Bioimpedance-based feedback for medical procedures

Abstract

Medical procedures and devices using bioimpedance-based feedback are disclosed. The bioimpedance-based feedback may include measuring or acquiring an electrical signal that includes or is indicative of a bioimpedance signal. The bioimpedance signal may be used to determine the location and / or status of a device (e.g., a catch or anchor of the device) and / or tissue in the vicinity of the device. The bioimpedance signal may be analyzed and converted into information presented to a clinician to indicate a status of a portion of a device, such as an anchoring element of an implant, to provide feedback regarding the positioning and / or status of the device. Some devices enable removal of electrodes or electrical leads when the devices are implanted.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 369,176, filed on July 22, 2022, entitled “BIOIMPEDANCE-BASED FEEDBACK FOR MEDICAL PROCEDURES,” and to U.S. Provisional Application No. 63 / 439,836, filed on January 18, 2023, entitled “BIOIMPEDANCE-BASED FEEDBACK FOR MEDICAL PROCEDURES,” each of which is expressly and entirely incorporated herein by reference for all purposes. Background Art

[0003] Various medical procedures involve implanting an object into a patient's body to solve one or more problems. Medical personnel may use various surgical techniques or other techniques to implant the object into the patient's body. This may involve fixing or anchoring the implant to a targeted tissue in the patient's body. Summary of the invention

[0004] The present disclosure is intended to provide some examples, and is not intended to limit the scope of the disclosed subject matter in any way. For example, any feature included in the examples of the present disclosure is not necessary for the claims unless the claims clearly describe these features. In addition, the features, components, steps, concepts, etc. described in the examples of the present disclosure and elsewhere in the present disclosure can be combined in a variety of ways. Various features and steps as described elsewhere in the present disclosure may be included in the examples summarized here.

[0005] In some embodiments, medical procedures, systems, and / or devices that sense or indicate bioimpedance and / or use bioimpedance-based feedback are disclosed. Sensing bioimpedance and / or bioimpedance-based feedback may include measuring or acquiring an electrical signal that includes and / or indicates a bioimpedance signal.

[0006] In some embodiments, the system, device and / or apparatus can be configured to measure or acquire an electrical signal including and / or indicating bioimpedance or a bioimpedance signal. The bioimpedance or bioimpedance signal can be used to obtain / provide information about autologous anatomical structures, blood, tissues, cells, blood vessels, etc. and / or information about various functions, features, locations, uses, operations, etc. of the system, device and / or apparatus when the system, device and / or apparatus is located in the patient's body.

[0007] In some embodiments, the bioimpedance or bioimpedance signal can be used to obtain / provide information about whether the system / device is in the correct position or positioning, whether the system / device is properly interacting with the autologous tissue, whether the system / device is properly anchored to the autologous tissue, whether the system / device is properly implanted, and / or obtain / provide other indications. In some embodiments, the bioimpedance signal is configured to indicate the leaflet capture status within an anchor (e.g., capture portion, hook, clamp, clip, etc.) of the system, device, and / or apparatus.

[0008] In some embodiments, the system and / or apparatus comprises a device, which may be one or more of a therapeutic device, a repair device, a valve repair device, an implantable device, a valve treatment device, a tissue treatment device, a catheter, an implant, an anchor, and the like.

[0009] In some embodiments, the system, equipment and / or device comprises one or more electrodes. In some embodiments, the system, equipment and / or device comprises two or more electrodes (or at least two electrodes). In some embodiments, the system, equipment and / or device comprises three electrodes. In some embodiments, the system, equipment and / or device comprises four electrodes.

[0010] In some embodiments, one or more electrodes (e.g., two or more electrodes) are configured such that when an electrical signal is applied to the one or more electrodes, a bioimpedance signal is measured and / or indicated in response to the applied electrical signal.

[0011] In some embodiments, the system, equipment and / or device comprises two or more electrodes, including a first electrode coupled to a first position of the system, equipment and / or device and a second electrode coupled to a second position of the system, equipment and / or device. In some embodiments, the first electrode is adjacent to the second electrode. In some embodiments, the first electrode comprises an electrode plate covering most of the first position, and the second electrode comprises an electrode plate covering most of the second position.

[0012] In some embodiments, the system, apparatus, and / or device comprises two or more electrodes, including a first electrode coupled to a first arm (e.g., a clamp arm, a hook arm, a paddle, etc.) of the system, apparatus, and / or device, and a second electrode coupled to a second portion or second arm (e.g., a second arm, a clamp arm, a hook arm, a paddle, an extension, etc.) of the system, apparatus, and / or device. Although many examples herein use "second arm" for illustrative purposes, other portions of the device (e.g., a mating element, a cover, a surface, etc.) may also serve as the second portion, even though the second portion is not generally considered an arm.

[0013] In some embodiments, after the first arm and the second arm are closed or moved together, the first electrode is adjacent to the second electrode.

[0014] In some embodiments, the first electrode and the second electrode are located on the same arm (eg, both located on the first arm or both located on the second arm).

[0015] In some embodiments, the first extension serves as or replaces the first arm, and the second extension serves as or replaces the second arm.

[0016] In some embodiments, the first surface is used as or replaces the first arm, and the second surface is used as or replaces the second arm. In some embodiments, the first panel is used as or replaces the first arm, and the second panel is used as or replaces the second arm.

[0017] In some embodiments, the first arm and the second arm are arms of a hook.In some embodiments, the first arm and the second arm are arms of a clamp or a clamping member.

[0018] In some embodiments, the first arm and the second arm are arms of a clamp or gripping portion of the system / device.

[0019] In some embodiments, the first arm and the second arm are arms of an anchor (e.g., a hook, a clip, a clamp, a clamping member, a paddle, a clamping member and a paddle, etc.) of an implant or device (e.g., a therapeutic device, a repair device, etc.).

[0020] In some embodiments, the first electrode comprises an electrode plate covering a majority of the first arm, and the second electrode comprises an electrode plate covering a majority of the second arm.

[0021] In some embodiments, the two or more electrodes include a first electrode coupled to the first arm and a second electrode coupled to the first arm. In some embodiments, the first electrode is separated from the second electrode by a gap. In some embodiments, the first electrode and the second electrode include electrode strips parallel to the length of the first arm. In some embodiments, the first electrode and the second electrode include electrode strips parallel to the width of the first arm (e.g., perpendicular to the length of the first arm).

[0022] In some embodiments, the system / device is configured to capture tissue, for example, between the first arm and the second arm and / or between the first surface and the second surface, etc. In some embodiments, the system / device is configured to capture the leaflet of the native valve, for example, between the first arm and the second arm and / or between the first surface and the second surface, etc.

[0023] In some embodiments, the first electrode is positioned on the first arm at a first leaflet capture depth and the second electrode is positioned on the first arm at a second leaflet capture depth. In some embodiments, the first electrode is positioned on the first arm at a target minimum leaflet capture depth and the second electrode is positioned on the first arm at a target maximum leaflet capture depth.

[0024] In some embodiments, the first electrode is positioned on the first arm at a first tissue capture depth and the second electrode is positioned on the first arm at a second tissue capture depth. In some embodiments, the first electrode is positioned on the first arm at a target minimum tissue capture depth and the second electrode is positioned on the first arm at a target maximum tissue capture depth.

[0025] In some embodiments, the system / device includes an electrode pad coupled to the second arm.

[0026] In some embodiments, the system / device includes an impedance measurement device configured to measure bioimpedance or a bioimpedance signal and determine tissue or leaflet capture depth based on the measured bioimpedance signal.

[0027] In some embodiments, the systems, devices and / or apparatus may be configured to repair or treat a native valve of a patient or simulated subject. In some embodiments, the systems, devices and / or apparatus may be configured to repair or treat a heart of a patient or simulated subject.

[0028] In some embodiments, the system, device and / or apparatus may include an anchor, a tissue engaging portion or a hook (e.g., one, two, three or more anchors, hooks or other tissue engaging portions), wherein the anchor or hook (e.g., each anchor and / or each hook) includes a first arm (e.g., a hook arm, a paddle, etc.) and a second arm (e.g., a hook arm, a paddle, etc.).

[0029] In some embodiments, the first arm and the second arm are joined by a hinge portion so that the first arm and the second arm can close (e.g., move toward each other, become close and / or optionally contact each other) to capture targeted tissue (e.g., leaflets and / or other tissue) in an anchor, tissue engaging portion, or hook.

[0030] In some embodiments, the anchor, tissue engaging portion, or hook is movable to form a capture zone for capturing tissue (e.g., for capturing the leaflets of a native valve). In some embodiments, the first arm of the anchor, tissue engaging portion, or hook is movable toward and away from the second arm (and / or other second portion) of the anchor, tissue engaging portion, or hook to form a capture zone for capturing tissue (e.g., for capturing the leaflets of a native valve).

[0031] In some embodiments, two or more electrodes are coupled to an anchor or hook. In some embodiments, the two or more electrodes are configured so that when an electrical signal is applied to the two or more electrodes, the bioimpedance or bioimpedance signal can be measured, for example, based on or in response to the applied electrical signal. In some embodiments, the bioimpedance signal is configured to indicate the state of the tissue within the anchor or hook (e.g., between the first arm and the second arm of the anchor or hook, between the first surface and the second surface of the anchor or hook, etc.) (e.g., leaflet capture state, etc.) and / or indicate the state or deployment state of the anchor or hook.

[0032] In some embodiments, the two or more electrodes include a first electrode coupled to the first arm and a second electrode coupled to the second arm. In some embodiments, after closing the anchor or hook, the first electrode is adjacent to the second electrode. In some embodiments, the first electrode includes an electrode plate covering most of the first arm and the second electrode includes an electrode plate covering most of the second arm.

[0033] In some embodiments, the two or more electrodes include a first electrode coupled to the first arm and a second electrode coupled to the first arm. In some embodiments, the first electrode is separated from the second electrode by a gap.

[0034] In some embodiments, the first electrode and the second electrode comprise electrode strips parallel to the length of the first arm. In some embodiments, the first electrode and the second electrode comprise electrode strips parallel to the width of the first arm.

[0035] In some embodiments, the first electrode is positioned on the first arm at a target minimum leaflet capture depth. In some embodiments, the second electrode is positioned on the first arm at a target maximum leaflet capture depth.

[0036] In some embodiments, the system, device, and / or apparatus includes an electrode pad coupled to the second arm.

[0037] In some embodiments, a system, apparatus, and / or device includes an impedance measurement device configured to measure a bioimpedance signal and determine a tissue (eg, leaflet, etc.) capture depth based on the measured bioimpedance signal.

[0038] In some embodiments, the impedance measurement device implements an algorithm to generate indicators of complete capture of tissue (e.g., complete capture of leaflets, etc.), partial capture of tissue (e.g., partial capture of leaflets, etc.), and / or excessive capture of tissue (e.g., excessive capture of leaflets, etc.).

[0039] In some embodiments, the impedance measurement device implements an algorithm to generate an indicator of tissue (eg, leaflet, etc.) capture depth.

[0040] In some embodiments, the impedance measurement device is configured to generate an indicator of the tissue (eg, leaflet, etc.) capture status of the anchor, tissue engaging portion, or hook when closed.

[0041] In some embodiments, the impedance measurement device is configured to generate an indicator of the tissue (eg, leaflet, etc.) capture status when the anchor, tissue engaging portion, or hook is open.

[0042] In some embodiments, the impedance measurement device implements an algorithm to generate an indicator of the angle of capture of tissue (eg, leaflets, etc.), or otherwise provide an indication when the captured tissue is skewed.

[0043] In some embodiments, the system / device comprises a device or implant configured to be used and / or implanted during a medical procedure. In some embodiments, the device comprises an anchor configured to secure the device to tissue within a patient.

[0044] In some embodiments, the system, device and / or apparatus includes electrodes (e.g., at least one electrode, two electrodes, three electrodes, four electrodes, electrode strips, two electrode strips, three electrode strips, four electrode strips, etc.) coupled to an anchor.

[0045] In some embodiments, the system, device, and / or apparatus is configured such that when an electrical signal is applied to the anchor, a bioimpedance signal can be measured based on and / or in response to the applied electrical signal.

[0046] In some embodiments, the bioimpedance signal is configured to indicate the positioning and / or deployment status of the anchor.

[0047] In some embodiments, a system, apparatus, and / or device comprises an edge-to-edge repair device.

[0048] In some embodiments, the systems, apparatus, and / or devices comprise an annuloplasty device (eg, an annuloplasty implant, annuloplasty ring, etc.).

[0049] In some embodiments, the system device and / or apparatus includes a plurality of anchors (e.g., two, three, four or more anchors), each anchor including an electrode. In some embodiments, when an electrical signal is applied to the plurality of anchors, a bioimpedance signal can be measured from each of the plurality of anchors based on and / or in response to the applied electrical signal.

[0050] In some embodiments, each bioimpedance signal is configured to indicate a position and / or deployment status of a corresponding anchor in the plurality of anchors.

[0051] In some embodiments, a system, device, and / or apparatus includes a plurality of anchors electrically shorted together.

[0052] In some embodiments, the system, device and / or apparatus includes an impedance measurement device configured to measure a bioimpedance signal and determine anchor positioning and / or anchor deployment status based on the measured bioimpedance signal.

[0053] In some embodiments, the impedance measuring device implements an algorithm to generate an indicator of the deployment status of the anchor.

[0054] In some embodiments, the impedance measurement device implements an algorithm to generate an indicator of the anchor deployment status including anchor contact with tissue.

[0055] In some embodiments, the impedance measuring device implements an algorithm to generate an indicator of a partially deployed anchor.

[0056] In some embodiments, the impedance measuring device implements an algorithm to generate an indicator of a fully deployed anchor.

[0057] In some embodiments, the system / device / apparatus may include a sensor, wherein the sensor is configured to measure impedance or bioimpedance.

[0058] In some embodiments, the sensor can be configured to compare one or more electrical signals and / or characteristics measured during use with previously measured electrical signals and / or characteristics (eg, which may correspond to known tissue and blood samples).

[0059] In some embodiments, the sensor can be configured to determine whether tissue is engaged.

[0060] In some embodiments, the sensor is configured to distinguish between leaflet tissue, annulus tissue and / or chord tissue (e.g., distinguishing when the anchor is in contact (or engaged) with leaflet tissue relative to annulus tissue relative to chord tissue, and / or whether the anchor is in contact only with blood).

[0061] In some embodiments, the first impedance or bio-impedance value is measured using a method that identifies the location and / or state of a system / device / device (e.g., a therapeutic device, a prosthetic device, an implantable device, a delivery device, etc.). In some embodiments, the first impedance value is compared to a reference value (e.g., to a previously measured or determined impedance value, etc.).

[0062] In some embodiments, the method includes determining and / or estimating one or more of the status or position of an anchor (e.g., hook, clip, tissue anchor, spiral anchor, dart, screw, etc.) of the system / device based on the comparison.

[0063] In some embodiments, the method includes determining and / or estimating one or more of a state or position of a catheter and / or other delivery device of the system / apparatus based on the comparison.

[0064] In some embodiments, a system, apparatus, and / or device includes a tissue engaging portion or a tissue capturing portion, which includes a first surface and a second surface, and the tissue engaging portion or the tissue capturing portion is configured such that the first surface and the second surface can be closed or moved closer together to engage and / or capture tissue in the tissue engaging portion or the tissue capturing portion.

[0065] In some embodiments, at least one of the first surface and the second surface is movable to form a capture zone between the first surface and the second surface for capturing tissue.

[0066] In some embodiments, the tissue engaging portion or tissue capturing portion is configured as or includes one or more of: an anchor, a dart, a hook, a hook, a clip, a clamp, a clamp, a clamping member, a paddle, an arm, a combination of these, etc.

[0067] In some embodiments, two or more electrodes are coupled to the tissue engaging portion or the tissue capturing portion. In some embodiments, the system, device and / or apparatus is configured such that: an electrical signal (e.g., a pulse, voltage, a cardiac signal, etc.) can be applied to the two or more electrodes. In some embodiments, the electrical signal provides an indication of the state of the tissue within the tissue engaging portion, the tissue capturing portion and / or the capture zone (e.g., tissue capture state, leaflet capture state, tissue engaging state, etc.).

[0068] In some embodiments, a bioimpedance signal can be measured (e.g., in response to an electrical signal applied to two or more electrodes, etc.) that provides an indication of the state of tissue within the tissue engaging portion, tissue capturing portion, and / or capture zone.

[0069] In some embodiments, the condition includes or indicates insufficient insertion of tissue into the tissue engaging portion, tissue capturing portion, and / or capture zone.

[0070] In some embodiments, the state includes or indicates complete insertion of tissue in the tissue engaging portion, tissue capturing portion, and / or capture zone.

[0071] In some embodiments, the condition includes or indicates over-insertion of tissue into the tissue engaging portion, the tissue capturing portion, and / or the capture zone.

[0072] In some embodiments, the condition includes or indicates angled insertion of tissue in the tissue engaging portion, tissue capturing portion, and / or capture zone.

[0073] In some embodiments, the state includes or indicates the insertion of non-targeted tissue in the tissue engaging portion, tissue capturing portion and / or capture zone. In some embodiments, the non-targeted tissue includes chordae tendineae and the like.

[0074] In some embodiments, the state includes or indicates insertion of tissue in the tissue engaging portion, tissue capturing portion and / or capture zone while the tissue engaging portion, tissue capturing portion and / or capture zone is in an open configuration comprising a first surface and a second surface separated from each other.

[0075] In some embodiments, the indication of the state is configured to generate or be used to generate a visual indicator for the user to generate a state (e.g., tissue engagement state, tissue capture state, leaflet capture state, etc.) for the user. In some embodiments, the visual indicator is configured to indicate one or more of no tissue insertion, insufficient tissue insertion, complete tissue insertion, and excessive tissue insertion. In some embodiments, the visual indicator is configured to indicate one or more of no tissue insertion, insufficient tissue insertion, complete tissue insertion, excessive tissue insertion, angled tissue insertion, and non-targeted tissue insertion.

[0076] In some embodiments, a system and / or device (e.g., a treatment system, a repair system, a valve repair system, a treatment device, etc., which may be the same or similar to other systems and / or devices described herein) includes a tissue engaging portion or a tissue capturing portion (e.g., an anchor, a hook, a clip, a clamp, multiple arms, multiple clamping members, two paddles, a hook arm and a paddle arm, a clamping member and a paddle, etc.).

[0077] In some embodiments, the tissue engaging portion or the tissue capturing portion includes a first surface (e.g., the surface of a clamp arm, a hook arm, a paddle, a mating element, other components, etc.) and a second surface (e.g., the surface of a clamp arm, a hook arm, a paddle, a mating element, other components, etc.), and the tissue engaging portion or the tissue capturing portion is configured so that the first surface and the second surface can be closed and / or moved closer to engage and / or capture tissue in the tissue engaging portion or the tissue capturing portion (e.g., to capture the leaflet of a native valve in the tissue capturing portion).

[0078] In some embodiments, the tissue engaging portion or the tissue capturing portion includes a first arm (e.g., a clamp arm, a hook arm, a paddle, etc.) and / or a second arm (e.g., a clamp arm, a hook arm, a paddle, etc.), and the tissue engaging portion or the tissue capturing portion is configured so that the first arm and the second arm can be closed and / or moved closer to engage and / or capture tissue in the tissue engaging portion or the tissue capturing portion (e.g., to capture the leaflet of a native valve in the tissue capturing portion).

[0079] In some embodiments, the first arm includes a first surface and / or the second arm includes a second surface.

[0080] In some embodiments, the systems, devices, and / or apparatus can be used to repair and / or treat a native valve of a patient or simulated subject.In some embodiments, the tissue is a leaflet of a native valve.

[0081] In some embodiments, a system, device, and / or apparatus comprises a plurality of tissue engaging portions, tissue capturing portions, and / or anchors.

[0082] In some embodiments, the system, device and / or apparatus includes a second tissue engaging portion or a second anchor, which includes a first surface (e.g., a surface of a clamp arm, a hook arm, a paddle, a mating element, etc.) and a second surface (e.g., a surface of a clamp arm, a hook arm, a paddle, a mating element, etc.), and the second tissue engaging portion or the second anchor is configured so that the first surface and the second surface can be closed and / or moved closer to engage and / or capture tissue (e.g., a second leaflet of a native valve, another portion of the leaflet, etc.) in the second tissue engaging portion or the anchor (e.g., the second tissue engaging portion or the anchor can act as a tissue capturing portion). In some embodiments, the second tissue engaging portion or the second anchor comprises a first arm (e.g., a clamp arm, a hook arm, a paddle, etc.) and / or a second arm (e.g., a clamp arm, a hook arm, a paddle, etc.), and the second tissue engaging portion or the second anchor is configured so that the first arm and the second arm can be closed and / or moved closer to engage and / or capture tissue (e.g., a second leaflet of a native valve, another portion of a leaflet, etc.) in the second tissue engaging portion or the anchor (e.g., in a hook, a clamp, etc.). In some embodiments, the first arm may include a first surface and / or the second arm may include a second surface. The configuration of the second tissue engaging portion or the second anchor may be the same or similar to the configuration of the first tissue engaging portion.

[0083] In some embodiments, the system, apparatus and / or device includes a third tissue engaging portion or a third anchor, which includes a first surface (e.g., a surface of a clamp arm, a hook arm, a paddle, a mating element, etc.) and a second surface (e.g., a surface of a clamp arm, a hook arm, a paddle, a mating element, etc.), and the third tissue engaging portion or the third anchor is configured such that the first surface and the second surface can be closed and / or moved closer to engage and / or capture tissue (e.g., a third leaflet of a native valve, another portion of a leaflet, etc.) in the third tissue engaging portion or the anchor (e.g., the third tissue engaging portion can act as a tissue capturing portion and capture tissue). In some embodiments, the third tissue engaging portion or the third anchor comprises a first arm (e.g., a clamp arm, a hook arm, a paddle, etc.) and / or a second arm (e.g., a clamp arm, a hook arm, a paddle, etc.), and the third tissue engaging portion or the third anchor is configured so that the first arm and the second arm can be closed and / or moved closer to engage and / or capture tissue (e.g., a third leaflet of a native valve, another portion of a leaflet, etc.) in the third tissue engaging portion or the anchor (e.g., in a hook, a clamp, etc.). In some embodiments, the first arm may include a first surface and / or the second arm may include a second surface. The configuration of the third tissue engaging portion or the third anchor may be the same or similar to the configuration of the first tissue engaging portion and / or the second tissue engaging portion or the anchor.

[0084] In some embodiments, at least one of (i) the first surface and / or the first arm and (ii) the second surface and / or the second arm (e.g., the first tissue capture portion and / or the second tissue capture portion, etc.) can be moved to form a capture area between the first surface and / or the first arm and the second surface and / or the second arm for capturing tissue (e.g., capturing the leaflets of a native valve).

[0085] In some embodiments, two or more electrodes are coupled to a tissue engaging portion or a tissue capturing portion (e.g., coupled to an anchor, a hook, etc.), wherein the system, device and / or apparatus is configured such that an electrical signal can be applied to the two or more electrodes.

[0086] In some embodiments, a bioimpedance signal can be measured, for example, based on an applied electrical signal.

[0087] In some embodiments, the two or more electrodes include: a first electrode strip coupled to the first surface and / or the first arm of a tissue engaging portion or a tissue capturing portion (e.g., an anchor, a hook, etc.) and a second electrode strip coupled to the first surface and / or the first arm of a tissue engaging portion or a tissue capturing portion (e.g., an anchor, a hook, etc.).

[0088] In some embodiments, the two or more electrodes include: a first electrode strip coupled to a first surface of a tissue engaging portion or a tissue capturing portion (e.g., an anchor, a hook, etc.) and / or a first edge of the first arm near the first surface of the first surface and / or the first arm; and a second electrode strip coupled to the first surface of a tissue engaging portion or a tissue capturing portion (e.g., an anchor, a hook, etc.) and / or a second edge of the first surface and / or the first arm near the second edge of the first surface of the tissue engaging portion or the tissue capturing portion (e.g., an anchor, a hook, etc.), the second edge being opposite to the first edge.

[0089] In some embodiments, the first electrode strips and the second electrode strips are parallel to each other and extend along the length of the first surface and / or the first arm.

[0090] In some embodiments, the first electrode strip and the second electrode strip are offset a specified distance relative to the first surface and / or free edge of the first arm of the tissue engaging portion or tissue capturing portion (eg, anchor, hook, etc.).

[0091] In some embodiments, the prescribed distance is between 1-15 mm. In some embodiments, the prescribed distance is between 2-10 mm. In some embodiments, the prescribed distance is between 5-8 mm. In some embodiments, the prescribed distance is at least 6 mm.

[0092] In some embodiments, the first bioimpedance signal may be measured, for example, based on an electrical signal applied to the first electrode strips, and the second bioimpedance signal may be measured, for example, based on an electrical signal applied to the second electrode strips.

[0093] In some embodiments, the first bioimpedance signal and the second bioimpedance signal indicate a state of tissue between a first surface and / or a first arm and a second surface and / or a second arm of a tissue engaging portion or a tissue capturing portion (e.g., an anchor, a hook, etc.), and / or indicate a state or a deployment state of the tissue engaging portion or the tissue capturing portion (e.g., the distance between the first surface and / or the first arm and the second surface and / or the second arm, an indication of whether the tissue engaging portion or the tissue capturing portion is closed or open, etc.).

[0094] In some embodiments, the difference between the capture states indicated by the first bioimpedance signal and by the second bioimpedance signal indicates that tissue is inserted at an angle between a first surface and / or first arm and a second surface and / or second arm of a tissue engaging portion or a tissue capturing portion (e.g., an anchor, a hook, etc.).

[0095] In some embodiments, an average of the first bioimpedance signal and the second bioimpedance signal is used to determine the capture state of the tissue.

[0096] In some embodiments, the first bioimpedance signal and the second bioimpedance signal provide a continuous indication of tissue insertion between the first surface and / or first arm and the second surface and / or second arm.

[0097] In some embodiments, the continuous indication of capture status is divided into quantified signal regions indicating four categories of capture status, including no tissue insertion, insufficient tissue insertion, complete tissue insertion, and excessive tissue insertion.Other status signals are also possible.

[0098] In some embodiments, a system, device, and / or apparatus includes a reference electrode configured to enable bipolar measurement of a bioimpedance signal.

[0099] In some embodiments, the bioimpedance signal can be measured in at least three configurations, including the first electrode strip relative to a reference electrode, the second electrode strip relative to a reference node, and the first electrode strip relative to the second electrode strip.

[0100] In some embodiments, the two or more electrodes include: a first electrode coupled to the first surface and / or the first arm of the tissue engaging portion or the tissue capturing portion near a free edge of the first surface and / or the first arm, the free edge being opposite to the hinged edge, the hinged edge being coupled to the second surface and / or the hinged edge of the second arm; and a second electrode coupled to the second surface and / or the second arm near a free edge of the second surface and / or the second arm of the tissue engaging portion or the tissue capturing portion, the free edge being opposite to the hinged edge of the second surface and / or the second arm.

[0101] In some embodiments, the first electrode and the second electrode are configured to contact each other when the tissue engaging portion or the tissue capturing portion is closed.

[0102] In some embodiments, the bioimpedance signal measured with the first electrode and the second electrode is configured to be used to determine the thickness of tissue inserted into the tissue engaging portion or the tissue capturing portion.

[0103] In some embodiments, the bioimpedance signal measured using the first electrode and the second electrode is configured to be used to determine a change in thickness of the tissue when the tissue is inserted into the tissue engaging portion or the tissue capturing portion.

[0104] In some embodiments, a cross-sectional map of the thickness of the tissue is generated based on the determined thickness and thickness variation of the tissue.

[0105] In some embodiments, the bioimpedance signal is measured using the first electrode and the second electrode while the tissue engaging portion or the tissue capturing portion is partially closed to bring the first electrode and the second electrode into proximity with tissue inserted into the tissue engaging portion or the tissue capturing portion.

[0106] In some embodiments, a system, device and / or apparatus (e.g., a treatment system, a repair system, a valve repair system, a treatment device, a repair device, etc., which may be the same or similar to other systems, devices and / or apparatus described herein) includes an anchor portion.

[0107] In some embodiments, a system, device, and / or apparatus includes a mate portion coupled to an anchor portion.

[0108] In some embodiments, the apposition portion includes an optional apposition element.

[0109] In some embodiments, the anchor portion includes a hook (or other anchor or tissue capture portion) configured to capture tissue (e.g., leaflets, membrane, muscle of a native valve, etc.) in the hook (or other anchor or tissue capture portion).

[0110] In some embodiments, one or more flexible electrodes protrude away from the mate portion and the reference electrode.

[0111] In some embodiments, the systems, devices, and / or apparatus are configured such that: an electrical signal can be applied to one or more flexible electrodes.

[0112] In some embodiments, a bioimpedance signal can be measured (eg, based on or in response to an applied electrical signal, etc.) to determine relative blood flow proximate to a system, device, and / or apparatus.

[0113] In some embodiments, one or more flexible electrodes are configured to measure blood flow through a native valve, for example, when the system, device, and / or apparatus is implanted in the native valve.

[0114] In some embodiments, the one or more flexible electrodes are configured to detect leakage through the native valve.

[0115] In some embodiments, the one or more flexible electrodes are configured to deflect in response to blood flowing through the one or more flexible electrodes.

[0116] In some embodiments, the bioimpedance signal changes in response to deflection of one or more flexible electrodes.

[0117] In some embodiments, changes in the bioimpedance signal are related to the amount of deflection, which is related to the blood flow rate through the valve.

[0118] In some embodiments, the bioimpedance signal is configured to decrease in response to regurgitant blood volume passing through the native valve.

[0119] In some embodiments, the reference electrode is coupled to the actuation element, and the actuation element is coupled to the apposition portion and the anchor portion.

[0120] In some embodiments, a system and / or device (eg, a valve repair system, apparatus, and / or device, which may be the same or similar to other systems / devices described herein) includes an anchor portion.

[0121] In some embodiments, a system, device, and / or apparatus includes a mate portion coupled to an anchor portion.

[0122] In some embodiments, the apposition portion optionally includes an apposition element.

[0123] In some embodiments, the anchor portion includes a hook (or other anchor or tissue capture portion) configured to capture tissue (e.g., leaflets, membrane, muscle of a native valve, etc.) in the hook (or other anchor or tissue capture portion).

[0124] In some embodiments, one or more electrodes are coupled to the anchor portion.

[0125] In some embodiments, the systems, devices, and / or apparatus are configured such that an electrical signal can be applied to one or more electrodes.

[0126] In some embodiments, a bioimpedance signal can be measured (eg, based on an applied electrical signal, etc.) to determine the force on a system, device, and / or apparatus.

[0127] In some embodiments, the bioimpedance signal is related to deflection of the apposition portion or the anchor portion.

[0128] In some embodiments, the deflection is related to the force applied to the system, device, and / or apparatus such that the bioimpedance signal is related to the force applied to the system, device, and / or apparatus.

[0129] In some embodiments, the anchor portion includes an inner blade coupled to an outer blade, wherein the inner and outer blades rotate relative to each other, wherein a force applied to the system, device and / or apparatus changes an opening distance between the inner and outer blades.

[0130] In some embodiments, a first electrode of the two or more electrodes is coupled to the inner paddle and a second electrode of the two or more electrodes is coupled to the outer paddle such that a change in the opening distance causes a change in the bioimpedance signal.

[0131] In some embodiments, a system, apparatus and / or device (e.g., a treatment system, a repair system, a valve repair system, a treatment device, a repair device, etc., which may be the same or similar to other systems and / or devices described herein) includes at least one tissue engaging portion or anchor (e.g., a helical anchor, a screw, a staple, a dart, a hook, a hook, a clip, a clamp, multiple arms, multiple clamping members, two paddles, a hook arm and a paddle arm, a clamping member and a paddle, etc.).

[0132] In some embodiments, the tissue engaging portion or anchor includes a first surface (e.g., a surface of a clamp arm, a hook arm, a paddle, etc.) and a second surface (e.g., a surface of a clamp arm, a hook arm, a paddle, etc.), and the tissue engaging portion or anchor is configured such that the first surface and the second surface can be closed or moved closer together to engage and / or capture tissue (e.g., leaflets, membranes, muscles, etc. of a native valve) in the tissue engaging portion or anchor (e.g., the tissue engaging portion or anchor can act as a tissue capturing portion and capture tissue).

[0133] In some embodiments, the tissue engaging portion or anchor comprises a first arm (e.g., a clamp arm, a hook arm, a paddle, etc.) and / or a second arm (e.g., a clamp arm, a hook arm, a paddle, etc.), and the tissue engaging portion or anchor is configured such that the first arm and the second arm can be closed or moved closer together to engage and / or capture tissue (e.g., leaflets, membranes, muscles, etc. of a native valve) in the tissue engaging portion or anchor (e.g., the tissue engaging portion or anchor can act as a tissue capturing portion and capture tissue). In some embodiments, the first arm comprises a first surface and / or the second arm comprises a second surface.

[0134] In some embodiments, at least one of the first surface and / or the first arm and the second surface and / or the second arm can be moved to form a capture area for capturing tissue (e.g., the leaflet of a native valve) in the first surface and / or the first arm and the second surface and / or the second arm.

[0135] In some embodiments, a plurality of electrodes are coupled to the tissue engaging portion or anchor.

[0136] In some embodiments, multiple electrodes are electrically coupled in series using electrical leads.

[0137] In some embodiments, the plurality of electrical components are electrically coupled in series with the plurality of electrodes using electrical leads.

[0138] In some embodiments, the systems, devices, and / or apparatus are configured such that an electrical signal can be applied to a plurality of electrodes via electrical leads.

[0139] In some embodiments, bioimpedance signals can be measured for multiple electrodes (eg, based on applied electrical signals, etc.).

[0140] In some embodiments, a measured bioimpedance value can be determined for each of the plurality of electrodes based on electrical characteristics and electrical signals of the plurality of electrical components.

[0141] In some embodiments, one or more electrical components of the plurality of electrical components are coupled in series between a pair of electrodes of the plurality of electrodes using electrical leads.

[0142] In some embodiments, the one or more electrical components include a resistor, a capacitor, or an inductor.

[0143] In some embodiments, electrical characteristics of one or more electrical components connected in series between a pair of electrodes in the plurality of electrodes are different from electrical characteristics of other one or more electrical components connected in series between a different pair of electrodes in the plurality of electrodes.

[0144] In some embodiments, the electrical signal may be applied at a predetermined current and frequency.

[0145] In some embodiments, the electrical lead comprises a single electrical lead.

[0146] In some implementations, a resistor having a fixed resistance value is coupled in series between a first electrode and a second electrode of the plurality of electrodes.

[0147] In some implementations, a capacitor having a fixed capacitance value is coupled in series between a second electrode and a third electrode of the plurality of electrodes.

[0148] In some implementations, an inductor having a fixed inductance value is coupled in series between a third electrode and a fourth electrode of the plurality of electrodes.

[0149] In some embodiments, the measured bioimpedance signals of the first, second, third, and fourth electrodes among the plurality of electrodes depend on the fixed resistance of the resistor, the fixed capacitance of the capacitor, and the fixed inductance of the inductor, as well as the predetermined frequency and current of the applied electrical signal.

[0150] In some embodiments, a system, apparatus and / or device (e.g., a treatment system, a repair system, a valve repair system, a treatment device, a repair device, which may be the same or similar to other systems, apparatus and / or devices described herein) includes a tissue engaging portion or anchor (e.g., a helical anchor, a screw, a staple, a dart, a hook, a hook, a clip, a clamp, multiple arms, multiple clamping members, two paddles, a hook arm and a paddle arm, a clamping member and a paddle, etc.).

[0151] In some embodiments, the tissue engaging portion or anchor includes a first arm (e.g., a clamp arm, a hook arm, a paddle, etc.) and / or a second arm (e.g., a clamp arm, a hook arm, a paddle, etc.), and the tissue engaging portion or anchor is configured so that the first arm and the second arm can be closed or moved closer together to engage and / or capture tissue (e.g., leaflets, membranes, muscles, etc. of a native valve) in the tissue engaging portion or anchor (e.g., the tissue engaging portion or anchor can act as a tissue capturing portion and capture tissue). In some embodiments, at least one of the first arm and the second arm is movable to form a capture zone for capturing tissue (e.g., leaflets, etc.) between the first arm and the second arm, and / or move closer to the other arm to capture tissue between the first arm and the second arm.

[0152] In some embodiments, a plurality of electrodes are coupled to the tissue engaging portion or anchor.

[0153] In some embodiments, an analog-to-digital converter (ADC) chip is coupled to the tissue engaging portion or anchor and is electrically coupled to the plurality of electrodes.

[0154] In some embodiments, electrical leads (eg, a single electrical lead, etc.) are configured to direct signals from the ADC chip to a measurement system.

[0155] In some embodiments, the system, device and / or apparatus is configured such that: an electrical signal can be applied to multiple electrodes through an ADC chip, the ADC chip digitizes the bioimpedance signal from each of the multiple electrodes, the digitized bioimpedance signal is transmitted to a measurement system through a single electrical lead, and a bioimpedance signal is determined for each of the multiple electrodes based on the applied electrical signal and the digitized bioimpedance signal.

[0156] In some embodiments, the digitized bioimpedance signal is sent through a single electrical lead using a digital data packet.

[0157] In some embodiments, the system, device and / or apparatus (which may be the same or similar to other systems and / or apparatus described herein) includes at least one tissue engaging portion or anchor (e.g., a hook, a clip, a clamp, multiple arms, multiple clamping members, two paddles, a hook arm and a paddle arm, a clamping member and a paddle, etc.).

[0158] In some embodiments, the tissue engaging portion or anchor includes a first surface (e.g., a surface of a clamp arm, a hook arm, a paddle, an apposition element, etc.) and a second surface (e.g., a surface of a clamp arm, a hook arm, a paddle, an apposition element, etc.), and the tissue engaging portion or anchor is configured so that the first surface and the second surface can be closed or moved closer together to engage and / or capture tissue (e.g., leaflets, membranes, muscles, etc. of a native valve) in the tissue engaging portion or anchor (e.g., the tissue engaging portion or anchor can act as a tissue capturing portion and capture tissue). In some embodiments, at least one of the first surface and the second surface is movable to form a capture zone for capturing tissue (e.g., leaflets, etc.) between the first surface and the second surface, and / or move closer to the other arm to capture tissue between the first surface and the second surface.

[0159] In some embodiments, the tissue engaging portion or anchor comprises a first arm (e.g., a clamp arm, a hook arm, a paddle, etc.) and / or a second arm (e.g., a clamp arm, a hook arm, a paddle, etc.), and the tissue engaging portion or anchor is configured so that the first arm and the second arm can be closed or moved closer together to engage and / or capture tissue (e.g., leaflets, membranes, muscles, etc. of an autologous valve) in the tissue engaging portion or anchor (e.g., the tissue engaging portion or anchor can act as a tissue capturing portion and capture tissue). In some embodiments, at least one of the first arm and the second arm is movable to form a capture zone for capturing tissue (e.g., leaflets, etc.) between the first arm and the second arm, and / or move closer to the other arm to capture tissue between the first arm and the second arm. In some embodiments, the first arm comprises a first surface and / or the second arm comprises a second surface.

[0160] In some embodiments, a flexible printed circuit board (PCB) includes a body, one or more electrodes coupled to the body, and electrical leads extending away from the body, and the flexible PCB is coupled to a tissue engaging portion or anchor (e.g., coupled to a hook, clip, paddle, etc.).

[0161] In some embodiments, the flexible PCB is coupled to the tissue engaging portion or anchor using one or more sutures.Other coupling mechanisms are also possible.

[0162] In some embodiments, a flexible PCB is coupled to a tissue engaging portion or anchor, and the system, device, and / or apparatus is configured such that: an electrical signal can be applied to one or more electrodes through electrical leads of the flexible PCB, and a bioimpedance signal can be measured using the electrical leads based on or in response to the applied electrical signal.

[0163] In some embodiments, the system, device, and / or apparatus includes a cover covering a tissue engaging portion or anchor, wherein the flexible PCB is secured to the cover covering the anchor to couple the flexible PCB to the tissue engaging portion or anchor.

[0164] In some embodiments, the system, device and / or apparatus includes a cover covering a tissue engaging portion or anchor, wherein the flexible PCB is secured to a first arm of the tissue engaging portion or anchor beneath the cover covering the tissue engaging portion or anchor to couple the flexible PCB to the tissue engaging portion or anchor.

[0165] In some embodiments, the flexible PCB includes one or more physical features that facilitate removal of the flexible PCB from the tissue engaging portion or anchor by applying force to the electrical leads.

[0166] In some embodiments, one or more physical features include a stress concentration point, which includes a narrow connection point between two openings, one or more sutures are configured to extend through the two openings and beyond the narrow connection point to couple the flexible PCB to a tissue engaging portion or anchor, and force is applied to the electrical lead to break the narrow connection point, thereby releasing the flexible PCB from the tissue engaging portion or anchor and retaining the one or more sutures coupled to the tissue engaging portion or anchor.

[0167] In some embodiments, one or more physical features include a Y-shaped protrusion extending from an end of the body, the flexible PCB, the end being opposite to an end of the electrical lead extending from the body away from the flexible PCB, the Y-shaped protrusion including a pair of legs extending away from a bridging portion, the bridging portion extending away from the body of the flexible PCB.

[0168] In some embodiments, the bridging portion forms a rotational cutout configured to promote rotation of the pair of legs toward each other by applying an inward force to the pair of legs. In some embodiments, one or more sutures are configured to extend across the bridging portion to secure the flexible PCB to the tissue engaging portion or anchor.

[0169] In some embodiments, a force is applied to the electrical lead so that the suture pushes a pair of legs toward each other to allow the flexible PCB to slide under the suture, thereby releasing the flexible PCB from the tissue engaging portion or anchor and retaining one or more sutures coupled to the tissue engaging portion or anchor.

[0170] In some embodiments, the one or more physical features include a circular protrusion extending from a side of the body, the flexible PCB. In some embodiments, the circular protrusion includes a neck portion connecting the circular portion to the body of the flexible PCB.

[0171] In some embodiments, the circular protrusion is configured to cover one side of the tissue engaging portion or anchor, and one or more sutures are configured to extend over the neck portion on one side of the tissue engaging portion or anchor to secure the flexible PCB to the tissue engaging portion or anchor.

[0172] In some embodiments, force is applied to the electrical lead such that the circular protrusion deforms to allow the flexible PCB to slide under the suture, thereby releasing the flexible PCB from the tissue engaging portion or anchor and retaining one or more sutures coupled to the tissue engaging portion or anchor.

[0173] In some embodiments, the one or more physical features include a pair of undercuts formed by the body of the flexible PCB, the undercuts formed in opposing sides of the body of the flexible PCB.

[0174] In some embodiments, the undercut is configured to provide a positive lock in a targeted position of the flexible PCB that is configured to not interfere with measurements taken with one or more electrodes of the flexible PCB.

[0175] In some embodiments, applying a force to the electrical leads causes the flexible PCB to slide under the sutures, thereby releasing the flexible PCB from the tissue engaging portion or anchor and retaining one or more sutures coupled to the tissue engaging portion or anchor.

[0176] In some embodiments, the one or more physical features include a hole formed in the body of the flexible PCB near an edge of the body of the flexible PCB, the edge being opposite the end of the electrical lead from which it extends away from the body of the flexible PCB. In some embodiments, one or more sutures are configured to pass through the hole over the body of the flexible PCB to secure the flexible PCB to the tissue engaging portion or anchor.

[0177] In some embodiments, force is applied to the electrical leads such that the body of the PCB breaks at an edge of the body of the flexible PCB, thereby releasing the flexible PCB from the tissue engaging portion or anchor and retaining one or more sutures coupled to the tissue engaging portion or anchor.

[0178] In some embodiments, the one or more physical features include a relief extending from the hole to the edge. In some embodiments, the relief is configured to allow one or more sutures to pass through the relief to release the flexible PCB from the tissue engaging portion or anchor.

[0179] In some embodiments, one or more physical features include a pair of bi-directional tongues forming a pair of protrusions on the body of the flexible PCB, the pair of protrusions being oriented in opposite directions from each other, each of the pair of protrusions being configured to allow one or more sutures to extend over a portion of the body of the flexible PCB and under the protrusions to secure the flexible PCB to a tissue engaging portion or anchor.

[0180] In some embodiments, force is applied to the electrical leads so that one or more sutures push corresponding protrusions away from the body of the PCB to allow the flexible PCB to slide under the one or more sutures, thereby releasing the flexible PCB from the tissue engaging portion or anchor and retaining the one or more sutures coupled to the tissue engaging portion or anchor.

[0181] In some embodiments, a system, apparatus and / or device (e.g., a treatment system, a repair system, a valve repair system, a treatment device, a repair device, etc., which may be the same or similar to other systems and / or devices described herein) includes a tissue engaging portion or anchor (e.g., a helical anchor, a screw, a dart, a staple, a hook, a hook, a clip, a clamp, multiple arms, multiple clamping members, two paddles, a hook arm and a paddle arm, a clamping member and a paddle, etc.).

[0182] In some embodiments, the tissue engaging portion or anchor comprises a first surface (e.g., a surface of a clamp arm, a hook arm, a paddle, etc.) and a second surface (e.g., a surface of a clamp arm, a hook arm, a paddle, etc.), and the tissue engaging portion or anchor is configured such that the first surface and the second surface can be closed or moved closer together to engage and / or capture tissue (e.g., leaflets, membranes, membranes, muscles, etc. of a native valve) in the tissue engaging portion or anchor (e.g., the tissue engaging portion or anchor can act as a tissue capturing portion and capture tissue).

[0183] In some embodiments, the tissue engaging portion or anchor comprises a first arm (e.g., a clamp arm, a hook arm, a paddle, etc.) and / or a second arm (e.g., a clamp arm, a hook arm, a paddle, etc.), and the tissue engaging portion or anchor is configured such that the first arm and the second arm can be closed or moved closer together to engage and / or capture tissue (e.g., leaflets, membranes, membranes, muscles, etc. of a native valve) in the tissue engaging portion or anchor (e.g., the tissue engaging portion or anchor can act as a tissue capturing portion and capture tissue). In some embodiments, the first arm comprises a first surface and / or the second arm comprises a second surface.

[0184] In some embodiments, at least one of the first arm and the second arm can be moved to form a capture zone between the first arm and the second arm for capturing tissue (eg, a leaflet, etc.).

[0185] In some embodiments, the tissue engaging portion or anchor includes a plurality of barbs for securing tissue (eg, leaflets, etc.) within the tissue engaging portion or anchor.

[0186] In some embodiments, the tissue engaging portion or anchor comprises a flexible printed circuit board (PCB) comprising an electrode pad or electrode array, wherein one or more electrodes are coupled to the electrode pad. In some embodiments, the electrical leads extend away from the electrode pad / array.

[0187] In some embodiments, the system, device and / or apparatus is configured such that: an electrical signal can be applied to one or more electrodes through the electrical leads of the flexible PCB. In some embodiments, the electrical leads can be used to measure a bioimpedance signal based on or in response to the applied electrical signal.

[0188] In some embodiments, applying a force to the electrical leads causes removal of the flexible PCB and / or one or more electrodes from the system, device, and / or apparatus.

[0189] In some embodiments, the flexible PCB is configured to be pulled through a pair of barbs in the plurality of barbs to remove the flexible PCB from a system, device, and / or apparatus.

[0190] In some embodiments, the electrical lead extends between a pair of barbs.

[0191] In some embodiments, the width of the electrode pad of the flexible PCB is greater than the distance between the pair of barbs, and the electrode pad of the flexible PCB is configured to bend to fit between the pair of barbs.

[0192] In some embodiments, the width of the electrode pad is less than or equal to 1.875 times the distance between a pair of barbs.

[0193] In some embodiments, the width of the electrode pad is less than or equal to 1.25 times the distance between a pair of barbs.

[0194] In some embodiments, the distance between a pair of barbs is less than or equal to 8 mm.

[0195] In some embodiments, the force required to pull the electrode pad through the pair of barbs is less than or equal to 1.5N.

[0196] In some embodiments, the flexible PCB is configured to be pulled around one side of the plurality of barbs to remove the flexible PCB from the system, device, and / or apparatus.

[0197] In some embodiments, the electrical lead has a diagonally bent section leading directly away from the electrode pad so that the electrode pad is laterally offset relative to the electrical lead, thereby placing the electrical lead along one side of the plurality of barbs while the electrode pad is located within the tissue engaging portion or anchor.

[0198] In some embodiments, the electrical lead is pulled so that the electrode pads are moved around the plurality of barbs and away from the tissue engaging portion or anchor from one side of the tissue engaging portion or anchor.

[0199] In some embodiments, the electrical lead is pulled so that the diagonally bent section contacts the plurality of barbs so as to cause the electrode pad to move laterally relative to the plurality of barbs, thereby moving away from one side of the tissue engaging portion or anchor using one or more of the plurality of barbs as a fulcrum.

[0200] In some embodiments, the electrode pad includes a relief cut through the electrode pad such that application of sufficient force causes the electrode pad to separate into a first lateral portion and a second lateral portion.

[0201] In some embodiments, the flexible PCB includes a second electrical lead coupled to the first lateral portion of the electrode pad and a second electrical lead coupled to the second lateral portion of the electrode pad.

[0202] In some embodiments, the electrical lead and the second electrical lead each include diagonally bent segments in opposite directions such that the electrical lead and the second electrical lead are each laterally offset relative to corresponding lateral portions of the electrode pad, thereby positioning the electrical lead along a first side of the plurality of barbs and the second electrical lead along a second side of the plurality of barbs opposite the first side, with the electrode pad positioned within the tissue engaging portion or anchor.

[0203] In some embodiments, applying a proximal force to the electrical lead and the second electrical lead causes the electrode pad to separate into a first lateral portion and a second lateral portion.

[0204] In some embodiments, after the electrode is separated into the first lateral portion and the second lateral portion, a proximal force is applied to the electrical lead and the second electrical lead so that the first lateral portion moves away from the tissue engaging portion or anchor around a first side of the plurality of barbs and so that the second lateral portion moves away from the tissue engaging portion or anchor around a second side of the plurality of barbs.

[0205] In some embodiments, the flexible PCB includes a reference electrode coupled to the electrical lead.

[0206] In some embodiments, the electrical lead is configured to extend proximally to a proximal end of a delivery system that is configured to be implanted in a system, device, and / or apparatus.

[0207] In some embodiments, a system, apparatus and / or device (e.g., a treatment system, a repair system, a valve repair system, a treatment device, a repair device, which may be the same or similar to other systems, apparatus and / or devices described herein) includes an anchor portion that includes a tissue engaging portion or anchor (e.g., a hook, a clip, a clamp, multiple arms, multiple clamping members, two paddles, a hook arm and a paddle arm, a clamping member and a paddle, etc.).

[0208] In some embodiments, the tissue engaging portion or anchor includes a first surface (e.g., a surface of a clamp arm, a hook arm, a paddle, etc.) and a second surface (e.g., a surface of a clamp arm, a hook arm, a paddle, etc.), wherein the first surface and the second surface are configured to engage (e.g., capture, attach to, etc.) tissue (e.g., a leaflet of a native valve, a membrane, a membrane, a muscle, etc.).

[0209] In some embodiments, the tissue engaging portion or anchor comprises a first arm (e.g., a clamp arm, a hook arm, a paddle, etc.) and / or a second arm (e.g., a clamp arm, a hook arm, a paddle, etc.) configured to engage (e.g., capture, attach to, etc.) tissue (e.g., a leaflet, a membrane, a film, a muscle, etc. of a native valve). In some embodiments, the first arm comprises a first surface and / or the second arm comprises a second surface.

[0210] In some embodiments, the systems, devices, and / or apparatus include a distal portion configured to engage an actuation element of a delivery system (e.g., a guide wire, a wire, a suture, a tube, a rod, etc.). In some embodiments, the actuation element is configured to rotate to deploy the anchor portion.

[0211] In some embodiments, a system, device, and / or apparatus includes an electrode coupled to a tissue engaging portion or anchor.

[0212] In some embodiments, one or more wires are coupled to the electrodes and to an actuation element of the delivery system.

[0213] In some embodiments, the system, device, and / or apparatus is configured such that: an electrical signal can be applied to the electrodes through one or more wires, and a bioimpedance signal can be measured based on or in response to the applied electrical signal.

[0214] In some embodiments, rotation of an actuation element of the delivery system causes one or more wires to wrap around the actuation element to pull the electrode away from the tissue engaging portion or anchor, thereby removing the electrode from the system, device, and / or apparatus.

[0215] In some embodiments, one or more wires are secured to a loop that is attached to an actuation element such that rotation of the actuation element rotates the loop.

[0216] In some embodiments, one or more electrical leads are coupled to one or more wires at the collar to provide an electrical connection to the proximal end of the delivery system.

[0217] In some embodiments, the electrode comprises a flexible printed circuit board.

[0218] In some embodiments, the electrode is releasably secured to the tissue engaging portion or anchor.

[0219] In some embodiments, rotation of the actuation element further causes the electrode to wrap around the actuation element, thereby removing the electrode and one or more leads from the system, device, and / or apparatus.

[0220] In some embodiments, the methods and / or techniques described herein relate to the operation or use of a system (which may be a system that can be used to repair and / or treat a patient's or simulated subject's native valve and may be the same or similar to other systems herein) comprising a delivery system and a valve repair device.

[0221] In some embodiments, the methods and / or techniques include using the system to access the interior of the body and repair and / or treat body tissue. In some embodiments, the methods and / or techniques include using the system to repair and / or treat a heart valve of the body.

[0222] In some embodiments, the methods and / or techniques include using a delivery system to advance a valve repair device to a heart valve, and deploying or otherwise using the valve repair device to repair and / or treat the heart valve. In some embodiments, deploying or otherwise using the valve repair device to repair and / or treat the heart valve includes anchoring the valve repair device to tissue of the heart and / or heart valve.

[0223] In some embodiments, the delivery system includes: a catheter having a proximal end and a distal end, an actuation element, a guide wire extending within a lumen of the catheter from the proximal end of the catheter to the distal end of the catheter, and / or a capture mechanism located at the distal end of the delivery system.

[0224] In some embodiments, the valve repair device includes: an attachment portion, which includes a proximal component (e.g., a proximal collar, a proximal ring, a proximal extension, etc.), which is configured to engage with a capture mechanism of a delivery system; and an anchor portion, which includes a tissue engaging portion or anchor (e.g., a spiral anchor, a screw, a dart, a staple, a hook, a hook, a clip, a clamp, multiple arms, multiple clamping members, two paddles, a hook arm and a paddle arm, a clamping member and a paddle, a combination of these, etc.).

[0225] In some embodiments, the tissue engaging portion or anchor includes a first surface (e.g., a surface of an anchor, an anchor head, a clamp arm, a hook arm, a paddle, etc.), which is configured to engage tissue (e.g., an annulus of a native valve, leaflets of a native valve, a membrane, a membrane, a muscle, etc.).

[0226] In some embodiments, the tissue engaging portion or anchor comprises a first surface (e.g., a surface of a clamp arm, a hook arm, a paddle, etc.) and a second surface (e.g., a surface of a clamp arm, a hook arm, a paddle, etc.), wherein the first surface and the second surface are configured to capture tissue (e.g., a leaflet of a native valve, a membrane, a membrane, a muscle, etc.).

[0227] In some embodiments, the tissue engaging portion or anchor comprises a first arm (e.g., a clamp arm, a hook arm, a paddle, etc.) and / or a second arm (e.g., a clamp arm, a hook arm, a paddle, etc.) configured to capture tissue (e.g., a leaflet, a membrane, a film, a muscle, etc. of a native valve). In some embodiments, the first arm comprises a first surface and / or the second arm comprises a second surface.

[0228] In some embodiments, the valve repair device includes a distal portion configured to engage an actuation element of a delivery system, the actuation element configured to deploy the anchor portion.

[0229] In some embodiments, the actuation element is further configured to release the capture mechanism from the proximal assembly.

[0230] In some embodiments, the electrode is coupled to a tissue engaging portion or anchor (eg, coupled to a first surface of the tissue engaging portion or anchor, etc.).

[0231] In some embodiments, the electrical lead has a distal end coupled to the electrode and a proximal end coupled to the proximal assembly.

[0232] In some embodiments, the valve repair device is configured such that an electrical signal can be applied to the electrode through the electrical lead, and a bioimpedance signal can be measured based on or in response to the applied electrical signal.

[0233] In some embodiments, the guide wire is configured to provide an electrical connection to the electrical lead during delivery and deployment of the valve repair device, the electrical connection being terminated upon withdrawal of the delivery system.

[0234] In some embodiments, the distal end of the guide wire includes a spring pin connector, the proximal end of the electrical lead is coupled to an electrical pad at the proximal assembly, and the spring pin connector of the guide wire is in electrical contact with the electrical pad of the electrical lead to provide an electrical connection to the electrode until the valve repair device is released from the delivery system.

[0235] In some embodiments, the distal end of the guide wire includes an electrical pad, the proximal end of the electrical lead is coupled to a spring pin connector at the proximal assembly, and the spring pin connector of the electrical lead is in electrical contact with the electrical pad of the guide wire to provide an electrical connection to the electrode until the valve repair device is released from the delivery system.

[0236] In some embodiments, the spring pin connector is configured to use a spring force parallel to the axis of the catheter to provide electrical contact between the electrical lead and the wire.

[0237] In some embodiments, the spring force of the pogo pin connector is configured to assist in separating the pogo pin connector from the electrical pad.

[0238] In some embodiments, the proximal component forms a recess within which the electrical lead is coupled to the proximal component.

[0239] In some embodiments, the capture mechanism includes a finger configured to cooperate with the groove of the proximal component to couple the valve repair device to the delivery system. In some embodiments, the wire is coupled to the inner surface of the finger so that the wire physically contacts the electrical lead in the groove to provide electrical contact between the wire and the electrical lead.

[0240] In some embodiments, releasing the valve repair device from the delivery system disengages the fingers from the proximal assembly, thereby releasing the valve repair device and terminating electrical contact between the wire and the electrical lead.

[0241] In some embodiments, the grooves and fingers are coated with an insulating material to electrically insulate the electrical connection between the wires and the electrical leads.

[0242] In some embodiments, the delivery system includes a tube coupled to a capture mechanism, wherein a wire is secured within the tube and a proximal end of an electrical lead is releasably secured within the tube to provide electrical contact between the wire and the electrical lead when the valve repair device is coupled to the delivery system.

[0243] In some embodiments, withdrawing the delivery system from the valve repair device moves the tube away from the proximal assembly, thereby releasing the electrical lead from the tube and terminating electrical contact between the wire and the electrical lead.

[0244] In some embodiments, the tube includes leaf springs for providing a clamping force on the wires and electrical leads to enhance the electrical connection.

[0245] In some embodiments, the delivery system includes a frame secured to a distal end of the catheter, the tube is coupled to the frame, and the frame is configured to maintain the tube in a targeted position relative to the valve repair device.

[0246] In some embodiments, the frame is made of a polymer to electrically insulate the electrical connections between the wires and the electrical leads.

[0247] In some embodiments, the frame includes a U-shaped support that engages with an attachment portion of the valve repair device.

[0248] In some embodiments, the distal end of the wire terminates in a coil crimp having an inner diameter, the proximal end of the electrical lead is positioned within the coil crimp, the inner diameter is configured to provide a friction fit between the electrical lead and the wire to establish an electrical connection between the wire and the electrical lead, and the coil crimp is configured to expand to release the electrical lead.

[0249] In some embodiments, the coil crimp is configured to expand upon exposure to a temperature above a threshold temperature.

[0250] In some embodiments, the coil crimp is configured to expand in response to a current above a threshold current being driven through the wire.

[0251] In some embodiments, the coil crimp is formed of a shape memory alloy in a martensitic state and has an inner diameter that is smaller than a diameter of the electrical lead.

[0252] In some embodiments, the coil crimp is configured to expand to have an inner diameter greater than a diameter of the electrical lead in response to transitioning to the austenitic state.

[0253] In some embodiments, the coil crimp includes a bend location for enhancing the friction fit between the wire and the electrical lead.

[0254] In some embodiments, the electrical leads are inserted into the coil crimp at the bend location.

[0255] In some embodiments, the capture mechanism includes a pair of fingers configured to engage the proximal component to releasably secure the valve repair device to the delivery system.

[0256] In some embodiments, the capture mechanism includes a disc crimp having a first section coupled to a first finger of a pair of fingers and a second section coupled to a second finger of the pair of fingers. In some embodiments, the first section and the second section of the disc crimp form a connecting channel when abutting against the pair of fingers.

[0257] In some embodiments, a connecting channel opens when the first segment and the second segment are separated, a wire is coupled to the connecting channel and an electrical lead is disposed within the connecting channel, and the connecting channel is sized to cause the wire to physically contact the electrical lead to form an electrical connection.

[0258] In some embodiments, releasing the valve repair device from the delivery system causes the pair of fingers to separate from the proximal assembly and the first section of the disc crimp to separate from the second section, thereby allowing the wire and electrical lead to separate to terminate the electrical connection.

[0259] In some embodiments, the disc crimp includes a polymer configured to electrically insulate the electrical connection between the wire and the electrical lead.

[0260] In some embodiments, the first segment is coupled to the first finger-shaped member by inserting a portion of the first segment through a window of the first finger-shaped member to establish a friction fit between the first segment and the first finger-shaped member, and the second segment is coupled to the second finger-shaped member by inserting a portion of the second segment through a window of the second finger-shaped member to establish a friction fit between the second segment and the second finger-shaped member.

[0261] In some embodiments, the first segment and the second segment include a shape set alloy welded to the first finger and the second finger, respectively.

[0262] In some embodiments, the connecting channel is coated with an electrically insulating coating to electrically insulate the electrical connection between the wire and the electrical lead.

[0263] In some embodiments, the delivery system includes a heat-activated electrical connector coupled to the capture mechanism, wherein the wire is secured within the heat-activated electrical connector and the proximal end of the electrical lead is releasably secured within the heat-activated electrical connector to provide electrical contact between the wire and the electrical lead when the valve repair device is coupled to the delivery system.

[0264] In some embodiments, the heat-activated electrical connector is configured to change shape in response to the application of heat or electrical current, and the change in shape is configured to release the electrical lead from the heat-activated electrical connector.

[0265] In some embodiments, withdrawing the delivery system from the valve repair device includes applying heat or current to the heat-activated electrical connector to cause the heat-activated electrical connector to open to release the electrical lead, thereby releasing the electrical lead from the heat-activated electrical connector and terminating electrical contact between the wire and the electrical lead.

[0266] In some embodiments, the heat-activated electrical connector comprises a shaped alloy having a transformation temperature above average body temperature.

[0267] In some embodiments, heated saline is used to heat the heat-activated electrical connector.

[0268] In some embodiments, the heat-activated electrical connector is opened by applying an electric current through a wire.

[0269] In some embodiments, a heat-activated electrical connector comprises a flat tube having an open aperture configured to transform into an open U-shape in response to application of heat or electrical current above a threshold to enable removal of the electrical leads.

[0270] In some embodiments, a thermally activated electrical connector includes a flat tube configured to transform into an open cylindrical shape in response to application of heat or electrical current above a threshold value to enable removal of the electrical leads.

[0271] In some embodiments, the distal end of the wire comprises a shape memory alloy formed into a shepherd hook and configured to transform into a straight wire with the application of heat or electric current. In some embodiments, the proximal end of the electrical lead comprises a shape memory alloy formed into a shepherd hook and configured to transform into a straight wire with the application of heat or electric current. In some embodiments, the shepherd hook of the wire and the shepherd hook of the electrical lead hook onto each other to form an electrical connection.

[0272] In some embodiments, withdrawing the delivery system from the valve repair device includes applying heat or current to the distal end of the wire and the proximal end of the electrical lead to straighten the wire and the electrical lead, thereby disconnecting the electrical lead and the wire, thereby terminating the electrical connection between the wire and the electrical lead.

[0273] In some embodiments, heated saline is used to heat the heat-activated electrical connector.

[0274] In some embodiments, the heat-activated electrical connector is opened by applying an electric current through a wire.

[0275] In some embodiments, the wire includes a first portion comprising a first metal and a second portion comprising a shape memory alloy, the first portion being joined to the second portion using a first crimp, and the electrical lead includes a first portion comprising a first metal and a second portion comprising a shape memory alloy, the first portion being joined to the second portion using a second crimp.

[0276] In some embodiments, the methods and / or techniques described herein relate to a device comprising a tissue engaging portion or a tissue capturing portion, wherein the tissue engaging portion or the tissue capturing portion comprises a first surface and a second surface. In some embodiments, the methods and / or techniques described herein relate to using a device at a tissue site in the body. In some embodiments, the methods and / or techniques described herein relate to using a device at a heart valve in the heart. In some embodiments, the methods and / or techniques described herein relate to advancing a device inside the heart, and deploying the device (e.g., anchoring, etc.) at a heart valve in the heart.

[0277] In some embodiments, the tissue capturing portion is configured such that the first surface and the second surface can be closed or moved closer together to capture tissue in the tissue capturing portion.

[0278] In some embodiments, at least one of the first surface and the second surface is movable to form a capture zone between the first surface and the second surface for capturing tissue, and / or is movable closer to capture tissue between the first surface and the second surface.

[0279] In some embodiments, two or more electrodes are coupled to the tissue capture portion. In some embodiments, the device is configured such that: an electrical signal can be applied to the two or more electrodes, and a bioimpedance signal can be measured in response to the applied electrical signal. In some embodiments, the bioimpedance signal provides an indication of the state of the tissue within the tissue capture portion and / or an indication of the state of the tissue capture portion (e.g., a distance between the first surface and / or first arm and the second surface and / or second arm, an indication of whether the tissue capture portion is closed or open, etc.).

[0280] In some embodiments, the two or more electrodes include a first electrode coupled to the first surface and a second electrode coupled to the second surface.

[0281] In some embodiments, when the tissue capturing portion is in the closed configuration, the first electrode is adjacent to the second electrode.

[0282] In some embodiments, the first electrode includes an electrode plate covering a majority of the first surface, and the second electrode includes an electrode plate covering a majority of the second surface.

[0283] In some embodiments, the two or more electrodes include a first electrode coupled to the first surface and a second electrode coupled to the first surface.

[0284] In some embodiments, the first electrode is separated from the second electrode by a gap.

[0285] In some embodiments, the first electrode and the second electrode comprise electrode strips parallel to the length of the first surface.

[0286] In some embodiments, the first electrode and the second electrode comprise electrode strips parallel to the width of the first surface.

[0287] In some embodiments, the first electrode is positioned on the first surface at a first tissue capture depth.

[0288] In some embodiments, the second electrode is positioned on the first surface at a second tissue capture depth that is greater than the first tissue capture depth.

[0289] In some embodiments, the device includes an electrode plate coupled to the second surface.

[0290] In some embodiments, the device includes an impedance measurement device configured to measure a bioimpedance signal and determine the tissue capture depth based on the measured bioimpedance signal.

[0291] In some embodiments, the impedance measurement device implements an algorithm to generate an indicator of complete tissue capture, partial tissue capture, or excessive tissue capture.

[0292] In some embodiments, the impedance measurement device implements an algorithm to generate an indicator of tissue capture depth.

[0293] In some embodiments, the impedance measuring device is configured to generate an indicator of the state of the tissue when the tissue capture portion is in a closed configuration and / or an indicator of the state of the tissue capture portion (e.g., the distance between the first surface and / or first arm and the second surface and / or second arm, an indication of whether the tissue engaging portion or the tissue capture portion is closed or open, etc.).

[0294] In some embodiments, the impedance measurement device is configured to generate an indicator of the state of the tissue when the tissue capturing portion is in the open configuration.

[0295] In some embodiments, the tissue capturing portion is configured as or includes one or more of: an anchor, a hook, a clip, a clamp, a gripper, a gripping member, a paddle, an arm, a combination of these, or the like.

[0296] In some embodiments, the methods and / or techniques described herein relate to devices that include a tissue engaging portion or anchor configured to secure the device to tissue within a patient (e.g., an implantable device configured to be implanted during a medical procedure, a therapeutic device configured to be used in a medical procedure even if not necessarily implanted, etc.). In some embodiments, at least one electrode is coupled to the tissue engaging portion or anchor.

[0297] In some embodiments, the device is configured such that: an electrical signal can be applied to the tissue engaging portion or anchor, and a bioimpedance signal can be measured based on or in response to the applied electrical signal. In some embodiments, the bioimpedance signal provides an indication of the state or deployment state of the tissue engaging portion or anchor and / or the state of the tissue relative to the tissue engaging portion or anchor.

[0298] In some embodiments, the device comprises an annuloplasty device.

[0299] In some embodiments, the device further comprises a plurality of anchors, each anchor comprising at least one electrode.

[0300] In some embodiments, an electrical signal can be applied to multiple anchors, and a bioimpedance signal can be measured from each of the multiple anchors based on or in response to the applied electrical signal, each bioimpedance signal being configured to indicate a deployment status of a corresponding anchor among the multiple anchors.

[0301] In some embodiments, the device includes multiple anchors that are electrically shorted together.

[0302] In some embodiments, the device includes an impedance measurement device configured to measure a bioimpedance signal and determine the anchor deployment state based on the measured bioimpedance signal.

[0303] In some embodiments, the impedance measurement device implements an algorithm to generate an indicator of anchor deployment status, including anchor in contact with tissue, anchor partially deployed, and anchor fully deployed.

[0304] In some embodiments, the methods and / or techniques described herein relate to systems, devices, and / or apparatuses (e.g., treatment systems, repair systems, valve repair systems, treatment devices, repair devices, etc.) that can be used to repair and / or treat a patient's or a simulated subject's native valve and / or other tissue. In some embodiments, the methods and / or techniques include using systems, devices, and / or apparatuses to repair and / or treat a patient's or a simulated subject's native valve and / or other tissue.

[0305] In some embodiments, the systems, devices and / or apparatus include a tissue engaging portion or anchor (e.g., a helical anchor, a screw, a dart, a staple, a hook, a hook, a clip, a clamp, multiple arms, multiple clamping members, two paddles, a hook arm and a paddle arm, a clamping member and a paddle, etc.).

[0306] In some embodiments, the tissue engaging portion or anchor includes a first arm (e.g., a clamp arm, a hook arm, a paddle, etc.) and a second arm (e.g., a clamp arm, a hook arm, a paddle, etc.), and the tissue engaging portion or anchor is configured so that the first arm and the second arm can be closed or moved closer together to engage and / or capture tissue (e.g., leaflets, membranes, membranes, muscles, etc. of autologous valves, etc.) in the tissue engaging portion or anchor.

[0307] In some embodiments, at least one of the first arm and the second arm is movable to form a capture zone between the first arm and the second arm for capturing tissue (e.g., a leaflet, etc.), and / or is movable to bring the first arm and the second arm closer together.

[0308] In some embodiments, two or more electrodes are coupled to the tissue engaging portion or anchor.

[0309] In some embodiments, the system, device, and / or apparatus is configured such that: an electrical signal can be applied to two or more electrodes, and a bioimpedance signal can be measured based on or in response to the applied electrical signal.

[0310] In some embodiments, the bioimpedance signal provides an indication of the state of tissue within the tissue engaging portion or anchor (e.g., tissue capture state, tissue engagement state, etc.) and / or an indication of the state of the tissue engaging portion or anchor (e.g., open, closed, etc.).

[0311] In some embodiments, the two or more electrodes include a first electrode coupled to the first arm and a second electrode coupled to the second arm.

[0312] In some embodiments, after closing the tissue engaging portion or anchor, the first electrode is adjacent to the second electrode.

[0313] In some embodiments, the first electrode includes an electrode plate covering a majority of the first arm, and the second electrode includes an electrode plate covering a majority of the second arm.

[0314] In some embodiments, the two or more electrodes include a first electrode coupled to the first arm and a second electrode coupled to the first arm.

[0315] In some embodiments, the first electrode is separated from the second electrode by a gap.

[0316] In some embodiments, the first electrode and the second electrode comprise electrode strips parallel to the length of the first arm.

[0317] In some embodiments, the first electrode and the second electrode comprise electrode strips parallel to the width of the first arm.

[0318] In some embodiments, the first electrode is positioned on the first arm at a target minimum tissue capture depth.

[0319] In some embodiments, the second electrode is positioned on the first arm at a targeted maximum tissue capture depth.

[0320] In some embodiments, the system, device, and / or apparatus includes an electrode pad coupled to the second arm.

[0321] In some embodiments, a system, device, and / or apparatus includes an impedance measurement device configured to measure a bioimpedance signal and determine a tissue capture depth based on the measured bioimpedance signal.

[0322] In some embodiments, the impedance measurement device implements an algorithm to generate indicators of complete tissue capture, partial tissue capture, and / or over-tissue capture.

[0323] In some embodiments, the systems, devices and / or apparatus are configured for capturing leaflet tissue at a native valve and the impedance measuring device implements an algorithm to generate an indicator of complete leaflet capture, partial leaflet capture and / or over-leaflet capture.

[0324] In some embodiments, the impedance measurement device implements an algorithm to generate an indicator of tissue capture depth.

[0325] In some embodiments, the impedance measurement device is configured to generate an indicator of the state of the tissue (eg, tissue capture state, tissue engagement state, etc.) when the tissue engaging portion or anchor is closed.

[0326] In some embodiments, the impedance measurement device is configured to generate an indicator of the capture state of the tissue engaging portion or anchor when open.

[0327] In some embodiments, a system (e.g., a measurement system, a detection system, a bioimpedance signal measurement system, etc.) may include a device including a tissue engaging portion, the tissue engaging portion including a first surface and a second surface. In some embodiments, the tissue engaging portion is configured so that the first surface and the second surface can be closed or moved closer together to capture tissue in the tissue engaging portion. In some embodiments, at least one of the first surface and the second surface can be moved to form a capture zone between the first surface and the second surface for capturing tissue.

[0328] In some embodiments, two or more electrodes are coupled to the tissue engaging portion.

[0329] In some embodiments, the system includes an impedance measurement device. In some embodiments, the impedance measurement device includes a power supply and an electrical sensor. The power supply can be configured to apply an electrical signal to two or more electrodes.

[0330] In some embodiments, the impedance measurement device is configured to measure the bioimpedance signal using an electrical sensor.

[0331] In some embodiments, the bioimpedance signal is a response to an applied electrical signal.

[0332] In some embodiments, the bioimpedance signal provides an indication of the state of tissue within and / or adjacent to the tissue engaging portion.

[0333] In some embodiments, two or more electrodes are coupled to one or more anchors of the device. In some embodiments, two or more electrodes are coupled to one or more hooks of the device.

[0334] In some embodiments, the impedance measurement device is configured to measure electrical characteristics of two or more electrodes to determine the relative position of the device's hook and anatomical structure, tissue, etc. (e.g., anatomical structure or tissue, etc. that is close to and / or in contact with the device).

[0335] In some embodiments, the electrical characteristic comprises a peak-to-peak amplitude of the oscillations of the bioimpedance signal. In some embodiments, the electrical characteristic comprises an average value of the amplitude of the bioimpedance signal.

[0336] In some embodiments, the system is configured to determine that two or more electrodes are located in the blood and / or are not in contact with the tissue based at least in part on the bioimpedance signal. In some embodiments, the system is further configured to determine that two or more electrodes are in contact with the targeted tissue based at least in part on the bioimpedance signal.

[0337] In some embodiments, the system is configured to differentiate tissue types based at least in part on the bioimpedance signal.

[0338] In some embodiments, the system is configured to determine, based at least in part on the bioimpedance signal, that two or more electrodes are transitioning from being primarily in contact with blood (and / or not in contact with tissue) to being in contact with tissue (e.g., partially in contact with tissue, primarily in contact with tissue, completely in contact with tissue, etc.).

[0339] In some embodiments, the system is configured to determine that two or more electrodes are transitioning from being partially or primarily in contact with tissue to being primarily in contact with blood (and / or not in contact with tissue) based at least in part on the bioimpedance signal.

[0340] In some embodiments, the impedance measurement device includes (eg, on a non-transitory computer readable medium) a signal processing algorithm capable of indicating the state of the device.

[0341] In some embodiments, the impedance measurement device implements and / or executes a signal processing algorithm to indicate the status of the device.

[0342] In some embodiments, states of the device include fully captured leaflets, under-captured leaflets, over-captured leaflets, and leaflets relatively positioned within hooks of the device.

[0343] In some embodiments, the system includes a display for displaying an export indicator to a user, the export indicator indicating a status of the device.

[0344] In some embodiments, the system (e.g., a bioimpedance-based feedback system, a bioimpedance system, a feedback system, etc.) is configured to measure a bioimpedance signal, determine a tissue state (e.g., a capture state, an insertion state, etc.) with respect to a device (e.g., an implantable device, a therapeutic device, a prosthetic device, etc.), and / or display or otherwise provide an indicator associated with the determined state. The system can employ any of the processes, procedures, algorithms, or methods described herein to measure bioimpedance and determine a tissue state relative to an implant.

[0345] In some embodiments, the system includes hardware, software, and / or firmware components for bioimpedance-based feedback. In some embodiments, the system includes one or more of a data storage area, one or more processors, a measurement module, a capture module, and an indicator module.

[0346] In some embodiments, the system includes one or more computing devices (eg, a single computing device, multiple computing devices, a distributed computing environment, a virtual device residing in a public or private computing cloud, etc.).

[0347] In some embodiments, the system includes a measurement module for acquiring or receiving an electrical signal from an electrical component (e.g., a sensor, an electrode, etc., such as any of the electrodes, sensors, arrays described anywhere herein). In some embodiments, the electrical signal corresponds to a bioimpedance signal, and may also correspond to resistance, capacitance, voltage, current, impedance components, etc. In some embodiments, the measurement module is configured to determine an impedance value based on the acquired bioimpedance signal.

[0348] In some embodiments, the system includes a state module (e.g., a capture module, a deployment module, etc.) for determining a state (e.g., of a system, device, and / or apparatus) based on bioimpedance measurements taken by the measurement module.

[0349] In some embodiments, the bioimpedance measurement (and resistance, inductance, capacitance, voltage, and / or current readings) measured by the measurement module vary based on one or more anatomical structures that the indicator electrode is close to or in contact with. In some embodiments, the electrical characteristics (e.g., bioimpedance signals) measured by the measurement module can be used to determine the relative positions of hooks, anchors, other device components, etc., and anatomical structures (e.g., tissue, etc.) or blood that a device associated with the system is close to and / or in contact with.

[0350] In some embodiments, the algorithms, methods, steps, processes, etc. herein may be stored on a non-transitory computer readable medium. In a certain embodiment, the algorithms, methods, steps, processes, etc. herein may be implemented in a state module to determine the state of (e.g., a device, tissue, etc.) based on the measurements obtained by the measurement module.

[0351] In some embodiments, the system includes an indicator module for indicating results from the status module.

[0352] In some embodiments, the system includes a data storage area configured to store configuration data, measurement data, analysis parameters, control commands, databases, algorithms, executable instructions (e.g., instructions for one or more processors), etc.

[0353] In some embodiments, the system includes one or more processors configured to control the operation of one or more of the measurement module, the capture module, the indicator module, and / or the data storage area. In some embodiments, the one or more processors implement, execute, and / or utilize software modules, hardware components, and / or firmware elements configured to provide bioimpedance-based feedback.

[0354] In some embodiments, a non-transitory computer-readable medium is provided that includes computer-executable instructions that cause one or more processors to perform any of the algorithms, procedures, processes, or methods described herein.

[0355] Any of the above methods, and any methods using the systems, assemblies, devices, apparatus, etc. described above or otherwise herein, can be performed on a living subject (e.g., a human or other animal) or on a simulated object (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). By simulation, a body part may optionally be referred to as "simulated" (e.g., a simulated heart, simulated tissue, etc.), and may optionally include a computerized and / or physical representation.

[0356] Any of the above-described systems, assemblies, devices, apparatuses, components, etc. may be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use on patients, and the methods herein may include sterilizing (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) one or more systems, devices, apparatuses, components, etc. herein (or additional methods include or consist of such sterilization).

[0357] A further understanding of the nature and advantages of the disclosed subject matter is set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like components have like reference numerals. BRIEF DESCRIPTION OF THE DRAWINGS

[0358] In order to further illustrate various aspects of the examples in the present disclosure, certain examples and embodiments will be described in more detail with reference to various aspects of the accompanying drawings. It should be understood that these drawings only depict exemplary embodiments of the present disclosure and should not be considered as limiting the scope of the present disclosure. In addition, although the drawings may be drawn to scale for certain examples, the drawings are not necessarily drawn to scale for all examples. By using the accompanying drawings, examples and other features and advantages of the present disclosure will be described and explained in conjunction with additional characteristics and details.

[0359] Figure 1 A cross-sectional view of a human heart is shown in the diastolic phase.

[0360] Figure 2 A cross-sectional view of a human heart is shown during systole.

[0361] Figure 3 A cross-sectional view of a human heart in systole is shown, illustrating valvular regurgitation.

[0362] Figure 4 yes Figure 3 , annotated to illustrate the natural shape of the mitral valve leaflets during systole.

[0363] Figure 5 A healthy mitral valve is shown with closed leaflets when viewed from the atrial side of the mitral valve.

[0364] Figure 6 A dysfunctional mitral valve is shown with visible gaps between the leaflets when viewed from the atrial side of the mitral valve.

[0365] Figure 7 The tricuspid valve is shown as viewed from the atrial side of the tricuspid valve.

[0366] Figure 8 , 9 , 10, 11, 12, 13 and 14 show examples of devices or implants at different stages of deployment.

[0367] Fig.15 An example of a device or implant similar to that shown in Figures 8-14, but in which the paddles are independently controllable.

[0368] Fig.16 , 17 , 18, 19, 20 and 21 show a valve delivered and implanted in a native valve. Figure 8-14 An exemplary device or implant of.

[0369] Fig. 22 A perspective view of an exemplary device or implant is shown in a closed position.

[0370] Fig.23 Shows Fig. 22 Front view of an exemplary device or implant.

[0371] Fig.24 Shows Fig. 22 A side view of an exemplary device or implant.

[0372] Fig.25 Shows Fig. 22 A front view of an exemplary device or implant with a cover covering the paddle and the apposition element or spacer.

[0373] Fig.26 Shown in open position Fig. 22 A top perspective view of an exemplary device or implant.

[0374] Fig. 27 Shown in open position Fig. 22 A bottom perspective view of an exemplary device or implant.

[0375] Fig.28 Exemplary hooks that may be used with a device or implant are shown.

[0376] Fig.29 A portion of native valve tissue is shown grasped by the hooks.

[0377] Fig.30 A side view of an exemplary device or implant is shown in a partially open position with the hooks in a closed position.

[0378] Fig.31 A side view of an exemplary device or implant is shown in a partially open position, with the hooks in an open position.

[0379] Fig.32 A side view of an exemplary device or implant is shown in a semi-open position with the hooks in a closed position.

[0380] Fig.33 A side view of an exemplary device or implant is shown in a semi-open position with the hook in the open position.

[0381] Fig.34 A side view of an exemplary device or implant is shown in a three-quarter open position with the hooks in a closed position.

[0382] Fig.35 A side view of an exemplary device or implant is shown in a three quarters open position with the hooks in the open position.

[0383] Fig.36A side view of an exemplary device is shown in a fully open or fully extended position, with the hook in a closed position.

[0384] Fig.37 A side view of an exemplary device in a fully open or fully salvaged position is shown, with the hook in the open position.

[0385] Fig.38 , 39 , 40, 41, 42, 43, 44, 45, 46, 47, 48 and 49 show a valve delivered and implanted in a native valve. Figure 30-38 An exemplary device or implant comprises a cover.

[0386] Fig.50A , 50B 50C illustrate exemplary systems, devices, and / or apparatus that may incorporate one or more concepts of the present application.

[0387] Fig.51A , 51B , 51C, 51D, and 51E illustrate examples of systems and / or devices that may incorporate one or more concepts of the present application.

[0388] Fig.52A , 52B 52C show exemplary hooks having two or more electrodes.

[0389] Fig.53A , 53B , 53C, 53D, 53E and 53F show hooks having various exemplary electrode configurations.

[0390] Fig.54 An exemplary bioimpedance signal from a hook having two or more electrodes for providing bioimpedance based feedback is shown.

[0391] Fig.55 and 56 Shown from Fig.53B An exemplary bioimpedance signal of a hook.

[0392] Fig.57 and 58 Shown from Fig.53C An exemplary bioimpedance signal of a hook.

[0393] Fig.59A and 59B shows the configuration with Figure 22-37 The configuration of the hook is similar to the exemplary hook with an optional cover over the hook, which includes a combination of an electrode plate on one arm and an electrode strip on the other arm.

[0394] Fig.60A and 60B shows the configuration with Figure 22-37 The configuration of the hook is similar to the hook with an optional cover over the hook, and the hook includes electrode strips on the arms of the hook.

[0395] Fig.60C Shown with Fig.60B A hook similar to the exemplary hook without a cover includes electrode strips on the arms of the hook.

[0396] Fig.61A and 61B Shows Figures 60A-60C Real and imaginary parts of the hook's bioimpedance signal for various capture states of the leaflet.

[0397] Fig.62A and 62B Shown with Figures 60A-60C An embodiment of a hook-like tissue engaging portion or hook wherein the electrode strip is offset a specified distance relative to the edge of the arm.

[0398] Fig.62C Shows Fig.62A and 62B Bioimpedance signals of the hook at various capture states of the leaflet.

[0399] Fig.62D An exemplary proximal end of a delivery system including an indicator panel is shown.

[0400] Fig.63A and 63B An exemplary device is shown including hooks each having a first electrode positioned on a first arm of the hook and a second electrode positioned on a second arm, the electrodes being configured to provide bioimpedance signals corresponding to different dies of a leaflet or other tissue.

[0401] Fig.64 Shown with Fig.53A The device comprising a hook is similar to an exemplary device comprising a tissue engaging portion or hook having an electrode, wherein there is additionally a reference electrode implemented on the device.

[0402] Fig.65 Shows Figure 22-37 An example of a device in which a flexible electrode is attached that protrudes away from the device.

[0403] Fig.66A and 66B An exemplary electrode array that reduces the number of electrical leads required to enable the electrical leads to fit into a small lumen catheter is shown.

[0404] Fig.67AAn example of a bioimpedance signal having oscillations corresponding to the relaxation and contraction of the heart is shown.

[0405] Fig.67B An example of a bioimpedance signal is shown as a delivery device implants an annuloplasty ring into the annulus.

[0406] Fig.68 An exemplary bioimpedance signal measurement system is shown.

[0407] Fig.69 A portion of a flexible PCB is shown having stress concentration points therein.

[0408] Fig.70 A portion of a flexible PCB is shown having a Y-shaped protrusion extending from one end of the PCB.

[0409] Fig.71 A portion of a flexible PCB is shown having a circular protrusion extending from the body of the PCB.

[0410] Fig.72 A portion of a flexible PCB is shown having undercuts for facilitating securing of sutures over the PCB and to a device to secure the PCB to the device.

[0411] Fig.73 A portion of a flexible PCB is shown forming a circular hole with a relief.

[0412] Fig.74 A portion of a flexible PCB forming a pair of bidirectional tongues is shown.

[0413] Fig.75A , 75B and 75C show a removable PCB that is configured to be pulled through the barbs of the device to remove the PCB from the device.

[0414] Fig.76A , 76B 76C shows another removable PCB that is configured to be pulled around the barbs of the device, through and away from one side of the hook to remove the PCB from the device.

[0415] Fig.77A , 77B 77C shows another removable PCB that is configured to separate when pulled so that half of the PCB leaves one side of the hook and the other half of the PCB leaves the other side of the hook, and the two halves of the PCB leave the hook around the barbs of the device to remove the PCB from the device.

[0416] Fig.78An electrode removable from the device is shown, the electrode coupled to a wire extending from the electrode toward the actuation element.

[0417] Fig.79A and 79B A spring pin electrical connector is shown that is configured to extend to the distal end of the delivery system to provide an electrical connection to wires coupled to electrodes of the device.

[0418] Fig.80A and 80B The use of radial forces to couple wires from a delivery system to electrical leads coupled to electrodes of the device via fingers of the delivery system is shown.

[0419] Fig.81A and 81B The use of a tube to achieve releasable electrical contact between a wire and an electrical lead is shown.

[0420] Fig.82A and 82B A coil crimp is shown that is configured to provide releasable electrical contact between a wire and an electrical lead.

[0421] Fig.83A and 83B A coil connection socket is shown that is configured to provide releasable electrical contact between the wires and the electrical leads.

[0422] Fig.84A , 84B , 84C and 84D illustrate exemplary disc crimps configured to provide a releasable electrical connection between a wire and an electrical lead.

[0423] Fig.85A , 85B , 85C, 85D, 85E and 85F show examples of heat-activated electrical connectors for providing a releasable electrical connection between a wire and an electrical lead.

[0424] Fig.86 A block diagram of an exemplary bioimpedance-based feedback system is shown. DETAILED DESCRIPTION

[0425] The following description refers to the accompanying drawings, which illustrate exemplary embodiments of the present disclosure. Other embodiments having different structures and operations do not depart from the scope of the present disclosure.

[0426] Overview

[0427] Disclosed herein are devices and methods for using bioimpedance or bioimpedance-based feedback to provide useful information during medical procedures. Bioimpedance or bioimpedance-based feedback includes measuring or acquiring an electrical signal including a bioimpedance signal (e.g., a signal indicating bioimpedance). The bioimpedance signal can be used to determine the position and / or state of a device (e.g., an implantable device, a therapeutic device, a delivery device, etc.) or a portion thereof (e.g., a hook, a valve, an anchor, etc.) relative to tissue or other parts of the body. The bioimpedance signal can be analyzed and converted into information presented to a clinician (e.g., text, images, symbols, colors, etc. displayed on a display, sounds, lights, etc.) to indicate the position and / or state of the device (e.g., the position and / or state of an anchoring element of an implant, etc.).

[0428] Bioimpedance is related to the electrical properties of tissue (or other biological materials) in the human body. Bioimpedance is a measure of how much tissue resists the flow of electrical current. Fat has a high resistivity; blood has a lower resistivity. At a given current applied to the tissue, low impedance will correspond to a low voltage, and vice versa. Tissue consists of cells and membranes, which are thinner and have a higher resistivity, and electrically act like capacitors. By using a high measurement frequency, the current flows through these capacitors, and the resultant signal depends on the tissue and the fluid inside and outside the cells. However, at low frequencies, the membrane resists the flow of current, so the resultant signal depends only on the fluid outside the cell. The magnitude and phase of the impedance Z are given by:

[0429]

[0430]

[0431] Where R is the resistance, X_L is the inductive reactance, X_C is the capacitive reactance, R is the total resistance, and X is the total reactance. Impedance can also be expressed using real and imaginary parts as: Z = R + jX.

[0432] In some embodiments, the systems and / or devices herein comprise a device (e.g., a therapeutic device, a prosthetic device, an implantable device, etc.) or a portion of a device comprising an electrode. In some embodiments, the systems and / or devices herein comprise a delivery system and / or device or a portion thereof comprising an electrode (e.g., a catheter with an electrode, etc.).

[0433] Electrical power, for example in the form of alternating current, direct current, etc., may be supplied to the electrodes and electrical signals measured (e.g., voltage, current, change in voltage, change in current, etc.). The bioimpedance signal forming part of (or determinable from) the measured electrical signal may be used to draw conclusions or estimates related to the system / device (e.g., related to the state of the device or an anchor portion of the device, etc.).

[0434] In some embodiments, where the electrode is implemented on a hook, clamp, clip, clamping portion, anchor, etc. of a device (e.g., an implantable device, a therapeutic device, a prosthetic device, etc.), the bioimpedance signal can be related to the amount of tissue within the hook, clamp, clip, clamping portion, anchor, etc. of the device.

[0435] In some embodiments, bioimpedance signals may also be used to monitor the depth of the device's anchors (e.g., helical anchors, tissue anchors, screws, darts, staples, etc.) in the tissue, valve height and positioning, continuous anchor deployment, etc.

[0436] In some embodiments, the bioimpedance signal can be analyzed and presented in real time to provide useful information to the clinician implanting the implantable device and / or when using a therapeutic device or prosthetic device (even if not permanently implanted). This is a unidirectional bioimpedance signal that can be used to provide useful feedback to the clinician or medical system about the status of the device or implant and / or its components.

[0437] In some embodiments, the value of the bioimpedance signal and / or a change in the bioimpedance signal can indicate a transition from being primarily in blood to contacting tissue. In some embodiments, the value of the bioimpedance signal and / or a change in the bioimpedance signal can indicate a transition from contacting a first type of tissue (e.g., leaflets, etc.) to contacting a second type of tissue (e.g., annulus, heart wall, etc.).

[0438] In some embodiments, the value or change in the bioimpedance signal can be related to the amount of contact the device has with the tissue (e.g., the amount of leaflets in the hooks, the depth of the anchors in the tissue, the valve height and / or positioning, etc.).

[0439] In some embodiments, the value or change in the bioimpedance signal can be correlated to the position / location of a delivery device (e.g., catheter, anchor driver, hypotube, pusher, etc.) and / or whether the delivery device is in contact with tissue or different types of tissue.

[0440] Figure 1 and 2 are cross-sectional views of a human heart H in diastole and systole, respectively. The right ventricle RV and the left ventricle LV are separated from the right atrium RA and the left atrium LA by the tricuspid valve TV and the mitral valve MV (i.e., the atrioventricular valves), respectively. In addition, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets (e.g., Figure 3-6 The leaflets 20, 22 and Figure 7The autologous valve repair system of the present application is often described and / or illustrated with respect to the mitral valve MV. Therefore, the anatomical structure of the left atrium LA and the left ventricle LV will be explained in more detail. However, the device described herein can also be used to repair other autologous valves, for example, the device can be used to repair the tricuspid valve TV, the aortic valve AV and the pulmonary valve PV.

[0441] The left atrium LA receives oxygenated blood from the lungs. Figure 1 During diastole or relaxation as seen in , blood previously collected in the left atrium LA (during systole) moves across the mitral valve MV and into the left ventricle LV due to the expansion of the left ventricle LV. Figure 2 During systole or contraction as seen in , the left ventricle LV contracts to force blood into the body through the aortic valve AV and the ascending aorta AA. During systole, the leaflets of the mitral valve MV close to prevent blood from flowing back from the left ventricle LV and back into the left atrium LA, and blood collects in the left atrium from the pulmonary veins. In some embodiments, the devices described in this application are used to repair 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 blood from flowing back from the left ventricle LV and back into the left atrium LA. Many of the devices described in this application are designed to easily grasp and secure native leaflets around an apposition element or spacer, which beneficially acts as a filler in the regurgitation orifice to prevent or inhibit reverse flow or regurgitation during systole, but this is not required.

[0442] Reference now Figure 1 7, the mitral valve MV includes two leaflets, namely the anterior leaflet 20 and the posterior leaflet 22. The mitral valve MV also includes an annulus 24, which is a variable density fibrous ring of tissue surrounding the leaflets 20, 22. Figure 3 and 4 , the mitral valve MV is anchored to the wall of the left ventricle LV by the chordae tendineae CT. The chordae tendineae CT are cord-like tendons that connect the papillary muscles PM (i.e., muscles located at the base of the chordae tendineae CT and within the wall of the left ventricle LV) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles PM serve to limit the movement of the leaflets 20, 22 of the mitral valve MV and prevent the mitral valve MV from reversing. The mitral valve MV opens and closes in response to pressure changes in the left atrium LA and the left ventricle LV. The papillary muscles PM do not open or close the mitral valve MV. Instead, the papillary muscles PM support or cradle the leaflets 20, 22 to resist the high pressure required to circulate blood throughout the body. The papillary muscles PM and the chordae tendineae CT are together referred to as the subvalvular structures, whose function is to prevent the mitral valve MV from prolapsing into the left atrium LA when the mitral valve is closed. As seen from Figure 3As seen in the left ventricular outflow tract (LVOT) view shown, the anatomy of the leaflets 20, 22 is such that the inner sides of the leaflets coapt at the free end portions and the leaflets 20, 22 begin to recede or separate from each other. The leaflets 20, 22 separate in an atrial direction until each leaflet meets the mitral annulus.

[0443] Various disease processes may impair the normal function of one or more native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow's disease, fibroelastic defects, etc.), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis, etc.). In addition, damage to the left ventricle LV or right ventricle RV from a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other heart diseases (e.g., cardiomyopathy, etc.) may distort the geometry of the native valve, which may lead to native valve dysfunction. However, most patients who undergo valve surgery, such as mitral valve MV surgery, suffer from degenerative diseases that cause the leaflets (e.g., leaflets 20, 22) of the native valve (e.g., mitral valve MV) to malfunction, leading to prolapse and regurgitation.

[0444] Generally speaking, native valves may malfunction in different ways: including (1) valvular stenosis; and (2) valvular regurgitation. Valvular stenosis occurs when the native valve does not fully open and thereby causes blood flow obstruction. Typically, valvular stenosis is caused by the accumulation of calcified material on the valve leaflets, which causes the leaflets to thicken and impairs the ability of the valve to fully open to allow forward blood flow. Valvular regurgitation occurs when the leaflets of the valve do not fully close, causing blood to leak back into the previous chamber (for example, causing blood to leak from the left ventricle to the left atrium).

[0445] There are three main mechanisms by which a native valve becomes regurgitant (or incompetent), including Carpentier Type I, II, and III dysfunctions. Carpentier Type I dysfunction involves dilation of the annulus, causing the normally functioning leaflets to separate from each other and fail to form a tight seal (i.e., the leaflets do not appose properly). Type I mechanism dysfunction includes leaflet perforations present in endocarditis. Carpentier Type II dysfunction involves prolapse of one or more leaflets of the native valve above the plane of apposition. Carpentier Type III dysfunction involves restriction of movement of one or more leaflets of the native valve, causing the leaflets to be abnormally constrained below the plane of the annulus. Leaflet restriction may be caused by rheumatic disease (Ma) or ventricular enlargement (IIIb).

[0446] refer to Figure 5, when the healthy mitral valve MV is in the closed position, the anterior leaflet 20 and the posterior leaflet 22 coapt, which prevents blood from leaking from the left ventricle LV into the left atrium LA. Figure 3 and 6 Mitral regurgitation 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 contraction so that the edges of the leaflets 20, 22 do not touch each other. This failure of coaptation causes a gap 26 to appear between the anterior leaflet 20 and the posterior leaflet 22, which allows blood to flow back from the left ventricle LV into the left atrium LA during contraction, as shown in FIG. Figure 3 The MR flow path of mitral regurgitation is shown in Figure 2. Figure 6 , gap 26 may have a width W of 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, gap 26 may have a width W greater than 15 mm. As described above, there are several different ways in which a leaflet (e.g., leaflets 20, 22 of the mitral valve MV) may malfunction, resulting in valvular regurgitation.

[0447] In any of the above situations, a system, apparatus and / or device (e.g., a treatment system, a repair system, a valve repair device, a valve treatment device, an implant, etc.) is needed that can engage the anterior leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent or inhibit blood regurgitation through the mitral valve MV. Figure 4 As can be seen, an abstract representation of a device, valve repair device or implant 10 is shown, which is implanted between leaflets 20, 22 so that regurgitation does not occur during contraction (the valve is not retracted). Figure 3 and Figure 4 ). In some embodiments, the apposition elements (e.g., spacers, coaptation elements, gap fillers, etc.) of device 10 have a generally conical or triangular shape that naturally adapts to the native valve geometry and its expanded leaflet properties (toward the annulus). In this application, the terms spacer, coaptation element, apposition element, and gap filler are used interchangeably and refer to elements that fill a portion of the space between the native valve leaflets and / or are configured to cause the native valve leaflets to coapt or "appose" (e.g., cause the native leaflets to appose with the coaptation element, apposition element, spacer, etc., rather than just apposition with each other).

[0448] Although stenosis or regurgitation can affect any valve, stenosis is primarily found to affect the aortic valve AV or the pulmonary valve PV, and regurgitation is primarily found to affect the mitral valve MV or the tricuspid valve TV. Both valvular stenosis and valvular regurgitation increase the workload of the heart H and, if left untreated, can lead to very serious conditions; such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. Because the left side of the heart (i.e., the left atrium LA, left ventricle LV, mitral valve MV, and aortic valve AV) is primarily responsible for circulating blood throughout the body. Therefore, cardiac dysfunction of the mitral valve MV or aortic valve AV is particularly problematic and often life-threatening, as the pressures on the left side are significantly higher.

[0449] Dysfunctional native heart valves may be repaired or replaced. Repair typically involves preservation and correction of the patient's native valve. Replacement typically involves replacing the patient's native valve with a biological or mechanical substitute. Typically, the aortic valve AV and the pulmonary valve PV are more prone to stenosis. Because the stenotic damage sustained by the leaflets is irreversible, treatment for a stenotic aortic valve or a stenotic pulmonary valve may be to remove the valve and replace the valve with a surgically implanted heart valve, or to replace the valve with a transcatheter heart valve. The mitral valve MV and the tricuspid valve TV are more susceptible to deformation of the leaflets and / or surrounding tissue, which, as described above, can prevent the mitral valve MV or tricuspid valve TV from closing properly and allow blood to flow back or reflux from the ventricles into the atria (e.g., a deformed mitral valve MV may allow blood to flow back or reflux from the left ventricle LV into the left atrium LA, as described above). Figure 3 ). Backflow or reverse flow of blood from the ventricles to the atria results in valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or the tricuspid valve TV are generally repairable. Additionally, regurgitation may occur because the chordae tendineae CT become dysfunctional (e.g., the chordae tendineae CT may stretch or rupture), which causes the anterior leaflet 20 and the posterior leaflet 22 to reverse, allowing blood to flow back into the left atrium LA. Problems occurring due to dysfunctional chordae tendineae CT can be repaired by repairing the structure of the chordae tendineae CT or the mitral valve MV (e.g., by fixing the leaflets 20, 22 at the affected portion of the mitral valve).

[0450] The devices and procedures disclosed herein are generally directed to treating and / or repairing the structure of the mitral valve. However, it should be understood that the devices and concepts provided herein can be used in conjunction with procedures involving any native valve (e.g., tricuspid valve) and any other medical procedure in which an implantable device is implanted and / or tissue is clamped (even if the device is not implanted) as part of a treatment and / or repair procedure.

[0451] Exemplary Devices

[0452] Exemplary devices or implants (e.g., therapeutic devices, repair devices, valve repair devices, implantable devices, implantable artificial devices, etc.) that can be utilized to implement the concepts herein optionally have a coaptation element (e.g., a spacer, a coaptation element, a gap filler, etc.) and at least one anchor (e.g., one, two, three or more anchors). In some embodiments, a device or implant may have any combination or subcombination of features disclosed herein without a coaptation element.

[0453] In some embodiments, when included, an apposition element (e.g., a coaptation element, a spacer, etc.) can be configured to be positioned within a native heart valve orifice to help fill the space between the leaflets and form a more effective seal, thereby reducing or preventing or inhibiting the above-mentioned regurgitation.

[0454] In some embodiments, the optional apposition element can have a structure that is impermeable to blood and / or resists blood flow therethrough (or otherwise reduces or inhibits blood flow) and allows the native leaflets to close around the apposition element during ventricular systole to prevent blood from flowing back from the left ventricle or right ventricle into the left atrium or right atrium, respectively. The apposition element is sometimes referred to herein as a spacer because the apposition element can fill the space between the dysfunctional native leaflets (e.g., mitral valve leaflets 20, 22 or tricuspid valve leaflets 30, 32, 34) that are not fully closed.

[0455] The device or implant may be configured to seal against two or three native valve leaflets; that is, the device may be used with both the native mitral (or bicuspid) valve and the tricuspid valve.

[0456] Optional apposition elements (e.g., spacers, engagement elements, etc.) can have various shapes. In some embodiments, the apposition element can have an elongated cylindrical shape having a circular cross-sectional shape. In some embodiments, the apposition element can have an elliptical cross-sectional shape, an oval cross-sectional shape, a crescent cross-sectional shape, a rectangular cross-sectional shape, or various other non-cylindrical shapes. In some embodiments, the apposition element can have an atrial portion positioned in or adjacent to the atrium, a ventricular portion or lower portion positioned in or adjacent to the ventricle, and a lateral surface extending between the native leaflets. In some embodiments configured for use in the tricuspid valve, the atrium or upper portion is positioned in or adjacent to the right atrium, and the ventricle or lower portion is positioned in or adjacent to the right ventricle, and the lateral surface extends between the native tricuspid valve leaflets.

[0457] In some embodiments, the anchor (e.g., a hook, a clip, a clamp, a plurality of arms, a plurality of clamping members, two paddles, a hook arm and a paddle arm, a clamping member and a paddle arm, etc.) can be configured to fix the device to one or two of the autologous leaflets so that the apposition element is positioned between the two autologous leaflets. In some embodiments configured for use in the tricuspid valve, the anchor is configured to fix the device to one, two or three tricuspid leaflets so that the apposition element is positioned between the three autologous leaflets. In some embodiments, the anchor may be attached to the apposition element at a position adjacent to the ventricular portion of the apposition element. In some embodiments, the anchor may be attached to an actuating element, such as a shaft or an actuating wire, to which the apposition element is also attached. In some embodiments, the anchor and the apposition element can be positioned independently relative to each other by individually moving each of the anchor and the apposition element along the longitudinal axis of the actuating element (e.g., an actuating shaft, an actuating rod, an actuating tube, an actuating wire, etc.). In some embodiments, the anchor and the apposition element can be positioned simultaneously by moving the anchor and the apposition element together along the longitudinal axis of the actuation element (e.g., shaft, actuation wire, etc.) The anchor can be configured to be positioned behind the native leaflet when in use and / or implanted so that the leaflet is grasped by the anchor.

[0458] Device or implant can be configured to use, operate and / or implant via delivery system or other delivery member.Delivery system can comprise one or more in guide / delivery sheath, delivery catheter, steerable catheter, implantation catheter, tube, these combination etc.Optional apposition element and anchor can be compressed to radial compression state, and can self-expand to radial expansion state when releasing compression pressure.Described device can be configured to make anchor initially radial expansion away from still compressed apposition element, so that gap is produced between apposition element and anchor.Then autologous leaflet can be positioned in gap.Apposition element can radial expansion, thereby close the gap between apposition element and anchor, and leaflet is captured between apposition element and anchor.In some embodiments, anchor and apposition element are optionally configured to self-expand.Various exemplary methods are discussed more comprehensively below about each embodiment.

[0459] Additional information regarding these and other delivery methods that can be used with the various systems and devices herein can be found in: U.S. Patent No. 8,449,599 and U.S. Patent Application Publication Nos. 2014 / 0222136, 2014 / 0067052, 2016 / 0331523, PCT Patent Application Publication No. WO2020 / 076898, PCT Patent Application No. PCT / US2022 / 035672, PCT Patent Application No. PCT / US2022 / 035673. 022 / 037983, PCT Patent Application No. PCT / US2022 / 050158, PCT Patent Application No. PCT / US2022 / 051232, PCT Patent Application No. PCT / US2022 / 049305, PCT Patent Application No. PCT / US2022 / 037176, and PCT Patent Application No. PCT / US2022 / 025390, each of which is incorporated herein by reference in its entirety for all purposes. These methods can be performed on live animals or on simulated objects, such as cadavers, cadaver hearts, anthropomorphic ghosts, simulators (e.g., having simulated body parts, hearts, tissues, etc.), etc., mutatis mutandis.

[0460] The disclosed device or implant can be configured so that the anchors are connected to the leaflets, using tension from native chordae tendineae to resist high systolic pressures that push the device toward the left atrium. During diastole, the device can rely on compression and retention forces exerted on the leaflets grasped by the anchors.

[0461] Reference now Figure 8-15, shows a schematically illustrated exemplary device or implant 100 (eg, a prosthetic septum device, a valve repair device, a valve treatment device, etc.) in various stages of deployment. The device or implant 100 and other similar devices / inserts that can be used with the various embodiments, systems and devices herein are described in more detail in PCT patent application publications No. WO 2018 / 195215, No. WO 2020 / 076898, No. WO 2019 / 139904, PCT patent application No. PCT / US2022 / 035672, PCT patent application No. PCT / US2022 / 037983, PCT patent application No. PCT / US2022 / 050158, PCT patent application No. PCT / US2022 / 051232, PCT patent application No. PCT / US2022 / 049305, PCT patent application No. PCT / US2022 / 037176, and PCT patent application No. PCT / US2022 / 025390, which are incorporated herein by reference in their entirety for all purposes. Device 100 (and other systems and devices described herein) may include any other features of the devices or implants discussed in the present or aforementioned applications, and 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 the present or aforementioned applications).

[0462] The device or implant 100 is deployed from a delivery system, delivery device, or other delivery member 102. The delivery system 102 can include one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implantation catheter, a tube, a channel, a passageway, combinations of these, etc. The device or implant 100 includes an apposition portion 104 and an anchor portion 106.

[0463] In some embodiments, the apposition portion 104 of the device or implant 100 may include an optional apposition element 110 (e.g., a spacer, a plug, a filler, a foam, a sheet, a film, a coupling element, etc.) that is suitable for implantation between the leaflets of a native valve (e.g., a native mitral valve, a native tricuspid valve, etc.) and is slidably attached to an actuation element 112 (e.g., an actuation wire, an actuation shaft, an actuation tube, etc.).

[0464] In some embodiments, the anchor portion 106 includes one or more anchors 108 that are actuatable between an open and closed state, and can take a variety of forms (e.g., paddles, clamping elements, hooks, clips, clamps, hook arms and paddle arms, clamping components and paddles, etc.), etc. Actuation of the actuating member or actuating element 112 causes the anchor portion 106 of the device 100 to open and close to grasp the native valve leaflet during implantation. The actuating member or actuating element 112 (as well as other actuating members and actuating elements herein) can take a variety of different forms (e.g., as a wire, rod, shaft, tube, screw, suture, line, strip, combination of these, etc.), be made of a variety of different materials, and have a variety of configurations. As an example, the actuating element can be threaded so that rotation of the actuating element causes the anchor portion 106 to move relative to the apposition portion 104. Alternatively, the actuation element may be non-threaded such that pushing or pulling the actuation element 112 moves the anchor portion 106 relative to the apposition portion 104 .

[0465] The anchor portion 106 and / or anchor of the device 100 includes an outer paddle 120 and an inner paddle 122, which in some embodiments are connected between the cover 114 and the mate element 110 by portions 124, 126, 128. Portions 124, 126, 128 can be connected and / or flexible to move between all positions described below. The interconnection of the outer paddle 120, the inner paddle 122, the mate element 110, and the cover 114 by portions 124, 126, and 128 can constrain the device to the positions and movements shown herein.

[0466] In some embodiments, the delivery system 102 includes a steerable catheter, an implant catheter, and an actuating member or actuating element 112 (e.g., an actuating wire, an actuating shaft, etc.). These can be configured to extend through a guide catheter / sheath (e.g., a transseptal sheath, etc.). In some embodiments, the actuating member or actuating element 112 extends through the delivery catheter and the engaging element 110 to the distal end (e.g., a hood 114 or other attachment portion at the distal connection of the anchor portion 106). Extending and retracting the actuating element 112 increases and decreases the spacing between the engaging element 110 and the distal end of the device (e.g., the hood 114 or other attachment portion), respectively. In some embodiments, a loop or other attachment element directly or indirectly removably attaches the mating element 110 to the delivery system 102 such that during actuation to open and close the anchor portion 106 and / or the paddles 120, 122 of the anchor 108, the actuating member or actuating element 112 slides through the loop or other attachment element, and in some embodiments, through the mating element 110.

[0467] In some embodiments, the anchor portion 106 and / or the anchor 108 can include an attachment portion or a clamping member. As shown, in some embodiments, the clamping member (or tissue engaging portion) can include a hook 130, which includes a base or fixed arm 132, a movable arm 134, an optional barb, a friction enhancing element or other fixing member 136 (e.g., a protrusion, a ridge, a groove, a textured surface, an adhesive, etc.), and a joint portion 138.

[0468] In some embodiments, a fixation arm may not be used, and another portion of the device (eg, another component, surface, element, etc.) may perform the functions described herein with respect to the fixation arm.

[0469] In some embodiments, the fixed arm 132 is attached to the inner blade 122. In some embodiments, the fixed arm 132 is attached to the inner blade 122, wherein the joint portion 138 is disposed proximate to the mating element 110. In some embodiments, the hook (e.g., a barbed hook, etc.) has a flat surface and does not fit into a recess of the inner blade. More specifically, the flat portion of the hook is disposed against the surface of the inner blade 122. The joint portion 138 provides a spring force between the fixed arm 132 and the movable arm 134 of the hook 130. The joint portion 138 can be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, etc. In some embodiments, the joint portion 138 is a flexible sheet of material integrally formed with the fixed arm 132 and the movable arm 134. The securing arm 132 is attached to the inner paddle 122 and remains stationary or substantially stationary relative to the inner paddle 122 when the movable arm 134 is opened to open the hook 130 and expose the optional barb, friction enhancing element, or securing member 136 .

[0470] In some embodiments, the hook 130 is opened by applying tension to an actuation wire 116 attached to the movable arm 134, thereby causing the movable arm 134 to articulate, bend, or pivot on the joint portion 138. The actuation wire 116 extends through the delivery system 102 (e.g., through a steerable catheter and / or an implanted catheter). Other actuation mechanisms are also possible.

[0471] The actuation wire 116 can take a variety of forms, such as a thread, suture, wire, rod, catheter, etc. The hook 130 can be spring loaded so that in the closed position, the hook 130 continues to provide a clamping force on the grasped autologous leaflet. The clamping force remains constant regardless of the position of the inner paddle 122. The optional barbs, friction enhancing elements or other fixing members 136 of the hook 130 can grab, clamp and / or pierce the autologous leaflet to further fix the autologous leaflet.

[0472] During implantation, the paddles 120, 122 may be opened and closed, for example, to grasp tissue (e.g., native leaflets, native mitral leaflets, native tricuspid leaflets, etc.) between the paddles 120, 122 and / or between the paddles 120, 122 and the apposition element 110. The hook 130 may be used to grasp and / or further secure tissue by engaging the tissue with optional barbs, friction enhancing elements, or securing members 136 and clamping the tissue (e.g., leaflets, etc.) between the movable arm 134 and the securing arm 132. The optional barbs, friction enhancing elements, or other securing members 136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.) of the tissue engaging portion or hook 130 increase friction with the tissue, or may partially or completely penetrate the tissue.

[0473] In some embodiments, the actuation wires 116 can be individually actuated so that each tissue engaging portion or hook 130 can be opened and closed individually. Individual operations allow for grasping of one leaflet at a time, or for repositioning of the tissue engaging portion or hook 130 on an insufficiently grasped tissue (e.g., leaflet, etc.) without altering the successful grasping of another leaflet. In some embodiments, the hook 130 can be opened and closed relative to the positioning of the inner paddle 122 (as long as the inner paddle is in an open or at least partially open position), thereby allowing the leaflet to be grasped in a variety of positions as required for a particular situation.

[0474] Reference now Figure 8 , the exemplary device 100 is shown in an extended or fully open state for deployment from an implant delivery catheter of a delivery system 102. In the fully open position, the device 100 is placed at the end of the catheter because the fully open position takes up the least space and allows the smallest catheter to be used (or the largest device to be used for a given catheter size). In the extended state, the cover 114 is spaced apart from the mate element 110 so that the paddles 120, 122 are fully extended. In some embodiments, the angle formed between the outer paddle 120 and the interior of the inner paddle 122 is approximately 180 degrees. During deployment through the delivery system 102, the hook 130 remains in a closed state so that the optional barb, friction enhancing element or other fixing member 136 ( Fig. 9 ) will not snag or damage the delivery system 102 or tissue in the patient's heart.

[0475] Reference now Fig. 9 , the device 100 is shown in a state similar to Figure 8The extended untangled state, but the hook 130 is in a fully open position, and the angle between the fixed arm 132 and the movable arm 134 of the hook 130 ranges from about 140 degrees to about 200 degrees, about 170 degrees to about 190 degrees, or about 180 degrees. It has been found that fully opening the paddles 120, 122 and the hook 130 can make it easier to untangle or disengage from patient anatomical structures such as chordae tendineae CT during implantation of the device 100.

[0476] Reference now Fig.10 , the device 100 is shown in a shortened or fully closed state. The compact size of the device 100 in the shortened state allows easier manipulation and placement in the heart. In order to move the device 100 from the extended state to the shortened state, the actuating member or actuating element 112 is retracted to pull the cover 114 toward the apposition element 110. The movement of the connecting portion 126 (e.g., a joint, a flexible connection, etc.) between the outer paddle 120 and the inner paddle 122 is restricted so that the compressive force acting on the outer paddle 120 from the cover 114 retracted toward the apposition element 110 causes the paddle or clamping element to move radially outward. During the movement from the open position to the closed position, the outer paddle 120 maintains an acute angle with the actuating member or actuating element 112. The outer paddle 120 is optionally biased toward the closed position. During the same movement, the inner paddle 122 moves through a considerable angle because they are oriented away from the apposition element 110 in the open state and collapse along the side of the apposition element 110 in the closed state. In some embodiments, inner paddle 122 is thinner and / or narrower than outer paddle 120, and connection portions 126, 128 (e.g., joints, flexible connections, etc.) connected to inner paddle 122 can be thinner and / or more flexible. For example, such increased flexibility can allow for more movement than connection portion 124 connecting outer paddle 120 to cover 114. In some embodiments, outer paddle 120 is narrower than inner paddle 122. Connection portions 126, 128 connected to inner paddle 122 can be more flexible, for example, to allow for more movement than connection portion 124 connecting outer paddle 120 to cover 114. In some embodiments, inner paddle 122 can have the same or substantially the same width as the outer paddle.

[0477] Reference now Figures 11 to 13, the device 100 is shown in a partially open, ready-to-grasp state. In order to transition from the fully closed state to the partially open state, the actuation member or actuation element (e.g., an actuation wire, an actuation shaft, etc.) is extended to push the cover 114 away from the mating element 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the anchor or anchor portion 106 to partially unfold. The actuation wire 116 is also retracted to open the hook 130 so that the targeted tissue or leaflet can be grasped. In some embodiments, the inner and outer paddles 122, 120 are moved in unison rather than independently by a single actuation member or a single actuation element 112. In addition, the position of the hook 130 depends on the position of the paddles 122, 120. For example, referring to Fig.10 , closing paddles 122, 120 also closes the hook. In some embodiments, paddles 120, 122 can be independently controlled. For example, device 100 can have two actuating elements and two independent covers (or other attached parts), so that one independent actuating element (e.g., wire, shaft, etc.) and cover (or other attached part) is used to control one paddle, and another independent actuating element and cover (or other attached part) is used to control the other paddle.

[0478] Reference now Fig.12 , one of the actuation lines 116 extends to allow one of the hooks 130 to close. Fig.13 , another actuation wire 116 extends to allow another hook 130 to close. Any one or two actuation wires 116 can be repeatedly actuated to repeatedly open and close the hook 130.

[0479] Reference now Fig.14, the device 100 is shown in a fully closed and deployed state. The delivery system or device for delivery 102 and the device for actuation or actuating element 112 are retracted, and the paddles 120, 122 and the hook 130 are maintained in the fully closed position. Once deployed, the device 100 can be maintained in the fully closed position with a mechanical latch, or can be biased to maintain closure by using a spring material such as steel, other metals, plastics, composite materials, or a shape memory alloy such as nitinol. For example, the connecting portion 124, 126, 128, the joint portion 138 and / or the inner and outer paddles 122 and / or an additional biasing assembly (not shown) can be formed of a metal such as steel or a shape memory alloy such as nitinol (e.g., produced in wire, sheet, tubing or laser sintering powder), and is biased to keep the outer paddle 120 closed around the apposition element 110 and the hook 130 clamped around the autologous leaflet. Similarly, the fixed arm 132 and the movable arm 134 of the hook 130 are biased to clamp the leaflets. In some embodiments, the attachment or connecting portions 124, 126, 128, the joint portion 138 and / or the inner and outer paddles 122 and / or additional biasing components (not shown) can be formed of any other suitable resilient material, such as metal or polymer materials, to maintain the device 100 in a closed state after implantation.

[0480] Fig.15 An example is shown where the blades 120, 122 are independently controllable. Fig.15 The device 101 shown is similar to Fig.11 The device 100 shown is different in that Fig.15 The device 101 includes an actuation element configured as two independent actuation elements 111, 113 coupled to two independent covers 115, 117. To transition the first inner paddle 122 and the first outer paddle 120 from a fully closed state to a partially open state, the actuation member or actuation element 111 is extended to push the cover 115 away from the mating element 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, so that the first anchor 108 is partially deployed. To transition the second inner paddle 122 and the second outer paddle 120 from a fully closed state to a partially open state, the actuation member or actuation element 113 is extended to push the cover 115 away from the mating element 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, so that the second anchor 108 is partially deployed. Fig.15 The independent blade control shown can be implemented on any device disclosed in this application. Fig.11 In the example shown, the inner and outer blades 122 , 120 are moved in unison rather than independently by a single actuation member or element 112 .

[0481] Reference now Figures 16 to 21 , Figures 8 to 14 The device 100 is shown delivered and implanted within the native mitral valve MV of the heart H. Fig.16 , the delivery sheath / catheter is inserted through the septum into the left atrium LA, and the implant / device 100 is deployed from the delivery catheter / sheath in a fully open state, as shown. Fig.16 The actuating member or element 112 is then retracted to move the implant / device to Fig.17 Shown in fully closed position.

[0482] like Fig.18 As can be seen in FIG. 1 , the implant / device is moved to a position within the mitral valve MV in the ventricle LV and partially opened so that the leaflets 20, 22 can be grasped. For example, the steerable catheter can be advanced and steered or bent to position the steerable catheter, such as Fig.18 An implant catheter connected to the implant / device can be advanced from within the steerable catheter to position the implant / device, such as Fig.18 shown.

[0483] Reference now Fig.19 , the implant catheter can be retracted into the steerable catheter to position the mitral valve leaflets 20, 22 in the hooks 130. The actuation wire 116 is extended to close one of the hooks 130, thereby capturing the leaflet 20. Fig. 20 Another actuation wire 116 is shown, which then extends to close another hook 130, thereby capturing the remaining leaflet 22. Finally, as shown in FIG. Fig.21 As can be seen in FIG. 1 , the delivery system 102 (eg, a steerable catheter, implant catheter, etc.), the actuation member or element 112, and the actuation wire 116 are then retracted, and the device or implant 100 is fully closed and deployed in the native mitral valve MV.

[0484] Reference now Figures 22 to 27 , showing an example of a device or implant 200. The device herein comprises Figures 8 to 14 , can be configured the same or similar to device 200. Device 200 can include any other features for devices or implants discussed in this application, and device 200 can be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). Device / implant 200 can be a prosthetic spacer device, a valve repair device, or another type of implant attached to the leaflets of a native valve.

[0485] In some embodiments, the device or implant 200 includes a commissure portion 204, a proximal or attachment portion 205, an anchor portion 206, and a distal portion 207. In some embodiments, the commissure portion 204 of the device optionally includes a commissure element 210 (e.g., a spacer, a commissure element, a plug, a film, a sheet, etc.) for implantation between the leaflets of the native valve. In some embodiments, the anchor portion 206 includes a plurality of anchors 208. The anchors can be configured in a variety of ways. In some embodiments, each anchor 208 includes an outer paddle 220, an inner paddle 222, a paddle extension member or paddle frame 224, and a clamping element or hook 230. In some embodiments, the attachment portion 205 includes a delivery system 202 ( Figures 38 to 42 and 49) of the capture mechanism 213 ( Figures 43 to 49 ) is coupled to a first or proximal component or collar 211 (or other attachment element, extension, ring, etc.). The delivery system 202 can be the same or similar to the delivery system 102 described elsewhere, and can include one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a passage, combinations of these, and the like.

[0486] In some embodiments, the apposition element 210 and the paddles 220, 222 are formed of a flexible material, which may be a metal fabric (e.g., a mesh) that is woven, braided, or formed in any other suitable manner, or a flexible material that is cut by laser or otherwise. The material may be cloth, a shape memory alloy wire such as Nitinol to provide shape-holding capabilities, or any other flexible material suitable for implantation in the human body.

[0487] An actuation element 212 (e.g., an actuation shaft, an actuation rod, an actuation tube, an actuation wire, an actuation wire, etc.) extends from the delivery system 202 to engage and enable actuation of the device or implant 200. In some embodiments, the actuation element 212 extends through the capture mechanism 213, the proximal assembly or collar 211, and the engagement element 210 to engage the cover 214 of the distal portion 207. The actuation element 212 can be configured to removably engage the cover 214 with a threaded connection or the like, so that the actuation element 212 can be disengaged and removed from the device 200 after implantation.

[0488] The engagement element 210 extends from the proximal assembly or collar 211 (or other attachment element) to the inner paddle 222. In some embodiments, the engagement element 210 has a generally elongated and circular shape, but other shapes and configurations are possible. In some embodiments, the engagement element 210 is positioned when viewed from above (e.g., Fig.53A ) has an elliptical shape or cross-section when viewed from the front view (e.g., Fig.23 ) has a conical shape or cross-section when viewed from the side (e.g., Fig.24 ) has a circular shape or cross-section when viewed from above. The mixture of these three geometric shapes can produce the three-dimensional shape of the illustrated juxtaposition element 210 that achieves the benefits described herein. When viewed from above, it can also be seen that the circular shape of the juxtaposition element 210 substantially follows or approximates the shape of the blade frame 224.

[0489] The size and / or shape of the apposition element 210 can be selected to minimize the number of implants (preferably one) that a single patient will need while maintaining a low transvalvular gradient. In some embodiments, the front-to-back distance at the top of the apposition element is about 5 mm, and the inside-outside distance of the apposition element at its widest point is about 10 mm. In some embodiments, the overall geometry of the device 200 can be based on these two dimensions and the above-mentioned overall shape strategy. It should be easily apparent that using other front-to-back distances and inside-outside distances as the starting point of the device will cause the device to have different sizes. In addition, using other sizes and the above-mentioned shape strategy will also cause the device to have different sizes.

[0490] In some embodiments, outer paddle 220 is connectably attached to cover 214 of distal portion 207 via connecting portion 221 and is connectably attached to inner paddle 222 via connecting portion 223. Inner paddle 222 is connectably attached to the apposition element via connecting portion 225. In this way, anchor 208 is configured to resemble a leg, as inner paddle 222 resembles an upper portion of a leg, outer paddle 220 resembles a lower portion of a leg, and connecting portion 223 resembles a knee portion of a leg.

[0491] In some embodiments, the inner paddle 222 is hard, relatively hard, rigid, has a rigid portion, and / or is hardened by a hardened member or fixed arm 232 of the hook 230. The hardening of the inner paddle allows the device to move to various different positions shown and described herein. The inner paddle 222, the outer paddle 220, and the mate can all be interconnected as described herein so that the device 200 is constrained to the movement and position shown and described herein.

[0492] In some embodiments, paddle frame 224 is attached to cover 214 at distal portion 207 and extends to connecting portion 223 between inner paddle 222 and outer paddle 220. In some embodiments, paddle frame 224 is formed of a material that is more rigid and harder than the material forming paddles 222, 220, such that paddle frame 224 provides support for paddles 222, 220.

[0493] The paddle frame 224 provides additional clamping force between the inner paddle 222 and the apposition element 210 and helps wrap the leaflet around the sides of the apposition element 210 to achieve a better seal between the apposition element 210 and the leaflet, such as Fig.53A20. That is, blade frame 224 can be configured to have a circular three-dimensional shape having a connecting portion 223 extending from cover 214 to anchor 208. The connections between blade frame 224, outer blade 220 and inner blade 222, cover 214, and mating element 210 can constrain each of these components to the movement and position described herein. In particular, connecting portion 223 is constrained by its connection between outer blade 220 and inner blade 222 and by its connection to blade frame 224. Similarly, blade frame 224 is constrained by its attachment to connecting portion 223 (and therefore inner blade 222 and outer blade 220) and cover 214.

[0494] Configuring the paddle frame 224 in this manner provides an increased surface area compared to the separate outer paddles 220. This can, for example, make it easier to grasp and secure the autologous leaflet. The increased surface area can also distribute the clamping force of the paddle 220 and paddle frame 224 on the autologous leaflet over a relatively large surface of the autologous leaflet to further protect the autologous leaflet tissue. Fig.53A The increased surface area of ​​the paddle frame 224 may also allow the native leaflets to be clamped to the device or implant 200 so that they fully appose around the apposition member or element 210. This may, for example, improve the sealing of the native leaflets 20, 22 and thereby prevent or further reduce mitral regurgitation.

[0495] In some embodiments, the hook comprises a movable arm coupled to an anchor. In some embodiments, the hook 230 comprises a base or fixed arm 232, a movable arm 234, an optional barb 236, and a joint portion 238. In some embodiments, the fixed arm 232 is attached to the inner blade 222, wherein the joint portion 238 is disposed proximate to the mating element 210. The joint portion 238 is spring loaded so that when the hook 230 is in a closed state, the fixed arm 232 and the movable arm 234 are biased toward each other. In some embodiments, the hook 230 comprises a friction enhancing element or fixing member, such as an optional barb, a protrusion, a ridge, a groove, a textured surface, an adhesive, etc.

[0496] In some embodiments, the fixed arm 232 is attached to the inner paddle 222 with sutures (not shown) through the hole or slot 231. The fixed arm 232 can be attached to the inner paddle 222 with any suitable means, such as screws or other fasteners, crimp sleeves, mechanical latches or snaps, welds, adhesives, clamps, latches, etc. When the movable arm 234 is opened to open the hook 230 and expose the optional barb or other friction enhancing element 236, the fixed arm 232 remains substantially stationary relative to the inner paddle 222. By attaching the actuation wire 216 (e.g., such as the inner paddle 222) to the hole 235 in the movable arm 234, the fixed arm 232 can be moved to the inner paddle 222. Figures 43 to 48) applies tension to open the hook 230, thereby causing the movable arm 234 to hinge, pivot and / or bend on the joint portion 238.

[0497] Reference now Fig.29 , showing a close-up view of one of the leaflets 20, 22 being grasped by a tissue engaging portion such as a hook 230. The leaflets 20, 22 are shown grasped between the movable arm 234 and the fixed arm 232 of the hook 230. The tissue of the leaflets 20, 22 is not pierced by the optional barbs or friction enhancing elements 236, but in some embodiments, the optional barbs 236 can partially or completely pierce the leaflets 20, 22. The angle and height of the optional barbs or friction enhancing elements 236 relative to the movable arms 234 help to secure the leaflets 20, 22 within the hooks 230. In particular, the force of pulling the device away from the native leaflets 20, 22 will cause the optional barbs or friction enhancing elements 236 to further engage the tissue, thereby ensuring better retention. When the hooks 230 are closed, the position of the fixed arms 232 near the optional barbs / friction enhancing elements 236 further improves the retention of the leaflets 20, 22 in the hooks 230. In this arrangement, the tissue is formed into an S-shaped tortuous path by the fixed arm 232 and the movable arm 234 and the optional barb / friction enhancing element 236. Thus, a force pulling the leaflets 20, 22 away from the hook 230 will cause the tissue to further engage the optional barb / friction enhancing element 236 before the leaflets 20, 22 can disengage. For example, leaflet tension during diastole can cause the optional barb 236 to be pulled toward the end portion of the leaflets 20, 22. Thus, the S-shaped path can utilize leaflet tension during diastole to more tightly engage the leaflets 20, 22 with the optional barb / friction enhancing element 236.

[0498] refer to Fig.25 , the device or implant 200 may further include a cover 240. In some embodiments, the cover 240 may be disposed on the apposition element 210, the outer paddle 220 and the inner paddle 222 and / or the paddle frame 224. The cover 240 may be configured to prevent or reduce blood flow through the device or implant 200 and / or promote autologous tissue ingrowth. In some embodiments, the cover 240 may be a cloth or fabric, such as PET, velvet or other suitable fabrics. In some embodiments, instead of or in addition to fabric, the cover 240 may include a coating (e.g., a polymer) applied to the device or implant 200.

[0499] During implantation, the paddles 220, 222 of the anchor 208 open and close to grasp the native valve leaflets 20, 22 between the paddles 220, 222 and the coaptation element 210. By extending and retracting the actuation element 212, the anchor 208 is in the closed position ( Figure 22-25 ) and various opening positions ( Figure 26-37). Extending and retracting the actuation element 212 increases and decreases the spacing between the apposition element 210 and the cover 214, respectively. During actuation, the proximal assembly or collar 211 (or other attachment element, extension, ring, etc.) and the apposition element 210 slide along the actuation element 212 so that the change in spacing between the apposition element 210 and the cover 214 causes the paddles 220, 220 to move between different positions to grasp the mitral valve leaflets 20, 22 during implantation.

[0500] When the device 200 is opened and closed, the inner and outer paddles 222, 220 are moved in unison, rather than independently, by a single actuating element 212. In addition, the position of the hook 230 depends on the position of the paddles 222, 220. For example, the hook 230 is arranged so that closing the anchor 208 simultaneously closes the hook 230. In some embodiments, the device 200 can be manufactured so that the paddles 220, 222 are independently controllable in the same manner (e.g., Fig.15 The device 101 shown in FIG.

[0501] In some embodiments, the hook 230 further secures the autologous 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 arm 234 and the fixed arm 232. In some embodiments, the hook 230 is a barbed hook, including barbs that increase friction with the leaflets 20, 22 and / or can partially or completely pierce the leaflets. Actuation wire 216 ( Figure 43-48 ) can be actuated individually so that each hook 230 can be opened and closed individually. Individual operations allow one leaflet 20, 22 to be grasped at a time, or allow the hook 230 on a leaflet 20, 22 that is not fully grasped to be repositioned without changing the successful grasping of another leaflet 20, 22. The hook 230 can be fully opened and closed when the inner paddle 222 is not closed, thereby allowing the leaflets 20, 22 to be grasped in a variety of positions as required by the specific situation.

[0502] Reference now Figure 22-25 , the device 200 is shown in a closed position. When closed, the inner paddle 222 is disposed between the outer paddle 220 and the apposition element 210. The hook 230 is disposed between the inner paddle 222 and the apposition element 210. After successfully capturing the autologous leaflets 20, 22, the device 200 is moved to and maintained in the closed position, so that the leaflets 20, 22 are fixed in the device 200 by the hook 230 and pressed against the apposition element 210 by the paddles 220, 222. The outer paddle 220 may have a wide curved shape that fits around the curved shape of the apposition element 210 to close the device 200 (e.g., as Fig.4920, 22. The curved shape and rounded edges of the outer paddles 220 also prevent or inhibit tearing of the leaflet tissue.

[0503] Reference now Figures 30 to 37 , the device or implant 200 described above is shown in various positions and configurations ranging from partially open to fully open. By extending the actuating element 212 from the fully retracted position to the fully extended position, the paddles 220, 222 of the device 200 are moved in a Figures 30 to 37 Each position shown is between Figures 22 to 25 Closed position transition shown.

[0504] Reference now Figures 30 to 31 , device 200 is shown in a partially open position. Device 200 is moved to the partially open position by extending actuating element 212. Extending actuating element 212 pulls downward on the bottom portion of outer paddle 220 and paddle frame 224. Outer paddle 220 and paddle frame 224 pull downward on inner paddle 222, to which inner paddle 222 is connected. Because proximal assembly or collar 211 (or other attachment element) and mating element 210 are held in place by capture mechanism 213, inner paddle 222 is caused to articulate, pivot and / or bend in the opening direction. Inner paddle 222, outer paddle 220, and paddle frame 224 are all bent to the position. Figures 30 to 31 Opening the paddles 222, 220 and frame 224 creates a gap between the apposition element 210 and the inner paddle 222 that can receive and grasp the autologous leaflets 20, 22. This movement also exposes the inner paddles 222 that can be in the closed position ( Fig.30 ) and the open position ( Fig.31 ) to form a hook 230 for grasping the second gap of the autologous leaflets 20, 22. The range of the gap between the fixed arm 232 and the movable arm 234 of the hook 230 is limited to the range in which the inner blade 222 has been spread away from the coaptation element 210.

[0505] Reference now Figure 32-33, the device 200 is shown in a laterally extended or open position. By continuing to extend the above-mentioned actuating element 212, the device 200 moves to the laterally extended or open position, thereby increasing the distance between the mating element 210 and the cover 214 of the distal portion 207. Continuing to extend the actuating element 212 pulls the outer paddle 220 and the paddle frame 224 downward, thereby causing the inner paddle 222 to expand further away from the mating element 210. In the laterally extended or open position, the inner paddle 222 extends horizontally more than in other positions of the device 200 and forms an angle of approximately 90 degrees with the mating element 210. Similarly, when the device 200 is in the laterally extended or open position, the paddle frame 224 is in its maximum expanded position. The increased gap between the mating element 210 and the inner paddle 222 formed in the laterally extended or open position allows the hook 230 to open further ( 100 degrees) before engaging the mating element 210. Fig.33 ), thereby increasing the size of the gap between the fixed arm 232 and the movable arm 234.

[0506] Reference now Figure 34-35 , the exemplary device 200 is shown in a three-quarter extended position. By continuing to extend the actuating element 212 described above, the device 200 moves to the three-quarter extended position, thereby increasing the distance between the mate element 210 and the cover 214 of the distal portion 207. Continued extension of the actuating element 212 pulls the outer paddle 220 and the paddle frame 224 downward, thereby causing the inner paddle 222 to expand further away from the mate element 210. In the three-quarter extended position, the inner paddle 222 is opened more than 90 degrees, forming an angle of approximately 135 degrees with the mate element 210. The paddle frame 224 expands less than when in the lateral extension or open position, and begins to move inward toward the actuating element 212 as the actuating element 212 is further extended. The outer paddle 220 also folds back toward the actuating element 212. As with the lateral extended or open position, the increased clearance between the engaging element 210 and the inner paddle 222 formed in the lateral extended or open position allows the hook 230 to open further ( Fig.35 ), thereby increasing the size of the gap between the fixed arm 232 and the movable arm 234.

[0507] Reference now Figure 36-37, the exemplary device 200 is shown in a fully extended position. By continuing to extend the above-mentioned actuating element 212, the device 200 moves to the fully extended position, thereby increasing the distance between the apposition element 210 and the cover 214 of the distal portion 207 to the maximum distance allowed by the device 200. Continuing to extend the actuating element 212 pulls the outer paddle 220 and the paddle frame 224 downward, thereby expanding the inner paddle 222 further away from the apposition element 210. The outer paddle 220 and the paddle frame 224 move to their positions close to the actuating element. In the fully extended position, the inner paddle 222 opens to an angle of approximately 180 degrees with the apposition element 210. The inner paddle 222 and the outer paddle 220 are stretched straight in the fully extended position to form an angle of approximately 180 degrees between the paddles 222, 220. The fully extended position of the device 200 provides the maximum size of the gap between the engaging element 210 and the inner paddle 222, and in some embodiments allows the hook 230 to also fully open to approximately 180 degrees (0.98 degrees) between the fixed arm 232 and the movable arm 234 of the hook 230. Fig.37 ). The position of the device 200 is the longest and narrowest configuration. Thus, the fully extended position of the device 200 can be a desired position for ejecting the device 200 from an attempted implantation, or can be a desired position for placing the device in a delivery catheter, etc.

[0508] Configuring the device or implant 200 so that the anchor 208 can extend to a straight or substantially straight configuration (e.g., approximately 120 to 180 degrees relative to the mate element 210) can provide several advantages. For example, such a configuration can reduce the radial curl profile of the device or implant 200. It can also make it easier to grasp the autologous leaflets 20, 22 by providing a larger opening between the mate element 210 and the inner paddle 222 in which to grasp the autologous leaflets 20, 22. In addition, the relatively narrow straight configuration can prevent or reduce the device or implant 200 from becoming entangled in autologous anatomical structures (e.g., Figure 3 and 4 Possibility of chordae tendineae CT).

[0509] Reference now Figures 38 to 49 , the exemplary device 200 is shown delivered and implanted within the native mitral valve MV of the heart H. As described above, Figures 38 to 49 The device 200 shown includes a mating element 210, a hook 230, an inner paddle 222, and / or an optional cover 240 (e.g., Fig.25 Device 200 is deployed from a delivery system 202 (eg, which may include an implant catheter that may extend from a steerable catheter 241 and / or an introducer sheath) and is retained by a capture mechanism 213 (see, e.g., Fig.43 and 48), and is actuated by extending or retracting the actuation element 212. The fingers of the capture mechanism 213 removably attach the collar 211 to the delivery system 202. In some embodiments, the capture mechanism 213 is held closed around the collar 211 by the actuation element 212, so that removal of the actuation element 212 allows the fingers of the capture mechanism 213 to open and release the collar 211 to separate the capture mechanism 213 from the device 200 after the device 200 has been successfully implanted.

[0510] Reference now Fig.38 , the delivery system 202 (e.g., its delivery catheter / sheath) is inserted through the septum into the left atrium LA, and the device / implant 200 is deployed from the delivery system 202 in a fully open state for the reasons discussed above with respect to the device 100 (e.g., the implant catheter holding the device / implant can be extended to deploy the device / implant from a steerable catheter). The actuation element 212 is then retracted to move the device 200 through the partially closed state ( Fig.39 ) and move to Figure 40-41 The fully closed state shown in . Then, as Fig.41 As shown in FIG. 1 , a delivery system or catheter is directed toward a mitral valve MV manipulation device / implant 200. Referring now to FIG. Fig.42 When the device 200 is aligned with the mitral valve MV, the actuation element 212 extends to open the paddles 220, 222 to a partially open position, and the actuation wire 216 ( Figure 43-48 ) retracts to open the hook 230 to prepare for grasping the leaflet. Figures 43 to 44 As shown, the partially opened device 200 is inserted through the native valve (eg, by advancing an implant catheter from a steerable catheter) until the leaflets 20 , 22 are properly positioned between the inner paddle 222 and the coaptation element 210 and within the opened hooks 230 .

[0511] Fig.45 Device 200 is shown with both tissue engaging portions / hooks 230 closed, but with the optional barb 236 of one hook 230 missing a leaflet 22. Figures 45 to 47 As can be seen in FIG. 2 , the hook 230 that is out of position opens and closes again to properly grasp the missing leaflet 22. When the two leaflets 20, 22 are properly grasped, the actuator 212 retracts to move the device 200 to the position in which the device 200 is positioned. Fig.48 With the device 200 fully closed and implanted in a native valve, the actuation element 212 is disengaged from the cover 214 and withdrawn to release the capture mechanism 213 from the proximal assembly or collar 211 (or other attachment element) so that the capture mechanism 213 can be withdrawn into the delivery system 202 (e.g., into a catheter / sheath), as shown. Fig.49Once deployed, the device 200 can be held in the fully closed position with a mechanical member such as a latch, or can be biased to remain closed using a spring material such as steel and / or a shape memory alloy such as Nitinol. For example, the paddles 220, 222 can be formed of steel or a Nitinol shape memory alloy produced in the form of a wire, sheet, tube, or laser sintered powder, and biased to hold the outer paddle 220 closed around the inner paddle 222, the apposition element 210, and / or to hold the hooks 230 clamped around the native leaflets 20, 22.

[0512] Fig.50A , 50B 50C show exemplary systems and / or devices to which the concepts of the present application may be applied. The system includes an implant-catheter assembly 1611 and a device 8200 (e.g., a valve repair device, a valve treatment device, an implantable device, etc.). The device 8200 includes a proximal or attachment portion 8205, a paddle frame 8224, and a distal portion 8207. The attachment portion 8205, the distal portion 8207, and the paddle frame 8224 can be configured in a variety of ways.

[0513] exist Fig.50A In the example shown, the blade frame 8224 can be symmetrical along the longitudinal axis YY. However, in some embodiments, the blade frame 8224 is not symmetrical about the axis YY. Fig.50A , the blade frame 8224 includes an outer frame portion 8256 and an inner frame portion 8260.

[0514] In some embodiments, a connector 8266 (e.g., a formed metal component, a formed plastic component, a tether, a wire, a strut, a wire, a rope, a suture, etc.) is attached to the outer frame portion 8256 at an outer end of the connector 8266 and to a coupler 8972 at an inner end 8968 of the connector 8266 (see Fig.50C ).

[0515] In some embodiments, the outer frame portion 8256 forms a curved shape between the connector 8266 and the attachment portion 8205. For example, in the example shown, the shape of the outer frame portion 8256 resembles an apple shape, wherein the outer frame portion 8256 is wider toward the attachment portion 8205 and narrower toward the distal portion 8207. However, in some embodiments, the outer frame portion 8256 can be shaped in other ways.

[0516] In some embodiments, the inner frame portion 8260 extends from the attachment portion 8205 toward the distal portion 8207. The inner frame portion 8260 then extends inwardly to form a retaining portion 8272 that is attached to the actuator cover 8214. The retaining portion 8272 and the actuator cover 8214 can be configured to attach in any suitable manner.

[0517] In some embodiments, the inner frame portion 8260 is a rigid frame portion and the outer frame portion 8256 is a flexible frame portion. Fig.50A As shown, the proximal end of the outer frame portion 8256 is connected to the proximal end of the inner frame portion 8260.

[0518] The width adjustment element 8211 (e.g., a width adjustment wire, a width adjustment shaft, a width adjustment tube, a width adjustment line, a width adjustment rope, a width adjustment suture, a width adjustment screw or bolt, etc.) is configured to be ... Fig.50C ) and a portion of connector 8266 are pulled into actuation cap 8214 to move outer frame portion 8256 from an extended position to a narrowed position. According to some embodiments disclosed herein, actuation element 8102 is configured to move inner frame portion 8260 to open and close the paddle.

[0519] like Fig.50B and 50C As shown, in some embodiments, the connector 8266 has an inner end 8968 that engages with the width adjustment element 8211 so that a user can move the inner end 8968 (e.g., an internal threaded element, a column, a pipe, a hollow component, a notched receiving portion, a tube, an axis, a sleeve, a strut, a housing, a cylinder, a track, etc.) within the receiver 8912 to move the outer frame portion 8256 between a narrowed position and an expanded position.

[0520] In the example shown, the inner end 8968 includes a support 8970 attached to the outer frame portion 8256 and a coupler 8972 extending from the support 8970. The coupler 8972 is configured to attach and detach both the width adjustment element 8211 and the receiver 8912. The coupler 8972 can take a variety of different forms. For example, the coupler 8972 can include one or more of a threaded connection, a feature that mates with a thread, a detent connection, such as an arm, wall or other portion that is biased outward.

[0521] In some embodiments, when the coupler 8972 is attached to the width adjustment element 8211, the coupler is released from the receiver 8912. In some embodiments, when the coupler 8972 is detached from the width adjustment element 8211, the coupler is fixed to the receiver.

[0522] The inner end 8968 of the connector can be configured in a variety of ways. Any configuration that can appropriately attach the outer frame portion 8256 to the coupler to allow the width adjustment element 8211 to move the outer frame portion 8256 between the narrowed position and the expanded position can be used. The coupler can also be configured in a variety of ways and can be a separate component or integral with another part of the device (such as the connector or the inner end of the connector).

[0523] In some embodiments, the width adjustment element 8211 allows a user to expand or contract the outer frame portion 8256 of the device 8200. Fig.50B and 50C In the example shown, the width adjustment element 8211 includes an externally threaded end that screws into the coupler 8972. In some embodiments, the width adjustment element 8211 moves the coupler in the receiver 8912 to adjust the width of the outer frame portion 8256. When the width adjustment element 8211 is unscrewed from the coupler 8972, the coupler engages the inner surface of the receiver 8912 to set the width of the outer frame portion 8256.

[0524] In some embodiments, the receiver 8912 can be integrally formed with the distal cover 8214. Moving the cover 8214 relative to the body of the attachment portion 8205 opens and closes the paddle. In the example shown, the receiver 8912 slides inside the body of the attachment portion. When the coupler 8972 is detached from the width adjustment element 8211, the width of the outer frame portion 8256 is fixed, and the actuating element 8102 moves the receiver 8912 and the cover 8214 relative to the body of the attachment portion 8205. Movement of the cover can open and close the device in the same manner as other embodiments disclosed above.

[0525] In the example shown, a driver head 8916 is disposed at the proximal end of the actuating element 8102. The driver head 8916 releasably couples the actuating element 8102 to the receiver 8912. In the example shown, the width adjustment element 8211 extends through the actuating element 8102. The actuating element is axially advanced in a direction opposite to the direction Y to move the distal cover 8214. The movement of the distal cover 8214 relative to the attachment portion 8205 effectively opens and closes the paddle, as shown in FIG. Fig.50B That is, the movement of the distal cover 8214 in the direction Y closes the device, and the movement of the distal cover in the direction opposite to the direction Y opens the device.

[0526] exist Fig.50B and 50C8968 to engage a coupler 8972 attached to the inner end 8968. In some embodiments, moving the outer frame portion 8256 to the narrowed position can allow the device or implant 8200 to be more easily maneuvered to an implantation position in the heart by reducing contact and / or friction between the heart's native structures (e.g., chordae tendineae) and the device 8200. In some embodiments, moving the outer frame portion 8256 to the expanded position provides a greater surface area for the anchor portion of the device or implant 8200 to engage and capture the leaflets of the native heart valve.

[0527] The device 8200 (e.g., anchors 8830, 8834, or another portion of the device) may include a tissue engaging portion or hook 8230, which may be the same or similar to hooks 130, 230, 330, 40856, 5030a, 5030b, 5030c, or other tissue engaging portions or hooks described herein.

[0528] The bioimpedance based feedback disclosed herein can be used to provide feedback regarding the engagement of tissue in the tissue engaging portion or hook of one or more of the distal anchor 8830 and / or the proximal anchor 8834 .

[0529] Fig.51A An example of a device or implant 300 (eg, a therapeutic device, a prosthetic device, an implantable device, etc.) is shown. The device herein includes Figures 8 to 15 The device 100 schematically shown in FIG. 1 may be the same as or similar to the device 300 (and / or the same as or similar to any other exemplary device disclosed herein, described in incorporated references, or otherwise compatible with the concepts herein).

[0530] Device 300 may include any other features used in the devices or implants discussed in this application, and device 300 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0531] In some embodiments, the device 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 apposition portion 304, and the apposition portion 304 can optionally include an apposition element 310 (e.g., a spacer, plug, membrane, sheet, etc.) for implantation between the leaflets 20, 22 of a native valve.

[0532] In some embodiments, the anchor portion 306 includes a plurality of anchors 308. In some embodiments, each anchor 308 can include one or more paddles, for example, an outer paddle 320, an inner paddle 322, a paddle extension member (e.g., a leaf spring, a shaped wire, etc.), a paddle frame 324, etc. The anchor can also include and / or be coupled to a hook 330. In some embodiments, the attachment portion 305 includes a first or proximal collar 311 (or other attachment element) for engaging with a capture mechanism of a delivery system.

[0533] The anchors 308 can be attached to other portions of the device and / or to each other in a variety of different ways (e.g., directly, indirectly, welded, sutured, adhesive, linkage, latch, integrally formed, a combination of some or all of these, etc.) In some embodiments, the anchors 308 are attached to the apposition element 310 via the connecting portion 325 and to the cover 314 via the connecting portion 321.

[0534] In some embodiments, anchor 308 may include a first portion or outer blade 320 and a second portion or inner blade 322 separated by a connecting portion 323. In some embodiments, connecting portion 323 may be attached to a blade frame 324, which may be hingedly attached to cover 314 or other attachment portion. In this way, anchor 308 is configured to resemble a leg, as inner blade 322 resembles an upper portion of a leg, outer blade 320 resembles a lower portion of a leg, and connecting portion 323 resembles a knee portion of a leg.

[0535] In some embodiments including the optional apposition element 310, the apposition element 310 and the anchor 308 can be coupled together in various ways. As shown in the illustrated example, the apposition element 310 and the anchor 308 can be coupled together by integrally forming the apposition element 310 and the anchor 308 as a single, unitary component. This can be achieved, for example, by forming the apposition element 310 and the anchor 308 from a continuous strip 301 of a braided or woven material, such as a braided or woven nitinol wire. In the illustrated example, the apposition element 310, the outer paddle portion 320, the inner paddle portion 322, and the connecting portions 321, 323, 325 are formed from a continuous fabric strip 301.

[0536] Similar to the anchor 208 of the device or implant 200 described above, the anchor 308 can be configured to move between various configurations by axially moving the distal end of the device (e.g., cover 314, etc.) relative to the proximal end of the device (e.g., proximal collar 311 or other attachment element, etc.). This movement can be along a longitudinal axis extending between the distal end (e.g., cover 314, etc.) and the proximal end (e.g., collar 311 or other attachment element, etc.) of the device.

[0537] In some embodiments, in the straight configuration, the paddle portions 320, 322 are aligned or straight in the direction of the longitudinal axis of the device. In some embodiments, the connecting portion 323 of the anchor 308 is adjacent to the longitudinal axis of the spacer or apposition element 310. From the straight configuration, the anchor 308 can be moved to a fully folded configuration (e.g., by moving the proximal and distal ends toward each other and / or toward the midpoint or center of the device). Fig.51A ).

[0538] In some embodiments, the hook comprises a movable arm coupled to an anchor. In some embodiments, the hook 330 comprises a base or fixed arm 332, a movable arm 334, an optional barb / friction enhancing element 336, and a joint portion 338. In some embodiments, when included, the fixed arm 332 can be attached to the inner blade 322, wherein the joint portion 338 is disposed proximate to the mating element 310. In some embodiments, the joint portion 338 is spring loaded so that when the hook 330 is in a closed state, the fixed arm 332 and the movable arm 334 are biased toward each other.

[0539] In some embodiments, fixed arm 332 is attached to inner paddle 322 with sutures through a hole or slot. Fixed arm 332 can be attached to inner paddle 322 with any suitable means, such as screws or other fasteners, crimp sleeves, mechanical latches or snaps, welding, adhesives, etc. Fixed arm 332 remains substantially stationary relative to inner paddle 322 when movable arm 334 is opened to open hook 330 and expose optional barb 336.

[0540] In some embodiments, the hook 330 is opened by applying tension to an actuation wire attached to the movable arm 334 , causing the movable arm 334 to articulate, pivot, and / or bend on the joint portion 338 .

[0541] Briefly, the device or implant 300 may be similar to the device or implant 200 described above in configuration and operation, but the apposition element 310, the outer paddle 320, the inner paddle 322 and the connecting portions 321, 323, 325 are formed by a single material strip 301. In some embodiments, the material strip 301 is attached to the proximal collar 311, the cover 314 and the paddle frame 324 by weaving or inserting through the openings in the proximal collar 311, the cover 314 and the paddle frame 324, and the openings are configured to receive the continuous material strip 301. The continuous strip 301 can be a single layer of material or can include two or more layers. In some embodiments, portions of the device 300 have a single layer of material strip 301, and other portions are formed by multiple overlapping or superimposed layers of the material strip 301.

[0542] For example, Fig.51AThe juxtaposed element 310 and inner paddle 322 are shown formed from multiple overlapping layers of a strip of material 301. A single continuous strip of material 301 may begin and end at various locations in the device 300. The ends of the strip of material 301 may be at the same location or at different locations in the device 300. Fig.51A In the example shown, the strip of material 301 begins and ends at the location of the inner blade 322.

[0543] As with the device or implant 200 described above, the size of the apposition element 310 can be selected to minimize the number of implants (preferably one) that will be required for a single patient while maintaining a low transvalvular gradient. In particular, forming many of the components of the device 300 from the strip of material 301 allows the device 300 to be made smaller than the device 200. For example, in some embodiments, the front-to-back distance at the top of the apposition element 310 is less than 2 mm, and the inside-out distance of the device 300 at its widest point (e.g., the width of the paddle frame 324, which is wider than the apposition element 310) is about 5 mm.

[0544] Additional features of the device 300, modified versions of the device, delivery systems of the device, and methods of using the device and delivery systems are disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO 2020 / 076898). Any combination or subcombination of features disclosed by the present application may be combined with any combination or subcombination of features disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO 2020 / 076898). Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO 2020 / 076898) is incorporated herein by reference in its entirety.

[0545] Fig.51B Another exemplary system and / or apparatus to which the concepts of the present application may be applied is shown. System 40056 includes a delivery device 40156 and a device 40256 (eg, a valve repair device, a valve treatment device, an implantable device, etc.).

[0546] In some embodiments, the valve repair device 40256 includes a base assembly 40456, a pair of paddles 40656 (e.g., hooks, clips, arms, etc.), and a pair of clamping members 40856 (e.g., hooks, clips, arms, etc.). In some embodiments, the paddles 40656 can be formed integrally with the base assembly. For example, the paddles 40656 can be formed as an extension of the connecting rod of the base assembly. In the example shown, the base assembly 40456 of the valve repair device 40256 has an axis 40356, a coupler 40556 configured to move along the axis, and a lock 40756 configured to lock the coupler in a fixed position on the axis. In some embodiments, the clamping member 40856 can be considered as a first arm, and the paddles 40656 can be considered as a second arm of a hook, a clip, a tissue engaging portion, etc.

[0547] In some embodiments, coupler 40556 is mechanically connected to paddle 40656 such that movement of coupler 40556 along shaft 40356 causes paddle 40656 to move between an open position and a closed position. In this manner, coupler 40556 acts as a means for mechanically coupling paddle 40656 to shaft 40356 and for moving paddle 40656 between its open position and a closed position when moved along shaft 40356.

[0548] In some embodiments, the clamping member 40856 is pivotally connected to the base assembly 40456 (e.g., the clamping member 40856 can be pivotally connected to the shaft 40356 or any other suitable component of the base assembly) so that the clamping member can be moved to adjust the width of the opening 41456 between the paddle 40656 and the clamping member 40856. The clamping member 40856 can include an optionally barbed portion 40956 (or other friction enhancing portion with or without barbs) for attaching the clamping member to the valve tissue when the valve repair device 40256 is attached to the valve tissue.

[0549] In some embodiments, when the paddle 40656 is in a closed position, the paddle engages the clamping member 40856 such that when the valve tissue is attached to the barbed portion 40956 of the clamping member (although described herein as a "barbed portion," alternative barbs or other friction enhancing elements in addition to barbs may be used), the paddle secures the valve repair device 40256 to the valve tissue.

[0550] In some embodiments, clamping member 40856 is configured to engage paddle 40656 such that barbed portion 40956 engages valve tissue and paddle 40656 to secure valve repair device 40256 to the valve tissue. For example, in some cases, it may be desirable to maintain paddle 40656 in an open position and move clamping member 40856 outward toward paddle 40656 to engage valve tissue and paddle 40656.

[0551] although Fig.51B The illustrated example shows a pair of paddles 40656 and a pair of clamping members 40856, but it will be appreciated that the valve repair device 40256 may include any suitable number of paddles and clamping members.

[0552] In some embodiments, system 40056 includes a placement shaft 41356 removably attached to shaft 40356 of base assembly 40456 of valve repair device 40256. After valve repair device 40256 is secured to valve tissue, placement shaft 41356 is removed from shaft 40356 to remove valve repair device 40256 from the remainder of valve repair system 40056 such that valve repair device 40256 can remain attached to valve tissue and delivery device 40156 can be removed from the patient.

[0553] The system 40056 may also include a paddle control mechanism 41056 (e.g., a relatively movable tube, shaft, etc.), a clamp control mechanism 41156 (e.g., a guide wire, a wire, a suture, etc.), and a lock control mechanism 41256 (e.g., a relatively movable tube, shaft, guide wire, a wire, a suture, etc.).

[0554] In some embodiments, paddle control mechanism 41056 is mechanically attached to coupler 40556 to move the coupler along the shaft, which moves paddle 40656 between an open position and a closed position. Paddle control mechanism 41056 can take any suitable form, such as a shaft or a rod. For example, paddle control mechanism can include a hollow shaft, conduit, or sleeve that fits over placement shaft 41356 and shaft 40356 and is connected to coupler 40556.

[0555] The clamp control mechanism 41156 is configured to move the clamp member 40856 so that the width of the opening 41456 between the clamp member and the paddle 40656 can be changed. The clamp control mechanism 41156 can take any suitable form, such as a wire, suture or guide wire, rod, catheter, etc.

[0556] The lock control mechanism 41256 is configured to lock and unlock the lock. The lock 40756 locks the coupler 40556 in a fixed position relative to the shaft 40356 and can take a variety of different forms, and the type of lock control mechanism 41256 can be specified by the type of lock used. In instances where the lock 40756 includes a pivotable plate, the lock control mechanism 41256 is configured to engage the pivotable plate to move the plate between an inclined position and a substantially non-inclined position. In some embodiments, the lock control mechanism 41256 can be, for example, a rod, a suture, a wire, or any other component that enables the pivotable plate of the lock 40756 to move between an inclined position and a substantially non-inclined position.

[0557] The valve repair device 40256 is movable from an open position to a closed position. In the example shown, the base assembly 40456 includes a connecting rod moved by a coupler 40556. The coupler 40556 is movably attached to the shaft 40356. To move the valve repair device from the open position to the closed position, the coupler 40556 is moved along the shaft 40356, thereby moving the connecting rod.

[0558] In some embodiments, the gripper control mechanism 41156 moves the gripper member 40856 to provide a wider or narrower gap at the opening 41456 between the gripper member and the paddle 40656. In the example shown, the gripper control mechanism 41156 includes a wire, such as a suture, a guide wire, etc., connected to the opening in the end of the gripper member 40856. When the wire is pulled, the gripper member 40856 moves inward, which widens the opening 41456 between the gripper member and the paddle 40656.

[0559] To move the valve repair device 40256 from the open position to the closed position, the lock 40756 is moved to the unlocked state by the lock control mechanism 41256. Once the lock 40756 is in the unlocked state, the coupler 40556 can be moved along the shaft 40356 by the paddle control mechanism 41056.

[0560] After paddle 40656 is moved to the closed position, lock 40756 is moved to a locked state by lock control mechanism 41256 to hold valve repair device 40256 in the closed position. After valve repair device 40256 is held in the locked state by lock 40756, valve repair device 40256 is removed from delivery device 40156 by disconnecting shaft 40356 from placement shaft 41356. Additionally, valve repair device 40256 is disengaged from paddle control mechanism 41056, gripper control mechanism 41156, and lock control mechanism 41256.

[0561] Additional features of device 40256, modified versions of the device, delivery systems of the device, and methods of using the device and delivery systems are disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904). Any combination or subcombination of features disclosed by the present application may be combined with any combination or subcombination of features disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904). Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904) is incorporated herein by reference in its entirety.

[0562] The tissue engaging portions disclosed herein, such as hooks or leaflet clamping devices, can take a variety of different forms. Examples of hooks are disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018195201). Any combination or subcombination of features disclosed by the present application can be combined with any combination or subcombination of features disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018195201). Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018195201) is incorporated herein by reference in its entirety.

[0563] Fig.51C and 51D An exemplary embodiment of a valve repair device 40256 including a coaptation element 3800 is shown. The valve repair device 40256 may have Fig.51B The same or similar configuration as the valve repair device shown, with the addition of an apposition element. The apposition element 3800 can take a variety of different forms.

[0564] In some embodiments, the apposition element 3800 can be compressible and / or expandable. For example, the apposition element can be compressed to fit inside one or more catheters of the delivery system, can be expanded when removed from one or more catheters, and / or can be compressed by the paddle 40656 to adjust the size of the apposition element. Fig.51C and 51D In the example shown, the size of the apposition element 3800 can be reduced by compressing the apposition element with the paddles 40656, and the size can be increased by moving the paddles 40656 away from each other. As shown, the apposition element 3800 can extend beyond the outer edge 4001 of the clamping member or hook 40856 to provide additional surface area for closing the gap of the mitral valve.

[0565] The apposition element 3800 can be coupled to the valve repair device 40256 in a variety of different ways. For example, the apposition element 3800 can be fixed to the shaft 40356, can be slidably disposed about the shaft, can be connected to the coupler 40556, can be connected to the lock 40756, and / or can be connected to the central portion of the hook or clamp member 40856. In some embodiments, the coupler 40556 can take the form of the apposition element 3800. That is, a single element can serve as the coupler 40556 that moves the paddle 40656 between the open position and the closed position, and the apposition element 3800 that closes the gap between the leaflets 20, 22 when the valve repair device 40256 is attached to the leaflets.

[0566] The coaptation element 3800 can be disposed around one or more of the shafts or other control elements of the valve repair system 40056. For example, the coaptation element 3800 can be disposed around the shaft 40356, the shaft 41356, the paddle control mechanism 41056, and / or the lock control mechanism 41256.

[0567] The valve repair device 40256 may include any other features for the valve repair devices discussed in the present application, and the valve repair device 40256 may be positioned to engage valve tissue as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application). Additional features of the device 40256, modified versions of the device, delivery systems of the device, and methods of using the device and delivery systems are disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO 2019139904). Any combination or subcombination of features disclosed by the present application may be combined with any combination or subcombination of features disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO 2019139904).

[0568] Fig.51EAnother example of one of the many valve repair systems for repairing a patient's native valve to which the concepts of the present application can be applied is shown. The valve repair system includes a device 8810, which includes a frame 8820, anchors 8830, 8834, a band 8840, an annular flap or sail 8850, and a valve body 8860. The device 8810 includes a proximal end 8812 and a distal end 8814, wherein an opening is defined at both ends 8812, 8814 so that a fluid can flow therethrough. In some embodiments, the proximal end 8812 can be placed in the left atrium, and the distal end 8814 can be placed in the left ventricle, so that the device 8810 can act as a substitute for the mitral valve. The device 8810 can allow blood to flow from the proximal end 8812 to the distal end 8814 in a first direction, while preventing blood from flowing from the distal end 8814 to the proximal end 8812 in a second direction.

[0569] The device or implant 8810 may include one or more distal anchors 8830. The distal anchors 8830 may be positioned along or near the distal end of the frame 8820 and may be connected to the frame 8820. The distal anchors 8830 may be designed so that when the frame 8820 is in the expanded configuration, the end or tip 8832 of each distal anchor 8830 is positioned radially outward from the frame 8820 and extends generally in the proximal direction. In some embodiments, the device 8810 may include one or more proximal anchors 8834. The proximal anchors 8834 may be positioned along or near the proximal end 8812 of the frame 8820 and may be connected to the frame 8820. The proximal anchors 8834 may be designed so that when the frame 8820 is in the expanded configuration, the end or tip 8836 of each proximal anchor 8834 is positioned radially outward from the frame 8820 and extends generally in the distal direction. In some embodiments, one or more anchors 8830, 8834 can include a soft pad 8838 covering one or more of such anchors.

[0570] In some embodiments, the device 8810 can be positioned so that the mitral valve annulus is located between the distal anchor 8830 and the proximal anchor 8834. In some embodiments, the device 8810 can be positioned so that the end or tip 8832 of the distal anchor 8830 contacts the annulus. In some embodiments, the device 8810 can be positioned so that the end or tip 8832 of the distal anchor 8830 does not contact the annulus. In some embodiments, the device 8810 can be positioned so that the distal anchor 8830 does not extend around the leaflets. In some embodiments, the device 8810 can be positioned so that some distal anchors 8830 contact the annulus while other distal anchors 8830 do not contact the annulus. In some embodiments, the device 8810 can be positioned such that the end or tip 8832 of the distal anchor 8830 is located on the ventricular side of the mitral annulus and the end or tip 8836 of the proximal anchor 8834 is located on the atrial side of the mitral annulus.

[0571] In some embodiments, the distal anchor 8830 can be positioned so that the end or tip 8832 of the distal anchor 8830 is located on the ventricular side of the native leaflet, beyond the location where the chordae are connected to the free ends of the native leaflets. The distal anchor 8830 can extend between at least some of the chordae and in some cases can contact or engage the ventricular side of the annulus. It is also contemplated that in some embodiments, the distal anchor 8830 may not contact the annulus and the distal anchor 8830 may contact the native leaflet. In some cases, the distal anchor 8830 may contact left ventricular tissue beyond the ventricular side of the annulus and / or leaflet. In some embodiments, during delivery, the distal anchor 8830 (together with the frame 8820) can be moved toward the ventricular side of the annulus, wherein the distal anchor 8830 extends between at least some of the chordae to provide tension on the chordae. Other examples of device 8810 are provided in U.S. Publication No. 2015 / 0328000, published on November 19, 2015, which is incorporated herein by reference in its entirety.

[0572] In certain embodiments, the device 8810 does not include a proximal anchor 8834. In such embodiments, the distal anchor 8830 can be configured to snap onto native leaflets, annulus, chordae tendineae, or a combination of two or more of these. The bioimpedance-based feedback disclosed herein can be used to provide feedback regarding the snapping of tissue in one or more of the distal anchor 8830 and / or the proximal anchor 8834.

[0573] Bioimpedance-based device feedback

[0574] Examples of devices capable of using bioimpedance or bioimpedance-based feedback in medical procedures are provided below. Although some of the description herein focuses on embodiments in devices designed for leaflet capture for illustrative purposes, it should be understood that the bioimpedance-based feedback capabilities, properties, and functionality are applicable to other devices used in various medical procedures and used with a variety of tissues. These devices include, for example, but are not limited to, annuloplasty devices, anchors for devices, implants, therapeutic devices, valves, stents, artificial valves, devices anchored to muscle, devices anchored to tissue, etc. Reference is made herein to Figures 8 to 15 , 22 to 37 and 50A to 51E describe some exemplary devices (e.g., including sensors, printed circuit boards, circuits, electrodes, measurement systems, etc.) that can be used with the disclosed bioimpedance-based feedback technology. In addition, the bioimpedance-based feedback capabilities, properties and functionality can be applied to other systems, devices, components, etc. that are not implanted, such as delivery systems, delivery devices, catheters, anchor drivers, pushers (e.g., push rods, etc.), leaflet repair tools that capture leaflets for treatment and then release the leaflets, chord repair / replacement devices, leaflet prolapse repair devices, other treatment and / or repair devices, etc.

[0575] Although many examples herein describe hooks for illustrative purposes, the same or similar concepts, configurations, measurements, principles, etc. (e.g., similar electrodes, etc.), such as those described with respect to "hooks", even if not conventional "hooks", may be used in other embodiments, anchors, anchor portions, clips, clamps, clamps, gripping members, paddles, configurations, etc. In some embodiments, tissue engaging portions, anchors, hooks, etc. may include arms that are not directly hinged to each other. In some embodiments, tissue engaging portions, hooks, etc. herein may not include fixed arms. In some embodiments, the gripping member may be pivotally connected to a base assembly and / or formed with a base assembly.

[0576] In some embodiments, the same or similar concepts, configurations, measurements, principles, etc. (e.g., similar electrodes, etc.), such as those described with respect to "hooks", can be used with Fig.51E The device 8810 is used in conjunction with a distal anchor 8830 or arm.

[0577] In some embodiments, the same or similar concepts, configurations, measurements, principles, etc. (e.g., similar electrodes, etc.), such as those described with respect to a "hook," can be used on an implantable device or a non-implantable device comprising a tissue engaging portion or a tissue capturing portion formed by a first surface and a second surface that move relative to each other, whether or not associated with a first arm and a second arm and / or whether or not the surfaces are directly connected or articulated to each other.

[0578] In some embodiments, the same or similar concepts, configurations, measurements, principles, etc. (e.g., similar electrodes, etc.), such as those described with respect to a "hook", can be used on an implantable device or a non-implantable device, the device comprising a tissue engaging portion or a tissue capturing portion formed by a first surface (e.g., a first surface of a clamping member, an arm, a hook arm, a first arm, etc.) and a second surface (e.g., a second surface of a paddle, an arm, a hook arm, a second arm, a mating element, etc.), wherein at least one of the first surface and the second surface can move relative to the other surface, regardless of whether the surfaces are directly connected or hinged to each other.

[0579] In typical transcatheter edge-to-edge repair (TEER) procedures and other such procedures that include leaflet capture, echo-based imaging is primarily used. Such imaging techniques can be helpful. However, as described herein, other techniques used with or without imaging can be helpful and have the potential to improve confidence and results. In some cases, the bioimpedance-based feedback techniques disclosed herein can be used to enhance imaging techniques. For example, even on the mitral valve side where echo imaging is typically good, the procedure may involve deploying more than one implant. In such cases, the first implant may cast a shadow when the second implant is deployed, making it difficult to accurately measure leaflet insertion and making it even more difficult to determine leaflet capture. Therefore, disclosed herein are systems, methods, and devices that use bioimpedance-based feedback to provide feedback related to tissue engagement, tissue capture, and / or anchor deployment for devices such as the devices disclosed herein. Bioimpedance-based feedback can be used to generate indicators to help users make decisions about leaflet capture, and the feedback is independent of echo imaging.

[0580] Additionally, it may be beneficial to generate indicators other than those related to leaflet insertion or leaflet capture. For example, it may be beneficial for a user to understand coaptation, tension, paraimplant leakage, strength of leaflet tissue, retention of hooks on leaflets, etc. Thus, the algorithms described herein may be used to provide indicators that provide useful information to a user to determine not only leaflet capture but also coaptation, tension, regurgitation, leaflet tissue strength, etc. Advantageously, these indicators may be used to achieve a desired outcome in a medical procedure.

[0581] Fig.52A , 52B , 52C show exemplary anchor portions, anchors, tissue engaging portions or hooks 5030a, 5030b, 5030c having at least one electrode 5040 (e.g., two or more electrodes 5040). The anchor portions, anchors, tissue engaging portions or hooks 5030a, 5030b, 5030c can be used with any of the system devices herein (mutatis mutandis), for example, these can be used with Figures 8 to 51DThe device may be used in conjunction with other implantable devices or non-implantable therapeutic devices that capture tissue.

[0582] Fig.52A An anchor, anchor portion, tissue engaging portion, hook, etc. 5030a is shown, wherein the electrode 5040 is above the cloth 5047 or cover (e.g., the electrode 5040 is exposed), and Fig.52B An anchor, anchor portion, tissue engaging portion, hook, etc. 5030b is shown with the electrode 5040 beneath a cloth 5047 or cover (eg, the cloth 5047 covers the electrode). Fig.52C An anchor, anchor portion, tissue engaging portion, hook, etc. 5030c is shown with the electrode 5040 secured to the first arm 5032 and / or the second arm 5034 without a cloth or cover.

[0583] The anchor portion, anchor, tissue engaging portion or hook 5030a, 5030b, 5030c can be similar to the tissue engaging portion or hook 130, 230, 330, 40856, etc. described herein, and share many of the same components (e.g., arms 5032, 5034, fixation members 5036, and joint portions 5038), properties, and functionality. The anchor, anchor portion, hook 5030a, 5030b, 5030c can be used in place of the anchor / hook 130, 230, or the features of the anchor, anchor portion, hook 5030a, 5030b, 5030c (e.g., electrodes, etc.) can be incorporated into the anchor / hook 130, 230. The anchor portion, anchor, hook 5030a, 5030b, 5030c can be implemented as a part of a device described herein, such as device 100, 200.

[0584] In some embodiments, the anchor portion, anchor, tissue engaging portion, hook 5030a, 5030b, 5030c can include a frame 5046, which can be conductive (e.g., made of nitinol or other conductive material), and a cloth 5047, which can be insulating to cover the frame 5046 (e.g., cover 240). Although many embodiments of the anchor portion described herein include a cloth or cover, such as cloth 5047 or cover 240, it should be noted that the anchor portion can be implemented without the cloth or cover, and in such embodiments, the bioimpedance technology described herein can be used with little or no modification to the disclosed anchor portion.

[0585] The electrode 5040 can take a variety of different forms. For example, the electrode 5040 can include one or more plates (e.g., covering most of the surface of the device, such as most of the surface of the arm), one or more tracks (rectangular thin strips along the length or width of the arm), one or more disks, one or more circles, etc. The electrode 5040 can be incorporated into a printed circuit board (PCB), including a flexible PCB, attached to the tissue engaging portion or hook 5030a, 5030b, 5030c.

[0586] In some embodiments, the electrode 5040 can be coupled to a first surface of the device (e.g., a surface of the first arm 5032 of the hook 5030a, 5030b, 5030c), coupled to a second surface of the device (e.g., a surface of the second arm 5034 of the hook 5030a, 5030b, 5030c), coupled to both the first surface and the second surface, and / or coupled to one or more other portions of the device.

[0587] In some embodiments, the electrode 5040 can be coupled to the fixed arm 5032 of the hooks 5030a, 5030b, 5030c, coupled to the movable arm 5034 of the hooks 5030a, 5030b, 5030c, coupled to both the fixed arm 5032 and the movable arm 5034, and / or coupled to one or more other parts of the device.

[0588] In some embodiments, the electrode 5040 can be releasably coupled to the first surface and / or the first arm 5032 (e.g., a fixed arm). In some embodiments, the electrode 5040 can additionally or alternatively be releasably coupled to the second surface and / or the second arm 5034 (e.g., a movable arm). In such embodiments, the electrode 5040 (e.g., a PCB, a lead, etc., incorporating the electrode 5040) can be removed after implantation of the device to which the electrode 5040 is coupled, as described in more detail herein.

[0589] In some embodiments, electrical leads can be coupled to the electrodes 5040. Furthermore, in some embodiments, the electrical leads can be removed after implantation of the device to which the electrodes 5040 are coupled, as described in more detail herein. The individual electrodes 5040 can be made of one or more individual conductor strips, tracks, disks, plates, etc. The electrodes 5040 can be made of any suitable conductive material.

[0590] In some embodiments, one or more electrodes 5040 can be positioned at or near a minimum acceptable or targeted tissue insertion depth (e.g., a leaflet insertion depth, etc.). In some embodiments, one or more electrodes 5040 can be positioned at or near a maximum acceptable or targeted tissue insertion depth. In some embodiments, one or more electrodes 5040 can be positioned at or near a minimum acceptable or targeted tissue insertion depth (e.g., a leaflet insertion depth, etc.), and can also be positioned at or near a maximum acceptable or targeted tissue insertion depth.

[0591] In some embodiments, an alternating current is applied to the electrode 5040, and one or more impedance measurements are performed and / or derived. For example, an electrical lead can be electrically coupled to the electrode 5040, as described herein, and the electrical lead can be used to apply a current or voltage to the electrode 5040. Similarly, the electrical lead can be used to measure an electrical signal associated with the electrode 5040 to determine an impedance characteristic and / or a change in the impedance characteristic. The applied voltage amplitude and / or the alternating current frequency can be changed. Different materials may have different impedance characteristics for different applied voltages or currents. Therefore, applying a varying voltage amplitude can achieve enhanced differentiation between different biomaterials placed in anchors, tissue engaging portions, hooks, etc.

[0592] In some embodiments, a voltage is applied, and one or more impedance characteristics are measured and / or determined. This can be done, for example, when the anchor or hook is closed. In some embodiments, a voltage is applied, and one or more impedance characteristics are measured and / or determined when the anchor or hook is open, partially open, or not fully closed. The measured impedance characteristics can then be used to determine the tissue state relative to the anchor, tissue engaging portion, hook, etc. For example, the tissue state can be fully inserted, minimally inserted, too little inserted, no insertion, insertion of the wrong tissue type, etc. In some embodiments, the configuration of the electrodes can determine the tissue state before closing the anchor, tissue engaging portion, hook, etc. This can advantageously avoid additional puncture of the leaflet by the barb during hook closure, as described herein. Thus, taking impedance measurements (e.g., measurements of electrical signals indicative of impedance and / or based on which impedance is calculated) to determine tissue state when the tissue engaging portion or hook is open, partially open, or not fully closed can be advantageous in confirming that tissue is properly positioned in the hook and / or confirming that another undesirable tissue (e.g., chordae) is not positioned in the anchor prior to closure of the anchor. Taking impedance measurements (e.g., measurements of electrical signals indicative of impedance and / or based on which impedance is calculated) to determine tissue state when the anchor, tissue engaging portion, hook, etc. is open, partially open, or not fully closed can prevent or inhibit the optional barb from piercing or penetrating tissue (e.g., leaflets, etc.) until it is confirmed that tissue is properly positioned in the anchor, tissue engaging portion, hook, etc. Taking impedance measurements to determine tissue status when an anchor, tissue engaging portion, hook, etc. is open, partially open, or not fully closed can help the user avoid capturing non-targeted tissue (e.g., tendons, etc.) in the anchor, tissue engaging portion, hook, etc. (e.g., avoiding closing the anchor, tissue engaging portion, hook, etc. when non-targeted tissue is located inside the anchor, tissue engaging portion, hook, etc.).

[0593] In some embodiments, one or more impedance characteristics measured and / or determined when an anchor, tissue engaging portion, hook, etc. is open, partially open, or not fully closed can be used to determine whether a target tissue (e.g., a leaflet) is within the anchor, tissue engaging portion, hook, etc. In such embodiments, the impedance characteristics measured or determined when an anchor, tissue engaging portion, hook, etc. is open, partially open, or not fully closed can also be used to generate an indicator (e.g., to an operator) that the target tissue is within the capture zone of the anchor, tissue engaging portion, hook.

[0594] In some embodiments, the measured and / or determined one or more impedance characteristics may be used to determine whether the target tissue has been over-inserted into an anchor, tissue engaging portion, hook, etc. and / or whether the target tissue is folded or bundled into an anchor, tissue engaging portion, hook, etc. In such embodiments, the measured or determined impedance characteristics may also be used to generate an indicator that the target tissue has been over-inserted, folded or bundled into an anchor, tissue engaging portion, hook, etc.

[0595] In some embodiments, the measured and / or determined one or more impedance characteristics can be used to determine whether non-targeted tissue has been captured in an anchor, tissue engaging portion, hook, etc. (e.g., a chordae tendineae have been accidentally captured). In such embodiments, the measured or determined impedance characteristics can also be used to generate an indicator that non-targeted tissue has been captured.

[0596] In some embodiments, the measured and / or determined one or more impedance characteristics can be used to determine whether the captured target tissue is skewed or angled in the anchor, tissue engaging portion, hook, etc. (e.g., one side of the leaflet is deeper in the tissue engaging portion or hook than the other side). In such embodiments, the measured or determined impedance characteristics can also be used to generate an indicator indicating that the captured tissue is angled or skewed relative to the anchor, tissue engaging portion, hook, etc.

[0597] In some embodiments, electrode 5040 can be included in the circuit together with AC power supply, electrical sensor and wiring or electrical lead.Sensor and power supply (for example, AC power supply, etc.) can be single device or separate device.Wiring connects electrode 5040 to power supply and electrical sensor to measure resistance, inductance, capacitance, voltage, current and / or impedance, impedance component, etc. in particular.As described herein, the electrical characteristics measured by the electrical sensor can be used to determine the position of the anatomical structure of the hook and / or contact with the hook based on the resistance, inductance, capacitance, voltage, impedance and / or current readings obtained by the sensor.The sensor can take a variety of different forms, including impedance meter.In some embodiments, the sensor is implemented in a PCB or other such components attached or coupled to the hook 5030a, 5030b, 5030c.In such embodiments, electrode 5040 and sensor can be integrated into the same PCB or other such components.

[0598] For example, it has been surprisingly discovered that when the electrical signal is measured during leaflet capture, the amplitude and shape of the electrical signal are different when the electrode 5040 contacts the leaflet or other portion of the heart valve (e.g., chordae tendineae). The electrical signal can distinguish the type of tissue contacted, as well as the degree of contact with the electrode 5040 (e.g., if the electrode is at the edge of the leaflet or near the root). Therefore, by placing electrodes on the device (e.g., on one or more of the devices 100, 200, 300, 40256, or other devices), the electrical signal can help the user determine whether the leaflet or other tissue is captured or partially captured in the device, whether the device is not capturing tissue, and / or whether the device is contacting the chordae tendineae or other portion of the heart valve (e.g., non-targeted tissue) instead of the leaflet (e.g., targeted tissue).

[0599] The electrodes 5040 measure electrical signals to help the user determine whether the device has captured or partially captured tissue (e.g., targeted tissue, leaflets, etc.). Each of the electrodes 5040 provides a signal in a material such as blood and / or in contact with a material (e.g., tissue) at different locations. For example, in some embodiments, the electrodes 5040 can provide a signal based on blood positioned in the atrium (and not in contact with tissue), based on blood positioned in the ventricle (and not in contact with tissue), based on contact with valve leaflet tissue, and / or based on contact with chordal tissue.

[0600] In some embodiments, three, four, five or more electrodes are included. Each hook 5030a, 5030b, 5030c can include any number of electrodes.

[0601] The electrical signal can take a variety of different forms and can be processed in a variety of different ways to determine the position of the device in the body (e.g., the position within the heart and / or the position of the leaflets relative to the device). In some embodiments, a bioimpedance signal is measured on an electrode 5040 as described herein. The bioimpedance signal can be divided into a real part and an imaginary part, as is well known in electrical engineering calculations. In addition, in some embodiments, when the power provided to the electrode 5040 is provided using an alternating current, the bioimpedance signal can also be represented by amplitude and phase. The bioimpedance signal can be analyzed to provide an indication of the position of the electrode 5040, and therefore provide an indication of the position of the tissue engaging portion or hook 5030a, 5030b, 5030c relative to the targeted tissue (e.g., the leaflets) and / or relative to other tissues or non-targeted tissues (e.g., chord tissue).

[0602] When measuring the bioimpedance signal, different signal readings correspond to different relative positions of the tissue (e.g., target tissue, leaflet, etc.) and the electrode 5040. For example, in some embodiments, if the leaflet contacts only one electrode, a bioimpedance signal reading of a lower amplitude can be generated. However, when the leaflet contacts two or more electrodes sufficiently, a bioimpedance signal reading of a higher amplitude can be generated, indicating that the device is correctly placed. This is because the leaflet blocks the current more than the blood. Therefore, the more the leaflet covers the electrode, the higher the impedance (e.g., a thicker leaflet will have a higher impedance). Therefore, the configuration of the electrode can be used to determine whether the target tissue is partially captured or is in the hook when the hook is open or not fully closed, whether the target tissue is skewed or angled relative to the hook, whether the target tissue is over-inserted or folded in the hook, and / or whether the non-target tissue has been captured in the hook. Examples of bioimpedance signals generated by different electrode and tissue configurations are described herein.

[0603] Figures 53A to 53F Anchors, tissue engaging portions or hooks with different electrode configurations are shown. Fig.53A and 53B An exemplary device 5100 is shown in which an anchor, tissue engaging portion or hook 5130 has electrodes 5140, 5145 located on an arm 5132 of the anchor, tissue engaging portion or hook 5130. The device 5100 can be the same or similar to any device described or incorporated herein (e.g., device 100, 200, 300, 8200, 8810, 40256, or another device). In addition, the tissue engaging portion or hook 5130 can be the same or similar to the hooks 130, 230, 330, 40856, 5030a, 5030b, 5030c (or other tissue engaging portions) described herein and share many of the same components (e.g., arms 5132, 5134, fixing members 5136, and joint portions 5138), properties, and functionality.

[0604] In some embodiments of the anchor, tissue engaging portion, or hook 5130, there are two electrode strips 5140, 5145 that fully or partially span the width of the first surface (e.g., the surface of the arm 5132). Thus, the electrodes 5140, 5145 provide bioimpedance signals corresponding to different amounts of tissue capture. A benefit of this type of configuration is that the hook 5130 can be configured to indicate that tissue capture is present when tissue (e.g., leaflets, etc.) contacts the electrodes 5140, 5145, even when the hook 5130 is in a capture-ready configuration (e.g., the hook 5130 is open or partially open).

[0605] Fig.53C and 53DAn exemplary device 5200 is shown in which an anchor, tissue engaging portion, or hook 5230 each has a first electrode 5240 positioned on a first surface (e.g., a surface of a first arm 5232) of the device (e.g., of the hook 5230 of the device, of another portion of the device, etc.) and a second electrode 5245 positioned on a second surface (e.g., a surface of a second arm 5234) of the device. The device 5200 can be the same or similar to any device described or incorporated herein (e.g., device 100, 200, 300, 8200, 8810, 40256, or another device). In addition, the tissue engaging portion or hook 5230 can be the same or similar to the hooks 130, 230, 330, 40856, 5030a, 5030b, 5030c (or other tissue engaging portions) described herein and share many of the same components (e.g., arms 5232, 5234, fixing members 5236 and joint portions 5238), properties and functionality.

[0606] In some embodiments of the tissue engaging portion or hook 5230, there are two electrode strips 5240, 5245 that completely or partially span the width of the respective surface and / or the width of the respective arms 5232, 5234. Thus, the electrodes 5240, 5245 provide bioimpedance signals corresponding to different sides of the leaflet or other tissue. The benefit of this type of configuration is that the tissue engaging portion or hook 5230 can be configured to indicate that there is no tissue or leaflet capture when the tissue engaging portion or hook 5230 is closed, which is at least in part due to the electrodes 5240, 5245 being shorted or in contact with each other, resulting in a substantially reduced impedance value relative to a configuration in which the electrodes 5240, 5245 are separated and / or in contact with the tissue.

[0607] Fig.53E and 53F An exemplary device 5300 is shown, wherein each tissue engaging portion or hook 5330 has a first electrode plate 5340 positioned on a first surface (e.g., surface of a first arm 5332) of the device (e.g., hook 5230) and a second electrode plate 5345 positioned on a second surface (e.g., surface of a second arm 5334) of the device. The device 5200 can be the same or similar to any device described or incorporated herein (e.g., device 100, 200, 300, 8200, 8810, 40256 or another device). In addition, the tissue engaging portion or hook 5230 can be the same or similar to the hook 130, 230, 330, 40856, 5030a, 5030b, 5030c (or other tissue engaging portion) described herein, and share many of the same components (e.g., arms 5332, 5334, fixing member 5336 and joint portion 5338), properties and functionality.

[0608] In some embodiments of the tissue engaging portion or hook 5330, there are two electrode plates 5340, 5345 that completely or partially cover the area of ​​the corresponding surface and / or the corresponding arm 5332, 5334. Therefore, the electrode plates 5340, 5345 provide bioimpedance signals corresponding to different capture depths of the leaflets or other tissues, and can provide detailed information about the relative capture depth of the leaflets or other tissues relative to other electrode configurations (e.g., the electrodes of the hooks 5130, 5230). The advantage of this configuration is that the tissue engaging portion or hook 5330 is configured to indicate the tissue capture depth when the tissue or leaflet is between the electrode plates 5340, 5345, and the tissue or leaflet acts as a dielectric. Similarly, another benefit of this configuration is that the hook 5330 is configured to indicate that there is no tissue or leaflet capture when the hook 5330 is closed, which is at least in part due to the electrodes 5340, 5345 being short-circuited or in contact with each other, resulting in a significant reduction in impedance values ​​relative to a configuration in which the electrodes 5340, 5345 are separated and / or in contact with the tissue.

[0609] Fig.54 An exemplary bioimpedance signal from a tissue engaging portion or hook having two or more electrodes to provide bioimpedance based feedback, such as hooks 5030a, 5030b, 5030c, 5130, 5230, and / or 5330, is shown. The exemplary bioimpedance signal is shown as a function of time, corresponding to an exemplary process of moving the device into position next to a leaflet and then grasping the leaflet, examples of which are described herein with reference to Figures 16 to 21 and 38 to 49. The different lines of the graph correspond to: fully captured leaflets ("Full"); over-captured leaflets ("Over"), which may cause the leaflets to partially fold within the hook; extremely over-captured leaflets ("xOver"), in which the length of the leaflets captured in the hook is about twice or more than twice the length of the hook, causing the leaflets to pile up on the hook; under-captured leaflets ("Under") (e.g., the leaflets are inserted between about 4 mm and about 5.9 mm); extremely under-captured leaflets ("xUnder") (e.g., the leaflets are inserted between about 1 mm and about 3 mm); and in which chordae tendineae are captured ("Chord"). In addition, a control bioimpedance signal ("Control") is shown, which corresponds to the bioimpedance signal when the leaflets are not captured.

[0610] The initial baseline portion of the graph corresponds to moving the device into position before the leaflets enter the hooks. An example of this configuration is shown in Fig.18 and 43 When the leaflet enters the open or partially open hook, the bioimpedance signal rises sharply. An example of this configuration is shown in Fig.19 and 44 When the hook is closed on the leaflet, the bioimpedance signal drops to a steady-state signal that is different from the baseline signal produced by an open hook without a leaflet in the hook. An example of this configuration is shown in Fig.19 , 20 and 45 in.

[0611] The amount of leaflet capture (or other tissue capture) can be determined based at least in part on a bioimpedance signal from electrodes on a tissue engaging portion or hook. Prior to capturing tissue (e.g., a leaflet), the bioimpedance signal is a steady-state (or substantially steady-state) signal, which can be referred to as an empty, open hook baseline. As the tissue or leaflet enters the open hook or other tissue engaging portion, the bioimpedance signal increases (as shown in contrast in the control signal, which does not increase because the leaflet does not enter the open hook). Fig.54 As shown, over-captured tissue ("over" and "extremely over-captured") produces a larger increase in the bioimpedance signal than fully captured tissue ("full") and under-captured tissue ("under" and "extremely under-captured"). Similarly, under-captured tissue ("under" and "extremely under-captured") produces a smaller increase in the bioimpedance signal than fully captured tissue ("full"). Therefore, based on the increase or change in the bioimpedance signal, the amount of tissue captured can be determined. In addition, as the hook closes, the bioimpedance signal drops to a steady-state value (or approximately steady-state), which can be referred to as a closed hook baseline. This change in bioimpedance value also provides information about the state of tissue capture and / or the state of the tissue engaging portion or anchor. For example, if the chordae are captured in the hook, a different bioimpedance signal distribution curve is generated relative to the hook that captures the leaflet. The increase in the bioimpedance signal in the "chordae" and "under-captured" cases is similar, but due to the different closed hook or leaflet capture portion baseline bioimpedance signals, it can be determined that the chordae are captured in the hook or leaflet capture portion.

[0612] As described herein, bioimpedance signals can be understood as the amount of resistance that reflects an electrical signal. Tissue type and the amount of tissue between electrodes can affect bioimpedance signals. For example, if the hook (or other tissue engaging portion) is closed without tissue between the electrodes, it is similar to a short circuit with very little resistance between the electrodes. This is why the control signal has the lowest impedance in the graph after the hook is closed. In the open position, there is no leaflet between the hooks, and the blood between the electrodes provides a low resistance electrical path. This is why each impedance signal in the graph has approximately the same open hook baseline. When tissue enters the hook, the amount of tissue in the hook (reflecting whether the leaflet is fully captured, over-captured or under-captured) affects impedance, where more tissue generally increases the amount of impedance of the electrical signal. In the case of hook closure, the amount of tissue in the hook also affects impedance, where more tissue generally increases the amount of impedance of the electrical signal. Therefore, the bioimpedance signal distribution curve (which includes impedance signals from different parts of the implantation process) can be analyzed to determine the state of leaflet capture of the hook. Thus, the bioimpedance signals acquired, measured, or determined using electrodes on the hook as described herein can be used to determine whether the targeted tissue is within the hook even before the hook closes, determine whether tissue has been over-inserted, determine whether non-targeted tissue is being or has been captured, and / or determine whether the targeted tissue is skewed or angled relative to the hook.

[0613] Fig.55 and 56 Shown from Fig.53C and 53D An exemplary bioimpedance signal of the tissue engaging portion or hook 5230 (which may be incorporated into any device herein). Fig.55 The top graph of shows the bioimpedance signal when the tissue engaging portion or hook 5230 is in an open position, and the bioimpedance signal changes relative to the insertion depth of the leaflet (or other tissue) in the hook 5230. Fig.55 The middle graph shows the increase in bioimpedance when the leaflet is fully inserted into the hook 5230. Fig.55 The bottom graph of shows the control signal where no leaflet (or other tissue) is inserted into the hook 5230, but the hook is closed and then opened. Fig.56 The top graph of shows the real (left) and imaginary (right) parts of the bioimpedance signal of a fully captured leaflet (or other tissue). Fig.56 The middle graph of shows the real (left) and imaginary (right) parts of the bioimpedance signal of an over-captured leaflet (or other tissue). Fig.56The bottom graph of shows the real (left) and imaginary (right) parts of the bioimpedance signal for an under-captured leaflet (or other tissue). The different lines in the graph correspond to various different measurements (e.g., using different leaflets) with a sample size of 4. This configuration of electrodes 5240, 5245 provides a relative binary output for the state of the leaflet or tissue (e.g., captured or not captured). As shown, the exemplary bioimpedance signal exhibits significant differences between complete leaflet capture, insufficient leaflet capture, and excessive leaflet capture, making the situation relatively clear for classification in the analysis.

[0614] In some embodiments, various algorithms can be implemented to analyze the bioimpedance signal of the tissue engaging portion or hook 5230. For example, a signal processing algorithm can be implemented. In such cases, some embodiments can generate a binary output, such as tissue contact or no tissue contact electrode. In such cases, some embodiments use multiple electrodes (e.g., arranged in an array), where the signals from each electrode or electrode pair can be compared with each other to determine the tissue state. For example, if six electrodes are evenly spaced on the inner paddle, and the leaflet is in contact with the outer four electrodes, but the leaflet is folded at the middle pair, then each outer pair has a signal similar to each other but different from the middle pair. Then, certain embodiments can use a user interface to display the electrodes (or the signals measured at the electrodes) to show the user the tissue state (e.g., folded leaflets), examples of which are described herein.

[0615] As another example of an algorithm, a threshold algorithm may be implemented that outputs an indication of an under-captured leaflet or a fully captured leaflet after the hook 5230 (or other tissue capture portion) has been closed. This is similar to a mechanical indication of leaflet capture, with the advantage that it provides a clearer user interface and is quick and simple to implement. As another example, a feature-based decision tree algorithm may be implemented that outputs an indication of an under-captured, over-captured, or fully captured leaflet after the hook 5230 is closed. This algorithm may be configured to distinguish between thick and thin leaflets and help avoid over-insertion of leaflets. This can reduce residual regurgitation and single leaflet device attachment (SLDA) complications. As another example, a feature-based random forest algorithm may be implemented that outputs an indication of an under-captured, over-captured, or fully captured leaflet when the hook 5230 is open and after the hook 5230 has been closed. This advantageously provides an indication of leaflet capture before closing the hook 5230, which provides confirmation of leaflet capture before the implant is released. Similar principles apply to capturing other types of tissue.

[0616] Fig.57 and 58 Shown from Fig.53E and 53FAn exemplary bioimpedance signal of the tissue engaging portion or hook 5330. Fig.57 The top graph in shows the bioimpedance signal as a function of leaflet capture depth with the tissue engaging portion or hook 5330 in the open position. This indicates that the electrode pads 5340, 5345 provide a signal that can be used to relatively accurately determine the leaflet capture depth due at least in part to the configuration of the electrode pads 5340, 5345. Fig.57 The bottom graph of shows the magnitude of the bioimpedance signal when the tissue engaging portion or hook 5330 is in the open position under various conditions, such as when the leaflet is gradually pulled out of the hook and when there is no leaflet inserted. The different lines in the bottom graph correspond to various different measurements (e.g., using different leaflets) for a sample size of 5. Fig.58 The top graph of shows the real (left) and imaginary (right) parts of the bioimpedance signal in the case of a fully captured leaflet. Fig.58 The middle graph shows the real (left) and imaginary (right) parts of the bioimpedance signal in the case of an over-captured leaflet. Fig.58 The bottom graph of shows the real (left) and imaginary (right) parts of the bioimpedance signal with under-captured leaflets. The different lines in the graph correspond to various different measurements (e.g., using different leaflets) for a sample size of 4. Similar principles apply to capturing other types of tissue.

[0617] Fig.59A and 59B An exemplary tissue engaging portion or hook 5930 having a combination of an electrode plate 5945 and electrode strips 5940, 5942 is shown. The tissue engaging portion or hook 5930 has electrode strips 5940, 5942 positioned on a first surface and / or first arm 5932 of the hook 5930 and an electrode plate 5945 positioned on a second surface and / or second arm 5334 of the hook (e.g., electrode strips 5940, 5942 and electrode plate 5945 above a cover 5947). The tissue engaging portion or hook 5930 can be implemented on any device described herein. In addition, the tissue engaging portion or hook 5930 can be the same or similar to the hooks 130, 230, 330, 40856, 5030a, 5030b, 5030c (or other tissue engaging portions) described herein and share many of the same components (e.g., arms 5932, 5934, fixing members 5936 and joint portions 5938), properties and functionality.

[0618] In the illustrated example of the tissue engaging portion or hook 5930, the electrode plate 5945 completely or partially covers the area of ​​the surface or arm 5934. In addition, the electrode strips 5940, 5942 extend parallel to the length of the surface or arm 5932 and cover a portion of the length of the surface or arm 5932, with spaces between the electrode strips 5940, 5942 along the width of the surface or arm 5932.

[0619] In some embodiments, the combination of the electrode plate 5945 and the electrode strips 5940, 5942 provides a bioimpedance signal corresponding to different capture depths of the leaflet, and can provide detailed information about the relative capture depth of the leaflet relative to the tissue engaging portion or hook 5130, 5230, 5330. For example, when the hook 5930 is open, the impedance between the electrode strips 5940, 5942 can be measured to determine the leaflet insertion depth. When the hook 5930 is closed, the impedance between each electrode strip 5940, 5942 and the electrode plate 5945 can be measured to determine the leaflet capture depth. Advantageously, this configuration provides a continuous signal related to the amount of the leaflet inserted when the hook 5930 is open. Advantageously, this configuration confirms the leaflet capture when the hook 5930 is closed. Advantageously, this configuration can distinguish different leaflet insertion scenarios (e.g., angled, skewed, twisted, partially inserted or under-inserted, fully inserted, over-inserted, etc.) due at least in part to the configuration of the electrode strips 5940, 5942 and the electrode plate 5945. For example, asymmetry in the bioimpedance signals from the electrode strips 5940, 5942 may indicate that the tissue is angulated or skewed in the hook 5930. Similar principles apply to capturing other types of tissue.

[0620] Figures 60A to 62C An exemplary tissue engaging portion or hook 6030 having electrode strips 6040, 6042 and an exemplary bioimpedance signal from the exemplary tissue engaging portion or hook 6030 are shown. Fig.60A and 60B A tissue engaging portion or hook 6030 is shown, which can be configured the same or similar to hook 230 (or another tissue engaging portion or hook herein), with a cover 6047 (similar to Fig.25 cover 240). Fig.60C Shows Fig.60B 6047. It should be noted that each of the tissue engaging portions or hooks and associated bioimpedance-based components described herein can be implemented with or without a cover, an example of which is exemplified by the hook 6030, which is shown in FIG. Fig.60B is shown as having a cover 6047 and in Fig.60C Shown without cover.

[0621] The tissue engaging portion or hook 6030 has electrode strips 6040, 6042 positioned on the first surface and / or the first arm 6032 (e.g., above the portion of the cover 6047 above the first arm 6032). The tissue engaging portion or hook 6030 can be implemented on any device described herein. In addition, the tissue engaging portion or hook 6030 can be the same or similar to the hooks 130, 230, 330, 40856, 5030a, 5030b, 5030c, 5930 (or other tissue engaging portions) described herein and share many of the same components (e.g., arms 6032, 6034, joint portions 6038, fixing members 6036, and electrode strips 6040, 6042), properties, and functionality.

[0622] In the illustrated example of the tissue engaging portion or hook 6030, the electrode strips 6040, 6042 extend parallel to the length of the arm 6032 and cover a portion of the length of the arm 6032 with spacing between the electrode strips 6040, 6042 along the width of the arm 6032. In this exemplary embodiment of the tissue engaging portion or hook 6030, the electrode strips 6040, 6042 are implemented above the cover 6047, but it should be noted that the electrode strips 6040, 6042 can be implemented below the cover 6047.

[0623] Fig.61A The top graph shows the real (left) and imaginary (right) parts of the bioimpedance signal of the hook 6030 when the leaflet is fully captured. Fig.61A The bottom graph shows the real (left) and imaginary (right) parts of the bioimpedance signal of the hook 6030 when the leaflet is over-captured. Fig.61B The top graph shows the real (left) and imaginary (right) parts of the bioimpedance signal of the hook 6030 when the leaflet is under-captured. Fig.61B The middle graph shows the real part (left figure) and imaginary part (right figure) of the bioimpedance signal of the hook 6030 when the leaflet is under-captured, particularly when 1 / 4 of the leaflet is under-captured. Fig.61B The bottom graph of 6010 shows the real part of the bioimpedance signal of the hook 6030 when the leaflet is under-captured (signal portion 6101), when the leaflet is fully captured (signal portion 6102), and when the leaflet is over-captured (signal portion 6103). Asymmetry in the bioimpedance signal from the electrode strips 6040, 6042 can indicate that the tissue is angulated or skewed in the tissue engagement portion or hook 6030. Similar principles apply to capturing other types of tissue.

[0624] Fig.62A and 62B An embodiment of a tissue engaging portion or hook 6230 is shown, which can be used with Fig.60A-C are identical or similar to the tissue engaging portion or hook 6030, except that the electrode strips 6240, 6242 are offset from the surface and / or edge of the arm 6032 (e.g., free edge, edge opposite the hinged end, etc.) by a specified distance d (e.g., about 6 mm). Fig.62C As shown in the graph of , this offset changes the bioimpedance signal distribution curve used for leaflet capture. Fig.62C The top graph shows the real part (left) and phase part (right) of the bioimpedance signal for a fully captured leaflet (signals 6201a, 6201b) and an over-captured leaflet (signals 6202a, 6202b). Fig.62C The bottom graph of shows the magnitude (left) and phase (right) portions of the bioimpedance signal for two full insertions (signal portions 6203a, 6203b, 6204a, 6204b) and one over-insertion (signal portions 6205a, 6205b) on an ex vivo beating heart. In this exemplary embodiment of the hook 6230, the electrode strips 6240, 6242 are implemented above the cover 6047, but it should be noted that the electrode strips 6240, 6242 can be implemented below the cover 6047. In some embodiments, no cover is used.

[0625] Various algorithms can be implemented to analyze the bioimpedance signals of the tissue engaging portion or hook 6030, 6230. These algorithms can include machine learning algorithms, such as neural networks and other machine learning algorithms. For example, a feature-based random forest algorithm can be implemented, which outputs an indication of insufficient, excessive or fully captured leaflets when the tissue engaging portion or hook 6030, 6230 is opened and closed. This algorithm can be configured to determine whether the leaflet is skewed or angled in the tissue engaging portion or hook 6030, 6230 and / or when only one electrode is covered. Advantageously, this provides an indicator before closing the hook 6030, 6230. As another example, another feature-based random forest algorithm can be implemented, which outputs a continuous leaflet insertion indicator when the hook 6030, 6230 is opened and closed. This advantageously provides a larger amount of information to the user and can be configured to distinguish between captured targeted tissue (e.g., leaflet capture) and captured non-targeted tissue (e.g., chord capture).

[0626] In some embodiments, the tissue engaging portion or hook 6030, 6230 may include a reference electrode (not shown). In some embodiments, the reference electrode may be similar to that described herein. Fig.64 A reference electrode is described, for example, the reference electrode may be part of the actuation element.

[0627] In some embodiments, the reference electrode can be a dedicated reference electrode in the blood, an electrode on a catheter, or an external patch on the patient's skin. In some embodiments, bioimpedance can be measured in three configurations: electrode A relative to electrode B (e.g., electrode 6040 relative to electrode 6042 or electrode 6240 relative to electrode 6242), electrode A relative to a reference electrode, and electrode B relative to a reference electrode.

[0628] In some embodiments, the reference electrode can be used to measure a bioimpedance-based signal that can provide detailed information about tissue contact on the tissue engaging portion or hooks 6030, 6230 by comparing two monopolar measurements from each electrode (e.g., electrode 6040 and electrode 6042 or electrode 6240 and electrode 6242). For example, if one electrode has a relatively high impedance indicating full insertion, but the other electrode indicates insufficient insertion, this means that the leaflet is inserted askew or at an angle. As another example, in the commissure region where most of the chordae tendineae are captured, each electrode 6040, 6042 or each electrode 6240, 6242 will show a different impedance, but both impedances will be too low to be confused with full leaflet capture.

[0629] In some embodiments, when bipolar impedance is measured, the comparison between leaflet and no leaflet / blood is amplified at least in part due to both electrodes contacting the leaflet and / or blood simultaneously. This provides a more pronounced indication of leaflet insertion, which may be more pronounced when the leaflet is inserted directly into the tissue engaging portion or hook and the device or implant is perpendicular to the free edge of the leaflet.

[0630] The electrode configuration of the exemplary tissue engaging portion or hook 6030 may be beneficial, at least in part due to the fact that the electrode strips 6040, 6042 provide a continuous indication of leaflet insertion (which may be substantially linear) over the length of the entire tissue engaging portion or hook 6030. This can be decomposed into a quantitative signal area indicating, for example, four categories of leaflet insertion: no leaflet, insufficient insertion, complete insertion, and excessive insertion. In some embodiments, the average measurement of the electrode strips 6040, 6042 can be used to determine the label or category of leaflet insertion. The electrode configuration of the tissue engaging portion or hook 6230 may be beneficial because the signal changes little or no before the leaflet reaches the edge of the electrode strips 6242, 6240 within the hook 6230 (which is already a distance d). The distance d can be configured to indicate a favorable distance that is sufficient to achieve a sufficient insertion distance for good leaflet capture. For example, in certain embodiments, the distance d may be about 6 mm or between about 4 mm and about 8 mm. Comparing this to hook 6030, the indication of leaflet insertion can be divided into 3 categories, combining the no leaflet insertion indicator with the under-insertion indicator, as there may not be enough signal to distinguish between no leaflet insertion and under-insertion of a leaflet with hook 6230.

[0631] In some embodiments, a machine learning or other algorithm can be implemented that automatically determines tissue or leaflet status based on the bioimpedance signals from the electrodes. For example, an algorithm can be implemented in conjunction with the hook 6030 that will be used with the Fig.61B The signal consistent with signal 6101 is interpreted as corresponding to the absence of tissue / lobule in the hook, which will be Fig.61B The signal 6102 is interpreted as corresponding to complete tissue / leaflet insertion and will be consistent with Fig.61B The signal 6103 is interpreted as a signal corresponding to over-insertion of tissue / leaflet. The algorithm can also be used to generate indicators for the user. For example, Fig.62D It is shown that a delivery system 6206 (similar to the delivery systems 102, 202 described herein) can include an indicator panel 6207 on the proximal end of the delivery system 6206. The indicator panel 6207 includes lights or other indicators that indicate no leaflet in the hook, complete leaflet capture, and over-insertion of the leaflet. The user can visually inspect the indicator panel 6207 to determine the leaflet status, rather than relying solely on echography or other imaging techniques.

[0632] Fig.63A and 63BAn exemplary device 6300 is shown in which each tissue engaging portion or hook 6330 has a first electrode 6340 positioned on a first surface and / or first arm 6332 of the tissue engaging portion or hook 6330 and a second electrode 6345 positioned on a second surface and / or second arm 6334 of the tissue engaging portion or hook. The device 6300 can be the same or similar to the devices 100, 200, 300, 8200, 8810, 40256, 5200 described herein. In addition, the tissue engaging portion or hook 6330 can be the same or similar to the hooks 130, 230, 330, 40856, 5030a, 5030b, 5030c (or other tissue engaging portions) described herein and share many of the same components (e.g., arms 6332, 6334, fixation members 6336, and joint portions 6338), properties, and functionality.

[0633] In the illustrated example of the tissue engaging portion or hook 6330, there are two opposing electrodes 6340, 6345 coupled to the first surface or first arm 6332 and the second surface or second arm 6334 (or coupled to another portion of the device in an embodiment without a second arm), respectively. Thus, the electrodes 6340, 6345 provide bioimpedance signals corresponding to different sides of the leaflet or other tissue. The benefit of this type of configuration is that the hook 6330 can be configured to determine the thickness of the tissue between the electrodes 6340, 6345, and scan the tissue thickness as the tissue passes through the hook 6330 between the electrodes 6340, 6345. In addition, this configuration of the electrodes 6340, 6345 provides a benefit similar to that of the hook 5230 in that it can be configured to indicate that there is no leaflet or tissue capture when the hook 6330 is closed, which is at least in part due to the electrodes 6340, 6345 being shorted or in contact with each other, resulting in a substantially reduced impedance value relative to a configuration in which the electrodes 6340, 6345 are separated and / or in contact with the tissue.

[0634] In some embodiments, the first electrode can be coupled to the arm and the second electrode or opposing electrode can be coupled to another portion of the device (eg, if the second arm is not included).

[0635] For example, opposing electrodes 6340, 6345 can be positioned on each side of the leaflet as it enters the tissue engaging portion or hook 6330, and can effectively scan the leaflet as it passes the electrodes 6340, 6345. Signals acquired as the tissue / leaflet passes between the electrodes 6340, 6345 can be used to generate a cross-sectional view of the thickness of the tissue / leaflet. In some embodiments, these signals are acquired when the hook 6330 is partially closed, so that the electrodes 6340, 6345 are close to the tissue / leaflet.

[0636] In some embodiments, the thickness of the leaflet tissue can be used by the operator to estimate or determine the strength of the leaflet. The thickness and strength of the leaflet can indicate how much tension can be applied to the leaflet and / or whether the leaflet needs to be fully inserted into the hook for secure capture. For example, stronger leaflet tissue can withstand higher forces, and the barbs of the hook 6330 can be better retained in the stronger tissue relative to weaker tissue. Advantageously, this can produce less stenosis and more coaptation.

[0637] Fig.64 An exemplary device 6400 is shown in which a tissue engaging portion or hook 6430 is provided with a Fig.53A and 53B The device 5100 of the tissue engaging portion or hook 5130 of the present invention similarly has electrodes 6440, 6445. The device 6400 can be the same or similar to the devices 100, 200, 300, 8200, 8810, 40256, etc. described herein. In addition, the tissue engaging portion or hook 6430 can be the same or similar to the hooks 130, 230, 330, 40856, 5030a, 5030b, 5030c (or other tissue engaging portions) described herein and share many of the same components (e.g., arms 6432, 6434, fixing members 6436, and joint portions 6438), properties, and functionality.

[0638] In some embodiments of the device 6400, an additional reference electrode 6442 is implemented on the device 6400. This configuration can provide increased sensitivity because the reference electrode 6442 is near the sensing electrodes 6440, 6445. The reference electrode 6442 or a similar reference electrode can be implemented on any device described herein to provide a bipolar measurement of bioimpedance. A bipolar configuration includes a measurement configuration in which the sensing electrode and the reference electrode are located in the same region, such as the heart. This can be compared to a monopolar configuration in which the reference electrode is located in a different region than the sensing electrode (e.g., where the sensing electrode is in the heart and the reference electrode is on the patient's skin).

[0639] Fig.65 An example of the device 200 is shown in which flexible electrodes 6545a-6545b are added that protrude distally from the device 200. Figures 22 to 37The device 200 is described in more detail. The flexible electrodes 6545a to 6545b are configured to measure blood flow and / or detect leakage through a valve in which the device 200 is implanted. The flexible electrodes 6545a to 6545b deflect when blood flows through them, wherein the amount of deflection is related to the pressure difference or flow rate. When the flexible electrodes 6545a to 6545b deflect, the impedance relative to the reference electrode 6542 (e.g., on the actuator 212) changes, and the change can be used to determine the amount of deflection, which in turn can be used to determine the relative blood flow adjacent to the device 200. For example, the amount of reflux blood pushes the flexible electrodes 6545a, 6545b toward the atrium and brings it closer to the reference electrode 6542, which reduces the impedance. The amount of deflection (measured by the impedance change) can be used as a pressure sensor on either side of the device 200, so that the measurement can be used to determine whether there is a reflux amount adjacent to the device 200.

[0640] This is advantageous because the typical method for quantifying leaks in percutaneous procedures is through echo-based imaging. However, if there are no echoes of sufficient quality, it may be difficult to determine if a leak exists after the device 200 is deployed. Many things may affect the quality of echo imaging, including but not limited to shadowing or ringing by metal in the device. Therefore, bioimpedance measurements may advantageously provide an additional or alternative method for determining or monitoring leaks across a valve.

[0641] In some embodiments, the device 200 may include flexible electrodes in addition to the flexible electrodes 6545a-6545b dispersed around the device 200 to monitor for leaks. The flexible electrodes 6545a-6545b may have a predetermined size and weight so that the force on the flexible electrodes 6545a-6545b may be determined based on the deflection of the electrodes 6545a, 6545b.

[0642] The amount of deflection can be determined using the bioimpedance measurements described herein, at least in part because the flexible electrodes 6545a, 6545b act like a spring in which the force is proportional to the deflection. Once the force or pressure of the blood is calculated, the flow rate can be calculated based on Bernoulli's equation. In some embodiments, the amount of regurgitation can also be calculated based on the size of the orifice (e.g., determined in the echo).

[0643] In some embodiments, bioimpedance measurements can be used to determine the force on the device / implant. For example, the frame of the device can act as a spring. Before deployment and / or implantation, a force can be applied to the device, and the deflection can be measured to determine the response of the device to a known force. In addition, impedance measurements can be performed when the device is deflected by a known amount. Therefore, the measured impedance can be related to the force on the device through the relationship between the opening distance of the device and the measured impedance. When the hook is closed, the patient can be calibrated using the impedance value at the baseline, and then the baseline change is measured after the device is released to calculate the force during contraction and relaxation. This measurement can be used for verification and testing during design and manufacturing or during deployment, where the force indicates whether the possibility of single leaflet device attachment (SLDA) is high. In addition, the electrodes on the device can act as implantable sensors that monitor the force during the service life of the implant. Measurements can also be made to determine the tension of the leaflets that pull the closed implant apart. If the tension is high enough, such measurements can be used to predict the risk of leaflet damage or SLDA. In addition, when more tension is applied, these measurements can be related to stenosis, higher pressure gradients, and / or slippage of the leaflets during implant closure. Such measurements can also provide an indication of whether the device is completely closed.

[0644] In addition, in embodiments where forces on either side of the implant are measured, asymmetry can indicate asymmetric tension on the leaflet, indicating that the delivery device is likely distorting the leaflet, and when the device / implant is released, the clinical outcome of the treatment may potentially change. Asymmetric forces may be undesirable because they may cause changes in the alignment or other properties of the implant device when the device is released from the delivery system. Symmetrical forces are expected to reduce or eliminate performance changes of the device / implant after release from the delivery system. Therefore, it may be desirable to be able to measure and / or monitor the forces on the device / implant.

[0645] Example Configuration of Impedance Measurement System

[0646] As described herein, the configuration and placement of electrodes on the device (e.g., on the anchors, tissue engaging portions, hooks, etc. of the device) can provide many different advantages because it is suitable for feedback measurements based on bioimpedance. However, the electrical wiring of sensors and electrodes in the catheter may be difficult, which is at least partially due to the limited space in the catheter. If it is desired to include multiple sensors or electrodes, a typical solution will require wiring for each electrode along the length of the catheter. However, the limited inner diameter of the catheter can limit the number of wires that can extend from the proximal end of the catheter or other delivery system to the electrode, thereby limiting the number of electrodes that can be used at the device or implant. This will result in a reduction in the amount of information or the accuracy of the bioimpedance measurement obtained with the electrodes. In addition, increasing the number of electrical leads extending to the device will make the manufacture of the device and delivery system very complicated.

[0647] therefore, Fig.66A and 66B An exemplary electrode array is shown that reduces the number of electrical leads required to enable them to fit into a small lumen catheter. Fig.66A An exemplary tissue engaging portion or hook 6630a is shown, which can be the same or similar to hooks 130, 230, 330, 40856, 5030a, 5030b, 5030c (or other tissue engaging portions) described herein, wherein a series of electrodes 6640a to 6640f are coupled to arms 6632, 6634 of the hook 6630a, wherein a connector portion 6638 couples the arms 6632, 6634 to each other. One or more of the electrodes and / or electrode arrays may optionally be implemented on other surfaces and / or portions of the device (e.g., not necessarily the arms).

[0648] In some embodiments, the electrical lead 6646 couples the electrodes 6640a to 6640f in series with one or more electrical components 6643a to 6643e coupled in series between each electrode 6640a to 6640f. In some embodiments, the electrical lead 6646 then extends through a delivery device to deliver an electrical signal to achieve bioimpedance measurement.

[0649] In some embodiments, the electrodes are coupled in parallel, and each electrode has an electrical lead, which electrically couples the corresponding electrode to the measurement system at the proximal end of the delivery system. In some embodiments, the tissue engaging portion or hook 6630a includes an electrical lead 6646 with an electrical component 6643a to 6643e, which is coupled in series with electrodes 6640a to 6640f to achieve the individual measurement of each electrode without the need for the electrical lead of each electrode. In some embodiments, this is achieved by using a resistor, capacitor and / or inductor with a known and fixed value as an electrical component 6643a to 6643e connected in series between each electrode 6640a to 6640f. By using an electrical component with different properties, the impedance measurement from each electrode can be determined individually using electrical leads 6646. For example, even if electrodes 6640a to 6640f are coupled in series, the measured bioimpedance value can also be separated because the current through the electrical lead 6646 and its frequency are known. From the measured impedance, it is possible to calculate the resistance, capacitance and / or inductance and subtract the known values ​​of the electrical components inserted in series. Thus, it is possible to determine the measured impedance from the electrodes as if the electrodes were coupled in parallel.

[0650] Fig.66BAn exemplary hook 6630b having a plurality of electrodes 6640a to 6640f and an analog-to-digital converter (ADC) chip 6643 coupled to each electrode 6640a to 6640f is shown. The ADC chip 6643 is configured to convert the signals from the electrodes 6640a to 6640f into digital signals that can be sent via electrical leads 6646 using digital packets, thereby isolating each electrode signal using a digital data transmission protocol.

[0651] Fig.67A An example of a bioimpedance signal 6706 having oscillations corresponding to the diastole and contraction of the heart is shown. Changes in contact between the electrode and the tissue caused by fluctuations caused by the beating of the heart may cause oscillations in the measured bioimpedance signal 6706. A signal processing algorithm may be implemented that uses the oscillations of the bioimpedance signal (e.g., the peak-to-peak amplitude of the bioimpedance signal) and the average value to determine the tissue state relative to the hook or anchor. For example, when there are relatively high peak-to-peak oscillations, it may be determined or concluded that there is not ideal contact between the hook and the tissue. When more tension is applied, the tissue is better in contact with the tissue engaging portion (e.g., anchor, hook, etc.), and the peak-to-peak oscillations decrease, while the amplitude of the average signal increases. This can be used to generate, for example, the following binary determinations: no tissue contact in time period 6710, tissue contact during time period 6715, and no tissue contact during time period 6720.

[0652] The bioimpedance concepts described above with respect to tissue capture may also be applied to various medical systems, devices, and procedures. In some embodiments, the bioimpedance concepts described herein may also be applied to anchor deployment of anchors for various medical systems and devices in various medical procedures. For example, annuloplasty procedures (e.g., annulus reduction) may benefit from the measurement of bioimpedance signals. Various indications of anchor placement and / or tissue engagement would be valuable and improve procedures and safety.

[0653] In some embodiments, when anchors of a transcatheter annuloplasty system / device are implanted at or around the annulus, bioimpedance signals may be monitored to determine the deployment status of each anchor and / or associated device (eg, annuloplasty implant).

[0654] Fig.67BAn example of a bioimpedance signal is shown when a delivery device implants a tissue anchor (e.g., a helical tissue anchor, a dart anchor, a hook anchor, etc.) at the annulus of a native valve. The bioimpedance signal indicates contact with the tissue (signal portions 6701, 6702), partial and complete deployment or insertion into the tissue (signal portions 6703 and 6704, respectively), and removal of the delivery device (signal portion 6705). In some embodiments, the bioimpedance signal represents a single anchor deployed or inserted into the tissue, and this process can be repeated sequentially for each anchor to be deployed (e.g., 5 to 25 anchors, 10 to 20 anchors, 12 to 17 anchors, etc.) (or if the anchors are deployed simultaneously, each anchor can be analyzed simultaneously). In some embodiments, the bioimpedance signal can indicate a situation where all anchors are electrically shorted together.

[0655] In some embodiments, the disclosed medical systems, devices, and surgeries utilize one or more anchors (e.g., helical anchors, darts, hooks, clasps, clamps, barbs, arms, etc.). An individual anchor may include one or two or more than two electrodes. Electrical signals may be provided to the electrodes, and one or more electrical sensors may be configured to measure various electrical signals, including bioimpedance signals. When the anchor is implanted in the tissue, the bioimpedance signal decreases, similar to a short circuit. In vitro measurements may be performed, and these measurements may be used to determine the anchor depth based on or in response to electrical signals from the anchor deployed in vivo. Thus, the anchor depth may be determined based on in vitro measurements and based on electrical signals from the anchor when the anchor is implanted. This is enhanced by changes in impedance as the anchor moves from the blood to the tissue. Thus, an indicator may be determined and provided to the user to indicate when the tissue has been contacted and the depth of penetration of the anchor in the tissue. The indicator can be configured to indicate the anchor deployment status, including anchors in contact with tissue, partially deployed anchors, and fully deployed anchors. In some embodiments, amplitude modulation can be used when considering the length of the DFT wire connected between anchors as a resistor. This can be used to monitor continuous anchor deployment.

[0656] In some embodiments, an anchor having two electrodes is configured to facilitate monitoring of bioimpedance. This can be used to monitor anchoring of the anchor to indicate successful and / or complete penetration of the anchor into the tissue. An impedance measuring device (e.g., Fig.68An impedance measuring device) can be coupled to the proximal end of the anchor driver or the anchor driver. The impedance measuring device can be configured to use a bipolar connection in a manner that isolates the positive lead and the negative lead from each other but still resides in the same area (e.g., the heart). This configuration can provide increased sensitivity because the reference electrode is near the sensing electrode. Advantageously, this reduces noise relative to systems that measure electrical signals through a large amount of tissue (e.g., relative to a unipolar configuration). The algorithm can be implemented with intelligent thresholds that can be applied to the electrical signals from the impedance measuring device. The algorithm can generate a real-time indicator that can be provided to the user to indicate when the catheter or anchor is in contact with the tissue and / or is partially or completely deployed in the tissue. It should be noted that the electrical measurements described herein can be unipolar (e.g., with electrodes on the skin or electrodes away from the measurement site) or bipolar (e.g., where the reference electrode is very close to the measuring electrode).

[0657] Fig.68 An exemplary bioimpedance signal measurement system 6850 is shown, which includes a device 6800 (e.g., an implantable device, a delivery device, a treatment device, etc.) and an impedance measurement device 6860. The impedance measurement device 6860 may include a power source 6862 and an electrical sensor 6864. The device 6800 may include an electrode 6840 configured to receive power from the power source 6862. Wiring connects the electrode 6840, the power source 6862, and the electrical sensor 6864. The device 6800 can be any of the devices described herein, such as devices 100, 200, 300, 5100, 5200, 5300, 6300, 6400, 8200, 8810, an annuloplasty implant, a stent, a valve, a prosthetic valve, a delivery device, an anchor driver, a chord repair device, etc.

[0658] In some embodiments, the electrode 6840 is coupled to one or more anchors of the device 6800. In some embodiments, the electrode 6840 is coupled to a hook, such as hooks 130, 230, 330, 40856, 5030a, 5030b, 5030c (or other tissue engaging portions) described herein.

[0659] The electrical sensor 6864 is configured to measure electrical signals from the electrode 6840, such as a bioimpedance signal, voltage, current, etc. The electrical sensor 6864 may be configured to measure other electrical properties, such as, but not limited to, resistance, inductance, capacitance, voltage, current, impedance components, etc. The bioimpedance measurements (and resistance, inductance, capacitance, voltage, and / or current readings) obtained by the electrical sensor 6864 may vary based on one or more anatomical structures that the indicator electrode 6840 is proximate to or in contact with. Thus, the electrical characteristics measured by the electrical sensor 6864, particularly the bioimpedance signal, may be used to determine the relative position of the hook, anchor, other device components, etc., and the anatomical structure (e.g., tissue, etc.) that the device is in contact with, as described herein. For example, the value of the bioimpedance signal and / or changes in bioimpedance may signal that the electrode is in blood, in contact with tissue (e.g., lobule), differentiates tissue (e.g., lobule tissue versus chordal tissue), transitions from primarily in contact with blood to partially or primarily in contact with tissue, and / or transitions from partially or primarily in contact with tissue to primarily in contact with blood.

[0660] The power supply 6862 and the electrical sensor 6864 may be separate devices or combined in a single device. The power supply 6862 may be configured to provide alternating current to the device 6800. The electrical sensor 6864 may take a variety of different forms, including an impedance meter. By controlling the alternating current and measuring the voltage, the impedance may be calculated. The impedance may be used to determine the position of the electrode relative to the target tissue (e.g., the annulus, leaflet, etc. of the valve). The impedance measuring device 6860 may implement any algorithm described herein to indicate the state of the device 6800 or its components (e.g., hooks or anchors), which may include: fully captured leaflets, insufficient leaflet capture, excessive leaflet capture, relative position of leaflets in the hooks, the state of the hooks (e.g., open, closed, etc.), the state of the anchors (e.g., partially deployed, fully deployed, in contact with tissue, etc.), or any combination of these, etc. The algorithm may include a machine learning algorithm, such as a neural network, a decision tree algorithm, a random forest algorithm, a threshold-based algorithm, etc. Thus, the impedance measurement device 6860 may include one or more processors and non-volatile memory configured to store and execute one or more algorithms to determine a target quantity based at least in part on measurements provided by the electrical sensor 6864. In some embodiments, indicators derived from the impedance measurement device 6860 may be displayed or otherwise provided to a user or a partially or fully automated system to provide bioimpedance-based feedback for a medical procedure.

[0661] Remove the impedance measurement sensor from the device

[0662] As described herein, it is advantageous to use bioimpedance-based feedback in medical procedures (e.g., implanting a device in a valve). For example, bioimpedance-based feedback can be used to determine leaflet insertion. To this end, in some embodiments, an electrode or sensor is coupled to a device disclosed herein (e.g., an anchor, a tissue engaging portion, a hook, etc. of the device), wherein an electrical lead is directed from the electrode to the proximal end of the delivery system to achieve acquisition and measurement of a bioimpedance signal. However, it is also desirable to disconnect the electrode from the electrical lead or remove the electrode (or sensor) and the electrical lead after implanting the device (e.g., so that after the operation, the wire does not work in the implant). Therefore, methods and devices for facilitating the removal of electrodes from the device and disconnecting the electrical lead are disclosed herein. In addition, methods and devices for removing electrodes or sensors from the device after the device has been implanted are disclosed herein. In addition, methods and devices for connecting a flexible PCB (which may include electrodes and / or other sensors of various embodiments described herein) to a device are disclosed herein, so that it can be easily removed from the proximal side of a delivery system (e.g., a catheter) during transcatheter surgery.

[0663] The use of PCBs (including flexible PCBs) is advantageous because it allows for detailed design in both the shape and number of electrodes. The PCB may include an electrode array that further enables the acquisition of many bioimpedance measurements. With a larger amount of measurements and data, machine learning and other such algorithms can be used that provide more useful and accurate indicators associated with the implantation process (e.g., leaflet capture, leak detection, force monitoring, etc.). In addition, the non-conductive portion of the PCB may be designed to achieve certain purposes, such as enabling the removal of the PCB as part of the implantation process. This may also be advantageous because there are challenges associated with making the flexible PCB biocompatible, meaning that it may not be desirable to leave the flexible PCB in the patient as part of the device.

[0664] Although the examples shown and described herein generally focus on examples of flexible PCBs, other arrangements, configurations, arrays, sensors, electrodes, conductors, leads, wires, etc. may be used and / or connected in a similar manner even if a PCB itself is not used (i.e., while a PCB is advantageous, the concepts herein do not require a PCB, even if a PCB is used as an example in various embodiments herein).

[0665] Figures 69 to 74 Various configurations of connecting the flexible PCB, electrodes, electrode arrays, sensors, etc. to the device are shown, which allow for easy removal of the flexible PCB, electrodes, electrode arrays, sensors, etc. Fig.69A portion of an exemplary flexible PCB 6900 having a stress concentration point 6902 in the flexible PCB 6900 is shown. A suture 6910 can be looped over the stress concentration point 6902 to secure the flexible PCB 6900 to a device (e.g., the devices 100, 200 described herein). The stress concentration point 6902 is configured so that a relatively small applied force will cause the stress concentration point 6902 to tear. In the event that the stress concentration point 6902 tears, the flexible PCB 6900 can be removed because the suture 6910 no longer secures the PCB to the device, although the suture 6910 remains secured to the device.

[0666] Fig.70 A portion of a flexible PCB 7000 is shown having a Y-shaped protrusion 7002 extending from one end of the flexible PCB 7000. The protrusion 7002 includes legs 7004 having rotational cutouts 7006 configured to enable the legs 7004 to rotate toward each other when force is applied to the legs 7004. Sutures 7010 are looped over bridge portions 7008 of the protrusion 7002 to secure the flexible PCB 7000 to the device. When the flexible PCB 7000 is pulled in the direction of arrow 7011, the protrusion 7002 moves downward toward the sutures 7010. With sufficient force applied, the legs 7004 rotate toward each other to allow the flexible PCB 7000 to be detached from the device while the sutures 7010 remain attached to the device. The wider portion 7001 of the flexible PCB 7000 is such that only force in the direction indicated by arrow 7011 will cause the suture 7010 to pass over the protrusion 7002 to release the flexible PCB 7000 from the device.

[0667] Fig.71 A portion of a flexible PCB 7100 is shown having a circular protrusion 7102 extending from a body 7101 of the flexible PCB 7100. Sutures 7110 are looped over a neck portion 7104 of the circular protrusion 7102 to secure the flexible PCB 7100 to the device. The circular protrusion 7102 can be configured to be folded or wrapped over a side of the device (e.g., around a side of the hooks 130, 230). By pulling away from the device (e.g., pulling out of the plane of the drawing), the circular protrusion 7102 allows the sutures 7110 to pass over the circular portion to release the flexible PCB 7100 from the device while allowing the sutures 7110 to remain attached to the device.

[0668] Fig.72A portion of a flexible PCB 7200 is shown having a side recess 7202 to facilitate securing a suture 7210 over the flexible PCB 7200 and to a device to secure the flexible PCB 7200 to the device. The side recess 7202 is configured to provide a positive lock at a targeted location of the flexible PCB 7200 so that the suture 7210 does not interfere with measurements taken by electrodes incorporated into the flexible PCB 7200. The size and configuration of the side recess 7202 affect the amount of force required to pull the flexible PCB 7200 out from under the suture 7210. Pulling parallel to the length of the flexible PCB 7200 causes the flexible PCB 7200 to pass under the suture 7210 so that it can be removed while allowing the suture 7210 to remain attached to the device.

[0669] Fig.73 A portion of a flexible PCB 7300 is shown in which a hole 7302 (e.g., a circular hole) is formed with a release 7303. The flexible PCB 7300 can be fixed to the device using one or more sutures 7310a, 7310b. The release 7303 is cut through the end of the flexible PCB 7300 so that when a force is applied to pull the flexible PCB 7300 away from the end with the hole 7302, the sutures 7310a, 7310b can leave the hole 7302. In some embodiments, the release 7303 only partially passes from the hole 7302 to the end of the flexible PCB 7300. The length of this bridge can be configured to adjust the force required to remove the flexible PCB 7300 from the device.

[0670] Fig.74 A portion of a flexible PCB 7400 is shown forming a pair of bi-directional tongues 7402a, 7402b. 6. The bi-directional tongues 7402a, 7402b form tabs that allow sutures 7410a, 7410b to pass underneath to secure the flexible PCB 7400 to the device. This configuration facilitates assembly of the device with the flexible PCB 7400 because the sutures 7410a, 7410b can be implemented in a fabric implant cover and then the flexible PCB 7400 can be added with the sutures 7410a, 7410b woven through the tongue flaps of the bi-directional tongues 7402a, 7402b to lock the flexible PCB 7400 to the device. In some embodiments, the depth of the tongue flap affects the force required to pull the PCB out. It should be noted that for reference herein, Figures 69 to 74 In each of the described flexible PCBs, the flexible PCB may be attached above the cover of the device (e.g., sutures are attached to the cover) or below the cover of the device (e.g., sutures are attached to the frame). However, in any embodiment, a cover is not required, and the flexible PCB can be attached to the device in a variety of ways.

[0671] Fig.75A ,75B 75C shows a PCB 7500 configured to be pulled through the barbs 236 of the device 200 (or any other device described herein, such as ...

Claims

1. A device comprising: a tissue engaging portion comprising a first surface and a second surface, the tissue engaging portion being configured such that the first surface and the second surface can be closed or moved closer together to capture tissue in the tissue engaging portion, at least one of the first surface and the second surface being movable to form a capture zone between the first surface and the second surface to capture the tissue; and two or more electrodes, the two or more electrodes coupled to the tissue engaging portion, The device is configured such that: An electrical signal can be applied to the two or more electrodes, and A bioimpedance signal can be measured in response to the applied electrical signal, the bioimpedance signal providing an indication of a state of the tissue within the tissue engaging portion.

2. The device of claim 1, wherein the condition comprises insufficient insertion of tissue into the tissue engaging portion.

3. The device of any one of claims 1 to 2, wherein the state comprises complete insertion of tissue in the tissue engaging portion.

4. The device of any one of claims 1 to 3, wherein the condition comprises over-insertion of tissue into the tissue engaging portion.

5. The device of any one of claims 1 to 4, wherein the state comprises angled insertion of tissue in the tissue engaging portion.

6. The device of any one of claims 1 to 5, wherein the state comprises insertion of non-targeted tissue in the tissue engaging portion.

7. The device of claim 6, wherein the non-targeted tissue comprises chordae tendineae.

8. The device of any one of claims 1 to 7, wherein the state comprises insertion of tissue in the tissue engaging portion while the tissue engaging portion is in an open configuration comprising the first surface and the second surface separated from each other.

9. An apparatus according to any one of claims 1 to 8, wherein the indication of the status is configured to generate a visual indicator of the status for a user.

10. The device of claim 9, wherein the visual indicator is configured to indicate one or more of no tissue insertion, insufficient tissue insertion, complete tissue insertion, and excessive tissue insertion.

11. An apparatus comprising: a tissue engaging portion comprising a first arm and a second arm, the first arm and the second arm being configured such that the first arm and the second arm can be closed or moved closer together to capture tissue in the tissue engaging portion, at least one of the first arm and the second arm being movable to form a capture zone therebetween to capture the tissue; and two or more electrodes, the two or more electrodes coupled to the tissue engaging portion, The device is configured such that: An electrical signal can be applied to the two or more electrodes, and The bioimpedance signal can be measured based on or in response to the applied electrical signal.

12. The device of claim 11, wherein the two or more electrodes comprise: a first electrode strip coupled to the first arm of the tissue engaging portion proximate a first edge of the first arm; and a second electrode strip coupled to the first arm of the tissue engaging portion proximate a second edge of the first arm, the second edge being opposite the first edge, The first electrode strip and the second electrode strip are parallel to each other and extend along the length of the first arm.

13. The device of claim 12, wherein the first electrode strip and the second electrode strip are offset a specified distance from a free edge of the first arm of the tissue engaging portion.

14. The device of claim 13, wherein the specified distance is at least 6 mm.

15. The device according to any one of claims 12 to 14, wherein a first bioimpedance signal can be measured based on an electrical signal applied to the first electrode strips, and a second bioimpedance signal can be measured based on an electrical signal applied to the second electrode strips.

16. The apparatus of claim 15, wherein the first bioimpedance signal and the second bioimpedance signal indicate a capture state of the tissue between the first arm and the second arm of the tissue engaging portion.

17. The apparatus of claim 16, wherein a difference between the capture state indicated by the first bioimpedance signal and the capture state indicated by the second bioimpedance signal indicates angled insertion of the tissue between the first arm and the second arm of the tissue engaging portion.

18. The apparatus of claim 16, wherein an average of the first bioimpedance signal and the second bioimpedance signal is used to determine a capture state of the tissue.

19. The apparatus of claim 16, wherein the first bioimpedance signal and the second bioimpedance signal provide a continuous indication of tissue insertion between the first arm and the second arm.

20. The apparatus of claim 19, wherein the continuous indication of the capture status is divided into quantified signal regions indicating four categories of capture status, including no tissue insertion, insufficient tissue insertion, complete tissue insertion, and excessive tissue insertion.

21. The apparatus according to any one of claims 12 to 20, further comprising a reference electrode configured to enable bipolar measurement of the bioimpedance signal.

22. The device of claim 21, wherein the bioimpedance signal is measurable in at least three configurations, the at least three configurations comprising the first electrode strip relative to the reference electrode, the second electrode strip relative to the reference electrode, and the first electrode strip relative to the second electrode strip.

23. The device of claim 11, wherein the two or more electrodes comprise: a first electrode coupled to the first arm of the tissue engaging portion proximate a free edge of the first arm opposite an articulated edge coupled to an articulated edge of the second arm; and a second electrode coupled to the second arm of the tissue engaging portion proximate a free edge of the second arm, the free edge being opposite the articulated edge, Wherein the first electrode and the second electrode are configured to contact each other when the tissue engaging portion is closed.

24. The apparatus of claim 23, wherein the bioimpedance signal measured with the first electrode and with the second electrode is configured to be used to determine the thickness of the tissue inserted into the tissue engaging portion.

25. The apparatus of claim 24, wherein the bioimpedance signal measured with the first electrode and with the second electrode is configured to be used to determine a change in thickness of the tissue when the tissue is inserted into the tissue engaging portion.

26. The apparatus of claim 25, wherein a cross-sectional map of the thickness of the tissue is generated based on the determined thickness and thickness variation of the tissue.

27. The device according to any one of claims 23 to 26, wherein when the tissue engaging portion is partially closed to bring the first electrode and the second electrode into proximity with the tissue inserted into the tissue engaging portion, a bioimpedance signal is measured with the first electrode and with the second electrode.

28. A therapeutic device for treating an autologous anatomical structure, the therapeutic device comprising: a tissue engaging portion comprising a first surface and a second surface, the first surface and the second surface being configured such that the first surface and the second surface can be closed or moved closer together to capture tissue in the tissue engaging portion, at least one of the first surface and the second surface being movable to form a capture zone therebetween to capture the tissue, the tissue engaging portion further comprising a plurality of barbs to secure the tissue within the tissue engaging portion; and a flexible printed circuit board (PCB), the flexible PCB comprising electrode pads including one or more electrodes, and electrical leads extending away from the electrode pads, wherein the therapeutic device is configured such that: capable of applying an electrical signal to the one or more electrodes through the electrical leads of the flexible PCB, capable of measuring a bioimpedance signal using the electrical lead based on or in response to the applied electrical signal, and Applying a force to the electrical leads causes the flexible PCB to be removed from the therapeutic device.

29. The therapeutic device of claim 28, wherein the flexible PCB is configured to be pulled through a pair of the plurality of barbs to remove the flexible PCB from the therapeutic device.

30. The treatment device of claim 29, wherein the electrical lead extends between the pair of barbs.

31. The therapeutic device of claim 30, wherein a width of the electrode pad of the flexible PCB is greater than a distance between the pair of barbs, and the electrode pad of the flexible PCB is configured to bend to fit between the pair of barbs.

32. The therapeutic device of claim 31 , wherein the width of the electrode pad is less than or equal to 1.875 times the distance between the pair of barbs.

33. The therapeutic device of claim 31 , wherein the width of the electrode pad is less than or equal to 1.25 times the distance between the pair of barbs.

34. The therapeutic device of any one of claims 31 to 33, wherein the distance between the pair of barbs is less than or equal to 8 mm.

35. A therapeutic device according to any one of claims 31 to 33, wherein the force required to pull the electrode pad through the pair of barbs is less than or equal to 1.5N.

36. The therapeutic device of claim 28, wherein the flexible PCB is configured to be pulled around one side of the plurality of barbs to remove the flexible PCB from the therapeutic device.

37. A therapeutic device according to claim 36, wherein the electrical lead has a diagonally bent section that leads immediately away from the electrode pad so that the electrode pad is laterally offset from the electrical lead so that the electrical lead is placed along the side of the plurality of barbs while the electrode pad is located within the tissue engaging portion.

38. The treatment device of claim 37, wherein pulling the electrical lead causes the electrode pad to move away from the tissue engaging portion from a side of the tissue engaging portion surrounding the plurality of barbs.

39. The therapeutic device of claim 38, wherein pulling the electrical lead causes the diagonally bent section to contact the plurality of barbs, thereby causing the electrode pad to move laterally relative to the plurality of barbs to move away from the side of the tissue engaging portion using one or more of the plurality of barbs as a fulcrum.

40. The therapeutic device of claim 28, wherein the electrode pad includes a relief cut therethrough such that application of sufficient force causes the electrode pad to separate into a first lateral portion and a second lateral portion.

41. The therapeutic device of claim 40, wherein the flexible PCB further comprises a second electrical lead coupled to the first lateral portion of the electrode pad, and a second electrical lead coupled to the second lateral portion of the electrode pad.

42. The therapeutic device of claim 41 , wherein the electrical lead and the second electrical lead each comprise diagonally bent segments in opposite directions such that the electrical lead and the second electrical lead are each laterally offset from respective lateral portions of the electrode pad such that when the electrode pad is positioned within the tissue engaging portion, the electrical lead is positioned along a first side of the plurality of barbs and the second electrical lead is positioned along a second side of the plurality of barbs opposite the first side.

43. The treatment device of claim 42, wherein applying a proximal force on the electrical lead and the second electrical lead causes the electrode pad to separate into the first lateral portion and the second lateral portion.

44. The treatment device of claim 43, wherein applying the proximal force on the electrical lead and the second electrical lead causes the first lateral portion to move away from the tissue engaging portion around the first side of the plurality of barbs and causes the second lateral portion to move away from the tissue engaging portion around the second side of the plurality of barbs.

45. The therapeutic device of any one of claims 28 to 44, wherein the flexible PCB further comprises a reference electrode coupled to the electrical lead.

46. ​​The therapeutic device of any one of claims 28 to 45, wherein the electrical lead is configured to extend proximally to a proximal end of a delivery system configured to advance the therapeutic device to a treatment location within a subject.

47. The treatment device of any one of claims 28 to 46, wherein the treatment device is a valve repair device and is configured to capture leaflet tissue of a native valve in the tissue engaging portion.

48. A system for repairing a native valve, the system comprising: A delivery system, the delivery system comprising: a catheter having a proximal end and a distal end; Actuating element; a guide wire extending within the lumen of the catheter from the proximal end of the catheter to the distal end of the catheter; as well as a capture mechanism located at a distal end of the delivery system; and A therapeutic device, comprising: an attachment portion comprising a proximal component configured to engage the capture mechanism of the delivery system; an anchor portion comprising a tissue engaging portion having a first surface and a second surface configured to capture tissue; a distal portion configured to engage the actuation element of the delivery system, the actuation element configured to deploy the anchor portion and release the capture mechanism from the proximal assembly; an electrode coupled to the tissue engaging portion; as well as an electrical lead having a distal end coupled to the electrode and a proximal end coupled to the proximal assembly, wherein the therapeutic device is configured such that: An electrical signal can be applied to the electrode through the electrical lead, and capable of measuring a bioimpedance signal based on or in response to an applied electrical signal, Wherein the guide wire is configured to provide an electrical connection to the electrical lead during delivery and deployment of the therapeutic device, the electrical connection terminating when the delivery system is withdrawn.

49. The system of claim 48, wherein: The distal end of the wire includes a spring pin connector, The proximal end of the electrical lead is coupled to an electrical pad at the proximal assembly, and The spring pin connector of the lead wire makes electrical contact with the electrical pad of the electrical lead to provide an electrical connection to the electrode until the therapeutic device is released from the delivery system.

50. The system of claim 48, wherein: The distal end of the lead comprises an electrical pad, The proximal end of the electrical lead is coupled to a spring pin connector at the proximal assembly, and The spring pin connector of the electrical lead makes electrical contact with the electrical pad of the wire to provide an electrical connection to the electrode until the therapeutic device is released from the delivery system.

51. The system of claim 50, wherein the spring pin connector is configured to provide electrical contact between the electrical lead and the wire using a spring force parallel to the axis of the catheter.

52. The system of any one of claims 50 to 51, wherein the spring force of the pogo pin connector is configured to assist in separating the pogo pin connector from the electrical pad.

53. The system of claim 48, wherein: The proximal component forms a groove, the electrical lead being coupled to the proximal assembly within the recess; The capture mechanism includes a finger configured to cooperate with the groove of the proximal component to couple the therapeutic device to the delivery system, The wire is coupled to the inner surface of the finger so that the wire physically contacts the electrical lead in the groove to provide electrical contact between the wire and the electrical lead, and Releasing the therapeutic device from the delivery system disengages the fingers from the proximal assembly, thereby releasing the therapeutic device and terminating electrical contact between the wire and the electrical lead.

54. The system of claim 53, wherein the groove and the finger are coated with an insulating material to electrically insulate the electrical connection between the wire and the electrical lead.

55. The system of claim 48, wherein: The delivery system further comprises a tube coupled to the capture mechanism, wherein the guide wire is secured within the tube, The proximal end of the electrical lead is releasably secured within the tube to provide electrical contact between the wire and the electrical lead when the therapeutic device is coupled to the delivery system, and Withdrawing the delivery system from the treatment device moves the tube away from the proximal assembly, thereby releasing the electrical lead from the tube and terminating electrical contact between the wire and the electrical lead.

56. The system of claim 55, wherein the tube includes a leaf spring for providing a clamping force on the wire and the electrical lead to enhance the electrical connection.

57. The system of any one of claims 55 to 56, wherein the delivery system further comprises a frame secured to the distal end of the catheter, the tube being coupled to the frame, and the frame being configured to maintain the tube in a targeted position relative to the therapeutic device.

58. The system of claim 57, wherein the frame is made of a polymer to electrically insulate the electrical connections between the wires and the electrical leads.

59. The system of any one of claims 57 to 58, wherein the frame comprises a U-shaped support that engages with the attachment portion of the therapeutic device.

60. The system of claim 48, wherein: The distal end of the wire terminates in a coil crimp having an inner diameter, The proximal end of the electrical lead is seated within the coil crimp, the inner diameter is configured to provide a friction fit between the electrical lead and the wire to establish an electrical connection between the wire and the electrical lead, and The coil crimp is configured to expand to release the electrical lead.

61. The system of claim 60, wherein the coil crimp is configured to expand in response to exposure to a temperature above a threshold temperature.

62. The system of claim 60, wherein the coil crimp is configured to expand in response to a current above a threshold current being driven through the wire.

63. The system of any one of claims 60 to 62, wherein the coil crimp is formed of a shape memory alloy in a martensitic state, the inner diameter being smaller than a diameter of the electrical lead.

64. The system of claim 63, wherein the coil crimp is configured to expand to have an inner diameter greater than the diameter of the electrical lead in response to transitioning to an austenitic state.

65. The system of any one of claims 60 to 64, wherein the coil crimp includes a curved location for enhancing a friction fit between the wire and the electrical lead.

66. The system of claim 65, wherein the electrical lead is inserted into the coil crimp at the bend location.

67. The treatment device of any one of claims 48 to 66, wherein the treatment device is a valve repair device and is configured to capture leaflet tissue of a native valve in the tissue engaging portion.

68. A bioimpedance signal measurement system, comprising: a device comprising a tissue engaging portion, the tissue engaging portion comprising a first surface and a second surface, the tissue engaging portion being configured such that the first surface and the second surface can be closed or moved closer together to capture tissue in the tissue engaging portion, at least one of the first surface and the second surface being movable to form a capture zone between the first surface and the second surface to capture the tissue; and two or more electrodes coupled to the tissue engaging portion; as well as An impedance measuring device comprising a power source and an electrical sensor, wherein the power source is configured to apply an electrical signal to the two or more electrodes, and the impedance measuring device is configured to use the electrical sensor to measure a bioimpedance signal, wherein the bioimpedance signal is a response to the applied electrical signal, and the bioimpedance signal provides an indication of the state of the tissue within the tissue joint portion.

69. The system of claim 68, wherein the two or more electrodes are coupled to one or more anchors of the device.

70. The system of claim 68, wherein the two or more electrodes are coupled to one or more hooks of the device.

71. A system according to any one of claims 68 to 70, wherein the impedance measurement device is configured to measure electrical characteristics of the two or more electrodes to determine the relative position of the hook of the device and the anatomical structure in contact with the device.

72. The system of claim 71, wherein the electrical characteristic comprises a peak-to-peak amplitude of oscillations of the bioimpedance signal.

73. The system of claim 71, wherein the electrical characteristic comprises an average value of the amplitude of the bioimpedance signal.

74. The system of any one of claims 68 to 73, wherein the system is further configured to determine that the two or more electrodes are in the blood based at least in part on the bioimpedance signal.

75. The system of any one of claims 68 to 74, wherein the system is further configured to determine that the two or more electrodes are contacting a target tissue based at least in part on the bioimpedance signal.

76. The system of any one of claims 68 to 75, wherein the system is further configured to determine that the two or more electrodes are transitioning from being primarily in contact with blood to being partially in contact with tissue based at least in part on the bioimpedance signal.

77. The system of any one of claims 68 to 76, wherein the system is further configured to determine, based at least in part on the bioimpedance signal, that the two or more electrodes are transitioning from being partially or primarily in contact with tissue to being primarily in contact with blood.

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