Heart valve repair devices and systems comprising the same

Abstract

A valve repair device for repairing a patient's native valve. The valve repair device includes a paddle, a gripping member, and an indicator. The paddle and / or the gripping member is movable to form an opening or capture area between the gripping member and the paddle. The indicator is configured to indicate whether a leaflet of the native valve has been inserted into the opening or capture area between the paddle and the gripping member to at least a minimum insertion depth.

Description

Technical Field

[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 Device and Delivery Device Thereof,” and U.S. Provisional Application No. 63 / 307,589, filed February 7, 2022, entitled “Heart Valve Repair Device and Delivery Device Thereof,” which are incorporated herein by reference in their entirety. Prior Technology

[0003] Background of the Invention

[0004] Native heart valves (i.e., the aortic, pulmonary, tricuspid, and mitral valves) provide crucial function in ensuring the proper flow of blood through the cardiovascular system. These valves can be damaged and rendered less effective due to conditions such as congenital malformations, inflammatory processes, infectious diseases, or other illnesses. Such damage to these valves can lead to severe cardiovascular dysfunction or death. Damaged valves can be surgically repaired or replaced during open-heart surgery. However, open-heart surgery is highly invasive and prone to complications. Transvascular techniques can be used to introduce and implant artificial devices in a less invasive manner than open-heart surgery. As an example, one transvascular technique that can be used to access the native mitral and aortic valves is the transseptal technique. The transseptal technique involves advancing a catheter into the right atrium (e.g., inserting a catheter into the right femoral vein, superior to the inferior vena cava, and into the right atrium). The septum is then punctured, and the catheter is inserted into the left atrium. A similar transvascular technique can be used to implant an artificial device into the tricuspid valve, which begins similarly to the transseptal technique but nearly punctures the septum, and instead redirects the delivery catheter to the tricuspid valve in the right atrium.

[0005] A healthy heart has a generally conical shape, tapering to a 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 known as the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has an anatomical structure quite different from other native heart valves. The mitral valve includes an annular portion, a ring of native valvular tissue surrounding the orifice of the mitral valve; and a pair of cusps or leaflets extending downwards from the annulus into the left ventricle. The mitral valve annulus can form a D-shape, an oval shape, or other non-circular cross-sectional shape with long and short axes. The anterior leaflet may be larger than the posterior leaflet, and when they are closed together, a generally C-shaped boundary is formed between the abutting sides of these leaflets.

[0006] 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 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 systole), the increased blood pressure within the left ventricle pushes the two leaflets together, thereby closing the one-way mitral valve. This prevents blood from flowing back into the left atrium and instead drains it out of 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, multiple bundles of fibers called chordae tendineae embolize the leaflets to the mastoid muscle of the left ventricle.

[0007] Valvular regurgitation involves a valve inappropriately allowing some blood to flow through it in the wrong direction. For example, mitral regurgitation occurs when the primary mitral valve fails to close properly and blood flows from the left ventricle to the left atrium during the systolic phase of cardiac contraction. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation can have many different causes, such as leaflet prolapse, dysfunctional mastoid muscle, mitral valve annulus extension due to left ventricular dilation, and more. Mitral regurgitation located in the central portion of one of the leaflets is called central jet mitral regurgitation, while mitral regurgitation near the leaflet commissure (i.e., where the leaflets meet) is called eccentric jet mitral regurgitation. Central jet regurgitation occurs when the edges of the leaflets do not meet in the middle and therefore the valve does not close. Tricuspid regurgitation can be similar, but occurs on the right side of the heart. Summary of the Invention

[0008] This summary is intended to provide examples and is not intended to limit the scope of the invention in any way. For example, unless the claims expressly list any feature included in the examples of this summary, such feature is not essential to the claims. Furthermore, the features, components, steps, concepts, etc., described in this summary and other examples thereof can be combined in various ways. Various features and steps described elsewhere in this invention may be included in the examples outlined herein.

[0009] This document discloses devices for repairing and / or treating a patient's native valve. These devices may be valve repair devices, implantable devices, valve treatment devices, implants, etc. Although sometimes described as an implantable device for illustrative purposes in the various examples herein, similar configurations can be used with other devices, such as valve repair devices, which may not be implanted and can be removed after treatment.

[0010] These devices may include an indicator (which may be the same as or similar to other indicators described anywhere herein) and a gripping member or hook (which may be the same as or similar to other gripping members, gripping arms, and hook arms described anywhere herein). These devices 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 / hook (e.g., a hook arm of the hook, a gripping arm, etc.) is movable to form an opening or capture area for receiving a leaflet. In some embodiments, the opening or capture area is formed between the gripping member / hook (e.g., a hook arm of the hook, etc.) and the paddle (e.g., a portion of the paddle, etc.). The indicator is configured to indicate whether a leaflet of the native valve is inserted into the opening or capture area at at least a minimum insertion depth or engagement depth. This minimum insertion depth or engagement depth may be pre-selected and / or configured to a specific depth as desired.

[0011] The indicators described herein can be assembled in various shapes, sizes, and materials. In some implementations, these indicators may include a wavy shape, an S-shape, a C-shape, a U-shape, a V-shape, a hook shape, a calibration mark shape, a curved hook shape, etc.

[0012] In some implementations, a valve repair device (or valve treatment device, etc.) includes a hook and / or a hook arm and an indicator (e.g., leaflet depth indicator, indicator arm, marker, sensor, electrode, etc.). The device may also include a paddle. The indicator may be configured as an indicator arm and / or configured to be movable (e.g., via the hook, paddle, and / or another part of the device) to indicate whether one leaflet of the native valve is inserted into the opening or capture area at at least a minimum insertion depth. This minimum insertion depth may be pre-selected and / or configured to a specific depth as desired.

[0013] In some embodiments, the indicator may include an indicator arm, which is coupled to the valve repair device at a first end and a second end. The indicator arm may be coupled to an optional engagement element of the valve repair device. The indicator arm may be compressible and configurable to engage the leaflet of the native valve. The indicator arm may include one or more protrusions extending from it. The hook and the indicator arm may each include a marker containing a radiopaque material. The capture area may be formed between a portion of the paddle and an arm of the hook. The paddle may include an outer paddle and an inner paddle.

[0014] In some embodiments, the indicator or indicator arm may be configured to pass through a channel, slot, gap, and / or opening of the hook. In some embodiments, the indicator or indicator arm may be configured to pass through a channel, slot, gap, and / or opening of the propeller. 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 hook.

[0015] In some embodiments, the hook may optionally include a fixing arm. In some embodiments, the fixing arm of the hook may include a first beam, a second beam, and / or a connecting member between the first beam and the second beam.

[0016] In some embodiments, an indicator 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 hook. The fixed end of the indicator arm may be coupled to a movable arm of the hook. The movable end may include an indicator containing a radiopaque material. The fixed end and the movable end may be positioned on a first side of a movable arm of the hook.

[0017] In some implementations, the indicator or indicator arm includes a leaf-shaped connecting member (e.g., an 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 connecting member can be assembled to pass through at least one of the movable arms of the hook and at least one of the paddles.

[0018] In some embodiments, the leaflet connecting member is mounted on a second side of one of the movable arms of the hook. In some embodiments, the leaflet connecting member may include one or more protrusions extending from the leaflet connecting member.

[0019] In some implementations, an indicator may include a first arm and a second arm. The first arm and the second arm may be coupled to the mobile end and may be connected at a connection point of the fixed end.

[0020] In some implementations, the indicator arm is formed from a portion of the hook. The indicator arm may be formed between the outer beams of one of the movable arms of the hook, and / or on the outside of the outer beam of the hook (or the hook arm of the hook).

[0021] In some implementations, the indicator arm may include a torsion section. This torsion section may comprise one or more torsion structures between 0 degrees and 180 degrees.

[0022] In some embodiments, the indicator 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 the outer beams of the hook and / or on the outer side of the outer beams of the hook. 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 hook. 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 torsion structures in a clockwise direction between 0 degrees and 180 degrees.

[0023] In some implementations, a second arm portion may include a torsion portion. The torsion portion of the second arm portion may include one or more torsion structures rotating counterclockwise between 0 degrees and 180 degrees.

[0024] In some implementations, 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 comprising a radiopaque material pressed to at least one of the first arm portion and the second arm portion.

[0025] In some embodiments, a valve repair system for repairing a patient's native 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, indicator arm, sensor, etc.), and a gripping member or hook. The gripping member / hook and / or the paddle is movable to form an opening or capture area for receiving a leaflet of the native valve. The indicator is coupled to the valve repair device. In some embodiments, the indicator is configured as an indicator arm and / or is movable to indicate whether the leaflet of the native valve is inserted into the opening or capture area to at least a minimum insertion depth. The device may be configured to have desired minimum insertion depths (e.g., one or more of 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, etc.). The indicator or indicator arm can be assembled to pass through one or more of the paddle and the gripping member / hook.

[0026] In some implementations, a valve repair device includes a gripping member or hook (e.g., a hook arm, gripping arm, etc.) and a leaflet depth indicator. The leaflet depth indicator includes at least one first electrode and one second electrode. The first and second electrodes provide electrical signals to indicate whether one leaflet of the native valve has been inserted into an opening or capture zone to at least a minimum insertion depth. This minimum insertion depth can be pre-selected and / or configured to a specific depth as desired. The device may also include a blade.

[0027] In some implementations, a valve repair device for repairing a native heart valve includes a gripping member or hook (e.g., a hook arm, gripper arm, etc.) and a leaflet depth indicator. The hook (or a hook arm / grip arm of the hook) is movable to form an opening or capture area for receiving a native leaflet of the native valve. The leaflet depth indicator may include a first electrode and a second electrode. The first and second electrodes can provide electrical signals to indicate whether a leaflet of the native valve has been inserted into the opening to a specific insertion depth.

[0028] In some embodiments, the electrical signals include an electrocardiogram (ECG) signal or a bioimpedance signal. The first and second electrodes may be coupled to the gripping member / hook (or hook arm, gripper arm, etc.). In some embodiments, the gripping member / hook 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 move within an opening or capture area.

[0029] In some implementations, a valve repair system for repairing a native 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 gripping member or hook (e.g., a hook arm, gripping arm, etc.) and a leaflet depth indicator. The gripping member / hook (e.g., a portion thereof, hook arm, gripping arm, etc.) is movable to form an opening or capture area for receiving a native leaflet of the native valve. The leaflet depth indicator includes a first electrode and a second electrode. The first and second electrodes provide electrical signals to indicate whether a leaflet of the native valve has been inserted into the opening or capture area to at least a minimum insertion depth. This minimum insertion depth can be pre-selected and / or configured to a specific depth as desired.

[0030] In some embodiments, a leaflet depth indicator may be integrally formed with the gripping member / hook. For example, the leaflet depth indicator may be formed of the same material as the gripping member / hook. In some embodiments, the gripping member / hook and the leaflet depth indicator may be cut from a single piece of sheet material.

[0031] In some implementations, the material of the leaflet depth indicator may be bent, twisted, and / or shaped relative to the material of the gripping member / hook, such that the leaflet depth indicator is positioned in a plane so that it can contact a native leaflet and determine whether the gripping member / hook has properly engaged the native leaflet. The leaflet depth indicator may extend from a movable arm of the hook, a hinge portion of the hook, and / or a fixed arm of the hook.

[0032] In some implementations, a valve repair device includes a gripping member or hook (and / or its hook arm, gripping arm, etc.) and an indicator. The device may also include a paddle. The valve repair device may also include an insulator disposed between at least a portion of the gripping member / hook / hook arm and the indicator. The indicator includes one or more conductive indicator contacts connectable to a sensor to indicate whether one leaflet of the native valve has been inserted into the opening or capture area to at least a minimum insertion depth. This minimum insertion depth may be pre-selected and / or configured to a specific depth as desired.

[0033] In some embodiments, the signal can be transmitted to the sensors via electrical wiring from the valve repair device to the sensors. The signal can also be transmitted to the sensors via the conductivity of a portion of the valve repair device from the indicator. In some embodiments, the signal is transmitted to the sensors via the conductivity of at least one of a conductive retaining arm, a conductive coupling element, a conductive collar, a conductive conduit coupling element, and a conductive actuation wire from the indicator.

[0034] In some implementations, a gripping member or hook may include a movable arm and a fixed arm, a first indicator plate coupled to the fixed arm, and a second indicator plate coupled to the movable arm.

[0035] In some implementations, the valve repair device may include a rod coupled to the hook, wherein the rod includes a leaflet connection portion and a device connection portion. The leaflet connection portion may reinforce the blade and prevent or inhibit a leaflet from accumulating around the indicator or between multiple portions of the indicator.

[0036] In some implementations, a valve repair device for repairing a patient's native valve includes a gripping member or hook (and / or hook arm, gripping arm, etc.) and an indicator. The gripping member / hook (a portion of the gripping member / hook, arm, etc.) is movable to form an opening or capture area for capturing a leaflet of the native valve. The indicator is coupled to the valve repair device. The indicator may include one or more conductive indicator contacts. The indicator indicates whether the leaflet of the native valve has been inserted into the opening or capture area to at least a minimum insertion depth.

[0037] In some implementations, the indicator may include two conductive indicator contacts. These two conductive indicator contacts may be bridged when the gripping member / hook is in a closed position and the leaflet tissue has not been inserted to the minimum insertion depth. Alternatively, these two conductive indicator contacts may be electrically isolated when the gripping member / hook is in a closed position and the leaflet tissue has been inserted to the minimum insertion depth. The one or more conductive indicator contacts may be mounted on one of the blades of the valve repair device.

[0038] In some implementations, a valve repair device for repairing a native heart valve includes a conductive hook (or other gripping member), a conductive paddle, and an insulator. The insulation system is disposed between a portion of the conductive hook and the conductive paddle. The conductive hook is assembled to move to form a capture area for capturing one leaflet of the native valve. When the hook is in a closed position and the leaflet tissue has not been inserted to a minimum insertion depth, the conductive hook contacts the conductive paddle.

[0039] In some implementations, when the hook is in a closed position and the leaflet tissue is inserted to the minimum insertion depth, the hook is electrically isolated from the conductive blade.

[0040] In some implementations, the conductive blade is coupled to a conductive collar. The conductive blade can be coupled to the conductive collar via a conductive bonding element.

[0041] In some implementations, a valve repair system includes a valve repair device and a delivery device. The valve repair device includes a conductive hook (or other gripping member), a conductive paddle, an insulator, and a conductive collar. The insulation system is disposed between a portion of the conductive hook 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 hook and is configured to move the hook to form a capture area for capturing one leaflet of the native valve. When the hook is in a closed position and leaflet tissue has not been inserted to a minimum insertion depth, the conductive hook contacts the conductive paddle.

[0042] In some implementations, the conductive paddle can be coupled to the conductive collar via a conductive coupling element. When the hook is in a closed position and the leaflet tissue is inserted to the minimum insertion depth, the hook can be electrically isolated from the conductive paddle.

[0043] In some implementations, a valve repair device for repairing a native heart valve includes a conductive hook (or other gripping member), a conductive leaflet depth indicator, and an insulator. The insulation system is positioned between a portion of the conductive hook and the conductive leaflet depth indicator. The conductive hook (or hook arm) is assembled to move to form a capture area for capturing one leaflet of the native valve.

[0044] In some implementations, the conductive leaflet depth indicator contacts the conductive hook when the hook is in a closed position and the leaflet tissue has not been inserted to a minimum insertion depth.

[0045] In some implementations, when the hook is in a closed position and the leaflet tissue is inserted to the minimum insertion depth, the hook is electrically isolated from the conductive leaflet depth indicator.

[0046] In some implementations, when the hook is in a closed position and the leaflet tissue is inserted to the minimum insertion depth, the conductive leaflet depth indicator moves relative to the hook (or hook arm).

[0047] In some implementations, a valve repair device includes a hook (or hook arm), an indicator, and a sensor. The hook includes a movable arm and a fixed arm. The hook (or its movable arm) is movable to form an opening or capture area for capturing one leaflet of the native valve. The indicator includes a first indicator plate coupled to the fixed arm and a second indicator plate coupled to the movable arm. The indicator is configured to detect one or more characteristics of blood or tissue. The sensor is coupled to the indicator.

[0048] In some implementations, the sensor is configured to measure one or more of the following: resistance, inductance, capacitance, voltage, current, and impedance. The sensor can be configured to measure impedance. The sensor can be configured to compare the sensed electrical characteristics with previously measured electrical characteristics corresponding to known tissue and blood samples. The sensor can be configured to determine whether tissue is attached. The sensor can be configured to distinguish between leaflet tissue and chordae tendineae tissue.

[0049] In some implementations, a first impedance value is measured in a method for identifying a hook condition (or gripping member condition). This first impedance value is compared with a previously measured impedance value. Based on this comparison, one or more of the hook condition or position are determined or estimated. The method can be performed on a living object or on a simulation, such as a corpse, a corpse's heart, or a simulator (e.g., having simulated body parts, heart, valves, tissues, etc.).

[0050] In some embodiments, a valve repair device for repairing a patient's native valve includes a paddle, an indicator, a lever, and a gripping member or hook. The gripping member / hook (or a portion thereof or a movable arm) is movable to form a capture area for capturing one leaflet of the native valve. In some embodiments, the indicator is coupled to the gripping member / hook. The indicator is configured as an indicator arm and / or configured to be movable to indicate whether the leaflet of the native valve is inserted into the opening or capture area at least a minimum insertion depth. This minimum insertion depth can be pre-selected and / or configured to a specific depth as desired. The lever is coupled to the paddle. The lever reinforces the paddle and reduces space within the capture area.

[0051] In some implementations, the rod includes a leaflet connecting portion and a device connecting portion. The leaflet connecting portion may include one or more peaks positioned to contact the leaflet. When viewed from the side, the peaks may overlap the indicator.

[0052] One of the properties and advantages of the present invention is further understood as set forth in the following description and the claims, particularly when considered in conjunction with the accompanying drawings, wherein similar parts are given similar reference numerals. Simple Explanation of the Diagram

[0053] To further clarify the various embodiments of this disclosure, specific examples and implementations will be described in more detail with reference to the accompanying drawings. It should be understood that these drawings only illustrate embodiments of this disclosure and should not be considered as limiting the scope of this disclosure. Furthermore, while the drawings may be drawn to scale for some examples, they may not be drawn to scale for all examples. Examples of this disclosure, as well as other features and advantages, will be illustrated and explained with additional specificity and detail using the accompanying drawings, wherein:

[0054] Figure 1 illustrates a cross-sectional view of the human heart during diastole;

[0055] Figure 2 illustrates a cross-sectional view of the human heart during systole;

[0056] Figure 3 illustrates a cross-sectional view of a human heart during systole, showing valvular regurgitation;

[0057] Figure 4 is a cross-sectional view of Figure 3, annotated to illustrate the natural shape of the petals of the monk's cap during the contraction phase;

[0058] Figure 5 illustrates a healthy mitral valve, wherein the leaflets examined from one atrial side of the mitral valve are closed;

[0059] Figure 6 illustrates a malfunctioning mitral valve, wherein a visible gap exists between the leaflets when viewed from the atrial side of one of the mitral valves;

[0060] Figure 7 illustrates a tricuspid valve viewed from the atrial side of one of the tricuspid valves;

[0061] Figure 8-14 shows an example of an implantable device or implant at one of the various deployment phases;

[0062] Figure 15 shows an example of an implantable device or implant that is similar to the device illustrated in Figures 8-14, but in which the paddles are independently controllable;

[0063] Figure 16-21 shows the example implantable device or implant from Figure 8-14 being delivered and implanted within a native valve;

[0064] Figure 22 shows a perspective view of an example of an implantable device or implant located in a closed position;

[0065] Figure 23 shows a front view of one of the implantable devices or implants of Figure 22;

[0066] Figure 24 shows a side view of one of the implantable devices or implants of Figure 22;

[0067] Figure 25 shows a front view of the implantable device or implant of Figure 22, which has a cover covering the paddle and a coupling element or spacer;

[0068] Figure 26 shows a top perspective view of the implantable device or implant of Figure 22 in an open position;

[0069] Figure 27 shows a bottom perspective view of one of the implantable devices or implants of Figure 22 in an open position;

[0070] Figure 28 shows a hook for use with an implantable device or implant;

[0071] Figure 29 shows a portion of the native valve tissue held by a hook;

[0072] Figure 30 shows a side view of an example of an implantable device or implant in one of the partially open positions, with the hook in a closed position;

[0073] Figure 31 shows a side view of an example of an implantable device or implant in one of the partially open positions, with the hook in an open position;

[0074] Figure 32 shows a side view of an example of an implantable device or implant in a semi-open position, with the hook in a closed position;

[0075] Figure 33 shows a side view of an example of an implantable device or implant in a semi-open position, with the hook in an open position;

[0076] Figure 34 shows a side view of an example of an implantable device or implant in one of the three-quarters open positions, with the hook in a closed position;

[0077] Figure 35 shows a side view of an example of an implantable device or implant in one of the three-quarters open positions, with the hook in an open position;

[0078] Figure 36 shows a side view of an example of an implantable device in one of two positions: fully open or fully bailout, with the hook in a closed position.

[0079] Figure 37 shows a side view of an example of an implantable device in one of two positions: fully open or fully parachute-ready, with the hook in an open position.

[0080] Figures 38-49 show examples of implantable devices or implants of Figures 30-38 including a cap, being delivered and implanted within a native valve;

[0081] Figure 50 shows a schematic diagram illustrating a path along one of the original valve leaflets on each side of one of the connecting elements or spacers of an example valve repair device or implant;

[0082] Figure 51 shows a top view illustrating the path of one of the native valve leaflets around one of the connecting elements or spacers of an example valve repair device or implant;

[0083] Figure 52 shows a connecting element or spacer in the interatrial space of one of the primary valves when viewed from the atrial side of one of the primary valves;

[0084] Figure 53 shows a valve repair device or implant attached to a leaflet of the original valve when viewed from the ventricular side of one of the original valves, wherein the connecting element or spacer is located in the gap of the original valve;

[0085] Figure 54 shows a perspective view of a valve repair device or implant attached to a leaflet of the original valve, shown from the ventricular side of one of the original valves, wherein the connecting element or spacer is located in the gap of the original valve;

[0086] Figure 55 shows a perspective view of an example of an implantable device or implant located in a closed position;

[0087] Figure 56 shows a perspective view of an example of an implantable device or implant hook in a closed position;

[0088] Figure 57 illustrates a valve repair device in which the blades are in an open position;

[0089] Figure 58 illustrates the valve repair device of Figure 57, wherein the blades are in the open position and the gripping members (e.g., gripping arms, hook arms, etc.) are moved to create a wider gap between the gripping members and the blades;

[0090] Figure 59 illustrates the valve repair device of Figure 57, wherein the valve repair device is located in the position shown in Figure 57, and the valve tissue is placed between the gripping member and the blade;

[0091] Figure 60 illustrates the valve repair device of Figure 57, wherein the gripping members are moved to reduce the gap between the gripping members and the blades;

[0092] Figures 61A-61B illustrate the movement of the blades of the valve repair device in Figure 57 from an open position to a closed position;

[0093] Figure 62 illustrates the valve repair device of Figure 57 in a closed position, wherein the gripping member is engaged with the valve tissue;

[0094] Figure 63 illustrates the valve repair device of Figure 57 after it has been disconnected from a delivery device and attached to the valve tissue, wherein the valve repair device is in a closed and locked position;

[0095] Figures 64-67 show an example of a hook or leaflet capture component being deployed to engage with one of the leaflets of a native valve;

[0096] Figures 68-77 show a device with a hook and latch, in which an indicator arm is being delivered and deployed within a native valve;

[0097] Figures 78-84 illustrate an example valve repair device, wherein the blades are in an open position;

[0098] Figures 85-87 show a device with a hook containing an indicator arm;

[0099] Figures 88-93 illustrate an example of a hook and clasp having an indicator arm at a shaped end;

[0100] Figures 94 and 95A-95G illustrate an example of a hook having an indicator arm in a closed position, which has a shaped portion;

[0101] Figures 96A and 96B illustrate a hook with an indicator arm in an open position, which has a shaped portion as shown in Figure 94;

[0102] Figures 97-98 illustrate an example valve repair device with a hook containing a leaflet depth indicator;

[0103] Figure 99-101 illustrates an example hook and loop with a leaflet depth indicator;

[0104] Figures 102A and 102B illustrate a valve repair device having a hook containing a leaflet depth indicator;

[0105] Figures 103-109 illustrate example hooks with leaflet depth indicators;

[0106] Figure 110 illustrates a fixed end of a leaflet depth indicator;

[0107] Figures 111-114 illustrate example hooks with leaflet depth indicators;

[0108] Figures 115-116 illustrate a device having a hook containing a leaflet depth indicator;

[0109] Figures 117-118 illustrate an example leaflet path between the hook and the leaflet depth indicator;

[0110] Figures 119-120 illustrate example leaflet depth indicators for hook and / or capture devices;

[0111] Figures 121-126 illustrate example hooks with leaflet depth indicators;

[0112] Figures 127-128 illustrate an example of an implantable device having a hook containing a leaflet depth indicator;

[0113] Figure 129 illustrates an example hook and loop with a leaf depth indicator;

[0114] Figure 130 illustrates an example device with a hook for a leaflet depth indicator;

[0115] Figure 131 illustrates an example hook and loop with a leaf depth indicator;

[0116] Figure 132 illustrates an example of an implantable device having a hook containing a leaflet depth indicator;

[0117] Figure 133 illustrates an example hook and loop with a leaf depth indicator;

[0118] Figure 134 illustrates an example of an implantable device having a hook containing a leaflet depth indicator;

[0119] Figure 135 illustrates an example hook and loop with a leaf depth indicator;

[0120] Figures 136, 137A, and 137B illustrate the intracardiac electrocardiogram (IECG) signals measured using the electrodes of the example leaflet depth indicator;

[0121] Figures 137C-137F illustrate bipolar IECG signals measured from the electrodes of an example leaflet depth indicator;

[0122] Figure 138 illustrates an example hook and loop with a leaf depth indicator;

[0123] Figure 139 illustrates an example hook with an integrated leaflet depth indicator;

[0124] Figure 140A illustrates an example hook with an arm, which can be configured as an integrated leaflet depth indicator;

[0125] Figure 140B illustrates an example hook and loop with an integrated leaflet depth indicator made from the arm shown in Figure 140A;

[0126] Figure 140C illustrates an example hook and loop with an integrated leaflet depth indicator made from the arm shown in Figure 140A;

[0127] Figure 141A illustrates an example hook having an arm that can be formed as one of the movable arms of the hook and an arm that can be formed as an integrated leaflet depth indicator;

[0128] Figure 141B illustrates an example hook having an arm that can be formed as one of the movable arms of the hook and an arm that can be formed as an integrated leaflet depth indicator;

[0129] Figure 141C illustrates an example hook and loop with a movable arm made from the arm shown in Figure 141A or Figure 141B and an integrated leaflet depth indicator;

[0130] Figure 141D illustrates an example hook having an arm that can be formed as one of the movable arms of the hook and an arm that can be formed as an integrated leaflet depth indicator;

[0131] Figure 142A shows an example hook with an integrated leaflet depth indicator, wherein a valve leaflet is not inserted to a depth that causes displacement of the leaflet depth indicator;

[0132] Figure 142B shows an example hook with an integrated leaflet depth indicator, wherein a valve leaflet is inserted to a depth that causes displacement of the leaflet depth indicator;

[0133] Figure 143A shows an example hook with an integrated leaflet depth indicator, wherein a valve leaflet is not inserted to a depth that causes displacement of the leaflet depth indicator;

[0134] Figure 143B shows an example hook with an integrated leaflet depth indicator, wherein a valve leaflet is inserted to a depth that causes displacement of the leaflet depth indicator;

[0135] Figures 144-147 illustrate an example device having a hook containing an electrical leaflet depth indicator;

[0136] Figures 148-155 illustrate example hooks with leaflet depth indicators, which are assembled to visually and electrically indicate leaflet insertion;

[0137] Figures 156, 156A, 156B, 156C, and 156D illustrate hooks with different sensor board configurations;

[0138] Figures 157-158 illustrate example hooks with electrical leaflet depth indicators;

[0139] Figure 159 illustrates an example hook with one of the electrical valve leaflet depth indicators in Figures 157-158 that senses blood flow;

[0140] Figure 160 illustrates an example hook with one of the electrical leaflet depth indicators in Figures 157-158 that senses a valve leaflet;

[0141] Figure 161 illustrates an example hook with one of the electrical leaflet depth indicators shown in Figures 157-158, which senses chordae tendineae;

[0142] Figure 162 illustrates a circuit for measuring impedance according to some implementations of a hook with an electrical indicator;

[0143] Figure 163 illustrates an example of calculating impedance components;

[0144] Figure 164 illustrates one implementation of a method for identifying a hook condition based on an electrical measurement;

[0145] Figures 165-169 illustrate example devices and / or parts thereof, which have a hook containing a leaf depth indicator. Implementation

[0146] The following description, with reference to the accompanying drawings, illustrates exemplary implementations of the contents of this disclosure. Other implementations with different structures and operations do not depart from the scope of this disclosure.

[0147] The embodiments disclosed herein pertain to systems, devices, and methods for repairing a defective heart valve. 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 is permissible unless specifically excluded. In other words, individual components of the disclosed devices and systems can be combined unless mutually exclusive or physically impossible. Furthermore, the techniques and methods described herein can be implemented on a living object or on a simulation, such as a cadaver, a cadaver's heart, or a simulator (e.g., having simulated body parts, heart, tissue, etc.).

[0148] As described herein, when one or more components are described as being connected, joined, attached, coupled, attached, or otherwise interconnected, such interconnection structures may be direct, such as between components; or they may be indirect, such as through the use of one or more intermediate components. Also as described herein, references to a “component,” “assembly,” or “part” are not limited to a single structural component, assembly, or element, but may include an assembly of components, components, or elements. Also 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 “hook” and “hook arm” are generally used herein in relation to specific instances, but the terms “gripping component” and / or “gripping arm” may be used instead and function in the same or similar manner, even if not assembled in the same way as a general hook.

[0149] Figures 1 and 2 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 the mitral valve (MV); that is, 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 extending inward across individual orifices (e.g., leaflets 20 and 22 shown in Figures 3-6 and leaflets 30, 32, and 34 shown in Figure 7), which converge or "join" in the flow to form a one-way fluid barrier surface. The original valve repair system of this application is 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 native valves, such as the tricuspid valve (TV), aortic valve (AV), and pulmonary valve (PV).

[0150] The left atrium (LA) receives oxygenated blood from the lungs. During diastole, as shown in Figure 1, blood previously collected in the left atrium (LA) (during systole) moves through the mitral valve (MV) and into the left ventricle (LV) by the expansion of the left ventricle (LV). During systole, as shown in Figure 2, the left ventricle (LV) contracts to force blood through the aortic valve (AV) and the ascending aorta (AA) into the body. During systole, the leaflets of the mitral valve (MV) close to prevent backflow of blood from the left ventricle (LV) back into the left atrium (LA), and blood is collected in the left atrium from the pulmonary veins. In some embodiments, the device described in this application is used to correct the function of a defective mitral valve (MV). That is, these devices are configured to help close the leaflets of the mitral valve to prevent or inhibit backflow of blood from the left ventricle (LV) back into the left atrium (LA). Many of the devices described in this application are designed to easily hold and secure the original leaflets around a connecting element or spacer, which advantageously acts as a filler in the backflow orifice to prevent or suppress backflow or reverse flow during contraction, but this is not necessary.

[0151] Referring now to Figures 1-7, the mitral valve MV comprises two leaflets: anterior leaflet 20 and posterior leaflet 22. The mitral valve MV also includes a valve ring 24, which is a variable, dense fibrous ring surrounding the tissue of leaflets 20 and 22. Referring to Figures 3 and 4, the mitral valve MV is anchored to the wall of the left ventricle (LV) by chordae tendineae (CT). The chordae tendineae (CT) are chord-like tendons that connect the mastoid muscle (PM) (i.e., the muscle 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 mastoid muscle (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 mastoid muscle (PM) does not open or close the mitral valve MV. Instead, the mastoid muscle (PM) supports or braces the leaflets 20 and 22 against the high pressure required for systemic blood circulation. The mastoid muscle (PM) and chordae tendineae (CT) together form a subvalvular apparatus. Their function is to prevent the mitral valve (MV) from prolapsed into the left atrium (LA) during mitral valve closure. As shown in Figure 3, a view of the left ventricular outflow tract (LVOT), the anatomy of leaflets 20 and 22 is such that their medial surfaces join at their free ends, and leaflets 20 and 22 begin to recede or disperse. Leaflets 20 and 22 disperse in the atrial direction until each leaflet encounters the mitral valve annulus.

[0152] Various disease processes can impair the normal function of one or more of the heart's primary valves. These processes include degenerative processes (e.g., Barlow's disease, fibroelastic deficiency), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis). Additionally, damage to the left ventricle (LV) or right ventricle (RV) due to a previous heart attack (i.e., myocardial infarction due to coronary artery disease) or other cardiac conditions (e.g., cardiomyopathy) can distort the geometry of a primary valve, potentially leading to its dysfunction. However, most patients undergoing valve surgery, such as mitral valve (MV) repair, suffer from a degenerative disease causing dysfunction of one leaflet (e.g., leaflets 20 and 22) of a primary valve (e.g., mitral valve MV), resulting in prolapse and regurgitation.

[0153] Generally, a primary valve can exhibit dysfunction in various ways, including (1) valvular stenosis and (2) valvular regurgitation. Valvular stenosis occurs when a primary valve fails to open fully, thereby obstructing blood flow. Typically, valvular stenosis is caused by the growth of calcified material on the leaflets of a valve, which thickens the leaflets and impairs the valve's ability to open fully to allow blood to flow forward. Valvular regurgitation occurs when the leaflets of a valve fail to close fully, thereby causing blood to leak back into the previous chamber (e.g., causing blood to leak from the left ventricle into the left atrium).

[0154] There are three main mechanisms that cause a primary valve to become incompetent—or incapacitated—including Carpentier type I, II, and III dysfunction. Carpentier type I dysfunction involves dilation of the annulus, causing the normally functioning leaflets to become separated and unable to form a tight seal (i.e., the leaflets cannot properly engage). Type I mechanism dysfunction includes leaflet perforation, as seen in endocarditis. Carpentier type II dysfunction involves prolapse of one or more leaflets of a primary valve above the plane of engagement. Carpentier type III dysfunction involves restricted movement of one or more leaflets of a primary valve, causing the leaflet system to be abnormally restrained below the plane of the annulus. Leaflet restriction may be caused by rheumatic disease (Ma) or ventricular dilation (IIIb).

[0155] Referring to Figure 5, when a healthy mitral valve MV is in a closed position, the anterior leaflet 20 and the posterior leaflet 22 engage, preventing blood leakage from the left ventricle (LV) to the left atrium (LA). Referring to Figures 3 and 6, mitral valve retrograde MR occurs when the anterior leaflet 20 and / or the posterior leaflet 22 of the mitral valve MV are displaced into the left atrium (LA) during systole, such that the edges of these leaflets 20, 22 are not in contact with each other. This failure of engagement results in a gap 26 between the anterior leaflet 20 and the posterior leaflet 22, which allows blood to flow from the left ventricle (LV) back into the left atrium (LA) during systole, as illustrated by the mitral valve retrograde MR flow path shown in Figure 3. Referring to Figure 6, this gap 26 may have one of the following widths 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 explained above, a leaflet (e.g., leaflets 20, 22 of a monk's cap MV) can present dysfunction in several different ways, which can lead to valvular regurgitation.

[0156] In any of the aforementioned scenarios, a valve repair device or implant is desired that connects the anterior leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent or inhibit backflow of blood through the mitral valve MV. As shown in Figure 4, an abstract representation of a valve repair device, implantable device, or implant 10 is shown implanted between the leaflets 20, 22 to prevent backflow during contraction (compare Figures 3 and 4). In some implementations, the engaging elements of the device 10 (e.g., spacers, anastomotic elements, gap fillers, membranes, plates, plugs, wedges, balloons, etc.) have a generally push-pull or triangular shape that is naturally adapted to the geometry of the native valve and the nature of its extended leaflets (towards the annulus). In this application, the terms spacer, anastomotic element, ferrule element, and gap filler are used interchangeably and refer to an element that fills a portion of the space between the native valve leaflets and / or is assembled to cause the native valve leaflets to engage or "jointly" abut (e.g., to cause the native leaflets to join against the anastomotic element, ferrule element, spacer, etc., rather than merely against each other).

[0157] Although stenosis or regurgitation can affect any valve, stenosis is commonly found to affect the aortic valve (AV) or pulmonary valve (PV), and regurgitation is commonly found to affect the mitral valve (MV) or tricuspid valve (TV). Both valvular stenosis and valvular regurgitation increase the workload of the heart and, if left untreated, can lead to extremely serious conditions such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. Because the left side of the heart (i.e., the left atrium (LA), left ventricle (LV), mitral valve (MV), and aortic valve (AV)) is primarily responsible for circulating blood throughout the body, dysfunction of the mitral valve (MV) or aortic valve (AV) is particularly problematic and often fatal due to the substantially higher pressure on the left side of the heart.

[0158] Dysfunctional native heart valves can be repaired or replaced. Repair typically involves maintaining and correcting the patient's native valve. Replacement typically involves replacing the patient's native valve with a biological or mechanical replacement. The aortic valve (AV) and pulmonary valve (PV) are generally more prone to stenosis. Because stenosis damage from the leaflets is irreversible, treatment for a stenotic aortic or pulmonary valve can involve removal and replacement with a surgically implanted heart valve, or replacement with a transcatheter heart valve. The mitral valve (MV) and tricuspid valve (TV) are more prone to leaflet and / or surrounding tissue deformities, as described above, which prevent proper closure of the mitral valve (MV) or tricuspid valve (TV) and allow retrograde or regurgitation of blood from the ventricle to the atrium (e.g., a deformed mitral valve (MV) may allow retrograde or regurgitation from the left ventricle (LV) to the left atrium (LA), as shown in Figure 3). Retrograde or regurgitation of blood from the ventricle to the atrium leads to valvular insufficiency. Deformities in the structure or shape of the mitral valve MV and tricuspid valve TV are usually repairable. Additionally, backflow can occur due to dysfunction of the chordae tendineae (e.g., chordae tendineae can stretch or rupture), which allows the anterior leaflet 20 and posterior leaflet 22 to return to their normal position, resulting in blood backflow into the left atrium LA. Problems arising from dysfunctional chordae tendineae can be repaired by structurally repairing the chordae tendineae or the mitral valve MV (e.g., by fixing the affected leaflets 20, 22 of the mitral valve).

[0159] The devices and procedures disclosed herein are generally designed with reference to the structure of a mitral valve. However, it should be understood that the devices and concepts provided herein can be used to repair any native valve and any component of a native valve. These devices can be used between leaflets 20 and 22 of the mitral valve MV to prevent or inhibit backflow of blood from the left ventricle to the left atrium. Regarding the tricuspid valve TV (Figure 7), any device and concept herein can be used between any two of the anterior leaflet 30, the septal leaflet 32, and the posterior leaflet 34 to prevent or inhibit backflow of blood from the right ventricle to the right atrium. Furthermore, any device and concept provided herein can be used with all three of these leaflets 30, 32, and 34 to prevent or inhibit backflow of blood from the right ventricle to the right atrium. That is, the valve repair device or implant provided herein can be centrally positioned between these three leaflets 30, 32, and 34.

[0160] An implantable device (e.g., an implantable artificial device, etc.) or implant may optionally have a coupling element (e.g., a spacer, anastomotic element, gap filler, etc.) and at least one anchor (e.g., one, two, three, or more). In some embodiments, an implantable device or implant may have any combination or sub-combination of the features disclosed herein without a coupling element. When included, the coupling element (e.g., anastomotic element, spacer, etc.) is assembled and positioned within the orifice of the native heart valve to help fill the space between the leaflets and form a more effective seal, thereby reducing or preventing or inhibiting the backflow described above. The coupling element may have a structure that is impermeable to blood (or resists blood flow) and allows the native leaflets to close near the coupling element during ventricular systole to block the flow of blood from the left or right ventricle back into the left or right atrium, respectively. The device or implant can be assembled to seal against two or three native valve leaflets; that is, the device can be used for native mitral and tricuspid valves. The connecting element is sometimes referred to herein as a spacer because it can fill a space between abnormally functioning native leaflets that cannot close completely (e.g., mitral leaflets 20, 22 or tricuspid leaflets 30, 32, 34).

[0161] The chosen coupling element (e.g., spacer, anastomotic element, etc.) can have various shapes. In some embodiments, the coupling element can have an elongated cylindrical shape with a rounded cross-sectional shape. In some embodiments, the coupling element can have an oval cross-sectional shape, an oval-shaped cross-sectional shape, a crescent-shaped cross-sectional shape, a rectangular cross-sectional shape, or various other non-cylindrical shapes. In some embodiments, the coupling element can have an atrial portion located in or near the atrium, a ventricular or lower portion located in or near the ventricle, and a lateral surface extending between the primary leaflets. In some embodiments assembled for the tricuspid valve, the atrium or upper portion is located in or near the right atrium, and the ventricular or lower portion is located in or near the right ventricle, and the lateral surface extends between the primary tricuspid valve leaflets.

[0162] In some embodiments, the anchor can be assembled to secure the device to one or both of the primary leaflets, such that the engagement element is positioned between the two primary leaflets. In some embodiments assembled for the tricuspid valve, the anchor is assembled to secure the device to one, two, or all three of the tricuspid valve, such that the engagement element is positioned between the three primary leaflets. In some embodiments, the anchor can be attached to the engagement element at a location adjacent to the ventricular portion of the engagement element. In some embodiments, the anchor can be attached to an actuating element such as a shaft or actuating wire, and the engagement element is also attached to the actuating element. In some embodiments, the anchor and the engagement element can be positioned independently of each other by moving each of the anchor and the engagement element separately along the longitudinal axis of the actuating element (e.g., actuating shaft, actuating rod, actuating tube, actuating wire, etc.). In some implementations, the anchor and the engagement element can be positioned simultaneously by moving the anchor and the engagement element together along the longitudinal axis of the actuation element, such as a shaft or actuation wire. The anchor can be assembled to be positioned behind a native leaflet during implantation so that the leaflet is held by the anchor.

[0163] The device or implant can be assembled for implantation via a delivery system or other delivery components. The delivery system may include one or more of the following: a guide / delivery sheath, a delivery catheter, a maneuverable catheter, an implant catheter, a tube, combinations thereof, etc. The engaging element and the anchor may be compressible to a radially compressed state and may self-expand to a radially expanded state upon release of compressive pressure. To create a gap between the engaging element and the anchor, the device may be assembled to allow the anchor to initially expand radially from the still-compressed engaging element. A native leaflet may then be positioned in the gap. The engaging element may expand radially, close the gap between the engaging element and the anchor, and capture the leaflet between the engaging element and the anchor. In some embodiments, the anchor and the engaging element are optionally assembled for self-expansion. Implantation methods may differ for various embodiments, and each embodiment is discussed more fully below. Additional 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. These methods can be performed on a living animal or on a simulation, such as a corpse, a corpse's heart, a simulator (e.g., having simulated body parts, heart, tissues, etc.). Clause with respect to these methods.

[0164] The disclosed devices or implants can be assembled such that the anchor is connected to a leaflet, utilizing the tension of the native chordae tendineae to resist the high systolic pressure that propels the device toward the left atrium. During diastole, these devices can rely on the compressive and holding forces applied to the leaflet held by the anchor.

[0165] Referring now to Figures 8-15, a schematically illustrated device or implant 100 (e.g., an artificial spacer device, valve repair device, implantable device, etc.) is shown at various deployment stages. This device or implant 100 and other similar devices / implants are described in more detail in PCT patent applications Publications WO2018 / 195215, WO 2020 / 076898, and WO2019 / 139904, which are incorporated herein by reference in their entirety. The device 100 may include any other features used in another device or implant discussed in this application, and the device 100 may be positioned to engage valve tissue (e.g., leaflets 20, 22, 30, 32, 34) as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application or any of the applications cited above).

[0166] The device or implant 100 is deployed from a delivery system or other component 102 for delivery. The delivery system 102 may include one or more of the following: a catheter, a sheath, a guiding catheter / sheath, a delivery catheter / sheath, a manipulable catheter, an implant catheter, a tube, a channel, a pathway, combinations thereof, etc. The device or implant 100 includes a connecting portion 104 and an anchoring portion 106.

[0167] In some implementations, the engagement portion 104 of the device or implant 100 includes an engagement element 110 (e.g., spacer, plug, filler, foam, sheet, membrane, anastomotic element, etc.) adapted to be implanted between the leaflets of a native valve (e.g., a native mitral valve, native tricuspid valve, etc.) and slidably attached to an actuating element 112 (e.g., actuating wire, shaft, tube, hypotube, thread, suture, braid, etc.). The anchoring portion 106 includes one or more anchors 108 actuated between open and closed states and can take various forms, such as, for example, paddles, gripping elements, or the like. Actuation of the actuating member or actuating element 112 during implantation opens and closes the anchoring portion 106 of the device 100 to grip the native valve leaflets. The actuating member or actuating element 112 (and other actuating members and actuating elements herein) can take many different forms (e.g., as a wire, bar, shaft, tube, screw, thread, cord, strip, combination thereof, etc.), be made of various different materials, and have various configurations. As an example, the actuating element can be threaded, such that rotation of the actuating element causes the anchor portion 106 to move relative to the engagement portion 104. Alternatively, the actuating element can be unthreaded, such that pushing or pulling the actuating element 112 causes the anchor portion 106 to move relative to the engagement portion 104.

[0168] The anchoring portion 106 and / or anchoring element of the device 100 includes an outer blade 120 and an inner blade 122, which in some embodiments are connected between a cap 114 and the engaging element 110 by portions 124, 126, and 128. These portions 124, 126, and 128 may be interlocking and / or flexible, allowing movement between all the positions described below. The outer blade 120, the inner blade 122, the engaging element 110, and the cap 114, through the interconnection of these portions 124, 126, and 128, can restrain the device to the positions illustrated herein and allow movement.

[0169] In some embodiments, the delivery system 102 includes a manipulable catheter, an implant catheter, and an actuating member or actuating element 112 (e.g., an actuating wire, an actuating shaft, etc.). These can be assembled to extend through a guiding catheter / sheath (e.g., a septated sheath, etc.). In some embodiments, the actuating member or actuating element 112 extends through a delivery catheter and the engagement element 110 to a distal end (e.g., a cap 114 or other attachment at the distal connection structure of the anchor portion 106). Extending and retracting the actuating element 112 respectively increases and decreases the distance between the engagement element 110 and the distal end (e.g., cap 114 or other attachment) of the device. In some embodiments, a collar or other attachment element (e.g., clamp, clip, lock, stitch, friction engagement, fastener, snap fastener, lasso, etc.) is removably attached to the engagement element 110 to the delivery system 102, directly or indirectly, such that the actuating member or actuating element 112 slides through the collar or other attachment element during the opening and closing of the paddles 120, 122 and / or the anchor 108 of the anchor portion 106, and in some embodiments through the engagement element 110.

[0170] In some embodiments, the anchor portion 106 and / or anchor 108 may include an attachment portion or a gripping member. An illustrated gripping member may include a hook 130 comprising a base or fixed arm 132, a movable arm 134, an optional barb, friction-enhancing element, or other stabilizing member 136 (e.g., a protrusion, ridge, groove, textured surface, adhesive, etc.), and a junction portion 138. The fixed arms 132 are attached to the inner paddles 122. In some embodiments, the fixed arms 132 are attached to the inner paddles 122, wherein the junction portion 138 is disposed near a connecting element 110. In some embodiments, the hook (e.g., a barbed hook, barbed gripping member, etc.) has a flat surface and does not engage in a recess of the inner paddle. Instead, the flat portion of the hook rests against the surface of the inner paddle 122. The junction portion 138 provides a spring force between the fixed and movable arms 132, 134 of the hook 130. The junction portion 138 can be any suitable junction structure, such as a flexible junction structure, a spring junction structure, a pivot junction structure, or the like. In some embodiments, the junction portion 138 is a flexible material element integrally formed with the fixed and movable arms 132, 134. The fixed arms 132 are attached to the inner paddles 122 and remain stable or substantially stable relative to the inner paddles 122 when the movable arms 134 are opened to open the hooks 130 and expose any barbs or friction-enhancing elements or stabilizing members 136.

[0171] In some implementations, the hooks 130 are opened by applying tension to the actuation lines 116 attached to the movable arms 134, thereby causing the movable arms 134 to hinge, flex, or pivot at the junctions 138. The actuation lines 116 extend through the delivery system 102 (e.g., through a steerable catheter and / or an implant catheter). Other actuation mechanisms are also possible.

[0172] The actuation line 116 can take various forms, such as, for example, a single thread, a suture, a wire, a rod, a conduit, or the like. The hooks 130 can be spring-loaded, such that when in the closed position, they continue to provide a clamping force on the grasped primary leaflets. This clamping force remains constant regardless of the position of the inner blades 122. Any barbs or friction-enhancing elements or other stabilizing members 136 of the hooks 130 can grasp, clamp, and / or pierce the primary leaflets to further secure them.

[0173] During implantation, the paddles 120, 122 can open and close, for example, to grasp native leaflets (e.g., native cap leaflets, etc.) between the paddles 120, 122 and / or between the paddles 120, 122 and a coupling element 110. The hooks 130 can be used to engage the leaflets with optional barbs, friction-enhancing elements, or stabilizing members 136, and to clamp the leaflets between the movable and fixed arms 134, 132, to grasp and / or further stabilize the native leaflets. The optional barbs, friction-enhancing elements, or other stabilizing members 136 of the hooks 130 (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.) increase friction with the leaflets or can partially or completely puncture the leaflets. The actuation lines 116 can be separately actuated, such that each hook 130 can be separately opened and closed. The separate operation allows for the grasping of one leaf at a time, or for repositioning a hook 130 on a leaf that was not adequately grasped, without altering a successful grasp on another leaf. These hooks 130 can be opened and closed relative to the position of the inner propeller 122 (provided the inner propeller is in an open or at least partially open position), thereby allowing the leaf to be grasped in various positions as needed in specific situations.

[0174] Referring now to Figure 8, device 100 is shown in an extended or fully open position for deployment of an implantable catheter from one of the delivery systems 102. 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 position, cap 114 is spaced apart from engagement element 110 so that paddles 120, 122 are fully extended. In some implementations, the angle formed between the interiors of the outer and inner paddles 120, 122 is approximately 180 degrees. Hooks 130 remain in a closed position during deployment through the delivery system 102 so that any barbs, friction-enhancing elements, or other stabilizing members 136 (Figure 9) do not become lodged in or damage the delivery system 102 or tissue in the patient's heart.

[0175] Referring now to Figure 9, the device 100 is shown in a detangling position, similar to Figure 8, but with the hooks 130 in a fully open position. The range of the hooks 130's fixation to the movable arms 132, 134 is approximately 140 to approximately 200 degrees, approximately 170 to approximately 190 degrees, or approximately 180 degrees. It has been found that fully opening the paddles 120, 122 and the hooks 130 during implantation of the device 100 improves the ease of detangling or detachment from the patient's anatomy, such as chordae tendineae CT scans.

[0176] Referring now to Figure 10, the device 100 is shown in either a shortened or fully closed position. The compact size of the device 100 in the shortened position allows for easier manipulation and placement within the heart. To move the device 100 from the extended position to the shortened position, the actuating member or actuating element 112 retracts to pull the cap 114 toward the engaging element 110. The connection portion 126 (e.g., a junction structure, flexible connection structure, etc.) between the outer blades 120 and the inner blades 122 is movably restrained such that the compressive force acting on the outer blades 120 from the cap 114 toward the engaging element 110 causes the blades or gripping elements to move radially outward. During movement from the open position to the closed position, the outer blades 120 maintain an acute angle with the actuating member or actuating element 112. The outer blades 120 can be selectively biased toward a closed position. The inner blades 122 move through a significantly larger angle during the same movement because they are oriented away from the engagement element 110 when open and collapse along the side of the engagement element 110 when closed. In some embodiments, the inner blades 122 are thinner and / or narrower than the outer blades 120, and the connection portions 126, 128 (e.g., junction structures, flexible connection structures, etc.) connecting to the inner blades 122 can be thinner and / or more flexible. For example, this increased flexibility allows for more movement than the connection portion 124 connecting the outer blades 120 to the cap 114. In some embodiments, the outer blades 120 are narrower than the inner blades 122. The connecting portions 126, 128 to the inner blades 122 may be more flexible, for example, to allow more movement than the connecting portion 124 to which the outer blade 120 is connected to the cap 114. In some implementations, the inner blades 122 may be the same or substantially the same in width as the outer blades.

[0177] Referring now to Figures 11-13, the device 100 is shown in a partially open, ready-to-grip position. To transition from fully closed to partially open, an actuating member or actuating element (e.g., actuating wire, actuating shaft, etc.) extends to push the cap 114 away from the engaging element 110, thereby pulling the outer blade 120, which in turn pulls the inner blade 122, causing the anchor or anchor portion 106 to partially unfold. The actuating wire 116 also retracts to open the hooks 130, allowing the flaps to be gripped. In some implementations, the pair of inner and outer blades 122, 120 are moved in unison by a single actuating member or a single actuating element 112, rather than independently. Furthermore, the position of the hooks 130 depends on the position of the blades 122, 120. For example, referring to Figure 10, closing the blades 122, 120 also closes the hooks. In some implementations, the blades 120, 122 may be independently controllable. For example, the device 100 may have two actuating elements and two separate caps (or other attachments) such that one independent actuating element (e.g., wire, shaft, etc.) and cap (or other attachment) is used to control one blade, and the other independent actuating element and cap (or other attachment) is used to control the other blade.

[0178] Referring now to Figure 12, one of the actuation lines 116 extends to allow one of the hooks 130 to close. Referring now to Figure 13, another actuation line 116 extends to allow another hook 130 to close. Any or both of the actuation lines 116 can be repeatedly actuated to repeatedly open and close the hooks 130.

[0179] Referring now to Figure 14, the device 100 is shown in a fully closed and deployed position. The delivery system or delivery member 102 and the actuating member or actuating element 112 are retracted, and the paddles 120, 122 and hooks 130 are held in a fully closed position. Once deployed, the device 100 can be maintained in the fully closed position by a mechanical latch, or it can be biased to remain closed by using a spring material, such as steel, other metals, plastics, composites, or a shape memory alloy such as Nitinol. For example, the connecting portions 124, 126, 128, the junction portion 138, and / or the inner and outer blades 122, and / or an additional biasing assembly (not shown) may be formed of metal, such as steel or a shape memory alloy such as nitinol—produced as a wire, sheet, tube, or laser-sintered powder—and biased to hold the outer blade 120 closed around the connecting element 110, and the hooks 130 clamping around the original leaflets. Similarly, the fixing and movable arms 132, 134 of the hooks 130 are biased to clamp the leaflets. In some embodiments, the attachment or connecting portions 124, 126, 128, the junction portion 138 and / or the inner and outer blades 122, and / or an additional biasing assembly (not shown) may be formed of any other suitable elastic material, such as a metal or polymer material, to maintain the device 100 in a closed position after implantation.

[0180] Figure 15 illustrates an example where the blades 120 and 122 are independently controllable. The device 101 illustrated in Figure 15 is similar to the device 100 illustrated in Figure 11, except that the device 101 in Figure 15 includes an actuating element, which is configured to couple to two independent actuating elements 111 and 113 of two independent caps 115 and 117. In order to transition a first inner blade 122 and a first outer blade 120 from a fully closed to a partially open state, the actuating member or actuating element 111 extends to push the cap 115 away from the engaging element 110, thereby pulling the outer blade 120, which in turn pulls the inner blade 122, causing the first anchor 108 to partially unfold. To transition a second inner blade 122 and a second outer blade 120 from a fully closed to a partially open position, the actuating member or actuating element 113 extends to push the cap 115 away from the engaging element 110, thereby pulling the outer blade 120, which in turn pulls the inner blade 122, causing the second anchor 108 to partially unfold. The independent blade control illustrated in Figure 15 can be implemented in any device disclosed in this application. For comparison, in the example illustrated in Figure 11, the pair of inner and outer blades 122, 120 are moved uniformly by a single actuating member or actuating element 112, rather than independently.

[0181] Referring now to Figures 16-21, the device 100 of Figures 8-14 is shown being delivered and deployed within the native mitral valve MV of the heart H. Referring to Figure 16, a delivery sheath / catheter is inserted into the left atrium LA through the septum, and the implant / device 100 is deployed from the delivery catheter / sheath in a fully open position, as shown in Figure 16. The actuating member or actuating element 112 is then retracted to move the implant / device to the fully closed position shown in Figure 17.

[0182] As shown in Figure 18, the implant / device is moved into the position within the mitral valve (MV) and partially opened, allowing leaflets 20 and 22 to be grasped. For example, a maneuverable catheter can be moved forward and manipulated or flexed to position the maneuverable catheter, as shown in Figure 18. An implant catheter connected to the implant / device can be moved forward from within the maneuverable catheter to position the implant, as shown in Figure 18.

[0183] Referring now to Figure 19, the implant catheter is retractable into the manipulative catheter to position the mitral valve leaflets 20, 22 within the hooks 130. A co-actuator 116 extends to close one of the hooks 130, capturing one leaflet 20. Figure 20 shows another actuation line 116 then extending to close the other hook 130, capturing the remaining leaflets 22. Finally, as seen in Figure 21, the delivery system 102 (e.g., manipulative catheter, implant catheter, etc.), actuating member or actuating element 112, and actuation line 116 then retract, and the device or implant 100 is fully closed and deployed within the native mitral valve MV.

[0184] Referring now to Figures 22-27, an example of an implantable device or implant 200 is shown. This implantable device 200 is one of many different configurations that the device 100 schematically illustrated in Figures 8-14 can take. The device 200 may include any other features used for one of the implantable devices or implants discussed in this application, and the device 200 may be positioned to engage valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). The device / implant 200 may be an artificial spacer device attached to the leaflet of a native valve, a valve repair device, or another type of implant.

[0185] In some embodiments, the implantable device or implant 200 includes a connecting portion 204, a proximal or attachment portion 205, an anchor portion 206, and a distal portion 207. In some embodiments, the connecting portion 204 of the device optionally includes an engaging element 210 (e.g., a spacer, anastomotic element, plug, membrane, sheet, etc.) for implantation between the leaflets of a native valve. In some embodiments, the anchor portion 206 includes a plurality of anchors 208. These anchors can be assembled in various ways. In some embodiments, each anchor 208 includes an outer blade 220, an inner blade 222, a blade extension member or blade frame 224, and a hook 230. In some implementations, the attachment portion 205 includes a first or proximal collar 211 (or other attachment element) for engagement with a capture mechanism 213 (see, for example, Figures 43-49) of a delivery system 202 (Figures 38-42 and 49). The delivery system 202 may be the same as or similar to the delivery system 102 described elsewhere, and may include one or more of the following: a catheter, a sheath, a guiding catheter / sheath, a delivery catheter / sheath, a manipulable catheter, an implant catheter, a tube, a channel, a pathway, combinations thereof, etc. The capture mechanism can be assembled in various ways, and in some implementations may include one or more of the following: a clamp, clip, pin, suture, thread, noose, snare, fastener, lock, latch, etc.

[0186] In some implementations, the coupling 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 formed in any other suitable manner, or laser-cut, or otherwise cut. The material may be cloth, shape memory alloy wires providing shape setting capabilities—such as nitinol—or any other flexible material suitable for implantation in the human body.

[0187] An actuating element 212 (e.g., 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 the capture mechanism 213, the proximal collar 211, and the engagement element 210 to engage a cap 214 of the distal portion 207. The actuating element 212 can be assembled to removably engage the cap 214 to a threaded connection or similar structure, allowing the actuating element 212 to detach and be removed from the device 200 after implantation.

[0188] The coupling element 210 extends from the proximal collar 211 (or other attachment element) to the inner blade 222. In some embodiments, the coupling element 210 has a generally elongated and rounded shape, although other shapes and configurations are possible. In some embodiments, the coupling element 210 has an elliptical shape or cross-section when viewed from above (e.g., FIG. 51), a push-out shape or cross-section when viewed from a front view (e.g., FIG. 23), and a rounded shape or cross-section when viewed from a side view (e.g., FIG. 24). A combination of these geometries can result in the three-dimensional shape of the illustrated coupling element 210, which achieves the benefits described herein. The rounded shape of the coupling element 210 is also visible when viewed from above, substantially following or approximating the shape of the blade frame 224.

[0189] The size and / or shape of the connecting 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 implementations, the anterior-posterior distance at the top of the connecting element is approximately 5 mm, and the medial-lateral distance at its widest point is approximately 10 mm. In some implementations, the overall geometry of the device 200 can be based on these two size and overall shape strategies described above. It will be readily apparent that using other anterior-posterior and medial-lateral distances as the starting point for the device will result in devices of different sizes. Furthermore, using other size and shape strategies described above will also result in devices of different sizes.

[0190] In some implementations, the outer blade 220 is jointly attached to the cap 214 of the distal portion 207 via connecting portion 221, and jointly attached to the inner blade 222 via connecting portion 223. The inner blade 222 is jointly attached to the coupling element via connecting portion 225. In this way, the anchor 208 is assembled to resemble a foot, because the inner blades 222 resemble the upper portion of the foot, the outer blades 220 resemble the lower portion of the foot, and the connecting portions 223 resemble the knee portion of the foot.

[0191] In some implementations, the inner propeller 222 is rigid, relatively rigid, and has a rigid portion and / or is rigidified by a rigid member of the hook 230 or a fixing arm 232. This rigidification of the inner propeller allows the device to move to various positions shown and described herein. The inner propeller 222, outer propeller 220, and couplings can be interconnected as described herein, such that the device 200 is restrained to the movements and positions shown and described herein.

[0192] In some embodiments, the blade frame 224 is attached to a cap 214 at the distal end 207 and extends to the connection portion 223 between the inner and outer blades 222, 220. In some embodiments, the blade frame 224 is formed of a material that is more rigid and stiffer than the material forming the blades 222, 220, such that the blade frame 224 provides support for the blades 222, 220.

[0193] The blade frame 224 provides additional clamping force between the inner blade 222 and the coupling element 210, and assists in covering the lobes around the sides of the coupling element 210 for a better seal between the coupling element 210 and the lobes, as can be seen in FIG51. That is, the blade frames 224 can be assembled into a rounded three-dimensional shape with a connecting portion 223 extending from the cap 214 to the anchor 208. The connection structure between the blade frames 224, the outer and inner blades 220, 222, the cap 214 and the coupling element 210 can restrain each of these components to the movement and position described herein. Specifically, the connecting portion 223 is restrained by its connection structure between the outer and inner blades 220, 222 and by its connection structure to the blade frame 224. Similarly, the blade frame 224 is restrained by its attachment to the connection portion 223 (and thus the inner and outer blades 222, 220) and to the cap 214.

[0194] Assembling the blade frames 224 in this manner provides an increased surface area compared to the individual outer blades 220. For example, this makes it easier to grasp and secure the native leaflets. This increased surface area also distributes the clamping force of the blades 220 and blade frames 224 against the native leaflets over a relatively larger surface of the native leaflets, further protecting the native leaflet tissue. Referring again to FIG51, the increased surface area of ​​the blade frames 224 also allows the native leaflets to be clamped to the implantable device or implant 200 so that the native leaflets are fully engaged around the engagement member or engagement element 210. For example, this improves the seal of the native leaflets 20, 22, and thus prevents or further reduces mitral valve backflow.

[0195] In some embodiments, the hook system includes a movable arm coupled to an anchor. In some embodiments, the hook 230 includes a base or fixed arm 232, a movable arm 234, an optional barb 236, and a junction portion 238. The fixed arm 232 is attached to the inner paddle 222, wherein the junction portion 238 is positioned near the engagement element 210. The junction portion 238 is spring-loaded, such that when the hook 230 is closed, the fixed and movable arms 232, 234 are biased toward each other. In some embodiments, the hook 230 includes friction-enhancing elements or components for stabilization, such as optional barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc.

[0196] In some implementations, the fixed arms 232 are attached to the inner paddles 222 via holes or slots 231 using stitching (not shown). The fixed arms 232 can be attached to the inner paddles 222 using any suitable material, such as screws or other fasteners, retractable sleeves, mechanical latches or fasteners, welds, adhesives, clamps, latches, or the like. The fixed arms 232 remain substantially stable relative to the inner paddles 222 when the movable arms 234 are opened to open the hooks 230 and expose an optional barb or other friction-enhancing element 236. The hooks 230 are opened by applying tension to the actuation lines 216 (e.g., shown in Figures 43-48) attached to the holes 235 in the movable arms 234, thereby causing the movable arms 234 to hinge, pivot, and / or flex at the junctions 238.

[0197] Referring now to Figure 29, an enlarged view is shown of one of the leaflets 20, 22 held by a hook, such as hook 230. The leaflets 20, 22 are held between the movable and fixed arms 234, 232 of the hook 230. The tissue of the leaflets 20, 22 is not pierced by the chosen barbs or friction-enhancing elements 236, but in some embodiments, the chosen barbs 236 may partially or completely pierce the leaflets 20, 22. The angle and height of the chosen barbs or friction-enhancing elements 236 relative to the movable arm 234 help to secure the leaflets 20, 22 within the hook 230. Specifically, a force pulling the implant away from the native leaflets 20, 22 will promote further engagement of the tissue by the chosen barbs or friction-enhancing elements 236, thereby ensuring better retention. When the hook 230 is closed, the engagement of the leaflets 20 and 22 within the hook 230 is further enhanced by the position of the fixed arm 232 near the optional barb / friction enhancement element 236. In this configuration, the tissue is formed into an S-shaped twisted path by the fixed arms 232, the movable arms 234, and the optional barb / friction enhancement element 236. Therefore, before the leaflets 20 and 22 can escape, the force pulling the leaflets 20 and 22 away from the hook 230 will promote further engagement of the tissue with the optional barb / friction enhancement element 236. For example, leaflet tension during diastole can promote the pulling of the optional barbs 236 toward the end portions of the leaflets 20 and 22. Thus, the S-shaped path can utilize the leaflet tension during diastole to more tightly engage the leaflets 20 and 22 with the optional barb / friction enhancement element 236.

[0198] Referring 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 engagement element 210, the outer and inner paddles 220, 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 native tissue. In some embodiments, the cover 240 may be a fabric such as PET, velvet, or other suitable cloth or textile. In some embodiments, instead of or in addition to a fabric, the cover 240 may include a coating (e.g., a polymer) applied to the implantable device or implant 200.

[0199] During implantation, the paddles 220, 222 of the anchors 208 are opened and closed to grasp the native valve leaflets 20, 22 between the paddles 220, 222 and the engagement element 210. The anchors 208 move between a closed position (Figures 22-25) and various open positions (Figures 26-37) by extending and retracting the actuating element 212. Extending and retracting the actuating element 212 increases and decreases the distance between the engagement element 210 and the cap 214, respectively. The proximal collar 211 (or other attachment element) and the engagement element 210 slide along the actuating element 212 during actuation, causing the distance between the engagement element 210 and the cap 214 to change, resulting in the paddles 220, 220 moving between different positions to grasp the mitral valve leaflets 20, 22 during implantation.

[0200] As the device 200 is opened and closed, the inner and outer blades 222, 220 move in unison via a single actuating element 212, rather than independently. Furthermore, the position of the hooks 230 depends on the position of the blades 222, 220. For example, the hooks 230 are configured such that the closing of the anchors 208 simultaneously closes the hooks 230. In some implementations, the device 200 may be configured to allow the blades 220, 222 to be independently controllable in the same manner (e.g., device 101 illustrated in FIG. 15).

[0201] In some embodiments, the hooks 230 further secure the original leaflets 20, 22 by engaging the leaflets 20, 22 with optional barbs and / or other friction-enhancing elements 236, and / or clamping the leaflets 20, 22 between the movable and fixed arms 234, 232. In some embodiments, the hooks 230 are barbed hooks, including barbs that increase friction with the leaflets 20, 22 and / or can partially or completely pierce the leaflets 20, 22. The actuation lines 216 (Figures 43-48) are separately actuated, allowing each hook 230 to be opened and closed separately. The separate operation allows for the grasping of one leaflet 20, 22 at a time, or for repositioning a hook 230 that is not adequately grasped on one leaflet 20, 22, without altering a successful grasp on another leaflet 20, 22. These hooks 230 can be fully opened and closed when the inner paddle 222 is not closed, thereby allowing the leaflets 20, 22 to be held in various positions as needed in specific situations.

[0202] Referring now to Figures 22-25, the device 200 is shown in a closed position. When closed, the inner blades 222 are positioned between the outer blades 220 and the engagement element 210. Hooks 230 are positioned between the inner blades 222 and the engagement element 210. After successfully capturing the native leaflets 20, 22, the device 200 moves to and engages in the closed position, such that the leaflets 20, 22 are secured within the device 200 by the hooks 230 and pressed against the engagement element 210 by the blades 220, 222. The outer blades 220 may have a wide curved shape that, when the device 200 is closed (e.g., as seen in Figure 51), conforms to the curved shape of the engagement element 210 to more firmly grasp the leaflets 20, 22. The curved shape and rounded edges of the outer blades 220 also prevent or inhibit tearing of the leaflet tissue.

[0203] Referring now to Figures 30-37, the implantable device or implant 200 described above is shown in various positions and configurations ranging from partially open to fully open. The blades 220, 222 of the device 200 transition between each position shown in Figures 30-37, beginning in the closed position shown in Figures 22-25, with the actuating element 212 extending upward from a fully retracted position to a fully extended position.

[0204] Referring now to Figures 30-31, the device 200 is shown in a partially open position. The device 200 is moved to this partially open position by extending the actuating element 212. Extending the actuating element 212 pulls downward the bottom portions of the outer blades 220 and blade frames 224. The outer blades 220 and blade frames 224 pull downward the inner blades 222, which are connected to the outer blades 220 and blade frames 224. Because the proximal collar 211 (or other attachment element) and engagement element 210 are held in place by the capturing mechanism 213, the inner blades 222 are caused to hinge, pivot, and / or flex in an open direction. The inner blades 222, outer blades 220, and blade frames are all flexed to the position shown in Figures 30-31. Opening the blades 222, 220 and the frame 224 creates a gap between the engaging element 210 and the inner blade 222, allowing for the reception and gripping of the primary leaflets 20, 22. This movement also exposes the hooks 230, which are movable between a closed (FIG. 30) and an open (FIG. 31) position to create a second gap for gripping the primary leaflets 20, 22. The degree of the gap between the fixed and movable arms 232, 234 of the hooks 230 is limited by the extent to which the inner blade 222 has dispersed away from the engaging element 210.

[0205] Referring now to Figures 32-33, the device 200 is shown in a laterally extended or open position. By continuously extending the aforementioned actuating element 212, the device 200 moves to this laterally extended or open position, thereby increasing the distance between the engaging element 210 and the cap 214 of the distal portion 207. Continuously extending the actuating element 212 pulls downward on the outer blades 220 and blade frames 224, thereby causing the inner blades 222 to further disperse away from the engaging element 210. In the laterally extended or open position, the inner blades 222 extend more horizontally than in other positions of the device 200 and form an approximately 90-degree angle with the engaging element 210. Similarly, when the device 200 is in the laterally extended or open position, the blade frames 224 are in their most dispersed position. The increased gap formed between the engaging element 210 and the inner paddle 222 when in the laterally extended or open position allows the hook 230 to open further before engaging the engaging element 210 (Fig. 33), thereby increasing the size of the gap between the fixed and movable arms 232, 234.

[0206] Referring now to Figures 34-35, the example device 200 is shown in the three-quarters extended position. By continuously extending the aforementioned actuator 212, the device 200 moves to the three-quarters extended position, thereby increasing the distance between the engaging element 210 and the cap 214 of the distal portion 207. Continuing to extend the actuator 212 pulls the outer blades 220 and blade frames 224 downward, thereby causing the inner blades 222 to further disperse away from the engaging element 210. In the three-quarters extended position, the inner blades 222 are opened more than 90 degrees to form an angle of approximately 135 degrees with the engaging element 210. As the actuator 212 extends further, the blade frames 224 are less dispersed than when in the laterally extended or open position and begin to move inward toward the actuator 212. The outer blades 220 also flex back toward the actuator 212. When in the lateral extension or open position, the increased gap formed between the engaging element 210 and the inner paddle 222 when in the lateral extension or open position allows the hook 230 to open even further (Fig. 35), thereby increasing the size of the gap between the fixed and movable arms 232, 234.

[0207] Referring now to Figures 36-37, the example device 200 is shown in a fully extended position. By continuously extending the aforementioned actuating element 212, the device 200 moves to the fully extended position, thereby increasing the distance between the engaging element 210 and the cap 214 of the distal portion 207 to a maximum distance permissible by the device 200. Continuing to extend the actuating element 212 pulls downward on the outer blades 220 and blade frame 224, thereby causing the inner blades 222 to further disperse away from the engaging element 210. The outer blades 222 and blade frame 224 move to a position where they are close to the actuating element. In the fully extended position, the inner blades 222 are opened to an angle of approximately 180 degrees with the engaging element 210. When the inner and outer blades 222 and 220 are in the fully extended position, they extend straight out to form an angle of approximately 180 degrees between them. The fully extended position of the device 200 provides the maximum size of the gap between the engaging element 210 and the inner blade 222, and in some implementations, allows the hook 230 to also be fully open, reaching approximately 180 degrees between the fixed and movable arms 232 and 234 of the hook 230 (Figure 37). This position of the device 200 is its longest and narrowest configuration. Therefore, the fully extended position of the device 200 can be a desired location for parachuting from an attempt to implant the device 200, or a desired location for placing the device in a delivery conduit, or similar.

[0208] Assembling the device or implant 200 such that the anchors 208 extend in a straight or approximately straight configuration (e.g., approximately 120-180 degrees relative to the engagement element 210) offers several advantages. For example, this configuration reduces the radially coiled profile of the device or implant 200. It also facilitates the gripping of the native leaflets 20, 22 by providing a larger opening between the engagement element 210 and the inner paddles 222 for gripping therein. Additionally, this relatively narrow, straight configuration prevents or reduces the likelihood that the device or implant 200 will become entangled in the native anatomical structures (e.g., the chordae tendineae CT shown in Figures 3 and 4) when positioned and / or retracted into the delivery system 202.

[0209] Referring now to Figures 38-49, an example device 200 is shown being delivered and deployed within the native mitral valve MV of the heart H. As described above, the device 200 shown in Figures 38-49 includes an optional cap 240 (e.g., Figure 25), hook 230, inner paddle 222, and / or outer paddle 220 on the engagement element 210. The device 200 is deployed from a delivery system 202 (e.g., which may include an implant catheter extendable from a manipulable catheter 241 and / or a guide sheath), held by a capture mechanism 213 (see, for example, Figures 43 and 48), and actuated by extending or retracting the actuating element 212. The fingers of the capture mechanism 213 removably attach a collar 211 to the delivery system 202. In some implementations, the capture mechanism 213 is held closed around the collar 211 by the actuating element 212, so that after the device 200 has been successfully implanted, the 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.

[0210] Referring now to Figure 38, the delivery system 202 (e.g., one of its delivery catheters / sheaths) is inserted into the left atrium LA via the septum, and the device / implant 200 is deployed from the delivery system 202 (e.g., an implant catheter holding the device / implant may be extended to deploy the device / implant from a maneuverable catheter) to a fully open position, for the reasons discussed above regarding the device 100. The actuating element 212 then retracts to move the device 200 through a partially closed position (Figure 39) and to a fully closed position as shown in Figures 40-41. Then, as shown in Figure 41, the delivery system or catheter maneuvers the device / implant 200 toward the mitral valve MV. Referring now to Figure 42, when the device 200 is aligned with the cap flap MV, the actuating element 212 extends to open the paddles 220, 222 to a partially open position, and the actuating lines 216 (Figures 43-48) retract to open the hooks 230 in preparation for leaflet grasping. Next, as shown in Figures 43-44, the partially opened device 200 is inserted through the native valve (e.g., by advancing an implant catheter from a maneuverable catheter) until the leaflets 20, 22 are properly positioned between the inner paddles 222 and the engagement element 210 and within the opened hooks 230.

[0211] Figure 45 shows the device 200, in which two hooks 230 are closed, but an optional barb 236 of one hook 230 misses a leaflet 22. As seen in Figures 45-47, the hook 230 in the inappropriate position is reopened and closed to properly grasp the missed leaflet 22. When the leaflets 20, 22 are properly grasped, the actuating element 212 retracts to move the device 200 to the fully closed position shown in Figure 48. With the device 200 fully closed and implanted in the native valve, the actuating element 212 is disengaged from the cap 214 and withdrawn to release the capture mechanism 213 from the proximal collar 211 (or other attachment element), so that the capture mechanism 213 can be drawn into the delivery system 202 (e.g., to a catheter / sheath), as shown in Figure 49. Once deployed, the device 200 can be maintained in the fully closed position by a mechanical component such as a latch, or it can be biased to remain closed by using a spring material such as steel and / or a shape memory alloy such as nitinol. For example, the blades 220, 222 can be formed from steel or nitinol shape memory alloys—produced as wires, sheets, tubes or laser-sintered powders—and biased to hold the outer blades 220, the engagement element 210, and / or the hooks 230 clamped around the original leaflets 20, 22 closed around the inner blades 222.

[0212] Referring to Figures 50-54, once the device 200 is implanted into a native valve, the engaging element 210 acts as a gap filler in the valvular regurgitation orifice, such as gap 26 in the mitral valve MV shown in Figure 6 or a gap in another native valve. In some implementations, when the device 200 has been deployed between two opposing valve leaflets 20, 22, the leaflets 20, 22 no longer engage abut against each other in the region of the engaging element 210, but rather engage abut against the engaging element 210. This reduction in the distance required for the leaflets 20, 22 to approach so that the mitral valve MV closes during systole promotes the repair of functional valvular disease that may cause mitral valve regurgitation. A reduction in the leaflet approach distance can also lead to several other advantages. For example, the reduced approach distance required for the leaflets 20, 22 reduces or minimizes the stress experienced by the native valve. The shorter approach distance of the valve leaflets 20, 22 may also require less approach force, which can result in less tension on the leaflets 20, 22 and a smaller diameter of the valve annulus. Compared to a device without a connecting element or spacer, the smaller reduction—or non-existent reduction—of the valve annulus can result in a smaller reduction in the orifice area. In this way, the connecting element 210 can reduce the transvalvular gradient.

[0213] To adequately fill the gap 26 between the leaflets 20, 22, the device 200 and its components can have various shapes and sizes. For example, the outer blades 220 and blade frames 224 can be assembled to conform to the shape or geometry of the engagement element 210, as shown in Figures 50-54. In this way, the outer blades 220 and blade frames 224 can mate with both the engagement element 210 and the native valve leaflets 20, 22. In some embodiments, when the leaflets 20, 22 engage against the engagement element 210, the leaflets 20, 22 completely surround or "hug" the entire engagement element 210, thus preventing or suppressing minor leaks at the lateral and central surfaces 201, 203 of the engagement element 210. The interaction between the leaflets 20, 22 and the device 200 is clearly visible in Figure 51, which shows a schematic view from an atrium or surgeon's perspective, illustrating that the paddle frame 224 (which would not actually be seen in a real atrium view, such as Figure 52) conforms to the geometry of the engagement element 210. The opposing leaflets 20, 22 (whose ends would also not be seen in a real atrium view, such as Figure 52) are approached by the paddle frame 224 to completely surround or "embrace" the engagement element 210.

[0214] The engagement of the leaflets 20, 22 against the lateral and medial surfaces 201, 203 (shown atrially in Figure 52 and ventricularly in Figure 53) of the engagement element 210 appears to contradict the statement above: the presence of the engagement element 210 minimizes the distance required for the leaflets to approach each other. However, if the engagement element 210 is precisely positioned at a backflow gap 26, the distance required for the leaflets 20, 22 to approach each other is still minimized, and the backflow gap 26 is smaller than the width of the engagement element 210 (medial-lateral).

[0215] Figure 50 illustrates the geometry of the engagement element 210 and the paddle frame 224 in an LVOT perspective view. As can be seen in this view, the engagement element 210 has a tapered shape and is smaller in size closer to the region where the inner surfaces of the leaflets 20, 22 need to be engaged, and increases in size as the engagement element 210 extends toward the atrium. Therefore, the illustrated native valve geometry conforms to a tapered engagement element geometry. Referring again to Figure 50, this tapered engagement element geometry, in relation to the illustrated extended paddle frame shape (towards the valve annulus), helps achieve engagement at the lower ends of the leaflets, reduces stress, and minimizes transvalvular gradients.

[0216] Referring to Figure 54, the shapes of the coupling element 210 and the blade frames 224 can be defined based on an internal combined view of the original valve and the device 200. Two factors of these shapes are the engagement of the leaflets against the coupling element 210 and the reduction of stress on the leaflets due to the engagement. Referring to Figures 54 and 24, for both: engaging the valve leaflets 20, 22 against the coupling element 210; and reducing the stress applied to the valve leaflets 20, 22 by means of the coupling element 210 and / or the blade frames 224, the coupling element 210 may have a rounded or circular shape, and the blade frames 224 may have a full radius that spans almost the entire length of the blade frames 224. The rounded shape of the connecting element 210 and / or the illustrated fully rounded shape of the blade frames 224 distributes stress across a large, curved connection region 209 on the leaflets 20, 22. For example, in Figure 54, when the leaflets 20 attempt to open during diastole, the force on the leaflets 20, 22 via the blade frames is distributed along the entire rounded length of the blade frames 224.

[0217] Referring now to Figure 55, an example of one implantable device or implant 300 is shown. This implantable device 300 is one of many different configurations that the device 100 schematically illustrated in Figures 8-14 can take. The device 300 may include any other features used for one of the implantable devices or implants discussed in this application, and the device 300 may be positioned to engage valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0218] The implantable device or implant 300 includes a proximal or attachment portion 305, an anchor portion 306, and a distal portion 307. In some embodiments, the device / implant 300 includes an engagement portion 304, which may optionally include an engagement element 310 (e.g., a spacer, plug, membrane, sheet, etc.) for implantation between the leaflets 20, 22 of the native valve. In some embodiments, the anchor portion 306 includes a plurality of anchors 308. In some embodiments, each anchor 308 may include one or more blades, such as an outer blade 320, an inner blade 322, a blade extension member, or a blade frame 324. The anchors may also include and / or be coupled to a hook 330. In some implementations, the attachment portion 305 includes a first or proximal collar 311 (or other attachment element) for engagement with a capture mechanism of a delivery system (e.g., a capture mechanism 213 as shown in Figures 43-49, or another capture mechanism described herein or otherwise known) of a delivery system (e.g., a delivery system such as the system shown in Figures 38-42 and 49).

[0219] Anchors 308 can be attached to other parts of the device and / or to each other in various ways (e.g., directly, indirectly, by welding, stitching, adhesive, linkage, latch, integrally formed, some or all of these combinations, etc.). In some implementations, anchors 308 are attached to a connecting member or connecting element 310 by means of connecting portion 325 and to a cap 314 by means of connecting portion 321.

[0220] Anchor 308 may include a first portion or outer blade 320 and a second portion or inner blade 322 separated by connecting portions 323. These connecting portions 323 may be attached to a blade frame 324, or hingedly attached to a cap 314 or other attachment portion. In this way, anchor 308 is assembled to resemble a foot, because the inner blades 322 resemble the upper portion of the foot, the outer blades 320 resemble the lower portion of the foot, and the connecting portions 323 resemble the knee portion of the foot.

[0221] In an embodiment with a joining member or joining element 310, the joining member or joining element 310 and the anchoring elements 308 can be coupled together in various ways. For example, as illustrated in the example, the joining element 310 and the anchoring elements 308 can be coupled together by integrally forming the joining element 310 and the anchoring elements 308 as a single integral component. This can be achieved, for example, by forming the joining element 310 and the anchoring elements 308 from a continuous strip 301 formed from a braided or woven material such as braided or woven nickel-titanium yarn. In the illustrated example, the joining element 310, the outer paddle portions 320, the inner paddle portions 322, and the connecting portions 321, 323, 325 are formed from the continuous strip 301 of the fabric.

[0222] Similar to the anchors 208 of the implantable device or implant 200 described above, these anchors 308 can be assembled 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 anchors 308 relative to a 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, the anchors 308 can be positioned in a fully extended or straight configuration (e.g., similar to the configuration of device 200 shown in FIG. 36) by moving the distal end (e.g., cap 314, etc.) away from the proximal end of the device.

[0223] In some embodiments, in a straight configuration, the blade portions 320, 322 are aligned or straightened along the longitudinal axis of the device. In some embodiments, the connecting portions 323 of the anchors 308 are adjacent to the longitudinal axis of the connecting element 310 (e.g., similar to the configuration of device 200 shown in FIG. 36). From this straight configuration, the anchors 308 can be moved to a fully folded configuration (e.g., FIG. 55), for example by moving the proximal and distal ends toward each other and / or toward one of the midpoints or centers of the device. Initially, as the distal end (e.g., cap 314, etc.) moves toward the proximal end and / or midpoint or center of the device, the anchors 308 bend 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 toward the midpoint and / or proximal end of the device (e.g., similar to the configuration of device 200 shown in FIG. 34). As the cap 314 continues to move toward the midpoint and / or proximal end of the device, the connecting portion 323 moves radially inward relative to the longitudinal axis of the device 300 and toward the proximal end of the device (e.g., similar to the configuration of device 200 shown in FIG. 30).

[0224] In some embodiments, the hooks include a movable arm coupled to an anchor. In some embodiments, the hooks 330 (as shown in detail in FIG. 56) include a base or fixed arm 332, a movable arm 334, an optional barb / friction enhancement element 336, and a junction portion 338. The fixed arm 332 is attached to the inner paddle 322, wherein the junction portion 338 is located near the engagement element 310. The junction portion 338 is spring-loaded, such that when the hooks 330 are closed, the fixed and movable arms 332, 334 are biased toward each other.

[0225] The fixed arms 332 are attached to the inner paddles 322 via holes or slots 331 using stitching (not shown). The fixed arms 332 can be attached to the inner paddles 322 using any suitable component, such as screws or other fasteners, retractable sleeves, mechanical latches or fasteners, welds, adhesives, or the like. The fixed arms 332 remain substantially stable relative to the inner paddles 322 when the movable arms 334 are opened to open the hooks 330 and expose the optional barbs 336. The hooks 330 are opened by applying tension to an actuation line (e.g., actuation line 216 shown in Figures 43-48) attached to a hole 335 in the movable arms 334, thereby causing the movable arms 334 to hinge, pivot, and / or flex at the junction 338.

[0226] 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 coupling element 310, outer blade 320, inner blade 322, and connecting portions 321, 323, and 325 are formed from a single material strip 301. In some embodiments, the material strip 301 is attached to the proximal collar 311, the cap 314, and the blade frames 324 by weaving or inserting it through openings in the assembled receiving continuous material strip 301. The continuous strip 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 or overlay layers of material strip 301.

[0227] For example, Figure 55 shows a bonding element 310 and an inner blade 322 formed by multiple overlapping layers of material strips 301. The single continuous material strip 301 can begin and end at various locations within the device 300. The ends of the material strip 301 can be at the same or different locations within the device 300. For example, in the instance illustrated in Figure 55, the material strip 301 begins and ends at the location of the inner blade 322.

[0228] As described above regarding the implantable device or implant 200, the size of the engagement element 310 can be selected to minimize the number of implants (preferably one) a single patient would require, while maintaining a low transvalvular gradient. Specifically, many components of the device 300 formed by the material strip 301 allow 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 engagement element 310 is less than 2 mm, and the mid-lateral distance of the device 300 (i.e., the width of the paddle frame 324, which is wider than the engagement element 310) is approximately 5 mm at its widest point.

[0229] Figures 57-63 illustrate another example of one of a plurality of valve repair systems 400 used to repair a patient's native valve, to which the concepts of this application can be applied. The valve repair system 400 includes a delivery device 401 and a valve repair device 402.

[0230] The valve repair device 402 includes a base assembly 404, a pair of blades 406, and a pair of gripping members 408 (e.g., hooks, hook arms, grippers, gripper arms, latches, etc.). In some embodiments, the blades 406 may be integrally formed with the base assembly. For example, the blades 406 may be formed as extensions of a linkage 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 stable position on the shaft. The coupling member 405 is mechanically connected to the blades 406 such that movement of the coupling member 405 along the shaft 403 causes the blades to move between an open position and a closed position. In this manner, the coupling member 405 serves as a component for mechanically coupling the blades 406 to the shaft 403 and for causing the blades 406 to move between their open and closed positions when moving along the shaft 403.

[0231] In some implementations, the gripping members 408 are pivotally connected to the base assembly 404 (e.g., the gripping members 408 are pivotally connected to the shaft 403, or any other suitable member of the base assembly) so that the gripping members are movable to adjust the width of the opening 414 between the paddles 406 and the gripping members 408. When the valve repair device 402 is attached to valve tissue, the gripping members 408 may include an optional barb portion 409 for attaching the gripping members to the valve tissue. The gripping member 408 forms a component for gripping valve tissue (particularly valve leaflet tissue) having an adhesive component or portion such as the optional barb portion 409. When the blades 406 are in the closed position, they engage the gripping members 408 such that, when valve tissue attaches to the optional barb portions 409 of the gripping members, the blades act as holding or stabilizing members to hold the valve tissue at the gripping members and to secure the valve repair device 402 to the valve tissue. In some embodiments, the gripping members 408 are assembled to engage the blades 406 such that the optional barb portions 409 engage the valve tissue portion and the blades 406 to secure the valve repair device 402 to the valve tissue portion. For example, in some cases, it may be advantageous to maintain the blades 406 in an open position and to move the gripping members 408 outward toward the blades 406 to engage the valve tissue and the blades 406.

[0232] Although the examples shown in Figures 57-63 illustrate a pair of blades 406 and a pair of gripping members 408, it should be understood that the valve repair device 402 may include any suitable number of blades and gripping members.

[0233] In some implementations, the valve repair system 400 includes a placement shaft 413 detachably attached to a shaft 403 of the 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 rest of the valve repair system 400, so that the valve repair device 402 remains attached to the valve tissue and the delivery device 401 can be removed from a patient's body.

[0234] The valve repair system 400 may also include a blade control mechanism 410, a gripper control mechanism 411, and a locking control mechanism 412. The blade control mechanism 410 is mechanically attached to the coupling member 405 to move the coupling member along the shaft, causing the blades 406 to move between open and closed positions. The blade 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 blade control mechanism may include a hollow shaft, a catheter tube, or a sleeve that engages with the placement shaft 413 and the shaft 403 and is connected to the coupling member 405.

[0235] The gripper control mechanism 411 is assembled to move the gripping members 408 such that the width of the opening 414 between the gripping members and the blades 406 is variable. The gripper control mechanism 411 can take any suitable form, such as, for example, a single thread, a stitch, a single wire, a rod, a conduit, a tube, a thallium tube, etc.

[0236] The lock control mechanism 412 is assembled to lock and unlock the lock. The lock 407 acts as a locking member to lock the coupling 405 in a stable position relative to the shaft 403, and can take many different forms, with the type of lock control mechanism 412 specified by the type of lock used. In some implementations, the lock 407 includes a pivotable plate with an opening in which the shaft 403 of the valve repair device 402 is housed. In this example, when the pivotable plate is in an inclined position, it engages the shaft 403 to maintain a position on the shaft 403, but when the pivotable plate is in a substantially non-inclined position, it can move along the shaft (allowing the coupling 405 to move along the shaft 403). In other words, when the pivotable plate of the lock 407 is in an inclined (or locked) position, the coupling 405 is prevented or inhibited from moving along the shaft 403 in the Y direction (as shown in FIG. 61A), and when the pivotable plate is in a substantially non-inclined (or unlocked) position, the coupling is allowed to move along the shaft 403 in the Y direction. In an example where the lock 407 includes a pivotable plate, the lock control mechanism 412 is configured to engage the pivotable plate to move the plate between inclined and substantially non-inclined positions. The lock control mechanism 412 may be, for example, a bar, a thread, a wire, or any other component that enables one of the pivotable plates of the lock 407 to move between an inclined and substantially non-inclined position. In some implementations, the pivotable plate of the lock 407 is biased into the tilted (or locked) position, and the lock control mechanism 412 is used to move the plate from the tilted position to the substantially non-tilted (or unlocked) position.

[0237] Figures 61A-61B illustrate the valve repair device 402 moving from an open position (as shown in Figure 61A) to a closed position (as shown in Figure 61B). 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. The coupling member 405 is movably attached to the 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 member 405 at point A, such that the coupling member 405 moves along the movement system of the shaft 403 to position 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. One blade 406a is attached to the first link 1021 such that the movement system of the first link 1021 causes the blade 406a to move, and another blade 406b is attached to the second link 1022 such that the movement system of the second link 1022 causes the blade 406b to move. In some implementations, the blades 406a, 406b may be connected to the connecting rods 1023, 1024 or extensions of the connecting rods 1023, 1024.

[0238] To move the valve repair device from the open position (as shown in FIG. 61A) to the closed position (as shown in FIG. 61B), the coupling member 405 moves along the shaft 403 in the Y direction, causing the pivot point A of the first link 1021 and the second link 1022 to a new position. Moving the coupling member 405 (and pivot point A) in the Y direction causes a portion of the first link 1021 near point A to move in the H direction, and a portion of the first link 1021 near point B to move in the J direction. The blade 406a is attached to the first link 1021 such that the movement of the coupling member 405 in the Y direction causes the blade 406a to move in the Z direction. Furthermore, the third link 1023 is pivotally attached to the first link 1021 at point B, such that movement of the coupling member 405 in the Y direction causes the third link 1023 to move in the K direction. Similarly, movement of the coupling member 405 (and pivot point A) in the Y direction causes a portion of the second link 1022 near point A to move in the L direction, and a portion of the second link 1022 near point C to move in the M direction. The blade 406b is attached to the second link 1022, such that movement of the coupling member 405 in the Y direction causes the blade 406b to move in the V direction. Furthermore, the fourth link 1024 is pivotally attached to the second link 1022 at point C, such that movement of the coupling member 405 in the Y direction causes the fourth link 1024 to move in the N direction. Figure 61B illustrates the final position of the valve repair device 402 after the coupling 405 has been moved as shown in Figure 61A.

[0239] Referring to Figure 58, the valve repair device 402 is shown in the open position (similar to the position shown in Figure 61A), and the gripping member control mechanism 411 is shown moving the gripping member 408 to provide a wider gap at the opening 414 between the gripping member and the paddles 406. In the illustrated example, the gripping member control mechanism 411 includes a wire, such as a suture or a thread, which passes through an opening at one end of the gripping member 408. Both ends of the wire extend through the delivery opening 516 of the delivery device 401. When the wire is pulled in the direction Y through the delivery opening 516, the gripping member 408 moves inward in the direction X, causing the opening 414 between the gripping member and the paddles 406 to widen.

[0240] Referring to Figure 59, the valve repair device 402 is shown such that valve tissues 20, 22 are positioned in an opening 414 between the gripping members 408 and the blades 406. Referring to Figure 60, after the valve tissues 20, 22 are positioned between the gripping members 408 and the blades 406, a gripping control mechanism 411 is used to reduce the width of the opening 414 between the gripping members and the blades. That is, in the illustrated example, the line of the gripping control mechanism 411 is released or extended in direction H from the opening 516 of the delivery member, which allows the gripping members 408 to move in direction D to reduce the width of the opening 414. Although the gripper control mechanism 411 is shown to be moving the gripper 408 to increase the width of the opening 414 between the gripper and the paddles 406 (FIG. 59), it should be understood that it may not be necessary to move the gripper to position the valve tissue in the opening 414. However, in certain situations, the opening 414 between the paddles 406 and the gripper 408 may be wider to facilitate receiving the valve tissue.

[0241] Referring to Figure 62, the valve repair device 402 is in the closed position and securely attached to the valve tissues 20 and 22. The valve repair device 402 is secured to the valve tissues 20 by means of paddles 406a and 406b and gripping members 408a and 408b. Specifically, the valve tissues 20 and 22 are attached to the valve repair device 402 by optional barb portions 409 of the gripping members 408a and 408b, and the paddles 406a and 406b are connected to the gripping members 408 to secure the valve repair device 402 to the valve tissues 20 and 22.

[0242] To move the valve repair device 402 from the open position to the closed position, the lock 407 is moved to an unlocked position by the lock control mechanism 412 (as shown in Figure 62). Once the lock 407 is in the unlocked position, the coupling member 405 can be moved along the shaft 403 by the paddle control mechanism 410. In the illustrated example, the paddle control mechanism 410 moves the coupling member 405 along the shaft in the Y direction, causing one paddle 406a to move in the X direction and another paddle 406b to move in the Z direction. The movement of the paddles 406a and 406b in the X and Z directions causes the paddles to engage the gripping members 408a and 408b, and secures the valve repair device 402 to the valve tissues 20 and 22.

[0243] Referring to Figure 63, after the paddles 406 move to the closed position to secure the valve repair device 402 to the valve tissues 20, 22 (as shown in Figure 62), the lock 407 is moved to the locked position by the lock control mechanism 412 (Figure 62) to maintain the valve repair device 402 in the closed position. After the valve repair device 402 is maintained in the locked position by the lock 407, the valve repair device 402 is removed from the delivery device 401 by disengaging the shaft 403 from the placement shaft 413 (Figure 62). Furthermore, the valve repair device 402 disengages from the paddle control mechanism 410 (Figure 62), the gripper control mechanism 411 (Figure 62), and the lock control mechanism 412. Removing the valve repair device 402 from the delivery device 401 allows the valve repair device to remain securely attached to the valve tissues 20, 22, while simultaneously removing the delivery device 401 from a patient.

[0244] The concepts disclosed in this application can be used with a 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 blades, septa, and other components that can be narrowed and widened, such as the valve repair device disclosed in U.S. Provisional Application No. 63 / 278,037, the entire contents of which are incorporated herein by reference.

[0245] In many of the examples disclosed herein, the native valve leaflets are positioned in a gap between an assembly such as a hook and a fixed arm, or between a hook arm to which the leaflets are secured, and a blade. Once the leaflet is positioned within the gap, the assembly is actuated to clamp the leaflet tissue, thereby securing the leaflet. When the device includes a hook, further positioning the leaflet in the opening between the arms of the hook before actuating the movable arm to clamp the leaflet allows the movable arm to engage a greater portion of the leaflet tissue. As the tissue is further positioned within the gap, not only is a greater portion of the tissue then engaged by the hook, but any optional barbs or other securing devices located at the distal ends of the movable or fixed arms are positioned to engage a thicker portion of the native leaflet tissue. Engaging more and thicker tissue with the hooks ensures a more secure grip of the native leaflet.

[0246] Determining the depth of native leaflet engagement within the gap between the movable and fixed arms using current imaging techniques presents a challenge. Specifically, the leaflet tissue moves with each heartbeat and can be translucent or visually indistinguishable from surrounding tissue. In contrast, hooks made of materials such as metal (e.g., hooks with optional barbs) are much easier to see with imaging devices. Therefore, a surgeon can determine whether the hooks have properly engaged the native leaflet by observing the position of the movable arm and one or more indicators.

[0247] Example valve repair devices may include an indicator for determining whether the native leaflet is adequately engaged or contained therein by a hook or hook with optional barbs during implantation, deployment, or other use of the valve repair device. 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 display or otherwise indicate to the user that the leaflet is inserted into the orifice to a desired capture depth and / or that the leaflet has not yet reached the desired capture depth. Using an indicator allows the user to observe the indicator and / or the signal from the indicator to determine that the leaflet is properly engaged.

[0248] The various indicators described herein can be assembled in various shapes, sizes, and materials. In some implementations, these indicators may include a curved shape, a wavy shape, an S-shape, a C-shape, a U-shape, a V-shape, a hook shape, a calibration mark shape, a hook shape, a linear shape, a planar shape, a circular shape, a rectangular shape, a triangular shape, etc.

[0249] Referring now to Figures 64-67, an example hook 500 (which may be a barbed hook or include other friction or gripping enhancement features) is shown deployed within a native valve 40, such as a mitral valve, tricuspid valve, aortic valve, or pulmonary valve, to couple a device (not shown) such as any device described herein, valve repair device, valve treatment device, implantable device, or implant to one of the native leaflets 42, 44. These leaflets 42, 44 may be mitral valve leaflets 20, 22 or leaflets of the tricuspid, aortic, or pulmonary valve. Referring now to Figure 64, the hook 500 is shown in an open position, wherein a native leaflet 42, 44 is partially inserted into an opening formed between the fixed and movable arms 510, 530 of the hook 500. To determine whether leaflets 42 and 44 have reached the desired engagement depth, indicator arm 550 can be actuated via a consistent path (not shown), such as a consistent actuator, actuating stitch, actuating thread, etc. The indicator arm has an optional barb 555 to further secure the leaflet in place. Referring now to Figure 65, the barb is shown in a closed configuration and is closed on leaflets 42 and 44. The indicator arm 550 is not yet actuated.

[0250] Referring now to Figure 66, the indicator arm 550 is shown in a consistent motion configuration. The optional barb 540 on the illustrated movable arm 530 has pierced the original leaflet. When the leaflets 42, 44 are inserted into the opening of the hook 500 to half or less than half between the optional barb portion 540 and the connecting, flexible, or hinged portion 520, and / or not inserted far enough into the hook to overlap the length of the indicator arm 550, the indicator arm 550 is not engaged with the leaflets 42, 44. Instead, the indicator arm swings towards the fixed arm 510. The position of the indicator arm is visible via an imaging device used to monitor the implantation and deployment of the device.

[0251] Referring now to Figure 67, the hook is closed on leaflets 42, 44, and the leaflets are positioned sufficiently deep into the hook 500 to overlap the indicator arm 550. An optional barb 540 on the movable arm 530 has pierced the original leaflet. The indicator arm rests on the leaflet tissue, and the leaflets prevent or inhibit the indicator arm from moving toward the fixing arm 510 of the hook. The indicator arm illustrated in Figure 67 has an optional barb 540 to further secure the leaflet in place. In instances without a barb on the indicator arm, the indicator arm may bounce in sync with the heartbeat that causes the leaflet to pulsate. This pulsation can be seen using the imaging techniques described above and can be used to indicate to the operator that the leaflet is positioned sufficiently deep into the hook. Any indicator disclosed herein can be assembled to bounce or pulsate in sync with the heartbeat along with the leaflet.

[0252] Referring now to Figures 68-77, example hooks 500 are shown attached to the paddle of a device disclosed herein, such as any of the following devices, valve repair devices, valve treatment devices, implantable devices, implants, etc., and are deployed within a native valve 40 and coupled to one or more of the native leaflets 42, 44. These hooks 500 are attached to the paddle 122 of device 100 and are movable between open and closed positions to capture and secure the native leaflets 42, 44 within device 100, as described above.

[0253] Referring now to Figure 69, the device 100 is shown at the native valve 40, where the paddles 122 are open. The hooks 500 are then opened by applying tension to actuation lines 502, 504 respectively attached to the ends of the movable arm 530 and the indicator arms 550. The indicator arms disclosed herein may be active (e.g., opened and closed by an active step, such as pulling the lines 504) or passive (e.g., no additional action is required for the operation of the indicator arms other than the opening and closing of the hooks). The opening of the hooks 500 and the paddles 122, as shown in Figure 69, allows the device 100 to operate such that the leaflets 42, 44 are at least partially positioned in the opening 506 formed between the fixing of the hooks and the movable arms 510, 530, to facilitate capture of the leaflets 42, 44 by the hooks 500.

[0254] Referring now to Figure 69, the propellers 122 and hooks 500 are partially closed to position the leaflets for detection by the indicator arms 550 and ultimately for capture by the hooks 500. The partially closed position of the propellers 122 and hooks 500 allows the optional barbs 540 of the movable arms 530 to clamp the leaflets 42, 44 against the fixed arms 510 without extending or moving the leaflets 42, 44 too far so that the leaflets 42, 44 are pushed aside by the movable arms 530 or slip off the optional barbs 540 during an attempt to capture the leaflets.

[0255] Referring now to Figure 70, two indicator arms 550 are actuated by releasing tension on the actuation lines 504 (e.g., actuation threads, actuation sutures, etc.), which may be the same as or similar to other actuation lines described elsewhere herein. Both indicator arms 550 are deflected or slipped off the leaflets 42, 44 and moved to a fully actuated position beyond the retaining arms 510 of the hooks 500. The indicator arms 550 intersecting the retaining arms 510 form an X shape, which is visible through an imaging device used to monitor the implantation and deployment of the device.

[0256] Referring now to Figure 71, the indicator arms 550 are retracted and the device 100 is repositioned by applying tension to the actuation lines 504 (e.g., actuation threads, actuation stitching, etc.), causing the flaps 42, 44 to be inserted more deeply into the openings 506 of the hooks 500. One of the indicator arms 550 is then allowed to close by releasing the tension on one of the actuation lines 504, as can be seen in Figure 72. The indicator arm 550 engages the flap 42 and clamps the flap 42 against the fixed arm 510 and the paddle 122. Figure 73 shows the same situation, where another indicator arm 550 is actuated to engage another flap 44 and clamp the flap 44 against the other fixed arm 510 and the paddle 122. The engagement with the leaflets 42, 44 prevents or inhibits the indicator arms 550 from moving beyond the fixing arms 510 of the hooks 500 to form an X-shape as shown in FIG70. Therefore, the indicator arms 550 indicate to an observer viewing this installation via an imaging device that the leaflets 42, 44 are inserted into the openings 506 beyond the minimum engagement depth or minimum insertion depth determined by the length of the indicator arms 550.

[0257] Although the terms minimum cohesion depth or minimum insertion depth are frequently used in this disclosure, other similar terms may be used for their positions, such as an insertion depth, a cohesion depth, a selected insertion depth, a selected cohesion depth, a pre-selected insertion depth, a pre-selected cohesion depth, a predetermined insertion depth, a predetermined cohesion depth, etc.

[0258] Referring now to Figures 74-77, once the indicator arms 550 indicate that the leaflets 42, 44 are fully inserted into the openings 506, the movable arms 530 are actuated by releasing tension on the actuation lines 502, such that the leaflets 42, 44 are clamped between the optional barbs 540 and the retaining arms 510 of each hook 500. The paddles 122 then move to a fully closed position, shown in Figure 76, to securely hold the leaflets within the device 100. The indicators 550 can be monitored in any of the positions illustrated in Figures 72-76. For example, the indicators 550 will beat or jump with the heartbeat. This beating or jumping can be visualized to confirm that the valve repair device is correctly positioned. Because the indicators 550 are sufficiently flexible to bend or bounce with the heartbeat, the movable arms 530 can be made rigid and / or have a sufficiently high force to close, such force preventing the movable arms 530 from bouncing or jumping with the heartbeat. Any indicator disclosed herein may be sufficiently flexible to bend or bounce with the heartbeat.

[0259] Referring now to Figure 77, one of the leaflets 44 is shown partially withdrawn from the device 100, which may occur due to the movement of the leaflets 42, 44 during cardiac pulsation. As can be seen in Figure 77, the leaflet 44 remains partially secured by the optional barb portion 540. However, the leaflet 44 is no longer secured at or beyond the minimum engagement depth as determined by the length of the indicator arm 550. The withdrawal of the leaflet 44 allows the indicator arm 550 to move beyond the fixed arm 510, thereby forming an X-shape visible to an observer using an imaging device. Alternatively, the indicator arm 550, which is not in contact with the valve leaflets, will not bounce or jump with cardiac pulsation. Therefore, insufficient holding or sliding of the leaflets 42, 44 from the device 100 can be detected before the device 100 is detached from a delivery device (not shown). Once a sliding leaflet is detected, the hooks 500 and paddles 122 can be opened and repositioned to better secure the sliding leaflet. Any indicator arm disclosed herein can be assembled to detect a sliding leaflet. In some implementations, a single actuation line can be used to raise and lower a movable arm of a hook, allowing the indicator to move to a leaflet detection position.

[0260] Any feature of any leaflet depth indicator disclosed in PCT Patent Application Publication No. 2020 / 168,081 may be combined with the leaflet depth indicator disclosed herein, the entire contents of which are incorporated herein by reference. The leaflet depth indicator may also be used with various leaflet-grasping devices. For example, the leaflet depth indicator may be used with valve repair devices, implants, etc., shown and described in US 2019 / 0290260 and WO 2018167388, as well as chordae tendineae repair devices that require grasping the ends of the leaflets (see, for example, US 2019 / 0290260 and WO 2018167388).

[0261] Referring now to 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.

[0262] As illustrated in Figure 78, an example device 600 includes a connecting portion 604, a proximal or attachment portion 605, an anchoring portion 606, and a distal portion 607. In some embodiments, the connecting portion 604 optionally includes an engagement element 610 (e.g., a spacer, anastomotic element, plug, membrane, sheet, etc.) for implantation between the leaflets of a native valve. In some embodiments, the anchoring portion 606 includes a plurality of anchors 608. These anchors can be assembled in various ways. In some embodiments, each anchor 608 includes an outer blade 620, an inner blade 622, a blade extension member or blade frame (not shown), and a hook 630. In some embodiments, the hook 630 includes a base or fixing arm 632, a movable arm 634, an optional barb 636, and a junction portion 638. In some implementations, the attachment portion 605 includes a first or proximal collar 611.

[0263] Referring now to Figure 78, the device 600 is shown in a laterally extended or open position. By continuously extending the aforementioned actuating element 612, the device 600 moves to this laterally extended or open position, thereby increasing the distance between the engaging element 610 and the cap 614 of the distal portion 607. In this laterally extended or open position, the inner blades 622 extend more horizontally than in other positions of the device 600 and form an approximately 90-degree angle with the engaging element 610. Similarly, when the device 600 is in this laterally extended or open position, the blade frames (not shown) are in their most dispersed position. The increased gap formed between the engaging element 610 and the inner blades 622 in the laterally extended or open position allows the hook 630 to open further before engaging the engaging element 610, thereby increasing the size of the gap between the fixed and movable arms 632, 634.

[0264] To determine whether a leaf has reached the engagement depth, the device 600 may include an indicator arm 650. The indicator arm 650 may be of 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 the device 600 at various locations. In some embodiments, a first end 652 of the indicator arm 650 is fixedly attached to the engagement element 610.

[0265] Referring to Figure 79, according to some embodiments, the fixed arm 632, the movable arm 634, the outer blade 620, the inner blade 622, and the blade frames (not shown) may each include one or more channels or slots through which the indicator arm 650 can be housed. For example, as shown in Figure 79, the indicator arm 650 may be housed 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 blade channel or slot 664 of the inner blade 622, and the outer blade channel or slot 666 of the outer blade 620.

[0266] 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 at the distal end of the outer blade 620, while in other embodiments, the second end 654 of the indicator arm 650 can terminate between the outer blade 620 and the inner blade 622, or between the fixed arm 632 and the movable arm 634. The second end 654 of the indicator arm 650 can also terminate in any of the movable arm channel or slot 660, the fixed arm channel or slot 662, the inner blade channel or slot 664, or the outer blade 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 is closed, the indicator arm 650 will flatten, align, and / or press against the device 600. Therefore, the indicator arm 650 will not increase in size, or significantly increase the size of the device 600.

[0267] In some implementations, the indicator arm 650 may include any number of loops, turns, bends, or twists between the first end 652 and the second end 654. Referring to FIG80, the indicator arm 650 may include a bend 658 between the first end 652 and the second end 654. As shown in FIG80, the bend 658 is disposed at the distal end of the outer blade 620, but the bend may also be disposed between the movable arm 634 and the fixed arm 632, or between the fixed arm 632 and the outer blade 620. At the distal end of the bend 658, the second end 654 of the indicator arm 650 may be positioned toward or attached to the engagement element 610.

[0268] Referring to Figures 81 and 82, the indicator arm 650 is attached to the opposite indicator arm 650 of the device 600. For example, the two indicator arms may be formed from a single wire. This single wire may be thin and flexible, such that when the device is closed, the wire is compressed within the device 600. Therefore, the indicator arm 650 does not increase in size, or significantly increases the size of the device 600. In the example illustrated in Figure 81, the portion connecting the indicator arms is housed within the paddles. In the example illustrated in Figure 82, the portion connecting the indicator arms 650 extends beyond and / or through the paddles.

[0269] The indicator arm 650 may include an indicator 656, and / or the indicator arm itself may serve as an indicator or include a portion serving as an indicator. The indicator 656 may be a radiopaque material, which may be printed or attached to the indicator 656 as a separate material. For example, the radiopaque material may be a coil made of platinum or another radiopaque material. The indicator 656 may be visible under fluorescence microscopy and / or other imaging techniques and may assist the user in determining whether the leaflets are properly positioned in the hook 630. The indicator does not need to be a separate component. For example, in some embodiments, the indicator is integrated with the indicator arm; for instance, the indicator may be a portion of the indicator arm containing radiopaque material and / or may be thicker or have a larger surface area (which helps increase visibility).

[0270] The indicator arm 650 is movable separately from the movable arm 634 to facilitate the detection of the engagement depth of the native leaflet between the movable arm 634 and the fixed arm 632 of the hook 630. In one example, the indicator arm 650 is more resilient and / or flexible than the movable arm 634. This increased resilience and / or flexibility allows the indicator arm to bounce, twitch, or jump, while the movable arm 634 provides a firm grip on the leaflet tissue without bouncing, twitching, or jumping. The bouncing, twitching, or jumping of the indicator arm 650 can be examined using standard imaging equipment to determine that the hook is correctly engaged with the leaflet tissue.

[0271] When examined using fluorescence microscopy and / or other imaging techniques, the distance the indicator arm 650 and the indicator 656 move assist the user in determining whether the leaflets are properly positioned within the hook 630. If the leaflets 42, 44 positioned within the hook 630 are engaged or otherwise actuated, the indicator arm 650 and the indicator 656 will move a distance that can be measured using various techniques. The sufficient distance indicating proper alignment of the leaflets 42, 44 within the hook 630 can be predetermined by the user. On the other hand, if the leaflets 42, 44 positioned within the hook 630 are not engaged or otherwise actuated to a sufficient distance, it may be necessary to adjust the device 600 until proper alignment is achieved.

[0272] The relative positioning of the indicator arm 650 and the indicator 656 helps determine a minimum engagement depth of the leaflets 42, 44, as measured from the end of the movable arm 634 of the hook 630. Positioning the indicator 656 closer to or further away from the first end 652 of the indicator arm 650 alters the distance the indicator 656 moves when engaged by the leaflets 42, 44. For example, when engaged by the leaflets 42, 44, an indicator 656 positioned closer to the first end 652 of the indicator arm 650 will not move the same distance as an indicator 656 positioned further away from the first end 652 of the indicator arm 650.

[0273] Referring now to Figures 83-84, the hook 630 is shown in an open configuration, with leaflets 42 and 44 engaging the indicator arm 650. These leaflets 42 and 44 push the indicator 656 on the indicator arm closer to the movable arm 634 of the hook and closer to the engagement element 610. This movement indicates that the leaflets are positioned at an acceptable depth. Once the user sees the leaflets positioned at an acceptable depth, the movable arm 634 and / or the inner and outer blades 622 and 620 close to capture the leaflets.

[0274] Referring now to Figures 85-87, the example hook 700 is shown attached to the paddle of an 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 native valve 40 to secure the device to the native leaflets 42, 44. Furthermore, the device illustrated in Figures 85-87 is similar to the device illustrated in Figures 75-84, except that the indicator arms 750 are connected to the movable arms rather than spacers. Thus, any feature of the device illustrated in Figures 85-87 can be used in the device illustrated in Figures 49-64.

[0275] Referring now to Figure 85, the device 702 is shown at the native valve 40, where the paddle 722 is open. The hooks 700 are then opened by applying tension to the actuation line 704 attached to the end of the movable arm 730. This tension causes the hinge portion 720 of the hooks to flex to open the hooks. As shown in Figure 85, opening the hooks 700 and the paddle 722 allows the device 702 to operate such that the leaflets 42, 44 are at least partially positioned in the opening 706 formed between the hooks and the movable arms 710, 730, to facilitate capture of the leaflets 42, 44 by the hooks 700.

[0276] Referring now to Figure 86, the propellers 722 and hooks 700 are partially closed to position the leaflets for detection by the indicator arms 750 and ultimately for capture by the hooks 700. The partially closed position of the propellers 722 and hooks 700 allows the optional barb portions 740 of the movable arms 730 to clamp the leaflets 42, 44 against the fixed arms 710 without extending or moving the leaflets 42, 44 too far so that the leaflets 42, 44 are pushed aside by the movable arms 730 or slip off the optional barb portions 740 during an attempt to capture the leaflets.

[0277] Once the indicator arms 750 indicate that the leaflets 42, 44 are fully inserted into the openings 706, the movable arms 730 are actuated by releasing tension on the actuation lines 704, such that the leaflets 42, 44 are clamped between the selected barbs 740 and the fixing arms 710 of each hook 700. The paddles 722 move to a fully closed position, shown in FIG. 86, to securely hold the leaflets within the device 702.

[0278] Referring now to Figure 87, one of the leaflets 44 is shown partially withdrawn from the device 702, which can occur for various reasons, including movement of the leaflets 42, 44 during cardiac pulsation. The leaflet 44 remains partially secured by the optional hook portion 740. However, the leaflet 44 is no longer secured at or beyond the minimum engagement depth determined by the position of the indicator arm 750 and the indicator 756. Insufficient holding or sliding of the leaflets 42, 44 from the device 702 can be detected before the device 702 is detached from a delivery device (not shown). Once a sliding leaflet is detected, the hooks 700 and the paddle 722 can be opened and repositioned to better secure the sliding leaflet.

[0279] Referring to Figure 88, a valve repair device hook 830 includes an indicator arm 850 having a shaped portion 852, which can be used with a valve repair device (see, for example, a valve repair device disclosed in WO 2020 / 168081). The hook 830 includes a fixed arm 832, a flexure or hinge portion 838, a movable arm 834 having an optional barb portion 836, and an indicator 850 connected to the movable arm 834 via an 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 will not indicate that the native leaflet has reached a minimum engagement depth until the leaflet is inserted at or beyond the shaped portion 852. Once the leaflets 42 and 44 have reached the desired engagement depth, the indicator arm 850 is pressed against the movable arm 834 by the leaflets 42 and 44, causing the shaped portion 852 of the indicator arm to pass through the opening 860 of the movable arm 834. Because the shaped portion is located on the atrial side of the valve, it can be examined under a fluorescence microscope. Therefore, the shaped portion 852, positioned on the outside of the movable arm, indicates that the leaflets 42 and 44 have reached a sufficient depth, relative to the internal space between the movable and fixed arms 834 and 832 of the hook. The shaped portion can be assembled in various shapes, such as a circle, square, triangle, rectangle, D-shape, P-shape, S-shape, oval, ovoid, coil, etc.

[0280] Figures 89-90 illustrate a hook 830 in an open position, wherein an indicator 850 with a shaped portion 852 is in a normal or non-connected configuration. Figures 91-93 illustrate the hook 830 being deployed within a native valve to secure at least one of the leaflets 42, 44. In Figure 91, the hook 830 is shown in an open position, wherein a native leaflet 42, 44 is partially inserted into an opening formed between the fixed and movable arms 832, 834. To determine whether the leaflets 42, 44 have reached the desired engagement depth, the movable arm 834 is actuated to close the hook, so that the movable arm and the fixed arm move closer together. When pressure is applied to the indicator arm via the leaflets 42, 44 or the fixed arm 832, the indicator arm is free to flex, move or pivot about the indicator flexure or hinge portion 854.

[0281] In Figure 92, when the movable arm 834 is actuated to close the hook on the leaflets 42, 44, the indicator arm will not be forced out of its resting configuration if the leaflet is not deep enough within the hook. That is, when the leaflet is not positioned deep enough within the hook, the indicator arm and the shaped portion 852 will remain in their resting configuration between the movable arm and the fixed arm.

[0282] In Figure 93, the movable arm 834 is actuated to close the hook on leaflets 42, 44 when the leaflets are positioned sufficiently deep within the hook. The indicator arm 850 and its shaped portion 852 indicate to the operator that leaflets 42, 44 are sufficiently deep. When the leaflets are sufficiently deep and the movable arm 834 is actuated, pressure is applied to 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 to the side of the movable arm opposite to the fixed arm (i.e., into the open space on the atrial side of the valve leaflets).

[0283] Referring to Figures 94-98, the hook 930 includes a fixed arm 932, a flexible or hinged portion 938, a movable arm 934 having an optional barb portion 936, and an indicator arm 950 connected to the movable arm 934. The movable arm 934 may have at least one opening 960 therein (e.g., an aperture, channel, slot, etc.), through which the indicator arm 950 passes. In some embodiments, instead of an opening, the indicator arm is movable adjacent to the movable arm or through a notch in its side. The indicator arm 950 may include an optional indicator 956, and / or the movable hook arm 934 may include an optional indicator 957. Any embodiment disclosed herein may include the optional indicator 956 and / or the optional indicator 957. In some embodiments, the indicator 956 and / or the indicator 957 comprises a translucent material, which may be printed or attached to the indicator 956 and / or the indicator 957 as a separate material element. For example, the translucent material may be a coil made of platinum or another translucent material. The indicator is not necessarily a separate component. For example, in some embodiments, the indicator 956 is integrated with the indicator arm; for example, the indicator 956 may be part of the indicator arm containing translucent material and / or may be thicker or have a larger surface area (which helps increase visibility); and / or the indicator 957 is integrated with the movable hook arm; for example, the indicator 957 may be part of the hook arm containing translucent material and / or may be thicker or have a larger surface area (which helps increase visibility).

[0284] The indicator 956 and / or the indicator 957 may be visible under fluorescence microscopy and / or other imaging techniques, and may assist the user in determining whether the leaflet is properly positioned in the hook 930. The indicator arm 950 may be used with a suitable valve treatment device or valve repair device (see, for example, the device disclosed in WO 2020 / 168081, which is incorporated herein by reference). Although some valve repair devices or valve treatment devices may be shown or described herein as implantable devices for illustrative purposes, the concepts and configurations described herein (e.g., indicator portions, etc.) may be adapted for use with various devices that do not necessarily need to be implanted and can be removed after treatment.

[0285] 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 positions 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 an optional barb portion 936.

[0286] As shown in Figures 94-98, the indicator arm 950 is coupled at a first side F of the hook 930 to a movable arm 934 of the hook 930. The indicator arm 950 can bypass or pass through the movable arm 934 of the hook 930 such that a portion of the indicator arm 950 is positioned on a second side G of the hook 930 (relative to the first side F). In some embodiments, the indicator arm 950 includes a shaped leaflet connecting member or leaflet connecting portion 958 at least partially positioned on the second side G, which can contact a native leaflet when inserted into the hook 930. Alternatively, the leaflet connecting member or leaflet connecting portion 958 extends into a space between portions of the fixed arm or into an opening in the fixed arm. Compared to the possibility that the leaflet connecting member or leaflet connecting portion 958 may stop at the surface of the fixed arm, this additional extension of the leaflet connecting member or leaflet connecting portion 958 facilitates further movement of the indicator and / or end portion.

[0287] The indicator arm includes one or more arms extending from the movable end to the fixed end. In some embodiments, as illustrated in Figures 95A-95G and 96A-96B, the indicator arm 950 may include a first arm 972 and a second arm 974 extending from the movable end 952 of the indicator arm 950 to the 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 hook 930. In some embodiments, between the movable end 952 of the indicator arm 950 and the leaflet connecting member or leaflet connecting portion 958, the first arm 972 extends through a first opening 962 disposed in the surface of the movable arm 934, and the second arm 974 extends through a second opening 964 disposed in the surface of the movable arm 934 (but other configurations, such as adjacent to or through a side notch, are also possible). The movable arm 934 of the hook includes a first beam 990 and a second beam 992, which extend perpendicularly to each other and define the first opening 962 and the second opening 964. The beams 990 and 992 define the size of the openings 962 and 964 and the travel path of the indicator arm 950. The beam 990 prevents or inhibits torsion of the indicator. The beam 992 causes the indicator to move substantially orthogonally into space F when the indicator engages with the leaflet tissue.

[0288] Between the leaflet connecting member or leaflet connecting 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 hook 130 and return to the first side F of the hook 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 hook 130.

[0289] The indicator arm 950 is used to indicate whether the flap has reached a desired depth within the hook 930. Once the flap has reached the desired engagement depth within the hook 930, the flap engages the indicator arm 950 on the second side G of the hook 930. For example, the flap may engage one or more of the first arm 972 and the second arm 974 at the flap engagement portion 958 of the indicator arm 950. The flap engagement member or flap engagement portion 958 is pressed toward the movable arm 934 of the hook 930, causing the movable end 952 and the optional indicator 956 (if included) to move away from the movable arm 934 of the hook 930 and the optional indicator 957 (if included). The movement of the indicator 956 away from the movable arm 934 of the hook 930 can be examined and / or measured under a fluorescence microscope to determine whether the leaflet is properly engaged in the hook 930.

[0290] In an implementation including both indicator markers 956 and 957, displaying an image (e.g., a fluorescence microscopy image) of only a single marker (i.e., the two markers 956 and 957 are adjacent to or abut against each other, and only a single block is visible in the image) indicates that tissue, such as valve leaflet tissue, is not positioned at a sufficient depth in the hook 930. When both indicator markers 956 and 957 are included, displaying an image (e.g., a fluorescence microscopy image) of only two separate markers (i.e., the two markers 956 and 957 are spaced apart) indicates that tissue, such as valve leaflet tissue, is positioned at a sufficient depth in the hook 930.

[0291] Referring to Figures 95A-95G and 96A-96B, the indicator arm 950 can be pushed such that the movable end 952 moves vertically away from the movable arm 934 (Figures 95F-95G) or parallel to the movable arm 934 toward the chosen barb portion 936. For example, when the device is partially open and the indicator arm 950 is engaged by a valve leaflet 42, 44, the indicator arm will take the position illustrated in Figures 95F-95G to clearly indicate that the valve tissue is at a sufficient depth. Referring to Figures 96A-96B, when the device is fully closed, the indicator will push against a spacer, central assembly, and / or actuating element, and be pressed into a flattened state (see Figure 101). As a result, a device with the indicator 950 occupies little or no additional space compared to an identical device without the indicator. Alternatively, a wire or suture can be connected to the indicator 950 to move the indicator to a flattened configuration during the procedure of capturing the valve leaflets 42, 44. Therefore, the indicator will not occupy the space between the fixed and movable arms 932, 934 during the leaflet capture procedure.

[0292] Figures 97-98 illustrate a valve repair device 900, which includes hooks 930 illustrated in Figures 95A-95G and 96A-96B. In Figures 97 and 98, the valve repair device 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 blade frame assembly 924 instead of the blade frame 224 of the valve repair device 200. The adjustable-width blade 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 blade frame assembly 924 can take various forms. In the illustrated example, the adjustable-width blade frame assembly 924 includes a rigid inner blade frame 925 and a flexible outer blade frame 927. The rigid inner blade frame 925 has a fixed width. The flexible outer blade frame 927 has an adjustable width, which is controllable and / or settable during deployment of the valve repair device 900.

[0293] Referring to Figures 95F and 95G, the movable arm 934 may include a crossbar 980. The indicator arm 950 can contact the crossbar 980. When the indicator arm 950 is in the engaged position, it contacts the movable arm 934 of the hook 930 to restrict the movement of the indicator arm 950. Thus, in the engaged position, the crossbar 980 acts as a stop for the indicator arm 950. When the indicator arm 950 is in the disengaged position (Figures 95C-95E), the moving end 952 of the indicator arm 950 contacts the movable arm 934 of the hook 930 to set or restrict the position of the indicator arm 950. Thus, in the disengaged position, the back of the movable arm 934 and the moving end 952 acts as a stop for the indicator arm 950.

[0294] Figures 99-101 illustrate an example of a hook 1030 operating in a manner similar to that of hook 930. Figure 99 illustrates the hook 1030 in a disengaged position. In some implementations, referring to Figures 99-101, the indicator arm 1050 extends through a single opening (e.g., opening 1060) of the movable arm 1034 of the hook 1030 between the fixed end 1054 and the movable end 1052. In this example, the fixed arm 1032 has a forked configuration such that, in the disengaged position (Figure 99), the movable end 1052 of the indicator arm 1050 can be positioned parallel to, or partially angled into, a second opening 1062 of the movable arm 1034. The hook described herein can be used with various valve repair devices or valve treatment devices, whether implanted or removed post-treatment.

[0295] The indicator arm 1050 may include one or more protrusions 1080 extending outward from the indicator arm 1050. These protrusions 1080 may be positioned on the leaf-connecting member or leaf-connecting portion 1058 of the indicator arm 1050 such that, when the indicator arm 1050 is in the engaged position (FIGs 100-101), the protrusions 1080 engage the movable arm 1034 of the hook 1030 to prevent or inhibit the leaf-connecting member or leaf-connecting portion 1058 from traveling through the opening 1060 to the first side F. The indicator arm may be pushed such that the movable end 1052 moves vertically away from the movable arm 1034 (FIG 100) or parallel to the movable arm 1034 toward an optional barb portion 1064 (FIG 101). For example, when the device is partially open and the indicator 1050 is connected by a valve leaflet 42, 44, the indicator arm will take the position illustrated in FIG100 to clearly indicate that the leaflet tissue is at a sufficient depth. When the device is fully closed, the indicator will push against the spacer and be pressed into the flattened state illustrated in FIG101. As a result, a device with the indicator 1050 occupies no or very little additional space compared to the same device without the indicator. Alternatively, a suture or thread can be attached to the indicator 1050 to move the indicator to the configuration illustrated in FIG11 during the procedure of capturing the valve leaflets 42, 44. Therefore, the indicator will not occupy the space between the fixed and movable arms 1032, 1034 during the leaflet capture procedure.

[0296] Referring to Figures 102A-102B, a device 1100 with two hooks is illustrated. Figure 102A illustrates the device as viewed in an open space. Figure 102B illustrates the device as examined under a fluorescence microscope. A first hook 1130 is engaged with a leaflet, and a second hook 1230 is not engaged with a leaflet. The leaflet 42 engages the indicator arm 1150, for example at the leaflet engagement member or leaflet engagement portion 1158, such that the leaflet engagement member or leaflet engagement portion 1158 is pressed toward the movable arm 1134 of the hook 1130, causing the moving end 1152 and the indicator (not shown) to move or extend away from the movable arm 1134 of the hook 1130. As can be seen in Figures 102A and 102B, a clear indication of leaflet capture is provided.

[0297] Referring again to Figures 102A-102B, the second hook 1230 is not engaged with a leaflet, and therefore the movable end 1252 of the second indicator arm 1250 is adjacent to and / or coupled to the movable arm 1234. These first and second indicator arms 1150, 1250 can be any of the indicators or indicator arms disclosed herein. For example, these indicator arms 1150, 1250 can have any of the features of the indicator arms shown in Figures 94, 95A-95G, 96A, 96B, 99-101 and 103-118.

[0298] Figures 103-105 illustrate additional examples of indicator arm configurations. The indicator arm can be positioned along the hook in various ways. For example, referring to Figure 103, the movable end 1352 of the indicator arm 1350 can be oriented such that, in the disengaged position, it is located on a first side F of the movable arm 1334 of the hook 1330 and bends toward the movable arm 1334. Referring to Figure 104, the movable end 1352 of the indicator arm 1350 can be oriented such that, in the disengaged position, it is located on a second side G of the movable arm 1334 of the hook 1330 and bends toward the movable arm 1334. Referring to 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 hook 1330 and extends along the plane AA of the movable arm 1334.

[0299] Referring to Figure 106, the movable arm 1434 of the hook 1430 may include a rod 1490 extending along the movable arm 1434 through an opening along axis AA. The rod 1490 prevents or reduces torsion of the indicator arm 1450 by providing a path along which the foot of the indicator arm 1450 slides. In the disengaged position, the movable end 1452 of the indicator arm 1450 is positioned on a first side F of the hook 1430, adjacent to the rod 1490.

[0300] Referring to Figure 107, the movable arm 1434 of the hook 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 along which the foot of the indicator arm 1450 slides.

[0301] Figures 108-109 illustrate a hook 1530 in a closed position. Referring to Figure 108, the leaflets are located within the hook 1530, but not far enough to engage the indicator arm 1550. Therefore, the indicator 1556 does not move from the movable arm 1534 of the hook 1530. The position of the indicator 1556, which can be seen by fluorescence microscopy and / or other imaging techniques, helps the user determine whether the leaflets 42, 44 are properly positioned within the hook 1530. In the embodiment of Figure 108, when the leaflets 42, 44 are not engaged with the indicator arm 1550, the indicator 1556 rests against one of the back sides of the movable arm 1534. In this way, when the back side of the movable arm 1534 is in a "no connection" state, it acts as a stop for the indicator arm 1550.

[0302] Referring to Figure 109, the leaflets are positioned sufficiently within the hook 1530 to engage the indicator arm 1550. Movement of the indicator arm 1550 causes movement of the indicator 1556 from the movable arm 1534 of the hook 1530. The position of the indicator 1556, which is visible under a fluorescence microscope and / or other imaging techniques, helps the user determine that the leaflets 42, 44 are properly positioned within the hook 1530. In the embodiment of Figure 109, when the leaflets 42, 44 engage the indicator arm 1550, the indicator arm 1550 is pressed against a cross-beam 1560 (see also a similar cross-beam in the embodiments illustrated in Figures 106 and 107) on the front side of the movable arm 1534. In this way, when the crossbeam 1560 of the movable arm 1534 is in an "engaged" state, it acts as a stop for the indicator arm 1550. Thus, the "unengaged" stop in Figure 108 and the "engaged" stop in Figure 109 help to provide a clear indication of whether the leaflets 42, 44 have been inserted into the hook to a sufficient depth.

[0303] Referring 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 connection point 1676. This connection of the first arm 1672 and the second arm 1674 at connection point 1676 can occur in various ways, such as by welding, hinge, adhesion, linkage, interconnection, etc. At the fixed end 1654, the indicator arm 1650 can also be connected to a movable arm of a hook (see Figure 96). This split connection point 1676 allows the indicator arm to be made from a single piece and to route both as illustrated in any of Figures 95A-95G, 96A, 96B, 97, 98, 103-109. That is, the split connection point 1676 can be dispersed, routed through the opening and / or positioned relative to the movable arm around the rod of the movable arm, brought back together, and secured to the movable arm.

[0304] Referring to Figures 111-113, in addition to the indicator on indicator 1750, the movable arm 1732 of hook 1730 may include one or more indicators 1790. The indicator 1790 may be a material similar to one of the indicator indicators 1756 on the indicator arm 1750. The indicator 1790 may be a radiopaque material, which may be printed or attached to the indicator 1756 as a separate material piece. For example, the radiopaque material may be a coil made of platinum or another radiopaque material. The indicator does not need to be a separate component. For example, in some embodiments, the indicator is integrated with the indicator arm; for instance, the indicator may be a portion of the indicator arm containing the radiopaque material and / or is thicker or has a larger surface area (which helps increase visibility).

[0305] The indicator 1756 may be visible under a fluorescence microscope and / or other imaging techniques, and can assist the user in determining whether the leaflets are properly positioned within the hook 1730. For example, when engaged with a leaflet, the indicator arm 1750 is pushed, causing the indicator 1756 to move away from the indicator 1790 on the movable arm 1732 of the hook 1730. The distance between the indicator 1756 and the indicator 1790 on the movable arm 1732 (both of which may be visible under a fluorescence microscope and / or other imaging techniques) can assist the user in determining whether the leaflets 42, 44 are properly positioned within the hook 1730 or not.

[0306] In some implementations, the various indicator arms described herein can be pulled, extended, and / or moved to open up more capture space. For example, Figure 114 illustrates that one end 1852 of an indicator arm 1850 and / or an indicator 1856 can be pulled, as indicated by arrow 1851, during the process of capturing a valve leaflet 42, 44 between the fixed and movable arms 1832, 1834 of the hook 1830. For example, when the hook is open, the end 1852 of the indicator arm 1850 can be pulled by a thread or stitch. Thus, the indicator arm does not obstruct the space between the fixed and movable arms 1832, 1834, or occupies less 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 is bendable, as shown by reference character 1858, entering space G from the attachment structure between the movable arm and the indicator arm, but not all the way to the fixed arm. The indicator arm 1850 then bends back through the movable arm to space F, but not to the extent it would extend when engaged by a valve leaflet. The indicator arm 1850 then extends back toward the free end of the movable arm 1834. Once 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 closing the hook 1830 will capture the leaflet.

[0307] Referring to Figures 115-116, according to some embodiments, one or more of the fixed arm 1932, movable arm 1934, outer blade 1920, inner blade 1922, and / or blade frame (not shown) of device 1900 may include openings, channels, cuts, notches, etc., through which the leaflet connecting member or leaflet connecting portion 1958 of the indicator arm 1950 can travel. Otherwise, the fixed arm 1932, movable arm 1934, outer blade 1920, inner blade 1922, and blade frame (not shown) of device 1900 may operate in the same or similar manner as and / or be the same or similar to the fixed arm, movable arm, outer blade, inner blade, and blade frame of device 200 described above or other devices herein. In some embodiments, the fixed arm 1932, the movable arm 1934, the outer blade 1920, and the inner blade 1922 may be formed from a single sheet or strip of material. In some embodiments, as illustrated in Figures 115-116, the leaflet connecting member or leaflet connecting portion 1958 of the indicator arm 1950 may be arranged to pass through the movable arm channel 1960 of the movable arm 1934, the fixed arm channel 1962 of the fixed arm 1932, and the inner blade channel 1964 of the inner blade 1922. By allowing the leaflet connecting portion 1958 to extend through the fixed arm channel 1962 and the inner blade channel 1964, the free end of the indicator arm 1950 may extend further from the movable arm 1934 to provide a clearer indication of the leaflet connection.

[0308] The various devices, hooks, and indicator arms of the various devices described herein (including, for example, devices 900, 1100, 1900, and hooks 930, 1030, 1130, 1330, 1430, 1530, 1730, 1830, 2030, etc.) can be assembled such that even when the device is in a closed configuration (e.g., as shown in Figures 97, 98, 115, and 116), if the leaflet tissue is captured by the hook, the indicator arm remains extended in an extended position away from the movable arm. Therefore, the device can provide an indication of proper leaflet capture during capture when the device is in a partially open or ready-to-capture configuration, and when the device transitions from the partially open to the closed configuration, it can still provide an indication that the leaflet remains properly captured and has not slipped or been pulled off the hook in any way. This allows the user to be confident that the device has been properly implanted, even in the closed configuration.

[0309] Furthermore, the various devices, hooks, and indicator arms of the various apparatuses described herein (including, for example, devices 900, 1100, 1900, and hooks 930, 1030, 1130, 1330, 1430, 1530, 1730, 1830, 2030, etc.) can be assembled such that the indicator arm can bounce, jump, or leap in a manner visible using standard imaging equipment to aid in determining the correct placement and engagement with the leaflet tissue. For example, these devices, hooks, and indicator arms can be assembled such that the indicator arm bounces, jumps, or leaps before the movable arm of the hook has closed, while the leaflet tissue is within the capture area of ​​the hook. This allows the end user to ensure that the leaflet tissue is deep enough to engage the leaflet connection portion and will be properly engaged before releasing the movable arm to the fully closed position (and therefore before any barb used on the movable arm of the hook to penetrate or deeply penetrate the tissue).

[0310] Referring to Figure 117, the hook 2030 includes a connecting member 2090 between the first beam 2092 and the second beam 2094 of a fixed arm 2034. This connecting member 2090 assists in further stabilizing the leaflets 42 and 44 when they are engaged in the hook 2030 by the indicator arm 2050. Specifically, the leaflets 42 and 44 press against the two feet of the indicator arm 2050, the first beam 2092 of the fixed arm 2034, the second beam 2094 of the fixed arm, and the connecting member 2090, resulting in further stabilization of the leaflets 42 and 44. Figure 117 illustrates the wavy path of the leaflets 42 and 44 with the connecting member included. Figure 118 illustrates the path of the hook 2030 and the resulting leaflets without the connecting member 2090.

[0311] In some implementations, the indicator arm may be coupled to an inner blade and / or a fixation arm hooked onto one of a valve repair device or valve therapy device. The valve repair device may have any of the valve repair device configurations disclosed herein, such as valve repair device 200. Referring to Figures 119-123, the indicator arm 2150 is assembled to attach to the inner blade 2122 (see Figure 121). This configuration allows the indicator arm 2150 to remain positioned between the inner and outer blades at all times. Thus, the indicator arm 2150 is contained within the envelope of the valve repair device 2100. The indicator arm 2150 may include a leaflet connecting member or leaflet connecting portion 2158 (e.g., an extension, protrusion, arm, edge, bump, recess, descending portion, U-shaped portion, V-shaped portion, triangular portion, curved portion, circular portion, rectangular portion, etc.) for connecting the leaflets, and an indicator 2156 for assisting the user in determining whether the leaflets are properly positioned in the hook. 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 be of various shapes and sizes and may include a pin 2192 (FIG. 119) and / or a curved portion 2194 (FIG. 120) for assisting coupling. In some embodiments, the coupling member 2190 may include one or more of a joint, pivot, hinge, pin, clip, clamp, flexible connection structure, stitch, strip, bridge, plate, etc. The indicators described herein (e.g., indicator arms, markers, sensors, electrodes, etc.) can be used with various valve repair or valve treatment devices, whether implanted or removed after treatment.

[0312] Referring to Figures 121-123, the device 2100 has a hook 2130, which includes a movable arm 2134, a fixed arm 2132, and an indicator arm 2150 coupled to the inner propeller 2122 via a coupling member 2190. When the leaflets 42 and 44 are not positioned sufficiently far within the hook 2130 to engage the indicator arm 2150 (see Figure 122), the indicator 2156 is positioned against the inner propeller 2122. When the leaflets 42 and 44 are positioned sufficiently far within the hook 2130 to engage the indicator arm 2150, the indicator 2156 moves away from the inner propeller 2122 (Figure 123). The position of the indicator 2156, which is visible by fluorescence microscopy and / or other imaging techniques, can help the user determine whether the leaflets 42 and 44 are properly positioned in the hook 2130.

[0313] In some implementations, the device may include multiple indicators coupled to the hook. Any of the hooks disclosed herein may include two or more indicators. For example, referring 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 the indicator arm 2150 of Figures 121-123. However, any of the indicator configurations disclosed herein may be used, and / or the indicators disclosed herein may be divided into two halves, or have a portion divided into two halves providing two indicator portions. Having multiple indicators adjacent to each other (e.g., having leaflet engagement portions with a depth or distance similar to the hook hinge and / or an optional hook barb / friction enhancement morphology) allows a user to determine whether the leaflets are properly oriented in the hook (e.g., without a significant angle), or whether the leaflets are positioned too far from one side or the other of the hook. For example, referring to Figure 125, leaflets 42 and 44 are positioned within hook 2230 to engage the second indicator arm 2204, but not the first indicator arm 2202. This can be determined by positioning the indicator using fluorescence microscopy and / or other imaging techniques. This may be because the device is tilted relative to the valve leaflets. Referring to Figure 126, the device 2200 can be readjusted so that the leaflets engage the first indicator arm 2202 and the second indicator arm 2204, illustrating that leaflets 42 and 44 are securely engaged within the device 2200 and the hook has an acceptable orientation on the leaflets. In some implementations, multiple indicators may have leaflet engagement portions located at different depths (or at different distances from the hook hinge or optional hook barbs / friction-enhancing morphology) to allow you to distinguish whether the leaflets are partially or fully engaged at a certain depth.

[0314] Referring to Figures 127-135, leaflet depth can be determined by analyzing electrical signals from electrodes placed on a valve repair device. These 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 or part of a device disclosed herein, such as on a hook, a paddle, or a spacer. When the electrodes (or other electrical measurement components) are placed on a visual indicator, leaflet depth can be determined by both imaging and analysis of the electrical signals.

[0315] The measured signals can take many different forms. For example, these signals may 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 these electrical signals differ depending on whether the electrodes are in contact with the leaflets or other parts of the heart valve (e.g., chordae tendineae). These electrical signals can distinguish the type of tissue being contacted and the extent of tissue contact with the electrode (i.e., whether the electrode is at the edge of the leaflet or near its root). Thus, by placing the electrodes on the device, these electrical signals can help the user determine whether the leaflet is captured or partially captured by the device, regardless of whether no tissue is captured by the device, and / or whether the device is in contact with the chordae tendineae or other parts of the heart valve rather than the leaflet.

[0316] In the example illustrated in Figure 127, an implantable valve repair device or valve treatment device includes a plurality of anchors 2308. These anchors can be assembled in various ways. In some embodiments, each anchor 2308 includes an outer blade 2320, an inner blade 2322, a blade extension member or blade frame (not shown), and a hook 2330 with fixed and movable arms 2332, 2334. The device can take many different forms. In some embodiments, the device 2300 is the same as or similar to the device 200 described herein. Although the example shown in Figure 127 is an implantable device, similar configurations and concepts described in Figure 127 can be used in other devices, such as valve repair devices, and they do not necessarily need to be implanted and can be removed after treatment.

[0317] In some embodiments, to determine whether a leaflet has reached a specific engagement depth, the device 2300 may include an indicator arm 2350. The indicator arm may include one or more electrodes that measure electrical signals to assist the user in determining whether the leaflet is captured or partially captured in the device. For example, the 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 at two different locations within and / or in contact with tissues within the heart. For example, these electrodes may provide a signal based on blood located in the atrium (without contact with tissue), based on blood located in the ventricle (without contact with tissue), based on contact with valve leaflet tissue, and / or based on contact with chordae tendineae tissue. In some embodiments, three, four, five, or more electrodes are included. Each hook may include any number of electrodes.

[0318] These 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 valve leaflets relative to the heart. In some implementations, the IECG signal is measured on the first and second electrodes 2356, 2358. A bipolar signal can be calculated by subtracting the signal from the second electrode 2358 from the signal from the first electrode 2356. The resulting bipolar signal and / or the original signal can provide the following indications of the first and / or second electrodes 2356, 2358: in the atrium (and not in contact with tissue), located in the blood in the ventricle (and not in contact with tissue), in contact with valve leaflet tissue and / or in contact with chordae tendineae tissue.

[0319] When measuring bioimpedance signals, different signal readings will be observed for leaflets that are in contact with one electrode or two electrodes. For example, if a leaflet is in contact with only the first electrode, it may result in a higher amplitude signal reading. However, if the leaflet makes sufficient contact with both the first electrode 2356 and the second electrode 2358, it may result in a lower amplitude signal reading, indicating that the device is correctly positioned.

[0320] Referring to Figures 128-129, the hooks 2330 of the device 2300 can be partially closed (Figure 128) or fully closed (Figure 129) so that the positions of the leaflets 42, 44 can be detected by the indicator arms 2350 for final capture by the hooks 2330. Leaflet 42 is partially secured within the hooks 2330 and only contacts the first electrode 2356. Leaflet 44 is partially secured within the hooks 2330 but does not contact the first electrode 2356 or the second electrode 2358. Figure 129 illustrates the partial capture of leaflet 42 within the hooks 2330. Electrical signals from the first electrode 2356 and the second electrode 2358 can indicate to a user that the leaflets 42, 44 are in an insufficient position and that the hooks 2330 need to be repositioned. The device 2300 is detachable and reattached so that the petals can be recaptured within the hooks 2330.

[0321] Referring to Figures 130-131, the leaflets 42 and 44 are repositioned within the hooks 2330 such that they are in 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 a user that the leaflets 42 and 44 are in an acceptable position and that repositioning of the hooks 2330 is not required.

[0322] Referring now to Figures 132-133, the hook 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 a fixed arm 2432 of the hook 2430 and / or on a paddle portion within the device. When the hook is closed, the flaps engage the electrodes, and electrical signals from the electrodes can indicate to a user that the flaps are in a sufficient position and that repositioning of the hook is required. In some implementations, IECG signals are measured on the first and second electrodes 2456, 2458. A bipolar signal can be calculated by subtracting the signal from the second electrode 2458 from the signal from the first electrode 2456. The resulting bipolar signal and / or raw signal can provide the following indications for the first and / or second electrodes 2456, 2458: in the atrium (and not in contact with tissue), in the blood in the ventricle (and not in contact with tissue), in contact with valve leaflet tissue and / or in contact with chordae tendineae tissue.

[0323] The device may also include multiple indicator arms, each having an electrode for indicating whether the leaflets are in a sufficient position. Referring now to Figures 134-135, device 2500 has a pair of hooks 2530, each including a first indicator arm 2550 and a second indicator arm 2252. The first indicator arm 2550 includes a first electrode 2556, and the second indicator arm 2252 includes a second electrode 2558. In this case, when the hooks are closed, the leaflets engage 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 these electrodes can indicate to the user that the leaflets are in a sufficient position and that the hooks need to be repositioned.

[0324] Figure 136 illustrates an IECG signal reading. The P wave represents a small deviation wave indicating atrial depolarization, the Q wave corresponds to ventricular septal depolarization, the R wave reflects the depolarization of the major ventricular mass, and the S wave represents the final ventricular depolarization, based on the heart.

[0325] IECG readings from an electrode anchored at a suitable depth to one of the leaflets (e.g., leaflet 42 shown in Figures 130-131 or 133) in a device are illustrated in Figures 137A-137C. Figure 137A illustrates the waveform signal of electrode 2358 (or 2458) alone. Figure 137B illustrates the waveform signal of the first electrode 2356 (or 2456) alone. Figure 137C illustrates the bipolar waveform signal (the waveform signal of Figure 137A minus the waveform signal of Figure 137B).

[0326] Figure 137D illustrates a bipolar waveform signal with only one leaflet in contact with the first electrode 2356 (or 2456). For example, this could be the signal provided by the example illustrated in Figures 128-129. The signal from the first electrode will be significantly lower than the signal illustrated in Figure 137B because a smaller portion of the leaflet is inserted into the hook. This reduced insertion causes a thinner portion of the leaflet to be contacted by the electrode, resulting in a lower amplitude signal. The lack of contact between electrode 2358 (2458) and a leaflet results in a very low amplitude signal, such as the signal illustrated in Figure 137F. The bipolar signal illustrated in Figure 137D and / or individual signals from both electrodes can be used to determine that the leaflet is inserted to the first electrode 2356 (or 2456) but not as far as the second electrode 2358 (2458). For example, the waveform illustrated in Figure 137E may correspond to a desired waveform when the leaflet is inserted to the first electrode 2356 (or 2456) but not as far as the second electrode 2358 (2458). Alternatively, the set of bipolar signals and the individual signals from the electrodes may correspond to a desired set of waveforms when the leaflet is inserted to the first electrode 2356 (2456) but not as far as the second electrode 2358 (2458).

[0327] Figure 137E illustrates a bipolar waveform signal in which a portion of the chordae tendineae is in contact with the first electrode 2356 (or 2456). The signal from the first electrode will differ when in contact with the leaflet tissue from the signal when in contact with the chordae tendineae tissue. For example, the signal illustrated in Figure 137E may have a higher amplitude and / or a longer wavelength than the signal illustrated in Figure 137C (i.e., when the electrode is in contact with the leaflet tissue) (i.e., when one electrode is in contact with the chordae tendineae). The bipolar signal illustrated in Figure 137E and / or individual signals from the two electrodes can be used to determine whether one or both of the electrodes are in contact with the chordae tendineae. For example, the waveform illustrated in Figure 137E may correspond to a desired 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 tissue. Alternatively, the set of bipolar signals and individual signals from the electrodes may correspond to a set of expected waveforms when the chordae tendineae are in contact with the first electrode 2356 (2456) but not with the second electrode 2358 (2458).

[0328] Figure 137F illustrates a bipolar waveform signal when there is no cardiac tissue in contact with the electrodes. This signal is substantially flat and / or zero because the sensors are only in contact with the blood in the heart. When the second electrode 2358 (2458) is deeper in the device than the first electrode 2356 (or 2456) (e.g., further in the hook) and therefore more shielded, the signal may have the shape illustrated in Figure 137F. The signal from these electrodes will differ from the signal when there is no contact with tissue (e.g., only with the blood in the heart). For example, the signal illustrated in Figure 137F may have a lower amplitude and / or may be flat or substantially flat. The bipolar signal illustrated in Figure 137F and / or the individual signals from the two electrodes can be used to determine whether one or both of the electrodes are in the blood in the heart. The signals from the electrodes will differ when the electrodes (and thus the device) are located in the atrium, compared to when the electrodes are placed in the ventricle. For example, the signal from each electrode may have a higher amplitude in the ventricle than in the atrium.

[0329] Signals from these electrodes can be used to determine various aspects of the device. For example, these electrodes can be used to determine and / or confirm whether the device is placed in the atrium, whether it is placed in the ventricle, whether the device is in contact with a leaflet, whether the leaflet is at a sufficient depth in a hook, whether the chordae tendineae are placed in the device, such as in a hook, etc.

[0330] In some implementations, a portion of the indicator may be formed from the hook. 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 a native leaflet and determine whether the hook has properly engaged the native leaflet.

[0331] Referring to Figure 138, a flat material 2630 is illustrated, which can be bent to form a hook and an indicator arm for a valve repair device. The flat hook material 2630 includes a fixed arm 2632, a flexible or hinged portion 2638, a movable arm 2634 having a gripping portion 2636 (such as an optional illustrated barb end), and an indicator arm 2650. The movable arm 2634 may have at least one opening 2661 therein (e.g., an aperture, channel, slot, etc.), through which the indicator arm 2650 is assembled. The entire flat hook material 2630 may be formed from a single piece of flat material.

[0332] The indicator arm 2650 is formed from a portion of the movable arm 2634 of the flat hook-and-loop 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 the flat hook-and-loop material such that the indicator arm remains attached to the movable arm at the joint 2660. The indicator arm 2650 can be coupled to the movable arm 2634 at any point between the hinge portion 2638 and the gripping portion 2636.

[0333] The indicator arm 2650 may include an optional indicator 2656. In some embodiments, the indicator 2656 includes a translucent material, which may be printed or attached to the indicator 2656 as a separate material element. For example, the translucent material may be a coil made of platinum or another translucent material. The indicator is not necessarily a separate component. For example, in some embodiments, the indicator 2656 is integrated with the indicator arm; for instance, the indicator 2656 may be the portion of the indicator arm containing the translucent material, and / or may be thicker or have a larger surface area (which can help increase visibility).

[0334] The indicator 2656 may be visible under fluorescence microscopy and / or other imaging techniques and may assist the user in determining whether the leaflet is properly positioned in the hook 2630. The indicator arm 2650 may be used with a suitable valve repair device, such as any valve repair device disclosed herein (see, for example, the valve repair device disclosed in published PCT application WO 2020 / 168081, the entire contents of which are incorporated herein by reference).

[0335] The indicator arm 2650 meets the movable arm 2634 at a joint 2660. The joint 2660 can be located at various positions along the movable arm 2634. For example, the joint 2660 can be located on a base 2662 on the movable arm 2634 near a position of the hinge portion 2638. The joint 2660 can also be located at any point between the hinge portion 2638 and the gripping portion 2636, along one side of an inner edge (see Figures 139 and 141A-B) or outer edge (see Figures 140A-C) of the movable arm. In another embodiment, the joint 2660 can be located at the end of the gripping portion 2636 of the movable arm and extend toward the base 2662.

[0336] The indicator arm 2650 can be of various lengths. In some embodiments, the indicator arm 2650 is cut along one length of the movable arm 2634 from the hinge portion 2638 to the gripping portion 2636. In other embodiments, the indicator arm 2650 extends only along one portion of the movable arm 2634 between the hinge portion 2638 and the gripping 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.

[0337] The indicator arm 2650 may 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 may have any sub-range of these thicknesses.

[0338] The indicator arm 2650 may 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 may have a width within any sub-range of these ranges. In one example embodiment, by cutting both the movable arm and the indicator arm from a single, single-thickness 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.

[0339] 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. Referring to FIG138, the indicator arm 2650 may include a torsional portion 2658 between the moving end 2652 and the fixed end 2654. The torsional portion may include one or more torsions, each torsion ranging from 0 degrees to 180 degrees relative to the non-torsional portion of the indicator arm. In some embodiments, the torsional portion may be torsion between 5 degrees and 170 degrees, between 15 degrees and 145 degrees, between 30 degrees and 120 degrees, or between 60 degrees and 90 degrees. In some embodiments, the torsional portion is torsion 90 degrees relative to the non-torsional portion. These torsions relative to the non-torsional portion may be clockwise or counterclockwise. The twisting of the torsional portion causes the movable end of the indicator arm to be positioned between the movable arm 2634 and the fixed arm 2632 of the hook 2630 (e.g., on the second side G, as illustrated in Figures 139, 140B, 140C and 141C). This twisting causes the movable end 2652 to be positioned so that the indicator arm 2650 can contact a native leaflet when inserted into the hook 2630.

[0340] In some implementations, the torsional system of the indicator arm is configured to make the indicator arm easier (or less easy) to bend. For example, when the indicator arm is narrower than its thickness, an indicator arm bent at 90 degrees will be more likely to bend when connected by leaflet tissue than an indicator arm that is not bent. Therefore, the flexibility or responsiveness of the indicator arm can be controlled by the width of the indicator arm and by torsion of the indicator arm.

[0341] Figure 139 illustrates one embodiment of a hook 2730 having an indicator arm 2750 that may be made of a single piece of flat material. The indicator arm 2750 of the hook 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 various respects (including length, width, and thickness) to the indicator arm 2650 of Figure 138. In some embodiments, the movable arm 2734 includes a central beam 2790 and two outer beams 2735 disposed between the hinge portion 2738 and the gripping portion 2736 (such as, alternatively, the illustrated barb end). The central beam 2790 and the two outer beams define the size of openings 2762, 2764.

[0342] 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 disposed of to manufacture 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 disposed of to form the indicator arm portions 2770 and 2780 shown in FIG. 139. The first arm portion 2770 includes a bent portion 2772 adjacent to the fixed end 2754 of the first arm portion 2770. The second arm portion 2780 also includes a bent portion 2782 adjacent to the fixed end 2755 of the second arm portion 2780.

[0343] The bent portions 2772 and 2782 cause the first and second arm portions 2770 and 2780 to extend to the second side G of the hook 2730, wherein the indicator arm 2650 can contact a native leaflet when inserted into the hook 2730. The first arm portion 2770 and the second arm portion 2780 can be connected at a connection point 2792 on the first side F of the hook 2830. The first arm portion 2770 and the second arm portion 2780 can be connected by various components, including by welding, pressing, etc. In some embodiments, the indicator arm 2750 includes an indicator 2756, which is similar in material state to the indicator 2656. In some implementations, the first arm portion 2770 is secured to the second arm portion 2780 by the indicator 2756, which is pressed into both the first arm portion 2770 and the second arm portion 2780. The axis of the indicator 2756 can be pressed into the first arm portion 2770 and the second arm portion 2780 within a space formed by a connection structure at the end of the indicator arm, a stacking configuration, or a mirror configuration. In a stacking configuration, the axis of the indicator 2756 can be positioned perpendicular to the plane of the indicator arm 2750, while in a mirror configuration, the axis of the indicator 2756 is placed within the plane of the indicator arm 2750. Depending on the size of the indicator 2756 used, different orientations may be more visible for the available fluorescence microscopy viewing angle.

[0344] Figures 140A-140C illustrate exemplary embodiments of a hook-and-loop fastener with an integrated indicator arm 2850, wherein the indicator arm is formed of a material outside the outer beam 2835. In these embodiments, the first arm portion 2870 and the second arm portion 2880 of the indicator arm 2850 are formed of a flat material, which is laterally positioned relative to the flat material of the outer beams 2835 that form the movable arm 2834. The first arm portion 2870 and the second arm portion 2880 may be similar to the indicator arm 2650 of Figure 138 in various aspects (including length, width, and thickness), except that the arm portions 2870 and 2880 are made of a material outside the hook-and-loop fastener.

[0345] Referring to Figures 140A-140C, the first arm portion 2870 encounters the movable hook arm 2834 at a first engagement 2860 on the movable arm 2834. The second arm portion 2880 encounters the movable arm 2834 at a second engagement 2861 on the movable arm 2834. The engagements 2860 and 2861 can be located at various positions along the movable arm 2834. For example, the engagements 2860 and 2861 can be located on the movable arm 2834, near a position close to the hinge portion 2838. The engagements 2860 and 2861 can also be located along the outer beams 2835 of the movable arm 2834 at any point between the hinge portion 2838 and the gripping portion 2836 (such as, arbitrarily illustrated, barbed ends). Figure 140A illustrates the first arm portion 2870 and the second arm portion 2880 of the indicator arm 2850 after they are formed from the material of the outer beams 2835 adjacent to the movable arm 2834, but before they are shaped to form the indicator arm 2850.

[0346] Referring to Figures 140B and 140C, the first arm portion 2870 and the second arm portion 2880 can be assembled in various ways. Referring to Figure 140B, the first arm portion 2870 includes a torsion and / or bending portion 2872 adjacent to the fixed end 2854 of the first arm position 2870. The second arm portion 2880 also includes a torsion and / or bending portion 2882 adjacent to the fixed end 2855 of the second arm portion 2880. In the embodiment of Figure 140B, the torsion and / or bending portions 2872 and 2882 are assembled such that the first and second indicator arm portions 2870 and 2880 extend across the outer beams 2835 on side F. Next, the first and second indicator arm portions 2870, 2880 extend through the spaces 2862, 2864 between the outer beams 2835 and the central beam 2890 to the second side G of the hook 2830, wherein the indicator arm 2850 can contact a native leaflet when inserted into the hook 2830. The first and second indicator arm portions may include additional torsion and / or bending to allow the first arm portion 2870 and the second arm portion 2880 to be connected at a connection point 2892 on the first side F of the hook 2830. The first arm portion 2870 and the second arm portion 2880 can be connected by various components, including by welding. In some embodiments, the indicator arm 2850 may include an indicator 2856, which is similar in material form to indicators 2656, 2756.

[0347] Referring to Figure 140C, the first arm portion 2870 includes a twisted and / or bent portion 2872 adjacent to the fixed end 2854 of the first arm position 2870. The second arm portion 2880 also includes a twisted and / or bent portion 2882 adjacent to the fixed end 2855 of the second arm portion 2880. In the embodiment of Figure 140C, the twisted and / or bent portions 2872 and 2882 are assembled such that the first and second indicator arm portions 2870 and 2880 extend across the outer beams 2835 on the inner side G. The first and second indicator arm portions 2870 and 2880 are bent in one configuration in which the indicator arm 2850 can contact a native leaflet when inserted into the hook 2830. The first and second indicator arm portions may include additional torsion and / or bending 2880 to extend through the spaces 2862, 2864 between the outer beams 2835 and the central beam 2890 to the side F of the hook 2830, and may be connected at a connection point 2892. The first arm portion 2870 and the second arm portion 2880 may be connected by various components, including by welding. In some embodiments, the indicator arm 2850 may include an indicator 2856, which is similar in material form to the indicator 2656, 2756.

[0348] Hooks with integrated leaflet depth indicators can be made from a single piece of flat material in various ways. Referring to Figures 141A-141B, in some embodiments, the gripping portion 2936 of the hook 2930 may include a first gripping member 2910, a second gripping member 2912, and a third gripping member 2914. These gripping members may be the same as or similar to other gripping members, hooks, hook arms, etc. described elsewhere herein. The first gripping member 2910 and the second gripping member 2912 may be connected to the third gripping member 2914 by connecting members 2916. These connecting members 2916 may take various forms. For example, these connecting members 2916 may include stitching, fasteners, pins, snap fasteners, magnets, etc. In some embodiments, these connecting members may extend through an opening in one or more of the first gripping member 2910, the second gripping member 2912, and the third gripping member 2914.

[0349] Assembling the first gripping member 2910, the second gripping member 2912, the third gripping member 2914, the first indicator arm portion 2970, and / or the second indicator arm portion 2980 as illustrated in Figures 141A and 141B facilitates easier manufacturing of the hook 2930 with an integrated leaflet depth indicator. For example, in the implementation illustrated in Figures 141A and 141B, the first indicator arm portion 2970 and the second indicator arm portion 2980 extend through the first gripping member 2910, the second gripping member 2912, and the third gripping member 2914. If the arms are formed only from the material of one window of the movable arm, this allows the leaflet depth indicator to be longer.

[0350] The hooks 2930 illustrated in Figures 141A and 141B are similar, except that the indicator arm portions 2970 and 2980 in Figure 141A do not include a connecting member, and the indicator arm portion in Figure 141B includes a connecting member 2918. In the embodiment of Figure 141A, the indicator arm portions 2970 and 2980 are not attached to each other and can form two independently movable leaflet depth indicators. Including two side-by-side leaflet depth indicators provides additional information about the position of the leaflets relative to the hook. For example, in addition to the leaflet depth in the hook, the two side-by-side leaflet depth indicators can provide an indication of the rotation and / or deflection of the hook relative to the leaflets. Two independent leaflet depth indicator arms can be used in any of the embodiments disclosed herein.

[0351] In the embodiment of FIG141B, the first indicator arm portion 2970 can be connected to the second indicator arm portion 2980 by means of connecting members or shapes 2918. These connecting members or shapes 2918 can take various forms. For example, these connecting members or shapes 2918 may include complementary stitches, fasteners, pins, snap fasteners, magnets, etc. In some embodiments, these connecting members may extend through openings 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 components. For example, referring to FIG141C, the first indicator arm portion 2970 can be connected to the second indicator arm portion, similar to the first and second indicator arm portions of FIG140C.

[0352] Referring to Figures 141A and 141B, the gripping portion 2936 (such as, optionally, the illustrated barb end) is illustrated in a preliminary configuration, so the first gripping member 2910 and the second gripping member 2912 are not yet connected to the third gripping member 2914. Referring to Figure 141C, the gripping portion 2936 is illustrated in a formed or assembled configuration, so the first gripping member 2910 and the second gripping member 2912 are connected to the third gripping member 2914 by corresponding connecting members 2916.

[0353] Referring to Figure 141C, the first arm portion 2970 includes a twisted and / or bent portion 2972 ​​adjacent to the fixed end 2954 of the first arm position 2970. The second arm portion 2980 also includes a twisted and / or bent portion 2982 adjacent to the fixed end 2955 of the second arm portion 2980. The first and second indicator arm portions 2970, 2980 extend on the second side G of the spaces 2962, 2964 between the outer beam 2835 and the central beam 2990, wherein the indicator arm 2950 can contact a native leaflet when inserted into the hook 2930. The first and second indicator arm portions may include additional twists and / or bends to allow the first arm portion 2970 and the second arm portion 2980 to be connected at a connection point 2992 on the first side F of the hook 2930. The first arm portion 2970 and the second arm portion 2980 can be connected by various components, including by welding. In some embodiments, the indicator arm 2950 may include an indicator 2956.

[0354] Referring 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 and second indicator arm portions 2970, 2980 extend on the second side G of the spaces 2962, 2964 between the outer beam 2934 and the central beam 2990, wherein the indicator arm 2950 may contact a native leaflet when inserted into the hook 2930. The first and second indicator arm portions 2970, 2980 are integrally formed with a transition portion 2920. The first and second indicator arm portions 2970, 2980 may include additional torsion and / or bending to allow the transition portion 2920 to be positioned on the first side F of the hook 2930. In some implementations, the transition portion 2920 may include an indicator.

[0355] Referring to Figures 142A-142B, a hook 3030 is illustrated in a closed position. In some embodiments, the hook 3030 is the same as or substantially similar to any of hooks 2630, 2730, 2830, or 2930. Referring to Figure 142A, a leaflet is located within the hook 3030, but not far enough within the hook 3030 to engage the indicator arm 3050. The optional indicator 3056 (if included) therefore does not move away from the movable arm 3034 of the hook 3030 or the optional indicator 3057 (if included). The position of the indicator 3056 and / or the indicator 3057, which may be visible by fluorescence microscopy and / or other imaging techniques, assists the user in determining that the leaflets 42, 44 are not properly positioned within the hook 3030. For example, when both indicator markers 3056 and 3057 are included, an image displaying only a single indicator (i.e., the two indicators 3056 and 3057 are adjacent to or abut against each other, and only a single block can be seen in the image) (e.g., a fluorescence microscopy image) indicates that tissue such as valve leaflet tissue is not placed in the hook 3030 to a sufficient depth.

[0356] Referring to Figure 142B, the leaflets are positioned sufficiently far within the hook 3030 to engage the indicator arm 3050. Movement of the indicator arm 3050 causes movement of the indicator 3056 from the movable arm 3034 of the hook 3030. The position of the indicator 3056, which is visible under a fluorescence microscope and / or other imaging techniques, assists the user in determining whether the leaflets 42 and 44 are properly positioned within the hook 3030. For example, when both indicators 3056 and 3057 are included, an image displaying only the two separate indicators (i.e., the two indicators 3056 and 3057 are spaced apart) (e.g., a fluorescence microscope image) indicates that tissue, such as leaflet tissue, is positioned at a sufficient depth within the hook 3030.

[0357] In the embodiments illustrated in Figures 138, 139, 140A-140C, 141A-141D, and 142A-142B, the leaflet depth indicators 2650, 2750, 2850, and 2950 extend from the movable arm of the hook. However, in other embodiments, the leaflet depth indicators may extend from the hinge portion or the fixed arm portion of the hook. For example, in the embodiment of the hook 3130 illustrated in Figures 143A and 143B, a leaflet depth indicator 3150 extends from the fixed arm 3132 of the hook. The leaflet depth indicator 3150 may be integrally formed with the hook 3130. In the embodiments illustrated in Figures 143A and 143B, the leaflet depth indicator 3150 originates from the fixed arm 3132. As shown in Figures 143A and 143B, the leaflet depth indicator 3150 includes a curved portion 3160 extending along the hinge portion 3138. The leaflet depth indicator then extends along the movable arm 3134 of the hook 3130.

[0358] Referring to Figure 143A, the leaflets are located within the hook 3030, but not far enough within the hook 3130 to connect with the indicator arm 3150. Therefore, the indicator 3156 will not move from the movable arm 3134 of the hook 3130. The position of the indicator 3156, which is visible by fluorescence microscopy and / or other imaging techniques, helps the user determine whether the leaflets 42 and 44 are not properly positioned within the hook 3030. For example, when both indicators 3156 and 3157 are included, an image displaying only a single indicator (i.e., the two indicators 3156 and 3157 are adjacent to or abut against each other, and only a single block is visible in the image) (e.g., a fluorescence microscopy image) indicates that tissue such as leaflet tissue is not positioned to a sufficient depth within the hook 3130.

[0359] Referring to Figure 143B, the leaflets are positioned sufficiently far within the hook 3130 to engage the indicator arm 3150. Movement of the indicator arm 3150 causes movement of the indicator 3156 from the movable arm 3134 of the hook 3130. The position of the indicator 3156, which is visible by fluorescence microscopy and / or other imaging techniques, assists the user in determining whether the leaflets 42, 44 are properly positioned within the hook 3030. For example, when both indicators 3156 and 3157 are included, displaying an image (e.g., a fluorescence microscopy image) of only two separate indicators (i.e., the two indicators 3156 and 3157 are spaced apart) indicates that tissue, such as leaflet tissue, is positioned at a sufficient depth within the hook 3130.

[0360] Figures 144-145 illustrate one embodiment of a device 3200 having a leaflet indicator 3250. The leaflet indicator 3250 can be used with various 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 blade 3222 and an outer blade 3220, and a hook 3230 comprising a movable arm 3234 and a fixed arm 3232. The leaflet indicator 3250 can be coupled to various components of the device, such as the inner blade 3222, the fixed arm 3232 of the hook, and / or the movable arm 3234 of the hook 3230. In the illustrated example, the leaflet indicator 3250 is mounted on the inner blade 3222.

[0361] The indicator 3250 can take many different forms. For example, the indicator 3250 may include one or more components capable of sensing the electrical properties of a material, such as blood or tissue, which may be a valve leaflet, chordae tendineae, mastoid muscle, heart wall tissue, etc., and / or contacted by a valve repair device assembly such as a hook arm, a paddle portion, a coupling element, etc. 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 Figures 144-145 illustrate two indicator contacts, any number of indicator contacts may be used for the indicator. These indicator contacts may be electrically coupled to one or more sensors. These sensors may be coupled to the indicator contacts in various ways including conductive wiring. These sensors may include electrical sensors that can measure one or more of resistance, inductance, capacitance, voltage, current, and impedance.

[0362] Referring to Figure 144, one leaflet is not positioned within the hook 3230. If the hook 3230 closes without a leaflet positioned between the movable arm 3234 and the fixed arm 3232, the movable arm 3234 is movable and contacts the indicator 3250, creating a bridge between the first indicator contact 3252 and the second indicator contact 3254. In this case, the sensor 3260 senses a lack of resistance (e.g., the circuit is closed by the movable hook arm). This information can be used to determine that the leaflet is not present in the hook 3230.

[0363] Referring to Figure 145, a leaflet 42, 44 is positioned within the hook 3230. If the hook 3230 is closed when the leaflets 42, 44 are positioned between the movable arm 3234 and the fixed arm 3232, then the movable arm 3234 is not in contact with the indicator 3250 when it is bent to a closed position. In this case, the sensor 3260 can observe or otherwise indicate a measurable resistance between the contacts 3252, 3254, which can be used to determine that the leaflet is present within the hook 3230.

[0364] Referring to Figures 146-147, an embodiment of a system 3301 having a leaflet indicator 3350 is illustrated. In this embodiment, components of the valve repair system itself are used as the indicator 3350. Various configurations of the valve repair system components can be used as a leaflet depth indicator. The illustrated device 3300 includes an inner blade 3322 and an outer blade 3320, and a hook 3330 including a movable arm 3334 and a fixed arm 3332. In the illustrated example, an insulator 3356 is positioned between the inner blade 3322 and the fixed arm 3332. The device 3300 may include any of the devices disclosed herein, as well as any other valve repair device. The leaflet indicator 3350 may include various components on the device, which may 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 hook 3330. A second electrical path is defined by inner blade 3322, coupling element 3372, and coupling element 3376. These electrical paths can be formed in a variety of different ways. For example, a component, a portion of a component, or an auxiliary component traveling along the component can be formed of a conductive material.

[0365] The indicator 3350 may be electrically coupled to one or more sensors 3360. These sensors may include electrical sensors capable of measuring one or more of the following: resistance, inductance, capacitance, voltage, current, impedance, etc. The sensor 3360 may be coupled to the indicator 3350 in several ways. The indicator 3350 may be electrically coupled to the sensor 3360 via a first path defined by the control line 3362 and the hook 3330, and a second path defined by the inner paddle 3322, the engagement element 3372, and the coupling element 3376. In some embodiments, the device is made of conductive components. For example, the movable arm, engagement element 3372, collar 3374, conduit coupling element 3376, and / or actuation line 3378 may be conductive.

[0366] Referring to Figure 146, one petal is not positioned within the hook 3330. If the hook 3330 closes without a petal positioned between the movable arm 3334 and the fixed arm 3332, the movable arm 3334 is movable and contacts the indicator 3350, thereby closing the circuit between the first path, the sensor 3360, and the second path. In this case, the sensor 3360 indicates a lack of resistance (e.g., the circuit is closed by the movable hook arm), which can be used to determine that the petal is not present in the hook 3330.

[0367] Referring to Figure 147, one of the leaflets 42 and 44 is positioned within the hook 3330. If the hook 3330 is closed when the leaflets 42 and 44 are positioned between the movable arm 3334 and the fixed arm 3332, then the movable arm 3334 is not in contact with the inner paddle 3322. In this case, the circuit between the sensor 3360, the first path, and the second path is interrupted (opened), and the sensor 3360 can determine that the leaflets are present within the hook 3330.

[0368] Referring to Figures 148-155, in some embodiments, a visual indicator 3450 is coupled to the movable arm 3434 of the hook 3430, and the visual indicator 3450 and the hook 3430 function as an electrical indicator. The visual indicator 3450 and the hook 3430 can take various forms. For example, the indicator 3450 and the hook 3430 can be any hook and indicator disclosed in this patent application. In the embodiment illustrated in Figures 148-155, the visual indicator 3450 can be according to Figures 94-98. A circuit can be formed by the sensor 3460, the hook 3430, and the visual indicator 3450 via wiring connecting the hook 3430 and the visual indicator 3450 to a sensor 3460.

[0369] Referring to Figures 148-151, in some embodiments, an insulator 3480 insulates one or more portions of the indicator 3450 from the hook 3430. The insulator 3480 can take various forms. In the example of Figures 148-151, the electrically insulated portions of the indicator 3450 and the hook 3430 are schematically illustrated by the dashed area 3480. The schematically illustrated insulator 3480 can be achieved in various ways. Referring to Figures 152-155, the indicator 3450 and the hook 3430 are electrically insulated from each other by, for example, one or more insulating components, such as a first insulator 3482 and a second insulator 3484. The first insulator 3482 insulates the visual indicator 3450 and the hook 3430 at the connection between the hook and the indicator. When the visual indicator 3450 is in the leaflet connection position, the second insulator 3484 insulates the crossbar of the hook 3430 from the curved portion of the visual indicator.

[0370] Referring to Figures 148-155, an electrical signal indicating whether a petal is disposed within the hook can be determined by the sensor 3460 by means of insulation, such as by one or more insulating components, in area 3480. When a petal is not engaged with the indicator 3450 within the hook 3430, the visual indicator 3450 makes electrical contact with the hook 3430, and the circuit is closed (see Figures 148, 149, 152, and 153). When a petal is engaged with the indicator 3450 within the hook 3430, the visual indicator 3450 does not make electrical contact with the hook 3430, and the circuit is open (see Figures 150, 151, 154, and 155).

[0371] Referring to Figures 148-149 and 152-153, the indicator 3450 is in a non-engaged position, which can be when a leaflet is not positioned within the hook 3430. In this non-engaged position, the indication of no leaflet is visually visible through the position of the indicator 3456, which is not moving from the movable arm 3434 of the hook 3430; and through the closed circuit comprising the sensor 3460, the hook 3430, and the indicator 3450; and the wiring connecting the hook 3430 and the indicator 3450 to the sensor 3460. However, in other embodiments, the insulators may be configured such that the circuit is open when the visual indicator is in the non-engaged position. For example, an insulator may be positioned at the indicator 3456 and at the crossbar of the hook to insulate the visual indicator from the hook when in the non-connected position.

[0372] Referring to Figures 150-151 and 154-155, the indicator 3450 is in a connected position, which can be when a leaflet is positioned within the hook 3430. In this connected position, the indication of a leaflet is visible through the position of the indicator 3456, which has moved a measurable distance from the movable arm 3434 of the hook 3430; and through an opening circuit including the sensor 3460, the hook 3430, and the indicator 3450; and through wiring connecting the hook 3430 and the indicator 3450 to the sensor 3460. However, in other embodiments, the insulators may be assembled such that the circuit is closed when the visual indicator is in the connected position. For example, these insulators can be assembled such that the crossbar of the hook is not insulated from the curved portion of the visual indicator, so that the curved portion of the indicator directly engages the crossbar of the hook when it is in the engagement position.

[0373] Referring to Figures 156-158, an embodiment of a hook 3530 having an electrical indicator 3550 is illustrated. These electrical indicators 3550 can take various forms. For example, the indicator 3550 may comprise one or more plates. Referring to Figure 156, an 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 a fixed arm 3532 of the hook 3530, and the second indicator plate 3554 is coupled to a movable arm 3534 of the hook 3530. Referring to Figure 158, these indicator plates may be made of one or more separate plates. These indicator plates may be made of a conductive material.

[0374] Figures 156A-156D illustrate additional indicator panel configurations. The implementations illustrated in Figures 156, 156A-156D, and 158 are several examples of many possible configurations. In the implementation illustrated in Figure 156A, the first and second plates 3552, 3554 are positioned approximately to the hinge portion of the hook 3530. In other implementations, a plate is positioned only on the movable arm 3534 of the hook, or only on the fixed arm of the hook. These plates 3552, 3554 may be positioned at or near a minimum acceptable leaflet insertion depth.

[0375] In the embodiment illustrated in Figure 156B, the first and second plates 3552 and 3554 are positioned on the fixed arm 3532 of the hook 3530. In other embodiments, the first and second plates 3552 and 3554 are positioned on the movable arm 3534 of the hook. In other embodiments, a pair of plates are mounted on the fixed arm 3532 of the hook, and a pair of plates are mounted on the movable arm of the hook. In the embodiment illustrated in Figure 156B, the indicator plate 3554 may correspond to a minimum leaflet insertion depth, and the indicator plate 3552 may correspond to a maximum leaflet insertion depth.

[0376] In the embodiment illustrated in Figure 156C, the first and second plates 3552, 3554 are positioned on the fixed arm 3532 of the hook 3530. In other embodiments, the first and second plates 3552, 3554 are positioned on the movable arm 3534 of the hook. In the embodiment illustrated in Figure 156C, the first and second plates 3552, 3554 extend along a length of the hook arm. The first and second plates 3552, 3554 are spaced apart by a gap. The embodiment illustrated in Figure 156C allows the indicator 3550 to detect the presence or depth changes of tissues such as leaflet tissue across the width of the hook. For example, the configuration illustrated in Figure 156C can sense whether a leaflet is crooked, skewed, or otherwise improperly held by the hook. The implementation shown in Figure 156D is the same as that shown in Figure 156C, except that a pair of plates are mounted on the fixed hook arm 3532 and a pair of plates are mounted on the movable hook arm 3534.

[0377] Referring to Figures 157 and 158, in some implementations, an AC voltage is applied across an electrical indicator, and one or more impedance measurements are performed and / or derived. The applied AC voltage can be varied. Different materials may have different impedance characteristics for different applied AC voltages. In this way, applying varying AC voltages can enhance the differentiation between different biomaterials placed in the hook and loop. Any electrical indicator disclosed herein can be used in conjunction with one or more applied AC voltages and one or more impedance measurements performed.

[0378] In some embodiments, an AC voltage is applied and one or more impedance characteristics are measured when the hook is closed. In other embodiments, an AC voltage is applied and one or more impedance characteristics are measured when the hook is open, partially open, or not fully closed. Performing impedance measurements when the hook is open, partially open, or not fully closed has the advantage of confirming that the leaflet tissue is properly positioned within the hook, and / or confirming that another unwanted tissue, such as a chordae tendineae, was not positioned within the hook before it closed. The hook can take various forms. For example, the hook can be any hook disclosed in this patent application. Such hooks may include optional barbs or other friction-enhancing or stabilizing elements. Performing impedance measurements when the hook is open, partially open, or not fully closed prevents or inhibits optional barbs from piercing or penetrating the leaflet until it is confirmed that the leaflet is properly positioned within the hook. Impedance measurement when the hook is open, partially open, or not fully closed can prevent or inhibit the tendon cord from being closed in the hook.

[0379] Referring to Figures 157-162, indicator 3550 may be included in a circuit along with an AC power supply, an electrical sensor 3560, and wiring. The sensor 3560 and the AC power supply may be a single device or separate devices. The wiring connects a first indicator plate 3552 and a second indicator plate 3554 to the AC power supply and the electrical sensor 3560 to measure resistance, inductance, capacitance, voltage, current, and / or impedance, impedance components, and others. The sensor 3560 can measure electrical characteristics in various locations and conditions, including when indicator 3550 is present with blood 3590 (Figure 159), leaflets 42, 44 (Figure 160), and chordae tendineae 3592, or other parts of the heart valve other than leaflets (Figure 161). The resistance, inductance, capacitance, voltage, impedance, and / or current readings taken by the sensor may vary based on the anatomical structure or such structures in contact with indicator 3550. Therefore, the electrical characteristics measured by the electrical sensor 3560 can be used to determine the location of the hook and / or the anatomical structure that the hook contacts, based on the resistance, inductance, capacitance, voltage, impedance and / or current readings taken by the sensor.

[0380] Referring to Figure 162, this impedance can be measured using a sensor 3560. This sensor can take many different forms, including an impedance meter. Impedance is a quantification of 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, impedance can be calculated by controlling the AC voltage and measuring the current for any given situation.

[0381] Referring to Figure 163, the impedance of an ideal resistor is purely real and is called its resistive impedance ZR, which can be measured by dividing the voltage (V) by the current (I). Ideal inductors and capacitors have a purely virtual reactive 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 inverse of the product of frequency and capacitance.

[0382] Referring to Figure 164, a method 3600 for identifying hook and loop conditions is illustrated. The method 3600 includes a step 3610 of measuring a first impedance value. 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 these measurements. Impedance can be measured by a sensor used in one of the circuits according to Figures 144-161, and can be measured based on the measurement results described in Figures 162-163. For example, the impedance between the plates of the indicator 3550 illustrated in Figures 156-161 can be measured. In other implementations, the impedance between the components of any indicator disclosed herein can be measured.

[0383] The method 3600 also includes a step 3620 of comparing the impedance Z-value with a set of previously collected measurements. The previously collected impedance values ​​may correspond to known conditions. For example, each of the previously collected impedance values ​​may correspond to a tissue type in a hook, such as leaflet tissue or chordae tendineae, a tissue volume in the hook, or a fluid, such as blood in and / or around the tissue. The previously measured impedance values ​​and associated conditions may be collected, analyzed, and / or processed to predict or estimate conditions associated with future measurement results. For example, lookup tables, prediction algorithms, and / or machine learning strategies may be formed using the previously measured impedance values ​​and corresponding conditions. These lookup tables, prediction algorithms, and / or machine learning strategies may then be used to identify, estimate, and / or predict a condition corresponding to a future measured impedance value (such as the impedance value measured in step 3610).

[0384] The method 3600 also includes a step 3630 of identifying or estimating the condition and / or position of the hook. The hook condition can be determined by comparing a measured impedance value with a corresponding value associated with a previously measured impedance value. The hook condition may include a determination of where the hook is located, to which the hook is attached, etc. The method 3600 may determine, for example, whether the hook is coupled to a leaflet, and if so, the amount by which the leaflet is inserted into the hook.

[0385] When the leaflet is captured by a valve repair device, it can be pressed between the indicator and the hook. In some cases, a small or thin leaflet may at least partially converge between portions of the indicator or between the indicator and the hook, thereby reducing the distance the indicator is pushed. Referring to Figures 165-169, in some embodiments, device 3700 may include a rod coupled to at least one of the retaining arm 3732 of hook 3730 and inner paddle 3722. The rod may reinforce the inner paddle 3722 and prevent or inhibit the leaflet from converging around or between portions of indicator 3750. In this way, when the leaflet is captured within the hook of the device, the contact between the leaflet and the rod ensures that the contact between the leaflet and the indicator is sufficiently identifiable by a user. The rod may be included in any device disclosed herein, as well as any other valve repair device.

[0386] Referring to Figure 165, the rod 3760 may include a leaflet connecting portion 3762 and a device connecting portion 3764. The rod 3760 may be positioned in a gap between the leaflet connecting portions 3758 of the indicator 3750 (see Figure 166). The leaflet connecting portion 3762 may have various shapes and sizes. For example, the leaflet connecting portion 3762 of the rod 3760 may contact the fixing arm 3732 of the hook 3730, and / or be flush with a surface of the fixing arm of the hook 3730 from a first end 3766 of the leaflet connecting portion 3762 to a second end 3768 of the leaflet connecting portion. The rod 3760 can be positioned to pass through or surround the fixing arm 3732 of the hook 3730 and the inner blade 3722, such that the connecting portion 3764 of the device is hooked or otherwise secured to the inner blade 3722 at a position between the inner blade 3722 and the outer blade 3720. The rod 3760 can assist in further stabilizing the leaflets 42 and 44 when they are connected to the hook 3730 by the indicator arm 3750. Specifically, the leaflets 42 and 44 are pressed against the indicator arm 2050 and the two legs of the rod 3760, resulting in further stabilization of the leaflets 42 and 44. The rod 3760 causes a wavy path for the leaflets 42 and 44.

[0387] The rod can have various shapes. For example, these shapes can be selected to optimize or enhance the visualization of the indicator 3750, and / or optimize or enhance the leaflet engagement or gripping by the hook 3730. In the implementation illustrated in Figure 166, the rod 3770 may include one or more ridges 3774 located on or adjacent to the leaflet engagement portion 3772. The rod 3767 extends substantially into the gap between the leaflet engagement portions 3758 of the indicator 3750. In this way, the rod 3770 will increase the movement of the indicator 3750 when the leaflets are positioned in the hook, and / or the leaflets will be more securely gripped by the closed hook.

[0388] Referring to Figure 167, a rod 3780 can be positioned such that surface 3788 does not contact the fixing arm 3732 of hook 3730, and / or surface 3788 is spaced apart from the fixing arm 3732 of hook 3730. The device connection portion 3784 may include a hook area 3786, which can be positioned around inner paddle 3722 to secure the rod 3780 to the device 3700.

[0389] Referring to Figures 168-169, a leaflet junction 3792 of a lever 3790 may include one or more peaks 3796. The peaks 3796 of the lever 3790 can be configured to cause substantial movement of the indicator 3750 and to provide a visual indication immediately when the leaflet reaches a minimum insertion depth. The peaks can be configured to cause substantial movement of the indicator 3750 immediately when the leaflet has reached the minimum insertion depth in various ways. In the illustrated example, the peak 3796 abuts against and / or is very close to the movable arm 3734. Furthermore, when viewed from the side, as shown in Figure 168, the outline of the peak 3796 overlaps the leaflet junction of the indicator 3750. Therefore, the indicator 3750 will substantially move immediately when the leaflet has reached the overlap between the peak 3796 and the leaflet junction of the indicator 3750. In some implementations, the overlap system is selected to correspond to the minimum leaflet insertion depth.

[0390] In some embodiments, the peak 3796 can be configured such that the hook 3730 more securely engages the portion of the leaflet in the proximal end (facing the open end) of the hook 3730 than in the distal end (facing the closed end). The peak 3796 can be configured in various ways to make the hook 3730 more securely engage the portion of the leaflet in the proximal end of the hook 3730 than in the distal end. In the embodiments illustrated in Figures 168 and 169, a peak 3796 is included near the proximal end of the hook, but no peak is included at the distal end. Thus, a portion of the leaflet near the proximal end of the hook is more securely engaged than a portion of the leaflet near the distal end of the hook. In other implementations, the peak 3796 may be included at multiple locations, such as both at the proximal end and the distal end of the hook.

[0391] Any of the various systems, devices, equipment, etc. disclosed herein may be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are used safely for patients, and the methods described herein may include sterilization of associated systems, devices, equipment, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0392] Various inventive forms, concepts, and features disclosed herein are described and illustrated, and, as in the examples herein, are implemented in combination. These various forms, concepts, and features may be used individually or in various combinations and sub-combinations in many alternative embodiments. Unless expressly excluded herein, all such combinations and sub-combinations are intended to be within the scope of this application. Furthermore, while various alternative embodiments of the various forms, concepts, and features of this disclosure may be described herein—such as alternative materials, structures, configurations, methods, apparatuses and components, alternative solutions, etc., relating to formation, combination, and function—such descriptions are not intended to be a complete or exhaustive list of embodiments, whether now known or subsequently developed. Those skilled in the art will readily adopt one or more of the inventive forms, concepts, or features to additional embodiments and uses within the scope of this application, even if such embodiments are not expressly disclosed herein.

[0393] Additionally, even if some features, concepts, or states of this disclosure may be described herein as a preferred configuration or method, such description is not intended to suggest that such features are necessary or essential unless expressly stated otherwise. Furthermore, examples 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 only considered key values ​​or ranges when expressly stated otherwise.

[0394] Furthermore, while various forms, features, and concepts may be clearly identified herein as inventive or forming part of a disclosure, such identification is not intended to be exclusive. Rather, it is possible for inventive forms, concepts, and features described herein not to be explicitly identified or identified as part of a specific disclosure, but rather for the disclosure to be alternatively set forth in the appended claims. Unless explicitly stated otherwise, the description of exemplary methods or procedures is not limited to including all steps in all cases, nor is it necessary or required that steps be interpreted in the order presented. Moreover, the techniques, methods, operations, steps, etc., described or suggested herein may be practiced on a living animal or on an inanimate simulation, such as a corpse, a corpse's heart, a simulator (e.g., with simulated body parts, tissues, etc.), etc. The terms used in the claims have their full ordinary meaning and are not in any way limited by the description of the implementation methods in this specification.

[0395] 106, 206, 306, 606: Anchoring components 10,100: Device, implant 20: Leaflet, anterior leaflet, valvular tissue, primary leaflet, monk's cap leaflet, primary valvular leaflet 22: Leaflet, posterior leaflet, valve tissue, primary leaflet, monk's cap leaflet, primary valve leaflet 24: Lobe ring 26: Gap 30: Leaflet, anterior leaflet, tricuspid leaflet 32: Leaflet, septal leaflet, tricuspid leaflet 34: Leaflet, posterior leaflet, tricuspid leaflet 40: Native valve 42: Leaflet, primary leaflet, valvular leaflet 44: Leaflet, primary leaflet, valvular leaflet 101,600,702,1100,1900,2100,2200,2300,2400,2500,3200,3300,3700: Device 102: Delivery system, delivery component 104, 204, 304, 604: Joint parts 106, 206, 306, 606: Anchoring components 108: Anchoring component, first anchoring component, second anchoring component 110, 210, 310, 610, 3372: Connecting elements 111,112,113,212,612,111,113: Actuating elements 114,115,117,214,314,614: Cap 116,216,502,704,3378: Actuation Line 120: Propeller blade, outer propeller blade, first outer propeller blade, second outer propeller blade 122: Blade, inner blade, first inner blade, second inner blade 124, 126, 128: Parts, connecting parts 130, 230, 330, 500, 630, 700, 930, 1030, 1330, 1430, 1530, 1730, 1830, 2030, 2130, 2230, 2330, 2430, 2530, 2730, 2830, 2930, 3030, 3130, 3230, 3330, 3430, 3530, 3730: Hooks and loops 132,232,332,510,632,710,832,932,1032,1832,1932,2034,2132,2332,2432,2632,3132,3232,3332,3732: Fixed arm 134,234,334,530,634,730,834,1034,1134,1234,1334,1434,1534,1732,1834,1934,2134,2334,2434,2634,2734,3034,3134,3234,3334,3434,3734: Movable arm 136: Stable components 138,238,338,638: Handover section 200: Device, implant, valve repair device 201: Lateral surface 202: Delivery System 203: Middle surface 205, 305, 605: Attachment section 207, 307, 607: Remote portion 208, 308, 608, 2308: Anchoring components 209: Connecting Area 211: Collar, Proximal Collar 213: Capture Mechanism 220: Propeller blade, outer propeller blade 221,223,225,321,323,325: Connecting parts 222: Propeller blade, inner propeller blade 224: Frame, blade frame 231,331,660,662,664,666: Slots 235,335: Holes 236: Barb, friction-enhancing element 240: Cover 241: Maneuverable catheter 300: Device, implant, implantable device 301: Material strip, continuous strip 311: Collar, First Collar, Proximal Collar 320: Outer blade, blade section, outer blade section 322: Inner blade, blade section, inner blade section 324: Blade frame 336: Barbed hook, any type of barbed hook 400: Valve Repair System 401: Delivery device 402: Valve Repair Device 403: Shaft 404: Base Assembly 405: Coupler 406, 406a, 406b, 722: Paddle Blades 407: Lock 408, 408a, 408b: Grip components 409,740,836,936,1064: The chosen barb part 410: Paddle control mechanism 411: Grip control mechanism 412: Lock control mechanism 413: Placement of the shaft 414,506,706,860,960,1060,2661,2762,2764: Opening 504: Line, Actuation Line 516: Opening, delivery opening 520,720,838,2638,2738,2838,3138: Hinges 540: Any choice of barb, any choice of barb part 550, 850, 950, 1050, 1750, 3750: Indicator, Indicator Arm 555: Barrel hook 611: Proximal collar 620, 1920, 2320, 3220, 3320, 3720: Outer propeller blades 622,1922,2122,2322,3222,3322,3722: Inner propeller blades 636: Any Choice of Barrier 650, 750, 1350, 1450, 1550, 1650, 1850, 1950, 2050, 2150, 2350, 3050: Indicator Arm 652,3766: First end 654,3768: Second end 656,1756,3056,3057,3156,3157,3456: Indicators, indicator indicators 658: Curve 756,957,1556,2156,2856,2956,2656,2756: Indicators 830: Hook and loop, valve repair device hook and loop 852: The part that has been shaped 854: Indicator flexure or hinge portion 900: Device, valve repair device 924: Adjustable width blade frame assembly 925: Rigid inner blade frame 927: Flexible outer blade frame 934,3534: Movable arm, movable hook arm 938: Hinge section, flexure or hinge section 952,1052,1152,1252,1352,1452,2652: Mobile devices 954,1054,1654,2654,2754,2755,2854,2855,2954,2955: Fixed end 956: Indicator, indicator, optional indicator 958, 1958, 1058, 1158, 2158: Leaflet connecting components, leaflet connecting parts 962: Opening, first opening 964: Opening, second opening 972,1672: First Arm 974,1674: Second Arm 976,1676,2792,2892,2992: Connection points 980: Crossbar 990: Beam, First Beam 992: Beam, Second Beam 1021: First Link 1022: Second Link 1023: Link, Third Link 1024: Link, Fourth Link 1025: Fifth Link 1062: Second opening 1080, 1492: Protrusions 1130: Hook and Loop, First Hook and Loop 1150: Indicator arm, first indicator arm 1230: Second hook 1250: Indicator arm, second indicator arm 1490, 3760, 3767, 3770, 3780, 3790: Rod 1560: Crossbeam 1790, 1856: Illuminators 1851: Arrow 1852: End 1858: Reference Characters 1960: Movable arm passage 1962: Fixed Arm Access 1964: Internal blade channel 2090: Connecting components 2092: First Beam 2094: Second Beam 2190: Coupling component 2192: Sales 2194,3160: Bending section 2202,2550: First indicator arm 2204, 2252: Second indicator arm 2356, 2556: First electrode 2358, 2458: Electrode, second electrode 2456: Electrode, First Electrode 2558: Second electrode 2630: Hook and loop, flat material, flat hook and loop material 2636, 2736, 2836, 2936: Grasping part 2650, 2750, 2950, ​​3150: Indicator arm, leaflet depth indicator 2658: Twisted section 2660: Joint 2662: Base 2735: Outer beam, indicator arm 2770: First arm section, indicator arm section 2772,2782,2872,2882,2972,2982: Bending section 2780: Second arm section, indicator arm section 2790, 2890, 2990: Center beam 2834: Hook and loop arm, movable arm 2835, 2934: Outer beams 2850: Indicator arm, integrated indicator arm, leaflet depth indicator 2860: Joint, First Joint 2861: Joint, Second Joint 2862,2864,2962,2964: Space 2870: Arm section, first arm section, first arm position, first indicator arm section 2880: Arm section, second arm section, second indicator arm section 2910: First gripping component 2912: Second gripping component 2914: Third gripping component 2916: Connecting components 2918: Connecting component, connecting element or topographic feature 2920: Transition Section 2970: First arm position, first arm section, indicator arm section, first indicator arm section 2980: Second arm section, indicator arm section, second indicator arm section 3250, 3350: Indicator, Leaflet Indicator 3252: Contact, First Contact, First Indicator Contact 3254: Contact, second contact, second indicator contact 3260, 3360, 3460: Sensors 3301: System 3356: Insulator 3362: Control Line 3374: Collar 3376: Coupling components, conduit coupling components 3450: Indicator, visual indicator 3480: Zone, Insulator, Dashed Line Zone 3482: First Insulator 3484: Second Insulator 3532: Fixed arm, fixed hook arm 3550: Indicator, Electrical Indicator 3552: Board, First Board, Indicator Board, First Indicator Board 3554: Board, Second Board, Indicator Board, Second Indicator Board 3560: Sensor, Electrical Sensor 3590: Blood 3592, CT: chordae tendineae 3600: Method 3610, 3620, 3630: Steps 3758, 3762, 3772, 3792: ​​Leaflet junction 3764, 3784: Device connection parts 3774: Spine 3786: Hook and Loop Area 3788: Surface 3796: Peak A: Point, pivot fulcrum AA: Plane, axis, ascending aorta AV: aortic valve B, E: Points C: Point, capacitance component D: Point, direction F: side, space, first side G: inner side, space, second side H: Heart, direction I: Current J, K, M, N, Y: Direction L: Direction, inductance component LA: left atrium LV: Left ventricle LVOT: Left ventricular outflow tract MR: Monk's cap petal retrograde MV: Monk's Hat Petal PA: Pulmonary artery PM: mastoid muscle PV: Pulmonary valve R: Resistance component RA: Right atrium RV: Right ventricle TV: Tricuspid V: Direction, voltage W: Width Z: Direction, impedance ZR: Resistance

Claims

1. A valve repair device for repairing a native valve of a patient, the valve repair device comprising: a gripping member; a paddle; wherein the gripping member is movable to form a capture area for capturing a leaflet of the native valve; an indicator coupled to the valve repair device, wherein the indicator is movable to indicate whether the leaflet of the native valve is inserted into the capture area to at least a minimum insertion depth; and wherein the indicator is configured to pass through one or more of the paddle and the gripping member; wherein the indicator is configured as an indicator arm including a fixed end and a movable end; wherein the fixed end of the indicator arm is coupled to a movable arm of the gripping member; wherein the fixed end and the movable end are disposed on a first side of the movable arm of the gripping member; wherein the indicator arm includes a leaflet connecting member between the fixed end and the movable end; The leaflet connecting member is disposed on a second side of a movable arm of one of the gripping members; and the leaflet capturing area is located on the second side of the movable arm.

2. The valve repair device of claim 1, wherein the capture area is formed between a portion of the paddle and an arm of the gripping member.

3. The valve repair device as claimed in claim 2, wherein the blade comprises an outer blade and an inner blade.

4. A valve repair device as claimed in any of claims 1 to 3, wherein the indicator is configured to pass through at least one of a channel of the gripping member and a channel of the paddle.

5. The valve repair device according to any one of claims 1 to 3, wherein one of the fixing arms of the gripping member includes a first beam, a second beam, and a connecting member between the first beam and the second beam.

6. The valve repair device of any one of claims 1 to 3 further includes an indicator attached to the indicator.

7. The valve repair device of any one of claims 1 to 3, wherein the movable end includes an indicator containing a radiopaque material.

8. A valve repair device as claimed in any of claims 1 to 3, wherein the leaflet connection member is the only part of the indicator that is assembled to pass through at least one of the gripping member and the paddle.

9. A valve repair device as claimed in any of claims 1 to 3, wherein the leaflet connection member includes one or more protrusions extending from the leaflet connection member.

10. The valve repair device of any one of claims 1 to 3, wherein the indicator arm includes 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.

11. The valve repair device of any one of claims 1 to 3, wherein the indicator is formed as a part of the gripping member.

12. The valve repair device of any one of claims 1 to 3, wherein the indicator comprises a first arm portion and a second arm portion.

13. The valve repair device of claim 12, wherein the first arm portion includes a torsion portion, wherein the torsion portion of the first arm portion includes one or more torsion structures in a first direction between 0 degrees and 180 degrees, and wherein a second arm portion includes a torsion portion, wherein the torsion portion of the second arm portion includes one or more torsion structures in a second direction opposite to the first direction between 0 degrees and 180 degrees.

14. The valve repair device of claim 12, wherein the first arm portion and the second arm portion are coupled to the movable end at a connection point.

15. The valve repair device of claim 14, wherein the connection point includes an indicator containing a radiopaque material, which is pressed into at least one of the first arm portion and the second arm portion.

16. A system comprising the valve repair device as claimed in any one of claims 1 to 15.

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