Heart valve repair device and delivery device therefor

Abstract

A valve repair device, and a valve repair system including a delivery device and a valve repair device for repairing a target natural valve. A valve repair device and / or delivery device having one or more force measuring devices for detecting a force applied to a target natural valve due to the connection between the valve repair device and the natural valve.

Description

Technical Field

[0001] Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 506,814, filed Jun. 7, 2023, entitled “Heart Valve Repair Devices and Delivery Devices Therefor”, which is hereby incorporated by reference in its entirety.

Background Art

[0002] Natural heart valves (i.e., aortic valve, pulmonary valve, tricuspid valve, and mitral valve) play an important role in ensuring anterograde flow with respect to adequate blood supply through the cardiovascular system. These heart valves can be damaged, for example, by congenital malformations, inflammatory processes, infectious diseases, diseases, etc., and thus their effectiveness may be reduced. If such damage occurs to the valve, it can lead to severe cardiovascular disorders or death. A damaged valve can be surgically repaired or replaced during open-heart surgery. However, open-heart surgery is highly invasive and complications can occur. Transvascular techniques can be used to introduce and implant devices in a much less invasive manner than open-heart surgery to treat the heart. As one example, a transvascular technique that can be used to access the native 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, advancing it up the inferior vena cava, and then advancing it into the right atrium). Thereafter, the septum is punctured and the catheter is passed into the left atrium. Using a similar transvascular technique, starting the same as the transseptal technique but not reaching the puncture of the septum, instead, a device that pivots a delivery catheter towards the tricuspid valve within the right atrium can be implanted inside the tricuspid valve.

[0003] A healthy heart has a roughly conical shape, tapering towards the apex and base. The heart is a four-chambered structure, containing the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall commonly called the septum. The natural mitral valve in the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomical structure from other natural heart valves. The mitral valve includes an annular portion, which is the ring-shaped part of the natural valve tissue surrounding the mitral valve opening, and a pair of leaflets, which extend downward from the annular portion into the left ventricle. The mitral annulus can form a "D" shape, an elliptical shape, or other non-circular cross-sectional shape with a long axis and a short axis. Because the anterior leaflet is larger than the posterior leaflet, when they are closed together, a roughly "C" shaped boundary can be formed between the abutting sides of the leaflets.

[0004] When functioning correctly, the anterior and posterior leaflets work together 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 relax (also called "ventricular diastole" or "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 called "ventricular systole" or "systole"), the blood pressure in the left ventricle rises, causing the two leaflets to press together laterally. This closes the one-way mitral valve, preventing blood from flowing back into the left atrium, and instead expelling it from the left ventricle through the aortic valve. To prevent the two leaflets from dislodging due to pressure or folding back towards the left atrium through the mitral annulus, several fibrous cords called chordae tendineae tether the leaflets to the papillary muscles within the left ventricle.

[0005] Valve regurgitation involves a valve improperly allowing some blood to flow through the valve in the wrong direction. For example, mitral regurgitation occurs when the natural mitral valve fails to properly close during systole, allowing blood to flow from the left ventricle into the left atrium. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation can have many different causes, including leaflet prolapse, papillary muscle dysfunction, stretching of the mitral annulus due to left ventricular dilation, or two or more of these. Mitral regurgitation in the central part of the leaflet can be called central jet mitral regurgitation, while mitral regurgitation closer to one of the leaflet's commissures (i.e., where the leaflets meet) can be called eccentric jet mitral regurgitation. Central jet regurgitation occurs when the edges of the leaflets do not meet in the middle, resulting in valve closure and regurgitation. Tricuspid valve regurgitation, while similar, can occur on the right side of the heart. [Overview of the Initiative]

[0006] This summary is intended to provide some embodiments and is not intended to limit the scope of the invention in any way. For example, no feature included in the embodiments of this summary is a requirement of the claims unless the claims expressly enumerate such feature. Furthermore, the features, components, steps, concepts, etc., described in this summary and the examples elsewhere in the disclosure can be combined in various ways. Various features and steps described elsewhere in the disclosure can be included in the examples summarized herein.

[0007] In some implementations, a device or implant (e.g., an implantable device, an artificial device, etc.) is provided, configured to be positioned within a natural heart valve so that a more effective seal can be formed. The natural heart valve may be a target heart valve, such as that of a living animal or a simulation.

[0008] In some implementations, the portable device or implant includes one or more anchors. In some implementations, each anchor includes multiple paddles, each of which is movable between an open position and a closed position.

[0009] In some implementations, the exemplary valve repair device includes at least one paddle, at least one gripping member, and a force measuring device. In some implementations, at least one paddle is movable between an open position and a closed position, such that at least one paddle is configured to attach the valve repair device to a natural valve of interest (e.g., of a living subject or a simulated subject).

[0010] In some implementations, at least one gripping member is configured to capture a natural valve, and a force measuring device is attached to at least one gripping member.

[0011] In some implementations, the force measuring device is configured to measure the force applied to at least one gripping member when the valve repair device is attached to the natural valve.

[0012] In some implementations, the gripping member has a fastener that includes a fixed arm attached to at least one paddle, a movable arm, and a hinge portion that hinges the fixed arm to the movable arm.

[0013] In some implementations, the force measuring device is attached to a movable arm of the fastener.

[0014] In some implementations, the force measuring device is attached to the hinge portion of the fastener.

[0015] In some implementations, the force measuring device includes strain gauges.

[0016] In some implementations, the force measuring device has a wire attached to a strain gauge, and the wire has a weak portion configured to allow the user to break the wire after the valve repair device has been attached to the natural valve.

[0017] In some implementations, at least one gripping member includes a first gripping member and a second gripping member, with a force measuring device attached to the first gripping member and a second force measuring device attached to the second gripping member.

[0018] In some implementations, the valve repair device includes an actuating element, and a separate force measuring device is attached to the actuating element.

[0019] In some implementations, the valve repair device includes a bonding element.

[0020] In some implementations, the valve repair device includes a cap, and at least one paddle is attached to the cap such that movement of the cap moves at least one paddle between an open position and a closed position.

[0021] In some implementations, the valve repair device includes a shaft and a coupler, the coupler being attached to the shaft and movable along the shaft. At least one paddle is attached to the coupler such that the movement of the coupler along the shaft causes at least one paddle to move between an open position and a closed position.

[0022] In some implementations, the force measuring device is integrally formed with one or more components of the valve repair device.

[0023] In some implementations, force measurement forms part of at least one gripping member.

[0024] In some implementations, the force measuring device forms at least a portion of the hinge of at least one gripping member.

[0025] In some embodiments, the force measurement forms a portion of at least one paddle.

[0026] In some embodiments, the force measurement device forms at least a portion of at least one hinge portion of a paddle.

[0027] In some embodiments, an exemplary valve repair system includes a delivery device and a valve repair device. In some embodiments, the delivery device includes an actuating element and a force measurement device, and the force measurement device is attached to the actuating element.

[0028] In some embodiments, the valve repair device includes a cap and at least one paddle attached to the cap.

[0029] In some embodiments, at least one paddle is movable between an open position and a closed position, and at least one paddle is configured to attach the valve repair device to a native valve of a subject (e.g., a living subject or a simulation).

[0030] In some embodiments, the actuating element is configured to engage with the cap to move the cap and move at least one paddle between an open position and a closed position.

[0031] In some embodiments, the force measurement device is configured to detect a force applied to the actuating element when the valve repair device is attached to the native valve and at least one paddle is in the closed position.

[0032] In some embodiments, the force measurement device includes a strain gauge and a wire attached to the strain gauge.

[0033] In some embodiments, the valve repair device includes at least one gripping member configured to capture the native valve of the subject.

[0034] In some implementations, the valve repair device includes a second force measuring device attached to at least one gripping member, the second force measuring device being configured to measure the force applied to at least one gripping member when the valve repair device is attached to the natural valve.

[0035] In some implementations, the gripping member has a fastener that includes a fixed arm attached to at least one paddle, a movable arm, and a hinge portion that hinges the fixed arm to the movable arm.

[0036] In some implementations, the second force measuring device is attached to a movable arm of the fastener.

[0037] In some implementations, the second force measuring device is attached to the hinge portion of the clasp.

[0038] In some implementations, the second force measuring device includes a strain gauge.

[0039] In some implementations, the second force measuring device has a wire attached to a strain gauge, and the wire has a weak portion configured to allow the user to break the wire after the valve repair device has been attached to the natural valve.

[0040] In some implementations, at least one gripping member includes a first gripping member and a second gripping member, the second force measuring device is attached to the first gripping member, and the third force measuring device is attached to the second gripping member.

[0041] In some implementations, the exemplary valve repair system includes a delivery device and a valve repair device. In some implementations, the delivery device includes a paddle control mechanism and a force measuring device, the force measuring device being attached to the paddle control mechanism.

[0042] In some implementations, the valve repair device includes a shaft, a coupler, and at least one paddle attached to the coupler.

[0043] In some implementations, at least one paddle is movable between an open position and a closed position, and at least one paddle is configured to attach the valve repair device to the target (e.g., a living or simulated) natural valve.

[0044] In some implementations, the paddle control mechanism of the delivery device is configured to engage with a coupler to move the coupler along a shaft, thereby moving at least one paddle between an open position and a closed position.

[0045] In some implementations, the force measuring device is configured to detect the force applied to the paddle control mechanism when the valve repair device is attached to the natural valve and at least one paddle is in the closed position.

[0046] In some implementations, the force measuring device includes a strain gauge and a wire attached to the strain gauge.

[0047] In some implementations, the valve repair device includes at least one gripping member configured to capture the natural valve in question.

[0048] In some implementations, the valve repair device includes a second force measuring device attached to at least one gripping member, the second force measuring device being configured to measure the force applied to at least one gripping member when the valve repair device is attached to the natural valve.

[0049] In some implementations, the gripping member has a fastener that includes a fixed arm attached to at least one paddle, a movable arm, and a hinge portion that hinges the fixed arm to the movable arm.

[0050] In some implementations, the second force measuring device is attached to a movable arm of the fastener.

[0051] In some implementations, the second force measuring device is attached to the hinge portion of the clasp.

[0052] In some implementations, the second force measuring device includes a strain gauge.

[0053] In some implementations, the second force measuring device has a wire attached to a strain gauge, and the wire has a weak portion configured to allow the user to break the wire after the valve repair device has been attached to the natural valve.

[0054] In some implementations, at least one gripping member includes a first gripping member and a second gripping member, the second force measuring device is attached to the first gripping member, and the third force measuring device is attached to the second gripping member.

[0055] In some implementations, an exemplary method for determining whether the tension supplied to a target natural valve (e.g., a living animal or simulation) due to the installation between a valve repair device and a natural valve is at a desired level includes delivering the valve repair device to the target natural valve using a delivery device, wherein at least one of the valve repair device and the delivery device includes a force measuring device.

[0056] In some implementations, exemplary methods further include attaching a valve repair device to the natural valve in question and detecting the force applied to at least one of the valve repair device and the delivery device via a force measuring device.

[0057] In some implementations, the exemplary method further includes determining whether the tension applied to the natural valve is at a desired level based on the force detected by a force measuring device.

[0058] In some implementations, exemplary methods include removing the valve repair device from the natural valve and reattaching the valve repair device to the natural valve when the tension is not at a desired level.

[0059] In some implementations, exemplary methods may further include re-detecting the force applied to at least one of the valve repair device and the delivery device via a force measuring device, and determining whether the tension applied to the leaflet is at a desired level based on the force re-detected by the force measuring device.

[0060] In some implementations, the valve repair device includes at least one paddle and at least one gripping member, and the force measuring device is attached to at least one gripping member.

[0061] In some implementations, the gripping member has a fastener that includes a fixed arm attached to at least one paddle, a movable arm, and a hinge portion that hinges the fixed arm to the movable arm.

[0062] In some implementations, the second force measuring device is attached to a movable arm of the fastener.

[0063] In some implementations, the second force measuring device is attached to the hinge portion of the clasp.

[0064] In some implementations, the second force measuring device includes a strain gauge.

[0065] In some implementations, the detected force is detected via an ohmmeter.

[0066] In some implementations, the delivery device includes an actuation element, and the force measuring device is attached to the actuation element.

[0067] In some implementations, the valve repair device comprises a cap and at least one paddle attached to the cap, the at least one paddle being configured to attach the valve repair device to a natural valve.

[0068] In some implementations, the actuating element can be configured to engage with the cap, move the cap, and move at least one paddle between an open position and a closed position.

[0069] In some implementations, the delivery device has a paddle control mechanism, and the force measuring device is attached to the paddle control mechanism.

[0070] In some implementations, the valve repair device comprises a shaft, a coupler attached to the shaft and movable along the shaft, and at least one paddle attached to the coupler.

[0071] In some implementations, at least one paddle can be movable between an open position and a closed position, and at least one paddle can be configured to attach a valve repair device to the natural valve.

[0072] In some implementations, the paddle control mechanism can be configured to engage with a coupler to move the coupler along a shaft, thereby moving at least one paddle between an open position and a closed position.

[0073] Any of the above methods, and any method using the systems, assemblies, apparatus, devices, etc., described herein, may be performed on living subjects (e.g., humans or other animals) or on simulations (e.g., corpses, corpse hearts, virtual humans, simulators, etc.). With respect to simulations, body parts may optionally be referred to as "simulated" (e.g., simulated hearts, simulated tissues, etc.) and may optionally include computerized and / or physical representations.

[0074] Any of the above-mentioned systems, assemblies, devices, apparatus, components, etc., can be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use in the subject matter, and the methods of the present disclosure may include (or additional methods may include or consist of) sterilization (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of one or more of the systems, devices, apparatus, components, etc., described herein.

[0075] Further understanding of the nature and advantages of the present invention is provided in the following description and claims, in particular when considered in conjunction with the accompanying drawings, which use the same reference numerals for similar parts.

[0076] To further clarify the various aspects of the implementations of this disclosure, specific embodiments and implementations will be described in more detail by reference to various aspects of the accompanying drawings. These drawings only illustrate exemplary implementations of this disclosure and are therefore not intended to limit the scope of this disclosure. Furthermore, while some embodiments may be shown to scale, not all embodiments are necessarily shown to scale. Embodiments of this disclosure and other features and advantages will be described and explained with additional specificity and detail by using the accompanying drawings. [Brief explanation of the drawing]

[0077] [Figure 1] This example illustrates a cross-sectional view of a human heart during diastole. [Figure 2] This example illustrates a cross-sectional view of the human heart during systole. [Figure 3] This example illustrates a cross-sectional view of a human heart during systole, showing mitral valve regurgitation. [Figure 4] Figure 3 is a cross-sectional view, annotated to show the natural shape of the mitral valve leaflet during systole. [Figure 5] This example illustrates a healthy mitral valve where the leaflets are blocked when viewed from the atrial side. [Figure 6] This example illustrates a dysfunctional mitral valve, where a visible gap exists between the leaflets when viewed from the atrial side of the mitral valve. [Figure 7] Let's illustrate the tricuspid valve as viewed from the atrial side. [Figure 8] This document illustrates examples of implantable devices or implants at various stages of development. [Figure 9] This document illustrates examples of implantable devices or implants at various stages of development. [Figure 10] This document illustrates examples of implantable devices or implants at various stages of development. [Figure 11] This document illustrates examples of implantable devices or implants at various stages of development. [Figure 12] This document illustrates examples of implantable devices or implants at various stages of development. [Figure 13] This document illustrates examples of implantable devices or implants at various stages of development. [Figure 14] This document illustrates examples of implantable devices or implants at various stages of development. [Figure 15] Figures 8 to 14 illustrate examples of implantable devices or implants, similar to those illustrated, but in which the paddles are independently controllable. [Figure 16] Figures 8–14 show exemplary implantable devices or implants that are delivered to and implanted inside the natural valve. [Figure 17] Figures 8–14 show exemplary implantable devices or implants that are delivered to and implanted inside the natural valve. [Figure 18] Figures 8–14 show exemplary implantable devices or implants that are delivered to and implanted inside the natural valve. [Figure 19] Figures 8–14 show exemplary implantable devices or implants that are delivered to and implanted inside the natural valve. [Figure 20] Figures 8–14 show exemplary implantable devices or implants that are delivered to and implanted inside the natural valve. [Figure 21] Figures 8–14 show exemplary implantable devices or implants that are delivered to and implanted inside the natural valve. [Figure 22] An exemplary perspective view of an implantable device or implant in a closed position is shown. [Figure 23] An exemplary perspective view of an implantable device or implant in a closed position is shown. [Figure 24] An exemplary valve repair device with an open-position paddle is illustrated. [Figure 25A] With the paddle in the closed position, another exemplary valve repair device is illustrated. [Figure 25B] An illustrative top view of an exemplary valve repair device is provided. [Figure 26] An illustrative perspective view of an exemplary portable device having a paddle with an adjustable width is provided. [Figure 27] Figure 26 shows a cross-section of the implantable device, divided into two equal parts. [Figure 28] This is another cross-section of the implantable device shown in Figure 26, obtained by bisecting the implantable device along a plane perpendicular to the plane illustrated in Figure 28. [Figure 29] This is a schematic diagram of an exemplary implantable catheter assembly coupled to an implantable device, where the actuation elements are coupled to paddle actuation controls and the driver head of the implantable device. [Figure 30] Figure 29 shows the assembly with the portable device rotated 90 degrees, illustrating the paddle width adjustment element coupled to the inner end of the connector of the portable device and coupled to the paddle width control. [Figure 31]Figures 8 to 14 illustrate the devices, but the illustrative force measuring device is positioned on or within a delivery system for delivering the implantable device or implant, and the diagram shows a partial view of one embodiment of an implantable device or implant. [Figure 32] Figures 8 to 14 illustrate the devices, but the illustrative force measuring device is similar to that shown in a partial diagram of an embodiment of an implantable device or implant, where the device is placed on the implantable device or implant. [Figure 33] Similar to the device illustrated in Figure 22, this example illustrates an embodiment of an implantable device or implant in which the exemplary force measuring device is positioned on at least one of the implantable device or implant and a delivery system for delivering the implantable device or implant. [Figure 34] Similar to the device illustrated in Figure 23, this example illustrates an embodiment of an implantable device or implant in which the exemplary force measuring device is positioned on at least one of the implantable device or implant and a delivery system for delivering the implantable device or implant. [Figure 35] The following example illustrates an embodiment of an implantable device or implant, similar to the device illustrated in Figure 24, but in which the exemplary force measuring device is positioned on at least one of the implantable device or implant and a delivery system for delivering the implantable device or implant. [Figure 36] Similar to the device illustrated in Figure 25A, this example shows an embodiment of an implantable device or implant in which the exemplary force measuring device is placed on an implantable device or implant. [Figure 37] The following examples illustrate devices similar to those illustrated in Figures 26-28, but show embodiments of implantable devices or implants in which the exemplary force measuring device is positioned on at least one of the implantable device or implant and an implant catheter assembly for delivering the implantable device or implant. [Figure 38] The following examples illustrate devices similar to those illustrated in Figures 26-28, but show embodiments of implantable devices or implants in which the exemplary force measuring device is positioned on at least one of the implantable device or implant and an implant catheter assembly for delivering the implantable device or implant. [Figure 39] The following examples illustrate devices similar to those illustrated in Figures 26-28, but show embodiments of implantable devices or implants in which the exemplary force measuring device is positioned on at least one of the implantable device or implant and an implant catheter assembly for delivering the implantable device or implant. [Figure 40] Figures 8 to 14 illustrate the devices, but the diagram shows a partial view of an embodiment of an implantable device or implant in which the exemplary force measuring device is integrally formed with one or more components of the implantable device or implant. [Figure 41] Similar to the device illustrated in Figure 22, this example shows an embodiment of an implantable device or implant in which the exemplary force measuring device is integrally formed with one or more components of at least one of the implantable devices or implants. [Figure 42] Figure 23 illustrates an example of an implantable device or implant, similar to the device illustrated in Figure 23, but in which the exemplary force measuring device is integrally formed with one or more components of the implantable device or implant. [Figure 43] Similar to the device illustrated in Figure 24, this shows an embodiment of an implantable device or implant in which the exemplary force measuring device is integrally formed with one or more components of the implantable device or implant. [Figure 44]Figures 26-28 illustrate the devices, but the example force measuring device is formed integrally with one or more components of the implantable device or implant, as shown in one embodiment of an implantable device or implant. [Modes for carrying out the invention]

[0078] The following description refers to accompanying drawings illustrating some implementations of this disclosure. Some implementations having different structures and operations do not deviate from the scope of this disclosure.

[0079] The exemplary implementations of this disclosure relate to systems, devices, methods, etc., for repairing defective heart valves. For example, some implementations of valve repair devices, implantable devices, implants, and systems (including systems for delivering them) are disclosed herein, and any combination of these options is possible unless otherwise specified. In other words, the individual components of the disclosed devices and systems can be combined as long as they are not mutually exclusive or not physically impossible. Furthermore, the techniques and methods of this disclosure can be performed on living animals or on simulations such as cadavers, cadaver hearts, simulators (e.g., in which body parts, hearts, tissues, etc., are simulated), fictitious subjects (e.g., in which a fictitious heart is shown in the air), etc.

[0080] Where, as described herein, one or more components are described as being interconnected by connection, joining, fastening, coupling, mounting or other means, such interconnections may be direct, such as between components, or indirect, such as by using one or more intermediate components. Also, as described herein, references to “member,” “component,” or “part” are not limited to a single structural member, component, or element, but may include assemblies of components, members, or elements. Furthermore, the terms “substantially” and “about” as described herein 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%).

[0081] Figures 1 and 2 are cross-sectional views of a human heart H in 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 (e.g., leaflets 20, 22 shown in Figures 3-6, and leaflets 30, 32, 34 shown in Figure 7) that extends inward across their respective openings, forming a unidirectional fluid occlusion surface by joining or "joining" in the flow. The natural valve repair system of this application is frequently described and / or illustrated with respect to the mitral valve MV. Therefore, the anatomical structures of the left atrium LA and left ventricle LV are described in more detail. However, the device described herein can also be used in the repair of other natural valves, for example, the device can be used in the repair of the tricuspid valve (TV), aortic valve (AV), and pulmonary valve (PV).

[0082] The left atrium (LA) receives oxygen-rich blood from the lungs. During the diastolic phase, as shown in Figure 1, the blood already collected in the left atrium (LA) (during the systolic phase) moves into the left ventricular LV through the mitral valve (MV) as the left ventricular LV expands. During the systolic phase, as shown in Figure 2, the left ventricular LV contracts, pumping blood into the body through the aortic valve (AV) and ascending aorta (AA). During systole, the leaflet of the mitral valve (MV) closes, preventing blood from flowing back from the left ventricular LV into the left atrium (LA), and blood is collected into the left atrium from the pulmonary veins. In some implementations, the device described in this application is used to repair the function of a defective mitral valve (MV). Specifically, the device is configured to assist in the closure of the mitral valve leaflet to prevent, block, or reduce blood from flowing back from the left ventricular LV into the left atrium (LA). Many of the devices described in this application are designed to easily grip and secure natural leaflets around joint elements or spacers that act beneficially as fillers in backflow openings to prevent or block backflow during systole, but this is not essential.

[0083] Referring to Figures 1-7, the mitral valve MV contains two leaflets, the anterior leaflet 20 and the posterior leaflet 22. The mitral valve MV also contains an annulus 24 (see Figure 5), which is a variablely dense, fibrous annular tissue surrounding the leaflets 20 and 22. Referring to Figures 3 and 4, the mitral valve MV is anchored to the wall of the left ventricle (LV) by chordae tendineae (CT). The chordae tendineae (CT) are cord-like tendons that connect the papillary muscle PM (i.e., muscle located at the base of the chordae tendineae (CT) and within the wall of the left ventricle (LV) to the leaflets 20 and 22 of the mitral valve MV. The papillary muscle PM functions to restrict the movement of the leaflets 20 and 22 of the mitral valve MV and to prevent the mitral valve MV from inverting. The mitral valve MV opens and closes in response to pressure changes within the left atrium (LA) and the left ventricle (LV). The papillary muscles (PM) do not open or close the mitral valve (MV). Rather, the papillary muscles (PM) support and hold up leaflets 20 and 22 against the high pressure necessary to circulate blood throughout the body. The papillary muscles (PM) and chordae tendineae (CT) together are known as the subvalvular tissue, which functions to maintain the mitral valve MV so that it does not prolapse into the left atrium (LA) when the mitral valve is closed. As can be seen from the left ventricular outflow tract (LVOT) diagram shown in Figure 3, the anatomical structure of leaflets 20 and 22 is such that the inner surfaces of the leaflets join at their free ends, and leaflets 20 and 22 begin to retract and spread apart from each other. Leaflets 20 and 22 spread apart towards the atrium until each leaflet contacts the mitral valve annulus.

[0084] Various disease processes can impair the proper function of one or more of the natural valves in the heart. These disease processes include degenerative processes (e.g., Barlow's disease, elastic fiber defects, etc.), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis, etc.). In addition, damage to the left ventricular LV or right ventricular RV due to a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other heart disease (e.g., cardiomyopathy, etc.) can distort the shape of the natural valve, which can lead to natural valve dysfunction. However, the majority of patients undergoing valve surgery, such as mitral valve MV surgery, suffer from degenerative diseases that cause dysfunction of the natural valve (e.g., mitral valve MV) (e.g., leaflets 20, 22), resulting in prolapse and regurgitation.

[0085] Generally, natural valves can malfunction in different ways, including (1) stenosis and (2) regurgitation. Stenosis occurs when the natural valve does not open completely, causing impaired blood flow. Typically, stenosis is caused by the accumulation of calcification on the valve leaflet, which thickens and impairs the valve's ability to open completely and allow antegrade blood flow. Regurgitation occurs when the valve leaflet does not completely close, causing blood to leak back into the previous chamber (for example, blood leaking from the left ventricle into the left atrium).

[0086] There are three main mechanisms by which a natural valve can become regurgitant or inoperable, including Carpentier type I, type II, and type III dysfunctions. Carpentier type I dysfunction involves annular dilation, which causes normally functioning leaflets to separate from each other, preventing the formation of a tight seal (i.e., the leaflets do not properly join). Examples of dysfunction constituting the type I mechanism include leaflet perforation, such as that seen in endocarditis. Carpentier type II dysfunction involves one or more leaflets of the natural valve protruding above the joining plane. Carpentier type III dysfunction involves restricted movement of one or more leaflets of the natural valve, resulting in abnormal restriction of the leaflets below the plane formed by the annulus. Leaflet restriction can be caused by rheumatic diseases or ventricular dilation.

[0087] Referring to Figure 5, when a healthy mitral valve (MV) is in the closed position, the anterior leaflet 20 and posterior leaflet 22 join together, thereby preventing blood from leaking from the left ventricle (LV) to the left atrium (LA). Referring to Figures 3 and 6, mitral regurgitation (MR) occurs when the anterior leaflet 20 and / or posterior leaflet 22 of the mitral valve (MV) are displaced into the left atrium (LA) during systole, causing the edges of the leaflets 20 and 22 to no longer contact each other. When joining does not occur in this way, a gap 26 is created between the anterior leaflet 20 and the posterior leaflet 22, which can cause blood to flow back from the left ventricle (LV) to the left atrium (LA) during systole, as illustrated by the mitral regurgitation (MR) pathway shown in Figure 3. Referring to Figure 6, the gap 26 can have a width W of approximately 2.5 mm to 17.5 mm, 5 mm to 15 mm, 7.5 mm to 12.5 mm, or 10 mm. In some situations, the gap 26 can have a width W greater than 15 mm or even greater than 17.5 mm. As described above, there are several different embodiments in which a leaflet (e.g., leaflets 20, 22 of the mitral valve MV) may malfunction, which can lead to valvular regurgitation.

[0088] In any of the situations described above, a valve repair device or implant is desirable that can engage with the anterior leaflet 20 and the posterior leaflet 22, close the gap 26, and prevent or suppress the regurgitation of blood through the mitral valve MV. As can be seen from Figure 4, an abstract description of an implantable device, valve repair device, or implant 10 is shown implanted between leaflets 20 and 22 so that regurgitation does not occur during systole (compare Figure 3 with Figure 4). In some implementations, the connecting elements of the device 10 (e.g., spacers, connecting elements, gap fillers, etc.) have a substantially tapered or triangular shape that naturally conforms to the geometry of the natural valve and the nature of its leaflets expanding (towards the annulus). In this application, the terms spacer, connecting element, and gap filler are used interchangeably and refer to elements that fill a portion of the space between the leaflets of the natural valve and / or are configured so that the leaflets of the natural valve engage or "join" (e.g., so that the natural leaflets join not only to each other but also to the connecting element, spacer, etc.). In some implementations, the bonding element or spacer is optional in any of the valve repair devices disclosed herein.

[0089] While stenosis or regurgitation can affect any valve, stenosis has been found to primarily affect either the aortic valve (AV) or the pulmonary valve (PV), and regurgitation has been found to primarily affect either the mitral valve (MV) or the tricuspid valve (TV). Both valve stenosis and regurgitation increase the burden on 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. 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 circulating blood throughout the body. Therefore, because the pressure is substantially higher on the left side of the heart, mitral valve (MV) or aortic valve (AV) dysfunction is particularly problematic and often life-threatening.

[0090] For malfunctioning natural heart valves, either repair or replacement is possible. Repair typically involves preserving and modifying the natural valve in question. Replacement typically involves replacing the natural valve with a biological or mechanical substitute. Typically, the aortic valve (AV) and pulmonary valve (PV) are more prone to stenosis. Because stenotic damage sustained by Leaflet is irreversible, treatment for stenotic aortic or pulmonary valves can involve removing the valve and replacing it with a surgically implanted valve, or replacing it with a transcatheter valve. The mitral valve (MV) and tricuspid valve (TV) are more prone to deformation of Leaflet and / or surrounding tissues, which, as described above, can prevent proper occlusion of the mitral valve (MV) or tricuspid valve (TV), thereby allowing regurgitation or backflow of blood from the ventricle to the atrium (for example, deformation of the mitral valve (MV) can allow regurgitation or backflow from the left ventricle (LV) to the left atrium (LA), as shown in Figure 3). Backflow or regurgitation of blood from the ventricle to the atrium results in valve insufficiency. Deformities in the structure or shape of the mitral valve (MV) or tricuspid valve (TV) are often repairable. In addition, regurgitation can occur due to dysfunction of the chordae tendineae (CT) (for example, the chordae tendineae can become stretched or ruptured), which allows the anterior leaflet 20 and posterior leaflet 22 to invert, causing blood to flow back into the left atrium (LA). Problems arising from dysfunctional chordae tendineae can be repaired by repairing the chordae tendineae or by repairing the structure of the mitral valve (MV) (for example, by fixing leaflets 20 and 22 at the affected area of ​​the mitral valve).

[0091] The devices and procedures disclosed herein often refer to the repair of mitral valve structures. However, it will be understood that the devices and concepts provided herein can be used to repair any natural valve, and any component of a natural valve. Such devices can be used between leaflets 20 and 22 of the mitral valve MV to prevent or block the regurgitation of blood from the left ventricle into the left atrium. With respect to the tricuspid valve TV (Figure 7), any of the devices and concepts herein can be used between any two of the anterior leaflet 30, septal leaflet 32, and posterior leaflet 34 to prevent or block the regurgitation of blood from the right ventricle into the right atrium. In addition, any of the devices and concepts provided herein can be used together with all three leaflets 30, 32, and 34 to prevent or block the regurgitation of blood from the right ventricle into the right atrium. That is, the valve repair devices or implants provided herein can be positioned centrally between the three leaflets 30, 32, and 34.

[0092] An exemplary implantable device or implant may optionally include a connecting element (e.g., a spacer, connecting element, gap filler, etc.) and at least one anchor (e.g., one, two, three, or more). In some implementations, the implantable device or implant may have any combination or partial combination of the features disclosed herein without a connecting element. The connecting element (e.g., a spacer, connecting element, gap filler, etc.), if included, is configured to be positioned inside the natural heart valve opening to assist in filling the space between the leaflets and to form a more effective seal, thereby reducing, preventing, or blocking the regurgitation described above. The connecting element may be impermeable to blood (or resistant to blood flow through it) and may have a structure that blocks the regurgitation of blood from the left ventricle or right ventricle to the left atrium or right atrium, respectively, by allowing the natural leaflets to close around the connecting element during ventricular systole. The device or implant can be configured to seal to two or three natural valve leaflets, i.e., the device can be used with natural mitral valves (bicuspid valves) and natural tricuspid valves. The jointing element is sometimes referred to herein as a spacer because the jointing element can fill the space between dysfunctional natural leaflets that do not close completely (e.g., mitral leaflets 20, 22 or tricuspid leaflets 30, 32, 34).

[0093] Optional connecting elements (e.g., spacers, connecting elements, gap fillers, etc.) can have a variety of shapes. In some implementations, the connecting element can have an elongated cylindrical shape with a circular cross-section. In some implementations, the connecting element can have an elliptical, oval, crescent, rectangular, or various other non-cylindrical cross-sections. In some implementations, the connecting element can have an atrial portion positioned within or adjacent to the atrium, a ventricular portion or lower portion positioned within or adjacent to the ventricle, and a side extending between the natural leaflets. In some implementations configured for use in tricuspid valves, the atrial portion or upper portion is positioned within or adjacent to the right atrium, the ventricular portion or lower portion is positioned within or adjacent to the right ventricle, and the side extends between the natural tricuspid leaflets.

[0094] In some implementations, the anchor can be configured to fix the device to one or both of the natural leaflets so that the coupling element is positioned between the two natural leaflets. In some implementations configured for use in tricuspid valves, the anchor is configured to fix the device to one, two, or three of the tricuspid leaflets so that the coupling element is positioned between the three natural leaflets. In some implementations, the anchor can be attached to the coupling element at a position adjacent to the ventricular portion of the coupling element. In some implementations, the anchor can be attached to the actuating element (e.g., actuating shaft, actuating tube, actuating wire, etc.), to which the coupling element is also attached. In some implementations, the anchor and coupling element can be positioned independently of each other by moving the anchor and coupling element separately along the longitudinal axis of the actuating element (e.g., actuating shaft, actuating rod, actuating tube, actuating wire, etc.). In some implementations, the anchor and connecting elements can be positioned simultaneously by moving them together along the longitudinal axis of the actuating element (e.g., shaft, actuating wire, etc.). The anchor can be configured to be positioned behind the natural leaflet when transplanted so that the leaflet is gripped by the anchor.

[0095] The device or implant may be configured to be implanted via a delivery system or other delivery means. The delivery system may comprise one or more of the following: a guide / delivery sheath, a delivery catheter, a maneuverable catheter, an implant catheter, a tube, or a combination thereof. The joint element and anchor may be compressible to a radially compressed state and self-expandable to a radially expanded state when the compressive pressure is released. The device may be configured such that the anchor expands radially away from the joint element, which is initially still compressible, in order to create a gap between the joint element and the anchor. The natural leaflet can then be positioned within the gap. The joint element can close the gap between the joint element and the anchor by expanding radially, thereby trapping the leaflet between the joint element and the anchor. In some implementations, the anchor and joint element are optionally configured to self-expand. The implantation method for some implementations may differ and will be described in more detail below for each implementation. Further information regarding these delivery methods and other delivery methods can be found in U.S. Patent No. 8,449,599, and U.S. Patent Application Publications 2014 / 0222136, 2014 / 0067052, 2016 / 0331523, and PCT Patent Application Publication WO2020 / 076898, each of which, by reference, is incorporated herein by reference in whole for all purposes. These methods can be carried out on living animals with necessary modifications, or on simulations such as corpses, corpse hearts, simulators (where body parts, hearts, tissues, etc., are simulated), etc.

[0096] The disclosed device or implant may be configured such that the anchor is connected to the leaflet, and by utilizing the tension from the natural chordae tendineae, it can resist large systolic pressures that bias the device toward the left atrium. During diastole, the device may rely on compressive and retaining forces acting on the leaflet, which is grasped by the anchor.

[0097] Referring here to Figures 8 to 15, the implantable device or implant 100 (e.g., an implantable prosthesis, an artificial spacer device, a valve restoration device, etc.) is schematically illustrated and shown in various stages of development. The device or implant 100, as well as other similar devices / implants, are described in more detail in PCT Patent Publications WO2018 / 195215, WO2020 / 076898, and WO2019 / 139904, which are incorporated herein by reference in their entirety. The device 100 may include any other features relating to an implantable device or implant described in this application or the applications cited above, and the device 100 may be positioned to engage with valve tissue (e.g., leaflets 20, 22, 30, 32, 34) as part of any suitable valve restoration system (e.g., any valve restoration system / device disclosed in this application or the applications cited above).

[0098] The device or implant 100 is deployed from the delivery system 102. The delivery system 102 may include one or more of the following: a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a maneuverable catheter, an implant catheter, a tube, a channel, a route, or a combination thereof. The device or implant 100 includes a joint portion 104 and an anchor portion 106.

[0099] In some implementations, the joint portion 104 of the device or implant 100 includes a joint element 110 that is slidably attached to an actuation element 112 (e.g., actuation wire, actuation shaft, actuation tube, etc.) and is adapted to be implanted between leaflets of natural valves (e.g., natural mitral valve, natural tricuspid valve, etc.). The anchor portion 106 is actuated between an open and closed position and includes one or more anchors 108 that can take on a wide variety of forms, such as paddles, gripping elements, or the like. When the actuation element 112 is actuated, the anchor portion 106 of the device 100 opens and closes, gripping the natural valve leaflets during implantation. The actuation element 112 (and other actuation elements disclosed herein) can take on a wide variety of different forms (e.g., wires, rods, shafts, tubes, screws, sutures, lines, strips, combinations thereof, etc.), can be made from a wide variety of different materials, and can have a wide variety of forms. In one embodiment, the operating element may have threads so as to rotate the operating element to move the anchor portion 106 relative to the joint portion 104. Alternatively, the operating element may not have threads so as to move the anchor portion 106 relative to the joint portion 104 by pushing or pulling the operating element 112.

[0100] The anchor portion 106 and / or anchor of device 100 includes, in some implementations, an outer paddle 120 and an inner paddle 122 connected between the cap 114 and the joint element 110 by portions 124, 126, and 128. Portions 124, 126, and 128 can be articulated and / or flexible to move between all of the positions described below. The interconnection of the outer paddle 120, the inner paddle 122, the joint element 110, and the cap 114 by portions 124, 126, and 128 can restrain the device to the positions and movements shown herein.

[0101] In some implementations, the delivery system 102 includes a maneuverable catheter, an implantable catheter, and an actuation element 112 (e.g., an actuation wire, actuation shaft, etc.). These can be configured to extend through a guide catheter / sheath (e.g., a transseptal sheath, etc.). In some implementations, the actuation element 112 extends through the delivery catheter and through the connecting element 110 to the distal end (e.g., a cap 114 or other attachment portion at the distal connection of the anchor portion 106). Extending and retracting the actuation element 112 increases and decreases the distance between the connecting element 110 and the distal end of the device (e.g., a cap 114 or other attachment portion), respectively. In some implementations, a collar or other mounting element (e.g., a coupler, clamp, removable fastener, clip, etc.) directly or indirectly attaches the connecting element 110 to the delivery system 102, and as a result, the actuating element 112 slides through the collar or other mounting element, and in some implementations, through the connecting element 110 during operation, to open and close the paddles 120, 122 of the anchor portion 106 and / or anchor 108.

[0102] In some implementations, the anchor portion 106 and / or anchor 108 may include a mounting portion or a gripping member. An illustrated gripping member may include a clasp 130 including a base or fixed arm 132, a movable arm 134, an optional friction-enhancing element, and other fixing structures 136 (e.g., a return, projection, ridge, groove, textured surface, adhesive, etc.), and a joint portion 138. The fixed arm 132 is attached to the inner paddle 122. In some implementations, the fixed arm 132 is attached to the inner paddle 122 with the joint portion 138 positioned in close proximity to the joint element 110. The joint portion 138 provides a spring force between the fixed arm 132 and the movable arm 134 of the clasp 130. The joint portion 138 can be any preferred joint, such as a flexible joint, a spring joint, a pivot joint, or a joint of the same type. In some implementations, the joint 138 is a flexible material piece integrally formed by 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 in the open position, opening the latch 130 and exposing an optional return or other optional friction-enhancing element 136.

[0103] In some implementations, the clasp 130 is opened by applying tension to the actuation line 116 attached to the movable arm 134, thereby causing the movable arm 134 to articulate, flex, or pivot on the joint 138. The actuation line 116 extends through the delivery system 102 (e.g., through a maneuverable catheter and / or implant catheter). Other actuation mechanisms are also possible.

[0104] The working line 116 can take on a wide variety of forms, such as a line, suture, wire, rod, catheter, or the like. The clasp 130 may be equipped with a spring force so that it continues to provide a clamping force to the grasped natural leaflet in the closed position. Optional punctures or other friction-enhancing elements 136 of the clasp 130 can grip, clamp, and / or puncture the natural leaflet to further secure it.

[0105] During implantation, paddles 120 and 122 can be opened and closed, for example, to grasp a natural leaflet (e.g., a leaflet of a natural mitral valve) between paddle 120 and paddle 122 and / or between paddles 120 and 122 and the connecting element 110 (e.g., a spacer, plug, membrane, etc.). The natural leaflet can be grasped and / or further secured by using the clasp 130 to engage the leaflet with an optional return or other optional friction-enhancing element 136 and clamping the leaflet between the movable arm 134 and the fixed arm 132. The return of the clasp 130 or other friction-enhancing element 136 (e.g., a projection, ridge, groove, textured surface, adhesive, etc.) can increase friction with the leaflet or partially or completely puncture the leaflet. The actuation line 116 can be actuated separately so that each clasp 130 can be opened and closed independently. By operating independently, one leaflet can be gripped at a time, or the clasp 130 can be repositioned on a leaflet that was not properly gripped without altering the good grip on other leaflets. The clasp 130 opens and closes relative to the position of the inner paddle 122 (as long as the inner paddle is in the open position or at least partially open position), thereby allowing the leaflet to be gripped in various positions required by specific circumstances.

[0106] Referring here to Figure 8, the device 100 is shown in an extended or fully open state for deployment from the implant delivery catheter of the delivery system 102. The device 100 is positioned at the end of the catheter of the delivery system 102 in the fully open position. In the extended state, the cap 114 is separated from the connecting element 110 so that the paddles 120, 122 are fully extended. In some implementations, the angle formed between the interiors of the outer paddle 120 and the inner paddle 122 is approximately 180 degrees. The clasp 130 can be kept closed during deployment through the delivery system. The working line 116 extends to and can be attached to the movable arm 134.

[0107] Referring now to Figure 9, the device 100 is shown in an extended state similar to that in Figure 8, but the clasp 130 is in a fully open position with a range of approximately 140 to 200 degrees, approximately 170 to 190 degrees, or approximately 180 degrees between the fixed portion 132 and the movable portion 134 of the clasp 130.

[0108] Referring here to Figure 10, the device 100 is shown in either the retracted or fully closed state. To move the device 100 from the extended state to the retracted state, the actuating element 112 is retracted, pulling the cap 114 toward the joining element 110. The connection portion 126 (e.g., joint, flexible connection, etc.) between the outer paddle 120 and the inner paddle 122 is constrained to move such that a compressive force acting from the cap 114 onto the outer paddle 120 pulls the paddle or gripping member toward the joining element 110 and moves radially outward. When moving from the open position to the closed position, the outer paddle 120 maintains an acute angle with respect to the actuating element 112. The outer paddle 120 can optionally be biased toward the closed position. The inner paddle 122 moves over a fairly large angle during the same operation to orient itself away from the open joining element 110 and to fold along the side of the closed joining element 110.

[0109] Referring here to Figures 11-13, the device 100 is shown in a partially open gripping-ready state. The actuating element (e.g., actuating wire, actuating shaft, etc.) extends to push the cap 114 away from the joining element 110 to transition from a fully closed state to a partially open state, thereby pulling the outer paddle 120 and then the inner paddle 122, causing the anchor or anchor portion 106 to partially open. The actuating line 116 is also retracted, opening the clasp 130, and as a result, the leaflet can be gripped. In some implementations, the pair of inner and outer paddles 122, 120 are driven integrally, rather than individually, by a single actuating element 112. Also, the position of the clasp 130 depends on the position of the paddles 122, 120. Referring to Figure 10, for example, closing the paddles 122, 120 is also closing the clasp. In some implementations, the paddles 120 and 122 can be controlled independently. In the embodiment illustrated in Figure 15, the device 100 may have two actuation elements 111 and 113 and two independent caps 115 and 117 (or other mounting parts), thereby controlling one paddle using one independent actuation element (e.g., a wire, shaft, etc.) and cap (or other mounting part), and controlling the other paddle using the other independent actuation element and cap (or other mounting part).

[0110] Referring to Figure 12, one of the actuation lines 116 can be extended to close one of the latches 130. Referring to Figure 13, the other actuation line 116 can be extended to close the other latch 130. The latches 130 can be opened and closed by operating one or both of the actuation lines 116 in a projectile manner.

[0111] Referring here to Figure 14, device 100 is shown in a fully closed and deployed state. The delivery system 102 and the actuation element 112 are retracted, and the paddles 120, 122 and the latch 130 remain in the fully closed position. After deployment, device 100 can be maintained in the fully closed position by a mechanical latch, or it can be biased to remain closed by using a spring material such as steel, other metals, plastic, composite material, etc., or by using a shape memory alloy such as Nitinol. For example, the connecting portions 124, 126, 128, the joint portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) can be formed from a metal such as steel, or from a shape memory alloy such as Nitinol, which can be manufactured from wire, sheet, tube, or laser-sintered powder, and are biased to hold the outer paddle 120 closed around the joining element 110, and the clasp 130 clamping around the natural leaflet. Similarly, the fixed arm 132 and movable arm 134 of the clasp 130 are biased to clamp the leaflet. In some implementations, the mounting or connecting portions 124, 126, 128, the joint portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) can be formed from any other suitable elastic material such as metal or polymer material to maintain the device 100 in a closed state after implantation.

[0112] Figure 15 illustrates an embodiment in which the paddles 120 and 122 are independently controllable. The device 101 illustrated in Figure 15 is similar to the device illustrated in Figure 11, except that the device 101 in Figure 15 includes actuation elements configured as two independent actuation elements 111 and 113 coupled to two independent caps 115 and 117. The actuation element 111 extends to push the cap 115 away from the coupling element 110 in order to move the first inner paddle 122 and the first outer paddle 120 from a fully closed state to a partially open state, thereby pulling the outer paddle 120 and then the inner paddle 122, causing the first anchor 108 to partially expand. The actuating element 113 extends to push the cap 115 away from the spacer or connecting element 110 in order to move the second inner paddle 122 and the second outer paddle 120 from a fully closed state to a partially open state, thereby pulling the outer paddle 120 and then the inner paddle 122, causing the second anchor 108 to partially expand. The independent paddle control illustrated in Figure 15 can be implemented in any device disclosed in this application. For comparison, in the embodiment illustrated in Figure 11, the pair of inner paddles 122 and outer paddles 120 are driven collectively, rather than individually, by a single actuating element 112.

[0113] Figures 31 and 32 illustrate embodiments of device 3100 and / or delivery system 3102 configured to detect tension supplied to a leaflet due to the connection between device 3100 and the leaflet. The device 3100 and delivery system 3102 illustrated by Figures 31 and 32 may be identical or similar to the device 100 and delivery system 102 illustrated by Figures 8 to 14. In some implementations, the device 3100 and / or delivery system 3102 of Figures 31 and 32 includes one or more force measuring devices 3110a to 3110c for detecting tension supplied to the leaflet. That is, the connection between device 3100 and the leaflet applies tension to the leaflet, and the force measuring devices 3110a to 3110c may be configured to measure the tension supplied to the leaflet so that a user can determine whether the tension is higher or lower than an optimal tension range. For example, if the tension is below a certain amount, there may be an insufficient connection between device 3100 and the leaflet. If the tension exceeds a predetermined amount, the excess leaflet may be gripped by the device 3100.

[0114] The force measuring devices 3110a to 3110c can take on various different forms. For example, the force measuring devices 3110a to 3110c can be one or more of the following: strain gauges, optical sensors, proximity sensors, and / or Hall sensors.

[0115] The force measuring device can be placed anywhere on the device 3100 and / or the delivery system 3102, enabling the force measuring device to measure the tension supplied to the leaflet and / or measure tensions correlated with the tension on the leaflet, other forces, positions, etc. For example, referring to Figure 31, the force measuring device 3110a can be placed on the actuation element 112 of the delivery system 3102.

[0116] In some implementations, the actuation of the actuation element 112 opens and closes one or more anchors 108 of the device 3100, gripping the leaflet of the natural valve during implantation. For example, as described herein with reference to Figures 8 to 14, extension of the actuation element 112 moves a cap (e.g., cap 114) away from the joint element 110, moving one or more anchors 108 to the open position, and retraction of the actuation element 112 moves the cap towards the joint element 110, moving one or more anchors 108 to the closed position.

[0117] When the valve repair device 3100 is attached to the leaflet and in the closed position, this attachment between the valve repair device 3100 and the leaflet can exert tension on the leaflet and generate forces corresponding to one or more anchors 108. In some situations, this force supplied to the anchors 108 may cause them to partially open, which can generate a force F1 on the actuating element 112 as the anchors 108 open and close due to the movement of the actuating element 112. In some implementations, a force measuring device 3110a is configured to measure the force F1 on the actuating element 112, and by measuring the force F1, the user can determine whether the corresponding tension supplied to the leaflet is at a desired or undesirable level.

[0118] In the illustrated embodiment, the force measuring device 3110a includes a strain gauge having one or more wires 3116a extending to a device (not shown) for measuring electrical resistance (e.g., an ohmmeter). In some implementations, after the valve repair device 3100 is attached to the natural valve and the tension supplied to the leaflet is determined to be at a desired level, the actuating element 112 is removed from the valve repair device 3100 and removed from the object using a delivery system 3102.

[0119] In some implementations, the force measuring device 3110a can be attached to a portion of the actuation element 112 integrated with the valve repair device 3100. In these embodiments, the strain gauge wire 3116a may include a weak portion (similar to, for example, the weak portions 3114b, 3114c described with reference to Figure 32) that allows the wire 3116a to break so that the delivery system 3102 can be removed from the object while the strain gauge remains on the valve repair device 3100 to be implanted in the object.

[0120] Referring to Figure 32, in some examples, the force measuring device 3110b may be positioned on one gripping member of the valve repair device 3100, and the other force measuring device 3110c may be positioned on another gripping member of the valve repair device 3100. The illustrated embodiment shows a valve repair device 3100 having two gripping members, but it should be understood that the valve repair device 3100 may have any number of gripping members, fasteners, etc., and the force measuring devices may be positioned on one or more of the gripping members / fasteners / etc. In the illustrated embodiment, the force measuring devices 3110b, 3110c are positioned on the movable arm 134 of the fastener 130 of the gripping member, but it should be understood that the force measuring devices 3110b, 3110c may be positioned at any location on the gripping member that enables the force measuring devices 3110b, 3110c to measure the tension supplied to the leaflet.

[0121] When the valve repair device 3100 is attached to the leaflet and in the closed position, this attachment between the valve repair device 3100 and the leaflet can apply tension to the leaflet and induce a corresponding force F2 on the gripping member. In some implementations, force measuring devices 3110b, 3110c are configured to measure the force F2 on the corresponding gripping member, and by measuring the force F2, the user can determine whether the corresponding tension provided to one or more of the leaflets is at a desired or undesirable level.

[0122] In some implementations, each of the force measuring devices 3110b, 3110c may include a strain gauge having one or more corresponding wires 3116b, 3116c extending into the device to measure another electrical property that can be used to measure electrical resistance or force and / or strain. In some implementations, each of the wires 3116b, 3116c may have a separation feature such as a connector or fragile portion 3114b, 3114c that allows the wire to be broken and / or separated so that the strain gauge can remain on the valve repair device 3100 and at least a portion of each of the wires 3116b, 3116c can be removed from the object using the delivery system 3102. In some implementations, the weak portions 3114b, 3114c can be, for example, soldered joints, thinner portions of wire, thin portions of printed circuit traces, temporary mechanical connections such as twisted wire connections, electrical connectors such as plugs and / or sockets, or any other suitable means that allow the user to separate and / or break wires 3116b, 3116c after the implantation of valve repair device 3100. In some embodiments, wires 3116b, 3116c can be cut and broken using a cutting device (not shown).

[0123] Although the force measuring devices 3110a to 3110c are described as including strain gauges, it should be understood that the force measuring devices 3110a to 3110c can take any other preferred form that can determine the tension applied to the leaflets by the valve repair device 3100. For example, the force measuring devices 3110a to 3110c may include load cell sensors, strain pads, piezoelectric sensors, any preferred position sensors for detecting changes in the position of the sensor due to the force generated by the connection between the valve repair device and the natural valve, or any other preferred type of sensor that allows the user to determine the tension applied to one or more leaflets of the natural valve.

[0124] The illustrated embodiments shown in Figures 31 and 32 show a valve repair device 3100 and a delivery system 3102 having three force measuring devices 3110a to 3110c, but it should be understood that the valve repair device 3100 and / or the delivery system 3102 may have any preferred number of force measuring devices. In some examples, only the valve repair device 3100 includes one or more force measuring devices. In some examples, only the delivery device 3102 includes one or more force measuring devices.

[0125] Referring here to Figures 16–21, the implantable device 100 shown in Figures 8–14 is delivered and implanted inside the natural mitral valve MV of the heart H. Referring to Figure 16, the delivery sheath / catheter is inserted through the septum into the left atrium LA, and the implant / device 100 is deployed from the fully open delivery catheter / sheath, as illustrated in Figure 16. The actuarial element 112 is then retracted, moving the implant / device to the fully closed position shown in Figure 17.

[0126] As can be seen from Figure 18, the implant / device is moved to a position within the mitral valve MV and into the ventricular LV, and partially opened to allow grasping of leaflets 20 and 22. For example, as illustrated in Figure 18, the maneuverable catheter can be advanced and steered, or bent to position the maneuverable catheter. The implant catheter connected to the implant / device can be advanced from inside the maneuverable catheter to position the implant, as illustrated in Figure 18.

[0127] Referring to Figure 19, the implant catheter can be retracted into the maneuverable catheter to position the mitral valve leaflets 20 and 22 within the clasps 130. The actuation line 116 extends to close one of the clasps 130 and capture leaflet 20. Figure 20 shows another actuation line 116 that then extends to close the other clasp 130 and capture the remaining leaflet 22. Finally, as can be seen from Figure 21, the delivery system 102 (e.g., maneuverable catheter, implant catheter, etc.), actuation element 112, and actuation line 116 are then retracted, and the device or implant 100 is fully closed and deployed within the natural mitral valve MV.

[0128] Any of the features disclosed in this application can be used in a wide variety of different valve repair devices. Figures 22–24 illustrate embodiments of valve repair devices that can be modified to include any of the features disclosed in this application. Any combination or subcombination of the features disclosed in this application can be combined with, replaced by, and / or added to any combination or subcombination of the features of the valve repair devices illustrated in Figures 8–24.

[0129] Referring here to Figure 22, an embodiment of the implantable device or implant 200 is shown. The implantable device 200 is one of many different forms that the device 100 schematically illustrated in Figures 8 to 14 can take. The device 200 may include any other features for the implantable device or implant discussed herein, and the device 200 may be positioned to engage with valve tissue 20, 22 as part of any suitable valve restoration system (e.g., any valve restoration system disclosed herein). The device / implant 200 may be an artificial spacer device, a valve restoration device, or another type of implant attached to the leaflet of a natural valve.

[0130] In some implementations, the implantable device or implant 200 includes a joint portion 204, a proximal or attachment portion 205, an anchor portion 206, and a distal portion 207. In some implementations, the joint portion 204 of the device optionally includes a joint element 210 (e.g., a spacer, joint element, plug, membrane, sheet, gap filler, etc.) 210 for implantation between leaflets of a natural valve. In some implementations, the anchor portion 206 includes a plurality of anchors 208. The anchors can be configured in various ways. In some implementations, each anchor 208 includes an outer paddle 220, an inner paddle 222, a paddle extension member or paddle frame 224, and a clasp 230. In some implementations, the attachment portion 205 includes a first or proximal collar 211 (or other attachment element) for engaging with the capture mechanism of the delivery system. The delivery system for device 200 may be identical or similar to the delivery system 102 described above, and may comprise one or more of the following: catheter, sheath, guide catheter / sheath, delivery catheter / sheath, maneuverable catheter, implantable catheter, tube, channel, route, combination thereof, etc.

[0131] In some implementations, the joining elements 210 and paddles 220, 222 are made from a flexible material which may be a metal fabric formed in a mesh, woven, braided or any other preferred manner, or a flexible material which is laser-cut or otherwise cut. The material may be a cloth, a shape memory alloy wire such as Nitinol to provide shape-setting ability, or any other flexible material suitable for implantation in the human body.

[0132] Actuating elements (e.g., acting shafts, acting rods, acting tubes, acting wires, acting lines, etc.) may extend from a delivery system (not shown) and engage with an implantable device or implant 200 to enable its operation. In some implementations, the acting elements extend through a proximal collar 211 and a spacer or bonding element 210 and engage with a cap 214 of the distal portion 207. The acting elements may be configured to engage with the cap 214 detachably by a screw connection or similar connection, so that after implantation, the acting elements can be disengaged and removed from the device 200.

[0133] The joint element 210 extends from the proximal collar 211 (or other mounting member) to the inner paddle 222. In some configurations, the joint element 210 has an overall elongated and circular shape, but other shapes and configurations are possible. In some configurations, the joint element 210 has an elliptical shape or cross-section when viewed from above, a tapered shape or cross-section when viewed from the front, and a circular shape or cross-section when viewed from the side. A mixture of these three geometric shapes can result in a three-dimensional shape relating to the illustrated joint element 210 that achieves the advantages described herein. It can also be understood that the circular shape of the joint element 210 substantially follows or approximates the shape of the paddle frame 224 when viewed from above.

[0134] The size and / or shape of the joint element 210 can be selected to minimize the number of implants (preferably one) required for a single target, while simultaneously maintaining a low trans-valve slope. In some implementations, the anterior-posterior distance at the top of the joint element is approximately 5 mm, and the inward-outward distance at the widest point of the joint element is approximately 10 mm. In some implementations, the overall geometry of the device 200 can be based on these two dimensions and the overall shape strategy described above. It will be readily apparent that using other anterior-posterior distances and inward-outward distances as a starting point for the device will result in devices with different dimensions. Furthermore, using other dimensions and shape strategies described above will also result in devices with different dimensions.

[0135] In some implementations, the outer paddle 220 is articulately attached to the cap 214 of the distal portion 207 by a connecting portion 221, and to the inner paddle 222 by a connecting portion 223. The inner paddle 222 is articulately attached to the joint element by a connecting portion 225. Thus, the anchor 208 is constructed similarly to a leg, with the inner paddle 222 resembling the upper portion of a leg, the outer paddle 220 resembling the lower portion of a leg, and the connecting portion 223 resembling the knee portion of a leg.

[0136] In some implementations, the inner paddle 222 is rigid, relatively rigid, or stiff, and has a rigid portion and / or is hardened by a reinforcing member (e.g., a bar, a support, etc.) or a fixing portion of the fastener 230. The inner paddle 222, the outer paddle 220, and the connecting elements can all be interconnected as described herein.

[0137] In some configurations, the paddle frame 224 is attached to the cap 214 at its distal portion 207 and extends to the connecting portion 223 between the inner paddle 222 and the outer paddle 220. In some configurations, the paddle frame 224 is formed from a more rigid and harder material than the material forming the paddles 222 and 220, so that the paddle frame 224 provides support for the paddles 222 and 220.

[0138] The paddle frame 224 can provide additional clamping force between the inner paddle 222 and the connecting element 210, and can assist in winding the leaflet around the side of the connecting element 210. That is, the paddle frame 224 can be configured to have a rounded three-dimensional shape extending from the cap 214 to the connecting portion 223 of the anchor 208. The connections between the paddle frame 224, the outer paddle 220 and the inner paddle 222, the cap 214, and the connecting element 210 can restrict each of these members to the movement and position described herein. In particular, the connecting portion 223 is restricted by its connection between the outer paddle 220 and the inner paddle 222, and by its connection to the paddle frame 224. Similarly, the paddle frame 224 is restricted by its attachment to the connecting portion 223 (and thus to the inner paddle 222 and the outer paddle 220), and by its attachment to the cap 214.

[0139] The wider configuration of the paddle frame 224 provides an increased surface area compared to the case with only the inner paddle 222. This increased surface area allows the clamping force of the paddle 220 and paddle frame 224 on the natural leaflet to be distributed over a relatively large surface area of ​​the natural leaflet, further protecting the natural leaflet tissue.

[0140] Additional features of device 200, modified versions of the device, a delivery system for the device, and methods for using the device and the delivery system are disclosed in Patent Cooperation Treaty International Application PCT / US2018 / 028189 (International Publication 2018 / 195215). Any combination or subcombination of the features disclosed in this application may be combined with any combination or subcombination of the features disclosed in Patent Cooperation Treaty International Application PCT / US2018 / 028189 (International Publication 2018 / 195215). Patent Cooperation Treaty International Application PCT / US2018 / 028189 (International Publication 2018 / 195215) is incorporated herein by reference in its entirety.

[0141] Figure 33 illustrates an embodiment of device 3300 and / or actuarial element 3312 of a delivery system configured to detect tension supplied to a leaflet due to the connection between device 3300 and the leaflet. Device 3300 may be identical or similar to device 200 illustrated by Figure 22. In some implementations, device 3300 in Figure 33 includes one or more force measuring devices 3310a-3310c for detecting tension supplied to the leaflet. That is, the connection between device 3300 and the leaflet causes tension in the leaflet, and force measuring devices 3310a-3310c may be configured to measure the tension supplied to the leaflet so that a user can determine whether the tension is higher or lower than an optimal force range. For example, if the tension is below a predetermined amount, there may be an insufficient attachment between device 3300 and the leaflet. If the tension is above a predetermined amount, too much leaflet may be gripped by device 3300.

[0142] The force measuring devices 3110a to 3110c can take on various different forms. For example, the force measuring devices 3110a to 3110c can be one or more of the following: strain gauges, optical sensors, proximity sensors, and / or Hall sensors.

[0143] The force measuring device can be positioned anywhere on the device 3300 and / or the delivery system, enabling the force measuring device to measure the tension supplied to the leaflet and / or measure tensions, other forces, positions, etc., correlated with the tension on the leaflet. In the illustrated embodiment, the force measuring device 3310a is positioned on the actuation element 3312 of the delivery system.

[0144] In some implementations, the actuation of the actuation element 3312 opens and closes one or more anchors 208 of the device 3300, gripping the leaflet of the natural valve during implantation. For example, extension of the actuation element 3312 can move the cap 214 of the device 3300 away from the connecting element 210, moving one or more anchors 208 to the open position, while retraction of the actuation element 3312 can move the cap 214 towards the connecting element 210, moving one or more anchors 208 to the closed position.

[0145] When the valve repair device 3300 is attached to the leaflet and in the closed position, this attachment between the valve repair device 3300 and the leaflet can exert tension on the leaflet and generate a force corresponding to one or more anchors 208. This force supplied to the anchors 208 may cause the anchors to partially open, which generates a force F1 on the actuating element 3312 as the anchors 208 open and close due to the movement of the actuating element 3312. A force measuring device 3310a is configured to measure the force F1 on the actuating element 3312, and by measuring the force F1, the user can determine whether the corresponding tension supplied to the leaflet is at a desired or undesirable level.

[0146] In the illustrated embodiment, the force measuring device 3310a includes a strain gauge having one or more wires 3316a extending to a device (not shown) for measuring electrical resistance (e.g., an ohmmeter). After the valve repair device 3300 is attached to the natural valve and it is determined that the tension supplied to the leaflet is at a desired level, the actuating element 3312 is removed from the valve repair device 3300 and removed from the object using a delivery system. In other embodiments, the force measuring device 3310a may be attached to a portion of the actuating element 3312 integrated with the valve repair device 3300. In these embodiments, the wires 3316a of the strain gauge may include weak portions (similar to the weak portions 3314b, 3314c of the wires 3316b, 3316c of the force measuring devices 3310b, 3310c) that allow the wires 3316a to be broken and / or separated so that the delivery system can be removed from the object while the strain gauge remains on the valve repair device 3300 to be implanted in the object.

[0147] In some embodiments, the force measuring device 3310b may be positioned on one fastener 230 of the valve repair device 3300, and the other force measuring device 3310c may be positioned on another fastener 230 of the valve repair device 3300. The illustrated embodiment shows a valve repair device 3300 having two fasteners 230, but it should be understood that the valve repair device 3300 may have any preferred number of fasteners, and the force measuring devices may be positioned on one or more of the fasteners. In the illustrated embodiment, the force measuring devices 3310b, 3310c are positioned on the movable arms 234 of the fasteners 230, but it should be understood that the force measuring devices 3310b, 3310c may be positioned at any location on the fasteners 230 that allows the force measuring devices 3310b, 3310c to measure the tension supplied to the leaflet.

[0148] When the valve repair device 3300 is attached to the leaflet and in the closed position, this attachment between the valve repair device 3300 and the leaflet can apply tension to the leaflet and induce a corresponding force F2 in the fastener 230. Force measuring devices 3310b, 3310c are configured to measure the force F2 on the corresponding gripping members, and by measuring the force F2, the user can determine whether the tension supplied to one or more of the leaflets is at a desired or undesirable level.

[0149] In some implementations, each of the force measuring devices 3310b, 3310c may include a strain gauge having one or more corresponding wires 3316b, 3316c extending into the device for measuring electrical resistance. In some implementations, each of the wires 3316b, 3316c may have a weak portion 3314b, 3314c that allows the wire to be separated and / or broken so that the strain gauge can remain on the valve repair device 3300 and at least a portion of each of the wires 3316b, 3316c can be removed from the object using a delivery system.

[0150] In some implementations, the weak portions 3314b, 3314c can be, for example, soldered joints, thinner portions of wire, thin portions of printed circuit traces, temporary mechanical connections such as twisted wire connections, electrical connectors such as plugs and / or sockets, or any other suitable means that allow the user to break the wires 3316b, 3316c after the installation of the valve repair device 3300. In some embodiments, the wires 3316b, 3316c can be cut and broken using a cutting device (not shown).

[0151] Although the force measuring devices 3310a to 3310c are described as including strain gauges, it should be understood that the force measuring devices 3310a to 3310c can take any other preferred form that can determine the tension applied to the leaflet by the valve repair device 3300 and / or measure tension, another force, position, etc., correlated with the tension on the leaflet. For example, the force measuring devices 3310a to 3310c may include load cell sensors, strain pads, piezoelectric sensors, any preferred position sensors for detecting changes in the position of the sensor due to the force generated by the connection between the valve repair device and the natural valve, or any other preferred type of sensor that allows the user to determine and / or correlate the tension applied to one or more leaflets of the natural valve.

[0152] The illustrated embodiment shown in Figure 33 shows a delivery system having a valve repair device 3300 and three force measuring devices 3310a to 3310c, but it should be understood that the valve repair device 3300 and / or the delivery system may have any preferred number of force measuring devices. In some examples, only the valve repair device 3300 includes one or more force measuring devices. In other examples, only the delivery device includes one or more force measuring devices.

[0153] Referring here to Figure 23, an embodiment of the implantable device or implant 300 is shown. The implantable device 300 is one of many different forms that the device 100 schematically illustrated in Figures 8 to 14 can take. The device 300 may include any other features of the implantable device or implant described herein, and the device 300 may be positioned to engage with valve tissue 20, 22 as part of any suitable valve restoration system (e.g., any valve restoration system disclosed herein).

[0154] In some implementations, the implantable device or implant 300 includes a proximal or attachment portion 305, an anchor portion 306, and a distal portion 307. In some implementations, the device / implant 300 includes a bonding portion 304, which optionally includes bonding elements 310 (e.g., spacers, plugs, membranes, sheets, etc.) for implantation between leaflets 20 and 22 of the natural valve.

[0155] In some implementations, the anchor portion 306 includes a plurality of anchors 308. In some implementations, each anchor 308 may include, for example, one or more paddles of an outer paddle 320, an inner paddle 322, a paddle extension member (e.g., a leaf spring, a shaping wire, etc.), or a paddle frame 324. The anchors may also include and / or be coupled to a fastener 330. In some implementations, the mounting portion 305 includes a first collar or proximal collar 311 (or other mounting member) for engaging with the capture mechanism of the delivery system.

[0156] The anchor 308 can be attached to and / or to other parts of the device in a variety of different ways (e.g., directly, indirectly, by welding, sutures, adhesive, links, latches, integral molding, or a combination of some or all of these). In some implementations, the anchor 308 is attached to the joint element 310 by a connecting portion 325 and to the cap 314 by a connecting portion 321.

[0157] In some implementations, the anchor 308 can consist of a first part or outer paddle 320 and a second part or inner paddle 322, separated by a connecting part 323. The connecting part 323 can be attached to a paddle frame 324 that is hinged to a cap 314 or to another mounting part. Thus, the anchor 308 is constructed similarly to a leg, with the inner paddle 322 resembling the upper part of a leg, the outer paddle 320 resembling the lower part of a leg, and the connecting part 323 resembling the knee part of a leg.

[0158] In some implementations equipped with a joining element 310, the joining element 310 and the anchor 308 can be joined together in various ways. As shown in the illustrated embodiment, the joining element 310 and the anchor 308 can be joined together by forming the joining element 310 and the anchor 308 integrally as a single, integrated component. This can be achieved, for example, by forming the joining element 310 and the anchor 308 from a continuous piece 301 of a braided or woven material, such as braided or woven Nitinol wire. In the illustrated embodiment, the joining element 310, the outer paddle portion 320, the inner paddle portion 322, and the connecting portions 321, 323, and 325 are formed from a continuous piece of woven fabric 301.

[0159] Similar to the anchor 208 of the implantable device or implant 200 described above, the anchor 308 can be configured to move between various configurations by moving the distal end of the device (e.g., cap 314, etc.) axially relative to the proximal end of the device (e.g., proximal collar 311, or other mounting element, etc.). This movement can be performed along a longitudinal axis extending between the distal end (e.g., cap 314, etc.) and the proximal end (e.g., collar 311, or other mounting element, etc.) of the device.

[0160] In some implementations, in the linear configuration, the paddle portions 320 and 322 are aligned with or linear to the orientation of the longitudinal axis of the device. In some implementations, the connecting portion 323 of the anchor 308 is adjacent to the longitudinal axis of the spacer or joining element 310. From the linear configuration, the anchor 308 can be moved to a fully folded configuration (e.g., Figure 23) by, for example, moving its proximal and distal ends toward each other and / or moving it toward the midpoint or center of the device.

[0161] In some implementations, the fastener includes a movable arm connected to the anchor. In some implementations, the fastener 330 includes a base or fixed arm 332, a movable arm 334, an optional thrust / friction-enhancing element 336, and a joint portion 338.

[0162] In some implementations, the fixed arm 332 is attached to the inner paddle 322 with the joint portion 338 positioned close to the joint element 310. The joint portion 338 is equipped with a spring force so that the fixed arm 332 and the movable arm 334 are biased toward each other when the fastener 330 is closed.

[0163] In some configurations, the fixing arm 332 is attached to the inner paddle 322 by sutures through holes or slots. In some configurations, the fixing arm 332 can be attached to the inner paddle 322 by any suitable means, such as screws or other fasteners, crimp sleeves, mechanical latches or snaps, welding, adhesives, or the like.

[0164] In some implementations, the fixed arm 332 remains substantially stationary relative to the inner paddle 322 when the movable arm 334 is released, thereby releasing the fastener 330 and exposing an optional projection 336.

[0165] In some implementations, the fastener 330 is opened by applying tension to the actuation line attached to the movable arm 334, thereby causing the movable arm 334 to articulate, rotate, and / or bend at the joint portion 338.

[0166] In summary, the implantable device or implant 300 is similar in structure and operation to the implantable device or implant 200 described above, except that the bonding element 310, the outer paddle 320, the inner paddle 322, and the connecting portions 321, 323, and 325 are formed from a single piece of material 301. In some implementations, the piece of material 301 is attached to the proximal collar 311, the cap 314, and the paddle frame 324 by being woven or inserted through openings in the proximal collar 311, the cap 314, and the paddle frame 324 configured to receive a continuous piece of material 301.

[0167] In some implementation configurations, the continuous piece 301 may be a single layer made of material, or it may include two or more layers. In some implementation configurations, part of the device 300 has a single layer made of material piece 301, and the other part is formed from multiple overlapping or overlapping layers made of material piece 301.

[0168] For example, Figure 23 shows a joint element 310 and an inner paddle 322, such that they are formed from multiple overlapping layers consisting of material pieces 301. A single continuous piece of material 301 can start and end at various locations on the device 300. The ends of the material pieces 301 can be located at the same or different locations on the device 300. In the illustrated embodiment of Figure 23, the material piece 301 starts and ends at the location of the inner paddle 322.

[0169] Similar to the implantable device or implant 200 described above, the size of the joint element 310 can be selected to minimize the number of implants (preferably one) required for a single target, while simultaneously maintaining a low transflap gradient. In particular, by forming many of the components of the device 300 from material pieces 301, the device 300 can be fabricated to be smaller than the device 200. For example, in some implementations, the front-to-back distance at the top of the joint element 310 is less than 2 mm, and the inside-to-outside distance at the widest point of the device 300 (i.e., the width of the paddle frame 324 wider than the joint element 310) is about 5 mm.

[0170] Additional features of device 300, modified versions of the device, a delivery system for the device, and methods for using the device and the delivery system are disclosed in Patent Cooperation Treaty International Application PCT / US2019 / 055320 (International Publication 2020 / 076898). Any combination or subcombination of the features disclosed in this application may be combined with any combination or subcombination of the features disclosed in Patent Cooperation Treaty International Application PCT / US2019 / 055320 (International Publication 2020 / 076898). Patent Cooperation Treaty International Application PCT / US2019 / 055320 (International Publication 2020 / 076898) is incorporated herein by reference in its entirety.

[0171] Figure 34 illustrates an embodiment of device 3400 and / or actuarial element 3412 of a delivery system configured to detect tension supplied to a leaflet due to a connection between device 3400 and the leaflet. Device 3400 may be identical or similar to device 300 illustrated by Figure 23. In some implementations, device 3400 of Figure 34 includes one or more force measuring devices 3410a to 3410c for detecting tension supplied to the leaflet and / or for measuring tension, other forces, position, etc., correlated with the tension on the leaflet.

[0172] In some implementations, the connection between device 3400 and leaflet can be configured to apply tension to the leaflet, and force measuring devices 3410a-3410c can be configured to measure the tension supplied to the leaflet and / or to measure a force that can correlate with the tension applied to the leaflet, so that the user can determine whether the tension is higher or lower than the optimal tension range. For example, if the tension is below a predetermined amount, there may be an insufficient attachment between device 3400 and leaflet. If the tension is above a predetermined amount, too much leaflet may be gripped by device 3400.

[0173] A force measuring device can be positioned anywhere on device 3400 and / or the delivery system, enabling the force measuring device to measure the tension supplied to the leaflet. In the illustrated embodiment, the force measuring device 3410a is positioned on the actuating element 3412 of the delivery system. In some implementations, the actuation of the actuating element 3412 opens and closes one or more anchors 308 of device 3400, gripping the leaflet of the natural valve during transplantation. For example, extension of the actuating element 3412 can move the cap 314 of device 3400 away from the joining element 310, moving one or more anchors 308 to the open position, while retraction of the actuating element 3412 can move the cap 314 towards the joining element 310, moving one or more anchors 308 to the closed position.

[0174] When the valve repair device 3400 is attached to the leaflet and in the closed position, this attachment between the valve repair device 3400 and the leaflet can exert tension on the leaflet and generate a force corresponding to one or more anchors 308. This force supplied to the anchors 308 may cause the anchors to partially open, which generates a force F1 on the actuating element 3312 as the anchor 208 opens and closes due to the movement of the actuating element 3412. A force measuring device 3410a is configured to measure the force F1 on the actuating element 3412, and by measuring the force F1, the user can determine whether the corresponding tension supplied to the leaflet is at a desired or undesirable level.

[0175] In the illustrated embodiment, the force measuring device 3410a includes a strain gauge having one or more wires 3416a extending to a device (not shown) for measuring electrical resistance (e.g., an ohmmeter). After the valve repair device 3400 is attached to the natural valve and it is determined that the tension supplied to the leaflet is at a desired level, the actuating element 3412 is removed from the valve repair device 3400 and removed from the object using a delivery system. In other embodiments, the force measuring device 3410a may be attached to a portion of the actuating element 3412 integrated with the valve repair device 3400. In these embodiments, the strain gauge wire 3416a may include a removable and / or weak portion (for example, similar to the weak portions 3414b, 3414c of the wires 3416b, 3416c of the force measuring devices 3410b, 3410c) that allows the wire 3416a to be separated and / or broken so that the delivery system can be removed from the target while the strain gauge remains on the valve repair device 3400 to be implanted in the target.

[0176] In some embodiments, the force measuring device 3410b may be positioned on one latch 330 of the valve repair device 3400, and the other force measuring device 3410c may be positioned on another latch 330 of the valve repair device 3400. The illustrated embodiment shows a valve repair device 3400 having two latches 330, but it should be understood that the valve repair device 3400 may have any preferred number of latches, and the force measuring devices may be positioned on one or more of the latches. In the illustrated embodiment, the force measuring devices 3410b, 3410c are positioned on the movable arms 334 of the latches 330, but it should be understood that the force measuring devices 3410b, 3410c may be positioned at any location on the latches 330 that allows the force measuring devices 3410b, 3410c to measure the tension supplied to the leaflet and / or allow force, position, or other measured characteristics to correlate with the tension on the leaflet. When the valve repair device 3400 is attached to the leaflet and in the closed position, this attachment between the valve repair device 3400 and the leaflet can exert tension on the leaflet and cause a corresponding force F2 to be exerted on the fastener 330.

[0177] In some implementations, the force measuring devices 3410b and 3410c are configured to measure a force F2 on the corresponding gripping member, and by measuring the force F2, the user can determine whether the tension provided to one or more of the leaflets is at a desired or undesirable level.

[0178] In some implementations, each of the force measuring devices 3410b, 3410c may include a strain gauge having one or more corresponding wires 3416b, 3416c extending into the device for measuring electrical resistance.

[0179] In some implementations, wires 3416b and 3416c may each have a removable and / or fragile portion 3414b, 3414c that allows the wire to be separated and / or broken so that the strain gauge can remain on the valve repair device 3400, and at least a portion of each wire 3416b and 3416c can be removed from the object using a delivery system. In some implementations, the fragile portions 3414b and 3414c can be, for example, a soldered joint, a thinner portion of the wire, a thin portion of a printed circuit trace, a temporary mechanical connection such as a twisted wire connection, an electrical connector such as a plug and / or socket, or any other preferred means that allows the user to separate and / or break wires 3416b and 3416c after the valve repair device 3400 has been implanted. In some embodiments, wires 3416b and 3416c may be cut and broken using a cutting device (not shown).

[0180] Although the force measuring devices 3410a to 3410c are described as including strain gauges, it should be understood that the force measuring devices 3410a to 3410c can take any other preferred form that can determine the tension applied to the leaflets by the valve repair device 3400. For example, the force measuring devices 3410a to 3410c may include load cell sensors, strain pads, piezoelectric sensors, any preferred position sensors for detecting changes in the position of the sensor due to the force generated by the connection between the valve repair device and the natural valve, or any other preferred type of sensor that allows the user to determine the tension applied to one or more leaflets of the natural valve.

[0181] The illustrated embodiment shown in Figure 34 shows a delivery system having a valve repair device 3400 and three force measuring devices 3410a to 3410c, but it should be understood that the valve repair device 3400 and / or the delivery system may have any preferred number of force measuring devices. In some examples, only the valve repair device 3400 includes one or more force measuring devices. In other examples, only the delivery device includes one or more force measuring devices.

[0182] Figure 24 illustrates one of many valve repair systems 40056 for repairing a natural valve in question to which the concepts of this application can be applied. The valve repair system 40056 includes a delivery device 40156 and a valve repair device 40256.

[0183] The valve repair device 40256 includes a base assembly 40456, a pair of paddles 40656, and a pair of gripping members 40856 (e.g., fasteners, clips, arms, etc.). In one embodiment, the paddles 40656 can be formed integrally with the base assembly. For example, the paddles 40656 can be formed as extensions of links in the base assembly. In the illustrated embodiment, the base assembly 40456 of the valve repair device 40256 includes a shaft 40356, a coupler 40556 configured to move along the shaft, and a lock 40756 configured to lock the coupler in a stationary position on the shaft.

[0184] In some implementations, the coupler 40556 is mechanically connected to the paddle 40656, so that as the coupler 40556 moves along the shaft 40356, the paddle moves between an open and a closed position. Thus, the coupler 40556 is a means for mechanically coupling the paddle 40656 to the shaft 40356, and when moving along the shaft 40356, it functions as a means for moving the paddle 40656 between their open and closed positions.

[0185] In some implementations, the gripping member 40856 is pivotably connected to the base assembly 40456 (for example, the gripping member 40856 can be pivotably connected to the shaft 40356 or any other suitable member of the base assembly), and as a result, the gripping member can move to adjust the width of the opening 41456 between the paddle 40656 and the gripping member 40856. In some implementations, the gripping member 40856 may include an optional return portion 40956 for attaching the gripping member to the valve tissue when the valve repair device 40256 is attached to the valve tissue.

[0186] In some implementations, when the paddle 40656 is in the closed position, the paddle engages with the gripping member 40856, and as a result, if the valve tissue is attached to the barbed portion 40956 of the gripping member, the paddle secures the valve repair device 40256 to the valve tissue. In some implementations, the gripping member 40856 is configured to engage with the paddle 40656, and as a result, the barbed portion 40956 engages with the valve tissue and the paddle 40656 to secure the valve repair device 40256 to the valve tissue. For example, in certain situations, it may be advantageous to keep the paddle 40656 in the open position and move the gripping member 40856 outward toward the paddle 40656 in order to engage with the valve tissue and the paddle 40656.

[0187] Although the embodiment shown in Figure 24 illustrates a pair of paddles 40656 and a pair of gripping members 40856, it will be understood that the valve repair device 40256 may include any preferred number of paddles and gripping members.

[0188] In some implementations, the valve repair system 40056 includes an installation shaft 41356 that is detachably attached to the shaft 40356 of the base assembly 40456 of the valve repair device 40256. The installation shaft 41356 is removed from the shaft 40356 after the valve repair device 40256 has been secured to the valve tissue, thereby removing the valve repair device 40256 from the remainder of the valve repair system 40056, so that the valve repair device 40256 can remain attached to the valve tissue and the delivery device 40156 can be removed from the body of the subject.

[0189] In some implementations, the valve repair system 40056 may also include a paddle control mechanism 41056 (e.g., a relatively movable tube, shaft, etc.), a gripper control mechanism 41156 (e.g., a wire, line, suture, etc.), and a lock control mechanism 41256 (e.g., a relatively movable tube, shaft, wire, line, suture, etc.). In some implementations, the paddle control mechanism 41056 is mechanically attached to a coupler 40556 to move the coupler along the shaft, thereby moving the paddle 40656 between an open position and a closed position.

[0190] The paddle control mechanism 41056 can take any preferred form, such as a shaft or rod. For example, the paddle control mechanism may include a hollow shaft and a catheter tube or sleeve that fits onto the mounting shaft 41356 and shaft 40356 and is connected to the coupler 40556.

[0191] In some implementations, the gripper control mechanism 41156 is configured to move the gripping member 40856 so that the width of the opening 41456 between the gripping member and the paddle 40656 can be changed. The gripper control mechanism 41156 can take any preferred form, such as a line, suture or wire, rod, catheter, etc.

[0192] In some implementations, the lock control mechanism 41256 is configured to lock and unlock the lock. In some implementations, the lock 40756 locks the coupler 40556 to the stationary position relative to the shaft 40356, and can take on a wide variety of different forms, with the type of lock control mechanism 41256 being determined by the type of lock used.

[0193] In embodiments in which the lock 40756 includes a pivotable plate, the lock control mechanism 41256 is configured to engage with the pivotable plate to move the plate between an inclined position and a substantially non-inclined position. In some implementations, the lock control mechanism 41256 can be, for example, a rod, suture, wire, or any other member that can move the pivotable plate of the lock 40756 between an inclined position and a substantially non-inclined position.

[0194] In some implementations, the valve repair device 40256 is movable from an open position to a closed position. In some implementations, the base assembly 40456 includes a link that is moved by a coupler 40556. In some implementations, the coupler 40556 is movably mounted on the shaft 40356. To move the valve repair device from an open position to a closed position, the coupler 40556 is moved along the shaft 40356, thereby moving the link.

[0195] In some implementations, the gripper control mechanism 41156 moves the gripping member 40856 to widen or narrow the gap in the opening 41456 between the gripping member and the paddle 40656. In the illustrated embodiment, the gripper control mechanism 41156 includes a line, such as a suture or wire, connected to the opening in the end of the gripper member 40856. In some implementations, when the line is pulled, the gripping member 40856 moves inward, widening the opening 41456 between the gripping member and the paddle 40656.

[0196] In some implementations, the lock 40756 is moved to the unlocked state by the lock control mechanism 41256 in order to move the valve repair device 40256 from the open position to the closed position. After the lock 40756 is unlocked, the coupler 40556 can be moved along the shaft 40356 by the paddle control mechanism 41056.

[0197] In some implementations, after the paddle 40656 is moved to the closed position, the lock 40756 is moved to the locked position by the lock control mechanism 41256, maintaining the valve repair device 40256 in the closed position. In some implementations, after the valve repair device 40256 is maintained in the locked position by the lock 40756, the valve repair device 40256 is removed from the delivery device 40156 by disconnecting the shaft 40356 from the installation shaft 41356. In addition, the valve repair device 40256 can be disengaged from the paddle control mechanism 41056, the gripper control mechanism 41156, and the lock control mechanism 41256.

[0198] Additional features of device 40256, modified versions of the device, a delivery system for the device, and methods for using the device and the delivery system are disclosed in Patent Cooperation Treaty International Application PCT / US2019 / 012707 (International Publication 2019 / 139904). Any combination or subcombination of the features disclosed in this application may be combined with any combination or subcombination of the features disclosed in Patent Cooperation Treaty International Application PCT / US2019 / 012707 (International Publication 2019 / 139904). Patent Cooperation Treaty International Application PCT / US2019 / 012707 (International Publication 2019 / 139904) is incorporated herein by reference in its entirety.

[0199] The clasps or leaflet gripping devices disclosed herein can take on a wide variety of different forms. Examples of clasps are disclosed in Patent Cooperation Treaty International Application PCT / US2018 / 028171 (International Publication 2018 / 195201). Any combination or partial combination of the features disclosed in this application can be combined with any combination or partial combination of the features disclosed in Patent Cooperation Treaty International Application PCT / US2018 / 028171 (International Publication 2018 / 195201). Patent Cooperation Treaty International Application PCT / US2018 / 028171 (International Publication 2018 / 195201) is incorporated herein by reference in its entirety.

[0200] Figure 35 illustrates another embodiment of one of many valve repair systems for repairing a natural valve in question to which the concepts of the present application can be applied, the valve repair system 3501 being configured to detect the tension supplied to the leaflet due to the connection between the valve repair device 3500 of system 3501 and the leaflet, and / or to measure tension, another force, position, etc., correlated with the tension on the leaflet.

[0201] In some implementations, the valve repair system 3501 includes a delivery device 3502 and a valve repair device 3500. The delivery device 3502 and the valve repair device 3500 may be the same as or similar to the delivery device 40156 and the valve repair device 41456 illustrated by Figure 24, respectively. In some implementations, at least one of the delivery device 3502 and the valve repair device 3500 in Figure 34 includes one or more force measuring devices 3510a to 3510c for detecting the tension supplied to the leaflet and / or tension, other forces, positions, etc., correlated with the tension on the leaflet. That is, the connection between device 3500 and the leaflet is configured to apply tension to the leaflet, and the force measuring devices 3510a to 3510c are configured to measure the tension supplied to the leaflet, or correlated forces, distances, or other characteristics, so that the user can determine whether the tension is outside a preferred tension range. For example, if the tension is below a predetermined amount, there may be insufficient attachment between the device 3500 and the leaflet. If the tension is above a predetermined amount, too much leaflet may be gripped by the device 3500.

[0202] The force measuring device can be positioned anywhere on device 3500 and / or delivery device 3502, enabling the force measuring device to measure the tension supplied to the leaflet. In the illustrated embodiment, the force measuring device 3510a is positioned on the paddle control mechanism 41056 of the delivery device 3502. The paddle control mechanism 41056 is mechanically mounted to the coupler 40556, and by moving the coupler 40556 along the shaft 40356, it moves the paddle 40656 between an open position and a closed position. When the valve repair device 3500 is mounted to the leaflet and in the closed position, this mounting between the valve repair device 3500 and the leaflet can apply tension to the leaflet and the corresponding force to the paddle 40656. The force applied to the paddle 40656 can partially open the paddle, causing a force F1 on the paddle control mechanism 41056 as the opening of the paddle 40656 engages the coupler 40556 with the paddle control mechanism 41056. The force measuring device 3510a is configured to measure the force F1 on the paddle control mechanism 41056, and by measuring the force F1, the user can determine whether the corresponding tension applied to the leaflet is at a desired or undesirable level.

[0203] In the illustrated embodiment, the force measuring device 3510a includes a strain gauge having one or more wires 3516a extending to a device (not shown) for measuring electrical resistance (e.g., an ohmmeter). After the valve repair device 3500 is attached to the natural valve and it is determined that the tension supplied to the leaflet is at a desired level, the delivery system 3502 is removed from the object. In other embodiments, the force measuring device 3510a may be attached to a part of a paddle control mechanism 41056 or coupler 40556 integrated with the valve repair device 3500. In these embodiments, the wires 3516a of the strain gauge may include weak portions (similar to the weak portions 3514b, 3514c of the wires 3516b, 3516c of the force measuring devices 3510b, 3510c) that allow the wires 3516a to be separated and / or broken so that the delivery system can be removed from the object while the strain gauge remains on the valve repair device 3500 implanted in the object.

[0204] In some embodiments, a force measuring device 3510b may be positioned on one gripping member 40856 of the valve repair device 3500, and another force measuring device 3510c may be positioned on another gripping member 40856 of the valve repair device 3500. The embodiments illustrated show a valve repair device 3500 having two gripping members 40856, but it should be understood that the valve repair device 3500 may have any preferred number of gripping members, and that force measuring devices may be positioned on one or more of the gripping members.

[0205] The force measuring devices 3510b and 3510c can be positioned at any location on the corresponding gripping member 40856, enabling the force measuring devices 3510b and 3510c to measure the tension supplied to the leaflet and / or to correlate with the tension on the leaflet being measured, another force, position, etc. When the valve repair device 3500 is attached to the leaflet and in the closed position, this attachment between the valve repair device 3500 and the leaflet can apply tension to the leaflet and induce a corresponding force F2 on the gripping member 40856. The force measuring devices 3510b and 3510c are configured to measure the force F2 on the corresponding gripping member, and by measuring the force F2, the user can determine whether the tension supplied to one or more of the leaflets is at a desired or undesirable level.

[0206] In some implementations, each of the force measuring devices 3510b, 3510c may include a strain gauge having one or more corresponding wires 3516b, 3516c extending into the device for measuring electrical resistance. In some implementations, each of the wires 3516b, 3516c may have a weak portion 3514b, 3514c that allows the wire to be separated and / or broken so that the strain gauge can remain on the valve repair device 3500 and at least a portion of each of the wires 3516b, 3516c can be removed from the object using a delivery system. In some implementations, the weak portions 3514b, 3514c can be, for example, soldered joints, thinner portions of wires, thin portions of printed circuit traces, temporary mechanical connections such as twisted wire connections, electrical connectors such as plugs and / or sockets, or any other suitable means that allow the user to separate and / or break the wires 3516b, 3516c after the installation of the valve repair device 3500.

[0207] In some embodiments, a cutting device (not shown) may be used to cut and break the wires 3416b and 3416c.

[0208] Although the force measuring devices 3510a to 3510c are described as including strain gauges, it should be understood that the force measuring devices 3510a to 3510c can take any other preferred form that can determine the tension applied to the leaflets by the valve repair device 3500. For example, the force measuring devices 3510a to 3510c may include load cell sensors, strain pads, piezoelectric sensors, any preferred position sensors for detecting changes in the position of the sensor due to the force generated by the connection between the valve repair device and the natural valve, or any other preferred type of sensor that allows the user to determine the tension applied to one or more leaflets of the natural valve.

[0209] The illustrated embodiment shown in Figure 35 shows a delivery system having a valve repair device 3500 and three force measuring devices 3510a to 3510c, but it should be understood that the valve repair device 3500 and / or the delivery device 3502 may have any preferred number of force measuring devices. In some examples, only the valve repair device 3500 includes one or more force measuring devices. In other examples, only the delivery device 3502 includes one or more force measuring devices.

[0210] Referring to Figures 25A and 25B, an exemplary implementation of the valve repair device 40256 has a connecting element 3800. The valve repair device 40256 may have the same or similar configuration as the valve repair device illustrated by Figure 24 by adding a connecting element.

[0211] The joint element 3800 can take on a wide variety of different forms. The joint element 3800 can be compressible and / or expandable. For example, the joint element can be compressed to fit into one or more catheters of a delivery system, can be expanded when moved out of one or more catheters, and / or can be compressed by paddles 40656 to adjust the size of the joint element. In the embodiments illustrated by Figures 25A and 25B, the size of the joint element 3800 can be reduced by compressing the joint element with paddles 40656 and increased by moving the paddles 40656 apart from each other.

[0212] In some implementations, the joining element 3800 may extend beyond the outer edge 4001 of the gripping member or fastener 40856, as illustrated in the example, to provide an additional surface area for closing the gap of the mitral valve.

[0213] The connecting element 3800 can be coupled to the valve repair device 40256 in a variety of different ways. For example, the connecting element 3800 can be fixed to the shaft 40356, slidably positioned around the shaft, connected to the coupler 40556, connected to the lock 40756, and / or connected to the central portion of the clasp or gripping member 40856. In some implementations, the coupler 40556 can take the form of the connecting element 3800. That is, a single element can be used as both the coupler 40556 that moves the paddle 40656 between the open and closed positions and the connecting element 3800 that closes the gap between the leaflets 20 and 22, when the valve repair device 40256 is attached to the leaflets.

[0214] In some implementations, the connecting element 3800 can be positioned around one or more of the shafts or other control elements of the valve repair system 40056. For example, the connecting element 3800 can be positioned around shaft 40356, shaft 41356, paddle control mechanism 41056, and / or lock control mechanism 41256.

[0215] The valve repair device 40256 may include any other features to the valve repair device considered in this application, and the valve repair device 40256 may be positioned to engage with valve tissue as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). Additional features of device 40256, modified versions of the device, delivery systems for the device, and methods for using the device and delivery systems are disclosed in Patent Cooperation Treaty International Application PCT / US2019 / 012707 (International Publication 2019 / 139904). Any combination or subcombination of the features disclosed in this application may be combined with any combination or subcombination of the features disclosed in Patent Cooperation Treaty International Application PCT / US2019 / 012707 (International Publication 2019 / 139904).

[0216] Figure 36 illustrates another embodiment of one of many valve repair devices for repairing a natural valve in question to which the concepts of this application can be applied, wherein the valve repair device 3600 is configured to detect the tension supplied to the leaflet and / or to detect tension, other forces, position, etc., correlated with the tension on the leaflet due to the connection between the valve repair device 3600 and the leaflet. The valve repair device 3600 may be identical or similar to the valve repair device 40256 illustrated by Figures 25A and 25B.

[0217] In some implementations, the valve repair device 3600 in Figure 36 includes one or more force measuring devices 3610b to 3610c for detecting the tension supplied to the leaflet and / or for detecting tension, other forces, position, etc., correlated with the tension on the leaflet. That is, the connection between device 3600 and the leaflet is configured to apply tension to the leaflet, and the force measuring devices 3610b to 3610c are configured to measure the tension supplied to the leaflet and / or for measuring tension, other forces, position, etc., correlated with the tension on the leaflet, so that the user can determine whether the tension is outside a preferred tension range. For example, if the tension is below a predetermined amount, there may be an insufficient fit between device 3600 and the leaflet. If the tension is above a predetermined amount, too much leaflet may be gripped by device 3600.

[0218] The force measuring devices can be positioned anywhere on the device 3600, enabling the force measuring devices to measure the tension supplied to the leaflet and / or to measure tensions, other forces, positions, etc., that correlate with the tension on the leaflet. For example, force measuring device 3610b can be positioned on one gripping member 40856 of the valve repair device 3600, and another force measuring device 3610c can be positioned on another gripping member 40856 of the valve repair device 3500.

[0219] The illustrated embodiment shows a valve repair device 3600 having two gripping members 40856, but it should be understood that the valve repair device 3600 may have any preferred number of gripping members, and that force measuring devices may be positioned on one or more of the gripping members. Force measuring devices 3610b, 3610c may be positioned at any location on the corresponding gripping members 40856, enabling the force measuring devices 3610b, 3610c to measure the tension supplied to the leaflet. When the valve repair device 3600 is attached to the leaflet and in the closed position, this attachment between the valve repair device 3600 and the leaflet can apply tension to the leaflet, causing a corresponding force F on the gripping members 40856. The force measuring devices 3610b, 3610c are configured to measure the force on the corresponding gripping members, and by measuring the force F, the user can determine whether the tension supplied to one or more of the leaflets is at a desired or undesirable level.

[0220] In some implementations, each of the force measuring devices 3610b, 3610c may include a strain gauge having one or more corresponding wires 3616b, 3616c extending into the device for measuring electrical resistance. Each of the wires 3616b, 3616c may have a weak portion 3614b, 3614c that allows the wire to be separated and / or broken so that the strain gauge can remain on the valve repair device 3600 and at least a portion of each of the wires 3616b, 3616c can be removed from the object by a delivery system. The weak portions 3614b, 3614c can be, for example, a soldered joint, a thinner portion of a wire, a thin portion of a printed circuit trace, a temporary mechanical connection such as a twisted wire connection, an electrical connector such as a plug and / or socket, or any other preferred means that allows the user to break the wires 3616b, 3616c after the valve repair device 3600 has been installed. In some embodiments, a cutting device (not shown) may be used to cut and break the wires 3616b and 3616c.

[0221] Although the force measuring devices 3610b to 3610c are described as including strain gauges, it should be understood that the force measuring devices 3610b to 3510c can take any other preferred form that can determine the tension applied to the leaflets by the valve repair device 3600. For example, the force measuring devices 3610b to 3610c may include load cell sensors, strain pads, piezoelectric sensors, any preferred position sensors for detecting changes in the position of a sensor due to the force generated by the connection between the valve repair device and the natural valve, or any other preferred type of sensor that can enable a user to determine the tension applied to one or more leaflets of the natural valve and / or measure tension, another force, position, etc., correlated with the tension on the leaflets.

[0222] In some implementations, one or more force measuring devices (not shown) may be positioned on a delivery device (not shown) that delivers the valve repair device 3600 to the target natural valve. For example, a force measuring device may be mounted on a paddle control mechanism (not shown) of the delivery device, which is configured to engage with a coupler 40556 to move a paddle 40656 between an open and closed position. In some implementations, when the valve repair device 3600 is mounted on a leaflet and in the closed position, this mounting between the valve repair device 3600 and the leaflet can exert tension on the leaflet, causing a corresponding force on the paddle 40656. This force supplied to the paddle 40656 can partially open the paddle, causing a force (not shown) on the paddle control mechanism as the opening of the paddle 40656 engages the coupler 40556 with the paddle control mechanism.

[0223] In some implementations, the force measuring device can be configured to measure a force on the paddle control mechanism, and by measuring this force, the user can determine whether the corresponding tension provided to the leaflet is at a desired or undesirable level. The force measuring device can take any preferred form, such as any form for the force measuring device described in this application.

[0224] The illustrated embodiment shown in Figure 36 shows a valve repair device 3600 having two force measuring devices 3610b to 3610c, but it should be understood that the valve repair device 3600 may have any preferred number of force measuring devices. In various examples, both the valve repair device 3600 and the delivery device (not shown) include one or more force measuring devices. In some examples, only the valve repair device 3600 includes one or more force measuring devices. In other examples, only the delivery device includes one or more force measuring devices.

[0225] Figures 26 to 30 illustrate one of many valve repair systems for repairing a natural valve in question to which the concepts of this application can be applied, or another embodiment. Referring to Figures 29 and 30, the valve repair system includes an implantable catheter assembly 1611 and an implantable valve repair device 8200. Referring to Figures 26 to 28, the implantable device 8200 includes a proximal or attachment portion 8205, paddles (including an inner paddle portion 8122 and an outer paddle portion 8120), a paddle frame 8224, and a distal portion 8207. The attachment portion 8205, the distal portion 8207, and the paddle frame 8224 can be configured in various ways.

[0226] In the embodiment illustrated in Figure 26, the paddle frame 8224 can be symmetrical along the longitudinal axis YY. However, in some implementations, the paddle frame 8224 is not symmetrical about axis YY. Furthermore, referring to Figure 26, the paddle frame 8224 includes an outer or adjustable width frame portion 8256 and an optional inner frame portion 8260.

[0227] In some implementations, the connector 8966 (e.g., a molded metal component, a molded plastic component, a tether, a wire, a support, a line, a cord, a suture, etc.) is attached to the outer or adjustable width frame portion 8256 at the outer end or connecting portion 8266 of the connector 8966, and to the coupler 8972 at the inner end 8968 of the connector 8966 (see Figure 28). Between the connector 8966 and the mounting portion 8205, the outer or adjustable width frame portion 8256 forms a curved shape. In the illustrated embodiment, the shape of the outer or adjustable width frame portion 8256 resembles an apple shape, with the outer or adjustable width frame portion 8256 being wider towards the mounting portion 8205 and narrower towards the distal portion 8207. However, in some implementations, the outer frame portion 8256 can be molded in other ways.

[0228] In the embodiment illustrated in Figure 26, an outer or adjustable width frame member 8256 (e.g., a wire frame, a metal frame, etc.) comprises front and rear frame members 8967. The front and rear frame members 8967 are connected to a connection portion 8266 of a connector 8966. In the illustrated embodiment, the connector 8966 is attached to both of the adjustable width frame members 8967 via two joints, such as suture joints. However, in some implementations, the connector 8966 can be attached to both the front and rear frame members 8967 in any preferred manner.

[0229] In some implementations, the inner frame portion 8260 extends from the mounting portion 8205 toward the distal portion 8207. In some implementations, the inner frame portion 8260 then extends inward to form a retaining portion 8272 attached to the operating cap 8214. In some implementations, the retaining portion 8272 and the operating cap 8214 can be configured to be attached in any preferred manner.

[0230] In some implementations, an optional inner frame portion 8260 is a rigid frame portion, while an outer or adjustable width frame portion 8256 is a flexible frame portion. The proximal end of the outer frame portion 8256 can be connected to or integrally formed with the proximal end of the inner frame portion 8260, as illustrated in Figure 26.

[0231] In some implementations, the width adjustment element 8211 (e.g., width adjustment wire, width adjustment shaft, width adjustment tube, width adjustment line, width adjustment cord, width adjustment suture, width adjustment screw or bolt, etc.) is configured to move the outer frame portion 8256 from an expanded position to a narrowed position by pulling the inner end 8968 (Figure 28) and a portion of the connector 8266 into the operating cap 8214.

[0232] In some implementations, the actuation element 8102 is configured to move the inner frame portion 8260 to open and close the paddle, according to some implementations disclosed herein.

[0233] As shown in Figures 27 and 28, the connector 8966 has an inner end 8968 that engages with a width adjustment element 8211, and as a result, the user can move the inner end 8968 inside the receiver 8912 (e.g., a female threaded element, column, conduit, hollow member, notched receiving portion, tube, shaft, sleeve, post, housing, cylinder, track, etc.) and move the outer frame portion 8256 between a constricted position and an expanded position.

[0234] In the illustrated embodiment, the inner end 8968 includes a post 8970 that attaches the outer portion 8266 of the connector 8966 to the coupler 8972. In some implementations, the coupler 8972 is configured to be attached to and detached from both the width adjustment element 8211 and the receiver 8912.

[0235] Coupler 8972 can take on a wide variety of different forms. For example, coupler 8972 may include one or more of the following: a screw connection, a screw-fitting feature, an outwardly biased arm, a retaining connection such as a wall, or other parts.

[0236] When the coupler 8972 is attached to the width adjustment element 8211, the coupler is released from the receiver 8912. When the coupler 8972 is removed from the width adjustment element 8211, the coupler is secured to the receiver 8912. However, the inner end 8968 of the connector can be configured in various ways. Any configuration can be used that allows the outer frame portion 8256 to be suitably attached to the coupler in order to enable the width adjustment element 8211 to move the outer frame portion 8256 between a narrowed position and an expanded position.

[0237] Couplers can also be configured in various ways; for example, they can be a separate component of a connector or the inner end of a connector, or they can be integrated with another part of the device.

[0238] In some implementations, the width adjustment element 8211 allows the user to expand or contract the outer frame portion 8256 of the portable device 8200. In the embodiment illustrated in Figures 27 and 28, the width adjustment element 8211 includes a male threaded end that screws into a coupler 8972. In some implementations, the width adjustment element 8211 adjusts the width of the outer frame portion 8256 by moving the coupler into the receiver 8912. When the width adjustment element 8211 is unscrewed from the coupler 8972, the coupler engages with the inner surface of the receiver 8912 to set the width of the outer frame portion 8256.

[0239] In some implementations, the receiver 8912 can be integrally formed with the distal cap 8214. The paddle is opened and closed by moving the cap 8214 relative to the body of the mounting portion 8205. In the illustrated embodiment, the receiver 8912 slides inside the body of the mounting portion. When the coupler 8972 is removed from the width adjustment element 8211, the width of the outer frame portion 8256 is fixed, while the actuation element 8102 moves the receiver 8912 and cap 8214 relative to the body of the mounting portion 8205. As the cap moves, the device can be opened and closed in the same manner as in some implementations disclosed above.

[0240] In the illustrated embodiment, a driver head 8916 is positioned at the proximal end of the actuating element 8102. In some implementations, the driver head 8916 detachably connects the actuating element 8102 to a receiver 8912. In the illustrated embodiment, a width adjustment element 8211 extends through the actuating element 8102. In some implementations, the actuating element moves the distal cap 8214 by advancing axially in the opposite direction to direction Y.

[0241] In some implementations, as indicated by the arrows in Figure 27, movement of the distal cap 8214 relative to the mounting portion 8205 is effective in opening and closing the paddle. That is, moving the distal cap 8214 in the direction Y closes the device, and moving the distal cap in the opposite direction to Y opens the device.

[0242] As illustrated in Figures 27 and 28, the width adjustment element 8211 extends through the actuating element 8102, the driver head 8916, and the receiver 8912, and engages with a coupler 8972 attached to the inner end 8968. In some implementations, when the outer frame portion 8256 is moved to a narrowed position, the device or implant 8200 can be more easily operated to a position for implantation in the heart by reducing contact and / or friction between the device 8200 and the natural structures of the heart (e.g., chordae tendineae). In some implementations, when the outer frame portion 8256 is moved to an expanded position, the anchor portion of the device or implant 8200 is provided with a larger surface area to engage with and capture the leaflet of the natural heart valve.

[0243] Referring to Figures 29 and 30, an embodiment of the implant catheter assembly 1611 is shown in which a clasp actuation line 624 extends through the handle 1616, an actuation element 8102 is coupled to a paddle actuation control 1626, and a width adjustment element 8211 is coupled to a paddle width control 1628. In some implementations, the proximal end portion 1622a of the shaft or catheter of the implant catheter assembly 1611 can be coupled to the handle 1616, and the distal end portion 1622b of the shaft or catheter can be coupled to an implantable device 8200.

[0244] In some implementations, the actuation element 8102 may extend distally from the paddle actuation control device 1626, through the handle 1616, through the delivery shaft or catheter of the implant catheter assembly 1611, and through the proximal end of the device 8200, and the actuation element may be coupled with the driver head 8916. In some implementations, the actuation element 8102 may be axially movable relative to the outer shafts of the implant catheter assembly 1611 and the handle 1616 in order to open and close the device.

[0245] In some implementations, the width adjustment element 8211 can extend distally from the paddle width control device 1628 through the paddle actuation control device 1626 and through the actuation element 8102 (and consequently through the handle 1616, the outer shaft of the implant catheter assembly 1611, and the device 8200), and the width adjustment element is coupled to a movable coupler 8972. In some implementations, the width adjustment element 8211 can be made axially movable relative to the actuation element 8102, the outer shaft of the implant catheter assembly 1611, and the handle 1616.

[0246] In some implementations, the clasp actuation line 624 may extend through the outer shafts of the handle 1616 and the implant catheter assembly 1611 and be axially movable relative to them. The clasp actuation line 624 may also be axially movable relative to the actuation element 8102.

[0247] Referring to Figures 29 and 30, the width adjustment element 8211 can be detachably connected to the coupler 8972 of the device 8200. By moving the width adjustment element 8211 forward or backward using the paddle width control member 1628, the paddle is expanded or narrowed. When the actuation element 8102 is moved forward and retracted by the paddle actuation control 1626, the paddle of the device opens and closes.

[0248] In the embodiments shown in Figures 29 and 30, the catheter or shaft of the implant catheter assembly 1611 is an elongated shaft that extends axially between a proximal end portion 1622a connected to the handle 1616 and a distal end portion 1622b connected to the device 8200. The outer shaft of the implant catheter assembly 1611 may also include an intermediate portion 1622c positioned between the proximal end portion 1622a and the distal end portion 1622b.

[0249] Figures 37–39 illustrate one of many valve repair systems for repairing a natural valve in question to which the concepts of this application can be applied, and the valve repair system is configured to detect the tension supplied to the leaflet due to the connection between the valve repair device 3700 and the leaflet. Referring to Figure 39, the valve repair system includes an implantable catheter assembly 3711 and an implantable valve repair device 3700. The implantable catheter assembly 3711 and the valve repair device 3700 may be identical or similar to the implantable catheter assembly 1611 and the valve repair device 8200 illustrated by Figures 26–30, respectively.

[0250] In some implementations, at least one of the implant catheter assembly 3711 and valve repair device 3700 shown in Figures 37 to 39 includes one or more force measuring devices 3710a to 3710c for detecting the tension supplied to the leaflet and / or measuring tension, other forces, position, etc., correlated with the tension on the leaflet. That is, the connection between device 3700 and the leaflet is configured to apply tension to the leaflet, and the force measuring devices 3710a to 3710c are configured to measure the tension supplied to the leaflet and / or measure tension, other forces, position, etc., correlated with the tension on the leaflet, so that the user can determine whether the tension is outside a desirable range. For example, if the tension is below a predetermined amount, there may be an insufficient attachment between device 3700 and the leaflet. If the tension is above a predetermined amount, too much leaflet may be gripped by device 3700.

[0251] The force measuring device can be positioned anywhere on the device 3700 and / or the implant catheter assembly 3711, enabling the force measuring device to measure the tension supplied to the leaflet and / or measure tensions, other forces, positions, etc., that correlate with the tension on the leaflet. For example, the force measuring device 3710a can be positioned on the actuation element 8102 of the implant catheter assembly 3711.

[0252] In some implementations, the actuation of the actuation element 8102 causes one or more paddles 3708 of the device 3700 to open and close, gripping the leaflet of the natural valve during implantation. For example, extension of the actuation element 8102 moves the cap 8214 distally from the mounting portion 8205, which moves one or more paddles 3708 to the open position, and retraction of the actuation element 8102 moves the cap toward the mounting portion 8205, which moves one or more paddles 3708 to the closed position.

[0253] When the valve repair device 3700 is attached to the leaflet and in the closed position, this attachment between the valve repair device 3700 and the leaflet can exert tension on the leaflet and generate a force corresponding to one or more paddles 3708. This force provided to the paddles 3708 can cause the paddles to partially open, which generates a force F1 on the actuating element 8102 as the paddle opens and closes by the movement of the actuating element 8102.

[0254] In some implementations, the force measuring device 3710a is configured to measure a force F1 on the actuating element 8102, and by measuring the force F1, the user can determine whether the corresponding tension provided to the leaflet is at a desired or undesirable level.

[0255] The paddle 3708 can take any preferred form, such as any form of the paddle for the valve repair device described in this application.

[0256] In the illustrated embodiments, the force measuring device 3710a includes a strain gauge having one or more wires 3716a extending to a device (not shown) for measuring electrical resistance (e.g., an ohmmeter). After the valve repair device 3700 is attached to the natural valve and it is determined that the tension supplied to the leaflet is at a desired level, the implant catheter assembly 3711 is removed from the object. In some implementations, the force measuring device 3710a can be attached to a portion of the actuarial element 8102 integrated with the valve repair device 3700. In these embodiments, the wires 3716a of the strain gauge may include weak portions (similar to the weak portions 3714b, 3714c of the wires 3716b, 3716c of the force measuring devices 3710b, 3710c) that allow the delivery system to be removed from the object while the strain gauge remains on the valve repair device 3700 implanted in the object.

[0257] In some embodiments, the force measuring device 3710b may be positioned on one gripping member 3730 of the valve repair device 3700, and another force measuring device 3710c may be positioned on another gripping member 3730 of the valve repair device 3700.

[0258] The gripping member 3730 can take any preferred form, such as any form described herein. In the illustrated embodiment, the gripping member 3730 is a fastener comprising a fixed arm 3732 attached to a paddle 3708, a movable arm 3734 for gripping one or more leaflets of a natural valve, and a hinged portion 3738 for hingely attaching the fixed arm 3732 to the movable arm 3734. The illustrated embodiment shows a valve repair device 3700 having two gripping members 3730, but it should be understood that the valve repair device 3700 may have any preferred number of gripping members, and that a force measuring device may be positioned on one or more of the gripping members.

[0259] In some implementations, the force measuring devices 3710b and 3710c can be positioned at any location on the corresponding gripping member 3730, enabling the force measuring devices 3710b and 3710c to measure the tension applied to the leaflet. When the valve repair device 3700 is attached to the leaflet and in the closed position, this attachment between the valve repair device 3700 and the leaflet can apply tension to the leaflet and induce a corresponding force F2 on the gripping member 3730.

[0260] In some implementations, the force measuring devices 3710b and 3710c are configured to measure a force F2 on the corresponding gripping member, and by measuring the force F2, the user can determine whether the tension provided to one or more of the leaflets is at a desired or undesirable level.

[0261] In some implementations, each of the force measuring devices 3710b, 3710c may include a strain gauge having one or more corresponding wires 3716b, 3716c extending into the device for measuring electrical resistance. In some implementations, each of the wires 3716b, 3716c may have a weak portion 3714b, 3714c that allows the wire to be cut, separated, and / or broken so that the strain gauge can remain on the valve repair device 3700 and at least a portion of each of the wires 3716b, 3716c can be removed from the object using a delivery system. In some implementations, the weak portions 3714b, 3714c may be, for example, a soldered joint, a thinner portion of the wire, a thin portion of a printed circuit trace, a temporary mechanical connection such as a twisted wire connection, an electrical connector such as a plug and / or socket, or any other suitable means that allows the user to break the wires 3716b, 3716c after the valve repair device 3700 has been installed.

[0262] In some embodiments, a cutting device (not shown) may be used to cut and break the wires 3716b and 3716c.

[0263] Although the force measuring devices 3710a to 3710c are described as including strain gauges, it should be understood that the force measuring devices 3710a to 3710c can take any other preferred form that can determine the tension applied to the leaflets by the valve repair device 3700. For example, the force measuring devices 3710a to 3710c may include load cell sensors, strain pads, piezoelectric sensors, any preferred position sensors for detecting changes in the position of a sensor due to a force generated by the connection between the valve repair device and the natural valve, or any other preferred type of sensor configured to allow a user to determine the tension applied to one or more leaflets of the natural valve and / or to allow a user to determine tension, another force, position, etc., correlated with the tension on the leaflets.

[0264] The illustrated embodiments shown in Figures 37-39 show an implant catheter assembly 3711 having a valve repair device 3700 and three force measuring devices 3710a-3710c, but it should be understood that the valve repair device 3700 and / or the implant catheter assembly 3711 may have any preferred number of force measuring devices. In some embodiments, only the valve repair device 3700 includes one or more force measuring devices. In other embodiments, only the implant catheter assembly 3711 includes one or more force measuring devices.

[0265] An exemplary method for determining whether the tension provided to the leaflet due to the connection between the valve repair device and the leaflet is at a desired level includes delivering the valve repair device to the native valve of interest using a delivery device or an implant catheter assembly. The valve repair device and the delivery device or implant catheter assembly can take any suitable form, such as any of the forms described in this application, including, for example, at least one of the valve repair device and the delivery device or implant catheter assembly including one or more force measurement devices for detecting the tension applied to the leaflet. The force measurement device can take any suitable form, such as any of the forms described in this application.

[0266] In some implementations, the method further includes attaching the valve repair device to one or more leaflets of the native valve. In some implementations, after the valve repair device is attached to the one or more leaflets, the method includes determining the tension provided to the leaflet based on the force measurement detected by the force measurement device.

[0267] In some implementations, the method can include removing the delivery device or implant catheter assembly from the subject when the tension provided to the leaflet is at the desired level.

[0268] In some implementations, the method can include removing the valve repair device from the one or more leaflets and reattaching the valve repair device to the leaflet when the tension provided to the leaflet is at an undesired level.

[0269] In some implementations, the method can include detaching and reattaching the valve repair device to the leaflet until the tension provided to the leaflet is at the desired level.

[0270] In some implementations, the force measuring device can be integrally formed with one or more components of the valve repair device.

[0271] A integrally formed force measuring device can take on a variety of different forms. For example, an integrally formed force measuring device may include a material that emits a signal when the material is stretched or deformed. For example, the material may be a piezoelectric material that generates a voltage in response to strain applied to it. For example, the piezoelectric material may be a ceramic piezoelectric material. In some implementations, the piezoelectric material generates a voltage at a known strain-to-voltage ratio when subjected to strain. However, an integrally formed force measuring device may include any material that generates a signal in response to applied strain.

[0272] In some implementations, the material forming the integrated force measuring device can be different from the material forming the rest of the component that includes the integrated force measuring device. For example, the component that includes the integrated force measuring device can be made from a metal such as steel or aluminum, or a shape memory alloy such as nitinol, while the integrated force measuring device is made from a ceramic material. In some implementations, the material forming the integrated force measuring device can be the same as the material forming the rest of the component that includes the integrated force measuring device. If the integrated force measuring device is made from the same material as the rest of the component, the integrated force measuring device can be configured to provide a signal in response to strain (for example, by changing the size and / or shape of the integrated force measuring device compared to the rest of the device). For example, the integrated force measuring device can be a narrower and / or thinner portion of the component than the rest of the component in order to provide a signal in response to applied strain.

[0273] Various components of a valve repair device may include integrated force measuring devices. For example, one of the movable joints of a valve repair device can be configured as an integrated force measuring device. In some implementations, one or more of the movable joints of a valve repair device may be configured to provide a signal, such as a voltage signal, in response to the application of strain to the movable joint. For example, one or more hinge portions of a latch and / or one or more pivot or bent portions of a paddle or paddle frame may be configured to provide a signal, such as a voltage signal, in response to the application of strain. The signal, such as a voltage signal, may have a known ratio to the strain.

[0274] In some implementations, the integrated force measuring device can be configured to transmit strain indicator signals without being physically attached to or connected to a device that correlates the strain indicator signals with strain. For example, one or more components of a delivery system can be configured to read strain indicator signals without being physically attached to the integrated force measuring device. For example, one or more components of the implant catheter assembly 1611, such as the actuation element 112, actuation line 116, coupler and / or catheter, and the maneuverable catheter can be configured to read strain indicator signals without being physically attached to the integrated force measuring device.

[0275] In some implementations, one or more components of the implant catheter assembly 1611, such as the actuating element 112, the actuating line 116, the coupler and / or the catheter, and the maneuverable catheter, may have an induction-based measurement system that reads electrical signals, such as voltage signals from piezoelectric materials, without being physically attached to an integrated force measuring device.

[0276] In some implementations, the induction-based measurement system can read strain indicator signals, such as changes in potential, as the valve repair device is operated to indicate whether the strain on the leaflet exceeds a predetermined acceptable strain and / or determine the amount of leaflet to be captured. In some implementations, the measurement system acts on the induction reading of currents passively generated by the implant components, so the cutting does not require a separate mechanical cutting from the integrated force measuring device.

[0277] In some implementations, the force measuring device remains with the device after it is transferred from and removed from the delivery system. In some implementations, the force measuring device and / or monitoring system can be configured to transmit, read, and / or analyze strain indicator signals. For example, the device may include a processor or microchip and / or power supply, and the monitoring system may include a wireless communication device. In some implementations, the processor or microchip and / or power supply may store and / or transmit data, and the wireless communication device may non-invasively read data from the force measuring device of the valve repair device. For example, the wireless communication device may read data from the force measuring device of the valve repair device from outside the body of the subject, and it may be possible to read and analyze continuous data from the force measuring device.

[0278] In some implementations, wireless communication devices are omitted, and data from force measurement devices can be read minimally invasively. For example, a minimally invasive guidewire can be routed through the target vascular structure back to or near the valve repair device to read the amount of strain sensed by the force measurement device and / or to retrieve data stored by a processor or microchip.

[0279] Referring to Figure 40, in some examples, the integrated force measuring device 4000 can be part of the hinge or joint of the clasp 130 and / or part of the joint of the paddle 122. The illustrated embodiment shows a valve repair device 3100 having two gripping members, but it should be understood that the valve repair device 3100 may have any preferred number of gripping members, and the integrated force measuring device may be positioned on one or more of the gripping members. The illustrated embodiment shows a valve repair device 3100 having two paddles, but it should be understood that the valve repair device 3100 may have any preferred number of paddles, and the integrated force measuring device may be positioned on one or more of the paddles. In the illustrated embodiment, the integrated force measuring device 4000 is located on the hinge or joint of the fastener 130 of the gripping member and / or on the hinge or joint of the paddle, but it should be understood that the integrated force measuring device 4000 can be provided at any location on the gripping member and / or paddle that enables the integrated force measuring device to measure the tension supplied to the leaflet.

[0280] When the valve repair device 3100 is attached to the leaflet and in the closed position, this attachment between the valve repair device 3100 and the leaflet can apply tension to the leaflet and induce a corresponding force on the gripping member. In some implementations, a force measuring device 4000 is configured to measure a force F2 on the corresponding gripping member, and by measuring the force F2, the user can determine whether the corresponding tension provided to one or more of the leaflets is at a desired or undesirable level.

[0281] The illustrated embodiment shown in Figure 40 shows a valve repair device 3100 having four force measuring devices 4000, but it should be understood that the valve repair device 3100 may have any preferred number of force measuring devices.

[0282] Figure 41 shows an embodiment of device 3300 configured to detect the tension supplied to a leaflet due to the connection between device 3300 and the leaflet. Device 3300 is similar to device 200 illustrated by Figure 22, except that device 3300 in Figure 33 includes one or more integrated force measuring devices 4000 for detecting the tension supplied to the leaflet. That is, the connection between device 3300 and the leaflet causes tension in the leaflet, and the integrated force measuring devices 4000 are configured to measure the tension supplied to the leaflet so that a user can determine whether the tension is higher or lower than an optimal force range. For example, if the tension is below a predetermined amount, there may be an insufficient attachment between device 3300 and the leaflet. If the tension is above a predetermined amount, too much leaflet may be gripped by device 3300.

[0283] The force measuring device can be positioned anywhere on the device 3300, enabling the force measuring device to measure the tension supplied to the leaflet and / or measure tensions correlated with the tension on the leaflet, other forces, positions, etc. In the embodiment illustrated by Figure 41, the force measuring device 4000 can be positioned on the joint or hinge of the gripping member or fastener, on the joint or hinge of the inner paddle 222, and / or on the joint or hinge of the outer paddle 220.

[0284] In some implementations, the actuation of the actuation element 3312 opens and closes one or more anchors 208 of the device 3300, gripping the leaflet of the natural valve during implantation. For example, extension of the actuation element 3312 can move the cap 214 of the device 3300 away from the connecting element 210, moving one or more anchors 208 to the open position, while retraction of the actuation element 3312 can move the cap 214 towards the connecting element 210, moving one or more anchors 208 to the closed position.

[0285] When the valve repair device 3300 is attached to the leaflet and in the closed position, this attachment between the valve repair device 3300 and the leaflet can exert tension on the leaflet and generate a force corresponding to one or more anchors 208. This force provided to the anchors 208 can cause them to partially release.

[0286] In some implementations, after the valve repair device 3300 is attached to the natural valve and it is determined that the tension supplied to the leaflet is at the desired level, the actuarial element 3312 is removed from the valve repair device 3300 and removed from the object using a delivery system.

[0287] In some embodiments, the integrated force measuring device 4000 may be included on one or both of the latches 230 of the valve repair device 3300. The illustrated embodiment shows a valve repair device 3300 having two latches 230, but it should be understood that the valve repair device 3300 may have any preferred number of latches, and the integrated force measuring device may be positioned on one or more of the latches. In the illustrated embodiment, the integrated force measuring device is positioned on the hinge or joint of the latch 230, but it should be understood that the integrated force measuring device 4000 may be positioned at any location on the latch 230 that allows the force measuring device 4000 to measure the tension supplied to the leaflet.

[0288] In some embodiments, the integrated force measurement device 4000 can be included on one or both of the inner paddles 222 of the valve repair device 3300. The illustrated embodiment shows a valve repair device 3300 having two inner paddles 222, but it should be understood that the valve repair device 3300 can have any suitable number of inner paddles, and that the integrated force measurement device can be disposed on one or more of the inner paddles. In the illustrated embodiment, the integrated force measurement device is disposed on the hinge or joint of the inner paddle 222, but it should be understood that the integrated measurement device 4000 can be positioned at any location on the inner paddle 222 that enables the integrated force measurement device 4000 to measure the tension provided to the leaflet.

[0289] In some embodiments, the integrated force measurement device 4000 can be included on one or both of the outer paddles 220 of the valve repair device 3300. The illustrated embodiment shows a valve repair device 3300 having two outer paddles 220, but it should be understood that the valve repair device 3300 can have any suitable number of inner paddles, and that the integrated force measurement device 4000 can be disposed on one or more of the outer paddles. In the illustrated embodiment, the integrated force measurement device is disposed on the hinge or joint of the outer paddle 220, but it should be understood that the integrated measurement device 4000 can be positioned at any location on the outer paddle 220 that enables the force measurement device 4000 to measure the tension provided to the leaflet.

[0290] When the valve repair device 3300 is attached to the leaflet and in the closed position, this attachment between the valve repair device 3300 and the leaflet can apply tension to the leaflet and induce a corresponding force in the fastener 230. In some implementations, the force measuring device 4000 is configured to measure the force on the corresponding gripping member, inner paddle, and / or outer paddle, and the force measurement allows the user to determine whether the tension supplied to one or more of the leaflets is at a desired or undesirable level. The illustrated embodiment shown in Figure 41 shows a valve repair device 3300 having six integrated force measuring devices 4000, but it should be understood that the valve repair device 3300 can have any number of integrated force measuring devices.

[0291] Figure 42 shows an embodiment of device 3400 and / or actuation element 3412 of a delivery system configured to detect the tension supplied to a leaflet due to the connection between device 3400 and the leaflet. Device 3400 may be identical or similar to device 300 illustrated by Figure 23.

[0292] In some implementations, the device 3400 in Figure 34 includes one or more integrated force measuring devices 4000 for detecting the tension supplied to the leaflet and / or measuring tension, other forces, position, etc., that correlate with the tension on the leaflet. That is, the connection between the device 3400 and the leaflet is configured to apply tension to the leaflet, and the integrated force measuring devices 4000 are configured to measure the tension supplied to the leaflet and / or measure forces that can correlate with the tension applied to the leaflet, so that the user can determine whether the tension is higher or lower than an optimal tension range. For example, if the tension is below a predetermined amount, there may be an insufficient attachment between the device 3400 and the leaflet. If the tension is above a predetermined amount, too much leaflet may be gripped by the device 3400.

[0293] The integrated force measuring device can be placed anywhere on device 3400, enabling the force measuring device to measure the tension supplied to the leaflet.

[0294] In some implementations, the actuation of the actuation element 3412 opens and closes one or more anchors 308 of the device 3400, gripping the leaflet of the natural valve during implantation. For example, extension of the actuation element 3412 can move the cap 314 of the device 3400 away from the joint element 310, moving one or more anchors 308 to the open position, and retraction of the actuation element 3412 can move the cap 314 toward the joint element 310, moving one or more anchors 308 to the closed position. When the valve repair device 3400 is attached to the leaflet and in the closed position, this attachment between the valve repair device 3400 and the leaflet can exert tension on the leaflet, generating a force corresponding to one or more anchors 308. This force provided to the anchors 308 can partially release them.

[0295] In some embodiments, the integrated force measuring device 4000 may be included on one or both of the latches 330 of the valve repair device 3400. The illustrated embodiment shows a valve repair device 3400 having two latches 330, but it should be understood that the valve repair device 3400 may have any preferred number of latches, and the integrated force measuring device may be positioned on one or more of the latches. In the illustrated embodiment, the integrated force measuring device is positioned on the hinge or joint of the latch 330, but it should be understood that the integrated force measuring device 4000 may be positioned at any location on the latch 330 that allows the force measuring device 4000 to measure the tension supplied to the leaflet.

[0296] In some embodiments, the integrated force measuring device 4000 may be included on one or both of the inner paddles 322 of the valve repair device 3400. The illustrated embodiment shows a valve repair device 3400 having two inner paddles 322, but it should be understood that the valve repair device 3400 may have any preferred number of inner paddles, and the integrated force measuring device may be positioned on one or more of the inner paddles. In the illustrated embodiment, the integrated force measuring device is positioned on the hinge or joint of the inner paddle 322, but it should be understood that the integrated force measuring device 4000 may be positioned at any location on the inner paddle 322 that enables the force measuring device 4000 to measure the tension supplied to the leaflet.

[0297] In some embodiments, the integrated force measuring device 4000 may be included on one or both of the outer paddles 320 of the valve repair device 3400. The illustrated embodiment shows a valve repair device 3400 having two outer paddles 320, but it should be understood that the valve repair device 3400 may have any preferred number of inner paddles, and the integrated force measuring device 4000 may be positioned on one or more of the outer paddles. In the illustrated embodiment, the integrated force measuring device is positioned on a hinge or joint of the outer paddle 320, but it should be understood that the integrated force measuring device 4000 may be positioned at any location on the outer paddle 320 that allows the force measuring device 4000 to measure the tension supplied to the leaflet.

[0298] When the valve repair device 3400 is attached to the leaflet and in the closed position, this attachment between the valve repair device 3400 and the leaflet can apply tension to the leaflet and induce a corresponding force in the fastener 330. The integrated force measuring device 4000 is configured to measure and / or correlate the force on the corresponding gripping member, and by measuring and / or correlating the force, the user can determine whether the tension supplied to one or more of the leaflets is at a desired or undesirable level.

[0299] The illustrated embodiment shown in Figure 42 shows a valve repair device 3400 having three integrated force measuring devices 4000, but it should be understood that the valve repair device 3400 and / or delivery system may have any suitable number of force measuring devices.

[0300] Figure 43 illustrates another embodiment of one of many valve repair systems for repairing a natural valve in question to which the concepts of this application can be applied, the valve repair system 3501 being configured to measure tension, other forces, position, etc., which correlate with tension on a leaflet.

[0301] In some implementations, the valve repair system 3501 includes a delivery device 3502 and a valve repair device 3500. In some implementations, the delivery device 3502 and the valve repair device 3500 are the same as, or similar to, the delivery device 40156 and the valve repair device 41456 illustrated in Figure 24, respectively.

[0302] In some implementations, the valve repair device 3500 in Figure 43 includes one or more integrated force measuring devices 4000 for detecting the tension supplied to the leaflet and / or tension, other forces, positions, etc., correlated with the tension on the leaflet. That is, the connection between the device 3500 and the leaflet is configured to apply tension to the leaflet, and the force measuring devices 4000 are configured to measure the tension supplied to the leaflet, or correlated forces, distances, or other characteristics, so that the user can determine whether the tension is outside a desirable tension range. For example, if the tension is below a predetermined amount, there may be an insufficient fit between the device 3500 and the leaflet. If the tension is above a predetermined amount, too much leaflet may be gripped by the device 3500.

[0303] The force measuring device can be positioned anywhere on the device 3500, enabling the force measuring device to measure the tension supplied to the leaflet. The paddle control mechanism 41056 is mechanically attached to the coupler 40556, causing the coupler 40556 to move along the shaft 40356, thereby moving the paddle 40656 between the open and closed positions. When the valve repair device 3500 is attached to the leaflet and in the closed position, this attachment between the valve repair device 3500 and the leaflet can apply tension to the leaflet and a corresponding force to the paddle 40656. This force supplied to the paddle 40656 can cause the paddle to partially open.

[0304] In some implementations, the valve repair device 3500 is attached to the natural valve, and after it is determined that the tension supplied to the leaflet is at the desired level, the delivery system 3502 is removed from the object.

[0305] In some embodiments, the integrated force measuring device 4000 may be included on one or both gripping members 40856 of the valve repair device 3500. The illustrated embodiment shows a valve repair device 3500 having two gripping members 40856, but it should be understood that the valve repair device 3500 may have any preferred number of gripping members 40856, and the integrated force measuring device may be positioned on one or more of the gripping members 40856. In the illustrated embodiment, the integrated force measuring device is positioned on a hinge or joint of the gripping member 40856, but it should be understood that the integrated force measuring device 4000 may be positioned at any location on the gripping member 40856 that enables the force measuring device 4000 to measure the tension supplied to the leaflet.

[0306] In some embodiments, the integrated force measuring device 4000 may be included on one or both paddles 40656 of the valve repair device 3500. The illustrated embodiment shows a valve repair device 3500 having two paddles 40656, but it should be understood that the valve repair device 3500 may have any preferred number of paddles, and the integrated force measuring device may be positioned on one or more of the paddles. In the illustrated embodiment, the integrated force measuring device is positioned on a hinge or joint of the paddle 40656, but it should be understood that the integrated force measuring device 4000 may be positioned at any location on the paddle 40656 that enables the force measuring device 4000 to measure the tension supplied to the leaflet.

[0307] The illustrated embodiment shown in Figure 43 shows a valve repair device 3500 having four force measuring devices 4000, but it should be understood that the valve repair device 3500 and / or delivery device 3502 may have any preferred number of force measuring devices.

[0308] Figure 44 illustrates one of many valve repair systems for repairing a natural valve in question to which the concepts of this application can be applied, the valve repair system being configured to detect the tension supplied to the leaflet due to the connection between the valve repair device 3700 and the leaflet. In some implementations, the valve repair system includes an implantable catheter assembly 3711 and an implantable valve repair device 3700. The implantable catheter assembly 3711 and the valve repair device 3700 may be identical or similar to the implantable catheter assembly 1611 and the valve repair device 8200 illustrated by Figures 26 to 30, respectively.

[0309] In some implementations, the valve repair device 3700 in Figure 44 includes one or more integrated force measuring devices 4000 for detecting the tension supplied to the leaflet and / or for measuring tension, other forces, position, etc., correlated with the tension on the leaflet. That is, the connection between the device 3700 and the leaflet is configured to apply tension to the leaflet, and the integrated force measuring devices 4000 are configured to measure the tension supplied to the leaflet and / or for measuring tension, other forces, position, etc., correlated with the tension on the leaflet, so that the user can determine whether the tension is outside a desirable range. For example, if the tension is below a predetermined amount, there may be an insufficient fit between the device 3700 and the leaflet. If the tension is above a predetermined amount, too much leaflet may be gripped by the device 3700.

[0310] The integrated force measuring device 4000 can be placed anywhere on the device 3700, enabling the force measuring device to measure the tension supplied to the leaflet, and / or to measure tensions correlated with the tension on the leaflet, other forces, positions, etc.

[0311] In some implementations, the actuation of the actuation element 8102 causes one or more paddles 3708 of the device 3700 to open and close, gripping the leaflet of the natural valve during implantation. For example, extension of the actuation element 8102 moves the cap 8214 distally from the mounting portion 8205, which moves one or more paddles 3708 to the open position, and retraction of the actuation element 8102 moves the cap toward the mounting portion 8205, which moves one or more paddles 3708 to the closed position.

[0312] When the valve repair device 3700 is attached to the leaflet and in the closed position, this attachment between the valve repair device 3700 and the leaflet can exert tension on the leaflet and generate a force corresponding to one or more paddles 3708. This force supplied to the paddles 3708 can cause the paddles to partially release. The integrated force measuring device 4000 is configured to measure the force so that a user can determine whether the corresponding tension supplied to the leaflet is at a desired or undesirable level. The paddles 3708 can take any preferred form, such as any form of the paddles of the valve repair device described in this application.

[0313] In some implementations, the implant catheter assembly 3711 is removed from the object after the valve repair device 3700 is attached to the natural valve and it is determined that the tension supplied to the leaflet is at the desired level.

[0314] In some embodiments, the integrated force measuring device 4000 may be included on one or both of the latches 3730 of the valve repair device 3700. The illustrated embodiment shows a valve repair device 3700 having two latches 330, but it should be understood that the valve repair device 3700 may have any preferred number of latches, and the integrated force measuring device may be positioned on one or more of the latches. In the illustrated embodiment, the integrated force measuring device is positioned on the hinge or joint of the latch 3730, but it should be understood that the integrated force measuring device 4000 may be positioned at any location on the latch 3730 that enables the force measuring device 4000 to measure the tension supplied to the leaflet.

[0315] In some embodiments, the integrated force measuring device 4000 may be included on one or both of the inner paddles 8122 of the valve repair device 3700. The illustrated embodiment shows a valve repair device 3700 having two inner paddles 8122, but it should be understood that the valve repair device 3700 may have any preferred number of inner paddles 8122, and the integrated force measuring device may be positioned on one or more of the inner paddles. In the illustrated embodiment, the integrated force measuring device is positioned on the hinge or joint of the inner paddle 8122, but it should be understood that the integrated force measuring device 4000 may be positioned at any location on the inner paddle 8122 that enables the force measuring device 4000 to measure the tension supplied to the leaflet.

[0316] In some embodiments, the integrated force measuring device 4000 may be included on one or both of the outer paddles 8120 of the valve repair device 3700. The illustrated embodiment shows a valve repair device 3700 having two outer paddles 8120, but it should be understood that the valve repair device 3700 may have any preferred number of inner paddles, and the integrated force measuring device 4000 may be positioned on one or more of the outer paddles. In the illustrated embodiment, the integrated force measuring device is positioned on a hinge or joint of the outer paddle 8120, but it should be understood that the integrated force measuring device 4000 may be positioned at any location on the outer paddle 8120 that enables the force measuring device 4000 to measure the tension supplied to the leaflet.

[0317] The gripping member 3730 can take any preferred form, such as any form described herein. In the illustrated embodiment, the gripping member 3730 is a fastener comprising a fixed arm 3732 attached to a paddle 3708, a movable arm 3734 for gripping one or more leaflets of a natural valve, and a hinged portion 3738 for hingely attaching the fixed arm 3732 to the movable arm 3734. The illustrated embodiment shows a valve repair device 3700 having two gripping members 3730, but it should be understood that the valve repair device 3700 may have any preferred number of gripping members, and that the force measuring device may be positioned on one or more of the gripping members. The force measuring device 4000 may be positioned at any location on the corresponding gripping member 3730, enabling the force measuring device 4000 to measure the tension supplied to the leaflet.

[0318] When the valve repair device 3700 is attached to the leaflet and in the closed position, this attachment between the valve repair device 3700 and the leaflet can apply tension to the leaflet and induce a corresponding force on the gripping member 3730. The force measuring device 4000 is configured to measure the force on the corresponding gripping member, and by measuring the force, the user can determine whether the tension provided to one or more of the leaflets is at a desired or undesirable level.

[0319] An exemplary method for determining whether the tension supplied to a leaflet due to the connection between the valve repair device and the leaflet is at a desired level includes delivering the valve repair device to the natural valve of interest using a delivery device or implant catheter assembly. The valve repair device and the delivery device or implant catheter assembly can take any preferred form, such as any form described in this application, in which the valve repair device includes one or more integrated force measuring devices for detecting the tension applied to the leaflet. The integrated force measuring devices can take any preferred form, such as any form described in this application.

[0320] In some implementations, the method further includes attaching a valve repair device to one or more leaflets of a natural valve. In some implementations, after the valve repair device has been attached to one or more leaflets, the method includes determining the tension supplied to the leaflets based on force measurements detected by an integrated force measuring device.

[0321] In some implementations, the method may include removing the delivery device or implant catheter assembly from the target when the tension provided to the leaflet is at the desired level.

[0322] In some implementations, the method may include removing the valve repair device from one or more leaflets and reattaching the valve repair device to the leaflets if the tension supplied to the leaflets is at an undesirable level.

[0323] In some implementations, the method may include attaching and detaching the valve repair device until the tension supplied to the leaflet reaches a desired level, and then reattaching the valve repair device to the leaflet. [Examples]

[0324] Example 1. A valve repair device for repairing a natural heart valve, At least one paddle movable between an open position and a closed position, wherein at least one paddle is configured to attach a valve repair device to a natural valve, At least one gripping member configured to capture a natural valve, A force measuring device attached to at least one gripping member, A valve repair device in which a force measuring device is configured to detect the force applied to at least one gripping member when the valve repair device is attached to a natural valve. Example 2. At least one gripping member, A fixed arm attached to at least one paddle, A movable arm, A valve repair device according to Embodiment 1, including a fastener having a hinge portion that hinges a fixed arm to a movable arm. Example 3. The valve repair device according to Example 2, wherein the force measuring device is attached to a movable arm of the fastener. Example 4. The valve repair device according to Example 2, wherein the force measuring device is attached to the hinge portion of the fastener. Example 5. A valve repair device according to any one of Examples 1 to 4, wherein the force measuring device includes a strain gauge. Example 6. The valve repair device according to Example 5, wherein the force measuring device comprises a wire attached to a strain gauge, and the wire has a weak portion configured to allow the user to break the wire after the valve repair device has been attached to the natural valve. Example 7. A valve repair device according to any one of Examples 1 to 6, wherein at least one gripping member includes a first gripping member and a second gripping member, a force measuring device is attached to the first gripping member and a second force measuring device is attached to the second gripping member. Example 8. A valve repair device according to any one of Examples 1 to 7, further comprising an actuation element, wherein a second force measuring device is attached to the actuation element. Example 9. A valve repair device according to any one of Examples 1 to 8, wherein the valve repair device further comprises a bonding element. Example 10. A valve repair device according to any one of Examples 1 to 9, wherein the valve repair device further comprises a cap, and at least one paddle is attached to the cap such that movement of the cap causes at least one paddle to move between an open position and a closed position. Example 11. The valve repair device is shaft, The system further comprises a coupler that is attached to a shaft and is movable along the shaft, A valve repair device according to any one of Embodiments 1 to 10, wherein at least one paddle is attached to a coupler such that the movement of the coupler along the shaft causes at least one paddle to move between an open position and a closed position. Example 12. Valve repair system, A delivery device comprising an operating element and a force measuring device, wherein the force measuring device is attached to the operating element, A valve repair device, cap, A valve repair device comprising at least one paddle attached to a cap, the at least one paddle being movable between an open position and a closed position, and the at least one paddle being configured to attach the valve repair device to a natural valve, A valve repair system in which the actuation element of a delivery device is configured to engage with a cap, move the cap, and move at least one paddle between an open position and a closed position. Example 13. The valve repair system according to Example 12, wherein a force measuring device is configured to measure the force applied to the actuating element when the valve repair device is attached to the natural valve and at least one paddle is in the closed position. Example 14. The valve repair system according to Example 12 or 13, wherein the force measuring device comprises a strain gauge and a wire attached to the strain gauge. Example 15. The valve repair system according to any one of Examples 12 to 14, wherein the valve repair device further comprises at least one gripping member configured to capture a natural valve. Example 16. The valve repair system according to Example 15, wherein the valve repair device further comprises a second force measuring device attached to at least one gripping member, the second force measuring device being configured to measure the force applied to at least one gripping member when the valve repair device is attached to a natural valve. Example 17. At least one gripping member, A fixed arm attached to at least one paddle, A movable arm, A valve repair device according to Embodiment 16, including a fastener having a hinge portion that hinges a fixed arm to a movable arm. Example 18. The valve repair system according to Example 17, wherein a second force measuring device is attached to a movable arm of the fastener. Example 19. The valve repair system according to Example 17, wherein a second force measuring device is attached to the hinge portion of the fastener. Example 20. The valve repair system according to Example 16, wherein the second force measuring device includes a strain gauge. Example 21. The valve repair system according to Example 20, wherein the second force measuring device comprises a wire attached to a strain gauge, the wire having a weak portion configured to allow the user to break the wire after the valve repair device has been attached to the natural valve. Example 22. The valve repair system according to Example 16, wherein at least one gripping member comprises a first gripping member and a second gripping member, a second force measuring device is attached to the first gripping member, and a third force measuring device is attached to the second gripping member. Example 23. Valve repair system, A delivery device comprising a paddle control mechanism and a force measuring device, wherein the force measuring device is attached to the paddle control mechanism. A valve repair device, shaft, A coupler that is attached to a shaft and is movable along the shaft. A valve repair device comprising at least one paddle attached to a coupler, the at least one paddle being movable between an open position and a closed position, and the at least one paddle being configured to attach the valve repair device to a natural valve, A valve repair system in which a paddle control mechanism of a delivery device is configured to engage with a coupler and move the coupler along a shaft, thereby moving at least one paddle between an open position and a closed position. Example 24. The valve repair system according to Example 23, wherein a force measuring device is configured to measure the force applied to the paddle control mechanism when the valve repair device is attached to the natural valve and at least one paddle is in the closed position. Example 25. The valve repair system according to Example 23 or 24, wherein the force measuring device comprises a strain gauge and a wire attached to the strain gauge. Example 26. The valve repair system according to any one of Examples 23 to 25, wherein the valve repair device further comprises at least one gripping member configured to capture a natural valve. Example 27. The valve repair system according to Example 26, wherein the valve repair device further comprises a second force measuring device attached to at least one gripping member, the second force measuring device being configured to measure the force applied to at least one gripping member when the valve repair device is attached to a natural valve. Example 28. At least one gripping member, A fixed arm attached to at least one paddle, A movable arm, A valve repair system according to Embodiment 27, including a fastener having a hinge portion that hinges a fixed arm to a movable arm. Example 29. The valve repair system according to Example 28, wherein a second force measuring device is attached to a movable arm of the fastener. Example 30. The valve repair system according to Example 28, wherein a second force measuring device is attached to the hinge portion of the fastener. Example 31. The valve repair system according to Example 27, wherein the second force measuring device includes a strain gauge. Example 32. The valve repair system according to Example 31, wherein the second force measuring device comprises a wire attached to a strain gauge, the wire having a weak portion configured to allow the user to break the wire after the valve repair device has been attached to the natural valve. Example 33. The valve repair system according to Example 27, wherein at least one gripping member comprises a first gripping member and a second gripping member, a second force measuring device is attached to the first gripping member, and a third force measuring device is attached to the second gripping member. Example 34. A method for determining whether the tension supplied to a natural valve in question due to the installation between a valve repair device and a natural valve is at a desired level, The delivery of a valve repair device to a target natural valve using a delivery device, wherein at least one of the valve repair device and the delivery device is equipped with a force measuring device. Attaching a valve repair device to the target natural valve, The force applied to at least one of the valve repair device and the delivery device is detected via a force measuring device. A method comprising determining whether the tension applied to a natural valve is at a desired level based on the force detected by a force measuring device. Example 35. When the tension is not at the desired level, remove the valve repair device from the natural valve, Reattaching the valve repair device to the natural valve, Re-detecting the force applied to at least one of the valve repair device and the delivery device via a force measuring device, The method of Example 34, further comprising determining whether the tension applied to the natural valve is at a desired level based on the force re-detected by a force measuring device. Example 36. The valve repair device is At least one paddle movable between an open position and a closed position, wherein at least one paddle is configured to attach a valve repair device to a natural valve, A gripping member configured to capture a natural valve, The method according to Example 34 or 35, further comprising a force measuring device attached to at least one gripping member. Example 37. At least one gripping member, A fixed arm attached to at least one paddle, A movable arm, The method according to Embodiment 36, including a fastener having a hinge portion that hinges a fixed arm to a movable arm. Example 38. The method according to Example 37, wherein the force measuring device is attached to a movable arm of a fastener. Example 39: The method according to Example 37, wherein the force measuring device is attached to the hinge portion of the fastener. Example 40. The method according to any one of Examples 34 to 39, wherein the force measuring device includes a strain gauge. Example 41. The method according to Example 40, wherein the detected force is detected via an ohmmeter. Example 42. The method according to any one of Examples 34 to 41, wherein the delivery device comprises an actuation element and a force measuring device is attached to the actuation element. Example 43. A valve repair device, cap, The device comprises at least one paddle attached to the cap, the at least one paddle being movable between an open position and a closed position, and the at least one paddle being configured to attach a valve repair device to the natural valve, The method according to Embodiment 42, wherein the actuation element of the delivery device is configured to engage with the cap and move the cap, thereby moving at least one paddle between an open position and a closed position. Example 44. The method according to any one of Examples 34 to 43, wherein the delivery device comprises a paddle control mechanism and the force measuring device is attached to the paddle control mechanism. Example 45. A valve repair device, shaft, A coupler that is attached to a shaft and is movable along the shaft. A coupler comprising at least one paddle, the at least one paddle being movable between an open position and a closed position, and the at least one paddle being configured to attach a valve repair device to a natural valve, The method according to Embodiment 44, wherein the paddle control mechanism of the delivery device is configured to engage with a coupler and move the coupler along a shaft, thereby moving at least one paddle between an open position and a closed position. Example 46. A valve repair device according to any one of Examples 34 to 45, wherein the force measuring device is integrally formed with one or more components of the valve repair device. Example 47. The valve repair device according to Example 46, wherein a force measuring element forms part of at least one gripping member. Example 48. The valve repair device according to Example 47, wherein the force measuring device forms at least a portion of the hinge portion of at least one gripping member. Example 49. The valve repair device according to Example 46, wherein the force measuring element forms part of at least one paddle. Example 50. The valve repair device according to Example 49, wherein the force measuring device forms at least a portion of the hinge portion of at least one paddle.

[0325] The techniques, methods, operations, steps, etc. described or suggested in this specification or the reference materials incorporated herein may be performed on living subjects (e.g., humans, other animals, etc.) or on simulations such as corpses, corpse hearts, simulators, virtual characters, etc. When performed in a simulation, body parts such as hearts, tissues, valves, etc. may be assumed to be simulated or, at the discretion of the author, be referred to as “simulated” (e.g., simulated heart, simulated tissue, simulated valves, etc.), and may include computerized and / or physical representations of body parts, tissues, etc. The term “simulation” is used to refer to corpses, computer simulators, virtual characters (e.g., simply demonstrating a virtual heart in the air), etc.

[0326] Any of the various systems, assemblies, devices, components, apparatus, etc. in this disclosure can be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use in the subject matter, and the methods of this disclosure may include (or additional methods may include or consist of) sterilization of the relevant systems, devices, components, apparatus, etc. (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0327] Although various inventive aspects, concepts, and features of this disclosure may be described and illustrated in combination in the examples of this disclosure, these various aspects, concepts, and features can be used individually or in various combinations and subcombinations in many alternative examples. Unless expressly excluded in this disclosure, all such combinations and subcombinations are intended to be within the scope of this application. Furthermore, although various alternative examples relating to various aspects, concepts, and features of this disclosure, such as alternative materials, alternative structures, alternative configurations, alternative methods, alternative devices, alternative components, alternative forms, alternatives relating to fit, alternatives relating to function, and similar examples, such descriptions are not intended to be a complete or exhaustive list of available alternatives, whether currently known or to be developed later. Those skilled in the art will readily be able to incorporate one or more aspects, concepts, or features of the present invention into additional examples and uses within the scope of this application, even if such examples are not expressly disclosed herein.

[0328] In addition, even if certain features, concepts, or aspects of the present disclosure are described herein as preferred configurations or methods, such descriptions are not intended to imply that such features are essential or indispensable unless expressly stated. Furthermore, although exemplary or representative values ​​and ranges may be included to aid in understanding the present application, such values ​​and ranges are not intended to be constrained and are only significant when expressly stated.

[0329] Furthermore, while various aspects, features, and concepts may be expressly identified in this disclosure as inventive or as forming part of the disclosure, such identification is not intended to be exclusive. Rather, there may be inventive aspects, concepts, and features that are not expressly identified or expressed as part of a particular disclosure but are fully described herein and are instead described in the appended claims. Descriptions of exemplary methods or processes are not limited to including all steps as essential in all cases, and the order in which multiple steps are presented is not to be construed as essential or indispensable unless expressly stated. The terms used in the claims are to have their entirely ordinary meanings and are not in any way limited by the descriptions of examples herein.

Claims

1. A valve repair device for repairing natural heart valves, At least one paddle movable between an open position and a closed position, wherein the at least one paddle is configured to attach the valve repair device to the natural valve, At least one gripping member configured to capture the natural valve, A force measuring device attached to at least one of the gripping members, A valve repair device in which the force measuring device is configured to detect the force applied to the at least one gripping member when the valve repair device is attached to the natural valve.

2. The valve repair device according to claim 1, wherein the force measuring device is attached to one or more of the movable arm of the gripping member and the hinge portion of the gripping member.

3. The valve repair device according to claim 1 or 2, wherein the force measuring device comprises a wire attached to a strain gauge, the wire having a weak portion configured to allow a user to break the wire after the valve repair device has been attached to the natural valve.

4. The valve repair device according to any one of claims 1 to 3, further comprising an operating element, wherein a second force measuring device is attached to the operating element.

5. A valve repair system, A delivery device comprising an operating element and a force measuring device, wherein the force measuring device is attached to the operating element, A valve repair device, cap, A valve repair device comprising at least one paddle attached to the cap, wherein the at least one paddle is movable between an open position and a closed position, and the at least one paddle is configured to attach the valve repair device to the natural valve, A valve repair system in which the actuation element of the delivery device is configured to engage with the cap, move the cap, and move the at least one paddle between the open position and the closed position.

6. The valve repair system according to claim 5, wherein the force measuring device is configured to measure the force applied to the actuating element when the valve repair device is attached to the natural valve and the at least one paddle is in the closed position.

7. The valve repair system according to claim 5 or 6, wherein the force measuring device comprises a strain gauge and a wire attached to the strain gauge.

8. The valve repair system according to claim 6, wherein the valve repair device further comprises at least one gripping member configured to capture the natural valve, and the valve repair device further comprises a second force measuring device attached to the at least one gripping member, the second force measuring device configured to measure the force provided to the at least one gripping member when the valve repair device is attached to the natural valve.

9. The valve repair system according to claim 8, wherein the second force measuring device is attached to one or more of the movable arm of the gripping member and the hinge portion of the gripping member.

10. The valve repair system according to claim 9, wherein the second force measuring device comprises a wire attached to a strain gauge, the wire having a weak portion configured to allow a user to break the wire after the valve repair device has been attached to the natural valve.

11. The valve repair system according to claim 8, wherein the at least one gripping member includes a first gripping member and a second gripping member, the second force measuring device is attached to the first gripping member, and the third force measuring device is attached to the second gripping member.

12. A valve repair system, A delivery device comprising a paddle control mechanism and a force measuring device, wherein the force measuring device is attached to the paddle control mechanism, A valve repair device, shaft, A coupler attached to the shaft and movable along the shaft, A valve repair device comprising at least one paddle attached to the coupler, wherein the at least one paddle is movable between an open position and a closed position, and the at least one paddle is configured to attach the valve repair device to a natural valve, A valve repair system in which the paddle control mechanism of the delivery device is configured to engage with the coupler and move the coupler along the shaft and move the at least one paddle between the open position and the closed position.

13. The valve repair system according to claim 12, wherein the force measuring device is configured to measure the force applied to the paddle control mechanism when the valve repair device is attached to the natural valve and the at least one paddle is in the closed position.

14. The valve repair system according to claim 12 or 13, wherein the force measuring device comprises a strain gauge and a wire attached to the strain gauge.

15. The valve repair system according to claim 13, wherein the valve repair device further comprises a second force measuring device attached to at least one gripping member, the second force measuring device being configured to measure the force applied to the at least one gripping member when the valve repair device is attached to the natural valve.

16. The valve repair system according to claim 15, wherein the second force measuring device is attached to at least one of the movable arm of the gripping member and the hinge portion of the gripping member.

17. The valve repair system according to claim 16, wherein the second force measuring device includes a strain gauge.

18. The valve repair system according to claim 17, wherein the second force measuring device comprises a wire attached to the strain gauge, the wire having a weak portion configured to allow a user to break the wire after the valve repair device has been attached to the natural valve.

19. A method for determining whether the tension supplied to a natural valve in question, resulting from the installation between a valve repair device and a natural valve, is at a desired level, The valve repair device is delivered to the target natural valve using a delivery device, wherein at least one of the valve repair device and the delivery device is equipped with a force measuring device. Attaching the valve repair device to the natural valve of the target, The force measuring device detects the tension applied to at least one of the valve repair device and the delivery device, A method comprising determining, based on the force detected by the force measuring device, whether the tension applied to the natural valve is at the desired level.

20. If the tension is not at the desired level, the valve repair device is removed from the natural valve. Reattaching the valve repair device to the natural valve, The force applied to at least one of the valve repair device and the delivery device is re-detected via the force measuring device, The method of claim 19, further comprising determining whether the tension applied to the natural valve is at the desired level based on the force re-detected by the force measuring device.

21. The valve repair device, At least one paddle movable between an open position and a closed position, wherein the at least one paddle is configured to attach the valve repair device to the natural valve, At least one gripping member configured to capture the natural valve, The method according to claim 19 or 20, further comprising a force measuring device attached to at least one of the gripping members.

22. The method according to claim 21, wherein the force measuring device is attached to one or more of the movable arm of the gripping member and the hinge portion of the gripping member.

23. The method according to any one of claims 19 to 22, wherein the force measuring device includes a strain gauge.

24. The method according to claim 23, wherein the detected force is detected via an ohmmeter.

25. The method according to any one of claims 19 to 24, wherein the delivery device comprises an operating element, and the force measuring device is attached to the operating element.

26. The method according to any one of claims 19 to 25, wherein the delivery device comprises a paddle control mechanism, and the force measuring device is attached to the paddle control mechanism.

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