Bio-Impedance Based Feedback for Medical Treatment

Abstract

Medical treatments and devices using bioimpedance-based feedback are disclosed. Bioimpedance-based feedback can include measuring or acquiring an electrical signal that includes or indicates a bioimpedance signal. The bioimpedance signal can be used to determine the position and / or state of a device (e.g., a device clip or anchor) and / or tissue near the device. The bioimpedance signal can be analyzed and converted into information presented to a clinician to indicate the state of a portion of the device and provide feedback regarding the position and / or state of the device, e.g., an anchor element of an implant. Some devices allow for removal of electrodes or electrical leads when the device is implanted.

Description

Background Art

[0001] Cross - Reference to Related Applications This application is filed on July 22, 2022, and is described in U.S. Provisional Patent Application No. 63 / 369,176, entitled "BIOIMPEDANCE - BASED FEEDBACK FOR MEDICAL PROCEDURES", and in U.S. Provisional Patent Application No. 63 / 439,836, entitled "BIOIMPEDANCE - BASED FEEDBACK FOR MEDICAL PROCEDURES", filed on January 18, 2023, each of which is hereby expressly and fully incorporated by reference herein for all purposes.

[0002] Various medical procedures involve implanting an object into a patient's body to address one or more problems. Healthcare providers can use various surgical or other techniques to implant the object into the patient. This may involve fixing or anchoring the implant to the target tissue within the patient.

Summary of the Invention

[0003] This summary is intended to illustrate some examples and is not intended to limit the scope of the disclosed subject matter. For example, any feature included in an example of this summary is not claimed by the claims unless the claims expressly enumerate those features. Also, the features, components, steps, concepts, etc., described in the examples in this summary and elsewhere in this disclosure can be combined in various ways. The various features and steps described elsewhere in this disclosure can be included in the embodiments outlined herein.

[0004] In some implementations, medical procedures, systems, and / or devices that sense or indicate bioimpedance and / or use bioimpedance-based feedback are disclosed. Detecting bioimpedance and / or bioimpedance-based feedback can include measuring or obtaining an electrical signal that includes and / or indicates a bioimpedance signal.

[0005] In some implementations, a system, apparatus, and / or device can be configured to measure or obtain an electrical signal that includes and / or indicates a bioimpedance or bioimpedance signal. When the bioimpedance or bioimpedance signal is inside a patient's body, it can be used to obtain / provide information about natural anatomical structures, blood, tissue, cells, blood vessels, etc., and / or information about various functions, features, positions, uses, operations, etc. of the system, apparatus, and / or device.

[0006] In some implementations, bioimpedance or a bioimpedance signal can be used to obtain / provide information about whether a system / device is in the correct location or position, whether the system / device is interacting properly with natural tissue, whether the system / device is properly fixed to natural tissue, whether the system / device is properly implanted, and / or other indications. In some implementations, the bioimpedance signal is configured to indicate the state of valve tip capture within an anchor (e.g., a capture portion, a fastener, a clamp, a clip, etc.) of a system, apparatus, and / or device.

[0007] In some implementations, the system and / or apparatus can include devices that can be one or more of a treatment device, a repair device, a valve repair device, a transplantable device, a valve treatment device, a tissue treatment device, a catheter, an implant, an anchor, etc.

[0008] In some implementations, a system, apparatus, and / or device includes one or more electrodes. In some implementations, a system, apparatus, and / or device includes two or more electrodes (or at least two electrodes). In some implementations, a system, apparatus, and / or device includes three electrodes. In some implementations, a system, apparatus, and / or device includes four electrodes.

[0009] In some implementations, an electrode or electrodes (e.g., two or more electrodes) are configured to measure and / or indicate a bioimpedance signal in response to an applied electrical signal when the electrical signal is applied to the electrode or electrodes.

[0010] In some implementations, a system, apparatus, and / or device includes two or more electrodes, including a first electrode coupled to a first location of the system, apparatus, and / or device and a second electrode coupled to a second location of the system, apparatus, and / or device. In some implementations, the first electrode is adjacent to the second electrode. In some implementations, the first electrode includes an electrode plate that covers most of the first location, and the second electrode includes an electrode plate that covers most of the second location.

[0011] In some implementations, a system, apparatus, and / or device includes two or more electrodes, including a first electrode coupled to a first arm (e.g., a clip arm, a clasp arm, a paddle, etc.) of the system, apparatus, and / or device and a second electrode coupled to a second part or a second arm (e.g., a second arm, a clip arm, a clasp arm, a paddle, an extension, etc.) of the system, apparatus, and / or device. Although many examples in this specification use "second arm" for illustrative purposes, other parts of the device (e.g., a bonding element, a cover, a surface, etc.) can be used as the second part even if they are not typically considered an arm.

[0012] In some implementations, when the first electrode closes or moves the first arm and the second arm together, it is adjacent to the second electrode.

[0013] In some implementations, the first electrode and the second electrode are on the same arm (e.g., both are on the first arm or both are on the second arm).

[0014] In some implementations, the first extension is used as or instead of the first arm, and the second extension is used as or instead of the second arm.

[0015] In some implementations, the first surface is used as or instead of the first arm, and the second surface is used as or instead of the second arm. In some implementations, the first panel is used as or instead of the first arm, and the second panel is used as or instead of the second arm.

[0016] In some implementations, the first arm and the second arm are latch arms. In some implementations, the first arm and the second arm are arms of a gripper or a gripping member.

[0017] In some implementations, the first arm and the second arm are arms of a clamp or a clamping part of a system / device.

[0018] In some implementations, the first arm and the second arm are arms of an anchor (e.g., a latch, a clip, a clamp, a gripping member, a paddle, a gripping member and a paddle, etc.) of an implant or a device (e.g., a therapeutic device, a prosthetic device, etc.).

[0019] In some implementations, the first electrode includes an electrode plate that covers most of the first arm, and the second electrode includes an electrode plate that covers most of the second arm.

[0020] In some implementations, two or more electrodes include a first electrode coupled to the first arm and a second electrode coupled to the first arm. In some implementations, the first electrode is separated from the second electrode by a gap. In some implementations, the first electrode and the second electrode include electrode strips parallel to the length of the first arm. In some implementations, 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).

[0021] In some implementations, the system / device is configured to capture tissue, e.g., between the first arm and the second arm and / or between the first surface and the second surface. In some implementations, the system / device is configured to capture the tip of a native valve, e.g., between the first arm and the second arm and / or between the first surface and the second surface.

[0022] In some implementations, the first electrode is positioned on the first arm at a first tip capture depth and the second electrode is positioned on the first arm at a second tip capture depth. In some implementations, the first electrode is positioned on the first arm at a target minimum tip capture depth and the second electrode is positioned on the first arm at a target maximum tip capture depth.

[0023] In some implementations, 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 implementations, 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.

[0024] In some implementations, the system / device includes an electrode plate coupled to the second arm.

[0025] In some implementations, the system / device includes an impedance measurement device configured to measure a bioimpedance or bioimpedance signal and determine a tissue or valve tip capture depth based on the measured bioimpedance signal.

[0026] In some implementations, the system, apparatus, and / or device may be configured to repair or treat a patient's native valve or simulation. In some implementations, the system, apparatus, and / or device may be configured to repair or treat a patient's heart or simulation.

[0027] In some implementations, the system, apparatus, and / or device may include an anchor, tissue engagement portion, or clip (e.g., one, two, three, or more anchors, clips, or other tissue engagement portions), and the anchor or clip (e.g., each anchor and / or each clip) includes a first arm (e.g., a clip arm, paddle, etc.) and a second arm (e.g., a clip arm, paddle, etc.).

[0028] In some implementations, the first arm and the second arm are joined by a hinge portion such that the first arm and the second arm close (e.g., move towards each other, come together, and / or optionally contact each other) to enable capture of a target tissue (e.g., a valve tip and / or other tissue) within the anchor, tissue engagement portion, or clip.

[0029] In some implementations, the anchor, tissue engagement portion, or clip is movable to form a capture region for capturing tissue, e.g., for capturing a valve tip of a native valve. In some implementations, the first arm of the anchor, tissue engagement portion, or clip is movable towards and away from the second arm (and / or other second portion) of the anchor, tissue engagement portion, or clip to form a capture region for capturing tissue, e.g., for capturing a valve tip of a native valve.

[0030] In some implementations, two or more electrodes are coupled to an anchor or a clip. In some implementations, two or more electrodes are configured to measure a bioimpedance or a bioimpedance signal when an electrical signal is applied to the two or more electrodes, e.g., based on or in response to the applied electrical signal. In some implementations, the bioimpedance signal is configured to indicate a state of tissue (e.g., a valve tip capture state, etc.) within the anchor or clip (e.g., between a first arm and a second arm of the anchor or clip, between a first surface and a second surface of the anchor or clip, etc.) and / or to indicate a state or deployment state of the anchor or clip.

[0031] In some implementations, two or more electrodes include a first electrode coupled to a first arm and a second electrode coupled to a second arm. In some implementations, the first electrode is adjacent to the second electrode when closing the anchor or clip. In some implementations, 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.

[0032] In some implementations, two or more electrodes include a first electrode coupled to a first arm and a second electrode coupled to the first arm. In some implementations, the first electrode is separated from the second electrode by a gap.

[0033] In some implementations, the first electrode and the second electrode include electrode strips parallel to the length of the first arm. In some implementations, the first electrode and the second electrode include electrode strips parallel to the width of the first arm.

[0034] In some implementations, the first electrode is positioned on the first arm at a target minimum valve tip capture depth. In some implementations, the second electrode is positioned on the first arm at a target maximum valve tip capture depth.

[0035] In some implementations, the system, apparatus, and / or device includes an electrode plate coupled to the second arm.

[0036] In some implementations, the system, apparatus, and / or device includes an impedance measurement device configured to measure a bioimpedance signal and determine a tissue capture depth (e.g., such as a valve tip) based on the measured bioimpedance signal.

[0037] In some implementations, the impedance measurement device implements an algorithm to generate indicators for fully captured tissue (e.g., such as a fully captured valve tip), partially captured tissue (e.g., such as a partially captured valve tip), and / or overly captured tissue (e.g., such as an overly captured valve tip).

[0038] In some implementations, the impedance measurement device implements an algorithm to generate an indicator of the capture depth of the tissue (e.g., such as a valve tip).

[0039] In some implementations, the impedance measurement device is configured to generate an indicator of the tissue capture state (e.g., such as a valve tip) when the anchor, tissue engagement portion, or clip is closed.

[0040] In some implementations, the impedance measurement device is configured to generate an indicator of the tissue capture state (e.g., such as a valve tip) when the anchor, tissue engagement portion, or clip is open.

[0041] In some implementations, the impedance measurement device implements an algorithm to generate an indicator of the tissue capture angle (e.g., such as a valve tip), or otherwise provides an indication when the captured tissue is biased to one side.

[0042] In some implementations, the system / device includes a device or implant configured to be used and / or implanted during a medical procedure. In some implementations, the device includes an anchor configured to secure the device to the patient's tissue.

[0043] In some implementations, the system, apparatus, and / or device includes electrodes (e.g., at least one electrode, two electrodes, three electrodes, four electrodes, an electrode strip, two electrode strips, three electrode strips, four electrode strips, etc.) coupled to the anchor.

[0044] In some implementations, the system, apparatus, and / or device is configured to measure a bioimpedance signal based on and / or in response to an applied electrical signal when the electrical signal is applied to the anchor.

[0045] In some implementations, the bioimpedance signal is configured to indicate the position and / or deployment state of the anchor.

[0046] In some implementations, the system, apparatus, and / or device includes an edge-to-edge repair device.

[0047] In some implementations, the system, apparatus, and / or device includes an annular formation device (e.g., an annular formation implant, an annular formation ring, etc.).

[0048] In some implementations, the system, apparatus, and / or device includes a plurality of anchors (e.g., two, three, four, or more anchors), each anchor including an electrode. In some implementations, 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.

[0049] In some implementations, each bioimpedance signal is configured to indicate the position and / or deployment state of a corresponding anchor of a plurality of anchors.

[0050] In some implementations, a system, apparatus, and / or device includes a plurality of anchors that are electrically shorted together.

[0051] In some implementations, a system, apparatus, and / or device includes an impedance measurement device configured to measure a bioimpedance signal and determine a position and / or anchor deployment state based on the measured bioimpedance signal.

[0052] In some implementations, the impedance measurement device implements an algorithm that generates an indicator of the anchor deployment state.

[0053] In some implementations, the impedance measurement device implements an algorithm that generates an indicator of the anchor deployment state that includes an anchor in contact with tissue.

[0054] In some implementations, the impedance measurement device implements an algorithm that generates an indicator of a partially deployed anchor.

[0055] In some implementations, the impedance measurement device implements an algorithm that generates an indicator of a fully deployed anchor.

[0056] In some implementations, the system / apparatus / device can include a sensor configured to measure impedance or bioimpedance.

[0057] In some implementations, the sensor can be configured to compare one or more electrical signals and / or characteristics measured during use to previously measured electrical signals and / or characteristics (e.g., corresponding to known tissue and blood samples).

[0058] In some implementations, the sensor can be configured to determine whether the tissue is engaged.

[0059] In some implementations, the sensor is configured to distinguish between leaflet tissue, annulus tissue, and / or chordae tissue (e.g., when the anchor contacts (or engages) leaflet tissue versus annulus tissue versus chordal tissue and / or to distinguish whether it only contacts blood).

[0060] In some implementations, the first impedance or bio-impedance value is measured in a way that identifies the location and / or state of a system / device / apparatus (e.g., a treatment device, a prosthetic device, an implantable device, a delivery device, etc.). In some implementations, the first impedance value is compared to a reference value (e.g., a previously measured or determined impedance value, etc.).

[0061] In some implementations, the method includes determining and / or estimating one or more of the state or position of an anchor (e.g., a clip, a clamp, a tissue anchor, a helical anchor, a dart, a screw, etc.) of the system / device based on the comparison.

[0062] In some implementations, the method includes determining and / or estimating one or more of the state or location of a catheter and / or other delivery device of the system / device based on the comparison.

[0063] In some implementations, the system, apparatus, and / or device includes a tissue engagement portion or tissue capture portion that includes a first surface and a second surface, and the tissue engagement portion or tissue capture portion is configured such that the first surface and the second surface can close together or move closer to engage and / or capture tissue within the tissue engagement portion or tissue capture portion.

[0064] In some implementations, at least one of the first surface and the second surface is movable to form a capture region between the first surface and the second surface to capture tissue.

[0065] In some implementations, the tissue engagement portion or tissue capture portion is configured as or includes one or more of an anchor, barb, hook, fastener, clip, clamp, gripper, grasping member, paddle, arm, combinations thereof, etc.

[0066] In some implementations, two or more electrodes are coupled to the tissue engagement portion or tissue capture portion. In some implementations, the system, device, and / or apparatus are configured to apply an electrical signal (e.g., impulse, voltage, cardiac signal, etc.) to two or more electrodes. In some implementations, the electrical signal provides an indication of the state of the tissue in the tissue engagement portion, tissue capture portion, and / or capture region (e.g., tissue capture state, valve tip capture state, tissue engagement state, etc.).

[0067] In some implementations, a bioimpedance signal can be measured (e.g., in response to an electrical signal applied to two or more electrodes), and the bioimpedance signal provides an indication of the state of the tissue in the tissue engagement portion, tissue capture portion, and / or capture region.

[0068] In some implementations, the state includes or indicates insufficient insertion of the tissue in the tissue engagement portion, tissue capture portion, and / or capture region.

[0069] In some implementations, the state includes or indicates complete insertion of the tissue in the tissue engagement portion, tissue capture portion, and / or capture region.

[0070] In some implementations, the state includes or indicates over-insertion of the tissue in the tissue engagement portion, tissue capture portion, and / or capture region.

[0071] In some implementations, the state includes or indicates the angled insertion of tissue in the tissue engagement portion, tissue capture portion, and / or capture region.

[0072] In some implementations, the state includes or indicates the insertion of non-target tissue in the tissue engagement portion, tissue capture portion, and / or capture region. In some implementations, non-target tissue includes chordae tendineae and the like.

[0073] In some implementations, the state includes or indicates the insertion of tissue in the tissue engagement portion, tissue capture portion, and / or capture region, but the tissue engagement portion, tissue capture portion, and / or capture region are in an open configuration that includes the first and second surfaces being spaced apart from each other.

[0074] In some implementations, the display of the state is configured to generate or be used to generate a visual indicator for the user of the state (such as the tissue engagement state, tissue capture state, leaflet capture state, etc.). In some implementations, 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 implementations, 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-target tissue insertion.

[0075] In some implementations, the system and / or device (such as a treatment system, repair system, valve repair system, treatment device, etc., which may be the same as or similar to other systems and / or devices herein) includes a tissue engagement portion or a tissue capture portion (such as an anchor, fastener, clip, clamp, plurality of arms, plurality of gripping members, two paddles, fastener arm and paddle arm, gripping member and paddle, etc.).

[0076] In some implementations, the tissue engagement portion or tissue capture portion includes a first surface (e.g., the surface of a clip arm, a fastener arm, a paddle, a joining element, other components, etc.) and a second surface (e.g., the surface of a clip arm, a fastener arm, a paddle, a joining element, other components, etc.), and the first surface and the second surface are configured to move closer together and close to engage and / or capture tissue of the tissue engagement portion or tissue capture portion (e.g., capture the valve tip of a native valve within the tissue capture portion).

[0077] In some implementations, the tissue engagement portion or tissue capture portion includes a first arm (e.g., a clip arm, a fastener arm, a paddle, etc.) and / or a second arm (e.g., a clip arm, a fastener arm, a paddle, etc.), and the first arm and the second arm are configured to close together and / or move closer to engage and / or capture tissue within the tissue engagement portion or tissue capture portion (e.g., capture the valve tip of a native valve within the tissue capture portion).

[0078] In some implementations, the first arm includes a first surface and / or the second arm includes a second surface.

[0079] In some implementations, a system, device, and / or apparatus can be used to repair and / or treat a patient's native valve or simulation. In some implementations, the tissue is the valve tip of a native valve.

[0080] In some implementations, a system, device, and / or apparatus includes a plurality of tissue engagement portions, tissue capture portions, and / or anchors.

[0081] In some implementations, a system, apparatus, and / or device includes a second tissue engagement portion or second anchor that includes a first surface (e.g., the surface of a clip arm, a clasp arm, a paddle, a joining element, etc.) and a second surface (e.g., the surface of a clip arm, a clasp arm, a paddle, a joining element, etc.), and the first surface and the second surface close together and move closer to engage and / or capture tissue (e.g., the second leaflet tip of a native valve, another portion of a leaflet tip, etc.) within the second tissue engagement portion or anchor (e.g., the second tissue engagement portion or anchor can act as a tissue capture portion). In some implementations, the second tissue engagement portion or second anchor includes a first arm (e.g., a clip arm, a clasp arm, a paddle, etc.) and / or a second arm (e.g., a clip arm, a clasp arm, a paddle, etc.), and the first arm and the second arm close together and / or move closer to engage and / or capture tissue (e.g., the second leaflet tip of a native valve, another portion of a leaflet tip, etc.) within the second tissue engagement portion or anchor (e.g., a clasp, a clip, etc.). In some implementations, the first arm can include the first surface and / or the second arm can include the second surface. The second tissue engagement portion or second anchor can be configured the same or similar to the first tissue engagement portion.

[0082] In some implementations, a system, apparatus, and / or device includes a third tissue engagement portion or third anchor that includes a first surface (e.g., the surface of a clip arm, a clasp arm, a paddle, a joining element, etc.) and a second surface (e.g., the surface of a clip arm, a clasp arm, a paddle, a joining element, etc.), and the first surface and the second surface are configured to close together and / or move closer to engage and / or capture tissue (e.g., the third leaflet tip of a native valve, another portion of the leaflet tip, etc.) within the third tissue engagement portion or anchor (e.g., where the third tissue engagement portion can act as a tissue capture portion to capture the tissue). In some implementations, the third tissue engagement portion or third anchor includes a first arm (e.g., a clip arm, a clasp arm, a paddle, etc.) and / or a second arm (e.g., a clip arm, a clasp arm, a paddle, etc.), and the first arm and the second arm are configured to close and / or move closer to engage and / or capture tissue (e.g., the third leaflet tip of a native valve, another portion of the leaflet tip, etc.) within the third tissue engagement portion or anchor (e.g., a clasp, a clip, etc.). In some implementations, the first arm can include the first surface and / or the second arm can include the second surface. The third tissue engagement portion or third anchor can be configured the same or similar to the first tissue engagement portion and / or the second tissue engagement portion or anchor.

[0083] In some implementations, 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.) is movable to form a capture region therebetween to capture tissue (e.g., capture the leaflet tip of a native valve).

[0084] In some implementations, two or more electrodes are coupled to a tissue engagement portion or a tissue capture portion (e.g., an anchor, a clip, etc.), and a system, device, and / or apparatus is configured to apply an electrical signal to the two or more electrodes.

[0085] In some implementations, for example, a bioimpedance signal can be measured based on the applied electrical signal.

[0086] In some implementations, two or more electrodes include a first electrode strip coupled to a first surface and / or a first arm of a tissue engagement portion or a tissue capture portion (e.g., an anchor, a clip, etc.), and a second electrode strip coupled to the first surface and / or the first arm of the tissue engagement portion or the tissue capture portion (e.g., an anchor, a clip, etc.).

[0087] In some implementations, two or more electrodes include a first electrode strip (e.g., an anchor, a clip, etc.) coupled to a first surface and / or a first arm of a tissue engagement portion or a tissue capture portion near a first edge of the first surface and / or the first arm, and a second electrode strip (e.g., an anchor, a clip, etc.) coupled to the first surface and / or the first arm of the tissue engagement portion or the tissue capture portion near a second edge of the first surface and / or the first arm that is opposite the first edge.

[0088] In some implementations, the first electrode strip and the second electrode strip are parallel to each other and extend along the length of the first surface and / or the first arm.

[0089] In some implementations, the first electrode strip and the second electrode strip are offset by a predetermined distance from a free edge of the first surface and / or the first arm of the tissue engagement portion or the tissue capture portion (e.g., an anchor, a clip, etc.).

[0090] In some implementations, the predetermined distance is 1 to 15 mm. In some implementations, the predetermined distance is 2 to 10 mm. In some implementations, the predetermined distance is 5 to 8 mm. In some implementations, the predetermined distance is at least 6 mm.

[0091] In some implementations, the first bioimpedance signal can be measured based on, for example, an electrical signal applied to the first electrode strip, and the second bioimpedance signal can be measured based on, for example, an electrical signal applied to the second electrode strip.

[0092] In some implementations, the first bioimpedance signal and the second bioimpedance signal indicate the state of the tissue between the first surface and / or the first arm and the second surface and / or the second arm of the tissue engagement portion or tissue capture portion (e.g., anchor, fastener, etc.), and / or indicate the state or deployment state of the tissue engagement portion of the tissue capture 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 that the tissue engagement portion or tissue capture portion is closed or open, etc.).

[0093] In some implementations, the difference in the capture states indicated by the first bioimpedance signal and indicated by the second bioimpedance signal indicates an angled insertion of the tissue between the first surface and / or the first arm and the second surface and / or the second arm of the tissue engagement portion or tissue capture portion (e.g., anchor, fastener, etc.).

[0094] In some implementations, the average of the first bioimpedance signal and the second bioimpedance signal is used to determine the capture state of the tissue.

[0095] In some implementations, the first bioimpedance signal and the second bioimpedance signal provide a continuous indication of tissue insertion between the first surface and / or the first arm and the second surface and / or the second arm.

[0096] In some implementations, the continuous display of the capture state is divided into a quantified signal region indicating four categories of capture states, including no tissue insertion, insufficient tissue insertion, complete tissue insertion, and excessive tissue insertion, without tissue insertion. Other state signals are also possible.

[0097] In some implementations, the system, device, and / or device includes a reference electrode configured to enable bipolar measurement of the bioimpedance signal.

[0098] In some implementations, the bioimpedance signal can be measured in at least three configurations, including a first electrode strip relative to the reference electrode, a second electrode strip relative to the reference node, and a first electrode strip relative to the second electrode strip.

[0099] In some implementations, two or more electrodes are coupled to the first surface and / or the first surface and / or the first arm of the tissue engagement portion or tissue capture portion near the free edge of the first arm, and the free edge is on the opposite side of the hinged edge coupled to the second surface and / or the hinged edge of the second arm. A first electrode, and a second electrode coupled to the second surface and / or the second surface and / or the second arm of the tissue engagement portion or tissue capture portion near the free edge of the second arm, the free edge being on the opposite side of the hinged edge.

[0100] In some implementations, the first electrode and the second electrode are configured to contact each other with the tissue engagement portion, or the tissue capture portion is closed.

[0101] In some implementations, the bioimpedance signal measured by the first electrode and the second electrode is configured to be used to determine the thickness of the tissue inserted into the tissue engagement portion or tissue capture portion.

[0102] In some implementations, the bio - impedance signals measured at the first and second electrodes are configured to be used to determine a change in tissue thickness as the tissue is inserted into the tissue engagement portion or tissue capture portion.

[0103] In some implementations, a cross - sectional map of the tissue thickness is generated based on the determined tissue thickness and changes in thickness.

[0104] In some implementations, the bio - impedance signals are measured at the first and second electrodes while the tissue engagement portion or tissue capture portion is partially closed to approximate the first and second electrodes to the tissue inserted into the tissue engagement portion or tissue capture portion.

[0105] In some implementations, 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 as or similar to other systems, apparatuses, and / or devices herein) includes an anchor portion.

[0106] In some implementations, a system, apparatus, and / or device includes a junction portion coupled to the anchor portion.

[0107] In some implementations, the junction portion includes optional junction elements.

[0108] In some implementations, the anchor portion includes a clip (or other anchor or tissue capture portion) configured to capture tissue (e.g., valve leaflets, membranes, muscles, etc. of a native valve) within the clip (or other anchor or tissue capture portion).

[0109] In some implementations, one or more flexible electrodes protrude away from the junction portion and the reference electrode.

[0110] In some implementations, a system, apparatus, and / or device is configured such that an electrical signal can be applied to one or more flexible electrodes.

[0111] In some implementations, a bioimpedance signal can be measured (e.g., based on or in response to an applied electrical signal) to determine a relative blood flow adjacent to a system, device, and / or apparatus.

[0112] In some implementations, one or more flexible electrodes are configured to measure blood flow through a native valve, e.g., when a system, device, and / or apparatus is implanted in the native valve.

[0113] In some implementations, one or more flexible electrodes are configured to detect leakage through a native valve.

[0114] In some implementations, one or more flexible electrodes are configured to flex in response to blood flowing through the one or more flexible electrodes.

[0115] In some implementations, a bioimpedance signal changes in response to flexure of one or more flexible electrodes.

[0116] In some implementations, the change in the bioimpedance signal correlates with the amount of flexure that correlates with the blood flow velocity through the valve.

[0117] In some implementations, the bioimpedance signal is configured to decrease in response to a volume of regurgitant blood through a native valve.

[0118] In some implementations, a reference electrode is coupled to an actuating element, and the actuating element is coupled to a junction portion and an anchor portion.

[0119] In some implementations, a system and / or apparatus (e.g., a valve repair system, device, and / or apparatus that can be the same as or similar to other systems / devices herein) includes an anchor portion.

[0120] In some implementations, a system, apparatus, and / or device includes a junction portion that is coupled to an anchor portion.

[0121] In some implementations, the junction portion may optionally include a junction element.

[0122] In some implementations, the anchor portion includes a clip (or other anchor or tissue capture portion) and is configured to capture tissue (e.g., the leaflet of a native valve, a membrane, muscle, etc.) within the clip (or other anchor or tissue capture portion).

[0123] In some implementations, one or more electrodes are coupled to the anchor portion.

[0124] In some implementations, a system, apparatus, and / or device is configured such that an electrical signal can be applied to one or more electrodes.

[0125] In some implementations, a bioimpedance signal can be measured (e.g., based on an applied electrical signal, etc.) to determine a force on the system, apparatus, and / or device.

[0126] In some implementations, the bioimpedance signal correlates with the deflection of the junction portion or the anchor portion.

[0127] In some implementations, the deflection correlates with the force applied to the system, apparatus, and / or device such that the bioimpedance signal correlates with the force applied to the system, apparatus, and / or device.

[0128] In some implementations, the anchor portion includes an inner paddle coupled to outer paddles that rotate relative to each other, and the force applied to the system, apparatus, and / or device changes the opening distance between the inner paddle and the outer paddles.

[0129] In some implementations, a first electrode of two or more electrodes is coupled to an inner paddle, and a second electrode of the two or more electrodes is coupled to an outer paddle such that a change in the opening distance causes a change in the bioimpedance signal.

[0130] In some implementations, 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 as or similar to other systems and / or devices herein) includes at least one tissue engagement portion or anchor (e.g., a helical anchor, a screw, a staple, a dart, a hook, a fastener, a clip, a clamp, a plurality of arms, a plurality of gripping members, two paddles, a fastener arm and a paddle arm, a gripping member and a paddle, etc.).

[0131] In some implementations, the tissue engagement portion or anchor includes a first surface (e.g., the surface of a clip arm, a fastener arm, a paddle, etc.) and a second surface (e.g., the surface of a clip arm, a fastener arm, a paddle, etc.), and the first surface and the second surface close together or move closer to engage and / or capture tissue (e.g., the leaflet, membrane, muscle of a native valve) within the tissue engagement portion or anchor (e.g., the tissue engagement portion or anchor acts as a tissue capture portion and can capture the tissue).

[0132] In some implementations, the tissue engagement portion or anchor includes a first arm (e.g., a clip arm, a clasp arm, a paddle, etc.) and / or a second arm (e.g., a clip arm, a clasp arm, a paddle, etc.), and the first arm and the second arm are configured to close together or move closer to engage and / or capture tissue (e.g., the cusp of a native valve, a membrane, a muscle) within the tissue engagement portion or anchor (e.g., the tissue engagement portion or anchor can act as a tissue capture portion and capture the tissue). In some implementations, the first arm includes a first surface and / or the second arm includes a second surface.

[0133] In some implementations, at least one of the first surface and / or the first arm and the second surface and / or the second arm is movable to form a capture region therebetween for capturing tissue (e.g., the cusp of a native valve).

[0134] In some implementations, a plurality of electrodes are coupled to the tissue engagement portion or anchor.

[0135] In some implementations, a plurality of electrodes are electrically coupled in series using electrical leads.

[0136] In some implementations, a plurality of electrical components are electrically coupled in series with a plurality of electrodes using electrical leads.

[0137] In some implementations, a system, device, and / or apparatus is configured to apply an electrical signal to a plurality of electrodes through electrical leads.

[0138] In some implementations, a bioimpedance signal can be measured for a plurality of electrodes (e.g., based on an applied electrical signal, etc.).

[0139] In some implementations, the measured bioimpedance value can be determined for each of a plurality of electrodes based on the electrical characteristics of a plurality of electrical components and electrical signals.

[0140] In some implementations, one or more of the plurality of electrical components are coupled in series between a pair of electrodes of the plurality of electrodes using electrical leads.

[0141] In some implementations, one or more electrical components include a resistor, a capacitor, or an inductor.

[0142] In some implementations, one or more electrical components in series between electrode pairs of the plurality of electrodes have different electrical characteristics than another of one or more electrical components in series between different electrode pairs of the plurality of electrodes.

[0143] In some implementations, an electrical signal can be applied at a predetermined current and frequency.

[0144] In some implementations, the electrical leads include a single electrical lead.

[0145] 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.

[0146] 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.

[0147] 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.

[0148] In some implementations, the measured bioimpedance signals of the first, second, third, and fourth electrodes of a plurality of electrodes depend on the fixed resistance of a resistor, the fixed capacitance of a capacitor, and the fixed inductance of an inductor, in combination with a predetermined frequency and current of an applied electrical signal.

[0149] In some implementations, a system, apparatus, and / or device (e.g., a treatment system, a repair system, a valve repair system, a treatment device, a repair device that may be the same as or similar to other systems, apparatuses, and / or devices herein) includes a tissue engagement portion or an anchor (e.g., a helical anchor, a screw, a staple, a dart, a hook, a clasp, a clip, a clamp, a plurality of arms, a plurality of gripping members, two paddles, a clasp arm and a paddle arm, a gripping member and a paddle, etc.).

[0150] In some implementations, the tissue engagement portion or anchor includes a first arm (e.g., a clip arm, a clasp arm, a paddle, etc.) and / or a second arm (e.g., a clip arm, a clasp arm, a paddle, etc.), and the first arm and the second arm are configured to close together or move closer to engage and / or capture tissue (e.g., the leaflet, membrane, muscle of a native valve) within the tissue engagement portion or anchor (e.g., the tissue engagement portion or anchor acts as a tissue capture portion and can capture the tissue). In some implementations, at least one of the first arm and the second arm is movable to form a capture region therebetween to capture tissue (e.g., a leaflet, etc.) and / or is movable closer to the other arm to capture tissue therebetween.

[0151] In some implementations, a plurality of electrodes are coupled to the tissue engagement portion or anchor.

[0152] In some implementations, an analog-to-digital converter (ADC) chip is coupled to the tissue engagement portion or anchor and is electrically coupled to the plurality of electrodes.

[0153] In some implementations, an electrical lead (e.g., a single electrical lead, etc.) is configured to direct signals from an ADC chip to a measurement system.

[0154] In some implementations, a system, apparatus, and / or device (which may be the same as or similar to other systems and / or devices herein) can apply an electrical signal to a plurality of electrodes via an ADC chip, the ADC chip digitizes the bioimpedance signals from each of the plurality of electrodes, the digitized bioimpedance signals are transmitted to a measurement system via a single electrical lead, and the bioimpedance signals are determined for each of the plurality of electrodes based on the applied electrical signal and the digitized bioimpedance signals.

[0155] In some implementations, the digitized bioimpedance signals are transmitted via a single electrical lead using digital packets.

[0156] In some implementations, a system, apparatus, and / or device (which may be the same as or similar to other systems and / or devices herein) includes at least one tissue engagement portion or anchor (e.g., a clip, a clamp, a plurality of arms, a plurality of gripping members, two paddles, a clip arm and a paddle arm, a gripping member and a paddle, etc.).

[0157] In some implementations, the tissue engagement portion or anchor includes a first surface (e.g., the surface of a clip arm, a clasp arm, a paddle, a joining element, etc.) and a second surface (e.g., the surface of a clip arm, a clasp arm, a paddle, a joining element, etc.), and the first surface and the second surface close together or move closer to engage and / or capture tissue (e.g., the tip of a natural valve, a membrane, muscle, etc.) within the tissue engagement portion or anchor (e.g., the tissue engagement portion or anchor can act as a tissue capture portion and capture the tissue). In some implementations, at least one of the first surface and the second surface is movable to form a capture region therebetween to capture tissue (e.g., a valve tip, etc.), and / or is movable closer to another arm to capture tissue therebetween.

[0158] In some implementations, the tissue engagement portion or anchor includes a first arm (e.g., a clip arm, a clasp arm, a paddle, etc.) and / or a second arm (e.g., a clip arm, a clasp arm, a paddle, etc.), and the first arm and the second arm close together or move closer to engage and / or capture tissue (e.g., the tip of a natural valve, a membrane, muscle) within the tissue engagement portion or anchor (e.g., the tissue engagement portion or anchor can act as a tissue capture portion and capture the tissue). In some implementations, at least one of the first arm and the second arm is movable to form a capture region therebetween to capture tissue (e.g., a valve tip, etc.), and / or is movable closer to another arm to capture tissue therebetween. In some implementations, the first arm includes the first surface, and / or the second arm includes the second surface.

[0159] In some implementations, a flexible printed circuit board (PCB) includes a body, one or more electrodes coupled to the body, and electrical lead wires extending away from the body, and the flexible PCB is coupled to a tissue engagement portion or an anchor (e.g., a clip, a clamp, a paddle, etc.).

[0160] In some implementations, the flexible PCB is coupled to a tissue engagement portion or an anchor using one or more sutures. Other coupling mechanisms are possible.

[0161] In some implementations, the flexible PCB is coupled to a tissue engagement portion or an anchor, and a system, device, and / or apparatus is configured such that an electrical signal can be applied to one or more electrodes through the electrical lead wires of the flexible PCB, and a bioimpedance signal can be measured using the electrical lead wires based on or in response to the applied electrical signal.

[0162] In some implementations, a system, device, and / or apparatus includes a cover that covers the tissue engagement portion or the anchor, and the flexible PCB is secured to the cover that covers the anchor to couple the flexible PCB to the tissue engagement portion or the anchor.

[0163] In some implementations, a system, device, and / or apparatus includes a cover that covers the tissue engagement portion or the anchor, and the flexible PCB is secured to a first arm of the tissue engagement portion or the anchor under the cover that covers the tissue engagement portion or the anchor to couple the flexible PCB to the tissue engagement portion or the anchor.

[0164] In some implementations, the flexible PCB includes one or more physical features that facilitate removal of the flexible PCB from the tissue engagement portion or the anchor by applying a force to the electrical lead wires.

[0165] In some implementations, one or more physical features include stress concentration points that include a narrow connection point between two openings, and one or more suture threads are configured to extend across the narrow connection point through the two openings to couple the flexible PCB to a tissue engagement portion or an anchor, and when a force is applied to the electrical lead, the narrow connection point is broken, thereby releasing the flexible PCB from the tissue engagement portion or the anchor, leaving one or more suture threads that are coupled to the tissue engagement portion or the anchor.

[0166] In some implementations, one or more physical features include a Y-shaped protrusion extending from an end of the body, the flexible PCB is on the opposite side of the end where the electrical lead extends away from the body of the flexible PCB, and the Y-shaped protrusion includes a pair of legs extending away from a bridge portion that extends away from the body of the flexible PCB.

[0167] In some implementations, the bridge portion forms a rotational cutout configured to facilitate rotation of the pair of legs towards each other with an inward force applied to the pair of legs. In some implementations, one or more suture threads are configured to extend over the bridge portion to secure the flexible PCB to a tissue engagement portion or an anchor.

[0168] In some implementations, when a force is applied to the electrical lead, the suture threads push the pair of legs towards each other, enabling the flexible PCB to slide out from under the suture threads, thereby releasing the flexible PCB from the tissue engagement portion or the anchor and leaving one or more suture threads that are coupled to the tissue engagement portion or the anchor.

[0169] In some implementations, one or more physical features include rounded protrusions extending from the side of the body of the flexible PCB. In some implementations, the rounded protrusion includes a neck portion connecting the rounded portion to the body of the flexible PCB.

[0170] In some implementations, the rounded protrusion is configured to wrap around the tissue engagement portion or the side of the anchor, and one or more sutures extend on the neck portion on the side of the tissue engagement portion or the anchor to fix the flexible PCB to the tissue engagement portion or the anchor.

[0171] In some implementations, when a force is applied to the electrical lead, the rounded protrusion deforms to allow the flexible PCB to slide out from under the suture, thereby releasing the flexible PCB from the tissue engagement portion or the anchor and leaving one or more sutures that are coupled to the tissue engagement portion or the anchor.

[0172] In some implementations, one or more physical features include side protrusions formed from the body of the flexible PCB, and the side protrusions are formed on both sides of the body of the flexible PCB.

[0173] In some implementations, the side protrusions are configured to provide a positive block at the target location of the flexible PCB, and the target location is configured not to interfere with measurements taken at one or more electrodes of the flexible PCB.

[0174] In some implementations, when a force is applied to the electrical lead, the flexible PCB slides out from under the suture, thereby releasing the flexible PCB from the tissue engagement portion or the anchor and leaving one or more sutures that are coupled to the tissue engagement portion or the anchor.

[0175] In some implementations, one or more physical features include holes formed within the body of the flexible PCB near the edge of the body of the flexible PCB on the opposite side of the end where the electrical lead extends away from the body of the flexible PCB. In some implementations, one or more sutures are configured to pass through the holes in the body of the flexible PCB to fix the flexible PCB to the tissue engagement portion or the anchor.

[0176] In some implementations, applying force to the electrical lead causes the body of the PCB to break at the edge of the body of the flexible PCB, thereby releasing the flexible PCB from the tissue engagement portion or anchor and leaving one or more suture threads that are coupled to the tissue engagement portion or anchor.

[0177] In some implementations, one or more physical features include a relief that extends from a hole to an edge. In some implementations, the relief is configured such that one or more suture threads can pass through the relief to release the flexible PCB from the tissue engagement portion or anchor.

[0178] In some implementations, one or more physical features include a pair of bi-directional tongues that form a pair of tabs on the body of the flexible PCB, the pair of tabs being oriented in opposite directions from each other, and each of the pair of tabs being configured such that a suture thread of one or more suture threads can pass over a portion of the body of the flexible PCB and under the tab to secure the flexible PCB to the tissue engagement portion or anchor.

[0179] In some implementations, applying force to the electrical lead causes one or more suture threads to push the corresponding tab away from the body of the PCB, enabling the flexible PCB to slide under one or more suture threads, thereby releasing the flexible PCB from the tissue engagement portion or anchor and leaving one or more suture threads that are coupled to the tissue engagement portion or anchor.

[0180] In some implementations, 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 as or similar to other systems and / or devices described herein) includes a tissue engagement portion or anchor (e.g., a helical anchor, a screw, a dart, a staple, a hook, a clasp, a clip, a clamp, a plurality of arms, a plurality of gripping members, two paddles, a clasp arm and a paddle arm, a gripping member and a paddle, etc.).

[0181] In some implementations, the tissue engagement portion or anchor includes a first surface (e.g., the surface of a clip arm, a clasp arm, a paddle, etc.) and a second surface (e.g., the surface of a clip arm, a clasp arm, a paddle, etc.), and the first surface and the second surface close together or move closer to engage and / or capture tissue (e.g., the leaflet of a native valve, a membrane, a lining, muscle) within the tissue engagement portion or anchor (e.g., the tissue engagement portion or anchor acts as a tissue capture portion and can capture tissue).

[0182] In some implementations, the tissue engagement portion or anchor includes a first arm (e.g., a clip arm, a clasp arm, a paddle, etc.) and / or a second arm (e.g., a clip arm, a clasp arm, a paddle, etc.), and the first arm and the second arm close together or move closer to engage and / or capture tissue (e.g., the leaflet of a native valve, a membrane, a lining, muscle, etc.) within the tissue engagement portion or anchor (e.g., the tissue engagement portion or anchor acts as a tissue capture portion and can capture tissue). In some implementations, the first arm includes a first surface and / or the second arm includes a second surface.

[0183] In some implementations, at least one of the first arm and the second arm is movable to form a capture region therebetween for capturing tissue (e.g., a leaflet, etc.).

[0184] In some implementations, the tissue engagement portion or anchor includes a plurality of barbs for securing tissue (e.g., a leaflet, etc.) within the tissue engagement portion or anchor.

[0185] In some implementations, the tissue engagement portion or anchor includes a flexible printed circuit board (PCB) that includes an electrode pad or an electrode array having one or more electrodes coupled to the electrode pad. In some implementations, electrical leads extend away from the electrode pad / array.

[0186] In some implementations, a system, apparatus, and / or device is configured to apply an electrical signal to one or more electrodes through the electrical leads of the flexible PCB. In some implementations, a bioimpedance signal can be measured using the electrical leads based on or in response to the applied electrical signal.

[0187] In some implementations, applying a force to the electrical leads removes the flexible PCB and / or one or more electrodes from the system, apparatus, and / or device.

[0188] In some implementations, the flexible PCB is configured to be pulled through a pair of loops of a plurality of loops to remove the flexible PCB from the system, apparatus, and / or device.

[0189] In some implementations, the electrical leads extend between a pair of loops.

[0190] In some implementations, the electrode pads of the flexible PCB have a width greater than the distance between a pair of loops, and the electrode pads of the flexible PCB are configured to bend to fit between the pair of loops.

[0191] In some implementations, the width of the electrode pad is 1.875 times or less the distance between a pair of loops.

[0192] In some implementations, the width of the electrode pad is 1.25 times or less the distance between a pair of loops.

[0193] In some implementations, the distance between a pair of loops is 8 mm or less.

[0194] In some implementations, the force required to pull the electrode pad through a pair of returns is 1.5 N or less.

[0195] In some implementations, a flexible PCB is drawn around the sides of a plurality of returns and configured to remove the flexible PCB from the system, device, and / or apparatus.

[0196] In some implementations, the electrode pad has a diagonally bent section leading away immediately from the electrode pad such that the electrode pad is laterally offset from the electrical lead wire, such that the electrical lead wire is positioned along the sides of a plurality of returns while the electrode pad is within the tissue engagement portion or anchor.

[0197] In some implementations, by pulling on the electrical lead wire, the electrode pad exits the tissue engagement portion or anchor from the sides of the tissue engagement portion or anchor around a plurality of returns.

[0198] In some implementations, pulling on the electrical lead wire uses one or more of the plurality of returns as a fulcrum to laterally move the electrode pad relative to the plurality of returns and out of the sides of the tissue engagement portion or anchor, contacting the diagonally bent section to the plurality of returns.

[0199] In some implementations, the electrode pad includes a relief cut passing through the electrode pad such that applying sufficient force causes the electrode pad to split into a first lateral portion and a second lateral portion.

[0200] In some implementations, the flexible PCB includes a second electrical lead wire, the electrical lead wire being coupled to the first lateral portion of the electrode pad and the second electrical lead wire being coupled to the second lateral portion of the electrode pad.

[0201] In some implementations, the electrical lead and the second electrical lead each include a section that is angled obliquely 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 while the electrode pad is within the tissue engagement portion, the electrical lead is positioned along a first side of a plurality of turns, and the second electrical lead is positioned along a second side of the plurality of turns on an opposite side of the first side.

[0202] In some implementations, applying a proximal force to the electrical lead and the second electrical lead causes the electrode pad to split into a first lateral portion and a second lateral portion.

[0203] In some implementations, applying a proximal force to the electrical lead and the second electrical lead after the electrode has split at the first lateral portion and the second lateral portion causes the first lateral portion to exit the tissue engagement portion or anchor around the first side of the plurality of turns and the second lateral portion to exit the tissue engagement portion or anchor around the second side of the plurality of turns.

[0204] In some implementations, the flexible PCB includes a reference electrode coupled to the electrical lead.

[0205] In some implementations, the electrical lead is configured to extend proximally to the proximal end of a delivery system configured to implant a system, device, and / or apparatus.

[0206] In some implementations, a system, device, and / or apparatus (e.g., a treatment system, a repair system, a valve repair system, a treatment device, a repair device, which may be the same as or similar to other systems, devices, and / or apparatuses herein) includes an anchor portion that includes a tissue engagement portion or anchor (e.g., a clasp, a clip, a clamp, a plurality of arms, a plurality of gripping members, two paddles, a clasp arm and a paddle arm, a gripping member, and a paddle, etc.).

[0207] In some implementations, the tissue engagement portion or anchor includes a first surface (e.g., the surface of a clip arm, a fastener arm, a paddle, etc.) and a second surface (e.g., the surface of a clip arm, a fastener arm, a paddle, etc.) configured to engage (e.g., capture, attach, etc.) with tissue (e.g., the leaflet of a native valve, a membrane, a lining, muscle, etc.).

[0208] In some implementations, the tissue engagement portion or anchor includes a first arm (e.g., a clip arm, a fastener arm, a paddle, etc.) and / or a second arm (e.g., a clip arm, a fastener arm, a paddle, etc.) configured to engage (e.g., capture, attach, etc.) with tissue (e.g., the leaflet of a native valve, a membrane, a lining, muscle, etc.). In some implementations, the first arm includes a first surface and / or the second arm includes a second surface.

[0209] In some implementations, the system, device, and / or apparatus includes a distal portion configured to engage with an operating element (e.g., a wire, a line, a suture, a tube, a rod, etc.) of a delivery system. In some implementations, the operating element is configured to rotate to deploy an anchor portion.

[0210] In some implementations, the system, device, and / or apparatus includes an electrode coupled to the tissue engagement portion or anchor.

[0211] In some implementations, one or more wires are coupled to the electrode and to an operating element of the delivery system.

[0212] In some implementations, the system, device, and / or apparatus is configured such that an electrical signal can be applied to the electrode through one or more wires and a bioimpedance signal can be measured based on or in response to the applied electrical signal.

[0213] In some implementations, rotation of an operating element of the delivery system spools one or more wires around the operating element, thereby pulling the electrode away from the tissue engagement portion or anchor and removing the electrode from the system, device, and / or apparatus.

[0214] In some implementations, one or more wires are secured to a collar that is fixed to the operating element such that rotation of the operating element rotates the collar.

[0215] In some implementations, one or more electrical leads are coupled to the one or more wires with a collar to provide an electrical connection to the proximal end of the delivery system.

[0216] In some implementations, the electrode includes a flexible printed circuit board.

[0217] In some implementations, the electrode is removably fixed to the tissue engagement portion or anchor.

[0218] In some implementations, rotation of the operating element further spools the electrode around the operating element, thereby removing the electrode and one or more wires from the system, device, and / or apparatus.

[0219] In some implementations, 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 native valve, or may be a simulation and may be the same as or similar to other systems herein) that includes a delivery system and a valve repair device.

[0220] In some implementations, the methods and / or techniques include accessing the interior of the body using the system and repairing and / or treating body tissue. In some implementations, the methods and / or techniques include using the system to repair and / or treat a heart valve of the body.

[0221] In some implementations, the method and / or technique includes advancing a valve repair device to a heart valve using a delivery system and deploying or otherwise using the valve repair device to repair and / or treat the heart valve. In some implementations, deploying or otherwise using the valve repair device to repair and / or treat the heart valve includes securing the valve repair device to the tissue of the heart and / or heart valve.

[0222] In some implementations, the delivery system includes a catheter having a proximal end and a distal end, an actuating element, a wire extending within the lumen of the catheter from the proximal end of the catheter to the distal end of the catheter, and / or a capture mechanism at the distal end of the delivery system.

[0223] In some implementations, the valve repair device includes an attachment portion that includes a proximal component (e.g., a proximal collar, a proximal ring, a proximal extension, etc.) configured to engage the capture mechanism of the delivery system, and an anchor portion that includes a tissue engagement portion or an anchor (e.g., a helical anchor, a screw, a dart, a staple, a hook, a fastener, a clip, a clamp, a plurality of arms, a plurality of gripping members, two paddles, a fastener arm and a paddle arm, a gripping member and a paddle, combinations thereof, etc.).

[0224] In some implementations, the tissue engagement portion or the anchor includes a first surface (e.g., the surface of an anchor, an anchor head, a clip arm, a fastener arm, a paddle, etc.) configured to engage tissue (e.g., the annulus of a native valve, the leaflet of a native valve, a membrane, a lining, muscle, etc.).

[0225] In some implementations, the tissue engagement portion or the anchor includes a first surface (e.g., the surface of a clip arm, a fastener arm, a paddle, etc.) and a second surface (e.g., the surface of a clip arm, a fastener arm, a paddle, etc.) and is configured to capture tissue (e.g., the leaflet of a native valve, a membrane, a lining, muscle, etc.).

[0226] In some implementations, the tissue engagement portion or anchor includes a first arm (e.g., a clip arm, a clasp arm, a paddle, etc.) and / or a second arm (e.g., a clip arm, a clasp arm, a paddle, etc.) configured to capture tissue (e.g., the tip of a native valve, a membrane, a lining, muscle, etc.). In some implementations, the first arm includes a first surface and / or the second arm includes a second surface.

[0227] In some implementations, the valve repair device includes a distal portion configured to engage an actuating element of a delivery system, and the actuating element is configured to deploy an anchor portion.

[0228] In some implementations, the actuating element is also configured to release a capture mechanism from a proximal component.

[0229] In some implementations, electrodes are coupled to the tissue engagement portion or anchor (e.g., coupled to its first surface, etc.).

[0230] In some implementations, the electrical lead has a distal end coupled to the electrode and a proximal end coupled to a proximal component.

[0231] In some implementations, the valve repair device is configured to be able to apply an electrical signal to the electrodes through the electrical leads and to measure a bioimpedance signal based on or in response to the applied electrical signal.

[0232] In some implementations, the wire is configured to provide an electrical connection to the electrical leads that terminates upon withdrawal of the delivery system during delivery and deployment of the valve repair device.

[0233] In some implementations, the distal end of the wire includes a spring pin connector, the proximal end of the electrical lead is coupled to the electrical pad by a proximal component, and the spring pin connector of the wire provides electrical connection to the electrode by making electrical contact with the electrical pad of the electrical lead until the valve repair device is released from the delivery system.

[0234] In some implementations, the distal end of the wire includes an electrical pad, the proximal end of the electrical lead is coupled to a spring pin connector by a proximal component, and the spring pin connector of the electrical lead provides electrical connection to the electrode by making electrical contact with the electrical pad of the wire until the valve repair device is released from the delivery system.

[0235] In some implementations, the spring pin connector is configured to provide electrical contact between the electrical lead and the wire using a spring force parallel to the catheter shaft.

[0236] In some implementations, the spring force of the spring pin connector is configured to assist in removing the spring pin connector from the electrical pad.

[0237] In some implementations, the proximal component forms a groove and the electrical lead is coupled to the proximal component within the groove.

[0238] In some implementations, the capture mechanism includes fingers configured to mate with the groove of the proximal component to couple the valve repair device to the delivery system. In some implementations, the wire is coupled to the inner surface of the fingers such that the wire physically contacts the electrical lead within the groove to provide electrical contact between the wire and the electrical lead.

[0239] In some implementations, the release of the valve repair device from the delivery system disengages the fingers from the proximal component, thereby releasing the valve repair device and terminating the electrical contact between the wire and the electrical lead.

[0240] In some implementations, the grooves and fingers are coated with an insulating material to electrically insulate the electrical connection between the wire and the electrical lead.

[0241] In some implementations, the delivery system includes a tube coupled to a capture mechanism having a wire fixed within the tube, and the proximal end of the electrical lead is removably fixed within the tube to provide electrical contact between the wire and the electrical lead while the valve repair device is coupled to the delivery system.

[0242] In some implementations, withdrawal of the delivery system from the valve repair device moves the tube away from the proximal component, thereby releasing the electrical lead from the tube and terminating the electrical contact between the wire and the electrical lead.

[0243] In some implementations, the tube includes a leaf spring to provide a clamping force to the wire and the electrical lead to strengthen the electrical connection.

[0244] In some implementations, the delivery system includes a frame fixed to the distal end of a catheter, the tube is coupled to the frame, and the frame is configured to hold the tube in a target position relative to the valve repair device.

[0245] In some implementations, the frame is made of a polymer to electrically separate the electrical connection between the wire and the electrical lead.

[0246] In some implementations, the frame includes a U-shaped support that engages the attachment portion of the valve repair device.

[0247] In some implementations, the distal end of the wire terminates in a coil crimp having an inner diameter, and the proximal end of the electrical lead is positioned within the coil crimp, the inner diameter being 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 being configured to expand to release the electrical lead.

[0248] In some implementations, the coil crimp is configured to expand in response to being exposed to a temperature above a threshold temperature.

[0249] In some implementations, the coil crimp is configured to expand in response to a current that exceeds a threshold current driven through the wire.

[0250] In some implementations, the coil crimp is formed of a shape memory alloy in a martensite state and has an inner diameter smaller than the diameter of the electrical lead wire.

[0251] In some implementations, the coil crimp is configured to expand to have an inner diameter larger than the diameter of the electrical lead wire in response to a transition to an austenite state.

[0252] In some implementations, the coil crimp includes a bent position for strengthening the friction fit between the wire and the electrical lead wire.

[0253] In some implementations, the electrical lead wire is inserted into the coil crimp at the bent position.

[0254] In some implementations, the capture mechanism includes a pair of fingers configured to engage a proximal component and removably secure the valve repair device to the delivery system.

[0255] In some implementations, the capture mechanism includes a disk crimp having a first section coupled to a first finger of the pair of fingers and a second section coupled to a second finger of the pair of fingers. In some implementations, the first and second sections of the disk crimp form a connection channel when abutted by the pair of fingers.

[0256] In some implementations, when the first section and the second section are separated, the connection channel opening is sized such that a wire is coupled to the connection channel, an electrical lead seats within the connection channel, and the connection channel is sized such that the wire physically contacts the electrical lead to form an electrical connection.

[0257] In some implementations, by releasing the valve repair device from the delivery system, a pair of fingers separates from the proximal component, separating the first section from the second section of the disk crimp, thereby enabling the wire and the electrical lead to separate and terminate the electrical connection.

[0258] In some implementations, the disk crimp includes a polymer configured to electrically insulate the electrical connection between the wire and the electrical lead.

[0259] In some implementations, the first section is coupled to the first finger by inserting a portion of the first section through a window of the first finger to establish a friction fit between the first section and the first finger, and the second section is coupled to the second finger by inserting a portion of the second section through a window of the second finger to establish a friction fit between the second section and the second finger.

[0260] In some implementations, the first section and the second section each include a shape-setting alloy welded to the first finger and the second finger, respectively.

[0261] In some implementations, the connection channel is coated with an electrical insulation coating to electrically insulate the electrical connection between the wire and the electrical lead.

[0262] In some implementations, the delivery system includes a thermally actuated electrical connector coupled to a capture mechanism having a wire fixed within a thermally actuated electrical connector, wherein a proximal end of the electrical lead is removably fixed within the thermally actuated electrical connector to provide electrical contact between the wire and the electrical lead while the valve repair device is coupled to the delivery system.

[0263] In some implementations, the thermally actuated electrical connector is configured to change shape in response to the application of heat or current, and the change in shape is configured to release the electrical lead from the thermally actuated electrical connector.

[0264] In some implementations, withdrawal of the delivery system from the valve repair device includes applying heat or current to the thermally actuated electrical connector to open the thermally actuated electrical connector and release the electrical lead, thereby releasing the electrical lead from the thermally actuated electrical connector and terminating electrical contact between the wire and the electrical lead.

[0265] In some implementations, the thermally actuated electrical connector includes a shape memory alloy having a transition temperature above the average body temperature.

[0266] In some implementations, the thermally actuated electrical connector is heated using heated saline.

[0267] In some implementations, the thermally actuated electrical connector is released by applying current through the wire.

[0268] In some implementations, the thermally actuated electrical connector includes a flat tube having an opening orifice configured to transition to an open U-shape in response to the application of heat or current above a threshold to enable removal of the electrical lead.

[0269] In some implementations, the thermally actuated electrical connector includes a flat tube configured to transition to an open cylinder in response to the application of heat or current above a threshold to enable removal of the electrical lead.

[0270] In some implementations, the distal end of the wire includes a shape memory alloy formed in a shear hook and configured to transition to a straight wire upon application of heat or current. In some implementations, the proximal end of the electrical lead includes a shape memory alloy formed in a shear hook and configured to transition to a straight wire upon application of heat or current. In some implementations, the shear hook of the wire and the shear hook of the electrical lead are hooked together to form an electrical connection.

[0271] In some implementations, withdrawal of 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 severing the electrical lead and the wire and terminating the electrical connection between the wire and the electrical lead.

[0272] In some implementations, the thermally activated electrical connector is heated using heated saline.

[0273] In some implementations, the thermally activated electrical connector is released by applying current through the wire.

[0274] In some implementations, the wire includes a first portion including a first metal and a second portion including a shape memory alloy, the first portion being coupled to the second portion using a first crimp, and the electrical lead includes a first portion including a first metal and a second portion including a shape memory alloy, the first portion being coupled to the second portion using a second crimp.

[0275] In some implementations, the methods and / or techniques described herein relate to a device that includes a tissue engagement portion or a tissue capture portion that includes a first surface and a second surface. In some implementations, the methods and / or techniques described herein relate to the use of the device at a tissue site of the body. In some implementations, the methods and / or techniques described herein relate to using the device at a heart valve of the heart. In some implementations, the methods and / or techniques described herein relate to advancing the device within the heart and deploying (e.g., an anchoring ring, etc.) the device at a heart valve of the heart.

[0276] In some implementations, the tissue capture portion is configured such that the first surface and the second surface can close together or move closer together to capture tissue within the tissue capture portion.

[0277] In some implementations, at least one of the first surface and the second surface is movable to form a capture region between the first surface and the second surface to capture tissue, and / or is movable closer together to capture tissue therebetween.

[0278] In some implementations, two or more electrodes are coupled to the tissue capture portion. In some implementations, 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 implementations, 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., 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 capture portion is closed or open, etc.).

[0279] In some implementations, the two or more electrodes include a first electrode coupled to the first surface and a second electrode coupled to the second surface.

[0280] In some implementations, when the tissue capture portion is in a closed configuration, the first electrode is adjacent to the second electrode.

[0281] In some implementations, the first electrode includes an electrode plate that covers most of the first surface, and the second electrode includes an electrode plate that covers most of the second surface.

[0282] In some implementations, two or more electrodes include a first electrode coupled to the first surface and a second electrode coupled to the first surface.

[0283] In some implementations, the first electrode is separated from the second electrode by a gap.

[0284] In some implementations, the first electrode and the second electrode include electrode strips parallel to the length of the first surface.

[0285] In some implementations, the first electrode and the second electrode include electrode strips parallel to the width of the first surface.

[0286] In some implementations, the first electrode is positioned on the first surface at a first tissue capture depth.

[0287] In some implementations, the second electrode is positioned on the first surface at a second tissue capture depth greater than the first tissue capture depth.

[0288] In some implementations, the device includes an electrode plate coupled to the second surface.

[0289] In some implementations, the device includes an impedance measurement device configured to measure a bioimpedance signal and determine a tissue capture depth based on the measured bioimpedance signal.

[0290] In some implementations, the impedance measurement device implements an algorithm that generates an indicator of fully captured tissue, partially captured tissue, or over-captured tissue.

[0291] In some implementations, the impedance measurement device implements an algorithm that generates an indicator of tissue capture depth.

[0292] In some implementations, the impedance measurement device is configured to generate an indicator of the state of the tissue and / or the state of the tissue capture 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 that the tissue engagement portion or the tissue capture portion is closed or open, etc.) when the tissue capture portion is in a closed configuration.

[0293] In some implementations, the impedance measurement device is configured to generate an indicator of the state of the tissue when the tissue capture portion is in an open configuration.

[0294] In some implementations, the tissue capture portion is configured as one or more of, or includes, an anchor, a fastener, a clip, a clamp, a gripper, a grasping member, a paddle, an arm, combinations thereof, etc.

[0295] In some implementations, the methods and / or techniques described herein relate to a device (e.g., an implantable device configured to be implanted during a medical procedure, a treatment device configured to be used in a medical procedure even if not necessarily implanted) that includes a tissue engagement portion or an anchor configured to secure the device to the patient's tissue. In some implementations, at least one electrode is coupled to the tissue engagement portion or the anchor.

[0296] In some implementations, the device can apply an electrical signal to a tissue engagement portion or an anchor, and is configured to measure a bioimpedance signal based on or in response to the applied electrical signal. In some implementations, the bioimpedance signal provides an indication of the state or deployment state of the tissue engagement portion or anchor, and / or the state of the tissue relative to the tissue engagement portion or anchor.

[0297] In some implementations, the device includes an annular forming device.

[0298] In some implementations, the device further includes a plurality of anchors, each anchor including at least one electrode.

[0299] In some implementations, an electrical signal can be applied to the plurality of anchors, and a bioimpedance signal can be measured from each of the plurality of anchors based on or in response to the applied electrical signal, with each bioimpedance signal configured to indicate the deployment state of the corresponding anchor of the plurality of anchors.

[0300] In some implementations, the device includes a plurality of anchors that are electrically shorted together.

[0301] In some implementations, the device includes an impedance measurement device configured to measure a bioimpedance signal and determine an anchor deployment state based on the measured bioimpedance signal.

[0302] In some implementations, the impedance measurement device implements an algorithm to generate an indicator of the anchor deployment state, the anchor deployment state including an anchor in contact with the tissue, a partially deployed anchor, and a fully deployed anchor.

[0303] In some implementations, 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 native valve and / or other tissue of the simulation. In some implementations, the methods and / or techniques described include using a system, device, and / or apparatus to repair and / or treat a patient's native valve and / or other tissue or simulation.

[0304] In some implementations, the system, device, and / or apparatus includes a tissue engagement portion or anchor (e.g., a helical anchor, screw, dart, staple, hook, fastener, clip, clamp, multiple arms, multiple grasping members, two paddles, a fastener arm and a paddle arm, a grasping member and a paddle, etc.).

[0305] In some implementations, the tissue engagement portion or anchor includes a first arm (e.g., a clip arm, fastener arm, paddle, etc.) and a second arm (e.g., a clip arm, fastener arm, paddle, etc.), and the first arm and the second arm are configured to close together or move closer to engage and / or capture tissue (e.g., valve leaflets, membrane, lining, muscle, etc.) within the tissue engagement portion or anchor.

[0306] In some implementations, at least one of the first arm and the second arm is movable to form a capture region therebetween for capturing tissue (e.g., valve leaflets, etc.) and / or is movable to bring the first arm and the second arm closer together.

[0307] In some implementations, two or more electrodes are coupled to the tissue engagement portion or anchor.

[0308] In some implementations, a system, apparatus, and / or device can apply an electrical signal to two or more electrodes and can be configured to measure a bioimpedance signal based on or in response to the applied electrical signal.

[0309] In some implementations, the bioimpedance signal provides an indication of the state of the tissue within the tissue engagement portion or anchor (e.g., tissue capture state, tissue engagement state, etc.) and / or an indication of the state of the tissue engagement portion or anchor (e.g., open, closed, etc.).

[0310] In some implementations, two or more electrodes include a first electrode coupled to a first arm and a second electrode coupled to a second arm.

[0311] In some implementations, the first electrode is adjacent to the second electrode when closing the tissue engagement portion or anchor.

[0312] In some implementations, 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.

[0313] In some implementations, two or more electrodes include a first electrode coupled to a first arm and a second electrode coupled to the first arm.

[0314] In some implementations, the first electrode is separated from the second electrode by a gap.

[0315] In some implementations, the first electrode and the second electrode include electrode strips parallel to the length of the first arm.

[0316] In some implementations, the first electrode and the second electrode include electrode strips parallel to the width of the first arm.

[0317] In some implementations, the first electrode is positioned on the first arm at a target minimum tissue capture depth.

[0318] In some implementations, the second electrode is positioned on the first arm at the target maximum tissue capture depth.

[0319] In some implementations, the system, apparatus, and / or device includes an electrode plate coupled to the second arm.

[0320] In some implementations, the system, apparatus, and / or device includes an impedance measurement device configured to measure a bioimpedance signal and determine a measured bioimpedance signal based on tissue capture depth.

[0321] In some implementations, the impedance measurement device implements an algorithm that generates indicators of fully captured tissue, partially captured tissue, and / or overly captured tissue.

[0322] In some implementations, the system, apparatus, and / or device is configured to use a natural valve to capture valve tip tissue, and the impedance measurement device implements an algorithm that generates indicators of fully captured valve tips, partially captured valve tips, and / or overly captured valve tips.

[0323] In some implementations, the impedance measurement device implements an algorithm that generates an indicator of tissue capture depth.

[0324] In some implementations, the impedance measurement device is configured to generate an indicator of the state of the tissue (e.g., tissue capture state, tissue engagement state, etc.) when the tissue engagement portion or anchor is closed.

[0325] In some implementations, the impedance measurement device is configured to generate an indicator of the capture state when the tissue engagement portion or anchor is open.

[0326] In some implementations, a system (e.g., a measurement system, a detection system, a bioimpedance signal measurement system, etc.) may include a device that includes a tissue engagement portion having a first surface and a second surface. In some implementations, the tissue engagement portion is configured such that the first surface and the second surface can close together or move closer to capture tissue within the tissue engagement portion. In some implementations, at least one of the first surface and the second surface is movable to form a capture region between the first surface and the second surface to capture tissue.

[0327] In some implementations, two or more electrodes are coupled to the tissue engagement portion.

[0328] In some implementations, the system includes an impedance measurement device. In some implementations, the impedance measurement device includes a power source and an electrical sensor. The power source may be configured to apply an electrical signal to two or more electrodes.

[0329] In some implementations, the impedance measurement device is configured to measure a bioimpedance signal using the electrical sensor.

[0330] In some implementations, the bioimpedance signal responds to the applied electrical signal.

[0331] In some implementations, the bioimpedance signal provides an indication of the state of tissue within and / or in the vicinity of the tissue engagement portion.

[0332] In some implementations, two or more electrodes are coupled to one or more anchors of the device. In some implementations, two or more electrodes are coupled to one or more fasteners of the device.

[0333] In some implementations, an impedance measurement device is configured to measure electrical characteristics from two or more electrodes to determine the relative position of the device's fasteners and anatomical structures, tissues, etc. (e.g., anatomical structures or tissues such as those the device is adjacent to and / or in contact with).

[0334] In some implementations, the electrical characteristics include the amplitude between peaks of the oscillation of the bioimpedance signal. In some implementations, the electrical characteristics include the average value of the magnitude of the bioimpedance signal.

[0335] In some implementations, the system is configured to determine that two or more electrodes are in the blood and / or not in contact with tissue, at least in part based on the bioimpedance signal. In some implementations, the system is further configured to determine that two or more electrodes are in contact with the target tissue, at least in part based on the bioimpedance signal.

[0336] In some implementations, the system is configured to distinguish tissue types, at least in part based on the bioimpedance signal.

[0337] In some implementations, the system is configured to determine that two or more electrodes are transitioning from being primarily in contact with blood (and / or not in contact with tissue), at least in part based on the bioimpedance signal, to being in contact with tissue (e.g., partially in contact, primarily in contact, fully in contact, etc.).

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

[0339] In some implementations, an impedance measurement device includes a signal processing algorithm (e.g., on a non-transitory, computer-readable medium) that can indicate the state of the device.

[0340] In some implementations, an impedance measurement device implements and / or executes a signal processing algorithm to indicate the state of the device.

[0341] In some implementations, the state of the device includes complete capture of the valve tip, insufficient capture of the valve tip, excessive capture of the valve tip, and the relative position of the valve tip within the clip of the device.

[0342] In some implementations, the system includes a display that presents a derived indicator to the user, the derived indicator indicating the state of the device.

[0343] In some implementations, a system (e.g., a bioimpedance-based feedback system, a bioimpedance system, a feedback system, etc.) measures a bioimpedance signal, determines a tissue state (e.g., a capture state, an insertion state, etc.) for a device (e.g., an implantable device, a treatment device, a prosthetic device, etc.), and / or presents or otherwise provides 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 regarding an implant.

[0344] In some implementations, the system includes hardware, software, and / or firmware components for bioimpedance-based feedback. In some implementations, the system includes one or more of a data store, one or more processors, a measurement module, a capture module, and an indicator module.

[0345] In some implementations, the system includes one or more computing devices (e.g., a single computing device, multiple computing devices, a distributed computing environment, virtual devices existing within a public or private computing cloud, etc.).

[0346] In some implementations, the system includes a measurement module for obtaining or receiving an electrical signal from electrical components (e.g., sensors such as electrodes, sensors, arrays, etc. described anywhere in this specification, electrodes, etc.). In some implementations, the electrical signal corresponds to a bioimpedance signal and may also correspond to components such as resistance, capacitance, voltage, current, impedance. In some implementations, the measurement module is configured to determine an impedance value based on the obtained bioimpedance signal.

[0347] In some implementations, the system includes a state module (e.g., a capture module, a deployment module, etc.) for determining a state (e.g., the system, device, and / or device) based on the bioimpedance measurement value by the measurement module.

[0348] In some implementations, the bioimpedance measurement values (as well as readings of resistance, inductance, capacitance, voltage, and / or current) measured by the measurement module vary based on the anatomical structure or structures that the indicator electrode is close to or in contact with. In some implementations, the electrical characteristics measured by the measurement module, e.g., the bioimpedance signal, are used to determine the relative position of clasps, anchors, other device components, etc., and the anatomical structure (e.g., tissue, etc.) or blood that the device associated with the system is close to and / or in contact with.

[0349] In some implementations, the algorithms, methods, steps, processes, etc. described herein can be stored on a non-transitory computer-readable medium. In some implementations, the algorithms, methods, steps, processes, etc. described herein can be implemented in a state module to determine a state (e.g., of a device, of an organization, etc.) based on measurement values obtained by a measurement module.

[0350] In some implementations, the system includes an indicator module for indicating the results from the state module.

[0351] In some implementations, the system includes a data store configured to store configuration data, measurement data, analysis parameters, control commands, databases, algorithms, executable instructions (e.g., instructions for one or more processors), etc.

[0352] In some implementations, the system includes one or more processors configured to control the operation of one or more of the measurement module, capture module, indicator module, and / or data store. In some implementations, the one or more processors implement, execute, and / or utilize software modules, hardware components, and / or firmware elements configured to provide bioimpedance-based feedback.

[0353] In some implementations, a non-transitory computer-readable medium is provided that includes computer-executable instructions for causing one or more processors to execute any of the algorithms, procedures, processes, or methods described herein.

[0354] The above methods and any methods using the systems, assemblies, devices, apparatuses, etc. described herein can be performed on a living subject (e.g., a human or other animal) or a simulation (e.g., a cadaver, a cadaver heart, a virtual person, a simulator, etc.). In a simulation, body parts can optionally be referred to as "simulated" (e.g., a simulated heart, simulated tissue, etc.) and can optionally include a computerized and / or physical representation.

[0355] Any of the above systems, assemblies, devices, apparatuses, components, etc. can be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure safe use on a patient, and the methods herein can include (or additional methods can include or consist of) the sterilization (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of one or more of the systems, devices, apparatuses, components, etc. described herein.

[0356] A further understanding of the nature and advantages of the disclosed subject matter will be provided in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts bear like reference numerals.

Brief Description of the Drawings

[0357] To further clarify the various aspects of the embodiments of the present disclosure, a more specific description of specific embodiments and implementation examples will be made with reference to the various aspects of the accompanying drawings. It will be understood that these drawings show only exemplary implementation examples of the present disclosure and are not to be considered as limiting the scope of the present disclosure. Moreover, for some embodiments, the drawings can be shown to scale, while not necessarily for all embodiments. The embodiments of the present disclosure as well as other features and advantages will be described and explained with additional specificity and detail by the use of the accompanying drawings.

[0358]

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Mode for Carrying Out the Invention

[0359] In the following description, reference is made to the accompanying drawings that illustrate exemplary implementations of the present disclosure. Other implementations having different structures and operations are not outside the scope of the present disclosure.

[0360] Abstract This specification discloses devices and methods that use bioimpedance or bioimpedance-based feedback to provide useful information during a medical procedure. Bioimpedance or bioimpedance-based feedback includes measuring or acquiring an electrical signal that includes a bioimpedance signal (e.g., a signal indicative of bioimpedance). The bioimpedance signal can be used to determine the position and / or state of a device (e.g., an implantable device, a delivery device of a therapeutic device, etc.) or a portion thereof (e.g., a clip, a valve, an anchor, etc.) relative to a tissue or other part of the body. The bioimpedance signal can be analyzed and converted into information presented to a clinician (e.g., words, 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 anchor element of an implant, etc.).

[0361] Bioimpedance is related to the electrical properties of tissues (or other biological materials) within the body. Bioimpedance is a measure of how much a tissue impedes the flow of an electric current. Fat has a high specific resistance, and blood has a low specific resistance. For a given current applied to a tissue, a low impedance corresponds to a low voltage, and vice versa. Tissues contain cells and membranes, and membranes are thin with a high resistivity and behave electrically as capacitors. By using a high measurement frequency, the current passes through these capacitors, and the resulting signal depends on both the tissue and the liquid inside and outside the cell. However, at low frequencies, the membrane impedes the flow of the current, and the result depends only on the liquid outside the cell. The magnitude and phase of the impedance Z are given by the following. [Number] When R is resistance, X_L is inductive reactance, X_C is capacitive reactance, R is the total resistance, and X is the total reactance. The impedance can also be expressed as follows using real and imaginary components. Z = R + jX

[0362] In some implementations, the systems and / or devices of this specification include a device (e.g., a therapeutic device, a prosthetic device, an implantable device, etc.) or a portion of a device that includes electrodes. In some implementations, the systems and / or devices of this specification include a delivery system and / or device or a portion thereof that includes electrodes (e.g., a catheter having electrodes, etc.).

[0363] For example, power in the form of alternating current, direct current, etc. can be provided to the electrodes being measured and electrical signals (e.g., voltage, current, change in voltage, change in current, etc.). Using a bioimpedance signal that forms part of (or can be determined from) the measured electrical signal, conclusions or estimations related to the system / device (e.g., related to the state of the device or the anchor portion of the device) can be drawn.

[0364] In some implementations, when the electrodes are implemented in a fastener, clamp, clip, gripping portion, anchor, etc. of a device (e.g., an implantable device, a therapeutic device, a prosthetic device, etc.), the bioimpedance signal can correlate with the amount of tissue within the fastener, clamp, clip, gripping portion, anchor, etc. of the device.

[0365] In some implementations, the bioimpedance signal can be used to monitor the depth of an anchor (e.g., a helical anchor, a tissue anchor, a screw, a dart, a staple, etc.) of a device in tissue, valve height and positioning, continuous anchor deployment, etc.

[0366] In some implementations, the bioimpedance signal can be analyzed and presented in real time to provide useful information to a clinician implanting an implantable device and / or while using a therapeutic device or a prosthetic device (even if not permanently implanted). This can use a unidirectional bioimpedance signal to provide useful feedback to the clinician or medical system regarding the state of the device or implant and / or its components.

[0367] In some implementations, the value of the bioimpedance signal and / or the change in the bioimpedance signal may primarily indicate the transfer from the blood into the contacting tissue. In some implementations, the value of the bioimpedance signal and / or the change in the bioimpedance signal may indicate a transition from a state of contacting a first type of tissue (e.g., valve leaflet, etc.) that is in contact with a second type of tissue (e.g., annulus, heart wall, etc.).

[0368] In some implementations, the value or change of the bioimpedance signal may correlate with the amount of contact with the tissue that the device has (e.g., the amount of valve leaflet within a clip, the depth of an anchor within the tissue, the height and / or positioning of a valve, etc.).

[0369] In some implementations, the value or change of the bioimpedance signal may correlate with the position / location of the delivery device (e.g., catheter, anchor driver, hypodermic tube, pusher, etc.), and / or whether the delivery device is in contact with the tissue or a different type of tissue.

[0370] Figures 1 and 2 are cross-sectional views of a human heart H during 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, respectively, i.e., the atrioventricular valves. Further, 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 valve leaflets (e.g., leaflets 20, 22 shown in FIGS. 3-6 and leaflets 30, 32, 34 shown in FIG. 7) that come together or "coapt" in the flow to form a one-way fluid occluding surface and extend inwardly across their respective valve orifices. The native valve repair system of the present application is frequently described and / or illustrated with respect to the mitral valve MV. Accordingly, the anatomical structure of the left atrium LA and the left ventricle LV is described in more detail. However, the devices described herein can also be used in the repair of other native valves, e.g., the devices can be used in the repair of the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV.

[0371] The left atrium LA receives oxygen-rich blood from the lungs. During the diastolic phase, i.e., the expansion phase as seen in Figure 1, the blood that has already been collected within the left atrium LA (during the systolic phase) moves through the mitral valve MV into the left ventricle LV due to the expansion of the left ventricle LV. During the systolic phase, i.e., the contraction phase as seen in Figure 2, the contraction of the left ventricle LV pumps the blood through the aortic valve AV and the ascending aorta AA into the body. During the systolic phase, the closure of the leaflets of the mitral valve MV prevents the backflow of blood from the left ventricle LV back into the left atrium LA, and the blood is collected from the pulmonary veins into the left atrium. In some implementations, the devices described in this application are used to repair the function of a defective mitral valve MV. That is, the device is configured to assist in the closure of the leaflets of the mitral valve to prevent or inhibit the backflow of blood from the left ventricle LV back into the left atrium LA. Many of the devices described in this application are designed to easily grip and fix the natural leaflets around a bonding element or spacer that beneficially acts as a filling material within the backflow orifice to prevent or inhibit backflow during the systolic phase, but this is not essential.

[0372] Referring now to FIGS. 1-7, the mitral valve MV includes two valve leaflets, an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also includes an annulus 24, which is a variably dense fibrous annular tissue surrounding the leaflets 20, 22. Referring to FIGS. 3 and 4, the mitral valve MV is secured to the wall of the left ventricle LV by chordae tendineae CT. The chordae tendineae CT are cord-like tendons that connect the papillary muscles PM (i.e., the muscles located within the wall of the left ventricle LV at the base of the chordae tendineae CT) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles PM function to limit the movement of the leaflets 20, 22 of the mitral valve MV and prevent the mitral valve MV from inverting. The mitral valve MV opens and closes in response to pressure changes within the left atrium LA and the left ventricle LV. The papillary muscles PM do not open and close the mitral valve MV. Rather, the papillary muscles PM support or reinforce the leaflets 20, 22 against the high blood pressure necessary to circulate blood throughout the body. The papillary muscles PM and the chordae tendineae CT together are known as the subvalvular apparatus, which functions to prevent the mitral valve MV from prolapsing into the left atrium LA when the mitral valve closes. As can be seen from the left ventricular outflow tract (LVOT) view shown in FIG. 3, the anatomical structure of the leaflets 20, 22 is such that the inner surfaces of the leaflets join at the free end portion and the leaflets 20, 22 begin to recede or spread apart from each other. The leaflets 20, 22 spread apart in the atrial direction until each leaflet contacts the annulus of the mitral valve.

[0373] Various disease processes can impair one or more of the suitable functions of the native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow's disease, elastin deficiency, etc.), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis, etc.). In addition, damage to the left ventricle LV or the right ventricle RV due to a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other heart diseases (e.g., cardiomyopathy, etc.) can distort the shape of the native valve, which can lead to native valve insufficiency. However, the majority of patients undergoing valve surgery, such as mitral valve MV surgery, suffer from degenerative diseases that cause insufficiency in the leaflets (e.g., leaflets 20, 22) of the native valve (e.g., mitral valve MV), resulting in prolapse and regurgitation.

[0374] In general, native valves can malfunction in different ways, including (1) valvular stenosis and (2) valvular regurgitation. Valvular stenosis occurs when the native valve does not open fully, thereby causing an obstruction to blood flow. Typically, valvular stenosis is due to the accumulation of calcific material on the valve leaflets, which thickens the leaflets and impairs the ability of the valve to open fully and allow forward blood flow. Valvular regurgitation occurs when the valve leaflets do not close fully, thereby allowing blood to leak back into the previous cardiac chamber (e.g., blood leaks from the left ventricle into the left atrium).

[0375] There are three main mechanisms by which native valves become regurgitant or insufficient, and these mechanisms include Carpentier's type I, II, and III insufficiencies. Carpentier's type I insufficiency is associated with dilation of the valve annulus, as a result of which the normally functioning valve leaflets move apart and are unable to form a tight seal (i.e., the leaflets do not appose properly). Included in type I mechanism insufficiencies are perforations of the valve leaflets, such as those present in endocarditis. Carpentier's type II insufficiency is associated with one or more of the native valve leaflets prolapsing above the plane of coaptation. Carpentier's type III insufficiency is associated with restriction of the movement of one or more of the native valve leaflets, such that the leaflets are abnormally constrained below the plane of the valve annulus. Restriction of the leaflets can be caused by rheumatic disease (Ma) or ventricular dilation (IIIb).

[0376] Referring to FIG. 5, when the healthy mitral valve MV is in the closed position, the anterior leaflet 20 and the posterior leaflet 22 are joined, thereby preventing blood from leaking from the left ventricle LV to the left atrium LA. Referring to FIGS. 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 systole, and as a result, the edges of the leaflets 20, 22 do not contact each other. Such a poor junction results in a gap 26 between the anterior leaflet 20 and the posterior leaflet 22, thereby allowing blood to flow backward from the left ventricle LV to the left atrium LA during systole, as shown by the mitral regurgitation MR flow path shown in FIG. 3. Referring to FIG. 6, the gap 26 may have a width W of about 2.5 mm to about 17.5 mm, about 5 mm to about 15 mm, about 7.5 mm to about 12.5 mm, or about 10 mm. In some situations, the gap 26 may have a width W greater than 15 mm. As described above, there are several different ways in which leaflet dysfunction (e.g., leaflets 20, 22 of the mitral valve MV) can cause valvular regurgitation.

[0377] 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 designed such that the anterior leaflet 20 and the posterior leaflet 22 can be engaged to close the gap 26 and prevent or suppress the backward flow of blood through the mitral valve MV. As can be understood from FIG. 4, an abstract representation of the device, valve repair device, or implant 10 is shown embedded between the leaflets 20, 22 so that no backward flow occurs during systole (compare FIG. 3 with FIG. 4). In some implementations, the joining elements (e.g., spacers, coaptive elements, gap fillers, etc.) of the device 10 have a generally tapered or triangular shape that naturally conforms to the geometry of the native valve and the nature of the leaflets that expand (toward the annulus). In this application, terms such as spacer, coaption element, joining element, and gap filler are used interchangeably and refer to elements that fill a portion of the space between the leaflets of the native valve and / or are configured such that the leaflets of the native valve engage or "coapt" (e.g., the native leaflets engage not only with each other but also with coaptive elements, joining elements, spacers, etc.).

[0378] Although stenosis or regurgitation can affect any valve, stenosis has been found to primarily affect either the aortic valve (AV) or the pulmonary valve (PV), and regurgitation has been found to primarily affect either the mitral valve (MV) or the tricuspid valve (TV). Both valvular stenosis and valvular regurgitation increase the burden on the heart (H), and if left untreated, can lead to extremely serious conditions such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. This is 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, because the pressure is substantially higher in the left side of the heart, dysfunction of the mitral valve (MV) or aortic valve (AV) is particularly problematic and often life-threatening.

[0379] Dysfunctional native heart valves can be either repaired or replaced. Repair typically involves maintaining and correcting a patient's native valve. Replacement typically involves replacing a patient's native valve with a biological or mechanical substitute. Typically, the aortic valve (AV) and pulmonary valve (PV) are more prone to stenosis. Because the stenotic damage sustained by the valve leaflets is irreversible, treatment for a stenotic aortic valve or pulmonary valve can involve removal of the valve and replacing it with a surgically implanted heart valve or a transcatheter heart valve. The mitral valve (MV) and tricuspid valve (TV) are more prone to 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 regurgitation or backflow of blood from the ventricle into the atrium (e.g., a deformed mitral valve (MV) can allow regurgitation or backflow from the left ventricle (LV) into the left atrium (LA), as shown in FIG. 3). Regurgitation, or backflow, of blood from the ventricle to the atrium results in valvular insufficiency. Deformities in the structure or shape of the mitral valve MV or tricuspid valve TV are often repairable. In addition, regurgitation can occur due to dysfunction of the chordae tendineae CT (e.g., the chordae tendineae CT may stretch or rupture), allowing the anterior and posterior leaflets 20 and 22 to evertate, resulting in regurgitation of blood into the left atrium LA. Problems caused by dysfunctional chordae tendineae CT can be ameliorated by repairing the structure of the chordae tendineae CT or mitral valve MV (e.g., by fixating the leaflets 20, 22 at the affected portion of the mitral valve).

[0380] The devices and procedures disclosed herein often refer 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 on any native valve (e.g., the tricuspid valve), as well as any other medical procedure that implants an implantable device and / or grasping tissue as part of a treatment and / or repair procedure (even if the device is not implanted).

[0381] Exemplary Devices Exemplary devices or implants that can implement the concepts described herein (e.g., therapeutic devices, prosthetic devices, valve repair devices, implantable devices, implantable artificial devices, etc.) can optionally include a joining element (e.g., a spacer, a fusion element, a gap filler, etc.) and at least one anchor (e.g., one, two, three, or more). In some implementations, the device or implant can have any combination or sub - combination of the mechanisms disclosed herein without a joining element.

[0382] In some implementations, when included, the joining element (e.g., a fusion element, a spacer, etc.) can be configured to be positioned inside the natural heart valve opening to assist in filling the space between the valve leaflets and form a more effective seal, thereby reducing, preventing, or suppressing the backflow described above.

[0383] In some implementations, the optional joining element has impermeability and / or resistance to blood flow (or reduces or suppresses blood flow) and has a structure that allows the natural valve leaflets to close around the joining element to block the backflow of blood from the left or right ventricle to the left or right atrium, respectively, during ventricular contraction. Since the joining element can fill the space between the dysfunctional natural valve leaflets (e.g., the mitral valve leaflets 20, 22 or the tricuspid valve leaflets 30, 32, 34) that do not close completely, it is sometimes referred to herein as a spacer.

[0384] The device or implant can be configured to seal against the leaflets of two or three natural valves, i.e., the device can be used with the natural mitral valve (bicuspid valve) and the natural tricuspid valve.

[0385] Optional joining elements (e.g., spacers, healing elements, etc.) can have various shapes. In some implementations, the joining element can have an elongate cylindrical shape with a circular cross-sectional shape. In some implementations, the joining 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 implementations, the joining element can have an atrial portion positioned within or adjacent to the atrium, a ventricular portion or a lower portion positioned within or adjacent to the ventricle, and a side surface extending between natural valve leaflets. In some implementations configured for use with the tricuspid valve, the atrial portion or upper portion is positioned within or adjacent to the right atrium, the ventricular portion or lower portion is positioned within or adjacent to the right ventricle, and the side surface extends between the natural tricuspid valve leaflets.

[0386] In some implementations, an anchor (e.g., a clasp, a clip, a clamp, multiple arms, multiple gripping members, two paddles, a clasp arm and a paddle arm, a gripping member and a paddle arm, etc.) can be configured to secure the device to one or both of the native valve leaflets such that the joining element is positioned between the two native valve leaflets. In some implementations configured for use with a tricuspid valve, the anchor is configured to secure the device to one, two, or three of the tricuspid valve leaflets such that the joining element is positioned between the three native valve leaflets. In some implementations, the anchor can be attached to the joining element at a location adjacent to the ventricular portion of the joining element. In some implementations, the anchor can be attached to an actuating element such as a shaft or an actuating wire to which the joining element is also attached. In some implementations, the anchor and the joining element can be positioned independently of each other by moving each of the anchor and the joining element separately along the longitudinal axis of an actuating element (e.g., an actuating shaft, an actuating rod, an actuating tube, an actuating wire, etc.). In some implementations, the anchor and the joining element can be positioned simultaneously by moving the anchor and the joining element together along the longitudinal axis of an actuating element such as a shaft, an actuating wire, etc. The anchor can be configured to be positioned behind the native valve leaflet when used and / or implanted such that the valve leaflet is gripped by the anchor.

[0387] The device or implant can be configured to be used, operated, and / or implanted via a delivery system or other delivery means. The delivery system can include one or more of a guide / delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, a tube, combinations thereof, and the like. Optional bonding elements and anchors can be compressible into a radially compressed state and can be self-expanding into a radially expanded state when the compression pressure is released. The device can be configured such that the anchor expands radially away from a bonding element that is initially still compressed to create a gap between the bonding element and the anchor. Thereafter, the native valve leaflet can be positioned within the gap. The bonding element can be expanded radially to close the gap between the bonding element and the anchor and capture the valve leaflet between the bonding element and the anchor. In some implementations, the anchor and the bonding element are optionally configured to self-expand. Various exemplary methods are discussed more fully below with respect to each implementation.

[0388] Additional information regarding these and other delivery methods that can be used with the various systems and devices of this specification 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 Nos. PCT / US2022 / 035672, PCT / US2022 / 037983, PCT / US2022 / 050158, PCT / US2022 / 051232, PCT / US2022 / 049305, PCT / US2022 / 037176, PCT / US2022 / 025390, each of which is hereby incorporated by reference in its entirety for all purposes. These methods can be performed on a live animal with necessary modifications, or can be performed in simulations on cadavers, cadaver hearts, anthropomorphic ghosts, simulators (e.g., where a body part, heart, tissue, etc. is simulated), and the like.

[0389] The disclosed device or implant can be configured such that the anchor is connected to the valve leaflet and utilizes the tension from the natural chordae tendineae to resist the high systolic pressure that biases the device towards the left atrium. During diastole, the device can rely on the compressive and holding forces acting on the valve leaflet gripped by the anchor.

[0390] Referring now to FIGS. 8 - 15, an exemplary device or implant 100 (exemplary, artificial spacer device, valve repair device, valve treatment device, etc.), schematically illustrated, is shown at various deployment stages. The device or implant 100 and other similar devices / implants that can be used with the various implementations, systems, and devices herein are described in detail in PCT Patent Application Publication Nos. WO2018 / 195215, WO2020 / 076898, WO2019 / 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 hereby incorporated by reference in their entirety for all purposes. The device 100 (and other systems and devices referred to herein) can include any other features for the devices or implants described in this application or the applications referred to above, and the device 100 can be positioned to engage valve tissue (e.g., valve leaflets 20, 22, 30, 32, 34) as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application or the applications referred to in this application).

[0391] The device or implant 100 is deployed from a delivery system, delivery device, or other delivery means 102. The delivery system 102 can include one or more of a catheter, sheath, guide catheter / sheath, delivery catheter / sheath, steerable catheter, implant catheter, tube, channel, pathway, combinations thereof, and the like. The device or implant 100 includes a junction portion 104 and an anchor portion 106.

[0392] In some implementations, the junction portion 104 of the device or implant 100 is configured to be implanted between the leaflets of a native valve (e.g., a native mitral valve, a native tricuspid valve, etc.) and includes an optional junction element 110 (e.g., a spacer, plug, filler, foam, sheet, membrane, healing member, etc.) that is slidably attached to an actuating element 112 (e.g., an actuating wire, actuating shaft, actuating tube, etc.).

[0393] In some embodiments, the anchor portion 106 is operable between an open state and a closed state and includes one or more anchors 108 that can take a variety of forms, such as paddles, gripping elements, clasps, clips, clamps, clasp arms and paddle arms, gripping members and paddles. Actuation of the actuating means or actuating element 112 causes the anchor portion 106 of the device 100 to open and close and grip the leaflets of the native valve during implantation. The actuating means or actuating element 112 (as well as other actuating means and actuating elements herein) can take a variety of different forms (e.g., wires, rods, shafts, tubes, screws, sutures, lines, strips, combinations thereof, etc.), can be made of a variety of different materials, and can have a variety of configurations. As one example, the actuating element can be threaded such that rotation of the actuating element causes the anchor portion 106 to move relative to the junction portion 104. Alternatively, the actuating element can be unthreaded such that pushing or pulling on the actuating element 112 causes the anchor portion 106 to move relative to the junction portion 104.

[0394] In some implementations, the anchor portion 106 and / or the anchor of device 100 includes outer paddles 120 and inner paddles 122 that are connected between cap 114 and joining element 110 by portions 124, 126, 128. Portions 124, 126, 128 can be jointed and / or flexible so as to move between all positions described hereinafter. The mutual connection of outer paddle 120, inner paddle 122, joining element 110, and cap 114 by portions 124, 126, 128 can constrain the device to the positions and movements illustrated herein.

[0395] In some implementations, delivery system 102 includes a steerable catheter, an implant catheter, and an actuating means or 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 implementations, actuating means or element 112 extends through the delivery catheter and joining element 110 to the distal end (e.g., cap 114 or other attachment portion at the distal connection of anchor portion 106). The extension and retraction of actuating element 112 increase and decrease, respectively, the distance between joining element 110 and the distal end of the device (e.g., cap 114 or other attachment portion). In some implementations, a collar or other attachment element removably attaches joining element 110 to delivery system 102, either directly or indirectly, whereby actuating means or element 112 slides through the collar or other attachment element and, in some implementations, through joining means or joining element 110 during actuation to open and close paddles 120, 122 of anchor portion 106 and / or anchor 108.

[0396] In some implementations, the anchor portion 106 and / or the anchor 108 can include an attachment portion or a gripping member. As shown, in some implementations, the gripping member (or tissue engagement portion) includes a clasp 130 and a joining portion 138 that includes a base or fixed arm 132, a movable arm 134, an optional return, a friction enhancing element, or other securing means 136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.).

[0397] In some implementations, a fixed arm may not be used, and another part of the device (e.g., another component, surface, element, etc.) can perform the functions described herein with respect to the fixed arm.

[0398] In some implementations, the fixed arm 132 is attached to the inner paddle 122. In some implementations, the fixed arm 132 is attached to the inner paddle 122 with the joining portion 138 positioned proximate to the joining element 110. In some implementations, the clasp (e.g., a return clasp, etc.) has a flat surface and does not fit within a recess of the inner paddle. Rather, the flat portion of the clasp is positioned against the surface of the inner paddle 122. The joining portion 138 provides a spring force between the fixed arm 132 and the movable arm 134 of the clasp 130. The joining portion 138 can be any suitable joint, such as a flexible joint, a spring joint, a swivel joint, or the like. In some implementations, the joining portion 138 is a flexible piece of material integrally formed with the fixed arm 132 and the movable arm 134. The fixed arm 132 is attached to the inner paddle 122 and remains stationary or substantially stationary with respect to the inner paddle 122 when the movable arm 134 is in an open position, opening the clasp 130 and exposing the optional return, friction enhancing element, or securing means 136.

[0399] In some implementations, the fastener 130 is opened by applying tension to an actuating line 116 attached to the movable arm 134, thereby causing the movable arm 134 to articulate, flex, or pivot on the joint 138. The actuating line 116 extends through the delivery system 102 (e.g., through a steerable catheter and / or an implant catheter). Other actuation mechanisms are also possible.

[0400] The actuating line 116 can take a variety of forms, such as, for example, a line, suture, wire, rod, catheter, or the like. The fastener 130 can be spring-loaded, such that the fastener 130 continues to provide a clamping force against the grasped native valve leaflet in the closed position. This clamping force remains constant regardless of the position of the inner paddle 122. Optional returns, friction enhancing elements, or other securing means 136 of the fastener 130 can grip, clamp, and / or pierce the native valve leaflet to further secure it.

[0401] During implantation, the paddles 120, 122 can be opened and closed, for example, to grasp tissue (e.g., a native valve leaflet, a native mitral valve leaflet, a native tricuspid valve leaflet, etc.) between the paddles 120, 122 and / or between the paddles 120, 122 and the engagement element 110. The fastener 130 can be used to grip and / or further secure the tissue by engaging the tissue with an optional return, friction enhancing element, or securing means 136 and by sandwiching the tissue (e.g., the valve leaflet, etc.) between the movable arm 134 and the fixed arm 132. The tissue engagement portion or an optional return, friction enhancing element, or other securing means 136 of the fastener 130 (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.) can increase friction with the tissue or can partially or fully penetrate the tissue.

[0402] In some implementations, the actuation lines 116 can be actuated separately, so that each tissue engagement portion or fastener 130 can be opened and closed separately. The separate actuation allows for gripping one valve tip at a time, or repositioning the tissue engagement portion or fastener 130 on the tissue (e.g., valve tip, etc.) where the gripping was insufficient without successfully gripping the other valve tip. In some implementations, the fastener 130 can be opened and closed relative to the position of the inner paddle 122 (as long as the inner paddle is in the open position or at least a partially open position), thereby allowing the valve tip to be gripped at various positions required by the particular situation.

[0403] Referring now to FIG. 8, an exemplary device 100 is shown in an extended or fully open state for deployment from an implant delivery catheter of a delivery system 102. The device 100 is positioned at the end of the catheter in the fully open position because the fully open position occupies the least amount of space and can use the smallest catheter (or, for a given catheter size, can use the largest device). The cap 114 is spaced from the engagement element 110 in the extended state such that the paddles 120, 122 are fully extended. In some implementations, the angle formed between the inside of the outer paddle 120 and the inner paddle 122 is about 180 degrees. The fastener 130 is maintained in the closed state during deployment through the delivery system 102 so that optional returns, friction enhancing elements or other securing means 136 (FIG. 9) do not capture or damage the tissue within the delivery system 102 or the patient's heart.

[0404] Referring now to FIG. 9, the device 100 is shown in an extended relaxed state similar to FIG. 8, but with the fastener 130 in a fully open position in the range of about 140 degrees to about 200 degrees, in the range of about 170 degrees to about 190 degrees or about 180 degrees between the fixed arm 132 and the movable arm 134 of the fastener 130. It has been found that the full opening of the paddles 120, 122 and the fastener 130 improves the ease of disengagement or peeling from the patient's anatomical structures such as the chordae tendineae CT during implantation of the device 100.

[0405] Referring now to FIG. 10, device 100 is shown in a retracted or fully closed state. The compact size of device 100 in the retracted state can make the operation and placement inside the heart easier. To move device 100 from the extended state to the retracted state, by housing the actuating means or actuating element 112, cap 114 is pulled towards joining element 110. The connection portion 126 (e.g., joint, flexible connection, etc.) between outer paddle 120 and inner paddle 122 is constrained in movement, and as a result, due to the compressive force acting on outer paddle 120 from cap 114 being housed towards joining element 110, the paddle or gripping element moves radially outward. Outer paddle 120 maintains an acute angle with the actuating means or actuating element 112 during the movement from the open position to the closed position. Outer paddle 120 can optionally be biased towards the closed position. Inner paddle 122 is oriented away from the open joining element 110 during the same movement, thus moving over a very large angle and crushing along the side of the closed joining element 110. In some implementations, inner paddle 122 is thinner and / or narrower than outer paddle 120, and the connection portions 126, 128 (e.g., joints, flexible connections, etc.) connected to inner paddle 122 can be thinner and / or more flexible. For example, this increased flexibility can allow for greater movement than the connection portion 124 connecting outer paddle 120 to cap 114. In some implementations, outer paddle 120 is narrower than inner paddle 122. The connection portions 126, 128 connected to inner paddle 122 can be made more flexible to allow for greater movement, for example, than the connection portion 124 connecting outer paddle 120 to cap 114. In some implementations, inner paddle 122 can have the same width or substantially the same width as the outer paddle.

[0406] Referring now to FIGS. 11 - 13, the device 100 is shown in a partially open grasping preparation state. Actuating means or elements (e.g., an actuating wire, an actuating shaft, etc.) extend to push the cap 114 away from the joining element 110 in order to transition from a fully closed state to a partially open state, thereby pulling the outer paddle 120 and then pulling the inner paddle 122, causing the anchor or anchor portion 106 to spread partially. The actuating line 116 is retracted and the fastener 130 is opened, enabling the grasping of the target tissue or valve tip. In some implementations, the pair of inner and outer paddles 122, 120 are moved integrally rather than independently by a single actuating means or a single actuating element 112. Also, the position of the fastener 130 depends on the position of the paddles 122, 120. For example, referring to FIG. 10, closing the paddles 122, 120 closes the fastener as well. In some implementations, the paddles 120, 122 may be controllable independently. For example, the device 100 can have two actuating elements and two independent caps (or other attachment parts), such that by using one independent actuating element (e.g., a wire, a shaft, etc.) and a cap (or other attachment part), one paddle can be controlled, and by using the other independent actuating element and a cap (or other attachment part), the other paddle can be controlled.

[0407] Referring now to FIG. 12, one of the actuating lines 116 can be extended to close one of the fasteners 130. Referring now to FIG. 13, the other actuating line 116 can be extended to close the other fastener 130. One or both of the actuating lines 116 can be actuated repeatedly to open and close the fastener 130 repeatedly.

[0408] Referring now to FIG. 14, device 100 is shown in a fully closed and deployed state. Delivery system or means 102 and actuating means or elements 112 are housed, and paddles 120, 122 and clasps 130 remain in their fully closed positions. When deployed, device 100 can be maintained in its fully closed position by a mechanical latch or biased to remain closed by the use of a spring material such as steel, other metals, plastics, composite materials, or a shape memory alloy such as nitinol. For example, connecting portions 124, 126, 128, joining portion 138, and / or inner and outer paddles 122, and / or additional biasing components (not shown) can be formed from a metal such as steel, manufactured from wire, sheet, tube or laser sintered powder, or from a shape memory alloy such as nitinol, and are biased to hold outer paddle 120 in a closed state around joining element 110 and to hold clasp 130 in a clamped state around the natural valve tip. Similarly, the fixed arm 132 and movable arm 134 of clasp 130 are biased to clamp the valve tip. In some implementations, attachment or connecting portions 124, 126, 128, joining portion 138, and / or inner and outer paddles 122, and / or additional biasing components (not shown) can be formed from any other suitable elastic material such as a metal or polymer material to maintain device 100 in a closed state after implantation.

[0409] FIG. 15 shows an embodiment in which the paddles 120, 122 are independently controllable. The device 101 shown in FIG. 15 is similar to the device 100 shown in FIG. 11, except that the device 101 of FIG. 15 includes actuation elements configured as two independent actuation elements 111, 113 coupled to two independent caps 115, 117. The actuation means or actuation element 111 extends to push the cap 115 away from the joining element 110 in order to move the first inner paddle 122 and the first outer paddle 120 from the fully closed state to the partially open state, thereby pulling the outer paddle 120 and then pulling the inner paddle 122, causing the first anchor 108 to partially expand. The actuation means or actuation element 113 extends to push the cap 115 away from the joining element 110 in order to move the second inner paddle 122 and the second outer paddle 120 from the fully closed state to the partially open state, thereby pulling the outer paddle 120 and then pulling the inner paddle 122, causing the second anchor 108 to partially expand. The independent paddle control shown in FIG. 15 can be implemented in any device disclosed in this application. For comparison, in the embodiment shown in FIG. 11, a pair of inner and outer paddles 122, 120 are moved integrally, not independently, by a single actuation means or actuation element 112.

[0410] Referring now to FIGS. 16 - 21, there is shown the manner in which the implantable device 100 of FIGS. 8 - 14 is delivered and implanted inside the native mitral valve MV of the heart H. Referring to 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 the fully open state as illustrated in FIG. 16. Thereafter, the actuation means or actuation element 112 is retracted, moving the implant / device to the fully closed state shown in FIG. 17.

[0411] As can be confirmed from FIG. 18, the implant / device is moved to a position within the mitral valve MV and further into the ventricle LV and assumes a partially open state so as to be able to grip the valve leaflets 20, 22. For example, a steerable catheter can be advanced, steered or bent, and the steerable catheter is positioned as shown in FIG. 18. An implant catheter connected to the implant / device can be advanced from within the steerable catheter and the implant / device is positioned as shown in FIG. 18.

[0412] Here, referring to FIG. 19, the implant catheter can be housed within the steerable catheter and positions the mitral valve leaflets 20, 22 within the clip 130. The actuating line 116 extends to close one of the clips 130 and captures the valve leaflet 20. FIG. 20 shows another actuating line 116 that extends to close the other clip 130 and captures the remaining valve leaflet 22. Finally, as can be confirmed from FIG. 21, the delivery system 102 (e.g., the steerable catheter, the implant catheter, etc.), the actuating means or element 112, and the actuating lines 116 are then housed, and the device or implant 100 is fully closed and deployed within the natural mitral valve MV.

[0413] Here, referring to FIGS. 22-27, an embodiment of the device or implant 200 is shown. The devices of this specification including the device 100 schematically illustrated in FIGS. 8-14 can be configured identically or similarly to the device 200. The device 200 can include any other optional features of the device or implant contemplated in this application, and the device 200 can be positioned to engage the valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). The device / implant 200 can be an artificial spacer device, a valve repair device or another type of implant attached to the valve leaflets of a natural valve.

[0414] In some implementations, the device or implant 200 includes a junction portion 204, a proximal or attachment portion 205, an anchor portion 206, and a distal portion 207. In some implementations, the junction portion 204 of the device optionally includes a junction element 210 (e.g., a spacer, a healing element, a plug, a membrane, a sheet, etc.) for embedding between the valve tips of a native valve. In some implementations, the anchor portion 206 includes a plurality of anchors 208. The anchors can be configured in various ways. In some implementations, each anchor 208 includes an outer paddle 220, an inner paddle 222, a paddle extension member or paddle frame 224, and a gripping element or fastener 230. In some implementations, the attachment portion 205 includes a first or proximal component or collar 211 (or other attachment element, extension, ring, etc.) for engaging a capture mechanism 213 (Figs. 43 - 49) of a delivery system 202 (Figs. 38 - 42 and 49). The delivery system 202 can be the same as 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 path, combinations thereof, etc.

[0415] In some implementations, the junction element 210 and paddles 220, 222 are formed from a metallic cloth formed by a mesh, a woven fabric, a braid, or other suitable method, or a flexible material cut by laser cutting or other methods. The material can be a cloth, a shape memory alloy wire such as nitinol, or any other flexible material suitable for implantation into the human body to provide shape setting ability.

[0416] The actuating element 212 (e.g., an actuating shaft, an actuating rod, an actuating tube, an actuating wire, an actuating line, etc.) extends from the delivery system 202 to engage the device or implant 200 and enable its actuation. In some implementations, the actuating element 212 extends through the capture mechanism 213, the proximal component or collar 211, and the joining element 210 and engages the cap 214 of the distal portion 207. The actuating element 212 can be configured to removably engage the cap 214 by a screw connection or the like, such that the actuating element 212 can be disengaged from and removed from the device 200 after implantation.

[0417] The joining element 210 extends from the proximal component or collar 211 (or other attachment element) to the inner paddle 222. In some implementations, the joining element 210 has an overall elongated and round shape, although other shapes and configurations are possible. In some implementations, the joining element 210 has an oval shape or cross-section when viewed from above (e.g., FIG. 53A), a tapered shape or cross-section when viewed in a front view (e.g., FIG. 23), and a circular shape or cross-section when viewed in a side view (e.g., FIG. 24). The combination of these three geometries can result in a three-dimensional shape of the joining element 210 that exemplifies the advantages described herein. It can also be confirmed that the round shape of the joining element 210 substantially follows or is close to the shape of the paddle frame 224 when viewed from above.

[0418] The size and / or shape of the engagement element 210 can be selected to minimize (preferably to one) the number of implants required for a patient while maintaining a low transvalvular gradient. In some implementations, the anterior-posterior distance at the top of the engagement element is about 5 mm, and the medial-lateral distance at the widest position of the engagement element is about 10 mm. In some implementations, the overall geometry of the device 200 can be based on these two dimensions and the overall shape plan described above. Starting from the device, it will be readily apparent that the device can have different dimensions by using other anterior-posterior distances and medial-lateral distances. Further, by using other dimensions and the shape plan described above, the device will have different dimensions.

[0419] In some implementations, the outer paddle 220 is pivotally attached to the cap 214 of the distal portion 207 by the connection portion 221 and to the inner paddle 222 by the connection portion 223. The inner paddle 222 is pivotally attached to the engagement element by the connection portion 225. Thus, the anchor 208 is configured to be similar to a leg in that the inner paddle 222 is like the upper portion of the leg, the outer paddle 220 is like the lower portion of the leg, and the connection portion 223 is like the knee portion of the leg.

[0420] In some implementations, the inner paddle 222 is rigid, relatively rigid, stiff, has a rigid portion, and / or is stiffened by the reinforcement member or fixing arm 232 of the clip 230. Stiffening the inner paddle enables the device to be movable to various different positions described and explained herein. The inner paddle 222, the outer paddle 220, and the joints can all be interconnected as described herein to constrain the device 200 to the movements and positions shown and described herein.

[0421] In some implementations, the paddle frame 224 is attached to the cap 214 of the distal portion 207 and extends to the connection portion 223 between the inner paddle 222 and the outer paddle 220. In some implementations, the paddle frame 224 is formed from a material that is more rigid and harder than the material forming the paddles 222, 220 such that the paddle frame 224 provides support for the paddles 222, 220.

[0422] As can be seen from FIG. 53A, the paddle frame 224 provides additional clamping force between the inner paddle 222 and the joining element 210 and helps to wrap the valve tip around the side surface of the joining element 210 for better sealing between the joining element 210 and the valve tip. That is, the paddle frame 224 can be configured to have a rounded three-dimensional shape that extends from the cap 214 to the connection portion 223 of the anchor 208. The connections between the paddle frame 224, the outer paddle 220 and the inner paddle 222, the cap 214, and the joining element 210 can constrain each of these components to the movements and positions described herein. In particular, the connection portion 223 is constrained by its connection between the outer paddle 220 and the inner paddle 222 and by its connection to the paddle frame 224. Similarly, the paddle frame 224 is constrained by its attachment to the connection portion 223 (and thus the inner paddle 222 and the outer paddle 220) and by its attachment to the cap 214.

[0423] By configuring the paddle frame 224 in this way, the surface area is increased as compared to only the outer paddle 220. Thereby, for example, it is possible to more easily grip and fix the natural valve tip. The increased surface area can also disperse the clamping force of the paddles 220 and the paddle frame 224 against the natural valve tip onto a relatively large surface of the natural valve tip in order to further protect the natural valve tip tissue. Referring again to FIG. 53A, the increased surface area of the paddle frame 224 may also enable the natural valve tip to be clamped against the device or implant 200 such that the natural valve tip joins generally around the joining member or joining element 210. This can, for example, improve the sealing of the natural valve tips 20, 22 and thus prevent or further reduce mitral valve regurgitation.

[0424] In some implementations, the clip includes a movable arm coupled to the anchor. In some implementations, the clip 230 includes a base or fixed arm 232, a movable arm 234, an optional return 236, and a joining portion 238. In some implementations, the fixed arm 232 is attached to the inner paddle 222 with the joining portion 238 positioned proximate the joining element 210. A spring load acts on the joining portion 238 such that the fixed arm 232 and the movable arm 234 are biased towards each other when the clip 230 is in the closed state. In some implementations, the clip 230 includes friction enhancing elements or securing means such as optional returns, protrusions, ridges, grooves, textured surfaces, adhesives, and the like.

[0425] In some implementations, the fixed arm 232 is attached to the inner paddle 222 through a hole or slot 231 by a suture (not shown). The fixed arm 232 can be attached to the inner paddle 222 by any suitable means such as screws or other fasteners, crimp sleeves, mechanical latches or snaps, welding, adhesives, clamps, latches or the like. The fixed arm 232 remains substantially stationary with respect to the inner paddle 222 when the movable arm 234 is opened to open the fastener 230 and expose an optional return or other friction enhancing element 236. The fastener 230 is opened by applying tension to an actuating line 216 (e.g., as shown in FIGS. 43-48) attached to a hole 235 in the movable arm 234, thereby causing the movable arm 234 to articulate, pivot, and / or flex on the joint portion 238.

[0426] Next, referring to FIG. 29, a close-up view of one of the valve tips 20, 22 gripped at the tissue engagement portion such as the clip 230 is shown. The valve tips 20, 22 are shown to be gripped between the movable arm 234 and the fixed arm 232 of the clip 230. The tissue of the valve tips 20, 22 is not pierced by the optional return or friction enhancement element 236, although in some implementations, the optional return 236 can partially or fully pierce the valve tips 20, 22. The angle and height of the optional return or friction enhancement element 236 relative to the movable arm 234 helps to fix the valve tips 20, 22 within the clip 230. In particular, the force to pull the device away from the natural valve tips 20, 22 will facilitate further engagement of the optional return or friction enhancement element 236 with the tissue, thereby ensuring better retention. The retention of the valve tips 20, 22 within the clip 230 is further improved by the position of the fixed arm 232 near the optional return / friction enhancement element 236 when the clip 230 is closed. In this arrangement, the tissue is formed by the fixed arm 232, the movable arm 234, and the optional return / friction enhancement element 236 into an S-shaped distortion path. Thus, the force to pull the valve tips 20, 22 away from the clip 230 facilitates further engagement of the tissue with the optional return / friction enhancement element 236 before the valve tips 20, 22 can escape. For example, during diastole, the tension of the valve tip can cause the optional return 236 to be urged to pull towards the ends of the valve tips 20, 22. Thus, the S-shaped path can utilize the tension of the valve tip during diastole and engage the valve tips 20, 22 more tightly with the optional return / friction enhancement element 236.

[0427] Referring to FIG. 25, the device or implant 200 may also include a cover 240. In some implementations, the cover 240 may be disposed on the engagement element 210, the outer paddles 220 and the inner paddles 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 may be configured to promote ingrowth of natural tissue. In some implementations, the cover 240 may be a cloth or fabric such as PET, velour, or other suitable fabric. In some implementations, instead of or in addition to the fabric, the cover 240 may include a coating (e.g., a polymer) applied to the device or implant 200.

[0428] During implantation, by opening and closing the paddles 220, 222 of the anchor 208, the leaflets 20, 22 of the natural valve are gripped between the paddles 220, 222 and the engagement element 210. The anchor 208 is moved between a closed position (FIGS. 22-25) and various open positions (FIGS. 26-37) by extending and retracting the actuating element 212. By extending and retracting the actuating element 212, the distance between the engagement element 210 and the cap 214 increases and decreases, respectively. Since the proximal component or collar 211 (or other attachment element, extension, ring, etc.) and the engagement element 210 slide along the actuating element 212 during operation, by changing the distance between the engagement element 210 and the cap 214, the paddles 220, 220 move between different positions to grip the leaflets 20, 22 of the mitral valve during implantation.

[0429] When opening and closing the device 200, the pair of inner and outer paddles 222, 220 are moved together, not independently, by a single actuating element 212. Also, the position of the fastener 230 depends on the position of the paddles 222, 220. For example, the fastener 230 is arranged such that when the anchor 208 is closed, the fastener 230 closes simultaneously. In some implementations, the device 200 may be fabricated to allow the paddles 220, 222 to be controllable independently in the same manner (e.g., the device 101 shown in FIG. 15).

[0430] In some implementations, the clip 230 further secures the natural valve tips 20, 22 by engaging the valve tips 20, 22 with an optional return and / or other friction enhancing element 236 and / or sandwiching the valve tips 20, 22 between the movable arm 234 and the fixed arm 232. In some implementations, the clip 230 is a snap clip that includes a return that increases friction with the valve tips 20, 22 and / or that may partially or fully puncture the valve tips 20, 22. The actuation lines 216 (Figs. 43 - 48) may be actuated separately so that each clip 230 can be opened and closed separately. By operating separately, one valve tip 20, 22 can be gripped at a time, or the clip 230 can be repositioned onto a valve tip 20, 22 that was not fully gripped without changing the good grip on the other valve tips 20, 22. The clip 230 can be fully opened and closed when the inner paddle 222 is not closed, whereby the valve tips 20, 22 can be gripped at various positions as required by the particular situation.

[0431] Referring now to FIGS. 22 - 25, the device 200 is shown in the closed position. The inner paddle 222, when closed, is disposed between the outer paddle 220 and the joining element 210. The clip 230 is disposed between the inner paddle 222 and the joining element 210. At the point where the natural valve tips 20, 22 are successfully captured, the device 200 is moved to and held in its closed position such that the valve tips 20, 22 are fixed within the device 200 by the clip 230 and pressed against the joining 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 joining element 210 (e.g., as can be seen in Fig. 49) to more firmly grip the valve tips 20, 22 when the device 200 is closed. The curved shape and circular edge of the outer paddle 220 also prevent or inhibit tearing of the valve tip tissue.

[0432] Referring now to FIGS. 30 - 37, the device or implant 200 described above is shown in various positions and configurations ranging from partially open to fully open. The paddles 220, 222 of the device 200 transition between each of the positions shown in FIGS. 30 - 37 by extension of the actuating element 212 from the closed position shown in FIGS. 22 - 25 to from the fully retracted position to the fully extended position.

[0433] Referring now to FIGS. 30 and 31, the device 200 is shown in a partially open position. The device 200 is moved to the partially open position by extending the actuating element 212. Extension of the actuating element 212 pulls down the bottom of the outer paddle 220 and the paddle frame 224. The outer paddle 220 and the paddle frame 224 pull down the inner paddle 222, and the inner paddle 222 is connected to the outer paddle 220 and the paddle frame 224. Since the proximal component or collar 211 (or other attachment element) and the engagement element 210 are held in place by the capture mechanism 213, the inner paddle 222 is articulated, pivoted, and / or flexed in the direction of the opening. The inner paddle 222, the outer paddle 220, and the paddle frame 224 all flex to the positions shown in FIGS. 30 and 31. By opening the paddles 222, 220 and the frame 224, a gap is formed between the engagement element 210 and the inner paddle 222 that can receive and grip the native valve leaflets 20, 22. This movement also exposes the clip 230 that can be moved between the closed position (FIG. 30) and the open position (FIG. 31) to form a second gap for gripping the native valve leaflets 20, 22. The range of the gap between the fixed arm 232 and the movable arm 234 of the clip 230 is limited to the range where the inner paddle 222 spreads away from the engagement element 210.

[0434] Referring now to FIGS. 32 and 33, device 200 is shown in a laterally extended position or a laterally open position. Device 200 is moved to the laterally extended position or the laterally open position by continuing the extension of the actuating element 212 described above, thereby increasing the distance between the engaging element 210 and the cap 214 of the distal portion 207. By continuing the extension of the actuating element 212, the outer paddle 220 and the paddle frame 224 are pulled down, thereby spreading the inner paddle 222 further away from the engaging element 210. In the laterally extended position or the laterally 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 engaging element 210. Similarly, the paddle frame 224 is in its most expanded position when the device 200 is in the laterally extended position or the laterally open position. The increase in the gap between the engaging element 210 and the inner paddle 222 formed in the laterally extended position or the laterally open position allows the fastener 230 to open further (FIG. 33) before engaging the engaging element 210, thereby increasing the size of the gap between the fixed arm 232 and the movable arm 234.

[0435] Referring now to FIGS. 34 and 35, exemplary device 200 is shown in a three-quarter extended position. Device 200 is moved to the three-quarter extended position by continuing the extension of actuating element 212 described above, thereby increasing the distance between engagement element 210 and cap 214 of distal portion 207. By continuing the extension of actuating element 212, outer paddle 220 and paddle frame 224 are pulled down, thereby spreading inner paddle 222 further away from engagement element 210. At the three-quarter extended position, inner paddle 222 is open to an angle of greater than 90 degrees and approximately 135 degrees with respect to engagement element 210. Paddle frame 224 spreads less than in the lateral extended position or the lateral open position and begins to move inwardly toward actuating element 212 as actuating element 212 extends further. Outer paddle 220 also bends rearwardly toward actuating element 212. Similar to the lateral extended position or the lateral open position, the increase in the gap between engagement element 210 and inner paddle 222 formed at the lateral extended position or the lateral open position allows clip 230 to still open further (FIG. 35), thereby increasing the size of the gap between fixed arm 232 and movable arm 234.

[0436] Referring now to FIGS. 36 and 37, an exemplary device 200 is shown in a fully extended position. The device 200 is moved to the fully extended position by continuing the extension of the actuating element 212 described above, thereby increasing the distance between the engaging element 210 and the cap 214 of the distal portion 207 to the maximum distance allowable by the device 200. By continuing the extension of the actuating element 212, the outer paddles 220 and paddle frame 224 are pulled down, thereby spreading the inner paddle 222 further away from the engaging element 210. The outer paddles 220 and paddle frame 224 move to a position where they approach the actuating element. In the fully extended position, the inner paddle 222 is opened to an angle of approximately 180 degrees with respect to the engaging element 210. The inner and outer paddles 222, 220 are linearly extended 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 a maximum-sized gap between the engaging element 210 and the inner paddle 222, and in some implementations, the fastener 230 is also capable of a full opening of approximately 180 degrees between the fixed arm 232 and the movable arm 234 of the fastener 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 withdrawing the device 200 from a tried implantation or can be a desired position for installation into the delivery catheter of the device or the like.

[0437] Configuring the device or implant 200 such that the anchor 208 can extend to a linear or substantially linear configuration (e.g., about 120 degrees to 180 degrees with respect to the engagement element 210) can provide several advantages. For example, this configuration can reduce the radially crimped profile of the device or implant 200. This configuration can make it easier to grip the native valve leaflets 20, 22 by providing a larger opening between the engagement element 210 and the inner paddle 222 for gripping the native valve leaflets 20, 22. Additionally, the relatively narrow and linear configuration can prevent or reduce the likelihood that the device or implant 200 becomes entangled within the natural anatomical structure (e.g., chordae CT shown in FIGS. 3 and 4) when positioning and / or retrieving the device or implant 200 within the delivery system 202.

[0438] Referring now to FIGS. 38 - 49, an exemplary device 200 is shown being delivered and implanted into the native mitral valve MV of the heart H. As described above, the device 200 shown in FIGS. 38 - 49 includes an engagement element 210, a clip 230, and an optional cover 240 (e.g., FIG. 25) over the inner paddle 222 and / or outer paddle 220. The device 200 is deployed from a delivery system 202 (which may include, for example, a steerable catheter 241 and / or an implant catheter extendable from a guide sheath), held by a capture mechanism 213 (see, e.g., FIGS. 43 and 48), and actuated by extending and retracting an actuation element 212. The finger portions of the capture mechanism 213 removably attach a collar 211 to the delivery system 202. In some implementations, the capture mechanism 213 is held in a closed state around the collar 211 by the actuation element 212 such that, after the device 200 has been successfully implanted, removing the actuation element 212 can open and release the finger portions of the capture mechanism 213 from the collar 211, detaching the capture mechanism 213 from the device 200.

[0439] Referring now to 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 described above with respect to device 100 (e.g., the implant catheter holding the device / implant can be extended and the device / implant is deployed out of the steerable catheter). Thereafter, the actuating element 212 is retracted, moving the device 200 from a partially closed state (FIG. 39) to the fully closed state shown in FIGS. 40 and 41. Thereafter, the delivery system or catheter steers the device / implant 200 toward the mitral valve MV as shown in FIG. 41. Referring now to FIG. 42, when the device 200 is aligned with the mitral valve MV, the actuating element 212 is extended to open the paddles 220, 222 to a partially open position, and the actuating line 216 (FIGS. 43-48) is retracted to open the clip 230 to prepare for grasping the valve leaflets. Next, as shown in FIGS. 43 and 44, the partially open device 200 is inserted through the native valve (e.g., by advancing the implant catheter from the steerable catheter) until the valve leaflets 20, 22 are properly positioned between the inner paddle 222 and the engagement element 210 and further inside the open clip 230.

[0440] Figure 45 shows the device 200 with both tissue engagement portions / fasteners 230 closed, but with an optional return 236 of one fastener 230 releasing one valve tip 22. As can be seen from FIGS. 45 - 47, the misaligned fastener 230 is reopened to properly grip the unengaged valve tip 22. When both valve tips 20, 22 are properly gripped, the device 200 is moved to the fully closed position shown in FIG. 48 by housing the actuating element 212. With the device 200 fully closed and implanted in the native valve, the actuating element 212 is disengaged from and withdrawn from the cap 214, releasing the capture mechanism 213 from the proximal component or collar 211 (or other attachment element), such that the capture mechanism 213 can be withdrawn into the delivery system 202 (e.g., into a catheter / sheath), as shown in FIG. 49. Once deployed, the device 200 can be maintained in the fully closed position by mechanical means such as a latch, or biased to remain closed by use of a spring material such as steel and / or a shape memory alloy such as nitinol. For example, the outer paddles 220, 222 can be formed from steel or nitinol shape memory alloy, manufactured in wire, sheet, tube or laser sintered powder, and biased to hold the outer paddle 220 in a closed state around the inner paddle 222, joining element 210, and / or to hold the fasteners 230 in a clamped state around the native valve tips 20, 22.

[0441] FIGS. 50A, 50B, and 50C show exemplary systems and / or devices to which the concepts of the present application can 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, distal portion 8207, and paddle frame 8224 can be configured in various ways.

[0442] In the embodiment shown in FIG. 50A, the paddle frame 8224 may be symmetric along the longitudinal axis YY. However, in some implementations, the paddle frame 8224 is not symmetric about the axis YY. Further referring to FIG. 50A, the paddle frame 8224 includes an outer frame portion 8256 and an inner frame portion 8260.

[0443] In some implementations, a connector 8266 (e.g., a shape memory metal component, a shaped plastic component, a tether, a wire, a strut, a line, a cord, a suture thread, etc.) is attached to the outer frame portion 8256 at the outer end of the connector 8266 and to a coupler 8972 at the inner end 8968 of the connector 8266 (see FIG. 50C).

[0444] In some implementations, between the connector 8266 and the attachment portion 8205, the outer frame portion 8256 forms a curved shape. For example, in the illustrated embodiment, the shape of the outer frame portion 8256 is apple-shaped, where the outer frame portion 8256 is wider towards the attachment portion 8205 and narrower towards the distal portion 8207. However, in some implementations, the outer frame portion 8256 may be shaped in other ways.

[0445] In some implementations, the inner frame portion 8260 extends from the attachment portion 8205 towards the distal portion 8207. Thereafter, the inner frame portion 8260 extends inwards to form a holding portion 8272 that is attached to the actuating cap 8214. The holding portion 8272 and the actuating cap 8214 may be configured to be attached in any suitable manner.

[0446] In some implementations, while the inner frame portion 8260 is a rigid frame portion, the outer frame portion 8256 is a flexible frame portion. As shown in FIG. 50A, the proximal end of the outer frame portion 8256 is connected to the proximal end of the inner frame portion 8260.

[0447] The width adjustment element 8211 (e.g., width adjustment wire, width adjustment shaft, width adjustment tube, width adjustment line, width adjustment cord, width adjustment sewing thread, width adjustment screw or bolt, etc.) is configured to move the outer frame portion 8256 from the extended position to the narrowed position by pulling the inner end 8968 (FIG. 50C) and a portion of the connector 8266 toward the actuating cap 8214. The actuating element 8102 is configured to move the inner frame portion 8260 to open and close the paddle, according to some implementations disclosed herein.

[0448] In some implementations, as shown in FIGS. 50B and 50C, the connector 8266 has an inner end 8968 that engages with the width adjustment element 8211, such that the user can move the inner end 8968 inside the receiver 8912 (e.g., female threaded element, post, conduit, hollow member, notched receiving portion, tube, shaft, sleeve, post, housing, cylinder, track, etc.) and move the outer frame portion 8256 between the narrowed and extended positions.

[0449] In the illustrated embodiment, the inner end 8968 includes a post 8970 attached to the outer frame portion 8256 and a coupler 8972 extending from the post 8970. The coupler 8972 is configured to be attached to and removed from both the width adjustment element 8211 and the receiver 8912. The coupler 8972 can take a wide variety of different forms. For example, the coupler 8972 can include one or more of a threaded connection, a feature that mates with a screw, an outwardly biased arm, a detent connection such as a wall, or other portions.

[0450] In some implementations, when the coupler 8972 is attached to the width adjustment element 8211, the coupler is released from the receiver 8912. In some implementations, when the coupler 8972 is removed from the width adjustment element 8211, the coupler is fixed to the receiver.

[0451] The inner end 8968 of the connector can be configured in various ways. Any form that can properly attach the outer frame portion 8256 to the coupler can be used so that the width adjustment element 8211 can move the outer frame portion 8256 between a narrowed position and an extended position. The coupler can be configured similarly in various ways and can be a separate component or can be integrated with another part of the device, such as another part of the connector or the inner end of the connector.

[0452] In some implementations, the width adjustment element 8211 allows the user to expand or contract the outer frame portion 8256 of the device 8200. In the embodiments shown in FIGS. 50B and 50C, the width adjustment element 8211 includes a male threaded end that is screwed into the coupler 8972. In some implementations, the width adjustment element 8211 moves the coupler into 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.

[0453] In some implementations, the receiver 8912 can be integrally formed with the distal cap 8214. When the cap 8214 is moved relative to the body of the attachment portion 8205, the paddle opens and closes. In the illustrated embodiment, the receiver 8912 slides inside the body of the attachment portion. When the coupler 8972 is removed from the width adjustment element 8211, the width of the outer frame portion 8256 is fixed while the actuating element 8102 moves the receiver 8912 and the cap 8214 relative to the body of the attachment portion 8205. When the cap moves, the device can open and close in the same manner as the other implementation modes disclosed above.

[0454] In the illustrated embodiment, the driver head 8916 is disposed at the proximal end of the actuating element 8102. The driver head 8916 removably couples the actuating element 8102 to the receiver 8912. In the illustrated embodiment, the width adjustment element 8211 extends through the actuating element 8102. The actuating element is axially advanced in the opposite direction of the Y direction to move the distal cap 8214. As indicated by the arrow in FIG. 50B, the movement of the distal cap 8214 relative to the attachment portion 8205 is effective for opening and closing the paddle. That is, when the distal cap 8214 moves in the Y direction, the device is closed, and when the distal cap moves in the direction opposite to the Y direction, the device is opened.

[0455] In some implementations, as shown in FIGS. 50B and 50C, the width adjustment element 8211 extends through the actuating element 8102, the driver head 8916, and the receiver 8912 and engages a coupler 8972 attached to the inner end 8968. In some implementations, when the outer frame portion 8256 moves to a narrowed position, the device or implant 8200 can be more easily maneuvered into position for implantation in the heart by reducing contact and / or friction between the natural structure of the heart (e.g., chordae tendineae) and the device 8200. In some implementations, when the outer frame portion 8256 moves to an expanded position, the anchor portion of the device or implant 8200 provides a larger surface area for engaging and capturing the leaflets of the natural heart valve.

[0456] The device 8200 (e.g., anchors 8830, 8834 or another portion of the device) may include fasteners 130, 230, 330, 40856, 5030a, 5030b, 5030c, or tissue engagement portions or fasteners 8230 that may be the same as or similar to other tissue engagement portions or fasteners described herein.

[0457] Using the bioimpedance-based feedback disclosed herein, feedback related to the grasping of tissue in one or more tissue engagement portions or clasps of the distal anchor 8830 and / or the proximal anchor 8834 can be provided.

[0458] FIG. 51A shows an example of a device or implant 300 (e.g., a therapeutic device, a repair device, a transplantable device, etc.). The devices of this specification, including the device 100 schematically illustrated in FIGS. 8 - 15, can be the same as or similar to the device 300 (and / or any other exemplary device disclosed in this specification and described in the incorporated references, or the same as or similar to any device that conforms differently to the concepts of this specification).

[0459] The device 300 can include any other features of the device or implant considered in this application, and the device 300 can be positioned to engage the valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0460] In some implementations, the device 300 includes a proximal or attachment portion 305, an anchor portion 306, and a distal portion 307. In some implementations, the device / implant 300 includes a junction portion 304, and the junction portion 304 can optionally include a junction element 310 (e.g., a spacer, a plug, a membrane, a sheet, etc.) for implantation between the valve tips 20, 22 of the native valve.

[0461] In some implementations, the anchor portion 306 includes a plurality of anchors 308. In some implementations, each anchor 308 can include one or more paddles such as, for example, an outer paddle 320, an inner paddle 322, a paddle extension member (such as a leaf spring, a shape setting wire, etc.) or a paddle frame 324. The anchor can also include a fastener 330 and / or can be coupled to the fastener 330. In some implementations, the attachment portion 305 includes a first or proximal collar 311 (or other attachment element) for engaging a capture mechanism of the delivery system.

[0462] The anchors 308 can be attached to other parts of the device and / or to each other in various different ways (such as directly, indirectly, by welding, suturing, adhesives, links, latches, integrally formed, combinations of some or all of these, etc.). In some implementations, the anchors 308 are attached to the joining element 310 by the connecting portion 325 and to the cap 314 by the connecting portion 321.

[0463] In some implementations, the anchor 308 can be composed of a first or outer paddle 320 and a second or inner paddle 322 separated by a connecting portion 323. In some implementations, the connecting portion 323 can be attached to a paddle frame 324 that is hingedly attached to a cap 314 or other attachment portion. Thus, the anchor 308 is configured to be similar to a leg in that the inner paddle 322 is like the upper portion of the leg, the outer paddle 320 is like the lower portion of the leg, and the connecting portion 323 is like the knee portion of the leg.

[0464] In some implementations with an optional coupling element 310, the coupling element 310 and the anchor 308 can be coupled together in various ways. As shown in the illustrated embodiment, the coupling element 310 and the anchor 308 can be coupled together by integrally forming the coupling element 310 and the anchor 308 as a single, unitary component. This can be achieved, for example, by forming the coupling element 310 and the anchor 308 from a continuous piece 301 of braided material or woven material such as braided or woven Nitinol wire. In the illustrated embodiment, the coupling element 310, the outer paddle portion 320, the inner paddle portion 322, and the connection portions 321, 323, 325 are formed from a continuous piece of fabric 301.

[0465] Similar to the anchor 208 of the device or implant 200 described above, the anchor 308 can be configured to transition between various configurations by axially moving the distal end of the device (e.g., the cap 314, etc.) relative to the proximal end of the device (e.g., the proximal collar 311 or other attachment element, etc.). This movement can occur along the longitudinal axis extending between the distal end (e.g., the cap 314, etc.) and the proximal end (e.g., the collar 311 or other attachment element, etc.) of the device.

[0466] In some implementations, in a linear configuration, the paddle portions 320, 322 are aligned in the direction of the longitudinal axis of the device or are linear. In some implementations, the connection portion 323 of the anchor 308 is adjacent to the longitudinal axis of the spacer or coupling element 310. From the linear configuration, the anchor 308 can be moved to a fully folded configuration (as shown in FIG. 51A), for example, by moving the proximal and distal ends towards each other and / or towards the midpoint or center of the device.

[0467] In some implementations, the fastener includes a movable arm coupled to an anchor. In some implementations, the fastener 330 includes a base or fixed arm 332, a movable arm 334, an optional return / friction enhancing element 336, and a joint portion 338. In some implementations, when included, the fixed arm 332 can be attached to the inner paddle 322 with the joint portion 338 positioned near the joint element 310. In some implementations, the joint portion 338 is spring biased so that the fixed arm 332 and the movable arm 334 are drawn towards each other when the fastener 330 is in the closed state.

[0468] In some implementations, the fixed arm 332 is attached to the inner paddle 322 through a hole or slot by a suture. The fixed arm 332 can be attached to the inner paddle 322 by any suitable means such as a screw or other fastening member, a crimp sleeve, a mechanical latch or snap, welding, an adhesive, or the like. The fixed arm 332 remains substantially stationary with respect to the inner paddle 322 when opening the fastener 330 by releasing the movable arm 334 to expose the optional return 336.

[0469] In some implementations, the fastener 330 is opened by applying tension to an actuating line attached to the movable arm 334, thereby causing the movable arm 334 to articulate, pivot and / or flex on the joint portion 338.

[0470] In summary, the device or implant 300 may be similar to the device or implant 200 described above in terms of configuration and operation, but the joining element 310, the outer paddle 320, the inner paddle 322, and the connecting portions 321, 323, 325 are formed from a single piece of material 301. In some implementations, the piece of material 301 is woven or inserted through openings in the proximal collar 311, within the cap 314, and within the paddle frame 324 configured to receive the continuous piece of material 301, thereby attaching to the proximal collar 311, the cap 314, and the paddle frame 324. The continuous piece 301 can be a single layer of material or can include two or more layers. In some implementations, a portion of the device 300 has a single layer of the piece of material 301, and other portions are formed from multiple overlapping layers or stacked layers of the piece of material 301.

[0471] For example, FIG. 51A shows the joining element 310 and the inner paddle 322 formed from multiple overlapping layers of the piece of material 301. The single continuous piece of material 301 can start and end at various locations on the device 300. The ends of the piece of material 301 can be located at the same or different locations on the device 300. In the illustrated example of FIG. 51A, the strip of material 301 starts and ends at the location of the inner paddle 322.

[0472] Similar to the device or implant 200 described above, the size of the joining element 310 can be selected to minimize (preferably to one) the number of implants required for a single patient while simultaneously maintaining a low transvalvular gradient. In particular, by forming many components of the device 300 from the piece of material 301, the device 300 can be made smaller than the device 200. For example, in some implementations, the anterior-posterior distance at the top of the joining element 310 is less than 2 mm, and the inner-outer distance of the device 300 (e.g., the width of the paddle frame 324 wider than the joining element 310) is approximately 5 mm at its widest.

[0473] Additional features of device 300, modified versions of the device, delivery systems for the device, and methods for using the device and delivery systems are disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO2020 / 076898). Any combination or sub - combination of features disclosed by this application can be combined with any combination or sub - combination of features disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO2020 / 076898). Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO2020 / 076898) is hereby incorporated by reference in its entirety into this specification.

[0474] FIG. 51B illustrates another exemplary system and / or apparatus to which the concepts of this application can be applied. System 40056 includes a delivery device 40156 and a device 40256 (e.g., a valve repair device, a valve treatment device, an implantable device, etc.).

[0475] In some implementations, the valve repair device 40256 includes a base assembly 40456, a pair of paddles 40656 (e.g., clasps, clips, arms, etc.), and a pair of gripping members 40856 (e.g., clasps, clips, arms, etc.). In some implementations, the paddles 40656 can be formed integrally with the base assembly. For example, the paddles 40656 can be formed as an extension of a link of the base assembly. In the illustrated embodiment, the base assembly 40456 of the valve repair device 40256 has a shaft 40356, a coupler 40556 configured to move along the shaft, and a lock 40756 configured to lock the coupler in a stationary position on the shaft. In some implementations, the gripping members 40856 can be regarded as a first arm, and the paddles 40656 can be regarded as a second arm of a clasp, clip, tissue - engaging portion.

[0476] For example, in some implementations, the coupler 40556 is mechanically connected to the paddle 40656 such that when the coupler 40556 moves along the shaft 40356, the paddle moves between an open position and a closed position. Thus, the coupler 40556 is a means for mechanically coupling the paddle 40656 to the shaft 40356 and functions as a means for moving the paddle 40656 between their open and closed positions when moving along the shaft 40356.

[0477] In some implementations, the gripping member 40856 is pivotally connected to the base assembly 40456 (e.g., the gripping member 40856 can be pivotally connected to the shaft 40356 or any other suitable member of the base assembly), such that the gripping member can be moved to adjust the width of the opening 41456 between the paddle 40656 and the gripping member 40856. The gripping member 40856 can include an optional return portion 40956 (or a portion that increases friction regardless of the presence of a return) for attaching the gripping member to the valve tissue when the valve repair device 40256 is attached to the valve tissue.

[0478] In some implementations, when the paddle 40656 is in the closed position, the paddle engages the gripping member 40856 such that when the valve tissue is attached to the return portion 40956 of the gripping member (herein described as the "return portion", although a friction enhancing element can be used instead of or in addition to a return), the paddle secures the valve repair device 40256 to the valve tissue.

[0479] In some implementations, the gripping member 40856 is configured to engage the paddle 40656 such that the return portion 40956 engages the valve tissue and the paddle 40656 to secure the valve repair device 40256 to the valve tissue. For example, in certain situations, it may be advantageous to maintain the paddle 40656 in the open position and move the gripping member 40856 outwardly towards the paddle 40656 to engage the valve tissue and the paddle 40656.

[0480] Although the embodiment shown in FIG. 51B shows a pair of paddles 40656 and a pair of gripping members 40856, it will be understood that the valve repair device 40256 can include any suitable number of paddles and gripping members.

[0481] In some implementations, the system 40056 includes an installation shaft 41356 removably attached to the shaft 40356 of the base assembly 40456 in the valve repair device 40256. The installation shaft 41356 is removed from the shaft 40356 after the valve repair device 40256 is secured to the valve tissue, removing the valve repair device 40256 from the remainder of the valve repair system 40056, such that the valve repair device 40256 can remain attached to the valve tissue and the delivery device 40156 can be removed from the patient's body.

[0482] The system 40056 can include a paddle control mechanism 41056 (e.g., a relatively movable tube, shaft, etc.), a gripper control mechanism 41156 (e.g., a wire, line, suture, etc.), and a lock control mechanism 41256 (e.g., a relatively movable tube, shaft, wire, line, suture, etc.).

[0483] In some implementations, the paddle control mechanism 41056 is mechanically attached to the coupler 40556 to move the coupler along the shaft, thereby moving the paddle 40656 between an open position and a closed position. The paddle control mechanism 41056 can take any suitable form, such as, for example, a shaft or rod. For example, the paddle control mechanism can include a hollow shaft and a catheter tube or sleeve that fits over the installation shaft 41356 and the shaft 40356 and is connected to the coupler 40556.

[0484] The gripper control mechanism 41156 is configured to move the gripping member 40856 such that the width of the opening 41456 between the gripping member and the paddle 40656 can be changed. The gripper control mechanism 41156 can take any suitable form, for example, a line, a suture thread or wire, a rod, a catheter, etc.

[0485] The lock control mechanism 41256 is configured to lock and unlock the lock. The lock 40756 locks the coupler 40556 in a stationary position relative to the shaft 40356 and can take a wide variety of different forms, and the type of the lock control mechanism 41256 can be determined by the type of lock used. In an embodiment 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 implementations, the lock control mechanism 41256 can be, for example, a rod, a suture thread, a wire, or any other member capable of moving the pivotable plate of the lock 40756 between an inclined position and a substantially non-inclined position.

[0486] The valve repair device 40256 is movable from an open position to a closed position. In the illustrated example, the base assembly 40456 includes a link that is 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, whereby the link moves.

[0487] In some implementations, the gripper control mechanism 41156 moves the gripping member 40856 to widen or narrow the gap at the opening 41456 between the gripping member and the paddle 40656. In the illustrated embodiment, the gripper control mechanism 41156 includes a line such as a suture, wire, etc. that is connected to an opening within the end of the gripper member 40856. When the line is pulled, the gripping member 40856 moves inwardly, causing the opening 41456 between the gripping member and the paddle 40656 to become wider.

[0488] 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.

[0489] After the paddle 40656 is moved to the closed position, the lock 40756 is moved to the locked state by the lock control mechanism 41256 to maintain the valve repair device 40256 in the closed position. After the valve repair device 40256 is maintained in the locked state by the lock 40756, the valve repair device 40256 is removed from the delivery device 40156 by disconnecting the shaft 40356 from the installation shaft 41356. Additionally, the valve repair device 40256 is disengaged from the paddle control mechanism 41056, the gripper control mechanism 41156, and the lock control mechanism 41256.

[0490] Additional features of device 40256, modified versions of the device, delivery systems for the device, and methods for using the device and delivery systems are disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904). Any combination or sub - combination of features disclosed by this application can be combined with any combination or sub - combination 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 hereby incorporated by reference in its entirety.

[0491] The tissue engagement portions such as the clasps and valve tip gripping devices disclosed herein can take a wide variety of different forms. Examples of clasps are disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018195201). Any combination or sub - combination of features disclosed by this application can be combined with any combination or sub - combination of features disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. 2018195201). Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018195201) is hereby incorporated by reference in its entirety.

[0492] Figures 51C and 51D show an exemplary implementation of valve repair device 40256 that includes a joining element 3800. The valve repair device 40256 can have the same configuration as the valve repair device shown in Figure 51B with the addition of a joining element. The joining element 3800 can take a wide variety of different shapes.

[0493] In some implementations, the engagement element 3800 is compressible and / or expandable. For example, the engagement element can be compressed to fit within one or more catheters of a delivery system and can expand when moved out of one or more catheters and / or can be compressed by paddle 40656 to adjust the size of the engagement element. In the embodiments shown in FIGS. 51C and 51D, the size of the engagement element 3800 can be decreased by pressing the engagement element with paddle 40656 and can be increased by moving paddles 40656 away from each other. The engagement element 3800 can extend beyond the outer edge 4001 of the gripping member or clip 40856 as illustrated to provide additional surface area for closing the mitral valve gap.

[0494] The engagement element 3800 can be coupled to the valve repair device 40256 in a variety of different ways. For example, the engagement element 3800 can be fixed to a shaft 40356, slidably disposed around the shaft, connected to a coupler 40556, connected to a lock 40756, and / or connected to the central portion of a clip or gripping member 40856. In some implementations, the coupler 40556 can take the form of the engagement element 3800. That is, a single element can be used as a coupler 40556 that moves paddle 40656 between an open position and a closed position and as an engagement element 3800 that closes the gap between valve leaflets 20, 22 when the valve repair device 40256 is attached to the valve leaflet.

[0495] The engagement 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 engagement element 3800 can be disposed around shaft 40356, shaft 41356, paddle control mechanism 41056, and / or lock control mechanism 41256.

[0496] The valve repair device 40256 may include any other optional features for the valve repair device contemplated in this application, and the valve repair device 40256 may be positioned to engage the valve tissue as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). Additional features of the device 40256, modified versions of the device, delivery systems for the device, and methods for 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 sub - combination of the features disclosed by this application may be combined with any combination or sub - combination of the features disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904).

[0497] FIG. 51 shows another example of one of many valve repair systems for repairing a patient's native valve to which the concepts of this application may be applied. The valve repair system includes a device 8810 that includes a frame 8820, anchors 8830, 8834, a band 8840, an annular flap or sail 8850, and a valve body 8860. The device 8810 scan includes a proximal end 8812 and a distal end 8814, and an opening is defined at both ends 8812, 8814 such that fluid can flow therethrough. In some implementations, the proximal end 8812 may be disposed within the left atrium, while the distal end 8814 may be disposed within the left ventricle such that the device 8810 can function as an alternative to the mitral valve. The device 8810 may allow blood flow in a first direction from the proximal end 8812 to the distal end 8814 while preventing blood flow in a second direction from the distal end 8814 to the proximal end 8812.

[0498] The device or implant 8810 may include one or more distal anchors 8830. The distal anchors 8830 may be positioned along or adjacent to the distal end of the frame 8820 and may be connected to the frame 8820. The distal anchors 8830 may be designed such that when the frame 8820 is in an expanded configuration, the ends or tips 8832 of each distal anchor 8830 are positioned radially outward from the frame 8820 and generally extend in a proximal direction. In some implementations, the device 8810 may include one or more proximal anchors 8834. The proximal anchors 8834 may be positioned along or adjacent to the proximal end 8812 of the frame 8820 and may be connected to the frame 8820. The proximal anchors 8834 may be designed such that when the frame 8820 is in an expanded configuration, the ends or tips 8836 of each proximal anchor 8834 are positioned radially outward from the frame 8820 and generally extend in a distal direction. In some implementations, one or more of the anchors 8830, 8834 may include a cushion 8838 that covers one or more of such anchors.

[0499] In some implementations, the device 8810 may be arranged such that the annulus of the mitral valve is between the distal anchor 8830 and the proximal anchor 8834. In some implementations, the device 8810 may be arranged such that the end or tip portion 8832 of the distal anchor 8830 contacts the annulus. In some implementations, the device 8810 may be arranged such that the end or tip portion 8832 of the distal anchor 8830 does not contact the annulus. In some implementations, the device 8810 may be arranged such that the distal anchor 8830 does not extend around the cusp tip. In some implementations, the device 8810 may be positioned such that some of the distal anchors 8830 contact the annulus while other distal anchors 8830 do not. In some implementations, the device 8810 may be arranged such that the end or tip portion 8832 of the distal anchor 8830 is located on the ventricular side of the annulus of the mitral valve and the end or tip portion 8836 of the proximal anchor 8834 is located on the atrial side of the annulus of the mitral valve.

[0500] In some implementations, the distal anchor 8830 can be positioned such that the end or tip 8832 of the distal anchor 8830 is located on the ventricular side of the native valve leaflet beyond the position where the chordae tendineae connect to the free end of the native valve leaflet. The distal anchor 8830 may extend between at least some of the chordae tendineae and, in some situations, can contact or engage the ventricular side of the valve annulus. Also, in some implementations, it is contemplated that the distal anchor 8830 may not contact the valve annulus and the distal anchor 8830 may contact the native valve leaflet. In some situations, the distal anchor 8830 can contact the left ventricular tissue beyond the valve annulus and / or beyond the ventricular side of the valve leaflet. In some implementations, during delivery, the distal anchor 8830 (along with the frame 8820) can move toward the ventricular side of the valve annulus using the distal anchor 8830 that extends between at least a portion of the chordae tendineae to provide tension to the chordae tendineae. A further example of the device 8810 is described in U.S. Patent Publication No. 2015 / 0328000, published November 19, 2015, which is hereby incorporated by reference in its entirety.

[0501] In certain embodiments, the device 8810 does not include a proximal anchor 8834. In such implementations, the distal anchor 8830 can be configured to be secured on the native valve leaflet, valve annulus, chordae tendineae, or a combination of two or more thereof. Feedback related to the grasping of tissue at one or more of the distal anchor 8830 and / or proximal anchor 8834 can be provided using the impedance-based feedback disclosed herein.

[0502] Bio-Impedance Based Feedback by Devices The following provides examples of devices that enable the use of bioimpedance or bioimpedance-based feedback in medical procedures. While some of the descriptions herein focus on implementations in devices designed for valve cusp capture for illustrative purposes, it will be understood that bioimpedance-based feedback capabilities, characteristics, and functions can be applied to other devices used in various medical procedures and to various tissues. These include, for example, but are not limited to, annuloplasty devices, anchors for devices, implants, treatment devices, valves, stents, prosthetic valves, devices for fixing to muscle, devices for fixing to tissue, and the like. Several exemplary devices that can be used with the bioimpedance-based feedback techniques of the present disclosure (including, for example, sensors, printed circuit boards, circuits, electrodes, measurement systems, etc.) are described herein with reference to FIGS. 8-15, 22-37, and 50A-51E. Further, bioimpedance-based feedback capabilities, characteristics, and functions can be applied to other systems, devices, components, etc. that are not implanted, such as, for example, delivery systems, delivery devices, catheters, anchor drivers, pushers (e.g., push rods, etc.), valve cusp repair tools that capture a therapeutic valve cusp and then release the valve cusp, tendon repair / replacement devices, valve cusp prolapse repair devices, and other therapeutic and / or repair devices.

[0503] Many of the examples herein describe clasps for illustrative purposes, but the same or similar concepts, configurations, measurements, principles, etc. (such as, for example, similar electrodes) described with respect to "clasps" can be used in other implementations, anchors, anchor portions, clips, clamps, gripping members, paddles, configurations, etc., even if they are not conventional "clasps". In some implementations, tissue engagement portions, anchors, clasps, etc. can include arms that are not directly hinged to each other. In some implementations, the tissue engagement portions, clasps, etc. herein may not include fixed arms. In some implementations, the gripping member may be pivotally connected to and / or formed with the base assembly.

[0504] In some implementations, the same or similar concepts, configurations, measurements, principles, etc. (e.g., similar electrodes, etc.) as those described with respect to the "fastener" can be used in conjunction with the distal anchor 8830 or the arm of the device 8810 of FIG. 51E.

[0505] In some implementations, whether the same or similar concepts, configurations, measurements, principles, etc. (e.g., similar electrodes, etc.) as those described with respect to the "fastener" are associated with the first arm and the second arm, and / or whether the surfaces are directly connected or hinged to each other, it can be used on a transplantable device or a non-transplantable device that includes, for example, a tissue engagement portion or a tissue capture portion formed by a first surface and a second surface that move relative to each other.

[0506] In some implementations, the same or similar concepts, configurations, measurements, principles, etc. (e.g., similar electrodes, etc.) as those described with respect to the "fastener" are formed by a first surface (e.g., of a gripping member, an arm, a fastener arm, a first arm, etc.) and a second surface (e.g., of a paddle, an arm, a fastener arm, a second arm, a joining element, etc.), and can be used in a transplantable device or a non-transplantable device that includes a tissue engagement portion or a tissue capture portion, and 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.

[0507] In typical transcatheter edge-to-edge repair (TEER) procedures, and other such procedures that involve leaflet grasping, acoustic-based imaging is primarily used. Such imaging techniques can be useful. However, as described herein, other techniques used with or without imaging can be useful and can potentially improve reliability and outcomes. In some examples, the impedance-based feedback techniques disclosed herein can be used to enhance imaging techniques. For example, even on the mitral valve side where acoustic imaging is typically good, the procedure can involve the deployment of two or more implants. In such examples, the first implant can cast a shadow when deploying the second implant, making it difficult to accurately measure the insertion of the leaflet to determine leaflet capture. Thus, systems, methods, and devices are disclosed herein for providing impedance-based feedback related to tissue engagement, tissue capture, and / or anchor deployment for devices such as the devices disclosed herein. Impedance-based feedback can be used to generate indicators that assist a user in making decisions regarding leaflet capture, and the feedback is independent of acoustic imaging.

[0508] Furthermore, in addition to those related to leaflet insertion or leaflet capture, it can be beneficial to generate indicators. For example, it can be beneficial for a user to understand things such as apposition, tension, implant pararelease, leaflet tissue strength, the holding force of the clip on the leaflet, and the like. Thus, the algorithms described herein can be used to provide indicators that provide useful information for a user to determine not only leaflet capture but also apposition, tension, regurgitation, leaflet tissue strength, and the like. Advantageously, these indicators can be used to achieve desirable results in a medical procedure.

[0509] Figures 52A, 52B, and 52C illustrate exemplary anchor portions, anchors, tissue engagement portions, or fasteners 5030a, 5030b, 5030c having at least one electrode 5040, e.g., two or more electrodes 5040. The anchor portion, anchor, tissue engagement portion, or fastener 5030a, 5030b, or 5030c can be used, with necessary modifications, in any of the systems and devices described herein, e.g., they can be used in the devices of FIGS. 8 - 51D and other implantable devices or non-implantable treatment devices that capture tissue.

[0510] FIG. 52A shows an anchor, anchor portion, tissue engagement portion, fastener, etc. 5030a having an electrode 5040 on a cloth 5047 or cover (e.g., where the electrode 5040 is exposed), and FIG. 52B shows an anchor, anchor portion, tissue engagement portion, fastener, etc. 5030b having an electrode 5040 under a cloth 5047 or cover (e.g., where the electrode is covered by the cloth 5047). FIG. 52C illustrates an anchor, anchor portion, tissue engagement portion, fastener, etc. 5030c having an electrode 5040 fixed to a second arm 5034 without a first arm 5032 and / or cloth or cover.

[0511] The anchor portion, anchor, tissue engagement portion, or fastener 5030a, 5030b, 5030c can be similar to the tissue engagement portions or fasteners 130, 230, 330, 40856, etc. described herein and can share many of the same components (e.g., arms 5032, 5034, fixing means 5036, and joining portion 5038), characteristics, and functionality. The anchors, anchor portions, fasteners 5030a, 5030b, 5030c can be used in place of the anchors / fasteners 130, 230, or features of the anchors, anchor portions, fasteners 5030a, 5030b, 5030c (e.g., electrodes, etc.) can be incorporated into the anchors / fasteners 130, 230. The anchor portion, anchor, fastener 5030a, 5030b, 5030c can be implemented as part of the devices described herein, such as devices 100, 200, etc.

[0512] In some implementations, the anchor portion, the anchor, the tissue engagement portion, and the clasps 5030a, 5030b, 5030c can include a frame 5046 that can be conductive (e.g., made of nitinol or other conductive material), and a cloth 5047 that can be insulating to cover the frame 5046 (such as the cover 240). Many of the implementations of the anchor portion described herein include a cloth or a cover such as the cloth 5047 or the cover 240, but the anchor portion can be implemented without a cloth or a cover, and it should be noted that in such implementations, the bioimpedance techniques described herein can be used with little or no modification to the disclosed anchor portion.

[0513] The electrodes 5040 can take a variety of different forms. For example, the electrodes 5040 can include one or more plates (e.g., covering most of the surface of the arm, most of the surface of the device), one or more rails (thin rectangular strips along the length or across the width of the arm), one or more disks, one or more circles, etc. The electrodes 5040 can be incorporated into a printed circuit board (PCB) attached to the tissue engagement portion or the clasps 5030a, 5030b, 5030c that includes a flexible PCB.

[0514] In some implementations, the electrodes 5040 can be coupled to the first surface of the device (e.g., the surface of the first arm 5032 of the clasps 5030a, 5030b, 5030c), the second surface of the device (e.g., the surface of the second arm 5034 of the clasps 5030a, 5030b, 5030c), both the first and second surfaces, and / or one or more other portions of the device.

[0515] In some implementations, the electrodes 5040 can be coupled to the fixed arm 5032 of the clasps 5030a, 5030b, 5030c, the movable arm 5034 of the clasps 5030a, 5030b, 5030c, both the fixed arm 5032 and the movable arm 5034, and / or one or more other portions of the device.

[0516] In some implementations, the electrode 5040 can be removably coupled to the first surface and / or the first arm 5032 (e.g., the fixed arm). In some implementations, the electrode 5040 can be removably coupled, additionally or alternatively, to the second surface and / or the second arm 5034 (e.g., the movable arm). In such implementations, as described in more detail herein, the electrode 5040 (e.g., a PCB incorporating the electrode 5040, a lead wire, etc.) can be removed after transplantation of the device to which the electrode 5040 is coupled.

[0517] In some implementations, an electrical lead wire can be coupled to the electrode 5040. Further, in some implementations, the electrical lead wire can be removed after transplantation of the device to which the electrode 5040 is coupled, as described in more detail herein. The individual electrodes 5040 can be fabricated from one or more discrete conductor strips, rails, disks, plates, etc. The electrode 5040 can be made of any suitable conductive material.

[0518] In some implementations, one or more electrodes 5040 can be positioned at or near the minimum acceptable or target tissue insertion depth (e.g., the insertion depth of the valve tip, etc.). In some implementations, one or more electrodes 5040 can be positioned at or near the maximum acceptable or target tissue insertion depth. In some implementations, one or more electrodes 5040 can be positioned at or near the minimum acceptable or target tissue insertion depth (e.g., the valve tip insertion depth, etc.) and also at or near the maximum acceptable or target tissue insertion depth.

[0519] In some implementations, an alternating current is applied across electrode 5040 and one or more impedance measurements are obtained and / or derived. For example, electrical leads can be electrically coupled to electrode 5040 as described herein, and a current or voltage can be applied to electrode 5040 using the electrical leads. Similarly, an electrical signal associated with electrode 5040 can be measured using the electrical leads to determine impedance characteristics and / or changes in impedance characteristics. The applied voltage amplitude and / or the alternating current frequency can vary. Different materials can have different impedance characteristics for different applied voltages or currents. Thus, various voltage amplitudes can be applied to improve discrimination between different biological materials disposed in an anchor, tissue engagement portion, clip, etc.

[0520] In some implementations, a voltage is applied and one or more impedance characteristics are measured and / or determined. This can be done, for example, while the anchor or clasp is closed. In some implementation modes, a voltage is applied with the anchor or clasp not fully closed, partially open, or fully closed, and one or more impedance characteristics are measured and / or determined. Next, the measured impedance characteristics can be used to determine the tissue state with respect to the anchor, tissue engagement portion, clasp, etc. For example, the tissue state may be fully inserted, minimally executable insertion, too little insertion, no insertion, or the wrong tissue type may be inserted. In some implementations, the electrode configuration can enable determination of the tissue state before closing the anchor, tissue engagement portion, clasp, etc. This can advantageously avoid foreign puncture of the valve tip by the return during clasp closure, as described herein. Thus, taking impedance measurements (e.g., electrical signals indicating impedance and / or impedance can be calculated) to determine the tissue state while the tissue engagement portion or clasp is open, partially open, or not fully closed can have the advantage of confirming that the tissue is properly positioned within the clasp and / or that no other undesirable tissue (such as chordae tendineae) is positioned within the anchor before the anchor is closed. Taking impedance measurements (e.g., measurements of impedance and / or electrical signals from which impedance can be calculated) to determine the tissue state while the anchor, tissue engagement portion, clasp, etc. are open, partially open, or not fully closed can prevent or inhibit an optional return from piercing or penetrating the tissue (such as the valve tip) until it is confirmed that the tissue is properly positioned within the anchor, tissue engagement portion, clasp, etc.Taking impedance measurements to determine tissue state while an anchor, tissue engagement portion, clip, etc. is open, partially open, or not fully closed can help a user avoid capturing non-target tissue (e.g., chordae tendineae, etc.) of the anchor, tissue engagement portion, clip, etc. (e.g., avoiding closing the anchor, tissue engagement portion, clip while non-target tissue is inside the anchor, tissue engagement portion, clip, etc.).

[0521] In some implementations, one or more impedance characteristics that are measured and / or determined can be used to determine whether target tissue (e.g., valve leaflets) is present in an anchor, tissue engagement portion, clip, etc. while the anchor, tissue engagement portion, clip, etc. is open, partially open, or not fully closed. In such implementations, the measured or determined impedance characteristics can also be used to generate an indicator (e.g., for an operator) that the target tissue is within the capture region of the anchor, tissue engagement portion, clip, etc. but is open, partially open, or not fully closed.

[0522] In some implementations, one or more impedance characteristics that are measured and / or determined can be used to determine whether target tissue has been overly inserted into an anchor, tissue engagement portion, clip, etc. and / or whether target tissue is folded or bundled in the anchor, tissue engagement portion, clip, etc. In such implementations, the measured or determined impedance characteristics can be used to generate an indicator that the target tissue has been overly inserted, folded, or bundled in the anchor, tissue engagement portion, clip, etc.

[0523] In some implementations, one or more impedance characteristics that are measured and / or determined can be used to determine whether non-target tissue has been captured (e.g., a chordae tendineae has been incidentally captured) in an anchor, tissue engagement portion, clip, etc. In such implementations, an indicator indicating that non-target tissue has been captured can be generated using the measured or determined impedance characteristics.

[0524] In some implementations, one or more measured and / or determined impedance characteristics can be used to determine whether captured target tissue is offset or angled to one side in an anchor, tissue engagement portion, clip, etc. (e.g., one side of a valve tip is deeper in a tissue engagement portion or clip than the other side). In such implementations, an indicator indicating that captured tissue is angled or offset with respect to an anchor, tissue engagement portion, clip, etc. can be generated using the measured or determined impedance characteristics.

[0525] In some implementations, electrode 5040 can be included in a circuit along with an AC power source, an electrical sensor, and wiring or electrical leads. The sensor and the power source (e.g., an AC power source, etc.) can be a single device or separate devices. The wiring connects electrode 5040 to the power source and, in particular, to an electrical sensor that measures resistance, inductance, capacitance, voltage, current, and / or impedance, components of impedance, etc. Thus, the electrical characteristics measured by the electrical sensor can be used, and based on the resistance, inductance, capacitance, voltage, impedance, and / or current readings obtained by the sensor, the position of the clip and / or the anatomical structure with which the clip is in contact can be determined. The sensor can take a variety of different forms, including an impedance meter. In some implementations, the sensor is mounted or attached to a PCB or other such component that is attached to or coupled to clips 5030a, 5030b, 5030c. In such implementations, electrode 5040 and the sensor can be integrated on the same PCB or other such component.

[0526] As an example, it has been surprisingly discovered that when measuring an electrical signal during valve tip capture, the amplitude and shape of the electrical signal are different if electrode 5040 is in contact with the valve tip or other parts of the heart valve (e.g., chordae tendineae). The electrical signal can distinguish the type of tissue in contact and the degree of contact with electrode 5040 (e.g., if the electrode is at the edge of the valve tip or near the root). Thus, by placing the electrode on a device (e.g., on one or more of devices 100, 200, 300, 40256, or other devices), the electrical signal can assist the user in determining whether the valve tip or other tissue is captured within the device, whether the tissue is not being captured by the device, and / or whether the device is in contact with a chordae tendineae or other part of the heart valve (e.g., non-target tissue) instead of the valve tip (e.g., the target tissue).

[0527] The electrode 5040 measures an electrical signal to assist a user in determining whether a tissue (e.g., a target tissue, a valve leaflet, etc.) is captured or partially captured by the device. Each of the electrodes 5040 provides a signal of a material such as blood and / or contacts the material (e.g., tissue) at different locations. For example, in some implementations, based on the electrode 5040 being positioned in the blood of the atrium (and not in contact with tissue), based on being positioned in the blood of the ventricle (and not in contact with tissue), based on being in contact with the valve leaflet tissue of the valve, and / or based on being in contact with the chordal tissue, a signal can be supplied.

[0528] In some implementations, three, four, five or more electrodes are included. Each of the clasps 5030a, 5030b, 5030c can incorporate any number of electrodes.

[0529] The electrical signal can be processed in various ways to determine the position of the device in the body (e.g., the position within the heart and / or the position of the valve leaflet relative to the device). In some implementations, a bioimpedance signal is measured on the electrode 5040 as described herein. The bioimpedance signal can be separated into a real part and an imaginary part as is well known in electrical engineering calculations. Also, in some implementations where the power supplied to the electrode 5040 is provided using an alternating current, the bioimpedance signal can also be represented in magnitude and phase. Analyzing the bioimpedance signal can provide an indication of the position of the electrode 5040 and thus the tissue engagement portion or the position of the clasps 5030a, 5030b, 5030c relative to the target tissue (e.g., valve leaflet) and / or relative to other tissues or non-target tissues (e.g., chordal tissue).

[0530] When measuring a bioimpedance signal, different signal readings correspond to different relative positions of the tissue (e.g., target tissue, valve tip, etc.) and the electrodes 5040. For example, in some implementations, when the valve tip contacts only one electrode, a lower magnitude bioimpedance signal reading may occur. However, when the valve tip sufficiently contacts two or more electrodes, a higher magnitude bioimpedance signal reading is produced, indicating that the device is properly positioned. This is due to the valve tip obstructing the current more than the blood. Thus, the more valve tips covering the electrodes, the higher the impedance (e.g., a thicker valve tip has a higher impedance). Accordingly, the electrode configuration can be used to determine whether the target tissue is partially captured, or captured within the clip, or offset or angled relative to the clip, or over-inserted or folded within the clip, and / or whether non-target tissue is captured within the clip while the target tissue is open or not fully closed. Examples of bioimpedance signals resulting from different electrode and tissue configurations are described herein.

[0531] Figures 53A - 53F illustrate anchors, tissue engagement portions, or clips having different electrode configurations. Figures 53A and 53B illustrate an exemplary device 5100 having electrodes 5140, 5145 positioned on an arm 5132 of an anchor, tissue engagement portion, or clip 5130. The device 5100 can be identical or similar to any of the devices described or incorporated herein (e.g., device 100, 200, 300, 8200, 8810, 40256, or another device). Further, the tissue engagement portion or clip 5130 may be identical or similar to the clips 130, 230, 330, 40856, 5030a, 5030b, 5030c (or other tissue engagement portions) described herein and may share many of the same components (e.g., arms 5132, 5134, fixation means 5136, and junction portion 5138), characteristics, and functionality.

[0532] In some implementations of the anchor, tissue engagement portion, or clip 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. The advantage of this type of configuration is that the clip 5130 can be configured to indicate that there is tissue capture when tissue (e.g., the tip of a valve) contacts the electrodes 5140, 5145, even when the clip 5130 is in a capture-ready configuration (e.g., the clip 5130 is open or partially open).

[0533] Figures 53C and 53D show an exemplary device 5200 having an anchor, tissue engagement portion, or clip 5230, each having a first electrode 5240 positioned on a first surface of the device (e.g., the surface of the first arm 5232) and a second electrode 5245 positioned on a second surface of the device (e.g., the surface of the second arm 5234) (e.g., of the clip 5230 of the device, other portions of the device, etc.). The device 5200 can be the same as or similar to any of the devices described or incorporated herein (e.g., device 100, 200, 300, 8200, 8810, 40256, or another device). Further, the tissue engagement portion or clip 5230 may be the same as or similar to the clips 130, 230, 330, 40856, 5030a, 5030b, 5030c (or other tissue engagement portions) described herein and can share many of the same components (e.g., arms 5232, 5234, securing means 5236, and junction portion 5238), characteristics, and functionality.

[0534] In some implementations of the tissue engagement portion or clip 5230, there are two strips 5240, 5245 of electrodes that extend wholly or partially across the respective surfaces and / or widths of the respective arms 5232, 5234. Thus, the electrodes 5240, 5245 provide bio-impedance signals corresponding to different sides of the valve tip or other tissue. The advantage of this type of configuration is that the tissue engagement portion or clip 5230 indicates no tissue or valve tip capture when the tissue engagement portion or clip 5230 is closed because at least partially the electrodes 5240, 5245 are shorted or in contact with each other, and as a result, the impedance value can be configured to be dramatically reduced compared to a configuration where the electrodes 5240, 5245 are away from and / or in contact with the tissue.

[0535] Figures 53E and 53F illustrate an exemplary device 5300 having a tissue engagement portion or clip 5330, each having a first electrode plate 5340 positioned on a first surface (e.g., the surface of the first arm 5332) of the device (e.g., of the clip 5230), and a second electrode plate 5345 positioned on a second surface (e.g., the surface of the second arm 5334). The device 5200 can be the same or similar to any of the devices described or incorporated herein (e.g., device 100, 200, 300, 8200, 8810, 40256, or another device). Further, the tissue engagement portion or clip 5230 can be the same or similar to the clips 130, 230, 330, 40856, 5030a, 5030b, 5030c (or other tissue engagement portions) described herein and can share many of the same components (e.g., arms 5332, 5334, securing means 5336, and junction portion 5338), characteristics, and functionality.

[0536] In some implementations of the tissue engagement portion or clip 5330, there are two electrode plates 5340, 5345 that completely or partially cover the respective surfaces and / or the regions of the respective arms 5332, 5334. Thus, the electrode plates 5340, 5345 can provide bioimpedance signals corresponding to different capture depths of the valve tip or other tissue, and can provide detailed information regarding the relative capture depth of the valve tip or other tissue with respect to other electrode configurations (e.g., the electrodes of clips 5130, 5230). The advantage of this configuration is that the tissue engagement portion or clip 5330 is configured to indicate the tissue capture depth when the tissue or valve tip is between the electrode plates 5340, 5345 and the tissue or valve tip acts as a dielectric. Similarly, another advantage of this configuration is that the clip 5330 is configured to indicate that there is no tissue or valve tip capture when the clip 5330 is closed because the electrodes 5340, 5345 are at least partially shorted or in contact with each other, and the impedance value is dramatically reduced compared to a configuration where the electrodes 5340, 5345 are away from and / or in contact with the tissue.

[0537] FIG. 54 shows an exemplary bio - impedance signal from a tissue engagement portion or clip having two or more electrodes for providing bio - impedance - based feedback, such as clips 5030a, 5030b, 5030c, 5130, 5230, and / or 5330. The exemplary bio - impedance signal is shown as a function of time corresponding to an exemplary process of moving the device to a position adjacent the valve tip and then grasping the valve tip, examples of which are described herein with respect to FIGS. 16 - 21 and FIGS. 38 - 49. Different lines of the graph correspond to a fully captured valve tip ("Full"), an over - captured valve tip that can become a valve tip partially folded within the clip ("Over"), a very over - captured valve tip where the length of the valve tip captured within the clip is about two or more times the length of the clip and the valve tip is bundled within the clip ("xOver"), an under - captured valve tip ("Under") (e.g., the valve tip insertion is about 4 mm to about 5.9 mm), a chord captured ("Chord"), an overly under - captured valve tip ("xUnder") (e.g., the valve tip insertion is about 1 mm to about 3 mm). Additionally, a control bio - impedance signal ("Control") corresponding to the bio - impedance signal when the valve tip is not captured is shown.

[0538] The initial baseline portion of the plot corresponds to the device being moved to a predetermined position before the valve tip enters the clip. Examples of this configuration are shown in FIGS. 18 and 43. When the valve tip enters an open or partially open clip, the bio - impedance signal rises sharply. Examples of this configuration are shown in FIGS. 19 and 44. When the clip closes over the valve tip, the bio - impedance signal drops to a steady - state signal different from the baseline signal resulting from an open clip with no valve tip within the clip. Examples of this configuration are shown in FIGS. 19, 20, and 45.

[0539] The amount of leaflet capture (or other tissue capture) can be determined based at least in part on the bioimpedance signal from the tissue engagement portion or the electrode on the clip. Before capturing the tissue (e.g., the leaflet), the bioimpedance signal is a steady state (or near steady state) signal, which may be referred to as an empty open clip baseline. When the tissue or leaflet enters the open clip or other tissue engagement portion, the bioimpedance signal increases (the contrast is shown in a control signal that does not increase because the leaflet does not enter the open clip). As shown in FIG. 54, overly captured tissue (“Over” and “xOver”) results in a greater increase in the bioimpedance signal than fully captured tissue (“Full”) and undercaptured tissue (“Under” and “xUnder”). Similarly, below undercaptured tissue (“Under” and “xUnder”), the increase in the bioimpedance signal is less than that of fully captured tissue (“Full”). Thus, the amount of tissue capture can be determined based on the increase or change in the bioimpedance signal. Further, when the clip closes, the bioimpedance signal drops to a steady state value (or near steady state), which may be referred to as a closed clip baseline. The change in the bioimpedance value also provides information regarding the state of tissue capture and / or the state of the tissue engagement portion or anchor. For example, when a chordae tendineae is captured within the clip, a different bioimpedance signal profile results for the clip that captures the leaflet. The increase in the bioimpedance signal for the “Chord” situation and the “Under” situation is similar, but it can be determined that the chordae tendineae is captured within the clip or the leaflet capture portion due to the different baseline bioimpedance signals of the closed clip or leaflet capture portion.

[0540] As described herein, it can be understood that a bioimpedance signal reflects the amount of resistance to an electrical signal. The type of tissue and the amount of tissue between the electrodes affect the bioimpedance signal. For example, when the clip (or other tissue engagement portion) is closed with no tissue between the electrodes, it is similar to a short circuit with very little resistance between the electrodes. For this reason, the control signal has the lowest impedance in the graph after the clip is closed. In the open position with no valve tip between the clips, the blood between the electrodes provides a low-resistance electrical path. For this reason, each impedance signal in the graph has approximately the same open-clip baseline. When tissue enters the clip, the amount of tissue within the clip (reflecting whether the valve tip is fully, overly, or inadequately captured) affects the impedance, and more tissue typically increases the amount of impedance to the electrical signal. With the clip closed, the amount of tissue within the clip affects the impedance, and more tissue typically increases the amount of impedance to the electrical signal. Thus, a bioimpedance signal profile (including impedance signals from different parts of the implantation process) can be analyzed to determine the state of valve tip capture of the clip. Thus, using the bioimpedance signal obtained, measured, or determined as described herein using the electrodes on the clip, it can be determined whether the target tissue is within the clip even before the clip is closed, whether the tissue has been inserted overly, whether non-target tissue has been or is being captured, and / or whether the target tissue is off to one side of or angled with respect to the clip.

[0541] Figures 55 and 56 show exemplary bioimpedance signals from the tissue engagement portion of FIGS. 53C and 53D or the clip 5230 (which can be incorporated into any of the devices of this specification). The upper graph of FIG. 55 illustrates a bioimpedance signal having the tissue engagement portion or clip 5230 in the open position, with the bioimpedance signal varying with respect to the insertion depth of the valve tip (or other tissue) within the clip 5230. The middle graph of FIG. 55 illustrates the increase in bioimpedance when the valve tip is fully inserted within the clip 5230. The lower graph of FIG. 55 illustrates a control signal where the valve tip (or other tissue) is not inserted into the clip 5230, but the clip is closed and then opened. The upper graph of FIG. 56 illustrates the real (left graph) and imaginary (right graph) portions of the bioimpedance signal for a fully captured valve tip (or other tissue). The middle graph of FIG. 56 illustrates the real (left graph) and imaginary (right graph) portions of the bioimpedance signal for an overcaptured valve tip (or other tissue). The lower graph of FIG. 56 illustrates the real (left graph) and imaginary (right graph) portions of the bioimpedance signal for an undercaptured valve tip (or other tissue). Different lines in the graphs correspond to different measurements of a sample size of 4 (e.g., using different valve tips). This configuration of electrodes 5240, 5245 provides a relatively binary output with respect to the state of the valve tip or tissue (e.g., captured or not captured). As shown, the exemplary bioimpedance signals show significant differences for full valve tip capture, under valve tip capture, and over valve tip capture, making it relatively clear that the situations can be analyzed and classified.

[0542] In some implementations, various algorithms can be implemented to analyze the bio - impedance signal of the tissue engagement portion or the clip 5230. For example, a signal - processing algorithm can be implemented. In such examples, some implementations can generate binary outputs such as tissue contact or no tissue contact with the electrodes. In such examples, some implementations can use multiple electrodes (e.g., arranged within an array) and compare the signals from each electrode or electrode pair to each other to determine the tissue state. For example, there are six electrodes evenly spaced on the inner paddle and the valve tip contacts the outer four electrodes. When the valve tip is folded at the middle pair, each outer pair has signals similar to each other but different from the middle pair. Then, a particular implementation can use a user interface to display the electrodes (or the signals measured by the electrodes) to show the user the tissue state (e.g., the folded valve tip), examples of which are described herein.

[0543] As another example of an algorithm, after the clip 5230 (or other tissue capture portion) is closed, a threshold algorithm can be implemented that outputs a display of an inadequately captured valve tip or a fully captured valve tip. This is similar to the mechanical display of valve tip capture, which has the advantage of providing a clearer user interface and being quick and simple to implement. As another example, after the clip 5230 is closed, a feature - based decision tree algorithm can be implemented that outputs a display of an inadequately, overly, or fully captured valve tip. This algorithm may be configured to distinguish between thick and thin valve tips and can help avoid over - insertion of the valve tip. This can reduce the remaining backflow and complications of single - leaflet device attachment (SLDA). As another example, a feature - based random forest algorithm can be implemented that outputs a display of an inadequately, overly, or fully captured valve tip while the clip 5230 is open and after the clip 5230 is closed. This advantageously provides a display of valve tip capture before closing the clip 5230, which provides confirmation of valve tip capture before implant liberation. Similar principles apply to the capture of other types of tissue.

[0544] Figures 57 and 58 show exemplary bioimpedance signals from the tissue engagement portion or clip 5330 of FIGS. 53E and 53F. The upper graph of FIG. 57 shows the bioimpedance signal with the tissue engagement portion or clip 5330 in the open position as a function of the tip capture depth. This indicates that the electrode plates 5340, 5345 provide a signal that can be used to provide a relatively accurate determination of the tip capture depth, at least in part due to the configuration of the electrode plates 5340, 5345. The lower graph of FIG. 57 shows the magnitude of the bioimpedance signal with the tissue engagement portion or clip 5330 in the open position for various situations such as gradually pulling the tip out of the clip and no tip insertion. The different lines of the lower graph correspond to different measurements with a sample size of 5 (e.g., using different tips). The upper graph of FIG. 58 illustrates the real (left graph) and imaginary (right graph) parts of the bioimpedance signal with a fully captured tip. The middle graph of FIG. 58 shows the real part (left graph) and imaginary part (right graph) of the bioimpedance signal with an overcaptured tip. The lower graph of FIG. 58 shows the real part (left graph) and imaginary part (right graph) of the bioimpedance signal with an undercaptured tip. The different lines of the graph correspond to different measurements with a sample size of 4 (e.g., using different tips). Similar principles apply to the capture of other types of tissue.

[0545] Figures 59A and 59B show an exemplary tissue engagement portion or fastener 5930 having a combination of an electrode plate 5945 and electrode strips 5940, 5942. The tissue engagement portion or fastener 5930 has electrode strips 5940, 5942 positioned on a first surface and / or first arm 5932, and an electrode plate 5945 (e.g., electrode strips 5940, 5942 and electrode plate 5945 on a cover 5947) positioned on a second surface and / or second arm 5934 of the fastener 5930. The tissue engagement portion or fastener 5930 may be implemented in any of the devices described herein. Further, the tissue engagement portion or fastener 5930 may be the same as or similar to fasteners 130, 230, 330, 40856, 5030a, 5030b, 5030c (or other tissue engagement portions) described herein and may share many of the same components (e.g., arms 5932, 5934, securing means 5936, and junction portion 5938), characteristics, and functionality.

[0546] In the illustrated example of the tissue engagement portion or fastener 5930, the electrode plate 5945 completely or partially covers an area of the surface or arm 5934. Further, the electrode strips 5940, 5942 extend parallel to the length of the surface or arm 5932, cover a portion of the length of the surface or arm 5932, and the separation between the electrode strips 5940, 5942 is along the width of the surface or arm 5932.

[0547] In some implementations, the combination of the electrode plate 5945 and the electrode strips 5940, 5942 can provide bioimpedance signals corresponding to different capture depths of the valve tip and can provide detailed information regarding the relative capture depth of the valve tip with respect to the tissue engagement portion or the fasteners 5130, 5230, 5330. For example, when the fastener 5930 is open, the impedance between the electrode strips 5940, 5942 can be measured to determine the insertion depth of the valve tip. When the fastener 5930 is closed, the impedance between each electrode strip 5940, 5942 and the electrode plate 5945 can be measured to determine the valve tip capture depth. Advantageously, this configuration provides a continuous signal that correlates with the amount of valve tip inserted while the fastener 5930 is open. Advantageously, this configuration confirms valve tip capture when the fastener 5930 is closed. Advantageously, this configuration can distinguish different valve tip insertion scenarios (e.g., angled, off to one side, curved, partial or inadequate insertion, full insertion, over-insertion, etc.) at least in part by the configuration of the electrode strips 5940, 5942 along with the electrode plate 5945. For example, the asymmetry of the bioimpedance signals from the electrode strips 5940, 5942 can indicate that the tissue within the fastener 5930 is angled or off to one side. The same principle applies to the capture of other types of tissue.

[0548] Figures 60A - 62C show examples of tissue engagement portions or fasteners 6030 having electrode strips 6040, 6042, and examples of bio - impedance signals from the tissue engagement portion or fastener 6030. FIGS. 60A and 60B illustrate a tissue engagement portion or fastener 6030 that can be configured the same as or similar to the fastener 230 (or another tissue engagement portion or fastener herein), with a cover 6047 over the fastener 6030 (similar to cover 240 in FIG. 25). FIG. 60C shows an exemplary implementation of the tissue engagement portion or fastener 6030 of FIG. 60B without the cover 6047. Each of the tissue engagement portions or fasteners and related bio - impedance - based components described herein can be implemented with or without a cover, and one example is shown by the fastener 6030 in FIG. 60B having a cover 6047 and FIG. 60C having no cover.

[0549] The tissue engagement portion or fastener 6030 has electrode strips 6040, 6042 positioned on a first surface and / or on a first arm 6032 (e.g., on a portion of the cover 6047 over the first arm 6032). The tissue engagement portion or fastener 6030 can be implemented in any of the devices described herein. Further, the tissue engagement portion or fastener 6030 may be the same as or similar to the fasteners 130, 230, 330, 40856, 5030a, 5030b, 5030c, 5930 (or other tissue engagement portions) described herein and can share many of the same components (e.g., arms 6032, 6034, junction 6038, securing means 6036, and electrode strips 6040, 6042), characteristics, and functionality.

[0550] In the illustrated example of the tissue engagement portion or clip 6030, the electrode strips 6040, 6042 extend parallel to the length of the arm 6032, cover a portion of the length of the arm 6032, and the separation between the electrode strips 6040, 6042 is along the width of the arm 6032. In this exemplary implementation of the tissue engagement portion or clip 6030, the electrode strips 6040, 6042 are mounted on the cover 6047, but it should be noted that the electrode strips 6040, 6042 can be mounted under the cover 6047.

[0551] The upper graph of FIG. 61A illustrates the real (left graph) and imaginary (right graph) parts of the bioimpedance signal of the clip 6030 when the valve tip is fully captured. The lower graph of FIG. 61A illustrates the real (left graph) and imaginary (right graph) parts of the bioimpedance signal of the clip 6030 when the valve tip is overcaptured. The upper graph of FIG. 61B illustrates the real (left graph) and imaginary (right graph) parts of the bioimpedance signal of the clip 6030 when the valve tip is undercaptured. The middle graph of FIG. 61B shows the real (left graph) and imaginary (right graph) parts of the bioimpedance signal of the clip 6030 when the valve tip is undercaptured, particularly when the valve tip is 1 / 4 undercaptured. The lower graph of FIG. 61B illustrates the real part of the bioimpedance signal of the clip 6030 when the valve tip is undercaptured (signal portion 6101), when the valve tip is fully captured (signal portion 6102), and when the valve tip is overcaptured (signal portion 6103). The asymmetry of the bioimpedance signal from the electrode strips 6040, 6042 can indicate whether the tissue within the tissue engagement portion or clip 6030 is angled or biased to one side. The same principle applies to the capture of other types of tissue.

[0552] Figures 62A and 62B illustrate the implementation of a tissue engagement portion or clip 6230 that may be the same as or similar to the tissue engagement portion or clip 6030 of FIGS. 60A - C, except that electrode strips 6240, 6242 are offset from the surface and / or the edge of the arm 6032 (e.g., free edge, edge opposite the hinge end, etc.) by a predetermined distance d (e.g., about 6 mm). This offset changes the bio - impedance signal profile for cusp capture, as shown in the graph of FIG. 62C. The upper graph of FIG. 62C illustrates the real (left graph) and phase (right graph) portions of the bio - impedance signals for fully captured cusps (signals 6201a, 6201b) and over - captured cusps (signals 6202a, 6202b). The lower graph of FIG. 62C shows the magnitude (left graph) and phase (right graph) portions of the bio - impedance signals for two full insertions (signal portions 6203a, 6203b, 6204a, 6204b) and one over - insertion (signal portion 6205a, 6205b) on an ex - vivo beating heart. In this exemplary implementation of clip 6230, electrode strips 6240, 6242 are mounted on cover 6047, but it should be noted that electrode strips 6240, 6242 may be mounted under cover 6047. In some implementations, the cover is not used.

[0553] Various algorithms can be implemented to analyze the bioimpedance signals of the tissue engagement portion or fasteners 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 that outputs an indication of an inadequately, overly, or fully captured valve tip when the tissue engagement portion or fasteners 6030, 6230 are opened and closed. This algorithm can be configured to determine when the valve tip is off to one side or angled within the tissue engagement portion or fasteners 6030, 6230 and / or when only one electrode is covered. Advantageously, this provides an indicator before closing the fasteners 6030, 6230. As another example, another feature-based random forest algorithm can be implemented that outputs a continuous valve tip insertion indicator while the fasteners 6030, 6230 are opening and closing. This can advantageously provide the user with a greater amount of information and can be configured to distinguish between captured target tissue (e.g., valve tip capture) and captured non-target tissue (e.g., chord capture).

[0554] In some implementations, the tissue engagement portion or fasteners 6030, 6230 can include a reference electrode (not shown). In some implementations, the reference electrode can be similar to the reference electrode described herein with reference to FIG. 64, for example, the reference electrode can be part of an actuating element.

[0555] In some implementations, the reference electrode can be a dedicated reference electrode in the blood, an electrode on the catheter, or an external patch on the patient's skin. In some implementations, the bioimpedance can be measured in three configurations: electrode A versus electrode B (e.g., electrode 6040 versus electrode 6042 or electrode 6240 versus electrode 6242), electrode A versus the reference electrode, and electrode B versus the reference electrode.

[0556] In some implementations, a reference electrode can measure a bio-impedance-based signal that can provide detailed information regarding tissue contact on the tissue engagement portion or clip 6030, 6230 by comparing two monopolar measurements from each electrode (e.g., electrode 6040 and electrode 6042 or electrode 6240 and electrode 6242). As an example, if one electrode has a relatively high impedance indicating full insertion while the other electrode has an impedance indicating insufficient insertion, this can mean that the valve tip is inserted off to one side or at an angle. As another example, in the commissure region where mainly the tendon is captured, each electrode 6040, 6042 or each electrode 6240, 6242 shows a different impedance, but both impedances are too low to be confused with full valve tip capture.

[0557] In some implementations, when bipolar impedance is measured, the comparison of the valve tip and valve tip-less / blood is amplified, at least in part, due to the electrodes that are in contact with the valve tip and / or blood simultaneously. This can provide a greater indication of valve tip insertion, which can be more pronounced when the valve tip is inserted straight into the tissue engagement portion or clip and the device or implant is perpendicular to the free edge of the valve tip.

[0558] The exemplary tissue engagement portion or clip 6030's electrode configuration can be beneficial at least in part by electrode strips 6040, 6042, providing a continuous indication (which can be substantially linear) of tip insertion over the entire length of the tissue engagement portion or clip 6030. This can be decomposed, for example, into a quantified signal region indicating four categories of tip insertion (no tip, insufficient insertion, complete insertion, and over-insertion). In some implementations, the average measurements of electrode strips 6040, 6042 can be used to determine the label or category of tip insertion. The electrode configuration of the tissue engagement portion or clip 6230 can be beneficial because there is little or no signal change until the tip reaches the edge of electrode strips 6242, 6240 which is already at a distance d within the clip 6230. The distance d can be configured to be an advantageous distance indicating an insertion distance sufficient to achieve good tip capture. As an example, the distance d can be, in a particular implementation, about 6 mm or about 4 mm to about 8 mm. Comparing this to clip 6030, the indication of tip insertion can be divided into three categories, and since there is not a sufficient signal difference between no tip insertion and insufficient tip insertion at clip 6230, the no tip insertion indicator can be combined with the insufficient insertion indicator.

[0559] In some implementations, machine learning or other algorithms can be implemented to automatically determine the state of tissue or the valve tip based on the bioimpedance signal from the electrodes. For example, the algorithm may interpret a signal that matches signal 6101 in FIG. 61B as indicating no tissue / valve tip within the clip, a signal that matches signal 6102 in FIG. 61B as corresponding to complete tissue / valve tip insertion, and a signal that matches signal 6103 in FIG. 61B as corresponding to over-insertion of the tissue / valve tip, and can be implemented in conjunction with clip 6030. The algorithm can also be used to generate an indicator for the user. For example, FIG. 62D shows a delivery system 6206 that may include an indicator panel 6207 on the proximal end of the delivery system 6206 (similar to the delivery systems 102, 202 described herein). The indicator panel 6207 includes lights or other indicators indicating no valve tip in the clip, complete valve tip capture, and over-insertion of the valve tip. The user can visually check the indicator panel 6207 to determine the valve tip state without relying solely on acoustic imaging or other imaging techniques.

[0560] FIGS. 63A and 63B show an exemplary device 6300 having a tissue engagement portion or clip 6330, each having a first electrode 6340 positioned on a first surface and / or a first arm 6332 of the tissue engagement portion or clip 6330, and a second electrode 6345 positioned on a second surface and / or a second arm 6334. Device 6300 may be the same or similar to devices 100, 200, 300, 8200, 8810, 40256, 5200 described herein. Further, the tissue engagement portion or clip 6330 may be the same or similar to clips 130, 230, 330, 40856, 5030a, 5030b, 5030c (or other tissue engagement portions) described herein and may share many of the same components (e.g., arms 6332, 6334, fixation means 6336, and junction portion 6338), characteristics, and functionality.

[0561] In the illustrated example of the tissue engagement portion or clip 6330, there are two opposing electrodes 6340, 6345 that are coupled to the first surface or first arm 6332 and the second surface or second arm 6334, respectively (or, in an implementation without a second arm, to another part of the device). Thus, electrodes 6340, 6345 provide bioimpedance signals corresponding to different sides of the valve tip or other tissue. An advantage of this type of configuration is that the clip 6330 can be configured to determine the thickness of the tissue between electrodes 6340, 6345 and scan the tissue thickness as the tissue passes through the clip 6330 between electrodes 6340, 6345. Further, this configuration of electrodes 6340, 6345 provides a benefit similar to that of clip 5230 in that it can indicate the absence of valve tip or tissue capture when the clip 6330 is closed, at least in part due to the electrodes 6340, 6345 being shorted or in contact with each other, and the impedance value is dramatically reduced compared to a configuration where the electrodes 6340, 6345 are separated and / or in contact with the tissue.

[0562] In some implementations, the first electrode may be coupled to an arm and the second or opposing electrode may be coupled to another part of the device (e.g., if a second arm is not included).

[0563] As an example, the opposing electrodes 6340, 6345 can be positioned on each side of the valve tip as it enters the tissue engagement portion or clip 6330 and can effectively scan the valve tip as it passes through the electrodes 6340, 6345. A cross-sectional map of the thickness of the tissue / valve tip can be generated using the signals acquired as the tissue / valve tip passes between electrodes 6340, 6345. In some implementations, these signals are acquired while the clip 6330 is partially closed such that the electrodes 6340, 6345 are close to the tissue / valve tip.

[0564] In some implementations, the thickness of the valve tip tissue can be used by an operator to estimate or determine the strength of the valve tip. The thickness and strength of the valve tip can indicate the amount of tension that can be applied to the valve tip and / or whether the valve tip needs to be fully inserted into the clip for secure capture. For example, stronger valve tip tissue can withstand higher forces, and the return of clip 6330 can hold well in stronger tissue compared to weaker tissue. Advantageously, this can result in less stenosis and more anastomosis.

[0565] FIG. 64 shows an exemplary device 6400 having tissue engagement portions or clips 6430 with electrodes 6440, 6445 similar to the tissue engagement portions or clips 5130 of devices 5100 of FIGS. 53A and 53B. Device 6400 can be the same as or similar to devices 100, 200, 300, 8200, 8810, 40256, etc. described herein. Further, the tissue engagement portion or clip 6430 can be the same as or similar to clips 130, 230, 330, 40856, 5030a, 5030b, 5030c (or other tissue engagement portions) described herein and can share many of the same components (e.g., arms 6432, 6434, fixation means 6436, and junction portion 6438), characteristics, and functionality.

[0566] In some implementations of device 6400, there is an additional reference electrode 6442 implemented on device 6400. This configuration can provide additional sensitivity because reference electrode 6442 is near sensing electrodes 6440, 6445. A reference electrode 6442 or a similar reference electrode can be implemented on any of the devices described herein to provide bipolar measurements of bioimpedance. The bipolar configuration includes a measurement configuration where 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 where the reference electrode is located in a different region than the sensing electrode (e.g., the sensing electrode is in the heart and the reference electrode is on the patient's skin).

[0567] FIG. 65 shows an embodiment of device 200 with flexible electrodes 6545a - b protruding away from device 200. Device 200 is described in more detail herein with reference to FIGS. 22 - 37. Flexible electrodes 6545a - b are configured to measure blood flow and / or detect leakage through a valve into which device 200 is implanted. Flexible electrodes 6545a - b flex as blood flows through them, and the amount of flexure is related to differential pressure or flow. When flexible electrodes 6545a - b flex, the impedance relative to reference electrode 6542 (e.g., on actuating element 212) changes, which can be used to determine the amount of flexure and then can be used to determine the relative blood flow adjacent to device 200. For example, retrograde blood volume pushes flexible electrodes 6545a, 6545b towards the atrium, near reference electrode 6542, reducing impedance. The amount of flexure (measured by the change in impedance) can be used as pressure sensors on both sides of device 200 such that the measured values can be used to determine whether there is retrograde volume adjacent to device 200.

[0568] This is advantageous because a typical method for quantifying leakage in a percutaneous procedure is by echocardiography - based imaging. However, it can be difficult to determine if there is leakage after deploying device 200 if there is not sufficient quality acoustics. Many things, including but not limited to metal within the device that causes shadowing or ringing, can affect the quality of acoustic imaging. Thus, bio - impedance measurements can be advantageous in providing an additional or alternative method for determining or monitoring leakage through a valve.

[0569] In some implementations, device 200 can include flexible electrodes in addition to flexible electrodes 6545a - b that extend around device 200 for monitoring leakage. Flexible electrodes 6545a - b can have a predetermined size and weight such that the force on flexible electrodes 6545a - b can be determined based on the flexure of electrodes 6545a, 6545b.

[0570] The amount of deflection can be determined using the bio - impedance measurements described herein, at least in part, by the flexible electrodes 6545a, 6545b that act in a manner similar to a spring where 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 implementations, the reverse fluid volume can also be calculated based on the size of the orifice (e.g., determined acoustically).

[0571] In some implementations, the force on the device / implant can be determined using bio - impedance measurements. 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 device's response to a known force. Additionally, the impedance measurement can be made with the device deflected by a known amount. Thus, the measured impedance can be related to the force on the device through the relationship between the device's opening distance and the measured impedance. The impedance value at baseline can be used to calibrate the patient when the clip is closed, and then the change from baseline can be measured after the device is released to calculate the forces during systole and diastole. These measurements can be used for verification and testing during design, manufacturing, or deployment, and can indicate whether there is a high likelihood of single - leaflet device attachment (SLDA). Further, the electrodes on the device can act as implantable sensors that monitor the force during the life of the implant. Measurements can also be made to determine the tension of the leaflet pulling on the closed implant. Such measurements can be used to predict the risk of leaflet damage or SLDA if the tension is high enough. Additionally, these measurements can correlate with leaflet stenosis, higher pressure gradients, and / or slippage during implant closure as more tension is applied. These measurements can also provide an indication of whether the device is fully closed.

[0572] Furthermore, in implementations where forces are measured on both sides of the implant, the asymmetry can indicate asymmetric tension on the valve tip, suggesting that the delivery device may be deflecting the valve tip and that the clinical outcome of the therapy may potentially change when the device / implant is released. Asymmetric forces may be undesirable because they can cause changes in the bonding or other characteristics of the implanted device when the device is released from the delivery system. It is desirable to reduce or eliminate changes in the performance of the device / implant after release from the delivery system. Thus, it may be desirable to be able to measure and / or monitor the forces on the device / implant.

[0573] Exemplary Configuration of Impedance Measurement System As described herein, the configuration and placement of electrodes on a device (e.g., anchors of the device, tissue engagement portions, clasps, etc.) can provide many different advantages as they are applied to bioimpedance-based feedback measurements. However, the electrical wiring of sensors and electrodes within a catheter can be at least partially difficult due to the limited space within the catheter. If it is desirable to include multiple sensors or electrodes, a typical solution requires running wiring for each electrode along the length of the catheter. However, the limited inner diameter of the catheter restricts the number of wires that can run from the proximal end of the catheter or other delivery system to the electrodes, thereby restricting the number of electrodes that can be used in the device or implant. This then results in a decrease in the amount or accuracy of the bioimpedance measurement information obtained with the electrodes. Additionally, increasing the number of electrical leads running to the device significantly complicates the manufacture of the device and delivery system.

[0574] Accordingly, FIGS. 66A and 66B show an exemplary electrode array that reduces the number of electrical lead wires necessary to enable an electrical lead wire to fit within a small lumen catheter. FIG. 66A depicts an exemplary tissue engagement portion or clip 6630a that may be the same as or similar to clips 130, 230, 330, 40856, 5030a, 5030b, 5030c (or other tissue engagement portions) described herein, with a series of electrodes 6640a-f coupled to arms 6632, 6634 of clip 6630a, and a junction 6638 coupling arms 6632, 6634 to each other. One or more of the electrodes and / or electrode arrays may optionally be mounted on other surfaces and / or portions of the device (e.g., not necessarily arms).

[0575] In some implementations, electrical lead wire 6646 couples electrodes 6640a-f in series with one or more electrical components 6643a-e that are coupled in series between each of the electrodes 6640a-f. In some implementations, electrical lead wire 6646 then passes through the delivery device to deliver an electrical signal and enable a bioimpedance measurement.

[0576] In some implementations, the electrodes are coupled in parallel, and each electrode has an electrical lead wire that electrically couples the respective electrode to the measurement system at the proximal end of the delivery system. In some implementations, the tissue engagement portion or clip 6630a includes an electrical lead wire 6646 having electrical components 6643a - e coupled in series with electrodes 6640a - f, enabling individual measurements of each electrode without the need for an electrical lead wire for each electrode. In some implementations, this is achieved by using resistors, capacitors, and / or inductors having known and fixed values as electrical components 6643a - e in series between each of the electrodes 6640a - f. By using electrical components with different characteristics, impedance measurements from each electrode can be determined individually using the electrical lead wire 6646. For example, even when the electrodes 6640a - f are coupled in series, the measured bio - impedance value can be separated because the current through the electrical lead wire 6646 and its frequency are known. From the measured impedance, it is possible to calculate resistance, capacitance, and / or inductance and subtract the known values of the electrical components inserted in series. As a result, it is possible to determine the impedance measured from the electrodes as if they were coupled in parallel.

[0577] FIG. 66B shows an exemplary clip 6630b having a plurality of electrodes 6640a - f and analog - to - digital converter (ADC) chips 6643 coupled to each of the electrodes 6640a - f. The ADC chips 6643 are configured to convert signals from the electrodes 6640a - f into digital signals that can be transmitted via the electrical lead wire 6646 using digital packets, thereby separating each electrode signal using a digital data transfer protocol.

[0578] FIG. 67A shows an example of a bio - impedance signal 6706 having vibrations corresponding to the diastolic and systolic phases of the heart. Changes in the contact between the electrodes and the tissue resulting from the variations caused by the beating of the heart can result in vibrations in the measured bio - impedance signal 6706. Using the vibrations (e.g., the peak - to - peak amplitude of the bio - impedance signal) and the average value of the bio - impedance signal, a signal - processing algorithm can be implemented to determine the tissue state with respect to the clip or anchor. For example, if there are high peak - to - peak vibrations, it can be determined or concluded that there is not an ideal contact between the clip and the tissue. As more tension is applied, the tissue contacts the tissue engagement portion (e.g., anchor, clip, etc.) better, and while the magnitude of the average signal increases, the peak - to - peak vibrations are reduced. This can be used, for example, to generate a binary decision such as no tissue contact in period 6710, no tissue contact in period 6715, and no tissue contact in period 6720.

[0579] The above - described bio - impedance concepts related to tissue capture can also be applied to various medical systems, devices, and procedures. In some implementations, the bio - impedance concepts described herein can also be applied to the anchor deployment of various medical systems and devices in various medical procedures. For example, annuloplasty (e.g., reduction of the valve annulus) can benefit from the measurement of bio - impedance signals. Various displays of anchor placement and / or tissue engagement are beneficial and improve the procedure and safety.

[0580] In some implementations, when an anchor of a trans - catheter annuloplasty system / device is implanted around or in the valve annulus, the bio - impedance signal can be monitored to determine the deployment status of each anchor and / or related devices such as the annuloplasty implant.

[0581] FIG. 67B shows an example of a bioimpedance signal when a delivery device implants tissue anchors (e.g., spiral tissue anchors, dirt-like anchors, hook-like anchors, etc.) into the valve ring of a native valve. The bioimpedance signal indicates contact with tissue (signal portions 6701, 6702), partial and complete deployment or insertion into tissue (signal portions 6703 and 6704 respectively), and removal of the delivery device (signal portion 6705). In some implementations, the bioimpedance signal represents a single anchor deployed or inserted into tissue, and the process can be repeated sequentially for each anchor deployed (e.g., 5 - 25 anchors, 10 - 20 anchors, 12 - 17 anchors, etc.) (or if the anchors are deployed simultaneously, each anchor can be analyzed simultaneously). In some implementations, the bioimpedance signal can indicate a situation where all the anchors are electrically shorted together.

[0582] In some implementations, the disclosed medical systems, devices, and procedures utilize one or more anchors (e.g., spiral anchors, darts, hooks, clasps, clamps, returns, arms, etc.). Individual anchors can include one or two, or more than two electrodes. Electrical signals can be provided to the electrodes, and one or more electrical sensors can be configured to measure various electrical signals, including bioimpedance signals. When an anchor is implanted into tissue, the bioimpedance signal decreases, similar to a short circuit. Ex vivo measurements can be taken and used to determine the anchor depth based on, or in response to, electrical signals from the anchor deployed in vivo. Thus, the anchor depth can be determined based on ex vivo measurements and on electrical signals from the anchor when it is implanted. This is enhanced by the change in impedance as the anchor moves from blood to tissue. Thus, an indicator can be determined and provided to the user to indicate when the tissue was contacted and the depth of penetration of the anchor into the tissue. The indicator can be configured to indicate the anchor deployment state, which can include an anchor in contact with the tissue, a partially deployed anchor, and a fully deployed anchor. In some implementations, amplitude modulation can be used when considering the length of the DFT wire connection between anchors as a resistor. This can be used to monitor continuous anchor deployment.

[0583] In some implementations, an anchor having two electrodes is configured to facilitate monitoring of bioimpedance. This can be done to monitor the anchor of the anchor to indicate successful and / or complete penetration of the anchor into tissue. An impedance measurement device (e.g., the impedance measurement device of FIG. 68) can be coupled to the proximal end of the anchor drive or anchor driver. The impedance measurement device can be configured to use a bipolar connection in such a way that the positive and negative leads are separated from each other but still located in the same region (e.g., the heart). This configuration can provide additional sensitivity because the reference electrode is near the sensing electrode. Advantageously, this reduces noise (e.g., relative to a monopolar configuration) compared to a system that measures electrical signals through the spread of tissue. An algorithm can be implemented with a smart threshold that can be applied to the electrical signals from the impedance measurement 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 fully deployed within the tissue. Note that the electrical measurements described herein can be monopolar (e.g., having an electrode on the skin or far from the measurement site) or bipolar (e.g., when the reference electrode is in proximity to the measurement electrode).

[0584] FIG. 68 shows an exemplary bio - impedance signal measurement system 6850 that 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 supply 6862 and an electrical sensor 6864. The device 6800 may include electrodes 6840 configured to receive power from the power supply 6862. Wiring connects the electrodes 6840, the power supply 6862, and the electrical sensor 6864. The device 6800 may be any of the devices described herein, such as the devices 100, 200, 300, 5100, 5200, 5300, 6300, 6400, 8200, 8810, an annuloplasty implant, a stent, a valve, an artificial valve, a delivery device, an anchor driver, a tendon repair device, etc.

[0585] In some implementations, the electrodes 6840 are coupled to one or more anchors of the device 6800. In some implementations, the electrodes 6840 are coupled to clasps such as the clasps 130, 230, 330, 40856, 5030a, 5030b, 5030c (or other tissue engagement portions) described herein.

[0586] The electrical sensor 6864 is configured to measure electrical signals such as bioimpedance signals, voltages, and currents from the electrode 6840. The electrical sensor 6864 can be configured to measure other electrical characteristics such as, for example, components of resistance, inductance, capacitance, voltage, current, impedance, etc., but is not limited thereto. The bioimpedance measurement values (resistance, inductance, capacitance, voltage, and / or current measurement values) obtained by the electrical sensor 6864 can vary depending on the anatomical structure to which the indicator electrode 6840 is proximate or in contact. Thus, using the electrical characteristics measured by the electrical sensor 6864, particularly the bioimpedance signal, as described herein, the relative positions of fasteners, anchors, other device components, etc., and the anatomical structure (e.g., tissue, etc.) with which the device is in contact can be determined. For example, the value of the bioimpedance signal and / or the change in bioimpedance can indicate that the electrode is in the blood, in contact with tissue (e.g., valve leaflet), differentiating tissue (e.g., valve leaflet tissue vs. chordal tissue), transitioning from mainly in contact with blood to mainly in contact with tissue and / or vice versa, and / or transitioning from partially in contact with tissue to mainly in contact with blood.

[0587] The power source 6862 and the electrical sensor 6864 can be separate devices or incorporated into a single device. The power source 6862 can be configured to provide alternating current to the device 6800. The electrical sensor 6864 can take various different forms, including an impedance meter. Impedance can be calculated by controlling the alternating current and measuring the voltage. The impedance can be used to determine the position of the electrodes relative to the target tissue (e.g., the annulus of the valve, the valve tip, etc.). The impedance measurement device 6860 can implement any of the algorithms described herein to indicate the state of the device 6800 or its components (e.g., the clip or the anchor), including complete capture of the valve tip, insufficient capture of the valve tip, excessive capture of the valve tip, the relative position of the valve tip within the clip, the state of the clip (e.g., open, closed, etc.), the state of the anchor (e.g., in contact with tissue, partially deployed, fully deployed, etc.), or any combination thereof and the like. The algorithms can include machine learning algorithms such as neural network algorithms, decision tree algorithms, random forest algorithms, threshold-based algorithms, and the like. Accordingly, the impedance measurement device 6860 can 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 the measurements provided by the electrical sensor 6864. In some implementations, the derived indicator from the impedance measurement device 6860 can be displayed to a user or provided to a partially or fully automated system to provide impedance-based feedback for a medical procedure.

[0588] Removing the Impedance Measurement Sensor from the Device As described herein, it can be advantageous to use bioimpedance-based feedback in medical procedures such as implanting a device within a valve. Bioimpedance-based feedback can be used to determine, for example, valve tip insertion. To that end, in some implementations, electrodes or sensors are coupled to devices disclosed herein (such as anchors, tissue engagement portions, clasps, etc. of the device) with electrical leads that conduct from the electrodes to the proximal end of the delivery system, enabling acquisition and measurement of bioimpedance signals. However, it may also be desirable to sever the electrodes from the electrical leads after implantation of the device, or remove the electrodes (or sensors) and electrical leads (e.g., so that the electrical wires are not active within the implant after the procedure). Accordingly, methods and devices are disclosed herein for facilitating removal and separation of electrical leads from electrodes on a device. Further disclosed herein are methods and devices for removing electrodes or sensors from a device after implantation. Further disclosed herein are methods and devices for enabling connection of a flexible PCB (which may include electrodes and / or other sensors in various implementations described herein) to a device such that it can be easily removed in a transcatheter procedure from the proximal side of a delivery system (such as a catheter).

[0589] The use of a PCB (including a flexible PCB) is advantageous because it allows for detailed design in both the shape and number of electrodes. The PCB can include an array of electrodes that further enables acquisition of a large number of bioimpedance measurements. Using a greater number of measurements and data, machine learning and other such algorithms can be used to p...

Claims

1. A system for treating natural anatomical structures, wherein the system is An implantable device having a tissue engagement portion, wherein the tissue engagement portion The first arm section, The second arm section, A capture region is positioned between the first arm portion and the second arm portion, wherein the first arm portion and the second arm portion are movable between an open position and a closed position in order to capture tissue within the capture region. A portable device equipped with, A flexible electrode detachably coupled to the aforementioned portable device, wherein the flexible electrode comprises an electrode pad including one or more electrodes and an electrical lead wire extending away from the electrode pad, Equipped with, The flexible electrode is configured to be removed from the portable device by applying force to the electrical lead wires in the system.

2. The system according to claim 1, wherein the flexible electrode is configured to receive an electrical signal via the electrical lead wire, and the electrical signal is configured to be applied to one or more electrodes.

3. The system according to claim 2, wherein the flexible electrode is configured to receive a bioimpedance signal in response to the applied electrical signal.

4. The system according to claim 1, wherein the flexible electrode is coupled to the implantable device such that when the flexible electrode is removed, the electrode pad moves toward the distal end of the implantable device and moves toward the proximal end of the implantable device and outward from the proximal end.

5. The system according to claim 1, wherein the tissue engagement portion comprises a plurality of return points for fixing the tissue.

6. The system according to claim 5, wherein the electrical lead wires extend between a pair of return points so that the flexible electrode is pulled through a pair of return points among the plurality of return points to remove the flexible electrode from the implantable device.

7. The system according to claim 6, wherein the width of the electrode pad is greater than the distance between the pair of returns.

8. The system according to claim 7, wherein the distance between the pair of returns is 8 mm or less.

9. The system according to claim 5, wherein the flexible electrode is configured to be pulled around the plurality of return sides in order to remove the flexible electrode from the implantable device.

10. The system according to claim 9, wherein the electrical lead wire has a bent section that guides it away from the electrode pad so that the electrode pad is offset laterally from the electrical lead wire, so that the electrical lead wire is positioned along the sides of the plurality of return surfaces while the electrode pad is in the tissue engagement portion.

11. The system according to claim 1, wherein the force is 1.5 N or less.

12. The system according to claim 1, wherein the electrode pad includes a relief cut through the electrode pad such that, when sufficient force is applied, the electrode pad is divided into a first lateral portion and a second lateral portion.

13. The system according to claim 12, wherein the flexible electrode further includes a second electrical lead wire, the electrical lead wire being coupled to the first lateral portion of the electrode pad, and the second electrical lead wire being coupled to the second lateral portion of the electrode pad.

14. The system according to claim 1, wherein the system further comprises a reference electrode.

15. The system according to claim 14, wherein the reference electrode is capable of receiving a bioimpedance signal in response to an electrical signal applied to the electrode pad.

16. The system according to claim 1, further comprising a delivery system, wherein the electrical lead wires are configured to extend proximal to the proximal end of the delivery system, and the delivery system is configured to advance the implantable device to a treatment site within the body of the target.

17. The system according to claim 1, wherein the implantable device is a valve repair device and is configured to capture the leaflet tissue of a natural valve with the tissue engagement portion.

18. The system according to claim 1, wherein the flexible electrode is coupled to the capture region and is configured to contact the first arm portion and the second arm portion.

19. A valve repair device for repairing a natural valve, wherein the valve repair device is A tissue engagement portion comprising a first arm and a second arm, configured such that the first arm and the second arm can close together or move closer together to capture tissue within the tissue engagement portion, and at least one of the first arm and the second arm is movable to form a capture area between them for capturing the tissue, and the tissue engagement portion further comprises a plurality of return points for securing the tissue within the tissue engagement portion. A flexible printed circuit board (PCB) detachably coupled to the tissue engagement portion, wherein the flexible PCB includes an electrode pad to which one or more electrodes are bonded, and an electrical lead wire extending away from the electrode pad, Equipped with, The valve repair device is The one or more electrodes receive an electrical signal via the electrical lead wires of the flexible PCB. The output signal can be measured in response to the applied electrical signal, and, A valve repair device configured such that the flexible PCB is removed from the valve repair device by applying force to the electrical lead wires.

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