 of the curvature of the wing 120 can be less than 60 degrees (e.g., less than 45 degrees, such as less than 35 degrees) relative to an anchor axis ax1 of the anchor 30. The angle between the tangent line ax2 and the axis ax1 can depend at least in part on the geometry of the interface 110 and/or an anchor receiver 150 (described below) located at the interface, for example, relative to the geometry of the anchor 30.

For some applications, and as described in more detail below, an angled arrangement of wings 120 relative to interface 110 and/or anchor receiver 150 is such that positioning the interface against tissue of an atrium of the heart (e.g., against an annulus of an atrioventricular valve of the heart, or against a wall of the atrium) positions tip 132 within the ventricle downstream of the atrium and the atrioventricular valve.

Figures 68A-G show, according to some applications, at least some steps in the implantation of implant 100. Within catheter 40, implant 100 is advanced into a heart chamber located upstream of the heart valve to be treated (Figure 68A). For example, catheter 40 can be advanced into the chamber before implant 100 is advanced through the catheter, or the catheter can be advanced into the chamber with the implant already positioned therein. In the illustrated example, the mitral valve 10 of heart 4 is being treated, and therefore implant 100 is advanced into the left atrium 6 of the heart. Mitral valve 10 has a first leaflet (e.g., a posterior leaflet) 12 and an opposing leaflet (e.g., an anterior leaflet) 14. In the illustrated example, the posterior leaflet is the leaflet that is experiencing flail. The portion of the posterior leaflet that is experiencing flail is designated by reference numeral 16. It is noted that the system 20 can be similarly used to treat flail in the anterior leaflet 14.

In the illustrated example, catheter 40 is advanced transluminally into the heart chamber. However, a transatrial approach is also within the scope of this disclosure. Similarly, while a transfemoral approach is shown, the scope of this disclosure includes advancement through the superior vena cava. Note that while a transseptal approach is shown from the right atrium 5 to the left atrium 6, the atrial septum is not shown because it is posterior to the aorta 7. To illustrate its posterior position to the aorta 7, a portion of catheter 40 is shown in dashed lines.

As shown, advancement of the implant 100 within the catheter 40 is performed while the shaft 60 (e.g., its head 62) is engaged with the implant's interface 110. In some applications, the implant 100 is advanced within the catheter 40 while the wings 120 are constrained (e.g., compressed, folded, and/or rolled) within the catheter.

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

Subsequently, again using shaft 60, implant 100 is positioned in a position in which interface 110 is located at a location 18 in the heart, wing 120 extends beyond first leaflet 12 toward opposite leaflet 14, and contact surface 122 faces the first leaflet (Figure 68D). For some applications, and as shown, wing 120 extends beyond first leaflet 12 so that tip 132 is disposed beyond the lip of the first leaflet (e.g., downstream), e.g., within left ventricle 8, e.g., with opposite surface 123 facing opposite leaflet 14. Typically, this is due at least in part to the geometry and dimensions of implant 100 and/or at least in part to location 18. Location 18 can, but need not necessarily, be located on the annulus of the valve being treated, for example, at the root of the leaflet undergoing flail. Thus, in the illustrated example, wing portion 120 extends from interface 110 at location 18 on the mitral annulus 11 at the root of posterior leaflet 12, across posterior leaflet 12 toward the opposing leaflet 14, and curves downstream between leaflets 12, 14, beyond the lip of leaflet 12, such that tip 132 is disposed within ventricle 8.

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

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

The optimum for a given position of the implant 100 can be determined during the implantation procedure, for example, before the implant is anchored to the tissue. For example, optimum can be determined using blood pressure sensing techniques and/or imaging techniques such as fluorescence fluoroscopy and echocardiography. For example, Doppler echocardiography can be used to determine the extent to which regurgitation through the valve is maintained or reduced. To illustrate an advantage of the system 20, FIG68D shows that the implant 100 is initially suboptimally positioned, for example, with the wings 120 positioned away from the flail 16. That is, the address 18 is an initial address 18a at which the interface 110 has been positioned. At this point, the implant 100 is not yet anchored to the tissue, and the interface 110 can simply be moved to another location 18, for example, a second location 18b (Figure 68E). For example, the interface 110 can simply be slid along the ring 11. Alternatively, the interface can be lifted away from the tissue at the first location and then repositioned against the tissue at the second location. As shown, this repositioning can be performed without withdrawing (e.g., even partially withdrawing) the implant 100 into the catheter 40. In the illustrated example, the second position of the implant 100 is more suitable (e.g., optimal) than the first position, such that the wings 120 are positioned over the flails 18 and valvular insufficiency is minimized or eliminated.

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

It is 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 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 (e.g., within the ventricle downstream of the valve being treated), e.g., the implant 100 does not include a downstream anchor (e.g., a ventricular anchor). For example, and as shown, at least for applications in which interface 110 is anchored to annulus 11, any anchoring of implant 100 to the tissue of the heart is typically located within the atrium upstream of the valve being treated.

For some applications, implant 100 can be repositioned even after anchoring by using actuator 70 to unanchor interface 110 from the tissue (e.g., by loosening anchor 30).

FIG68G shows the implant 100 after its implantation, and the subsequent detachment of the tool 50 from the implant (e.g., the detachment of the driver 70 from the anchor 30, and the detachment of the shaft 60 from the interface 110), and the extraction of the tool from the subject.

It is assumed that the ease of repositioning implant 100 is due, at least in part, to the simplicity and minimalist nature of the implant itself and/or to the simplicity of its anchoring (e.g., via a single anchor). It is further assumed that because shaft 60 holds implant 100 in various locations into which the implant may be anchored (e.g., because the shaft holds interface 110 at (e.g., against) various locations 18 into which the interface may be anchored), and because subsequent anchoring of the implant results in minimal (e.g., no) change in the implant's position, the positional optimality determination described above is advantageously particularly accurate and reliable for system 20. It is further hypothesized that this advantage may be further facilitated by fully deploying the wings 120 (e.g., the entire implant 100) prior to placement of the implant in various locations.

Furthermore, if a decision is made to interrupt implant 100 after it has been deployed within the atrium, it is possible to withdraw the implant back into catheter 40 and outside the subject's body simply by retracting shaft 60 into the catheter. The shape and flexibility of wings 120 facilitate their recompression by reentry into the catheter. If interface 110 is already anchored before the decision to interrupt is made, actuator 70 can be used to unlock anchor 30 before retraction of shaft 60.

With further regard to the simplicity of implant 100, for some applications, implant 100 is essentially comprised of: interface 110 and wings 120 (i.e., frame 124 and sheet 126).

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

Anchor 30 may include a tissue anchor 34, and actuator 70 may anchor interface 110 to the tissue by driving the tissue anchor into the tissue. Tissue anchor 34 may take one of various different shapes known in the art, such as a screw, a target, a staple, etc. In the illustrated example, tissue anchor 34 is a screw-type tissue anchor, which actuator 70 tightens into the tissue.

For some applications, implant 100 includes an anchor receiver 150 at interface 110 (or interface 110 includes an anchor receiver 150), such that anchoring of the interface to the tissue is achieved by anchoring the receiver to the tissue. This can itself be achieved by using actuator 70 to anchor anchor 30 to receiver 150 (e.g., by driving the anchor through the receiver and into the tissue).

For some applications, and as shown, the receptacle 150 defines an aperture therethrough and includes a blocker 152 that projects medially into or across the aperture. For such applications, the anchor 30 and the actuator 70 can be configured such that the actuator can drive the tissue attachment member 34 past the blocker 152 until the head 32 becomes blocked by the blocker.

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

Referring to Figures 69, 70, and 71, according to some applications, these figures are schematic illustrations of valve 10 during the transition from ventricular diastole to ventricular systole. In frames B-D of each of these figures, the series of small arrows pointing upward represent the pressure from the contraction of ventricle 8 during ventricular systole. Figure 69 shows valve 10 as a healthy valve 10, while Figures 70-71 show valve 10 as a damaged valve 10, in which the leaflets 12 are experiencing flail (e.g., as described above for valve 10). According to some applications, Figure 70 shows the damaged valve 10 before implantation of 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, leaflets 12 and 14 close synchronously during ventricular systole, thereby coapting and preventing retrograde flow into the atrium 6. In a damaged valve 10, flail 16 occurs at a location in the leaflet 12 (e.g., due to one or more damaged chordae tendineae), thereby allowing retrograde leakage into the atrium 6. Previously described treatments for flail are based on inhibiting movement of the leaflet in an atrial direction (e.g., along an atrioventricular axis ax3), such as by implanting a restraint device (e.g., a prosthetic chord) in the ventricle or a restraint device (e.g., a barrier frame) in the atrium. The restraint device opposes (e.g., directly opposes) the flail ventriculo-atrial movement and thus requires substantial strength to oppose the force of ventricular pressure applied to the leaflet. It is hypothesized that implant 100 advantageously manipulates the force of ventricular pressure, deflecting the original ventriculo-atrial movement of leaflet 12 toward the opposing leaflet 14, causing the portion of leaflet 12 that would otherwise flail to coapt with leaflet 14, albeit with wings 120 interposed therebetween.

It is hypothesized that this directed coaptation mimics the physiological coaptation in a healthy valve, allowing the leaflets to cooperatively resist ventricular pressure. That is, due to the directed coaptation, leaflet 14 provides support to leaflet 12 against flail. It is further hypothesized that, as a result of this, implant 100 advantageously does not require the substantial strength that would be required to resist the forces exerted by ventricular pressure. Instead, implant 100 advantageously can be anchored by a single anchor (although multiple anchors can also be used), can be implanted using a single, highly maneuverable delivery system, and wings 120 can be highly flexible. For some applications, implant 100 and/or its anchoring may not actually be strong enough to directly resist (e.g., prevent) the valve leaflet 12 from flail in response to forces from ventricular pressure—but the flail can still be reduced or eliminated by (re)directing the leaflet toward the opposing leaflet.

A comparison of Figures 70 and 71 further illustrates one 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 that the intact leaflet 14 swings toward leaflet 12 in response to ventricular pressure. That is, although the ventricular pressure is broadly directed toward the atrium (e.g., along axis ax3), and although 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 FIG. 70 , the damaged leaflet 12 (e.g., its flail portion 16 ) has relatively little movement toward the leaflet 14 and is therefore able to slide past the lip and flail of the leaflet 14 into the atrium 6 . In FIG. 71 , the implant 100 (e.g., its wing portion 120 ) redirects the leaflet 12 toward the leaflet 14 , promoting closure of the valve 10 .

In many applications, a portion of the native leaflet being treated (e.g., leaflet 12) remains directly coapted against the other native leaflet. In some cases, greater than 20%, greater than 30%, greater than 40%, greater than 50%, greater than 60%, or greater than 70% of the native leaflet being treated (or one of its coapting surfaces) is directly coapted against the other native leaflet. Furthermore, typically, the native leaflet being treated (in this case, leaflet 12) is separated from wing 120 during at least part of the cardiac cycle (e.g., ventricular diastole) ( FIG. 71 , frame A), while during another part of the cardiac cycle (e.g., ventricular systole), the leaflet becomes urged against wing 120 by ventricular pressure. Thus, wing 120 does not act as an artificial leaflet, but rather as a guide and/or support for the native leaflet, helping the native leaflet to assume a proper configuration for coaptation with the opposing leaflet. It is hypothesized that, at least for some applications, the shape of wing 120 and/or the position and orientation in which implant 100 is implanted are such that, during contraction, the native leaflet becomes molded to or conforms to the shape of wing 120 as the contact between the native leaflet and the wing expands toward the leaflet's lip and the wing's tip 132, for example, as shown.

Implant/device 100 (and any of the implants/devices herein) can advantageously be configured to extend beyond (and/or below) the edges of the native leaflets (e.g., when the valve is closed). It is hypothesized that this can advantageously help ensure that the leaflets assume the correct shape without requiring the ends of the implant/device 100 to be anchored within the ventricle or clipped to the edges of the native leaflets.

It is hypothesized that the holes 140 [or other opening(s)] facilitate the native leaflet to become molded to or conform to the shape of the wing 120 by allowing blood to flow downstream through the wing 120 during diastole (e.g., pushing the leaflet 12 away from the wing), and by allowing blood to escape between the leaflet and the wing during the first moments of systole, thereby allowing the leaflet to quickly flatten against the wing and coapt with the opposing leaflet, thereby facilitating a small amount of backflow. A permeable portion and/or open/exposed portion similar to that described with respect to FIG. 21A may provide similar benefits, and it is possible for the device to include or use similar covered portions and/or exposed portions to those shown and described with respect to FIG. 21A. The holes, open portions, and/or permeable portions may also help facilitate implantation in a beating heart and allow for earlier positioning of the device, without circulating blood catching on the wings like a sail and causing excessive movement of the wings or device. This similarly helps avoid undesirable device/implant migration after implantation.

Typically, and as shown, the wings 120 beat or move during the heart cycle, for example, due to the manner in which the implant 100 is anchored and/or the flexibility of the wings (e.g., frame 124). For example, as the valve 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 the entire implant 100 pivoting about the anchor 30 in response to the leaflet 12 being pushed against the wings 120, for example, because the implant 100 is only anchored at the 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 the anchor 30 in response to the wing being further pushed by the leaflet 12, for example, due to the flexibility of the wing (e.g., the frame 124).

FIG72A schematically illustrates an implant 100a, FIG72B schematically illustrates an implant 100b, and FIG72C schematically illustrates an implant 100c. Implants 100a, 100b, and 100c are variations of implant 100. Implants 100a, 100b, and 100c may be identical to one another, except that example implant 100a includes an anchor receiver 150 or a receiver 150a of interface 110, example implant 100b includes an anchor receiver 150 or a receiver 150b of interface 110, and example implant 100c includes an anchor receiver 150 or a receiver 150c of 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 anchoring element 34 is driven through and beyond the sheet (e.g., piercing the sheet) until head 32 becomes blocked by (e.g., abuts) the sheet, e.g., pressing/sandwiching the sheet toward/against the tissue. For some applications, receptacle 150a may 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 extending across (or defined by) the aperture defined by the anchor receptacle. During anchoring, tissue-anchoring element 34 is driven past the crossbar until head 32 becomes blocked (e.g., abuts) by the crossbar, e.g., pressurizing/sandwiching the crossbar toward/against the tissue. For some applications, receptor 150b may have features identical to those described with reference to Figures 23B-C. For example, the crossbar defining the baffle element 152b may correspond to or be similar to the crossbar extending through the aperture 2317. For some applications, the crossbar defining the baffle element 152b may correspond to or be similar to the support shaft 1905 described with reference to FIG. 19A .

Receptacle 150c includes an exemplary barrier element 152c of barrier 152. Barrier element 152c includes (or is defined by) a collar. During anchoring, tissue-anchoring element 34 is driven beyond the collar until head 32 becomes blocked by (e.g., abuts) the collar, e.g., pressurizing/sandwiching the collar toward/against the tissue.

A variety of different types of barrier elements are possible, such as sheet(s), cloth(s), fabric(s), plate(s), metal (e.g., sheet(s), metal cloth(s), metal structure(s) configured to interconnect with an anchor, etc.), one or more holes [e.g., holes(s) sized to allow passage of a tissue penetrating portion of an anchor but not the head of the anchor], crossbar(s), collar(s), hub(s), polymer layer(s), mesh, nut(s), threaded portion(s) (e.g., with threads that interact with the anchor to allow tissue penetration but keep the anchor attached to the device), stop(s), etc.

For some applications, implant 100 includes a sidewall (e.g., a tubular wall) 112 that defines at least a portion of interface 110, and coupler 114 may be defined within the sidewall. For example, implant 100 may include a housing 108 that includes or defines interface 110 (e.g., wall 112 and its coupler 114) and receiver 150 (e.g., its baffle 152). Housing 108 may be formed from a single piece of stock that incorporates all of these components. Housing 108 may, by analogy, have the same features as housing 2313 described above.

For some applications, implant 100 includes a counter-force support, such as support 1113 and/or support 2309 described above. For some such applications, during delivery, the counter-force support is positioned proximally from interface 110 and/or receptacle 150 while located within catheter 40. For example, the counter-force support may be deployed from catheter 40 only after the optimal position of implant 100 has been determined and/or only after interface 110 has been anchored to the tissue (e.g., such that shaft 60 extends proximally within the catheter away from the interface and through the counter-force support as wings 120 are being deployed out of the catheter). Optionally, although the counter-force bearing is positioned proximally from interface 110, it can be deployed from catheter 40 prior to placement of interface 110 against the tissue. For some applications, during delivery, the counter-force bearing is positioned distally from interface 110 and/or receptacle 150 (e.g., beside wings 120) while within catheter 40 and can be deployed from the catheter simultaneously with the wings.

Once deployed, the counterforce support extends from the interface 110 and away from the wings 120, and after implantation, the implant 100 typically rests against the wall of the cavity in which it has been implanted, e.g., similarly as described with reference to Figures 11-12, mutatis mutandis.

Referring to FIG. 73 , there is shown a schematic illustration of multiple implants 100 implanted at a single heart valve, according to certain applications. Advantageously, and at least in part due to the simplicity of the implant 100, the implant typically allows for multiple implants 100 to be implanted at the same valve. It is assumed that the simplicity of the implant 100 and/or the flexibility of the wings 120 allow for multiple implants to be implanted without preventing the underlying leaflet from coapting with the opposing leaflet—even if the wings 120 of the implants overlap, for example, as shown.

Although all three implants 100 are shown on the same leaflet in FIG. 73 , it should be understood that the scope of the present disclosure includes implanting one or more implants 100 on one leaflet of the valve, as well as one or more implants 100 on another leaflet of the valve.

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

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

74-75 , which are schematic illustrations of implant 100 having been implanted at a different location than that shown above, according to some applications.

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

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

In Figures 68A-G and 71, the implant 100 is shown as being implanted medially over the leaflets 12 (e.g., at the P2 scallop). In contrast, in Figure 75, the implant 100 has been implanted more laterally over the leaflets, e.g., 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. Moreover, it is further hypothesized that this flexibility and configuration itself may make the implant 100 particularly suitable for implantation at such a location, e.g., compared to a more rigid implant that may inhibit the first leaflet from moving toward and coapting with the opposing leaflet. In the illustrated example, implant 100 has been implanted at a site in an orientation in which wings 120 are asymmetrically deflected, promoting coaptation between the P3 scallops of leaflet 12 and the A3 scallops of leaflet 14 at commissure 15. For such applications, the bicyclic structure of wings 120 can facilitate such asymmetric deflection, for example, allowing the wings to fold along a central longitudinal axis of the wings (the cross-section indicated by reference A in FIG. 67A is located on this central longitudinal axis).

Referring to FIG. 76 , a schematic diagram of an implant 100d is shown, according to certain applications. Implant 100d is a variation of implant 100 and may be identical or similar to implant 100 as described above, except that implant 100d is anchored by multiple anchors. In certain applications, implant 100d may include multiple separate anchor receivers 150, or multiple anchors may be received by a single anchor receiver or interface.

In some applications, and as shown, implant 100d may have a single anchor receiver 150 that receives a single anchor 30, along with additional anchors 30a driven through sheet 126 located adjacent to interface 110. For some applications, implant 100d may include multiple interfaces 110, each of which may include an anchor receiver. For some applications, implant 100d (e.g., an anchor interface thereof) is configured to receive multiple anchors at different angles so that the anchors cooperate to provide improved anchoring.

Having a single anchor point offers the benefit of easier and faster implantation, making it very easy to position the device, confirm proper function (e.g., using fluoroscopy and/or cardiac ultrasound), and simply anchor it in place. Having multiple anchors and anchor connection points allows for greater stability and redundancy, ensuring the implant is securely and permanently anchored in place. Where multiple anchor connection points and anchors are used, a delivery device can be used that is configured to simultaneously deliver multiple (e.g., two, three, four, etc.) anchors to help provide greater stability and redundancy while maintaining a fast and secure delivery.

77A-B , which are schematic illustrations of an implant 100 e, according to certain applications. Implant 100 e is a variation of implant 100 and may be identical to implant 100 described above, except that it includes a wing 120 e that is a variation of wing 120. A contact surface 122 e of wing 120 e (corresponding to contact surface 122 of wing 120) defines protrusions (e.g., hairs or ridges) 160 and/or recesses (e.g., dimples or pockets) 162 configured to capture blood cells and cell fragments and/or induce tissue growth and/or mild inflammation that locally thickens the underlying leaflet (indicated by reference numeral 17). It is hypothesized that this thickening further contributes to the reduction of regurgitation, for example, by increasing the local stiffness and/or contact of the inferior leaflet, thereby improving coaptation with the opposing leaflet.

As shown, the protruding features and/or recessed portions may be defined by the sheet 126e, for example, by the sheet being textured. For some applications, the protruding features and/or recessed portions may be defined by separate components attached to the sheet.

Referring now to Figures 78A-B and 79 , there are schematic illustrations of an anchor 30b and an anchor 30c, depending on certain applications. Anchors 30b and 30c can be used, as appropriate, in place of any of the other anchors described above. For certain applications, anchors 30b and 30c can be considered variations of anchor 30. Furthermore, the features of anchors 30b and 30c can be combined with each other and/or with the features of the other anchors described herein.

While anchor 30 has a single helical tissue anchor 34, anchors 30b and 30c each have two tissue anchors arranged in a double helix, each with a sharp distal tip. Anchor 30b includes two tissue anchors 34b (i.e., a first tissue anchor 34b' and a second tissue anchor 34b"), while anchor 30c includes two tissue anchors 34c (i.e., a first tissue anchor 34c' and a second tissue anchor 34c").

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

Although anchors 30b and 30c are shown with the two tissue anchoring elements having the same length, for some applications, one tissue anchoring element may be longer than the other, for example, so that one penetrates the tissue first to provide stability while the other is penetrated into the tissue.

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

For some applications, anchor 30b or 30c may include a separate component 32b that serves as an anchor head and/or the portion of the anchor to which the anchor driver is attached. Component 32b is shown in Figures 78A-B as a rod extending across a central longitudinal axis of the anchor between wires 36b' and 36b". For some applications, anchor 30b or 30c may include a single wire defining (i) the two structural attachment elements and (ii) a head 32c and/or the portion of the anchor to which the anchor driver is attached. This is shown in Figure 79. Other anchor head designs are also possible.

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

For some applications, pitch d1 facilitates compression of tissue anchoring region 38 within the tissue, whereas pitch d2 configures head region 39 to resist being compressed into the tissue, for example, such that head region 39 acts as an anchor head.

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

Although the above description contains many specific embodiments of the present invention, these should not be construed as limitations on the scope of the invention, but rather as illustrative examples of such embodiments. Accordingly, the scope of the invention should be determined not by the embodiments illustrated, but by the appended patent claims and their equivalents. Features of one embodiment may be combined with features of other embodiments herein. In particular, features of a given variant of implant 100 may be combined with features of another variant of implant 100, mutatis mutandis.

6: Left atrium 10: Valve, mitral valve 11: Mitral annulus 12: First leaflet, posterior leaflet 14: Opposite leaflet, anterior leaflet 16: Flailing portion of posterior leaflet 30: Anchor 40: Catheter 50: Delivery tool 60: Shaft 70: Actuator 100: Implant 110: Interface 120: Wing 150: Anchor receiver

Claims (57)

A system (20) for use with a valve (10) in a heart of a subject, the valve (10) having a first leaflet (12) and at least one opposing leaflet (14), the heart having a chamber upstream of the valve (10), and the system (20) comprising: an implant (100) comprising: an interface (110), and a flexible wing (120) coupled to the interface ( 110), and having a contact surface (122) and an opposite surface (123) relative to the contact surface (122), wherein the wing (120) includes a frame (124) and a sheet (126) covered on the frame (124); an anchor (30); a catheter (40) that can be advanced through the cavity to the cavity and is configured to receive the implant (100); and a delivery tool (50), comprising: a shaft (60) coupled to the interface (110) and configured, via coupling to the interface (110), to: deploy the implant (100) out of the catheter (40) such that the wing (120) extends away from the interface (110) within the chamber, and to position the implant (100) in a position in which the interface (110) is located within the chamber. At a location in the heart, the wing (120) extends beyond the first leaflet (12) toward the opposing leaflet (14), and the contact surface (122) faces the first leaflet (12), and an actuator (70) coupled to the anchor (30) and configured to anchor the implant (100) in the location by anchoring the interface (110) to the tissue of the heart using the anchor (30). The system of claim 1, wherein the framework is attached to the interface. The system of claim 1, wherein the implant does not include a downstream anchor. The system of claim 1, wherein the location is on an annulus of the valve, the delivery tool is configured to position the implant in the location in which the interface is at the location on the annulus, and the actuator is configured to anchor the implant in the location by anchoring the interface to tissue of the annulus using the anchor. The system of claim 1, wherein the location is on a wall of the chamber, the delivery tool is configured to position the implant in the location in which the interface is at the location on the wall of the chamber, and the actuator is configured to anchor the implant in the location by anchoring the interface to the structure of the wall of the chamber using the anchor. The system of claim 1, wherein the shaft is configured to deploy the wings entirely out of the catheter via an anchoring connection with the interface, and the actuator is configured to anchor the implant in position after the shaft deploys the wings entirely out of the catheter. The system of any one of claims 1-6, wherein the frame is compressible to fit within the conduit. The system of claim 7, wherein the frame is self-expanding, and the catheter is configured to receive the implant, and the wings are constrained within the catheter. The system of any one of claims 1-6, wherein the implant is configured to be received within the catheter, with the wing being located distal to the interface. The system of claim 9, wherein the shaft is configured to deploy the implant out of the catheter such that the wings become exposed from the catheter before the interface. The system of any of claims 1-6, wherein: the position is a first position, the address is a first address, and the shaft, via the coupling with the interface, is configured to, after placement of the implant in the first position, reposition the implant to a second position, wherein the interface is at a second address in the heart, the wing extends beyond the first leaflet toward the opposing leaflet, and the contact surface faces the first leaflet, the second position being different from the first position, and the second address being different from the first address. The system of claim 11, wherein the shaft is configured to reposition the implant into the second position while the wings remain entirely outside of the catheter. The system of any one of claims 1-6, wherein the wing has: a root coupled to the interface, a tip at an end of the wing opposite the root, and two sides extending from the root to the tip. The system of claim 13, wherein: the chamber is an upstream chamber, the heart has a downstream chamber downstream of the valve, and the wing portion is arranged at an angle relative to the interface such that the implant positions the tip within the downstream chamber by positioning the shaft in the position. The system of claim 13, wherein: the first leaflet has a lip, and the wing portion is arranged at an angle relative to the interface such that the implant, with the shaft positioned in the position, positions the tip downstream of the lip of the first leaflet. The system of claim 13, wherein the frame defines two rings extending side by side from the root. The system of claim 16, wherein the two rings extend side by side from the root to the tip. The system of claim 16, wherein the frame connects the two rings to each other only at the interface. The system of claim 16, wherein the sheet is laid over the frame such that the sheet extends over and between the two rings. The system of claim 16, wherein each of the rings defines a space that is substantially free of frame components. The system of claim 16, wherein each of the rings is substantially teardrop-shaped. The system of claim 16, wherein the frame defines an elongated space between the two rings extending from the root toward the tip, and the sheet is laid over the frame such that the sheet extends across the two rings and the space. The system of claim 22, wherein the elongated space is along a reflection symmetry plane of the wing. The system of any one of claims 1-6, wherein the implant defines an interface angle that is adjustable relative to the valve tissue. The system of claim 24, wherein the implant comprises a shaft; and the delivery tool comprises a cable configured to cooperate with the shaft to adjust the angle of the contact surface relative to the valve tissue. The system of claim 24, wherein the implant comprises a hinge, wherein the angle of the contact surface is adjustable relative to the anchor, and wherein the anchor anchors the interface to tissue of the heart. The system of claim 24, wherein the implant comprises a hinge, wherein the angle of the interface is adjustable relative to the valve tissue, and wherein the anchor anchors the interface to the heart tissue. The system of any one of claims 1-6, wherein the implant comprises a gap filler. The system of claim 28, wherein the gap filler comprises a material selected from the group consisting of foam, hydrogel, and silicone. The system of claim 28, wherein the gap filler comprises an expansion mechanism or a coil. A system (20) for use with a valve (10) in a heart of a subject, the valve (10) having a first leaflet (12) and at least one opposing leaflet (14), the heart having a chamber upstream of the valve (10), the system (20) comprising: an implant (100) comprising: an anchor receiver (150) at an interface (110), and a flexible wing (120) coupled to the interface (110) and having a contact surface (122) and an opposite surface (123) relative to the contact surface (122); an anchor (30); a catheter (40) that can be advanced into the cavity and is configured to receive the implant (100); and a delivery tool (50) comprising: a shaft (60) and The implant (100) is anchored to the interface (110) and is configured, through the anchoring to the interface (110), to: deploy the implant (100) out of the catheter (40) such that the wings (120) extend away from the interface (110) within the chamber; and to position the implant (100) in a position in which the interface (110) is located at a site in the heart. The wing (120) extends beyond the first leaflet (12) toward the opposing leaflet (14), and the contact surface (122) faces the first leaflet (12), and an actuator (70) is coupled to the anchor (30) and configured to anchor the implant (100) in position by anchoring the anchor receiver (150) to the tissue of the heart using the anchor (30). According to the system of claim 31, the implant comprises a housing that defines at least a portion of the interface and at least a portion of the anchor receiver. The system of claim 32, wherein the housing includes a sidewall defining an aperture, and wherein the sidewall defines the interface. The system of claim 33, wherein the housing defines a barrier body that protrudes at least partially through the aperture, and wherein the actuator is configured to anchor the interface to the tissue by driving the anchor through the housing until the anchor presses the barrier body toward the tissue. The system of claim 33, wherein the sidewall and the shaft define respective anchoring elements, the shaft being anchored to the interface via anchoring between the anchoring elements of the shaft and the anchoring elements of the sidewall. The system of claim 31, wherein: the anchor comprises a tissue anchoring element and a head, the anchor receptacle defines a bore therethrough and comprises a blocker body, the blocker body protruding inwardly into the bore in a manner that facilitates passage of the tissue anchoring element through the bore but inhibits passage of the head through the bore, and the driver is configured to anchor the anchor to the anchor receptacle by driving the tissue anchoring element through the anchor receptacle until the head of the anchor becomes blocked by the blocker body. The system of claim 36, wherein the obstruction body comprises a crossbar extending across the orifice. The system of claim 36, wherein the baffle body comprises a shaft ring. The system of claim 36, wherein the barrier comprises a sheet of material through which the tissue anchoring element can penetrate. The system of claim 36, wherein the tissue anchoring element is a helical tissue anchoring element, and the driver is configured to drive the tissue anchoring element through the anchor receiver by tightening the tissue anchoring element through the anchor receiver. A system (20) for use with a valve (10) in a heart of a subject, the valve (10) having a first leaflet (12) and at least one opposing leaflet (14), the heart having a chamber upstream of the valve (10), the system (20) comprising: an implant (100) comprising: an interface (110), a flexible wing (120), coupled to the interface (110) and having a contact surface (122) and an opposing surface (123) relative to the contact surface (122), and a reaction force support extending from the interface and away from the wing; an anchor (30); a catheter (40) that can be advanced through the cavity to the chamber and is configured to receive the implant (100); and a delivery tool (50) comprising: a shaft ( 60), is coupled to the interface (110), and is configured, through coupling to the interface (110), to: deploy the implant (100) out of the catheter (40) such that within the chamber, the wings (120) extend away from the interface (110), and to position the implant (100) in a position in which the interface (110) is located at a position in the heart. The implant (100) is provided at a position where the wing (120) extends beyond the first leaflet (12) toward the opposing leaflet (14), and the contact surface (122) faces the first leaflet (12), and an actuator (70) is coupled to the anchor (30) and is configured to anchor the interface (110) to the tissue of the heart using the anchor (30) to anchor the implant (100) in the position. The system of claim 41, wherein the reaction force support comprises a wire loop. The system of claim 41, wherein the counterforce support is configured to prevent the contact surface from moving toward the cavity when the implant is in the position. The system of claim 41, wherein: in the absence of the implant, the first leaflet prolapses into the chamber upstream of the valve during a cardiac cycle of the heart, and the counterforce support is configured to maintain the implant in the position such that the implant supports the first leaflet in a manner that reduces prolapse of the first leaflet. The system of any one of claims 41-44, wherein the counter-force support is shaped so that, when the implant is in the position, the counter-force support contacts a wall of the chamber. The system of claim 45, wherein the counterforce support is configured to press against a wall of the chamber when the implant is in the position. A system (20) for use with a valve (10) in a heart of a subject, the valve (10) having a first leaflet (12) and at least one opposing leaflet (14), the heart having a chamber upstream of the valve (10), and the system (20) comprising: an implant (100) comprising: an interface (110), and a flexible wing (120) coupled to the interface The invention relates to a device for implanting a prosthesis (100) through a first anchor (30) and a second anchor (30) having a contact surface (122) and an opposite surface (123) opposite to the contact surface (122); a first anchor and a second anchor (30); a catheter (40) that can be advanced into the cavity and is configured to receive the implant (100); and a delivery tool (50) comprising: a shaft (60) that is coupled to the interface (110) and is connected to the interface (110) is configured to: deploy the implant (100) out of the catheter (40) such that within the chamber, the wing portion (120) extends away from the interface (110); and position the implant (100) in a position in which the interface (110) is located at a location in the heart and the wing portion (120) extends beyond the first leaflet (12) toward the The opposing leaflet (14), and the contact surface (122) faces the first leaflet (12), and a first actuator (70) that is anchored to the first anchor (30), and a second actuator that is anchored to the second anchor, wherein each actuator is configured to anchor the implant (100) in position by anchoring the interface (110) to the tissue of the heart using the respective anchor (30). The system of claim 47, wherein each actuator is configured to anchor the implant in the location by anchoring the interface to the location using the respective anchor. The system of claim 47, wherein the address is located on an annulus of the valve, the delivery tool is configured to position the implant in the location in which the interface is at the address located on the annulus, and each actuator is configured to anchor the implant in the location by anchoring the interface to tissue of the annulus using the respective anchor. The system of claim 47, wherein the location is on a wall of the chamber, the delivery tool is configured to position the implant in the location in which the interface is at the location on the wall of the chamber, and each actuator is configured to anchor the implant in the location by anchoring the interface to the structure of the wall of the chamber using the respective anchor. The system of claim 47, wherein each actuator extends through the shaft. The system of claim 47, wherein the shaft is configured, via coupling to the interface, to deploy the implant out of the catheter when the actuators are positioned within the shaft. The system of claim 47, wherein the shaft is configured, via coupling to the interface, to deploy the implant out of the catheter when the anchors are positioned within the shaft. The system of any of claims 47-53, wherein the shaft is configured, via coupling to the interface, to fully deploy the wings out of the catheter, and each actuator is configured to anchor the implant in position after the shaft fully deploys the wings out of the catheter. The system of claim 54, wherein the shaft is configured to deploy the implant entirely out of the catheter via an anchoring connection with the interface, and each actuator is configured to anchor the implant in position after the shaft deploys the implant entirely out of the catheter. The system of any of claims 47-53, wherein: the position is a first position, the address is a first address, and the shaft, via the coupling with the interface, is configured to, after placement of the implant in the first position, reposition the implant to a second position, wherein the interface is at a second address in the heart, the wing extends beyond the first leaflet toward the opposing leaflet, and the contact surface faces the first leaflet, the second position being different from the first position, and the second address being different from the first address. The system of claim 56, wherein the shaft is configured to reposition the implant into the second position while each actuator remains engaged with the respective anchor.