Heart valve repair device and delivery device therefor

Abstract

Heart valve repair devices and delivery devices therefor. A valve repair device for repairing a native valve of a patient. The valve repair device includes a paddle, a clamping member, and an indicator. The paddle and / or the clamping member are movable to form an opening or capture region between the clamping member and the paddle. The indicator is configured to indicate whether a leaflet of the native valve is inserted into the opening or capture region between the paddle and the clamping member at least to a minimum insertion depth.

Description

[0001] Related applications

[0002] This application claims the benefits of U.S. Provisional Application No. 63 / 225,387, filed July 23, 2021, entitled “Heart Valve Repair Devices and Delivery Devices Therefor,” and U.S. Provisional Application No. 63 / 307,589, filed February 7, 2022, entitled “Heart Valve Repair Devices and Delivery Devices Therefor,” which are incorporated herein by reference in their entirety. Background Technology

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

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

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

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

[0007] This overview is intended to provide examples and is not intended to limit the scope of the invention in any way. For example, any feature included in the examples outlined herein is not required by the claims unless the claims expressly recite that feature. Moreover, features, components, steps, concepts, etc., described in the examples in this overview and elsewhere in this disclosure can be combined in various ways. Various features and steps described elsewhere in this disclosure may be included in the examples outlined herein.

[0008] Devices for repairing and / or treating a patient's natural valves are disclosed. These devices may be valve repair devices, implantable devices, valve treatment devices, implants, etc. Although sometimes described as implantable devices for illustrative purposes in the various examples herein, similar configurations can be used for other devices, such as valve repair devices, that are not necessarily implantable and can be removed after treatment.

[0009] The device may include indicators (which may be the same as or similar to other indicators described anywhere herein) and gripping members or clasp (which may be the same as or similar to other gripping members, gripper arms, clasp, and clasp arms described anywhere herein). The device may also include a paddle (which may be the same as or similar to other paddles described anywhere herein). The paddle and / or the gripping member / clasp (e.g., the clasp arm of the clasp, gripping arm, etc.) are movable to form an opening or capture region for receiving the leaflet. In some embodiments, the opening or capture region is formed between the gripping member / clasp (e.g., the clasp arm of the clasp, etc.) and the paddle (e.g., a portion of the paddle, etc.). The indicator is configured to indicate whether the leaflet of the natural valve is inserted into the opening or capture region at least to a minimum insertion depth or engagement depth. The minimum insertion depth or engagement depth may be pre-selected and / or configured to a specific depth as needed.

[0010] The indicators described herein can be configured in various shapes, sizes, and materials. In some embodiments, the indicators may include wave shapes, S-shaped shapes, C-shaped shapes, U-shaped shapes, V-shaped shapes, hook shapes, checkmark shapes, swoosh shapes, etc.

[0011] In some embodiments, the valve repair device (or valve treatment device, etc.) includes fasteners and / or fastener arms and indicators (e.g., leaflet depth indicators, indicator arms, markers, sensors, electrodes, etc.). The device may also include a paddle. The indicator may be configured such that the indicator arm and / or may be configured to be movable (e.g., via fasteners, paddles, and / or another part of the device) to indicate whether the leaflet of the natural valve is inserted into the opening or capture region at least to a minimum insertion depth. The minimum insertion depth may be pre-selected and / or configured to a specific depth as needed.

[0012] In some embodiments, the indicator may include an indicator arm, which may be coupled to the valve repair device at a first end and at a second end. The indicator arm may be coupled to an optional coaptation element of the valve repair device. The indicator arm may be compressible and may be configured to engage the leaflet of the natural valve. The indicator arm may include one or more protrusions extending from it. The fastener and the indicator arm may each include a marking comprising a radiopaque material. The capture area may be formed between a portion of the paddle and the arm of the fastener. The paddle may include an outer paddle and an inner paddle.

[0013] In some embodiments, the indicator or indicator arm may be configured to pass through a channel, slot, gap, and / or opening of the fastener. In some embodiments, the indicator or indicator arm may be configured to pass through a channel, slot, gap, and / or opening of the paddle-like structure. In some embodiments, the indicator or indicator arm may be configured to pass through a channel, slot, gap, and / or opening of a movable arm of the fastener.

[0014] In some embodiments, the fastener may optionally include a fixing arm. In some embodiments, the fixing arm of the fastener may include a first beam, a second beam, and / or a connecting member between the first beam and the second beam.

[0015] In some embodiments, an indicator marker may be attached to the indicator arm. The indicator arm may include a fixed end and a movable end. The fixed end of the indicator arm may be coupled to the fastener. The fixed end of the indicator arm may be coupled to a movable arm of the fastener. The movable end may include the indicator marker, which comprises a radiopaque material. The fixed end and the movable end may be disposed on a first side of the movable arm of the fastener.

[0016] In some embodiments, the indicator or indicator arm includes a leaf-shaped engagement member (e.g., extension, protrusion, arm, edge, bump, dip, swoop, U-shaped portion, V-shaped portion, triangular portion, curved portion, circular portion, rectangular portion, etc.) between the fixed end and the movable end. The leaf-shaped engagement member may be configured to pass through at least one of the movable arm of the fastener and the paddle-like structure.

[0017] In some embodiments, the leaflet engaging member is disposed on a second side of the movable arm of the fastener. In some embodiments, the leaflet engaging member may include one or more protrusions extending from the leaflet engaging member.

[0018] In some embodiments, the indicating arm may include a first arm and a second arm. The first arm and the second arm may be coupled to the movable end and may be connected at a connection point at the fixed end.

[0019] In some embodiments, the indicator arm is formed as a portion of the fastener. The indicator arm may be formed between the outer beams of the movable arm of the fastener and / or outside the outer beams of the fastener (or the fastener arm of the fastener).

[0020] In some embodiments, the indicator arm may include a twisted portion. The twisted portion may include one or more twisted sections between 0 degrees and 180 degrees.

[0021] In some embodiments, the indicating arm may include a first arm portion and a second arm portion. At least one of the first arm portion and the second arm portion may be formed between and / or outside the outer beam of the fastener. At least one of the first arm portion and the second arm portion may be formed from a portion of the first beam of the fastener. In some embodiments, the first arm portion may include a torsion portion. The torsion portion of the first arm portion may include one or more torsional portions rotating clockwise between 0 degrees and 180 degrees.

[0022] In some embodiments, the second arm portion may include a torsion portion. The torsion portion of the second arm portion may include one or more torsional portions rotating counterclockwise between 0 degrees and 180 degrees.

[0023] In some embodiments, the first arm portion and the second arm portion are coupled to the movable end at a connection point. The connection point may include an indicator mark comprising a radiopaque material press-fitted into at least one of the first arm portion and the second arm portion.

[0024] In some embodiments, a valve repair system for repairing a patient's natural valve includes a delivery system and a valve repair device coupled to the delivery system. The valve repair device may include a paddle, an indicator (e.g., a leaflet depth indicator, an indicator arm, a sensor, etc.), and a clamping member or fastener. The clamping member / fastener and / or the paddle may be movable to form an opening or capture area to receive a leaflet of the natural valve. The indicator is coupled to the valve repair device. In some embodiments, the indicator is configured to indicate whether the leaflet of the natural valve is inserted into the opening or capture area at least to a minimum insertion depth. The device may be configured to have different minimum insertion depths as needed (e.g., one or more of 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, etc.). The indicator or indicator arm may be configured to pass through one or more of the paddle and the clamping member / fastener.

[0025] In some embodiments, the valve repair device includes a clamping member or fastener (e.g., a fastener arm, clamping arm, etc.) and a leaflet depth indicator. The leaflet depth indicator includes at least a first electrode and a second electrode. The first and second electrodes provide electrical signals indicating whether the leaflet of the natural valve has inserted into the opening or capture region at least to a minimum insertion depth. The minimum insertion depth can be pre-selected and / or configured to a specific depth as needed. The device may also include a paddle-like component.

[0026] In some embodiments, a valve repair device for repairing a natural heart valve includes a clamping member or fastener (e.g., a fastener arm, gripping arm, etc.) and a leaflet depth indicator. The fastener (or a fastener arm / gripping arm of the fastener) may be movable to form an opening or capture region for receiving the natural leaflet of the natural valve. The leaflet depth indicator may include a first electrode and a second electrode. The first and second electrodes can provide electrical signals indicating whether the leaflet of the natural valve is inserted into the opening to a specific insertion depth.

[0027] In some embodiments, the electrical signal includes an endocrine electrocardiogram (ECG) signal or a bioimpedance signal. The first and second electrodes may be coupled to the clamping member / fastener (or fastener arm, clamping arm, etc.). In some embodiments, the clamping member / fastener includes a movable arm, and the first and second electrodes are coupled to the movable arm. In some embodiments, the first and second electrodes are coupled to an indicator arm. The indicator arm may be coupled to the valve repair device and may be movable within the opening or capture region.

[0028] In some embodiments, a valve repair system for repairing a natural heart valve includes a delivery system and a valve repair device. The valve repair device is releasably coupled to the delivery system. The valve repair device includes a clamping member or fastener (e.g., a fastener arm, clamping arm, etc.) and a leaflet depth indicator. The clamping member / fastener (e.g., a portion thereof, a fastener arm, clamping arm, etc.) is movable to form an opening or capture region for receiving the natural leaflet of the natural valve. The leaflet depth indicator includes a first electrode and a second electrode. The first and second electrodes provide an electrical signal indicating whether the leaflet of the natural valve is inserted into the opening or capture region at least to a minimum insertion depth. The minimum insertion depth can be pre-selected and / or configured to a specific depth as needed.

[0029] In some embodiments, the leaflet depth indicator may be integrally formed with the clamping member / fastener. For example, the leaflet depth indicator may be formed of the same material as the clamping member / fastener. In some embodiments, the clamping member / fastener and the leaflet depth indicator may be cut from a single sheet of material.

[0030] In some embodiments, the material of the leaflet depth indicator may be bent, twisted, and / or shaped relative to the material of the clamping member / fastener, such that the leaflet depth indicator is positioned in a plane so that it can contact the natural leaflet and determine whether the clamping member / fastener has properly engaged the natural leaflet. The leaflet depth indicator may extend from a movable arm of the fastener, a hinge portion of the fastener, and / or a fixed arm of the fastener.

[0031] In some embodiments, the valve repair device includes a clamping member or fastener (and / or its fastener arm, clamping arm, etc.) and an indicator. The device may also include a paddle-like structure. The valve repair device may further include an insulating element disposed between at least a portion of the clamping member / fastener / fastener arm and the indicator. The indicator includes one or more conductive indicator contacts that can be connected to a sensor to indicate whether the leaflet of the natural valve is inserted into the opening or capture region at least to a minimum insertion depth. The minimum insertion depth may be pre-selected and / or configured to a specific depth as needed.

[0032] In some embodiments, the signal can be transmitted to the sensor via electrical wiring from the valve repair device to the sensor. The signal can also be transmitted to the sensor via electrical conduction from the indicator through a portion of the valve repair device. In some embodiments, the signal can be transmitted to the sensor via electrical conduction from the indicator through at least one of a conductive retaining arm, a conductive mating element, a conductive collar, a conductive conduit coupling element, and a conductive actuation wire.

[0033] In some embodiments, the clamping member or fastener may include a movable arm and a fixed arm, as well as a first indicator plate and a second indicator plate, the first indicator plate being coupled to the fixed arm and the second indicator plate being coupled to the movable arm.

[0034] In some embodiments, the valve repair device may include a bar coupled to the fastener, wherein the bar includes a leaflet engagement portion and a device engagement portion. The leaflet engagement portion may reinforce the paddle and may prevent or inhibit leaflet bundling around the indicator or between portions of the indicator.

[0035] In some embodiments, a valve repair device for repairing a patient's natural valve includes a clamping member or fastener (and / or fastener arm, clamping arm, etc.) and an indicator. The clamping member / fastener (or a portion of the clamping member / fastener, arm, etc.) is movable to form an opening or capture region for capturing the leaflet of the natural valve. The indicator is coupled to the valve repair device. The indicator may include one or more conductive indicator contacts. The indicator may indicate whether the leaflet of the natural valve is inserted into the opening or capture region at least to a minimum insertion depth.

[0036] In some embodiments, the indicator may include two conductive indicator contacts. When the clamping member / fastener is in the closed position and the lobular tissue is not inserted to the minimum insertion depth, the two conductive indicator contacts may be bridged. Alternatively, when the clamping member / fastener is in the closed position and the lobular tissue is inserted to the minimum insertion depth, the two conductive indicator contacts may be electrically isolated. The one or more conductive indicator contacts may be arranged on the paddle-shaped part of the valve repair device.

[0037] In some embodiments, a valve repair device for repairing a natural heart valve includes a conductive fastener (or other clamping member), a conductive paddle, and an insulating element. The insulating element is disposed between a portion of the conductive fastener and the conductive paddle. The conductive fastener is configured to move to form a capture area for capturing the leaflet of the natural valve. When the fastener is in a closed position and the leaflet tissue is not inserted to a minimum insertion depth, the conductive fastener contacts the conductive paddle.

[0038] In some embodiments, the fastener is electrically isolated from the conductive paddle when the fastener is in the closed position and the lobular tissue is inserted to the minimum insertion depth.

[0039] In some embodiments, the conductive paddle is coupled to a conductive collar. The conductive paddle can be coupled to the conductive collar via a conductive mating element.

[0040] In some embodiments, the valve repair system includes a valve repair device and a delivery device. The valve repair device includes a conductive fastener (or other clamping member), a conductive paddle, an insulator, and a conductive collar. The insulator is disposed between a portion of the conductive fastener and the conductive paddle. The conductive collar is electrically coupled to the conductive paddle. The delivery device includes a catheter, a conductive coupling element, and a conductive actuation wire. The conductive coupling element is releasably coupled to the conductive collar. The conductive actuation wire is connected to the conductive fastener, which is configured to move to form a capture area for capturing the leaflet of the native valve. When the fastener is in a closed position and the leaflet tissue is not inserted to a minimum insertion depth, the conductive fastener contacts the conductive paddle.

[0041] In some embodiments, the conductive paddle is coupled to the conductive collar via a conductive mating element. When the fastener is in the closed position and the lobular tissue is inserted to the minimum insertion depth, the fastener can be electrically isolated from the conductive paddle.

[0042] In some embodiments, a valve repair device for repairing a natural heart valve includes a conductive fastener (or other clamping member), a conductive leaflet depth indicator, and an insulating member. The insulating member is disposed between a portion of the conductive fastener and the conductive leaflet depth indicator. The conductive fastener (or fastener arm) is configured to move to form a capture area for capturing the leaflet of the natural valve.

[0043] In some embodiments, the conductive lobule depth indicator contacts the conductive fastener when the fastener is in the closed position and the lobule tissue is not inserted to the minimum insertion depth.

[0044] In some embodiments, when the fastener is in the closed position and the lobule tissue is inserted to the minimum insertion depth, the fastener is electrically isolated from the conductive lobule depth indicator.

[0045] In some embodiments, when the fastener is in the closed position and the lobule tissue is inserted to the minimum insertion depth, the conductive lobule depth indicator moves relative to the fastener (or fastener arm).

[0046] In some embodiments, the valve repair device includes a fastener (or fastener arm), an indicator, and a sensor. The fastener includes a movable arm and a fixed arm. The fastener (or its movable arm) is movable to form an opening or capture region for capturing the leaflet of the natural valve. The indicator includes a first indicator plate and a second indicator plate, the first indicator plate being coupled to the fixed arm and the second indicator plate being coupled to the movable arm. The indicator is configured to detect one or more electrical properties of blood or tissue. The sensor is coupled to the indicator.

[0047] In some embodiments, the sensor is configured to measure one or more of resistance, inductance, capacitance, voltage, current, and impedance. The sensor may be configured to measure impedance. The sensor may be configured to compare one or more sensed electrical characteristics with previously measured electrical characteristics corresponding to known tissue and blood samples. The sensor may be configured to determine whether tissue is bonded. The sensor is configured to distinguish between lobular tissue and chordae tendineae tissue.

[0048] In some embodiments, a first impedance value is measured in the method for identifying the state of the fastener (or the state of the clamping member). The first impedance value is compared with a previously measured impedance value. Based on the comparison, one or more of the states or positions of the fastener are determined or estimated. The method(s) can be performed on a living animal or on a simulation, such as on a cadaver, a cadaver's heart, a simulator (e.g., where body parts, hearts, lobules, tissues, etc., are simulated), etc.

[0049] In some embodiments, a valve repair device for repairing a patient's natural valve includes a paddle, an indicator, a rod, and a clamping member or fastener. The clamping member / fastener (or a portion thereof or a movable arm) is movable to form a capture area for capturing the leaflet of the natural valve. In some embodiments, the indicator is coupled to the clamping member / fastener. The indicator may be configured to indicate whether the leaflet of the natural valve is inserted into the opening or capture area at least to a minimum insertion depth. The minimum insertion depth may be pre-selected and / or configured to a specific depth as needed. The rod is coupled to the paddle. The rod reinforces the paddle and reduces the space within the capture area.

[0050] In some embodiments, the rod may include a leaflet engagement portion and a device engagement portion. The leaflet engagement portion may include one or more crests positioned to contact the leaflet. When viewed from the side, the crests may overlap with the indicator.

[0051] A further understanding of the nature and advantages of the invention is set forth in the following description and claims—particularly when considered in conjunction with the accompanying drawings, wherein like parts have like reference numerals. Attached Figure Description

[0052] To further clarify various aspects of the examples in this disclosure, certain examples and embodiments will be described in more detail with reference to various aspects of the accompanying drawings. It should be understood that these drawings depict only exemplary embodiments of this disclosure and should not be considered as limiting the scope of the invention. Furthermore, while some example figures may be drawn to scale, not all example figures are necessarily drawn to scale. Examples of the invention and other features and advantages will be described and illustrated in a more targeted and detailed manner with the use of the accompanying drawings, in which:

[0053] Figure 1 The illustration shows a cross-sectional view of the human heart during diastole.

[0054] Figure 2 The illustration shows a cross-sectional view of the human heart during systole.

[0055] Figure 3 The illustration shows a cross-sectional view of the human heart during systole, illustrating valvular regurgitation.

[0056] Figure 4 yes Figure 3 A cross-sectional view, annotated to illustrate the natural shape of the mitral leaflet in systole;

[0057] Figure 5 The illustration shows a healthy mitral valve with leaflet closure as viewed from the atrial side.

[0058] Figure 6 The illustration shows a dysfunctional mitral valve with visible gaps between the leaflets, viewed from the atrial side.

[0059] Figure 7 The diagram shows the tricuspid valve as viewed from the atrial side.

[0060] Figure 8-14 Examples of implantable devices or implants at various stages of deployment are shown;

[0061] Figure 15 Examples of implantable devices or implants are shown, which are similar to Figure 8-14 The device shown is an example of a device where the paddle is independently controllable.

[0062] Figure 16-21 It shows Figure 8-14 Examples include implantable devices or implants being delivered and placed within a natural valve;

[0063] Figure 22 A three-dimensional view of an example implantable device or implant in a closed position is shown;

[0064] Figure 23 It shows Figure 22 A front view of an implantable device or implant;

[0065] Figure 24 It shows Figure 22 A side view of the implantable device or implant;

[0066] Figure 25 A cover with a paddle-shaped covering and mating elements or spacers is shown. Figure 22 Front view of an implantable device or implant;

[0067] Figure 26 It is shown in the open position. Figure 22 Top-view diagram of an implantable device or implant;

[0068] Figure 27 It is shown in the open position. Figure 22 A three-dimensional view of the bottom of an implantable device or implant;

[0069] Figure 28 Fasteners for use in implantable devices or implants are shown;

[0070] Figure 29 A portion of natural valve tissue is shown being held in place by fasteners;

[0071] Figure 30A side view of an example implantable device or implant in a partially open position is shown, with the fastener in the closed position.

[0072] Figure 31 A side view of an example implantable device or implant in a partially open position is shown, with the fastener in the open position;

[0073] Figure 32 A side view of an example implantable device or implant in a semi-open position is shown, with the fastener in the closed position;

[0074] Figure 33 A side view of an example implantable device or implant in a semi-open position is shown, with the fastener in the open position;

[0075] Figure 34 A side view of an example implantable device or implant in the three-quarters open position is shown, with the fastener in the closed position.

[0076] Figure 35 A side view of an example implantable device or implant in the three-quarters open position is shown, with the fastener in the open position;

[0077] Figure 36 A side view of an example implantable device in the fully open or fully bailout position is shown, with the fastener in the closed position;

[0078] Figure 37 A side view of an example implantable device in the fully open or fully salvage position is shown, with the fastener in the open position;

[0079] Figures 38-49 The image shows a covering, delivered and implanted within a natural valve. Figures 30-38 Examples include implantable devices or implants;

[0080] Figure 50 This diagram illustrates the path of a natural valve leaflet along each side of the occlusal element or spacer of an example valve repair device or implant.

[0081] Figure 51 A top schematic diagram showing the path of a natural valve leaflet around the occlusal element or spacer of an example valve repair device or implant;

[0082] Figure 52 The diagram shows the occlusal element or spacer in the gap of a natural valve, viewed from the atrial side.

[0083] Figure 53A valve repair device or implant attached to a leaflet of a natural valve is shown as viewed from the ventricular side of the natural valve, wherein the occlusal element or spacer is in the gap of the natural valve.

[0084] Figure 54 A perspective view is shown of a valve repair device or implant attached to a leaflet of a natural valve, shown from the ventricular side of the natural valve, wherein the occlusal element or spacer is in the gap of the natural valve.

[0085] Figure 55 A three-dimensional view of an example implantable device or implant in a closed position is shown;

[0086] Figure 56 A perspective view of an example fastener for an example implantable device or implant in a closed position is shown;

[0087] Figure 57 The illustration shows a valve repair device with the paddle in the open position;

[0088] Figure 58 The diagram shows... Figure 57 A valve repair device in which the paddle is in the open position and the clamping member (e.g., clamping arm, fastening arm, etc.) is moved to create a wider gap between the clamping member and the paddle.

[0089] Figure 59 The diagram shows... Figure 57 The valve repair device, wherein the valve repair device is located in Figure 57 The location shown is where the valve tissue is placed between the clamping member and the paddle-shaped structure;

[0090] Figure 60 The diagram shows... Figure 57 A valve repair device in which the clamping member is moved to reduce the gap between the clamping member and the paddle;

[0091] Figures 61A-61B The diagram shows... Figure 57 The movement of the paddle-shaped part of the valve repair device from the open position to the closed position;

[0092] Figure 62 The diagram shows the closed position. Figure 57 A valve repair device in which clamping components engage valve tissue;

[0093] Figure 63 The illustration shows the process after disconnection from the delivery device and attachment to the valve tissue. Figure 57 A valve repair device, wherein the valve repair device is in a closed and locked state;

[0094] Figures 64-67An example fastener or leaflet capture section is shown, deployed to engage with the leaflet of a natural valve;

[0095] Figures 68-77 A device with a fastener having an indicator arm is shown that is delivered and deployed within a natural valve;

[0096] Figures 78-84 The illustration shows an example valve repair device with the paddle in the open position;

[0097] Figures 85-87 A device with a fastener having an indicator arm is shown;

[0098] Figure 88-93 An example of a fastener with an indicator arm having a shaped end is illustrated;

[0099] Figure 94 and 95A -95G illustrates an example of a fastener with an indicator arm featuring a shaped portion, in the closed position;

[0100] Figure 96A and 96B The diagram shows... Figure 94 A fastener having an indicator arm with a shaped portion, the fastener being in the open position;

[0101] Figures 97-98 The illustration shows an example valve repair device with fasteners featuring leaflet depth indicators;

[0102] Figure 99-101 The illustration shows an example fastener with a leaflet depth indicator;

[0103] Figure 102A and 102B The illustration shows a valve repair device with fasteners featuring leaflet depth indicators;

[0104] Figures 103-109 The illustration shows an example fastener with a leaflet depth indicator;

[0105] Figure 110 The diagram shows the fixed end of the leaf depth indicator;

[0106] Figures 111-114 The illustration shows an example fastener with a leaflet depth indicator;

[0107] Figures 115-116 The diagram illustrates a device with a fastener featuring a leaf-shaped depth indicator;

[0108] Figures 117-118 The illustration shows an example leaf path between the fastener and the leaf depth indicator;

[0109] Figures 119-120The illustration shows an example leaf depth indicator for fasteners and / or capture devices;

[0110] Figures 121-126 The illustration shows an example fastener with a leaflet depth indicator;

[0111] Figures 127-128 The illustration shows an example implantable device with a fastener featuring a leaflet depth indicator;

[0112] Figure 129 The illustration shows an example fastener with a leaflet depth indicator;

[0113] Figure 130 The illustration shows an example device with a fastener featuring a leaf-shaped depth indicator;

[0114] Figure 131 The illustration shows an example fastener with a leaflet depth indicator;

[0115] Figure 132 The illustration shows an example implantable device with a fastener featuring a leaflet depth indicator;

[0116] Figure 133 The illustration shows an example fastener with a leaflet depth indicator;

[0117] Figure 134 The illustration shows an example implantable device with a fastener featuring a leaflet depth indicator;

[0118] Figure 135 The illustration shows an example fastener with a leaflet depth indicator;

[0119] Figure 136 , 137A Figure 137B illustrates an electrocardiogram (IECG) signal measured by electrodes of an example leaflet depth indicator;

[0120] Figure 137C-137F The illustration shows a bipolar IECG signal measured from the electrodes of an example leaflet depth indicator;

[0121] Figure 138 The illustration shows an example fastener with a leaflet depth indicator;

[0122] Figure 139 The illustration shows an example fastener with an integrated leaflet depth indicator;

[0123] Figure 140A The illustration shows an example fastener with an arm having a leaf-shaped depth indicator that can be formed as an integral part;

[0124] Figure 140B The diagram illustrates a structure composed of... Figure 140A The example fastener shown is an integral leaf-shaped depth indicator made of an arm;

[0125] Figure 140C The diagram illustrates a structure composed of... Figure 140A The example fastener shown is an integral leaf-shaped depth indicator made of an arm;

[0126] Figure 141A The illustration shows an example fastener with an arm having a movable arm that can be formed as a fastener and an arm having a leaf-shaped depth indicator that can be formed as an integral part;

[0127] Figure 141B The illustration shows an example fastener with an arm having a movable arm that can be formed as a fastener and an arm having a leaf-shaped depth indicator that can be formed as an integral part;

[0128] Figure 141C The illustration shows a device with a movable arm and... Figure 141A or Figure 141B The example fastener shown is an integral leaf-shaped depth indicator made of an arm;

[0129] Figure 141D The illustration shows an example fastener with an arm having a movable arm that can be formed as a fastener and an arm having a leaf-shaped depth indicator that can be formed as an integral part;

[0130] Figure 142A The illustration shows an example fastener with an integrated leaflet depth indicator, wherein the valve leaflet is not inserted to the depth that causes displacement of the leaflet depth indicator;

[0131] Figure 142B The illustration shows an example fastener with an integrated leaflet depth indicator, wherein the valve leaflet is inserted to a depth that causes displacement of the leaflet depth indicator;

[0132] Figure 143A The illustration shows an example fastener with an integrated leaflet depth indicator, wherein the valve leaflet is not inserted to the depth that causes displacement of the leaflet depth indicator;

[0133] Figure 143B The illustration shows an example fastener with an integrated leaflet depth indicator, wherein the valve leaflet is inserted to a depth that causes displacement of the leaflet depth indicator;

[0134] Figures 144-147 The illustration shows an example device with a fastener having an electric leaflet depth indicator;

[0135] Figures 148-155 The illustration shows an example fastener with a leaf depth indicator configured to visually and electrically indicate leaf insertion.

[0136] Figure 156 , 156A Figures 156B, 156C, and 156D illustrate fasteners with different sensor plate configurations;

[0137] Figures 157-158 The illustration shows an example fastener with an electric leaflet depth indicator;

[0138] Figure 159 The illustration shows a device that senses blood. Figures 157-158 An example fastener of an electric leaflet depth indicator;

[0139] Figure 160 The illustration shows a sensor valve leaflet. Figures 157-158 An example fastener of an electric leaflet depth indicator;

[0140] Figure 161 The illustration shows a sensory chordae tendineae. Figures 157-158 An example fastener of an electric leaflet depth indicator;

[0141] Figure 162 The diagram illustrates a circuit for measuring impedance according to some embodiments of a fastener with an electrical indicator;

[0142] Figure 163 An example of calculating impedance components is illustrated;

[0143] Figure 164 The illustration shows an implementation of a method for identifying fastener status based on electrical measurements;

[0144] Figures 165-169 The illustration shows an example device and / or part of a device with a fastener having a leaf depth indicator. Detailed Implementation

[0145] The following description refers to the accompanying drawings, which illustrate exemplary embodiments of the present disclosure. Other embodiments with different structures and operations do not depart from the scope of this disclosure.

[0146] The exemplary embodiments of this disclosure relate to systems, apparatuses, methods, etc., for repairing defective heart valves. For example, various embodiments of valve repair devices, implantable devices, implants, and systems (including systems for their delivery) are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, individual components of the disclosed apparatuses and systems can be combined unless they are mutually exclusive or otherwise physically impossible. Furthermore, the techniques and methods described herein can be performed on living animals or in simulations, such as on cadavers, cadaver hearts, simulators (e.g., in which body parts, hearts, tissues, etc., are simulated).

[0147] As described herein, when one or more components are described as being connected, linked, fixed, coupled, attached, or otherwise interconnected, such interconnection may be direct between the components or may be indirect, such as by using one or more intermediary components. Furthermore, as described herein, references to “component,” “part,” or “section” should not be limited to a single structural component, part, or element, but may include combinations of components, parts, or elements. Moreover, as described herein, the terms “substantially” and “about” are defined as at least close to (and including) a given value or state (preferably within 10%, more preferably within 1%, and most preferably within 0.1%). The terms “fastener” and “fastener arm” are often used herein in relation to specific examples; however, the terms “clamping component” and / or “clamping arm” may be used instead and function in the same or similar manner, even if not configured in the same way as a typical fastener.

[0148] Figure 1 and 2 These are cross-sectional views of the human heart (H) during diastole and systole, respectively. The right ventricle (RV) and left ventricle (LV) are separated from the right atrium (RA) and left atrium (LA) by the tricuspid valve (TV) and mitral valve (MV), respectively (i.e., the atrioventricular valves). Additionally, the aortic valve (AV) separates the left ventricle (LV) from the ascending aorta (AA), and the pulmonary valve (PV) separates the right ventricle from the pulmonary artery (PA). Each of these valves has flexible leaflets (e.g., Figure 3-6 The leaflets 20, 22 and shown Figure 7 The leaflets (30, 32, 34) shown extend inwardly across corresponding orifices that converge or "oppose" in the flow to form a unidirectional fluid occlusion surface. The natural valve repair systems of this application are frequently described and / or illustrated with respect to the mitral valve (MV). Therefore, the anatomy of the left atrium (LA) and left ventricle (LV) will be explained in more detail. However, the devices described herein can also be used to repair other natural valves, such as the tricuspid valve (TV), aortic valve (AV), and pulmonary valve (PV).

[0149] The left atrium (LA) receives oxygenated blood from the lungs. During diastole or during relaxation, such as... Figure 1 As shown, blood previously collected in the left atrium (LA) (during systole) moves through the mitral valve (MV) and into the left ventricle (LV) due to the dilation of the left ventricle (LV). During systole or systole, as... Figure 2As shown, the left ventricle (LV) contracts to force blood through the aortic valve (AV) and ascending aorta (AA) into the body. During systole, the leaflets of the mitral valve (MV) close to prevent blood from regurgitating from the LV and returning to the left atrium (LA), and blood is collected from the pulmonary veins into the left atrium. In some embodiments, the devices described in this application are used to restore the function of a defective mitral valve (MV). That is, these devices are configured to assist in closing the leaflets of the mitral valve to prevent or inhibit blood regurgitation from the LV and returning to the LA. Many of the devices described in this application are designed to easily grasp and secure the natural leaflets around the occlusal element or spacer, which advantageously acts as a filler in the regurgitation orifice to prevent or inhibit backflow or reflux during systole, but this is not necessary.

[0150] Now for reference Figure 1-7 The mitral valve MV comprises two leaflets, anterior leaflet 20 and posterior leaflet 22. The mitral valve MV also includes a valve annulus 24, which is a variable-density fibrous ring surrounding the leaflets 20 and 22. (Reference) Figure 3 and 4 The mitral valve MV is anchored to the wall of the left ventricle (LV) via the chordae tendineae (CT). The chordae tendineae (PM) are cord-like tendons that connect the papillary muscles (PM) (i.e., muscles located at the base of the chordae tendineae and within the wall of the LV) to the leaflets 20 and 22 of the mitral valve MV. The PM restricts the movement of the leaflets 20 and 22 of the mitral valve MV and prevents the mitral valve MV from reverting. The mitral valve MV opens and closes in response to pressure changes in the left atrium (LA) and left ventricle (LV). The PM does not open or close the mitral valve MV. Instead, the PM supports or braces the leaflets 20 and 22 against the high pressure required to circulate blood throughout the body. The PM, along with the chordae tendineae (CT), is known as the subvalvular apparatus, which is used to prevent the mitral valve MV from prolapsed into the left atrium (LA) during mitral valve closure. Figure 3 As shown in the left ventricular outflow tract (LVOT) view, the anatomy of leaflets 20 and 22 causes the medial parts of the leaflets to align at their free ends, and leaflets 20 and 22 begin to recede or unfold from each other. Leaflets 20 and 22 unfold in the atrial direction until each leaflet meets the mitral valve annulus.

[0151] Various disease processes can impair the normal function of one or more of the heart's natural valves (V). These processes include degenerative processes (e.g., Barlow's disease, fibroelastosis, etc.), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis, etc.). Furthermore, damage to the left ventricle (LV) or right ventricle (RV) from a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other heart diseases (e.g., cardiomyopathy, etc.) can distort the geometry of the natural valve, leading to its dysfunction. However, most patients who undergo valve surgery (such as surgery on the mitral valve MV) have degenerative disease that causes dysfunction of the leaflets (e.g., leaflets 20, 22) of the natural valve (e.g., mitral valve MV), resulting in prolapse and regurgitation.

[0152] Natural valves can typically malfunction in different ways: including (1) valvular stenosis; and (2) valvular regurgitation. Valvular stenosis occurs when a natural valve does not open completely, resulting in obstruction of blood flow. Typically, valvular stenosis is caused by the accumulation of calcified material on the valve leaflets, which leads to thickening of the leaflets and impairs the valve's ability to open fully to allow forward blood flow. Valvular regurgitation occurs when the valve leaflets do not close completely, resulting in blood leaking back into the previous chamber (e.g., causing blood to leak from the left ventricle into the left atrium).

[0153] There are three main mechanisms by which a natural valve becomes regurgitant or incompetent, including Carpentier type I, II, and III dysfunction. Carpentier type I dysfunction involves dilation of the valve annulus, causing the normally functioning leaflets to separate from each other and fail to form a tight seal (i.e., the leaflets do not properly occlude). Type I dysfunction includes leaflet perforation, as seen in endocarditis. Carpentier type II dysfunction involves one or more leaflets of the natural valve detaching above the occlusal plane. Carpentier type III dysfunction involves restriction of movement of one or more leaflets of the natural valve, causing the leaflets to be abnormally constricted below the plane of the valve annulus. Leaflet restriction can be caused by rheumatic disease (Ma) or ventricular dilation (IIIb).

[0154] refer to Figure 5 When a healthy mitral valve (MV) is in the closed position, the anterior leaflet 20 and posterior leaflet 22 align, preventing blood from leaking from the left ventricle (LV) into the left atrium (LA). (Reference) Figure 3 and 6 Mitral regurgitation (MR) occurs when the anterior leaflet 20 and / or posterior leaflet 22 of the mitral valve MV shift into the left atrium LA during systole, causing the edges of leaflets 20 and 22 to not contact each other. This failure to align results in a gap 26 between the anterior leaflet 20 and the posterior leaflet 22, which allows blood to flow back from the left ventricle LV to the left atrium LA during systole, as if through... Figure 3 The mitral regurgitation MR flow path is illustrated in the diagram. (Reference) Figure 6 The gap 26 may have a width W between about 2.5 mm and about 17.5 mm, between about 5 mm and about 15 mm, between about 7.5 mm and about 12.5 mm, or about 10 mm. In some cases, the gap 26 may have a width W greater than 15 mm. As described above, the presence of leaflets (e.g., leaflets 20, 22 of the mitral valve MV) can lead to dysfunction (which may thus cause valvular regurgitation) in several different ways.

[0155] In any of the above-mentioned cases, a valve repair device or implant is desired that can engage the anterior leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent or inhibit regurgitation of blood through the mitral valve MV. Figure 4 As can be seen, the abstract representation of the valve repair device, implantable device, or implant 10 is shown as being implanted between the leaflets 20 and 22, so that no regurgitation occurs during systole (which will... Figure 3 and Figure 4 (Comparison). In some embodiments, the occlusive elements of device 10 (e.g., spacers, engagement elements, gap fillers, membranes, sheets, plugs, wedges, balloons, etc.) have a generally conical or triangular shape that naturally adapts to the geometry of the natural valve and the nature of its expanding leaflets (or towards the valve annulus). In this application, the terms spacer, engagement element, occlusive element, and gap filler are used interchangeably and refer to elements that fill a portion of the space between the natural valve leaflets and / or are configured such that the natural valve leaflets abut against engagement or "occlusion" (e.g., such that the natural leaflets abut against engagement elements, occlusive elements, spacers, etc., rather than merely against each other).

[0156] Although stenosis or regurgitation can affect any valve, stenosis is primarily found affecting the aortic valve (AV) or pulmonary valve (PV), and regurgitation is primarily found affecting the mitral valve (MV) or tricuspid valve (TV). Both valvular stenosis and regurgitation increase cardiac hemorrhage and workload, and if left untreated, can lead to very serious conditions such as endocarditis, congestive heart failure, permanent cardiac damage, cardiac arrest, and ultimately death. Because the left side of the heart (i.e., the left atrium (LA), left ventricle (LV), mitral valve (MV), and aortic valve (AV)) is primarily responsible for systemic blood flow, mitral valve (MV) or aortic valve (AV) dysfunction is significantly more problematic and often life-threatening due to the significantly higher pressure on the left side of the heart.

[0157] Dysfunctional natural heart valves can be repaired or replaced. Repair generally involves preserving and correcting the patient's natural valve. Replacement generally involves replacing the patient's natural valve with a biological or mechanical substitute. Generally, the aortic valve (AV) and pulmonary valve (PV) are more prone to stenosis. Because the stenosis damage to the leaflets is irreversible, treatment for aortic or pulmonary valve stenosis involves removing the valve and replacing it with a surgically implanted heart valve or a transcatheter heart valve. The mitral valve (MV) and tricuspid valve (TV) are more prone to leaflet and / or surrounding tissue deformation, which, as described above, can prevent the normal closure of the mitral valve (MV) or tricuspid valve (TV) and allow blood to regurgitate or flow back from the ventricle into the atrium (e.g., a deformed mitral valve (MV) can allow regurgitation or backflow from the left ventricle (LV) to the left atrium (LA), such as...). Figure 3 (As shown). Regurgitation or backflow of blood from the ventricle to the atrium causes valvular insufficiency. Structural or morphological deformities of the mitral valve MV or tricuspid valve TV are usually repairable. Additionally, regurgitation can occur due to chordae tendineae dysfunction (e.g., chordae tendineae that are stretched or ruptured), which allows the anterior leaflet 20 and posterior leaflet 22 to revert, allowing blood to flow back into the left atrium LA. Problems arising from chordae tendineae dysfunction can be corrected by repairing the structure of the chordae tendineae or mitral valve MV (e.g., by fixing leaflets 20, 22 to the affected portion of the mitral valve).

[0158] The devices and procedures disclosed herein generally relate to the repair of the mitral valve structure. However, it should be understood that the devices and concepts provided herein can be used to repair any natural valve and any component of a natural valve. This device can be used between leaflets 20 and 22 of the mitral valve MV to prevent or inhibit the regurgitation of blood from the left ventricle into the left atrium. Regarding the tricuspid valve TV (… Figure 7 Any device or concept described herein may be used between any two of the anterior leaflet 30, septal leaflet 32, and posterior leaflet 34 to prevent or inhibit blood backflow from the right ventricle to the right atrium. Furthermore, any device or concept provided herein may be used together on all three leaflets 30, 32, and 34 to prevent or inhibit blood backflow from the right ventricle to the right atrium. That is, the valve repair device or implant described herein may be centrally located between the three leaflets 30, 32, and 34.

[0159] Example implantable devices (e.g., implantable prosthetic devices, etc.) or implants may optionally have occlusion elements (e.g., spacers, engagement elements, gap fillers, etc.) and at least one anchoring element (e.g., one, two, three, or more). In some embodiments, without occlusion elements, implantable devices or implants may have any combination or sub-combination of the features disclosed herein. When included, occlusion elements (e.g., engagement elements, spacers, etc.) are configured to be positioned within the natural heart valve orifice to help fill the space between the leaflets and form a more effective seal, thereby reducing or preventing or inhibiting the aforementioned regurgitation. Occlusion elements may have a blood-impermeable (or blood-resistant) structure and allow the natural leaflets to close around the occlusion element during ventricular systole to prevent blood from flowing from the left or right ventricle back into the left or right atrium, respectively. The device or implant may be configured to seal two or three natural valve leaflets; that is, the device may be used for both natural mitral valves (mitral valve) and tricuspid valves. The antagonistic element is sometimes referred to as the spacer in this document because it can fill the space between incompletely closed, dysfunctional natural leaflets (e.g., mitral leaflets 20, 22 or tricuspid leaflets 30, 32, 34).

[0160] Optional occlusive elements (e.g., spacers, coupling elements, etc.) can have various shapes. In some embodiments, the occlusive element can have an elongated cylindrical shape with a circular cross-sectional shape. In some embodiments, the occlusive element can have an elliptical cross-sectional shape, an oval cross-sectional shape, a crescent-shaped cross-sectional shape, a rectangular cross-sectional shape, or various other non-cylindrical shapes. In some embodiments, the occlusive element can have an atrial portion located in or near the atrium, a ventricular or lower portion located in or near the ventricle, and lateral surfaces extending between the natural leaflets. In some embodiments configured for the tricuspid valve, the atrium or upper portion is located in or near the right atrium, and the ventricle or lower portion is located in or near the right ventricle, and the lateral surfaces extend between the natural tricuspid valve leaflets.

[0161] In some embodiments, the anchor may be configured to secure the device to one or two natural leaflets, such that the occlusal element is positioned between the two natural leaflets. In some embodiments configured for the tricuspid valve, the anchor is configured to secure the device to one, two, or three tricuspid leaflets, such that the occlusal element is positioned between the three natural leaflets. In some embodiments, the anchor may be attached to the occlusal element at a location adjacent to the ventricular portion of the occlusal element. In some embodiments, the anchor may be attached to an actuating element such as a shaft or actuating wire, to which the occlusal element is also attached. In some embodiments, the anchor and occlusal element can be positioned independently of each other by moving each of the anchor and the occlusal element along the longitudinal axis of the actuating element (e.g., actuating shaft, actuating rod, actuating tube, actuating wire, etc.). In some embodiments, the anchor and the occlusal element can be positioned simultaneously by moving the anchor and the occlusal element together along the longitudinal axis of the actuating element such as a shaft, actuating wire, etc. The anchor can be configured to be positioned behind the natural lobule during implantation, so that the lobule is gripped by the anchor.

[0162] The device or implant can be configured for implantation via a delivery system or other means for delivery. The delivery system may include one or more of a guide / delivery sheath, delivery catheter, manipulable catheter, implant catheter, tube, combinations thereof, etc. The occlusal element and anchor can be compressed to a radially compressed state and self-expand to a radially expanded state when the compression pressure is released. The device can be configured to initially expand the anchor away from the still-compressed occlusal element radially to create a gap between the occlusal element and the anchor. A natural lobule can then be positioned within the gap. The occlusal element can expand radially to close the gap between the occlusal element and the anchor and capture the lobule between the occlusal element and the anchor. In some embodiments, the anchor and occlusal element are optionally configured to self-expand. Implantation methods for various embodiments can be different and are discussed more fully below with respect to each embodiment. Further information regarding these and other delivery methods can be found in U.S. Patent No. 8,449,599 and U.S. Patent Application Publications Nos. 2014 / 0222136, 2014 / 0067052, 2016 / 0331523 and PCT Patent Application Publication No. WO2020 / 076898, each of which is incorporated herein by reference in its entirety for all purposes. With necessary modifications, these methods can be performed on living animals or on simulations, such as on cadavers, cadaver hearts, simulators (e.g., in which body parts, hearts, tissues, etc., are simulated), etc.

[0163] The disclosed device or implant can be configured such that the anchor connects to the leaflet, utilizing tension from natural chordae tendineae to resist the high systolic pressure that pushes the device toward the left atrium. During diastole, the device can rely on compressive and retaining forces applied to the leaflet held by the anchor.

[0164] Now for reference Figure 8-15 The present invention illustrates schematic diagrams of devices or implants 100 (e.g., prosthetic septum devices, valve repair devices, implantable devices, etc.) at various deployment stages. Devices or implants 100 and other similar devices / implants are described in more detail in PCT patent applications publications WO2018 / 195215, WO20 / 076898, and WO2019 / 139904, which are incorporated herein by reference in their entirety. Device 100 may include any other features of another device or implant discussed in this application or the above-cited applications, and device 100 may be positioned as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application or the above-cited applications) to engage valve tissue (e.g., leaflets 20, 22, 30, 32, 34).

[0165] Device or implant 100 is deployed from a delivery system or other means 102 for delivery. Delivery system 102 may include one or more of catheters, sheaths, guiding catheters / sheaths, delivery catheters / sheaths, manipulable catheters, implant catheters, tubes, channels, access routes, combinations thereof. Device or implant 100 includes an occlusion portion 104 and an anchoring portion 106.

[0166] In some embodiments, the mating portion 104 of the device or implant 100 includes mating elements 110 (e.g., spacers, plugs, fillers, foams, sheets, membranes, coupling elements, etc.) adapted for implantation between the leaflets of a natural valve (e.g., a natural mitral valve, a natural tricuspid valve, etc.) and slidably attached to an actuation element 112 (e.g., an actuation wire, shaft, tube, hypotube, thread, suture, braid, etc.). The anchoring portion 106 includes one or more anchors 108 actuated between an open and closed state and can take various forms, such as paddles, clamping elements, or the like. The actuation of the device or actuation element 112 opens and closes the anchoring portion 106 of the device 100 to grip the natural valve leaflets during implantation. The actuating device or actuating element 112 (and other actuating devices and actuating elements herein) can take various forms (e.g., as wire, rod, shaft, tube, screw, thread, cord, strip, combination thereof, etc.), be made of various materials, and have various configurations. As an example, the actuating element can be threaded, such that rotation of the actuating element moves the anchoring portion 106 relative to the mating portion 104. Alternatively, the actuating element can be non-threaded, such that pushing or pulling the actuating element 112 moves the anchoring portion 106 relative to the mating portion 104.

[0167] The anchoring portion 106 and / or anchoring element of device 100 includes an outer paddle 120 and an inner paddle 122, which in some embodiments are connected between cap 114 and mating element 110 via portions 124, 126, and 128. Portions 124, 126, and 128 may be connected and / or flexible to move between all the positions described below. The interconnection of portions 124, 126, and 128 constrains the device to the positions shown herein and allows movement.

[0168] In some embodiments, the delivery system 102 includes a manipulable catheter, an implant catheter, and a device or actuating element 112 for actuation (e.g., an actuation wire, actuation shaft, etc.). These may be configured to extend through a guide catheter / sheath (e.g., a septal sheath, etc.). In some embodiments, the device or actuating element 112 for actuation extends through the delivery catheter and the occlusion element 110 to a distal end (e.g., a cap 114 or other attachment at the distal connection of the anchoring portion 106). Extending and retracting the actuating element 112 increases and decreases the distance between the occlusion element 110 and the distal end of the device (e.g., the cap 114 or other attachment), respectively. In some embodiments, a collar or other attachment element (e.g., a clamp, a lever, a lock, a stitch, a friction fit, a snap fastener, a snap-fit, a lasso, etc.) removably attaches the mating element 110 directly or indirectly to the delivery system 102, such that the actuation device or actuation element 112 slides through the collar or other attachment element during actuation and, in some embodiments, through the mating element 110 to open and close the paddles 120, 122 of the anchoring portion 106 and / or the anchor 108.

[0169] In some embodiments, the anchoring portion 106 and / or the anchoring member 108 may include an attachment portion or a clamping member. The illustrated clamping member may include a fastener 130, which includes a base or fixing arm 132, a movable arm 134, optional barbs, friction-enhancing elements, or other means 136 for securing (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.), and a connecting portion 138. The fixing arm 132 is attached to the inner paddle 122. In some embodiments, the fixing arm 132 is attached to the inner paddle 122, wherein the connecting portion 138 is disposed close to the engaging element 110. In some embodiments, the fastener (e.g., a barbed fastener, a barbed clamping member, etc.) has a flat surface and does not engage in a recess in the inner paddle. Specifically, the flat portion of the fastener is disposed against the surface of the inner paddle 122. The connecting portion 138 provides a spring force between the fixed arm 132 and the movable arm 134 of the fastener 130. The connecting portion 138 can be any suitable connection, such as a flexible connection, a spring connection, a pivot connection, or a similar connection. In some embodiments, the connecting portion 138 is a flexible material piece integrally formed with the fixed arm 132 and the movable arm 134. The fixed arm 132 is attached to the inner paddle 122, and when the movable arm 134 is opened to open the fastener 130 and expose optional barbs, friction-enhancing elements, or securing devices 136, the fixed arm 132 remains stationary or substantially stationary relative to the inner paddle 122.

[0170] In some embodiments, the fastener 130 is opened by applying tension to the actuation line 116 attached to the movable arm 134, thereby allowing the movable arm 134 to hinge, flex, or pivot on the connecting portion 138. The actuation line 116 extends through the delivery system 102 (e.g., through a steerable catheter and / or implant catheter). Other actuation mechanisms are also possible.

[0171] The actuation line 116 can take many forms, such as, for example, thread, suture, cord, rod, conduit, or the like. The fastener 130 can be spring-loaded so that, in the closed position, the fastener 130 continues to provide clamping force to the grasped natural leaflet. This clamping force remains constant regardless of the position of the inner paddle 122. Optional barbs, friction-enhancing elements, or securing devices 136 of the fastener 130 can grasp, clamp, and / or pierce the natural leaflet to further secure it.

[0172] During implantation, paddles 120, 122 can be opened and closed, for example, to grip the natural leaflet (e.g., a natural mitral leaflet, etc.) between paddles 120, 122 and / or between paddles 120, 122 and the occlusal element 110. Fastener 130 can be used to grip and / or further secure the natural leaflet by engaging the leaflet with optional barbs, friction-enhancing elements, or other securing devices 136 and clamping the leaflet between the movable arm 134 and the fixed arm 132. Optional barbs, friction-enhancing elements, or other securing devices 136 of fastener 130 (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.) increase friction with the leaflet or can partially or completely puncture the leaflet. Actuation lines 116 can be actuated individually, such that each fastener 130 can be opened and closed individually. Separate operation allows for gripping one leaf at a time, or repositioning fastener 130 on a leaf that is not properly gripped, without altering the successful gripping of another leaf. Fastener 130 can be opened and closed relative to the position of the inner paddle 122 (as long as the inner paddle is in an open or at least partially open position), thus allowing for gripping of leaf in various positions as needed for specific situations.

[0173] Now for reference Figure 8The device 100 is shown in an extended or fully open state for deployment of an implant delivery catheter from the delivery system 102. The device 100 is positioned at the end of the catheter in the fully open position because this position occupies minimal space and allows for the use of the smallest catheter (or the largest device for a given catheter size). In the extended state, the cap 114 is spaced apart from the mate element 110, such that the paddles 120, 122 are fully extended. In some embodiments, the angle formed between the interior of the outer paddle 120 and the inner paddle 122 is approximately 180 degrees. The fastener 130 remains closed during deployment via the delivery system 102, such that optional barbs, friction-enhancing elements, or other means 136 for fixation ( Figure 9 It will not jam or damage the delivery system 102 or the tissue in the patient's heart.

[0174] Now for reference Figure 9 The device 100 is shown in an elongated, detangling state, similar to... Figure 8 However, with the fastener 130 in the fully open position, the range between the fixed arm 132 and the movable arm 134 of the fastener 130 is approximately 140 degrees to approximately 200 degrees, approximately 170 degrees to approximately 190 degrees, or approximately 180 degrees. It has been found that fully opening the paddles 120, 122 and the fastener 130 increases the ease of detaching from or separating from tangled or disentangled anatomical structures such as chordae tendineae during implantation of the device 100.

[0175] Now for reference Figure 10Device 100 is shown in either a shortened or fully closed state. The compact size of device 100 in the shortened state allows for easier manipulation and placement within the heart. To move device 100 from the extended state to the shortened state, the actuating device or actuating element 112 retracts to pull cap 114 toward engaging element 110. Movement of the connecting portions 126 (e.g., connections, flexible connections, etc.) between the outer paddle 120 and the inner paddle 122 is restricted, such that the compressive force exerted on the outer paddle 120 by the cap 114 retracting toward engaging element 110 causes the paddle or clamping element to move radially outward. During the movement from the open to the closed position, the outer paddle 120 remains at an acute angle to the actuating device or actuating element 112. The outer paddle 120 may optionally be biased toward the closed position. During the same movement, the inner paddle 122 travels a considerable angle because it is oriented away from the mating element 110 in the open state and collapses along the side of the mating element 110 in the closed state. In some embodiments, the inner paddle 122 is thinner and / or narrower than the outer paddle 120, and the connecting portions 126, 128 (e.g., connections, flexible connections, etc.) to the inner paddle 122 can be thinner and / or more flexible. For example, this increased flexibility can allow movement beyond the connecting portion 124 connecting the outer paddle 120 to the cap 114. In some embodiments, the outer paddle 120 is narrower than the inner paddle 122. The connecting portions 126, 128 to the inner paddle 122 can be more flexible, for example, to allow movement beyond the connecting portion 124 connecting the outer paddle 120 to the cap 114. In some embodiments, the inner paddle 122 may have the same or substantially the same width as the outer paddle.

[0176] Now for reference Figure 11-13 The device 100 is shown in a partially open, gripping-ready state. To transition from a fully closed state to a partially open state, an actuating device or actuating element (e.g., actuating wire, actuating shaft, etc.) extends to push the cap 114 away from the mating element 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the anchor or anchoring portion 106 to partially unfold. The actuating wire 116 is also retracted to open the fastener 130, allowing the leaflet to be gripped. In some embodiments, the paired inner paddle 122 and outer paddle 120 are moved together by a single actuating device or single actuating element 112, rather than independently. Furthermore, the position of the fastener 130 depends on the position of the paddles 122, 120. For example, refer to... Figure 10The closing of paddles 122 and 120 also closes the fastener. In some embodiments, paddles 120 and 122 can be independently controllable. For example, device 100 can have two actuating elements and two separate caps (or other attachments), such that one separate actuating element (e.g., wire, shaft, etc.) and cap (or other attachment) is used to control one paddle, while another separate actuating element and cap (or other attachment) is used to control the other paddle.

[0177] Now for reference Figure 12 This causes one of the actuation lines 116 to extend, allowing one of the fasteners 130 to close. Now refer to... Figure 13 This causes another actuation line 116 to extend, allowing another fastener 130 to close. Either or both actuation lines 116 can be repeatedly actuated to repeatedly open and close fastener 130.

[0178] Now for reference Figure 14 The device 100 is shown in its fully closed and deployed state. The delivery system or delivery device 102 and the actuation device or actuating element 112 are retracted, and the paddles 120, 122 and fastener 130 remain in the fully closed position. After deployment, the device 100 can be maintained in the fully closed position by a mechanical latch, or by being biased to remain closed using a spring material such as steel, other metals, plastics, composites, or shape memory alloys such as nitinol. For example, the connecting portions 124, 126, 128, the connecting portion 138, and / or the inner and outer paddles 122 and / or other biasing components (not shown) can be formed of metals such as steel or shape memory alloys such as nitinol—prepared as wire, sheet, tubing, or laser-sintered powder—and biased to keep the outer paddle 120 closed around the mating element 110 and the fastener 130 clamped around the natural leaflet. Similarly, the retaining arm 132 and movable arm 134 of the fastener 130 are biased to clamp the leaflet. In some embodiments, the attachment or connection portions 124, 126, 128, the connecting portion 138, and / or the inner and outer paddles 122 and / or other biasing components (not shown) may be formed of any other suitable resilient material such as metal or polymer material to keep the device 100 closed after implantation.

[0179] Figure 15 The illustration shows an example where paddles 120 and 122 can be controlled independently. Figure 15 The device 101 shown in the figure is similar to Figure 11 The device 100 shown in the figure, except for Figure 15The device 101 includes an actuating element configured to couple to two separate actuating elements 111 and 113 of two separate caps 115 and 117. To change the first inner paddle 122 and the first outer paddle 120 from a fully closed state to a partially open state, the actuating device or actuating element 111 extends away from the mating element 110 to push the cap 115, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the first anchor 108 to partially deploy. To change the second inner paddle 122 and the second outer paddle 120 from a fully closed state to a partially open state, the actuating device or actuating element 113 extends away from the mating element 110 to push the cap 115, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the second anchor 108 to partially deploy. This can be implemented with any device disclosed in this application. Figure 15 The illustration shows independent paddle-shaped controls. For comparison, in Figure 11 In the example shown, the paired inner paddle 122 and outer paddle 120 move together rather than independently via a single actuation device or actuation element 112.

[0180] Now for reference Figure 16-21 , showed Figure 8-14 The device 100 was delivered and deployed within the natural mitral valve MV of the heart H. (Reference) Figure 16 The delivery sheath / catheter is inserted into the left atrium (LA) through the septum, and the implant / device 100 is placed as follows: Figure 16 Deployment from the delivery catheter / sheath in the fully open state, as shown. The actuating device or actuating element 112 then retracts to move the implant / device to... Figure 17 The fully closed state is shown.

[0181] As in Figure 18 As can be seen, the implant / device moves to a position within the mitral valve MV, enters the ventricular LV, and partially opens, allowing for the grasping of leaflets 20 and 22. For example, a maneuverable catheter can be advanced and manipulated or flexed to position the maneuverable catheter, such as... Figure 18 As shown. An implant catheter connected to the implant / device can be advanced from within a maneuverable catheter to position the implant, as... Figure 18 As shown.

[0182] Now for reference Figure 19 The implant catheter can be retracted into a maneuverable catheter to position the mitral valve leaflets 20, 22 in the fastener 130. The actuation line 116 extends to close one of the fasteners 130, thereby capturing the leaflet 20. Figure 20 This is shown by then extending another actuation line 116 to close another fastener 130, thereby capturing the remaining leaflet 22. Finally, as in Figure 21As can be seen, the delivery system 102 (e.g., a manipulable catheter, implant catheter, etc.), the actuation device or actuation element 112 and actuation line 116 are then retracted, and the device or implant 100 is fully closed and deployed in the natural mitral valve MV.

[0183] Now for reference Figure 22-27 An example of an implantable device or implantable implant 200 is shown. The implantable device 200 is... Figure 8-14 The device 100, schematically illustrated, can take one of many different configurations. Device 200 may include any other features used for implantable devices or implants discussed in this application, and device 200 may be positioned as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application) to engage valve tissues 20, 22. Device / implant 200 may be a prosthetic spacer device, a valve repair device, or another type of implant attached to the leaflet of a natural valve.

[0184] In some embodiments, the implantable device or implant 200 includes an occlusive portion 204, a proximal or attachment portion 205, an anchoring portion 206, and a distal portion 207. In some embodiments, the occlusive portion 204 optionally includes an occlusive element 210 (e.g., spacer, engagement element, plug, membrane, sheet, etc.) for implantation between the leaflets of a natural valve. In some embodiments, the anchoring portion 206 includes a plurality of anchors 208. The anchors can be configured in various ways. In some embodiments, each anchor 208 includes an outer paddle 220, an inner paddle 222, a paddle extension member or paddle frame 224, and a fastener 230. In some embodiments, the attachment portion 205 includes a connection for use with a delivery system 202 ( Figure 38-42 The capturing mechanism 213 (see example 49) Figures 43-49 The first or proximal collar 211 (or other attachment element) engages. Delivery system 202 may be the same as or similar to delivery system 102 described elsewhere, and may include one or more of catheters, sheaths, guiding catheters / sheaths, delivery catheters / sheaths, maneuverable catheters, implant catheters, tubes, channels, pathways, combinations thereof, etc. The capture mechanism may be configured in various ways, and in some embodiments may include one or more of clamps, grippers, pins, sutures, threads, lassos, snares, loops, buckles, locks, latches, etc.

[0185] In some embodiments, the mating element 210 and the paddles 220, 222 are formed of a flexible material, which may be a metal fabric, such as a mesh, woven, braided, or any other suitable flexible material formed or laser-cut or otherwise cut. The material may be cloth, shape memory alloy wire—such as nitinol—to provide shape retention, or any other flexible material suitable for implantation in the human body.

[0186] An actuating element 212 (actuating shaft, actuating rod, actuating tube, actuating wire, actuating cord, etc.) extends from the delivery system 202 to engage and actuate the implantable device or implant 200. In some embodiments, the actuating element 212 extends through a capture mechanism 213, a proximal collar 211, and an engagement element 210 to engage a cap 214 of the distal portion 207. The actuating element 212 may be configured to removably engage the cap 214 using a threaded connection or similar connection, such that the actuating element 212 can be disengaged and removed from the device 200 after implantation.

[0187] The mating element 210 extends from the proximal collar 211 (or other attachment element) to the inner paddle 222. In some embodiments, the mating element 210 has a generally elongated circular shape, but other shapes and configurations are also possible. In some embodiments, the mating element 210 has an elliptical shape or cross-section when viewed from above (e.g., Figure 51 ), and has a tapered shape or cross-section when viewed from the front view (e.g., Figure 23 ), and has a circular shape or cross-section when viewed from the side (e.g., Figure 24 The combination of these three geometries produces the three-dimensional shape of the mating element 210 illustrated, achieving the benefits described herein. When viewed from above, it can also be seen that the circular shape of the mating element 210 substantially follows or approximates the shape of the paddle frame 224.

[0188] The size and / or shape of the occlusal element 210 can be selected to minimize the number of implants (preferably one) required for a single patient while maintaining a low transvalvular gradient. In some embodiments, the anterior-posterior distance at the top of the occlusal element is approximately 5 mm, and the medial-lateral distance at its widest point is approximately 10 mm. In some embodiments, the overall geometry of the device 200 can be based on these two dimensions and the overall shape strategy described above. It should be apparent that using other anterior-posterior and medial-lateral distances as the starting point of the device will result in devices with different sizes. Furthermore, using other size and shape strategies described above will also result in devices with different sizes.

[0189] In some embodiments, the outer paddle 220 is connectably attached to the cap 214 of the distal portion 207 via a connecting portion 221 and connectably attached to the inner paddle 222 via a connecting portion 223. The inner paddle 222 is connectably attached to the mating element via a connecting portion 225. In this way, the anchor 208 is configured to resemble a leg, with the inner paddle 222 resembling the upper part of the leg, the outer paddle 220 resembling the lower part of the leg, and the connecting portion 223 resembling the knee of the leg.

[0190] In some embodiments, the inner paddle 222 is rigid, relatively rigid, and stiff, having a rigid portion and / or being stiffened by the fixing arm 232 of the stiffening member or fastener 230. The stiffening of the inner paddle allows the device to move to a variety of different positions shown and described herein. The inner paddle 222, the outer paddle 220, and the mating assembly can all be interconnected as described herein, such that the device 200 is secured to the movements and positions shown and described herein.

[0191] In some embodiments, the paddle frame 224 is connected to the cap 214 at the distal portion 207 and extends to the connection portion 223 between the inner paddle 222 and the outer paddle 220. In some embodiments, the paddle frame 224 is formed of a more rigid and stiffer material than the material forming the paddles 222, 220, such that the paddle frame 224 provides support for the paddles 222, 220.

[0192] The paddle frame 224 can provide additional clamping force between the inner paddle 222 and the mating element 210, and facilitates wrapping the leaflets around the sides of the mating element 210 for a better seal between the mating element 210 and the leaflets, as in Figure 51 As can be seen in the diagram, the paddle frame 224 can be configured with a circular 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 mating element 210 constrain each of these components to the movement and position described herein. In particular, the connecting portion 223 is constrained 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 constrained by its attachment to the connecting portion 223 (and thus to the inner paddle 222 and the outer paddle 220) and to the cap 214.

[0193] Configuring the paddle frame 224 in this manner provides an increased surface area compared to a standalone outer paddle 220. This, for example, makes it easier to grip and secure the natural leaflet. The increased surface area allows the clamping forces of the paddle 220 and paddle frame 224 against the natural leaflet to be distributed over a relatively larger surface area of ​​the natural leaflet, thereby further protecting the natural leaflet tissue. (See again) Figure 51 The increased surface area of ​​the paddle frame 224 also allows the natural leaflets to be clamped to the implantable device or implant 200, such that the natural leaflets are fully occluded around the occlusion member or occlusion element 210. This can, for example, improve the seal of the natural leaflets 20, 22, thereby preventing or further reducing mitral regurgitation.

[0194] In some embodiments, the fastener includes a movable arm coupled to the anchor. In some embodiments, the fastener 230 includes a base or fixed arm 232, a movable arm 234, optional barbs 236, and a connecting portion 238. The fixed arm 232 is attached to the inner paddle 222, wherein the connecting portion 238 is disposed close to the mating element 210. The connecting portion 238 is spring-loaded such that when the fastener 230 is in the closed state, the fixed arm 232 and the movable arm 234 are biased toward each other. In some embodiments, the fastener 230 includes friction-enhancing elements or devices for securing, such as optional barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc.

[0195] In some embodiments, the retaining arm 232 is attached to the inner paddle 222 via a hole or slot 231 using a stitch (not shown). The retaining arm 232 can be attached to the inner paddle 222 by any suitable means such as a screw or other fastener, crimp sleeve, mechanical latch or snap, welding, adhesive, clamp, latch, or similar means. The retaining arm 232 remains substantially stationary relative to the inner paddle 222 when the movable arm 234 is opened to open the fastener 230 and expose optional barbs or other friction-enhancing elements 236. This is achieved by an actuation line 216 (e.g., such as...) attached to the hole 235 in the movable arm 234. Figures 43-48 (As shown in the figure) Applying tension causes the movable arm 234 to hinge, pivot and / or flex on the connecting portion 238 to open the fastener 230.

[0196] Now for reference Figure 29This image shows a close-up view of one of the leaflets 20, 22 gripped by a fastener such as fastener 230. Leaflets 20, 22 are gripped between the movable arm 234 and the fixed arm 232 of fastener 230. While the tissue of leaflets 20, 22 is not pierced by the optional barbs or friction-enhancing element 236, in some embodiments the optional barbs 236 may partially or completely pierce through the leaflets 20, 22. The angle and height of the optional barbs or friction-enhancing element 236 relative to the movable arm 234 help secure leaflets 20, 22 within fastener 230. Specifically, the force pulling the implant away from the natural leaflets 20, 22 will cause the optional barbs or friction-enhancing element 236 to further engage the tissue, thereby ensuring better retention. When fastener 230 is closed, the retention of leaflets 20, 22 within fastener 230 is further enhanced by the position of the fixed arm 232 near the optional barbs / friction-enhancing element 236. In this arrangement, the tissue forms an S-shaped zigzag path via the fixed arm 232, the movable arm 234, and the optional barb / friction enhancement element 236. Therefore, the force pulling the leaflets 20, 22 away from the fastener 230 will cause the tissue to further engage with the optional barb / friction enhancement element 236 before the leaflets 20, 22 could escape. For example, leaflet tension during diastole can cause the optional barb 236 to pull towards the ends of the leaflets 20, 22. Thus, the S-shaped path utilizes the leaflet tension during diastole to more tightly engage the leaflets 20, 22 with the optional barb / friction enhancement element 236.

[0197] refer to Figure 25 The device or implant 200 may also include a cover 240. In some embodiments, the cover 240 may be disposed on the engaging element 210, the outer paddle 220 and the inner paddle 222 and / or the paddle frame 224. The cover 240 may be configured to prevent or reduce blood flow through the device or implant 200 and / or promote inward growth of natural tissue. In some embodiments, the cover 240 may be a cloth or fabric such as PET, fleece or other suitable fabric. In some embodiments, instead of a fabric or other than a fabric, the cover 240 may also include a coating (e.g., polymeric) applied to the implantable device or implant 200.

[0198] During implantation, the paddles 220, 222 of the anchor 208 are opened and closed to hold the natural valve leaflets 20, 22 between the paddles 220, 222 and the occlusal element 210. The anchor 208 is in the closed position by extending and retracting the actuating element 212. Figure 22-25 ) to various open positions ( Figure 26-37The extension and retraction of the actuating element 212 increases and decreases the distance between the occlusal element 210 and the cap 214, respectively. The proximal collar 211 (or other attachment element) and the occlusal element 210 slide along the actuating element 212 during actuation, causing the change in the distance between the occlusal element 210 and the cap 214 to cause the paddles 220, 220 to move between different positions during implantation to grip the mitral valve leaflets 20, 22.

[0199] When the device 200 is opened and closed, the paired inner paddle 222 and outer paddle 220 move together rather than independently via a single actuating element 212. Furthermore, the position of the fastener 230 depends on the position of the paddles 222 and 220. For example, the fastener 230 is arranged such that closing the anchor 208 simultaneously closes the fastener 230. In some embodiments, the device 200 can be configured in the same manner (e.g., Figure 15 The device 101 shown has independently controllable paddles 220 and 222.

[0200] In some embodiments, the fastener 230 further secures the natural leaflets 20, 22 by engaging the leaflets 20, 22 with optional barbs and / or other friction-enhancing elements 236 and / or by clamping the leaflets 20, 22 between the movable arm 234 and the fixed arm 232. In some embodiments, the fastener 230 is a barbed fastener, which includes barbs that increase friction with the leaflets 20, 22 and / or can partially or completely pierce the leaflets 20, 22. Actuation line 216 ( Figures 43-48 Each fastener 230 can be actuated individually, allowing each fastener 230 to open and close independently. Individual operation allows for the clamping of one leaflet 20, 22 at a time, or for the repositioning of a fastener 230 on a leaflet 20, 22 that is not sufficiently clamped, without altering the successful clamping of another leaflet 20, 22. When the inner paddle 222 is not closed, the fastener 230 can be fully opened and closed, thus allowing the leaflets 20, 22 to be clamped in various positions as needed.

[0201] Now for reference Figure 22-25 The device 200 is shown in the closed position. When closed, the inner paddle 222 is arranged between the outer paddle 220 and the mating element 210. A fastener 230 is arranged between the inner paddle 222 and the mating element 210. After successfully capturing natural leaflets 20, 22, the device 200 moves to and remains in the closed position, such that the leaflets 20, 22 are secured within the device 200 by the fastener 230 and pressed against the mating element 210 by the paddles 220, 222. The outer paddle 220 may have a wide curved shape adapted to fit around the curved shape of the mating element 210 to more securely clamp the leaflets 20, 22 (e.g., as in...). Figure 51(As can be seen in the image). The curved shape and rounded edges of the outer paddle-like structure 220 also prevent or inhibit leaflet tissue tearing.

[0202] Now for reference Figures 30-37 The aforementioned implantable device or implant 200 is shown in various positions and configurations, ranging from partially open to fully open. When the actuating element 212 extends from the fully retracted position to the fully extended position, the paddles 220, 222 of the device 200... Figure 22-25 The closed position shown is in Figures 30-37 Transform between each of the positions shown.

[0203] Now for reference Figures 30-31 The device 200 is shown in a partially open position. The device 200 is moved to the partially open position by extending the actuating element 212. The extending actuating element 212 pulls downward the bottom portions of the outer paddle 220 and the paddle frame 224. The outer paddle 220 and the paddle frame 224 pull downward the inner paddle 222, which is connected to the outer paddle 220 and the paddle frame 224. Because the proximal collar 211 (or other attachment element) and the mating element 210 are held in place by the capturing mechanism 213, the inner paddle 222 is caused to hinge, pivot, and / or flex in the opening direction. The inner paddle 222, the outer paddle 220, and the paddle frame all flex to… Figures 30-31 The positions shown. Opening the paddles 222, 220 and the frame 224 creates a gap between the mating element 210 and the inner paddle 222 that can receive and grip the natural leaflets 20, 22. This movement also exposes the space that can be closed in the position ( Figure 30 ) and opening position ( Figure 31 The fastener 230 moves between the fixed arm 232 and the movable arm 234 of the fastener 230 to form a second gap for gripping the natural leaflets 20, 22. The degree of gap between the fixed arm 232 and the movable arm 234 of the fastener 230 is limited to the extent to which the inner paddle 222 has moved away from the unfolded engagement element 210.

[0204] Now for reference Figures 32-33The device 200 is shown in a laterally extended or open position. By continuing to extend the aforementioned actuating element 212, the distance between the engaging element 210 and the cap 214 of the distal portion 207 is increased, moving the device 200 to the laterally extended or open position. Continuing to extend the actuating element 212 pulls down the outer paddle 220 and the paddle frame 224, causing the inner paddle 222 to extend further away from the engaging element 210. In the laterally extended or open position, the inner paddle 222 extends more horizontally than in other positions of the device 200 and forms an angle of approximately 90 degrees with the engaging element 210. Similarly, when the device 200 is in the laterally extended or open position, the paddle frame 224 is in its maximum extended position. The increased gap formed between the engaging element 210 and the inner paddle 222 in the laterally extended or open position allows the fastener 230 to open further before engaging the engaging element 210. Figure 33 This increases the size of the gap between the fixed arm 232 and the movable arm 234.

[0205] Now for reference Figures 34-35 Example device 200 is shown in a three-quarters extended position. By continuing to extend the aforementioned actuating element 212, the distance between the engaging element 210 and the cap 214 of the distal portion 207 is increased, moving device 200 to the three-quarters extended position. Continuing to extend the actuating element 212 pulls down the outer paddle 220 and paddle frame 224, causing the inner paddle 222 to unfold further away from the engaging element 210. In the three-quarters extended position, the inner paddle 222 opens at an angle greater than 90 degrees to approximately 132 degrees with the engaging element 210. The paddle frame 224 unfolds less than in the laterally extended or open position and begins to move inward toward the actuating element 212 as the actuating element 212 extends further. The outer paddle 220 also flexes rearward toward the actuating element 212. Similar to the laterally extended or open position, the increased gap formed between the mating element 210 and the inner paddle 222 in the laterally extended or open position allows the fastener 230 to open further. Figure 35 This increases the size of the gap between the fixed arm 232 and the movable arm 234.

[0206] Now for reference Figures 36-37Example device 200 is shown in its fully extended position. By continuing to extend the aforementioned actuating element 212, the distance between the mating element 210 and the cap 214 of the distal portion 207 is increased to the maximum distance allowed by device 200, moving device 200 to the fully extended position. Continuing to extend the actuating element 212 pulls down the outer paddle 220 and paddle frame 224, causing the inner paddle 222 to unfold further away from the mating element 210. The outer paddle 220 and paddle frame 224 move to their positions close to the actuating element. In the fully extended position, the inner paddle 222 opens to approximately a 180-degree angle with the mating element 210. In the fully extended position, the inner paddle 222 and outer paddle 220 are stretched straight so that approximately a 180-degree angle is formed between the paddles 222 and 220. The fully extended position of device 200 provides the maximum clearance between engaging element 210 and inner paddle 222, and in some embodiments allows fastener 230 to also be fully opened to approximately 180 degrees between the fixed arm 232 and the movable arm 234 of fastener 230. Figure 37 The position of device 200 is the longest and narrowest configuration. Therefore, the fully extended position of device 200 can be the desired position for salvaging device 200 from the site of attempted implantation, or the desired position for placing the device in the delivery catheter, or a similar position.

[0207] Configuring the device or implant 200 such that the anchor 208 can extend into a straight or near-straight configuration (e.g., approximately 120-180 degrees relative to the occlusal element 210) can offer several advantages. For example, this configuration can reduce the radial crease profile of the device or implant 200. Grasping the natural lobules 20, 22 can also be made easier by providing a larger opening between the occlusal element 210 and the inner paddle 222 for gripping the natural lobules 20, 22. Additionally, the relatively narrow, straight configuration can prevent or reduce the device or implant 200 from impacting natural anatomical structures (e.g., Figure 3 and 4 The possibility of tangles in the chordae tendineae shown in CT scans.

[0208] Now for reference Figures 38-49 Example device 200 is shown as being delivered and deployed within the natural mitral valve MV of the heart H. As described above, Figures 38-49 The illustrated device 200 includes optional covers 240 (e.g., on the engaging element 210, fastener 230, inner paddle 222 and / or outer paddle 220) on the engaging element 210, fastener 230, inner paddle 222 and / or outer paddle 220. Figure 25 Device 200 is deployed from delivery system 202 (e.g., which may include an implantable catheter extendable from steerable catheter 241 and / or guide sheath) and captured by capture mechanism 213 (see, for example...). Figure 43 and 48 The capture mechanism 213 is held closed around the collar 211 by extending or retracting the actuating element 212. The fingers of the capture mechanism 213 removably attach the collar 211 to the delivery system 202. In some embodiments, the capture mechanism 213 is held closed around the collar 211 by the actuating element 212, such that removal of the actuating element 212 allows the fingers of the capture mechanism 213 to open and release the collar 211, thereby decoupling the capture mechanism 213 from the device 200 after successful implantation.

[0209] Now for reference Figure 38 The delivery system 202 (e.g., its delivery catheter / sheath) is inserted into the left atrium LA through the septum, and for the reasons discussed above with respect to device 100, device / implant 200 is deployed from the delivery system 202 in a fully open state (e.g., the implant catheter holding the device / implant can be extended to deploy the device / implant from the steerable catheter). Then, the actuating element 212 retracts to move device 200 through a partially closed state ( Figure 39 and achieve Figures 40-41 The fully closed state is shown. Then, the delivery system or catheter is directed toward the mitral valve MV manipulator / implant 200, as shown. Figure 41 As shown. Now refer to Figure 42 When the device 200 is aligned with the mitral valve MV, the actuator 212 extends to open the paddles 220, 222 to a partially open position, and the actuator line 216 ( Figures 43-48 The retraction opens fastener 230, preparing for Xiaoye to grab. Next, as... Figures 43-44 As shown, the partially opened device 200 is inserted through the natural valve (e.g., by advancing the implant catheter from a steerable catheter) until the leaflets 20, 22 are properly positioned between the inner paddle 222 and the occlusal element 210 and inside the opened fastener 230.

[0210] Figure 45 A device 200 is shown with both fasteners 230 closed, although a small leaf 22 is missing from the optional barb 236 of one fastener 230. (See diagram) Figures 45-47 As can be seen, the misaligned fastener 230 is opened and closed again to properly grip the missed leaflet 22. When both leaflets 20 and 22 are properly gripped, the actuating element 212 is retracted to move the device 200 to... Figure 48 The fully closed position is shown. With device 200 fully closed and a natural valve implanted, actuating element 212 disengages from cap 214 and is retracted to release capture mechanism 213 from proximal collar 211 (or other attachment element), allowing capture mechanism 213 to be retracted into delivery system 202 (e.g., into catheter / sheath), as shown. Figure 49As shown. After deployment, device 200 can be maintained in a fully closed position by mechanical means such as a latch, or by being biased to remain closed by the use of a spring material such as steel and / or a shape memory alloy such as nitinol. For example, paddles 220, 222 can be formed of steel or nitinol shape memory alloy—prepared as wire, sheet, tube, or laser-sintered powder—and biased to keep the outer paddle 220 closed around the inner paddle 222, the mating element 210, and / or the fastener 230 clamped around the natural leaflets 20, 22.

[0211] refer to Figures 50-54 After the device 200 is implanted into the natural valve, the occlusal element 210 acts as the valve regurgitation orifice (e.g., Figure 6 The gap filling in the gap 26 in the mitral valve MV (or the gap in another natural valve). In some embodiments, when the device 200 has been deployed between the two opposing leaflets 20, 22, in the region of the occlusal element 210, the leaflets 20, 22 will not occlude against each other, but rather against the occlusal element 210. This reduces the approximated distance that the leaflets 20, 22 need to approach during systole to close the mitral valve MV, thereby promoting the repair of functional valvular disease that can lead to mitral regurgitation. The reduced approximation distance of the leaflets can also have several other advantages. For example, the reduced approximation distance required for the leaflets 20, 22 reduces or minimizes the stress experienced by the natural valve. The shorter approximation distance of the valve leaflets 20, 22 may require a smaller approximation force, which can result in less tension on the leaflets 20, 22 and less reduction in the annular diameter. Less annular reduction—or no annular reduction—results in less reduction of valve orifice area compared to devices without occlusion elements or spacers. In this way, occlusion element 210 can reduce transvalvular gradient.

[0212] To fully fill the gap 26 between leaflets 20 and 22, the device 200 and its components can have various shapes and sizes. For example, the outer paddle 220 and paddle frame 224 can be configured to conform to the shape or geometry of the mating element 210, such as... Figures 50-54 As shown. Therefore, the outer paddle 220 and paddle frame 224 can cooperate with both the occlusal element 210 and the natural valve leaflets 20, 22. In some embodiments, when the leaflets 20, 22 occlude against the occlusal element 210, the leaflets 20, 22 completely surround or "hug" the occlusal element 210, thus preventing or suppressing minor leakage on the lateral surface 201 and medial surface 203 of the occlusal element 210. The interaction between the leaflets 20, 22 and the device 200 in Figure 51 It becomes clear in the middle, Figure 51A schematic atrial / surgeon's view is shown—showing a paddle-shaped frame 224 conforming to the geometry of the occlusal element 210 (which is actually not visible from a true atrial view). Opposite leaflets 20, 22 (whose ends are visible from a true atrial view, for example...) Figure 52 (Also invisible below) approaching through the paddle frame 224 to completely surround or "closely" the mating element 210.

[0213] The engagement of leaflets 20 and 22 against the outer and inner surfaces of mating element 210 will appear to contradict the mating element 210 mentioned above (in... Figure 52 It is shown from the side of the atrium, while Figure 53 The presence of the locomotor element (shown from the ventricular side) minimizes the distance the lobules need to approach. However, if the locomotor element 210 is precisely positioned in the regurgitation gap 26 and the regurgitation gap 26 is smaller than the width of the locomotor element 210 (medial-lateral), the distance the lobules 20, 22 need to approach is still minimized.

[0214] Figure 50 The diagram illustrates the geometry of the occlusal element 210 and the paddle frame 224 from an LVOT view. From this perspective, the occlusal element 210 has a tapered shape, with a smaller size closer to the area where the inner surfaces of the leaflets 20, 22 need to align, and its size increases as the occlusal element 210 extends toward the atrium. Therefore, the depicted natural valve geometry is adapted to the tapered occlusal element geometry. (Referring to...) Figure 50 The tapered mating element geometry, combined with the example of the expanded paddle frame shape (towards the leaflet ring), can help achieve mating at the lower end of the leaflet, reduce stress, and minimize the translobe gradient.

[0215] refer to Figure 54 The shapes of the aligning element 210 and the paddle frame 224 are defined based on the intra-commissural view of the natural valve and device 200. Two factors in these shapes are the alignment of the leaflet against the aligning element 210 and the reduction in leaflet stress caused by this alignment. (Reference) Figure 54 and 24 To facilitate the abutment of the leaflets 20, 22 against the occlusal element 210 and reduce the stress exerted on the leaflets 20, 22 by the occlusal element 210 and / or the paddle frame 224, the occlusal element 210 may have a circular or rounded shape, and the paddle frame 224 may have a radius spanning almost the entire length of the paddle frame 224. The circular shape of the occlusal element 210 and / or the fully rounded shape of the paddle frame 224 cause the stress on the leaflets 20, 22 to be distributed across a large, curved engagement region 209. For example, in Figure 54In the process, as the leaflets 20 and 22 attempt to open during the diastolic cycle, the force exerted by the paddle frame 224 on the leaflets 20 and 22 extends along the entire circumferential length of the paddle frame.

[0216] Now for reference Figure 55 An example of an implantable device or implant 300 is shown. The implantable device 300 is... Figure 8-14 The device 100, schematically illustrated, can be one of many different configurations. The device 300 may include any other features for implantable devices or implants discussed in this application, and the device 300 may be positioned as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application) to engage valve tissues 20, 22.

[0217] The implantable device or implant 300 includes a proximal or attachment portion 305, an anchoring portion 306, and a distal portion 307. In some embodiments, the device / implant 300 includes an occlusion portion 304, and the occlusion portion 304 may optionally include an occlusion element 310 (e.g., a spacer, plug, membrane, sheet, etc.) for implantation between the leaflets 20, 22 of a natural valve. In some embodiments, the anchoring portion 306 includes a plurality of anchor members 308. In some embodiments, each anchor member 308 may include one or more paddles, such as an outer paddle 320, an inner paddle 322, a paddle extension member, or a paddle frame 324. The anchor members may also include and / or be coupled to a fastener 330. In some embodiments, the attachment portion 305 includes a delivery system (e.g., such as...) Figure 38-42 The capture mechanism (e.g., such as the delivery system of the system shown in 49) Figures 43-49 The first or proximal collar 311 (or other attachment element) engages with the capture mechanism of the capture mechanism 213 shown herein, or another capture mechanism described herein or otherwise known.

[0218] Anchor 308 can be attached to other parts of the device and / or to each other in a variety of different ways (e.g., directly, indirectly, by welding, stitching, adhesive, linking, latching, integrally formed, some or all of these combinations, etc.). In some embodiments, anchor 308 is attached to mating member or mating element 310 via connecting portion 325 and to cap 314 via connecting portion 321.

[0219] Anchor 308 may include a first portion or outer paddle 320 and a second portion or inner paddle 322 separated by a connecting portion 323. The connecting portion 323 may be attached to a paddle frame 324, which may be hingedly attached to a cap 314 or other attachment portion. In this way, anchor 308 is configured to resemble a leg, with the inner paddle 322 resembling the upper part of the leg, the outer paddle 320 resembling the lower part of the leg, and the connecting portion 323 resembling the knee of the leg.

[0220] In embodiments having mating members or mating elements 310, the mating members or mating elements 310 and the anchoring elements 308 can be coupled together in various ways. For example, as shown in the illustrated example, the mating elements 310 and the anchoring elements 308 can be coupled together by integrally forming the mating elements 310 and the anchoring elements 308 into a single integral component. This can be achieved, for example, by forming the mating elements 310 and the anchoring elements 308 from a continuous strip 301 of a braided or woven material (such as braided or woven nitinol yarn). In the illustrated example, the mating elements 310, the outer paddle portion 320, the inner paddle portion 322, and the connecting portions 321, 323, 325 are formed from a continuous strip 301 of fabric.

[0221] 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 axially moving the distal end of the device (e.g., cap 314, etc.) relative to the proximal end of the device (e.g., proximal collar 311 or other attachment elements, etc.) and thus moving the anchor 308 relative to the midpoint of the device. This movement can be along a longitudinal axis extending between the distal end (e.g., cap 314, etc.) and the proximal end (e.g., collar 311 or other attachment elements, etc.). For example, by moving the distal end (e.g., cap 314, etc.) away from the proximal end of the device, the anchor 308 can be positioned in a fully extended or straight configuration (e.g., similar to...). Figure 36 In the configuration of the device 200 shown.

[0222] In some embodiments, in a straight configuration, the paddle portions 320, 322 are aligned or straight along the longitudinal axis of the device. In some embodiments, the connecting portion 323 of the anchor 308 is adjacent to the longitudinal axis of the mating element 310 (e.g., similar to...). Figure 36 The configuration of the device 200 shown). The anchor 308 can be moved from a straight configuration to a fully folded configuration (e.g., by moving the proximal and distal ends toward each other and / or toward the midpoint or center of the device, for example. Figure 55Initially, as the distal end (e.g., cap 314, etc.) moves toward the proximal end and / or midpoint or center of the device, the anchor 308 bends at the connecting portions 321, 323, 325, and the connecting portion 323 moves radially outward relative to the longitudinal axis of the device 300 and axially toward the midpoint of the device and / or toward the proximal end of the device (e.g., similar to...). Figure 34 (The configuration of the device 200 shown). As the cap 314 continues to move toward the midpoint of the device and / or toward the proximal end of the device, the connecting portion 323 moves radially inward relative to the longitudinal axis of the device 300 and axially toward the proximal end of the device (e.g., similar to...). Figure 30 The configuration of the device 200 shown.

[0223] In some embodiments, the fastener includes a movable arm coupled to the anchor. In some embodiments, fastener 330 (e.g.) Figure 56 (As shown in detail) includes a base or fixed arm 332, a movable arm 334, an optional barb / friction enhancement element 336, and a connecting portion 338. The fixed arm 332 is attached to the inner paddle 322, and the connecting portion 338 is disposed close to the mating element 310. The connecting portion 338 is spring-loaded such that when the fastener 330 is in the closed position, the fixed arm 332 and the movable arm 334 are biased toward each other.

[0224] The retaining arm 332 is attached to the inner paddle 322 via a hole or slot 331 using a stitch (not shown). The retaining arm 332 can be attached to the inner paddle 322 using any suitable means such as a screw or other fastener, a crimp sleeve, a mechanical latch or snap, welding, adhesive, or similar means. When the movable arm 334 is opened to open the fastener 330 and expose the optional barbs 336, the retaining arm 332 remains substantially stationary relative to the inner paddle 322. This is achieved by means of an actuation line (e.g., such as...) attached to the hole 335 in the movable arm 334. Figures 43-48 The actuation line 216 shown applies tension, thereby causing the movable arm 334 to hinge, pivot and / or flex on the connecting portion 338 to open the fastener 330.

[0225] In short, the implantable device or implant 300 is similar in configuration and operation to the implantable device or implant 200 described above, except that the engaging element 310, outer paddle 320, inner paddle 322, and connecting portions 321, 323, 325 are formed from a single strip of material 301. In some embodiments, the strip of material 301 is attached to the proximal collar 311, cap 314, and paddle frame 324 by weaving or inserting it through openings in the proximal collar 311, cap 314, and paddle frame 324, the openings being configured to receive a continuous strip of material 301. The continuous strip of material 301 may be a single layer of material or may include two or more layers. In some embodiments, portions of the device 300 have a single layer of material strip 301, while other portions are formed from multiple overlapping layers or overlays of material strip 301.

[0226] For example, Figure 55 The diagram shows an mating element 310 and an inner paddle 322 formed by multiple overlapping layers of material strips 301. A single continuous material strip 301 can begin and end at various locations within the device 300. The ends of the material strips 301 can be at the same or different locations within the device 300. For example, in… Figure 55 In the illustrated example, the material strip 301 begins and ends at the position of the inner paddle 322.

[0227] Similar to the implantable device or implant 200 described above, the size of the occlusal element 310 can be selected to minimize the number of implants (preferably one) that a single patient would require, while maintaining a low transvalvular gradient. Specifically, the formation of numerous components of the device 300 by the material strips 301 allows the device 300 to be manufactured smaller than the device 200. For example, in some embodiments, the anterior-posterior distance at the top of the occlusal element 310 is less than 2 mm, and the medial-lateral distance at its widest point (i.e., the width of the paddle frame 324, which is wider than the occlusal element 310) is approximately 5 mm.

[0228] Figures 57-63 The illustration shows another example of one of a variety of valve repair systems 400 to which the concepts of this application are applicable for repairing a patient's natural valve. The valve repair system 400 includes a delivery device 401 and a valve repair device 402.

[0229] The valve repair device 402 includes a base assembly 404, a pair of paddles 406, and a pair of clamping members 408 (e.g., fasteners, fastener arms, clamping members, clamping arms, latches, etc.). In some embodiments, the paddles 406 may be integrally formed with the base assembly. For example, the paddles 406 may be formed as extensions of a link of the base assembly. In the illustrated example, the base assembly 404 of the valve repair device 402 has a shaft 403, a coupling member 405 configured to move along the shaft, and a lock 407 configured to lock the coupling member in a stationary position on the shaft. The coupling member 405 is mechanically connected to the paddles 406 such that movement of the coupling member 405 along the shaft 403 causes the paddles to move between an open position and a closed position. In this way, the coupling 405 acts as a means for mechanically coupling the paddle 406 to the shaft 403 and for causing the paddle 406 to move between its open and closed positions when moved along the shaft 403.

[0230] In some embodiments, the clamping member 408 is pivotally connected to the base assembly 404 (e.g., the clamping member 408 may be pivotally connected to the shaft 403 or any other suitable member of the base assembly), such that the clamping member can be moved to adjust the width of the opening 414 between the paddle 406 and the clamping member 408. The clamping member 408 may include an optional barbed portion 409 for attaching the clamping member to the valve tissue when the valve repair device 402 is attached to the valve tissue. The clamping member 408 forms a means for clamping the valve tissue (particularly the tissue of the valve leaflets) using an insertion device or portion (such as the optional barbed portion 409). When the paddle 406 is in the closed position, the paddle engages the clamping member 408, such that when the valve tissue is attached to the optional barbed portion 409 of the clamping member, the paddle acts as a holding or fixing means for retaining the valve tissue at the clamping member and securing the valve repair device 402 to the valve tissue. In some embodiments, the clamping member 408 is configured to engage the paddle 406 such that an optional barbed portion 409 engages the valve tissue member and the paddle 406 to secure the valve repair device 402 to the valve tissue member. For example, in some cases, it may be advantageous to maintain the paddle 406 in an open position and move the clamping member 408 outward toward the paddle 406 to engage the valve tissue and the paddle 406.

[0231] Although Figures 57-63 The example shown illustrates a pair of paddles 406 and a pair of clamping members 408, but it should be understood that the valve repair device 402 may include any suitable number of paddles and clamping members.

[0232] In some embodiments, the valve repair system 400 includes a placement shaft 413 that is removably attached to a base assembly 404 of the valve repair device 402. After the valve repair device 402 is secured to the valve tissue, the placement shaft 413 is removed from the shaft 403 to remove the valve repair device 402 from the remainder of the valve repair system 400, such that the valve repair device 402 remains attached to the valve tissue and the delivery device 401 can be removed from the patient's body.

[0233] The valve repair system 400 may also include a paddle control mechanism 410, a clamping mechanism 411, and a locking mechanism 412. The paddle control mechanism 410 is mechanically attached to the coupling member 405 to move the coupling member along an axis, causing the paddle 406 to move between an open and closed position. The paddle control mechanism 410 can take any suitable form and may include, for example, a shaft, wire, tube, hypotube, rod, suture, thread, etc. For example, the paddle control mechanism may include a hollow shaft, a catheter tube, or a sleeve adapted to accommodate the shaft 413 and shaft 403 and connected to the coupling member 405.

[0234] The clamping control mechanism 411 is configured to move the clamping member 408, thereby changing the width of the opening 414 between the clamping member and the paddle 406. The clamping control mechanism 411 can take any suitable form, such as, for example, thread, suture, wire, rod, conduit, tube, hypotube, etc.

[0235] Lock control mechanism 412 is configured to lock and unlock the lock. Lock 407 acts as a locking device that locks coupling 405 in a stationary position relative to shaft 403 and can take various forms, and the type of lock control mechanism 412 can be determined by the type of lock used. In some embodiments, lock 407 includes a pivotable plate with a hole in which shaft 403 of valve repair device 402 is arranged. In this example, when the pivotable plate is in an inclined position, the pivotable plate engages shaft 403 to maintain position on shaft 403, but when the pivotable plate is in a substantially non-inclined position, the pivotable plate can move along the shaft (this allows coupling 405 to move along shaft 403). In other words, when the pivotable plate of lock 407 is in an inclined (or locked) position, it prevents or inhibits coupling 405 from moving along shaft 403 in the direction Y (e.g., Figure 61AThe pivotable plate moves along axis 403 in the direction Y when it is in a substantially non-tilted (or unlocked) position. In an example where lock 407 includes a pivotable plate, lock control mechanism 412 is configured to engage the pivotable plate to move the plate between a tilted position and a substantially non-tilted position. Lock control mechanism 412 may be, for example, a lever, stitching, thread, or any other component capable of moving the pivotable plate of lock 407 between a tilted position and a substantially non-tilted position. In some embodiments, the pivotable plate of lock 407 is biased in a tilted (or locked) position, and lock control mechanism 412 is used to move the plate from the tilted position to a substantially non-tilted (or unlocked) position. In some embodiments, the pivotable plate of lock 407 is biased in a substantially non-tilted (or unlocked) position, and lock control mechanism 412 is used to move the plate from the substantially non-tilted position to the tilted (or locked) position.

[0236] Figures 61A-61B The illustration shows the valve repair device 402 in the open position (e.g.) Figure 61A Move to the closed position (as shown) Figure 61B (As shown). The base assembly 404 includes a first link 1021 extending from point A to point B, a second link 1022 extending from point A to point C, a third link 1023 extending from point B to point D, a fourth link 1024 extending from point C to point E, and a fifth link 1025 extending from point D to point E. A coupling 405 is movably attached to a shaft 403, and the shaft 403 is fixed to the fifth link 1025. The first link 1021 and the second link 1022 are pivotally attached to the coupling 405 at point A, such that movement of the coupling 405 along the shaft 403 moves the position of point A, and thus moves the first link 1021 and the second link 1022. The first link 1021 and the third link 1023 are pivotally attached to each other at point B, and the second link 1022 and the fourth link 1024 are pivotally attached to each other at point C. A paddle 406a is attached to a first link 1021 such that movement of the first link 1021 causes movement of the paddle 406a, while another paddle 406b is attached to a second link 1022 such that movement of the second link 1022 causes movement of the paddle 406b. In some embodiments, the paddles 406a and 406b may be connected to links 1023 and 1024 or extensions of links 1023 and 1024.

[0237] In order to move the valve repair device from the open position (e.g.) Figure 61A Move to the closed position (as shown) Figure 61BAs shown, the coupling member 405 is moved along axis 403 in direction Y, which moves the pivot point A of the first link 1021 and the second link 1022 to a new position. The movement of the coupling member 405 (and pivot point A) in direction Y causes the portion of the first link 1021 near point A to move in direction H, and causes the portion of the first link 1021 near point B to move in direction J. The paddle 406a is attached to the first link 1021, such that the movement of the coupling member 405 in direction Y causes the paddle 406a to move in direction Z. In addition, the third link 1023 is pivotally attached to the first link 1021 at point B, such that the movement of the coupling member 405 in direction Y causes the third link 1023 to move in direction K. Similarly, movement of coupling member 405 (and pivot point A) in direction Y causes a portion of the second link 1022 near point A to move in direction L, and a portion of the second link 1022 near point C to move in direction M. Paddle 406b is attached to the second link 1022 such that movement of coupling member 405 in direction Y causes paddle 406b to move in direction V. Additionally, the fourth link 1024 is pivotally attached to the second link 1022 at point C such that movement of coupling member 405 in direction Y causes the fourth link 1024 to move in direction N. Figure 61B The diagram illustrates the coupling 405, such as Figure 61A The valve repair device 402 is moved to its final position as shown.

[0238] refer to Figure 58 The valve repair device 402 is shown in the open position (similar to...). Figure 61A (as shown in the diagram), and the clamping control mechanism 411 is shown to move the clamping member 408 to provide a wider gap at the opening 414 between the clamping member and the paddle 406. In the illustrated example, the clamping control mechanism 411 includes a thread, such as suture thread, wire, etc., passing through an opening in the end of the clamping member 408. Both ends of the thread extend through delivery openings 516 of the delivery device 401. When the thread is pulled through the delivery opening 516 in the Y direction, the clamping member 408 moves inward in the X direction, which causes the opening 414 between the clamping member and the paddle 406 to become wider.

[0239] refer to Figure 59 The valve repair device 402 is shown such that valve tissues 20, 22 are arranged in an opening 414 between the clamping member 408 and the paddle 406. (Reference) Figure 60After the valve tissues 20, 22 are arranged between the clamping member 408 and the paddle 406, the clamping member control mechanism 411 is used to reduce the width of the opening 414 between the clamping member and the paddle. That is, in the illustrated example, the line of the clamping member control mechanism 411 releases or extends from the opening 516 of the delivery member in direction H, which allows the clamping member 408 to move in direction D to reduce the width of the opening 414. Although the clamping member control mechanism 411 is shown as moving the clamping member 408 to increase the width of the opening 414 between the clamping member and the paddle 406 ( Figure 59 However, it should be understood that it may not be necessary to move the clamping member to position the valve tissue in the opening 414. However, in some cases, the opening 414 between the paddle 406 and the clamping member 408 may be wider to receive the valve tissue.

[0240] refer to Figure 62 The valve repair device 402 is in the closed position and secured to the valve tissues 20, 22. The valve repair device 402 is secured to the valve tissues 20 by paddles 406a, 406b and clamping members 408a, 408b. Specifically, the valve tissues 20, 22 are attached to the valve repair device 402 by optional barbed portions 409 of the clamping members 408a, 408b, and the paddles 406a, 406b engage the clamping members 408 to secure the valve repair device 402 to the valve tissues 20, 22.

[0241] In order to move the valve repair device 402 from the open position to the closed position, the lock 407 is moved to the unlocked state via the lock control mechanism 412 (e.g., ...). Figure 62 (As shown). After lock 407 is in the unlocked state, coupling member 405 can be moved along axis 403 via paddle control mechanism 410. In the illustrated example, paddle control mechanism 410 moves coupling member 405 along axis in direction Y, which causes one paddle 406a to move in direction X and the other paddle 406b to move in direction Z. The movement of paddles 406a and 406b in directions X and Z causes paddles to engage clamping members 408a and 408b and secure valve repair device 402 to valve tissues 20 and 22.

[0242] refer to Figure 63 The paddle 406 is moved to the closed position to fix the valve repair device 402 to the valve tissues 20, 22 (e.g., ...). Figure 62 (As shown) After that, through the locking control mechanism 412 ( Figure 62 Move lock 407 to the locked state to hold valve repair device 402 in the closed position. After valve repair device 402 is held in the locked state by lock 407, by connecting shaft 403 with placement shaft 413 ( Figure 62 The valve repair device 402 is disconnected from the delivery device 401 and removed from the paddle control mechanism 410. Figure 62 ), clamping component control mechanism 411 ( Figure 62 The valve repair device 402 is disengaged from the delivery device 401 and the locking control mechanism 412. Removal of the valve repair device 402 from the delivery device 401 allows the valve repair device to remain fixed to the valve tissues 20, 22 when the delivery device 401 is removed from the patient.

[0243] The concepts disclosed in this application can be used with a wide variety of different valve repair devices. For example, the concepts disclosed in this application can be used with any of the different valve repair devices disclosed herein. The concepts disclosed in this application can be used with valve repair devices having paddles, spacers, and other components that can be narrowed and widened (such as the valve repair device disclosed by U.S. Provisional Application No. 63 / 278,037, which is incorporated herein by reference in its entirety).

[0244] In many of the examples disclosed herein, the natural valvular leaflet is positioned in a gap between components to be secured to the leaflet (such as the movable and fixed arms of a fastener) or between the fastener arm and the paddle. After the leaflet is positioned within the gap, one or more components are actuated to clamp the leaflet tissue, thereby securing the leaflet. When the device includes a fastener, further positioning the leaflet into the opening between the arms of the fastener before actuating the movable arm to clamp the leaflet allows the movable arm to engage more leaflet tissue. Then, not only is more tissue engaged by the fastener, but as the tissue is further arranged within the gap, any optional barbs or other securing elements arranged at the distal end of the movable or fixed arm are positioned to engage thicker portions of the natural leaflet tissue. Engaging more and thicker tissue with the fastener ensures a more secure clamping of the natural leaflet by the fastener.

[0245] Determining the depth of natural lobule engagement within the gap between the movable and fixed arms using current imaging techniques is challenging. In particular, lobular tissue moves with each heartbeat and can be translucent or visually difficult to distinguish from surrounding tissue. In contrast, fasteners made of materials such as metal (e.g., fasteners with optional barbs) are much easier to see with imaging devices. Therefore, the surgeon can examine the position of the movable arm and one or more indicators to determine if the fasteners have properly engaged the natural lobule.

[0246] Example valve repair devices may include an indicator for determining, during implantation, deployment, or other use of the valve repair device, whether the natural leaflet is adequately engaged or within a fastener or optionally a barbed fastener. In some embodiments, the indicator is visible via an imaging device during implantation. In some embodiments, the indicator generates an electrical signal indicating leaflet insertion or capture. The indicator may be configured to show or otherwise indicate to the user that the leaflet has been inserted into the opening to a desired capture depth and / or that the leaflet has not yet reached the desired capture depth. Using the indicator allows the user to observe the indicator and / or the signal therefrom to determine that the leaflet is properly engaged.

[0247] The various indicators described herein can be configured in various shapes, sizes, and materials. In some embodiments, the indicators may include curved shapes, wave shapes, S-shaped shapes, C-shaped shapes, U-shaped shapes, V-shaped shapes, hook shapes, checkmark shapes, vortex shapes, linear shapes, planar shapes, circular shapes, rectangular shapes, triangular shapes, etc.

[0248] Now for reference Figures 64-67 Example fastener 500 (which may be a barbed fastener or include other friction or clamping enhancement features) is shown deployed within a natural valve 40, such as a mitral, tricuspid, aortic, or pulmonary valve, to couple a device (not shown) such as those described herein, valve repair devices, valve treatment devices, implantable devices, implants, etc., to one of the natural leaflets 42, 44. Leaflets 42, 44 may be mitral valve leaflets 20, 22 or tricuspid, aortic, or pulmonary valve leaflets. Reference now. Figure 64 The fastener 500 is shown in the open position, with natural leaflets 42, 44 partially inserted into the opening of the fastener 500 formed between the fixed arm 510 and the movable arm 530. To determine whether the leaflets 42, 44 have reached the desired engagement depth, the indicator arm 550 can be actuated via an actuation line (not shown), such as an actuating element, actuating suture, actuating thread, etc. The indicator arm has optional barbs 555 to further secure the leaflets in place. Referring now... Figure 65 The fasteners are shown in a closed configuration, closed on leaflets 42 and 44. Indicator arm 550 has not yet been actuated.

[0249] Now for reference Figure 66The indicator arm 550 is shown in an actuated state. The optional barbs 540 illustrated on the movable arm 530 have pierced the natural leaflets. The indicator arm 550 does not engage the leaflets 42, 44 when they are inserted into the opening of the fastener 500, at half or less than half the distance between the optional barbed portion 540 and the connected, flexible, or hinged portion 520, and / or not inserted far enough into the fastener to overlap with the length of the indicator arm 550. Alternatively, the indicator arm swings toward the fixed arm 510. The position of the indicator arm is visible via an imaging device for the implantation and deployment of the monitoring device.

[0250] Now for reference Figure 67 The fastener closes on leaflets 42 and 44, and the leaflets are positioned deep enough in the fastener 500 that they overlap with the indicator arm 550. Optional barbs 540 on the movable arm 530 have pierced the natural leaflets. The indicator arm rests on the leaflet tissue, and the leaflets prevent or inhibit the indicator arm from moving towards the fixing arm 510 of the fastener. Figure 67 The indicated arm shown has optional barbs 540 to further secure the leaflet in place. In an example without barbs on the indicated arm, the indicated arm can bounce (rebound) with the heartbeat—which causes the leaflet to pulsate. This pulsation is visible via the imaging technique described above and can be used to indicate to the operator that the leaflet is sufficiently deeply positioned within the fastener. Any of the indicators disclosed herein can be configured to pulsate or bounce with the leaflet in response to the heartbeat.

[0251] Now for reference Figures 68-77 Example fastener 500 is shown as a paddle-shaped attachment to any of the devices disclosed herein, valve repair devices, valve treatment devices, implantable devices, implants, etc., and is deployed within the natural valve 40 and coupled to one or more of the natural leaflets 42, 44. Fastener 500 is attached to paddle 122 of device 100, paddle 122 being movable between an open position and a closed position to capture and secure the natural leaflets 42, 44 within device 100, as described above.

[0252] Now for reference Figure 69 The device 100 is shown at the natural valve 40, where the paddle 122 is open. The fastener 500 is then opened by applying tension to actuation lines 502, 504, respectively attached to the ends of the movable arm 530 and the indicator arm 550. The indicator arm disclosed herein can be active (e.g., opened and closed by active steps such as pulling line 504) or passive (e.g., no additional action is required for the operation of the indicator arm other than opening and closing the fastener). Figure 69As shown, opening the fastener 500 and paddle 122 allows the manipulator 100 to be operated such that leaflets 42, 44 are at least partially arranged in the opening 506 formed between the fixed arm 510 and the movable arm 530 of the fastener, so as to capture leaflets 42, 44 by the fastener 500.

[0253] Now for reference Figure 69 The paddle 122 and fastener 500 are partially closed to position the leaflets for detection by the indicator arm 550 and ultimately capture by the fastener 500. The partially closed position of the paddle 122 and fastener 500 allows the optional barbed portion 540 of the movable arm 530 to clamp the leaflets 42, 44 against the fixed arm 510 without stretching or moving the leaflets 42, 44 so far that they are pushed away or slid off the optional barbed portion 540 by the movable arm 530 during the attempt to capture the leaflets.

[0254] Now for reference Figure 70 The two indicator arms 550 are actuated by releasing tension on an actuation line 504 (e.g., an actuation suture, actuation thread, etc.), which may be the same as or similar to other actuation lines described elsewhere herein. Both indicator arms 550 miss or slip off leaflets 42, 44 and move to a fully actuated position beyond the retaining arm 510 of fastener 500. The indicator arms 550 spanning the retaining arm 510 form an X-shape visible via an imaging device for monitoring implantation and deployment.

[0255] Now for reference Figure 71 The indicator arm 550 is retracted and the device 100 is repositioned by applying tension to the actuation line 504 (e.g., actuation wire, actuation suture, etc.) so that the leaflets 42, 44 are inserted deeper into the opening 506 of the fastener 500. Then, one of the indicator arms 550 is allowed to close by releasing the tension on one of the actuation lines 504, as in Figure 72 As can be seen, the indicator arm 550 engages with the leaflet 42 and clamps the leaflet 42 against the fixing arm 510 and the paddle 122. Figure 73 A similar configuration is shown, where another indicator arm 550 is actuated to engage another leaflet 44 and clamp the leaflet 44 against another fixed arm 510 and the paddle 122. Engagement with the leaflets 42, 44 prevents or inhibits movement of the indicator arm 550 through the fixed arm 510 of the fastener 500. Figure 70 The X-shape is shown. Therefore, the indicator arm 550 indicates to the observer, who is observing the installation via the imaging device, the minimum engagement depth or minimum insertion depth of the leaflets 42, 44 into the opening 506, which is determined by the length of the indicator arm 550.

[0256] Although the terms minimum engagement depth or minimum insertion depth are frequently used in this disclosure, other similar terms such as insertion depth, engagement depth, selected insertion depth, selected engagement depth, pre-selected insertion depth, pre-selected engagement depth, predetermined insertion depth, predetermined engagement depth, etc., may be used in their place.

[0257] Now for reference Figures 74-77 After the indicator arm 550 instructs the leaflets 42 and 44 to be fully inserted into the opening 506, the movable arm 530 is actuated by releasing the tension on the actuation line 502, causing the leaflets 42 and 44 to be clamped between the optional barbed portion 540 of each fastener 500 and the fixed arm 510. The paddle 122 is then moved... Figure 76 The fully closed position shown securely fixes the leaflet within the device 100. This can be achieved... Figures 72-76 Any position monitoring indicator 550 shown. For example, indicator 550 will pulsate or bounce with the heartbeat. This pulsation or bounce can be visualized to confirm that the valve repair device is correctly positioned. Because the flexibility of indicator 550 is sufficient to flex or bounce with the heartbeat, movable arm 530 can be made rigid and / or close with a sufficiently high force such that the closed movable arm 530 does not pulsate or bounce with the heartbeat. Any indicator disclosed herein is flexible enough to flex or bounce with the heartbeat.

[0258] Now for reference Figure 77 One of the leaflets 44 is shown as partially withdrawn from the device 100, which may be due to the movement of leaflets 42, 44 during heartbeat. Figure 77 As shown, leaflet 44 remains partially secured by the optional barbed portion 540. However, leaflet 44 is no longer secured at or beyond the minimum engagement depth determined by the length of the indicator arm 550. Retraction of leaflet 44 allows the indicator arm 550 to move beyond the fixed arm 510, thus forming an X-shape visible to an observer using the imaging device. Alternatively or additionally, the indicator arm 550, which does not contact the valve leaflet, does not pulsate or jump with the heartbeat. Therefore, insufficient retention or slippage of leaflets 42, 44 can be detected before the device 100 is separated from the delivery device (not shown). Upon detection of a slipped leaflet, fastener 500 and paddle 122 can be opened and repositioned to better secure the slipped leaflet. Any indicator arm disclosed herein can be configured to detect a slipped leaflet. In some embodiments, a single actuation line can be used to raise and lower the movable arm of the fastener and allow the indicator to move to the leaflet detection position.

[0259] Any feature of any lobular depth indicator disclosed in PCT patent application publication number 2020 / 168,081 (which is incorporated herein by reference in its entirety) can be combined with the lobular depth indicator disclosed herein. The lobular depth indicator can also be used with various devices for grasping the lobule. For example, the lobular depth indicator can be used with valve repair devices, implants, etc., shown and described in US2019 / 0290260 and WO2018167388, as well as chordae tendineae repair devices that require grasping the lobular tip (see, for example, US2019 / 0290260 and WO2018167388).

[0260] Now for reference Figures 78-87 Example device 600 (e.g., which may be the same as or similar to other devices, valve repair devices, valve treatment devices, implants, etc. described herein) is shown in various positions and configurations ranging from partially open to closed.

[0261] like Figure 78 As shown, the example device 600 includes an apposition portion 604, a proximal or attachment portion 605, an anchoring portion 606, and a distal portion 607. In some embodiments, the apposition portion 604 optionally includes an apposition element 610 (e.g., spacer, engagement element, plug, membrane, sheet, etc.) for implantation between the leaflets of a natural valve. In some embodiments, the anchoring portion 606 includes a plurality of anchor members 608. The anchor members can be configured in various ways. In some embodiments, each anchor member 608 includes an outer paddle 620, an inner paddle 622, a paddle extension member or paddle frame (not shown), and a fastener 630. In some embodiments, the fastener 630 includes a base or fixing arm 632, a movable arm 634, optional barbs 636, and a connecting portion 638. In some embodiments, the attachment portion 605 includes a first or proximal collar 611.

[0262] refer to Figure 78 The device 600 is shown in a laterally extended or open position. By continuing to extend the aforementioned actuating element 612, thereby increasing the distance between the engaging element 610 and the cap 614 of the distal portion 607, the device 600 is moved to the laterally extended or open position. In the laterally extended or open position, the inner paddle 622 extends more horizontally than in other positions of the device 600 and forms an angle of approximately 90 degrees with the engaging element 610. Similarly, when the device 600 is in the laterally extended or open position, the paddle frame (not shown) is in its maximum extended position. The increased gap between the engaging element 610 and the inner paddle 622 formed in the laterally extended or open position allows the fastener 630 to open further before engaging the engaging element 610, thereby increasing the size of the gap between the fixed arm 632 and the movable arm 634.

[0263] To determine whether the leaflet has reached the engagement depth, the device 600 may include an indicator arm 650. The indicator arm 650 may have various shapes and sizes and may be made of various materials. In some embodiments, the indicator arm 650 is a wire. The indicator arm 650 may be attached to various locations on the device 600. In some embodiments, a first end 652 of the indicator arm 650 is fixedly attached to the mating element 610.

[0264] refer to Figure 79 According to some embodiments, the fixed arm 632, the movable arm 634, the outer paddle 620, the inner paddle 622, and the paddle frame (not shown) may each include one or more channels or slots through which the indicating arm 650 can be arranged. For example, as Figure 79 As shown, the indicator arm 650 can be arranged through the movable arm channel or slot 660 of the movable arm 634, the fixed arm channel or slot 662 of the fixed arm 632, the inner paddle channel or slot 664 of the inner paddle 622, and the outer paddle channel or slot 666 of the outer paddle 620.

[0265] The second end 654 of the indicator arm 650 can terminate in various positions. In some embodiments, the second end 654 of the indicator arm 650 can terminate distal to the outer paddle 620, while in other embodiments, the second end 654 of the indicator arm 650 can terminate between the outer paddle 620 and the inner paddle 622, or between the fixed arm 632 and the movable arm 634. The second end 654 of the indicator arm 650 can also terminate within any of the movable arm channel or slot 660, the fixed arm channel or slot 662, the inner paddle channel or slot 664, or the outer paddle channel or slot 666. As the device 600 moves and progresses from open to closed, the second end 654 of the indicator arm 650 will also move. For example, when the device 600 is closed, the indicator arm 650 will flatten, align with, and / or press against the device 600. Therefore, the indicator arm 650 does not increase the size of the device 600 or significantly increases the size of the device 600.

[0266] In some embodiments, the indicator arm 650 may include any number of loops, rotating portions, bent portions, or torsional portions between the first end 652 and the second end 654. (See reference) Figure 80 The indicator arm 650 may include a curved portion 658 between a first end 652 and a second end 654. For example... Figure 80The bend 658 shown is located distal to the outer paddle 620, but it can also be located between the movable arm 634 and the fixed arm 632, or between the fixed arm 632 and the outer paddle 620. Distal to the bend 658, the second end 654 of the indicator arm 650 can be positioned toward or attached to the mating element 610.

[0267] refer to Figure 81 and 82 The indicator arm 650 is attached to the opposite indicator arm 650 of the device 600. For example, both indicator arms can be formed from a single wire. The single wire can be thin and flexible, such that the wire is compressed inside the device 600 when the device is closed. Therefore, the indicator arm 650 does not increase the size of the device 600 or does not significantly increase the size of the device 600. Figure 81 In the example shown, the portion connecting the indicator arm is arranged inside the paddle-like structure. Figure 82 In the example shown, a portion of the connecting indicator arm 650 extends through and / or through the paddle-like structure.

[0268] The indicator arm 650 may include an indicator mark 656, and / or the indicator arm itself may serve as a mark or include a portion that serves as a mark. The indicator mark 656 may be a radiopaque material, which may be printed as a separate material or attached to the indicator mark 656. For example, the radiopaque material may be a coil made of platinum or another radiopaque material. The indicator mark 656 may be visible using fluorescence inspection and / or other imaging techniques and may help the user determine whether the leaflet is properly positioned in the fastener 630. The indicator mark does not need to be a separate component. For example, in some embodiments, the indicator mark is integral with the indicator arm; for example, the indicator mark may be a portion of the indicator arm that includes a radiopaque material and / or is thicker or has a larger surface area (which may help improve visibility).

[0269] The indicator arm 650 can move independently relative to the movable arm 634 to facilitate the detection of the engagement depth of the natural lobule between the movable arm 634 and the fixed arm 632 of the fastener 630. In this example, the indicator arm 650 is more elastic and / or flexible than the movable arm 634. This increased elasticity and / or flexibility allows the indicator arm to bounce, pulsate, or jump, while the movable arm 634 provides a firm grip on the lobule tissue and does not bounce, pulsate, or jump. The bouncing, pulsating, or jumping of the indicator arm 650 can be observed using standard imaging equipment to determine proper engagement of the fastener with the lobule tissue.

[0270] When observed using fluorescence inspection and / or other imaging techniques, the distance moved by the indicator arm 650 and the indicator mark 656 can help the user determine whether the leaflets are properly positioned in the fastener 630. If the leaflets 42, 44 positioned within the fastener 630 engage or otherwise actuate the indicator arm 650, the indicator arm 650 and the indicator mark 656 will move a distance that can be measured using various techniques. The sufficient distance by which the indicator leaflets 42, 44 are properly aligned in the fastener 630 can be predetermined by the user. On the other hand, if the leaflets 42, 44 positioned within the fastener 630 are not engaged or otherwise actuate the indicator arm 650 by a sufficient distance, then the adjustment device 600 will be necessary until proper alignment is achieved.

[0271] The relative positioning of the indicator arm 650 and the indicator mark 656 helps determine that the minimum engagement depth of the leaflets 42, 44, measured from the end of the movable arm 634 of the fastener 630, has been achieved. Positioning the indicator mark 656 closer to or further away from the first end 652 of the indicator arm 650 changes the distance the indicator mark 656 moves when engaged by the leaflets 42, 44. For example, when engaged by the leaflets 42, 44, the indicator mark 656 positioned closer to the first end 652 of the indicator arm 650 will not move the same distance as the indicator mark 656 positioned further away from the first end 652 of the indicator arm 650.

[0272] Now for reference Figures 83-84 Fastener 630 is shown in an open configuration, with leaflets 42, 44 engaging indicator arm 650. Leaflets 42, 44 push mark 656 on the indicator arm closer to the movable arm 634 of the fastener and closer to the mating element 610. This movement of the indicator leaflet is positioned at an acceptable depth. Once the user sees the leaflet positioned at the acceptable depth, the movable arm 634 and / or the inner paddle 622 and outer paddle 620 can be closed to capture the leaflet.

[0273] refer to Figures 85-87 Example fastener 700 is shown as a paddle attached to example device 702, which is similar in many respects to other devices, valve repair devices, valve treatment devices, implantable devices, implants, etc. disclosed herein, and is deployed within a natural valve 40 and secures the device to natural leaflets 42, 44. Furthermore, Figures 85-87 The device shown is similar to Figures 75-84 The device shown is different, except that the indicator arm 750 is connected to the movable arm instead of the spacer. Therefore, Figures 85-87 Any feature of the device shown can be used Figures 49-64 In the device shown.

[0274] Now for reference Figure 85Device 702 is shown at the natural valve 40, where the paddle 722 is open. Fastener 700 is then opened by applying tension to an actuation line 704 attached to the end of the movable arm 730. The tension causes the hinge portion 720 of the fastener to flex to open the fastener. Figure 85 As shown, opening the fastener 700 and paddle 722 allows the manipulator 702 to be operated such that leaflets 42, 44 are at least partially arranged in the opening 706 formed between the fixed arm 710 and the movable arm 730 of the fastener, so that the fastener 700 can capture leaflets 42, 44.

[0275] Now for reference Figure 86 The paddle 722 and fastener 700 are partially closed to position the leaflets for detection by the indicator arm 750 and ultimately capture by the fastener 700. The partially closed position of the paddle 722 and fastener 700 allows the optional barbed portion 740 of the movable arm 730 to clamp the leaflets 42, 44 against the fixed arm 710 without stretching or moving the leaflets 42, 44 so far that they are pushed away or slid off the optional barbed portion 740 by the movable arm 730 during the attempt to capture the leaflets.

[0276] After the indicator arm 750 instructs the leaflets 42 and 44 to be fully inserted into the opening 706, the movable arm 730 is actuated by releasing the tension on the actuation line 704, causing the leaflets 42 and 44 to be clamped between the optional barbed portion 740 of each fastener 700 and the fixed arm 710. The paddle 722 is then moved... Figure 86 The fully closed position is shown to securely fix the leaflet within the device 700.

[0277] Now for reference Figure 87 One of the leaflets 44 is shown partially retracted from the device 702, which may occur due to various reasons—including movement of leaflets 42, 44 during heartbeat. Leaflet 44 remains partially secured by an optional barbed portion 740. However, leaflet 44 is no longer secured at or beyond the minimum engagement depth determined by the positions of the indicator arm 750 and indicator mark 756. Insufficient retention or slippage of leaflets 42, 44 can be detected before the device 702 is separated from the delivery device (not shown). Upon detection of a slipped leaflet, fastener 700 and paddle 722 can be opened and repositioned to better secure the slipped leaflet.

[0278] refer to Figure 88The valve repair device fastener 830 includes an indicator arm 850 having a shaped portion 852, which can be used with a valve repair device (see, for example, the valve repair device disclosed in WO2020 / 168081). The fastener 830 includes a retaining arm 832, a flexure or hinge portion 838, a movable arm 834 having an optional barbed portion 836, and an indicator 850 connected to the movable arm 834 via the indicator flexure or hinge portion 854. The indicator 850 is used to indicate whether the leaflet has reached a minimum engagement depth. The movable arm 834 may have at least one opening 860 through which the indicator passes. Therefore, the shaped portion 852 of the indicator arm 850 does not indicate that the natural leaflet has reached a minimum engagement depth until the leaflet is inserted into or beyond the shaped portion 852. After leaflets 42 and 44 have reached the desired engagement depth, the indicator arm 850 is pressed against the movable arm 834 by leaflets 42 and 44, causing the shaped portion 852 of the indicator arm to pass through the opening 860 of the movable arm 834. This can be observed under fluorescence examination because the shaped portion is on the atrial side of the valve. Therefore, unlike the internal space between the movable arm 834 and the fixed arm 832 of the fastener, the shaped portion 852, positioned on the outside of the movable arm, indicates that leaflets 42 and 44 have reached sufficient depth. The shaped portion can be configured in various shapes, such as circular, square, triangular, rectangular, D-shaped, P-shaped, S-shaped, elliptical, oval, coiled, etc.

[0279] Figures 89-90 The illustration shows the fastener 830 in the open position, wherein the indicator 850 with the formed portion 852 is in a normal or non-engaged configuration. Figures 91-93 The illustration shows fastener 830 deployed within a natural valve to secure at least one of leaflets 42, 44. Figure 91 In the diagram, fastener 830 is shown in the open position, with natural leaflets 42, 44 partially inserted into the opening of fastener 830 formed between fixed arm 832 and movable arm 834. To determine whether leaflets 42, 44 have reached the desired engagement depth, movable arm 834 is actuated to close the fastener, causing the movable arm and fixed arm to move closer together. When pressure is applied to the indicator arm via leaflets 42, 44 or fixed arm 832, the indicator arm flexes, moves, or pivots freely about the indicator flexure or hinge portion 854.

[0280] exist Figure 92 When the movable arm 834 is actuated to close the fastener onto the leaflets 42, 44, the indicator arm will not be forced out of its resting configuration if the leaflets are not sufficiently deep within the fastener. That is, when the leaflets are not deeply positioned within the fastener, the indicator arm and the forming part 852 will maintain their resting configuration between the movable arm and the fixed arm.

[0281] exist Figure 93 In this configuration, when the leaflets are positioned sufficiently deep within the fastener, the movable arm 834 is actuated to close the fastener onto the leaflets 42, 44. The indicator arm 850 and its shaped portion 852 indicate to the operator that the leaflets 42, 44 are sufficiently deep. When the leaflets are sufficiently deep and the movable arm 834 is actuated, the leaflets exert pressure on the indicator arm. This pressure causes the indicator arm 850 to move toward the movable arm, such that the shaped portion 852 of the indicator arm 850 passes through the opening 860 of the movable arm and reaches the side of the movable arm opposite to the fixed arm (i.e., into the open space on the atrial side of the valve leaflet).

[0282] refer to Figures 94-98 The fastener 930 includes a fixed arm 932, a flexible or hinged portion 938, a movable arm 934 having an optional barbed portion 936, and an indicator arm 950 connected to the movable arm 934. The movable arm 934 may have at least one opening 960 (e.g., orifice, channel, slot, etc.) through which the indicator arm 950 passes. In some embodiments, instead of an opening, the indicator arm moves adjacent to the movable arm or moves through a notch in its side. The indicator arm 950 may include an optional indicator mark 956, and / or the movable fastener arm 934 may include an optional indicator mark 957. Any embodiment disclosed herein may include optional indicator marks 956 and / or optional indicator marks 957. In some embodiments, indicator marks 956 and / or indicator marks 957 comprise a radiopaque material, which may be printed as a separate material piece or attached to indicator marks 956 and / or indicator marks 957. For example, the radiopaque material may be a coil made of platinum or another radiopaque material. The indicator mark is not necessarily a separate component. For example, in some embodiments, the indicator mark 956 is integrated with the indicator arm; for example, the indicator mark 956 may be a portion of the indicator arm that includes a non-transparent material and / or is thicker or has a larger surface area (which can help improve visibility), and / or the indicator mark 957 is integrated with the movable fastening arm; for example, the indicator mark 957 may be a portion of the fastening arm that includes a non-transparent material and / or is thicker or has a larger surface area (which can help improve visibility).

[0283] Indicator markers 956 and / or 957 are visible using fluorescence examination and / or other imaging techniques and can help the user determine whether the leaflet is properly positioned in the fastener 930. Indicator arm 950 can be used with suitable valve therapy devices or valve repair devices (see, for example, the device disclosed by WO2020 / 168081, which is incorporated herein by reference). While some valve repair devices or valve therapy devices may be shown or described herein as implantable devices for illustrative purposes, the concepts and configurations described herein (e.g., indicator portions, etc.) are applicable to a variety of devices that are not necessarily implantable but can be removed after treatment.

[0284] The indicator arm 950 includes a fixed end 954 and a movable end 952. The fixed end 954 of the indicator arm 950 can be coupled to the movable arm 934 in various ways and at various locations along the movable arm 934. The indicator arm 950 can be coupled to the movable arm 934 at any point between the hinge portion 938 and the optional barbed portion 936.

[0285] like Figures 94-98 As shown, the indicator arm 950 is coupled to the movable arm 934 of the fastener 930 on a first side F of the fastener 930. The indicator arm 950 can bypass or pass through the movable arm 934 of the fastener 930, such that a portion of the indicator arm 950 is arranged on a second side G of the fastener 930 (opposite to the first side F). In some embodiments, the indicator arm 950 includes a shaped leaflet engaging member or leaflet engaging portion 958 at least partially located on the second side G, which can contact the natural leaflet when it is inserted into the fastener 930. Optionally, the leaflet engaging member or leaflet engaging portion 958 extends into the space between portions of the fixed arm or into a cutout in the fixed arm. This additional extension of the leaflet engaging member or leaflet engaging portion 958 facilitates greater movement of the mark and / or end compared to a case where the leaflet engaging member or leaflet engaging portion 958 might stop on the surface of the fixed arm.

[0286] The indicating arm includes one or more arms extending from a movable end to a fixed end. In some embodiments, such as Figure 95A-95GAs shown in 96A-96B, the indicator arm 950 may include a first arm 972 and a second arm 974 extending from a movable end 952 of the indicator arm 950 to a fixed end 954. The first arm 972 and the second arm 974 are connected to the movable end 952 on a first side F of the fastener 930. In some embodiments, between the movable end 952 of the indicator arm 950 and the leaflet engagement member or leaflet engagement portion 958, the first arm 972 extends through a first opening 962 arranged in the surface of the movable arm 934, while the second arm 974 extends through a second opening 964 arranged in the surface of the movable arm 934 (but other arrangements, such as adjacent to or through a side notch, are also possible). The movable arm 934 of the fastener includes a first beam 990 and a second beam 992 extending perpendicularly to each other and defining the first opening 962 and the second opening 964. Beams 990 and 992 define the dimensions of the openings 962 and 964 and the travel path of the indicator arm 950. Beam 990 prevents or inhibits torsion of the indicator. When the indicator engages with the leaflet structure, beam 992 moves the indicator substantially orthogonally into space F.

[0287] Between the leaflet engaging member or leaflet engaging portion 958 and the fixed end of the indicator arm 950, the first arm 972 and the second arm 974 of the indicator arm surround the movable arm 934 of the fastener 130 and return to the first side F of the fastener 130. At the fixed end 954, the first arm 972 and the second arm 974 can be connected to each other at the connection point 976 (see also...). Figure 110 At the fixed end 954, the indicator arm 950 is also connected to the movable arm 934 of the fastener 130.

[0288] The indicator arm 950 is used to indicate whether the leaflet has reached the desired engagement depth in the fastener 930. After the leaflet has reached the desired engagement depth in the fastener 930, the leaflet engages the indicator arm 950 on the second side G of the fastener 930. For example, the leaflet may engage one or more of the first arm 972 and the second arm 974 at the leaflet engagement portion 958 of the indicator arm 950. The leaflet engagement member or the leaflet engagement portion 958 is pressed against the movable arm 934 of the fastener 930, which causes the movable end 952 and optional indicator mark 956 (when included) to move away from the movable arm 934 of the fastener 930 and optional indicator mark 957 (when included). The movement of indicator mark 956 away from the movable arm 934 of the fastener 930 can be observed and / or measured under fluorescent inspection to determine whether the leaflet is engaged in the appropriate position in the fastener 930.

[0289] In embodiments that include two indicator marks 956 and 957, an image showing only a single mark (i.e., the two marks 956 and 957 are adjacent to or next to each other, and only a single mass is visible in the image) (e.g., a fluorescence examination image) indicates that tissue such as valve leaflet tissue is not arranged to a sufficient depth in the fastener 930. Conversely, when two indicator marks 956 and 957 are included, an image showing two separate marks (i.e., the two marks 956 and 957 are spaced apart) (e.g., a fluorescence examination image) indicates that tissue such as valve leaflet tissue is arranged to a sufficient depth in the fastener 930.

[0290] refer to Figure 95A-95G In 96A-96B, the indicator arm 950 can be pushed so that the moving end 952 is perpendicularly moved away from the movable arm 934. Figure 95F-95G The indicator arm 950 may move, or move parallel to the movable arm 934 toward the optional barbed portion 936. For example, when the device is partially opened and the indicator arm 950 is engaged by the valve leaflets 42, 44, the indicator arm will move... Figure 95F-95G The location shown is clearly indicated to show that the leaflet tissue is at sufficient depth. (Reference) Figures 96A-96B When the device is fully closed, the indicator will push against the spacer, central component, and / or actuating element, and be compressed into a flat state (see [reference]). Figure 101 Therefore, compared to the same device without indicator 950, the device with indicator 950 occupies no additional space or occupies very little additional space. Optionally, a thread or suture may be attached to indicator 950 to move the indicator to a flattened configuration during the capture of valve leaflets 42, 44. Thus, during the leaflet capture process, the indicator does not occupy the space between the fixed arm 932 and the movable arm 934.

[0291] Figures 97-98 The diagram includes Figure 95A-95G The valve repair device 900 with fastener 930 as shown in 96A-96B. Figure 97 and 98The valve repair device 900 is in a closed configuration. The valve repair device 900 can operate in substantially the same manner as the valve repair device 200 described above. The valve repair device 900 may optionally include an adjustable-width paddle frame assembly 924 instead of the paddle frame 224 of the valve repair device 200. The adjustable-width paddle frame assembly 924 allows the width of the device 900 to narrow and widen during deployment of the valve repair device 900. The adjustable-width paddle frame assembly 924 can take various forms. In the illustrated example, the adjustable-width paddle frame assembly 924 includes a rigid inner paddle frame 925 and a flexible outer paddle frame 927. The rigid inner paddle frame 925 has a fixed width. The flexible outer paddle frame 927 has an adjustable width that is controllable and / or settable during deployment of the valve repair device 900.

[0292] refer to Figure 95F and 95G The movable arm 934 may include a crossbar 980. The indicator arm 950 may contact the crossbar 980. When the indicator arm 950 is in the engaged position, it contacts the movable arm 934 of the fastener 930 to limit movement of the indicator arm 950. Therefore, the crossbar 980 acts as a stop for the indicator arm 950 in the engaged position. When the indicator arm 950 is in the disengaged position (… Figure 95C-95E The movable end 952 of the indicator arm 950 contacts the movable arm 934 of the fastener 930 to set or limit the position of the indicator arm 950. Therefore, the rear part of the movable arm 934 and the movable end 952 act as a stop for the indicator arm 950 in the disengaged position.

[0293] Figure 99-101 An example of fastener 1030 that operates in a similar manner to fastener 930 is illustrated. Figure 99 The illustration shows the fastener 1030 in the disengaged position. In some embodiments, reference is made to... Figure 99-101 Between the fixed end 1054 and the movable end 1052, the indicating arm 1050 extends through a single opening (e.g., opening 1060) of the movable arm 1034 of the fastener 1030. In this example, the fixed arm 1032 has a fork-shaped configuration, such that in the disengaged position ( Figure 99 In this embodiment, the movable end 1052 of the indicator arm 1050 may be arranged parallel to or partially angled into the second opening 1062 in the movable arm 1034. The fasteners described herein can be used with various valve repair or valve treatment devices (whether implanted or removed after treatment).

[0294] The indicator arm 1050 may include one or more protrusions 1080 extending outwardly from the indicator arm 1050. The protrusions 1080 may be located on the leaflet engagement member or leaflet engagement portion 1058 of the indicator arm 1050, such that when the indicator arm 1050 is in the engaged position ( Figure 100-101 The protrusion 1080 engages the movable arm 1034 of the fastener 1030 to prevent or inhibit the leaflet engaging member or leaflet engaging portion 1058 from traveling through the opening 1060 and reaching the first side F. The indicator arm can be pushed such that the moving end 1052 moves vertically away from the movable arm 1034. Figure 100 ) moves, or parallel to the movable arm 1034 toward the optional barbed portion 1064 ( Figure 101 Movement. For example, when the device is partially opened and the indicator 1050 is engaged by the valve leaflets 42, 44, the indicator arm will move. Figure 100 The indicated position clearly indicates that the lobular tissue is at sufficient depth. When the device is fully closed, the indicator will push against the spacer and be compressed. Figure 101 The device is in a flattened state as shown. Therefore, compared to the same device without the indicator 1050, the device with the indicator occupies little or no additional space. Optionally, a thread or suture may be attached to the indicator 1050 to move the indicator during the capture of the valve leaflets 42, 44. Figure 101 The configuration shown indicates that the indicator will not occupy the space between the fixed arm 1032 and the movable arm 1034 during the leaflet capture process.

[0295] refer to Figure 102A-102B The illustration shows a device 1100 with two fasteners. Figure 102A The illustration shows the apparatus for observation in an open space. Figure 102B The diagram illustrates the apparatus under fluorescence inspection. A first fastener 1130 engages with a leaflet, while a second fastener 1230 does not. Leaflet 42 engages an indicator arm 1150, for example, at a leaflet engagement member or leaflet engagement portion 1158, such that the leaflet engagement member or leaflet engagement portion 1158 is pressed against the movable arm 1134 of the fastener 1130. This causes the moving end 1152 and the indicator mark (not shown) to move or extend away from the movable arm 1134 of the fastener 1130. Figure 102A and 102B As can be seen in the image, clear instructions are provided for leaf capture.

[0296] Still referencing Figure 102A-102BThe second fastener 1230 does not engage with the leaflet; therefore, the movable end 1252 of the second indicator arm 1250 is adjacent to and / or coupled to the movable arm 1234. The first indicator arm 1150 and the second indicator arm 1250 can be any indicator or indicator arm disclosed herein. For example, indicator arms 1150 and 1250 can have… Figure 94 , 95A - Any feature or combination of features of the indicator arm shown in 95G, 96A, 96B, 99-101 and 103-118.

[0297] Figures 103-105 Other examples of indicator arm configurations are illustrated. The indicator arm can be positioned along the fastener in various ways. For example, see reference... Figure 103 The movable end 1352 of the indicator arm 1350 can be oriented such that, in the disengaged position, it is located on the first side F of the movable arm 1334 of the fastener 1330 and bent toward the movable arm 1334. (Reference) Figure 104 The movable end 1352 of the indicator arm 1350 can be oriented such that, in the disengaged position, it is located on the second side G of the movable arm 1334 of the fastener 1330 and bent toward the movable arm 1334. (Reference) Figure 105 The movable end 1352 of the indicator arm 1350 can be oriented such that, in the disengaged position, it is located within the opening of the movable arm 1334 of the fastener 1330 and extends along the plane AA of the movable arm 1334.

[0298] refer to Figure 106 The movable arm 1434 of the fastener 1430 may include a rod 1490 extending along the movable arm 1434 and through an opening along axis AA. The rod 1490 prevents or reduces torsion of the indicator arm 1450 by providing a path for the leg of the indicator arm 1450 to slide along it. In the disengaged position, the movable end 1452 of the indicator arm 1450 is positioned on a first side F of the fastener 1430 adjacent to the rod 1490.

[0299] refer to Figure 107 The movable arm 1434 of the fastener 1430 may include one or more protrusions 1492 extending from the movable arm 1434. In addition to or in place of the lever 1490, the protrusions 1492 prevent or reduce torsion of the indicator arm 1450 by providing a path for the legs of the indicator arm 1450 to slide along it.

[0300] Figures 108-109 The diagram shows fastener 1530 in the closed position. (Reference) Figure 108The leaflets are located within fastener 1530, but not far enough within fastener 1530 to engage indicator arm 1550. Therefore, indicator mark 1556 does not move from the movable arm 1534 of fastener 1530. The position of indicator mark 1556, visible using fluorescence inspection and / or other imaging techniques, can help the user determine that leaflets 42, 44 are not properly positioned within fastener 1530. Figure 108 In this embodiment, when leaflets 42 and 44 are not engaged with indicator arm 1550, indicator mark 1556 is positioned against the rear side of movable arm 1534. Therefore, in the "unengaged" state, the rear side of movable arm 1534 acts as a stop for indicator arm 1550.

[0301] refer to Figure 109 The leaflets are positioned sufficiently far within the fastener 1530 to engage the indicator arm 1550. Movement of the indicator arm 1550 causes the indicator mark 1556 to move from the movable arm 1534 of the fastener 1530. The position of the indicator mark 1556, visible using fluorescence inspection and / or other imaging techniques, can help the user determine that the leaflets 42, 44 are properly positioned within the fastener 1530. Figure 109 In this embodiment, when leaflets 42 and 44 engage the indicator arm 1550, the indicator arm 1550 presses against the crossbeam 1560 on the front side of the movable arm 1534 (see also...). Figure 106 and 107 (Similar to the crossbeam in the illustrated embodiment). Therefore, the crossbeam 1560 of the movable arm 1534 acts as a stop for the indicator arm 1550 in the "engaged" state. Therefore, Figure 108 "Unengaged" stop and Figure 109 The "engagement" stop helps to provide a clear indication of whether leaflets 42 and 44 have been inserted into the fastener to a sufficient depth.

[0302] refer to Figure 110 At the fixed end 1654 of the indicator arm 1650, the first arm 1672 and the second arm 1674 can be connected to each other at the connection point 1676. The connection of the first arm 1672 and the second arm 1674 at the connection point 1676 can be made in various ways, such as by welding, hinge, adhesive, linking, interconnection, etc. At the fixed end 1654, the indicator arm 1650 can also be connected to the movable arm of the fastener (see Figure 96). The split connection point 1676 allows the indicator arms to be made from a single piece, and as... Figure 95A-95G As shown in any of 96A, 96B, 97, 98, 103-109, the assembly connection point 1676 can be unfolded, routed through the opening and / or around the rod of the movable arm to position the indicator arm relative to the movable arm, return together, and be fixed to the movable arm.

[0303] refer to Figures 111-113 In addition to the markings on the indicator 1750, the movable arm 1732 of the fastener 1730 may include one or more markings 1790. Markings 1790 may be made of a material similar to the indicator marking 1756 on the indicator arm 1750. Markings 1790 may be a radiopaque material, which may be printed as a separate material piece or attached to marking 1756. For example, the radiopaque material may be a coil made of platinum or another radiopaque material. The indicator marking does not need to be a separate component. For example, in some embodiments, the indicator marking is integrated with the indicator arm; for example, the indicator marking may be a portion of the indicator arm that includes radiopaque material and / or is thicker or has a larger surface area (which can help improve visibility).

[0304] Mark 1756 is visible using fluorescence inspection and / or other imaging techniques and can help the user determine whether the leaflet is properly positioned within the fastener 1730. For example, when engaged with the leaflet, the indicator arm 1750 is pushed, causing the indicator mark 1756 to move away from mark 1790 on the movable arm 1732 of the fastener 1730. The distance between the indicator mark 1756 and mark 1790 on the movable arm 1732—both of which are visible using fluorescence inspection and / or other imaging techniques—can help the user determine whether the leaflets 42, 44 are properly positioned within the fastener 1730 or not.

[0305] In some implementations, the various indicator arms described herein can be pulled, stretched, and / or moved to open up more capture space. For example, Figure 114The illustration shows that during the process of capturing valve leaflets 42, 44 between the fixed arm 1832 and the movable arm 1834 of the fastener 1830, the end 1852 and / or mark 1856 of the indicator arm 1850 can be pulled as indicated by arrow 1851. For example, when the fastener is open, the end 1852 of the indicator arm 1850 can be pulled by a thread or suture. Therefore, the indicator arm does not obstruct the space between the fixed arm 1832 and the movable arm 1834, or occupies minimal space between them. In the illustrated example, the indicator arm 1850 has a curved path when pulled as indicated by arrow 1851. For example, the indicator arm can bend from the attachment between the movable arm and the indicator arm into space G as indicated by reference numeral 1858, but not all the way to the fixed arm. The indicator arm 1850 then bends rearward through the movable arm to space F, but not to the extent that the indicator arm extends when engaged by the valve leaflets. Then, the indicator arm 1850 extends rearward toward the free end of the movable arm 1834. After the leaflet is positioned in space G (or the user believes the leaflet is in space G), the indicator arm can be released to indicate whether the leaflet is positioned in space G, and the closing fastener 1830 will capture the leaflet.

[0306] refer to Figures 115-116 According to some embodiments, one or more of the fixed arm 1932, movable arm 1934, outer paddle 1920, inner paddle 1922, and / or paddle frame (not shown) of device 1900 may include a leaflet engagement member of the indicator arm 1950 or an opening, channel, cutout, notch, etc., through which the leaflet engagement portion 1958 can travel. Otherwise, the fixed arm 1932, movable arm 1934, outer paddle 1920, inner paddle 1922, and paddle frame (not shown) of device 1900 may be the same as or similar to the fixed arm, movable arm, outer paddle, inner paddle, and paddle frame of device 200 or other devices herein and / or be able to operate in the same or similar manner as the fixed arm, movable arm, outer paddle, inner paddle, and paddle frame of device 200 or other devices herein. In some embodiments, the fixed arm 1932, the movable arm 1934, the outer paddle 1920, and the inner paddle 1922 may be formed from a single sheet or strip of material. In some embodiments, such as Figures 115-116 As shown, the leaflet engagement member or leaflet engagement portion 1958 of the indicator arm 1950 can be arranged through the movable arm channel 1960 of the movable arm 1934, the fixed arm channel 1962 of the fixed arm 1932, and the inner paddle channel 1964 of the inner paddle 1922. By allowing the leaflet engagement portion 1958 to extend through the fixed arm channel 1962 and the inner paddle channel 1964, the free end of the indicator arm 1950 can extend further from the movable arm 1934 to provide a clearer indication of the leaflet engagement.

[0307] The devices, fasteners, and indicator arms of the various apparatuses described herein (including, for example, devices 900, 1100, 1900 and fasteners 930, 1030, 1130, 1330, 1430, 1530, 1730, 1830, 2030, etc.) can be configured such that even when the apparatus is in a closed configuration (e.g., as...) Figure 97 , 98 As shown in 115 and 116, if the leaflet tissue is captured within the fastener, the indicator arm remains extended away from the movable arm in its extended position. Therefore, when the device is in a partially open or capture-ready configuration, it can provide indication of proper capture of the leaflet upon capture, and when the device changes from a partially open to a closed configuration, it can still provide indication that the leaflet is still properly captured and has not somehow slipped or been torn away from the fastener. Even in the closed configuration, this allows the user to be confident that the device has been properly implanted.

[0308] Furthermore, the devices, fasteners, and indicator arms of the various apparatuses described herein (including, for example, devices 900, 1100, 1900 and fasteners 930, 1030, 1130, 1330, 1430, 1530, 1730, 1830, 2030, etc.) can be configured such that the indicator arm can jump, pulsate, or bounce in a manner visible using standard imaging equipment to aid in determining proper placement and engagement with the lobular tissue. For example, the devices, fasteners, and indicator arms can be configured such that the indicator arm jumps, pulsates, or bounces while the lobular tissue is within the capture area of ​​the fastener before the movable arm of the fastener has closed. This allows the end user to ensure that the lobular tissue is sufficiently deep to engage the lobular engagement portion and will be properly captured before the movable arm is released to the fully closed position (and therefore before any optional barbs that can be used on the movable arm of the fastener to penetrate or deeply penetrate the tissue).

[0309] refer to Figure 117 The fastener 2030 includes a connecting member 2090 between the first beam 2092 and the second beam 2094 of the fixing arm 2034. When leaflets 42 and 44 are engaged in the fastener 2030 via the indicator arm 2050, the connecting member 2090 assists in further stabilizing leaflets 42 and 44. Specifically, leaflets 42 and 44 press against the two legs of the indicator arm 2050, the first beam 2092 of the fixing arm 2034, the second beam 2094 of the fixing arm, and the connecting member 2090, thereby resulting in further stabilization of leaflets 42 and 44. Figure 117 The diagram illustrates the waveform paths of leaflets 42 and 44 when the joining member is included. Figure 118 The illustration shows the fastener 2030 without the connecting member 2090 and the resulting leaf path.

[0310] In some embodiments, the indicator arm may be coupled to the fixing arm of the inner paddle and / or fastener of the valve repair device or valve treatment device. The valve repair device may have the configuration of any valve repair device disclosed herein, such as valve repair device 200. Reference Figures 119-123 The indicator arm 2150 is configured to attach to the inner paddle 2122 (see...) Figure 121 This configuration allows the indicator arm 2150 to remain positioned between the inner and outer paddles at all times. Therefore, the indicator arm 2150 is housed within the envolope of the valve repair device 2100. The indicator arm 2150 may include a leaflet engagement member or leaflet engagement portion 2158 for engaging the leaflets (e.g., extension, protrusion, arm, edge, bulge, recess, raised portion, U-shaped portion, V-shaped portion, triangular portion, curved portion, circular portion, rectangular portion, etc.) and an indicator mark 2156 to help the user determine whether the leaflets are properly positioned in the fastener. The indicator arm 2150 may also include a coupling member 2190 for coupling the indicator arm 2150 to the inner paddle. The coupling member 2190 may have various shapes and sizes and may include a pin 2192 for assisting coupling. Figure 119 ) and / or the curved portion 2194 ( Figure 120 In some embodiments, coupling member 2190 may include one or more of a connection, pivot, hinge, pin, clamp, clamping member, flexible connector, suture, band, bridging member, sheet, etc. Indicators described herein (e.g., indicator arms, markers, sensors, electrodes, etc.) can be used with various valve repair or treatment devices—whether implanted or removed after treatment.

[0311] refer to Figures 121-123 The device 2100 has a fastener 2130, which includes a movable arm 2134, a fixed arm 2132, and an indicator arm 2150. The indicator arm 2150 is coupled to the inner paddle 2122 via a coupling member 2190. When the leaflets 42, 44 are not sufficiently far within the fastener 2130 to engage the indicator arm 2150 (see [link to device 2100]), Figure 122 The indicator mark 2156 is positioned against the inner paddle 2122. When the leaflets 42, 44 are sufficiently far within the fastener 2130 to engage the indicator arm 2150, the indicator mark 2156 moves away from the inner paddle 2122. Figure 123 The location of the indicator mark 2156, which can be seen using fluorescence inspection and / or other imaging techniques, can help the user determine that leaflets 42, 44 are properly positioned in fastener 2130.

[0312] In some embodiments, the device may include multiple indicators coupled to the fastener. Any fastener disclosed herein may include two or more indicators. For example, refer to Figures 124-126 The device 2200 includes a first indicator arm 2202 and a second indicator arm 2204. The first indicator arm 2202 and the second indicator arm 2204 may be substantially similar to Figures 121-123 The indicator arm 2150. However, any indicator configuration disclosed herein can be used, and / or the indicators disclosed herein can be divided into two halves or have a divided portion, with the two halves providing two indicator portions. Having multiple indicators adjacent to each other (e.g., leaflet engagement portions with a depth or distance similar to that of a fastener hinge and / or optional fastener barbs / friction enhancement features) allows the user to determine whether the leaflets are properly oriented in the fastener (e.g., not obviously angled), or whether the leaflets are positioned too far from one side or the other of the fastener. For example, refer to Figure 125 Leaflets 42 and 44 are positioned within fastener 2230 such that they engage the second indicator arm 2204 but not the first indicator arm 2202. This can be determined by positioning the indicator markers under fluoroscopic examination and / or other imaging techniques. This may be due to the device being tilted relative to the valve leaflets. (Reference) Figure 126 The device 2200 can be readjusted such that the leaflets engage both the first indicator arm 2202 and the second indicator arm 2204, indicating that the leaflets 42, 44 are securely fitted within the device 2200 with an acceptable orientation of the fastener on the leaflets. In some embodiments, the plurality of indicators may have leaflet engagement portions at different depths (or at different distances from the fastener hinge or optional fastener barbs / friction enhancement features), allowing you to distinguish whether the leaflets are partially or fully engaged at a certain depth.

[0313] refer to Figures 127-135 Leaflet depth can be determined by analyzing electrical signals from electrodes placed on the valve repair device. The electrodes can be placed at various locations on the valve repair device. For example, the electrodes can be placed on a visual indicator (such as any indicator disclosed herein), on a part of the device (such as on a fastener, on a paddle, on a spacer, etc.). When the electrodes (or other electrical measuring components) are placed on the visual indicator, leaflet depth can be determined by imaging and by analyzing the electrical signals.

[0314] The measured signals can take many different forms. For example, signals can include intracardiac electrocardiogram (IECG) signals and bioimpedance signals. These signals measure the electrical activity of the heart during systole. It has been surprisingly found that when measuring electrical signals during leaflet capture, the amplitude and shape of the signals differ depending on whether the electrode is in contact with the leaflet or other parts of the heart valve (e.g., chordae tendineae). The electrical signals can distinguish the type of tissue being contacted and the degree of contact with the electrode (i.e., whether the electrode is at the edge of the leaflet or near the base of the leaflet). Therefore, by placing the electrode on the device, the electrical signals can help the user determine whether the leaflet is captured or partially captured in the device, whether the device is not capturing tissue, and / or whether the device is in contact with the chordae tendineae or other parts of the heart valve instead of the leaflet.

[0315] exist Figure 127 In the illustrated embodiments, the example implantable valve repair device or valve treatment device includes a plurality of anchors 2308. The anchors can be configured in various ways. In some embodiments, each anchor 2308 includes an outer paddle 2320, an inner paddle 2322, a paddle extension member or paddle frame (not shown), and a fastener 2330 having a fixed arm 2332 and a movable arm 2334. The device can take many different forms. In some embodiments, device 2300 is the same as or similar to device 200 described herein. Although Figure 127 The example shown is an implantable device, but regarding Figure 127 The similar configurations and concepts described can be used for other devices that do not necessarily need to be implanted but can be removed after treatment, such as valve repair devices.

[0316] In some embodiments, to determine whether a leaflet has reached a specific depth of engagement, device 2300 may include an indicator arm 2350. The indicator arm may include electrodes that measure electrical signals to help a user determine whether a leaflet is captured or partially captured in one or more parts of the device. For example, indicator arm 2350 may include a first electrode 2356 and a second electrode 2358. Each of the first electrode 2356 and the second electrode 2358 provides a signal in and / or in contact with material within the heart at two different locations. For example, the electrodes may provide signals based on being located in blood in the atrium (and not in contact with tissue), based on being located in blood in the ventricle (and not in contact with tissue), based on contact with valvular leaflet tissue, and / or based on contact with chordae tendineae tissue. In some embodiments, three, four, five, or more electrodes are included. Any number of electrodes may be included for each fastener.

[0317] Electrical signals can take many different forms and can be processed in many different ways to determine the location of the device in the heart and / or the position of the leaflet relative to the heart. In some embodiments, IECG signals are measured on the first electrode 2356 and the second electrode 2358. The bipolar signal can be calculated by subtracting the signal from the first electrode 2356 from the signal from the second electrode 2358. The resulting bipolar signal and / or the original signal can provide an indication that the first electrode 2356 and / or the second electrode 2358 are in the atrium (and not in contact with tissue), positioned in the blood in the ventricle (and not in contact with tissue), in contact with the valve leaflet tissue, and / or in contact with the chordae tendineae tissue.

[0318] When measuring bioimpedance signals, different signal readings will be observed for a leaflet in contact with one electrode or with both electrodes. For example, if the leaflet is in contact with only the first electrode, a much larger signal reading can be produced. However, when the leaflet is in full contact with both the first electrode 2356 and the second electrode 2358, a much smaller signal reading can be produced, indicating that the device is correctly positioned.

[0319] refer to Figures 128-129 The fastener 2330 of device 2300 can be partially closed. Figure 128 ) or completely closed ( Figure 129 This allows the positions of leaflets 42 and 44 to be detected by the indicator arm 2350 so that they can be ultimately captured by the fastener 2330. Leaflet 42 is partially fixed within the fastener 2330 and contacts only the first electrode 2356. Leaflet 44 is partially fixed within the fastener 2330 but does not contact either the first electrode 2356 or the second electrode 2358. Figure 129 The illustration shows partial capture of leaflet 42 within fastener 2330. Electrical signals from the first electrode 2356 and the second electrode 2358 can indicate to the user that leaflets 42, 44 are in an inadequate position and that fastener 2330 needs to be repositioned. Device 2300 can be detached and reattached so that leaflets can be recaptured within fastener 2330.

[0320] refer to Figures 130-131 Leaflets 42 and 44 are repositioned within fastener 2330 so that they come into contact with both the first electrode 2356 and the second electrode 2358. Electrical signals from the first electrode 2356 and the second electrode 2358 can indicate to the user that leaflets 42 and 44 are in an acceptable position and that fastener 2330 does not need to be repositioned.

[0321] Now for reference Figures 132-133The fastener 2430 of device 2400 includes electrodes on a movable arm 2434. Specifically, a first electrode 2456 and a second electrode 2458 may be coupled at different locations along the movable arm 2434. Alternatively or additionally, electrodes 2456, 2458 may be positioned on the fixed arm 2432 of the fastener 2430 and / or the inner paddle portion of the device. When the fastener is closed, the leaflet engages the electrodes, and electrical signals from the electrodes can indicate to the user whether the leaflet is in the correct position or whether the fastener needs to be repositioned. In some embodiments, IECG signals are measured on the first electrode 2456 and the second electrode 2458. The bipolar signal can be calculated as the signal from the second electrode 2458 minus the signal from the first electrode 2456. The resulting bipolar signal and / or raw signal can provide indications that the first electrode 2456 and / or the second electrode 2458 are located in the atrium (and not in contact with tissue), in the blood in the ventricle (and not in contact with tissue), in contact with the valve leaflet tissue, and / or in contact with the chordae tendineae tissue.

[0322] The device may also include multiple indicator arms, each having an electrode for indicating whether the leaflet is in a sufficient position. (See now for reference.) Figures 134-135 The device 2500 has a pair of fasteners 2530, each including a first indicator arm 2550 and a second indicator arm 2252. The first indicator arm 2550 includes a first electrode 2556, while the second indicator arm 2252 includes a second electrode 2558. In this configuration, when the fasteners are closed, the leaflet engages the first electrode 2556 of the first indicator arm 2550 and the second electrode 2558 of the second indicator arm 2252, and electrical signals from the electrodes can indicate to the user whether the leaflet is in the correct position or whether the fasteners need to be repositioned.

[0323] Figure 136 The diagram illustrates the IECG signal readings. The P wave represents a small deflection wave indicating atrial depolarization, the Q wave corresponds to interventricular septal depolarization, the R wave reflects the depolarization of the ventricular mass, and the S wave represents the final depolarization of the ventricle at the base of the heart.

[0324] exist Figure 137A-137C The diagram illustrates a leaflet (e.g., fixed at a sufficient depth within the device) Figures 130-131 The IECG reading of the electrode on the leaflet 42 shown in 133. Figure 137A The waveform signal of electrode 2358 (or 2458) is shown separately. Figure 137B The waveform signal of the first electrode 2356 (or 2456) is shown separately. Figure 137C The diagram illustrates a bipolar waveform signal. Figure 137A subtract the waveform signal Figure 137B (waveform signal).

[0325] Figure 137D The diagram illustrates a bipolar waveform signal of a leaflet that is only in contact with the first electrode 2356 (or 2456). For example, this could be generated by... Figures 128-129 The example shown provides a signal. The signal from the first electrode will be significantly lower than... Figure 137B The signal shown is due to less leaflet insertion into the fastener. This reduced insertion causes a thinner portion of the leaflet to be in contact with the electrode, resulting in a lower amplitude signal. The lack of contact between electrode 2358 (2458) and the leaflet results in a very low amplitude signal, such as Figure 137F The signal shown. Figure 137D The bipolar signal and / or individual signals from both electrodes shown can be used to determine that the leaflet is inserted into the first electrode 2356 (or 2456), but not far into the second electrode 2358 (2458). For example, Figure 137E The waveform shown can correspond to the expected waveform when the leaflet is inserted into the first electrode 2356 (or 2456) but not far into the second electrode 2358 (2458). Alternatively, the set of bipolar signals and individual signals from the electrodes can correspond to the expected waveform set when the leaflet is inserted into the first electrode 2356 (2456) but not far into the second electrode 2358 (2458).

[0326] Figure 137E The diagram illustrates the bipolar waveform signal when part of the chordae tendineae is in contact with the first electrode 2356 (or 2456). The signal from the first electrode when the chordae tendineae are in contact will differ from the signal when the chordae tendineae are in contact with the lobular tissue. For example, Figure 137E The signal shown can have a ratio Figure 137C The signal shown (i.e., when the electrode contacts the lobular tissue) has a higher amplitude and / or a longer wavelength (i.e., when the electrode contacts the chordae tendineae). Figure 137E The bipolar signal and / or individual signals from both electrodes shown can be used to determine if one or both electrodes are in contact with the chordae tendineae. For example, Figure 137E The waveform shown can correspond to the expected waveform when the chordae tendineae is inserted into the first electrode 2356 (or 2456) and the second electrode 2358 (2458) is not in contact with the tissue. Alternatively, the set of bipolar and individual signals from the electrodes can correspond to the expected waveform set when the chordae tendineae is in contact with the first electrode 2356 (or 2456) but not with the second electrode 2358 (2458).

[0327] Figure 137F The diagram illustrates the bipolar waveform signal when no heart tissue is in contact with the electrodes. The signal is substantially flat and / or zero because both sensors are only in contact with blood in the heart. The signal can have different characteristics when the second electrode 2358 (2458) is deeper in the device (e.g., further in the fastener) than the first electrode 2356 (or 2456) and therefore more shielded. Figure 137FThe shape shown. The signal from the electrode when it is not in contact with tissue (e.g., only with blood in the heart) will be different from the signal from the electrode when it is in contact with lobular tissue. For example, Figure 137F The signal shown may have a low amplitude and / or be flat or substantially flat. Figure 137F The bipolar signals and / or individual signals from the two electrodes shown can be used to determine whether one or both electrodes are present in the blood of the heart. The signals from the electrodes will differ when they are positioned in the atria compared to when they are positioned in the ventricles. For example, the signals from each electrode may have a higher magnitude in the ventricles than in the atria.

[0328] Signals from the electrodes can be used to determine various states of the device. For example, the electrodes can be used to determine and / or confirm whether the device is positioned in the atrium, in the ventricle, whether the device is in contact with the leaflets, whether the leaflets are at sufficient depth in the fastener, and whether the chordae tendineae are positioned in the device, such as in the fastener.

[0329] In some implementations, a portion of the indicator may be formed by a fastener. For example, the indicator may be formed by cutting a portion of the movable arm and shaping and / or twisting the cut portion. The indicator may be positioned in a plane such that it can contact the natural leaflet and determine whether the fastener has properly engaged the natural leaflet.

[0330] refer to Figure 138 The illustration depicts a flat material 2630 that can be bent to form a fastener and an indicator arm for a valve repair device. The flat fastener material 2630 includes a fixed arm 2632, a flexible or hinged portion 2638, a movable arm 2634 having a clamping portion 2636 (such as the optionally illustrated barbed end), and an indicator arm 2650. The movable arm 2634 may have at least one opening 2661 (e.g., orifice, channel, slot, etc.) through which the indicator arm 2650 is configured to pass. The entire flat fastener material 2630 may be formed from a single flat material piece.

[0331] The indicator arm 2650 is formed from a portion of a movable arm 2634 of flat fastener material 2630. The indicator arm 2650 can be cut into a portion of the movable arm 2634 by various methods, including laser cutting. The indicator arm 2650 includes a movable end 2652 and a fixed end 2654. The fixed end 2654 of the indicator arm 2650 can be coupled to the movable arm 2634 in various ways and at various locations along the movable arm 2634. In the illustrated example, the movable arm and the indicator arm are cut into flat fastener material such that the indicator arm remains attached to the movable arm at the junction 2660. The indicator arm 2650 can be coupled to the movable arm 2634 at any point between the hinge portion 2638 and the clamping portion 2636.

[0332] The indicator arm 2650 may include an optional indicator mark 2656. In some embodiments, the indicator mark 2656 comprises a radiopaque material, which may be printed as a separate material or attached to the indicator mark 2656. For example, the radiopaque material may be a coil made of platinum or another radiopaque material. The indicator mark is not necessarily a separate component. For example, in some embodiments, the indicator mark 2656 is integral with the indicator arm; for example, the indicator mark 2656 may be a portion of the indicator arm that includes radiopaque material and / or is thicker or has a larger surface area (which can help improve visibility).

[0333] Indicator marker 2656 is visible using fluorescence examination and / or other imaging techniques and can help the user determine whether the leaflet is properly positioned in fastener 2630. Indicator arm 2650 can be used with suitable valve repair devices such as any valve repair device disclosed herein (see also, for example, the valve repair device disclosed by published PCT application WO2020 / 168081, which is incorporated herein by reference in its entirety).

[0334] The indicator arm 2650 engages with the movable arm 2634 at a junction 2660 on the movable arm 2634. The junction 2660 can be located at various positions along the movable arm 2634. For example, the junction 2660 can be positioned near the hinge portion 2638 on the base 2662 of the movable arm 2634. The junction 2660 can also be located along the inner edge of the movable arm (see...). Figure 139 and 141A -B) or outer edge (see Figure 140A-C One side of the movable arm is positioned at any point between the hinge portion 2638 and the clamping portion 2636. In another embodiment, the connecting portion 2660 may be located at the end of the clamping portion 2636 of the movable arm and extend toward the base 2662.

[0335] The indicator arm 2650 can have various lengths. In some embodiments, the indicator arm 2650 is cut along the length of the movable arm 2634 from the hinge portion 2638 to the clamping portion 2636. In other embodiments, the indicator arm 2650 extends only along a portion of the movable arm 2634 between the hinge portion 2638 and the clamping portion 2636. In some embodiments, the length of the indicator arm is between 2.0 mm and 15.0 mm, including any subrange, including between 5.0 mm and 10.0 mm and between 6.0 mm and 8.0 mm.

[0336] The indicator arm 2650 can have a range of thicknesses. In some embodiments, the thickness of the indicator arm is between 0.100 mm and 0.500 mm, including between 0.250 mm and 0.400 mm and between 0.320 mm and 0.380 mm. In some embodiments, the thickness of the indicator arm is 0.380 mm. The indicator arm can have a thickness within any sub-range of these ranges.

[0337] The indicator arm 2650 can have a range of widths. In some embodiments, the width of the indicator arm is between 0.025 mm and 0.250 mm, including between 0.040 mm and 0.120 mm and between 0.075 mm and 0.100 mm. In some embodiments, the thickness of the indicator arm is 0.050 mm. The indicator arm can have a width within any sub-range of these ranges. In an example embodiment, by cutting both the movable arm and the indicator arm from a single, uniform thickness of material, the relative flexibility of the indicator arm and the movable arm can be controlled by selecting the relative widths of the material portions forming the movable arm and the material portions forming the indicator arm.

[0338] In some embodiments, the indicator arm may be bent to include one or more torsional portions between the moving end and the fixed end of the indicator arm. (Reference) Figure 138 The indicator arm 2650 may include a torsion portion 2658 between a movable end 2652 and a fixed end 2654. The torsion portion may include one or more torsional portions relative to a non-torsion portion of the indicator arm, wherein each torsion portion is in the range of 0 to 180 degrees. In some embodiments, the torsion portion may torsion between 5 and 170 degrees, between 15 and 145 degrees, between 30 and 120 degrees, or between 60 and 90 degrees. In some embodiments, the torsion portion torsional 90 degrees relative to the non-torsion portion. The torsion relative to the non-torsion portion may be clockwise or counterclockwise. The torsion of the torsion portion may position the movable end of the indicator arm between the movable arm 2634 and the fixed arm 2632 of the fastener 2630 (e.g., at the second side G, such as...). Figure 139 , 140B (As shown in 140C and 141C). Twisting positions the moving end 2652 such that the indicator arm 2650 can contact the natural leaflet when inserted into the fastener 2630.

[0339] In some embodiments, the torsional portion of the indicator arm is configured to make the indicator arm easier (or less easy) to flex. For example, when the indicator arm is narrower than its thickness, an indicator arm bent at 90 degrees will flex more easily when engaged by lobular tissue than an unbent indicator arm. Thus, the flexibility or responsiveness of the indicator arm can be controlled by utilizing its width and by torturing the indicator arm.

[0340] Figure 139 An example embodiment of a fastener 2730 with an indicator arm 2750 is illustrated. The fastener 2730 may be made from a single flat material piece. The indicator arm 2750 of the fastener 2730 may include a first arm portion 2770 and a second arm portion 2780. Both the first arm portion 2770 and the second arm portion 2780 may be similar in all aspects (including length, width, and thickness). Figure 138 The indicator arm 2650. In some embodiments, the movable arm 2734 includes a central beam 2790 and two outer beams 2735 arranged between a hinge portion 2738 and a clamping portion 2736 (such as the barbed end shown in the illustration). The central beam 2790 and the two outer beams define the dimensions of openings 2762, 2764.

[0341] The first arm portion 2770 and the second arm portion 2780 are each cut from the material between the central beam 2790 and the two outer beams 2735 of the movable arm 2734. The material between the central beam 2790 and the two outer beams 2735 can be straightened, stretched, bent, or otherwise processed or treated to form the indicator arm 2735. For example, the material between the central beam 2790 and the two outer beams 2735 of the indicator arm portions 2770 and 2780 can be cut along a tortuous path to extend the length of the material forming the indicator arm portion, and the material can be straightened, bent, or otherwise treated to form... Figure 139 The indicator arm portions 2770 and 2780 are shown. The first arm portion 2770 includes a curved portion 2772 adjacent to the fixed end 2754 of the first arm portion 2770. The second arm portion 2780 also includes a curved portion 2782 adjacent to the fixed end 2755 of the second arm portion 2780.

[0342] The curved portions 2772 and 2782 extend the first arm portion 2770 and the second arm portion 2780 to the second side G of the fastener 2730, wherein the indicator arm 2650 can contact the natural leaflet when inserted into the fastener 2730. The first arm portion 2770 and the second arm portion 2780 can be connected at the connection point 2792 on the first side F of the fastener 2730. The first arm portion 2770 and the second arm portion 2780 can be connected by various means, including welding, press-fitting, etc. In some embodiments, the indicator arm 2750 includes an indicator mark 2756 that is similar in material to the indicator mark 2656. In some embodiments, the first arm portion 2770 is secured to the second arm portion 2780 by means of the indicator mark 2756, the indicator mark 2756 being press-fitted into both the first arm portion 2770 and the second arm portion 2780. The axis of the indicator mark 2756 can be pressed into the space formed by the connection at the end of the indicator arm—either a stacked configuration or a mirror configuration—within the first arm portion 2770 and the second arm portion 2780. The stacked configuration positions the axis of the indicator mark 2756 perpendicular to the plane of the indicator arm 2750, while the mirror configuration places the axis of the indicator mark 2756 within the plane of the indicator arm 2750. Depending on the size of the indicator mark 2756 used, different orientations will be more visible at the available fluorescence inspection angle.

[0343] Figure 140A-140C An example embodiment of a fastener with an integral indicator arm 2850 is illustrated, wherein the indicator arm is formed from the material of the outer side of the outer beam 2835. In these examples, the first arm portion 2870 and the second arm portion 2880 of the indicator arm 2850 are formed of a flat material arranged laterally relative to the flat material of the outer beam 2835 forming the movable arm 2834. Both the first arm portion 2870 and the second arm portion 2880 may be similar in various aspects (including length, width, and thickness). Figure 138 The indicator arm 2650, except for the arm portions 2870 and 2880, is made of the material on the outside of the fastener.

[0344] refer to Figure 140A-140C The first arm portion 2870 may engage with the movable fastener arm 2834 at a first engagement 2860 on the movable arm 2834. The second arm portion 2880 may engage with the movable arm 2834 at a second engagement 2861 on the movable arm 2834. The engagements 2860 and 2861 may be located at various positions along the movable arm 2834. For example, the engagements 2860 and 2861 may be positioned on the movable arm 2834 near the connecting portion 2838. The engagements 2860 and 2861 may also be positioned along the outer beam 2835 of the movable arm 2834 at any point between the hinge portion 2838 and the clamping portion 2836 (such as the barbed end optionally illustrated). Figure 140A The illustration shows the first arm portion 2870 and the second arm portion 2880 of the indicator arm 2850 after they are formed from the material adjacent to the outer beam 2835 of the movable arm 2834, but before they are shaped to form the indicator arm 2850.

[0345] refer to Figure 140B and 140C The first arm portion 2870 and the second arm portion 2880 can be configured in various different ways. (See reference) Figure 140B The first arm portion 2870 includes a torsional portion and / or a bent portion 2872 adjacent to the fixed end 2854 of the first arm position 2870. The second arm portion 2880 also includes a torsional portion and / or a bent portion 2882 adjacent to the fixed end 2855 of the second arm portion 2880. Figure 140B In one embodiment, the torsional and / or bent portions 2872, 2882 are configured such that the first indicator arm portion 2870 and the second indicator arm portion 2880 extend across the outer beam 2835 on the side F. The first indicator arm portion 2870 and the second indicator arm portion 2880 then extend through the spaces 2862, 2864 between the outer beam 2835 and the center beam 2890 to reach the second side G of the fastener 2830, wherein the indicator arm 2850 can contact the natural leaflet when inserted into the fastener 2830. The first and second indicator arm portions may include additional torsional and / or bent portions to allow the first arm portion 2870 and the second arm portion 2880 to be connected at the connection point 2892 on the first side F of the fastener 2830. The first arm portion 2870 and the second arm portion 2880 can be connected by various means, including welding. In some embodiments, the indicator arm 2850 may include an indicator mark 2856 that is similar in material to the indicator marks 2656, 2756.

[0346] refer to Figure 140C The first arm portion 2870 includes a torsional portion and / or a bent portion 2872 adjacent to the fixed end 2854 of the first arm position 2870. The second arm portion 2880 also includes a torsional portion and / or a bent portion 2882 adjacent to the fixed end 2855 of the second arm portion 2880. Figure 140CIn some embodiments, the torsional and / or bent portions 2872, 2882 are configured such that the first indicator arm portion 2870 and the second indicator arm portion 2880 extend inwardly across the outer beam 2835. The first indicator arm portion 2870 and the second indicator arm portion 2880 are bent in a configuration such that the indicator arm 2850 can contact the natural leaflet when inserted into the fastener 2830. The first and second indicator arm portions may include additional torsional and / or bent portions 2880 to extend through the spaces 2862, 2864 between the outer beam 2835 and the central beam 2890 to the side surface F of the fastener 2830, and may be connected at connection point 2892. The first arm portion 2870 and the second arm portion 2880 may be connected by various means, including by welding, etc. In some embodiments, the indicator arm 2850 may include an indicator mark 2856 that is similar in material to the indicator marks 2656, 2756.

[0347] Fasteners with one or more integrated leaflet depth indicators can be made from a single flat material piece in various ways. (See reference) Figures 141A-141B In some embodiments, the clamping portion 2936 of the fastener 2930 may include a first clamping member 2910, a second clamping member 2912, and a third clamping member 2914. The clamping members may be the same as or similar to other clamping members, fasteners, fastener arms, etc., described elsewhere herein. The first clamping member 2910 and the second clamping member 2912 may each be connected to the third clamping member 2914 via a connecting member 2916. The connecting member 2916 may take many different forms. For example, the connecting member 2916 may include a stitch, a fastener, a pin, a snap-fit, a magnet, etc. In some embodiments, the connecting member may extend through an opening in one or more of the first clamping member 2910, the second clamping member 2912, and the third clamping member 2914.

[0348] by Figure 141A and 141B The configuration of the first clamping member 2910, the second clamping member 2912, the third clamping member 2914, the first indicator arm portion 2970, and / or the second indicator arm portion 2980 as shown facilitates easier manufacturing of fasteners 2930 with one or more integrated leaflet depth indicators. For example, in Figure 141A and 141B In the illustrated embodiment, the first indicator arm portion 2970 and the second indicator arm portion 2980 extend through the first clamping member 2910, the second clamping member 2912, and the third clamping member 2914. This allows the leaflet depth indicator to be longer than would be possible if one or more arms were formed solely from material within the window of a movable arm.

[0349] Figure 141A and 141B The fastener 2930 shown is similar, except... Figure 141A The indicator arm portions 2970 and 2980 do not include connecting members, while Figure 141B The indicator arm portion includes connecting member 2918. Figure 141A In this embodiment, the indicator arm portions 2970 and 2980 will not be attached to each other and can form two independently movable leaflet depth indicators. Including two side-by-side leaflet depth indicators can provide additional information about the position of the leaflet relative to the fastener. For example, in addition to the depth of the leaflet in the fastener, the two side-by-side leaflet depth indicators can provide an indication of the rotation and / or offset of the fastener relative to the leaflet. Two independent leaflet depth indicator arms can be used in any embodiment disclosed herein.

[0350] exist Figure 141B In some embodiments, the first indicator arm portion 2970 can be connected to the second indicator arm portion 2980 via a connecting member or feature 2918. The connecting member or feature 2918 can take various forms. For example, the connecting member or feature 2918 may include complementary stitches, fasteners, pins, snaps, magnets, etc. In some embodiments, the connecting member may extend through an opening in one or more of the first indicator arm portion 2970 and the second indicator arm portion 2980. In some embodiments, the first indicator arm portion 2970 can be connected to the second indicator arm portion 2980 by other means. For example, see reference... Figure 141C The first indicator arm portion 2970 can be connected to the second indicator arm portion, similar to... Figure 140C The first indicator arm portion and the second indicator arm portion.

[0351] refer to Figure 141A and 141B The clamping portion 2936 (such as the barbed end optionally shown in the illustration) is illustrated in a preliminary configuration, whereby the first clamping member 2910 and the second clamping member 2912 are not yet connected to the third clamping member 2914. Reference Figure 141C The clamping portion 2936 is illustrated in a forming or assembly configuration, whereby the first clamping member 2910 and the second clamping member 2912 are connected to the third clamping member 2914 via corresponding connecting members 2916.

[0352] refer to Figure 141CThe first arm portion 2970 includes a torsional portion and / or a bent portion 2972 ​​adjacent to the fixed end 2954 of the first arm position 2970. The second arm portion 2980 also includes a torsional portion and / or a bent portion 2982 adjacent to the fixed end 2955 of the second arm portion 2980. The first indicator arm portion 2970 and the second indicator arm portion 2980 extend on the second side G of the space 2962, 2964 between the outer beam 2835 and the central beam 2990, wherein the indicator arm 2950 can contact the natural leaflet when inserted into the fastener 2930. The first and second indicator arm portions may include additional torsional portions and / or bent portions to allow the first arm portion 2970 and the second arm portion 2980 to be connected at the connection point 2992 on the first side F of the fastener 2930. The first arm portion 2970 and the second arm portion 2980 may be connected by various means, including by welding, etc. In some embodiments, the indicator arm 2950 may include an indicator mark 2956.

[0353] refer to Figure 141D The first arm portion 2970 may have a bent portion 2972 ​​adjacent to the fixed end 2954 of the first arm position 2970. The second arm portion 2980 may also include a bent portion 2982 adjacent to the fixed end 2955 of the second arm portion 2980. When bent, the first indicator arm portion 2970 and the second indicator arm portion 2980 extend to the second side G of the space 2962, 2964 between the outer beam 2934 and the central beam 2990, wherein the indicator arm 2950 can contact the natural leaflet when inserted into the fastener 2930. The first indicator arm portion 2970 and the second indicator arm portion 2980 are integrally formed with the transition portion 2920. The first indicator arm portion 2970 and the second indicator arm portion 2980 may include additional torsional portions and / or bent portions to allow the transition portion 2920 to be positioned on the first side F of the fastener 2930. In some embodiments, the transition portion 2920 may include an indicator mark.

[0354] refer to Figures 142A-142B Fastener 3030 is illustrated in the closed position. In some embodiments, fastener 3030 is the same as or substantially similar to any of fasteners 2630, 2730, 2830, or 2930. (See reference) Figure 142AThe leaflets are located within fastener 3030, but not far enough within fastener 3030 to engage indicator arm 3050. Therefore, optional indicator mark 3056 (when included) does not move away from movable arm 3034 of fastener 3030, or optional indicator mark 3057 (when included). The position of indicator marks 3056 and / or indicator marks 3057, which can be seen using fluorescence examination and / or other imaging techniques, can help the user determine that leaflets 42, 44 are not properly positioned within fastener 3030. For example, when both indicator marks 3056, 3057 are included, an image showing only a single mark (i.e., the two marks 3056, 3057 are adjacent to or adjacent to each other, and only a single mass is visible on the image) (e.g., a fluorescence examination image) indicates that tissue such as valve leaflet tissue is not arranged to a sufficient depth within fastener 3030.

[0355] refer to Figure 142B The leaflets are positioned sufficiently far within the fastener 3030 to engage the indicator arm 3050. Movement of the indicator arm 3050 causes the indicator mark 3056 to move from the movable arm 3034 of the fastener 3030. The position of the indicator mark 3056, which can be seen using fluorescence examination and / or other imaging techniques, can help the user determine that the leaflets 42, 44 are properly positioned within the fastener 3030. For example, when two indicator marks 3056, 3057 are included, an image showing two separate marks (i.e., the two marks 3056, 3057 spaced apart) (e.g., a fluorescence examination image) indicates that tissues such as leaflet tissue are arranged to a sufficient depth within the fastener 3030.

[0356] exist Figure 138 , 139 In the embodiments shown in 140A-140C, 141A-141D, and 142A-142B, the leaflet depth indicators 2650, 2750, 2850, and 2950 extend from the movable arm of the fastener. However, in other embodiments, the leaflet depth indicator may extend from either the hinge portion or the fixed arm portion of the fastener. For example, in... Figure 143A and 143B In the illustrated embodiment, the fastener 3130 has a leaflet depth indicator 3150 extending from the fastener's fixing arm 3132. The leaflet depth indicator 3150 can be integrally formed with the fastener 3130. Figure 143A and 143B In the illustrated embodiment, the leaflet depth indicator 3150 originates from the fixed arm 3132. As shown... Figure 143A and 143B As shown, the leaf depth indicator 3150 includes a curved portion 3160 extending along the hinge portion 3138. The leaf depth indicator then extends along the movable arm 3134 of the fastener 3130.

[0357] refer to Figure 143AThe leaflets are located within fastener 3030, but not far enough within fastener 3130 to engage indicator arm 3150. Therefore, indicator mark 3156 does not move from the movable arm 3134 of fastener 3130. The position of indicator mark 3156, visible using fluorescence examination and / or other imaging techniques, can help the user determine that leaflets 42, 44 are not properly positioned within fastener 3030. For example, when two indicator marks 3156, 3157 are included, an image showing only a single mark (i.e., two marks 3156, 3157 adjacent to or adjacent to each other, and only a single mass is visible on the image) (e.g., a fluorescence examination image) indicates that tissue such as leaflet tissue is not arranged to a sufficient depth within fastener 3130.

[0358] refer to Figure 143B The leaflets are positioned sufficiently far within the fastener 3130 to engage the indicator arm 3150. Movement of the indicator arm 3150 causes the indicator mark 3156 to move from the movable arm 3134 of the fastener 3130. The position of the indicator mark 3156, which can be seen using fluorescence examination and / or other imaging techniques, can help the user determine that the leaflets 42, 44 are properly positioned within the fastener 3030. For example, when two indicator marks 3156, 3157 are included, an image showing two separate marks (i.e., the two marks 3156, 3157 spaced apart) (e.g., a fluorescence examination image) indicates that tissues such as leaflet tissue are arranged to a sufficient depth within the fastener 3130.

[0359] Figures 144-145 An embodiment of a device 3200 having a leaflet indicator 3250 is illustrated. The leaflet indicator 3250 can be used with a variety of different devices 3200. For example, the leaflet indicator 3250 can be used with any valve repair device disclosed herein or any other valve repair device. In the illustrated example, the device 3200 includes an inner paddle 3222 and an outer paddle 3220, and a fastener 3230 including a movable arm 3234 and a fixed arm 3232. The leaflet indicator 3250 can be coupled to various components on the device such as the inner paddle 3222, the fixed arm of the fastener 3232, and / or the movable arm 3234 of the fastener 3230. In the illustrated example, the leaflet indicator 3250 is arranged on the inner paddle 3222.

[0360] The indicator 3250 can take various forms. For example, the indicator 3250 may include one or more components capable of sensing the electrical characteristics of substances such as blood or tissue—which may be valve leaflets, chordae tendineae, papillary muscles, heart wall tissue, etc.—and / or contact with valve repair device components such as fastener arms, paddle portions, or occlusion elements. In the illustrated example, the indicator 3250 may include one or more conductive contacts, such as a first contact 3252 and a second contact 3254. Although in Figures 144-145The diagram illustrates two indicator contacts, but any number of indicator contacts can be used for indicators. The indicator contacts can be electrically coupled to one or more sensors. Sensors can be coupled to indicator contacts in various ways, including through conductive wiring. Sensors can include electrical sensors that can measure one or more of resistance, inductance, capacitance, voltage, current, and impedance.

[0361] refer to Figure 144 If the leaflet is not positioned within the fastener 3230, and the fastener 3230 is closed while the leaflet is not positioned between the movable arm 3234 and the fixed arm 3232, the movable arm 3234 can move and contact the indicator 3250, creating a bridge between the first indicator contact 3252 and the second indicator contact 3254. In this case, the sensor 3260 will not sense any resistance (e.g., the circuit is closed by the movable fastener arm). This information can be used to determine that the leaflet is not present in the fastener 3230.

[0362] refer to Figure 145 Leaflets 42 and 44 are positioned within fastener 3230. If fastener 3230 is closed with leaflets 42 and 44 positioned between movable arm 3234 and fixed arm 3232, then when movable arm 3234 bends to the closed position, movable arm 3234 may not contact indicator 3250. In this case, sensor 3260 can observe or otherwise indicate the existence of a measurable resistance between contacts 3252 and 3254, which can be used to determine the presence of leaflets within fastener 3230.

[0363] refer to Figures 146-147 The illustration depicts an embodiment of a system 3301 with a leaflet indicator 3350. In this embodiment, components of the valve repair system itself serve as the indicator 3350. Various configurations of valve repair system components can serve as leaflet depth indicators. The illustrated device 3300 includes an inner paddle 3322 and an outer paddle 3320, and a fastener 3330 including a movable arm 3334 and a fixed arm 3332. In the illustrated example, an insulator 3356 is positioned between the inner pedal 3322 and the fixed arm 3332. The device 3300 can include any of the devices disclosed herein, as well as any other valve repair devices. The leaflet indicator 3350 can include various components on the device that can be electrically coupled to a proximal control handle (not shown). In the illustrated example, a first electrical path is defined by a control line 3362 and the fastener 3330. A second electrical path is defined by an inner panel 3322, an engagement element 3372, and a coupling element 3376. Electrical paths can be formed in a variety of different ways. For example, components, parts of components, or auxiliary components extending along a component can be formed of conductive materials.

[0364] Indicator 3350 may be electrically coupled to one or more sensors 3360. The sensors may include electrical sensors capable of measuring one or more of resistance, inductance, capacitance, voltage, current, impedance, etc. Sensor 3360 may be coupled to indicator 3350 in various ways. Indicator 3350 may be electrically coupled to sensor 3360 via a first path defined by control line 3362 and fastener 3330 and a second path defined by inner panel 3322, mating element 3372, and coupling element 3376. In some embodiments, the device is made of conductive components. For example, the movable arm, mating element 3372, collar 3374, conduit coupling element 3376, and / or actuation line 3378 may be conductive.

[0365] refer to Figure 146 If the leaflet is not positioned within fastener 3330, and fastener 3330 is closed while the leaflet is not positioned between movable arm 3334 and fixed arm 3332, then movable arm 3334 can move and contact indicator 3350, thereby closing the circuit between the first path, sensor 3360, and the second path. In this case, sensor 3360 indicates no resistance (e.g., the circuit is closed by the movable fastener arm), which can be used to determine that the leaflet is not present in fastener 3330.

[0366] refer to Figure 147 Leaflets 42 and 44 are positioned within fastener 3330. If fastener 3330 closes with leaflets 42 and 44 positioned between movable arm 3334 and fixed arm 3332, movable arm 3334 does not contact inner paddle 3322. In this case, the circuit between sensor 3360, the first path, and the second path is interrupted (disconnected), and sensor 3360 can determine that leaflets are present within fastener 3330.

[0367] refer to Figures 148-155 In some embodiments, the visual indicator 3450 is coupled to the movable arm 3434 of the fastener 3430, and both the visual indicator 3450 and the fastener 3430 function as electrical indicators. The visual indicator 3450 and the fastener 3430 can take various different forms. For example, the indicator 3450 and the fastener 3430 can be any of the fasteners and indicators disclosed in this patent application. Figures 148-155 In the embodiment shown, the visual indicator 3450 can be based on Figures 94-98 The circuit can be formed by a sensor 3460, a fastener 3430, and a vision indicator 3450, via wiring that connects the fastener 3430 and the vision indicator 3450 to the sensor 3460.

[0368] refer to Figures 148-151In some embodiments, the insulating element 3480 insulates one or more portions of the indicator 3450 from the fastener 3430. The insulating element 3480 can take various different forms. Figures 148-151 In the example, the electrically insulated portions of the indicator 3450 and the fastener 3430 are schematically illustrated by the dashed area 3480. The schematically illustrated insulator 3480 can be implemented in various different ways. (See reference) Figures 152-155 The indicator 3450 and the fastener 3430 are electrically insulated from each other by one or more insulating components, such as a first insulator 3482 and a second insulator 3484. The first insulator 3482 insulates the indicator and the fastener at the connection between the fastener 3430 and the visual indicator 3450. When the visual indicator 3450 is in the leaflet engagement position, the second insulator 3484 insulates the crossbar of the fastener 3430 from the curved portion of the visual indicator.

[0369] refer to Figures 148-155 By insulating region 3480—such as through one or more insulating components—an electrical signal indicating the presence of a leaflet arranged within the fastener can be determined by sensor 3460. When the leaflet is not engaged with indicator 3450 within fastener 3430, visual indicator 3450 makes electrical contact with fastener 3430, and the circuit is closed (see [link to fastener description]). Figure 148 , 149 (152 and 153). When the leaflet engages the indicator 3450 within the fastener 3430, the visual indicator 3450 is not in electrical contact with the fastener 3430, and the circuit is broken (see 152 and 153). Figure 150 , 151 154 and 155).

[0370] refer to Figures 148-149 In positions 152-153, indicator 3450 is in the non-engaged position, which can be when the leaflet is not positioned within fastener 3430. In the non-engaged position, the absence of the leaflet can be visually indicated by the position of indicator mark 3456, which does not move from the movable arm 3434 of fastener 3430, and by a closed circuit comprising sensor 3460, fastener 3430, indicator 3450, and wiring connecting fastener 3430 and indicator 3450 to sensor 3460. However, in other embodiments, one or more insulators may be configured such that the circuit is broken when the visual indicator is in the non-engaged position. For example, insulators may be positioned at mark 3456 and at the crossbar of the fastener to insulate the visual indicator from the fastener in the non-engaged position.

[0371] refer to Figures 150-151At positions 154-155, indicator 3450 is in the engaged position, which could be when the leaflet is positioned within fastener 3430. In the engaged position, the presence of the leaflet is visually indicated by the position of indicator mark 3456, which has been moved a measurably distance from the movable arm 3434 of fastener 3430, and by a disconnected circuit including sensor 3460, fastener 3430, indicator 3450, and wiring connecting fastener 3430 and indicator 3450 to sensor 3460. However, in other embodiments, one or more insulators may be configured such that the circuit is closed when the visual indicator is in the engaged position. For example, the insulator may be configured such that the crossbar of the fastener is not insulated from the curved portion of the visual indicator, such that the curved portion of the indicator directly engages the crossbar of the fastener in the engaged position.

[0372] refer to Figures 156-158 The illustration shows an embodiment of a fastener 3530 having an electrical indicator 3550. The electrical indicator 3550 can take various forms. For example, the indicator 3550 may include one or more plates. (See reference...) Figure 156 Example indicator 3550 includes a first indicator plate 3552 and a second indicator plate 3554. According to some embodiments, the first indicator plate 3552 is coupled to the fixed arm 3532 of the fastener 3530, while the second indicator plate 3554 is coupled to the movable arm 3534 of the fastener 3530. (See reference...) Figure 158 The indicator panel can be made of one or more separate plates. The indicator panel can be made of a conductive material.

[0373] Figures 156A-156D Other indicator panel configurations are illustrated. Figure 156 , 156A The embodiments shown in -156D and 158 are several examples of various configurations that can be used. Figure 156A In the illustrated embodiment, the first plate 3552 and the second plate 3554 are positioned near the hinged portion of the fastener 3530. In other embodiments, the plates are positioned only on the movable arm 3534 of the fastener or only on the fixed arm of the fastener. Plates 3552 and 3554 may be positioned at or near the minimum acceptable leaflet insertion depth.

[0374] exist Figure 156B In the illustrated embodiment, the first plate 3552 and the second plate 3554 are positioned on the fixing arm 3532 of the fastener 3530. In other embodiments, the first plate 3552 and the second plate 3554 are positioned on the movable arm 3534 of the fastener. In other embodiments, a pair of plates are arranged on the fixing arm 3532 of the fastener, and a pair of plates are arranged on the movable arm of the fastener. Figure 156BIn the embodiment shown, indicator 3554 may correspond to the minimum leaflet insertion depth, while indicator 3552 may correspond to the maximum leaflet insertion depth.

[0375] exist Figure 156C In the illustrated embodiment, the first plate 3552 and the second plate 3554 are positioned on the fixing arm 3532 of the fastener 3530. In other embodiments, the first plate 3552 and the second plate 3554 are positioned on the movable arm 3534 of the fastener. Figure 156C In the embodiment shown, the first plate 3552 and the second plate 3554 extend along the length of the fastener arm. The first plate 3552 and the second plate 3554 are separated by a gap. Figure 156C The illustrated implementation allows the indicator 3550 to detect the presence or depth changes of tissue, such as lobular tissue, across the width of the fastener. For example, Figure 156C The configuration shown can sense if the leaflet is bent or misaligned by the fastener or otherwise improperly gripped. Figure 156D The implementation methods shown are the same as Figure 156C The implementation shown is the same, except that a pair of plates are arranged on the fixed fastener arm 3532 and a pair of plates are arranged on the movable fastener arm 3534.

[0376] refer to Figure 157 and 158 In some embodiments, an AC voltage is applied across one or more electrical indicators, and one or more impedance measurements are performed and / or derived. The applied AC voltage can be varied. Different materials can have different impedance characteristics for different applied AC voltages. Therefore, applying a varying AC voltage can allow for enhanced differentiation between different biological materials arranged in the fastener. Any electrical indicator disclosed herein can be used in conjunction with the applied one or more AC voltages and the performed one or more impedance measurements.

[0377] In some embodiments, an AC voltage is applied and one or more impedance characteristics are measured while the fastener is closed. In other embodiments, an AC voltage is applied and one or more impedance characteristics are measured while the fastener is open, partially open, or not fully closed. Performing impedance measurements while the fastener is open, partially open, or not fully closed can have the benefit of confirming that the lobular tissue is properly positioned within the fastener and / or confirming that other unwanted tissues, such as chordae tendineae, are not positioned within the fastener before the fastener is closed. The fastener can take various forms. For example, the fastener can be any of the fasteners disclosed in this patent application. The fastener may include optional barbs or other friction-enhancing or securing elements. Performing impedance measurements while the fastener is open, partially open, or not fully closed can prevent or inhibit optional barbs from piercing or penetrating the lobule until the lobule is confirmed to be properly positioned within the fastener. Performing impedance measurements while the fastener is open, partially open, or not fully closed can prevent or inhibit chordae tendineae from being closed within the fastener.

[0378] refer to Figures 157-162 The indicator 3550 can be included in the circuit along with an AC power supply, an electrical sensor 3560, and wiring. The sensor 3560 and the AC power supply can be a single device or separate devices. The wiring connects the first indicator plate 3552 and the second indicator plate 3554 to the AC power supply and the electrical sensor 3560, specifically for measuring resistance, inductance, capacitance, voltage, current, and / or impedance, components of impedance, etc. The sensor 3560 can measure electrical characteristics in various locations and conditions, including when the indicator 3550 is present in blood 3590 (…). Figure 159 ), small leaf 42, 44 ( Figure 160 ) and chordae tendineae 3592 or other parts of the heart valves, not the leaflets ( Figure 161 When the indicator 3550 is in contact with an anatomy structure, the resistance, inductance, capacitance, voltage, impedance, and / or current readings obtained by the sensor may vary based on one or more anatomy structures that the indicator 3550 is in contact with. Therefore, the electrical characteristics measured by the electrical sensor 3560 can be used to determine the position of the fastener and / or the anatomy structure that the fastener is in contact with based on the resistance, inductance, capacitance, voltage, impedance, and / or current readings obtained by the sensor.

[0379] refer to Figure 162 Impedance can be measured using a sensor 3560. Sensors can take various forms, including impedance meters. Impedance is a quantity that represents the resistance to the flow of AC current. The magnitude of the impedance Z is equal to the maximum value of the potential difference or voltage V (volts) across the circuit divided by the maximum value of the current I (amperes) flowing through the circuit. Therefore, the impedance can be calculated by controlling the AC voltage and measuring the current in any given scenario.

[0380] refer to Figure 163 The impedance of an ideal resistor is a purely real number and is called its resistance impedance Z.R And it can be measured by dividing the voltage (V) by the current (I). Ideal inductors and capacitors have purely imaginary reactance impedance. The impedance of an inductor increases with frequency and is calculated as jwL, or the imaginary product of frequency and inductance. The impedance of a capacitor decreases with frequency and can be calculated as 1 / (jwC), or the imaginary reciprocal of the product of frequency and capacitance.

[0381] refer to Figure 164 The diagram illustrates a method 3600 for identifying the condition of a fastener. Method 3600 includes the step of measuring a first impedance value 3610. Impedance can be measured in various ways. The resistive component R, the inductive component L, and / or the capacitive component C of the impedance can be measured or derived from the measurement. Impedance can be determined by... Figure 144-161 The circuit uses sensors to measure, and can be based on Figures 162-163 The measurement described in the text is used for measurement. For example, it can be measured. Figures 156-161 The impedance between the plates of the indicator 3550 shown. In other embodiments, the impedance between the components of any indicator disclosed herein can be measured.

[0382] Method 3600 further includes the step of comparing the impedance Z value with a set of previously collected measurements 3620. The previously collected impedance values ​​may correspond to known states. For example, each of the previously collected impedance values ​​may correspond to the type of tissue in the fastener, such as lobular tissue or chordae tendineae, the amount of tissue in the fastener, fluids such as blood in and / or around the tissue in the fastener, etc. The previously measured impedance values ​​and associated states can be collected, analyzed, and / or processed to predict or estimate the states associated with future measurements. For example, previously measured impedance values ​​and corresponding states can be used to form lookup tables, prediction algorithms, and / or machine learning strategies. These lookup tables, prediction algorithms, and / or machine learning strategies can then be used to identify, estimate, and / or predict states corresponding to future impedance values, such as the impedance value measured in step 3610.

[0383] Method 3600 also includes the step of identifying or estimating the state and / or position of the fastener 3630. The fastener state can be determined by comparing a measured impedance value with a state associated with a corresponding value of a previously measured impedance value. The fastener state may include determining where the fastener is located, what the fastener is attached to, etc. Method 3600 may determine, for example, whether the fastener is coupled to a leaflet, and if so, determine the amount by which the leaflet is inserted into the fastener.

[0384] When the leaflet is captured by the valve repair device, it can be pressed between the indicator and the fastener. In some cases, small or thin leaflets may be at least partially clustered between portions of the indicator, or between the indicator and the fastener, thus reducing the distance the indicator is pushed. (Reference) Figures 165-169 In some embodiments, device 3700 may include a rod coupled to at least one of the retaining arm 3732 of fastener 3730 and inner paddle 3722. The rod may reinforce the inner paddle 3722 and may prevent or inhibit leaflet clustering around or between portions of indicator 3750. Therefore, when the leaflets are captured within the fastener of the device, the contact between the leaflets and the rod ensures that the contact between the leaflets and the indicator is sufficient for user identification. The rod may be included in any device disclosed herein as well as any other valve repair device.

[0385] refer to Figure 165 The lever 3760 may include a leaflet engagement portion 3762 and a device engagement portion 3764. The lever 3760 may be arranged in the gap between the leaflet engagement portions 3758 of the indicator 3750 (see [link]). Figure 166 The leaflet engagement portion 3762 can have various shapes and sizes. For example, the leaflet engagement portion 3762 of the rod 3760 can contact the fixing arm 3732 of the fastener 3730 and / or be flush with the surface of the fixing arm of the fastener 3730 from the first end 3766 to the second end 3768 of the leaflet engagement portion 3762. The rod 3760 can be arranged through or around the fixing arm 3732 and the inner paddle 3722 of the fastener 3730, such that the device engagement portion 3764 is hooked onto or otherwise secured to the inner paddle 3722 at a position between the inner paddle 3722 and the outer paddle 3720. When the leaflets 42, 44 are engaged in the fastener 3730 by the indicator arm 3750, the rod 3760 can assist in further stabilizing the leaflets 42, 44. Specifically, leaflets 42 and 44 press against the two legs of indicator arm 2050 and rod 3760, resulting in further stabilization of leaflets 42 and 44. Rod 3760 causes the waveform path of leaflets 42 and 44.

[0386] The rod can have a variety of different profiles. For example, these profiles can be selected to optimize or enhance the visualization of the indicator 3750 and / or optimize or enhance the engagement or gripping of the fastener 3730 on the leaflet. Figure 166 In the illustrated embodiment, rod 3770 may include one or more ridges 3774 on or adjacent to leaflet engagement portion 3772. Rod 3767 extends substantially into the gap between leaflet engagement portions 3758 of indicator 3750. Thus, rod 3770 increases the movement of indicator 3750 when leaflets are arranged in fasteners and / or when leaflets are more securely gripped by fasteners that will be closed.

[0387] refer to Figure 167The rod 3780 can be positioned such that surface 3788 does not contact the retaining arm 3732 of fastener 3730 and / or surface 3788 is spaced apart from the retaining arm 3732 of fastener 3730. The device engagement portion 3784 may include a fastening region 3786, which may be positioned around the inner paddle 3722 to secure the rod 3780 to the device 3700.

[0388] refer to Figures 168-169 The leaflet engagement portion 3792 of the lever 3790 may include one or more tops 3796. One or more tops 3796 of the lever 3790 may be configured to cause a substantial movement of the indicator 3750 and provide a visual indication once the leaflet reaches the minimum insertion depth. The tops may be configured to cause a substantial movement of the indicator 3750 once the leaflet reaches the minimum insertion depth in various different ways. In the illustrated example, the top 3796 is adjacent to and / or very close to the movable arm 3734. Furthermore, when viewed from the side, as... Figure 168 As shown, the outline of the top 3796 overlaps with the leaflet engagement portion of the indicator 3750. Therefore, once the leaflet reaches the overlap between the top 3796 and the leaflet engagement portion of the indicator 3750, the indicator 3750 will move significantly. In some embodiments, the overlap is chosen to coincide with the minimum leaflet insertion depth.

[0389] In some embodiments, the top 3796 can be configured to provide a stronger engagement between the fastener 3730 and the proximal (open) leaflet portion of the fastener 3730 than the distal (closed) leaflet portion. The top 3796 can be configured in a variety of different ways to provide a stronger engagement between the fastener 3730 and the proximal leaflet portion of the fastener 3730 than the distal leaflet portion. Figure 168 and 169 In the illustrated embodiment, a top 3796 is included near the proximal end of the fastener, but not at the distal end. Therefore, the portion of the leaflet closer to the proximal end of the fastener is more securely engaged than the portion closer to the distal end. In other embodiments, the top 3796 may be included at multiple locations, such as both near the proximal end and at the distal end of the fastener.

[0390] Any of the various systems, devices, equipment, etc. disclosed herein may be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure their safety for patient use, and the methods described herein may include (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) sterilizing the associated systems, devices, equipment, etc.

[0391] While the various inventive aspects, concepts, and features of the disclosure may be described and illustrated herein in conjunction with the examples herein, these aspects, concepts, and features may be used individually or in various combinations or sub-combinations of many alternative embodiments. All such combinations and sub-combinations are intended to be within the scope of this application unless expressly excluded herein. Furthermore, while alternative embodiments of the various aspects, concepts, and features of the disclosure (such as alternative materials, structures, configurations, methods, apparatus, and components; alternatives in form, adaptation, and function, etc.) may be described herein, such description is not intended to be a full or exhaustive enumeration of available embodiments (whether currently known or developed hereafter). Even if such embodiments are not expressly disclosed herein, those skilled in the art can readily adapt one or more of these inventive aspects, concepts, and features to other embodiments and use them within the scope of this application.

[0392] Furthermore, even if some features, ideas, or aspects of the disclosed content may be described herein as preferred arrangements or methods, such description is not intended to imply that such features are needed or necessary unless expressly stated otherwise. Additionally, exemplary or representative values ​​and ranges may be included to aid in understanding this application; however, such values ​​and ranges should not be interpreted in a limiting sense and are intended to be critical values ​​or ranges only if so expressly stated otherwise.

[0393] Furthermore, while aspects, features, and concepts may be explicitly identified herein as inventive parts or forming parts of the disclosure, such identification is not intended to be exclusive, but rather may exist in inventive aspects, concepts, and features that are fully described herein but not so explicitly identified or as part of a specific disclosure, which is instead set forth in the appended claims. The description of exemplary methods or processes should not be limited to including all steps necessary in all cases, nor should the order in which the steps are presented be construed as necessary or essential unless expressly stated otherwise. Furthermore, the techniques, methods, operations, steps, etc., described or illustrated herein may be performed on living animals or on simulations, such as on carcasses, carcass hearts, simulators (e.g., in which body parts, tissues, etc., are simulated), etc. The terms used in the claims have their perfectly ordinary meaning and are not in any way limited by the description of the embodiments in the specification.

Claims

1. A valve repair device for repairing a patient's natural valve, the valve repair device comprising: Clamping components; paddle; The clamping member is movable to form a capture area for capturing the leaflets of the natural valve; An indicator coupled to the valve repair device, wherein the indicator is movable to indicate whether the leaflet of the natural valve is inserted into the capture region at least to a minimum insertion depth; The indicator is configured to pass through one or more of the paddle and the clamping member; The indicator is configured as an indicator arm including a fixed end and a movable end; The fixed end of the indicator arm is coupled to the movable arm of the clamping member; The fixed end and the movable end are arranged on the first side of the movable arm of the clamping member; The indicator arm includes a leaflet engaging member between the fixed end and the movable end; The leaflet engaging member is arranged on the second side of the movable arm of the clamping member; and The capture area is located on the second side of the movable arm.

2. The valve repair device of claim 1, wherein the indicator is compressible and configured to engage the leaflet of the natural valve.

3. The valve repair device of claim 1, wherein the indicator includes one or more protrusions extending from the indicator.

4. The valve repair device of claim 1, wherein the clamping member and the indicator each include a marker, the marker comprising a radiopaque material.

5. The valve repair device of claim 1, wherein the capture region is formed between a portion of the paddle and the arm of the clamping member.

6. The valve repair device according to claim 5, wherein the paddle-like structure comprises an outer paddle-like structure and an inner paddle-like structure.

7. The valve repair apparatus of claim 1, wherein the indicator is configured to pass through at least one of the channel of the clamping member and the channel of the paddle.

8. The valve repair device according to claim 1, wherein the fixing arm of the clamping member includes a first beam, a second beam, and a connecting member between the first beam and the second beam.

9. The valve repair device according to claim 1, further comprising an indicator mark attached to the indicator.

10. The valve repair device of claim 1, wherein the movable end includes an indicator mark comprising a radiopaque material.

11. The valve repair device of claim 10, wherein the leaflet engagement member is the only part of the indicator configured to pass through at least one of the clamping member and the paddle.

12. The valve repair device of claim 10, wherein the leaflet junction member includes one or more protrusions extending from the leaflet junction member.

13. The valve repair device of claim 10, wherein the indicator arm comprises a first arm and a second arm, wherein the first arm and the second arm are coupled to the movable end and connected at a connection point at the fixed end.

14. The valve repair device of claim 1, wherein the indicator is formed as a portion of the clamping member.

15. The valve repair apparatus of claim 14, wherein the indicator is formed between the outer beams of the movable arm of the clamping member or on the outside of the outer beam of the clamping member.

16. The valve repair device of claim 15, wherein the indicator includes a torsion portion, wherein the torsion portion includes one or more torsion sections between 0 degrees and 180 degrees.

17. The valve repair device according to claim 1, wherein the indicator comprises a first arm portion and a second arm portion.

18. The valve repair device of claim 17, wherein at least one of the first arm portion and the second arm portion is formed between the outer beams of the clamping member or outside the outer beams of the clamping member.

19. The valve repair device of claim 17, wherein at least one of the first arm portion and the second arm portion is formed by a portion of the first beam of the clamping member.

20. The valve repair device of claim 17, wherein the first arm portion includes a torsion portion, wherein the torsion portion of the first arm portion includes one or more torsional portions between 0 degrees and 180 degrees along a first direction, and wherein the second arm portion includes a torsion portion, wherein the torsion portion of the second arm portion includes one or more torsional portions between 0 degrees and 180 degrees along a second direction opposite to the first direction.

21. The valve repair device of claim 17, wherein the first arm portion and the second arm portion are coupled to the movable end at a connection point.

22. The valve repair device of claim 21, wherein the connection point includes an indicator mark comprising a radiopaque material press-fitted into at least one of the first arm portion and the second arm portion.

23. A valve repair system for repairing a patient's natural valve, the system comprising: Delivery system; A valve repair device, coupled to the delivery system, the valve repair device comprising: Fasteners; paddle; The fastener is movable to form a capture area to receive the leaflet of the natural valve; An indicator arm, coupled to the valve repair device, wherein the indicator arm is movable to indicate whether the leaflet of the natural valve is inserted into the capture region at least to a minimum insertion depth; The indicator arm is configured to pass through one or more of the paddle and the fastener; The indicator arm includes a fixed end and a movable end; The fixed end of the indicator arm is coupled to the movable arm of the fastener; The fixed end and the movable end are arranged on the first side of the movable arm of the fastener; The indicator arm includes a leaflet engaging member between the fixed end and the movable end; The leaflet engaging member is arranged on the second side of the movable arm of the fastener; and The capture area is located on the second side of the movable arm.

24. The valve repair system of claim 23, wherein the indicator arm is compressible and configured to engage the leaflet of the natural valve.

25. The valve repair system of claim 23, wherein the indicator arm includes one or more protrusions extending from the indicator arm.

26. The valve repair system of claim 23, wherein the fastener and the indicator arm each include a marker, the marker comprising a radiopaque material.

27. The valve repair system of claim 23, wherein the indicator arm includes a coupling member coupled to a paddle-like component of the device.

28. The valve repair system of claim 23, wherein the paddle comprises an outer paddle and an inner paddle, and wherein the fastener comprises a movable arm and a fixed arm.

29. The valve repair system of claim 28, wherein the indicator arm is configured to pass through at least one of a movable arm channel of the movable arm, a fixed arm channel of the fixed arm, an outer paddle channel of the outer paddle, and an inner paddle channel of the inner paddle.

30. The valve repair system of claim 28, wherein the fixing arm of the fastener includes a first beam, a second beam, and a connecting member between the first beam and the second beam.

31. The valve repair system of claim 23, further comprising an indicator mark attached to the indicator arm, wherein the indicator mark is formed of at least one of a radiopaque material and a radioactive reflective material.

32. The valve repair system of claim 31, wherein the movable end includes an indicator mark comprising a radiopaque material.

33. The valve repair system of claim 31, wherein the leaflet engagement member is the only part of the indicator arm configured to pass through at least one of the fastener and the paddle.

34. The valve repair system of claim 31, wherein the leaflet joint member includes one or more protrusions extending from the leaflet joint member.

35. The valve repair system of claim 31, wherein the indicator arm comprises a first arm and a second arm, wherein the first arm and the second arm are coupled to the movable end and connected at a connection point at the fixed end.

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