Heart valve sealing device, delivery device therefor, and retrieval device

Abstract

Methods and systems for implanting and repositioning implantable devices for native valves of a heart of a patient, including a delivery catheter, a collar, a coupler, and an actuation element. The actuation element extends through the delivery catheter and is attached to the device to open the device. The collar is connected to the device and the coupler is connected to the delivery catheter. The collar and coupler are tethered together by one or more coupling tethers that can be used to reengage the device after initial deployment.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 850,458, filed May 20, 2019, which is incorporated herein by reference in its entirety for all purposes. Background Technology

[0003] Natural heart valves (i.e., the aortic valve, pulmonary valve, tricuspid valve, and mitral valve) play a crucial role in ensuring an adequate supply of blood flows positively through the cardiovascular system. These valves can be damaged, for example, due to congenital malformations, inflammatory processes, infectious conditions, diseases, etc., and thus become less effective. Such damage to the valves can lead to serious cardiovascular injury or death. Damaged valves can be surgically repaired or replaced during open-heart surgery. However, open-heart surgery is highly invasive and can lead to complications. Transvascular techniques can be used to introduce and implant prosthetic devices in a much less invasive manner compared to open-heart surgery. As an example, a transvascular technique used to access the natural mitral and aortic valves is the transseptal technique. The transseptal technique involves advancing a catheter into the right atrium (e.g., inserting the catheter into the right femoral vein, ascending along the inferior vena cava, and into the right atrium). The septum is then punctured, allowing the catheter to enter the left atrium. A similar transvascular technique can be used to implant a prosthetic device into the tricuspid valve. This technique starts similarly to the transseptal technique, but instead of puncturing the septum and stopping, the delivery catheter is redirected to the tricuspid valve in the right atrium.

[0004] A healthy heart is typically conical in shape, tapering towards the lower apex. The heart has four chambers: the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall commonly called the septum. The natural mitral valve of the human heart connects the left atrium to the left ventricle. The anatomy of the mitral valve differs significantly from other natural heart valves. The mitral valve consists of: the annulus, which is the annular portion of the natural valve tissue surrounding the mitral orifice; and a pair of leaflets or cusps extending downwards from the annulus into the left ventricle. The mitral valve annulus can form a "D," oval, or other non-circular cross-sectional shape with long and short axes. The anterior leaflet can be larger than the posterior leaflet, and when the leaflets are close together, they form an overall "C"-shaped boundary between the adjacent free sides of the leaflets.

[0005] When functioning normally, the anterior and posterior leaflets together act as a one-way valve, allowing blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle dilates (also known as "ventricular diastole"), the oxygenated blood collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract (also known as "ventricular contraction"), the increased blood pressure in the left ventricle causes the two leaflets to come together side by side, causing the one-way mitral valve to close, preventing blood from flowing back to the left atrium and instead draining it from the left ventricle through the aortic valve. To prevent the two leaflets from dislodging under pressure and folding back towards the left atrium through the mitral valve annulus, numerous fibrous cords called chordae tendineae tether the leaflets to the papillary muscles in the left ventricle.

[0006] Valvular regurgitation involves a valve abnormally allowing some blood to flow through it in the wrong direction. For example, mitral regurgitation occurs when the natural mitral valve fails to close properly and blood flows from the left ventricle to the left atrium during the systolic phase of heart contractions. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation can have many different causes, such as leaflet prolapse, papillary muscle dysfunction, left ventricular dilation causing stretching of the mitral valve annulus, and more than one of these. Mitral regurgitation located in the central portion of the leaflet can be called central jet mitral regurgitation, and mitral regurgitation located closer to a commissure (i.e., where the leaflets meet) can be called eccentric jet mitral regurgitation. Central jet regurgitation occurs when the leaflet edges do not meet in the middle, causing the valve to fail to close and regurgitation to occur. Tricuspid regurgitation can be similar, but on the right side of the heart. Summary of the Invention

[0007] This summary is intended to provide examples and is not intended to limit the scope of the invention in any way. For example, the claims do not require any features included in the examples summarized herein unless those features are expressly recited by the claim. Furthermore, the features, components, steps, concepts, etc., described in the examples in this summary and other parts of this disclosure can be combined in various ways. The descriptions herein relate to systems, assemblies, methods, devices, combinations, etc., that can be used to repair valves such as the mitral or tricuspid valve. Various features and steps described in other parts of this disclosure may be included in the examples summarized herein. Furthermore, the processing techniques, methods, operations, steps, etc., described or implied herein can be performed on living animals or on non-living simulations, such as on cadavers, cadaver hearts, simulations (e.g., simulated body parts, hearts, tissues, etc.).

[0008] In some implementations, example systems include an implantable device, a delivery catheter, a coupler, an actuating element (e.g., an actuating wire, actuating shaft, actuating tube, actuating rod, etc.), and a tether. The implantable device has a pair of anchors movable between an open and closed position to secure the implantable device to a natural valve. The coupler is positioned distal to the delivery catheter. The actuating element extends through the delivery catheter and into the device. The coupler and collar are secured by a coupling tether, which allows the device to be reconnected to the coupler after the actuating element has been removed from the device.

[0009] In some implementations, an example system includes an implantable device having at least one clasp, a delivery catheter, and a clasp actuation wire. The clasp actuation wire has two portions, both extending from the delivery catheter and both passing through a loop of the clasp. The looped end of the clasp actuation wire is releasably coupled to at least one of the delivery catheter and the implantable device. The at least one clasp is movable from a closed position to an open position by pulling the clasp actuation wire. The at least one clasp is configured to secure the implantable device to a natural valve by moving the clasp from the open position to the closed position.

[0010] In some implementations, an example system includes an implantable device with at least one fastener, a delivery catheter, a fastener actuation wire with a looped end, and a fastener actuation element (e.g., a fastener actuation thread, a fastener actuation rod, etc.). The fastener actuation wire extends from the delivery catheter and passes through the loop of the fastener. The fastener actuation element has an end capable of moving from a hook configuration to a straight configuration. The looped end of the fastener actuation wire is releasably coupled to the end of the fastener actuation element / thread. The at least one fastener is movable from a closed position to an open position by pulling at least one of the fastener actuation wire and / or the fastener actuation element / thread. The at least one fastener is configured to secure the implantable device to a natural valve by moving the fastener from the open position to the closed position.

[0011] In some implementations, an example system includes an implantable device with at least one fastener, a delivery catheter, and at least one fastener actuation line. The fastener actuation line has a first portion and a second portion, both extending from the delivery catheter and passing through a loop of the fastener. The looped end of the first fastener actuation line is secured to at least one of the delivery catheter and the implantable device via a releasable knot. The at least one fastener is movable from a closed position to an open position by pulling the first portion of the fastener actuation line. The releasable knot is released by pulling the second portion of the fastener actuation line to release the at least one fastener from the fastener actuation line. The at least one fastener is configured to secure the implantable device to a natural valve by moving the fastener from an open position to a closed position.

[0012] In some implementations, example systems include: an implantable device comprising a pair of anchors; a collar attached to the device; a delivery conduit; a connector connected to the conduit; a compressible sleeve; and an actuating element (e.g., an actuating wire, actuating shaft, actuating tube, actuating rod, etc.). The compressible sleeve is arranged between the collar and the connector. The compressible sleeve encases the connecting tether. The actuating wire is coupled (e.g., directly or indirectly) to the pair of anchors for moving the pair of anchors between an open position and a closed position.

[0013] In some implementations, example systems include an implantable device, a delivery catheter, a connector, a collar, an actuating element (e.g., an actuating wire, an actuating shaft, an actuating tube, an actuating rod, etc.), and a pair of fastener actuating wires. The implantable device may have a pair of paddles movable between an open and closed position and a pair of clamping fasteners securing the implantable device to a natural valve. The actuating element extends through the delivery catheter and into the device. Each fastener actuating wire extends through the delivery catheter, passes through a fastener on one of the pair of clamping fasteners, around the actuating element, returns through the fastener, and returns through the delivery catheter.

[0014] In some example methods, a previously implanted valve repair device is observed and reconnected to the patient's natural valve. The previously implanted valve repair device has: a pair of anchors movable between an open and a closed position to secure the implantable device to the natural valve; and a collar. In this method, an actuating element (e.g., an actuating filament, actuating shaft, actuating cannula, actuating rod, etc.) is retracted from the implanted valve repair device. A delivery catheter and connector are retracted from the implanted valve repair device. A slack is introduced into the connecting tether connecting the implanted valve repair device. The state of the implanted valve repair device is observed. The connecting tether is pulled, and the connector is advanced to return to the collar. The actuating element is advanced into the implanted valve repair device. The valve repair device is opened using the actuating element and repositioned. The pair of anchors are moved back to the closed position. The actuating element is retracted from the implanted valve repair device again. The delivery catheter and connector are retracted from the implanted valve repair device. The connecting tether is then attached to the valve repair device. The delivery catheter, actuator, connector, connecting tether, and fastener actuation wire are removed, leaving the repositioned valve repair device implanted on the natural valve.

[0015] In some implementations, an example implantable prosthesis device includes a plurality of paddles, a cap, an engagement portion, and an extendable connector. The cap is attached to each of the paddles. The engagement portion is attached to each of the paddles. Movement of the cap relative to the engagement portion opens and closes the plurality of paddles. The extendable connector is attached to the cap and the engagement portion such that the extendable connector extends as the cap moves away from the engagement portion.

[0016] In some embodiments, an example implantable prosthesis device includes a pair of anchors, an apposition portion, and a collar. The pair of anchors is movable between an open position and a closed position to secure the implantable device to a natural valve. The apposition portion is connected to the pair of anchors. The apposition portion is made of multiple threads. Multiple ends of the multiple threads are gathered into multiple bundles. The multiple bundles are secured in multiple openings in the collar to connect the collar to the apposition element.

[0017] In some implementations, example systems include an implantable device, a delivery catheter, and an actuating element (e.g., an actuating wire, an actuating shaft, an actuating tube, an actuating rod, etc.). The implantable device has a pair of anchors movable between an open position and a closed position to secure the implantable device to a natural valve. The actuating element extends through the delivery catheter and is coupled to the device. At least one of the actuating element and the device includes a recapture feature configured to reconnect the actuating element to the device after initial separation of the actuating element from the device.

[0018] In some embodiments, an example implantable prosthesis device includes a pair of anchors, an apposition portion, a collar, a cover, and a connecting tether. The pair of anchors is movable between an open position and a closed position to secure the implantable device to a natural valve. The apposition portion is connected to the pair of anchors. The collar is connected to the apposition element. The cover is disposed on one or more of the pair of anchors, the apposition portion, and the collar. At least a portion of the cover is folded into a tube. The connecting tether extends through the tube.

[0019] In some embodiments, the example implantable device has a pair of paddles movable between an open position and a closed position, and a pair of clamping fasteners for securing the implantable device to a natural valve. The implantable device includes a delivery catheter, a connector disposed at the distal end of the delivery catheter, a collar attached to the device, and an actuating element extending through the delivery catheter and into the device. In some embodiments, the connector and collar are connected by a connecting tether that reconnects the device to the actuating element after the device has been moved to the closed position.

[0020] In some embodiments, the example implantable device has a pair of paddles movable between an open position and a closed position, and a pair of clamping fasteners for securing the implantable device to a natural valve. The implantable device includes a delivery catheter, a connector disposed at the distal end of the delivery catheter, a collar attached to the device, and an actuating element (e.g., actuating wire, actuating shaft, actuating tube, actuating rod, etc.) extending through the delivery catheter and into the device. The connector and collar are connected by a connecting tether that reconnects the device to the actuating element after the device has been moved to the closed position. In some embodiments, the connector and collar are configured such that pulling the end of the connecting tether results in a 1:2 ratio of movement to the longitudinal position of the collar.

[0021] In some embodiments, the example implantable device has a pair of paddles movable between an open position and a closed position, and a pair of clamping fasteners for securing the implantable device to a natural valve. The implantable device includes a delivery catheter, a connector disposed at the distal end of the delivery catheter, a collar attached to the device, and an actuating element (e.g., actuating wire, actuating shaft, actuating tube, actuating rod, etc.) extending through the delivery catheter and into the device. The connector and collar are connected by a connecting tether that reconnects the device to the actuating element after the device has been moved to the closed position. In some embodiments, the connector and collar are configured such that pulling the end of the connecting tether results in a 1:4 ratio of movement to the longitudinal position of the collar.

[0022] In some embodiments, the example implantable device has a pair of paddles movable between an open position and a closed position, and a pair of clamping fasteners for securing the implantable device to a natural valve. The implantable device includes: a delivery catheter having a tether passage disposed at its distal end; a collar attached to the device, the collar having a tether passage; an actuating element (e.g., an actuating wire, actuating shaft, actuating tube, actuating rod, etc.) extending through the delivery catheter and into the device; and an outer shaft disposed around the delivery catheter and having a connecting tether extending from its distal end. The delivery catheter and the collar are connected by the connecting tether, which reconnects the device to the actuating element after the device has been moved to the closed position. In some embodiments, the connecting tether extends from the distal end of the outer shaft, through the tether passage of the collar, and into the device through the tether passage of the delivery catheter.

[0023] In some embodiments, the example implantable device has a pair of paddles movable between an open position and a closed position, and a pair of clamping fasteners for securing the implantable device to a natural valve. The implantable device includes: a delivery catheter having a tether passage disposed at its distal end; a collar attached to the device, the collar having a tether passage; an actuating element (e.g., an actuating wire, actuating shaft, actuating tube, actuating rod, etc.) extending through the delivery catheter and into the device; and an outer shaft disposed around the delivery catheter and having a connecting tether extending from its distal end. The delivery catheter and the collar are connected by the connecting tether, which reconnects the device to the actuating element after the device has been moved to the closed position. In some embodiments, the connecting tether extends from the distal end of the outer shaft, through the tether passage of the delivery catheter, and into the device through the tether passage of the collar.

[0024] In some embodiments, the example implantable device has a pair of paddles movable between an open position and a closed position, and a pair of clamping fasteners for securing the implantable device to a natural valve. The implantable device includes: a delivery catheter having a lumen extending longitudinally through the delivery catheter; a collar attached to the device having a tether passage; and an actuating element (e.g., an actuating wire, actuating shaft, actuating tube, actuating rod, etc.) extending through the delivery catheter and into the device. The delivery catheter and the collar are connected by a connecting tether that reconnects the device to the actuating element after the device has been moved to the closed position. In some embodiments, the connecting tether extends through the lumen of the delivery catheter and enters the device through the tether passage of the collar.

[0025] In some embodiments, the example implantable device has a pair of paddles movable between an open position and a closed position, and a pair of clamping fasteners for securing the implantable device to a natural valve. The implantable device may include: a delivery catheter; a connector disposed at the distal end of the delivery catheter; a collar attached to the device; a compressible sleeve disposed between the collar and the connector, the compressible sleeve surrounding a connecting tether; an actuating element (e.g., an actuating wire, actuating shaft, actuating tube, actuating rod, etc.) extending through the delivery catheter and into the device; or some or all of these. In some embodiments, the connector and the collar are connected by a connecting tether that reconnects the device to the actuating element after the device has been moved to the closed position.

[0026] In some embodiments, the example implantable device has a pair of paddles movable between an open position and a closed position, and a pair of clamping fasteners for securing the implantable device to a natural valve. The implantable device may include: a delivery catheter; a connector disposed at the distal end of the delivery catheter and having a flange at the distal end of the connector; a collar attached to the device; an actuating element (e.g., an actuating wire, actuating shaft, actuating tube, actuating rod, etc.) extending through the delivery catheter and into the device; or some or all of these combinations. In some embodiments, the connector and the collar are connected by a connecting tether that reconnects the device to the actuating element after the device has been moved to the closed position.

[0027] In some implementations, an example method observes and reconnects a previously implanted valve repair device to the patient's natural valve, wherein the previously implanted valve repair device has a pair of paddles movable between an open and closed position, a pair of clamping fasteners for securing the previously implanted valve repair device to the natural valve, and a collar. In some embodiments, the method includes one, some, or all of the following: retracting an actuating element (e.g., actuating wire, actuating shaft, actuating tube, actuating rod, etc.) from the implanted valve repair device; retracting the delivery catheter and connector from the implanted valve repair device and introducing a slack into the connecting tether that connects the connector to the collar of the implanted valve repair device; observing the state of the implanted valve repair device; pulling the connecting tether to return the connector toward the collar and advancing the actuating element into the implanted valve repair device to engage the cap of the implanted valve repair device; opening the valve repair device through the actuating element and the fastener actuating wire; repositioning the valve repair device; moving the valve repair device to the closed position; retracting the actuating element from the implanted valve repair device; retracting the delivery catheter and connector from the implanted valve repair device; deconnecting the connecting tether and the fastener actuating wire to the valve repair device; removing the delivery catheter, actuating element, connector, connecting tether, and fastener actuating wire.

[0028] A further understanding of the nature and advantages of the invention is set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings, wherein like parts have like reference numerals. Attached Figure Description

[0029] To further clarify various aspects of embodiments of this disclosure, certain embodiments will be described in more detail with reference to various aspects of the accompanying drawings. It should be understood that these drawings depict only typical embodiments of this disclosure and should therefore not be considered as limiting the scope of this disclosure. Furthermore, while the drawings may be drawn to scale for some embodiments, they are not necessarily drawn to scale for all embodiments. Through the use of the drawings, embodiments and other features and advantages of this disclosure will be described and explained with additional specificity and detail, wherein:

[0030] Figure 1 An example of a cross-sectional view of the human heart during diastole;

[0031] Figure 2 An example of a cross-sectional view of a human heart during systole;

[0032] Figure 3 An example is a cross-sectional view of a human heart in diastole, where the chordae tendineae show the leaflets of the mitral and tricuspid valves attached to the ventricular wall;

[0033] Figure 4 An example of a healthy mitral valve with leaflet closure viewed from the atrial side;

[0034] Figure 5 An example of a dysfunctional mitral valve with visible gaps between the leaflets when viewed from the atrial side;

[0035] Figure 6 An example of a mitral valve with a wide gap between the posterior and anterior leaflets;

[0036] Figure 7 An example is shown of the tricuspid valve viewed from the atrial side;

[0037] Figures 8-14M Example implementations of implantable prosthetic devices at various stages of deployment and redeployment are shown;

[0038] Figures 15-20M Showing Figures 8-14M Examples of implantable prosthetic devices that are delivered and implanted, repositioned, and reimplanted within the natural mitral valve;

[0039] Figure 21 An example implementation of the implantable prosthesis device is shown;

[0040] Figure 21A An example implementation of the implantable prosthesis device is shown;

[0041] Figures 22A-22M Example implementations of implantable prosthetic devices at various stages of deployment and redeployment are shown;

[0042] Figures 23A-23M Example implementations of implantable prosthetic devices at various stages of deployment and redeployment are shown;

[0043] Figures 24A-24E Example implementations of collars and connectors that can be used with implantable prosthetic devices at various stages of deployment are shown;

[0044] Figures 25A-25G Example implementations of collars and connectors that can be used with implantable prosthetic devices at various stages of deployment are shown;

[0045] Figures 26A-26E Example implementations of implantable prosthetic devices at various stages of deployment and redeployment are shown;

[0046] Figures 27A-27E Example implementations of implantable prosthetic devices at various stages of deployment and redeployment are shown;

[0047] Figures 28A-28F Example implementations of implantable prosthetic devices at various stages of deployment and redeployment are shown;

[0048] Figures 29A-29O Example implementations of implantable prosthetic devices at various stages of deployment and redeployment are shown;

[0049] Figures 30A-30L Showing Figures 29A-29O Implantable prosthetic devices that are delivered and implanted, repositioned, and reimplanted within natural valves;

[0050] Figure 31A and Figure 31B A delivery catheter with a compressible sleeve for implantable prosthetic devices is shown;

[0051] Figure 31C and Figure 31D A delivery catheter with a compressible sleeve for implantable prosthetic devices is shown;

[0052] Figure 31E and Figure 31F A delivery catheter with a compressible sleeve for implantable prosthetic devices is shown;

[0053] Figures 31G-31I Examples of using Figure 31E and Figure 31F The delivery catheter releases an implantable prosthetic device;

[0054] Figure 32A and Figure 32B The compressible sleeve is shown in both the compressed and extended positions.

[0055] Figure 33A and Figure 33B The compressible sleeve is shown in both the extended and compressed positions.

[0056] Figure 34A and Figure 34B An example implementation of the implantable prosthesis device is shown;

[0057] Figure 35 An example implantable prosthesis device with an example extendable connector is provided;

[0058] Figure 36 yes Figure 35 Cross-sectional view of an example extendable connector without a prosthetic device;

[0059] Figure 37 Example Figure 36 An example of an extendable connector that connects to the actuating element;

[0060] Figure 38 Example Figure 36 An example of an extendable connector that can be moved to a partially extended state by an actuating element;

[0061] Figure 39 Example Figure 36 An example of an extendable connector that moves to its fully extended state via an actuator;

[0062] Figure 40 Example Figure 39 An example of a connector that can be extended is one in which the actuator moves the connector to a partially retracted state.

[0063] Figure 41 Example Figure 39 An example of an extendable connector that moves to a fully retracted state via an actuator;

[0064] Figure 42 Example Figure 35 An example of an implantable prosthesis device is shown where the central connector is moved to a partially extended state by an actuating element.

[0065] Figure 43 Example Figure 35 An example of an implantable prosthesis device is shown where the central connector is moved to a fully extended state via an actuating element.

[0066] Figure 44 Example Figure 43 An example of an implantable prosthesis device is shown where the central connector is moved to a partially retracted state by an actuating element.

[0067] Figure 45 Example Figure 43 An example of an implantable prosthesis device is shown where the central connector is moved to a fully retracted state by an actuating element.

[0068] Figure 46 Example Figure 35 An example of an implantable prosthetic device released from a delivery catheter;

[0069] Figure 47 An example implementation of an implantable prosthesis device with an example extendable connector is illustrated;

[0070] Figure 48 Example Figure 47 An example of an implantable prosthesis device is shown where the central connector is moved to a partially extended state by an actuating element.

[0071] Figure 49 Example Figure 47 An example of an implantable prosthesis device is shown where the central connector is moved to a fully extended state via an actuating element.

[0072] Figure 50 Example Figure 49 An example of an implantable prosthesis device is shown where the central connector is moved to a partially retracted state by an actuating element.

[0073] Figure 51 Example Figure 49 An example of an implantable prosthesis device is shown where the central connector is moved to a fully retracted state by an actuating element.

[0074] Figure 52 An exemplary implementation of an implantable prosthesis device coupled to a delivery system is illustrated;

[0075] Figure 53 Example Figure 52 The control thread or suture of the looped-through control ring in the delivery system;

[0076] Figure 54 An example is a delivery system in which a control line or suture loops through a control ring and is wound around a paddle-shaped control shaft;

[0077] Figure 55 Example Figure 54 A delivery system having one of the control lines or sutures to make the diagram clear;

[0078] Figure 56 Example Figure 54 A delivery system with one of the control lines or sutures to simplify the diagram;

[0079] Figures 57-60 Examples of using Figure 52 The delivery system shown deploys implantable devices;

[0080] Figure 61 An exemplary implementation of the fastener actuation arrangement is illustrated;

[0081] Figures 62-64 An exemplary implementation of an implantable prosthesis device coupled to a delivery system is illustrated;

[0082] Figure 65 An exemplary implementation of keyed coupling for connecting an implantable prosthetic device to a delivery system is illustrated;

[0083] Figure 66 Exemplary implementations of collars and connectors that can be used with implantable prosthetic devices are illustrated;

[0084] Figure 67 Exemplary implementations of collars and connectors that can be used with implantable prosthetic devices are illustrated;

[0085] Figure 68 An exemplary implementation of an implantable prosthesis device coupled to a delivery system is illustrated;

[0086] Figures 69-71 Examples from Figure 68 The control loop of the delivery system shown releases the control line or suture.

[0087] Figures 72-77 Examples of using Figure 68 The delivery system shown deploys implantable devices;

[0088] Figure 78 An exemplary implementation of an implantable prosthesis device coupled to a delivery system is illustrated;

[0089] Figure 79 Example Figure 78 The control line or suture tethered to the control ring of the delivery system;

[0090] Figures 80-84 An exemplary implementation of a releasable knot is illustrated;

[0091] Figure 85 An exemplary implementation of a releasable knot is illustrated;

[0092] Figures 86-89 Examples of using Figure 78 The delivery system shown deploys implantable devices;

[0093] Figure 90 and Figure 91An exemplary implementation of the connection between the mating element and the cap is illustrated;

[0094] Figure 92 and Figure 93 An exemplary implementation of the connection between the mating element and the cap is illustrated;

[0095] Figure 94 An exemplary implementation of the cap of the prosthetic device is illustrated;

[0096] Figures 95-97 An exemplary implementation of the arrangement for recapturing a prosthesis device is illustrated;

[0097] Figures 98-100 An exemplary implementation of the arrangement for recapturing a prosthesis device is illustrated;

[0098] Figure 101 An exemplary implementation of the cap of the prosthetic device is illustrated;

[0099] Figures 102-104 An exemplary implementation of the arrangement for recapturing a prosthesis device is illustrated;

[0100] Figures 105-107 An exemplary implementation of the arrangement for recapturing a prosthesis device is illustrated;

[0101] Figure 108 An exemplary embodiment of the structure of the cap or collar of a recaptureable prosthesis device is illustrated;

[0102] Figure 109 An exemplary embodiment of the structure of the cap or collar of a recaptureable prosthesis device is illustrated;

[0103] Figures 110-112 An exemplary implementation of the arrangement for recapturing a prosthesis device is illustrated;

[0104] Figures 113-115 An exemplary implementation of the arrangement for recapturing a prosthesis device is illustrated;

[0105] Figure 116 An exemplary embodiment of the structure of the cap or collar of a recaptureable prosthesis device is illustrated;

[0106] Figure 117 An exemplary embodiment of the structure of the cap or collar of a recaptureable prosthesis device is illustrated;

[0107] Figure 118 yes Figure 116 and Figure 117 A three-dimensional view of the structure shown;

[0108] Figure 119 and Figure 120This is a perspective view of an exemplary embodiment of a tethered implantable prosthesis device;

[0109] Figure 121 This is a partial perspective view of an exemplary embodiment of a tetherable implantable prosthesis device;

[0110] Figure 122 yes Figure 121 Side view of the tether routing structure of a tetherable implantable prosthesis device;

[0111] Figure 123 This is a partial perspective view of an exemplary embodiment of a tetherable implantable prosthesis device;

[0112] Figure 124 yes Figure 123 Side view of the tethering path setting structure of a tetherable implantable prosthesis device;

[0113] Figure 125 This is a partial three-dimensional view of an implantable prosthesis device with a covering attached to provide a tether path setting structure.

[0114] Figure 126 It has a tether path setting structure formed by the covering. Figure 125 A partial 3D view of the prosthetic device;

[0115] Figures 127-129 An exemplary embodiment of an implantable prosthesis device having a tether path setting structure is illustrated;

[0116] Figure 130 An exemplary embodiment of an implantable prosthesis device with a tether path setting structure is illustrated; and

[0117] Figure 131 An exemplary implementation of an implantable prosthesis device with a tether path setting structure is illustrated. Detailed Implementation Plan

[0118] The following description refers to the accompanying drawings, which illustrate specific embodiments of this disclosure. Other embodiments with different structures and operations do not depart from the scope of this disclosure.

[0119] This disclosure relates to exemplary embodiments of apparatus and methods for repairing defective heart valves. Various embodiments of natural valve repair devices, systems for delivering natural valve repair devices, and systems for removing implanted natural valve repair devices are disclosed herein, and any combination of these options may be made unless specifically excluded. In other words, the individual components of the disclosed apparatus and systems may be combined unless mutually exclusive or otherwise physically impossible.

[0120] As described herein, when one or more components are described as being connected, joined, affixed, coupled, attached, or otherwise interconnected, such interconnection may be direct between the components or indirect, such as by using one or more intermediate components. Furthermore, as described herein, references to “component,” “part,” or “section” should not be limited to a single structural component, part, or element, but may include combinations of components, components, or elements. Additionally, as described herein, the terms “substantially” and “about” are defined as at least close to (and including) a given value or state (preferably within 10%, more preferably within 1%, and most preferably within 0.1%).

[0121] Figure 1 and 2 These are cross-sectional views of the human heart (H) during diastole and systole, respectively. The right ventricle (RV) and left ventricle (LV) are separated from the right atrium (RA) and left atrium (LA) by the tricuspid valve (TV) and mitral valve (MV), respectively; i.e., the atrioventricular valves. Additionally, the aortic valve (AV) separates the left ventricle (LV) from the ascending aorta (AA), and the pulmonary valve (PV) separates the right ventricle from the pulmonary artery (PA). Each of these valves has a flexible leaflet extending inward across the corresponding orifice (e.g., Figure 4 and Figure 5 As shown in leaflets 20 and 22, the flexible leaflets meet or “clasp” in the flowstream to form a unidirectional fluid-blocking surface. The description and / or examples of the natural valve repair systems in this application are primarily concerned with the mitral valve (MV). Therefore, the anatomy of the left atrium (LA) and left ventricle (LV) will be described in more detail. However, it should be understood that the devices described herein can also be used to repair other natural valves, such as the tricuspid valve (TV), aortic valve (AV), and pulmonary valve (PV).

[0122] The left atrium (LA) receives oxygenated blood from the lungs. During diastole, or during relaxation... Figure 1 As shown, through the dilation of the left ventricle (LV), blood previously collected in the left atrium (LA) (during systole) moves through the mitral valve (MV) and into the left ventricle (LV). During systole, or the period of contraction... Figure 2 As shown, the left ventricle (LV) contracts to force blood through the aortic valve (AV) and ascending aorta (AA) into the body. During contraction, the leaflets of the mitral valve (MV) close to prevent blood from flowing back from the left ventricle (LV) into the left atrium (LA), and blood is collected in the left atrium from the pulmonary veins. In one example embodiment, the devices described in this application are used to restore the function of a defective mitral valve (MV). That is, these devices are configured to facilitate the closure of the mitral valve leaflets to prevent blood from flowing back from the left ventricle (LV) into the left atrium (LA).

[0123] Now for reference Figures 1-6 The mitral valve MV comprises two leaflets, anterior leaflet 20 and posterior leaflet 22. The mitral valve MV also includes a valve annulus 24, which is a variablely dense fibrous ring surrounding leaflets 20 and 22. (Reference) Figure 3 The mitral valve MV is anchored to the wall of the left ventricle (LV) via chordae tendineae 10. Chordalae 10 are band-like tendons that connect papillary muscles 12 (i.e., muscles located at the base of the chordae tendineae and within the left ventricular wall) to the leaflets 20 and 22 of the mitral valve MV. Papillary muscles 12 restrict mitral valve MV movement and prevent mitral valve reversion. The mitral valve MV opens and closes in response to pressure changes in the left atrium (LA) and left ventricle (LV). The papillary muscles do not open or close the mitral valve MV. Instead, they support the mitral valve MV against the high pressure required for systemic circulation. Together with the chordae tendineae, the papillary muscles form the subvalvular mechanism, which functions during mitral valve closure to prevent the mitral valve MV from detaching into the left atrium (LA).

[0124] Various disease processes can impair the normal function of one or more of the heart's natural valves (Vol. 1). These processes include degenerative processes (e.g., Barlow's disease, fibroelastosis, etc.), inflammatory processes (e.g., rheumatic heart disease, etc.), and infectious processes (e.g., endocarditis, etc.). Additionally, damage to the left ventricle (LV) or right ventricle (RV) resulting from pre-heart attacks (i.e., myocardial infarction secondary to coronary artery disease) or other heart conditions (e.g., cardiomyopathy) can distort the geometry of the natural valves, leading to their dysfunction. However, the vast majority of patients undergoing valve surgery, such as mitral valve MV surgery, have degenerative diseases that cause dysfunction of the leaflets (e.g., leaflets 20, 22) of the natural valve (e.g., mitral valve MV), resulting in prolapse and regurgitation.

[0125] In general, natural valves can become dysfunctional in different ways: (1) valvular stenosis; and (2) valvular regurgitation. Valvular stenosis occurs when a natural valve does not open fully, thus causing obstruction of blood flow. Generally, valvular stenosis is caused by the accumulation of calcified material on the valve leaflets, which leads to thickening of the leaflets and weakens the valve's ability to open fully to allow positive blood flow.

[0126] Valvular regurgitation occurs when the valve leaflets do not close completely, causing blood to leak back into the previous chamber (e.g., causing blood to leak from the left ventricle into the left atrium). There are three main mechanisms by which a natural valve becomes regurgitant or incompetent, including Carpentier type I, II, and III dysfunction. Carpentier type I dysfunction involves annular dilation, causing the normally functioning leaflets to separate from each other and fail to form a tight seal (i.e., the leaflets do not properly occlude). Type I mechanisms of dysfunction include leaflet perforation, as present in endocarditis. Carpentier type II dysfunction involves one or more leaflets of the natural valve prolapsing above the occlusal plane. Carpentier type III dysfunction involves restricted movement of one or more leaflets of the natural valve, causing the leaflets to be abnormally constricted below the annular plane. Leaflet restriction can be caused by rheumatic diseases (Ma) or ventricular dilation (IIIb).

[0127] refer to Figure 4 When a healthy mitral valve (MV) is in the closed position, the anterior leaflet 20 and posterior leaflet 22 align, preventing blood from leaking from the left ventricle (LV) into the left atrium (LA). (Reference) Figure 5 Regurgitation occurs when the anterior leaflet 20 and / or posterior leaflet 22 of the mitral valve MV shifts into the left atrium LA during systole. This failure to align results in a gap 26 between the anterior leaflet 20 and the posterior leaflet 22, which allows blood to flow from the left ventricle LV back to the left atrium LA during systole. As mentioned above, leaflets (e.g., leaflets 20, 22 of the bicuspid valve MV) can malfunction, leading to regurgitation in several different ways.

[0128] refer to Figure 6 In some cases, a patient's mitral valve MV may have a wide gap 26 between the anterior leaflet 20 and the posterior leaflet 22 when the mitral valve is in the closed position (i.e., during systole). For example, the gap 26 may have a width W between approximately 2.5 mm and approximately 17.5 mm, such as between approximately 5 mm and approximately 15 mm, such as between approximately 7.5 mm and approximately 12.5 mm, such as approximately 10 mm. In some cases, the gap 26 may have a width W greater than 15 mm. In any of the above cases, a valve repair device is needed that can engage with the anterior leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent backflow of blood through the mitral valve MV.

[0129] Although stenosis or regurgitation can affect any valve, stenosis is primarily found to affect the aortic valve (AV) or pulmonary valve (PV), and regurgitation is primarily found to affect the mitral valve (MV) or tricuspid valve (TV). Both valvular stenosis and valvular regurgitation increase the workload of the heart (H) and, if left untreated, can lead to very serious conditions such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. Because the left side of the heart (i.e., the left atrium (LA), left ventricle (LV), mitral valve (MV), and aortic valve (AV)) is primarily responsible for the flow of blood throughout the body and experiences higher pressures, dysfunction of the mitral valve (MV) or aortic valve (AV) is particularly problematic and often life-threatening.

[0130] Dysfunctional natural heart valves can be repaired or replaced. Repair generally involves preserving and correcting the patient's natural valve. Replacement generally involves replacing the patient's natural valve with a biological or mechanical substitute. Generally, the aortic valve (AV) and pulmonary valve (PV) are more prone to stenosis. Because the stenosis damage to the leaflets is irreversible, treatment for aortic or pulmonary valve stenosis can involve removing the valve and replacing it with a surgically implanted heart valve or a transcatheter heart valve. The mitral valve (MV) and tricuspid valve (TV) are more prone to leaflet and / or surrounding tissue deformation, which, as described above, can prevent normal closure of the mitral or tricuspid valves, allowing blood to regurgitate or flow back from the ventricle into the atrium (e.g., a deformed mitral valve (MV) can allow regurgitation or backflow from the left ventricle (LV) to the left atrium (LA). This regurgitation or backflow of blood from the ventricle to the atrium leads to valvular insufficiency. Structural or shape deformations of the mitral valve (MV) or tricuspid valve (TV) are usually repairable. Additionally, regurgitation can occur due to chordae tendineae 10 dysfunction (e.g., stretching or rupture of the chordae tendineae), which allows the anterior leaflet 20 and posterior leaflet 22 to revert, allowing blood to flow back into the left atrium (LA). Problems arising from chordae tendineae dysfunction can be repaired by repairing the chordae tendineae or mitral valve structures (e.g., by fixing leaflets 20 and 22 to the affected portion of the mitral valve).

[0131] The devices and procedures disclosed herein are for illustrative purposes and generally involve repairing the structure of the mitral valve or removing an implanted repair device from the mitral valve. However, it should be understood that the devices and concepts provided herein can be used to repair any natural valve and any component of a natural valve, or to remove an implanted repair device from any natural valve. For example, refer now to... Figure 7Any device or concept provided herein can be used to repair tricuspid valve reflux (TV) or to remove an implanted repair device from the tricuspid valve. For example, any device or concept provided herein can be used between any two of the anterior leaflet 30, septal leaflet 32, and posterior leaflet 34 to prevent or inhibit blood regurgitation from the right ventricle into the right atrium, and these devices and concepts can be used to remove an implanted repair device between any two of the anterior leaflet 30, septal leaflet 32, and posterior leaflet 34. Alternatively, any device or concept provided herein can be used on all three leaflets 30, 32, and 34 to prevent or inhibit blood regurgitation from the right ventricle into the right atrium, or to remove a repair device from all three leaflets 30, 32, and 34 of the tricuspid valve. In other words, the valve repair device provided herein can be centrally positioned between the three leaflets 30, 32, and 34.

[0132] Example implantable prosthetic devices may optionally have occlusion elements (e.g., spacers, coupling elements, etc.) and at least one anchoring element (e.g., one, two, three, or more). In some embodiments, the occlusion element is configured to be positioned within the natural heart valve orifice to help fill the space between the leaflets and form a more effective seal, thereby reducing or preventing the aforementioned regurgitation. The occlusion element may have a structure that is blood-impermeable (or resists blood flow through it) and allows the natural leaflets to close around the occlusion element during ventricular systole to prevent blood from flowing from the left or right ventricle back into the left or right atrium, respectively. The prosthetic device may be configured to seal against two or three natural valve leaflets; that is, the device may be used for natural mitral valves (bicuspid valves) and tricuspid valves. The occlusion element is sometimes referred to herein as a spacer because a spacer can be an occlusion element that can fill the space between incompletely closed, malfunctioning leaflets (e.g., natural mitral or tricuspid leaflets, etc.).

[0133] Optional occlusion elements (e.g., spacers, coupling elements, etc.) can have various shapes. In some embodiments, the occlusion element can have an elongated cylindrical shape with a rounded cross-sectional shape. In some embodiments, the occlusion element can have an elliptical cross-sectional shape, an oval cross-sectional shape, a crescent-shaped cross-sectional shape, a rectangular cross-sectional shape, or various other non-cylindrical shapes. In some embodiments, the occlusion element may have an atrial portion located in or adjacent to the atrium, a ventricular portion or lower portion located in or adjacent to the ventricle, and lateral surfaces extending between the natural leaflets. In embodiments configured for the tricuspid valve, the atrial portion or upper portion is located in or adjacent to the right atrium, and the ventricular portion or lower portion is located in or adjacent to the right ventricle, and the lateral surfaces extend between the natural tricuspid valve leaflets.

[0134] In some embodiments, the anchor may be configured to secure the device to one or two natural leaflets, such that the occlusal element is positioned between the two natural leaflets. In embodiments configured for the tricuspid valve, the anchor is configured to secure the device to one, two, or three tricuspid leaflets, such that the occlusal element is positioned between the three natural leaflets. In some embodiments, the anchor may be attached to the occlusal element at a location adjacent to the ventricular portion of the occlusal element. In some embodiments, the anchor may be attached to an actuating element, such as a shaft or actuating wire, to which the occlusal element is also attached. In some embodiments, the anchor and occlusal element can be positioned independently of each other by moving each of the actuating element (e.g., actuating shaft, actuating rod, actuating tube, actuating wire, etc.) separately along the longitudinal axis of the actuating element. In some embodiments, the anchor and occlusal element can be positioned simultaneously by moving the anchor and occlusal element together along the longitudinal axis of the actuating element (e.g., a shaft or actuating wire, etc.). The anchor can be configured to be positioned behind the natural leaflet when implanted, so that the leaflet is held in place by the anchor.

[0135] The prosthetic device can be configured for implantation via a guide / delivery sheath, a manipulable catheter, and / or an implant catheter. The occlusal element and anchor can be compressible to a radially compressed state and can self-expand to a radially expanded state when the compressive pressure is released. The device can be configured such that the anchor initially expands radially away from the compressible occlusal element, thereby creating a gap between the occlusal element and the anchor. A natural leaflet can then be positioned within this gap. The occlusal element can be radially expanded to close the gap between the occlusal element and the anchor and capture the leaflet between the occlusal element and the anchor. In some embodiments, the anchor and occlusal element are optionally configured to self-expand. Implantation methods can vary across different embodiments, and are discussed more fully below with respect to each embodiment. Further information regarding these and other delivery methods can be found in U.S. Patent No. 8,449,599 and U.S. Patent Application Publications Nos. 2014 / 0222136, 2014 / 0067052, 2016 / 0331523, U.S. Provisional Patent Application Serial No. 62 / 744,031 (filed October 10, 2018), and PCT Patent Application Publication No. WO2020 / 076898, all of which are incorporated herein by reference in their entirety for all purposes. These methods, with necessary modifications, can be performed on living animals or on simulations, such as on cadavers, cadaver hearts, simulations (e.g., simulated body parts, hearts, tissues, etc.).

[0136] The disclosed prosthetic device can be configured such that the anchor is connected to the leaflet, utilizing tension from the natural chordae tendineae to resist the high systolic pressure that pushes the device toward the left atrium. During diastole, the device can rely on the compressive and retaining forces applied to the leaflet held by the anchor.

[0137] Now for reference Figures 8-14M This document illustrates illustrative examples of implantable prosthetic devices 100 (e.g., prosthetic spacer devices, valve repair devices, etc.) at various stages of deployment. Prosthetic device 100 and other similar prosthetic devices are described in more detail in PCT patent applications WO2018 / 195215, WO2020 / 076898, and WO 2019 / 139904, which are incorporated herein by reference in their entirety. Device 100 may include any other features used in the implantable prosthetic devices discussed in this application or the above-cited applications, and device 100 may be positioned to engage valve tissue (e.g., leaflets 20, 22) as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application or the above-cited applications). The tethering embodiments disclosed herein can be used with any implantable prosthetic device, such as any transcatheter mitral valve repair device and any transcatheter tricuspid valve repair device. The implantable devices disclosed herein are merely a few examples among the many implantable devices to which the tethering embodiments disclosed herein can be used. Therefore, the tethering embodiments disclosed herein can be used with implantable devices that do not include all or any of the features of the implantable devices disclosed herein.

[0138] Device 100 is deployed from delivery catheter or implant catheter / shelter 102 and includes an engagement or mating portion 104 and an anchoring portion 106. One or more additional sheaths or catheters may be arranged around and / or inside delivery catheter 102. For example, in one exemplary embodiment, delivery catheter 102 is arranged within a guide or introduction sheath and a positioning catheter. The guide or introduction sheath may be used to position the positioning catheter at a first location, such as the left or right atrium. The positioning catheter may then extend from the guide or introduction sheath to position the delivery catheter or implant catheter at a delivery site, such as at the leaflet of the mitral or tricuspid valve in the left or right ventricle. One or more of the guide sheath, positioning catheter, and implant catheter or delivery catheter may optionally be maneuverable. In the following examples, only the delivery catheter or implant catheter is shown to simplify the figures.

[0139] In some embodiments, the engagement portion 104 of the device 100 includes an engagement device or engagement element 110 (e.g., a spacer, plunger, sheet, membrane, etc.) adapted for implantation between the leaflets of a natural valve (e.g., a natural mitral valve, tricuspid valve, etc.) and slidably attached to an actuating element 112 (e.g., an actuating filament, actuating shaft, actuating tube, etc.). The anchoring portion 106 includes one or more anchors 108, which are actuable between an open and closed state and can take various forms, such as paddles, clamping elements, etc. The actuation of the engagement device or actuating element 112 opens and closes the anchoring portion 106 of the device 100 to grip the natural valve leaflets during implantation. The actuating device or actuating element 112 (and other actuating devices and actuating elements herein) can take many different forms (e.g., as thread, rod, shaft, tube, screw, sewing thread, cord, strip, combination thereof, etc.), can be made of many different materials, and can have many different configurations. As an example, the actuating element can be threaded, such that rotation of the actuating element moves the anchor portion 106 relative to the mating portion 104. Alternatively, the actuating element can be unthreaded, such that pushing or pulling the actuating element 112 moves the anchor portion 106 relative to the mating portion 104.

[0140] The anchoring portion 106 and / or anchoring element of device 100 includes an outer paddle 120 and an inner paddle 122 connected between cap 114 and mating device or mating element 110 via portions 124, 126, and 128. Portions 124, 126, and 128 may have joints and / or be flexible to move between all the positions described below. The interlocking of the outer paddle 120, inner paddle 122, mating element 110, and cap 114 via portions 124, 126, and 128 secures and moves the device to the positions illustrated herein.

[0141] In some embodiments, the actuating device or actuating element 112 extends through the delivery conduit and the mating device or mating element 110 to a distal end (e.g., a cap 114 or other attachment at the distal connection of the anchor portion 106). Extending and retracting the actuating element 112 increases and decreases the distance between the mating element 110 and the distal end of the device (e.g., cap 114 or other attachment), respectively. In some embodiments, a collar or other attachment removably attaches the mating element 110 directly or indirectly to the delivery conduit 102, such that the actuating device or actuating element 112 slides through the collar or other attachment during actuation and, in some embodiments, through the mating device or mating element 110 to open and close the paddles 120, 122 of the anchor portion 106 and / or the anchor 108.

[0142] The device 100 may also include a connector 117 that removably attaches a collar 115 to a delivery conduit 102. The connector 117 may be removably attached to the collar 115 and may be fixedly or removably attached to the delivery conduit 102. The connector 117 may attach the delivery conduit 102 to the collar 115 in various ways. For example, as will be described with reference to the following embodiments, one or more tethers (see...) Figure 14C Reference number 119 in the document allows for the pull of the connector 117 against the cap to effectively connect them together. As detailed below, the tethered connector 117 facilitates the placement, inspection of proper deployment, repositioning, and / or replacement of the device 100. Alternatively or additionally, the connector 117 can attach the collar 115 to the delivery conduit 102 in any manner as described in PCT patent application publication WO2020 / 076898 (which is incorporated herein by reference in its entirety).

[0143] In some exemplary embodiments, the delivery catheter 102, actuating element 112, connector 117, and collar 115 may form a delivery and repositioning system. As will be described later, if it is necessary to remove the device 100 from the valve tissue after it has been connected to the valve tissue, the connector 117 and collar 115 can be used to connect or reconnect the device 100, such that the actuating element 112 can extend through the connector 117, collar 115, and engagement element 110 to engage the anchor portion 106, thereby opening the paddles 120, 122 and removing the device 100 from the valve tissue.

[0144] Now for reference Figure 11The anchoring portion 106 and / or the anchoring element includes an attachment portion or clamping member. An example clamping member may include a fastener 130, which includes a base or fixing arm 132, a movable arm 134, optional barbs, friction-enhancing elements, or other securing devices 136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.), and a joint portion 138. The fixing arm 132 is attached to the inner paddle 122. In some embodiments, the fixing arm 132 is attached to the inner paddle 122, wherein the joint portion 138 is arranged proximal to the engaging device or engaging element 110. In some embodiments, the fastener (e.g., a barbed fastener, etc.) has a flat surface and does not engage with a recess in the inner paddle. Instead, the flat portion of the fastener is arranged against the surface of the inner paddle 122. The joint portion 138 provides a spring force between the fixing arm 132 and the movable arm 134 of the fastener 130. The connector portion 138 can be any suitable connector, such as a flexible connector, spring connector, pivot connector, or similar connector. In some embodiments, the connector portion 138 is a flexible material piece integrally formed with the fixed arm 132 and the movable arm 134. The fixed arm 132 is attached to the inner paddle 122 and remains stationary or substantially stationary relative to the inner paddle 122 when the movable arm 134 is opened to open the fastener 130 and expose the barbs 136, friction-enhancing elements, or securing devices 136.

[0145] In some embodiments, fastener 130 is opened by applying tension to actuation line 116 attached to movable arm 134, thereby causing movable arm 134 to hinge, flex, or pivot on joint portion 138. Other actuation mechanisms are also possible.

[0146] During implantation, paddles 120, 122 can be opened and closed to, for example, grasp the natural leaflet (e.g., a natural mitral leaflet) between paddles 120, 122 and / or between paddles 120, 122 and the engagement device or engagement element 110. Fastener 130 can be used to grasp and / or further secure the natural leaflet by engaging the leaflet with barbs, friction-enhancing elements, or fixation devices 136 and clamping the leaflet between the movable arm 134 and the fixed arm 132. The barbs, friction-enhancing elements, or other fixation devices 136 (e.g., barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc.) of the fastener or barbed fastener 130 increase friction with the leaflet, or may partially or completely puncture the leaflet. Actuation lines 116 can be individually actuated so that each fastener 130 can be opened and closed individually. Individual operation allows for the clamping of one leaf at a time, or the repositioning of fastener 130 on insufficiently clamped leaves, without altering the successful clamping of other leaves. Fastener 130 can be opened and closed relative to the inner paddle 122 (as long as the inner paddle is in an open or at least partially open position), thus allowing the leaves to be clamped in multiple positions as needed.

[0147] The fastener 130 can be opened by pulling the attached actuation line 116, which extends through the delivery device or delivery conduit / sheath 102 to the fastener 130. The actuation line 116 can take many different forms, such as thread, suture, silk thread, rod, conduit, or the like. The fastener 130 may be spring-loaded so that the fastener 130 continues to provide clamping force to the grasped natural leaflet in the closed position. This clamping force remains constant or positive regardless of the position of the inner paddle 122. The barbs or fixing device 136 of the barbed fastener 130 can pierce the natural leaflet to further secure it.

[0148] Now for reference Figure 8 The device 100 is shown in an extended or fully open state during deployment of the delivery conduit 102. The device 100 is loaded into the delivery conduit 102 in the fully open position because this position occupies the least space and allows the use of the smallest conduit (or the largest device 100 for a given conduit size). In the extended state, the cap 114 is spaced apart from the engagement device or engagement element 110, such that the paddles 120, 122 are fully extended. In some embodiments, the angle formed between the interior of the outer paddle 120 and the inner paddle 122 is approximately 180 degrees. The fastener 130 remains closed during deployment through the delivery device or delivery conduit / shroud 102, such that the barbs, friction-enhancing elements, or fixing devices 136 ( Figure 11 It will not jam or damage the catheter or tissue in the patient's heart. The actuation line 116 can extend around the collar 115 via the connector 117 and be attached to the movable arm 134.

[0149] Now for reference Figure 9 Displays something similar to Figure 8 The device 100 is in an elongated, detangling state, but the fastener 130 is in the fully open position, with the fixed and movable portions of the fastener 130 within the following ranges: approximately 140 degrees to approximately 200 degrees, approximately 170 degrees to approximately 190 degrees, or approximately 180 degrees. It has been found that fully opening the paddles 120, 122 and the fastener 130 increases the ease of detangling or separating from chordae tendineae (such as tendineae) during implantation of the device 100.

[0150] Now for reference Figure 10The device 100 is shown in either a shortened or fully closed state. The compact size of the device 100 in the shortened state allows for easier manipulation and placement within the heart. To move the device 100 from the extended state to the shortened state, the actuating device or actuating element 112 retracts to pull the cap 114 toward the engaging device or engaging element 110. Movement of the connecting portion (one or more) 126 (e.g., joint (one or more), flexible connection (one or more), etc.) between the outer paddle 120 and the inner paddle 122 is restricted, such that the compressive force exerted on the outer paddle 120 by the cap 114 retracting toward the engaging device or engaging element 110 causes the paddle or clamping element to move radially outward. During movement from the open position to the closed position, the outer paddle 120 remains at an acute angle to the actuating device or actuating element 112. The outer paddle 120 may optionally be biased toward the closed position. During the same movement, the inner paddle 122 travels a considerable angle because it is oriented away from the mating device or mating element 110 in the open state and collapses along the side of the mating device or mating element 110 in the closed state. In some embodiments, the inner paddle 122 is thinner and / or narrower than the outer paddle 120, and the connecting portions 126, 128 (e.g., joints, flexible connections, etc.) connected to the inner paddle 122 may be thinner and / or more flexible. For example, this increased flexibility may allow more movement than the connecting portion 124 connecting the outer paddle 120 to the cap 114. In some embodiments, the outer paddle 120 is narrower than the inner paddle 122. The connecting portions 126, 128 connected to the inner paddle 122 may be more flexible, for example, to allow more movement than the connecting portion 124 connecting the outer paddle 120 to the cap 114. In some embodiments, the inner paddle 122 may have the same or substantially the same width as the outer paddle.

[0151] Now for reference Figures 11-13 The device 100 is displayed in a partially open, gripping-ready state. To transition from a fully closed state to a partially open state, the actuating device or actuating element (e.g., actuating wire, actuating shaft, etc.) extends to push the cap 114 away from the engaging device or engaging element 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the anchor or anchor portion 106 to partially unfold. The actuating wire 116 is also retracted to open the fastener 130, allowing the leaflet to be gripped. Figure 11 In the example shown, the paired inner paddle 122 and outer paddle 120 are moved together by a single actuating device or a single actuating element 112, rather than moving independently. Furthermore, the position of the fastener 130 depends on the position of the paddles 122 and 120. For example, refer to... Figure 10The closing of paddles 122 and 120 also closes the fastener. In some embodiments, paddles 120 and 122 can be independently controllable. For example, device 100 can have two actuating elements and two separate caps (or other attachments), such that one separate actuating element (e.g., a thread, a spool, etc.) and cap (or other attachment) is used to control one paddle, while another separate actuating element and cap (or other attachment) is used to control the other paddle.

[0152] Now for reference Figure 12 This causes one of the actuation lines 116 to extend, allowing one of the fasteners 130 to close. Now refer to... Figure 13 This causes another actuation line 116 to extend, allowing another fastener 130 to close. Either or both actuation lines 116 can be repeatedly actuated to repeatedly open and close fastener 130.

[0153] Now for reference Figures 14A to 14M Device 100 can be closed or attached, removed, repositioned, and redeployed. For example... Figure 14A As shown, the display device 100 is in a fully closed and deployed state. Paddles 120, 122 and fastener 130 are held in the fully closed position. Once deployed, the device 100 can be held in the fully closed position by a mechanical latch, or by being biased to maintain closure using a spring material such as steel, other metals, plastics, composite materials, or shape memory alloys such as nitinol. For example, connecting portions 124, 126, 128, connector portions (one or more) 138, and / or inner paddle 122 and outer paddle 120, and / or other biasing components can be formed of metals such as steel or shape memory alloys such as nitinol—prepared as wire, sheet, tubing, or laser-sintered powder—and biased to keep the outer paddle 120 closed around the mating element 110 and to keep the fastener 130 clamped around the natural leaflet. Similarly, the fixed arm 132 and movable arm 134 of the fastener 130 are biased to clamp the leaflet. In some embodiments, the attachment or connection portions 124, 126, 128, the connector portion (one or more) 138, and / or the inner paddle 122 and the outer paddle, and / or other biasing components may be formed of any other suitable resilient material such as metal or polymer material to keep the device closed after implantation.

[0154] Now for reference Figure 14BThe device 100 can be decoupled from the actuating element 112. The actuating element 112 can be retracted from the device 100 and the collar 115 and enter the connector 117 or delivery conduit 102. The actuating element 112 can be retracted such that the end of the actuating element 112 is positioned within the connector 117 or delivery conduit 102. In this position, the device 100 and the collar 115 can move or pivot relatively unrestricted by the connector 117, the delivery conduit 102, and the actuating element 112.

[0155] like Figure 14C As shown, slack can be introduced into the fastener actuation line 116, allowing the delivery conduit 102, actuation element 112, and connector 117 to retract from the device 100 and collar 115. The device 100 remains attached to the delivery conduit 102, actuation element 112, and / or connector 117 via one or more connecting cords 119. The device 100 can be held tethered in a variety of different ways. For example, the collar 115 can be attached to the delivery conduit 102, actuation element 112, and / or connector 117 via one or more connecting cords 119. However, any component of the device 100 can be tethered. One or more connecting cords 119 can be wrapped around or otherwise secured or attached to the collar 115, connector 117, actuation element 112, and / or delivery conduit 102. In this position, device 100 is tethered or secured to delivery catheter 102, actuation element 112, and / or connector 117, but with sufficient slack in the fastening actuation line 116 and tether to allow device 100 to move freely generally relative to delivery catheter 102, actuation element 112, and connector 117. In this position, a user, such as a physician, can observe or inspect how device 100 actually looks or functions when it is actually implanted in a natural leaflet of the heart (e.g., a natural mitral valve leaflet). That is, slack is selected in the tether 119 and actuation line such that the tether does not affect or substantially does not affect the position of device 100 and / or valve leaflet.

[0156] Now for reference Figures 14D to 14F The device 100 and the collar 115 can be reconnected to the delivery catheter 102, the actuating element 112, and the connector 117. For example, if the user observes that the device 100 is not properly implanted, does not achieve the desired efficacy (e.g., regurgitation is not reduced or not reduced to the expected level), is not in the proper intended position, and / or the device has moved from the initial capture position relative to the natural valve leaflet (e.g., one or more leaflets slip out or partially slip out of the fastener), the device 100 and the collar 115 can be reconnected to the delivery catheter 102, the actuating element 112, and the connector 117.

[0157] like Figure 14DAs shown, the device 100 and collar 115 can be reconnected to the delivery conduit 102 and connector 117. Tension can be applied to one or more connecting cords 119, allowing the delivery conduit 102 and connector 117 to advance toward the collar 115. When the connector 117 and collar 115 are brought back together, the device 100 can be reconnected to the delivery conduit 102, actuation element 112, and connector 117. Tension can also be applied to the fastener actuation line 116 to bring it closer to the device 100 and within the connector 117 and / or delivery conduit 102, preventing the fastener actuation line 116 from moving around, becoming tangled, or getting stuck between the collar 115 and connector 117.

[0158] Figure 14E An example is shown where the coupling 117 returns to contact with the collar 115. The actuating element 112 can be advanced and enter the device 100 through the coupling 117 and the collar 115. Figure 14F As shown, the actuating element 112 can be advanced and enter the device 100 through the collar 115 and the connector 117 until the actuating element 112 re-engages the cap 114 of the device 100.

[0159] Now for reference Figure 14G and Figure 14H The device 100 can be reopened or moved back to a partially open, gripping ready state. For example... Figure 14G As shown, to transition from a fully closed state to a partially open state, the actuating element 112 extends to push the cap 114 away from the engaging element 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the anchor portion 106 to partially unfold. The actuating line 116 is also retracted to open the fastener 130, allowing the leaflet to be released. However, the device can be moved to any position described herein to release or fully release the leaflet.

[0160] exist Figure 14G In the example shown, the paired inner paddle 122 and outer paddle 120 move together via a single actuating element 112, rather than moving independently. Furthermore, the position of the fastener 130 depends on the position of the paddles 122 and 120. For example, refer to... Figure 10The closing of paddles 122 and 120 also closes the fastener. In some embodiments, paddles 120 and 122 can be independently controllable. For example, device 100 can have two actuating elements and two separate caps (or other attachments), such that one separate actuating element (e.g., thread, spool, etc.) and cap (or other attachment) controls one paddle, while another separate actuating element (e.g., thread, spool, etc.) and cap (or other attachment) controls the other paddle. When in a partially open, gripping-ready state, device 100 can be moved or repositioned. For example, a user can reposition device 100 to properly grip a natural leaflet (e.g., a natural mitral leaflet, etc.).

[0161] like Figure 14H As shown, device 100 can be moved to a fully closed or deployed state. For example, after device 100 has been positioned or repositioned to a desired location, device 100 can be moved back to the deployed state. Actuation line 116 can be extended to allow fastener 130 to close. Any one or both actuation lines 116 can be repeatedly actuated to repeatedly open and close fastener 130. For example, fastener 130 can be repeatedly opened and closed to ensure that device 100 is properly positioned.

[0162] Now for reference Figures 14I to 14M The device 100 can be deployed from the delivery catheter 102, connector 117, and actuating element 112. For example, the device 100 can be deployed after it is in place and grips a natural leaflet (e.g., a natural mitral leaflet).

[0163] like Figure 14I As shown, the device 100 can be decoupled from the actuating element 112. The actuating element 112 can be retracted from the device 100 and the collar 115 and enter the connector 117 or delivery conduit 102. The actuating element 112 can be retracted such that the end of the actuating element 112 is positioned within the connector 117 or delivery conduit 102. In this position, the device 100 and the collar 115 can move or pivot relatively unrestricted by the connector 117, the delivery conduit 102, and the actuating element 112.

[0164] like Figure 14JAs shown, slack can be introduced into the fastener actuation line 116 and the tether 119, allowing the delivery conduit 102, actuation element 112, and connector 117 to retract away from the device 100 and the collar 115. The collar 115 can still be attached to the delivery conduit 102, actuation element 112, and / or connector 117 via one or more connecting tethers 119. One or more connecting tethers 119 can wrap around or otherwise secure or attach to the collar 115 and can attach the collar 115 to the mating portion 104 of the device 100. One or more connecting tethers 119 can attach the device 100 and the collar 115 to the connector 117, actuation element 112, and / or delivery conduit 102 in various ways. For example, one or more connecting cords 119 can connect the device 100 and the collar 115 to the connector 117, the actuating element 112, and / or the delivery catheter 102, as described herein. In this position, the device 100 remains tethered or secured to the delivery catheter 102, the actuating element 112, and / or the connector 117, but with sufficient slack in the fastener actuation line 116 and the cord, allowing the device 100 to move freely generally relative to the delivery catheter 102, the actuating element 112, and the connector 117. In this position, the user can observe or inspect how the device 100 actually looks or operates when it is actually deployed on a natural leaflet (e.g., a natural mitral leaflet).

[0165] like Figure 14K As shown, the actuating element 112 can optionally be retracted or withdrawn further into the delivery conduit 102 and away from the connector 117 to release one or more connecting tethers 119. One or more connecting tethers 119 can be released in a variety of ways. For example, one or more connecting tethers 119 can be released as described herein.

[0166] like Figure 14L As shown, the device 100 and collar 115 can be decoupled from one or more connecting cords 119, thereby releasing them from the delivery conduit 102, actuating element 112, and connector 117. One or more connecting cords 119 can retract away from the device 100 and collar 115. The fastener actuation line 116 can also detach from the movable arm 134 and be pulled toward or otherwise retracted into the connector 117 and / or delivery conduit 102. In such an embodiment, the device 100 and collar 115 are completely disengaged from the delivery conduit 102, connector 117, and actuating element 112.

[0167] like Figure 14MAs shown, the display device 100 is in a fully closed and deployed state. The delivery conduit 102, connector 117, and actuating element 112 are retracted, while the paddles 120, 122, and fastener 130 are held in the fully closed position. After deployment, the device 100 can be held in the fully closed position by a mechanical latch, or by being biased to maintain closure using spring materials such as steel, other metals, plastics, composite materials, or shape memory alloys such as nitinol. For example, the connector or flexible portions 124, 126, 128, 138, and / or the inner paddle 122 and outer paddle 120, and / or other biasing components can be formed of metals such as steel or shape memory alloys such as nitinol—prepared as wire, sheet, tubing, or laser-sintered powder—and biased to keep the outer paddle 120 closed around the mating element 110 and to keep the fastener 130 clamped around the natural leaflet. Similarly, the retaining arm 132 and movable arm 134 of the fastener 130 are biased to clamp the leaflet. In some embodiments, the connector portions 124, 126, 128, 138, and / or the inner paddle 122 and the outer paddle, and / or other biasing components may be formed of any other suitable resilient material such as metal or polymer to keep the device closed after implantation.

[0168] Now for reference Figures 15 to 20M ,show Figures 8 to 14M The implantable device 100 is delivered and implanted within the natural mitral valve MV of, for example, the heart H. (See now for reference.) Figure 15 The delivery sheath is inserted into the left atrium (LA) through the septum, and device 100 is deployed from the delivery catheter in a fully open state. Device 100 is moved to... Figure 16 The fully closed state shown can be achieved, for example, in some embodiments by retracting the actuator 112. (e.g.) Figure 17 As can be seen, device 100 is moved to the position within the mitral valve MV and enters the ventricular LV and is partially opened, allowing leaflets 20 and 22 to be grasped. Now refer to Figure 18 This causes the actuation line 116 to extend to close one of the fasteners 130, thereby capturing the leaflet 20. Figure 19 Another actuation line 116 is shown and then extended to close another fastener 130, thereby capturing the remaining leaflet 22.

[0169] Now for reference Figures 20A to 20M (and corresponding) Figures 14A-14M As shown in the figure, the implantable device 100 can be decoupled from, recoupled to, repositioned to, and redeployed within the natural mitral valve MV of the heart H. Figure 20A As shown (see also) Figure 14AThis releases the actuator line 116 and moves the device 100 to the fully closed position, securing the fastener 130 to the leaflets 20 and 22. The device 100 remains in contact with... Figure 20A The delivery conduit 102, actuator 112, and connector 117 are connected.

[0170] like Figure 20B As shown (see also) Figure 14B In some embodiments, device 100 may be decoupled from actuating element 112. Actuating element 112 may retract from device 100 and collar 115 and enter connector 117 or delivery conduit 102. Actuating element 112 may be retracted such that the end of actuating element 112 is positioned within connector 117 or delivery conduit 102. In such a position, device 100 and collar 115 may move or pivot relatively unrestricted by connector 117, delivery conduit 102, and actuating element 112.

[0171] like Figure 20C As shown (see also) Figure 14C Slack can be introduced into the fastener actuation line 116 and the tether 119, allowing the delivery conduit 102, actuation element 112, and connector 117 to retract from the device 100 and collar 115. The device 100 remains attached to the delivery conduit 102, actuation element 112, and / or connector 117 via one or more connecting tethers 119. The device 100 can be held tethered in a variety of different ways. For example, the collar 115 can be attached to the delivery conduit 102, actuation element 112, and / or connector 117 via one or more connecting tethers 119. However, any component of the device 100 can be tethered. One or more connecting tethers 119 can be wrapped around or otherwise secured or attached to the collar 115. Device 100 is held tethered or secured to delivery catheter 102, actuation element 112, and / or connector 117, but with sufficient slack in the fastening actuation line 116 and tether 119, allowing device 100 to move generally freely relative to delivery catheter 102, actuation element 112, and connector 117. In this position, a user, such as a physician, can observe or inspect how device 100 actually looks or functions when it is actually implanted on a mitral valve leaflet, such as in the heart. That is, slack is selected in the tether 119 and actuation line such that the tether does not affect, or substantially does not affect, the position of device 100 and / or valve leaflet.

[0172] like Figure 20D As shown (see also) Figure 14DThe device 100 and collar 115 can be reconnected to the delivery catheter 102, actuation element 112, and connector 117. For example, if the device 100 fails to properly grip the leaflets 20, 22, or if the natural valves of the heart H or the natural mitral valve MV experience regurgitation or dysfunction when the device 100 is in place, the device 100 can be reconnected to the delivery catheter 102, actuation element 112, and connector 117. Tension can be applied to one or more connecting tethers 119, and the connector 117 can be advanced along the tether toward the collar 115. When the connector 117 and collar 115 are returned together, the device 100 can be reconnected to the delivery catheter 102, actuation element 112, and connector 117. Tension can also be applied to the fastener actuation line 116 to bring it closer to the device 100 and within the connector 117 and / or delivery conduit 102, so that the fastener actuation line 116 does not move around, become tangled, or get stuck between the collar 115 and the connector 117.

[0173] Figure 20E (See also) Figure 14E The image shows the coupling 117 returning to contact with the collar 115. The actuating element 112 can be advanced through the coupling 117 and the collar 115 into the device 100. Figure 20F As shown (see also) Figure 14F The actuating element 112 can be advanced and enter the device 100 through the collar 115 and the connector 117 until the actuating element 112 re-engages the anchor portion 106 and / or cap 114 of the device 100.

[0174] Now for reference Figure 20G and Figure 20H (See also) Figure 20G and Figure 20H The device 100 can be reopened or moved back to a partially open, gripping ready state within the heart. For example... Figure 20G As shown, to transition from a fully closed state to a partially open state (or other position), the actuating element 112 extends to push the cap 114 away from the engaging element 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the anchor portion 106 to partially unfold. The fastener actuation line 116 is also retracted to open the fastener 130, allowing the leaflet to be released, the device to be repositioned, and the leaflet to be recaptured. However, the device can be moved to any position described herein to release or fully release the leaflet, or to recapture the leaflet after the device has been positioned.

[0175] exist Figure 20G In the example shown, the paired inner paddle 122 and outer paddle 120 move together via a single actuating element 112, rather than moving independently. Furthermore, the position of the fastener 130 depends on the position of the paddles 122 and 120. For example, refer to... Figure 10 Closing the paddles 122 and 120 also closes the fasteners. In some embodiments, the paddles 120 and 122 can be independently controllable. For example, the device 100 can have two actuating elements and two separate caps (or other attachments), such that one separate actuating element (e.g., thread, spool, etc.) and cap (or other attachment) controls one paddle, while another separate actuating element and cap (or other attachment) controls the other paddle. When in a partially open, gripping-ready state, the device 100 can be moved or repositioned. For example, a user can reposition the device 100 to properly grip one or more natural leaflets that were not properly captured or gripped in previous attempts.

[0176] like Figure 20H As shown (see also) Figure 14H The device 100 can be moved to a fully closed or deployed state within the natural valve or natural mitral valve MV of the heart H. For example, after the device 100 has been positioned or repositioned to the desired location, it can be moved back to the deployed state to properly grip the leaflets 20, 22 within the natural valve or natural mitral valve MV of the heart H. The actuation line 116 can be extended to allow the fastener 130 to close. Either or both actuation lines can be repeatedly actuated to repeatedly open and close the fastener 130. For example, the fastener 130 can be repeatedly opened and closed to ensure that the device 100 properly grips the leaflets 20, 22 and that the device 100 is properly positioned within the natural valve or natural mitral valve MV of the heart H.

[0177] Now for reference Figures 20I to 20M (See also) Figures 14I to 14M The device 100 can be detached from the delivery catheter 102, connector 117, and actuation element 112 and deployed in the natural valve of the heart H or the natural mitral valve MV. For example, after the device 100 is in place and has properly gripped the natural valve leaflets 20, 22, the device 100 can be irretrievably released.

[0178] like Figure 20I As shown (see also) Figure 14I The device 100 can be decoupled from the actuating element 112. The actuating element 112 can be retracted from the device 100 and the collar 115 and enter the connector 117 or delivery catheter 102. The actuating element 112 can be retracted such that the end of the actuating element 112 is positioned within the connector 117 or delivery catheter 102. With the actuating element in such a position, the device 100 and the collar 115 can move or pivot relatively independently with respect to the connector 117, the delivery catheter 102, and the actuating element 112 within the natural valve of the heart H or the mitral valve MV.

[0179] like Figure 20JAs shown (see also) Figure 14J The fastener actuation line 116 can be reintroduced into slack, allowing the delivery conduit 102, actuation element 112, and connector 117 to retract from the device 100 and collar 115. The device 100 can still be reattached to the delivery conduit 102, actuation element 112, and / or connector 117 via one or more connecting tethers 119. One or more connecting tethers 119 can wrap around or otherwise secure or attach to the collar 115. One or more connecting tethers 119 can connect the device 100 and collar 115 to the connector 117, actuation element 112, and / or delivery conduit 102 in various ways. For example, one or more connecting tethers 119 can connect the device 100 and collar 115 to the connector 117, actuation element 112, and / or delivery conduit 102, as described herein.

[0180] exist Figure 20K The location shown (see also) Figure 14K The device 100 remains tethered or secured to the delivery catheter 102, actuating element 112, and / or connector 117, but with sufficient slack in the fastener actuation line 116 and tether 119, allowing the device 100 to move freely again generally relative to the delivery catheter 102, actuating element 112, and connector 117. In this position, the user can again observe or check how the device 100 will function or otherwise operate when deployed in the natural valve of the heart H or the natural mitral valve MV.

[0181] One or more connecting ropes 119 can be released in various ways and / or using various release mechanisms. In one example implementation, such as Figure 20K As shown, one or more tethers are connected to the actuating element 112 and can be retracted or withdrawn further into the delivery conduit 102 and away from the connector 117 to release one or more connecting tethers 119. In an example embodiment, the tether 119 is simply looped around or through a component (such as a cap) of the device 100, and the tether 119 is released from the device 100 by pulling one end of the tether loop through the conduit. Further examples of releasing one or more connecting tethers 119 are described later herein.

[0182] like Figure 20L As shown (see also) Figure 14LThe device 100 and collar 115 can be connected to one or more connecting tethers 119 and one or more fastener actuation lines. One or more connecting tethers 119 and fastener actuation lines 116 can retract away from the device 100 and collar 115 and be pulled toward or otherwise retracted into the connector 117 and / or delivery catheter 102. In such an embodiment, the device 100 and collar 115 are completely isolated from the delivery catheter 102, connector 117, and actuation element 112, and the device 100 is implanted in the natural valve of the heart H (in this example, in the natural mitral valve MV).

[0183] like Figure 20M As shown, the display device 100 is in a fully closed and deployed state. The delivery conduit 102, connector 117, actuating element 112, one or more connecting tethers 119, and fastener actuation line 116 are retracted, while the paddles 120, 122, and fastener 130 are held in the fully closed position. After deployment, the device 100 can be held in the fully closed position by a mechanical latch, or by being biased to maintain closure using spring materials such as steel, other metals, plastics, composite materials, or shape memory alloys such as nitinol. For example, the connector or flexible portions 124, 126, 128, 138, and / or the inner paddle 122 and the outer paddle, and / or other biasing components can be formed of metals such as steel or shape memory alloys such as nitinol—prepared as wire, sheet, tubing, or laser-sintered powder—and biased to keep the outer paddle 120 closed around the engaging element 110 and to keep the fastener 130 clamped around the natural leaflet. Similarly, the retaining arm 132 and movable arm 134 of the fastener 130 are biased to clamp the natural leaflets (e.g., leaflets 20, 22) of the natural valve of the heart H. In some embodiments, the connector portions 124, 126, 128, 138, and / or the inner paddle 122 and the outer paddle, and / or other biasing components may be formed of any other suitable resilient material such as metal or polymer to keep the device closed after implantation.

[0184] The concepts disclosed in this patent application can be used in a variety of different valve repair devices 100. For example, the concepts disclosed herein can be applied to any valve repair device disclosed in PCT Patent Publication WO 2020 / 076898, PCT Patent Publication WO 2019 / 139904, and U.S. Patent No. 10,136,993 (which is incorporated herein by reference in its entirety). The concepts disclosed herein can be used in any implantable prosthetic device, such as any transcatheter mitral valve repair device and any transcatheter tricuspid valve repair device. The implantable devices disclosed herein are merely a few examples of the many implantable devices in which the concepts disclosed herein can be used. Therefore, the concepts disclosed herein can be used in implantable devices that do not include all or any of the features of the implantable devices disclosed herein. As an example, many embodiments show and / or describe prosthetic devices having an occlusive member or spacer member that provides many important benefits, but other similar devices without an occlusive member or spacer member may also be used.

[0185] Figure 21 and Figure 21A Examples are given of two of a variety of different valve repair devices in which the concepts of this application can be used. In some examples, Figure 21 The illustrated device 400 may optionally include a... Figure 21A The paddle frames shown in the examples 424a and 424b are similar to paddle frames. PCT patent application publication WO2020 / 076898 discloses... Figure 21 Details of implementation methods for devices having such paddle-shaped frames.

[0186] Figure 21 and Figure 21A The devices 400, 400A shown may include any other features of the implantable prosthesis devices discussed in this application, and the devices 400, 400A may be positioned or repositioned to engage valve tissue (e.g., leaflets 20, 22) as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0187] Now for reference Figure 21The device 400 (e.g., an implantable device, an implantable prosthesis device, a prosthesis spacer, or an engagement device, etc.) may include an engagement portion 404 and an anchor portion 406, the anchor portion 406 including a plurality of anchors 408. The engagement portion 404 includes an engagement member or spacer member 410. The anchor portion 406 includes a plurality of paddles 420 (e.g., two in the illustrated embodiment) and a plurality of fasteners 430 (e.g., two in the illustrated embodiment). A first or proximal collar 411 and a second collar or cap 414 are used to move the engagement portion 404 and the anchor portion 406 relative to each other. A first attachment portion 425 of the anchor 408 may be coupled to and extends from a first portion 417 of the engagement member or spacer member 410, while a second attachment portion 421 of the anchor 408 may be coupled to a second collar 414. The proximal collar 411 may be coupled to a second portion 419 of the engagement member 410.

[0188] The mating member 410 and the anchor member 408 can be joined together in various ways. For example, as shown in the illustrated embodiment, the mating member 410 and the anchor member 408 can be joined together by integrally forming the mating member 410 and the anchor member 408 as a single integral component. This can be achieved, for example, by forming the mating member 410 and the anchor member 408 from a braided or woven material such as braided or woven nitinol yarn. In some embodiments, the mating member 410 and the anchor member 408 can be joined together by welding, fasteners, adhesives, joints, stitching, friction fits, molding, and / or other joining means.

[0189] like Figure 21 As shown, the anchor 408 may include a first portion or outer paddle 420 and a second portion or inner paddle 422 separated by a joint portion 423. In this way, the anchor 408 is configured to resemble a leg, with the inner paddle 422 resembling the upper part of the leg, the outer paddle 420 resembling the lower part of the leg, and the joint portion 423 resembling the knee of the leg. In some embodiments, the inner paddle portion 422, the outer paddle portion 420, and the joint portion 423 are formed of a continuous strip of fabric, such as a metallic fabric or other fabric. In some embodiments, the fabric strip may be a composite material fabric strip.

[0190] Anchor 408 can be configured to move between various configurations—by axially moving the distal end (e.g., cap 414, etc.) relative to the proximal collar 411, and thus moving the anchor 408 along a longitudinal axis extending between the first or distal portion 417 and the second or proximal portion 419 of the mating member 410 (e.g., moving the anchor 408 relative to the mating member 410 and / or another portion of the device). For example, the anchor 408 can be positioned in an upright configuration by moving the distal end or cap 414 away from the mating member 410 and / or another portion of the device. In the upright configuration, the paddle portion is aligned or upright along the longitudinal axis of the device, and the joint portion 423 of the anchor 408 is adjacent to the longitudinal axis of the device and / or the mating member 410 of the device. The anchor 408 can be moved from the upright configuration to a fully folded configuration (e.g., by moving the anchor 408 toward the mating member 410 and / or another portion of the device) Figure 21 (or any position in between). Initially, as the distal end or cap 414 moves toward the mating member 410 and / or another part of the device, the anchor 408 bends at the joint portion 423, and the joint portion 423 moves radially outward relative to the longitudinal axis of the device and / or the mating member 410 of the device and axially toward the first part of the device and / or the mating member 410. As the distal end or cap 414 continues to move toward the mating member 410 and / or another part of the device, the joint portion 423 moves radially inward relative to the longitudinal axis of the device and / or the mating member 410 and axially toward the proximal portion 419 of the device and / or the mating member 410, as... Figure 21 As shown.

[0191] In some embodiments, the angle between the inner paddle 422 of the anchor 408 and the centerline of the mating member 410 and / or the device can be approximately 180 degrees when the anchor 408 is in a straight configuration, and the angle between the inner paddle 422 of the anchor 408 and the centerline of the mating member 410 and / or the device can be approximately 0 degrees when the anchor 408 is in a fully folded configuration. The anchor 408 can be positioned in various partially folded configurations such that the angle between the inner paddle 422 of the anchor 408 and the centerline of the mating member 410 and / or the device can be approximately 10-170 degrees or approximately 45-135 degrees. The centerline can be the longitudinal axis of the device.

[0192] Refer again Figure 21 The fastener 430 may include an attachment or fixing portion 432 and an arm or movable portion. The attachment or fixing portion may be connected to the inner paddle 422 of the anchor 408 in various ways, such as using stitching, adhesives, fasteners, welding, sewing, molding, friction fit, and / or other connecting means. The movable portion 434 may be in open or closed configurations. Figure 21The fastener 430 flexes, hinges, or pivots relative to the fixed portion 432. In some embodiments, the fastener 430 may be biased toward a closed configuration. In the open configuration, the fixed portion and the movable portion flex, hinge, or pivot away from each other, such that the natural leaflet can be positioned between the fixed portion and the movable portion. In the closed configuration, the fixed portion and the movable portion flex, hinge, or pivot toward each other, thereby clamping the natural leaflet between the fixed portion and the movable portion.

[0193] Now for reference Figure 21A This illustrates an example implementation of an implantable prosthetic device 400A. Device 400A may include any other features of the implantable prosthetic devices discussed in this application, and device 400A may be positioned to engage valve tissue (e.g., leaflets 20, 22) as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0194] The prosthetic device 400A may include an engagement portion 404A and an anchoring portion 406A, the anchoring portion 406A including a plurality of anchoring elements 408A. The engagement portion 404A includes engagement members or spacers 410A. The anchoring portion 406A includes a plurality of paddles 420A (e.g., two in the example embodiment) and a plurality of fasteners 430A (e.g., two in the example embodiment). A first or proximal collar 411A and a second collar or cap 414A are used to move the engagement portion 404A and the anchoring portion 406A relative to each other.

[0195] The mating member 410A extends from the proximal portion 419B of the collar 411A to the distal portion 417A that connects to the anchor member 408A. The mating member 410A and the anchor member 408A can be joined together in various ways. For example, as shown in the exemplary embodiment, the mating member 410A and the anchor member 408A can be joined together by integrally forming them as a single, integral component. This can be achieved, for example, by forming the mating member 410A and the anchor member 408A from a continuous strip 401A of a braided or woven material such as braided or woven nitinol yarn.

[0196] Anchor 408A is attached to mating member 410A via portion 425A and to cap 414A via portion 421A. Anchor 408A may include a first portion or outer paddle 420A separated by joint portion 423A and a second portion or inner paddle 422A. Joint portion 423A is attached to paddle frame 424A, paddle frame 424A is attached to cap 414A. In this way, anchor 408A is configured similarly to a leg, with inner paddle 422A similar to the upper part of a leg, outer paddle 420A similar to the lower part of a leg, and joint portion 423A similar to the knee of a leg. In an example embodiment, inner paddle portion 422A, outer paddle portion 420A, and joint portion 423A are formed from continuous fabric strips 401A, such as metallic fabric.

[0197] Anchor 408A can be configured to move between various configurations. For example, anchor 408A can be moved relative to mating member 410A and / or another part of the device. In some embodiments, the anchor is moved between these configurations by axially moving the distal end of the device (e.g., cap 414A) relative to the proximal end of the device (e.g., proximal collar 411A) and thus axially moving the anchor 408A along a longitudinal axis extending between the distal end (or cap 414A) and the proximal end (or proximal collar 411A). For example, by moving cap 414A away from mating member 410A and / or another part of the device, anchor 408A can be positioned in a vertical configuration (see example). Figure 8 , Figure 9 In the straight configuration, the paddle-shaped portions 420A and 422A are aligned or straight along the longitudinal axis of the device, and the joint portion 423A of the anchor 408A is adjacent to the longitudinal axis of the device and / or the mating member 410A of the device. The anchor 408A can be moved from the straight configuration to a fully folded configuration by moving the distal end of the device (or cap 414A) toward the mating member 410A and / or another portion of the device. Initially, as the cap 414A moves toward the mating member 410A and / or another portion of the device, the anchor 408A bends at the joint portions 421A, 423A, and 425A, and the joint portion 423A moves radially outward relative to the longitudinal axis of the device 400A and axially toward the distal portion 417A of the device and / or the mating member 410A. As the cap 414A continues to move toward the mating member 410A and / or another part of the device, the joint portion 423A moves radially inward relative to the longitudinal axis of the device 400A and axially toward the proximal portion 419B of the device and / or the mating member 410A.

[0198] In some embodiments, the angle between the inner paddle 422A of the anchor 408A and the centerline of the mating member 410A and / or the device can be approximately 180 degrees when the anchor 408A is in a straight configuration, and the angle between the inner paddle 422A of the anchor 408A and the centerline of the mating member 410A and / or the device is when the anchor 408A is in a fully folded configuration (see, for example...). Figure 21A The angle can be approximately 0 degrees. Anchor 408A can be positioned in various partially folded configurations such that the angle between the inner paddle 422A of anchor 408A and the centerline of the mating member 410A and / or the device can be approximately 10-170 degrees or approximately 45-135 degrees. The centerline can be the longitudinal axis of the device.

[0199] The configuration of the prosthesis 400A, allowing the anchor 408A to extend into a straight or near-straight configuration (e.g., approximately 120-180 degrees relative to the midline of the mate member 410A and / or the device), offers several advantages. For example, this reduces the radial crease profile of the prosthesis 400A. It also leads to easier grasping of the natural leaflet by providing a larger opening for gripping it. Additionally, the relatively narrow, straight configuration prevents or reduces the likelihood that the prosthesis 400A will become entangled in natural anatomical structures (e.g., chordae tendineae) when positioned and / or retrieved in the delivery device.

[0200] Fastener 430A may include an attachment or fixing portion 432C and an arm or movable portion 434C. The attachment or fixing portion 432C may be connected to the inner paddle 422A of the anchor 408A in various ways, such as by means of stitching, adhesive, fasteners, welding, sewing, molding, friction fit, and / or other connecting means. Fastener 430A is similar to fastener 430.

[0201] In some embodiments, the movable portion 434C may be hinged, flexed, or pivoted relative to the fixed portion 432C between an open configuration and a closed configuration. In some embodiments, the fastener 430A may be biased toward the closed configuration. In the open configuration, the fixed portion 432C and the movable portion 434C are hinged, pivoted, or flexed away from each other, such that the natural leaflet can be positioned between the fixed portion 432C and the movable portion 434C. In the closed configuration, the fixed portion 432C and the movable portion 434C are hinged, pivoted, or flexed toward each other, thereby clamping the natural leaflet between the fixed portion 432C and the movable portion 434C.

[0202] Strip 401A is attached to collar 411A, cap 414A, paddle frame 424A, and fastener 430A to form both the mating portion 404A and the anchoring portion 406A of device 400A. In an example embodiment, mating member 410A, hinge portions 421A, 423A, 425A, outer paddle 420A, and inner paddle 422A are formed of continuous strip 401A. Continuous strip 401A may be a single layer of material or may include two or more layers. In some embodiments, portions of device 400A have a single layer of material strip 401A, while other portions are formed of multiple overlapping or superimposed layers of material strip 401A. For example, Figure 21A The diagram shows an mating member 410A and an inner paddle 422A formed by multiple overlapping layers of material strips 401A. A single continuous material strip 401A can begin and end at various locations within the device 400A. The ends of the material strips 401A can be at the same or different locations within the device 400A. For example, in… Figure 21A In the embodiment shown, the material strip begins and ends at the position of the inner paddle 422A.

[0203] refer to Figures 22A to 22M According to one embodiment, an implantable prosthesis device 500, a delivery catheter 502, an actuating element 512, a collar 515, and a connector 517 are depicted. Device 500 may include any features of any of the devices 100, 400, 400a described herein, including a cap 514 (or other attachment portion) and a fastener 530, the fastener 530 including a base or fixed arm 532, a movable arm 534, barbs 536, and a connector portion 538. A fastener actuation line 516 connects the movable arm 534 to the connector 517 and / or the delivery catheter 502. The fastener 530 can be opened by applying tension to the actuation line 516 attached to the movable arm 534, thereby causing the movable arm 534 to flex, hinge, or pivot on the connector portion 538.

[0204] The collar 515 includes a first tether passage 540A, a second tether passage 540B, and a thread passage 542 extending through the collar 515. The connector 517 includes a first tether passage 544A and a second tether passage 544B in the top or upper part of the collar 515, a third tether passage 544C and a fourth tether passage 544D in the bottom or lower part of the connector 517, and a thread passage 546 extending through the connector 517. The collar 515 can be attached, connected, or secured to the delivery conduit 502, the actuating element 512, and / or the connector 517 by a connecting tether 519.

[0205] By aligning the tether passages 544A, 544B and their corresponding passages in conduit 502 diametrically opposite, the tension applied to the tether cancels each other out. This prevents undesirable bending of the conduit due to pulling the tether line. In some example embodiments, the tether passages 544A, 544B and their corresponding conduit passages are not diametrically opposite.

[0206] like Figure 22A As shown, the actuating element 512 can be inserted through the wire passage 546 of the connector 517 and the wire passage 542 of the collar 515 and enter the device 500, such that the actuating element 512 engages the cap 514. The connecting tether 519 can be inserted through the first tether passage 544A of the connector 517, through the third tether passage 544C of the connector 517, through the first tether passage 540A of the collar 515, around the bottom of the collar 515 and through the second tether passage 540B of the collar 515, through the fourth tether passage 544D of the connector 517, around the actuating element 512, back through the fourth tether passage 544D of the connector 517, through the second tether passage 540B of the collar 515, back around the bottom of the collar 515 and through the first tether passage 540A of the collar 515, through the third tether passage 544C of the connector 517, and through the second tether passage 544B of the connector 517.

[0207] The connector 517 may also include one or more actuation passages 548. One or more fastener actuation lines 516 may extend from the delivery conduit 502, through the actuation passages 548 and connect to the movable arm 534.

[0208] like Figure 22B As shown, the device 500 can be decoupled from the actuating element 512. For example, the actuating element can be unscrewed from the cap 514 or otherwise released. The actuating element 512 can be retracted from the device 500 and the collar 515 and into the connector 517, such that the connecting cord 519 remains around the actuating element 512. In this position, the device 500 and the collar 515 can move or pivot relatively unrestricted by the connector 517, the delivery conduit 502, and the actuating element 512, but are held connected to the connector 517, the delivery conduit 502, and the actuating element 512 by the connecting cord 519.

[0209] like Figure 22CAs shown, slack can be introduced into the connecting tether 519 and the fastener actuation line 516, and the delivery catheter 502, actuation element 512, and connector 517 can be retracted from the device 500 and the collar 515. The collar 515 and the device 500 can still be attached to the delivery catheter 502, actuation element 512, and / or connector 517 via the connecting tether 519 and the actuation line 516. In this position, the device 500 remains tethered and / or attached to the delivery catheter 502, actuation element 512, and / or connector 517, but there is sufficient slack in the fastener actuation line 516 and the connecting tether 519, allowing the device 500 to move freely generally relative to the delivery catheter 502, actuation element 512, and connector 517. In this position, the user can observe or inspect how the device 500 looks or operates when actually deployed on, for example, a natural leaflet or a natural mitral valve leaflet.

[0210] refer to Figures 22D to 22F The device 500 and collar 515 can be reconnected to the delivery conduit 502, actuation element 512, and connector 517. For example, if the user observes that the device 500 is not properly deployed or not properly positioned, the device 500 and collar 515 can be reconnected to the delivery conduit 502, actuation element 512, and connector 517.

[0211] like Figure 22D As shown, the device 500 and collar 515 can be reconnected to the delivery conduit 502, actuation element 512, and connector 517. Tension can be applied to the connecting cord 519 and / or the delivery conduit 502, actuation element 512, and connector 517 can be advanced so that the device 500 and collar 515 can be reconnected to the delivery conduit 502, actuation element 512, and connector 517. Tension can also be applied to the fastener actuation line 516 to bring it closer to the device 500 and within the connector 517 and / or delivery conduit 502, so that the fastener actuation line 516 does not move around, become tangled, or get caught between the connector 517 and cap 514. In one embodiment, the connector 517 and collar 515 are configured to operate as a pulley or force multiplier with the connecting cord 519. With the tether path set as shown, retracting only one end of the connecting tether 519 causes the collar 515 and the connector 517 to be together a distance equal to one-quarter of the retracted distance of that end of the connecting tether 519. Similarly, retracting both ends of the connecting tether 519 via the conduit causes the collar 515 and the connector 517 to be together a distance equal to half the retracted distance of both ends of the connecting tether 519.

[0212] like Figure 22EAs shown, the connector 517 can return to contact with the collar 515, and the actuating element 512 can be pushed through the wire passage 546 of the connector 517 and the wire passage 542 of the collar 515 and into the device 500. Figure 22F As shown, the actuating element can be pushed through the collar 515 and the connector 517 and into the device 500 until the actuating element 512 re-engages the anchor portion 506 and / or the cap 514 of the device 500.

[0213] Now for reference Figure 22G and Figure 22H The device 500 can be reopened or moved back to a partially open, gripping-ready state. This movement allows the device to be removed from the natural valve leaflet and allows the device to be repositioned on the natural valve leaflet. Figure 22G As shown, to transition from a fully closed state to a partially open state (or another position), the actuating element 512 extends to push the cap 514 away from the collar 515. The actuating element 512 can move the device 500 to a partially open, gripping-ready state in various ways. For example, as per [reference to...] Figure 14G As described, the actuating element 512 can move the device 500 to a partially open, gripping-ready state. When in the partially open, gripping-ready state, the device 500 can be moved or repositioned. For example, a user can reposition the device 500 to properly grip the natural valve leaflet.

[0214] like Figure 22H As shown, device 500 can be moved to a fully closed or deployed state. For example, after positioning or repositioning device 500 to a desired location, device 500 can be moved back to the deployed state. Actuation line 516 can be extended to allow fastener 530 to close. Any one or both actuation lines 516 can be repeatedly actuated to repeatedly open and close fastener 530. For example, fastener 530 can be repeatedly opened and closed to ensure device 500 is properly positioned.

[0215] Now for reference Figures 22I to 22M The device 500 can be deployed from the delivery catheter 502, connector 517, and actuation element 512. For example, the device 500 can be deployed after the device 500 has been repositioned in place and the natural valve leaflet has been grasped.

[0216] like Figure 22IAs shown, the device 500 can be coupled to the actuating element 512. The actuating element 512 can be retracted from the device 500 and the collar 115 toward the connector 517 and the delivery conduit 502. The actuating element 512 can be retracted such that the end of the actuating element 512 is positioned within the wire passage 546 of the connector 517. In this position, the device 500 and the collar 515 can move or pivot relatively unrestricted by the connector 517, the delivery conduit 502, and the actuating element 512.

[0217] like Figure 22J As shown, slack can be introduced into the fastener actuation line 516 and the connecting cord 519, allowing the delivery conduit 502, actuation element 512, and connector 517 to retract from the device 500 and collar 515. The collar 515 can be held attached to the delivery conduit 502, actuation element 512, and / or connector 517 via the connecting cord 519, and the device 500 can be held attached to the connector 517 and / or delivery conduit 502 via the fastener actuation line 516. The connecting cord 516 can be held around or otherwise secured to the actuation element 512 within the wire passage 546 of the connector 517. In some example embodiments, the connecting cord 516 can be wrapped around another structure of the connector 517 instead of around the wire. When the wire is in Figure 22J In the indicated position, device 500 remains tethered or attached to delivery, actuation element 512, and connector 517. With sufficient slack in the fastener actuation line 516 and connecting tether 519, device 500 generally moves freely relative to delivery catheter 502, actuation element 512, and connector 517. This allows the user to observe or inspect how device 500 appears or operates when fully implanted in, for example, a natural leaflet or natural mitral valve leaflet.

[0218] like Figure 22KAs shown, the actuating element 512 can be further retracted or withdrawn into the connector 517 or into the delivery conduit 502, beyond the connecting tether 519. As a result, the connecting tether 519 is no longer secured around the actuating element 512 above the third and fourth tether passages 544C, 544D of the connector 517. Thus, the connecting tether 519 no longer securely connects the collar 515 and the device 500 to the connector 517. As described above, in the example embodiment, the connecting tether 519 may wrap around another structure of the connector 517 rather than around a thread. In either case, one end of one or more connecting tethers 519 can be pulled into or retracted into the delivery conduit 502 to separate the tether from the collar 515, rather than having the looped end connect and withdraw the two free ends of the tether. Either end of the connecting cord 519 can be pulled or retracted, causing the looped portion of the connecting cord 519 to be pulled or retracted through the fourth cord passage 544D of the connector 517, through the second cord passage 540B of the collar 515, around the bottom of the collar 515, through the first cord passage 540A of the collar 515, through the third cord passage 544C of the connector, and through the first or second cord passages 544A and 544B of the connector 517, depending on which end of the connecting cord 519 is pulled or retracted. However, the connecting cord 519 can be pulled or retracted in various other ways to connect the connector 517 and the collar 515. For example, the two ends of the connecting cord 519 can be pulled or retracted, such that the looped portion of the connecting cord 519 is pulled or retracted through the fourth cord passage 544D of the connector 517, through the second cord passage 540B of the collar 515, around the bottom of the collar 515, through the first cord passage 540A of the collar 515, and through the third cord passage 544C of the connector. The connecting cord 519 can be pulled or retracted to a distance less than that through the third cord passage 544C of the connector 517. The connector 517 and the delivery conduit 502 can be retracted to pull or retract the looped portion of the connecting cord 519 through the fourth cord passage 544D of the connector 517, the second cord passage 540B of the collar 515, and the first cord passage 540A of the collar 515, or any combination thereof.

[0219] Although the retraction of the actuating element 512 before pulling the connecting cord 519 to decouple the collar 515 from the connector 517 has been described, other methods for decoupling the collar 515 from the connector 517 are also considered. For example, one end of the connecting cord 519 can be pulled, causing the opposite end of the connecting cord 519 to be pulled through the first or second cord passages 544A, 544B of the connector 517 (depending on which end of the connecting cord 519 is pulled), through the third cord passage 544C of the connector, through the first cord passage 540A of the collar 515, through the second cord passage 540B of the collar 515, through the fourth cord passage 544D of the connector 517, around the actuating element 512, back through the fourth cord passage 544D of the connector 517, through the second cord passage 540B of the collar 515, through the first cord passage 540A of the collar 515, through the third cord passage 544C of the connector 517, and optionally, through the other of the first or second cord passages 544A, 544B of the connector 517. In some example embodiments, one of the lines of the cord may be cut into a loop within or near the connector 517. This reduces the length of the tether that needs to be pulled through the connector 517 and / or cap 514 to release the tether when it is not released by the retraction actuator 512.

[0220] like Figure 22L As shown, when the device 500 and collar 515 are connected to the connecting cord 519 and actuating element 512, the connector 517 can be retracted away from the device 500. The fastener actuating line 516 can detach from the movable arm 534 and be pulled or otherwise retracted toward the connector 517 and / or delivery conduit 502, or be pulled or otherwise retracted into the connector 517 and / or delivery conduit 502. In such an embodiment, the device 500 is completely separated from the delivery conduit 502, the connector 517, and the actuating element 512.

[0221] like Figure 22M As shown, the display device 500 is in a fully closed and deployed state. The delivery conduit 502, connector 517, and actuating element 512 have been retracted, and the fastener 530 is held in the fully closed position. After deployment, the device 500 can be held in the fully closed position in a variety of ways. For example, the device 500 can be held in the fully closed position via... Figure 14M The device is held in a fully closed position in any of the described ways. In an example embodiment, the paddle-like part of the device is configured to open and close with the heartbeat, while the fastener remains in its closed configuration.

[0222] refer to Figures 23A to 23MAn implantable prosthesis device 600, a delivery catheter 602, an actuation element 612, a collar 615, and a connector 617 are depicted according to an example embodiment. Device 600 may include any feature of any of the devices 100, 400, and 500 described herein, including a cap 614 and a fastener 630, the fastener 630 including a base or fixed arm 632, a movable arm 634, barbs 636, and a connector portion 638. An actuation line 616 connects the movable arm 634 to the connector 617 and / or the delivery catheter 602. The fastener 630 can be opened by applying tension to the actuation line 616 attached to the movable arm 634, thereby causing the movable arm 634 to flex, hinge, or pivot on the connector portion 638.

[0223] The collar 615 includes a first tether passage 640A, a second tether passage 640B, and a thread passage 642 extending through the collar 615. The connector 617 includes a first tether passage 644A and a second tether passage 644B in the top or upper part of the collar 615, a third tether passage 644C and a fourth tether passage 644D in the bottom or lower part of the connector 617, and a thread passage 646 extending through the connector 617. The collar 615 can be attached, connected, or secured to the delivery conduit 602, the actuating element 612, and / or the connector 617 by a connecting tether 619.

[0224] like Figure 23A As shown, the actuating element 612 can be inserted through the wire passage 646 of the connector 617 and the wire passage 642 of the collar 615 and enter the device 600, such that the actuating element 612 engages the cap 614. The connecting tether 619 can be inserted through the first tether passage 644A of the connector 617, through the third tether passage 644C of the connector 617, through the second tether passage 640B of the collar 615, around the bottom of the collar 615 and through the first tether passage 640A of the collar 615, through the fourth tether passage 644D of the connector 617, and through the second tether passage 544B of the connector 617.

[0225] The connector 617 may also include one or more actuation passages 648. One or more fastener actuation lines 516 may extend from the delivery conduit 602, through the actuation passages 648 and connect to the movable arm 634.

[0226] like Figure 23BAs shown, the device 600 can be decoupled from the actuating element 612. The actuating element 612 can retract from the device 600 and the collar 615 and enter into the connector 617. In this position, the device 600 and the collar 615 can move or pivot relatively unrestricted by the connector 617, the delivery conduit 602, and the actuating element 612, but are held to the connector 617, the delivery conduit 602, and the actuating element 612 by the connecting cord 619.

[0227] like Figure 23C As shown, slack can be introduced into the connecting tether 619 and the fastener actuation line 616, and the delivery catheter 602, actuation element 612, and connector 617 can be retracted from the device 600 and the collar 615. The collar 615 and the device 600 can still be attached to the delivery catheter 602, actuation element 612, and / or connector 617 via the connecting tether 619 and the actuation line 616. In this position, the device 600 remains tethered to the delivery catheter 602, actuation element 612, and / or connector 617, but with sufficient slack in the fastener actuation line 616 and the connecting tether 619, the device 600 is generally free to move relative to the delivery catheter 602, actuation element 612, and connector 617. In this position, the user can observe or inspect how the device 600 will look or operate when it is fully implanted or released onto, for example, a natural valve leaflet.

[0228] refer to Figures 22D to 22F The device 600 and collar 615 can be reconnected to the delivery conduit 602, actuation element 612, and connector 617. For example, if the user observes that the device 600 is not properly deployed or not properly positioned, the device 600 and collar 616 can be reconnected to the delivery conduit 602, actuation element 612, and connector 617.

[0229] like Figure 23DAs shown, the device 600 and collar 615 can be reconnected to the delivery conduit 602, actuation element 612, and connector 617. Tension can be applied to the connecting tether 619, and the delivery conduit 602, actuation element 612, and connector 617 can be advanced on the tether 619, allowing the device 600 to be reconnected to the delivery conduit 602, actuation element 612, and connector 617. Tension can also be applied to the fastener actuation line 616 to bring it closer to the device 600 and within the connector 617 and / or delivery conduit 602, preventing the fastener actuation line 516 from moving around, becoming tangled, or getting stuck between the collar 615 and connector 617. In such an embodiment, the connector 617 and the collar 615 are structured as a pulley or force multiplier with a connecting rope 619, wherein retracting one end of the connecting rope 619 causes the collar 615 and the connector 617 to be together at a distance equal to half the retracted distance of that end of the connecting rope 619, and wherein retracting both ends of one of the connecting ropes 619 causes the collar 615 and the connector 617 to be together at a distance equal to the retracted distance of that end of the connecting rope 619.

[0230] like Figure 23E As shown, the connector 617 can return to contact with the collar 615, and the actuating element 612 can be pushed through the wire passage 646 of the connector 617 and the wire passage 642 of the collar 615 and into the device 600. Figure 23F As shown, the actuating element can be pushed through the collar 615 and the connector 617 and into the device 600 until the actuating element 612 re-engages the cap 614 of the device 600.

[0231] Now for reference Figure 23G and Figure 23H The device 600 can be reopened or moved back to the partially open position to release previously captured leaflets (one or more), move to a new location, and recapture leaflets. For example... Figure 23G As shown, in order to transition from a fully closed state to a partially open state, the actuating element 612 extends to push the cap 614 away from the collar 615. The actuating element 612 can move the device 600 to the partially open state in a variety of ways. For example, as per [reference to...] Figure 14G As described, the actuating element 612 can move the device 600 to a partially open state. When in the partially open, gripping-ready state, the device 600 can be moved or repositioned. For example, a user can reposition the device 600 to properly grip the natural valve leaflet.

[0232] like Figure 23HAs shown, device 600 can be moved to a fully closed or deployed state. For example, after positioning or repositioning device 600 to a desired location on the natural valve leaflet, device 600 can be moved back to the deployed state. Actuation line 616 can be extended to allow fastener 630 to close. Any one or both actuation lines 516 can be repeatedly actuated to repeatedly open and close fastener 630. For example, fastener 630 can be repeatedly opened and closed to ensure device 600 is properly positioned.

[0233] Now for reference Figures 23I to 23M The device 600 can be deployed from the delivery catheter 602, connector 617, and actuation element 612. For example, the device 600 can be deployed after it is in place and grips the natural valve leaflet.

[0234] like Figure 23I As shown, the device 600 can be coupled to the actuating element 612. The actuating element 612 can be retracted from the device 600 and the collar 115 toward the connector 617 and the delivery conduit 602. The actuating element 612 can be retracted such that the end of the actuating element 612 is positioned within the wire passage 646 of the connector 617 or within the delivery conduit 602. In this position, the device 600 and the collar 615 can move or pivot relatively unrestricted by the connector 617, the delivery conduit 602, and the actuating element 612.

[0235] like Figure 23J As shown, slack can be introduced into the fastener actuation line 616 and the connecting cord 619, allowing the delivery conduit 602, actuation element 612, and connector 617 to retract from the device 600 and the collar 615. The collar 615 can be held attached to the delivery conduit 602, actuation element 612, and / or connector 617 via the connecting cord 619, and the device 600 can be held attached to the connector 617 and / or delivery conduit 602 via the fastener actuation line 616. The connecting cord 616 can be held wrapped around or otherwise secured to the collar 615. In this position, the device 600 remains tethered or attached to the delivery conduit 602 and connector 617, but with sufficient slack in the fastener actuation line 616 and the connecting cord 619, the device 600 is generally free to move relative to the delivery conduit 602, actuation element 612, and connector 617. Thus, users can observe or inspect how the device 600 will look or operate when it is finally deployed on a natural valve leaflet.

[0236] like Figure 23KAs shown, the actuating element 612 can optionally be further retracted or withdrawn into the connector 617 or into the delivery conduit 602. The connecting tether 619 can be retracted from or disconnected from the collar 615. One end of the connecting tether 619 can be pulled such that the other end is pulled through the first tether passage 644A of the connector 617, through the third tether passage 644C of the connector 617, through the first tether passage 640A of the collar 615, and through the second tether passage 640B of the collar 615. Optionally, such an end can also be pulled through the fourth tether passage 644D of the connector, and can also be pulled through the second tether passage 644B. Conversely, the other end of the connecting tether 619 can be pulled, causing it to pass through the second tether passage 644B of the connector 617, through the fourth tether passage 644D of the connector 617, through the second tether passage 640B of the collar 615, and through the first tether passage 640A of the collar 615. Optionally, such an end can also be pulled through the third tether passage 644C of the connector, and can also be pulled through the first tether passage 644A.

[0237] like Figure 23L As shown, after the device 600 is decoupled from the connecting cord 619, the delivery conduit 602, actuating element 612, connector 617, and connecting cord 619 can be retracted away from the device 600. The fastener actuation line 616 can also detach from the movable arm 634 and be pulled or otherwise retracted toward the connector 617 and / or delivery conduit 602, or be pulled or otherwise retracted into the connector 617 and / or delivery conduit 602. In such an embodiment, the device 600 and collar 615 are completely separated from the delivery conduit 602, connector 617, and actuating element 612.

[0238] like Figure 23M As shown, the display device 600 is in a fully closed and deployed state. The delivery conduit 602, connector 617, and actuating element 612 have been retracted, and the fastener 630 is held in the fully closed position. After deployment, the device 600 can be held in the fully closed position in a variety of ways. For example, the device 600 can be held in the fully closed position via... Figure 14M The device is held in a fully closed position in any of the described ways. In one example implementation, the paddle-like part of the device is configured to open and close with the heartbeat, while the fastener remains in its closed configuration.

[0239] Now for reference Figures 24A to 24E According to one embodiment, an actuating element 712, a collar 715, a connector 717, and two connecting cords 719 are depicted. The collar 715 can be connected to any implantable prosthesis device 100, 400, 500, 600 previously described herein, or can be any other implantable prosthesis device.

[0240] The collar 715 includes a first tethering passage 740A, a second tethering passage 740B, a third tethering passage 740C, and a fourth tethering passage 740D, as well as a thread passage 742 extending through the collar 715. In the illustrated embodiment, the first, second, third, and fourth tethering passages 740A, 740B, 740C, and 740D are curved, wherein the second tethering passage 740B is radially located between the first tethering passage 740A and the thread passage 742, and the third tethering passage 740C is radially located between the thread passage 742 and the fourth tethering passage 740D. However, the first, second, third, and fourth tethering passages 740A, 740B, 740C, and 740D can have any shape or position. For example, the first, second, third, and fourth tethering passages 740A, 740B, 740C, and 740D can be circular and equidistant from the thread passage 742.

[0241] The connector 717 is generally cylindrical, with a cutout or window 724 defined between a top 720 and a bottom 722. The connector 717 also includes a first tether passage 744A, a second tether passage 744B, and a thread passage 746 extending through the top 720, wherein the first and second tether passages 744A and 744B are located on either side of the thread passage 746. The connector also includes a third tether passage 744C, a fourth tether passage 744D, a fifth tether passage 744E, a sixth tether passage 744F, and a thread passage 746 extending through the bottom 722. The thread passage 746 at the bottom 722 corresponds to the thread passage 746 at the top 720. The third and fourth tethering passages 744C and 744D are radially opposite to the fifth and sixth tethering passages 744E and 744F, respectively, with the fourth tethering passage 744D located radially between the third tethering passage 744C and the silk thread passage 746, and the fifth tethering passage 744E located radially between the silk thread passage 746 and the sixth tethering passage 744F.

[0242] In the illustrated embodiment, the third, fourth, fifth, and sixth tethering passages 744C, 744D, 744E, and 744F of the connector 717 correspond to the first, second, third, and fourth tethering passages 740A, 740B, 740C, and 740D of the collar 715, respectively. Although the connector 717 has been described as having the third, fourth, fifth, and sixth tethering passages 744C, 744D, 744E, and 744F in the bottom 722, it should be understood that the connector 717 can have various configurations. For example, the third and fourth tethering passages 744C, 744D and / or the fifth and sixth tethering passages 744E, 744F can each be combined into a single tethering passage.

[0243] In one example implementation, one or more of the passages 742, 746, 740A, 740B, 740C, 740D, 740E, 740F and / or other portions of the connector and / or collar may include keying features that align the passage of the connector 717 with the passage of the collar 715. For example, a lip or protrusion around one or more of the passages 742, 746, 740A, 740B, 740C, 740D, 740E, 740F may engage within the corresponding passage to key the connector 717 and the collar 715 (i.e., align the passages).

[0244] Optionally, the connector 717 may have two actuation passages 760 in the top or upper portion 720, which may receive one or more fastener actuation lines that can be coupled to a movable arm of the implantable device and extend through the delivery device as previously described herein. The fastener actuation lines extend from the connector 717 through a cutout or window 724.

[0245] like Figure 24A As shown, the collar 715 and the connector 717 can be connected together via a first connecting cord 719A and a second connecting cord 719B, wherein an actuating element 712 is arranged within the wire passage 746 of the connector 717. The actuating element 712 can extend through the wire passage 742 of the collar 715. As previously described herein, the actuating element 712 can extend into the implantable prosthesis device and engage the cap to open the device. The first connecting cord 719A passes through the first cord passage 744A of the connector 717, through the third cord passage 744C of the connector 717, through the first cord passage 740A of the collar 715, upward through the second cord passage 740B of the collar 715, through the fourth cord passage 740D of the connector 717, and returns through the first cord passage 744A of the connector 717. The second connecting rope 719B passes through the second connecting rope passage 744B of the connector 717, through the sixth connecting rope passage 744F of the connector 717, through the fourth connecting rope passage 740D of the collar 715, upwards through the third connecting rope passage 740C of the collar 715, through the fifth connecting rope passage 744E of the connector 717, and returns through the second connecting rope passage 744B of the connector 717. The first and / or second connecting ropes 719A, 719B can be threaded through the connector 717 and the collar 715 in reverse order.

[0246] As previously described herein, the actuating element 712, collar 715, connector 717, and two connecting tethers 719 can be used to position and reposition the implantable prosthetic device within the natural valves of the heart (e.g., natural mitral valve MV, natural tricuspid valve, etc.). Now refer to Figures 24B to 24EThe collar 715 can be decoupled from the connector 717, the actuating element 712, and the connecting cord 719. For example, the collar 715 can be decoupled to deploy an implantable prosthesis device in the closed position of the natural valve of the heart H.

[0247] like Figure 24B As shown, slack can be introduced into the first and second connecting cords 719A, 719B, allowing the collar 715 to be separated from the connector 717 and the actuating element 712. In this position, the collar 715 can move relatively freely without being restricted by the connector 717 and the actuating element 712. The collar 715 can be coupled to an implantable prosthesis device, and in this position, the user can check the placement and functionality of the device as previously described herein.

[0248] In this embodiment, the connecting ropes 719A, 719B, the third, fourth, fifth, and sixth rope passages 744C, 744D, 744E, and 744F of the connector 717, and the first, second, third, and fourth rope passages 740A, 740B, 740C, and 740D of the collar 715 operate as two pulleys or two force multipliers. For example, pulling one end of the first or second connecting ropes 719A, 719B results in a positional change of the collar 715 equivalent to half the distance of the pull, while pulling both ends of each of the first or second connecting ropes 719A, 719B results in a positional change equivalent to the distance of the push or pull.

[0249] like Figure 24C As shown, one end of each of the connecting ropes 719A and 719B can be pulled or otherwise retracted to begin releasing the collar 715 from the connector 717. In the illustrated embodiment, the first connecting rope 719A is retracted to pull one end of the first connecting rope 719A through the first connecting rope passage 744A of the connector 717 toward the fourth connecting rope passage 744D of the connector 717, while the second connecting rope 719B is retracted to pull one end of the second connecting rope 719B through the second connecting rope passage 744B of the connector 717 toward the fifth connecting rope passage 744E of the connector 717.

[0250] Optionally, the first and second connecting tethers 719A and 719B can be retracted to pull one end of the first connecting tether 719A through the first tether passage 744A of the connector 717 toward the third tether passage 744C of the connector 717 and / or pull one end of the second connecting tether 719B through the second tether passage 744B of the connector 717 toward the sixth tether passage 744F of the connector 717. For example, after the user observes that the device is properly positioned and functioning, the user can begin to retract or otherwise release the connecting tethers 719A and 719B.

[0251] like Figure 24D As shown, connecting cords 719A and 719B can be further retracted to further release the collar 715 from the connector 717. In the illustrated embodiment, the first connecting cord 719A is further retracted to pull one end of the first connecting cord 719A through the fourth cord passage 744D of the connector 717 and toward the second cord passage 740B of the collar 715. The second connecting cord 719B is further retracted to pull one end of the second connecting cord 719B toward the third cord passage 740C of the collar 715 through the fifth cord passage 744E of the connector 717. Optionally, the first and second connecting ropes 719A and 719B can be retracted to pull one end of the first connecting rope 719A through the third connecting rope passage 744C of the connector 717 toward the first connecting rope passage 740A of the collar 715 and / or pull one end of the second connecting rope 719B through the sixth connecting rope passage 744F of the connector 717 toward the fourth connecting rope passage 740D of the collar 715.

[0252] like Figure 24E As shown, connecting cords 719A and 719B are further retracted to completely release collar 715 from connector 717, actuator 712, and connecting cords 719A and 719B. In the illustrated embodiment, the first connecting cord 719A is further retracted to pull one end of the first connecting cord 719A downward through the second cord passage 740B of collar 715, upward through the first cord passage 740A of collar 715, and toward the third cord passage 744C of connector; and the second connecting cord 719B is further retracted to pull one end of the second connecting cord 719B downward through the third cord passage 740C of collar 715, upward through the fourth cord passage 740D of collar 715, and toward the sixth cord passage 744F of connector 717. Optionally, the first and second connecting tethers 719A and 719B can be retracted to pull one end of the first connecting tether 719A downward through the first tether passage 740A of the collar 715, upward through the second tether passage 740B of the collar 715, and toward the fourth tether passage 744D of the connector 717, and / or pull one end of the second connecting tether 719B downward through the fourth tether passage 740D of the collar 715, upward through the third tether passage 740C of the collar 715, and toward the fifth tether passage 744E of the connector 717. In this position, the collar 715 is completely decoupled from the connector 717, the actuating element 712, and the connecting tethers 719A and 719B, and the implantable prosthetic device can be deployed in a natural valve such as the heart valve H or the natural mitral valve MV.

[0253] Now for reference Figures 25A to 25GAccording to one embodiment, an actuating element 812, a collar 815, a connector 817, and two connecting ropes 819 are depicted. This embodiment is similar to... Figures 24A to 24E The implementation described is similar; however, the coupling 817, collar 815, and actuating element 812 are connected by two connecting ropes 819, resulting in a double pulley. Figures 25A to 25G In the example shown, the path of the tether 819 through the delivery catheter can be symmetrical so that the forces applied to opposite sides of the catheter by applying tension to the tether are equal. This path setting prevents undesirable deflection of the catheter due to tension applied by the tether.

[0254] The collar 815 includes a first tethering passage 840A, a second tethering passage 840B, a third tethering passage 840C, and a fourth tethering passage 840D, as well as a thread passage 842 extending through the collar 815. In the illustrated embodiment, the first, second, third, and fourth tethering passages 840A, 840B, 840C, and 840D are curved, with the second tethering passage 840B radially located between the first tethering passage 840A and the thread passage 842, and the third tethering passage 840C radially located between the thread passage 842 and the fourth tethering passage 840D. However, the first, second, third, and fourth tethering passages 840A, 840B, 840C, and 840D can have any shape or position. For example, the first, second, third, and fourth tethering passages 840A, 840B, 840C, and 840D can be circular and they can be equidistant from the thread passage 842.

[0255] The connector 817 is generally cylindrical, with a cutout or window 824 defined between a top 820 and a bottom 822. The connector 817 also includes a first tether passage 844A, a second tether passage 844B, and a thread passage 846 extending through the top 820, wherein the first and second tether passages 844A and 844B are located on either side of the thread passage 846. The connector also includes a third tether passage 844C, a fourth tether passage 844D, a fifth tether passage 844E, a sixth tether passage 844F, and a thread passage 846 extending through the bottom 822. The thread passage 846 at the bottom 822 corresponds to the thread passage 846 at the top 820. The third and fourth tethering passages 844C and 844D are radially opposite to the fifth and sixth tethering passages 844E and 844F, respectively, with the fourth tethering passage 844D located radially between the third tethering passage 844C and the silk thread passage 846, and the fifth tethering passage 844E located radially between the silk thread passage 846 and the sixth tethering passage 844F.

[0256] In the illustrated embodiment, the third, fourth, fifth, and sixth tethering passages 844C, 844D, 844E, and 844F of the connector 817 correspond to the first, second, third, and fourth tethering passages 840A, 840B, 840C, and 840D of the collar 815, respectively. Although the connector 817 has been described as having the third, fourth, fifth, and sixth tethering passages 844C, 844D, 844E, and 844F in the lower portion 822, it should be understood that the connector 817 can have various configurations. For example, the third and fourth tethering passages 844C, 844D and / or the fifth and sixth tethering passages 844E, 844F can each be combined into a single tethering passage.

[0257] Optionally, the connector 817 may have two actuation passages 860 in the top or upper portion 820, which may receive one or more fastener actuation lines that can be coupled to the movable arm of the implantable device and extend through the delivery device as previously described herein. The fastener actuation lines extend out from the window 424.

[0258] like Figure 25AAs shown, the collar 815 and the connector 817 can be connected together via a first connecting cord 819A and a second connecting cord 819B, wherein the actuating element 812 extends through the wire passage 846 of the connector 817 and the wire passage 842 of the collar 815. As previously described herein, the actuating element 812 can extend into the implantable prosthesis device and engage the cap to open the device. The first connecting tether 819A passes through the first tether passage 844A of the connector 817, behind the actuating element 812, through the sixth tether passage 844F of the connector 817, through the fourth tether passage 840D of the collar 815, around the bottom of the collar 815, upward through the third tether passage 840C of the collar 815, through the fifth tether passage 844E of the connector 817, upward and around the actuating element 812, back downward through the fifth tether passage 844E of the connector 817, through the third tether passage 840C of the collar 815, around the bottom of the collar 815, upward through the fourth tether passage 840D of the collar 815, through the sixth tether passage 844F of the connector 817, and through the second tether passage 844B of the connector 817. The second connecting tether 819B passes through the second tether passage 844B of the connector 817, behind the actuating element 812, through the third tether passage 844C of the connector 817, through the first tether passage 840A of the collar 815, around the bottom of the collar 815, upward through the second tether passage 840B of the collar 815, through the fourth tether passage 844D of the connector 817, upward and around the actuating element 812, through the fourth tether passage 844D of the connector 817, through the second tether passage 840B of the collar 815, around the bottom of the collar 815, upward through the first tether passage 840A of the collar 815, through the third tether passage 844C of the connector 817, and through the first tether passage 844A of the connector 817.

[0259] As previously described herein, the actuating element 812, collar 815, connector 817, and two connecting tethers 819 can be used to position and reposition the implantable prosthetic device within the natural valves of the heart (e.g., natural mitral valve MV, natural tricuspid valve, etc.). Now refer to Figures 25B to 25E The collar 815 can be decoupled to the connector 817, the actuating element 812, and the connecting cord 819. For example, the collar 815 can be decoupled to deploy an implantable prosthesis in the closed position of a natural valve (such as a natural mitral valve MV) of the heart.

[0260] like Figure 25BAs shown, the collar 815 can be connected to the actuating element 812. The actuating element 812 can be retracted through the wire passage 842 of the collar 815 and enter the connector 817. The collar 815 can be held to the connector 817 by connecting ropes 819A and 819B, which are held to surround the actuating element 812.

[0261] like Figure 25C As shown, slack can be introduced into the first and second connecting cords 819A, 819B, allowing the collar 815 to be separated from the connector 817 and the actuating element 812. In this position, the collar 815 can move relatively freely without being restricted by the connector 817 and the actuating element 812. The collar 815 can be connected to an implantable prosthesis device, and in this position, the user can check the placement and functionality of the device as previously described herein.

[0262] In this embodiment, the connecting ropes 819A, 819B, the third, fourth, fifth, and sixth rope passages 844C, 844D, 844E, and 844F of the connector 817, and the first, second, third, and fourth rope passages 840A, 840B, 840C, and 840D of the collar 815 are operated as two double pulleys or force multipliers. For example, pulling one end of the first and second connecting ropes 819A, 819B results in a positional change of the collar 815 equivalent to one-quarter of the pulling distance, and pulling both ends of each of the first and second connecting ropes 819A, 819B results in a positional change equivalent to half the pulling distance.

[0263] Now for reference Figure 25D and Figure 25E The collar 815 can be separated from the actuator 812. For example... Figure 25D As shown, the actuating element 812 can be retracted further away from the collar 815. For example, as previously described herein, the actuating element 812 can be retracted into the delivery catheter. Figure 25E As shown, the actuating element 812 can be retracted from the connector 817 so that the connecting ropes 819A and 819B no longer wrap around the actuating element 812.

[0264] Now for reference Figure 25F and Figure 25G The collar 815 can be released from the connector 817. For example... Figure 25F As shown, the first and second connecting ropes 819A and 819B can be pulled or otherwise retracted, such that the first and second connecting ropes 819A and 819B are respectively retracted through the fourth rope passage 844D of the connector 817 and the second rope passage 840B of the collar 815, and the fifth rope passage 844E of the connector 817 and the third rope passage 840C of the collar 815. Figure 25GAs shown, the first and second connecting tethers 819A and 819B can be further pulled or retracted, such that the first and second connecting tethers 819A and 819B are retracted through the first tether passage 840A of the collar 815 and through the fourth tether passage 840D of the collar 815. In this position, the collar 815 is completely decoupled from the connector 817, the actuating element 812, and the connecting tethers 819A and 819B, and the implantable prosthetic device will be deployed in a natural valve such as the heart valve H or the natural mitral valve MV.

[0265] Now for reference Figures 26A to 26E An implantable prosthesis device 900 is described according to one embodiment. Device 900 includes a cap 914 and a collar 915, and device 900 may include any features of any implantable prosthesis device 100, 400, 400A, or any other implantable prosthesis device described herein. For example, as previously described herein, device 900 may include a fastener or a barbed fastener, which includes a base or fixed arm, a movable arm, barbs, and a connector portion that can be coupled to an actuation wire of an openable fastener.

[0266] The device 900 can be deployed, reconnected, repositioned, and redeployed via a delivery conduit 902, an actuating element 912, an outer shaft 917, and one or more connecting tethers 918. The delivery conduit 902 can be sized such that its distal portion mates with or can otherwise be arranged within a collar 915 of the device 900. The outer shaft 917 can be arranged around the delivery conduit 902, and the connecting tethers 919 can be attached to or otherwise secured to the distal portion of the outer shaft 917.

[0267] The collar 915 generally extends upward from the device 900 and includes two laterally oriented tether passages 940 within the collar 915. The delivery conduit 902 also includes two laterally oriented tether passages 944 in the distal portion of the delivery conduit 902. The tether passages 940 of the collar 915 and the tether passages 944 of the delivery conduit 902 may correspond to the circumferential position of the connecting tether 918 attached to the outer shaft 917. In the illustrated embodiment, the connecting tether 919, the tether passages 940 of the collar 915, and the tether passages 944 of the delivery conduit 902 are located opposite each other.

[0268] like Figure 26AAs shown, device 900 is depicted in a fully closed position. Device 900 can be deployed in a fully open position and moved to a closed position by any other method previously described herein. Actuating element 912 extends through device 900 and engages cap 914. In this position, the tether passage 940 of collar 915 and the tether passage 944 of delivery catheter 902 are aligned, and connecting tether 919 extends through the tether passage 940 of collar 915 and the tether passage 944 of delivery catheter 902, each encircling actuating element 912. Before the procedure begins, connecting tether 919 can be inserted through the tether passage 940 of collar 915 and the tether passage 944 of delivery catheter 902 and encircling actuating element 912.

[0269] refer to Figure 26B The device 900 can be decoupled from the delivery conduit 902. For example... Figure 26B As shown, slack can be introduced into the connecting tether 919, allowing the delivery catheter 902 to retract from the device 900. Slack can be introduced into the connecting tether 919 by pushing or otherwise advancing the outer shaft 917 forward, thus reducing the distance between the distal end of the outer shaft 917 and the tether passage 940 of the collar 915. The actuating element 912 can be retracted to a point not exceeding the looped portion of the connecting tether 919, such that the actuating element is decoupled from the device, but the tether remains connected to the device. In this position, the device 900 and the collar 915 are decoupled from the actuating element 912 and can move relatively freely without restriction by the delivery catheter 902. In this position, the user can observe or inspect how the device 100 will function or otherwise operate when deployed in a natural valve such as the heart (e.g., a natural mitral valve MV).

[0270] It should be understood that device 900 can be coupled or otherwise allowed to move in a variety of ways. For example, actuation element 912 may be flexible enough that, when sufficient slack is introduced into the coupling tether 919, actuation element 912 can remain engaged with the cap of device 900, allowing a user to observe or inspect how device 100 will function or otherwise operate when deployed in a natural valve such as the heart valve (e.g., natural mitral valve MV). The method of using a flexible actuation element 912—which is not decoupled when the device is fully decoupled from the delivery catheter, and allows a user to observe or inspect how the device will function or otherwise operate when deployed—can also be used in any other embodiments presented herein.

[0271] If the user observes that device 900 is not properly positioned, the user can reconnect device 900, delivery conduit 902, and actuating element 912. For example, actuating element 912 can be retracted through the loop of connecting tether 919 and into device 900, causing actuating element 912 to engage cap 914 (this step can be omitted if the actuating element has not been decoupled). Outer shaft 917 can be retracted, allowing device 900 to be reconnected to delivery conduit 902, as... Figure 26A As shown. Then, the device 900 can be reopened, repositioned, and redeployed by any other method disclosed herein.

[0272] Now for reference Figures 26C to 26E The device 900 can be fully deployed from the delivery catheter 902, the actuating element 912, and the outer shaft 917. For example, the device 900 can be deployed after the user observes that it is properly positioned in a natural valve such as the heart valve (e.g., a natural mitral valve). Figure 26C As shown, the control wire 1012 retracts outward from the tether loop. The outer shaft 917 is retracted, thus retracting the connecting tether 919 from the tether passage 944 of the delivery conduit 902 and the tether passage 940 of the loop 940, as... Figure 26D As shown. Then the device 900 is completely disconnected from the delivery conduit 902, the outer shaft 917, the actuator 912, and the connecting rope 919.

[0273] like Figure 26E As shown, device 900 is displayed in a fully closed and deployed state. The delivery conduit 902, outer shaft 917, and actuating element 912 are retracted, and the fasteners of device 900 remain in the fully closed position. After deployment, device 900 can be held in the fully closed position in several ways. For example, device 900 can be held in the fully closed position via... Figure 14M Any method described should be kept in a fully closed position.

[0274] Now for reference Figures 27A to 27E An implantable prosthesis device 1000 is described according to one embodiment. Device 1000 includes a cap 1014 and a collar 1015, and device 1000 may include any features of any implantable prosthesis device 100, 400, 400A described herein. For example, device 1000 may include a fastener comprising a base or fixed arm, a movable arm, barbs, and a connector portion attachable to an actuation wire that can open the fastener as described above.

[0275] Device 1000 can be deployed, reconnected, repositioned, and redeployed via delivery conduit 1002, actuation element 1012, outer shaft 1017, and one or more connecting tethers 1019. Device 1000 and Figures 26A to 26EThe device 1000 described herein is substantially similar; however, the device 1000 is designed and shaped such that the collar 1015 or a portion thereof may be fitted or otherwise arranged within the delivery conduit 1002. An outer shaft 1017 may be arranged around the delivery conduit 1002, and a connecting tether 1019 may be attached to or otherwise secured to the distal portion of the outer shaft 1017.

[0276] The collar 1015 generally extends upward from the device 1000 and includes two laterally oriented tether passages 1040 within the collar 1015. The delivery conduit 1002 also includes two laterally oriented tether passages 1044 in the distal portion of the delivery conduit 1002. The tether passages 1040 of the collar 1015 and the tether passages 1044 of the delivery conduit 1002 may correspond to the circumferential positions of the connecting tether 1018 attached to the outer shaft 1017. In the illustrated embodiment, the connecting tether 1019, the tether passages 1040 of the collar 1015, and the tether passages 1044 of the delivery conduit 1002 are located in positions opposite to each other.

[0277] like Figure 27A As shown, device 1000 is in the fully closed position. Device 1000 can be deployed in the fully open position and moved to the closed position by any other method previously described herein. Actuating element 1002 extends through device 1000 and engages cap 1014. In this position, the tether passage 1040 of collar 1015 and the tether passage 1044 of delivery conduit 1002 are aligned, and connecting tether 1019 extends through the tether passage 1044 of delivery conduit 1002 and the tether passage 1040 of collar 1015 and each surrounds actuating element 1012. Before the procedure begins, connecting tether 1019 can be inserted through the tether passage 1044 of delivery conduit 1002 and the tether passage 1040 of collar 1015 and surrounds actuating element 1012.

[0278] refer to Figure 27B The device 1000 can be decoupled from the delivery catheter 1002. For example... Figure 27BAs shown, slack can be introduced into the connecting tether 1019, allowing the delivery catheter 1002 to retract from the device 1000. Slack can be introduced into the connecting tether 1000 by pushing forward or otherwise prior advancing the outer shaft 1017, thus reducing the distance between the distal end of the outer shaft 1017 and the tether passage 1044 of the delivery catheter 1002. The actuating element 1012 can be retracted to a point where it disengages from the cap but does not extend beyond the looped portion of the connecting tether 1019. In this position, the device 1000 and the collar 1015 are decoupled from the actuating element 1012 and can move relatively freely without restriction by the delivery catheter 1002. In this position, the user can observe or inspect how the device 100 will function when deployed in a natural valve such as the heart (e.g., a natural mitral valve MV, etc.). However, it will be understood that the device 1000 can be decoupled or otherwise allowed to move in various ways. For example, when sufficient slack is introduced into the connecting tether 1019, the actuating element 1012 can remain engaged with the cap of the device 1000, allowing the user to observe or inspect how the device 1000 will function or otherwise operate when deployed in a natural valve such as the heart valve (e.g., a natural mitral valve MV). The method of using a flexible actuating element 1012—which is not decoupled when the device is fully decoupled from the delivery catheter, and allows the user to observe or inspect how the device will operate when deployed—can also be used in any other embodiments presented herein.

[0279] If the user observes that the device 1000 is not properly positioned, the user can reconnect the device 1000, the delivery conduit 1002, and the actuator 1002. For example, the actuator 1012 can be pushed through the loop of the connecting tether 1019 and into the device 1000, such that the actuator 1002 engages the cap 1014, and the outer shaft 1017 can be retracted to reconnect the device 1000 to the delivery conduit 1002, as shown. Figure 26A As shown. Then, the device 1000 can be reopened, repositioned, and redeployed by any other method disclosed herein.

[0280] Now for reference Figures 27C to 27E The device 1000 can be fully deployed from the delivery catheter 1002, the actuating element 1012, and the outer shaft 1017. For example, the device 1000 can be deployed after the user observes that the device 1000 is properly positioned in a natural valve such as the heart valve (e.g., a natural mitral valve). Figure 27C As shown, the control wire 1012 retracts outward from the tether loop. The outer shaft 1017 is retracted, thus retracting the connecting tether 1019 from the tether passage 1040 of the loop 1040 and the tether passage 1044 of the delivery conduit 1002, as... Figure 27DAs shown. Then the device 1000 is completely disconnected from the delivery conduit 1002, the outer shaft 1017, the actuating element 1012, and the connecting rope 1019.

[0281] like Figure 27E As shown, device 1000 is displayed in a fully closed and deployed state. The delivery conduit 1002, outer shaft 1017, and actuating element 1012 are retracted, and the fasteners of device 1000 remain in the fully closed position. After deployment, device 1000 can be held in the fully closed position in several ways. For example, device 1000 can be held in the fully closed position via... Figure 14M The device may be held in a fully closed position in any of the ways described, or the device may be configured such that the paddle opens and closes with the heartbeat while the fasteners remain closed on the natural valve leaflets.

[0282] Now for reference Figures 28A to 28F An implantable prosthesis device 1100 is described according to one embodiment (see, for example...). Figure 28C The device 1100 includes a cap 1114 and a collar 1115, and may include any features of any implantable prosthesis device 100, 400, 400A described herein. For example, as previously described herein, the device 1100 may include a fastener comprising a base or fixed arm, a movable arm, barbs, and a connector portion connectable to an actuation line that can open the fastener.

[0283] The device 1100 can be deployed, reconnected, repositioned, and redeployed via a delivery conduit 1102, an actuating element 1112, and one or more connecting tethers 1119. The number of lumens 1104 of the delivery conduit 1102 corresponds to the number of connecting tethers 1119. The lumens 1104 extend longitudinally through the delivery conduit 1102, and the looping connecting tethers 1119 can extend through each lumen 1104.

[0284] like Figure 28A and Figure 28B As shown, the actuating element 1112 extends longitudinally through the delivery conduit 1102. Each connecting cord 1119 extends proximally beyond the proximal portion of the delivery conduit 1102 around the actuating element 1112, and each connecting cord 1119 extends longitudinally through one of the lumens 1104 of the delivery conduit 1102.

[0285] Now for reference Figures 28C to 28G, the device 1100 can be coupled to and deployed from the delivery catheter 1102 and the actuating element 1112. A collar 1115 generally extends upward from the device 1100 and includes two tethering passages 1140 laterally oriented through the collar 1115. The tethering passages 1140 of the collar 1115 may correspond to the circumferential position of the lumen 1104 and / or the connecting tether 1018 extending through the lumen 1104 of the delivery catheter 1102. In the illustrated embodiment, the connecting tether 1119, the tethering passages 1140 of the collar 1115, and the lumen 1104 of the delivery catheter 1102 are located opposite each other.

[0286] like Figure 28C As shown, device 1000 is connected to delivery conduit 1102, actuating element 1112, and connecting tether 1119. Device 1100 can be deployed in a fully open position and moved to a partially open, grip-ready, and closed position by any of the methods previously described herein. Actuating element 1112 extends through device 1100 and engages cap 1114. In such a position, connecting tether 1119 extends through tether passage 1140 of collar 1115 and each wraps around actuating element 1112. Before the procedure begins, connecting tether 1119 can be inserted through tether passage 1140 of collar 1115 and wrap around actuating element 1112.

[0287] like Figure 28D As shown, slack can be introduced into the connecting tether 1119, allowing the delivery catheter 1102 to be retracted from the device 1100 and / or the device 1100 to be advanced away from the delivery catheter 1102. Slack can be introduced into the connecting tether 1119 by advancing the actuating element 1112 through the delivery catheter 1102 or by any other means. In this position, the device remains tethered to the delivery catheter 1102 and directly attached to the actuating element 1112. In some example embodiments, the actuating element 1112 is flexible, and the user can observe or inspect how the device 1100 will function or otherwise operate when deployed in a natural valve such as the heart valve (e.g., a natural mitral valve MV). The tether 1119 can be used to return the catheter 1102 to the device, and the actuating element 1112 can reopen the device 1100 as previously described herein. For example, if a user observes that the device 1100 is not properly positioned in a natural valve such as the heart valve (e.g., the natural mitral valve MV), the user can reconnect the device 1100 to the catheter 1102 and reopen the device 1100.

[0288] like Figure 28E As shown, device 1100 can be coupled to actuation element 1112 and tether. For example, actuation element 1112 can retract from device 1110 and enter delivery conduit 1102 to detach the tether from the device.

[0289] like Figure 28F As shown, device 1100 can be deployed from delivery catheter 1102 and connecting tether 1119. Connecting tether 1119 can be retracted through tether passage 1140 via collar 1115 to decouple device 1100 from delivery catheter 1102. Connecting tether 1119 can be retracted by pulling the end of connecting tether 1119, thereby retracting actuator 1112, or by any other means. In this position, device 1100 is fully deployed in a natural valve such as the heart valve (e.g., natural mitral valve MV). Delivery catheter 1102, actuator 1112, and connecting tether 1119 can be further retracted, and device 1100 can remain in place.

[0290] Now for reference Figures 29A to 29O According to one embodiment, a system for implanting an implantable prosthetic device 100 is described. Device 100 may be any device described herein, any device described in any patent or patent application cited herein, or any other known device for repairing a natural heart valve (such as a mitral or tricuspid valve).

[0291] Figures 29A to 29O The illustrated device 100 is deployed from a delivery catheter 102 and includes an engagement portion 104 and an anchoring portion 106. The engagement portion 104 of the device 100 includes an engagement element 110 adapted for implantation between the leaflets of a natural valve and slidably attached to an actuating element or shaft 112. The anchoring portion 106 is actuable between an open and closed state and can take various forms, such as, for example, a paddle, a clamping element, etc. Actuation of the actuating element 112 opens and closes the anchoring portion 106 of the device 100 to grip the natural leaflet during implantation. The actuating element or shaft 112 can take many different forms. For example, the actuating element or shaft can be threaded, such that rotation of the actuating element or shaft causes the anchoring portion 106 to move relative to the engagement portion 104. Alternatively, the actuating element or shaft may be unthreaded, such that pushing or pulling the actuating element or shaft 112 causes the anchor portion 106 to move relative to the mating portion 104.

[0292] The anchoring portion 106 of device 100 includes an outer paddle 120 and an inner paddle 122 connected between cap 114 and mating element 110 via portions 124, 126, and 128. Portions 124, 126, and 128 may have joints and / or be flexible to move between all the positions described below. The interconnection of the outer paddle 120, inner paddle 122, mating element 110, and cap 114 via portions 124, 126, and 128 secures and moves the device to the positions illustrated herein.

[0293] Actuating element 112 extends through delivery conduit 102 and mating element 110 to cap 114 at the distal connection of anchor portion 106. Extending and retracting actuating element 112 increases and decreases the spacing between mating element 110 and cap 114, respectively. Collar 115 removably attaches mating element 110 directly or indirectly to delivery conduit 102, such that actuating element 112 slides through collar 115 and mating element 110 during actuation to open and close paddles 120, 122 of anchor portion 106.

[0294] The device 100 may also include a connector 117 that removably attaches a collar 115 to a delivery conduit 102. The connector 117 may be removably attached to the collar 115 and may be fixedly or removably attached to the delivery conduit 102. The connector 117 may attach the delivery conduit 102 to the collar 115 in a variety of ways. For example, the connector 117 may attach the collar 115 to the delivery conduit 102 in any of the ways described in PCT patent application publication WO2020 / 076898 or in any of the ways previously described herein. In such an embodiment, the actuating element 112 slides through the connector 117, collar 115, and engaging element 110 during actuation to open and close the paddles 120, 122 of the anchoring portion 106. As detailed below, the connector 117 may facilitate the placement, repositioning, and / or replacement of the device 100.

[0295] The device 100 also includes a compressible sleeve 121 disposed between the collar 115 and the connector 117. The sleeve 121 may be made of wire mesh, compressible rubber or plastic, helical spring material, or any other material that is particularly compressible and expandable in the longitudinal direction. The sleeve 121 is substantially the same width as the connector 117 and the collar 115. The sleeve 121 surrounds one or more connecting cords 119 that connect the collar 115 to the connector 117, the delivery conduit 102, and / or the actuating element 112. The sleeve 121 may surround one or more connecting cords 119 such that when the device 100 is decoupled, recoupled, repositioned, or redeployed, one or more connecting cords 119 do not separate, become tangled, and / or become jammed, as described below. Sleeve 121 may extend from connector 117 and / or delivery conduit 102 and may extend to or substantially extend to collar 115. As detailed below, in the expanded position, sleeve 121 prevents the fastener actuation line 116 from being clamped between connector 117 and collar 115 and / or from becoming entangled with one or more connecting tethers 119 and / or actuating elements 112. For example, when tethers 119 and / or fastener control lines 116 are loosened to check the device's effectiveness, a large gap exists between connector 117 and collar 115 (see, for example...). Figure 14CThe slack control line 116 may become entangled with the slack tether 119. Furthermore, when tension is applied to the tether 119 and the connector 117 is moved back to the collar 115, the slack control line 116 may be clamped between the connector 117 and the collar 115. This entanglement or clamping of the fastener control line 116 temporarily prevents the fastener control line from opening the fastener. The sleeve 121 prevents both clamping and entanglement. The sleeve 121 may also be used in any other embodiments described herein.

[0296] The device 100 can be inserted and deployed using any of the methods or procedures previously described herein. For example, it can be inserted by pressing... Figures 8-14A and Figures 15-20A Insert and deploy device 100 as described and exemplified in the text.

[0297] like Figure 29A As shown, device 100 is displayed in a fully closed and deployed state. Paddles 120, 122 and fastener 130 are held in the fully closed position. Once deployed, device 100 can be held in the fully closed position by a mechanical latch, or by being biased to maintain closure using a spring material such as steel, other metals, plastics, composite materials, or shape memory alloys such as nitinol. For example, the joint portions or flexible portions 124, 126, 128, 138, and / or the inner paddle 122 and the outer paddle, and / or other biasing components can be formed of metals such as steel or shape memory alloys such as nitinol—prepared as wire, sheet, tubing, or laser-sintered powder—and biased to keep the outer paddle 120 closed around the mating element 110 and to keep the fastener 130 clamped around the natural leaflet. Similarly, the fixed arm 132 and movable arm 134 of the fastener 130 are biased to clamp the leaflet. In some embodiments, the connector portions 124, 126, 128, 138, and / or the inner paddle 122 and the outer paddle, and / or other biasing components may be formed of any other suitable resilient material such as metal or polymer material to keep the device closed after implantation.

[0298] Now for reference Figure 29B The device 100 can be decoupled from the actuating element 112. The actuating element 112 can be retracted from the device 100 and the collar 115 and enter the sleeve 121, the connector 117, and / or the delivery conduit 102. The actuating element 112 can be retracted such that the end of the actuating element 112 is positioned within the sleeve 121, the connector 117, and / or the delivery conduit 102. In this position, the device 100 and the collar 115 can move or pivot relatively unrestricted by the sleeve 121, the connector 117, the delivery conduit 102, and the actuating element 112.

[0299] like Figure 29CAs shown, slack can be introduced into the fastener actuation line 116, allowing the delivery conduit 102, actuation element 112, and connector 117 to retract from the device 100 and collar 115. The collar 115 can still be secured to the delivery conduit 102, actuation element 112, and / or connector 117 by one or more connecting cords 119. One or more connecting cords 119 can be looped or otherwise secured or attached to the collar. Retraction of the delivery conduit 102 and connector 117 causes a compressible sleeve 121 to expand longitudinally between the retracted positions of the collar 115 and connector 117. The sleeve 121 surrounds one or more connecting cords 119 and can expand to the maximum distance that the sleeve 121 blocks or substantially blocks the gap between the collar 115 and connector 117. In this position, the device 100 remains tethered or attached to the delivery catheter 102, actuating element 112, and / or connector 117, but with sufficient slack in the fastener actuation line 116, the device 100 can generally move freely relative to the delivery catheter 102, actuating element 112, and connector 117. In this position, the user can observe or inspect how the device 100 will look or operate when actually deployed on, for example, a natural valve leaflet.

[0300] like Figure 29D As shown, the delivery conduit 102, actuating element 112, connector 117, and sleeve 121 can be retracted further from the collar 115. The sleeve 121 can optionally be separated from the collar 115. However, the sleeve 121 still blocks a portion of the gap between the connector 117 and the cap 114, and optionally blocks most of the gap. In this position, the device 100 remains tethered or attached to the delivery conduit 102, actuating element 112, and / or connector 117, but with sufficient slack in the fastener actuation line 116, the device 100 can generally move freely relative to the delivery conduit 102, actuating element 112, and connector 117. Furthermore, the expandable compressible sleeve 121 allows one or more connecting cords 119 to hold the collar 115 connected to the connector 117, and the sleeve 121 prevents one or more connecting cords 119 from becoming entangled with the fastener actuation line 116 and prevents the fastener actuation line 116 from getting caught between the collar 115 and the connector 117. In this position, the user can observe or inspect how the device 100 will look or operate when it is actually deployed on, for example, a natural valve leaflet.

[0301] Now for reference Figures 29E to 29HThe device 100 and collar 115 can be reconnected to the delivery catheter 102, actuation element 112, and connector 117. For example, if a user observes that the device 100 is not properly deployed or not properly positioned, the device 100 and collar 115 can be reconnected to the delivery catheter 102, actuation element 112, and connector 117.

[0302] like Figures 29E to 29G As shown, the device 100 and collar 115 can be reconnected to the delivery conduit 102, actuating element 112, connector 117, and sleeve 121. Tension can be applied to one or more connecting cords 119, and the connector 117 can be advanced along said one or more connecting cords, so that the device 100 and collar 115 can be reconnected to the delivery conduit 102, actuating element 112, connector 117, and sleeve 121. Tension can also be applied to the fastener actuation line 116, bringing it closer to the device 100 and within the connector 117 and / or delivery conduit 102, so that the fastener actuation line 116 does not move around or become tangled. Figure 29E and Figure 29F As shown, the delivery conduit 102, connector 117, and sleeve 121 can be advanced so that the sleeve 121 can return to contact the collar 115.

[0303] like Figure 29G and Figure 29H As shown, device 100 can be reconnected to actuator 112. For example... Figure 29G As shown, the delivery conduit 102 and connector 117 can be advanced further, causing the sleeve 121 to be compressed between the collar 115 and the connector 117. Figure 29H As shown, the actuating element 112 can be pushed through the coupling 117 and the collar 115 and into the device 100. The actuating element 112 can be pushed through the collar 115 and the coupling 117 and into the device 100 until the actuating element 112 re-engages the anchor portion 106 and / or the cap 114 of the device 100.

[0304] Now for reference Figure 29I The device 100 can be reopened or moved back to a partially open state to release the valve leaflet, reposition the device, and recapture the leaflet. To transition from a fully closed to a partially open state, the actuating element 112 extends to push the cap 114 away from the engaging element 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the anchor portion 106 to partially unfold. The actuating line 116 is also retracted to open the fastener 130, allowing the leaflet to be gripped. When in the partially open state, the device 100 can be moved or repositioned. For example, a user can reposition the device 100 to properly grip the natural valve leaflet.

[0305] like Figure 29J As shown, device 100 can be moved to a fully closed or deployed state. For example, after device 100 has been positioned or repositioned to a desired location, device 100 can be moved back to the deployed state. Actuation line 116 can be extended to allow fastener 130 to close. Any one or both actuation lines 116 can be repeatedly actuated to repeatedly open and close fastener 130. For example, fastener 130 can be repeatedly opened and closed to ensure that device 100 is properly positioned.

[0306] Now for reference Figures 29K to 29O The device 100 can be deployed from the delivery catheter 102, connector 117, actuation element 112, and sleeve 121. For example, the device 100 can be deployed after it is in place and grips the natural valve leaflet.

[0307] like Figure 29K As shown, the device 100 can be coupled to the actuating element 112. The actuating element 112 can retract from the device 100 and the collar 115 and enter into the connector 117, the sleeve 121, or the delivery conduit 102. The actuating element 112 can be retracted such that the end of the actuating element 112 is positioned within the connector 117, the sleeve 121, or the delivery conduit 102. In this position, the device 100 and the collar 115 can move or pivot relatively unrestricted by the connector 117, the delivery conduit 102, and the actuating element 112.

[0308] like Figure 29L As shown, slack can be introduced into the fastener actuation line 116, allowing the delivery conduit 102, actuation element 112, and connector 117 to retract from the device 100 and collar 115. The collar 115 can still be secured to the delivery conduit 102, actuation element 112, and / or connector 117 via one or more connecting cords 119. One or more connecting cords 119 can be looped or otherwise secured or attached to the collar 115 and can attach the collar 115 to the mating portion 104 of the device 100. Retraction of the delivery conduit 102 and connector 117 causes a compressible sleeve 121 to expand longitudinally between the retracted positions of the collar 115 and connector 117. The sleeve 121 surrounds one or more connecting cords 119 and can expand to its maximum distance. In this position, the device 100 remains tethered to the delivery catheter 102, actuating element 112, and / or connector 117, but with sufficient slack in the fastener actuation line 116 and tether 119, the device 100 can generally move freely relative to the delivery catheter 102, actuating element 112, and connector 117. In this position, the user can observe or inspect how the device 100 will look or operate when actually deployed on, for example, a natural valve leaflet.

[0309] like Figure 29MAs shown, the delivery catheter 102, actuating element 112, connector 117, and sleeve 121 can be retracted further from the collar 115. The sleeve 121 can be separated from the collar 115. In this position, the device 100 remains tethered or attached to the delivery catheter 102, actuating element 112, and / or connector 117, but with sufficient slack in the fastening actuation line 116, the device 100 can generally move freely relative to the delivery catheter 102, actuating element 112, and connector 117. Furthermore, the expandable compressible sleeve 121 allows one or more connecting tethers 119 to hold the collar 115 connected to the connector 117, and the sleeve 121 prevents one or more connecting tethers 119 from becoming entangled with the fastening actuation line 116. In this position, the user can observe or inspect how the device 100 will look or operate when actually deployed on, for example, a natural valve leaflet.

[0310] like Figure 29N As shown, the device 100 and collar 115 can be connected to one or more connecting cords 119, and the delivery conduit 102, actuating element 112, connector 117, sleeve 121, and one or more connecting cords 119 can be retracted away from the device 100 and collar 115. The one or more connecting cords 119 can be connected in various ways. For example, the one or more connecting cords can be connected in any of the ways previously described herein. The fastener actuation line 116 can be detached from the movable arm 134 and pulled or otherwise retracted toward the connector 117 and / or delivery conduit 102, or pulled or otherwise retracted into the connector 117 and / or delivery conduit 102. In such an embodiment, the device 100 and collar 115 are completely disengaged from the delivery conduit 102, connector 117, and actuating element 112.

[0311] like Figure 29O As shown, device 100 is displayed in a fully closed and deployed state. Delivery conduit 102, connector 117, actuating element 112, and sleeve 121 are retracted, and fastener 130 remains in the fully closed position. After deployment, device 100 can be held in the fully closed position in several ways. For example, device 100 can be held in the fully closed position via... Figure 14M Any method described should be kept in a fully closed position.

[0312] Now for reference Figures 30A to 30L , Figures 28A to 2 The implantable device 100 in 8O is shown to be implanted, and then reopened, repositioned, and redeployed within the natural valve of the heart H or the natural mitral valve MV. (As shown) Figure 30A As shown, device 100 is implanted within the natural mitral valve MV of heart H. Device 100 can be implanted within the natural mitral valve MV of heart H in various ways. For example, as... Figures 8-14H and Figures 15-20H As described and exemplified herein, device 100 can be implanted into a natural valve of the heart H or a natural mitral valve MV. Device 100 can also be implanted in other natural valves such as the tricuspid valve in a similar manner.

[0313] Now for reference Figure 30B The device 100 can be coupled to the actuating element 112. The actuating element 112 can be retracted from the device 100 and the collar 115 and enter into the sleeve 121, the connector 117, or the delivery conduit 102. The actuating element 112 can be retracted such that the end of the actuating element 112 is positioned within the sleeve 121, the connector 117, or the delivery conduit 102. In this position, the device 100 and the collar 115 can move or pivot relatively unrestricted by the sleeve 121, the connector 117, the delivery conduit 102, and the actuating element 112.

[0314] Now for reference Figure 30C A slack can be introduced into the fastener actuation line 116 and the tether 119, allowing the delivery conduit 102, actuation element 112, and connector 117 to retract from the device 100 and the collar 115. The collar 115 can still be secured to the delivery conduit 102, actuation element 112, and / or connector 117 by one or more connecting tethers 119. One or more connecting tethers 119 can be looped or otherwise secured or attached to the collar 115 and can attach the collar 115 to the mating portion 104 of the device 100. The retraction of the delivery conduit 102 and connector 117 causes the compressible sleeve 121 to expand longitudinally between the retracted positions of the collar 115 and connector 117. The sleeve 121 surrounds one or more connecting tethers 119 and can expand to its maximum distance. In this position, the device 100 remains tethered or attached to the delivery catheter 102, actuating element 112, and / or connector 117, but with sufficient slack in the fastener actuation line 116, the device 100 can generally move freely relative to the delivery catheter 102, actuating element 112, and connector 117. In this position, the user can observe or inspect how the device 100 will look or operate when actually deployed on, for example, a natural valve leaflet.

[0315] like Figure 30CAs shown, slack can be introduced into one or more connecting cords 119, allowing the delivery conduit 102, actuating element 112, and connector 117 to retract from the device 100 and collar 115. Sleeve 121 can remain in an expanded or extended state and can span or substantially span the distance between collar 115 and connector 117. Collar 115 can still be secured to delivery conduit 102, actuating element 112, and / or connector 117 by one or more connecting cords 119. One or more connecting cords 119 can loop around or otherwise secure or attach collar 115 to connector 117 in various ways. For example, one or more connecting cords 119 can loop around or otherwise secure or attach collar 115 to connector 117 in any of the ways previously described herein.

[0316] like Figure 30D As shown, the delivery conduit 102, actuating element 112, connector 117, and sleeve 121 can be retracted further from the collar 115. The sleeve 121 can be separated from the collar 115. In this position, the device 100 remains tethered or attached to the delivery conduit 102, actuating element 112, and / or connector 117, but with sufficient slack in the fastener actuation line 116, the device 100 can generally move freely relative to the delivery conduit 102, actuating element 112, and connector 117. Furthermore, the expandable compressible sleeve 121 allows one or more connecting tethers 119 to hold the collar 115 tethered to the connector 117, and the sleeve 121 prevents one or more connecting tethers 119 from becoming entangled with the fastener actuation line, and the sleeve 121 prevents the fastener actuation line 116 from being clamped between the collar 115 and the connector 117. In this position, the user can observe or inspect how the device 100 will look or operate when it is actually deployed on a natural valve leaflet.

[0317] Now for reference Figures 30D to 30F The device 100 and collar 115 can be reconnected to the delivery conduit 102 and actuating element 112. Tension can be applied to one or more connecting cords 119 and the connector 117 can be advanced forward, allowing the device 100 and collar 115 to be reconnected to the delivery conduit 102, actuating element 112, connector 117, and sleeve 121. Tension can also be applied to the fastener actuation line 116, bringing it closer to the device 100 and within the connector 117 and / or delivery conduit 102, preventing the fastener actuation line 116 from shifting or becoming tangled. Figure 30D and Figure 30E As shown, the delivery catheter 102, connector 117, and sleeve 121 can be advanced so that sleeve 121 can return to contact with collar 115. Furthermore, as... Figure 30EAs shown, the delivery catheter and connector 117 can be advanced further, causing the sleeve 121 to compress between the collar 115 and the connector 117.

[0318] Now for reference Figures 30F to 30H Device 100 can be reconnected to actuator 112, reopened, repositioned, and redeployed within the heart's natural valves. For example... Figure 30F As shown, the actuating element 112 can be pushed through the collar 115 and into the device 100, such that the actuating element 112 re-engages the cap 114 of the device 100. Figure 30G As shown, the actuating element 112 can be advanced to reopen the device 100 to a partially open, gripping-ready state. The actuating element 112 can reopen the device 100 in a variety of ways. For example, the actuating element 112 can reopen the device 100 in any of the ways previously described herein. When in the partially open state, the device 100 can be released, moved, or repositioned from the natural valve leaflets and recapture the natural valve leaflets. For example, a user can reposition the device 100 to properly grip the valve leaflets 20, 22.

[0319] like Figure 30H As shown, device 100 can be moved to a fully closed or deployed state. For example, after device 100 has been positioned or repositioned to a desired location, device 100 can be moved back to the deployed state. Actuation line 116 can be extended to allow fastener 130 to close. Any one or both actuation lines 116 can be repeatedly actuated to repeatedly open and close fastener 130. For example, fastener 130 can be repeatedly opened and closed to ensure that device 100 is properly positioned.

[0320] refer to Figures 30I to 30L The device 100 can be connected to the delivery catheter 102, connector 117, and actuating element 112, and the device 100 can be deployed in a natural valve such as the heart valve (e.g., a natural mitral valve MV). Figure 30I As shown, the device can be coupled to the actuating element 112. The actuating element 112 can retract from the device and collar 115 and enter into the sleeve 121, connector 117, or delivery conduit 102. The actuating element 112 can be retracted such that the end of the wire 112 is positioned within the sleeve 121, connector 117, or delivery conduit 102. In this position, the device 100 and collar 115 can move or pivot relatively unrestricted by the sleeve 121, connector 117, delivery conduit 102, and actuating element 112.

[0321] like Figure 30JAs shown, slack can be introduced into one or more connecting cords 119, allowing the delivery conduit 102, actuating element 112, and connector 117 to retract from the device 100 and collar 115. Sleeve 121 can remain in an expanded or extended state and can span or substantially span the distance between collar 115 and connector 117. Collar 115 can still be secured to delivery conduit 102, actuating element 112, and / or connector 117 by one or more connecting cords 119. One or more connecting cords 119 can wrap around collar 115 or otherwise secure collar 115 to connector 117 in various ways. For example, one or more connecting cords 119 can wrap around collar 115 or otherwise secure or attach collar 115 to connector 117 in any of the ways previously described herein.

[0322] like Figure 30K As shown, the device 100 and collar 115 can be connected to one or more connecting cords 119, delivery catheter 102, actuating element 112, and connector 117, and one or more connecting cords 119 can retract away from the device 100 and collar 115. The fastener actuation line 116 can be detached from the movable arm 134 and pulled or otherwise retracted toward the connector 117 and / or delivery catheter 102, or pulled or otherwise retracted into the connector 117 and / or delivery catheter 102. In such an embodiment, the device 100 and collar 115 are completely disengaged from the delivery catheter 102, connector 117, and actuating element 112, and the device 100 is deployed in the natural valve of the heart H or the natural mitral valve MV. One or more connecting cords 119 can be connected to the collar 115 in various ways. For example, one or more connecting ropes 119 can be connected to the collar 115 in any of the ways previously described herein.

[0323] like Figure 30L As shown, the device 100 can be detached from the delivery catheter 102, connector 117, and actuation element 112 and deployed in the natural valve of the heart H or the natural mitral valve MV. For example, the device 100 can be deployed after it is in place and grips the natural valve leaflets 20, 22.

[0324] The compressible sleeve 121 can take many different forms. Any sleeve configuration capable of expanding and compressing between the collar 115 and the coupling 117 can be used. Examples of the compressible sleeve 121 are provided by... Figure 31A – Figure 31I Example. In Figure 31A and Figure 31BThe example shown depicts a side view of the delivery conduit 102 and the compressible sleeve 121, wherein the compressible sleeve 121 is moved from an expanded or extended position to a retracted or compressed position. The sleeve 121 can be any expandable and compressible material or a composite material. The sleeve 121 can be wire mesh, compressible rubber or plastic, helical spring material, or any other material that is particularly compressible and expandable in the longitudinal direction. The compressible sleeve 121 may also have an end 123 at its distal end.

[0325] like Figure 31A As shown, sleeve 121 can be moved to an expanded or extended position. Sleeve 121 can expand such that the end 123 of sleeve 121 is at its maximum distance from the delivery conduit 102. In the extended position, sleeve 121 can retract radially. Sleeve 121 can be spring-loaded or otherwise configured such that sleeve 121 is biased to the deployed or extended position.

[0326] like Figure 31B As shown, sleeve 121 can be moved to a retracted or compressed position. Sleeve 121 can be compressed in several ways. For example, sleeve 121 can be compressed by advancing delivery catheter 102 toward the implantable prosthesis device such that the end 123 of sleeve 121 contacts the device. After this contact, the further the delivery catheter 102 is advanced, the more further sleeve 121 is compressed. Compressing sleeve 121 to the retracted position can cause sleeve 121 to expand radially. However, in some example embodiments, longitudinal compression is greater than radial expansion.

[0327] In some example implementations, the sleeve is configured such that when the sleeve is removed from... Figure 31A The elongation position shown is compressed to Figure 31B The position shown indicates that there is no radial expansion or a small amount of radial expansion, but the sleeve does not extend radially beyond the conduit, or the sleeve does not extend radially or substantially not radially beyond the conduit.

[0328] exist Figures 31C-31I In the illustrated example embodiment, the sleeve 121 tapers radially inward, such that the compressed sleeve does not extend radially beyond the conduit, or the compressed sleeve does not extend radially beyond the conduit, or substantially does not extend radially beyond the conduit. The sleeve 121 can taper radially inward in a variety of different ways. For example, the sleeve 121 may taper radially inward from a first end and then taper radially outward toward a second end; the sleeve may taper radially inward only from one end to a cylindrical portion; the sleeve may taper radially inward from each end to a central cylindrical portion; the sleeve may have an undulating outer surface, etc.

[0329] An example of the compressible sleeve 121 is provided by Figure 31C and Figure 31DAs shown. In this example, a side view of the delivery catheter 102 and the compressible sleeve 121 is shown, wherein the compressible sleeve 121 is in an expanded or extended position (as shown). Figure 31C The sleeve 121 is moved to the retracted or compressed position (31D). The compressible sleeve 121 may also have an end portion 3101 and a central portion 3102 in its proximal portion. In this example, the sleeve is tapered such that the outer diameter of the end portion 123, 3101 of the sleeve 121 is larger than the outer diameter of the central portion 3102 of the sleeve 121. The diameter of the central portion 3102 of the sleeve 121 is smaller than the outer diameter of the delivery conduit 102. When the sleeve 121 is compressed, the inner diameter of the central portion 3102 of the sleeve 121 increases, thereby allowing the sleeves 121 to stack neatly on the outer diameter of the delivery conduit 102 without exceeding or substantially exceeding the total diameter of the delivery conduit 102.

[0330] Another example of the compressible sleeve 121 is... Figure 31E and Figure 31F As shown. In this example, a side view of the delivery catheter 102 and the compressible sleeve 121 is shown, wherein the compressible sleeve 121 is in an expanded or extended position (as shown). Figure 31E Move to the contraction or compression position. Figure 31F In this example, the sleeve is tapered, such that the outer diameter of the proximal end 3101 of the sleeve 121 is larger than the rest of the sleeve 121. The diameter of the sleeve 121 is smaller than the outer diameter of the delivery catheter 102. When the sleeve 121 is compressed, the smaller diameter of the sleeve 121 increases, thereby allowing the sleeves 121 to stack neatly on the outer diameter of the delivery catheter 102. The compressed sleeve does not exceed or substantially does not exceed the total diameter of the delivery catheter 102.

[0331] like Figures 31G-31I As shown, in one example embodiment, sleeve 121 can be connected to collar 115 of device 100. Sleeve 121 can be connected to collar 115 in several different ways. In one example embodiment, sleeve 121 can be separated from collar 115 by pulling the conduit. Figures 31G-31I In the exemplary embodiment shown, the sleeve 121 is stretched and / or frictionally engaged with the collar 115 of the device 100. Figure 31G In this configuration, because the distal end 123 is stretched on the collar 115, the collar is fixed within the distal end 123 of the sleeve 121. (Referring to...) Figure 31G The compressed sleeve does not exceed or substantially does not exceed the total diameter of the delivery catheter 102. (Reference) Figure 31H and Figure 31IAs the sleeve 121 is extended, the inner diameter of the sleeve 121 decreases, causing tension to be applied to a portion of the retaining ring 115 of the sleeve, and the sleeve 121 is pulled away from the ring. Thus, the sleeve is passively deployed and then released from the device when the device 100 is separated from the conduit 102.

[0332] Although the compressible sleeve 121 is depicted as being directly attached to the delivery catheter 102, it should be understood that other embodiments are also contemplated. For example, the sleeve 121 may be attached to a connector disposed between the sleeve 121 and the delivery catheter 102. The sleeve 121 may be attached to or otherwise secured to a variety of connectors. For example, the sleeve may be attached to or otherwise secured to any of the connectors 117, 517, 617, 717, 817, 917, 1017 described herein. Furthermore, the compressible sleeve 121 may be used with any of the devices 100, 400, 500, 600, 900, 1000, 1100 described herein, or with any other implantable prosthetic device.

[0333] Now for reference Figure 32A and Figure 32B A cross-section of a compressible sleeve 121 is shown according to one embodiment. The compressible sleeve 121 is generally cylindrical, with a frame member 160 extending through the sleeve 121 and a cover 162 attached to the frame member 160. The frame member 160 may be a semi-rigid or rigid material movable between a compressed position and an expanded position, such as a wire spring material, and the cover 162 may be a fabric, mesh, or other suitable cover. In the illustrated embodiment, the frame member 160 is a helical or other compressible wire or spring, and the cover 162 is a fabric or mesh that spans the length of the sleeve 121 and covers or substantially covers the frame member 160. However, the frame member 160 and the cover 162 may take many other forms. For example, the frame member 160 may be a wire frame or a mesh frame or other suitable design.

[0334] like Figure 32A As shown, sleeve 121 is in the retracted or compressed position. Frame member 160 can be compressed to reduce its longitudinal length. Cover 162 extends between the helical portions of frame member 160.

[0335] like Figure 32B As shown, sleeve 121 is in the expanded or extended position. Frame member 160 can be expanded or extended to increase its longitudinal length. Cover 162 extends between the helical portions of frame member 160. Frame member 160 can be biased to the extended or expanded position in various ways, such as by biasing spring force.

[0336] Now for reference Figure 33A and Figure 33B A cross-section of a compressible sleeve 121 is shown according to one embodiment. The compressible sleeve 121 may be a single piece of compressible or other adjustable material, having an outer portion 170 having a first diameter, an inner portion 170 having a second diameter, and a middle portion 171 having a diameter between the first and second diameters and connecting the outer portion 170 and the inner portion 172. The sleeve 121 may be configured such that the inner portion 172 can move or otherwise slide within the outer portion 170 of the sleeve 121, thereby increasing the length of the middle portion 171 and decreasing the overall length of the sleeve 121. The sleeve 121 may also be configured such that the inner portion 172 can be moved or otherwise slid outside or away from the outer portion 170 of the sleeve, thereby decreasing the length of the middle portion 171 and increasing the overall length of the sleeve 121. The sleeve 121 may be a compressible, semi-flexible, or other movable material, such as rubber, plastic, polymer, or other similar materials. As previously described herein, the outer portion 170, the middle portion 171, and the inner portion 172 can be sized and shaped such that the sleeve 121 can cover the connector 117, the collar 115, and / or one or more connecting cords 119.

[0337] like Figure 33A As shown, sleeve 121 is in an expanded or extended position. The inner portion 172 is moved or otherwise slid outside or away from the outer portion 170 of sleeve 121, such that the length of the intermediate portion 171 decreases and the overall length of sleeve 121 increases. The inner portion 172 may extend beyond the outer portion 170, causing sleeve 121 to extend to its maximum length.

[0338] like Figure 33B As shown, sleeve 121 is in a retracted or compressed position. The inner portion 172 moves or otherwise slides within the outer portion 170 of sleeve 121, increasing the length of the intermediate portion 171 and decreasing the overall length of the sleeve. The inner portion 172 may extend into the outer portion 170, causing the sleeve to be compressed to its minimum length position.

[0339] Now for reference Figure 34A and Figure 34BAn implantable prosthesis device 100 is depicted according to one embodiment. The device 100 is deployed from a delivery catheter 102 and includes an occlusion portion 104 and an anchoring portion 106. In some embodiments, the occlusion portion 104 of the device 100 may optionally include an occlusion element 110 (e.g., a spacer, plunger, membrane, sheet, etc.) adapted for implantation between the natural leaflets of a natural valve and slidably attached to an actuating element or shaft 112. The anchoring portion 106 is actuable between an open and closed state and may take various forms, such as one or more of a paddle, a clamping element, and / or the like. Actuation of the actuating element 112 opens and closes the anchoring portion 106 of the device 100 to grip the natural valve leaflets during implantation. The actuating element or shaft 112 may take various different forms. For example, the actuating element or shaft may be threaded, such that rotation of the actuating element or shaft causes the anchor portion 106 to move relative to the mating portion 104. Alternatively, the actuating element or shaft may be unthreaded, such that pushing or pulling the actuating element or shaft 112 causes the anchor portion 106 to move relative to the mating portion 104.

[0340] In some embodiments, the anchoring portion 106 of the device 100 includes an outer paddle 120 and an inner paddle 122 connected between the cap 114 and the mating element 110 via portions 124, 126, and 128. Portions 124, 126, and 128 may have joints and / or be flexible to move between all the locations described herein. The interconnection of the outer paddle 120, inner paddle 122, mating element 110, and cap 114 via portions 124, 126, and 128 can secure the device to the positions illustrated herein and allow for movement.

[0341] In some embodiments, the actuating element 112 extends through the delivery conduit 102 and the center of the device (e.g., through the mating element 110, etc.) to a distal end (e.g., the cap 114 at the distal connection of the anchor portion 106). Extending and retracting the actuating element 112 increases and decreases the distance between the proximal and distal ends of the device, respectively (e.g., in some embodiments, it increases and decreases the distance between the mating element 110 and the cap 114). A collar 115 or other attachment removably attaches the mating element 110 directly or indirectly to the delivery conduit 102, such that the actuating element 112 slides through the collar 115 and the mating element 110 during actuation to open and close the paddles 120, 122 of the anchor portion 106.

[0342] In some embodiments, the device 100 may further include a connector 117 that removably attaches a collar 115 to a delivery conduit 102. The connector 117 may be removably attached to the collar 115 and may be fixedly or removably attached to the delivery conduit 102. The connector 117 may attach the delivery conduit 102 to the collar 115 in a variety of ways. For example, the connector 117 may attach the collar 115 to the delivery conduit 102 in any of the ways described in PCT patent application publication WO2020 / 076898 or in any of the ways previously described herein. In such embodiments, the actuating element 112 slides through the connector 117, collar 115, and engaging element 110 during actuation to open and close the paddles 120, 122 of the anchoring portion 106. As detailed below, the connector 117 may facilitate the placement, repositioning, and / or replacement of the device 100.

[0343] In some embodiments, the connector 117 includes a flange 131 on the distal portion of the connector 117, the flange 131 extending radially beyond the remainder of the connector 117. The flange 131 may extend radially beyond the diameter of the delivery conduit 102 and / or the collar 115. The flange 131 may take many different forms. The flange may be flexible, such that it can be radially compressed or flexed inward when the flange is arranged within another conduit (such as a guide sheath and / or a positioning conduit). For example, the flange 131 may be radially compressed or flexed inward such that the flange does not extend beyond the radially outer surface of the remainder of the connector.

[0344] Flange 131 can prevent the fastener actuation line 116 from becoming entangled with the tether or clamped between the connector 117 and the collar 115, for example, as the device 100 moves toward and away from the collar. For instance, flange 131 guides the fastener control line 116 radially outward away from the gap between the collar 115 and the connector 117. Flange 131 can be used in any other embodiments described herein.

[0345] The device 100 can be inserted and deployed by any of the methods or procedures previously described herein, or by simulations of such methods or procedures. For example, it can be as follows: Figures 8-14M and Figures 15-20M Insert and deploy device 100 as described and exemplified in the text.

[0346] like Figure 34A As shown, device 100 can be connected to actuating element 112 and connector 117. Connector 117 can contact collar 115, and connector 117 and collar 115 can be connected by one or more connecting cords 116. Figure 34BAs shown, the device 100 is decoupled from the actuating element 112, and the connector 117, actuating element 112, and delivery conduit 102 are retractable from the device 100 and the collar 115. The collar 115 is held connected to the connector 117 by one or more connecting cords 119. The flange 131 extends radially outward and pushes the fastener actuation line 116 outward, thereby preventing the fastener actuation line 116 from becoming entangled with one or more connecting cords 119 and from being clamped between the collar 115 and the connector.

[0347] refer to Figure 35 In one example embodiment, the actuating element 112 is attached to the device 100 proximally rather than directly to the cap 114 distally. This can be achieved in a variety of different ways by using various connectors that attach the actuating element 112 to the distal end or to the cap 114 positioned distally. In all the tethering embodiments described above, this proximal reconnection point makes reattaching the shaft 112 to the device easier. Thus, the following embodiment of attaching the actuating element proximally to the device can be applied to any tethering embodiment disclosed herein and can be used in applications that do not involve a tether.

[0348] like Figure 35 As shown, during installation, device 100 can be positioned in the natural valve or natural mitral valve and attached to the anterior leaflet 20 and posterior leaflet 22, as described above. Device 100 may need to be repositioned to achieve the desired result. This involves attaching device 100 and then observing the natural valve to determine if it is functioning correctly. To determine if device 100 has been adjusted to the natural valve as needed, device 100 can be released from actuation element 112 to allow device 100 and leaflets 20 and 22 to move without being affected by actuation element 112. However, if repositioning of device 100 is required, it may need to be reattached to actuation element 112 as described above. In other example embodiments shown herein, actuation element 112 may pass through the proximal end of device 100 and be screwed or otherwise coupled to a cap 114 located at the distal end of device 100. Figure 35 As shown in the example embodiment, the telescopic connector 3502 is positioned within the mating element 110 and attached to the cap 114, and is adapted to receive the threaded end 3504 (or other connection structure) of the actuating element 112.

[0349] Figure 36A cross-section of the connector 3502, separate from device 100, is illustrated. In the illustrated example embodiment, connector 3502 comprises three components. However, connector 3502 may include any number of components. In the illustrated embodiment, connector 3502 may be formed from an outer sleeve 3602, an inner sleeve 3604, and an inner shaft 3606. Each component may be annular, having an annular portion, or have other closed tubular shapes. The inner shaft 3606 may include a threaded portion 3608 or other connection structures that can be attached / released to an actuating element. The illustrated inner shaft 3606 also includes a threaded socket 3612 or other connection structures at the distal end of the inner shaft for attachment to cap 114. In the illustrated embodiment, the distal end of the inner shaft 3606 may be permanently attached to cap 114.

[0350] In some example embodiments, the components of the connector 3502 may optionally be formed in a shape that resists rotation between the outer sleeve 3602, the inner sleeve 3604, and / or the inner shaft 3606. For example, these components may be, but are not limited to, elliptical, rectangular, formed with alignment structures (such as splines), or other shapes that resist rotation between these components. Such shapes prevent rotation of the threaded chambers 3608, 3612 relative to other components of the connector 3502. However, in some example embodiments, the outer sleeve 3602, the inner sleeve 3604, and / or the inner shaft 3606 are configured to rotate relative to each other.

[0351] Figure 37 Example Figure 36 A cross-sectional view of the connector 3502, wherein the actuating element 112 is screwed into the threaded chamber 3608 of the proximal end 3610 of the connector 3502 (or otherwise attached to the connector). A first radially outwardly extending step 3702 is shown at the proximal end of the inner shaft 3606. A first radially inwardly extending step 3704 is shown at the distal end of the inner sleeve. A second radially outwardly extending step 3706 is shown at the proximal end of the inner sleeve 3604, while a second radially inwardly extending step 3708 is shown at the distal end of the outer sleeve 3602.

[0352] As previously described herein, the components of the device 100 are actuated by the extension of the actuating element 112. Figure 38 An example is shown when the actuator 112 is from the conduit ( Figure 38(Not shown) During extension, the connector 3502. The actuating element 112 extends the inner shaft 3606, causing it to extend outward from the inner sleeve 3604. At a certain extension, the first radially inward-extending step 3702 encounters the first radially outward-extending step 3704. However, in some embodiments, depending on the friction between the outer sleeve 3602, the inner sleeve 3604, and the inner shaft 3606, the inner sleeve 3604 may begin to extend away from the outer sleeve 3602 before the first radially inward-extending step 3702 encounters the first radially outward-extending step 3704.

[0353] like Figure 39 As shown, as the actuating element 112 continues to extend, the engagement of the first radially outward-extending step 3702 with the first radially inward-extending step 3704 causes the inner shaft 3606 to extend the inner sleeve 3604 outward from the outer sleeve 3602. As the actuating element 112 continues to extend into the connector 3502, the inner sleeve 3504 extends away from the outer sleeve 3602 until the second radially outward-extending step 3706 contacts the second radially inward-extending step 3708.

[0354] refer to Figure 40 and Figure 41 The process is reversed to pull the inner shaft 3606 back into the outer sleeve 3602. When the actuator 112 is retracted, the inner shaft 3606 is pulled into the inner sleeve 3604, as... Figure 40 As shown. Again, depending on the amount of friction between the outer sleeve 3602, the inner sleeve 3604, and the inner shaft 3606, the inner sleeve 3604 can begin to retract into the outer sleeve 3602 before the inner shaft 3606 is fully retracted. As the actuating element 112 continues to retract, the inner shaft 3606 and the inner sleeve 3604 are pulled into the outer sleeve 3602, as... Figure 41 As shown.

[0355] Figures 38-39 The process in Figure 35 and Figures 42-43 An example is provided within the example device 100. For example... Figure 35 As shown, the connector 3502 is located within the mating element 110, wherein a threaded inner cavity 3608 (or other connection structure) is positioned such that it is adjacent to the proximal end of the device 100. The distal end 3614 of the connector 3502 is attached to the cap 114 via a threaded socket 3612 (or other connection structure). Some example embodiments may use other fastening methods, such as, but not limited to, welding or interference fit.

[0356] Figure 42An example is illustrated where an actuating element 112 causes an inner shaft 3606 to extend from an inner sleeve 3604. As the inner shaft 3606 extends, it pushes a distal end (e.g., actuating cap 114, other attachments, etc.), thereby causing the outer paddle 120 and the inner paddle 122 to straighten relative to each other. As the actuating element 112 continues to extend from the delivery conduit 102, a section of the connector 3502 extends outward, as... Figure 38 and Figure 39 As shown, until the connector is fully extended, as Figure 43 As shown, the device 100 is fully extended, such that the anchor portion 106 is also in its fully extended configuration.

[0357] When the actuating element 112 is retracted, the device moves the inner paddle 122 and the outer paddle 120 outwards, as... Figure 44 As shown. Device 100 can be positioned in a natural valve (e.g., in a natural mitral valve MV and attached to the anterior leaflet 20 and posterior leaflet 22) and as shown. Figure 45 The device is closed as shown. The installer can decouple the actuator 112 from the connector 3502 so that the attachment of the actuator does not prevent the device from moving. For example, the installer can rotate the actuator 112 to unscrew and separate it from the connector 3502.

[0358] However, if, after releasing the device, it is determined that the device is not in the desired position, the actuating element 112 can be reattached to the device 100 to allow repositioning of the device 100 in any of the manner described herein. The threaded portion or other connecting portion 3608 of the connector 3502 remains proximal to the mating portion 104 of the device 100, such as... Figure 46 As shown.

[0359] Figure 47 An example implementation is illustrated herein. As shown, the connector 3502 is positioned between the cap 214 and the proximal collar 211. In one example implementation, the collar is used to connect and / or fasten the device 200 to the delivery sheath in any of the manner described herein. Figure 47 Examples of the apparatus shown and described in PCT patent application publication WO2020 / 076898 (which is incorporated herein by reference) include the mating element 210, connecting portion 223, paddle frame 224, inner paddle 222, paddle 220, and fastener 230.

[0360] When the actuator 112 ( Figures 47-51 When (not shown in the image) is extended, connector 3502 is related to... Figure 38 and Figure 39 As described, it extends. Figure 48 Showing Figure 47In an example implementation, the actuating element 112 causes the connector to extend partially. Figures 47-51 (Not shown in the figures). For simplicity, fasteners are not illustrated. Inner paddle 222 and paddle 220 are shown in the open position. Connecting portion 223, paddle frame 224, and cap 214 located on the distal portion 207 of device 200 are also illustrated. Figure 49 Showing Figure 47 and Figure 48 The device 200 in which the connector 3502 is fully extended.

[0361] Figure 47 The device 200 is shown in its installed state. After removing the actuating element from the device 100 to test its placement, the installer may decide to reposition the device. In this case, the actuating element 112 is reinserted into the threaded chamber or other connection structure 3608 near the proximal end of the device 100, and the paddle-like... Figure 48 The extension is shown. The device can also be as follows: Figure 49 The device may be extended fully or to any other location required to reposition it within the natural valve.

[0362] like Figure 50 and Figure 51 As shown, the actuating element 112 is pulled back into the delivery sheath (not shown) to close the device 200 using the coupling 3502. The repositioning and closure of the device 100 recaptures the device and attaches it to the natural valve, such as to the anterior leaflet 20 and posterior leaflet 22 of the natural valve.

[0363] Figure 47 The example illustrates an optional seal 213. In one example embodiment, seal 213 is omitted and the distal end of mating element 210 and outer sleeve 3602 are sealed together. Furthermore, a blood-tight seal may be provided between outer sleeve 3602, inner sleeve 3604, and inner shaft 3606. The sealed connection between mating element 210 and outer sleeve 3602, and the blood-tight connection between outer sleeve 3602, inner sleeve 3604, and inner shaft 3606, prevent or inhibit blood flow into the distal end of the mating element, regardless of the device's position.

[0364] Fastener control line 116 (see example) Figure 42 (As shown) and / or the tether 119 can be connected to the prosthesis device in a variety of different ways. Figures 52-60 An exemplary embodiment of a releasable connection between fastener control line 116 and device 100 is illustrated. However, Figures 52-60 The releasable connection shown can also be used to attach tethers (one or more) to the device. Figures 52-60The device 100 shown may be any device described herein, any device described in the patent or patent application cited herein, or any other known device for repairing a natural heart valve (such as a mitral or tricuspid valve).

[0365] Now for reference Figure 52 According to one embodiment, an implantable prosthesis device 100, a delivery catheter 102, an actuating element 112, a collar 115, and a connector 117 are depicted. The device 100 may also include a cap 114 (or other attachment portion) and / or a fastener 130. In some embodiments, the fastener includes a base or fixed arm 132, a movable arm 134, barbs 136, and a connector portion 138. Optionally, the device may include an engagement element (e.g., a spacer, etc.). In one embodiment, a fastener actuation line 116 is looped to connect to the movable arm 134 of the fastener. Figure 52 In the example shown, the fastener actuation line extends through the delivery conduit 102 and the connector 117, through a ring, a collar, or other opening 5201 of the movable arm 134, around the actuating element 112, returns through the ring 5201, returns through the connector 117, and returns proximally through the delivery conduit 102. The fastener 130 can be opened by applying tension to the actuation line 116 attached to the movable arm 134, thereby causing the movable arm 134 to flex, hinge, or pivot on the joint portion 138.

[0366] like Figure 53 As shown, the looping end 5302 of the fastener actuation line 116 extends through a ring, loop sleeve, or other opening 5201 on the movable fastener arm 134 of the device 100. Figure 53 (Not shown in the image). The end 5304 of the fastener actuation line 116 extends through a loop, ring, or other opening 5201 of the fastener. Therefore, removing the thread 112 from the looped end 5302 will decouple the fastener actuation line 116 from the fastener.

[0367] The catheter 102 can be designed in various ways and has one or more lumens / accesses. Figures 54-56 In the exemplary embodiment shown, catheter 102 includes a first thread passage 5202A, a second thread passage 5202B, a third thread passage 5202C, and a fourth thread passage 5202D. A thread passage 146 also extends through the catheter. (See reference...) Figure 54 and Figure 55 The first fastener actuation line 116 extends through the first line passage 5202A of the conduit 102, through the fastener's ring, sleeve, or other opening 5201, around the actuating element 112, returns through the fastener's ring, sleeve, or other opening 5201, and through the conduit 102's third line passage 5202C (including... Figure 55 (To more clearly show the actuator path settings). Reference Figure 54 and Figure 56 The second fastener actuation line 116 extends through the second wire passage 5202B of the conduit 102, through the fastener's ring, sleeve, or other opening 5201, around the actuating element 112, returns through the fastener's ring, sleeve, or other opening 5201, and through the conduit's fourth wire passage 5202D (including...). Figure 55 (to more clearly show the actuator path settings).

[0368] By aligning the wire passages 5202A and 5202C, and the wire passages 5202B and 5202D, with their diameters opposite, the tension applied to the conduit by these wires cancels each other out. This prevents undesirable bending of the conduit 102 due to pulling on the fastener actuation wire 116. In some embodiments, the wire passages 5202A, 5202C, 5202B, and 5202D are not diametrically opposite.

[0369] Now for reference Figures 57-60 The device 100 can be deployed from the delivery conduit 102, connector 117, actuating element 112, and fastener actuation line 116. (See reference) Figure 57 The barbs 130 can be closed by reducing the tension of the actuation line 116 attached to the movable arm 134, thereby closing the movable arm 134 toward the fixed arm 132 of the device 100. (As can be seen by comparison...) Figure 57 and Figure 58 As shown, the device can be connected to the actuating element 112. For example... Figure 58 As shown, the actuating element 112 is retractable from the device 100 and collar 115 toward the connector 117 and delivery conduit 102. The actuating element 112 can be retracted such that the end of the actuating element 112 is positioned within the wire passage 146 of the connector 117 (or further retracted). In this position, the fastener actuation wire 116 is no longer secured around the actuating element 112, allowing the delivery conduit 102 and connector 117 to retract from the device 100.

[0370] like Figure 59 As shown, after the device 100 and collar 115 are decoupled from the actuating element 112, the connector 117 can be retracted away from the device 100. The fastener actuation line 116 is pulled through the ring or other opening 5201 on the movable arm 134 of the device 100 and retracted into the connector 117. Thus, the device 100 is completely decoupled from the delivery conduit 102, the connector 117, and the actuating element 112.

[0371] like Figure 60As shown, device 100 is displayed in a fully closed and deployed state. Delivery conduit 102, connector 117, and actuating element 112 have been retracted, and fastener 130 remains in the fully closed position. After deployment, device 100 can remain in the fully closed position in several ways. For example, device 100 can be positioned relative to... Figure 14M The device remains in a fully closed position in any of the described ways. In another example embodiment, the paddle-like part of the device may optionally be configured to partially open and close with the heartbeat, while the fastener remains in its closed configuration.

[0372] When the fastener actuation line 116 is Figures 52-60 When the path is set as shown, pulling the two proximal ends 5304 a first distance causes the ring or other opening 5201 to move a second distance, which is half the first distance. This can be advantageous in some other applications. For example, a slower opening movement of the fastener makes the fastener easier to control, and the force applied to the ring or other opening 5201 will be twice or approximately twice the pulling force applied to the proximal end 5304. However, in some applications, it is beneficial to provide a one-to-one correlation between the proximal end 5304 of the fastener actuation line 116 and the movement of the fastener ring or other opening 5201 and / or to provide a one-to-one correlation between the force applied to the proximal end 5304 of the fastener actuation line and the fastener ring or other opening 5201.

[0373] The one-to-one correlation between the proximal end 5304 of the fastener actuation line and the movement of the fastener ring or other opening 5201 can be provided in a variety of different ways. Figure 61 An exemplary embodiment of a fastener actuation controller 6100 is shown, which can be used for... Figures 52-60 The fastener actuation arrangement shown provides a one-to-one correlation between the movement of the proximal end 5304 of the fastener actuation line and the movement of the fastener loop or other opening 5201. In this embodiment, both ends of the fastener actuation line 116 pass through the delivery conduit 102 along a predetermined path. The loop 5302 of the fastener actuation line 116 is arranged around the actuating element 112. The two ends 5304 of the fastener actuation line 116 enter the delivery conduit 102 and exit into a cavity 6102 at the proximal end of the delivery conduit 102. The cavity 6102, or a portion thereof, is movable relative to the end of the conduit 102. In some exemplary embodiments, the cavity 6102 is made of an elastic material, such as an elastic polymer, but can be made of a variety of different materials. The cavity 6102 bypasses a pin 6103 on a slider 6104. The slider rests on a handle 6105 of the delivery conduit 102.

[0374] The control line 116 exits the lumen 6102 and its end 5304 is connected to the delivery catheter 102 on the other side of the pin 6103. Pulling the pin 6103 causes the lumen 6102 to be pulled away from the catheter or stretched and pulled on the doubled-back control line within the lumen 6102. Pulling the pin 6103 a first distance causes the loop or other opening 5201 to move the same first distance. This equal movement is caused by the two ends 5304 both passing through the loop or other opening 5201 and looping around the pin 6103. At the distal end of the catheter, the control line is restrained by wrapping around the control wire 112, while at the proximal end of the catheter, the control line 116 is secured to the catheter.

[0375] The end 5304 of the control line 116 can be connected to the delivery catheter in various ways. For example, the end 5304 can be connected to the proximal end of the delivery catheter 102, to the distal end of the catheter, or tied to an intermediate pull wire connected to the catheter and providing equal tension. In the example shown, the fastener actuation line 116 passes through the delivery catheter 102 and terminates at the distal end of the delivery catheter 102 via a knot 6106 or a stop to provide equal tension to the catheter. Thus, Figure 61 The embodiment shown provides one-to-one actuation of the fastener 130 by moving the slider 6104.

[0376] Now for reference Figures 62-64 An exemplary embodiment of the delivery system and valve repair device 1300 is provided, wherein a portion of the device 1300 is fitted within a connector 1317 at the distal end of the delivery catheter 1302. The device 1300 can take many different forms. For example, the device 1300 can be any device described herein, any device described in any patent or patent application cited herein, or any other known device for repairing natural heart valves (such as the mitral or tricuspid valve). A portion of the device 1300 can fit within the connector 1317 in many different ways. In one embodiment, a portion of the connector 1317 may fit within a portion of the device.

[0377] refer to Figures 62-64 The example connector 1317 shown has at least one wire opening 6201A, 6201B. Fastener actuation wires 1316A, 1316B extend from the proximal end of the delivery conduit 1302, through the connector 1317, and outwardly through the wire openings 6201A, 6201B. The fastener actuation wires 1316A, 1316B can then be secured to the fastener 1330, such as by securing it to the movable arm 1334 of the fastener 1330.

[0378] refer to Figure 62The fastener 1330 can be closed by reducing the tension of the actuation wires 1336A and 1336B attached to the movable arm 1334. As a result, the movable arm 1334 flexes, hinges, or pivots at the attachment portion 1338 toward the fixed arm 1332 of the device 100. The fastener 1330 can be closed by retracting the control wire 112 in any of the ways described herein. Figures 62-64 (Not shown in the image) to close the paddle-shaped object 1320.

[0379] like Figure 64 As shown, this can be achieved, for example, by activating the silk thread ( Figures 62-64 (Not shown) The device 1300 is released from the connector 1317 by retracting it from the connector 1317. The device can be held attached to the delivery conduit 1302 by multiple connecting tethers 1319 extending from the distal end of the delivery conduit 1302 through the connector 1317 and attached to the device 1300, such as to the collar 1315. The device 1300 can be held tethered to the delivery conduit 1302 as a means of testing the positioning of the device 1300 before final disengagement. In some embodiments, the connecting tethers 1319 can be inserted through multiple holes in the top or upper part of the connector 1317. In some embodiments, the connecting tethers 1319 can be secured to the device 1300 by inserting the tethers 1319 through multiple holes in the surface of the collar 1315.

[0380] Rope 1319 can have many different configurations. For example, Figure 64 The four lines shown can be two tethers 1319. Each tether 1319 extends through the conduit 1302, and the loop device 1300 connects the tether to the device and returns to extend through the conduit. However, the tethers can have a variety of different path configurations.

[0381] In one example implementation, the connector 1317 and the collar 1315 may be keyed to prevent relative rotation between the connector 1317 (and the attached conduit 1305) and the collar 1315 (and the attached device 1300). The connector 1317 and the collar 1315 may be keyed in a variety of different ways. For example, the connector 1317 and the collar 1315 may have complementary shapes—they cannot rotate relative to each other when the collar is inserted into the connector, and vice versa.

[0382] Now for reference Figure 65An exemplary keying connector 6517 and collar 6515 are illustrated. In this figure, the conduit 6502 and connector 6517 are depicted in an exploded view, but will generally be shown as attached. The distal end of the conduit 6502 includes multiple tethering passages 6505 and actuation element passages 6504. The connector 65157 includes a wire passage 6507 aligned with the actuation element passages 6504 of the conduit 6502, multiple tethering passages 6503, and multiple keying features 6509. The connector 65157 has an inset portion 6512 having a profile similar in shape or substantially similar to that of the collar 6515. The collar 6515 fits within the inset portion 6512 of the collar 6517. The collar 6515 includes wire passages 6505 aligned with the wire passages 6504 and 6507 of the conduit 6502 and connector 6517, respectively. The collar also includes multiple tethering passages 6501 and at least one aperture 6508 for termination and connection of mating elements (not shown). In an exemplary embodiment, the aperture 6508 is C-shaped, but it can also be circular, S-shaped, or any other configuration.

[0383] exist Figure 65 In the exemplary embodiment shown, the collar 6515 has four tethering passages 6501. The collar 6515 has multiple keying features 6510. The keying features 6510 of the collar 6515 engage within the insert portion 6512 of the connector 6517 to prevent the collar 6515 from rotating within the connector 6517. The conduit 6502, connector 6517, and collar 6515 are designed to receive actuating elements (not shown) via threaded passages 6504, 6507, and 6506, respectively, for attaching, transporting, and deploying devices (not shown). In the exemplary embodiment, multiple tethers (not shown) can be inserted into the tethering passages 6505, 6503, and 6501 of the conduit 6502, connector 6517, and collar 6515, respectively. Due to the keyed engagement of the collar 6515 within the connector 6517, the illustrated embodiment prevents the device (not shown) and the conduit 6502 from rotating relative to each other.

[0384] The connectors and collars shown and described in this application can be fastened together in a variety of different ways. Reference now. Figure 66 According to one embodiment, an actuating element 6612, a collar 6615, a connector 6617, two fastener actuation lines 6616, and two connecting ropes 6619 are depicted. Figure 66 The path design of the depicted connecting tether 6619 and fastener actuation line 6616 prevents undesirable deflection of the conduit caused by tension applied by the tether due to placing the tether path close to the center of the connector 6617 and collar 6615.

[0385] The collar 6615 includes a first tethering passage 6604A, a second tethering passage 6604B, a third tethering passage 6604C, and a fourth tethering passage 6604D, as well as a thread passage 6650 extending through the collar 6615. In the illustrated embodiment, the first, second, third, and fourth tethering passages 6604A, 6604B, 6604C, and 6604D are circular and are equidistant from each other or substantially equidistant from each other and equidistant from the thread passage 6650 at the center of the collar 6615. However, the first, second, third, and fourth tethering passages 6604A, 6604B, 6604C, and 6604D can have any shape or position.

[0386] The connector 6617 is generally cylindrical, with a top 6620 and a bottom 6621 defining two cutout windows 6605A and 6605B therebetween. The connector 6617 includes a first tether passage 6602A, a second tether passage 6602B, a third tether passage 6602C, and a fourth tether passage 6602D, a thread passage 6646, and first thread passages 6601A, 6601B, 6601C, and 6601D extending through the top 6620. The first, second, third, and fourth tether passages 6602A, 6602B, 6602C, and 6602D are equidistant from each other or substantially equidistant and are equidistant from the thread passage 6646 at the center of the top 6620 of the connector 6617. The first, second, third, and fourth wire passages 6601A, 6601B, 6601C, and 6601D are equidistant from each other or substantially equidistant from each other and equidistant from the wire passage 6646, such that the first, second, third, and fourth wire passages 6601A, 6601B, 6601C, and 6601D are radially farther from the wire passage 6646 and closer to the outer edge of the top 6620 of the connector 6617 compared to the first, second, third, and fourth tethering passages 6602A, 6602B, 6602C, and 6602D.

[0387] The connector 6617 also includes a fifth tether passage 6603A, a sixth tether passage 6603B, a seventh tether passage 6603C, an eighth tether passage 6603D, and a thread passage 6648 extending through the bottom 6621. The fifth, sixth, seventh, and eighth tether passages 6603A, 6603B, 6603C, and 6603D are equidistant from each other or substantially equidistant from each other and are equidistant from the thread passage 6648 at the center of the bottom 6621 of the connector 6617. The thread passage 6646 at the top 6620 corresponds to the thread passage 6648 at the bottom 6621. The first and third tethering passages 6602A, 6602C are radially opposite to the second and fourth tethering passages 6602B, 6602D on the top 6620 of the connector 6617 and to the silk thread passage 6646, and the fifth and seventh tethering passages 6603A, 6603C are radially opposite to the sixth and eighth tethering passages 6603B, 6603D on the bottom 6621 of the connector 6617 and to the silk thread passage 6648.

[0388] In the illustrated embodiment, the first, second, third, and fourth tethering passages 6602A, 6602B, 6602C, and 6602D of the top 6620 of the connector 6617 correspond to the fifth, sixth, seventh, and eighth tethering passages 6603A, 6603B, 6603C, and 6603D of the bottom 6621 of the connector 6617, and respectively, and correspond to the first, second, third, and fourth tethering passages 6604A, 6604B, 6604C, and 6604D of the collar 6615.

[0389] like Figure 66As shown, the collar 6615 and the connector 6617 can be connected together via a first connecting cord 6619A and a second connecting cord 6619B, wherein the actuating element 6612 extends through the wire passages 6646, 6648 of the connector 6617 and the wire passage 6650 of the collar 6615. As previously described herein, the actuating element 6612 can extend into the implantable prosthesis device and engage the cap to open the device. The first connecting cord 6619A passes through the first cord passage 6602A of the connector 6617, through the fifth cord passage 6603A of the connector 6617, through the first cord passage 6604A of the collar 6615, around the bottom of the collar 6615, upward through the second cord passage 6604B of the collar 6615, through the sixth cord passage 6603B of the connector 6617, and through the second cord passage 6602B of the connector 6617. The second connecting rope 6619B passes through the third connecting rope passage 6602C of the connector 6617, through the seventh connecting rope passage 6603C of the connector 6617, through the third connecting rope passage 6604C of the collar 6615, around the bottom of the collar 6615, upward through the fourth connecting rope passage 6604D of the collar 6615, through the eighth connecting rope passage 6603D of the connector 6617, and through the fourth connecting rope passage 6602D of the connector 6617.

[0390] like Figure 66 As shown, the first fastener actuation line 6616A passes through the first line passage 6601A, surrounds the connecting tethers 6619A, 6619B and the actuating element 6612, passes through the second cut window 6605B in the connector 6617, attaches to the fastener of the implantable prosthesis device (not shown), returns through the second cut window 6605B, and passes through the third line passage 6601C. The second fastener actuation line 6616B passes through the second line passage 6601B, surrounds the connecting tethers 6619A, 6619B and the actuating element 6612, passes through the first cut window 6605A in the connector 6617, attaches to the fastener of the implantable prosthesis device (not shown), returns through the first cut window 6605A, and passes through the fourth line passage 6601D. In the illustrated embodiment, the first cut window 6605A is radially opposite to the first and third wire passages 6601A and 6601C, which are radially opposite to the wire passages 6646 and 6648, and the second cut window 6605B is radially opposite to the second and fourth wire passages 6601B and 6601D, which are radially opposite to the wire passages 6646 and 6648.

[0391] As previously described herein, the actuating element 6612, collar 6615, connector 6617, two connecting cords 6619, and two fastening actuating lines 6616 can be used to position and reposition implantable prosthetic devices in the natural valves of the heart (e.g., natural mitral valve MV, natural tricuspid valve, etc.).

[0392] Now for reference Figure 67 According to one embodiment, an actuating element 6712, a collar 6715, a connector 6717, two fastener actuation lines 6716, and two connecting ropes 6719 are depicted. Figure 67 The path design of the depicted connecting cord 6719 and fastener actuation line 6716 prevents conduit deflection caused by tension applied by the fastener actuation line due to placing the fastener actuation line path close to the center of the connector 6617 and collar 6615.

[0393] The collar 6715 includes a first tethering passage 6704A, a second tethering passage 6704B, a third tethering passage 6704C, and a fourth tethering passage 6704D, as well as a thread passage 6750 extending through the collar 6715. In the illustrated embodiment, the first, second, third, and fourth tethering passages 6704A, 6704B, 6704C, and 6704D are circular and are equidistant or substantially equidistant from each other along the outer edge of the collar 6715, and are equidistant from the thread passage 6704D. However, the first, second, third, and fourth tethering passages 6704A, 6704B, 6704C, and 6704D can have any shape or position.

[0394] The connector 6717 is generally cylindrical, with a top 6720 and a bottom 6771 defining two cutouts 6705A and 6705B therebetween. The connector 6717 includes a first tether passage 6702A, a second tether passage 6702B, a third tether passage 6702C, and a fourth tether passage 6702D, as well as a thread passage 6746. The connector also includes a first thread passage 6701A, a second thread passage 6701B, a third thread passage 6701C, and a fourth thread passage 6701D extending through the top 6720. The first, second, third, and fourth tether passages 6702A, 6702B, 6702C, and 6702D are equidistant from each other or substantially equidistant, and are equidistant from the thread passage 6746 in the top 6720 of the connector 6717. The first, second, third, and fourth wire passages 6701A, 6701B, 6701C, and 6701D are equidistant from each other or substantially equidistant from each other and are equidistant from the thread passage 6746. Compared to the first, second, third, and fourth tethering passages 6702A, 6702B, 6702C, and 6702D, the first, second, third, and fourth wire passages 6701A, 6701B, 6701C, and 6701D are radially closest to the thread passage 6746, and their positions are closer to the outer edge of the top 6720 of the connector 6717.

[0395] The connector 6717 also includes a fifth tether passage 6703A, a sixth tether passage 6703B, a seventh tether passage 6703C, an eighth tether passage 6703D, and a thread passage 6748 extending through the bottom 6721. The fifth, sixth, seventh, and eighth tether passages 6703A, 6703B, 6703C, and 6703D are equidistant or substantially equidistant from each other and equidistant from the thread passage 6748, close to the outer edge of the bottom 6721 of the connector 6717. The thread passage 6746 of the top 6720 corresponds to the thread passage 6748 of the bottom 6721. The first and second tether passages 6702A and 6702B are radially opposite the thread passage 6746 to the third and fourth tether passages 6702C and 6702D on the top 6720 of the connector 6717. The fifth and sixth tethering passages 6703A, 6703B are radially opposite to the seventh and eighth tethering passages 6703C, 6703D on the bottom 6721 of the connector 6717, which are the thread passages 6748.

[0396] In the illustrated embodiment, the first, second, third, and fourth tethering passages 6702A, 6702B, 6702C, and 6702D of the top 6720 of the connector 6717 correspond to the fifth, sixth, seventh, and eighth tethering passages 6703A, 6703B, 6703C, and 6703D of the bottom 6621 of the connector 6717, and respectively, and correspond to the first, second, third, and fourth tethering passages 6704A, 6704B, 6704C, and 6704D of the collar 6715.

[0397] like Figure 67As shown, collar 6715 and connector 6717 can be connected together via a first connecting cord 6719A and a second connecting cord 6719B, wherein actuating element 6712 extends through wire passages 6746, 6748 of connector 6717 and wire passage 6750 of collar 6715. As previously described herein, actuating element 6712 can extend into implantable prosthesis device and engage cap to open device. First connecting cord 6719A passes through first cord passage 6702A of connector 6717, through fifth cord passage 6703A of connector 6717, through first cord passage 6704A of collar 6715, around the bottom of collar 6715, upward through second cord passage 6704B of collar 6715, through sixth cord passage 6703B of connector 6717, and through second cord passage 6702B of connector 6717. The second connecting rope 6719B passes through the third connecting rope passage 6702C of the connector 6717, through the seventh connecting rope passage 6703C of the connector 6717, through the third connecting rope passage 6704C of the collar 6715, around the bottom of the collar 6715, upward through the fourth connecting rope passage 6704D of the collar 6715, through the eighth connecting rope passage 6703D of the connector 6717, and through the fourth connecting rope passage 6702D of the connector 6717.

[0398] like Figure 67 As shown, the first fastener actuation wire 6716A passes through the first wire passage 6701A, through the first cut window 6705A in the connector 6717, attaches to the fastener of the implantable prosthesis device (not shown), returns through the first cut window 6705A, and passes through the fourth wire passage 6701D. The second fastener actuation wire 6716B passes through the second wire passage 6701B, through the second cut window 6705B in the connector 6717, attaches to the fastener of the implantable prosthesis device (not shown), returns through the second cut window 6705B, and enters the passage 6701D. In the illustrated embodiment, the first cut window 6705A is radially opposite to the second and fourth wire passages 6701B, 6701D in relation to the wire passages 6746, 6748, and the second cut window 6705B is radially opposite to the first and third wire passages 6701A, 6701C in relation to the wire passages 6746, 6748.

[0399] As previously described herein, the actuating element 6712, collar 6715, connector 6717, two connecting cords 6719, and two fastening actuating lines 6716 can be used to position and reposition implantable prosthetic devices in the natural valves of the heart (e.g., natural mitral valve MV, natural tricuspid valve, etc.).

[0400] Figures 68-77An exemplary embodiment of a releasable connection between fastener control line 116 and device 100 is illustrated. However, Figures 69-77 The releasable connection shown can also be used to attach tethers (one or more) to the device. Device 100 can be any device described herein, any device described in any patent or patent application cited herein, or any other known device for repairing natural heart valves (such as the mitral or tricuspid valve).

[0401] Figure 68 An example implantable prosthesis device 100, delivery catheter 102, actuating element 112, collar 115, and connector 117 are illustrated. Device 100 may include any feature of any of the devices 100, 400, 400a, 500, 600, 700, 800, 900, 1000, and 1100 described herein. The illustrated device 100 includes a cap 114 (but may also be other types of attachment portions) and a fastener 130 (which may optionally include one or more of a base or fixing arm 132, a movable arm 134, barbs or fixing devices 136, and a connector portion 138). In one embodiment, a fastener actuation line 116 is connected to the movable arm 134. In the illustrated example, line 116 extends through the delivery catheter 102 and connector 117, through a loop, a collar, or other opening 5201 in arm 134, returns through connector 117, and is secured (directly or indirectly; for example, through a collar). A fastener 6802 (or a loop, hook, latch, and / or other similar means) is attached to a fastener actuation element 6801 (e.g., fastener actuation wire, fastener actuation shaft, fastener actuation rod, etc.). In some embodiments, the fastener actuation element is a hook-shaped rod or wire. Fastener 130 can be opened by applying tension to the actuation line 116 attached to the movable arm 134, thereby pivoting the movable arm 134 on the joint portion 138. In some embodiments, tension is applied directly to the actuation line 116. In some embodiments, tension can be applied to the actuation line 116 by pulling the fastener actuation element 6801.

[0402] like Figures 69-71As shown, the conduit 102 may include a first wire passage 6803A, a second wire passage 6803B, a third wire passage 6803C, and a fourth wire passage 6803D in the top or upper part of the collar 115, and a thread passage 146 extending through the conduit 102. An actuating element 112 may be inserted through the thread passage 146 of the conduit 102. A first fastener actuating wire 116 may be inserted through the first wire passage 6803A of the conduit 102, through the collar 5201, and secured directly or indirectly (e.g., by means of the collar 6802, ring, hook, latch, or similar means) to the fastener actuating element 6801 (e.g., shaft, rod, thread, hook-shaped rod, hook-shaped thread, etc.). This may be within the third wire passage 6803C of the conduit 102. The second fastener actuation wire 116 can be inserted through the second wire passage 6803B of the conduit 102, through the ring 5201, and secured directly or indirectly (e.g., by means of a ring 6802, a ring, a hook, a latch, or similar means) to the fastener actuation element 6801 (e.g., a hook-shaped rod, a hook-shaped wire, etc.). This can be within the fourth wire passage 6803D of the conduit 102.

[0403] refer to Figure 69 The fastener actuation element 6801 is configured as a hook-shaped rod / wire 6801, comprising a straight or substantially straight rod made of a material such that the distal end can be temporarily configured as a hook by bending the distal end back into the wire passage from which the fastener actuation element 6801 originates. The fastener actuation element or hook-shaped rod 6801 secures the fastener actuation line 116 until then: the user advances the fastener actuation element or hook-shaped rod 6801 through the distal end of the conduit 102. Figure 70 and Figure 71 As shown, after the fastener actuation element or hook rod 6801 leaves the line passage 6803C, the rod 6801 freely returns to a straight or substantially straight configuration, and the loop 6802 at the end of the fastener actuation line 116 is released from the end of the fastener actuation element or hook rod 6801. At this time, the fastener actuation line 116 can be removed from the loop 5201 on the fastener 130.

[0404] By aligning wire passages 6803A and 6803C diametrically opposite each other, and by aligning wire passages 6803B and 6803D diametrically opposite each other, the tension applied to these wires cancels each other out. This prevents undesirable bending of the conduit 102 due to pulling the fastener actuation wire 116. In some example embodiments, wire passages 6803A, 6803C, 6803B, and 6803D are not diametrically opposite each other.

[0405] Now for reference Figures 72-77The device 100 can be deployed from the delivery conduit 102, connector 117, actuating element 112, and fastener actuation line 116. Tension on the actuation line 116 attached to the movable arm 134 can be reduced by advancing the fastener actuating element or hook rod 6801 toward the distal end of the connector 117, thereby causing the movable arm 134 to flex, hinge, or pivot at the joint portion 138 toward the fixed arm 132 of the device 100. (As can be seen by comparison...) Figure 72 and Figure 76 As shown, the device can be connected to the actuating element 112.

[0406] like Figure 73 As shown, the fastener actuation element or hook rod 6801 can be advanced through the connector 117 until it reaches one of the plurality of orifices 7301 on either side of the connector 117, at which point the distal end of the fastener actuation element or hook rod 6801 will exit the connector 117 through one of the orifices. The fastener actuation element or hook rod 6801 is held in a hook configuration within the conduit 102 and / or the connector 117, wherein the inner wall of the conduit 102 and / or the connector 117 is under spring tension. After the fastener actuation element or hook rod 6801 exits the conduit 102 and / or the connector at other locations, such as through orifice 7301 or where the hook rod becomes unrestrained, the spring tension is released and the fastener actuation element or rod 6801 can expand outward.

[0407] like Figure 74 As shown, after the fastener actuating element or hook-shaped rod 6801 expands outward from the orifice 7301, the element or rod 6801 returns to a straight or substantially straight configuration. The straightening of the element or rod 6801 releases the looped end 6802 of the fastener actuating line 116.

[0408] like Figure 75 As shown, the user can pull the fastener actuation cable 116 toward the proximal end of the conduit. The fastener actuation cable 116 can exit through a ring or other opening 5201 on the fastener 130 and travel through an orifice 7301 in the connector 117. Reference Figure 76 The actuating element 112 can be retracted from the device 100 and the collar 115 and moved toward the connector 117 and the delivery catheter 102. The actuating element 112 can be retracted such that the end of the actuating element 112 is positioned within the wire passage 146 of the connector 117. In this position, the delivery catheter 102 and the connector 117 can be removed from the device 100.

[0409] like Figure 77As shown, device 100 is displayed in a fully closed and deployed state. Delivery conduit 102, connector 117, and actuating element 112 have been retracted, and fastener 130 remains in the fully closed position. After deployment, device 100 can be held in the fully closed position in several ways. For example, device 100 can be held in the fully closed position via... Figure 14M The device remains in a fully closed position in any of the described ways. In another example embodiment, the paddle-like part of the device may be configured to partially open and close with the heartbeat, while the fastener remains in its closed configuration.

[0410] Figures 78-89 An exemplary embodiment of a releasable connection between fastener control line 116 and device 100 is illustrated. However, Figures 78-89 The releasable connection shown can also be used to attach tethers (one or more) to the device. Device 100 can be any device described herein, any device described in any patent or patent application cited herein, or any other known device for repairing natural heart valves (such as the mitral or tricuspid valve).

[0411] refer to Figure 78 Examples of an implantable prosthesis device 100, a delivery catheter 102, an actuation element 112, a collar 115, and a connector 117 are illustrated herein. Device 100 may include any feature of any of the devices 100, 400, 400a, 500, 600, 700, 800, 900, 1000, and 1100 described herein. In some embodiments, device 100 includes a cap 114 (or other attachment portion) and a fastener 130 (which may include one or more of a base or fixing arm 132, a movable arm 134, a barb 136, and / or a connector portion 138). In one embodiment, a fastener actuation line 116 is directed toward device 100 through catheter 102 and connector 117, and then returns toward the proximal end of catheter through connector 117 and catheter 102, thereby forming a collar at the end of fastener actuation line 116. The loop can be secured to a ring 5201 on the movable arm 134 of the fastener 130. The looped fastener actuation wire 116 can be secured to the ring 5201 by tying a knot 7902, such that the knot 7902 can be tightened by pulling a first end 7803A of the fastener actuation wire 116 and loosened by pulling a second end 7803B of the fastener actuation wire 116. In some embodiments, the knot 7902 is a one-way knot, such as a highwayman's hitch, a tumble knot, or an equivalent. In some embodiments, the knot 7902 can be secured to the actuation element 112 instead of the fastener (see, for example...). Figure 52The fastener 130 can be opened by applying tension to the actuation line 116 attached to the movable arm 134, thereby causing the movable arm 134 to flex, hinge, or pivot on the joint portion 138.

[0412] like Figure 79 As shown, conduit 102 may include a first wire passage 7901A and a second wire passage 7901B. A first fastener actuation wire 116 may pass through the first wire passage 7901A of conduit 102 toward device 100 and return through the second wire passage 7901B of conduit 102. Sufficient slack is allowed in the wire to create a loop, such that a knot 7902 can be formed around the loop, loop, or other fastener opening 5201. The knot secures the fastener actuation wire 116 to the loop, loop, or other fastener opening 5201.

[0413] A one-way knot can be formed in many different ways. Any knot can be used that tightens when the first end is pulled and loosens when the second end is pulled. Figures 80-84 The steps for forming a shepherd's knot on the ring, loop, or other attachment portion 5201 of the fastener are shown. Figure 86 An example of a tumble structure on a fastener's ring, loop, or other attachment portion 5201 is shown.

[0414] Now for reference Figures 86-89 The device 100 can be deployed from the delivery conduit 102, connector 117, actuating element 112, and fastener actuation line 116. The barbed fastener 130 can close by reducing the tension on the actuation line 116 attached to the movable arm 134, thereby causing the movable arm 134 to flex, hinge, or pivot at the joint portion 138 toward the fixed arm 132 of the device 100. By comparison... Figure 86 and Figure 89 It can be seen that the device can be connected to the actuating element 112.

[0415] like Figure 87 As shown, the user can pull the second end 7903B of each fastener actuation line 116 to release and subsequently untie the knot 7902 from the ring 5201 on the fastener 130. Once untied, the fastener actuation line 116 can be pulled through the ring or other attachment 5201 of the fastener. Pulling the first end 7903A of each fastener actuation line 116 will pull the movable arm of the fastener without untying the knot. When the paddle is in the open position ( Figure 78 The first end 7903A of the fastener's actuation line is used to open the fastener.

[0416] like Figure 88As shown, the actuating element 112 is retractable from the device 100 and the collar 115 toward the connector 117 and the delivery conduit 102. The actuating element 112 can be retracted such that the end of the actuating element 112 is positioned within the wire passage 146 of the connector 117. In this position, the delivery conduit 102 and the connector 117 can be retracted from the device 100.

[0417] like Figure 89 As shown, device 100 is displayed in a fully closed and deployed state. Delivery conduit 102, connector 117, and actuating element 112 have been retracted, and fastener 130 remains in the fully closed position. After deployment, device 100 can remain in the fully closed position in several ways. For example, device 100 can be positioned relative to... Figure 14M The device remains in a fully closed position in any of the described ways. In another example embodiment, the paddle-like part of the device may be configured to partially open and close with the heartbeat, while the fastener remains in its closed configuration.

[0418] The collar and / or cap of the device disclosed herein can be attached to the mating element and / or paddle or other anchor in a variety of different ways. In some exemplary embodiments, the mating element and / or paddle / anchor is made of strands of wire. The strands of wire can be welded or otherwise attached to the collar and / or cap to attach the mating element and / or paddle to the collar and / or cap. The strands of wire can be welded or otherwise attached to the collar and / or cap in a variety of different ways. For example, individual strands can be welded or otherwise attached to the collar and / or cap, or the strands can be bundled and welded or attached to the collar and / or cap.

[0419] Figure 90 and Figure 91 An exemplary embodiment is illustrated, wherein the threads of the mating element are bundled, inserted into the opening of the cap, and soldered or otherwise attached to the cap to attach the cap to the mating portion. Figure 90 The exemplary device 1200 is shown with an engaging element 1210 and a paddle 1220. The engaging element 1210 and paddle 1220 can be made of a variety of different materials. The engaging element 1210 and paddle 1220 can be formed from a flexible material that may be a metallic fabric, such as a mesh, woven, braided, electrospun, or formed in any other suitable manner, or laser-cut or otherwise diced. The material can be cloth, shape memory alloy wire—such as nitinol—to provide shape retention, or any other flexible material suitable for implantation in the human body.

[0420] refer to Figure 90In one such exemplary embodiment, the mating element 1210 is made of a braided wire mesh, such as a braided nitinol wire mesh. The use of a shape memory material, such as a braided nitinol wire mesh, in constructing the mating element 1210 results in the mating element 1210 being self-expanding, anisotropically flexible, and / or resulting in low strain when the mating element 1210 is creased and / or bent. The material can be a single piece, two halves joined together, or multiple segments or pieces fastened or joined together in any suitable manner—such as by welding, adhesives, or similar methods.

[0421] like Figure 90 As shown, the ends of the material constituting the mating element 1210 can be joined together, for example, by curling them into multiple bundles, such as a first bundle 9001A, a second bundle 9001B, a third bundle 9001C, and a fourth bundle 9001D. The proximal collar 1211 has multiple corresponding openings, such as a first opening 9002A, a second opening 9002B, a third opening 9002C, and a fourth opening 9002D. (Reference) Figure 91 The proximal collar 1211 can be secured to the mating element 1210 by inserting each of the assembled bundles 9001A, 9001B, 9001C, and 9001D into the corresponding orifices 9002A, 9002B, 9002C, and 9002D, and by joining the collar 1211 and the assembled bundles together in any suitable manner (e.g., by welding, using adhesive, or similar methods). The first proximal collar 1211 may also include an actuator opening 9203 through which an actuator can be inserted, and a plurality of tether holes 9004. In some exemplary embodiments, during reattachment, the actuator is guided into the top of the device 1200 along the chamfer of the top surface of the first proximal collar 1211.

[0422] In some exemplary embodiments, the thread is attached to the cap in such a way that it leaves space for a lanyard passage. For example, the length and / or size of the thread end cut in a portion of the cap can be increased to leave space for a lanyard passage. That is, the length and / or size of the thread end cut in a portion of the cap outside the lanyard passage area is increased to leave space for the lanyard passage. The length and / or size of the thread cut in the cap can be increased in a variety of different ways. Figure 92 and Figure 93 This embodiment is shown in which the length of the cut at the end of the thread on part of the cap is increased to leave space on the cap for a tethering passage.

[0423] exist Figure 93In the example shown, the proximal collar 1211 has two serpentine openings 9201A, 9201B, an actuator opening 9203 through which an actuator element can be inserted, and a plurality of tethering holes 9204. The strands of wire constituting the mating element 1210 can be individually inserted into the serpentine openings 9201A, 9201B, or the strands can be secured or joined together, for example, by coiling them into bundles or rows and then inserting the bundles or rows into the serpentine openings 9201A, 9201B. The wires of the mating element 1210 within the serpentine openings 9201A, 9201B of the proximal collar 1211 can be joined together by any suitable means, such as by welding, using adhesives, or similar methods. In some exemplary embodiments, during reattachment, the actuator element is guided into the top of the device 1200 along the chamfer of the top surface of the first proximal disc 1211.

[0424] Figures 94-118 Various configurations of the cap 114 or collar 115 for reattaching the actuator 112 to the device 100 are shown. Many different reattachment configurations can be used. For example... Figures 95-97 As shown, the actuating element 112 can engage with the cap 114 of the device 100 and be held in place by a recapture feature 9403 at the end of the actuating element 112. The recapture feature 9403 can take many different forms. The recapture feature can be tapered, have one or more features that can flex inward and spring outward, have cutting or piercing surfaces or features, and / or have guiding surfaces. Recapture features can be provided on the cap 114, collar 115, actuating element 112, and / or other recapture components. The recapture features (one or more) can be made of many different materials. In an exemplary embodiment, the surface 9402 of the cap 114 and / or the recapture feature 9403 are made of a durable material for mechanical locking, such as metal, rigid polymer-based materials, etc. Figure 94 An exemplary embodiment of the cap 114 is shown, wherein a single aperture 9401 passes through the surface 9402 of the cap 114. This embodiment can also be used as a collar 115. Figure 95 An exemplary embodiment of the proximal end of the actuation element 112 with a recapture feature 9403 is shown. The recapture feature 9403 includes a tapered tip 9404 having a maximum diameter 9405. The recapture feature has a shelf 9406 with a diameter 9407 equal to or greater than the diameter 9405 of the tip 9404. The surface 9402 of the cap 114 has an aperture 9401. The diameter 9408 of the aperture is smaller than the maximum diameter 9405 of the tip 9404 and the diameter 9407 of the shelf 9406.

[0425] like Figure 96As shown, the tip 9403 of the actuating element 112 can be pushed through an aperture 9401 in the surface 9402 of the cap 114. This pushing causes the tip 9404 to flex or compress to allow the tip to pass through the aperture 9401. The actuating element 112 is pushed forward until the frame 9406 approaches the surface 9402 of the cap 114.

[0426] like Figure 97 As shown, because the frame 9406 is wider than the orifice 9401, it prevents the actuating element 112 from advancing further through the cap 114. Because the maximum diameter 9405 of the tapered tip 9404 is slightly larger than the diameter 9408 of the orifice 9401, the actuating element 112 is not easily removed from the cap 114. Thus, the device is recaptured by the thread 112. In one exemplary embodiment, the recaptured device can be operated in the same manner as any embodiment described herein via the thread 112, conduit, connector, and control line.

[0427] Figures 98-100 An exemplary embodiment of the actuating element 112 re-engages with the collar 115 of the device 100 is shown. Figure 98 An exemplary embodiment of the proximal end of the actuation element 112 with a recapture feature 9403 is shown. The recapture feature 9403 includes a tapered tip 9404 having a maximum diameter 9405. The wire also includes a frame 9406 with a diameter 9407 larger than the diameter 9405 of the tip 9404. The surface 911 of the collar 115 has an aperture 9410 with a diameter 9409 smaller than the maximum diameter 9405 of the tip 9404 and smaller than the diameter 9407 of the frame 9406.

[0428] like Figure 99 As shown, the tip 9404 of the actuating element 112 can be pushed through the orifice 9410 in the surface 9411 of the collar 115 until the frame 9406 approaches the surface 9411 of the collar 115. Figure 100 As shown, because the frame 9406 is wider than the orifice 9410, it prevents the actuating element 112 from advancing further through the collar 115. Because the maximum diameter 9405 of the tapered tip 9404 is slightly larger than the diameter 9409 of the orifice 9410, the actuating element 112 is not easily removed from the collar 115. Thus, the device is recaptured by the wire 112.

[0429] Figures 101-104 An exemplary embodiment of an actuating element 112 engaged with an end cap 114 is shown, wherein the end cap 114 has a plurality of orifices 9401. Figure 101 An exemplary embodiment of the cap 114 is shown, wherein a plurality of orifices 9401 pass through the surface 9402 of the cap 114. This embodiment can also be used as a collar 115. Figures 102-104As shown, the actuating element 112 can engage with the cap 114 of the device 100 and be held in place by the recapture feature 9403 at the proximal end of the actuating element 112.

[0430] Figure 102 An exemplary embodiment of the proximal end of the actuation element 112 with a recapture feature 9403 is shown. The recapture feature 9403 includes a tapered tip 9404 having a maximum diameter 9405. The wire 112 also includes a frame 9406 with a diameter 9407 greater than the diameter 9405 of the tip 9404. The surface 9402 of the cap 114 has a plurality of orifices 9401 with a diameter 9408 smaller than the maximum diameter 9405 of the tip 9404 and the diameter 9407 of the frame 9406.

[0431] like Figure 103 As shown, the tip 9403 of the actuator 112 can be pushed through one of the orifices 9401 in the surface 9402 of the cap 114 until the frame 9406 approaches the surface 9402 of the cap 114. Figure 104 As shown, because the frame 9406 is wider than the orifice 9401, it prevents the actuating element 112 from advancing further through the cap 114, and because the maximum diameter 9405 of the tapered tip 9404 is slightly larger than the diameter 9408 of the orifice 9401, the actuating element 112 is not easily removed from the cap 114. Thus, the device is recaptured by the thread 112. In one exemplary embodiment, the recaptured device can be operated in the same manner as any embodiment described herein via the thread 112, conduit, connector, and control line.

[0432] Figures 105-107 An exemplary embodiment of a reattachment mechanism is shown, which includes an actuating element 112 that engages with a collar 115 of the device 100. Figure 105 An exemplary embodiment of the proximal end of the actuation element 112 with a recapture feature 9403 is shown. The recapture feature 9403 includes a tapered tip 9404 having a maximum diameter 9405. The wire has a frame 9406 with a diameter 9407 greater than the diameter 9405 of the tip 9404. The surface 9811 of the collar 115 has a plurality of orifices 9410, each with a diameter 9409 smaller than the maximum diameter 9405 of the tip 9404 and the diameter 9407 of the frame 9406.

[0433] like Figure 106 As shown, the tip 9404 of the actuating element 112 can be pushed through one of the orifices 9410 in the surface 9411 of the collar 115 until the frame 9406 approaches the surface 9411 of the collar 115. Figure 107As shown, because the frame 9406 is wider than the orifice 9410, it prevents the actuating element 112 from advancing further through the collar 115, and because the maximum diameter 9405 of the tapered tip 9404 is slightly larger than the diameter 9409 of the orifice 9410, the actuating element 112 is not easily removed from the collar 115. Thus, the device is recaptured by the wire 112.

[0434] Figure 108 and Figure 109 An exemplary embodiment of a cap 1080 with a pierceable or permeable surface 1083 that facilitates recapture by the device is shown. For example, the pierceable or permeable surface 1083 may be pierced or penetrated by an actuating element 112 or a modified form of an actuating element. The pierceable or permeable surface 1083 can take many different forms. For example, the pierceable or permeable surface 1083 may be a mesh or weave, fabric, polymer sheet, etc. In the example shown in the figures, the pierceable or permeable surface 1083 is a mesh surface 1083 to facilitate engagement of the actuating element 112. Figure 109 As shown, the cap 1080 may further include at least one aperture 1084. Figure 108 and Figure 109 The design shown can also be an exemplary implementation of the collar 1088.

[0435] Figures 110-112 An exemplary embodiment of an actuating element 112 engaged with an end cap 1080 is shown, wherein the end cap 1080 has a punctureable or permeable surface 1083. Figure 110 An exemplary embodiment is shown in which the cap 1080 has a mesh that can pierce or penetrate a surface 1083 and the actuating element 112 has a piercing tip 1082 at its distal end. The piercing tip 1082 can take many different forms. The piercing tip 1082 can be any structure capable of piercing and connecting to the piercing or penetrating surface 1083. In some exemplary embodiments, the tip 1082 is threaded. In some exemplary embodiments, the tip 1082 tapers to a single point.

[0436] like Figure 111 As shown, the distal end of the actuating element 112 re-engages with the cap 1080 by rotating and / or moving downward toward the pierceable or permeable surface 1083 of the cap 1080. In the example shown, the tip 1082 of the actuating element 112 can enter any one of the plurality of gaps 1085 in the mesh of the pierceable or permeable surface 1083 of the cap 1080. The mesh pierceable or permeable surface 1083 shown is flexible enough to allow the tip 1082 to push through any one of the gaps 1085 in the surface 1083.

[0437] exist Figure 112In the example shown, the tension between the threads of the threaded tip 1082 and the mesh of the cap 1080, which can pierce or penetrate the surface 1083, allows the cap 1080 to retain the actuating element 112. This embodiment advantageously facilitates engagement of the actuating element 112 with the cap 1080 by providing multiple potential engagement points without requiring precise matching of a single male-female connection. The device is thus recaptured by the thread 112. In one exemplary embodiment, the recaptured device can be operated in the same manner as any embodiment described herein via the thread 112, a conduit, a connector, and a control line.

[0438] Figures 113-115 An exemplary embodiment of the actuating element 112 re-engaged with the collar 1088 is shown, wherein the collar 1088 has a punctureable or permeable surface 1089. Figure 113 An exemplary embodiment is shown of a collar 1088 having a mesh that can pierce or penetrate a surface 1089. An actuating element 112 has a penetrating tip 1082 at its proximal end. In some exemplary embodiments, the tip 1082 is threaded. In some exemplary embodiments, the tip 1082 tapers to a point.

[0439] like Figure 114 As shown, the proximal end of the actuating element 112 engages with the collar 1088 by rotation and / or downward movement toward the pierceable or permeable surface 1089 of the collar 1088. The mesh pierceable or permeable surface 1089 has sufficient flexibility to allow the threaded tip 1082 to push through any of the gaps 1085 in the surface 1089 of the collar 1088.

[0440] In some implementations, such as Figure 115 As shown, the tension between the thread of the threaded tip 1082 and the pierceable or penetrable surface 1089 of the collar 1088 allows the collar 1088 to retain the actuating element 112. This embodiment advantageously facilitates engagement of the actuating element 112 with the collar 1088 by providing multiple potential engagement points without requiring precise matching of a single male-female connection. Thus, the device is recaptured by the thread 112.

[0441] Figures 116-118 A funnel 1180 is shown, which facilitates engagement and retention of the actuating element 112 within attachment areas such as caps 114, 1080 or collars 115, 1088. Figure 116 As shown, the funnel 1180 has a wide opening 1086, which leads the proximal end of the actuating element 112 toward one of the plurality of orifices 9401 or other engagement structures of the cap 1080. In some embodiments, the actuating element 112 has a recapture feature 9403 such that the proximal end of the actuating element 112 can engage with one of the orifices 9401 or other engagement structures of the cap 1080.

[0442] In some implementations, such as Figure 117 As shown, the funnel 1180 can be used with caps 114, 1080 or collars 115, 1088 having pierceable or permeable surfaces 1883, 1089 (such as a mesh). The actuating element 112 has a recapture feature 9403 at its proximal end, which is directed toward the pierceable or permeable surface 1089 of the cap 1080. Figure 118 yes Figure 116 or Figure 117 A perspective view of the funnel. The funnel has a wide opening 1086 to capture the actuating element 112 and guide it toward the attachment area, such as the caps 114, 1080 or the collars 115, 1088, through the funnel 1180.

[0443] Devices, connectors, conduits, tethers, and fastener actuation lines can be configured to prevent tangling of the tethers and fastener actuation lines in a variety of different ways. See now. Figures 119-120 An exemplary embodiment of a device including a tether path setting tube 1192 is illustrated. This example shows a suitable... Figure 21A The device shown is 400A, but may be applied to any device described herein, any device described in the patents or patent applications cited herein, or any other known device for repairing natural heart valves (such as mitral or tricuspid valves).

[0444] refer to Figure 119 Example device 400A has a collar 411A, showing a tether path setting tube 1192 extending below the collar 411A. The end of the tube 1192 forms first and second tether openings 1193A, 1193B. In the illustrated example, the tether path setting tube 1192 extends through the collar 411A. In some embodiments, as shown, the end of the tube extends proximally beyond the surface of the collar 411A. In other exemplary embodiments, the end of the tether path setting tube 1192 is flush with or recessed from the proximal end of the collar.

[0445] like Figure 120 As shown, tube 1192 may extend around the outer surface of mating element 410A of device 400A. Tube 1192 may also be located within mating element 410A directly below collar 411A. Tether 1191 may be inserted into first tether opening 1193A, pass through tube 1192, and exit into second tether opening 1193B. In the illustrated embodiment, tube 1192 protects tether 1191 and prevents tether 1191 from becoming entangled with itself or any part of device 400A.

[0446] Now for reference Figures 121-122 An exemplary embodiment of a device including two tether path setting tubes 1192 is illustrated. This example shows a suitable... Figure 21 The device 400 shown is applicable to any device described herein, any device described in the patent or patent application cited herein, or any other known device for repairing natural heart valves (such as the mitral or tricuspid valve). Figure 121 The illustrated device includes a collar 411 with tether passages 1190, first 1211A, second 1211B, third 1211C, and fourth 1211D, and two tubes 1192. The two tubes 1192 extend below the collar 1210 and bend to pass through each other and engage within an engagement element 210. The end of the first tube 1192 connects the first tether passage 1211A to the second tether passage 1211B. The second tube 1192 connects the third tether passage 1211C to the fourth tether passage 1211D. A first tether (not shown) can be inserted through the first tether passage 1211A of the collar 1210, through the first tube 1192, and exit through the second tether passage 1211B of the collar 1210. A second tether (not shown) can be inserted through the third tether passage 1211C of the collar 1210, through the second tube 1192, and exit through the fourth tether passage 1211D.

[0447] In some embodiments, the tube 1192 is welded or otherwise attached to the bottom of the collar 411. In some embodiments, the end of the tube 1192 extends through the tethering passages 1211A, 1211B, 1211C, and 1211D of the collar 411. In some embodiments, the tube 1192 is welded or otherwise attached to a first disc, which itself is welded or otherwise attached to one or more other discs to form the collar 411 of the device 400. Figures 121-120 The tube 1192 of the illustrated embodiment protects the tether and prevents the tether from becoming entangled with itself or any part of the device 400.

[0448] Figure 123 An embodiment of device 400 is shown, which has a collar 411 having a thread passage 1230, a plurality of orifices 1233, a first tether passage 1232A and a second tether passage 1232B, and a tube 1243. The tube extends below the collar 411, close to the outer surface of the mating element 410 of device 400. The tube 1243 connects the first tether passage 1232A to the second tether passage 1232B. A tether 1191 can be inserted through the first tether passage 1232A, through the tube 1243, and back through the second tether passage 1232B. In some embodiments, the orifices 1233 are C-shaped, S-shaped, trapezoidal, or circular. In some embodiments, the tube 1243 is welded or otherwise attached to a first disc, which itself is welded or otherwise attached to one or more other discs to form the collar of device 400. Figure 124An example is shown of a collar 411 that is separate from the rest of the device 400.

[0449] refer to Figure 125 and Figure 126 In one exemplary embodiment, the cover 1250 of the device 400 is used to create one or more pathways for one or more tethers 1191. This example shows an application suitable for... Figure 21 The device 400 shown is applicable to any device described herein, any device described in the patents or patent applications cited herein, or any other known device for repairing natural heart valves (such as the mitral or tricuspid valve). Figure 125 As shown, a cover 1250 including multiple orifices can be placed near the end of the device 400 and folded over a collar 411 and an engaging element 410. In the folded configuration, the cover 1250 forms a tube through which a tether 1191 can be inserted, the tube being formed by the cover 1250.

[0450] refer to Figure 126 The tube 1260 may be optionally or additionally adapted individually to any part of the device 400, including the mating element 410, the collar 411, or both. In one exemplary embodiment, the tube 1260 may be attached to the device 400 adjacent to th...

Claims

1. A system, comprising: An implantable device having a pair of anchors, the pair of anchors comprising a pair of paddles and a cap or other attachment portion connected to each of the paddles; The paired paddles are movable from a closed position to an open position by moving the cap distal to the proximal end of the implantable device, and from the open position to the closed position by moving the cap proximal to the proximal end of the implantable device, so as to fix the implantable device to the natural valve. An extendable connector, the extendable connector comprising an inner shaft and an outer sleeve; The inner shaft is extendably arranged within the outer sleeve; and The inner shaft is attached to the cap such that the extendable connector extends as the cap moves away from the proximal end. A mating element is arranged on the outer sleeve such that the extendable connector extends through the mating portion; Delivery catheter; A delivery catheter connector, wherein the delivery catheter connector is disposed at the distal end of the delivery catheter; A collar, said collar being attached to the proximal end of the device; An actuating element that extends through the delivery conduit and into the device; and The delivery catheter connector and the collar are secured by a connecting rope, which allows the device to be reconnected to the delivery catheter connector after the actuating element is removed from the device.

2. The system of claim 1, wherein the connecting cord surrounds the actuating element.

3. The system according to any one of claims 1-2, wherein the looped end of the connecting rope extends from the connector through the collar and returns to extend through the collar into the connector.

4. The system according to any one of claims 1-2, wherein the connecting cord extends from the connector through the collar and returns to extend through the collar into the connector.

5. The system according to any one of claims 1-2, wherein the connecting rope is a first connecting rope, and the connector and the collar are tied together by a second connecting rope.

6. The system according to any one of claims 1-2, wherein the first passage of the connecting cord in the delivery conduit is offset by about 180 degrees from the second passage of the connecting cord in the delivery conduit.

7. The system of claim 5, wherein the first passage of the first connecting cord in the delivery conduit is offset by about 180 degrees from the second passage of the connecting cord in the delivery conduit, and wherein the third passage of the second connecting cord in the delivery conduit is offset by about 180 degrees from the fourth passage of the second connecting cord in the delivery conduit.

8. The system of claim 7, wherein the first path and the third path are biased by about 90 degrees.

9. The system according to any one of claims 1-2, wherein the collar extends into the connector.

10. The system according to any one of claims 1-2, wherein the coupling extends into the collar.

11. The system according to any one of claims 1-2, wherein the connecting cord extends from the end of the connector.

12. The system according to any one of claims 1-2, wherein the connecting cord extends from the side of the connector.

13. The system according to any one of claims 1-2, wherein the connecting cord extends to the end of the collar.

14. The system according to any one of claims 1-2, wherein the connecting cord extends into the side of the collar.

15. The system according to any one of claims 1-2, further comprising a compressible sleeve surrounding the connecting cord between the connector and the collar.

16. The system of claim 15, wherein the compressible sleeve is conical.

17. The system of claim 15, wherein when the compressible sleeve is compressed between the connector and the collar, the outer diameter of the compressible sleeve is less than or equal to the outer diameter of the connector.

18. The system according to any one of claims 1-2, wherein the connecting cord is connected to the implantable device via a releasable knot.

19. The system of claim 18, wherein the releasable knot is configured such that pulling a first end of the connecting rope tightens the releasable knot and pulling a second end of the connecting rope loosens the releasable knot.

20. The system according to any one of claims 1-2, wherein the actuating element includes a tapered recapture feature.

21. The system according to any one of claims 1-2, wherein the collar includes a plurality of recapture holes.

22. The system according to any one of claims 1-2, wherein the collar includes a permeable recapture surface configured to be penetrated by the actuating element.

23. The system of claim 22, wherein the penetrateable recapture surface comprises a wire mesh.

24. The system according to any one of claims 1-2, wherein the collar includes a connecting tether path setting passage.

25. The system of claim 24, wherein the tether path setting passage includes a tube.

26. The system of claim 24, wherein the tether path setting passage is defined inside the collar.

27. The system of claim 24, wherein the collar comprises a plurality of stacked disks.

28. The system according to any one of claims 1-2, wherein the connector, the collar, and the connecting rope are configured such that pulling on both ends of the connecting rope causes a longitudinal change in position of the ends relative to the collar in a ratio of 2:1.

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