The native heart valves (i.e., the aortic, pulmonary, tricuspid, and mitral valves) serve critical functions in assuring the forward flow of an adequate supply of blood through the cardiovascular system. These heart valves can be rendered less effective by congenital malformations, inflammatory processes, infectious conditions, or disease. Such damage to the valves can result in serious cardiovascular compromise or death. Treatment for such disorders can be done with the surgical repair or replacement of the valve during open heart surgery or with transcatheter transvascular techniques for introducing and implanting prosthetic devices in a manner that is much less invasive than open heart surgery.
A healthy heart has a generally 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 generally referred to as the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve includes an annulus portion, which is an annular portion of the native valve tissue surrounding the mitral valve orifice, and a pair leaflets (as referred to as cusps) that extend downward from the annulus into the left ventricle. The mitral valve annulus can form a “D” shaped, oval, or otherwise out-of-round cross-sectional shape having major and minor axes. The anterior leaflet can be larger than the posterior leaflet, forming a generally “C” shaped boundary between the abutting free edges of the leaflets when they are closed together.
When operating properly, the anterior leaflet and the posterior leaflet function together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle dilates, the oxygenated blood that is 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 urges the two leaflets together, thereby closing the one-way mitral valve so that blood cannot flow back to the left atrium and is instead expelled out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing or flailing under pressure and folding back through the mitral annulus toward the left atrium, a plurality of fibrous cords called chordae tendineae tether the leaflets to papillary muscles in the left ventricle.
Valve regurgitation occurs when the native valve fails to close properly and blood flows into the left atrium from the left ventricle during the systole phase of heart contraction. Valve regurgitation (especially 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/leaflet calcification), and/or dysfunctional papillary muscles stretching.
Some techniques for treating leaflet valve regurgitation due to flail and prolapse include stitching or otherwise coupling portions of the native valve leaflets directly to one another, but there is a continuing need for improved devices and methods for treating leaflet flail, prolapse, and restricted leaflet motion.
Many examples herein are directed to towards systems, apparatuses, devices, methods, etc. that can mitigate leaflet flail, prolapse, abnormal leaflet motion, and/or other problems. For example, various embodiments of systems, devices, etc. provide contact pressure on the flailed, prolapsed, or restricted region of the leaflet. Some embodiments of systems, devices, etc. herein are anchored within nearby vasculature. Some embodiments of systems, devices, etc. herein are anchored directly to the annulus and/or a leaflet. Some embodiments of systems, devices, etc. are compressed onto 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 within a heart valve. The system can include a device (e.g., a repair device, a leaflet repair device, an arrestor, etc.) comprising a contact face contoured to and capable of providing contact pressure onto an influent face of a heart valve leaflet (e.g., onto an atrial side of an atrioventricular valve). The system includes an anchor capable of anchoring within vasculature. And the system includes a connector or an anchor receiver that connects the device and the anchor.
In some applications, the device is an implant that comprises a flexible wing and an interface, and the system comprises a delivery tool that is engageable with the interface, and that can be used to position and anchor the interface to tissue of the heart (e.g., to an annulus of the valve being treated) such that the wing extends over a first leaflet of the valve (e.g., over a prolapsing or flailing portion of the leaflet), toward an opposing leaflet of the valve. For some such applications, the wing is curved, and the positioning and anchoring is such that the wing curves 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 face 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 face of the device is capable of providing contact pressure onto a prolapse or a flail of the heart valve leaflet.
In some applications, the system further includes a coaptation portion that is extended from the contact face, the coaptation portion is capable extending the length of the device into coaptation area of the valve.
In some applications, the coaptation portion is capable of helping promote coaptation between the leaflets of the valve.
In some applications, the device is a wire form.
In some applications, the wire form is nitinol, cobalt-chrome (CoCr), stainless steel, titanium, polyglycolic acid (PGA), polylactic acid (PLA), poly-D-lactide (PDLA), polyurethane (PU), poly-4-hydroxybutyrate (P4HB), polycaprolactone (PCL), polyether ether ketone (PEEK), cyclic olefin copolymers (COCs), polyethylene vinyl acetate (EVA), polytetrafluorethylene (PTFE), perfluoroether (PFA), or fluorinated ethylene propylene (FEP).
In some applications, the wire form is compactible to fit within a delivery catheter.
In some applications, the wire form is self-expanding.
In some applications, the system further includes a sheet that is attached upon the wire form, the sheet forming the contact face.
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 onto 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), polyvinylchloride (PVC), polyethylene (PE), polypropylene (PP), polytetrafluoroethylene (PTFE), polyurethane (PU), polyethylene terephthalate (PET), polyethersulfone (PES), polyglycolic acid (PGA), polylactic acid (PLA), poly-D-lactide (PDLA), poly-4-hydroxybutyrate (P4HB), or polycaprolactone (PCL).
In some applications, the system further includes a latch or a hook capable of latching or hooking within a heart valve leaflet commissure or cleft.
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 clasps a wire.
In some applications, the connector or anchor receiver comprises one or more of a rivet, suture, staple, wire, pin, shaft, sheet, mesh, housing, tubular member, cross-bar, etc.
In some applications, the system further includes a clamp that is capable of clamping the device (e.g., repair device, leaflet repair device, arrestor, etc.) to the leaflet.
In some applications, a tether extends from the device and is capable of extending to a pinning location on the effluent side of the valve (e.g., on the ventricular side of an atrioventricular valve).
In some applications, the device incorporates an internal gap in coaptation area of the device. The internal gap is free of wire form.
In some applications, the device incorporates a coaptation element, spacer, gap filler, etc.
In some applications, the coaptation element/spacer/filler comprises foam, hydrogel, or silicone.
In some applications, the coaptation element/spacer/filler comprises a scissor mechanism or a coil.
In some applications, the device incorporates an expandable stent.
In some applications, the device is configured to be implanted within a mitral valve, a tricuspid valve, an aortic valve, or a pulmonic valve.
In some applications, the anchor is configured to be implanted within vasculature nearby 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 traverses the left atrium wall.
In some applications, the system further includes a delivery catheter. The device, the connector, and the anchor are each compactable 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 methods herein, e.g., delivery of the systems/devices herein, can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc.
In some applications, a compressive device is for use within a heart valve. The compressive device includes an influent portion, an effluent portion, and a coaptation portion. The influent portion is capable of situating upon the influent face of a heart valve leaflet. The effluent portion is capable of situating upon the effluent face of a heart leaflet. In some applications, the coaptation portion connect the influent portion and the effluent portion. The influent portion and the effluent portion are capable of compressing together such that the stent can stabilize upon a heart valve leaflet when implanted. The stent is contoured to the shape of heart valve leaflet.
In some applications, the influent portion is capable of providing contact pressure onto a heart valve leaflet prolapse or flail.
In some applications, the compressive device is a wire form.
In some applications, the wire form is nitinol, cobalt-chrome (CoCr), stainless steel, titanium, polyglycolic acid (PGA), polylactic acid (PLA), poly-D-lactide (PDLA), polyurethane (PU), poly-4-hydroxybutyrate (P4HB), polycaprolactone (PCL), polyether ether ketone (PEEK), cyclic olefin copolymers (COCs), polyethylene vinyl acetate (EVA), polytetrafluorethylene (PTFE), perfluoroether (PFA), or fluorinated ethylene propylene (FEP).
In some applications, the wire form is compactible to fit within a delivery catheter.
In some applications, the wire form is self-expanding.
In some applications, the compressive device further includes a sheet that is attached upon the influent portion of 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 onto 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), polyvinylchloride (PVC), polyethylene (PE), polypropylene (PP), polytetrafluoroethylene (PTFE), polyurethane (PU), polyethylene terephthalate (PET), polyethersulfone (PES), polyglycolic acid (PGA), polylactic acid (PLA), poly-D-lactide (PDLA), poly-4-hydroxybutyrate (P4HB), or polycaprolactone (PCL).
In some applications, the compressive device further includes an extended coaptation portion that is capable of extending beyond a leaflet edge. The extended coaptation portion incorporates an impermeable sheet.
In some applications, the extended coaptation portion incorporates a thickened material. The impermeable sheet covers the thickened material, and the thickened material is capable of filling a gap within the aperture of a heart valve when it is closed.
In some applications, the extended coaptation portion includes a bent angle.
In some applications, the compressive device further includes an anchor capable of anchoring within vasculature and a connector or an anchor receiver that connect the compressive device and the anchor.
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 clasps a wire.
In some applications, the connector or anchor receiver comprises one or more of a rivet, suture, staple, wire, pin, shaft, sheet, mesh, housing, tubular member, cross-bar, etc.
In some applications, the compressive device is configured to be implanted within a mitral valve, a tricuspid valve, an aortic valve, or a pulmonic valve.
In some applications, the anchor is configured to be implanted within vasculature nearby the valve, and wherein the connector is traverse to a chamber wall.
In some applications, the compressive 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 traverse the left atrium wall.
In some applications, the compressive device further comprises a delivery catheter and the compressive device is compacted 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 methods herein, e.g., delivery of the systems/devices herein, can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc.
In some applications, a bar device is for use within a heart mitral valve. The bar device includes an arched bar. The bar device includes a hook or latch on each of the two distal ends of the arched bar that are capable of hooking or latching into the commissures of a mitral valve. The bar device includes an anchor capable of anchoring within vasculature. And the bar device includes a connector that connects the arched bar and the anchor.
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 clasps a wire.
In some applications, the connector comprises one or more of a rivet, suture, staple, wire, pin, shaft, sheet, mesh, housing, tubular member, cross-bar, etc.
In some applications, a sheet is extended from the arched bar.
In some applications, a gap filler/spacer/coaptation element is extended from the arched bar.
In some applications, the arched bar is a telescoping bar comprising an inner bar and an outer. The inner bar is capable of sliding within the outer bar such that the length of the telescoping bar is adjustable.
In some applications, a method is provided to deliver a system (e.g., a leaflet repair system, an arrestor system, a prolapse repair system, a flail repair system, a repair system, etc.) to a native valve (e.g., mitral valve, tricuspid valve, etc.) via transcatheter delivery. In some applications, the method includes guiding a puncture catheter or other puncture device (e.g., via a first guide wire, etc.) to vasculature of the heart (e.g., coronary sinus, coronary artery, etc.) adjacent a chamber of the heart (e.g., an atrium, a ventricle, etc.). The method includes puncturing the vasculature (e.g., coronary sinus, etc.) luminal wall and the chamber wall (e.g., atrium wall, etc.). The method includes guiding a delivery catheter (e.g., via a second guide wire, etc.) into the chamber (e.g., atrium, etc.) via the puncture in the vasculature (e.g., coronary sinus, etc.) luminal wall and the chamber wall (e.g., atrium wall, etc.).
In some applications, the method includes releasing a device (e.g., a repair device, a leaflet repair device, an arrestor, etc.) from the delivery catheter within the chamber (e.g., within the atrium, etc.). The method includes situating, using the delivery catheter, the device onto 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 within the vasculature (e.g., coronary sinus, etc.) and the connector or interface connects the device to the anchor traversing the vasculature (e.g., coronary sinus, etc.) luminal wall and the chamber wall (e.g., atrium wall, etc.).
In some applications, the delivery catheter reaches the vasculature (e.g., coronary sinus, etc.) via a transfemoral, a subclavian, a transapical, a transseptal, or a transaortic approach.
The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc.
In some applications, a method is to deliver a compressive device (e.g., stent, clasp, form, etc.) to a native valve (e.g., mitral valve, etc.) via transcatheter delivery. In some applications, the method includes guiding a puncture catheter or other puncture device (e.g., via a first guide wire, etc.) to vasculature of the heart (e.g., coronary sinus, coronary artery, etc.) adjacent a chamber of the heart (e.g., an atrium, a ventricle, etc.). In some applications, the method incudes puncturing the vasculature luminal wall (e.g., coronary sinus luminal wall, coronary artery luminal wall, etc.) and the chamber wall (e.g., atrium wall, ventricular wall, etc.).
In some applications, the method includes guiding a delivery catheter (e.g., via a second guide wire, etc.) into the chamber (e.g., atrium, ventricle, left atrium, left ventricle, etc.) via the puncture in the vasculature luminal wall and the chamber wall.
In some applications, the method includes releasing a compressive device 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 associated therewith) to compress the compressive device onto a portion of a posterior leaflet or other leaflet of the native valve (e.g., mitral valve, etc.) that is experiencing prolapse or flail.
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 within the vasculature (e.g., coronary sinus, etc.) and the connector or interface connects the compressive device to the anchor traversing the vasculature (e.g., coronary sinus, etc.) luminal wall and the chamber wall (e.g., atrium wall, etc.).
In some applications, the delivery catheter reaches the vasculature (e.g., coronary sinus, etc.) via a transfemoral, a subclavian, a transapical, a transseptal, or a transaortic approach.
In some applications, a gap filler/coaptation element/spacer system is configured for use within a heart valve. The gap filler/coaptation element/spacer system includes a gap filler, coaptation element, or spacer capable of expanding within gaps of a heart valve aperture when the valve is closed to fill any gaps in the valve and prevent or inhibit valvular regurgitation. The gap filler/coaptation element/spacer system includes an anchor capable of anchoring within vasculature. The gap filler/coaptation element/spacer system includes a connector or anchor receiver that connects the gap filler/coaptation element/spacer and the anchor.
In some applications, the gap filler/coaptation element/spacer comprises poly(lactic-co-glycolic) acid (PLGA), polyvinylchloride (PVC), polyethylene (PE), polypropylene (PP), polytetrafluoroethylene (PTFE), polyurethane (PU), polyethylene terephthalate (PET), polyethersulfone (PES), polyglycolic acid (PGA), polylactic acid (PLA), poly-D-lactide (PDLA), poly-4-hydroxybutyrate (P4HB), or polycaprolactone (PCL).
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 clasps a wire.
In some applications, the connector or anchor receiver comprises one or more of a rivet, suture, staple, wire, pin, shaft, sheet, mesh, housing, tubular member, cross-bar, etc.
In some applications, the gap filler/coaptation element/spacer is configured to be implanted within a mitral valve, a tricuspid valve, an aortic valve, or a pulmonic valve.
In some applications, the anchor is configured to be implanted within vasculature nearby the valve, and wherein the connector traverses a chamber wall.
In some applications, the device (e.g., repair device, leaflet repair device, arrestor, etc.) 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 atrium wall.
In some applications, the gap filler/coaptation element/spacer system further includes a delivery catheter. The gap filler/coaptation element/spacer, the connector, and the anchor are each compactable 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) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc.
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 within a heart valve for providing contact pressure onto a leaflet. The system includes a device (e.g., a repair device, a leaflet repair device, an arrestor, etc.) having a contact face capable of providing contact pressure onto an influent face 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 chamber wall.
In some applications, the contact face can be contoured to help provide appropriate contact pressure.
In some applications, the contact face 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 face of the device is capable of providing contact pressure onto a prolapse or a flail of the heart valve leaflet.
In some applications, the system includes a coaptation portion that is extended from the contact face. The coaptation portion is capable of extending the length of the device into coaptation area of the valve.
In some applications, the coaptation portion is capable of helping promote coaptation between the leaflets of the valve.
In some applications, the device is a wire form.
In some applications, the wire form is nitinol, cobalt-chrome (CoCr), stainless steel, titanium, polyglycolic acid (PGA), polylactic acid (PLA), poly-D-lactide (PDLA), polyurethane (PU), poly-4-hydroxybutyrate (P4HB), polycaprolactone (PCL), polyether ether ketone (PEEK), cyclic olefin copolymers (COCs), polyethylene vinyl acetate (EVA), polytetrafluorethylene (PTFE), perfluoroether (PFA), or fluorinated ethylene propylene (FEP).
In some applications, the wire form is compactible to fit within a delivery catheter.
In some applications, the wire form is self-expanding.
In some applications, the system includes undulating wire or intersecting wire to provide contact pressure onto a prolapse or a flail of the heart valve leaflet.
In some applications, the system includes a sheet that is attached upon the wire form. The sheet forms the contact face.
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 onto a prolapse or a flail of the heart valve leaflet.
In some applications, the device contains an impermeable coaptation portion and a permeable non-coaptation portion.
In some applications, the impermeable coaptation portion is thickened.
In some applications, the impermeable coaptation portion is capable of being thickened at the site of implantation.
In some applications, the sheet is poly(lactic-co-glycolic) acid (PLGA), polyvinylchloride (PVC), polyethylene (PE), polypropylene (PP), polytetrafluoroethylene (PTFE), polyurethane (PU), polyethylene terephthalate (PET), polyethersulfone (PES), polyglycolic acid (PGA), polylactic acid (PLA), poly-D-lactide (PDLA), poly-4-hydroxybutyrate (P4HB), or polycaprolactone (PCL).
In some applications, the system includes a counterforce support opposite the coaptation area.
In some applications, the counterforce support is configured to engage a heart chamber wall.
In some applications, the anchor is a helical anchor, W-shaped anchor, a T-shaped anchor, or 1-turn spiral.
In some applications, the anchor is one or more helical anchors within a tubular compartment housing. The tubular compartment housing is connected the device.
In some applications, the one or more helical anchors is a single helical anchor coiled within itself that is compressed within the tubular compartment housing.
In some applications, the one or more helical anchors is two more helical anchors layered on top of one another in tandem and compressed within the tubular compartment housing.
In some applications, the one or more helical anchors is two more helical anchors comprising an inner helix (or inner helical anchor portion) and an outer helix (or outer helical anchor portion) and compressed within the tubular compartment housing.
In some applications, the two or more helical anchors are configured to embed within the tissue at two angles askew from each other.
In some applications, the system includes a fulcrum connected to the tubular compartment housing such that the plane of the device contact face is adjustable.
In some applications, the system includes a sliding mechanism incorporated on edges of the tubular compartment housing such that the plane of the device contact face is adjustable.
In some applications, the system includes a swing hinge or a soft hinge connected to the device.
In some applications, the device incorporates an internal gap in coaptation area of the device. The internal gap is free of wire form.
In some applications, the device incorporates a gap filler, coaptation element, or spacer.
In some applications, the gap filler/coaptation element/spacer comprises material selected from: foam, hydrogel, or silicone.
In some applications, the gap filler/coaptation element/spacer comprises a scissor mechanism or a coil.
In some applications, the device incorporates an expandable stent.
In some applications, the device is configured to be implanted within the mitral valve.
In some applications, the system includes a delivery catheter, wherein the device and the anchor are each compactable within the delivery catheter.
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 via a transcatheter procedure through a coronary sinus to a mitral valve.
In some applications, a netting system is for used within a heart valve. The netting system includes a netting device having a netting with a contact face capable providing contact pressure onto an influent face of a heart valve leaflet. The lateral edges of the netting device are capable of situating within a heart valve crevice. The netting system includes an anchor attached to the netting and capable of anchoring within tissue of the leaflet, the annulus, or chamber wall.
In some applications, the netting is poly(lactic-co-glycolic) acid (PLGA), polyvinylchloride (PVC), polyethylene (PE), polypropylene (PP), polytetrafluoroethylene (PTFE), polyurethane (PU), polyethylene terephthalate (PET), polyethersulfone (PES), polyglycolic acid (PGA), polylactic acid (PLA), poly-D-lactide (PDLA), poly hydroxybutyrate (P4HB), or polycaprolactone (PCL).
In some applications, the anchor is a helical anchor configured to be housed within a tubular compartment connected to the netting device.
In some applications, the netting system includes a tether that extends from a coaptation portion of the netting device.
In some applications, the netting system includes a wire form outlining the netting.
In some applications, the netting device is configured to be implanted within a mitral valve, a tricuspid valve, an aortic valve, or a pulmonic valve.
In some applications, the netting system includes a delivery catheter. The netting device and the anchor are each compactable within the delivery catheter.
In some applications, a method of repairing a native heart valve of a heart comprises advancing a delivery catheter transvascularly to the native heart valve, advancing an anchor (which can be the same as or similar to any anchors or securing features described herein) from the delivery catheter into tissue of the heart, thereby anchoring a leaflet repair implant/device (which can be the same as or similar to any implants/devices 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 done prior to releasing the leaflet repair implant from the delivery catheter, such that the leaflet repair implant extends along a portion of the 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 done subsequently to releasing the leaflet repair implant from the delivery catheter, such that the leaflet repair implant extends along a portion of the leaflet of the native heart valve.
In some applications, advancing a delivery catheter transvascularly to the native heart valve is done via a transfemoral, a subclavian, a transapical, a transseptal, or a transaortic approach.
In some applications, advancing a delivery catheter transvascularly to the native heart valve is done 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 includes 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 and applies a contact pressure to at least one of a prolapse portion of the leaflet and a flail portion of the leaflet.
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 inside the delivery catheter to an expanded configuration outside of 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 anywhere herein that apply a contract pressure to a leaflet of a native valve.
In some applications, the leaflet repair implant/device is a compressive implant/device and releasing the leaflet repair implant from the delivery catheter includes attaching the compressive implant/device to the leaflet such that a portion of the leaflet experiencing prolapse, flail, or rigidity is compressed between an influent side (e.g., a side attached to or in contact with an influent side of the leaflet) and an effluent side (e.g., a side attached to or in contact with an effluent side of the leaflet) of the compressive device. The compressive implant/device can be the same as or similar to any of the implants/devices described anywhere herein that apply a compressive force to or compress a leaflet of a native valve.
In some applications, the leaflet repair implant/device is a bar implant/device, and wherein releasing the leaflet repair implant from the delivery catheter includes securing ends of the bar device into commissures of the native heart valve. The bar implant/device can be the same as or similar to any of the implants/devices described anywhere herein that comprise a bar, elongate extension, arch, arched bar, etc.
In some applications, the leaflet repair implant/device is a netting implant/device releasing the leaflet repair implant/device from the delivery catheter includes releasing the netting implant/device from the delivery catheter. The netting implant/device can be the same as or similar to any of the implants/devices described anywhere herein that include a netting.
There is further provided, in accordance with some applications, a system and/or an apparatus for use with a valve of a heart of a subject (e.g., a native valve, mitral valve, tricuspid valve, other valve, etc.), the heart having a chamber upstream of the valve, and the system/apparatus including an implant, an anchor, a catheter, and a delivery tool. The implant can include an interface, and/or a flexible wing. The wing can be coupled to the interface. The wing can have a contact face and an opposing face opposite the contact face. The catheter is typically, transluminally advanceable to the chamber, and configured to house the implant.
The delivery tool can comprise a shaft, engaged with the interface. The shaft can be configured, via engagement with the interface, to deploy the implant out of the catheter such that, within the chamber, the wing extends away from the interface. Alternatively or additionally, the shaft can be configured to position the implant in a position in which the interface is at a site in the heart, the wing extends over a first leaflet of the heart toward at least one opposing leaflet (e.g., an opposing leaflet portion) of the heart, and the contact face faces the first leaflet.
The delivery tool can comprise a driver, engaged with the anchor, and configured to secure the implant in the position by using the anchor to anchor the interface to tissue of the heart.
In some applications, the implant does not include a downstream anchor.
In some applications, the implant includes exactly one anchor.
In some applications, the contact face is concave.
In some applications, the catheter is configured to house the implant while the wing is constrained within the catheter.
In some applications, the driver is configured to secure the implant in the position by using the anchor to anchor the interface at the site.
In some applications, the site is on an annulus of the valve, the delivery tool is configured to position the implant in the position in which the interface is at the site on the annulus, and the driver is configured to secure the implant in the position by using the anchor to anchor the interface to tissue of the annulus.
In some applications, the site is on a wall of the chamber, the delivery tool is configured to position the implant in the position in which the interface is at the site on wall of the chamber, and the driver is configured to secure the implant in the position by using the anchor to anchor the interface to tissue of the wall of the chamber.
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 driver 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 driver is configured to secure the implant in the position by driving the anchor through the first leaflet and into the tissue of the heart.
In some applications, the shaft is configured, via the engagement with the interface, to deploy the wing entirely out of the catheter, and the driver is configured to secure the implant in the position subsequently to the shaft deploying the wing entirely out of the catheter.
In some applications, the shaft is configured, via the engagement with the interface, to deploy the implant entirely out of the catheter, and the driver is configured to secure the implant in the position subsequently to the shaft deploying the implant entirely out of the catheter.
In some applications, the driver extends through the shaft.
In some applications, the shaft is configured, via the engagement with the interface, to deploy the implant out of the catheter while the driver is disposed within the shaft.
In some applications, the shaft is configured, via the engagement with the interface, to deploy the implant out of the catheter while the anchor is disposed within the shaft.
In some applications, the implant is configured to be housed within the catheter with the wing distal to the interface.
In some applications, the shaft is configured to deploy the implant out of the catheter such that the wing becomes exposed from the catheter prior to the interface.
In some applications, the implant includes an anchor receiver at the interface (e.g., the interface can comprise an anchor receiver), and the driver is configured to anchor the interface to the tissue by using the anchor to anchor the anchor receiver to the tissue.
In some applications, the interface defines a space therein, and the anchor receiver is disposed in the space.
In some applications, the implant includes a housing that defines at least part of the interface and at least part of the anchor receiver.
In some applications, the housing includes a lateral wall that circumscribes an aperture, and the lateral wall defines the interface.
In some applications, the housing defines an obstruction that protrudes at least partway across the aperture, and the driver 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 lateral wall and the shaft define respective engagement elements, the shaft being engaged with the interface via engagement between the engagement elements of the shaft and the engagement elements of the lateral wall.
In some applications, the driver 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 anchor receiver by driving the anchor through the anchor receiver.
In some applications, the anchor includes a tissue-engaging element and a head, the anchor receiver defines an aperture therethrough, and includes an obstruction that protrudes medially into the aperture in a manner that facilitates passage of the tissue-engaging element through the aperture but inhibits obstructs passage of the head through the aperture, and the driver is configured to anchor the anchor to the anchor receiver by driving the tissue-engaging element through the anchor receiver until the head of the anchor becomes obstructed by the obstruction.
In some applications, the obstruction includes a cross-bar that traverses the aperture.
In some applications, the obstruction includes a collar.
In some applications, the obstruction includes a sheet that is penetrable by the tissue-engaging element.
In some applications, the tissue-engaging element is a helical tissue-engaging element, and the driver is configured to drive the tissue-engaging element through the anchor receiver by screwing the tissue-engaging element through the anchor receiver.
In some applications, the position is a first position, the site is a first site, and via the engagement with the interface, the shaft is configured to, after placing the implant in the first position, reposition the implant into a second position in which the interface is at a second site in the heart, the wing extends over the first leaflet toward the opposing leaflet, and the contact face faces the first leaflet, the second position being different from the first position, and the second site being different from the first site.
In some applications, the shaft is configured to reposition the implant into the second position while the wing remains 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 spread over the frame.
In some applications, the frame includes at least one frame material selected from the group consisting of: of nitinol, cobalt-chrome, stainless steel, titanium, polyglycolic acid, polylactic acid, poly-D-lactide, polyurethane, poly-4-hydroxybutyrate, polycaprolactone, polyether ether ketone, a cyclic olefin copolymer, polyethylene vinyl acetate, polytetrafluorethylene, a perfluoroether, and fluorinated ethylene propylene.
In some applications, the frame is compactible to fit within the catheter.
In some applications, the frame is self-expanding.
In some applications, the frame is attached to the interface.
In some applications, the sheet includes at least one sheet material selected from the group consisting of: poly(lactic-co-glycolic) acid, polyvinylchloride, polyethylene, polypropylene, polytetrafluoroethylene, polyurethane, polyethylene terephthalate, polyethersulfone, polyglycolic acid, polylactic acid, poly-D-lactide, poly-4-hydroxybutyrate, and polycaprolactone.
In some applications, the wing has a root that is coupled to the interface, a tip at an opposite end of the wing from the root, and two lateral 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 an angular disposition of the wing with respect to the interface is such that positioning, by the shaft, of the implant in the position disposes the tip within the downstream chamber.
In some applications, the first leaflet has a lip, and an angular disposition of the wing with respect to the interface is such that positioning, by the shaft, of the implant in the position disposes the tip downstream of the lip of the first leaflet.
In some applications, the frame defines two loops extending from the root alongside each other.
In some applications, the two loops extend alongside each other from the root to the tip.
In some applications, the frame connects the two loops to each other only at the interface.
In some applications, the sheet is spread over the frame such that the sheet extends over and between the two loops.
In some applications, each of the loops circumscribes a space that is substantially absent of frame components.
In some applications, each of the loops is substantially teardrop-shaped. In some applications, each of the loops is substantially oval, ovoid, or triangular.
In some applications, the wing is curved in the direction of the valve leaflet. In some applications, the wing curves from the interface in one direction and then curves in the opposite direction moving toward the end.
In some applications, the frame defines an elongate space between the two loops, extending from the root toward the tip, and the sheet is spread over the frame such that the sheet extends across the two loops and the space.
In some applications, the elongate space runs along a plane of reflectional symmetry of the wing.
In some applications, the elongate space extends from the root to the tip, such that the frame does not bridge the two loops at the tip.
In some applications, the sheet has a plurality of holes therethrough.
In some applications, the holes are polygonal and are 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 through the interface and the wing, the contact face 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 is in a plane of reflectional symmetry of the implant.
In some applications, the implant further includes a counterforce support, extending from the interface and away from the wing.
In some applications, the counterforce support is shaped such that, in the position, the counterforce support lies against a wall of the chamber.
In some applications, the catheter has a distal opening, and is configured to house the implant with the wing disposed distally from the interface, and the interface disposed distally from the counterforce support.
In some applications, the counterforce support includes a wire loop.
In some applications, the shaft is configured to be engaged with the interface within the catheter such that the shaft extends, within the catheter, proximally away from the interface and past the counterforce support.
In some applications, the anchor is a first anchor, and the system/apparatus further includes a second anchor that is configured to anchor the interface to the tissue.
In some applications, the driver is configured to secure the implant in the position by using the second anchor to anchor the interface to the tissue.
In some applications, the driver is a first driver, and the delivery tool further includes a second driver, engaged with the second anchor, and configured to secure the implant in the position by using the second anchor to anchor the interface to the tissue.
In some applications, the anchor includes a helical tissue-engaging element, and the driver is configured to secure the implant in the position by screwing the tissue-engaging element into the tissue.
In some applications, the tissue-engaging element is a first tissue-engaging element, and the anchor further includes a second helical tissue-engaging element, the first tissue-engaging element and the second tissue-engaging element arranged as a double helix.
In some applications, the anchor has a proximal end and a distal end, and each of the first tissue-engaging element and the second tissue-engaging element has a sharpened distal tip at the distal end of the anchor, and is shaped as a conic helix that widens toward the distal end of the anchor.
In some applications, the first tissue-engaging element is defined by a first wire, and the second tissue-engaging element is defined by a second wire.
In some applications, along a longitudinal axis of the anchor, the anchor has: a tissue-engaging region in which: a first wire defines the first tissue-engaging element, a second wire defines the second tissue-engaging element, and the first wire and the second wire each has a tissue-engaging pitch that is 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 has a head pitch that is such that, within the double helix, turns of the first wire abut turns of the second helix. The head region can also be arranged along the longitudinal axis of the anchor.
In some applications, the tissue-engaging 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 that has a sharpened distal tip. In some applications, the wire has: a first helical portion that has a first pitch, and that defines a head of the anchor, and a second helical portion that has a second pitch that is greater than the first pitch, that defines the tissue-engaging element, and that terminates at the sharpened distal tip. In some applications, the first pitch configures the first helical portion to resist being screwed into the tissue.
In some applications, the contact face is shaped to define leaflet-thickening elements, configured to induce thickening of the first leaflet where the wing extends over the first leaflet.
In some applications, the leaflet-thickening elements include protrusions.
In some applications, the leaflet-thickening elements include recesses.
There is further provided, in accordance with some applications, a method for use with a valve of a heart of a subject (e.g., a native valve, mitral valve, tricuspid valve, other valve, etc.), the heart having a chamber upstream of the valve, and the method including, within a catheter, advancing to the chamber (1) an implant that includes an interface and a flexible wing coupled to the interface, the wing having a contact face, and an opposing face opposite the contact face, and (2) a shaft engaged with the interface.
In some applications, the method further comprises, using the shaft to deploy the implant out of the catheter such that, within the chamber, the wing extends away from the interface.
In some applications, the method further comprises subsequently, using the shaft, positioning the implant in a position in which the interface is at a site in the heart, the wing extends over a first leaflet of the valve toward at least one opposing leaflet (e.g., an opposing leaflet portion) of the valve, and the contact face faces the first leaflet.
In some applications, the method further comprises subsequently securing the implant in the position by anchoring the interface to tissue of the heart.
In some applications, advancing the implant to the chamber includes advancing the implant to the chamber while the wing is constrained within the catheter.
In some applications, the wing has a root that is coupled to the interface, and a tip at an opposite end of the wing from the root, the chamber is an upstream chamber, the heart has a downstream chamber downstream of the valve, and positioning the implant in the position includes positioning the implant such that the tip is disposed within the downstream chamber.
In some applications, the wing has a root that is coupled to the interface, and a tip at an opposite end of the wing from 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 face is concave, and positioning the implant in the position includes positioning the implant such that the concave contact face contacts the first leaflet.
In some applications, positioning the implant in the position includes positioning the implant such that the opposing face 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 to the chamber includes advancing the implant to 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 to the chamber includes advancing the implant to 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 to the chamber includes advancing the implant to 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 to the chamber includes advancing the implant to the right ventricle.
In some applications, the site is on an annulus of the valve, and anchoring the interface to the tissue of the heart includes anchoring the interface to tissue of the annulus.
In some applications, the site is on a wall of the chamber, and anchoring the interface to the tissue of the heart includes anchoring the interface to tissue of the wall of the chamber.
In some applications, anchoring the interface to the tissue of the heart includes pinning the first leaflet to the tissue of the heart.
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 becomes sandwiched between the delivery tool and a wall of the downstream chamber, and securing 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-engaging element, and using the driver to drive the anchor into the tissue includes using the driver to screw the tissue-engaging element into the tissue.
In some applications, the implant includes an anchor receiver at the interface, and the method further includes using the driver to anchor the anchor to the anchor receiver.
In some applications, anchoring the interface to the tissue includes using the driver to drive the anchor through the anchor receiver and into the tissue.
In some applications, the anchor includes a tissue-engaging element and a head, the anchor receiver defines an aperture therethrough, and includes an obstruction that protrudes 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-engaging element beyond the obstruction until the head of the anchor becomes obstructed by the obstruction.
In some applications, the obstruction includes a cross-bar that traverses the aperture, and using the driver to drive the tissue-engaging element beyond the obstruction until the head of the anchor becomes obstructed by the obstruction includes using the driver to drive the tissue-engaging element beyond the cross-bar until the head of the anchor becomes obstructed by the cross-bar.
In some applications, the obstruction includes a collar, and using the driver to drive the tissue-engaging element beyond the obstruction until the head of the anchor becomes obstructed by the obstruction includes using the driver to drive the tissue-engaging element beyond the collar until the head of the anchor becomes obstructed by the collar.
In some applications, the obstruction includes a flexible sheet, and using the driver to drive the tissue-engaging element beyond the obstruction until the head of the anchor becomes obstructed by the obstruction includes using the driver to pierce the sheet with the tissue-engaging element, and to drive the tissue-engaging element through the sheet until the head of the anchor becomes obstructed by the sheet.
In some applications, the implant includes a housing that includes a lateral wall that circumscribes an aperture, the lateral wall defining at least part of the interface, and positioning the implant in the position includes positioning the implant in the position using the shaft while the shaft is engaged with the lateral wall.
In some applications, the implant defines an obstruction that protrudes at least partway across the aperture, and anchoring the interface to the tissue includes anchoring the housing to the tissue by using the driver to drive the anchor through the housing until the anchor presses the obstruction toward the tissue.
In some applications, the implant further includes a counterforce support, and deploying the implant out of the catheter includes deploying the implant out of the catheter such that the counterforce support extends from the interface and away from the wing.
In some applications, the position is a position in which the counterforce support lies against a wall of the chamber, and positioning the implant in the position includes positioning the implant in the position in which the counterforce support lies against the wall of the chamber.
In some applications, deploying the implant out of the catheter includes deploying, out of the catheter, the wing, followed by the interface, followed by the counterforce support.
In some applications, deploying the implant out of the catheter includes deploying the wing out of the catheter while the shaft extends, within the catheter, proximally away from the interface and past the counterforce support.
In some applications, positioning the implant in the position includes positioning the implant in the position subsequently to deploying the wing entirely out of the catheter.
In some applications, positioning the implant in the position includes positioning the implant in the position subsequently to deploying the implant entirely out of the catheter.
In some applications, the position is a first position, the site is a first site, and the method further includes, after placing the implant in the first position, repositioning the implant into a second position in which the interface is at a second site in the heart, the wing extends over the first leaflet toward the opposing leaflet, and the contact face faces the first leaflet, the second position being different from the first position, and the second site being different from the first site.
In some applications, the first site is a first site on an annulus of the valve and the second site is a second site on the annulus of the valve.
In some applications, repositioning the implant into the second position includes, using the shaft, sliding the interface along the annulus.
In some applications, repositioning the implant into the second position includes, using the shaft, lifting the interface away from the annulus at the first site, and replacing the interface against the annulus at the second site.
In some applications, repositioning the implant into the second position includes repositioning the implant into the second position prior to anchoring the interface to the tissue.
In some applications, the method further includes, subsequently to anchoring the interface to the tissue, de-anchoring the interface from the tissue, repositioning the implant into the second position includes repositioning the implant into the second position subsequently to de-anchoring the interface from the tissue, and the method further includes, subsequently to repositioning the implant into the second position, re-anchoring the interface to the tissue.
In some applications, the method further includes receiving information indicative of regurgitation through the valve while the implant is positioned at the first position, and repositioning the implant into the second position includes repositioning the implant into the second position responsively to receiving the information.
In some applications, the information is echocardiographic information, and repositioning the implant into the second position includes repositioning the implant into the second position responsively to receiving the echocardiographic 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 position includes repositioning the implant into the second position while the implant remains entirely outside of the catheter.
In some applications, the deploying the implant out of the catheter includes deploying the implant out of the catheter while the driver is disposed within the shaft.
In some applications, the deploying the implant out of the catheter includes deploying the implant out of the catheter while the anchor is disposed within the shaft.
The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc.
The present invention will be more fully understood from the following detailed description of applications thereof, taken together with the drawings, in which:
Systems, apparatuses, devices, methods, etc. for mitigating heart valve regurgitation are described herein. In some applications, systems, apparatuses, devices, methods, etc. include implants/devices that situate within the valvular annulus and anchor within the annulus and/or nearby vasculature. The systems, apparatuses, devices, methods, etc. can be configured to provide contact pressure onto and/or support to the leaflet region experiencing flail, prolapse, rigidity, etc. In some applications, systems, apparatuses, devices, methods, etc. capable of compressing onto a leaflet and providing contact pressure onto and/or support to the leaflet region experiencing flail, prolapse, rigidity, etc. are described, e.g., compressive devices, clasps, splints, forms, etc. In some applications, systems, apparatuses, devices, etc. are described that further anchor to into the leaflet annulus or a nearby vasculature, the systems, apparatuses, devices, etc. providing contact pressure onto and/or support to the leaflet region experiencing flail, prolapse, rigidity, etc. Various examples of methods of delivering to and implanting systems, apparatuses, devices, etc. at the site of flail, prolapse, rigidity, etc. are described. An example of where these can be helpful is when used at the posterior leaflet of a mitral valve experiencing flail, prolapse, rigidity, and/or another issue.
The described systems, apparatuses, devices, methods, etc. should not be construed as limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed implementations and applications, alone and in various combinations and sub-combinations with one another. The disclosed systems, apparatuses, devices, methods, etc. are not limited to any specific aspect, feature, or combination thereof, nor do the disclosed systems, apparatuses, devices, methods, etc. require that any one or more specific advantages be present or problems be solved. Further, the techniques, methods, operations, steps, etc. described or suggested herein can be performed on a living animal (e.g., human, other mammal, etc.) or on a non-living simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, tissue, etc. being simulated), anthropomorphic phantom, etc.
Various implementations of systems, devices, examples of prosthetic implants, etc. are disclosed herein, and any combination of the described features, components, and options can be made unless specifically excluded. For example, various descriptions of anchors, can be used with any appropriate prosthetic device, and/or delivered and implanted by any appropriate method, even if a specific combination is not explicitly described. Likewise, the different constructions and features of devices and systems can be mixed and matched, such as by combining any implant device type/feature, attachment type/feature, site of repair, etc., even if not explicitly disclosed. In short, individual components of the disclosed systems can be combined unless mutually exclusive or physically impossible.
Although the operations of some of the disclosed methods are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially can in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed systems, apparatuses, devices, methods, etc. can be used in conjunction with other systems, apparatuses, devices, methods, etc.
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Throughout the document, description and drawings often refer to the left chambers, and specifically to the mitral valve (MV) and coronary sinus (CS), as examples for the various implementations described. It is to be noted, however, that the various implementations and applications described can be utilized on other valves (e.g., tricuspid valve, pulmonary valve, aortic valve, etc.) and other vasculature (e.g., coronary artery, etc.) mutatis mutandis, as can be appreciated by those skilled in the art.
Several implementations and applications herein are directed towards systems, apparatuses, devices, etc. (e.g., leaflet repair systems, arrestor systems, prolapse repair systems, flail repair systems, repair systems, etc.) that arrest or otherwise treat valve leaflet issues, such as flail, prolapse, rigidity, etc. In some applications, a system, apparatus, device, etc. herein is capable of being situated at the influent side of a valve such that it can apply contact pressure or support onto a region of flail, prolapse, rigidity, etc. The contact pressure or support provided by various implementations can help flatten out and/or reshape the flail, prolapse, rigidity, and/or abnormality, which helps to extend the coapting edge of a leaflet back towards the coaptation area when in a closed position. Proper coaptation that results in a fully closed valve prevents valve regurgitation. In some applications, the system, apparatus, device, etc. is configured to support, arrest, and/or depress a leaflet to prevent the leaflet from flailing or flipping towards the influent side of the valve. Likewise, in some applications, the system, apparatus, device, etc. is configured to support, arrest, and/or depress a leaflet to prevent the leaflet from prolapsing or from protruding or bulging towards the influent side of the valve.
In some applications, a system, apparatus, device, etc. herein (e.g., leaflet repair system, arrestor system, prolapse repair system, flail repair system, repair system, etc.) includes (but is not limited to) one face that is to directly contact the face of a leaflet experiencing leaflet issues, e.g., flail, prolapse, rigidity, etc. Typically, the influent face of a leaflet is the face that experiences flail, prolapse, rigidity, and/or other issues. In some applications, the contact face of the device is contoured to the influent face of a leaflet, which can be a hyperbolic paraboloid-like contour. In some applications, the contact face of the system/device provides contact pressure on a leaflet flail, prolapse, rigidity, and/or abnormality. In some applications, the contact face has a width and a length such that it can cover the region of the leaflet experiencing flail, prolapse, rigidity, and/or abnormality. In some applications, the length of the system/device extends into the coaptation area 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 system, apparatus, device, etc. herein includes an anchor to stabilize the system/device at the site of implantation. In some applications, a system/device includes a portion that is in connection with the anchor. In some applications, the anchor connection point (e.g., anchor receiver, etc.) is near or in contact with the valve annulus or a ventricle or atrium wall. In some applications, an anchor connection point includes a hinge capable of adjusting the plane of the contact face of the system/device relative to the anchoring point. In some applications, a swing hinge is utilized. In some applications, a hinge is made of soft compliable material (e.g., cloth or mesh) such that the plane of the system/device contact face is adjustable relative to the anchoring point. In some applications, a fulcrum is incorporated at the anchoring point such that the plane of the contact face is adjustable relative to the anchoring point. In some applications, sliding mechanisms are incorporated at the edges of the anchoring point such that the plane of the contact face is adjustable relative to the anchoring point.
In some applications, the anchor connection point or anchor receiver is configured as an interface. The interface can connect with a catheter or shaft for delivering and positioning the system/device.
In some applications, an anchor is situated near or in contact with the valve annulus, leaflet area, or atrium/ventricle wall. In some applications, an anchor is a helical anchor, screw, or other feature capable of screwing/rotating within or embedding within the valve annulus, leaflet, or atrium/ventricle wall.
In some applications, a helical anchor is housed within a tubular compartment, the tubular compartment connected to or a part of the device to be anchored. In some applications, the tubular compartment includes one, two, or more helixes or helical anchor portions therein to anchor the device. In some applications, the helix(es) or helical anchor portion(s) are pushed through the tubular compartment to screw or rotate within the tissue at the anchoring site. In some applications, the helix(es) or helical anchor portion(s) are compressible (e.g., like a spring) within the tubular compartment such that the tubular compartment maintains a low profile; the helix(es) or helical anchor portion(s) are decompressed as the helix(es) or helical anchor portion(s) are screwed or rotated within the tissue at the anchoring site. In some applications having a single helix or helical anchor portion within the housing, the helix or helical anchor portion is coiled within itself to maintain a very low profile. In some applications having two or more helix(es) or helical anchor portion(s) within the housing, the helix(es) or helical anchor portion(s) are layered on top of one another in tandem. In some applications having two or more helix(es) or helical anchor portion(s) within the housing, one helix or helical anchor portion is radially within the other helix or helical anchor portion such that there is at least one an inner helix or inner helical anchor portion and at least one outer helix or outer helical anchor portion. In some applications having two or more helix(es) or helical anchor portion(s) within the housing, the helix(es) or helical anchor portion(s) are configured to embed within the tissue at the anchoring site at two angles askew from each other.
In some applications, an anchor is situated near or in contact with the ventricle or atrium wall on the opposite side of the wall from the anchor connection point (e.g., within nearby vasculature). In some applications, a connector is utilized to connect the anchor, the connector traversing through the ventricle or atrium wall. Any appropriate connector can be utilized, such as (for example) a screw, rivet, suture, staple, wire, pin, or shaft. In some applications, a connector wire is utilized such that the wire tension between the device and the anchor is taut.
In some applications, an anchor is situated within vasculature that is on the opposite side of a chamber (i.e., ventricle or atrium) wall. For example, various implant or device implementations herein are configured to mitigate leaflet issues, such as flail, prolapse, and/or rigidity, of the mitral valve and thus are situated within the left atrium. In these various implementations, a device can be connected with an anchor situated within the coronary sinus utilizing a connector traversing through the atrial wall. Any appropriate anchor can be utilized. In some applications, an anchor is wire stent or wire form capable of expanding within vasculature. In some applications, an anchor is a pin fastener (e.g., R-pin, etc.) or wire fastener capable of pinning a device via a connector to the ventricle or atrium wall. In some applications, a pin or wire fastener is utilized on the opposite side of a ventricle or atrium wall and the connector traverses the wall. In some applications, a pin fastener is utilized within vasculature that is on the opposite of a ventricle or atrium wall. In some applications, a wire fastener is capable of pinching a connector wire to hold the wire in place and create tension between the wire fastener anchor and the device.
In some applications, a system and/or device is anchored utilizing a T-shaped anchor capable of fitting within and clinging to a crevice within the heart valve (e.g., cleft or commissure). In some applications, a T-shaped anchor has two arms (i.e., the cross portion of the T-shape) and connecting portion (i.e., the vertical portion of the T-shape). In some applications, the connecting portion is connected to a device to hold the device at the site of deployment. In some applications, the two arms are capable of contracting and expanding; in a contracted state the two arms are parallel (or near parallel) with the connecting portion and in the expanded state the two arms are orthogonal (or near orthogonal) with the connecting portion. In some applications, when the anchored is deployed, the two arms enter into the crevice in a contracted state and are expanded within a crevice within the heart valve and under the leaflet such that it is secured within the crevice.
In some applications, a system, implant, and/or device herein is additionally directly anchored or fastened to the leaflet experiencing issues, e.g., flail, prolapse, rigidity, and/or other issues. In some applications, an anchor is a pin fastener (e.g., R-pin, R-key, etc.) or wire fastener capable of pinning a device via a connector to the leaflet. In some applications, a pin or wire fastener is utilized on the effluent side of a leaflet (e.g., a ventricular side of an atrioventricular valve leaflet) and the connector traverses through the leaflet. In some applications, an anchored system/device has a length that extends from the anchor to the coapting edge of a leaflet, where a clamp is utilized to anchor the system/device to the leaflet edge by pinching or compressing the device edge and leaflet edge together.
In some applications, a system and/or device herein incorporates a tether or artificial chord for further stabilization at the site of implantation. In some applications, a tether or chord extends from the coaptation portion of a device to a pinning location on the effluent side of the valve, where the tether is pinned down. The pinning location can be any sturdy feature, such as (for example) ventricle wall, atrium wall, papillary muscle, and/or nearby vasculature.
In some applications, a system and/or device herein (e.g., leaflet repair system/device, arrestor system/device, prolapse repair system/device, flail repair system/device, repair system/device, etc.) comprises wire form frame and/or a wire form device (e.g., a device comprising a wire form frame). Any appropriate material to produce a wire form can be utilized, including (but not limited to) nitinol, cobalt-chrome (CoCr), stainless steel, titanium, polyglycolic acid (PGA), polylactic acid (PLA), poly-D-lactide (PDLA), polyurethane (PU), poly-4-hydroxybutyrate (P4HB), polycaprolactone (PCL), polyether ether ketone (PEEK), cyclic olefin copolymers (COCs), poly ethylene vinyl acetate (EVA), polytetrafluorethylene (PTFE), perfluoroether (PFA), fluorinated ethylene propylene (FEP), additives thereof, and derivatives thereof. In some applications, a wire form device or wire form frame is contractible, which is useful to fit within a catheter in a more compact or collapsed configuration for less invasive catheter delivery methodologies. In some applications, nitinol is utilized for its self-expanding properties, which can be useful to implant the device in less invasive catheter delivery methodologies.
Various shapes of wire form devices or wire form frames can be utilized in various different implementations and applications. In some applications, a wire form frame/device is shaped to have portions of the wire form provide contact pressure or support on the leaflet issue, e.g., on the flail, prolapse, and/or rigidity of a leaflet. In some applications, a wire form frame/device has length and width to surround an area of flail or prolapse and utilizes a sheet extending across the area to provide contact pressure on the flail, prolapse, rigidity, etc. In some applications, a wire form frame or wire form device has length and width to surround an area of flail or prolapse and utilizes wire that undulates or intersects across the area to provide contact pressure on the flail, prolapse, rigidity, etc. In some applications, a wire form frame or wire frame device is free of wire at an internal portion of the coaptation area devoid of wire such that any future procedures that may be needed at some later time can still be performed on the native leaflet coaptation area (e.g., edge to edge repair, such as suturing or clamping leaflet edges together). In some applications, a wire form frame or wire form device includes a support or counterforce support extending from the portion of the wire form device opposite of the coaptation area, which can help the wire form device provide contact pressure on the flail, prolapse, rigidity, etc. In some applications, the support or counterforce support is configured to contact a heart chamber wall (e.g., atrium or ventricle wall). In some applications, a wire form device includes an indentation or hook formed via the wire, which can help secure the device within the site of implantation by fitting within or hooking onto the commissures, clefts or other similar valve areas.
In some applications, a system and/or device herein (e.g., leaflet repair system/device, arrestor system/device, prolapse repair system/device, flail repair system/device, repair system/device, etc.) incorporates a sheet attached on a wire form capable of forming a contact face. In some applications, a sheet provides a surface capable of providing contact pressure or support onto a leaflet experiencing issues, such as flail, prolapse, and/or rigidity. 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 utilizing interleaving strings that overlap and intersect. A mesh or permeable sheet can beneficially provide contact pressure/support without restricting the flow of blood or plasma, which can be important in various applications. For instance, an impermeable sheet may trap blood or plasma between the device and leaflet, which in turn might create undesired pressures with the valve and/or create pressures that dislodges the device or alters its position. In some applications, the sheet is partially an impermeable material and partially a permeable mesh. For instance, in some applications, a cooptation portion of a system/device herein utilizes an impermeable material while a non-coaptation portion of the device utilizes a permeable mesh. In some applications, the impermeable coaptation portion helps promote proper closure of a native valve when coapting. In some applications, a mesh is formed utilizing a mesh sheet. Any appropriate material can be utilized for a sheet and/or mesh, including (but not limited to) poly(lactic-co-glycolic) acid (PLGA), polyvinylchloride (PVC), polyethylene (PE), polypropylene (PP), polytetrafluoroethylene (PTFE), polyurethane (PU), polyethylene terephthalate (PET), polyethersulfone (PES), polyglycolic acid (PGA), polylactic acid (PLA), poly-D-lactide (PDLA), poly-4-hydroxybutyrate (P4HB), and polycaprolactone (PCL). Any appropriate means to attach a sheet and/or mesh onto a wire form can be utilized, including (but not limited to) stitching, staples, and glue. Optionally, in some applications, the sheet is a form-fitted cover that stretches across the wire form or wire form frame.
In some applications, a wire form device or a system/device having a wire form frame has a static portion and a dynamic portion. In some applications, the static portion is capable of situating within the valve and can include indents and or hooks to secure the device within the site of implantation by fitting with or hooking onto the commissures or other similar leaflet areas. In some applications, the dynamic portion includes a sheet to help provide contact pressure on and/or support to a leaflet, e.g., to address flail, prolapse, rigidity, etc. In some applications, the dynamic portion is capable of being repositioned and/or resized during the implantation process such that it can be adequately cover the leaflet region experiencing the flail, prolapse, rigidity, and/or other issue.
In some applications, the systems/devices are configured to help promote coaptation of the leaflets when closed. In some applications, a gap filler, coaptation element, or spacer is incorporated with the system/device. In some applications, the gap filler, coaptation element, or spacer extends from or within the coaptation portion, which can help fill gaps within the valve aperture. In some applications, the system/device includes an extended portion with an impermeable sheet that extends from the leaflet lip into the aperture, which can help form coaptation with the other leaflet(s). In some applications, the system/device includes an extended portion that is thickened, which acts as gap filler or spacer to help fill gaps within the valve aperture. Having a gap filler, coaptation element, or spacer is expected to beneficially help the systems/devices better treat functional mitral regurgitation by filling a gap in the valve.
In some applications, the systems/devices herein comprise an expandable gap filler, expandable coaptation element, or expandable spacer. The gap filler/coaptation element/spacer can be expandable in a variety of ways, e.g., via inflation, injection, filling, balloon-expansion, self-expansion (e.g., using a shape memory material), mechanical expansion, etc. Mechanisms of expanding the expandable gap filler/coaptation element/spacer herein can 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-expansion, mechanical expansion, expanding via a stent (e.g., self-expanding, balloon, mechanical), expanding via a scissor mechanism or scissor like mechanism (e.g., with articulating joints), expanding via twisting a coil, and/or any combinations of these.
In some applications, systems/devices herein comprise a gap filler/coaptation element/spacer that is filled or is fillable with a material at the site of implantation, which can be done as the device is implanted or in a subsequent procedure (e.g., right after or after some time as passed, such as days, weeks, or months). Accordingly, in these applications, a material is delivered via a catheter to the device at the site of implantation and then the device is filled, injected, inflated, etc. with the material, and thus increase the size of the gap filler/coaptation element/spacer in vivo. Various materials can be utilized, such as (for example) a foam, hydrogel, or silicone. In some applications, a system/device with a gap filler/coaptation element/spacer includes a stent that encases the gap-filling portion of the device. Accordingly, a stent can be expanded at the site of implantation, which can be self-expanding (e.g., nitinol), expanded mechanically, or expanded via a balloon. The systems/devices can have a guide or guide wire that helps advance the catheter to the correct location on the gap filler/coaptation element/spacer to inject the material into the gap filler/coaptation element/spacer.
In some applications, a system/device with a gap filler, coaptation element, or spacer is expanded at the site of implantation utilizing mechanical expansion. For example, an expansion mechanism configured as a scissor or scissor-like mechanism (or mechanism with pivoting struts) within the gap filler/coaptation element/spacer portion could be used to cause the mechanical expansion, which can be done as the device is implanted or in a subsequent procedure. Accordingly, in these applications, the scissor or scissor-like mechanism (or mechanism with pivoting struts) can be expanded via hydraulic, pneumatic, mechanical, or magnetic means, and thus increase the size of the gap filler/coaptation element/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 of the body to expand the expansion mechanism. In some applications, a series of struts can be connected at a joint and articulate or move from a radially expanded configuration to a radially compressed configuration by the various struts articulating or moving at the joints, e.g., in a scissor-like movement.
In some applications, systems/devices with gap filler/coaptation element/spacer are mechanically expanded at the site of implantation utilizing a coil within the gap filler/coaptation element/spacer portion, which can be done as the device is implanted or in a subsequent procedure. Accordingly, in some applications, the circumference of the coil can be increased by twisting the coil, and thus increase the gap filler/coaptation element/spacer size. Various mean can be used to relieve tension as the coil is twisted, such as (for example) the coil contain a number of slits or furrows on the inner portion of the coil.
In some applications, systems/devices herein incorporate or comprise an impermeable cooptation portion and a permeable and/or open non-coaptation portion. In some applications, the impermeable coaptation portion extends into the coaptation area of the leaflet. In some applications, the impermeable coaptation portion is elongated to reach the effluent side of one or two of the opposing leaflets to help the leaflets coapt. 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 aperture. In some applications, the impermeable coaptation portion is expanded at the site of implantation. Mechanisms of expanding the impermeable coaptation portion can 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-expansion, mechanical expansion, expanding via a stent (e.g., self-expanding, balloon, mechanical), expanding via a scissor mechanism or scissor like mechanism (e.g., with articulating joints), expanding via twisting a coil, and/or any combinations of these.
Various implementations and applications of devices herein are to be used on any leaflet experiencing flail or prolapse. Accordingly, in some applications, a device is capable of being utilized on a leaflet of a mitral, a tricuspid, an aortic, and/or a pulmonic valve. Likewise, various implementations and applications of devices can be utilized on any area of the leaflet experiencing flail or prolapse. In some applications, a device is capable of being utilized on or near a leaflet commissure and/or any area between a leaflet's commissures.
To reach the site of implantation, any appropriate surgical, minimally invasive, or percutaneous technique may be utilized, including (but not limited to) a transcatheter delivery system, which can utilize a transfemoral, subclavian, transapical, transseptal, or transaortic approach. In some applications, a delivery catheter is utilized to incorporate a device, then delivered to the site of deployment via a guidewire and utilized to anchor the device at the site of implantation.
Some applications are directed to methods of delivering a device to the site of deployment. The various techniques, methods, operations, steps, etc. described or suggested anywhere herein (including in documents incorporated by reference herein) can be performed on a living animal (e.g., human, mammal, other animal, etc.) or on a non-living simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, tissue, etc. being simulated), etc. Accordingly, methods of delivery include both methods of treatment (e.g., treatment of human subjects) and methods of training and/or practice (e.g., utilizing an anthropomorphic phantom that mimics human vasculature to perform method).
In some applications, the device 501 includes a coaptation portion 519 that extends beyond the edge of the posterior leaflet 511 and 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 leaflet to address an issue (e.g., such as flail, prolapse, and/or rigidity) and to help coaptation of the leaflets. The coaptation portion can be configured as a wing or wing portion or be part of a wing or wing portion.
In some applications, the anchor 503 is a stent (e.g., a wire stent, stent with alternating struts, laser-cut stent, braided stent, balloon-expandable stent, self-expanding stent, etc.) expanded within the coronary sinus 525 adjacent to the left atrium 517. The anchor 503 is connected to the connection point 527 (e.g., anchor receiver, etc.) of the device 501 via a connector 529 that traverses through the atrium wall 531. Accordingly, the anchor 503 stabilizes the device 501 at the mitral valve 505. In some applications, a different type of anchor (e.g., helical anchor, t-shaped anchor, clamp anchor, sutured anchor, etc.) can alternatively or additionally be used, e.g., an anchor could be used to anchor the device/system directly to the valve annulus or other nearby tissue.
In some applications, the anchor connection point or anchor receiver is configured as an interface. The interface can connect with a catheter or shaft for delivering and positioning the system/device.
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Although examples of implantation sites are depicted along the posterior leaflet of the mitral valve, it should be understood that various implementations and applications can be utilized on other leaflets or within other valves.
As shown in
In some applications, the device 1101 has a covering that spans the contact face and can help provide contact pressure and/or support on the flail, prolapse, rigidity, leaflet abnormality, etc. and can help coaptation. In some applications, the covering is mesh sheet. In some applications, the covering is one or more of a fabric sheet, polymer sheet, pericardium sheet, etc. The contact face and/or covering can be configured to allow blood and plasma to flow therethrough such that pressure from blood does not disrupt, deflect, or dislodge the device. A mesh covering can be particularly useful to allow 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 or abut against a wall of the heart (e.g., the wall of 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 leaflet (e.g., to mitigate or eliminate flail, prolapse, rigidity issues, and/or other leaflet abnormalities). The support 1113 can also be configured to help prevent the contact face and/or a cover thereon from flailing or otherwise moving back into or toward the atrium in an undesired way. For some applications, and as shown, support 1113 comprises (e.g., consists essentially 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 anchors or anchoring mechanisms described herein. In some applications, the anchor 1115 is a helical anchor (e.g., as shown in
In some applications, the device 1301 has a covering 1315. The covering 1315 can be the same as or similar to other coverings described herein. In some applications, the covering spans the contact face and can help provide contact pressure on the flail, prolapse, rigidity, etc. and can help coaptation.
In some applications, the coaptation portion 2105 can include an optional clip, fastener, or other anchor mechanism to be attached or clamped onto a leaflet edge, which may allow the device 2101 to move with the leaflet as it opens and closes.
In some applications, the device includes an optional counterforce support 2109 that can press against an atrium wall to help the device provide contact pressure on a leaflet flail, prolapse, rigidity, and/or abnormality.
In some applications, the device 2001 (e.g., the wing portion of the device) includes a permeable non-coaptation portion 2111, which can made of mesh or otherwise include openings, to provide contact pressure on a leaflet flail, prolapse, rigidity, and/or abnormality and includes an impermeable coaptation portion 2113 that can help promote coaptation. It is noted that various examples can include an elongated impermeable coaptation portion 2113 capable of reaching the effluent side (or ventricular side) of one or two opposing native leaflets to help valve closure. In various examples, the impermeable coaptation portion 2113 is thickened such that it can fill gaps within the valve aperture, e.g., serving as a gap filler/coaptation element/spacer. In some applications, coaptation portion 2113 can be filled and/or expanded at the site of implantation.
In some applications, as shown in
Illustrated in
Methods of delivering implant/device 2301 and other implants/devices herein (e.g., implant/device 2421, etc.) can 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 can be the same as or similar to any anchors or securing features 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, such that the implant/device extends along a portion of a leaflet of the native heart valve. Advancing the anchor from the delivery catheter into tissue of the heart and releasing the leaflet repair implant from the delivery catheter can be done in either order.
Where the anchor is a helical anchor, advancing the anchor can include rotating the helical anchor into the tissue (e.g., into the annulus or a wall of the heart).
The implant/device can transition from a compressed delivery configuration inside the delivery catheter (for a smaller delivery profile) to an expanded configuration outside of the delivery catheter to better cover the leaflet or problem portion of the leaflet.
This method can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc.
At least a distal end of the puncture catheter 3103 preferably has a slight curvature built therein, with a radially inner and a radially outer side, so as to conform to the curved coronary sinus. An expandable anchoring member 3105 is exposed along a radially outer side of the catheter 3103 adjacent a distal segment 3107 that may be thinner than or tapered narrower from the proximal extent of the catheter. Radiopaque markers 3109 on the catheter 3103 help determine the precise advancement distance for desired placement of the anchoring member 3105 within the coronary sinus.
The curvature at the distal end of the puncture catheter 3103 aligns proximal to the anatomy within the coronary sinus and orients the needle port 3111 inward, while the anchoring member 3105 holds the catheter 3103 in place relative to the coronary sinus. Subsequently, as seen in
Some examples herein are directed towards compressive devices (e.g., compressive stents, compressive clamps, compressive splints, compressive forms, etc.) for mitigating heart valve leaflet flail, prolapse, rigidity, and/or other abnormalities. In some applications, a compressive device is capable of clamping onto a leaflet, holding onto its place on the leaflet while providing compressive and contact pressure onto a region of flail, prolapse, rigidity, and/or abnormality. The compressive and contact pressure provided by various stent implementations helps flatten out and/or reshape the flail, prolapse, rigidity, and/or abnormality, which helps extend the coapting edge of a leaflet back towards the coaptation area when in a closed position. Proper coaptation that results in a fully closed valve prevents valve regurgitation.
In some applications, a compressive device has an effluent portion and an influent portion that compress together via compression forces. When attached onto the leaflet, the effluent portion sits on the effluent face of the leaflet and the influent portion sits on the influent face of the leaflet, the two portions interconnected. Accordingly, in some applications, the influent portion of a stent provides contact pressure on and/or support to a leaflet, e.g., to address flail, prolapse, rigidity, and/or another abnormality. In some applications, the effluent portion and influent portion compress together to create a force to hold to maintain its position on the leaflet. In some applications, a torsion spring is utilized to provide compressive forces. In some applications, a compressive device is contoured to the shape of leaflet. In some applications, a compressive device is texturized on its surface with a roughened surface, indentations, notches, protrusions, and/or barbs to provide further grip to hold the stent in place. In some applications, a compressive device incorporates a wavy ridged wire to provide further grip (like a bobby pin grip).
In some applications, a compressive device comprises a wire form stent. Any appropriate material to produce a wire form can be utilized, including (but not limited to) using nitinol, cobalt-chrome (CoCr), stainless steel, titanium, polyglycolic acid (PGA), polylactic acid (PLA), poly-D-lactide (PDLA), polyurethane (PU), poly-4-hydroxybutyrate (P4HB), polycaprolactone (PCL), polyether ether ketone (PEEK), cyclic olefin copolymers (COCs), poly ethylene vinyl acetate (EVA), polytetrafluorethylene (PTFE), perfluoroether (PFA), fluorinated ethylene propylene (FEP), additives thereof, and derivatives thereof. In some applications, a compressive device is contractible, which can be useful to fit within a catheter device for less invasive catheter delivery methodologies. In some applications, nitinol is utilized for its self-expanding properties, which may be useful to implant the compressive device via less invasive catheter delivery methodologies.
Various shapes of wire form compressive devices can be utilized in various different implementations. In some applications, a compressive wire form stent is shaped to have portions of the wire form to provide contact pressure on and/or support to the flail, prolapse, rigidity, and/or abnormality. In some applications, a compressive wire form stent has length and width to surround an area of flail or prolapse and utilizes a sheet extending across the area to provide contact pressure on and/or support to the flail, prolapse, rigidity, and/or abnormality.
In some applications, a compressive implant or compressive device incorporates a sheet on a wire form. In some applications, a sheet or cover is provided on the influent portion of a compressive device and provides a surface capable of providing contact pressure onto and/or support to a leaflet experiencing flail, prolapse, rigidity, and/or another issue. A sheet or cover can be impermeable, semipermeable, or permeable to fluids (e.g., blood or plasma). In some applications, the sheet or cover is a mesh. In some applications, a mesh is formed utilizing a mesh sheet. In some applications, a mesh is formed utilizing interleaving strings that overlap and intersect. 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 instance, an impermeable sheet or cover may trap blood within the compressive device, which in turn may create undesired pressures within the valve or possibly result in pressures that dislodge the implant/device or alter its position. A sheet, covering, and/or mesh herein can comprise any one or more of the following: poly(lactic-co-glycolic) acid (PLGA), polyvinylchloride (PVC), polyethylene (PE), polypropylene (PP), polytetrafluoroethylene (PTFE), polyurethane (PU), polyethylene terephthalate (PET), polyethersulfone (PES), polyglycolic acid (PGA), polylactic acid (PLA), poly-D-lactide (PDLA), poly-4-hydroxybutyrate (P4HB), and polycaprolactone (PCL).
Various implementations of compressive devices help promote coaptation of the leaflets when closed. In some applications, a gap filler/coaptation element/spacer is incorporated with the compressive device, which can help fill gaps within the valve aperture. In some applications, a compressive device includes an extended portion with an impermeable sheet that extends from the leaflet lip into the aperture, which can help form coaptation with the other leaflet(s). In some applications, a compressive device includes an extended portion that extends to the effluent face of another valve leaflet to contact the other leaflet when the valve closes such that it assists the opposite leaflet to come together with the stented leaflet and coapt. In some applications, an extended portion that extends to the effluent face of another valve leaflet has a bent angle towards the other leaflet (e.g., to reach another leaflet in a tricuspid, aortic, or pulmonary valve).
In some applications, a compressive device includes an anchor to stabilize the stent at the site of implantation. In some applications, the influent portion of a compressive device includes a portion that is in connection with the anchor. In some applications, the anchor connection point is near or in contact with the valve annulus or a ventricle or atrium wall. In some applications, an anchor is situated near or in contact with the valve annulus. In some applications, an anchor is situated near or in contact with the ventricle or atrium wall on the opposite side of the wall from the anchor connection point. In some applications, a connector is utilized to connect the anchor, the connector traversing through the ventricle or atrium wall. Any appropriate connector can be utilized, such as (for example) a screw, rivet, suture, staple, wire, pin, shaft, ribbon, sheet, etc.
In some applications, an anchor is situated within vasculature that is on the opposite side of a ventricle or atrium wall. For example, various compressive device implementations mitigate flail, prolapse, rigidity, and/or other abnormalities of the mitral valve and thus are situated within the left atrium. In these various implementations, a compressive device can be connected with an anchor situated within the coronary sinus utilizing a connector traversing through the atrial wall. Any appropriate anchor can be utilized. In some applications, an anchor is wire stent capable of expanding within vasculature. In some applications, an anchor is a pin, pin clamp (e.g., R-clamp, R-pin, R-key) or wire capable of pinning a compressive device via a connector to the ventricle or atrium wall. In some applications, a pin or wire fastener is utilized on the opposite side of a ventricle or atrium wall and the connector traverses the wall. In some applications, a pin or wire fastener is utilized within vasculature that is on the opposite of a ventricle or atrium wall. In some applications, a wire fastener is capable of pinching a connector wire to hold the wire in place and create tension between the wire fastener or wire anchor and the compressive device. In some applications, an anchor comprises a screw, helix, or helical anchor that is anchored within the valve annulus or an atrium or a ventricle wall.
In some applications, a compressive device is designed to include space and/or features permitting further medical intervention at a later time. In some applications, a wire form stent includes space within the coaptation area configured as a space between the wires of the wire form such that, if needed sometime in the future, a percutaneous edge to edge mitral valve repair device can still be implanted without the implant/device interfering.
Various implementations of compressive devices are to be used on any leaflet experiencing flail or prolapse. Accordingly, in some applications, a compressive device is capable of being utilized on a leaflet of a mitral, a tricuspid, an aortic, and/or a pulmonic valve. Likewise, various implementations of compressive devices can be utilized on any area of the leaflet experiencing flail or prolapse. In some applications, a compressive device is capable of being utilized on or near a leaflet commissure and/or any area between a leaflet's commissures.
To reach the site of implantation, any appropriate surgical technique can be utilized, including (but not limited to) a transcatheter delivery system, which can utilize a transfemoral, subclavian, transapical, transseptal, or transaortic approach. In some applications, a delivery catheter is utilized to incorporate a compressive device, then delivered to the site of deployment via a guidewire and utilized to attach the stent to a leaflet.
Some applications are directed to methods of delivering a compressive device to the site of deployment. The various methods described or suggested anywhere herein (including in documents incorporated by reference herein) can be performed on a living animal (e.g., human, mammal, other animal, etc.) or on a non-living simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, tissue, etc. being simulated), etc. Accordingly, methods of delivery include both methods of treatment (e.g., treatment of human subjects) and methods of training and/or practice (e.g., utilizing an anthropomorphic phantom that mimics human vasculature to perform method).
In some applications, the anchor is a wire form expanded within the coronary sinus 3521 adjacent to the left atrium 3515 (or within another blood vessel at or near another chamber of the heart). The anchor 3503 is connected to the compressive device 3501 via a connector 3523 that traverses through the atrium wall 3525. Accordingly, the anchor helps stabilize the implant/device 3501 at the native valve 3505.
After a puncture catheter is removed from the left chambers (see
Many examples herein are directed towards valve implants or devices for mitigating heart valve leaflet flail, prolapse, rigidity, and/or other abnormalities that include a bar or elongate extension that can span between portions or commissures of a native valve. In some applications, a valve device is capable of situating within the effluent side of a valve, the bar or elongate extension holding onto its place on the leaflet while providing contact pressure onto a region of flail, prolapse, rigidity, and/or abnormality. The contact pressure provided by various bar or extension implants/devices helps flatten out and/or reshape the flail, prolapse, rigidity, and/or abnormality, which helps extend the coapting edge of a leaflet back towards the coaptation area when in a closed position. Proper coaptation that results in a fully closed valve prevents valve regurgitation.
In some applications, a bar/elongate extension is configured as an elongated arch with two distal ends, each end having an anchor or means to hook, latch, anchor, fasten, etc. within two leaflet commissures. In some applications, each of the distal ends of the bar/extension includes an indentation or hook, which can help secure the bar/extension within the site of implantation by latching or hooking onto the commissures. In some applications, the bar/extension is telescoped such that there is an inner bar and an outer bar, allowing the bar to be shortened and elongated between a variety of sizes or lengths. Accordingly, in some applications, the telescoping bar/extension can be shortened or elongated to extend over and provide contact pressure upon a leaflet issue, e.g., flail or prolapse.
In some applications, a bar/extension/arch includes an anchor to stabilize the bar/extension/arch at the site of implantation beyond the anchors or means to hook, latch, anchor, fasten, etc. within two leaflet commissures (though in some circumstances the anchors or means to hook, latch, anchor, fasten, etc. within two leaflet commissures can be sufficient to secure the implant/device within the native valve without an additional anchor). In some applications, a bar/extension/arch includes a portion that is in connection with the anchor. In some applications, an anchor connection point extends from the bar/extension/arch and towards a ventricle or atrium wall. In some applications, an anchor is situated near or in contact with the ventricle or atrium wall on the opposite side of the wall from the bar/extension/arch connection point. In some applications, a connector is utilized to connect the anchor with the anchor connection point, the connector traversing through the ventricle or atrium wall. Any appropriate connector can be utilized, such as (for example) a screw, rivet, suture, staple, wire, pin, shaft, sheet, mesh, etc.
In some applications, an anchor is situated within vasculature that is on the opposite side of a ventricle or atrium wall. For example, various bar or elongate extension examples mitigate leaflet issues (e.g., flail, prolapse, rigidity, and/or abnormality) of the mitral valve and thus are situated within the left atrium. In these various implementations, a bar/extension can be connected with an anchor situated within the coronary sinus utilizing a connector traversing through the atrial wall. Any appropriate anchor can be utilized. In some applications, an anchor is wire stent capable of expanding within vasculature. In some applications, an anchor is a pin (e.g., R-pin) or wire fastener capable of pinning an arched telescoping bar via a connector to the ventricle or atrium wall. In some applications, a pin or wire fastener is utilized on the opposite side of a ventricle or atrium wall and the connector traverses the wall. In some applications, a pin or wire fastener is utilized within vasculature that is on the opposite of a ventricle or atrium wall. In some applications, a wire fastener is capable of pinching a connector wire to hold the wire in place and create tension between the wire anchor or wire fastener and the telescoping bar. In some applications, an anchor is a screw, helix, or helical anchor that is anchored within the valve annulus or wall of an atrium or ventricle.
Various implementations of bars, elongate extensions, arches, or arched bars help promote coaptation of the leaflets when closed. In some applications, a gap filler, coaptation element, or spacer is incorporated to extend from the bar/extension/arch and into the valve aperture, which can help fill gaps within the valve aperture. In some applications, a bar/extension/arch includes a sheet extension with an impermeable sheet that hangs off the bar/extension/arch along the leaflet coaptation area and into the valve aperture, which can help form coaptation with the other leaflet(s). In some applications, the sheet includes wire form along the border to help the sheet maintain within the aperture of a valve when implanted.
Any appropriate material to produce a bar form, elongate extension, arch, or an arched bar form can be utilized. In some applications, the bar/extension/arch comprises one or more of the following: nitinol, cobalt-chrome (CoCr), stainless steel, titanium, polyglycolic acid (PGA), polylactic acid (PLA), poly-D-lactide (PDLA), polyurethane (PU), poly-4-hydroxybutyrate (P4HB), polycaprolactone (PCL), polyether ether ketone (PEEK), cyclic olefin copolymers (COCs), poly ethylene vinyl acetate (EVA), polytetrafluorethylene (PTFE), perfluoroether (PFA), fluorinated ethylene propylene (FEP), additives thereof, and derivatives thereof.
Some examples herein are directed towards implants or devices comprising netting (e.g., mesh, sheet, drape, etc.) for mitigating heart valve leaflet issues, such as flail, prolapse, rigidity, and/or other abnormalities. In some applications, a netting implant/device is capable of situating within the effluent side of a valve, the lateral edges situated within a crevice within the heart valve (e.g., cleft or commissure) while providing contact pressure onto and/or support to a region of flail, prolapse, rigidity, and/or abnormality. The contact pressure provided by various netting devices/implants helps flatten out and/or reshape the leaflet or the flail, prolapse, rigidity, and/or abnormality of the leaflet, which helps extend the coapting edge of a leaflet back towards the coaptation area when in a closed position. Proper coaptation that results in a fully closed valve prevents valve regurgitation.
In some applications, a netting implant/device includes (but is not limited to) one face configured to directly contact the face of a leaflet experiencing flail, prolapse, rigidity, and/or other issues. Typically, the influent face of a leaflet is the face that experiences flail, prolapse, rigidity, and/or other issues. In some applications, the contact face of the netting device is pliable and thus contours to the influent face of a leaflet, which can be a hyperbolic paraboloid-like contour. In some applications, the contact face of the netting device provides contact pressure on a leaflet flail, prolapse, rigidity, and/or abnormality. In some applications, the contact face of the netting implant/device has a width and a length such that it can cover the region of the leaflet experiencing flail, prolapse, rigidity, and/or abnormality. In some applications, the length of an implant/device extends just beyond the coaptation area of the leaflet.
In some applications, a netting implant/device includes an anchor to stabilize the device at the site of implantation. In some applications, an anchor is situated near or in contact with the valve annulus, leaflet area, or atrium/ventricle wall. In some applications, an anchor is a screw, helix, helical anchor, or other feature capable of screwing within or embedding within the valve annulus, leaflet, or atrium/ventricle wall. In some applications, a helical anchor is housed within a tubular compartment, the tubular compartment connected to or a part of the netting implant/device to be anchored.
In some applications, an anchored netting implant/device incorporates a tether for further stabilization at the site of implantation. In some applications, a tether extends from the coaptation portion of a netting implant/device to a pinning location on the effluent side of the valve, where the tether is pinned down. The pinning location can be any sturdy feature, such as (for example) ventricle wall, atrium wall, papillary muscle, and/or nearby 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 utilizing interleaving strings that overlap and crisscross. In some applications, a mesh is formed utilizing a mesh sheet. Any appropriate material can be utilized for a netting, for example, a netting can comprise one or more of the following: poly(lactic-co-glycolic) acid (PLGA), polyvinylchloride (PVC), polyethylene (PE), polypropylene (PP), polytetrafluoroethylene (PTFE), polyurethane (PU), polyethylene terephthalate (PET), polyethersulfone (PES), polyglycolic acid (PGA), polylactic acid (PLA), poly-D-lactide (PDLA), poly-4-hydroxybutyrate (P4HB), and polycaprolactone (PCL). Any appropriate means to attach a netting to an anchor(s) can be utilized, including (but not limited to) stitching, staples, and glue.
In some applications, a netting device includes a wire form outlining the netting or a portion of the netting. Any appropriate material to produce a wire form can be utilized, for example, the wire form can comprise one or more of the following: nitinol, cobalt-chrome (CoCr), stainless steel, titanium, polyglycolic acid (PGA), polylactic acid (PLA), poly-D-lactide (PDLA), polyurethane (PU), poly-4-hydroxybutyrate (P4HB), polycaprolactone (PCL), polyether ether ketone (PEEK), cyclic olefin copolymers (COCs), poly ethylene vinyl acetate (EVA), polytetrafluorethylene (PTFE), perfluoroether (PFA), fluorinated ethylene propylene (FEP), additives thereof, and derivatives thereof.
In some applications, a netting device is contractible, which may be useful to fit within a catheter device for less invasive catheter delivery methodologies. In some applications, nitinol is utilized for its self-expanding properties, which may be useful to implant the device in less invasive catheter delivery methodologies.
Some applications of netting devices are configured to be used on any leaflet experiencing flail or prolapse. Accordingly, in some applications, a netting device is capable of being utilized on a leaflet of a mitral, a tricuspid, an aortic, and/or a pulmonic valve. Likewise, various devices/implants can be utilized on any area of the leaflet experiencing flail or prolapse. In some applications, a netting device is capable of being utilized on any area between a leaflet's crevices (e.g., commissures and clefts).
To reach the site of implantation, any appropriate surgical technique may be utilized, including (but not limited to) a transcatheter delivery system, which can utilize a transfemoral, subclavian, transapical, transseptal, or transaortic approach. In some applications, a delivery catheter is utilized to incorporate a device, then delivered to the site of deployment via a guidewire and utilized to anchor the device at the site of implantation.
Some examples herein are directed to methods of delivering a netting device to the site of deployment. The various methods described or suggested anywhere herein (including in documents incorporated by reference herein) can be performed on a living animal (e.g., human, mammal, other animal, etc.) or on a non-living simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, tissue, etc. being simulated), etc. Accordingly, methods of delivery include both methods of treatment (e.g., treatment of human subjects) and methods of training and/or practice (e.g., utilizing an anthropomorphic phantom that mimics human vasculature to perform method).
The lateral edges 6409 and 6411 of the netting implant/device 6401 can be positioned into the clefts between P1 and P2 6419 and between P2 and P3 6421. Any of the anchors described herein can be used. In some applications, the anchor 6403 is a helical anchor configured to be anchored into the valve annulus 6423. The anchor 6403 stabilizes the netting device 6401 at the native valve 6415.
Reference is made to
System 20 comprises an implant 100, an anchor 30, a catheter 40, and a delivery tool 50. Implant 100 comprises an interface 110, and a flexible wing 120, coupled to the interface. Wing 120 can comprise a contact face or surface 122 and an opposing face or surface 123 opposite the contact face. For some applications, implant 100 can have features or elements similar to those described for implant 1101, implant 2101, 2301, and/or 2421 described hereinabove, mutatis mutandis.
Delivery tool 50 can comprise a shaft 60 and a driver 70. Shaft 60 is configured to engage interface 110, and via this engagement, to deploy and position implant 100, e.g., as described in more detail hereinbelow. This engagement can be achieved by shaft 60 having a shaft head 62 that comprises one or more couplings 64, such as latches or arms, which engage one or more couplings 114 (e.g., recesses, slots, notches, or receptacles) of interface 110.
Driver 70 is configured to engage anchor 30 (e.g., a head 32 thereof), and is configured to secure implant 100 to tissue of the heart by using the anchor to anchor interface 110 to the tissue. In some applications, driver 70 comprises a flexible shaft 74 and a drive head 72 at a distal end of the shaft, the drive head engaging anchor 30.
For some applications, and as shown, wing 120 comprises a frame (e.g., a wire frame) 124, and a sheet 126 spread over the frame. For some applications, wing 120 has a root 130 that is coupled to interface 110, and a tip 132 at an opposite end of the wing from the root. Tip 132 represents a free end of wing 120.
For some applications, frame 124 is attached to interface 110. For example, and as shown, at root 130 frame 124 may define a ring 128 that fits around interface 110. Wing 120 may define two lateral sides 134 (e.g., a first lateral side 134a and a second lateral side 134b) extending from the root to the tip.
For some applications, and as shown, frame 124 defines two loops 136 (e.g., a first loop 136a and a second loop 136b) extending from root 130 alongside each other, e.g., all the way to tip 132. It is to be noted that, as shown, loops 136 can be discrete loops, rather than cells of a cellular or lattice structure. For example, loops 136 can be unconnected to each other and/or to any other metallic component of implant 100 except for at root 130 (e.g., at ring 128 and/or interface 110). Furthermore, each of loops 136 can be configured to circumscribe a space 137 that is substantially absent of frame components. For some applications, and as shown, each of loops 136 is substantially teardrop-shaped.
For some applications in which frame 124 defines loops 136, frame 124 defines an elongate space 138 between the two loops. Space 138 can extend from root 130 toward tip 132, e.g., all the way to the tip (e.g., such that the frame 124 does not bridge the two loops at the tip). For some applications, and as shown, space runs 138 along a plane of reflectional symmetry of wing 120.
For applications in which frame 124 defines loops 136, sheet 126 can be configured to extend over and between the loops, e.g., across both loops and space 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 tessellated with each other. For example, and as shown, holes 140 can be hexagonal. As shown, some of holes 140 can be disposed over spaces 137. Alternatively or additionally, some of holes 140 can be disposed over space 138. For some applications, and as shown, the size and number of openings or holes 140 is such that the wing 120 (or its area/surface area) is, overall, more 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 face 122 is concave. That is, a curvature of wing 120 is such that, in a cross-section of implant 100 through interface 110 and the wing, contact face 122 is concave.
For some applications, and as described in more detail hereinbelow, an angular disposition of wing 120 with respect 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) disposes tip 132 within the ventricle that is downstream of the atrium and the atrioventricular valve.
In the example shown, catheter 40 is advanced to the heart chamber transluminally. However, a transatrial approach is also within the scope of the disclosure. Similarly, although a transfemoral approach is shown, the scope of the disclosure includes advancement via the superior vena cava. It is to be noted that, although a transseptal approach is shown from right atrium 5 into left atrium 6, the interatrial septum is not shown, as it lies behind aorta 7. Part of catheter 40 is shown in phantom in order to illustrate that it is behind aorta 7.
As shown, the advancement of implant 100 within catheter 40 is performed while shaft 60 (e.g., head 62 thereof) is engaged with interface 110 of the implant. In some applications, implant 100 is advanced within catheter 40 while wing 120 is constrained (e.g., compressed, folded, and/or rolled) within the catheter.
Using shaft 60, implant 100 is deployed out of catheter 40 such that, within atrium 6, wing 120 extends away from interface 110 (
Subsequently, again using shaft 60, implant 100 is positioned in a position in which interface 110 is at a site 18 in the heart, wing 120 extends over first leaflet 12 toward opposing leaflet 14, and contact face 122 faces the first leaflet (
For some applications, and as shown, wing 120 (and optionally implant 100 as a whole) is entirely deployed (i.e., exposed) from catheter 40 prior to being positioned against the tissue.
The wing 120 can be configured to be at a variety of angles relative to the catheter shaft and/or relative to the native anatomy (e.g., the annulus and/or leaflet) during delivery to appropriately repair the function of the native leaflet as it is positioned for anchoring, for example, in some applications, the device is angled 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 tip of the catheter (and/or relative to a plane of the annulus) during delivery.
Optimality of a given position of implant 100 can be determined during the implantation procedure, e.g., prior to anchoring the implant to the tissue. For example, optimality can be determined using blood pressure sensing and/or imaging techniques such as fluoroscopy and echocardiography. For example, Doppler echocardiography can be used to determine a degree to which regurgitation through the valve remains or has been reduced. In order to illustrate an advantage of system 20,
Upon determining that implant 100 is positioned suitably (e.g., optimally), the implant is secured in its position by anchoring interface 110 to tissue of the heart, e.g., at the current site 18 (
It is to be noted that tip 132, which is a free end of wing 120, is typically not anchored to tissue during the implantation process. It is to be further noted that, at least for applications in which interface 110 is anchored to annulus 11, implant 100 is typically not anchored downstream of the leaflets of the valve being treated (e.g., within the ventricle downstream of the valve being treated), e.g., implant 100 does not comprise 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 tissue of the heart is typically within the atrium upstream of the valve being treated.
For some applications, implant 100 can be repositioned even after anchoring, by driver 70 being used to de-anchor interface 110 from the tissue (e.g., by unscrewing anchor 30).
It is hypothesized that the simplicity of repositioning implant 100 is at least in part due to the simplicity and minimalistic nature of the implant itself, and/or due to the simplicity of its anchoring (e.g., via a single anchor). It is further hypothesized that, because shaft 60 holds implant 100 in each position in which the implant will potentially be secured (e.g., because the shaft holds interface 110 at (e.g., against) each site 18 to which the interface will potentially be anchored), and because the subsequent anchoring of the implant causes minimal (e.g., no) alteration in the implant's position, the determination of position optimality described hereinabove is, advantageously, particularly accurate and reliable for system 20. It is still further hypothesized that this advantage can be additionally facilitated by the complete deployment of wing 120 (e.g., of implant 100 as a whole) prior to placing the implant at each position.
Moreover, if it is decided to abort the implantation after implant 100 has been deployed in the atrium, it is possible to withdraw the implant into catheter 40 and out of the subject simply by retracting shaft 60 into the catheter. The shape and flexibility of wing 120 facilitate it being recompressed by its reentry into the catheter. If interface 110 has already been anchored before the decision to abort has been made, driver 70 can be used to de-anchor anchor 30 before retraction of shaft 60.
Further regarding the simplicity of implant 100, for some applications, implant 100 consists essentially of interface 110 and wing 120 (i.e., frame 124 and sheet 126).
For some applications, and as shown, driver 70 is disposed within shaft 60, and can advance anchor 30 through the shaft. For some such applications, and as shown, driver 70 and anchor 30 can be present within shaft 60 throughout the procedure. In some applications, driver 70 and anchor 30 can be introduced into shaft 60 after implant 100 has been introduced to the heart.
Anchor 30 can include a tissue-engaging element 34, and driver 70 can anchor interface 110 to the tissue by driving the tissue-engaging element into the tissue. Tissue-engaging element 34 can take one of various forms known in the art, such as helical, dart, staple, etc. In the example shown, tissue-engaging element 34 is a helical tissue-engaging element, which driver 70 screws into the tissue.
For some applications, implant 100 comprises an anchor receiver 150 at interface 110 (or interface 110 comprises an anchor receiver 150), such that the anchoring of the interface to the tissue is achieved by anchoring the receiver to the tissue. This itself can be achieved by using driver 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, receiver 150 defines an aperture therethrough, and includes an obstruction 152 that protrudes medially into or across the aperture. For such applications, anchor 30 and driver 70 can be configured such that the driver can drive tissue-engaging element 34 beyond obstruction 152 until head 32 becomes obstructed by the obstruction.
For some applications, receiver 150 can be similar to and/or can be substituted with an anchor connection point described hereinabove, such as anchor connection point 2107, mutatis mutandis.
Reference is now made to
In healthy valve 10, leaflets 12 and 14 close synchronously during ventricular systole, thereby coapting and preventing retrograde flow into atrium 6. In injured valve 10, flail 16 occurs at a site on leaflet 12 (e.g., due to one or more damaged chordae tendineae), thereby allowing retrograde leakage into 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 constraining device in the ventricle (e.g., a prosthetic chorda tendinea) or in the atrium (e.g., an obstructing frame), the constraining device opposing (e.g., directly opposing) the ventriculo-atrial movement of the flail, and thereby requiring substantial strength to oppose the force that ventricular pressure applies to the leaflet. It is hypothesized that implant 100 advantageously manipulates the force of the ventricular pressure, deflecting the otherwise ventriculo-atrial movement of leaflet 12 toward opposing leaflet 14, such that the part of leaflet 12 that would otherwise flail coapts with leaflet 14—albeit with wing 120 sandwiched therebetween.
It is hypothesized that this directed coaptation simulates physiological coaptation in a healthy valve, allowing the leaflets to cooperatively resist ventricular pressure. That is, due to the directed coaptation leaflet 14 provides leaflet 12 with support to resist flailing. It is further hypothesized that, due to this, implant 100 advantageously does not require the substantial strength that would be required to oppose the force applied by ventricular pressure. Instead, advantageously, implant 100 can be anchored by a single anchor (though multiple anchors can also be used), can be implanted using a simple and highly maneuverable delivery system, and wing 120 can be highly flexible. For some applications, implant 100 and/or its anchoring can in fact be insufficiently strong to directly resist (e.g., obstruct) leaflet 12 from flailing in response to the force from ventricular pressure—but is nonetheless able to reduce or eliminate the flail by (re)directing the leaflet toward the opposing leaflet.
Comparison of
In many applications, portions of the native leaflet being treated (e.g., leaflet 12) still directly coapt against another native leaflet. In some cases, more than 20%, more than 30%, more than 40%, more than 50%, more than 60%, or more than 70% of the native leaflet being treated (or of a coaptation surface of the native leaflet) coapts directly against another native leaflet. Further, typically, at least during part of the cardiac cycle (e.g., ventricular diastole), the native leaflet being treated (in this case leaflet 12) separates from wing 120 (
It is hypothesized that holes 140 (or other opening(s)) facilitate the native leaflet becoming molded to or following or conforming to the shape of the wing by allowing blood to flow downstream through wing 120 during diastole (e.g., pushing leaflet 12 away from the wing), and allowing blood to escape from between the leaflet and the wing during the first moments of systole, thereby allowing the leaflet to promptly flatten against the wing and coapt with the opposing leaflet, thus facilitating a small regurgitant volume. A permeable portion and/or and open/uncovered portion similar to that described with respect to
Typically, and as shown, wing 120 beats or moves during the cardiac cycle, e.g., facilitated by manner in which implant 100 is anchored, and/or by the flexibility of the wing (e.g., of frame 124). For example, as the leaflet being treated is pushed upstream by ventricular pressure, it pushes wing 120 upstream. The transition from frame A to frame B of
Receiver 150a comprises an example obstruction element 152a of obstruction 152. Obstruction element 152a is defined by part of sheet 126 extending over the aperture defined by the anchor receiver. During anchoring, tissue-engaging element 34 is driven through and beyond the sheet (e.g., piercing the sheet) until head 32 becomes obstructed by (e.g., abuts) the sheet, e.g., pressing/sandwiching the sheet toward/against the tissue. For some applications, receiver 150a has features in common with those described with reference to
Receiver 150b comprises an example obstruction element 152b of obstruction 152. Obstruction element 152b comprises (or is defined by) a cross-bar that traverses the aperture defined by the anchor receiver. During anchoring, tissue-engaging element 34 is driven beyond the cross-bar until head 32 becomes obstructed by (e.g., abuts) the cross-bar, e.g., pressing/sandwiching the cross-bar toward/against the tissue. For some applications, receiver 150b has features in common with those described with reference to
Receiver 150c comprises an example obstruction element 152c of obstruction 152. Obstruction element 152c comprises (or is defined by) a collar. During anchoring, tissue-engaging element 34 is driven beyond the collar until head 32 becomes obstructed by (e.g., abuts) the collar, e.g., pressing/sandwiching the collar toward/against the tissue.
A variety of different types of obstruction elements are also possible, e.g., sheet(s), fabric(s), weave(s), panel(s), metal (e.g., metal sheet, metal fabric, metal structure configured to interface with anchor, etc.), one or more holes (e.g., hole(s) sized for allowing tissue penetration portion of anchor to pass, but not anchor head), cross-bar(s), collar(s), hub(s), polymer layer(s), mesh, nut(s), threaded portion(s) (e.g., with threads that interact with anchor to allow tissue penetration, but keep anchor attached to device), stop(s), etc.
For some applications, implant 100 comprises a lateral (e.g., tubular) wall 112 that defines at least part of interface 110, and in which couplings 114 may be defined. For example, implant 100 can comprise a housing 108 that comprises or defines interface 110 (e.g., wall 112 and couplings 114 thereof), and receiver 150 (e.g., obstruction 152 thereof). Housing 108 can be formed from a single piece of stock, integrating all of these elements. Housing 108 can have features in common with housing 2313, described hereinabove, mutatis mutandis.
For some applications, implant 100 comprises a counterforce support, such as support 1113 and/or support 2309, described hereinabove. For some such applications, during delivery the counterforce support is disposed proximally from interface 110 and/or receiver 150 while within catheter 40. For example, the counterforce support can be deployed from catheter 40 only after the optimal position of implant 100 has been identified and/or only after interface 110 has been anchored to the tissue (e.g., such that while wing 120 is being deployed out of the catheter, shaft 60 extends, within the catheter, proximally away from the interface and past the counterforce support). Alternatively, despite the counterforce support being disposed 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 counterforce support is disposed distally from interface 110 and/or receiver 150 (e.g., alongside wing 120) while within catheter 40, and can be deployed from the catheter simultaneously with the wing.
Once deployed, the counterforce support extends from interface 110 and away from wing 120, and following implantation of implant 100 typically lies against the wall of the chamber in which the implant has been implanted, e.g., similarly to as described with reference to
Reference is made to
Although all three implants 100 in
Furthermore, implant 100 is compatible with the implantation of other implants, either before or after the implantation of implant 100. For example, because implant 100 has a relatively small footprint on the valve annulus, an annuloplasty structure could also be implanted, if necessary. Similarly, because wing 120 is flexible, if it were to be subsequently determined that the subject requires a prosthetic valve to be implanted at the heart valve (e.g., due to further deterioration of the condition being treated), a transluminally-delivered prosthetic valve can be implanted without removing implant 100, e.g., by wing 120 being simply pushed/deflected laterally by the expansion of the prosthetic valve. It is hypothesized that the size and simple design of wing 120 would mean that the wing would not obscure the outflow of a prosthetic valve implanted without removing the implant.
Furthermore, it may be possible to implant implant 100 with wing 120 over one part of a leaflet, and to perform an edge-to-edge repair (e.g., by implanting a leaflet clip that holds edges of the leaflet together). This edge-to-edge repair can be done at another portion of the leaflet not covered by the implant, or in some applications, may be able to be performed over or through a portion of the implant 100.
Reference is made to
In
Typically, for applications in which this anchoring site is used, prior to anchoring interface 110 is pressed against the leaflet such that the leaflet becomes sandwiched between delivery tool 50 (e.g., shaft 60 thereof) and the wall of ventricle 8.
In
Reference is made to
In some applications, and as shown, implant 100d can have a single anchor receiver 150, which receives a single anchor 30, with additional anchors 30a being driven through sheet 126 in a vicinity of interface 110. For some applications, implant 100d comprises multiple interfaces 110, each of which can comprise an anchor receiver. For some applications, implant 100d (e.g., an anchor interface thereof) is configured to receive multiple anchors at different angular dispositions, e.g., such that the multiple anchors cooperate to provide improved anchoring.
Having one anchoring point provides the benefit of easier and quicker implantation, making it very easy to position the device, confirm proper functioning (e.g., using fluoroscopy and/or echocardiography), and simply anchor in place. Having multiple anchors and anchor connection points may allow for greater stability and redundancy ensuring the implant is safely and permanently secured in place. Where multiple anchor connection points and anchors are used, a delivery device can be use that is configured to delivery multiple (e.g., 2, 3, 4, etc.) anchors simultaneously to help provide greater stability and redundancy while maintaining a quick an easy delivery.
Reference is made to
As shown, the protrusions and/or recesses can be defined by sheet 126e, e.g., by the sheet being textured. For some applications, the protrusions and/or recesses can be defined by discrete elements that are attached to the sheet.
Reference is now made to
Whereas anchor 30 has a single helical tissue-engaging element 34, each of anchors 30b and 30c has two tissue-engaging elements, arranged as a double helix, each of the tissue-engaging elements having a sharpened distal tip. Anchor 30b comprises two tissue-engaging elements 34b (i.e., a first tissue-engaging element 34b′ and a second tissue-engaging element 34b″), and anchor 30c comprises two tissue-engaging elements 34c (i.e., a first tissue-engaging element 34c′ and a second tissue-engaging element 34c″).
It is hypothesized that such use of two tissue-engaging elements may provide greater stability during initial penetration of the anchor into the tissue, and/or greater anchoring strength.
Although anchors 30b and 30c are shown with both tissue-engaging elements having the same length, for some applications one tissue-engaging element can be longer than the other, e.g., such that one penetrates the tissue first, providing stability as the other is penetrated into the tissue.
For some applications, and as shown, each of the tissue-engaging elements is defined by a respective wire. This is indicated for anchor 30b as wire 36b, with a first wire 36b′ defining tissue-engaging element 34b′, and a second wire 36b″ defining tissue-engaging element 34b″.
For some applications, anchor 30b or 30c can comprise a discrete component 32b that serves as an anchor head and/or the part of the anchor that is engaged by the anchor driver. Component 32b is shown in
Anchor 30b has a tissue-engaging region 38 and a head region 39. For some applications, and as shown, (i) in tissue-engaging region 38, each wire 36b defines its respective tissue-engaging element, and has a tissue-engaging pitch d1 that is such that, within the double helix, turns of each wire are axially spaced apart from turns of the other wire, whereas (ii) in head region 39 each wire 36b has a head pitch d2 that is such that, within the double helix, turns of the first wire abut turns of the second wire.
For some applications, pitch d1 facilitates screwing of tissue-engaging region 38 into tissue, whereas pitch d2 configures head region 39 to resist being screwed into the tissue, e.g., such that head region 39 serves as an anchor head.
As shown for anchor 30c, tissue-engaging elements 34c can, individually and/or collectively, be shaped as a conic helix that widens toward the distal end of the anchor. For some applications, such tissue-engaging elements are delivered in a radially compressed state, and expand to become conical (or more conical) during deployment.
While the above description contains many specific embodiments of the invention, these should not be construed as limitations on the scope of the invention, but rather as an example of one embodiment thereof. Accordingly, the scope of the invention should be determined not by the embodiments illustrated, but by the appended claims and their equivalents. Features of one embodiment can be combined with the features of other embodiments herein. In particular, features of a given variant of implant 100 can be combined with features of another variation of implant 100, mutatis mutandis.
The present application is a Continuation of International Patent Application PCT/US2021/039587 to Chau et al., filed Jun. 29, 2021, which published as WO 2022/006087, and which claims priority to: U.S. Provisional Patent Application 63/046,638 to Chau et al., filed Jun. 30, 2020; and U.S. Provisional Patent Application 63/124,704 to Chau et al., filed Dec. 11, 2020. Each of the above-referenced applications is incorporated herein by reference in their entirety for all purposes.
Number | Date | Country | |
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63124704 | Dec 2020 | US | |
63046638 | Jun 2020 | US |
Number | Date | Country | |
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Parent | PCT/US2021/039587 | Jun 2021 | US |
Child | 17993563 | US |