WO2025155480A1 - Systems and methods for implantable medical devices - Google Patents

Abstract

Devices, including transcatheter heart valve repair devices and transcatheter replacement valves, are provided with sensing arrangements. The sensing arrangements can be configured such that a removable portion can be separated from an implantable portion, an entirety of the sensing arrangement can be removed from the device, an electrode of the sensing device is expandable, and/or a potentiometer of the sensing device can sense an amount of tension on a native valve leaflet. Fixation arrangements for fixating electronic components of the repair devices are also disclosed. Feedback indicators are further disclosed and can include, for example, haptic, visual and audio status indicators of leaflet position.

Description

SYSTEMS AND METHODS FOR IMPLANTABLE MEDICAL DEVICES

RELATED APPLICATIONS

[0001] The present application claims the benefit of US Provisional Patent Application No. 63/677,263, filed July 30, 2024, titled "SYSTEMS AND METHODS FOR IMPLANTABLE MEDICAL DEVICES" and claims the benefit of US Provisional Patent Application No. 63/622,024, filed on January 17, 2024, titled "SYSTEMS AND METHODS FOR IMPLANTABLE MEDICAL DEVICES", which are both incorporated herein by reference in their entirety.

BACKGROUND

[0002] The native heart valves (i.e., the aortic, pulmonary, tricuspid, and mitral valves) serve critical functions in assuring the forward flow of an adequate supply of blood through the cardiovascular system. These heart valves may be damaged, and thus rendered less effective, for example, by congenital malformations, inflammatory processes, infectious conditions, disease, etc. Such damage to the valves may result in serious cardiovascular compromise or death. Damaged valves can be surgically repaired or replaced during open heart surgery. However, open heart surgeries are highly invasive, and complications may occur. Transvascular techniques can be used to introduce and implant devices to treat a heart in a manner that is much less invasive than open heart surgery. As one example, a transvascular technique useable for accessing the native mitral, tricuspid, aortic, and/or pulmonary valves is the transseptal technique. The trans-septal technique comprises advancing a catheter into the right atrium (e.g., inserting a catheter into the right femoral vein, up the inferior vena cava and into the right atrium). The septum is then punctured, and the catheter passed into the left atrium. A similar transvascular technique can be used to implant a device within the tricuspid valve that begins similarly to the trans-septal technique but stops short of puncturing the septum and instead turns the delivery catheter toward the tricuspid valve in the right atrium.

[0003] A healthy heart has a generally conical shape that tapers to a lower apex. The heart is fourchambered and comprises the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall generally referred to as the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomy than other native heart valves. The mitral valve includes an annulus portion, which is an annular portion of the native valve tissue surrounding the mitral valve orifice, and a pair of cusps, or leaflets, extending downward from the annulus into the left ventricle. The mitral valve annulus may form a "D"-shaped, oval, or otherwise out-of-round cross-sectional shape having major and minor axes. The anterior leaflet may be larger than the posterior leaflet, forming a generally "C"-shaped boundary between the abutting sides of the leaflets when they are closed together.

[0004] When operating properly, the anterior leaflet and the posterior leaflet function together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle dilates (also referred to as "ventricular diastole" or "diastole"), the oxygenated blood that is collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract (also referred to as "ventricular systole" or "systole"), the increased blood pressure in the left ventricle urges the sides of the two leaflets together, thereby closing the one-way mitral valve so that blood cannot flow back to the left atrium and is instead expelled out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding back through the mitral annulus toward the left atrium, a plurality of fibrous cords called chordae tendineae tether the leaflets to papillary muscles in the left ventricle.

[0005] Valvular regurgitation involves the valve improperly allowing some blood to flow in the wrong direction through the valve. For example, mitral regurgitation occurs when the native mitral valve fails to close properly and blood flows into the left atrium from the left ventricle during the systolic phase of heart contraction. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation may have many different causes, such as leaflet prolapse, dysfunctional papillary muscles, stretching of the mitral valve annulus resulting from dilation of the left ventricle, more than one of these, etc. Mitral regurgitation at a central portion of the leaflets can be referred to as central jet mitral regurgitation and mitral regurgitation nearer to one commissure (i.e., location where the leaflets meet) of the leaflets can be referred to as eccentric jet mitral regurgitation. Central jet regurgitation occurs when the edges of the leaflets do not meet in the middle and thus the valve does not close, and regurgitation is present. Tricuspid regurgitation may be similar, but on the right side of the heart.

[0006] Various medical procedures involve implanting an object in the body of a patient to address one or more issues. Medical personnel may use various surgical techniques or other techniques to implant the object in the patient. This may involve securing or anchoring the implant to targeted tissue within the patient. SUMMARY

[0007] This summary is meant to provide some examples and is not intended to be limiting of the scope of the invention in any way. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly recite the feature. Also, the features, components, steps, concepts, etc. described in examples in this summary and elsewhere in this disclosure can be combined in a variety of ways. Various features and steps as described elsewhere in this disclosure can be included in the examples summarized here.

[0008] Systems and devices useable for repairing and/or treating a native valve of a patient are disclosed. The devices can be valve repair devices, valve treatment devices, implantable devices, implants, etc. While sometimes described as an implantable device for illustration purposes in some implementations herein, similar configurations can be used on other devices, e.g., valve repair devices, etc., that are not necessarily implanted and may be removed after treatment.

[0009] In some implementations, a device (e.g., a heart valve repair device, an implantable device, a treatment device, etc.) includes a flexible printed circuit board body. In some implementations, the flexible printed circuit board body has an implantable portion. In some implementations, the flexible printed circuit board body has a removable portion. In some implementations, the flexible printed circuit board body has a stress disconnection portion. In some implementations, the implantable portion has a first portion of one or more electrical traces connected to at least one of one or more electrodes and one or more sensors. In some implementations, the removable portion has a second portion of the one or more electrical traces. In some implementations, the stress disconnect portion includes at least one stress concentration area. In some implementations, the stress concentration area is configured to separate the removable portion from the implantable portion upon application of one or more stresses thereto.

[0010] In some implementations the stress concentration area comprises a high electrical resistance.

[0011] In some implementations the stress concentration area comprises one or more stress concentration portions. In some implementations, the one or more stress concentration portions can include one or more structurally weakened areas.

[0012] In some implementations the body comprises a plurality of electrical layers. In some implementations, the plurality of electrical layers include a first layer comprising one or more electrical traces that connect to the at least one of the one or more electrodes and the one or more sensors. In some implementations, the plurality of layers comprises a second layer comprising high resistance electrical trace portions.

[0013] In some implementations the implantable portion comprises a fixation portion. In some implementations, the implantable portion and/or the flexible printed circuit board body is coupled to the device via the fixation portion. In some implementations, the fixation portion can comprise a pin, wire, suture, loop, or other fixating device.

[0014] In some implementations the one or more stresses comprise heat stress.

[0015] In some implementations the one or more stresses comprise heat stress generated by electricity.

[0016] In some implementations the one or more stresses comprise mechanical stress.

[0017] In some implementations the one or more stresses comprise mechanical stress generated by a pulling force.

[0018] In some implementations the stress disconnect portion comprises a plurality of perforations. In some implementations, the plurality of perforations can be associated with the at least one stress concentration area.

[0019] In some implementations the stress disconnect portion comprises an electrical resistor. In some implementations, the electrical resistor can be associated with the at least one stress concentration area.

[0020] In some implementations the stress disconnect portion comprises a thickness that is less than a thickness of the removable portion.

[0021] In some implementations, the stress disconnect portion includes one or more electrical layers. In some implementations, the removable portion includes a greater number of electrical layers than the stress disconnect portion. In some implementations, the one or more material layers can include at least one electrical layer. In some implementations, the one or more material layers can include at least one polyimide layers.

[0022] In some implementations the stress disconnect portion comprises a thickness that is less than a thickness of the implantable portion. [0023] In some implementations, the stress disconnect portion includes one or more material layers and the implantable portion includes a greater number of material layers than the stress disconnect portion. In some implementations, the one or more material layers can include at least one electrical layer. In some implementations, the one or more material layers can include at least one polyimide layers.

[0024] In some implementations the stress disconnect portion is configured to separate the removable portion and the implantable portion into separate parts.

[0025] In some implementations the stress disconnect portion is positioned between the removable portion and the implantable portion.

[0026] In some implementations the implantable portion is positioned between the removable portion and the stress disconnect portion.

[0027] In some implementations the device further comprises a tissue engagement portion comprising a first arm and a second arm. In some implementations, the tissue engagement portion is configured such that the first arm and the second arm can close or be moved closer together to capture tissue in the tissue engagement portion. In some implementations, at least one of the first arm and the second arm are movable to form a capture region therebetween for capturing the tissue. In some implementations, the one or more electrodes (and/or one or more sensors) are coupled to the tissue engagement portion.

[0028] In some implementations the device further comprises a mechanical leaflet depth indicator.

[0029] In some implementations a method in accordance with this disclosure comprises fixating a flexible printed circuit board (PCB) to a device (e.g., a heart valve repair device, an implantable device, a treatment device, etc.) and releasing the flexible PCB from the device. In some implementations, the releasing comprises applying a pulling force to the flexible PCB.

[0030] In some implementations, the releasing comprises applying a pulling force to the flexible PCB while the stress disconnect portion is in a heated state.

[0031] In some implementations, the releasing can further comprise applying heat to a stress disconnect portion of the flexible PCB. [0032] In some implementations applying heat to a stress disconnect portion of the flexible PCB comprises applying an electrical current to a high resistance area with the stress disconnect portion.

[0033] In some implementations applying heat to a stress disconnect portion of the flexible PCB comprises using heat to plasticize an area of the stress disconnect portion.

[0034] In some implementations a device (e.g., a heart valve repair device, an implantable device, a treatment device, etc.) includes a flexible PCB. In some implementations, the device includes a base member. In some implementations, the device includes a fixation device. In some implementations, the flexible PCB has a fixation portion. In some implementations, the base member has at least one opening through which the flexible PCB extends.

[0035] In some implementations, the fixation device is connected to the fixation portion of the flexible PCB. The fixation device comprises a holding portion (e.g., a loop portion) that maintains the fixation device connected to the fixation portion and prevents the flexible PCB from withdrawing from the base member opening.

[0036] In some implementations, the loop portion unloops in response to a pulling force that allows the fixation device to be disconnected from the flexible PCB.

[0037] In some implementations the fixation device comprises a wire.

[0038] In some implementations the fixation device comprises a nitinol wire.

[0039] In some implementations the fixation portion comprises an opening.

[0040] In some implementations the fixation portion comprises an opening through which the loop portion extends.

[0041] In some implementations the device further includes a tissue engagement portion. In some implementations the device further includes one or more electrodes. In some implementations, the tissue engagement portion comprises a first arm and a second arm configured such that the first arm and the second arm can close or be moved closer together to capture tissue in the tissue engagement portion. In some implementations, at least one of the first arm and the second arm are movable to form a capture region therebetween for capturing the tissue. In some implementations, the one or more electrodes are coupled to the tissue engagement portion. [0042] In some implementations a method includes fixating a flexible printed circuit board (PCB) to a device (e.g., a heart valve repair device, an implantable device, a treatment device, etc.) and releasing the flexible PCB from the device. In some implementations, the releasing comprises unlooping a holding portion connected to the flexible PCB by applying a pulling force to the holding portion.

[0043] In some implementations the method further comprises disconnecting the holding portion from the flexible PCB.

[0044] In some implementations the method further comprises applying a pulling force to the flexible PCB after the holding portion disconnects from the flexible PCB.

[0045] In some implementations the method further comprises unlooping a wire of the holding portion by applying a pulling force to the wire.

[0046] In some implementations, a device (e.g., a heart valve repair device, an implantable device, a treatment device, etc.) includes a flexible PCB body. In some implementations, the device includes at least one electrode extension. In some implementations, the flexible PCB body has an electrode portion. In some implementations, the flexible PCB body is configured to be withdrawn through a catheter lumen. In some implementations, the electrode portion has one or more electrodes. In some implementations, the at least one electrode extension extends beyond the flexible PCB body and the electrode portion.

[0047] In some implementations the at least one electrode extension extends laterally beyond the flexible PCB body and the electrode portion.

[0048] In some implementations the at least one electrode extension extends vertically beyond the flexible PCB body and the electrode portion.

[0049] In some implementations, the at least one electrode extension can increase the surface area of an electrode portion of the flexible PCB body in at least one axis. In some implementations, the at least one electrode extension can increase the surface area of an electrode portion of the flexible PCB body in at least two axes.

[0050] In some implementations, the at least one electrode extension comprises a curled extension body. [0051] In some implementations, the at least one electrode extension comprises a curled extension body extending laterally beyond the flexible PCB body and the electrode portion.

[0052] In some implementations, the at least one electrode extension comprises a curled extension body extending vertically beyond the flexible PCB body and the electrode portion.

[0053] In some implementations, the at least one electrode extension comprises a curled wire.

[0054] In some implementations, the at least one electrode extension comprises a coiled wire.

[0055] In some implementations, the at least one electrode extension comprises a wire extending above the one or more electrodes and connected to a top surface of the one or more electrodes.

[0056] In some implementations, the at least one electrode extension comprises a first shape during operation and a second shape during withdrawal of the flexible PCB.

[0057] In some implementations, a device includes a flexible PCB body. In some implementations, the device includes an electrode portion. In some implementations, the device includes a sensing device. The flexible PCB body is configured to be withdrawn through a catheter lumen.

[0058] In some implementations, the electrode portion has first and second pads. In some implementations, the second pad comprises a variable resistance portion. In some implementations, the sensing device comprises a first portion connected to the first pad and a second portion in moveable contact with the variable resistance portion of the second pad.

[0059] In some implementations the sensing device comprises a wire.

[0060] In some implementations the sensing device comprises Nitinol material.

[0061] In some implementations the sensing device comprises a spring.

[0062] In some implementations the sensing device comprises a conductive material.

[0063] In some implementations the sensing device deflects under an applied force.

[0064] In some implementations the sensing device provides a signal indicative of a leaflet capture status.

[0065] In some implementations the sensing device provides a signal indicative of a leaflet tension status. [0066] In some implementations the sensing device provides a change in voltage when deflected.

[0067] In some implementations the sensing device deflects upon withdrawal of the flexible PCB through a catheter lumen.

[0068] In some implementations the device further comprises a tissue engagement portion comprising a first arm and a second arm. In some implementations, the tissue engagement portion is configured such that the first arm and the second arm can close or be moved closer together to capture tissue in the tissue engagement portion. In some implementations, at least one of the first arm and the second arm are movable to form a capture region therebetween for capturing the tissue. In some implementations, one or more electrodes coupled to the tissue engagement portion.

[0069] In some implementations a method of using the device includes sensing movement of the sensing device along the variable resistance portion of the second pad to indicate leaflet capture status and/or leaflet tension.

[0070] In some implementations, sensing movement of the sensing device comprises receiving a signal indicative of the movement of the sensing device along the variable resistance portion of the second pad.

[0071] In some implementations, a non-transitory computer readable medium is provided that includes computer executable instructions to cause one or more processors to perform any of the algorithms, procedures, processes, or methods described herein.

[0072] In some implementations, a device (e.g., a heart valve repair device, an implantable device, a treatment device, etc.) includes a fixation device or apparatus for attaching a flexible printed circuit to an implantable medical device. In some implementations, the flexible printed circuit can be removably coupled to the implantable medical device using the fixation device or apparatus.

[0073] In some implementations, the fixation device includes a body having a first and second cantilevered lug portions.

[0074] In some implementations, the fixation device can further include a beam portion between the first and second lug portions. In some implementations, the beam portion includes one or more spaced apart recesses in a first side. In some implementations, the beam portion can further include a projecting portion including at least one opening. [0075] In some implementations, the first and second cantilevered lug portions extend from the first side of the beam portion.

[0076] In some implementations, the beam includes a second side having a plurality of angled surfaces.

[0077] In some implementations, the beam includes a second side having a plurality of surfaces disposed with a non-zero degree angle between each surface.

[0078] In some implementations, the cantilevered lug portions (e.g., the first and second cantilevered lug portions) each include an extension portion and hook portion.

[0079] In some implementations, the cantilevered lug portions each include flexible material. In some implementations, at least a portion of the first or second cantilevered lug portion can be formed from the flexible material.

[0080] In some implementations, the first lug includes the projecting portion, the opening of the projecting portion configured to receive a fixating element. In some implementations, the projecting portion can extend from the first lug away from the first side.

[0081] In some implementations, a fixation apparatus has the first and second lug portions disposed on distal ends of the beam portion. In some implementations, the first lug portion can be disposed on a first end of the beam portion and the second lug portion can be disposed on a second distal end of the beam portion.

[0082] In some implementations, the fixation apparatus further includes one or more flexible bands disposed around the beam portion.

[0083] In some implementations, the flexible bands can be at least partially positioned in a corresponding recess formed on the first side of the beam portion.

[0084] In some implementations, the fixation apparatus includes a holder having a holder body. In some implementations, the holder body comprises third and fourth cantilevered lug portions. In some implementations, the holder body is a discrete component from the body of the fixation device.

[0085] In some implementations, a system includes a device (e.g., a heart valve repair device, an implantable device, a treatment device, etc.). In some implementations, the system includes a flexible printed circuit. In some implementations, the system includes a fixation device or mechanism. [0086] In some implementations, the device can have one or more paddles, each paddle including at least first and second openings.

[0087] In some implementations, the flexible printed circuit has a distal end portion.

[0088] In some implementations, the fixation mechanism includes a body having first and second cantilevered lug portions. In some implementations, the fixation mechanism includes a beam portion between the first and second lug portions. In some implementations, the beam portion including one or more recesses in a first side. In some implementations, the beam portion includes a projecting portion including at least one opening.

[0089] In some implementations, the first and second cantilevered lug portions extend from the first side of the beam portion.

[0090] In some implementations, the beam includes a second side having a plurality of angled surfaces.

[0091] In some implementations, the beam includes a second side having a plurality of surfaces disposed with a non-zero degree angle between each surface.

[0092] In some implementations, the cantilevered lug portions (e.g., the first and second cantilevered lug portions) each include an extension portion and hook portion.

[0093] In some implementations, the cantilevered lug portions each include flexible material. In some instances, at least a portion of the first or second cantilevered lug portion can be formed from the flexible material.

[0094] In some implementations, the first lug includes the projecting portion, the opening of the projecting portion configured to receive a fixating element. In some implementations, the projecting portion can extend from the first lug away from the first side.

[0095] In some implementations, the first and second lug portions are disposed on distal ends of the beam portion. In some implementations, the first lug portion can be disposed on a first end of the beam portion and the second lug portion can be disposed on a second distal end of the beam portion.

[0096] In some implementations, the fixation mechanism includes one or more flexible bands disposed around the beam portion. [0097] In some implementations, the flexible bands can be at least partially positioned in a corresponding recess formed on the first side of the beam portion.

[0098] In some implementations, fixation mechanism further includes a holder having a holder body.

[0099] In some implementations, the holder body comprises third and fourth cantilevered lug portions. In some implementations, the holder body is a discrete component from the body of the fixation mechanism.

[0100] In some implementations, the fixation mechanism has a wire body received within the projecting portion and the distal end portion of the flexible printed circuit.

[0101] In some implementations, the fixation element passes through the opening of the projecting portion.

[0102] In some implementations, apparatuses, systems, and/or methods (which can be used with a valve of a heart, e.g., of a living subject or of a simulation) described herein relate to a system. In some implementations, the system includes a device (e.g., a heart valve repair device, an implantable device, a treatment device, etc.). In some implementations, the system includes one or more sensors. In some implementations, the system includes a controller. In some implementations, the system includes one or more output devices. In some implementations the system can further comprise logic associated with the controller.

[0103] In some implementations the device includes one or more paddles, one or more claps spaced apart from the paddles, a space between the clasps and paddles.

[0104] In some implementations, the one or more sensors can be located in a space between the paddles and clasps.

[0105] In some implementations, the controller has inputs for reading signals generated by the one or more sensors and outputs for outputting one or more output signals.

[0106] In some implementations, the logic is configured to read the sensor signals and converting the read sensor signals to one or more status indicators. In some implementations, the one or more status indicators can be output via the one or more output signals. In some implementations, the logic is configured to receive the signals generated by the one or more sensors and output the one or more output signals indicative of one or more status indicators based on the signals generated by the one or more sensors.

[0107] In some implementations, one or more output devices receive the one or more output signals and generate outputs according to the output signals.

[0108] In some implementations, apparatuses, systems, and/or methods (which can be used with a valve of a heart, e.g., of a living subject or of a simulation) described herein relate to a system. In some implementations, the system includes a device (e.g., a heart valve repair device, an implantable device, a treatment device, etc.). In some implementations, the system includes one or more sensors. In some implementations, the system includes a controller. In some implementations, the system includes one or more output devices.

[0109] In some implementations, the device comprises one or more paddles and one or more clasps spaced apart from the paddles, such that a space is formed between the clasps and paddles.

[0110] In some implementations, the one or more sensors can be coupled to the device such that the one or more sensors are disposed in the space between the paddles and clasps.

[0111] In some implementations, the controller is configured to receive one or more sensor signals from the one or more sensors via an input and further configured to output one or more output signals via an output. In some implementations, the controller is associated with logic, the logic configured to generate the one or more output signals indicative of one or more status indicators based on the one or more sensor signals.

[0112] In some implementations, the one or more output devices are configured to receive the one or more output signals and generate outputs according to the output signals.

[0113] In some implementations, the status indicators include one or more leaflet insertion depth indicators.

[0114] In some implementations, the output signals include haptic output signals.

[0115] In some implementations, the output signals include visual output signals.

[0116] In some implementations, the output signals include audio output signals.

[0117] In some implementations, the output signals include first and second signal patterns indicative of first and second status indicators, respectively. [0118] In some implementations, the output signals include vibration signals.

[0119] In some implementations, the output signals include illuminable indicator signals.

[0120] In some implementations, the output signals include a plurality of color indicators.

[0121] In some implementations, one of the status indicators includes an insufficient leaflet grasping indicator.

[0122] In some implementations, one of the status indicators includes a sufficient leaflet grasping indicator.

[0123] In some implementations, one of the status indicators includes an optimal leaflet grasping indicator.

[0124] In some implementations, the logic is configured to read leaflet length.

[0125] In some implementations, the system further includes a handle having a vibration motor. In some implementations, the one or more output devices can comprise the vibration motor.

[0126] In some implementations, the system further including a handle having an audio output device. In some implementations, the one or more output devices can comprise the audio output device.

[0127] In some implementations, the system further includes a housing having a plurality of visual indicators. In some implementations, the one or more output devices can comprise the housing.

[0128] In some implementations, the sensors are positioned on the paddles at first, second and third insertion depths.

[0129] In some implementations, the sensors are positioned on the paddles at insertion depths including 3 mm, 6 mm, and 9 mm.

[0130] Any of the above method(s) and any methods of using the systems, assemblies, apparatuses, devices, etc. herein can be performed on a living subject (e.g., human or other animal) or on a simulation (e.g., a cadaver, cadaver heart, imaginary person, simulator, etc.). With a simulation, the body parts can optionally be referred to as "simulated" (e.g., simulated heart, simulated tissue, etc.) and can optionally comprise computerized and/or physical representations. [0131] Any of the above systems, assemblies, devices, apparatuses, components, etc. can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise (or additional methods comprise or consist of) sterilization of one or more systems, devices, apparatuses, components, etc. herein (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0132] A further understanding of the nature and advantages of the present invention are set forth 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

[0133] To further clarify various aspects of examples in the present disclosure, a more particular description of certain examples and implementations will be made by reference to various aspects of the appended drawings. It is appreciated that these drawings depict only examples of the present disclosure and are therefore not to be considered limiting of the scope of the disclosure. Moreover, while the figures can be drawn to scale for some examples, the figures are not necessarily drawn to scale for all examples. Examples and other features and advantages of the present disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings.

[0134] Figure 1 illustrates a cutaway view of the human heart in a diastolic phase.

[0135] Figure 2 illustrates a cutaway view of the human heart in a systolic phase.

[0136] Figure 3 illustrates a cutaway view of the human heart in a systolic phase showing valve regurgitation.

[0137] Figure 4 is the cutaway view of Figure 3 annotated to illustrate a natural shape of mitral valve leaflets in the systolic phase.

[0138] Figure 5 illustrates a healthy mitral valve with the leaflets closed as viewed from an atrial side of the mitral valve.

[0139] Figure 6 illustrates a dysfunctional mitral valve with a visible gap between the leaflets as viewed from an atrial side of the mitral valve.

[0140] Figure 7 illustrates a tricuspid valve viewed from an atrial side of the tricuspid valve. [0141] Figures 8, 9, 10, 11, 12, 13, and 14 show an example of a device or implant, in various stages of deployment.

[0142] Figure 15 shows an example of a device or implant that is similar to the device illustrated by Figures 8-14, but where the paddles are independently controllable.

[0143] Figures 16, 17, 18, 19, 20, and 21 show the example device or implant of Figures 8-14 being delivered and implanted within a native valve.

[0144] Figure 22 shows a perspective view of an example device or implant in a closed position.

[0145] Figure 23 shows a front view of the example device or implant of Figure 22.

[0146] Figure 24 shows a side view of the example device or implant of Figure 22.

[0147] Figure 25 shows a front view of the example device or implant of Figure 22 with a cover covering the paddles and a coaptation element or spacer.

[0148] Figure 26 shows a top perspective view of the example device or implant of Figure 22 in an open position.

[0149] Figure 1 shows a bottom perspective view of the example device or implant of Figure 22 in an open position.

[0150] Figure 28 shows an example clasp useable in a device or implant.

[0151] Figure 29 shows a portion of native valve tissue grasped by a clasp.

[0152] Figure 30 shows a side view of an example device or implant in a partially open position with clasps in a closed position.

[0153] Figure 31 shows a side view of an example device or implant in a partially open position with clasps in an open position.

[0154] Figure 32 shows a side view of an example device or implant in a half-open position with clasps in a closed position.

[0155] Figure 33 shows a side view of an example device or implant in a half-open position with clasps in an open position. [0156] Figure 34 shows a side view of an example device or implant in a three-quarters-open position with clasps in a closed position.

[0157] Figure 35 shows a side view of an example device or implant in a three-quarters-open position with clasps in an open position.

[0158] Figure 36 shows a side view of an example device in a fully open or full bailout position with clasps in a closed position.

[0159] Figure 37 shows a side view of an example device in a fully open or full bailout position with clasps in an open position.

[0160] Figures 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, and 49 show the example device or implant of Figures 30-38, including a cover, being delivered and implanted within a native valve.

[0161] Figures 50A, 50B, and 50C illustrate an example valve repair device attached to a delivery system that can incorporate any of the features disclosed herein.

[0162] Figures 51A illustrates an example valve repair device that can incorporate any of the features disclosed herein.

[0163] Figures 51B, 51C, and 51D, and 51E illustrate a examples of valve repair devices attached to a delivery system that can incorporate any of the features disclosed herein.

[0164] Figure 51E illustrates an example valve repair device that can incorporate any of the features disclosed herein.

[0165] Figures 52A, 52B, and 52C illustrate example clasps having two or more electrodes.

[0166] Figures 53A, 53B, 53C, 53D, 53E, and 53F illustrate clasps having example electrode configurations.

[0167] Figure 54 illustrates example bioimpedance signals from a clasp having two or more electrodes to provide bioimpedance-based feedback.

[0168] Figures 55 and 56 illustrate example bioimpedance signals from the clasp of Figure 53B.

[0169] Figures 57 and 58 illustrate example bioimpedance signals from the clasp of Figure 53C. [0170] Figures 59A and 59B illustrate an example clasp that is configured similar to the clasp of

Figures 22-37 with an optional cover over the clasp, the clasp including a combination of an electrode plate on one arm and electrode strips on the other arm.

[0171] Figures 60A and 60B illustrate a clasp that is configured similar to the clasp of Figures 22-37 with an optional cover over the clasp, the clasp including electrode strips on an arm of the clasp.

[0172] Figure 60C illustrates an example clasp similar to the clasp of Figure 60B without a cover, the clasp including electrode strips on an arm of the clasp.

[0173] Figures 61A and 61B illustrate the real and imaginary portions of bioimpedance signals of the clasp of Figures 60A-60C for capture states of a leaflet.

[0174] Figures 62A and 62B illustrate an implementation of a tissue engagement portion or clasp similar to the clasp of Figures 60A-60C with the electrode strips offset from an edge of an arm by a prescribed distance.

[0175] Figure 62C illustrates bioimpedance signals of the clasp of Figures 62A and 62B for capture states of a leaflet.

[0176] Figure 62D illustrates an example proximal end of a delivery system that includes an indicator panel.

[0177] Figures 63A and 63B illustrates an example device with clasps each having a first electrode positioned on a first arm and a second electrode positioned on a second arm of the clasps, the electrodes configured to provide bioimpedance signals corresponding to different dies of a leaflet or other tissue.

[0178] Figure 64 illustrates an example device with tissue engagement portions or clasps having electrodes similar to the device with clasps of Figure 53A, with the addition of a reference electrode implemented on the device.

[0179] Figure 65 illustrates an example of the device of Figures 22-37 with the addition of flexible electrodes that protrude away from the device.

[0180] Figures 66A and 66B illustrate example electrode arrays that reduce the number of electrical leads required to enable the electrical leads to fit into small-lumen catheters. [0181] Figure 67A illustrates an example of a bioimpedance signal with oscillations corresponding to diastole and systole of the heart.

[0182] Figure 67B illustrates an example of a bioimpedance signal as a delivery device implants an annuloplasty ring in an annulus.

[0183] Figure 68 illustrates an example bioimpedance signal measurement system.

[0184] Figure 69 illustrates a portion of a flexible PCB with a stress concentration point in the PCB.

[0185] Figure 70 illustrates a portion of a flexible PCB with a Y-shaped protrusion extending from one end of the PCB.

[0186] Figure 71 illustrates a portion of a flexible PCB with a round protrusion extending from a body of the PCB.

[0187] Figure 72 illustrates a portion of a flexible PCB with side indents to facilitate securing the suture over the PCB and to the device to secure the PCB to the device.

[0188] Figure 73 illustrates a portion of a flexible PCB forming a circular hole with a relief.

[0189] Figure 74 illustrates a portion of a flexible PCB that forms a pair of bi-directional tongues.

[0190] Figures 75A, 75B, and 75C illustrate a removable PCB that is configured to be pulled through the barbs of a device to remove the PCB from the device.

[0191] Figures 76A, 76B, and 76C illustrate an example of a removable PCB that is configured to be pulled and exit through a side of a clasp, around barbs of a device to remove the PCB from the device.

[0192] Figures 77A, 77B, and 77C illustrate an example of a removable PCB that is configured to be split apart when pulled so that half exits through one side of a clasp and the other half exits through the other side of the clasp, each half exiting the clasp around barbs of a device to remove the PCB from the device.

[0193] Figure 78 illustrates an electrode that is removable from a device, the electrode being coupled to wires extending from the electrode towards an actuation element.

[0194] Figures 79A and 79B illustrate spring pin electrical connectors configured to extend to a distal end of a delivery system to provide electrical connection with wires of an electrode coupled to the device. [0195] Figures 80A and 80B illustrate using radial forces via fingers of a delivery system to couple wires coming from the delivery system to electrical leads coupled to an electrode of the device.

[0196] Figures 81A and 81B illustrate the use of a tube to enable releasable electrical contact between wires and electrical leads.

[0197] Figures 82A and 82B illustrate a coil crimp configured to provide releasable electrical contact between wires and electrical leads.

[0198] Figures 83A and 83B illustrate a coil connection socket configured to provide releasable electrical contact between wires and electrical leads.

[0199] Figures 84A, 84B, 84C, and 84D illustrate an example disc crimp configured to provide releasable electrical connection between wires and electrical leads.

[0200] Figures 85A, 85B, 85C, 85D, 85E, and 85F illustrate examples of heat-activated electrical connectors to provide releasable electrical connections between wires and electrical leads.

[0201] Figure 86 illustrates a block diagram of an example bioimpedance-based feedback system.

[0202] Figure 87 illustrates an implementation of a method for removing a flexible PCB having separable portions or parts.

[0203] Figures 88A-88B illustrate an implementation of a flexible PCB having implantable and removable portions that disconnect the flexible PCB into separate parts.

[0204] Figures 89A, 89B, and 89C illustrate an implementation of a flexible PCB having implantable and removable portions.

[0205] Figures 90A and 90B illustrate an implementation of a flexible PCB configured to allow withdrawal of the flexible PCB from an implantable medical device.

[0206] Figures 91A-91O illustrate an implementation of a flexible PCB and a fixation device for releasably attaching a flexible PCB to an implantable medical device.

[0207] Figures 92A-92D illustrate examples of sensing electrodes.

[0208] Figures 93A-93D illustrate an implementation of a sensor configured to sense leaflet capture and/or leaflet tension. [0209] Figures 94A-94B illustrate an implementation of a sensor-based leaflet capture system and method.

[0210] Figures 95, 96A, and 96B illustrate an implementation of a sensor-based leaflet capture system and method having dynamic feedback indicator(s).

[0211] Figures 97 and 98 illustrate an implementation of a sensor-based leaflet capture system and method having visual feedback indicator(s).

[0212] Figure 99 illustrates one implementation of a control system for providing feedback indications.

DETAILED DESCRIPTION

[0213] The following description refers to the accompanying drawings, which illustrate examples of the present disclosure. Other examples having different structures and operation do not depart from the scope of the present disclosure.

[0214] Examples of the present disclosure are directed to systems, devices, methods, etc. for repairing a defective heart valve. For example, various examples of valve repair devices, implantable devices, implants, and systems (including systems for delivery thereof) are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, individual components of the disclosed devices and systems can be combined unless mutually exclusive or otherwise physically impossible. Further, the techniques and methods herein can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc.

[0215] As described herein, when one or more components are described as being connected, joined, affixed, coupled, attached, or otherwise interconnected, such interconnection can be direct as between the components or can be indirect such as through the use of one or more intermediary components. Also as described herein, reference to a "member," "component," or "portion" shall not be limited to a single structural member, component, or element but can include an assembly of components, members, or elements. Also as described herein, the terms "substantially" and "about" are defined as at least close to (and includes) a given value or state (preferably within 10% of, more preferably within 1% of, and most preferably within 0.1% of)." Overview

[0216] Disclosed herein are devices and methods that use electrical signals, sensed electrical properties, and/or electrical feedback to provide useful information during a medical procedure. The electrical signals or electrical-based feedback can include one or more of voltage, voltage drop, current, resistance, capacitance, inductance, and bioimpedance. When the electrical signal or electrical-based feedback is bioimpedance or bioimpedance-based feedback, electrical signals are measured or acquired that include a bioimpedance signal (e.g., a signal that is indicative of bioimpedance). The bioimpedance signal can be used to determine the position and/or status of a device (e.g., of an implantable device, of a treatment device, of a delivery device, etc.) or portion thereof (e.g., such as a clasp, valve, anchor, or the like) relative to tissue or other portions of a 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 a position and/or status of the device (e.g., a position and/or status of anchoring elements of an implant, etc.).

[0217] Bioimpedance is related to electrical properties of tissue within the body (or other biomaterials). Bioimpedance is a measure of how well the tissue impedes electric current flow. Fat has high resistivity; blood has lower resistivity. At a given current applied to the tissue, a low impedance will correspond to a low voltage and vice versa. Tissue includes cells and membranes, and membranes are thin with high resistivity and behave electrically as capacitors. By using high measuring frequencies, the current passes through these capacitors, and the resulting signal depends on tissue and liquids both inside and outside the cells. At low frequencies, however, the membranes impede current flow, and the results are dependent only on liquids outside the cells. The magnitude and phase of the impedance Z is given by:

Where R is the resistance, X_L is the inductive reactance, X_C is the capacitive reactance, R is the total resistance, and X is the total reactance. The impedance can also be expressed using real and imaginary components as: Z = R + /X.

[0218] In some implementations, the systems and/or apparatuses herein comprise devices (e.g., treatment devices, repair devices, implantable devices, etc.) or portions of devices including electrodes. In some implementations, the systems and/or apparatuses herein comprise delivery systems and/or devices or portions thereof including electrodes (e.g., catheters with electrodes, etc.).

[0219] Electrical power, e.g., in the form of alternating current, direct current, etc., can be provided to the electrodes and electrical signals measured (e.g., voltage, current, changes in voltage, changes in current, etc.). Bioimpedance signals, which form part of the measured electrical signals (or can be determined from the electrical signals), can be used to draw conclusions or estimates related to the system/device (e.g., related to the status of the device or an anchoring portion of the device, etc.).

[0220] In some implementations, where electrodes are implemented on a clasp, clamp, clip, gripping portion, anchor, etc. of a device (e.g., an implantable device, a treatment device, a repair device, etc.), the bioimpedance signal can be correlated to how much tissue is within the clasp, clamp, clip, gripping portion, anchor, etc. of the device.

[0221] In some implementations, bioimpedance signals can also 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, consecutive anchor deployment, and the like.

[0222] 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 treatment device or repair device (even if not permanently implanted). This is one-way bioimpedance signals can be used to provide useful feedback to clinicians or medical systems regarding the status of a device or implant and/or components thereof.

[0223] In some implementations, values of a bioimpedance signal and/or changes in the bioimpedance signal can indicate a transition from being primarily in blood to contacting tissue. In some implementations, values of a bioimpedance signal and/or changes in the bioimpedance signal can indicate a transition from being in contact with a first type of tissue (e.g., a leaflet, etc.) being in contact with a second type of tissue (e.g., an annulus, heart wall, etc.).

[0224] In some implementations, the value or change in bioimpedance signal can correlate to an amount of contact with tissue the device has (e.g., the amount of leaflet in a clasp, the depth of an anchor in tissue, valve height and/or positioning, and the like). [0225] In some implementations, the value or change in bioimpedance signal can correlate to the location/position of a delivery device [e.g., a catheter, anchor driver, hypotube, pusher, etc.) and/or whether the delivery device is in contact with tissue or different types of tissue.

[0226] Figures 1 and 2 are cutaway views of the human heart H in diastolic and systolic phases, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA, respectively, by the tricuspid valve TV and mitral valve MV; i.e., the atrioventricular valves. Additionally, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets (e.g., leaflets 20, 22 shown in Figures 3-6 and leaflets 30, 32, 34 shown in Figure 7) extending inward across the respective orifices that come together or "coapt" in the flow stream to form the one-way, fluid-occluding surfaces. The native valve repair devices and systems disclosed herein are frequently described and/or illustrated with respect to the mitral valve MV. Therefore, anatomical structures of the left atrium LA and left ventricle LV will be explained in greater detail. However, the devices described herein can also be used in repairing other native valves, e.g., the devices can be used in repairing the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV.

[0227] The left atrium LA receives oxygenated blood from the lungs. During the diastolic phase, or diastole, seen in Figure 1, the blood that was previously collected in the left atrium LA (during the systolic phase) moves through the mitral valve MV and into the left ventricle LV by expansion of the left ventricle LV. In the systolic phase, or systole, seen in Figure 2, the left ventricle LV contracts to force the blood through the aortic valve AV and ascending aorta AA into the body. During systole, the leaflets of the mitral valve MV close to prevent the blood from regurgitating from the left ventricle LV and back into the left atrium LA and blood is collected in the left atrium from the pulmonary vein. In some implementations, the devices described by the present application are used to repair the function of a defective mitral valve MV. That is, the devices are configured to help close the leaflets of the mitral valve to prevent or inhibit blood from regurgitating from the left ventricle LV and back into the left atrium LA. Many of the devices described in the present application are designed to easily grasp and secure the native leaflets around a coaptation element or spacer that beneficially acts as a filler in the regurgitant orifice to prevent or inhibit back flow or regurgitation during systole, though this is not necessary.

[0228] Referring now to Figures 1-7, the mitral valve MV includes two leaflets, the anterior leaflet 20 and the posterior leaflet 22. The mitral valve MV also includes an annulus 24, which is a variably dense fibrous ring of tissues that encircles the leaflets 20, 22. Referring to Figures 3 and 4, the mitral valve MV is anchored to the wall of the left ventricle LV by chordae tendineae CT. The chordae tendineae CT are cord-like tendons that connect the papillary muscles PM (i.e., the muscles located at the base of the chordae tendineae CT and within the walls of the left ventricle LV) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles PM serve to limit the movements of leaflets 20, 22 of the mitral valve MV and prevent the mitral valve MV from being reverted. The mitral valve MV opens and closes in response to pressure changes in the left atrium LA and the left ventricle LV. The papillary muscles PM do not open or close the mitral valve MV. Rather, the papillary muscles PM support or brace the leaflets 20, 22 against the high pressure needed to circulate blood throughout the body. Together the papillary muscles PM and the chordae tendineae CT are known as the subvalvular apparatus, which functions to keep the mitral valve MV from prolapsing into the left atrium LA when the mitral valve closes. As seen from a Left Ventricular Outflow Tract (LVOT) view shown in Figure 3, the anatomy of the leaflets 20, 22 is such that the inner sides of the leaflets coapt at the free end portions and the leaflets 20, 22 start receding or spreading apart from each other. The leaflets 20, 22 spread apart in the atrial direction, until each leaflet meets with the mitral annulus.

[0229] Various disease processes can impair proper function of one or more of the native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow's Disease, fibroelastic 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 from prior heart attacks (i.e., myocardial infarction secondary to coronary artery disease) or other heart diseases (e.g., cardiomyopathy, etc.) can distort a native valve's geometry, which can cause the native valve to dysfunction. However, the majority of patients undergoing valve surgery, such as surgery to the mitral valve MV, suffer from a degenerative disease that causes a malfunction in a leaflet (e.g., leaflets 20, 22) of a native valve (e.g., the mitral valve MV), which results in prolapse and regurgitation.

[0230] Generally, a native valve may malfunction in different ways: including (1) valve stenosis; and (2) valve regurgitation. Valve stenosis occurs when a native valve does not open completely and thereby causes an obstruction of blood flow. Valve stenosis can result from buildup of calcified material on the leaflets of a valve, which causes the leaflets to thicken and impairs the ability of the valve to fully open to permit forward blood flow. Valve regurgitation occurs when the leaflets of the valve do not close completely thereby causing blood to leak back into the prior chamber (e.g., causing blood to leak from the left ventricle to the left atrium). [0231] There are three main mechanisms by which a native valve becomes regurgitant— or incompetent— hich include Carpentier's type I, type II, and type III malfunctions. A Carpentier type I malfunction involves the dilation of the annulus such that normally functioning leaflets are distracted from each other and fail to form a tight seal (i.e., the leaflets do not coapt properly). Included in a type I mechanism malfunction are perforations of the leaflets, as are present in endocarditis. A Carpentier's type II malfunction involves prolapse of one or more leaflets of a native valve above a plane of coaptation. A Carpentier's type III malfunction involves restriction of the motion of one or more leaflets of a native valve such that the leaflets are abnormally constrained below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease (Ma) or dilation of a ventricle (I lib).

[0232] Referring to Figure 5, when a healthy mitral valve MV is in a closed position, the anterior leaflet 20 and the posterior leaflet 22 coapt, which prevents blood from leaking from the left ventricle LV to the left atrium LA. Referring to Figures 3 and 6, mitral regurgitation MR occurs when the anterior leaflet 20 and/or the posterior leaflet 22 of the mitral valve MV is displaced into the left atrium LA during systole so that the edges of the leaflets 20, 22 are not in contact with each other. This failure to coapt causes a gap 26 between the anterior leaflet 20 and the posterior leaflet 22, which allows blood to flow back into the left atrium LA from the left ventricle LV during systole, as illustrated by the mitral regurgitation MR flow path shown in Figure 3. Referring to Figure 6, the gap 26 can have a width W between about 2.5 mm and about 17.5 mm, between about 5 mm and about 15 mm, between about 7.5 mm and about 12.5 mm, or about 10 mm. In some situations, the gap 26 can have a width W greater than 15 mm. As set forth above, there are several different ways that a leaflet (e.g., leaflets 20, 22 of mitral valve MV) may malfunction which can thereby lead to valvular regurgitation.

[0233] In any of the above-mentioned situations, a system, an apparatus, and/or device (e.g., a treatment system, a repair system, valve repair device, valve treatment device, implant, etc.) is desired that is capable of engaging the anterior leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent or inhibit regurgitation of blood through the mitral valve MV. As can be seen in Figure 4, an abstract representation of a device, valve repair device, or implant 10 is shown implanted between the leaflets 20, 22 such that regurgitation does not occur during systole (compare Figure 3 with Figure 4). In some implementations, the coaptation element (e.g., spacer, coaption element, gap filler, etc.) of the device 10 has a generally tapered or triangular shape that naturally adapts to the native valve geometry and to its expanding leaflet nature (toward the annulus). In this application, the terms spacer, coaption element, coaptation element, and gap filler are used interchangeably and refer to an element that fills a portion of the space between native valve leaflets and/or that is configured such that the native valve leaflets engage or "coapt" against (e.g., such that the native leaflets coapt against the coaption element, coaptation element, spacer, etc. instead of only against one another).).

[0234] Although stenosis or regurgitation can affect any valve, stenosis is predominantly found to affect either the aortic valve AV or the pulmonary valve PV, and regurgitation is predominantly found to affect either the mitral valve MV or the tricuspid valve TV. Both valve stenosis and valve regurgitation increase the workload of the heart H and may lead to very serious conditions if left un-treated; such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. Because the left side of the heart (/.e., the left atrium LA, the left ventricle LV, the mitral valve MV, and the aortic valve AV) are primarily responsible for circulating the flow of blood throughout the body. Accordingly, because of the substantially higher pressures on the left side heart dysfunction of the mitral valve MV or the aortic valve AV is particularly problematic and often life threatening.

[0235] Malfunctioning native heart valves can either be repaired or replaced. Repair can involve the preservation and correction of the patient's native valve. Replacement typically involves replacing the patient's native valve with a biological or mechanical substitute. Typically, the aortic valve AV and pulmonary valve PV are more prone to stenosis. Because stenotic damage sustained by the leaflets is irreversible, treatments for a stenotic aortic valve or stenotic pulmonary valve can be removal and replacement of the valve with a surgically implanted heart valve, or displacement of the valve with a transcatheter heart valve. The mitral valve MV and the tricuspid valve TV are more prone to deformation of leaflets and/or surrounding tissue, which, as described above, prevents the mitral valve MV or tricuspid valve TV from closing properly and allows for regurgitation or back flow of blood from the ventricle into the atrium (e.g., a deformed mitral valve MV may allow for regurgitation or back flow from the left ventricle LV to the left atrium LA as shown in Figure 3). The regurgitation or back flow of blood from the ventricle to the atrium results in valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or the tricuspid valve TV are often repairable. In addition, regurgitation can occur due to the chordae tendineae CT becoming dysfunctional (e.g., the chordae tendineae CT may stretch or rupture), which allows the anterior leaflet 20 and the posterior leaflet 22 to be reverted such that blood is regurgitated into the left atrium LA. The problems occurring due to dysfunctional chordae tendineae CT can be repaired by repairing the chordae tendineae CT or the structure of the mitral valve MV (e.g., by securing the leaflets 20, 22 at the affected portion of the mitral valve).

- T1 - [0236] The devices and procedures disclosed herein often make reference to treating and/or repairing the structure of a 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 implanting an implantable device and/or gripping tissue as part of a treatment and/or repair procedure (even if the device is not implanted).

Example Devices

[0237] An example device or implant (e.g., a treatment device, a repair device, a valve repair device, an implantable device, an implantable prosthetic device, etc.) with which the concepts herein can be implemented can optionally have a coaptation element (e.g., spacer, coaption element, gap filler, etc.) and at least one anchor (e.g., one, two, three, or more). In some implementations, a device or implant can have any combination or sub-combination of the features disclosed herein without a coaptation element.

[0238] In some implementations, when included, the coaptation element (e.g., coaption element, spacer, etc.) can be configured to be positioned within the native heart valve orifice to help fill the space between the leaflets and form a more effective seal, thereby reducing or preventing or inhibiting regurgitation described above.

[0239] In some implementations, the optional coaptation element can have a structure that is impervious and/or resistant to blood flow therethrough (or otherwise reduces or inhibits blood flow) and that allows the native leaflets to close around the coaptation element during ventricular systole to block blood from flowing from the left or right ventricle back into the left or right atrium, respectively. The coaptation element is sometimes referred to herein as a spacer because the coaptation element can fill a space between improperly functioning native leaflets (e.g., mitral valve leaflets 20, 22 or tricuspid valve leaflets 30, 32, 34) that do not close completely.

[0240] The device or implant can be configured to seal against two or three native valve leaflets; that is, the device can be used in the native mitral (bicuspid) and tricuspid valves.

[0241] The optional coaptation element (e.g., spacer, coaption element, etc.) can have various shapes. In some implementations, the coaptation element can have an elongated cylindrical shape having a round cross-sectional shape. In some implementations, the coaptation element can have an oval cross-sectional shape, an ovoid cross-sectional shape, a crescent cross-sectional shape, a rectangular cross-sectional shape, or various other non-cylindrical shapes. In some implementations, the coaptation element can have an atrial portion positioned in or adjacent to the atrium, a ventricular or lower portion positioned in or adjacent to the ventricle, and a side surface that extends between the native leaflets. In some implementations the coaptation element is usable in and/or for use in the tricuspid valve. In some implementations, the atrial or upper portion is positioned in or adjacent to the right atrium, and the ventricular or lower portion is positioned in or adjacent to the right ventricle, and the side surface that extends between the native tricuspid leaflets.

[0242] In some implementations, the 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 leaflets such that the coaptation element is positioned between the two native leaflets. In some implementations usable in and/or configured for use in the tricuspid valve, the anchor is configured to secure the device to one, two, or three of the tricuspid leaflets such that the coaptation element is positioned between the three native leaflets. In some implementations, the anchor can attach to the coaptation element at a location adjacent to the ventricular portion of the coaptation element. In some implementations, the anchor can attach to an actuation element, such as a shaft or actuation wire, to which the coaptation element is also attached. In some implementations, the anchor and the coaptation element can be positioned independently with respect to each other by separately moving each of the anchor and the coaptation element along the longitudinal axis of the actuation element (e.g., actuation shaft, actuation rod, actuation tube, actuation wire, etc.). In some implementations, the anchor and the coaptation element can be positioned simultaneously by moving the anchor and the coaptation element together along the longitudinal axis of the actuation element, e.g., shaft, actuation wire, etc. The anchor can be configured to be positioned behind a native leaflet when used and/or implanted such that the leaflet is grasped by the anchor.

[0243] The device or implant can be configured to be used, operated, and/or implanted via a delivery system or other means for delivery. The delivery system can comprise one or more of a guide/delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, tube, combinations of these, etc. The optional coaptation element and the anchor can be compressible to a radially compressed state and can be self-expandable to a radially expanded state when compressive pressure is released. The device can be configured for the anchor to be expanded radially away from the still- compressed coaptation element initially in order to create a gap between the coaptation element and the anchor. A native leaflet can then be positioned in the gap. The coaptation element can be expanded radially, closing the gap between the coaptation element and the anchor and capturing the leaflet between the coaptation element and the anchor. In some implementations, the anchor and coaptation element are optionally configured to self-expand. Various example methods are more fully discussed below with respect to each implementation.

[0244] Additional information regarding these and other delivery methods that can be used with the various systems and devices herein can be found in U.S. Pat. No. 8,449,599 and U.S. Patent Application Publication Nos. 2014/0222136, 2014/0067052, 2016/0331523, PCT patent application publication No. W02020/076898, 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, each of which is incorporated herein by reference in its entirety for all purposes. These method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc. mutatis mutandis.

[0245] The disclosed devices or implants can be configured such that the anchor is connected to a leaflet, taking advantage of the tension from native chordae tendineae to resist high systolic pressure urging the device toward the left atrium. During diastole, the devices can rely on the compressive and retention forces exerted on the leaflet that is grasped by the anchor.

[0246] Referring now to Figures 8-15, a schematically illustrated example device or implant 100 (e.g., a prosthetic spacer device, valve repair device, valve treatment device, etc.) is shown in various stages of deployment. The device or implant 100 and other similar devices/implants that can be used with the various implementation, systems, and devices herein are described in more detail in PCT patent application publication Nos. WO 2018/195215, WO 2020/076898, WO 2019/139904, PCT patent application No. PCT/US2022/035672, PCT patent application No. PCT/US2022/037983, PCT patent application No. PCT/US2022/050158, PCT patent application No. PCT/US2022/051232, PCT patent application No. PCT/US2022/049305, PCT patent application No. PCT/US2022/037176, and PCT patent application No. PCT/US2022/025390 which are incorporated herein by reference in their entirety for all purposes. The device 100 (and other systems and devices herein) can include any other features for a device or implant discussed in the present application or the applications cited above, and the device 100 can be positioned to engage valve tissue (e.g., leaflets 20, 22, 30, 32, 34) as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application or the applications cited herein).

[0247] The device or implant 100 is deployed from a delivery system, delivery device, or other means for delivery 102. The delivery system 102 can comprise 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 pathway, combinations of these, etc. The device or implant 100 includes a coaptation portion 104 and an anchor portion 106.

[0248] In some implementations, the coaptation portion 104 of the device or implant 100 can include an optional coaptation element 110 (e.g., spacer, plug, filler, foam, sheet, membrane, coaption element, etc.) that is adapted to be implanted between leaflets of a native valve (e.g., a native mitral valve, native tricuspid valve, etc.) and is slidably attached to an actuation element 112 (e.g., actuation wire, actuation shaft, actuation tube, etc.).

[0249] In some implementations, the anchor portion 106 includes one or more anchors 108 that are actuatable between open and closed conditions and can take a wide variety of forms, such as, for example, paddles, gripping elements, a clasp, a clip, a clamp, a clasp arm and a paddle arm, a gripping member and a paddle, etc.) or the like. Actuation of the means for actuating or actuation element 112 opens and closes the anchor portion 106 of the device 100 to grasp the native valve leaflets during implantation. The means for actuating or actuation element 112 (as well as other means for actuating and actuation elements herein) can take a wide variety of different forms (e.g., as a wire, rod, shaft, tube, screw, suture, line, strip, combination of these, etc.), be made of a variety of different materials, and have a variety of configurations. As one example, the actuation element can be threaded such that rotation of the actuation element moves the anchor portion 106 relative to the coaptation portion 104. Or, the actuation element can be unthreaded, such that pushing or pulling the actuation element 112 moves the anchor portion 106 relative to the coaptation portion 104.

[0250] The anchor portion 106 and/or anchors of the device 100 include outer paddles 120 and inner paddles 122 that are, in some implementations, connected between a cap 114 and the coaptation element 110 by portions 124, 126, 128. The portions 124, 126, 128 can be jointed and/or flexible to move between all of the positions described below. The interconnection of the outer paddles 120, the inner paddles 122, the coaptation element 110, and the cap 114 by the portions 124, 126, and 128 can constrain the device to the positions and movements illustrated herein. [0251] In some implementations, the delivery system 102 includes a steerable catheter, implant catheter, and means for actuating or actuation element 112 (e.g., actuation wire, actuation shaft, etc.). These can be configured to extend through a guide catheter/sheath (e.g., a transseptal sheath, etc.). In some implementations, the means for actuating or actuation element 112 extends through a delivery catheter and the coaptation element 110 to the distal end (e.g., a cap 114 or other attachment portion at the distal connection of the anchor portion 106). Extending and retracting the actuation element 112 increases and decreases the spacing between the coaptation element 110 and the distal end of the device (e.g., the cap 114 or other attachment portion), respectively. In some implementations, a collar or other attachment element removably attaches the coaptation element 110 to the delivery system 102, either directly or indirectly, so that the means for actuating or actuation element 112 slides through the collar or other attachment element and, in some implementations, through a coaptation element 110 during actuation to open and close the paddles 120, 122 of the anchor portion 106 and/or anchors 108.

[0252] In some implementations, the anchor portion 106 and/or anchors 108 can include attachment portions or gripping members. As illustrated, in some implementations, gripping members (or tissue engagement portions) can comprise clasps 130 that include a base or fixed arm 132, a movable arm 134, optional barbs, friction-enhancing elements, or other means for securing 136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesive, etc.), and a joint portion 138.

[0253] In some implementations, a fixed arm is not used and another portion of the device (e.g., another component, surface, element, etc.) can perform functions described herein with respect to the fixed arm.

[0254] In some implementations, the fixed arms 132 are attached to the inner paddles 122. In some implementations, the fixed arms 132 are attached to the inner paddles 122 with the joint portion 138 disposed proximate a coaptation element 110. In some implementations, the clasps (e.g., barbed clasps, etc.) have flat surfaces and do not fit in a recess of the inner paddle. Rather, the flat portions of the clasps are disposed against the surface of the inner paddle 122. The joint portion 138 provides a spring force between the fixed and movable arms 132, 134 of the clasp 130. The joint portion 138 can be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, or the like. In some implementations, the joint portion 138 is a flexible piece of material integrally formed with the fixed and movable arms 132, 134. The fixed arms 132 are attached to the inner paddles 122 and remain stationary or substantially stationary relative to the inner paddles 122 when the movable arms 134 are opened to open the clasps 130 and expose the optional barbs, friction-enhancing elements, or means for securing

136.

[0255] In some implementations, the clasps 130 are opened by applying tension to actuation lines 116 attached to the movable arms 134, thereby causing the movable arms 134 to articulate, flex, or pivot on the joint portions 138. The actuation lines 116 extend through the delivery system 102 (e.g., through a steerable catheter and/or an implant catheter). Other actuation mechanisms are also possible.

[0256] The actuation line 116 can take a wide variety of forms, such as, for example, a line, a suture, a wire, a rod, a catheter, or the like. The clasps 130 can be spring loaded so that in the closed position the clasps 130 continue to provide a pinching force on the grasped native leaflet. This pinching force remains constant regardless of the position of the inner paddles 122. Optional barbs, friction-enhancing elements, or other means for securing 136 of the clasps 130 can grab, pinch, and/or pierce the native leaflets to further secure the native leaflets.

[0257] During implantation, the paddles 120, 122 can be opened and closed, for example, to grasp tissue (e.g., native leaflets, native mitral valve leaflets, native tricuspid valve leaflets, etc.) between the paddles 120, 122 and/or between the paddles 120, 122 and a coaptation element 110. The clasps 130 can be used to grasp and/or further secure the tissue by engaging the tissue with optional barbs, friction-enhancing elements, or means for securing 136 and pinching the tissue (e.g., leaflets, etc.) between the movable and fixed arms 134, 132. The optional barbs, friction-enhancing elements, or other means for securing 136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesive, etc.) of the tissue engagement portions or clasps 130 increase friction with the tissue or can partially or completely puncture the tissue.

[0258] In some implementations, the actuation lines 116 can be actuated separately so that each tissue engagement portion or clasp 130 can be opened and closed separately. Separate operation allows one leaflet to be grasped at a time, or for the repositioning of a tissue engagement portion or clasp 130 on tissue (e.g., a leaflet, etc.) that was insufficiently grasped, without altering a successful grasp on the other leaflet. In some implementations, the clasps 130 can be opened and closed relative to the position of the inner paddle 122 (as long as the inner paddle is in an open or at least partially open position), thereby allowing leaflets to be grasped in a variety of positions as the particular situation requires.

[0259] Referring now to Figure 8, the example device 100 is shown in an elongated or fully open condition for deployment from an implant delivery catheter of the delivery system 102. The device 100 is disposed at the end of the catheter in the fully open position, because the fully open position takes up the least space and allows the smallest catheter to be used (or the largest device to be used for a given catheter size). In the elongated condition the cap 114 is spaced apart from the coaptation element 110 such that the paddles 120, 122 are fully extended. In some implementations, an angle formed between the interior of the outer and inner paddles 120, 122 is approximately 180 degrees. The clasps 130 are kept in a closed condition during deployment through the delivery system 102 so that the optional barbs, friction-enhancing elements, or other means for securing 136 (Figure 9) do not catch or damage the delivery system 102 or tissue in the patient's heart.

[0260] Referring now to Figure 9, the device 100 is shown in an elongated detangling condition, similar to Figure 8, but with the clasps 130 in a fully open position, ranging from about 140 degrees to about 200 degrees, from about 170 degrees to about 190 degrees, or about 180 degrees between fixed and movable arms 132, 134 of the clasps 130. Fully opening the paddles 120, 122 and the clasps 130 has been found to improve ease of detanglement or detachment from anatomy of the patent, such as the chordae tendineae CT, during implantation of the device 100.

[0261] Referring now to Figure 10, the device 100 is shown in a shortened or fully closed condition. The compact size of the device 100 in the shortened condition allows for easier maneuvering and placement within the heart. To move the device 100 from the elongated condition to the shortened condition, the means for actuating or actuation element 112 is retracted to pull the cap 114 towards the coaptation element 110. The connection portion(s) 126 (e.g., joint(s), flexible connection(s), etc.) between the outer paddle 120 and inner paddle 122 are constrained in movement such that compression forces acting on the outer paddle 120 from the cap 114 being retracted towards the coaptation element 110 cause the paddles or gripping elements to move radially outward. During movement from the open to closed position, the outer paddles 120 maintain an acute angle with the means for actuating or actuation element 112. The outer paddles 120 can optionally be biased toward a closed position. The inner paddles 122 during the same motion move through a considerably larger angle as they are oriented away from the coaptation element 110 in the open condition and collapse along the sides of the coaptation element 110 in the closed condition. In some implementations, the inner paddles 122 are thinner and/or narrower than the outer paddles 120, and the connection portions 126, 128 (e.g., joints, flexible connections, etc.) connected to the inner paddles 122 can be thinner and/or more flexible. For example, this increased flexibility can allow more movement than the connection portion 124 connecting the outer paddle 120 to the cap 114. In some implementations, the outer paddles 120 are narrower than the inner paddles 122. The connection portions 126, 128 connected to the inner paddles 122 can be more flexible, for example, to allow more movement than the connection portion 124 connecting the outer paddle 120 to the cap 114. In some implementations, the inner paddles 122 can be the same or substantially the same width as the outer paddles.

[0262] Referring now to Figures 11-13, the device 100 is shown in a partially open, grasp-ready condition. To transition from the fully closed to the partially open condition, the means for actuating or actuation element (e.g., actuation wire, actuation shaft, etc.) is extended to push the cap 114 away from the coaptation element 110, thereby pulling on the outer paddles 120, which in turn pull on the inner paddles 122, causing the anchors or anchor portion 106 to partially unfold. The actuation lines 116 are also retracted to open the clasps 130 so that the targeted tissue or leaflets can be grasped. In some implementations, the pair of inner and outer paddles 122, 120 are moved in unison, rather than independently, by a single means for actuating or single actuation element 112. Also, the positions of the clasps 130 are dependent on the positions of the paddles 122, 120. For example, referring to Figure 10 closing the paddles 122, 120 also closes the clasps. In some implementations, the paddles 120, 122 can be independently controllable. For example, the device 100 can have two actuation elements and two independent caps (or other attachment portions), such that one independent actuation element (e.g., wire, shaft, etc.) and cap (or other attachment portion) are used to control one paddle, and the other independent actuation element and cap (or other attachment portion) are used to control the other paddle.

[0263] Referring now to Figure 12, one of the actuation lines 116 is extended to allow one of the clasps 130 to close. Referring now to Figure 13, the other actuation line 116 is extended to allow the other clasp 130 to close. Either or both of the actuation lines 116 can be repeatedly actuated to repeatedly open and close the clasps 130.

[0264] Referring now to Figure 14, the device 100 is shown in a fully closed and deployed condition. The delivery system or means for delivery 102 and means for actuating or actuation element 112 are retracted and the paddles 120, 122 and clasps 130 remain in a fully closed position. Once deployed, the device 100 can be maintained in the fully closed position with a mechanical latch or can be biased to remain closed through the use of spring materials, such as steel, other metals, plastics, composites, etc. or shape-memory alloys such as Nitinol. For example, the connection portions 124, 126, 128, the joint portions 138, and/or the inner and outer paddles 122, and/or an additional biasing component (not shown) can be formed of metals such as steel or shape-memory alloy, such as Nitinol— produced in a wire, sheet, tubing, or laser sintered powder— and are biased to hold the outer paddles 120 closed around the coaptation element 110 and the clasps 130 pinched around native leaflets. Similarly, the fixed and movable arms 132, 134 of the clasps 130 are biased to pinch the leaflets. In some implementations, the attachment or connection portions 124, 126, 128, joint portions 138, and/or the inner and outer paddles 122, and/or an additional biasing component (not shown) can be formed of any other suitably elastic material, such as a metal or polymer material, to maintain the device 100 in the closed condition after implantation.

[0265] Figure 15 illustrates an example where the paddles 120, 122 are independently controllable. The device 101 illustrated by Figure 15 is similar to the device 100 illustrated by Figure 11, except the device 101 of Figure 15 includes an actuation element that is configured as two independent actuation elements 111, 113 that are coupled to two independent caps 115, 117. To transition a first inner paddle 122 and a first outer paddle 120 from the fully closed to the partially open condition, the means for actuating or actuation element 111 is extended to push the cap 115 away from the coaptation element 110, thereby pulling on the outer paddle 120, which in turn pulls on the inner paddle 122, causing the first anchor 108 to partially unfold. To transition a second inner paddle 122 and a second outer paddle 120 from the fully closed to the partially open condition, the means for actuating or actuation element 113 is extended to push the cap 115 away from the coaptation element 110, thereby pulling on the outer paddle 120, which in turn pulls on the inner paddle 122, causing the second anchor 108 to partially unfold. The independent paddle control illustrated by Figure 15 can be implemented on any of the devices disclosed by the present application. For comparison, in the example illustrated by Figure 11, the pair of inner and outer paddles 122, 120 are moved in unison, rather than independently, by a single means for actuating or actuation element 112.

[0266] Referring now to Figures 16-21, the device 100 of Figures 8-14 is shown being delivered and implanted within the native mitral valve MV of the heart H. Referring to Figure 16, a delivery sheath/catheter is inserted into the left atrium LA through the septum and the implant/device 100 is deployed from the delivery catheter/sheath in the fully open condition as illustrated in Figure 16. The means for actuating or actuation element 112 is then retracted to move the implant/device into the fully closed condition shown in Figure 17.

[0267] As can be seen in Figure 18, the implant/device is moved into position within the mitral valve MV into the ventricle LV and partially opened so that the leaflets 20, 22 can be grasped. For example, a steerable catheter can be advanced and steered or flexed to position the steerable catheter as illustrated by Figure 18. The implant catheter connected to the implant/device can be advanced from inside the steerable catheter to position the implant/device as illustrated by Figure 18.

[0268] Referring now to Figure 19, the implant catheter can be retracted into the steerable catheter to position the mitral valve leaflets 20, 22 in the clasps 130. An actuation line 116 is extended to close one of the clasps 130, capturing a leaflet 20. Figure 20 shows the other actuation line 116 being then extended to close the other clasp 130, capturing the remaining leaflet 22. Lastly, as can be seen in Figure 21, the delivery system 102 (e.g., steerable catheter, implant catheter, etc.), means for actuating or actuation element 112 and actuation lines 116 are then retracted and the device or implant 100 is fully closed and deployed in the native mitral valve MV.

[0269] Referring now to Figures 2.- 1 , an example of a device or implant 200 is shown. The devices herein, including device 100 that is schematically illustrated in Figures 8-14, can be configured the same as or similar to device 200. The device 200 can include any other features for a device or implant discussed in the present application, and the device 200 can be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application). The device/implant 200 can be a prosthetic spacer device, valve repair device, or another type of implant that attaches to leaflets of a native valve.

[0270] In some implementations, the device or implant 200 includes a coaptation portion 204, a proximal or attachment portion 205, an anchor portion 206, and a distal portion 207. In some implementations, the coaptation portion 204 of the device optionally includes a coaptation element 210 (e.g., a spacer, coaption element, plug, membrane, sheet, etc.) for implantation between leaflets of a native valve. In some implementations, the anchor portion 206 includes a plurality of anchors 208. The anchors can be configured in a variety of ways. In some implementations, each anchor 208 includes outer paddles 220, inner paddles 222, paddle extension members or paddle frames 224, and gripping elements or clasps 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 with a capture mechanism 213 (Figures 43-49) of a delivery system 202 (Figures 38-42 and 49). Delivery system 202 can be the same as or similar to delivery system 102 described elsewhere and can comprise 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 pathway, combinations of these, etc. [0271] In some implementations, the coaptation element 210 and paddles 220, 222 are formed from a flexible material that can be a metal fabric, such as a mesh, woven, braided, or formed in any other suitable way or a laser cut or otherwise cut flexible material. The material can be cloth, shapememory alloy wire— such as Nitinol— to provide shape-setting capability, or any other flexible material suitable for implantation in the human body.

[0272] An actuation element 212 (e.g., actuation shaft, actuation rod, actuation tube, actuation wire, actuation line, etc.) extends from the delivery system 202 to engage and enable actuation of the device or implant 200. In some implementations, the actuation element 212 extends through the capture mechanism 213, proximal component or collar 211, and coaptation element 210 to engage a cap 214 of the distal portion 207. The actuation element 212 can be configured to removably engage the cap 214 with a threaded connection, or the like, so that the actuation element 212 can be disengaged and removed from the device 200 after implantation.

[0273] The coaptation element 210 extends from the proximal component or collar 211 (or other attachment element) to the inner paddles 222. In some implementations, the coaptation element 210 has a generally elongated and round shape, though other shapes and configurations are possible. In some implementations, the coaptation element 210 has an elliptical shape or cross-section when viewed from above e.g., Figure 53A) and has a tapered shape or cross-section when seen from a front view (e.g., Figure 23) and a round shape or cross-section when seen from a side view (e.g., Figure 24). A blend of these three geometries can result in the three-dimensional shape of the illustrated coaptation element 210 that achieves the benefits described herein. The round shape of the coaptation element 210 can also be seen, when viewed from above, to substantially follow or be close to the shape of the paddle frames 224.

[0274] The size and/or shape of the coaptation element 210 can be selected to minimize the number of implants that a single patient will require (preferably one), while at the same time maintaining low transvalvular gradients. In some implementations, the anterior-posterior distance at the top of the coaptation element is about 5 mm, and the medial-lateral distance of the coaptation element at its widest 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 strategy described above. It should be readily apparent that the use of other anterior-posterior distance anterior-posterior distance and medial-lateral distance as starting points for the device will result in a device having different dimensions. Further, using other dimensions and the shape strategy described above will also result in a device having different dimensions.

[0275] In some implementations, the outer paddles 220 are jointably attached to the cap 214 of the distal portion 207 by connection portions 221 and to the inner paddles 222 by connection portions 223. The inner paddles 222 are jointably attached to the coaptation element by connection portions 225. In this manner, the anchors 208 are configured similar to legs in that the inner paddles 222 are like upper portions of the legs, the outer paddles 220 are like lower portions of the legs, and the connection portions 223 are like knee portions of the legs.

[0276] In some implementations, the inner paddles 222 are stiff, relatively stiff, rigid, have rigid portions and/or are stiffened by a stiffening member or a fixed arm 232 of the clasps 230. The stiffening of the inner paddle allows the device to move to the various different positions shown and described herein. The inner paddle 222, the outer paddle 220, the coaptation can all be interconnected as described herein, such that the device 200 is constrained to the movements and positions shown and described herein.

[0277] In some implementations, the paddle frames 224 are attached to the cap 214 at the distal portion 207 and extend to the connection portions 223 between the inner and outer paddles 222, 220. In some implementations, the paddle frames 224 are formed of a material that is more rigid and stiff than the material forming the paddles 222, 220 so that the paddle frames 224 provide support for the paddles 222, 220.

[0278] The paddle frames 224 provide additional pinching force between the inner paddles 222 and the coaptation element 210 and assist in wrapping the leaflets around the sides of the coaptation element 210 for a better seal between the coaptation element 210 and the leaflets, as can be seen in Figure 53A. That is, the paddle frames 224 can be configured with a round three-dimensional shape extending from the cap 214 to the connection portions 223 of the anchors 208. The connections between the paddle frames 224, the outer and inner paddles 220, 222, the cap 214, and the coaptation element 210 can constrain each of these parts to the movements and positions described herein. In particular the connection portion 223 is constrained by its connection between the outer and inner paddles 220, 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 and outer paddles 222, 220) and to the cap 214. [0279] Configuring the paddle frames 224 in this manner provides increased surface area compared to the outer paddles 220 alone. This can, for example, make it easier to grasp and secure the native leaflets. The increased surface area can also distribute the clamping force of the paddles 220 and paddle frames 224 against the native leaflets over a relatively larger surface of the native leaflets in order to further protect the native leaflet tissue. Referring again to Figure 53A, the increased surface area of the paddle frames 224 can also allow the native leaflets to be clamped to the device or implant 200, such that the native leaflets coapt entirely around the coaptation member or coaptation element 210. This can, for example, improve sealing of the native leaflets 20, 22 and thus prevent or further reduce mitral regurgitation.

[0280] In some implementations, the clasps comprise a movable arm coupled to the anchors. In some implementations, the clasps 230 include a base or fixed arm 232, a movable arm 234, optional barbs 236, and a joint portion 238. In some implementations, the fixed arms 232 are attached to the inner paddles 222, with the joint portion 238 disposed proximate the coaptation element 210. The joint portion 238 is spring-loaded so that the fixed and movable arms 232, 234 are biased toward each other when the clasp 230 is in a closed condition. In some implementations, the clasps 230 include frictionenhancing elements or means for securing, such as optional barbs, protrusions, ridges, grooves, textured surfaces, adhesive, etc.

[0281] In some implementations, the fixed arms 232 are attached to the inner paddles 222 through holes or slots 231 with sutures (not shown). The fixed arms 232 can be attached to the inner paddles 222 with any suitable means, such as screws or other fasteners, crimped sleeves, mechanical latches or snaps, welding, adhesive, clamps, latches, or the like. The fixed arms 232 remain substantially stationary relative to the inner paddles 222 when the movable arms 234 are opened to open the clasps 230 and expose the optional barbs or other friction-enhancing elements 236. The clasps 230 are opened by applying tension to actuation lines 216 (e.g., as shown in Figures 43-48) attached to holes 235 in the movable arms 234, thereby causing the movable arms 234 to articulate, pivot, and/or flex on the joint portions 238.

[0282] Referring now to Figure 29, a close-up view of one of the leaflets 20, 22 grasped by a tissue engaging portion such as clasp 230 is shown. The leaflet 20, 22 is shown grasped between the movable and fixed arms 234, 232 of the clasp 230. The tissue of the leaflet 20, 22 is not pierced by the optional barbs or friction-enhancing elements 236, though in some implementations the optional barbs 236 can partially or fully pierce through the leaflet 20, 22. The angle and height of the optional barbs or friction- enhancing elements 236 relative to the movable arm 234 helps to secure the leaflet 20, 22 within the clasp 230. In particular, a force pulling the device off of the native leaflet 20, 22 will encourage the optional barbs or friction-enhancing elements 236 to further engage the tissue, thereby ensuring better retention. Retention of the leaflet 20, 22 in the clasp 230 is further improved by the position of fixed arm 232 near the optional barbs/friction-enhancing elements 236 when the clasp 230 is closed. In this arrangement, the tissue is formed by the fixed arms 232 and the movable arms 234 and the optional barbs/friction-enhancing elements 236 into an S-shaped torturous path. Thus, forces pulling the leaflet 20, 22 away from the clasp 230 will encourage the tissue to further engage the optional barbs/friction- enhancing elements 236 before the leaflets 20, 22 can escape. For example, leaflet tension during diastole can encourage the optional barbs 236 to pull toward the end portion of the leaflet 20, 22. Thus, the S-shaped path can utilize the leaflet tension during diastole to more tightly engage the leaflets 20, 22 with the optional barbs/friction-enhancing elements 236.

[0283] Referring to Figure 25, the device or implant 200 can also include a cover 240. In some implementations, the cover 240 can be disposed on the coaptation element 210, the outer and inner paddles 220, 222, and/or the paddle frames 224. The cover 240 can be configured to prevent or reduce blood-flow through the device or implant 200 and/or to promote native tissue ingrowth. In some implementations, the cover 240 can be a cloth or fabric such as PET, velour, or other suitable fabric. In some implementations, in lieu of or in addition to a fabric, the cover 240 can include a coating (e.g., polymeric) that is applied to the device or implant 200.

[0284] During implantation, the paddles 220, 222 of the anchors 208 are opened and closed to grasp the native valve leaflets 20, 22 between the paddles 220, 222 and the coaptation element 210. The anchors 208 are moved between a closed position (Figures 22-25) to various open positions (Figures 26- 37) by extending and retracting the actuation element 212. Extending and retracting the actuation element 212 increases and decreases the spacing between the coaptation element 210 and the cap 214, respectively. The proximal component or collar 211 (or other attachment element, extension, ring, etc.) and the coaptation element 210 slide along the actuation element 212 during actuation so that changing of the spacing between the coaptation element 210 and the cap 214 causes the paddles 220, 220 to move between different positions to grasp the mitral valve leaflets 20, 22 during implantation.

[0285] As the device 200 is opened and closed, the pair of inner and outer paddles 222, 220 are moved in unison, rather than independently, by a single actuation element 212. Also, the positions of the clasps 230 are dependent on the positions of the paddles 222, 220. For example, the clasps 230 are arranged such that closure of the anchors 208 simultaneously closes the clasps 230. In some implementations, the device 200 can be made to have the paddles 220, 222 be independently controllable in the same manner (e.g., the device 101 illustrated in Figure 15).

[0286] In some implementations, the clasps 230 further secure the native leaflets 20, 22 by engaging the leaflets 20, 22 with optional barbs and/or other friction-enhancing elements 236 and/or pinching the leaflets 20, 22 between the movable and fixed arms 234, 232. In some implementations, the clasps 230 are barbed clasps that include barbs that increase friction with and/or can partially or completely puncture the leaflets 20, 22. The actuation lines 216 (Figures 43-48) can be actuated separately so that each clasp 230 can be opened and closed separately. Separate operation allows one leaflet 20, 22 to be grasped at a time, or for the repositioning of a clasp 230 on a leaflet 20, 22 that was insufficiently grasped, without altering a successful grasp on the other leaflet 20, 22. The clasps 230 can be fully opened and closed when the inner paddle 222 is not closed, thereby allowing leaflets 20, 22 to be grasped in a variety of positions as the particular situation requires.

[0287] Referring now to Figures 22-25, the device 200 is shown in a closed position. When closed, the inner paddles 222 are disposed between the outer paddles 220 and the coaptation element 210. The clasps 230 are disposed between the inner paddles 222 and the coaptation element 210. Upon successful capture of native leaflets 20, 22 the device 200 is moved to and retained in the closed position so that the leaflets 20, 22 are secured within the device 200 by the clasps 230 and are pressed against the coaptation element 210 by the paddles 220, 222. The outer paddles 220 can have a wide curved shape that fits around the curved shape of the coaptation element 210 to more securely grip the leaflets 20, 22 when the device 200 is closed (e.g., as can be seen in Figure 49). The curved shape and rounded edges of the outer paddle 220 also prohibits or inhibits tearing of the leaflet tissue.

[0288] Referring now to Figures 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 Figures 30-37 from the closed position shown in Figures 22-25 by extension of the actuation element 212 from a fully retracted to a fully extended position.

[0289] Referring now to Figures 30-31, the device 200 is shown in a partially open position. The device 200 is moved into the partially open position by extending the actuation element 212. Extending the actuation element 212 pulls down on the bottom portions of the outer paddles 220 and paddle frames 224. The outer paddles 220 and paddle frames 224 pull down on the inner paddles 222, where the inner paddles 222 are connected to the outer paddles 220 and the paddle frames 224. Because the proximal component or collar 211 (or other attachment element) and coaptation element 210 are held in place by the capture mechanism 213, the inner paddles 222 are caused to articulate, pivot, and/or flex in an opening direction. The inner paddles 222, the outer paddles 220, and the paddle frames 224 all flex to the position shown in Figures 30-31. Opening the paddles 222, 220 and frames 224 forms a gap between the coaptation element 210 and the inner paddle 222 that can receive and grasp the native leaflets 20, 22. This movement also exposes the clasps 230 that can be moved between closed (Figure 30) and open (Figure 31) positions to form a second gap for grasping the native leaflets 20, 22. The extent of the gap between the fixed and movable arms 232, 234 of the clasp 230 is limited to the extent that the inner paddle 222 has spread away from the coaptation element 210.

[0290] Referring now to Figures 32-33, the device 200 is shown in a laterally extended or open position. The device 200 is moved into the laterally extended or open position by continuing to extend the actuation element 212 described above, thereby increasing the distance between the coaptation element 210 and the cap 214 of the distal portion 207. Continuing to extend the actuation element 212 pulls down on the outer paddles 220 and paddle frames 224, thereby causing the inner paddles 222 to spread apart further from the coaptation element 210. In the laterally extended or open position, the inner paddles 222 extend horizontally more than in other positions of the device 200 and form an approximately 90-degree angle with the coaptation element 210. Similarly, the paddle frames 224 are at their maximum spread position when the device 200 is in the laterally extended or open position. The increased gap between the coaptation element 210 and inner paddle 222 formed in the laterally extended or open position allows clasps 230 to open further (Figure 33) before engaging the coaptation element 210, thereby increasing the size of the gap between the fixed and movable arms 232, 234.

[0291] Referring now to Figures 34-35, the example device 200 is shown in a three-quarters extended position. The device 200 is moved into the three-quarters extended position by continuing to extend the actuation element 212 described above, thereby increasing the distance between the coaptation element 210 and the cap 214 of the distal portion 207. Continuing to extend the actuation element 212 pulls down on the outer paddles 220 and paddle frames 224, thereby causing the inner paddles 222 to spread apart further from the coaptation element 210. In the three-quarters extended position, the inner paddles 222 are open beyond 90 degrees to an approximately 135-degree angle with the coaptation element 210. The paddle frames 224 are less spread than in the laterally extended or open position and begin to move inward toward the actuation element 212 as the actuation element 212 extends further. The outer paddles 220 also flex back toward the actuation element 212. As with the laterally extended or open position, the increased gap between the coaptation element 210 and inner paddle 222 formed in the laterally extended or open position allows clasps 230 to open even further (Figure 35), thereby increasing the size of the gap between the fixed and movable arms 232, 234.

[0292] Referring now to Figures 36-37, the example device 200 is shown in a fully extended position. The device 200 is moved into the fully extended position by continuing to extend the actuation element 212 described above, thereby increasing the distance between the coaptation element 210 and the cap 214 of the distal portion 207 to a maximum distance allowable by the device 200. Continuing to extend the actuation element 212 pulls down on the outer paddles 220 and paddle frames 224, thereby causing the inner paddles 222 to spread apart further from the coaptation element 210. The outer paddles 220 and paddle frames 224 move to a position where they are close to the actuation element. In the fully extended position, the inner paddles 222 are open to an approximately 180-degree angle with the coaptation element 210. The inner and outer paddles 222, 220 are stretched straight in the fully extended position to form an approximately 180-degree angle between the paddles 222, 220. The fully extended position of the device 200 provides the maximum size of the gap between the coaptation element 210 and inner paddle 222, and, in some implementations, allows clasps 230 to also open fully to approximately 180 degrees (Figure 37) between the fixed and movable arms 232, 234 of the clasp 230. The position of the device 200 is the longest and the narrowest configuration. Thus, the fully extended position of the device 200 can be a desirable position for bailout of the device 200 from an attempted implantation or can be a desired position for placement of the device in a delivery catheter, or the like.

[0293] Configuring the device or implant 200 such that the anchors 208 can extend to a straight or approximately straight configuration (e.g., approximately 120-180 degrees relative to the coaptation element 210) can provide several advantages. For example, this configuration can reduce the radial crimp profile of the device or implant 200. It can also make it easier to grasp the native leaflets 20, 22 by providing a larger opening between the coaptation element 210 and the inner paddles 222 in which to grasp the native leaflets 20, 22. Additionally, the relatively narrow, straight configuration can prevent or reduce the likelihood that the device or implant 200 will become entangled in native anatomy (e.g., chordae tendineae CT shown in Figures 3 and 4) when positioning and/or retrieving the device or implant 200 into the delivery system 202. [0294] Referring now to Figures 38-49, an example device 200 is shown being delivered and implanted within the native mitral valve MV of the heart H. In some implementations, delivery to the tricuspid valve is similar. As described above, the device 200 shown in Figures 38-49 includes the optional covering 240 (e.g., Figure 25) over the coaptation element 210, clasps 230, inner paddles 222 and/or the outer paddles 220. The device 200 is deployed from a delivery system 202 (e.g., which can comprise an implant catheter that is extendable from a steerable catheter 241 and/or a guide sheath) and is retained by a capture mechanism 213 (see e.g., Figures 43 and 48) and is actuated by extending or retracting the actuation element 212. Fingers of the capture mechanism 213 removably attach the collar 211 to the delivery system 202. In some implementations, the capture mechanism 213 is held closed around the collar 211 by the actuation element 212, such that removal of the actuation element 212 allows the fingers of the capture mechanism 213 to open and release the collar 211 to decouple the capture mechanism 213 from the device 200 after the device 200 has been successfully implanted.

[0295] Referring now to Figure 38, the delivery system 202 (e.g., a delivery catheter/sheath thereof) is inserted into the left atrium LA through the septum and the device/implant 200 is deployed from the delivery system 202 (e.g., an implant catheter retaining the device/implant can be extended to deploy the device/implant out from a steerable catheter) in the fully open condition for the reasons discussed above with respect to the device 100. The actuation element 212 is then retracted to move the device 200 through the partially closed condition (Figure 39) and to the fully closed condition shown in Figures 40-41. Then the delivery system or catheter maneuvers the device/implant 200 towards the mitral valve MV as shown in Figure 41. Referring now to Figure 42, when the device 200 is aligned with the mitral valve MV, the actuation element 212 is extended to open the paddles 220, 222 into the partially opened position and the actuation lines 216 (Figures 43-48) are retracted to open the clasps 230 to prepare for leaflet grasp. Next, as shown in Figures 43-44, the partially open device 200 is inserted through the native valve (e.g., by advancing an implant catheter from a steerable catheter) until leaflets 20, 22 are properly positioned in between the inner paddles 222 and the coaptation element 210 and inside the open clasps 230.

[0296] Figure 45 shows the device 200 with both tissue engagement portions/clasps 230 closed, though the optional barbs 236 of one clasp 230 missed one leaflet 22. As can be seen in Figures 45-47, the out of position clasp 230 is opened and closed again to properly grasp the missed leaflet 22. When both leaflets 20, 22 are grasped properly, the actuation element 212 is retracted to move the device 200 into the fully closed position shown in Figure 48. With the device 200 fully closed and implanted in the native valve, the actuation element 212 is disengaged from the cap 214 and is withdrawn to release the capture mechanism 213 from the proximal component or collar 211 (or other attachment element) so that the capture mechanism 213 can be withdrawn into the delivery system 202 (e.g., into a catheter/sheath), as shown in Figure 49. Once deployed, the device 200 can be maintained in the fully closed position with a mechanical means such as a latch or can be biased to remain closed through the use of spring material, such as steel, and/or shape-memory alloys such as Nitinol. For example, the paddles 220, 222 can be formed of steel or Nitinol shape-memory alloy— produced in a wire, sheet, tubing, or laser sintered powder— and are biased to hold the outer paddles 220 closed around the inner paddles 222, coaptation element 210, and/or the clasps 230 pinched around native leaflets 20, 22.

[0297] Figures 50A, 50B, and 50C illustrate an example system and/or apparatus to which any of the features disclosed herein 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, paddle frames 8224, and a distal portion 8207. The attachment portion 8205, the distal portion 8207, and the paddle frames 8224 can be configured in a variety of ways.

[0298] In the example illustrated in Figure 50A, the paddle frames 8224 can be symmetric along longitudinal axis YY. However, in some implementations, the paddle frames 8224 are not symmetric about the axis YY. Moreover, referring to Figure 50A, the paddle frames 8224 include outer frame portions 8256 and inner frame portions 8260.

[0299] In some implementations, the connector 8266 (e.g., shaped metal component, shaped plastic component, tether, wire, strut, line, cord, suture, etc.) attaches to the outer frame portions 8256 at outer ends of the connector 8266 and to a coupler 8972 at an inner end 8968 of the connector 8266 (see Figure 50C).

[0300] In some implementations, between the connector 8266 and the attachment portion 8205, the outer frame portions 8256 form a curved shape. For example, in the illustrated example, the shape of the outer frame portions 8256 resembles an apple shape in which the outer frame portions 8256 are wider toward the attachment portion 8205 and narrower toward the distal portion 8207. In some implementations, however, the outer frame portions 8256 can be otherwise shaped.

[0301] In some implementations, the inner frame portions 8260 extend from the attachment portion 8205 toward the distal portion 8207. The inner frame portions 8260 then extend inward to form retaining portions 8272 that are attached to the actuation cap 8214. The retaining portions 8272 and the actuation cap 8214 can be configured to attach in any suitable manner.

[0302] In some implementations, the inner frame portions 8260 are rigid frame portions, while the outer frame portions 8256 are flexible frame portions. The proximal end of the outer frame portions 8256 connect to the proximal end of the inner frame portions 8260, as illustrated in Figure 50A.

[0303] The width adjustment element 8211 (e.g., width adjustment wire, width adjustment shaft, width adjustment tube, width adjustment line, width adjustment cord, width adjustment suture, width adjustment screw or bolt, etc.) is configured to move the outer frame portions 8256 from the expanded position to the narrowed position by pulling the inner end 8968 (Figure 50C) and portions of the connector 8266 into the actuation cap 8214. The actuation element 8102 is configured to move the inner frame portions 8260 to open and close the paddles in accordance with some implementations disclosed herein.

[0304] As shown in Figures 50B and 50C, in some implementations, the connector 8266 has an inner end 8968 that engages with the width adjustment element 8211 such that a user can move the inner end 8968 inside the receiver 8912 (e.g., an internally threaded element, a column, a conduit, a hollow member, a notched receiving portion, a tube, a shaft, a sleeve, a post, a housing, a cylinder, tracks, etc.) to move the outer frame portions 8256 between a narrowed position and an expanded position.

[0305] In the illustrated example, the inner end 8968 includes a post 8970 that attaches to the outer frame portions 8256 and a coupler 8972 that extends from the post 8970. The coupler 8972 is configured to attach and detach 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, features that mate with threads, detent connections, such as outwardly biased arms, walls, or other portions.

[0306] 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 detached from the width adjustment element 8211, the coupler is secured to the receiver.

[0307] The inner end 8968 of the connector can be configured in a variety of ways. Any configuration that can suitably attach the outer frame portions 8256 to the coupler to allow the width adjustment element 8211 to move the outer frame portions 8256 between the narrowed position and the expanded position can be used. The coupler can be configured in a variety of ways as well and can be a separate component or be integral with another portion of the device, e.g., of the connector or inner end of the connector.

[0308] In some implementations, the width adjustment element 8211 allows a user to expand or contract the outer frame portions 8256 of the device 8200. In the example illustrated in Figures 50B and 50C, the width adjustment element 8211 includes an externally threaded end that is threaded into the coupler 8972. In some implementations, the width adjustment element 8211 moves the coupler in the receiver 8912 to adjust the width of the outer frame portions 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 portions 8256.

[0309] In some implementations, the receiver 8912 can be integrally formed with a distal cap 8214. Moving the cap 8214 relative to a body of the attachment portion 8205 opens and closes the paddles. In the illustrated example, the receiver 8912 slides inside the body of the attachment portion. When the coupler 8972 is detached from the width adjustment element 8211, the width of the outer frame portions 8256 is fixed while the actuation element 8102 moves the receiver 8912 and cap 8214 relative to a body of the attachment portion 8205. Movement of the cap can open and close the device in the same manner as the other examples disclosed above.

[0310] In the illustrated example, a driver head 8916 is disposed at a proximal end of the actuation element 8102. The driver head 8916 releasably couples the actuation element 8102 to the receiver 8912. In the illustrated example, the width adjustment element 8211 extends through the actuation element 8102. The actuation element is axially advanced in the direction opposite to direction Y to move the distal cap 8214. Movement of the distal cap 8214 relative to the attachment portion 8205 is effective to open and close the paddles, as indicated by the arrows in Figure 50B. That is, movement of the distal cap 8214 in the direction Y closes the device and movement of the distal cap in the direction opposite to direction Y opens the device.

[0311] Also illustrated in Figures 50B and 50C, in some implementations, the width adjustment element 8211 extends through the actuation element 8102, the driver, head 8916, and the receiver 8912 to engage the coupler 8972 attached to the inner end 8968. In some implementations, the movement of the outer frame portions 8256 to the narrowed position can allow the device or implant 8200 to maneuver more easily into position for implantation in the heart by reducing the contact and/or friction between the native structures of the heart— e.g., chordae— and the device 8200. In some implementations, the movement of the outer frame portions 8256 to the expanded position provides the anchor portion of the device or implant 8200 with a larger surface area to engage and capture leaflet(s) of a native heart valve.

[0312] The device 8200 (e.g., the anchors 8830, 8834 or another portion of the device) can include tissue engagement portions or clasps 8230 that can be the same as or similar to the clasps 130, 230, 330, 40856, 5030a, 5030b, 5030c, or other tissue engagement portions or clasps herein.

[0313] The bioimpedance-based feedback disclosed herein can be used to provide feedback related to the clasping of tissue in tissue engagement portions or clasps of the one or more of the distal anchors 8830 and/or the proximal anchors 8834.

[0314] Figure 51A illustrates an example of a device or implant 300 (e.g., a treatment device, a repair device, an implantable device, etc.). The devices herein, including device 100 that is schematically illustrated in Figures 8-15, can be the same as or similar to device 300 (and/or the same as or similar to any other example devices disclosed herein, described in incorporated references, or any device otherwise compatible with the concepts herein).

[0315] The device 300 can include any other features for a device or implant discussed in the present application, and the device 300 can be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application).

[0316] 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 coaptation portion 304, and the coaptation portion 304 can optionally include a coaptation element 310 (e.g., spacer, plug, membrane, sheet, etc.) for implantation between the leaflets 20, 22 of the native valve.

[0317] 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, e.g., outer paddles 320, inner paddles 322, paddle extension members (e.g., leaf spring, shaped wire, etc.), paddle frames 324, etc. The anchors can also include and/or be coupled to clasps 330. In some implementations, the attachment portion 305 includes a first or proximal collar 311 (or other attachment element) for engaging with a capture mechanism of a delivery system. [0318] The anchors 308 can be attached to the other portions of the device and/or to each other in a variety of different ways (e.g., directly, indirectly, welding, sutures, adhesive, links, latches, integrally formed, a combination of some or all of these, etc.). In some implementations, the anchors 308 are attached to a coaptation element 310 by connection portions 325 and to a cap 314 by connection portions 321.

[0319] In some implementations, the anchors 308 can comprise first portions or outer paddles 320 and second portions or inner paddles 322 separated by connection portions 323. In some implementations, the connection portions 323 can be attached to paddle frames 324 that are hingeably attached to a cap 314 or other attachment portion. In this manner, the anchors 308 are configured similar to legs in that the inner paddles 322 are like upper portions of the legs, the outer paddles 320 are like lower portions of the legs, and the connection portions 323 are like knee portions of the legs.

[0320] In some implementations that include an optional coaptation element 310, the coaptation element 310 and the anchors 308 can be coupled together in various ways. As shown in the illustrated example, the coaptation element 310 and the anchors 308 can be coupled together by integrally forming the coaptation element 310 and the anchors 308 as a single, unitary component. This can be accomplished, for example, by forming the coaptation element 310 and the anchors 308 from a continuous strip 301 of a braided or woven material, such as braided or woven nitinol wire. In the illustrated example, the coaptation element 310, the outer paddle portions 320, the inner paddle portions 322, and the connection portions 321, 323, 325 are formed from a continuous strip of fabric 301.

[0321] Like the anchors 208 of the device or implant 200 described above, the anchors 308 can be configured to move between various configurations by axially moving the distal end of the device (e.g., cap 314, etc.) relative to the proximal end of the device (e.g., proximal collar 311 or other attachment element, etc.). This movement can be along a longitudinal axis extending between the distal end (e.g., cap 314, etc.) and the proximal end (e.g., collar 311 or other attachment element, etc.) of the device.

[0322] In some implementations, in the straight configuration, the paddle portions 320, 322 are aligned or straight in the direction of the longitudinal axis of the device. In some implementations, the connection portions 323 of the anchors 308 are adjacent to the longitudinal axis of the spacer or coaptation element 310. From the straight configuration, the anchors 308 can be moved to a fully folded configuration (as shown in Figure 51A), e.g., by moving the proximal end and distal end toward each other and/or toward a midpoint or center of the device.

[0323] In some implementations, the clasps comprise a moveable arm coupled to an anchor. In some implementations, the clasps 330 include a base or fixed arm 332, a moveable arm 334, optional barbs/friction-enhancing elements 336, and a joint portion 338. In some implementations, when included, the fixed arms 332 can be attached to the inner paddles 322, with the joint portion 338 disposed proximate the coaptation element 310. In some implementations, the joint portion 338 is spring-loaded so that the fixed and moveable arms 332, 334 are biased toward each other when the clasp 330 is in a closed condition.

[0324] In some implementations, the fixed arms 332 are attached to the inner paddles 322 through holes or slots with sutures. The fixed arms 332 can be attached to the inner paddles 322 with any suitable means, such as screws or other fasteners, crimped sleeves, mechanical latches or snaps, welding, adhesive, or the like. The fixed arms 332 remain substantially stationary relative to the inner paddles 322 when the moveable arms 334 are opened to open the clasps 330 and expose the optional barbs 336.

[0325] In some implementations, the clasps 330 are opened by applying tension to actuation lines attached to the moveable arms 334, thereby causing the moveable arms 334 to articulate, pivot, and/or flex on the joint portions 338.

[0326] In short, the device or implant 300 can be similar in configuration and operation to the device or implant 200 described above, but the coaptation element 310, outer paddles 320, inner paddles 322, and connection portions 321, 323, 325 are formed from the single strip of material 301. In some implementations, the strip of material 301 is attached to the proximal collar 311, cap 314, and paddle frames 324 by being woven or inserted through openings in the proximal collar 311, cap 314, and paddle frames 324 that are configured to receive the continuous strip of material 301. The continuous strip 301 can be a single layer of material or can include two or more layers. In some implementations, portions of the device 300 have a single layer of the strip of material 301 and other portions are formed from multiple overlapping or overlying layers of the strip of material 301.

[0327] For example, Figure 51A shows a coaptation element 310 and inner paddles 322 formed from multiple overlapping layers of the strip of material 301. The single continuous strip of material 301 can start and end in various locations of the device 300. The ends of the strip of material 301 can be in the same location or different locations of the device 300. In the illustrated example of Figure 51A, the strip of material 301 begins and ends in the location of the inner paddles 322.

[0328] As with the device or implant 200 described above, the size of the coaptation element 310 can be selected to minimize the number of implants that a single patient will require (preferably one), while at the same time maintaining low transvalvular gradients. In particular, forming many components of the device 300 from the strip of material 301 allows the device 300 to be made smaller than the device 200. For example, in some implementations, the anterior-posterior distance at the top of the coaptation element 310 is less than 2 mm, and the medial-lateral distance of the device 300 (e.g., the width of the paddle frames 324 which are wider than the coaptation element 310) at its widest is about 5 mm.

[0329] Additional features of the device 300, modified versions of the device, delivery systems for the device, and methods for using the device and delivery system are disclosed by Patent Cooperation Treaty International Application No. PCT/US2019/055320 (International Publication No. WO 2020/076898). Any combination or sub-combination of the features disclosed by the present application can be combined with any combination or sub-combination of the features disclosed by Patent Cooperation Treaty International Application No. PCT/US2019/055320 (International Publication No. WO 2020/076898). Patent Cooperation Treaty International Application No. PCT/US2019/055320 (International Publication No. WO 2020/076898) is incorporated herein by reference in its entirety.

[0330] Figure 51B illustrates an example system and/or apparatus to which the features disclosed herein can be applied. The 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.)

[0331] In some implementations, the valve repair device 40256 includes a base assembly 40456, a pair of paddles 40656 (e.g., clasp, clip, arm, etc.), and a pair of gripping members 40856 (e.g., clasp, clip, arm, etc.). In some implementations, the paddles 40656 can be integrally formed with the base assembly. For example, the paddles 40656 can be formed as extensions of links of the base assembly. In the illustrated example, 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, a gripping member 40856 can be considered a first arm and a paddle 40656 can be considered a second arm of a clasp, clip, tissue engagement portion, etc. [0332] In some implementations, the coupler 40556 is mechanically connected to the paddles 40656, such that movement of the coupler 40556 along the shaft 40356 causes the paddles to move between an open position and a closed position. In this way, the coupler 40556 serves as a means for mechanically coupling the paddles 40656 to the shaft 40356 and, when moving along the shaft 40356, for causing the paddles 40656 to move between their open and closed positions.

[0333] In some implementations, the gripping members 40856 are pivotally connected to the base assembly 40456 (e.g., the gripping members 40856 can be pivotally connected to the shaft 40356, or any other suitable member of the base assembly), such that the gripping members can be moved to adjust the width of the opening 41456 between the paddles 40656 and the gripping members 40856. The gripping member 40856 can include an optionally barbed portion 40956 (or otherwise frictionenhancing portion with or without barbs) for attaching the gripping members to valve tissue when the valve repair device 40256 is attached to the valve tissue.

[0334] In some implementations, when the paddles 40656 are in the closed position, the paddles engage the gripping members 40856, such that, when valve tissue is attached to the barbed portion 40956 (while described as a "barbed portion" here, other friction enhancing elements instead of or in addition to barbs can be used) of the gripping members, the paddles secure the valve repair device 40256 to the valve tissue.

[0335] In some implementations, the gripping members 40856 are configured to engage the paddles 40656 such that the barbed portion 40956 engages the valve tissue and the paddles 40656 to secure the valve repair device 40256 to the valve tissue. For example, it can be advantageous to have the paddles 40656 maintain an open position and have the gripping members 40856 move outward toward the paddles 40656 to engage valve tissue and the paddles 40656.

[0336] Although the example shown in Figure 51B illustrates a pair of paddles 40656 and a pair of gripping members 40856, it should be understood that the valve repair device 40256 can include any suitable number of paddles and gripping members.

[0337] In some implementations, the system 40056 includes a placement shaft 41356 that is removably attached to the shaft 40356 of the base assembly 40456 of the valve repair device 40256. After the valve repair device 40256 is secured to valve tissue, the placement shaft 41356 is removed from the shaft 40356 to remove 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 a patient's body.

[0338] The system 40056 can also include a paddle control mechanism 41056 (e.g., relatively movable tube(s), shaft(s), etc.), a gripper control mechanism 41156 (e.g., wire(s), line(s), suture(s), etc.), and a lock control mechanism 41256 (e.g., relatively movable tube(s), shaft(s), wire(s), line(s), suture(s), etc.).

[0339] In some implementations, the paddle control mechanism 41056 is mechanically attached to the coupler 40556 to move the coupler along the shaft, which causes the paddles 40656 to move between the open and closed positions. 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 comprise a hollow shaft, a catheter tube or a sleeve that fits over the placement shaft 41356 and the shaft 40356 and is connected to the coupler 40556.

[0340] The gripper control mechanism 41156 is configured to move the gripping members 40856 such that the width of the opening 41456 between the gripping members and the paddles 40656 can be altered. The gripper control mechanism 41156 can take any suitable form, such as, for example, a line, a suture or wire, a rod, a catheter, etc.

[0341] The lock control mechanism 41256 is configured to lock and unlock the lock. The lock 40756 locks the coupler 40556 in a stationary position with respect to the shaft 40356 and can take a wide variety of different forms and the type of lock control mechanism 41256 can be dictated by the type of lock used. In examples in which the lock 40756 includes a pivotable plate, the lock control mechanism 41256 is configured to engage the pivotable plate to move the plate between the tilted and substantially non-tilted positions. In some implementations, the lock control mechanism 41256 can be, for example, a rod, a suture, a wire, or any other member that is capable of moving a pivotable plate of the lock 40756 between a tilted and substantially non-tilted position.

[0342] The valve repair device 40256 is movable from an open position to a closed position. In the illustrated example, the base assembly 40456 includes links that are moved by the coupler 40556. The coupler 40556 is movably attached to the shaft 40356. In order to move the valve repair device from the open position to the closed position, the coupler 40556 is moved along the shaft 40356, which moves the links. [0343] In some implementations, the gripper control mechanism 41156 moves the gripping members 40856 to provide a wider or a narrower gap at the opening 41456 between the gripping members and the paddles 40656. In the illustrated example, the gripper control mechanism 41156 includes a line, such as a suture, a wire, etc. that is connected to an opening in an end of the gripper members 40856. When the line(s) is pulled, the gripping members 40856 move inward, which causes the opening 41456 between the gripping members and the paddles 40656 to become wider.

[0344] In order to move the valve repair device 40256 from the open position to the closed position, the lock 40756 is moved to an unlocked condition by the lock control mechanism 41256. Once the lock 40756 is in the unlocked condition, the coupler 40556 can be moved along the shaft 40356 by the paddle control mechanism 41056.

[0345] After the paddles 40656 are moved to the closed position, the lock 40756 is moved to the locked condition 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 condition by the lock 40756, the valve repair device 40256 is removed from the delivery device 40156 by disconnecting the shaft 40356 from the placement shaft 41356. In addition, the valve repair device 40256 is disengaged from the paddle control mechanism 41056, the gripper control mechanism 41156, and the lock control mechanism 41256.

[0346] Additional features of the device 40256, modified versions of the device, delivery systems for the device, and methods for using the device and delivery system are disclosed by Patent Cooperation Treaty International Application No. PCT/US2019/012707 (International Publication No. WO 2019139904). Any combination or sub-combination of the features disclosed by the present application can 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. WO 2019139904). Patent Cooperation Treaty International Application No. PCT/US2019/012707 (International Publication No. WO 2019139904) is incorporated herein by reference in its entirety.

[0347] Tissue engagement portions, such as clasps or leaflet 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. WO 2018195201). Any combination or sub-combination of the features disclosed by the present application can be combined with any combination or sub-combination of the features disclosed by Patent Cooperation Treaty International Application No. PCT/US2018/028171 (International Publication No. WO 2018195201).

Patent Cooperation Treaty International Application No. PCT/US2018/028171 (International Publication

No. WO 2018195201) is incorporated herein by reference in its entirety.

[0348] Figures 51C and 51D illustrate an example implementation of a valve repair device 40256 that includes a coaptation element 3800. The valve repair device 40256 can have the same or a similar configuration as the valve repair device illustrated by Figure 51B with the addition of the coaptation element. The coaptation element 3800 can take a wide variety of different forms.

[0349] In some implementations, the coaptation element 3800 can be compressible and/or expandable. For example, the coaptation element can be compressed to fit inside one or more catheters of a delivery system, can expand when moved out of the one or more catheters, and/or can be compressed by the paddles 40656 to adjust the size of the coaptation element. In the example illustrated by Figures 51C and 51D, the size of the coaptation element 3800 can be reduced by squeezing the coaptation element with the paddles 40656 and can be increased by moving the paddles 40656 away from one another. The coaptation element 3800 can extend past outer edges 4001 of the gripping members or clasps 40856 as illustrated for providing additional surface area for closing the gap of a mitral valve or tricuspid valve.

[0350] The coaptation element 3800 can be coupled to the valve repair device 40256 in a variety of different ways. For example, the coaptation element 3800 can be fixed to the shaft 40356, can be slidably disposed around the shaft, can be connected to the coupler 40556, can be connected to the lock 40756, and/or can be connected to a central portion of the clasps or gripping members 40856. In some implementations, the coupler 40556 can take the form of the coaptation element 3800. That is, a single element can be used as the coupler 40556 that causes the paddles 40656 to move between the open and closed positions and the coaptation element 3800 that closes the gap between the leaflets 20, 22 when the valve repair device 40256 is attached to the leaflets.

[0351] The coaptation element 3800 can be disposed around one or more of the shafts or other control elements of the valve repair system 40056. For example, the coaptation element 3800 can be disposed around the shaft 40356, the shaft 41356, the paddle control mechanism 41056, and/or the lock control mechanism 41256.

[0352] The valve repair device 40256 can include any other features for a valve repair device discussed in the present application, and the valve repair device 40256 can be positioned to engage valve tissue as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application). Additional features of the device 40256, modified versions of the device, delivery systems for the device, and methods for using the device and delivery system are disclosed by Patent Cooperation Treaty International Application No. PCT/US2019/012707 (International Publication No. WO 2019139904). Any combination or sub-combination of the features disclosed by the present application can 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. WO 2019139904).

[0353] Figure 51E illustrates an example of one of the many valve repair systems for repairing a native valve of a patient that the features disclosed herein can be applied to. 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 include a proximal end 8812 and a distal end 8814 with openings defined at both ends 8812, 8814 such that fluid can flow therethrough. In some implementations, the proximal end 8812 can be placed in the left atrium while the distal end 8814 can be placed in the left ventricle such that device 8810 can function as a replacement for a mitral valve. The device can be similarly configured for use in the tricuspid valve. The device 8810 can 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.

[0354] The device or implant 8810 can include one or more distal anchors 8830. The distal anchors 8830 can be positioned along or proximate a distal end of the frame 8820 and can be connected to the frame 8820. The distal anchors 8830 can be designed such that when the frame 8820 is in an expanded configuration an end or tip 8832 of each distal anchor 8830 is positioned radially outward from the frame 8820 and extends generally in a proximal direction. In some implementations, the device 8810 can include one or more proximal anchors 8834. The proximal anchors 8834 can be positioned along or proximate a proximal end 8812 of the frame 8820 and can be connected to the frame 8820. The proximal anchors 8834 can be designed such that when the frame 8820 is in an expanded configuration an end or tip 8836 of each proximal anchor 8834 is positioned radially outward from the frame 8820 and extends generally in a distal direction. In some implementations, one or more anchors 8830, 8834 can include cushions 8838 covering one or more of such anchors.

[0355] In some implementations, the device 8810 can be disposed so that the mitral annulus (or tricuspid annulus) is between the distal anchors 8830 and the proximal anchors 8834. In some

- 51 - implementations, the device 8810 can be positioned such that ends or tips 8832 of the distal anchors 8830 contact the annulus. In some implementations, the device 8810 can be positioned such that ends or tips 8832 of the distal anchors 8830 do not contact the annulus. In some implementations, the device 8810 can be positioned such that the distal anchors 8830 do not extend around the leaflet. In some implementations, the device 8810 can be positioned such that some distal anchors 8830 contact the annulus while other distal anchors 8830 do not. In some implementations, the device 8810 can be positioned so that the ends or tips 8832 of the distal anchors 8830 are on a ventricular side of the mitral annulus and the ends or tips 8836 of the proximal anchors 8834 are on an atrial side of the mitral annulus.

[0356] In some implementations, the distal anchors 8830 can be positioned such that the ends or tips 8832 of the distal anchors 8830 are on a ventricular side of the native leaflets beyond a location where chordae tendineae connect to free ends of the native leaflets. The distal anchors 8830 can extend between at least some of the chordae tendineae and, in some situations, can contact or engage a ventricular side of the annulus. It is also contemplated that in some implementations, the distal anchors 8830 do not contact the annulus, and the distal anchors 8830 can contact the native leaflet. In some situations, the distal anchors 8830 can contact tissue of the left ventricle beyond the annulus and/or a ventricular side of the leaflets. In some implementations, during delivery, the distal anchors 8830 (along with the frame 8820) can be moved toward the ventricular side of the annulus with the distal anchors 8830 extending between at least some of the chordae tendineae to provide tension on the chordae tendineae. Further examples of the device 8810 are provided in U.S. Pub. No. 2015/0328000 published November 19, 2015, which is incorporated by reference herein in its entirety.

[0357] In some implementations, the device 8810 does not include proximal anchors 8834. In some implementations, the distal anchors 8830 can be configured to clasp onto the native leaflet, the annulus, the chordae tendineae, or a combination of two or more of these. The bioimpedance-based feedback disclosed herein can be used to provide feedback related to the clasping of tissue in one or more of the distal anchors 8830 and/or the proximal anchors 8834.

Bioimpedance-Based Feedback with Devices

[0358] The following provides examples of devices that enable the use of bioimpedance or bioimpedance-based feedback in medical procedures. Although some of the description herein focuses on uses in devices designed for leaflet capture for illustrative purposes, it should be understood that the bioimpedance-based feedback capabilities, properties, and functionalities can be applied to other devices used in a variety of medical procedures and with a variety of tissues. These include, for example and without limitation, annuloplasty devices, anchors for devices, implants, treatment devices, valves, stents, prosthetic valves, devices that anchor to muscle, devices that anchor to tissue, and the like. Some example devices which can be used with the disclosed bioimpedance-based feedback techniques (e.g., including the sensors, printed circuit boards, circuits, electrodes, measurement systems, etc.) are described herein with reference to Figures 8-15, 22-37, and 50A-51E. Further, the bioimpedance-based feedback capabilities, properties, and functionalities can be applied to other systems, devices, components, etc. that are not implanted, e.g., delivery systems, delivery devices, catheters, anchor drivers, pushers (e.g., push rods, etc.), leaflet repair tools that capture a leaflet for treatment and later release the leaflet, chordae repair/replacement devices, leaflet prolapse repair devices, other treatment and/or repair devices, etc.

[0359] While many examples herein describe a clasp for illustrative purposes, the same or similar concepts, configurations, measurements, principles, etc. (e.g., similar electrodes, etc.), such as those described with respect to "clasps", can be used on other examples, anchors, anchor portions, clips, clamps, gripping members, paddles, configurations, etc. even if not a traditional "clasp." In some implementations, the 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 do not include a fixed arm. In some implementations, the gripping members can be pivotably connected to and/or formed with a base assembly.

[0360] In some implementations, the same or similar concepts, configurations, measurements, principles, etc. (e.g., similar electrodes, etc.), such as those described with respect to "clasps," can be used in conjunction with the distal anchors 8830 or arms of the device 8810 of Figure 51E.

[0361] In some implementations, the same or similar concepts, configurations, measurements, principles, etc. (e.g., similar electrodes, etc.), such as those described with respect to "clasps", can be used on an implantable device or non-implantable device that includes a tissue engagement portion or tissue capture portion that is formed by a first surface and a second surface that move relative to each other, whether or not associated with a first arm and a second arm and/or whether or not the surfaces are directly connected or hinged to each other.

[0362] In some implementations, the same or similar concepts, configurations, measurements, principles, etc. (e.g., similar electrodes, etc.), such as those described with respect to "clasps", can be used on an implantable device or non-implantable device that includes a tissue engagement portion or tissue capture portion that is formed by a first surface (e.g., of a gripping member, of an arm, of a clasp arm, of a first arm, etc.) and a second surface (e.g., of a paddle, of an arm, of clasp arm, of a second arm, of a coaptation element, etc.) wherein at least one of the first surface and the second surface can move relative to the other surface, whether or not the surfaces are directly connected or hinged to each other.

[0363] In typical transcatheter edge-to-edge repair (TEER) procedures and other such procedures that include leaflet grasping, echo-based imaging is predominantly used. Such imaging techniques can be helpful. However, as described herein, other techniques used with or without imaging can be helpful and potentially improve confidence and results. In some instances, the disclosed bioimpedance-based feedback techniques herein can be used to augment imaging techniques. For example, even on the mitral side where echo imaging is normally good, procedures can involve deploying more than one implant. In such instances, the first implant may cause shadowing when deploying a second implant, making accurate measurements of leaflet insertion difficult and making it more difficult to determine leaflet capture. Accordingly, disclosed herein are systems, methods, and devices that use bioimpedancebased feedback to provide feedback related to tissue engagement, tissue capture, and/or anchor deployment for devices, such as the devices disclosed herein. The bioimpedance-based feedback can be used to generate indicators to help users make decisions regarding leaflet capture, the feedback being independent of echo imaging.

[0364] Furthermore, it can be beneficial to generate indicators in addition to those related to leaflet insertion or leaflet capture. For example, it can be beneficial for a user to understand coaptation, tension, para-implant leak, the strength of leaflet tissue, the holding force of the clasp on the leaflet, and the like. Accordingly, algorithms described herein can be used to provide indicators that provide useful information for users to determine not only leaflet capture but also coaptation, tension, regurgitation, leaflet tissue strength, and the like. Advantageously, these indicators can be used to achieve desirable outcomes in medical procedures.

[0365] Figures 52A, 52B, 52C illustrate example anchor portions, anchors, tissue engagement portions, or clasps 5030a, 5030b, 5030c having at least one electrode 5040, e.g., two or more electrodes 5040. The anchor portions, anchors, tissue engagement portions, or clasps 5030a, 5030b, 5030c are useable with any of the systems devices herein mutatis mutandis, e.g., these are usable with the devices in Figures 8-51D, and with other implantable devices or non-implantable treatment devices that capture tissue.

- SO - [0366] Figure 52A illustrates an anchor, anchor portion, tissue engagement portion, clasp, etc. 5030a with electrodes 5040 over a cloth 5047 or cover (e.g., the electrodes 5040 are exposed) whereas Figure 52B illustrates an anchor, anchor portion, tissue engagement portion, clasp, etc. 5030b with electrodes 5040 under the cloth 5047 or cover (e.g., the electrodes are covered by the cloth 5047). Figure 52C illustrates an anchor, anchor portion, tissue engagement portion, clasp, etc. 5030c with electrodes 5040 secured to a first arm 5032 and/or to a second arm 5034 without a cloth or cover.

[0367] The anchor portions, anchors, tissue engagement portions, or clasps 5030a, 5030b, 5030c can be similar to the tissue engagement portions or clasps 130, 230, 330, 40856, etc. described herein and share many of the same components (e.g., arms 5032, 5034, means for securing 5036, and joint portion 5038), properties, and functionality. The anchors, anchor portions, clasps 5030a, 5030b, 5030c can be used in place of the anchors/clasps 130, 230 or features (e.g., electrodes, etc.) of the anchors, anchor portions, clasps 5030a, 5030b, 5030c can be incorporated into the anchors/clasps 130, 230. The anchor portions, anchors, clasps 5030a, 5030b, 5030c can be implemented as part of the devices described herein, such as the devices 100, 200.

[0368] In some implementations, the anchor portions, anchors, tissue engagement portions, clasps 5030a, 5030b, 5030c can include a frame 5046, which can be conductive (e.g., made of Nitinol or other conductive material), and a cloth 5047, which can be insulative, to cover the frame 5046 (such as the covering 240). Although many of the examples of anchor portions described herein include a cloth or cover, such as the cloth 5047 or the covering 240, it should be noted that the anchor portions can be implemented without a cloth or cover and in such examples the bioimpedance technologies described herein can be used with little or no modifications to the disclosed anchor portions.

[0369] The electrodes 5040 can take a variety of different forms. For example, the electrodes 5040 can comprise one or more plates (e.g., covering a majority of a surface of the device, such as a majority of a surface of an arm), one or more rails (a thin rectangular strip along a length or across a width of an arm), one or more discs, one or more circles, etc. The electrodes 5040 can be incorporated into sensing units. In some implementations, the sensing units can comprise printed circuit boards (PCBs) attached to the tissue engagement portions or clasps 5030a, 5030b, 5030c, including flexible PCBs.

[0370] In some implementations, the electrodes 5040 can be coupled to a first surface of a device

(e.g., a surface of first arm 5032 of a clasp 5030a, 5030b, 5030c), to a second surface of the device (e.g., a surface of a second arm 5034 of the clasp 5030a, 5030b, 5030c), to both the first surface and the second surface, and/or to one or more other portions of the device.

[0371] In some implementations, the electrodes 5040 can be coupled to a fixed arm 5032 of the clasp 5030a, 5030b, 5030c, to a moveable arm 5034 of the clasp 5030a, 5030b, 5030c, to both the fixed and moveable arms 5032, 5034, and/or to one or more other portions of the device.

[0372] In some implementations, the electrodes 5040 can be releasably coupled to a first surface and/or a first arm 5032 (e.g., a fixed arm). In some implementations, the electrodes 5040 can additionally or alternatively be releasably coupled to a second surface and/or a second arm 5034 (e.g., a moveable arm). In such examples, the electrodes 5040 (e.g., PCBs, leads, etc. which incorporate the electrodes 5040) can be removed after implantation of the device to which the electrodes 5040 are coupled, as described in greater detail herein.

[0373] In some implementations, electrical leads can be coupled to the electrodes 5040. Further, in some implementations, the electrical leads can be removed after implantation of the device to which the electrodes 5040 are coupled, as described in greater detail herein. Individual electrodes 5040 can be made of one or more separate conductor strips, rails, discs, plates, etc. The electrodes 5040 can be made of any suitable electrically conductive material.

[0374] In some implementations, one or more electrodes 5040 can be positioned at or near a minimum acceptable or targeted tissue insertion depth (e.g., leaflet insertion depth, etc.). In some implementations, one or more electrodes 5040 can be positioned at or near a maximum acceptable or targeted tissue insertion depth. In some implementations, one or more electrodes 5040 can be positioned at or near a minimum acceptable or targeted tissue insertion depth (e.g., leaflet insertion depth, etc.) and can also be positioned at or near a maximum acceptable or targeted tissue insertion depth.

[0375] In some implementations, an alternating current is applied across the electrodes 5040 and one or more impedance measurements are taken and/or derived. For example, electrical leads can be electrically coupled to the electrodes 5040, as described herein, and current or voltage can be applied to the electrodes 5040 using the electrical leads. Similarly, electrical signals associated with the electrodes 5040 can be measured using the electrical leads to determine impedance characteristics and/or changes to impedance characteristics. The applied voltage amplitude and/or alternating current frequency can be varied. Different materials can have different impedance characteristics for different applied voltages or currents. As such, applying varying voltage amplitudes can allow for enhanced differentiation between different biological materials disposed in the anchor, tissue engagement portion, clasp, etc.

[0376] In some implementations, the voltage is applied, and one or more impedance characteristics are measured and/or determined. This can be done, for instance, while the anchor or clasp is closed. In some implementations, the voltage is applied, and one or more impedance characteristics are measured and/or determined while the anchor or clasp is open, partially open, or not fully closed. The measured impedance characteristics can then be used to determine the tissue state relative to the anchor, tissue engagement portion, clasp, etc. For example, the tissue state can be fully inserted, minimal viable insertion, too little insertion, no insertion, wrong tissue type inserted, etc. In some implementations, the configuration of the electrodes can enable the determination of the tissue state before closing the anchor, tissue engagement portion, clasp, etc. This can advantageously avoid extraneous punctures of the leaflets by barbs during clasp closure, as described herein. Thus, taking the impedance measurements (e.g., measurements of electrical signals indicative of impedance and/or from which impedance can be calculated) to determine the tissue state while a tissue engagement portion or clasp is open, partially open, or not fully closed can have the benefit of being able to confirm that tissue is properly positioned in the clasp and/or to confirm that another unwanted tissue (such as chordae tendinea) is not positioned in the anchor before the anchor is closed. Taking the impedance measurements (e.g., measurements of electrical signals indicative of impedance and/or from which impedance can be calculated) to determine the tissue state while the anchor, tissue engagement portion, clasp, etc. is open, partially open, or not fully closed can prevent or inhibit the optional barbs from piercing or penetrating the tissue (e.g., leaflet, etc.) until it is confirmed that the tissue is properly positioned in the anchor, tissue engagement portion, clasp, etc. Taking the impedance measurements to determine the tissue state while the anchor, tissue engagement portion, clasp, etc. is open, partially open, or not fully closed can help the user avoid capturing non-targeted tissue (e.g., chordae tendinea, etc.) in the anchor, tissue engagement portion, clasp, etc. (e.g., avoid closing the anchor, tissue engagement portion, clasp, etc. while non-targeted tissue is inside the anchor, tissue engagement portion, clasp, etc.)

[0377] In some implementations, the one or more impedance characteristics that are measured and/or determined can be used to determine whether targeted tissue (e.g., a leaflet) is in the anchor, tissue engagement portion, clasp, etc. while the anchor, tissue engagement portion, clasp, etc. is open, partially open, or not fully closed. In some implementations, the measured or determined impedance characteristics can also be used to generate an indicator (e.g., for an operator) that the targeted tissue is in a capture region of the anchor, tissue engagement portion, clasp, etc. while it is open, partially open, or not fully closed.

[0378] In some implementations, the one or more impedance characteristics that are measured and/or determined can be used to determine whether targeted tissue has been over inserted in the anchor, tissue engagement portion, clasp, etc. and/or whether the targeted tissue is folded or bunched in the anchor, tissue engagement portion, clasp, etc. In some implementations, the measured or determined impedance characteristics can also be used to generate an indicator that the targeted tissue has been over inserted, is folded or bunched in the anchor, tissue engagement portion, clasp, etc.

[0379] In some implementations, the one or more impedance characteristics that are measured and/or determined can be used to determine whether non-targeted tissue has been captured in the anchor, tissue engagement portion, clasp, etc. (e.g., a chordae tendineae has been accidentally captured). In some implementations, the measured or determined impedance characteristics can also be used to generate an indicator that indicates that non-targeted tissue has been captured.

[0380] In some implementations, the one or more impedance characteristics that are measured and/or determined can be used to determine whether targeted tissue that has been captured is askew or angled in the anchor, tissue engagement portion, clasp, etc. (e.g., one side of a leaflet is deeper in a tissue engagement portion or clasp than the other side). In some implementations, the measured or determined impedance characteristics can also be used to generate an indicator that indicates that captured tissue is angled or askew relative to the anchor, tissue engagement portion, clasp, etc.

[0381] In some implementations, the electrodes 5040 can be included in a circuit along with the AC power supply, an electrical sensor, and the wiring or electrical leads. The sensor and the power supply (e.g., an AC power supply, etc.) can be a single device or separate devices. The wiring connects the electrodes 5040 to the power supply and the electrical sensor to measure, among other things, resistance, inductance, capacitance, voltage, current, and/or impedance, components of impedance, etc. As described herein, the electrical characteristics measured by the electrical sensor can be used to determine the location of the clasp and/or the anatomy that the clasp is in contact with, based on the resistance, inductance, capacitance, voltage, impedance and/or current readings taken by the sensor. The sensor can take a variety of different forms, including an impedance meter. In some implementations, the sensor is implemented in a PCB or other such component that is attached or coupled to the clasp 5030a, 5030b, 5030c. In some implementations, the electrodes 5040 and the sensor can be integrated into the same PCB or other such component.

[0382] By way of example, it has been surprisingly discovered that when electrical signals are measured during leaflet capture, the amplitude and shape of the electrical signals are distinct in instances where the electrodes 5040 contact the leaflet or other portion of the heart valve (e.g., chordae tendinea). The electrical signals can differentiate the type of tissue that is being contacted, and the extent of that contact with the electrode 5040 (e.g., if the electrode is at the edge or near the root of the leaflet). As such, by placing electrodes on a device (e.g., on one or more of the devices 100, 200, 300, 40256, or other device) the electrical signals can assist the user in determining if the leaflet or other tissue is captured or partially captured in the device, whether no tissue is captured by the device and/or whether the device is contacting chordae tendinea or other portion of the heart valve (e.g., non-targeted tissue) instead of the leaflet (e.g., targeted tissue).

[0383] The electrodes 5040 measure electrical signals to assist a user in determining if tissue (e.g., targeted tissue, a leaflet, etc.) is captured or partially captured by the device. Each of the electrodes 5040 provides a signal in material, such as blood, and/or in contact with material (e.g., tissue) at different locations. For example, in some implementations, the electrodes 5040 can provide a signal based on being positioned in blood in the atrium (and not in contact with tissue), based on being positioned in blood in the ventricle (and not in contact with tissue), based on being in contact with valve leaflet tissue and/or based on being in contact with chordae tissue.

[0384] In some implementations, three, four, five, or more electrodes are included. Any number of electrodes can be included for each clasp 5030a, 5030b, 5030c.

[0385] The electrical signals can take a wide variety of different forms and can be processed in a wide variety of different ways to determine the position of the device in the body (e.g., the position within a heart and/or the position of the leaflets relative to the device). In some implementations, bioimpedance signals are measured on the electrodes 5040 as described herein. The bioimpedance signal can be separated into a real portion and an imaginary portion, as is well known in electrical engineering calculations. Also, in some implementations, where the electrical power provided to the electrodes 5040 is provided using alternating current, the bioimpedance signal can also be represented with a magnitude and a phase. The bioimpedance signals can be analyzed to provide indications of the position of the electrodes 5040, and hence the tissue engagement portion or clasp 5030a, 5030b, 5030c relative to targeted tissue (e.g., leaflets) and/or relative to other tissue or non-targeted tissue (e.g., chordae tissue).

[0386] When measuring bioimpedance signals, different signal readings correspond to different relative positions of tissue (e.g., targeted tissue, leaflets, etc.) and the electrodes 5040. For example, in some implementations, if a leaflet contacts only one electrode, then a lower magnitude bioimpedance signal reading can result. However, when the leaflet sufficiently contacts two or more electrodes, then a higher magnitude bioimpedance signal reading can result, indicating that the device is correctly placed. This is due to the leaflet impeding the current more than the blood. Hence, the more a leaflet covers the electrodes, the higher the impedance becomes (e.g., a thicker leaflet will have a higher impedance). Thus, the configuration of the electrodes can be used to determine whether targeted tissue is partially captured or within a clasp while it is open or not fully closed, whether targeted tissue is askew or angled relative to a clasp, whether targeted tissue is over inserted or folded in the clasp, and/or whether nontargeted tissue has been captured in the clasp. Examples of bioimpedance signals resulting from different electrode and tissue configurations are described herein.

[0387] Figures 53A-53F illustrate anchors, tissue engagement portions, or clasps having different electrode configurations. Figures 53A and 53B illustrate an example device 5100 with anchors, tissue engagement portions, or clasps 5130 having electrodes 5140, 5145 positioned on an arm 5132 of the anchors, tissue engagement portions, or clasps 5130. The device 5100 can be the same as or similar to any of the devices (e.g., devices 100, 200, 300, 8200, 8810, 40256, or another device) described or incorporated herein. In addition, the tissue engagement portions or clasps 5130 can be the same as or similar to the clasps 130, 230, 330, 40856, 5030a, 5030b, 5030c (or other tissue engagement portions) described herein and share many of the same components (e.g., arms 5132, 5134, means for securing 5136, and joint portion 5138), properties, and functionality.

[0388] In some implementations of the anchors, tissue engagement portions, or clasps 5130, there are two strips of electrodes 5140, 5145 that fully or partially span a width of a first surface (e.g., a surface of the arm 5132). Thus, the electrodes 5140, 5145 provide bioimpedance signals corresponding to different amounts of tissue capture. A benefit of this type of configuration is that the clasp 5130 can be configured to indicate that there is tissue capture when the tissue (e.g., leaflet, etc.) contacts the electrodes 5140, 5145 even when the clasp 5130 is in a capture-ready configuration (e.g., the clasp 5130 is open or partially open). [0389] Figures 53C and 53D illustrates an example device 5200 with anchors, tissue engagement portions, or clasps 5230 each having a first electrode 5240 positioned on a first surface (e.g., a surface of a first arm 5232) and a second electrode 5245 positioned on a second surface (e.g., a surface of a second arm 5234) of the device (e.g., of clasps 5230 of the device, of other portions of the device, etc.). The device 5200 can be the same as or similar to any of the devices (e.g., devices 100, 200, 300, 8200, 8810, 40256, or another device) described or incorporated herein. In addition, the tissue engagement portions or clasps 5230 can be the same as or similar to the clasps 130, 230, 330, 40856, 5030a, 5030b, 5030c (or other tissue engagement portions) described herein and share many of the same components (e.g., arms 5232, 5234, means for securing 5236, and joint portion 5238), properties, and functionality.

[0390] In some implementations of the tissue engagement portions or clasps 5230, there are two strips of electrodes 5240, 5245 that fully or partially span a width of a respective surface and/or width of a respective arm 5232, 5234. Thus, the electrodes 5240, 5245 provide bioimpedance signals corresponding to different sides of a leaflet or other tissue. A benefit of this type of configuration is that the tissue engagement portion or clasp 5230 can be configured to indicate that there is no tissue or leaflet capture when the tissue engagement portion or clasp 5230 is closed due at least in part to the electrodes 5240, 5245 being shorted, or in contact with each other, resulting in the impedance value being drastically reduced relative to a configuration in which the electrodes 5240, 5245 are apart and/or in contact with tissue.

[0391] Figure 53E and 53F illustrates an example device 5300 with tissue engagement portions or clasps 5330 each having a first electrode plate 5340 positioned on a first surface (e.g., a surface of first arm 5332) and a second electrode plate 5345 positioned on a second surface (e.g., a surface of a second arm 5334) of the device (e.g., of clasps 5230). The device 5200 can be the same as or similar to any of the devices (e.g., devices 100, 200, 300, 8200,8810, 40256, or another device) described or incorporated herein. In addition, the tissue engagement portions or clasps 5230 can be the same as or similar to the clasps 130, 230, 330, 40856, 5030a, 5030b, 5030c (or other tissue engagement portions) described herein and share many of the same components (e.g., arms 5332, 5334, means for securing 5336, and joint portion 5338), properties, and functionality.

[0392] In some implementations of the tissue engagement portions or clasps 5330, there are two electrode plates 5340, 5345 that fully or partially cover the area of a respective surface and/or of a respective arm 5332, 5334. Thus, the electrode plates 5340, 5345 provide bioimpedance signals corresponding to different capture depths of a leaflet or other tissue and can provide detailed information regarding relative capture depths of the leaflet or other tissue relative to other electrode configurations (e.g., the electrodes of the clasps 5130, 5230). An advantage of this configuration is that the tissue engagement portion or clasp 5330 is configured to indicate the tissue capture depth when the tissue or leaflet is between the electrode plates 5340, 5345, the tissue or leaflet acting as a dielectric. Similarly, a benefit of this configuration is that the clasp 5330 is configured to indicate that there is no tissue or leaflet capture when the clasp 5330 is closed due at least in part to the electrodes 5340, 5345 being shorted, or in contact with each other, resulting in the impedance value being drastically reduced relative to a configuration in which the electrodes 5340, 5345 are apart and/or in contact with tissue.

[0393] Figure 54 illustrates example bioimpedance signals from a tissue engagement portion or clasp having two or more electrodes to provide bioimpedance-based feedback, such as the clasps 5030a, 5030b, 5030c, 5130, 5230, and/or 5330. The example bioimpedance signals are shown as a function of time which corresponds to an example process of moving a device into position next to leaflets and then grasping the leaflets, examples of which are described herein with respect to Figures 16-21 and 38-49. The different lines of the graph correspond to a fully captured leaflet ("Full"), an over captured leaflet ("Over") which may result in the leaflet partially folding within the clasp, an extremely over captured leaflet ("xOver") where the length of the leaflet captured in the clasp is about double or more than double the length of the clasp causing the leaflet to be bunched up on the clasp, an under captured leaflet ("Under") (e.g., leaflet insertion is between about 4 mm and about 5.9 mm), an extremely under captured leaflet ("xUnder") (e.g., leaflet insertion is between about 1 mm and about 3 mm), and where chordae tendineae are captured ("Chord"). In addition, a control bioimpedance signal ("Control") is shown which corresponds to the bioimpedance signals when no leaflet is captured.

[0394] The initial baseline portion of the plot corresponds to the device being moved into position, prior to the leaflets entering the clasps. Examples of this configuration are shown in Figures 18 and 43. As the leaflets enter the open or partially open clasps, the bioimpedance signal rises sharply. Examples of this configuration are shown in Figures 19 and 44. As the clasps close on the leaflets, the bioimpedance signal drops to a steady-state signal that is different from the baseline signal resulting from the open clasps with no leaflets within the clasps. Examples of this configuration are shown in Figures 19, 20, and 45.

[0395] The amount of leaflet capture (or other tissue capture) can be determined based at least in part on the bioimpedance signals from the electrodes on the tissue engagement portion or clasps. Prior to capturing tissue (e.g., a leaflet), the bioimpedance signal is a steady state (or roughly steady state) signal, which can be referred to as an empty open clasp baseline. As the tissue or leaflet enters the open clasp or other tissue engagement portion, the bioimpedance signal increases (the contrast of which is shown in the control signal which does not increase because a leaflet does not enter the open clasp). As shown in Figure 54, overly captured tissue ("Over" and "xOver") results in a larger increase in the bioimpedance signal than fully captured tissue ("Full") and under captured tissue ("Under" and "xUnder"). Similarly, under captured tissue ("Under" and "xUnder") results in a smaller increase in the bioimpedance signal than fully captured tissue ("Full"). Thus, based on the increase or change in the bioimpedance signal, the amount of capture of the tissue can be determined. In addition, as the clasps close, the bioimpedance signal drops to a steady-state value (or roughly steady state), which can be referred to as a closed clasp baseline. This change in bioimpedance value also provides information regarding the status of the tissue capture and/or status of the tissue engagement portion or anchor. For example, if chordae tendineae are captured in the clasps, a different bioimpedance signal profile results relative to the clasps capturing a leaflet. The increase in the bioimpedance signal for the "Chord" and the "Under" situations are similar, but due to the different closed clasp or leaflet capture portion baseline bioimpedance signals, it can be determined that chordae tendineae were captured in the clasps or leaflet capture portion.

[0396] As described herein, the bioimpedance signals can be understood to reflect the amount of resistance to an electrical signal. The type of tissue and the amount of tissue between the electrodes affects the bioimpedance signal. If, for example, the clasps (or other tissue engagement portion) close with no tissue between the electrodes, it is similar to a shorted circuit with very little resistance between the electrodes. This is why the control signal has the lowest impedance in the graph after the clasps close. In the open position with no leaflets between the clasps, the blood between the electrodes provides a low-resistance electrical path. This is why each impedance signal in the graph has roughly the same open clasp baseline. As tissue enters the clasp, the amount of tissue in the clasp (reflecting whether the leaflet is fully, overly, or underly captured) affects the impedance, with more tissue typically increasing the amount of impedance to the electrical signal. With the clasps closed, again the amount of tissue in the clasp affects the impedance, with more tissue typically increasing the amount of impedance to the electrical signal. Thus, the bioimpedance signal profiles (which includes impedance signals from different portions of the implanting process) can be analyzed to determine the status of leaflet capture of a clasp. Accordingly, bioimpedance signals acquired, measured, or determined as described herein using electrodes on clasps can be used to determine whether targeted tissue is within a clasp even before the clasp closes, to determine whether tissue has been over inserted, to determine if non- targeted tissue is being or has been captured, and/or to determine of the targeted tissue is askew or angled relative to the clasp.

[0397] Figures 55 and 56 illustrate example bioimpedance signals from the tissue engagement portion or clasp 5230 of Figures 53C and 53D (which can be incorporated on any of the devices herein). The top graph of Figure 55 illustrates the bioimpedance signals with the tissue engagement portion or clasp 5230 in the open position, the bioimpedance signal changing relative to the insertion depth of the leaflet (or other tissue) in the clasp 5230. The middle graph of Figure 55 illustrates the increase in the bioimpedance as the leaflet is inserted fully into the clasp 5230. The bottom graph of Figure 55 illustrates a control signal where no leaflet (or other tissue) is inserted in the clasp 5230 but the clasp is closed then opened. The top graphs of Figure 56 illustrate the real (left graph) and imaginary (right graph) portions of the bioimpedance signal for a fully captured leaflet (or other tissue). The middle graphs of Figure 56 illustrate the real (left graph) and imaginary (right graph) portions of the bioimpedance signal for an overly captured leaflet (or other tissue). The bottom graphs of Figure 56 illustrate the real (left graph) and imaginary (right graph) portions of the bioimpedance signal for an under captured leaflet (or other tissue). The different lines in the graphs correspond to a variety of different measurements (e.g., using different leaflets) with a sample size of 4. This configuration of electrodes 5240, 5245 provides a relatively binary output for the status of the leaflet or tissue (e.g., captured or not captured). As shown, the example bioimpedance signals exhibit a significant difference between full leaflet capture, under leaflet capture, and over leaflet capture, making the situations relatively clear to classify in an analysis.

[0398] In some implementations, algorithms can be implemented to analyze the bioimpedance signals of the tissue engagement portion or clasp 5230. For example, signal processing algorithms can be implemented. In such instances, some implementations can generate a binary output such as tissue contact or no tissue contact with the electrodes. In such instances, some implementations use a plurality of electrodes (e.g., arranged in an array) wherein the signals from each electrode or pairs of electrodes can be compared to one another to determine a tissue state. For example, if there are six electrodes evenly spaced on an inner paddle and a leaflet makes contact with the outer four electrodes, but the leaflet is folded at the middle pair, then each outer pair would have similar signals to one another but different from the middle pair. Some implementations can then use a user interface to display the electrodes (or the signals measured at the electrodes) to show a user the tissue state (e.g., a folded leaflet), examples of which are described herein. [0399] As another example of an algorithm, a threshold algorithm can be implemented that outputs an indication of an under captured leaflet or a fully captured leaflet after the clasps 5230 (or other tissue capture portion) have closed. This is similar to a mechanical indication of leaflet capture with an advantage that it provides a clearer user interface and is fast and simple to implement. In some implementations, a feature-based decision tree algorithm can be implemented that outputs an indication of an under, over, or fully captured leaflet after the clasps 5230 have closed. This algorithm can be configured to differentiate between thick and thin leaflets and helps to avoid over insertion of leaflets. This can reduce residual regurgitation and Single-Leaflet Device Attachment (SLDA) complications. In some implementations, a feature-based random forest algorithm can be implemented that outputs an indication of an under, over, or fully captured leaflet while the clasp 5230 is open and after the clasp 5230 has closed. This advantageously provides an indication of leaflet capture prior to closing the clasp 5230 which provides confirmation of leaflet capture prior to implant release. Similar principles apply to capture of other types of tissue.

[0400] Figures 57 and 58 illustrate example bioimpedance signals from the tissue engagement portion or clasp 5330 of Figures 53E and 53F. The top graph in Figure 57 illustrates the bioimpedance signal with the tissue engagement portion or clasp 5330 in the open position as a function of leaflet capture depth. This shows that the electrode plates 5340, 5345 provide signals that can be used to provide a relatively accurate determination of leaflet capture depth due at least in part to the configuration of the electrode plates 5340, 5345. The bottom graph of Figure 57 illustrates the magnitude of the bioimpedance signal with the tissue engagement portion or clasp 5330 in the open position for various situations, such as pulling the leaflet gradually out of the clasp and where there is no leaflet insertion. The different lines in the bottom graph correspond to a variety of different measurements (e.g., using different leaflets) with a sample size of 5. The top graphs of Figure 58 illustrate the real (left graph) and imaginary (right graph) portions of the bioimpedance signal with a fully captured leaflet. The middle graphs of Figure 58 illustrate the real (left graph) and imaginary (right graph) portions of the bioimpedance signal with an over-captured leaflet. The bottom graphs of Figure 58 illustrate the real (left graph) and imaginary (right graph) portions of the bioimpedance signal with an under-captured leaflet. The different lines in the graphs correspond to a variety of different measurements (e.g., using different leaflets) with a sample size of 4. Similar principles apply to capture of other types of tissue. [0401] Figures 59A and 59B illustrate an example tissue engagement portion or clasp 5930 with a combination of an electrode plate 5945 and electrode strips 5940, 5942. The tissue engagement portions or clasp 5930 has electrode strips 5940, 5942 positioned on a first surface and/or a first arm 5932 and an electrode plate 5945 positioned on a second surface and/or a second arm 5334 of the clasp 5930 (e.g., the electrode strips 5940, 5942 and electrode plate 5945 over the cover 5947). The tissue engagement portion or clasp 5930 can be implemented on any of the devices described herein. In addition, the tissue engagement portion or clasp 5930 can be the same as or similar to the clasps 130, 230, 330, 40856, 5030a, 5030b, 5030c (or other tissue engagement portions) described herein and share many of the same components (e.g., arms 5932, 5934, means for securing 5936, and joint portion 5938), properties, and functionality.

[0402] In the illustrated example of the tissue engagement portion or clasp 5930, the electrode plate 5945 fully or partially covers the area of the surface or arm 5934. In addition, the electrode strips 5940, 5942 run parallel to the length of the surface or arm 5932 and cover a portion of the length of the surface or arm 5932, with a separation between the electrode strips 5940, 5942 along a width of the surface or arm 5932.

[0403] In some implementations, the combination of the electrode plate 5945 and electrode strips 5940, 5942 provide bioimpedance signals corresponding to different capture depths of a leaflet and can provide detailed information regarding relative capture depths of the leaflet relative to the tissue engagement portions or clasps 5130, 5230, 5330. For example, when the clasp 5930 is open, the impedance between the electrode strips 5940, 5942 can be measured to determine leaflet insertion depth. When the clasp 5930 is closed, the impedance between each electrode strip 5940, 5942 and the electrode plate 5945 can be measured to determine leaflet capture depth. Advantageously, this configuration provides a continuous signal correlating to the amount of leaflet inserted while the clasp 5930 is open. Advantageously, this configuration confirms leaflet capture when the clasp 5930 is closed. Advantageously, this configuration can differentiate between different leaflet insertion scenarios (e.g., angled, askew, crooked, partial or under insertion, full insertion, over insertion, etc.) due at least in part to the configuration of the electrode strips 5940, 5942 along with the electrode plate 5945. For example, asymmetry in bioimpedance signals from the electrode strips 5940, 5942 can indicate that the tissue in the clasp 5930 is angled or askew. Similar principles apply to capture of other types of tissue.

[0404] Figures 60A-62C illustrate an example tissue engagement portion or clasp 6030 with electrode strips 6040, 6042 and example bioimpedance signals from the example tissue engagement portion or clasp 6030. Figures 60A and 60B illustrate the tissue engagement portion or clasp 6030, which can be configured the same as or similar to the clasp 230 (or another tissue engagement portion or clasp herein), with a cover 6047 over the clasp 6030 (similar to the cover 240 of Figure 25). Figure 60C illustrates an example implementation of the tissue engagement portion or clasp 6030 of Figure 60B without the cover 6047. It should be noted that each of the tissue engagement portions or clasps and associated bioimpedance-based components described herein can be implemented with or without a cover, an example of which is demonstrated by the clasp 6030 which is shown in Figure 60B with the cover 6047 and in Figure 60C without the cover.

[0405] The tissue engagement portion or clasp 6030 has electrode strips 6040, 6042 positioned on a first surface and/or first arm 6032 (e.g., over the portion of the cover 6047 that is over the first arm 6032). The tissue engagement portion or clasp 6030 can be implemented on any of the devices described herein. In addition, the tissue engagement portion or clasp 6030 can be the same as or similar to the clasps 130, 230, 330, 40856, 5030a, 5030b, 5030c, 5930 (or other tissue engagement portions) described herein and share many of the same components (e.g., arms 6032, 6034, joint portion 6038, means for securing 6036, and electrode strips 6040, 6042), properties, and functionality.

[0406] In the illustrated example of the tissue engagement portion or clasp 6030, the electrode strips 6040, 6042 run parallel to the length of the arm 6032 and cover a portion of the length of the arm 6032, with a separation between the electrode strips 6040, 6042 along a width of the arm 6032. In this example implementation of the tissue engagement portion or clasp 6030, the electrode strips 6040, 6042 are implemented over the cover 6047, but it should be noted that the electrode strips 6040, 6042 can be implemented below the cover 6047.

[0407] The top graphs of Figure 61A illustrate the real (left graph) and imaginary (right graph) portions of the bioimpedance signal of the clasp 6030 when the leaflet is fully captured. The bottom graphs of Figure 61A illustrate the real (left graph) and imaginary (right graph) portions of the bioimpedance signal of the clasp 6030 when the leaflet is over captured. The top graphs of Figure 61B illustrate the real (left graph) and imaginary (right graph) portions of the bioimpedance signal of the clasp 6030 when the leaflet is under captured. The middle graphs of Figure 61B illustrate the real (left graph) and imaginary (right graph) portions of the bioimpedance signal of the clasp 6030 when the leaflet is under captured, specifically when the leaflet is 1/4 under captured. The bottom graph of Figure 61B illustrates the real portion of the bioimpedance signal of the clasp 6030 when the leaflet is under captured (signal portion 6101), when the leaflet is fully captured (signal portion 6102), and when the leaflet is over captured (signal portion 6103). Asymmetry in bioimpedance signals from the electrode strips 6040, 6042 can indicate that the tissue in the tissue engagement portion or clasp 6030 is angled or askew. Similar principles apply to capture of other types of tissue.

[0408] Figures 62A and 62B illustrate an implementation of a tissue engagement portion or clasp 6230 which can be the same as or similar to the tissue engagement portion or clasp 6030 of Figures 60A- C except that the electrode strips 6240, 6242 are offset from an edge (e.g., a free edge, an edge opposite a hinged end, etc.) of the surface and/or arm 6032 by a prescribed distance, d (e.g., about 6 mm). This offset changes the bioimpedance signal profiles for leaflet capture, as illustrated in the graphs of Figure 62C. The top graphs of Figure 62C illustrate the real (left graph) and phase (right graph) portions of the bioimpedance signal for a fully captured leaflet (signals 6201a, 6201b) and for an over-captured leaflet (signals 6202a, 6202b). The bottom graphs of Figure 62C illustrate the magnitude (left graph) and phase (right graph) portions of the bioimpedance signal 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 example implementation of the clasp 6230, the electrode strips 6240, 6242 are implemented over the cover 6047, but it should be noted that the electrode strips 6240, 6242 can be implemented below the cover 6047. In some implementations, no cover is used.

[0409] In some implementations, algorithms can be implemented to analyze the bioimpedance signals of the tissue engagement portions or clasps 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 under, over, or fully captured leaflet when the tissue engagement portion or clasp 6030, 6230 is open and closed. This algorithm can be configured to determine if a leaflet is askew or angled in the tissue engagement portion or clasp 6030, 6230 and/or when only one electrode is covered. Advantageously, this provides indicators prior to closing the clasp 6030, 6230. In some implementations, a feature-based random forest algorithm can be implemented that outputs a continuous leaflet insertion indicator while the clasp 6030, 6230 is open and closed. This advantageously provides a larger amount of information to the user and can be configured to differentiate between captured targeted tissue (e.g., leaflet capture) and captured non-targeted tissue (e.g., chord capture).

[0410] In some implementations, the tissue engagement portions or clasps 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 Figure 64, e.g., the reference electrode can be part of the actuation element.

[0411] In some implementations, the reference electrode can be a dedicated reference electrode in the blood, an electrode on a catheter, or an external patch on the patient's skin. In some implementations, bio-impedance 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.

[0412] In some implementations, the reference electrode can be in measuring bioimpedance-based signals that can provide detailed information on tissue contact on the tissue engagement portion or clasp 6030, 6230 by comparing two unipolar measurements from each electrode (e.g., electrodes 6040 and electrode 6042 or electrode 6240 and electrode 6242). By way of example, if one electrode has a relatively high impedance indicating full insertion but the other electrode is indicating under insertion this means that the leaflet is inserted askew or at an angle. In some implementations, in a commissure area where mostly chordae are captured, each electrode 6040, 6042 or each electrode 6240, 6242 will show a different impedance but both impedances will be too low to be confused with full leaflet capture.

[0413] In some implementations, when the bipolar impedance is measured, the comparison between leaflet and no leaflet/blood is amplified due at least in part to the electrodes both touching leaflet and/or blood simultaneously. This provides a greater indication of leaflet insertion which can be more pronounced when the leaflet is inserted straight in the tissue engagement portion or clasp and the device or implant is perpendicular to the leaflet's free edge.

[0414] The electrode configuration of the example tissue engagement portion or clasp 6030 can be beneficial due at least in part to the electrode strips 6040, 6042 providing a continuous indication of leaflet insertion (which can be approximately linear) throughout the length of the tissue engagement portion or clasp 6030. This can be broken down into quantized signal regions indicating, for example, four categories of leaflet insertion: no leaflet, under insertion, full insertion, and over insertion. In some implementations, the average measurement of the electrode strips 6040, 6042 can be used to determine the label or category of leaflet insertion. The electrode configuration of the tissue engagement portion or clasp 6230 can be beneficial because there is little or no change in signal until the leaflet reaches the edge of the electrode strips 6242, 6240, which is already a distance, d, within the clasp 6230. The distance, d, can be configured to be an advantageous distance that indicates a sufficient insertion distance to achieve good leaflet capture. By way of example, the distance, d, can be about 6 mm or between about 4 mm and about 8 mm in some implementations. Comparing this to the clasp 6030, the indication of leaflet insertion can be divided into 3 categories, combining the no leaflet insertion indicator with the under-insertion indicator because there may not be sufficient signal differentiation between no leaflet insertion and under insertion of leaflet with the clasp 6230.

[0415] In some implementations, a machine learning or other algorithm can be implemented that automatically determines the tissue or leaflet state based on the bioimpedance signals from the electrodes. For example, an algorithm can be implemented in conjunction with the clasp 6030 that interprets signals consistent with the signals 6101 of Figure 61B as corresponding to no tissue/leaflet in the clasp, interprets signals consistent with the signals 6102 of Figure 61B as corresponding to full tissue/leaflet insertion, and interprets signals consistent with the signals 6103 of Figure 61B as corresponding to over insertion of the tissue/leaflet. The algorithm can also be used to generate an indicator for a user. For example, Figure 62D illustrates a delivery system 6206 (similar to the delivery systems 102, 202 described herein) can include an indicator panel 6207 on a proximal end of the delivery system 6206. The indicator panel 6207 includes light or other indicators indicating no leaflet in the clasp, full leaflet capture, and over insertion of the leaflet. The user can visually check the indicator panel 6207 to determine the leaflet status without relying solely on echo imaging or other imaging techniques.

[0416] Figures 63A and 63B illustrate an example device 6300 with tissue engagement portions or clasps 6330 each having a first electrode 6340 positioned on a first surface and/or first arm 6332 and a second electrode 6345 positioned on a second surface and/or second arm 6334 of the tissue engagement portions or clasps 6330. The device 6300 can be the same as or similar to the devices 100, 200, 300, 8200, 8810, 40256, 5200 described herein. In addition, the tissue engagement portions or clasps 6330 can be the same as or similar to the clasps 130, 230, 330, 40856, 5030a, 5030b, 5030c (or other tissue engagement portions) described herein and share many of the same components e.g., arms 6332, 6334, means for securing 6336, and joint portion 6338), properties, and functionality.

[0417] In the illustrated example of the tissue engagement portions or clasps 6330, there are two opposing electrodes 6340, 6345 coupled respectively to the first surface or first arm 6332 and to the second surface or second arm 6334 (or, in examples without a second arm, to another portion of the device). Thus, the electrodes 6340, 6345 provide bioimpedance signals corresponding to different sides of a leaflet or other tissue. A benefit of this type of configuration is that the clasp 6330 can be configured to determine a thickness of the tissue between the electrodes 6340, 6345 and to scan the tissue thickness as the tissue passes through the clasp 6330 between the electrodes 6340, 6345. Moreover, this configuration of electrodes 6340, 6345 provides similar benefits to the clasp 5230 in that it can be configured to indicate that there is no leaflet or tissue capture when the clasp 6330 is closed due at least in part to the electrodes 6340, 6345 being shorted, or in contact with each other, resulting in the impedance value being drastically reduced relative to a configuration in which the electrodes 6340, 6345 are apart and/or in contact with tissue.

[0418] In some implementations, the first electrode can be coupled to an arm and the second electrode or opposing electrode can be coupled to another portion of the device {e.g., if no second arm is included).

[0419] By way of example, the opposing electrodes 6340, 6345 can be positioned on each side of the leaflet as it enters the tissue engagement portion or clasp 6330 and can effectively scan the leaflet as it passes over the electrodes 6340, 6345. The signals acquired as the tissue/leaflet passes between the electrodes 6340, 6345 can be used to generate a cross-sectional map of the thickness of the tissue/leaflet. In some implementations, these signals are acquired while the clasp 6330 is partially closed so that the electrodes 6340, 6345 are close to the tissue/leaflet.

[0420] In some implementations, the thickness of the leaflet tissue can be used by an operator to estimate or determine the strength of the leaflet. The thickness and strength of the leaflet can indicate how much tension force can be applied to the leaflet and/or whether the leaflet needs to be fully inserted into the clasp for secure capture. For example, stronger leaflet tissue can withstand higher forces and the barbs of the clasp 6330 can hold well in stronger tissue relative to weaker tissue. Advantageously, this can result in less stenosis and more coaptation.

[0421] Figure 64 illustrates an example device 6400 with tissue engagement portions or clasps 6430 having electrodes 6440, 6445 similar to the device 5100 with tissue engagement portions or clasps 5130 of Figures 53A and 53B. The device 6400 can be the same as or similar to the devices 100, 200, 300, 8200, 8810, 40256, etc. described herein. In addition, the tissue engagement portions or clasps 6430 can be the same as or similar to the clasps 130, 230, 330, 40856, 5030a, 5030b, 5030c (or other tissue engagement portions) described herein and share many of the same components (e.g., arms 6432, 6434, means for securing 6436, and joint portion 6438), properties, and functionality.

[0422] In some implementations of the device 6400, there is an additional reference electrode 6442 implemented on the device 6400. This configuration can provide added sensitivity because the reference electrode 6442 is near the sensing electrodes 6440, 6445. The reference electrode 6442, or a similar reference electrode, can be implemented on any of the devices described herein to provide bipolar measurements of the bioimpedance. Bipolar configurations include measurement configurations where the sensing and reference electrodes are located in the same region, such as the heart. This can be compared to unipolar configurations where a reference electrode is located in a region different from the sensing electrode (e.g., where the sensing electrode is in the heart and the reference electrode is on the skin of the patient).

[0423] Figure 65 illustrates an example of device 200 with the addition of flexible electrodes 6545a- b that protrude away from the device 200. The device 200 is described herein in greater detail with reference to Figures 22-37. The flexible electrodes 6545a-b are configured to measure blood flow and/or to detect leakage through the valve in which the device 200 is implanted. The flexible electrodes 6545a-b deflect as blood flows past them, with the amount of deflection being related to the differential pressure or flow. As the flexible electrodes 6545a-b deflect, the impedance relative to a reference electrode 6542 (e.g., on the actuation element 212) changes which can be used to determine the amount of deflection which in turn can be used to determine relative blood flow adjacent to the device 200. For example, regurgitation blood volume pushes the flexible electrodes 6545a, 6545b towards the atrium and closer to the reference electrode 6542, which causes the impedance to decrease. The amount of deflection (as measured by the change in impedance) can be used as a pressure sensor on either side of the device 200 such that the measurements can be used to determine whether there is a regurgitant volume adjacent to the device 200.

[0424] This is advantageous because a typical method for quantifying leaks in percutaneous procedures is through echo-based imaging. However, if there is not an echo of sufficient quality, it can be difficult to determine whether there is a leak after deploying the device 200. Many things may affect the quality of echo imaging including but not limited to the metal in the devices causing shadowing or ringing. Accordingly, bioimpedance measurements can be advantageous to provide an additional or alternative method for determining or monitoring leakage through the valve.

[0425] In some implementations, the device 200 can include flexible electrodes in addition to the flexible electrodes 6545a-b that are spread around the device 200 to monitor for leaks. The flexible electrodes 6545a-b can have a predetermined size and weight so that the force on the flexible electrodes 6545a-b can be determined based on the deflection of the electrodes 6545a, 6545b. [0426] The amount of deflection can be determined using the bioimpedance measurements as described herein due at least in part to the flexible electrodes 6545a, 6545b acting similar to springs where force is proportional to 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 regurgitant volume can also be calculated based on the size of the orifice (e.g., determined in echo).

[0427] In some implementations, forces on the device/implant can be determined using bioimpedance measurements. For example, the frame of the device can act as a spring. Prior to deployment and/or implantation, forces can be applied to the device and the deflection can be measured to determine the response of the device to known forces. In addition, impedance measurements can be made with the device deflected known amounts. Thus, a measured impedance can be related to a force on the device through the relationship of the opening distance of the device and measured impedance. The impedance value at baseline can be used to calibrate to the patient when the clasp is closed and then the change in baseline can be measured after the device is released to calculate the forces during systole and diastole. This measurement can be used for validation and testing during design and manufacturing or during deployment with forces indicating if there is a higher likelihood of single leaflet device attachment (SLDA). Moreover, the electrodes on the device can act as an implantable sensor that monitors forces during the life of the implant. Measurements can also be taken to determine the tension of the leaflet pulling the closed implant open. Such measurements can be used to predict leaflet damage or the risk of SLDA if the tension is sufficiently high. In addition, these measurements can correlate to stenosis, higher pressure gradients, and/or slippage of the leaflet during the implant closing as more tension is applied. Such measurements can also provide an indication of whether the device fully closes.

[0428] In addition, in some implementations where forces are measured on either side of the implant, asymmetries can indicate asymmetrical tension on the leaflet, indicating that the delivery device is possibly warping the leaflets and when the device/implant is released the clinical results of the therapy could potentially change. Asymmetrical forces can be undesirable because it can cause changes in coaptation or other characteristics of the implanted device when the device is released from the delivery system. Symmetrical forces are desirable to reduce or eliminate changes in the performance of the device/implant after being released from the delivery system. Thus, being able to measure and/or monitor forces on the device/implant can be desirable. Example Configurations of Impedance Measurement Systems

[0429] As described herein, configuration and placement of electrodes on a device (e.g., on an anchor, tissue engagement portion, clasp, etc. of a device) can provide a number of different advantages as it applies to bioimpedance-based feedback measurements. However, electrical wiring of sensors and electrodes in a catheter may be difficult due at least in part to the limited space in the catheter. If it is desirable to include multiple sensors or electrodes, typical solutions would require running wiring for each electrode along the length of the catheter. However, the limited inner diameter of the catheter may restrict the number of wires that can be 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 at the device or implant. This would then result in a reduction in the amount of information or the precision of the bioimpedance measurements acquired with the electrodes. Furthermore, increasing the number of electrical leads running to the device greatly complicates manufacturing the device and delivery system.

[0430] Accordingly, Figures 66A and 66B illustrate example electrode arrays that reduce the number of electrical leads required to enable the electrical leads to fit into small-lumen catheters. Figure 66A illustrates an example tissue engagement portion or clasp 6630a, which can be the same as or similar to the clasps 130, 230, 330, 40856, 5030a, 5030b, 5030c (or other tissue engagement portions) described herein, with a series of electrodes 6640a-f coupled to the arms 6632, 6634 of the clasp 6630a with a joint portion 6638 coupling the arms 6632, 6634 to each other. One or more of the electrodes and/or electrode arrays can optionally be implemented on other surfaces and/or portions of a device (e.g., not necessarily arms).

[0431] In some implementations, electrical lead 6646 couples the electrodes 6640a-f in series with one or more electrical components 6643a-e coupled in series between each electrode 6640a-f. In some implementations, the electrical lead 6646 then runs through the delivery device to deliver electrical signals to enable bioimpedance measurements.

[0432] In some implementations, electrodes are coupled in parallel, each electrode having electrical leads that electrically couple the respective electrode to a measurement system at a proximal end of the delivery system. In some implementations, the tissue engagement portion or clasp 6630a includes the electrical lead 6646 with electrical components 6643a-e coupled in series with the electrodes 6640a-f to enable individual measurement of each electrode without requiring electrical leads for each electrode. In some implementations, this is accomplished by using a resistor, capacitor, and/or inductor with a known and fixed value as the electrical component 6643a-e in series between each electrode 6640a-f. By using electrical components with different properties, the impedance measurements from each electrode can be individually determined using the electrical lead 6646. For example, even with the electrodes 6640a-f coupled in series, the measured bioimpedance values can be separated because the current through the electrical lead 6646 is known as well as its frequency. From the impedance measured, it is possible to calculate resistance, capacitance, and/or inductance and subtract the known value of the electrical component that is inserted in series. As a result, it is possible to determine the measured impedance from the electrode as if it were coupled in parallel.

[0433] Figure 66B illustrates an example clasp 6630b with a plurality of electrodes 6640a-f and an analog-to-digital converter (ADC) chip 6643 coupled to each electrode 6640a-f. The ADC chip 6643 is configured to convert the signals from the electrodes 6640a-f into a digital signal that can be sent over the electrical lead 6646 using digital packets, thereby separating out each electrode signal using digital data transfer protocols.

[0434] Figure 67A illustrates an example of a bioimpedance signal 6706 with oscillations corresponding to diastole and systole of the heart. Changes in contact between the electrodes and the tissue arising with fluctuations caused by the beating of the heart may result in an oscillation in the measured bioimpedance signal 6706. A signal processing algorithm can be implemented that uses the oscillations (e.g., the peak-to-peak amplitude of the bioimpedance signal) and the mean value of the bioimpedance signal to determine a tissue state relative to a clasp or anchor. For example, when there are high peak-to-peak oscillations it can be determined or concluded that there is not ideal contact between the clasp and the tissue. As more tension is applied, the tissue makes better contact with the tissue engagement portion (e.g., anchor, clasp, etc.) and the peak-to-peak oscillations are reduced while the magnitude of the average signal increases. This can be used to generate a binary determination, for example, of no tissue contact in time period 6710, tissue contact during time period 6715, and no tissue contact during time period 6720.

[0435] The bioimpedance concepts described above with respect to tissue capture can also be applied to a variety of medical systems, devices, and procedures. In some implementations, the bioimpedance concepts described herein can also be applied to anchor deployment of anchors of a variety of medical systems and devices in a variety of medical procedures. For example, annuloplasty procedures (e.g., a reduction of the annulus) can benefit from the measurement of bioimpedance signals. In some implementations, indications of anchor placement and/or tissue engagement would be valuable and improve procedures and safety. [0436] In some implementations, as anchors of a transcatheter annuloplasty system/device are implanted at or around an annulus, bioimpedance signals can be monitored to determine the deployment status of each anchor and/or an associated device, such as an annuloplasty implant.

[0437] Figure 67B illustrates an example of a bioimpedance signal as a delivery device implants a tissue anchor (e.g., a helical tissue anchor, a dart-like anchor, a hook-like anchor, etc.) at an annulus of a native valve. The bioimpedance signal indicates contact with tissue (signal portions 6701, 6702), partial and full deployment or insertion in 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 being deployed or inserted in tissue and the process can be repeated for each anchor to be deployed (e.g., 5-25 anchors, 10-20 anchors, 12-17 anchors, etc.) sequentially (or if the anchors are deployed simultaneously, each anchor can be analyzed at the same time). In some implementations, the bioimpedance signal can indicate a situation in which all anchors are electrically shorted together.

[0438] In some implementations, the disclosed medical systems, devices, and procedures utilize one or more anchors (e.g., helical anchors, darts, hooks, clasps, clamps, barbs, arms, etc.). Individual anchors can include one or two, or more than two electrodes. An electrical signal can be provided to the electrodes and one or more electrical sensors can be configured to measure electrical signals, including bioimpedance signals. As an anchor is implanted in tissue, the bioimpedance signal decreases, similar to a short circuit. Ex vivo measurements can be made, and these measurements can be used to determine an anchor depth based on or in response to the electrical signals from the anchors being deployed in vivo. Thus, anchor depth can be determined based on the ex vivo measurements and based on the electrical signals from the anchor as it is being implanted. This is bolstered by the change in impedance as the anchor moves from blood to tissue. Thus, indicators can be determined and provided to a user to indicate when tissue has been contacted and the depth of penetration in tissue of an anchor. Indicators can be configured to indicate anchor deployment status, the anchor deployment status including the anchor in contact with tissue, a partially deployed anchor, and a fully deployed anchor. In some implementations, amplitude modulation can be used when considering the length of DFT wire connecting between anchors as a resistor. This can be used to monitor consecutive anchor deployment.

[0439] In some implementations, an anchor with two electrodes is configured to facilitate monitoring of bioimpedance. This can be done to monitor anchoring of the anchor to indicate a successful and/or complete penetration of the anchor into the tissue. An impedance measurement device (e.g., the impedance measurement device of Figure 68) can be coupled to a proximal end of an anchor drive or anchor driver. The impedance measurement device can be configured to use a bipolar connection in a way that the positive and negative leads are isolated from each other but still located in the same region (e.g., the heart). This configuration can provide added sensitivity because the reference electrode is near the sensing electrode. Advantageously, this reduces noise relative to systems that measure electrical signals through an expanse of tissue (e.g., relative to a unipolar configuration).

Algorithms can be implemented with smart thresholds that can be applied to the electrical signals from the impedance measurement device. The algorithms can generate real time indicators that can be provided to a user to indicate when a catheter or anchor is in contact with the tissue and/or partially or fully deployed in the tissue. It should be noted that the electrical measurements described herein can be unipolar (e.g., with an electrode on the skin or far away from the measurement site) or bipolar (e.g., where a reference electrode is in close proximity to the measurement electrode).

[0440] Figure 68 illustrates an example bioimpedance 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 can include a power supply 6862 and an electrical sensor 6864. The device 6800 can include electrodes 6840 configured to receive electrical power from the power supply 6862. Wiring connects the electrodes 6840, the power supply 6862, and the electrical sensor 6864. The device 6800 can 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, a prosthetic valve, a delivery device, an anchor driver, a chordae repair device, or the like.

[0441] 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.

[0442] The electrical sensor 6864 is configured to measure electrical signals, such as bioimpedance signals, voltage, current, etc. from the electrodes 6840. The electrical sensor 6864 can be configured to measure other electrical properties such as, for example and without limitation, resistance, inductance, capacitance, voltage, current, components of impedance, and the like. The bioimpedance measurements (as well as resistance, inductance, capacitance, voltage, and/or current readings) acquired by the electrical sensor 6864 can be different based on the anatomy or anatomies that the indicator electrodes 6840 are near or in contact with. Thus, the electrical characteristics measured by the electrical sensor 6864, in particular the bioimpedance signals, can be used to determine the relative locations of a clasp, anchor, other device components, etc. and anatomy (e.g., tissue, etc.) that the device is in contact with, as described herein. For example, the value of the bioimpedance signal and/or changes in bioimpedance can signal that the electrodes are in blood, contacting tissue (e.g., leaflets), differentiating tissue (e.g., leaflet tissue versus chord tissue), transitioning from being primarily in contact with blood to being partially or primarily in contact with tissue, and/or transitioning from being partially or primarily in contact with tissue to being primarily in contact with blood.

[0443] The power supply 6862 and the electrical sensor 6864 can be separate devices or combined in a single device. The power supply 6862 can be configured to provide alternating current to the device 6800. The electrical sensor 6864 can take a variety of different forms, including an impedance meter. By controlling the alternating current and measuring the voltage, the impedance can be calculated. The impedance can be used to determine the position of the electrodes with respect to targeted tissue (e.g., an annulus of a valve, a leaflet, etc.). The impedance measurement device 6860 can implement any of the algorithms described herein to indicate a status of the device 6800 or component thereof (e.g., clasps or anchors) that can include, full capture of a leaflet, under capture of a leaflet, over capture of a leaflet, a relative position of a leaflet in the clasp, a status of the clasp (e.g., open, closed, etc.), status of an anchor (e.g., partially deployed, fully deployed, in contact with tissue, etc.), or any combination of these and the like. The algorithms can include machine learning algorithms such as neural networks, decision tree algorithms, random forest algorithms, threshold-based algorithms, and the like. Thus, the impedance measurement device 6860 can include one or more processors and non-volatile memory configured to store and to execute the one or more algorithms to determine targeted quantities based at least in part on the measurements provided by the electrical sensor 6864. In some implementations, the derived indicators from the impedance measurement device 6860 can be displayed or otherwise provided to a user or a partially- or fully-automated system to provide bioimpedance-based feedback for medical procedures.

Removing Impedance Measurement Sensors from Device

[0444] As described herein, it is advantageous to use bioimpedance-based feedback in medical procedures, such as implanting a device in a valve. The bioimpedance-based feedback can be used to determine leaflet insertion, for example. To do so, in some implementations, electrodes or sensors are coupled to devices (e.g., anchors, tissue engagement portions, clasps, etc. of the devices) disclosed herein with electrical leads leading from the electrodes to a proximal end of the delivery system to enable acquisition and measurement of bioimpedance signals. However, it can also be desirable to disconnect the electrodes from the electrical leads or to remove the electrodes (or sensors) and electrical leads after implantation of the device (e.g., so electrical wires are not active in the implant after the procedure). Accordingly, disclosed herein are methods and devices to facilitate removal and disconnection of electrical leads from electrodes on the device. In addition, disclosed herein are methods and devices to remove electrodes or sensors from the device after it has been implanted. In addition, disclosed herein are methods and devices that enable connection of a sensing unit (e.g., flexible PCB, which can comprise the electrode(s) and/or other sensor(s) of various examples described herein) to the device such that it can be removed easily in a transcatheter procedure from the proximal side of the delivery system (e.g., a catheter).

[0445] The use of PCBs (including flexible PCBs) as a part of the sensing unit is advantageous because it allows detailed designs in both the shape and the number of electrodes. A PCB can comprise an array of electrodes which further enables the acquisition of many bioimpedance measurements. With a larger amount of measurements and data, machine learning and other such algorithms can be used that provide more useful and accurate indicators associated with the implantation process (e.g., leaflet capture, leak detection, force monitoring, etc.). In some implementations, the non-conductive portions of the PCB can be configured to enable the removal of the PCB as part of the implantation process. This can be advantageous as well because there are challenges associated with making flexible PCBs biocompatible, meaning that it may be undesirable to leave flexible PCBs in a patient as part of the device.

[0446] As used herein, reference to a PCB or flexible PCB can be understood to refer generally to a sensing unit. While the examples of a sensing unit as shown and described herein often focus on the example of a flexible PCB, other arrangements, configurations, arrays, sensors, electrodes, wires, leads, lines, etc. can be used and/or connected in similar ways, even if a PCB is not itself used (i.e., while a PCB is advantageous, the concepts herein do not require a PCB, even if PCBs are used as an example in various examples herein).

[0447] Figures 69-74 illustrate a variety of configurations of connecting a flexible PCB, electrode, electrode array, sensor, etc. to a device that allow for easy removal of the flexible PCB, electrode, electrode array, sensor, etc. Figure 69 illustrates a portion of an example flexible PCB 6900 with a stress concentration point 6902 in the flexible PCB 6900. A suture 6910 can be looped over the stress concentration point 6902 to secure the flexible PCB 6900 to a device (such as the devices 100, 200 described herein). The stress concentration point 6902 is configured so that a relatively small, applied force will cause the stress concentration point 6902 to tear. With the stress concentration point 6902 torn, the flexible PCB 6900 can be removed because the suture 6910 is no longer securing the PCB to the device although the suture 6910 remains secured to the device.

[0448] Figure 70 illustrates a portion of a flexible PCB 7000 with a Y-shaped protrusion 7002 extending from one end of the flexible PCB 7000. The protrusion 7002 includes legs 7004 with a rotation cutout 7006 configured to enable the legs 7004 to rotate toward one another when a force is applied to the legs 7004. A suture 7010 is looped over a bridge portion 7008 of the protrusion 7002 to secure the flexible PCB 7000 to a device. When the flexible PCB 7000 is pulled in the direction of the arrow 7011, the protrusion 7002 moves down toward the suture 7010. With the application of sufficient force, the legs 7004 rotate toward one another to allow the flexible PCB 7000 to be detached from the device while the suture 7010 remains attached to the device. The wider portion 7001 of the flexible PCB 7000 makes it so only a force in the direction indicated by the arrow 7011 will cause the suture 7010 to pass over the protrusion 7002 to free the flexible PCB 7000 from the device.

[0449] Figure 71 illustrates a portion of a flexible PCB 7100 with a round protrusion 7102 extending from a body 7101 of the flexible PCB 7100. A suture 7110 is looped over a neck portion 7104 of the round protrusion 7102 to secure the flexible PCB 7100 to a device. The round protrusion 7102 can be configured to fold or wrap over a side of a device (e.g., around a side of a clasp 130, 230). By pulling away from the device (e.g., out of the plane of the figure), the round protrusion 7102 allows the suture 7110 to pass over the rounded portion to free the flexible PCB 7100 from the device while allowing the suture 7110 to remain affixed to the device.

[0450] Figure 72 illustrates a portion of a flexible PCB 7200 with side indents 7202 to facilitate securing the suture 7210 over the flexible PCB 7200 and to the device to secure the flexible PCB 7200 to the device. The side indents 7202 are configured to provide a positive lock in a targeted location of the flexible PCB 7200 so that the suture 7210 does not interfere with measurements by electrodes incorporated into the flexible PCB 7200. The size and configuration of the side indents 7202 affects the amount of force required to pull the flexible PCB 7200 out from under the suture 7210. Pulling parallel to the length of the flexible PCB 7200 causes the flexible PCB 7200 to pass under the suture 7210 so that it can be removed while allowing the suture 7210 to remain affixed to the device.

[0451] Figure 73 illustrates a portion of a flexible PCB 7300 forming a hole 7302 (e.g., a circular hole) with a relief 7303. The flexible PCB 7300 can be secured to the device using one or more sutures 7310a, 7310b. The relief 7303 is cut through the end of the flexible PCB 7300 so that the sutures 7310a, 7310b can exit the hole 7302 when a force is applied to pull the flexible PCB 7300 away from the end with the hole 7302. In some implementations, the relief 7303 passes only partially from the hole 7302 to the end of the flexible PCB 7300. The length of this bridge can be configured to tailor the force required to remove the flexible PCB 7300 from the device.

[0452] Figure 74 illustrates a portion of a flexible PCB 7400 that forms a pair of bi-directional tongues 7402a, 7402b. 6. The bi-directional tongues 7402a, 7402b form tabs that allow sutures 7410a, 7410b to pass under to secure the flexible PCB 7400 to a device. This configuration facilitates assembly of the device with the flexible PCB 7400 because the sutures 7410a, 7410b can be implemented in the fabric implant cover and then the flexible PCB 7400 can be added with the sutures 7410a, 7410b being woven through the tongue flaps of the bi-directional tongues 7402a, 7402b to lock the flexible PCB 7400 to the device. In some implementations, the depth of the tongue flaps affects the force required to pull the PCB out. It should be noted that for each of the flexible PCBs described herein with reference to Figures 69-74, the flexible PCB can be attached over a cover of the device (e.g., the sutures attach to the cover) or under a cover of the device (e.g., the sutures attach to the frame). However, a cover is not required in any implementation, and the flexible PCB can be attached to the device in a variety of ways.

[0453] Figures 75A, 75B, and 75C illustrate a PCB 7500 that is configured to be pulled through the barbs 236 of the device 200 (or any other device described herein, such as the device 100) to remove the PCB 7500 from the device 200. The PCB 7500 is a flexible PCB and includes an electrode pad or electrode array 7501 comprising one or more electrodes at a distal end of the PCB 7500. The PCB 7500 includes leads 7502 extending proximally from the electrode pad/array 7501. The PCB 7500 can also include a reference electrode 7504. The leads 7502 are configured to extend from the electrode pad/array 7501 to a proximal end of the delivery system 202.

[0454] In some implementations, the PCB 7500 is secured to the tissue engagement portion or clasp 230, either to the frame of the clasp 230 or to the cover 240 covering the tissue engagement portion or clasp 230. When installed on the device 200, the leads 7502 can extend between (or around) optional friction enhancing elements or barbs 236 of the tissue engaging element or clasp 230. Pulling on a proximal end of the leads 7502 causes the electrode pad/array 7501 to pass between the friction enhancing elements or barbs 236 before entering a lumen of the delivery system 202 to be removed from the patient as part of the process of implanting the device 200. [0455] In some implementations, the space between barbs 236 is about 0.8 mm and for an electrode pad/array 7501 that is about 1 mm wide, it requires a force of around 1 N to remove the PCB 7500 from the device 200. For an electrode pad/array 7501 that is about 1.5 mm wide, a force of around 1.5 N is required to remove the PCB 7500 from the device 200.

[0456] Figures 75A-75C illustrate an example of routing the leads 7502 through the barbs 236 but it should be noted that the leads 7502 can be routed differently than illustrated. The leads 7502 can be routed out of the clasp 230 at any point. For example, the leads 7502 can be routed out of the side of the clasp 230 near optional friction enhancing elements or barbs 236 (similar to what is illustrated in Figures 76B and 76C). In some implementations, the leads 7502 can be routed out of the side of the tissue engagement portion or clasp 230 at some point along a first arm or a movable arm 234, e.g., at or near a joint portion 238, at or near a connection point between a movable arm and another portion of the device, e.g., a fixed arm, a paddle, a coaptation element, etc. In some implementations, the leads 7502 can be routed out of the side of the tissue engagement portion or clasp at some point along a second arm or a fixed arm 232 (or if no first arm or fixed arm is used, a corresponding portion of the device).

[0457] In some implementations, the leads 7502 can be routed around the first arm or movable arm 234 (and/or around an optional fixed arm 232 if a fixed arm is included in the device, or around another component) to a side opposite the grasping side {e.g., a non-grasping side or a side opposite the side that includes the barbs 236). This can include routing the leads 7502 through a cloth or cover if the clasp 230 includes a cover.

[0458] In some implementations, the leads 7502 can be routed to avoid interacting with tissue captured, gripped, contacted, or clasped by the friction enhancing elements or barbs 236. This can be advantageous to avoid interfering with capturing of tissue by the clasp 230. In some implementations, an opening can be maintained in the clasp 230 to facilitate removal of the leads 7502.

[0459] Figures 76A, 76B, and 76C illustrate an implementation of PCB 7600 that is configured to be pulled and exit through a side of an example tissue engagement portion or clasp 230, around the barbs 236 of the device 200 (or any other device described herein, such as the device 100) to remove the PCB 7600 from the device 200. The PCB 7600 is a flexible PCB and includes an electrode pad or electrode array 7601 comprising one or more electrodes at a distal end of the PCB 7600. In some implementations, the electrode pad/array 7601 is offset laterally relative to leads 7602 extending proximally from the electrode pad/array 7601. In some implementations, the PCB 7600 can also include a reference electrode 7604.

[0460] In some implementations, the leads 7602 are configured to extend from the electrode pad/array 7601 with a change in direction to a proximal end of the delivery system 202. In some implementations, the change in direction is configured to cause a pulling force on the leads 7602 to cause the electrode pad/array 7601 to exit the clasp by going around the barbs 236, using the barbs 236 as a fulcrum.

[0461] In some implementations, the PCB 7600 is secured to the tissue engagement portion or clasp 230, either to the frame of the clasp 230 or to the cover 240 covering the clasp 230. In some implementations, when installed on the device 200, the leads 7602 extend around friction enhancing elements or barbs 236 of the clasp 230. Pulling on a proximal end of the leads 7602 causes the electrode pad/array 7601 to pass around the friction enhancing elements or barbs 236 before entering a lumen of the delivery system 202 to be removed from the patient as part of the process of implanting the device 200. The PCB 7600 can be configured to exit the clasp 230 at or near a first arm 234 (e.g., a moveable arm), at or near a second arm 232 (e.g., a fixed arm, a paddle, etc.), at or near the joint portion 238, and/or at or near friction enhancing elements or barbs 236.

[0462] Figures 77A, 77B, and 77C illustrates an example of PCB 7700 that is configured to be split apart when pulled so that half exits through one side of the clasp 230 and the other half exits through the other side of the clasp 230, each half exiting the clasp around the friction enhancing elements or barbs 236 of the device 200 (or any other device described herein, such as the device 100) to remove the PCB 7700 from the device 200. In some implementations, the PCB 7700 is a flexible PCB and includes an electrode pad or electrode array 7701 comprising one or more electrodes at a distal end of the PCB 7700, the electrode pad or array 7701 configured to split apart responsive to a sufficient force being applied to it. In some implementations, the PCB 7700 and/or the electrode pad/array 7701 has a relief cut through it so that it splits apart at the relief cut responsive to a sufficient force being applied to the PCB 7700 and/or electrode pad/array 7701.

[0463] In some implementations, the PCB 7700 includes a pair of leads 7702 that each extend proximally from a respective portion or half of the electrode pad/array 7701. In some implementations, the PCB 7700 can also include a reference electrode 7704 for each lead 7702. In some implementations, the leads 7702 are configured to extend from the electrode pad/array 7701 to a proximal end of the delivery system 202.

[0464] In some implementations, there is a change in direction in each lead 7702 that is configured to cause the PCB 7700 and/or the electrode pad/array 7701 to split apart responsive to a pulling force on the leads 7702. In some implementations, once split apart, each portion or half of the electrode pad/array 7701 exits its respective side of the clasp 230 by going around the friction enhancing elements or barbs 236, using the friction enhancing elements or barbs 236 as a fulcrum. In some implementations, the PCB 7700 is secured to the clasp 230, e.g., to the frame of the clasp 230 or to an optional cover 240 covering the clasp 230. When installed on the device 200, the leads 7702 extend around the friction enhancing elements or barbs 236 of the tissue engagement portion or clasp 230. Pulling on a proximal end of the leads 7702 causes the electrode pad/array 7701 to split apart and to pass around the friction enhancing elements or barbs 236 before entering a lumen of the delivery system 202 to be removed from the patient as part of the process of implanting the device 200. The PCB 7700 can be configured to exit the clasp 230 at or near a first arm 234 [e.g., a moveable arm), at or near a second arm 232 (e.g., a fixed arm, a paddle, etc.), at or near the joint portion 238, and/or at or near friction enhancing elements or barbs 236.

[0465] Figure 78 illustrates an electrode 7800 that is removable from a device 200. The electrode 7800 is coupled to wires 7805 extending from the electrode 7800 towards the actuation element 212. The electrode 7800 comprises a flexible PCB or a flexible electrode releasably secured to the tissue engagement portion or clasp 230. The wires 7805 extend from the electrode 7800 to a collar 7803. In some implementations, the collar 7803 is coupled to the actuation element 212 so that the collar 7803 rotates in response to rotation of the actuation element 212. In some implementations, the collar 7803 is configured to secure the wires 7805 and to secure electrical leads 7802 that extend to the proximal end of a delivery system (such as the delivery systems 102, 202), the electrical leads 7802 electrically coupled to the wires 7805.

[0466] In some implementations, the electrode 7800 is configured to be removed responsive to rotation of the actuation element 212 during implant disconnection. Rotation of the actuation element 212 causes the collar 7803 to rotate which pulls the wires 7805 coupled to the electrode 7800 which in turn pulls the electrode 7800 off of the clasp 230. Continued rotation of the actuation element 212 causes the electrodes 7800 and wires 7805 to wrap around the actuation element 212, in preparation for removal. [0467] In some implementations, after the device 200 is closed, rotation of the actuation element 212 pulls the electrodes 7800 out of the clasps 230 without removing the leaflets and wraps the electrodes 7800 and wires 7805 around the actuation element 212. That is, in some implementations, the actuation element 212 acts as a spool wrapping the excess wire and electrodes up around it, gradually and gently pulling them out from the device 200. The whole wrap is then pulled out from the patient, leaving no electrode or wire in the patient. The wires 7805 and electrical leads 7802 can be secured to the collar 7803 using an adhesive. In some implementations, the wires 7805 and electrical leads 7802 are directly affixed to the actuation mechanism 212 (e.g., using an adhesive) without the use of the collar 7803.

[0468] Advantageously, this configuration is transparent to the user because the release of the device remains unchanged. That is, there are no additional steps to remove the electrode 7800 from the device 200 because closing the device 200 with the actuation element 212 is sufficient to remove the electrode 7800 and wires 7805. The force multiplier of the knob of the delivery system 202 to unscrew the actuation element 212 is already built in so no added knob or other such mechanism is required to remove the electrodes 7800. This means there is no added complexity for the user or during manufacturing and assembly from that perspective. Furthermore, if the force required to pull the electrodes 7800 out of the device 200 is somewhat large, the user will not feel it because the knob would apply a gradual, controlled force.

Detaching electrical connection from impedance measurement sensors

[0469] In some implementations, the electrodes are not removed from the device after implanting the device. However, it is sb'll necessary to provide an electrical path from the electrodes to the proximal end of the delivery device to provide bioimpedance-based feedback to the user (e.g., regarding leaflet capture). Accordingly, disclosed herein are methods and devices for releasably coupling electrical leads to an electrode coupled to a device, such as the devices 100, 200, 300, 8200, 8810, 40256, etc. described herein.

[0470] Figures 79A and 79B illustrate example spring pin electrical connectors 7902 configured to extend to a distal end of the delivery system 202 to provide electrical connecbon with wires 7901 of an electrode 7900 coupled to the device 200. The spring pin electrical connectors 7902 are configured to contact an electrical pad 7903 that is electrically coupled to the wires 7901 of the electrode 7900 when the device 200 is coupled to the delivery system 202 during implanting. Upon removing the device 200 from the delivery system 202, the spring pin electrical connectors 7902 move away from the electrical pad 7903, severing the electrical connection with the electrode 7900. The delivery device 202 is then removed along with the spring pin electrical connectors 7902 and associated wires 7904.

[0471] The spring pin electrical connectors 7902 are configured to use spring forces parallel to the shaft of the delivery system 202 to provide good electrical contact between wires 7901 (and electrical pad 7903) and the spring pin electrical connectors 7902. The spring pin electrical connectors 7902 are also easily removed as there is no physical coupling that secures the spring pin electrical connectors 7902 to the device 200 or to the wires 7901. The spring force of the spring pin electrical connectors 7902 is configured to assist in detaching the spring pin electrical connectors 7902 from the device 200, making sure there is a complete release of the device 200 from the delivery system 202. In some implementations, the spring pin electrical connectors 7902 are part of the device, replacing the electrical pad 7903. In some implementations, the distal end of the delivery system 202 includes electrical pads to interface with the spring pin electrical connectors of the device 200, essentially reversing the roles illustrated in Figures 79A and 79B.

[0472] Figures 80A and 80B illustrate using radial forces via fingers 8007 of the delivery system 202 to couple the wires 8004 coming from the delivery system 202 to electrical leads 8001 coupled to an electrode (not shown) of the device 200. Figure 80A shows the fingers 8007 as transparent to show the electrical connection between the wires 8004 to the electrical leads 8001, whereas Figure 80B shows the fingers 8007 as opaque. The delivery system 202 includes a proximal component or collar 211 with grooves 8008 that are configured to mate with the fingers 8007 of the delivery system 202. In some implementations, the wires 8004 are coupled to the fingers 8007 and the electrical leads 8001 are secured in individual grooves 8008 such that when the fingers 8007 mate with the grooves 8008, the wires 8004 contact the electrical leads 8001 to form an electrical connection between the wires 8004 (that extend from the device 200 to the proximal end of the delivery system 202) and the electrical leads 8001 (that extend from an electrode or PCB coupled to the clasp 230 of the device 200 to the proximal collar 211). In some implementations, both the inner side of the fingers 8007 and the grooves 8008 are coated with an insulative material to electrically isolate each measurement channel.

[0473] Advantageously, this method for electrically coupling the wires 8004 with the electrical leads 8001 is transparent to the user. The normal implant release procedure is not changed. Additionally, the electrical connection is maintained until the implant is released enabling leaflet indication until the end of the implant procedure. [0474] Figures 81A and 81B illustrate the use of a tube 8105 to enable releasable electrical contact between wires 8104 and electrical leads 8101. The tube 8105 can be secured at a distal end of the delivery system 202 using any suitable mechanism, such as a frame that holds the tube 8105 in a targeted location, the frame being a U-shaped frame that friction fits at the attachment portion 205 of the device 200 (e.g., near the proximal component or collar 211). The frame can include holes for the actuation element 212 and fingers of the delivery system 202. The frame can be made of a polymer to electrically isolate the wires 8104 from each other and to provide electrical isolation for each measurement channel (e.g., each connection between a wire 8104 and an electrical lead 8101). The frame can include a tube 8105 for each measurement channel.

[0475] When attaching the device 200 to the delivery system 202, the electrical leads 8101 can be inserted into the tubes 8105 along with the wires 8104, an electrical lead and a wire forming a measurement channel in a respective tube 8105. In some implementations, the tube 8105 can include a leaf spring 8103 to provide a clamping force on the wire 8104 and electrical lead 8101 to ensure a good electrical connection. Removal of the device 200 from the delivery system 202 causes the electrical leads 8101 to pull out from the tubes 8105.

[0476] Figures 82A and 82B illustrate a coil crimp 8202 configured to provide releasable electrical contact between wires 8204 and electrical leads 8201. The wires 8204 are configured to run from a proximal end of the delivery system 202 to a distal end to electrically couple with the electrical leads 8201, the electrical leads 8201 electrically coupled to an electrode as described herein. The wires 8204 terminate with a coil crimp 8202 that is configured to couple with the electrical leads 8201 due to a friction fit.

[0477] The coil crimp 8202 can be formed from a distal portion of the wires 8204. The coil crimp 8202 can be wrapped with different pitches and different diameters to create more or less holding force on the inserted electrical lead 8201. In some implementations, the coil crimp 8202 can be made with a shape memory alloy, such as nitinol, in a martensite state (e.g., at 37 deg. C) so that it switches to austenite when heated and expands slightly. The expansion is configured to release the electrical lead 8201. Expansion can be triggered by applying a targeted current through the wire 8204 to release the electrical lead 8201.

[0478] In some implementations, the coil crimp 8202 can be formed by wrapping the distal end of the wire 8204 around a mandrel that is slightly smaller than the electrical lead 8201 to achieve a friction fit with the electrical lead 8201. The friction fit is configured to maintain the electrical connection between the wire 8204 and the electrical lead 8201 until the coil crimp 8202 is caused to expand to release the electrical lead 8201. Once expanded, the wire 8204 can be withdrawn into the delivery system 202 to terminate the electrical and physical coupling of the coil crimp 8202 with the electrical lead 8201.

[0479] Figures 83A and 83B illustrate a coil connection socket 8302 configured to provide releasable electrical contact between wires 8304 and electrical leads 8301. The wires 8304 are configured to run from a proximal end of the delivery system 202 to a distal end to electrically couple with the electrical leads 8301, the electrical leads 8301 electrically coupled to an electrode as described herein. In some implementations, the wires 8304 terminate with a coil connection socket 8302 that is configured to couple with the electrical leads 8301 due to a friction fit, similar to the coil crimp 8202 described herein with reference to Figures 82A and 82B. A difference with the coil connection socket 8302 is that a distal portion 8303 of the coil is bent up so that the electrical lead 8301 is inserted at the bent location of the distal portion 8303 to increase the friction force on the electrical lead 8301 to increase the strength of the connection between the wire 8304 and the electrical lead 8301. For example, the spring constant of the coil determines the force applied to the electrical lead 8301 when a few coils are bent out of the way and the electrical lead 8301 is inserted and the bent part of distal portion 8303 of the coils are released and snap back in place.

[0480] The coil connection socket 8302 can be formed from a distal portion of the wires 8304. The coil connection socket 8302 can be wrapped with different pitches and different diameters to create more or less holding force on the inserted electrical lead 8301. In some implementations, the coil connection socket 8302 can be made with a shape memory alloy, such as nitinol, in a martensite state (e.g., at 37 deg. C) so that it switches to austenite when heated and expands slightly. The expansion is configured to release the electrical lead 8301. Expansion can be triggered by applying a targeted current through the wire 8304 to release the electrical lead 8301.

[0481] The coil connection socket 8302 can be formed by wrapping the distal end of the wire 8304 around a mandrel that is slightly smaller than the electrical lead 8301 to achieve a friction fit with the electrical lead 8301. The distal portion 8303 of the coil can be bent up to increase the friction fit. The friction fit is configured to maintain the electrical connection between the wire 8304 and the electrical lead 8301 until the coil connection socket 8302 is caused to expand to release the electrical lead 8301. Once expanded, the wire 8304 can be withdrawn into the delivery system 202 to terminate the electrical and physical coupling of the coil connection socket 8302 with the electrical lead 8301.

[0482] Figures 84A, 84B, 84C, and 84D illustrate an example disc crimp 8402 configured to provide releasable electrical connection between wires 8404 and electrical leads 8401. The wires 8404 are configured to run from a proximal end of the delivery system 202 to a distal end to electrically couple with the electrical leads 8401, the electrical leads 8401 electrically coupled to an electrode as described herein. In some implementations, the disc crimp 8402 provides slots 8406 which enable a wire 8404 to electrically couple to an electrical lead 8401 through physical contact. The slots 8406 are sized such that the wire and the electrical lead 8401 are pushed together in the slot 8406 to maintain physical contact with one another.

[0483] In some implementations, the disc crimp 8402 comprises disc halves 8405a, 8405b. While the fingers 8407 of the capture mechanism 213 are engaged with the device 200, the fingers 8407 hold the disc halves 8405a, 8405b together so the disc crimp 8402 can hold the wires 8404 and the electrical leads 8401 together. In some implementations, each disc half 8405a, 8405b is secured to a corresponding finger 8407 of the capture mechanism 213. When the fingers 8407 are closed, the slots are configured to electrically connect wires 8404 and electrical leads 8401. When the fingers 8407 open to release the device 200, the disc halves 8405a, 8405b separate, thereby allowing the wires 8404 to disconnect from the electrical leads 8401.

[0484] In some implementations, the disc halves 8405a, 8405b can be made of a polymer to be electrically insulative, as described herein. The disc halves 8405a, 8405b can be secured to the fingers 8407 using any suitable means, such as adhesives. In some implementations, windows can be cut into the fingers 8407 and portions of the disc halves 8405a, 8405b can be inserted through the windows to form a friction fit or the portions of the disc halves 8405a, 8405b can be otherwise affixed to the fingers 8407 using the windows, such as by melting into the window to create a rivet or snap-like connection. In some implementations, the disc halves 8405a, 8405b can be a shape set alloy and welded onto the fingers 8407 with electrically insulative coating on the inside holes where the wires 8404 and electrical leads 8401 are crimped. The force of the fingers 8407 locked around the device 200 to provide the crimp force between the disc halves 8405a, 8405b to close the connection between the wires 8404 and the electrical leads 8401. [0485] Advantageously, the disc crimp 8402 makes the disconnection of the wires 8404 and the electrical leads 8401 transparent to the user because there is no additional action to be taken to release the electrical connection. There is also little or minimal risk of accidentally or prematurely releasing the wires to terminate the electrical connection before the device 200 is ready because the electrical connection is maintained until the device 200 is released.

[0486] Figures 85A, 85B, 85C, 85D, 85E, and 85F illustrate examples of heat-activated electrical connectors 8503 to provide releasable electrical connections between wires 8504 and electrical leads 8501. The wires 8504 are configured to run from a proximal end of the delivery system 202 to a distal end to electrically couple with the electrical leads 8501, the electrical leads 8501 electrically coupled to an electrode as described herein. In some implementations, the heat-activated electrical connectors 8503 are configured to change shape with the application of heat or current to change shape. In some implementations, the change in shape releases the wires 8504 and the electrical leads 8501 to disconnect the electrical connection. In some implementations, heating the heat-activated electrical connectors 8503 transiently causes the connector to open to release the electrical leads 8501 to enable release of the device 200 from the delivery system 202 via the capture mechanism 213.

[0487] The heat-activated electrical connectors 8503 can be made of a shape set alloy, such as Nitinol, which is heat set to open upon being heated above its transition temperature. The transition temperature can be configured to be higher than body temperature (e.g., about 50°C). Until heating, the heat-activated electrical connectors 8503 serve as a crimp that connects the wire 8504 of the delivery system 202 to the electrical lead 8501 of the device 200 (e.g., the heat-activated electrical connector 8503 is wrapped around both).

[0488] In some implementations, when it is desired to release the wire 8504 and the electrical lead 8501, (e.g., just before mechanically releasing the device 200), the heat-acbvated electrical connector 8503 is heated, causing it to transiently open. The heat-activated electrical connectors 8503 can be fixedly attached to the device 200 or to the delivery system 202, so as to not embolize. Heating can be achieved by introducing heated saline or by applying a current via the wire of the delivery system 202 (e.g., the wire via which electrical signals were previously being received).

[0489] Figure 85C illustrates an example heat-activated electrical connector 8503a that comprises a

Nitinol laser-cut tube or sheet that is shape-set to have an open orifice. The Nitinol is heat-treated following the shape-setting procedure to have a 50C Af transition temperature, meaning the part is in a soft martensitic phase in room and body temperatures. The wire 8504 and the electrical lead 8501 are inserted into the heat-activated electrical connector 8503a and crimped inside it. Crimping is possible because the heat-activated electrical connector 8503a is in its soft martensitic phase. When the release of the wire 8504 and the electrical lead 8501 is desired, the heat-activated electrical connector 8503a is heated by saline or an electrical current. As a result of the heating the part momentarily transitions to austenite and recovers to its original shape with an open orifice. Following the recovery of the heat- activated electrical connector 8503a the wire 8504 and the electrical lead 8501 are free to be removed.

[0490] Figure 85D illustrates an example heat-activated electrical connector 8503b that is similar to the heat-acbvated electrical connector 8503a except that the shape is flat in its martensitic phase and a cylinder in its austenite phase. The open crimp of the cylinder allows the wire 8504 and the electrical lead 8501 to be removed.

[0491] Figures 85E and 85F illustrate an example heat-activated electrical connector 8503c that is configured to shape-set ends of the wire 8504 and the electrical lead 8501 so that they hook one another. The heat-activated electrical connector 8503c comprises a wire assembly that has two sections that are crimped to each other by a stainless-steel laser cut crimp. The proximal wire section of the electrical lead 8501 can be a low Af wire, e.g., 10C meaning that it is flexible at body temperature, and the distal wire section of the electrical lead 8501 can be a high Af wire, e.g., 50C meaning that it is soft at body temperature. Similarly, the proximal wire section of the wire 8504 can be a low Af wire, e.g., 10C meaning that it is flexible at body temperature, and the distal wire section of the wire 8504 can be a high Af wire, e.g., 50C meaning that it is soft at body temperature. The soft section is shape set in a straight geometry. The soft sections are looped around each other to form a connection feature. To release the wires, electrical current is introduced and heats the distal section for a split second. As a result of the heat the wire loops straighten, and the wires can be removed or disconnected. In some implementations, hot saline can be used to straighten the wires.

[0492] In some implementations, a sensing unit (e.g., flexible PCB) is configured such that a portion of the sensing unit is removable from an implantable device, such as a valve repair device or a replacement valve, while a portion of the flexible PCB is left with the implantable device. The implantable device can be any of the implantable devices shown and/or described herein. Figure 87 illustrates an example of a method 8700 for removing a portion of a sensing unit from an implantable device. [0493] In some implementations, the method 8700 includes providing a sensing unit (e.g., flexible PCB) 8702 having one or more electrodes. The electrodes can take a variety of different forms. For example, the electrodes can be configured to sense one or more of contact, resistance, capacitance, inductance, voltage, current, pressure, and/or bioimpedance and/or sense a biological characteristic of blood and/or biological tissue. A flexible PCB can be provided 8702, such as by anchoring the flexible PCB to the device in order to fixate its position. One or more stresses are applied 8704, 8706 to a portion of a flexible PCB proximate its distal end having the one or more electrodes.

[0494] In some implementations, an optional heat stress can be applied 8704 near the distal end to weaken and/or plasticize that portion of flexible PCB. The heat stress can be applied in a variety of different ways. In some implementations, the heat stress can be applied via electrical traces of one or more layers of the flexible PCB. The traces can be configured to provide a high electrical resistance at an area proximate the portion of the flexible PCB to be separated (e.g., the interface between a removable portion and an implantable portion of flexible PCB 8702).

[0495] In some implementations, when electric power is applied to the portions of the traces with high electrical resistance, these portions heat up to weaken and/or plasticize the adjacent portions of the flexible PCB. The traces can be configured in a variety of different ways to increase resistance. For example, the traces can be narrow, thin, and/or configured with a long and/or tortuous path.

[0496] Still referring to Figure 87, in some implementations, a mechanical stress can be applied in the form of, for example, a pulling (or other) force to cause separation 8708 of the flexible PCB in a stressed area (e.g., an area where heat stress was applied). This separation frees a portion of the flexible PCB from its fixation with the implantable device and allows a portion of the flexible PCB to be withdrawn from the implanted medical device.

[0497] In some implementations, a mechanical stress can be applied to one or more structurally weakened portion(s) of the flexible PCB to tear or break away portion(s) of the flexible PCB allowing withdrawal without applying a heat stress to the weakened portion(s).

[0498] In some implementations, the structurally weakened portions can take a variety of different forms. For example, the structurally weakened portions can include portions of flexible PCB having fewer material layers than other portions of the flexible PCB and/or stress concentration openings. In this manner, portion(s) of flexible PCB can be freed from the fixed, remaining portion, and withdrawn from the implanted device. [0499] Figures 88A-91I illustrate examples of flexible PCB configurations that allow a portion or all of the flexible PCB to be removed from the device.

[0500] Figures 88A-88B illustrate an example of a flexible PCB 8870 having an implantable portion 8876 that stays with the implanted device and a removable portion 8872 that is removed after the device is implanted. The flexible PCB illustrated by Figures 88A and 88B allows for the flexible PCB to relay signals to apparatus outside the patient's body while the device is being implanted. The flexible PCB can then be split into separate parts, one distal (e.g., implantable portion 8876) that will remain in the implant and one proximal (e.g., removable portion 8872) that will be removed. The implantable portion 8876 can include a variety of different components, such as sensor(s), electrode(s), traces electrically connect the components, etc.

[0501] In some implementations, the removable portion 8872 can be elongated to extend from the device, through a catheter, and outside a patient's body and can include traces that allow for communication between the implantable portion 8876 in a heart and sensing apparatus disposed outside a patient's body. In some implementations the removable portion 8872 can be retracted back into the delivery catheter shaft and the implantable portion 8876 can remain with the implantable medical device.

[0502] In the example illustrated by Figures 88A and 88B, a sensing unit (e.g., flexible PCB) 8870 has a removable portion 8872, a stress disconnection portion 8874, and an implantable portion 8876. As shown in the figures, the removable portion 8872 includes, for example, electrical trace(s) 8878 leading or connecting to one or more high electrical resistance portions 8880. As will be described in more detail, an electrical current is provided through trace(s) 8878 to one or more high resistance portions 8880 to generate heat, which can assist in separating the flexible PCB 8870 into parts.

[0503] The exact location and arrangement of one or more high electrical resistance portions 8880 is not critical so long as the heat generated thereby can be used to assist in the disconnection or separation process. Thus, one or more high electrical resistance portions 8880 can be located in the removable portion 8872, stress disconnection portion 8874, implantable portion 8876, or any other suitable location.

[0504] Implantable portion 8876 includes, for example, electrical traces 8882 and 8884, which connect to electrodes 8886 and 8888 and/or other electrical sensing features or components (e.g., contact, resistance, capacitance, inductance, voltage, current, and/or pressure sensors and the like). As previously described herein, electrodes 8886 and 8888 can be used for bioimpedance and other signal gathering and analysis purposes.

[0505] In the implementation shown, the electrical traces 8882 and 8884 extend from the removable portion 8872, through the stress disconnection portion 8874, and to the implantable portion 8876. The implantable portion 8876 can also include a fixation portion 8898, which can be of any arrangement suitable to fixate, hold, or positionally maintain the flexible PCB and/or the implantable portion 8876. In the implementation shown, the fixation portion 8898 can be an aperture or opening in implantable portion 8876 that receives a pin, suture, or similar structure that can be part of or connected to the implantable device.

[0506] The stress disconnection portion 8874 includes, for example, one or more stress concentration portions 8890. The one or more stress concentration portions 8890 provide structurally weakened areas of the PCB 8870 where imparted stresses can allow the flexible PCB to break or tear away.

[0507] In the implementation shown in Fig. 88A, the one or more stress concentration portions 8890 include openings or perforations 8892, 8894, and 8896 that at least partly to wholly extend through the flexible PCB body. The openings or perforations 8892, 8894, and 8896 can be of any shape, number or arrangement. Their exact configuration is not critical so long as they provide a stress concentration area that concentrates the force/stress to allow the flexible PCB to break or tear away at the stress disconnection portion 8874 (e.g., see Fig. 88B illustrating a break or tear away of removable portion 8872 from implantable portion 8876).

[0508] In the example illustrated by Figures 88A and 88B, the flexible PCB be arranged as a multilayer flexible PCB body. For example, the trace(s) 8878 and the one or more high electrical resistance portions 8880 can be formed on a different substrate surface/layer from that of electrical traces 8882 and 8884 and electrodes 8886 and 8888. In this manner, the respective electrical traces do not interfere with each other electrically and mechanically.

[0509] In some implementations, the trace(s) 8878 and the one or more high electrical resistance portions 8880 are formed in/on an inner layer/surface of the PCB whereas the electrical traces 8882 and 8884 and electrodes 8886 and 8888 are formed on an outer layer/surface of a substrate. Other configurations are also possible. [0510] In operation, after implantation of the device, the flexible PCB 8870 is arranged as shown in Fig. 88A. In that state, an electrical current can be applied to the optional one or more high electrical resistance portions 8880, which generate heat in the stress disconnection portion 8874. This reduces the amount of mechanical force needed to accomplish the separation.

[0511] In one implementation, the application of electrical current is small and quick (e.g., less than 1 sec., less than 14 sec., less than % sec., or less than 0.1 sec.) yet enough to generate the required amount of heat. The exact amount electrical current is not critical so long as the heat weakens the flexible PCB. The required amount of heat is generally one that is enough to plasticize the polyimide material (or other material) in stress disconnection portion 8874.

[0512] In some implementations, a mechanical pulling force can be imparted on the flexible PCB while the stress disconnection portion 8874 is heated. The exact amount of pulling force is not critical so long as it is enough to cause a break, tear, or separation. The combination of heat stress and mechanical stress in the stress concentration portions 8890, while flexible PCB is held in place via fixation portion 8898, causes the flexible PCB 8870 to break or tear away such that removable portion 8872 separates from implantable portion 8876, as shown in Fig. 88B.

[0513] The removable portion 8872 is then withdrawn or removed while implantable portion 8876 remains with the implantable medical device. In this manner, a process and method is provided that allows for removal of the flexible PCB by separating the removable portion 8872 from the implantable portion 8876.

[0514] Referring now to figures 89A, 89B, and 89C, an example sensing unit (e.g., flexible PCB) 8900 is illustrated that provides separation of a flexible PCB removable portion 8902 from the implantable portion 8906. In some implementations, the flexible PCB 8900 includes a stress concentration portion in the form of a weakened neck region.

[0515] In some implementations, the flexible PCB 8900 includes, for example, the removable portion 8902, a stress disconnect portion 8904, and an implantable portion 8906. The stress disconnect portion 8904 includes a neck portion 8908 that is not as wide (as shown in Figure 89A) and/or as thick (as shown in Figure 89B) as removable portion 8902 and/or the implantable portion 8906.

[0516] In some implementations, the neck portion 8908 can differ in either width or thickness from the removable portion 8902 and/or the implantable portion 8906. This variance in width and/or thickness creates a stress concentration area in the region of neck portion 8908. In some implementations, and as shown in Fig. 89A, stress concentration openings or perforations 8910 and 8911 can be included to further structurally weaken the area, if desired.

[0517] Referring now to Figure 89C, a cross-sectional layer view of the flexible PCB 8900 is provided. In some implementations, the flexible PCB 8900 includes a plurality of layers or substrates including polyimide layers 8914, 8915, 8920, and 8922 and copper (or other conductor) trace layer 8918 (for forming the electrical traces and/or electrodes). In some implementations, the removable portion 8902 and implantable portion 8906 can include all of the aforementioned layers while the stress disconnect portion 8904 and the neck portion 8908 can include less layers.

[0518] In this example, the neck portion 8908 does not include the polyamide layers 8914 and 8922. The absence of these layers structurally weakens the stress disconnect portion 8904 by concentrating any imparted forces in the remaining layers, which can be weaker than the polyamide layers.

[0519] The size and/or dimensions of the stress disconnect portion 8904 are not critical so long as they are configured to weaken the area so that the stress disconnection portion breaks, tears, or separates with the designed amount of imparted (pulling or other) force. While Figure 89C illustrates one example of a layer structure, other configurations are also possible. This includes, for example, stress disconnect portions having an alternating layer structure that includes portions where all layers are present followed by portions where one or more layers are not present. Thus, by varying the dimensions and/or geometry, the stress disconnect portion 8904 can be tuned to break, tear, or separate based on the amount of force desired and structural integrity needed to accomplish implantation of the medical device.

[0520] In operation, after implantation of the device, the flexible PCB is arranged as shown in Figs. 89A-89C. A mechanical force (e.g., pulling) can be imparted on the flexible PCB 8900. The exact amount of pulling force is not critical so long as it is enough to cause a break, tear, or separation in stress disconnect portion 8904 while implantable portion 8906 is in held in place by the fixation portion 8898.

[0521] The removable portion 8902 is then withdrawn or removed while implantable portion 8906 remains with the implantable medical device. In this manner, a method is provided that allows for removal of the flexible PCB 8900 by separating the removable portion 8902 from the implantable portion

8906. [0522] Figures 90A and 90B illustrate an example of a sensing unit (e.g., flexible PCB) 9000. In some implementations, the flexible PCB 9000 is configured to allow removal of the flexible PCB from the device, including the portion that includes one or more electrode, sensor (e.g., electrical sensor, pressure sensor, etc.).

[0523] In some implementations, the flexible PCB 9000 includes an elongated communication portion 9002, a sensing portion 9006, and a stress disconnect portion 9004. In this implementation, is disposed at the distal end of the flexible PCB body, (i.e., the stress disconnect portion 9004 is not located between elongated communication portion 9002 and the sensing portion 9006 as in previous examples).

[0524] In some implementations, the sensing portion 9006 includes electrodes 8886, 8888 and/or other electrical sensing features or components (e.g., contact, resistance, capacitance, inductance, voltage, current, and/or pressure sensors and the like). As previously described herein, electrodes 8886 and 8888 can be used for bioimpedance and other signal gathering and analysis purposes. In some implementation, a portion of electrical traces 9008 and 9012 can be included in the sensing portion.

[0525] In some implementations, the stress disconnect portion 9004 includes high resistance portions 9010 and 9014 respectively, which are connected to electrical traces 9008 and 9012. In some implementations, a portion of electrical traces 9008 and 9012 are included in the stress disconnect portion. As shown, the high resistance portions 9010 and 9014 are located on opposite sides of a disconnect region 9016. In some implementations, disconnect region 9016 includes, for example, stress concentration openings or perforations 9018, 9020, and 9022 and partial openings or perforations 9028. The high resistance portions 9010, 9014 and/or stress concentration openings or perforations 9018, 9020, 9022 function as previously described to weaken the stress disconnect portion 9004 and the disconnect region 9016 to allow it to break, tear or separate upon application of stress(es) and/or force(s).

[0526] As also described previously, the electrical traces 9008 and 9012 and high resistance portions 9010 and 9012 can be used to generate heat to further weaken the stress disconnect portion 9004 and the disconnect region 9016 by softening and/or plasticizing the polyimide or other material layers that form the region. While two high resistance portions are shown, in other examples more or less than two can be used so long as they provide the amount of heat stress needed to plasticize or weaken the material in stress disconnect portion 9004. [0527] In some implementations, the flexible PCB 9000 includes fixation portion 9024. The fixation portion 9024 can fixate the flexible PCB 9000 during implantation via use of a pin 9026, loop, suture, or other fixating device. As previously described, the pin 9026 can be, for example, part of or fixated to the implantable medical device.

[0528] In this implementation, the fixation portion 9024 and the pin 9026 are positioned proximal to the distal end of the flexible PCB and between electrodes 8886, 8888 (or other sensor, sensing component, etc.) and the stress disconnect portion 9004. This arrangement/positioning allows the pin 9026 to counteract the pulling force during removal of the flexible PCB and to thereby break, tear, or separate the stress disconnect portion 9004 (see Fig. 90B) allowing complete removal of the flexible PCB 9000.

[0529] In operation, after implantation of the medical device, the flexible PCB 9000 is arranged as shown in Fig. 90A. In that state, an electrical current is optionally applied to the one or more high electrical resistance portions 9010 and/or 9014, which generate heat in stress disconnection portion 9004. This heat reduces the amount of mechanical force needed to accomplish the separation.

[0530] In one implementation, the application of electrical current is small and quick (e.g., less than 1 sec., less than 1 sec., less than % sec., or less than .1 sec.) yet enough to generate the required amount of heat to assist separation. The exact amount electrical current is not critical so long as the required amount of heat to assist separation is generated. The required amount of heat is generally one that is enough to plasticize or soften the polyimide material (or other material) in stress disconnect portion 9004.

[0531] In some implementations, a mechanical force (pulling) is imparted on the flexible PCB. In some implementations, the mechanical force is imparted while the stress disconnection portion 9004 is heated. The exact amount of pulling force is not critical so long as it is enough to cause a break, tear, or separation. The combination of heat stress and mechanical stress in the stress disconnect portion 9004 weakens the flexible PCB in that area so that pin 9026 is able to break, tear or separate stress disconnect portion 9004 as shown in Fig. 90B.

[0532] Stress disconnect portion 9004 effectively separates or splits into two or more parts allowing release of the pin 9026, which allows the flexible PCB 9000 to be withdrawn from the implanted medical device. In this manner, a method is provided that allows for removal of the flexible PCB 9000 without any component thereof remaining with the implanted medical device. [0533] With any of the aforementioned examples, features can be combined. For example, heat stress can be added to PCB 8900 in a manner similar that of PCBs 8870 and 9000. Further, structurally weakened areas can be added to PCBs 8870 and 9000 in a manner similar to PCB 8900. Thus, these examples are not limited to the implementations disclosed herein.

[0534] Figures 91A-91I illustrate an example of an assembly 9100 of a flexible PCB 9102 and a fixation device 9108 that provides a removable connection to an implantable device 8200, such as any of the valve repair devices or a replacement valve disclosed herein.

[0535] Figures 91A and 91B show perspective views of the assembly 9100 having the sensing unit (e.g., flexible PCB) 9102 with a body 9104 that includes a fixation portion 9106. The assembly 9100 also includes a fixation device 9108 having a body that includes a holding portion 9110. The holding portion 9110 can be, for example, a loop portion 9112 that is threaded through the fixation portion 9106.

[0536] The fixation device 9108 provides for fixating and accurately positioning the flex PCB 9102 inside a device (e.g., device 8200) during implantation and then provides for releasing of the flex PCB 9102 for removal from the implanted device.

[0537] In one example, the fixation device 9108 comprises a tube, wire (e.g., Nitinol wire), rod, etc. that is looped through a hole through the fixation portion 9106 located at the distal end of flex PCB body 9104. This arrangement acts to prevent flex PCB 9102 from unthreading (or removing) itself from a threading window(s) or apertures in the clasp member(s) of the medical device through which the flex PCB 9102 is routed to be placed at its fixation position.

[0538] After implantation of the device (e.g., device 8200), the fixation device 9108 is pulled (via a pulling force) to unloop itself by pulling the loop portion 9112 through the hole in the fixation portion 9106. In some implementations, the wire (e.g., a nitinol wire) is shape set in a loop arrangement, but also the ability to flex upon an imparted force to allow unlooping. This unlooping releases fixation device 9108 from the flex PCB 9102 and allows for withdrawal of the unfixated flex PCB 9102 from the implanted medical device.

[0539] Figures 91C and 91D illustrate an example of an implantable device (e.g., device 8200) having the assembly 9100 disposed therein. Although shown with implantable device 8200, the implantable device can be any of the valve repair devices disclosed herein and/or can have any combination of the features of any of the valve repair devices disclosed herein or can be a replacement valve. [0540] The valve repair device 8200 illustrated by Figures 91C and 91D shares features with the valve repair device illustrated by Figures 50A-50C. The description and illustrations of the features of the valve repair device of Figures 50A-50C that are shared with the valve repair device illustrated by Figures 91C and 91D apply equally to the valve repair device illustrated by Figures 91C and 91D and are not repeated here.

[0541] Figure 91E is a magnified view of the cross-sectional area Figure 91E shown in Figure 91D; Figure 91H is a magnified view of the cross-sectional area of Figure 91G. As shown in Figures 91E and 91H, the body 9104 of the flexible PCB is threaded through a window or opening 9114 in a paddle 9116 (the paddle can be any of the paddles disclosed herein) of the device 8200 (e.g., analogous to threading a belt through a buckle). While only one opening 9114 is shown, the body 9104 of the flexible PCB can be threaded through more than one window or opening in the paddle 9116 (e.g., see window or opening 9122 in Fig. 91F) or other component(s) of the device 8200.

[0542] The fixation device 9108, by virtue of its connection to flex PCB body 9104 through the fixation portion 9106, fixates the flex PCB body 9104 in position and prevents its accidental withdrawal through the opening 9114 in the paddle 9116. As previously described, after implantation of the device 8200, the fixation device 9108 can be pulled by a pulling force acting thereon to unloop the loop portion 9112. This releases or unlocks the fixation device 9108 from the flex PCB body 9104 and thus releases the flex PCB 9102. The flex PCB 9102 can then also be pulled or withdrawn (e.g., unbuckled) from the implanted device.

[0543] Figure 91G is a side view of an example of a device 8200 having the flex PCB 9102 and the fixation device 9108 with some components removed . In some implementations, guides 9118 and 9120 can also be provided through which the fixation device 9108 can be threaded or received. In one implementation, the guides 9118 and/or 9120 can be provided on either and/or both sides of the distal end of the flex PCB body 9104. The guides prevent or inhibit the pulling force applied to the fixation device 9108 from being transferred to the distal end of the flex PCB body.

[0544] In some implementations, the guides 9118 and 9120 can be arranged as risers or an extension of paddle 9116 or clasp that have openings or through holes for receiving portions of fixation device 9108. The guides 9118 and/or 9120 can also be provided via an inner paddle stiffening member (e.g., 232) of the device that extends through one or more of the threading windows of the paddle 9116. [0545] The shape and arrangement of guides 9118 and/or 9120 are not critical so long as they at least partly provide for guiding the fixation device, positioning the flex PCB, and/or inhibiting pulling of the flex PCB body 9104 with the fixation device 9108. In Figure 91G, the guides are shown on only one side of the medical device for illustration only and can be provided on both sides of the device as well or can be omitted from each side.

[0546] Figures 91G (with additional guides shown on one side), 91H, and 911 are additional views of the device illustrated by Figure 91F but with some components removed to more clearly show the arrangement of flex PCB 9102 and fixation device 9108 within medical device 8200. Figure 91H is a magnified view of portion 91H identified in Figure 91G.

[0547] Figures 91H and 91G show the implementation within the device 8200 that includes an optional mechanical leaflet depth indicator 9124 thus providing the device with both mechanical and electrical (via flex PCB) sensing capabilities. Published Patent Cooperation Treaty application WO 2023/004098 shows and describes the mechanical leaflet depth indicator 9124 shown in Figures 91C- 91H of the present application and discloses other mechanical leaflet depth indicators that can be used in place of the leaflet depth indicator 9124.

[0548] Published Patent Cooperation Treaty application WO 2020/168081 also discloses other mechanical leaflet depth indicators that can be used in place of the leaflet depth indicator 9124. Any of the mechanical leaflet depth indicators shown and described by Published Patent Cooperation Treaty applications WO 2023/004098 and WO 2020/168081 can be used as the leaflet depth indicator 9124. Published Patent Cooperation Treaty applications WO 2023/004098 and WO 2020/168081 are incorporated herein by reference in their entireties. Figure 911 is similar to Figure 91G except that the optional mechanical leaflet depth indicator 9124 is not included in the device 8200.

[0549] Figures 91J-91O illustrate an example of a device 8200 that includes a fixation mechanism(s) 9126 and 9118 for securing a flexible printed circuit board (PCB) 9104 within the implant. The flexible PCB can be used to electronically sense the leaflet capture position and other relevant data during the procedure. In some implementations, the fixation arrangement includes a fixation device 9108, such as a nitinol wire or similar shape-memory alloy, which is used to fixate and position the flexible PCB 9104 inside the implant.

[0550] The fixation mechanism(s) 9126 and 9118 are configured to interact and/or attach to the implant device's internal structure such as, for example, paddle 9116, to securely hold the fixating device (e.g., nitinol wire) 9108 and/or flexible PCB 9104. The fixation mechanism(s) can inhibit the fixation device (e.g., nitinol wire) from being able to freely move inside of the implant while fixating the flexible PCB and inhibit the flexible PCB from excessively moving inside the implant. In some implementations, when retracting the fixation device (e.g., nitinol wire), the mechanism(s) inhibit the fixation device from folding or bending the flexible PCB ends/edges, which can affect the amount of retraction force necessary to remove the flexible PCB from the implant at the end of the procedure.

[0551] In some implementations, fixation mechanism(s) are positioned and anchored to the internal structure of the implant device to maintain positional reliability of the flexible PCB and to allow for controlled or guided movement (e.g., retraction) of the fixation device at the end of the procedure. Hence, the fixation mechanism(s) 9126 and/or 9118 (collectively or independently) inhibit excessive movement within the implant, ensuring stable fixation of the flexible PCB and minimize folding or bending the flexible PCB ends/edges during fixation device retraction.

[0552] Referring now to FIG. 91K, in one implementation, fixation mechanism/guide 9126 comprises a beam clip assembly secured to paddle 9116. In some implementations, at least two fixation mechanisms 9126 are provided: one for each paddle/clasp structure. In some implementations, one or more fixation mechanisms 9126 can be provided instead. In the implementation shown, a second optional fixation mechanism/guide 9118, which can be a wire holder element, is also provided and secured to paddle 9116. In some implementations, an end or fixation portion 9106 of flex PCB body 9104 is positioned between mechanism(s) 9126 and 9118. In some implementations, fixation device 9108 (e.g., nitinol wire) is passed through apertures or openings in mechanism(s) 9126 and 9118 and fixation portion 9106 to thereby securely position flex PCB body 9104 in the manner described above for minimizing movement thereof within the implant.

[0553] Fixation mechanisms 9126 and 9118 are secured, connected, or attached to the implant (e.g., device 8200 in FIG. 91J) by any suitable means including snap-fit, interference fit, adhesive, welding, fasteners, etc. In some implementations, fixation mechanisms 9126 and 9118 are connected to the inner portions of paddle 9116 by clipping, snap-fit, or interference fit. Portions of paddle 9116 can include windows or openings 9130, 9132, and 9134 that are sized to accommodate attachment portions (e.g., clips and/or cantilevered lug portions) of fixation mechanisms 9126 and 9118.

[0554] In some implementations, optional attachment elements, such as bands 9136 and 9138 can be provided to assist in securing flex PCB body 9104 to fixation mechanism 9126 and ensure flex PCB body 9104 is flat and follows the geometry of fixation mechanism 9126 base surface(s). Optional bands 9136 and 9138 can be in the form of, for example, elastic bands, sutures, cloth, polymers, tubing, etc. In one example, bands 9136 and 9138 can be made from Dyneema® material, which is an ultra-high molecular weight polyethylene (UHMWPE) fiber material. In practice, bands 9136 and 9138 can be positioned on fixation mechanism 9126 as shown, followed by threading of flex PCB body 9104 between the bands and fixation mechanism, followed by clipping or securing of fixation mechanism 9126 to paddle 9116. However, the components can be assembled in any order.

[0555] In this manner and as shown in FIG. 91K, fixation mechanism 9126 acts as a base for flex PCB body 9104. This allows for the inclined or angled base surfaces 9162, 9164, 9166 and/or 9168 (e.g., see FIG. 91M) to facilitate a smooth flex PCB retraction or removal from the implant device. This arrangement provides flex PCB body 9104 with a good fixation so that it does not move (excessively) during signal acquisition and leaflet capture.

[0556] Referring now to FIGS. 91L and 910, perspective and side views of one implementation of fixation mechanism 9126 are illustrated. Fixation mechanism 9126 includes, for example, a body 9140 having cantilevered lug portions 9142 and 9144. In some implementations, cantilevered lug portions 9142 and 9144 include extension portions 9146 and 9150 and hook portions 9148 and 9152, respectively. Cantilevered lug portions 9142 and 9144 can be positioned anywhere on body 9140. In the implementation shown, they are positioned at the distal end portions of body 9140. Nevertheless, other locations include positions inwards therefrom. The exact position of cantilevered lug portions 9142 and 9144 are not critical. Also, the exact physical arrangement of cantilevered lug portions 9142 and 9144 is not critical so long as a clip, snap-fit, interference fit, or other connection arrangement is provided allowing body 9140 to be connected to the implant device.

[0557] Body 9140 further includes recesses 9154, 9156, 9158 and 9160. In one implementation, these recesses can be grooves, channels, bores or other similar structures. The exact size, shape and position of the recesses is not critical so long as they allow, for example, bands 9136 and 9138 to be recessed so that body 9140 can make stable contact with paddle 9116 structure when connected thereto (e.g., see FIG. 91K). In some implementations, the location of one or more recesses (e.g., recesses 9154 and 9160) are associated with inclined or angled base surfaces 9162 and 9166.

[0558] The flex PCB body 9104 can flatly press against and follow the contour of the base surfaces 9162-9166 (and optionally surface 9168). As previously described, this positioning of flex PCB body 9104 facilitates placement of its sensor(s) in the proper position/location for sensing leaflet capture and other data. Specifically, this arrangement allows for placement of one or more sensor portions of flex PCB body 9104 to be flatly positioned on any of the one or more inclined or angled base surfaces to better and more reliably facilitate sensing of leaflet position and/or capture and other data. Further, when the sensor portion of flex PCB body 9104 is positioned on base surface 9164, the inclined or angled nature of base surfaces 9162 and 9166 allow bands 9136 and 9138 to be below the sensing (e.g., electrode(s)) plane 9137 of flex PCB body 9104. Hence, each of the base surfaces 9162-9168 are angled with respect to each other, as shown.

[0559] In some implementations, curved or arched base surfaces can also be used. For example, base surface 9162 can be curved or arched instead of flat and still achieve the same arrangement. Also, one or both of base surfaces 9166 and 9168 can also be curved or arched (even continuously) instead of flat and stil I achieve the same general arrangement. Hence, base surfaces can have many shapes and/or contours while still providing the same features and benefits described herein.

[0560] Body 9140 further includes guide portion 9170, which can be integral with body 9140 or a separate component affixed thereto and includes a fixation aperture 9176. As shown, guide portion 9170 protrudes, extends above, or adds to the height of cantilevered lug portion 9142 so that cantilevered lug portion 9142 extends higher or above cantilevered lug portion 9144. As shown in e.g., FIG. 91K and 910, this allows fixation device 9108 (e.g., a nitinol wire) to pass above body 9140 and through extended cantilevered lug portion 9142.

[0561] As previously described, body 9140 is affixed to paddle 9116 according to any number of ways and structures. In the implementation shown, cantilevered lug portions 9142 and 9144 are used to clip or snap-fit body 9140 to paddle 9116 structure though openings 9130 and 9134 in paddle 9116 (e.g., see FIG. 91K). Cantilevered lug portions 9142 and 9144 further include recessed portions 9172 and 9174 below hook portions 9148 and 9152, respectively. This combination of structures allows cantilevered lug portions 9142 and 9144 to be inserted and then retained within openings 9130 and 9132 to thereby also retain or affix body 9140 to paddle 9116.

[0562] Body 9140 can be made of any suitable material including metal such as nitinol, stainless steel, etc. Furthermore, in some implementations, portions of body 9140 can flex or bend and return to their original shape. This includes one or more part of cantilevered lug portions 9142 and 9144 (e.g., such as during clipping to paddle 9116). This can also include portion(s) of body 9140 between the cantilevers, which bending or flexing can be further facilitated by recess 9158 provided in body 9140 with a thinner body portion in that region.

[0563] Figure 91N shows a perspective view of second fixation mechanism/guide 9118. As previously described fixation mechanism 9118 can be a separate element or integrated into body 9140. In some implementations, fixation mechanism can optionally be used with fixation mechanism 9126. Fixation mechanism 9118 provides a further stabilizing element for fixation device 9108 (e.g., nitinol wire) (e.g., see FIG. 910). In either implementation, fixation mechanism 9118 is arranged to connect to an internal structure of the implantable device 8200 such as, for example, a portion of paddle 9116. This connection can be made according to any of the previously described ways including clipping, snap-fit or interference fit. Fixation mechanism 9118 can be made from any of the previously described materials for fixation mechanism 9126.

[0564] As shown in Figure 91N, fixation mechanism 9118 includes a body 9178 having cantilevered lug portions 9180 and 9182, which are spaced apart. Cantilevered lug portion 9180 includes extension portion 9190 and hook portion 9192; cantilevered lug portion 9182 includes extension portion 9194 and hook portion 9196. These cantilevered lug portions are arranged and operate in the same manner as cantilevered lug portions 9142 and 9144 previously described to connect fixation mechanism 9118 to, for example, paddle 9116. This connection between the fixation mechanism 9118 and the paddle 9116 is further facilitated by extensions 9184 and 9186, which also contact portions of paddle 9116 when attached thereto to provide a secure attachment. The attachment is made via opening 9134 in, for example, paddle 9116. Opening 9134 is sized to accommodate a snug fit that allows cantilevered lug portions 9180 and 9182 to be inserted consistent with a clipping, snap-fit or interference fit arrangement.

[0565] In some implementations, body 9178 further includes a central guide portion 9188 having fixation aperture 9198 for receiving fixation device 9108 (e.g., a nitinol wire) therethrough. When connected to paddle 9116, central guide portion 9188 extends above the plane thereof (e.g., see FIG. 91K) so that fixation device 9108 (e.g., nitinol wire) can extend in a substantially straight manner through the apertures in first fixation mechanism 9126, flex PCB body 9104, and second fixation mechanism 9118 (e.g., see FIG. 910).

[0566] Referring now to FIG. 910, a perspective view of the fixating arrangement and flex PCB body 9104 is shown isolated from the implantable device to which it is attached. The arrangement includes

- Ill - fixation mechanisms 9126 and 9118 positioned with fixation portion 9106 of flex PCB body 9104 therebetween. Fixation device 9108 (e.g., a nitinol wire) extends through openings or apertures (9176, 8898, and 9198) in first fixation mechanism 9126, fixation portion 9106 of the flex PCB body 9106, and second fixation mechanism 9118. In some implementation, all three opening or apertures 9176, 8898, and 9198 are on a common axis and/or concentric with each other to allow fixation device 9108 (e.g., a nitinol wire) to pass through to thereby fixate flex PCB body 9104. As shown in Figure 910, movement of the flex PCB body 9104 is inhibited because fixation device 9108 (e.g., nitinol wire) is fixated between two positions. One position is provided by first fixation mechanism 9126 and another is provided by second fixation mechanism 9118. Each position is connected to the implantable device's structure (e.g., paddle 9116).

[0567] In addition to providing fixation, this arrangement of the fixation mechanisms 9126, 9118 provides the benefit of reduced counterforces on flex PCB body 9104 during its withdrawal from the implantable device at the end of the repair procedure. During the withdrawal process, fixation device 9108 (e.g., nitinol wire) is first withdrawn. As the fixation device 9108 is withdrawn, second fixation mechanism 9118 provides a counterforce for unlooping fixation device 9108 (e.g., see FIG 910). Without second fixation mechanism 9118, this counterforce would have to be generated by flex PCB body 9104, which can be folded, bent, or otherwise undesirably deformed thereby hindering removal of flex PCB body 9104.

[0568] Hence, the implantable device structure incorporates an assembly mechanism having a one or two mechanism design. The first beam-type mechanism serves as a base substrate for a flexible printed circuit board (flex PCB), which is fixated to ensure smooth operation and to minimize mechanical stress. The first beam-type mechanism features one or more inclined or angled surfaces that facilitate the retraction of the flex PCB. This design enables the flex PCB to lie flat and conform to the geometry of the beam-type mechanism's surface(s) without any obstructions or interference. Attachment mechanisms or bands can be employed to fixate the flex PCB to the first beam-type mechanism and are positioned such that they remain below the sensing (electrode) plane of the flex PCB. The second beamtype mechanism can provide additional support and further reduce movement of the flex PCB.

[0569] When the assembly is arranged on the implantable device structure, the fixation openings in each component (first mechanism and flex PCB, and optionally the second mechanism) are concentrically aligned. A fixation device, such as a nitinol wire, can threaded through all fixation openings to provide a secure and reliable fixation arrangement. In some implementations with a two component design, the arrangement of fixation between two fixating apertures effectively converts the fixation device or wire into a positioning pin, ensuring precise alignment and preventing any unwanted movement or dislocation or operation. Additionally, this design provides a benefit during fixation device removal, as the second distal (wire) holder mechanism acts as a counterforce against the pulling action instead of the flex PCB.

[0570] The examples of Figures 91A-91O provide systems and methods for fixating a flex PCB inside an implantable medical device and for removal of the flexible PCB once the device has been implanted. The arrangement includes threading the flex PCB through one or more windows of the paddle and attaching a releasable fixating device through the distal end of the flex PCB. In some implementations, the fixating device prevents the flex PCB from withdrawing from the paddle member of the device. The fixating device can include a holding portion, which can be a loop of wire (e.g., steel, aluminum, Nitinol or similar materials), that acts as a stop if the flex PCB begins to withdraw or unbuckle from the paddle of the device.

[0571] After implantation of the medical device, the flex PCB can be released by pulling the fixating device, which frees it from the flex PCB. In the case of the fixating device having a loop holding portion, the pulling action can unloop the loop and free the fixating device from the flex PCB. The flex PCB can then be pulled or withdrawn from the medical device.

[0572] In some implementations, one or more electrodes or contacts are enlarged. The size of the electrodes or contacts can be enlarged in a variety of different ways. The measurement of electrical signals, such as voltage, current, resistance, capacitance, inductance, bioimpedance, etc. signals associated with tissue, such as heart valve leaflet tissue, chordae tendinea, etc., can require tissue contact with one or more electrodes or contacts or require the tissue to be in a close proximity with the one or more electrodes. An increase in electrode or contact size provides improved signal reading. However, the catheter lumens through which the electrodes or contacts (and the flexible PCB) must pass through are generally small and limit the overall size of the sensing electrodes.

[0573] The following examples increase the electrode size while still providing for the electrodes and flexible PCB to pass through the small lumen sizes used to implant transcatheter valve repair devices and transcatheter replacement valves. This increased electrode size allows for a larger electrode surface area and accordingly better signal reading. [0574] In the examples that follow, the electrode surface area can increase in any of one or more axis/dimensions. For example, the increase in surface area can be in 1, 2 and/or 3 axis/dimensions. Examples include increased surface areas in the lateral and/or vertical dimensions. Further, some implementations have one electrode shape when operating to sense signals and another shape when being withdrawn with the flexible PCB after implantation of the medical device.

[0575] Referring to Figure 92A, one example of an expanded electrode system 9200a is shown. The expanded electrode system 9200a includes a sensing unit (e.g., flexible PCB) 9202 (as has been described herein through multiple previous examples) having a body that includes one or more electrodes 9204, 9206.

[0576] In the example of Figure 92A, one or more electrode extensions 9208 and 9210 are also provided. The electrode extensions 9208 and 9210 are configured to provide an increased sensing area in 1, 2, and/or 3 dimensions, while still providing for the ability to withdraw the flexible PCB 9202 via a standard catheter lumen. In the example shown, the electrode extensions 9208 and 9210 have a curled or coiled shape that extends beyond flexible PCB 9202 and electrodes 9204 and 9206.

[0577] By extending beyond flexible PCB 9202 and electrodes 9204 and 9206, electrode extensions 9208 and 9210 provide an increased area for signal sensing and reading compared to just the area of electrodes 9204 and 9206. Curling and/or coiling provides for even more of an increase in signal sensing area and reading. In this implementation, electrode extensions 9208 and 9210 provide a 1, 2, or 3 dimensional increase (e.g., lateral, longitudinal, and/or vertical) in the electrode area of flexible PCB 9202.

[0578] In one example, the electrode extensions 9208 and 9210 are initially set to a first shape, which can be curled, coiled, twisted, wavy, undulating, etc. In some implementations, electrode extensions 9208 and 9210 can take a second shape when required for withdrawal of flexible PCB 9202 from a catheter lumen. In the example shown, the second shape can be an uncurled, uncoiled or uncrimped shape 9212 and 9214. This second shape allows for withdrawal of flexible PCB 9202.

[0579] Withdrawal of flexible PCB 9202 through the catheter lumen without having to modify the lumen. In some implementations, the electrode extensions 9208 and 9210 can be a wire material set to a first shape and then pulling the electrode extensions 9208 and 9210 into the catheter lumen changes the electrode extensions 9208 and 9210 to the second shape as flexible PCB 9202 is withdrawn. [0580] A Nitinol wire can provide for shape memory but still contains elasticity to allow it change or modify its shape when so forced (such as, for example, when being withdrawn with flexible PCB 9202 through a small lumen of a catheter). Uncoiled or uncrimped shapes 9212 and 9214 (e.g., second shapes) are shown schematically by dashed lines as being straight in Figure 92A with the understanding that they need not be straight. Uncoiled or uncrimped shapes 9212 and 9214 can be any shape that allows for effective withdrawal of flexible PCB 9202 from the implanted device through the lumen.

[0581] Referring now to Figure 92B, an implementation of an expanded electrode system 9200b is shown. In some implementations, the expanded electrode system 9200b includes an expanded electrode arrangement having an electrode extension 9216 in, for example, at least the z- axis/dimension. In one example, electrode extension 9216 can be one or more wires (or similar structures) connected to one or more electrodes 9204 and 9206.

[0582] The wire can be made of a metal and/or metallic material(s) such as, for example, gold, copper, silver, or other conductive material(s). The size and dimensions of electrode extension 9216 are not critical so long as it provides an increase in sensor area, height, width, length, etc. of the electrode(s) and can be welded or otherwise attached to the electrode(s). In this arrangement, electrode extension 9216 increases the sensor surface area by extending it above the flex plane of the electrodes/flex PCB (e.g., z-axis direction). Also, the system 9200b allows use of materials that do not have to change shape in order to allow withdrawal with the flexible PCB from the implanted medical device.

[0583] Referring to Figure 92C, an example of an expanded electrode system 9200c is illustrated. The expanded electrode system 9200c includes an expanded electrode arrangement having an electrode extension 9218 that extends in at least the z-axis/dimension. In one example, the electrode extension 9218 can be one or more wires (or similar structures) connected to one or more electrodes 9204 and 9206.

[0584] This wire can be a Nitinol wire having a shape that extends in the z-axis direction. This shape can be, for example, a looped or circular shape (as shown in Fig. 92C) or other similar arrangement that is welded or otherwise connected to the sensor electrode(s). This increases the sensor or electrode height and surface area and improves contact with leaflet tissue. The spring or resiliency of electrode extension 9218 allows contact with leaflet tissue even if the leaflet is bouncing, moving or otherwise not steady on the clasp. Further, when made of Nitinol or similar material, the electrode extension 9218 can assume a second shape (as described in connection with expandable electrode system 9200a (Fig. 92A)), for example a straight or substantially straight shape, to allow the flexible PCB and the electrode extension 9218 to be withdrawn from the implanted device.

[0585] Figure 92D illustrates an implementation of an expanded electrode arrangement 9200d having an electrode extension 9220 that can extend in the x-axis/dimension, y-axis/dimension, and z- axis/dimension. In this example, electrode extension 9220 is in a spring or resilient-like arrangement that a shape of a conical spiral and can funebon similarly to that of expanded electrode arrangement or system 9200c (Fig. 92C).

[0586] In any of the aforementioned examples, the spring or resilient-like arrangement can have a shape according to any one or more of the following including, for example, compression springs, leaf springs, spiral springs, disk springs, etc., which then can change to a second shape (as previously described) for withdrawal of the flexible PCB from the implanted medical device. As previously mentioned, the exact shape, materials, and dimensions are not critical so long as one or more of the aforementioned capabilities are provided.

[0587] In some implementations a sensor is configured to sense both contact with native valve tissue, such as leaflet tissue, chordae tendinea tissue, etc., and sense an amount of tension on the native valve tissue. Figures 93A and 93B illustrate an example of a system 9300 having leaflet capture and tension sensing and/or indication.

[0588] Mechanical leaflet capture systems and methods can involve the usage of fluoroscopy in order to visualize or ascertain leaflet capture status. In some implementations, the system 9300 can provide an electrical sensing arrangement for leaflet capture and tension via a variable resistance. The variable resistance is configured to change when a leaflet is captured and tension is applied. This change in resistance indicates capture status and how much tension is being applied to the leaflet. The system 9300 can be used with or without fluoroscopy or other imaging.

[0589] In some implementations, the system 9300 includes a sensing unit 9302 (e.g., flex PCB) 9302 having a potentiometer pad 9304 and electrode pad 9306. Connected between these pads is a sensor device 9308, which can be a conductive wire (e.g., metal wire or suitable conductive flexible material) that is shaped to have a curved or dome-like shape. One end of the sensor device 9308 is connected via weldment 9310 (or similar connection arrangement, such as soldering or with conductive adhesive) to electrode 9306. The other end of sensor device 9308 is arranged to make movable or sliding contact with the potentiometer pad 9304. [0590] The potentiometer pad 9304 is arranged to have a potentiometer area 9316 that provides variable electrical resistance along at least a portion of the body of potentiometer pad 9304. Electrical traces 9312 and 9314 provide pathways for signals indicative of an electrical characteristic of the sensor device 9308. In one implementation, the electrical trace 9312 can be its own signal line or can be connected to one or more other electrodes (e.g., 9204). Similarly, electrical trace 9314 can be its own signal line or can be connected to one or more electrodes (e.g., 9206).

[0591] Referring now to Figures 93C and 93D, the operation of the system 9300 will be described. In Figure 93C, a leaflet 9320 is captured by a movable arm 9318 or capture arm. The movable arm can take a variety of different forms. For example, the movable arm 9318 or capture arm can be the movable arm of any clasp or gripping element disclosed herein. In Figure 93C, the leaflet 9320 is deep enough in the movable arm 9318 to contact the sensor device 9308.

[0592] In some implementations, in response to the contact, the sensor device 9308 can provide an electrical signal that indicates that the native valve leaflet 9320 has been inserted to an acceptable depth. For example, an electrical characteristic (e.g., capacitance, inductance, bioimpedance, etc.) of the sensor device 9308 changes when contacted by the native valve leaflet 9320 to indicate insertion of the leaflet 9320 to an acceptable depth.

[0593] In the Figure 93C example, the leaflet 9320 is not under excessive tension and the sensor device remains at or substantially at its set or biased location 9322 and an electrical signal of the potentiometer (e.g., a resistance value or a voltage drop across the potentiometer pad 9304) remains at or substantially at its original or set value (i.e., the same or substantially the same value as if a leaflet were not inserted.

[0594] In Figure 93D, the leaflet 9320 is under increased tension, causing the sensor device 9308 to deflect downward and move along the potentiometer area 9316 to a location 9324 further away from the electrode 9306. This movement (e.g., flexure) of sensor device 9308 along potentiometer area 9316 causes a change in electrical potential (e.g., voltage drop) due to a change in resistance associated with location 9324. The change can be an increase or decrease, so long as a change is provided.

[0595] A change indicates both leaflet capture and the amount of change indicates how much tension (or force) is being applied to the leaflet 9320. The amount of tension can be relative, qualitative, and/or quantitative via calibrating voltage values to amounts of tension (or movement of sensor device 9308). Generally, the greater amount of flexure (or change in shape) of sensor device 9308, the greater amount of tension on leaflet 9320. In the example of sensor device 9308 being a shape-set wire, the wire can be spring-like and deflect upon an applied force and return to its original shape when the force is removed.

[0596] In some implementations, a leaf spring instead of a wire can be used. Other shapes and materials are also contemplated having the same or similar capabilities. Also, the flexure of sensor device 9308 allows it to change shape (i.e., flex downward) to allow withdrawal of flexible PCB from the implanted medical device (as previously described in other examples).

Example Systems for Bioimpedance-Based Feedback

[0597] Figure 86 illustrates a block diagram of an example system 770 (e.g., a bioimpedance-based feedback system, bioimpedance system, feedback system, etc.) configured to measure bioimpedance signals, determine tissue status (e.g., capture status, insertion status, etc.) with respect to a system, device, apparatus, etc. (e.g., any of the systems, devices, apparatuses, etc. disclosed herein), and/or to display or otherwise provide indicators associated with the determined status. The system 770 can employ any process, procedure, algorithm, or method described herein for measuring bioimpedance and determining tissue status with respect to an implant.

[0598] The system 770 (e.g., a bioimpedance-based feedback system, bioimpedance system, feedback system, etc.) can include hardware, software, and/or firmware components for bioimpedancebased feedback. The system 770 includes a data store 771, one or more processors 773, a measurement module 772, a capture module 774 (while referred to here as a "capture module", this module can also be referred to as a "status module" and provide status indications other than regarding capture, e.g., insertion status, contact status, etc.), and an indicator module 776. Components of the system 770 can communicate with one another, with external systems, and/or with other components of a network using communication bus 779. The system 770 can be implemented using one or more computing devices. For example, the system 770 can be implemented using a single computing device, multiple computing devices, a distributed computing environment, or it can be located in a virtual device residing in a public or private computing cloud. In a distributed computing environment, one or more computing devices can be configured to provide the measurement module 772, the capture module 774, and the indicator module 776 to provide the described functionality.

[0599] In some implementations, the system 770 includes the measurement module 772 to acquire or receive electrical signals from electrical components (e.g., sensors, electrodes, arrays, PCBs, etc., such as the electrical sensor 6864 described herein with reference to Figure 68.) In some implementations, the electrical signals correspond to bioimpedance signals and can also correspond to resistance, capacitance, voltage, current, components of impedance, and the like. The measurement module 772 is also configured to determine an impedance value based on the acquired bioimpedance signals. Thus, the measurement module 772 is configured to interface with hardware components that generate electrical signals and the measurement module 772 can implement one or more algorithms to determine electrical measurements, such as a bioimpedance measurement, based on the electrical signals from the hardware components.

[0600] In some implementations, the system 770 includes the capture module 774 to determine a capture status based on the bioimpedance measurements by the measurement module 772. The bioimpedance measurements (as well as resistance, inductance, capacitance, voltage, and/or current readings) measured by the measurement module 772 can be different based on the anatomy or anatomies that indicator electrodes are near or in contact with. Thus, the electrical characteristics measured by the measurement module 772, in particular the bioimpedance signals, can be used to determine the relative locations of a clasp, anchor, other device components, etc. and anatomy (e.g., tissue, etc.) that a device associated with the system 770 is in contact with, as described herein. For example, the value of the bioimpedance signal and/or changes in bioimpedance can signal that the electrodes are in blood, contacting tissue (e.g., leaflets), differentiating tissue (e.g., leaflet tissue versus chord tissue), transitioning from being primarily in contact with blood to being partially or primarily in contact with tissue, and/or transitioning from being partially or primarily in contact with tissue to being primarily in contact with blood. Examples of signals and what they indicate are described herein with reference to Figures 54-58, 61A, 61B, 62C, 67 A, and 67B. Thus, algorithms can be implemented by the capture module 774 to determine a capture status, or other similar status such as anchor deployment status, based on the measurements acquired by the measurement module 772.

[0601] In some implementations, the system 770 includes the indicator module 776 to indicate results from the capture module 774. An example indicator is described herein with reference to Figure 62D. However, other indicators can be employed such as one or more displays, LEDs, alarms, speakers, etc. and the indicator module 776 can interface with one or more of these indicators to relay information from the capture module 774 and/or the measurement module 772. Thus, algorithms can be implemented by the indicator module 776 to convert output from the capture module 774 into an indicator for a user (e.g., using visual and/or audible indicators) or for another device or computer system (e.g., using analog or digital communication protocols).

[0602] In some implementations, the system 770 includes one or more processors 773 that are configured to control operation of the measurement module 772, the capture module 774, the indicator module 776, and the data store 771. The one or more processors 773 implement and utilize the software modules, hardware components, and/or firmware elements configured to provide bioimpedance-based feedback. The one or more processors 773 can include any suitable computer processors, applicationspecific integrated circuits (ASICs), field programmable gate array (FPGAs), or other suitable microprocessors. The one or more processors 773 can include other computing components configured to interface with the various modules and data stores of the system 770.

[0603] In some implementations, the system 770 includes the data store 771 configured to store configuration data, measurement data, analysis parameters, control commands, databases, algorithms, executable instructions (e.g., instructions for the one or more processors 773), and the like. The data store 771 can include a combination of memory and/or storage devices. The data store 771 can be any suitable data storage device or combination of devices that include, for example and without limitation, random access memory, read-only memory, solid-state disks, hard drives, flash drives, and the like. For example, the data store 771 can include any suitable non-transitory computer readable medium. In some implementations, one or multiple or all of various steps, methods, procedures, algorithms, etc. of the systems, apparatuses, and/or devices herein can be stored on a non-transitory computer readable medium. In some implementations, the data store 771 can be configured to store computer executable instructions to cause the one or more processors 773 to perform any of the algorithms, procedures, processes, or methods described herein. Similarly, the measurement module 772, the capture module 774, and the indicator module 776 can represent hardware or software modules that provide the described functionality in conjunction with the data store 771 and the one or more processors 773.

[0604] In some implementations, a sensor-based system is shown in FIGS. 94A-98 that can provide information regarding leaflet contact and activity during the repair procedure. For example, leaflet contact can be sensed when the paddles and/or clasps contact the leaflet. The sensing and feedback can be qualitative and/or quantitative. One example of qualitative sensing and feedback is providing an indication when leaflet contact has occurred. One example of quantitative sensing and feedback is providing indication(s) of the amount of contact. The indications or feedback can be via any number of methods and/or devices. This includes tactile (or haptic), audio, and/or visual. Moreover, the indications or feedback can be dynamic or in real-time. Real-time or dynamic feedback can assist users when performing precise implanting procedures by providing realistic sensations of positioning and deployment on tissues and/or organs being operated on. This includes use of tactile or haptic feedback. In one implementation, the haptic feedback can be implemented via vibration motor that receives leaflet touch indications from the sensors and vibrates, for example, the operating handle of the implant system. The frequency, duration, pattern, and/or intensity of the vibrations can also be used to provide the feedback. For example, the vibration intensity can be dynamically varied depending on the amount of leaflet tissue being sensed. Similarly, the frequency, duration, pattern, and/or intensity of the audio and/or visual signals can also be used to provide feedback.

[0605] Figure 94A is a schematic illustration of one implementation of a system having feedback indication that includes the implantable device 604 having one or more sensors 9400 positioned on anchors or paddles of the device 604. In some implementations, the one or more sensors 9400 can be positioned on inner paddles 122.

[0606] In some implementations, the sensors 9400 can be, for example, one or more electrodes as previously described herein or another similar-type sensor. The number of sensors can range from one or more and be capable of qualitative and/or quantitative tissue, organ or biological matter sensing. The one or more sensors can be connected to a digital controller which can read and process the sensor information and provide appropriate output signals as feedback indicators. This includes any and all of the previously described types of indicators. In one implementation the sensors are arranged to send the length or depth of leaflet contact. This assists in determining how much of the leaflet has been inserted or placed between the inner paddles 122 and clasps 130. As previously described the amount of leaflet insertions (e.g., a quantitative assessment) can be sensed and indicated via any number of ways including, for example, haptic feedback using a vibration motor in the operating handle of the system.

[0607] Referring now to Figures 94B and 95, an example of a system or assembly 600 (e.g., a valve treatment system or assembly, valve repair system or assembly, valve replacement system or assembly, etc.) and its components are shown. The system or assembly 600 can comprise the delivery assembly or delivery system 602 and an implantable device or implant 604. The delivery system 602 can comprise a plurality of catheter assemblies. The delivery system 602 can also comprise one or more optional catheter stabilizers or stabilizing systems/devices (not shown). [0608] In some implementations, as shown in the illustrated example in Figure 95, the delivery system 602 includes a first catheter assembly 606, a second catheter assembly 608, and a third catheter assembly 610. Though, in some implementation, the delivery system 602 can include fewer or more catheter assemblies than shown. In some implementations, the first catheter assembly 606 is configured as a delivery catheter assembly and will often be referred to as such for illustration herein, though it can also be other types of catheters or catheter assemblies. In some implementations, the second catheter assembly 608 is configured as a steerable catheter assembly and will often be referred to as such for illustration herein, though it can also be other types of catheters or catheter assemblies. In some implementations, the third catheter assembly 610 is configured as an implant catheter assembly and will often be referred to as such for illustration herein, though it can also be other types of catheters or catheter assemblies.

[0609] In some implementations, the second catheter assembly or steerable catheter assembly 608 extends coaxially through the first catheter assembly or delivery catheter assembly 606, and the third catheter assembly or implant catheter assembly 610 extends coaxially through the second catheter assembly 608 and the first catheter assembly 606. The implantable device 604 can be releasably coupled to a distal portion of the third catheter assembly or implant catheter assembly 610, as further described below. It should be appreciated that the implantable device 604 can be any device described herein.

[0610] As shown in Figure 95, each of the catheter assemblies (e.g., delivery catheter assembly 606, the steerable catheter assembly 608, and the implant catheter assembly 610) includes a sheath or shaft 607, 609, 611 extending from a handle 612, 614, 616, respectively. The handles 612, 614, 616 are located at a proximal end of each of the corresponding sheaths or shafts, and include one or more control members to enable a user to manipulate the catheter assembly (e.g., bend or rotate the sheath or shaft of the catheter assembly) and/or control a component coupled to the corresponding catheter assembly (e.g., a control wire extending through the shaft of the catheter assembly).

[0611] The delivery catheter assembly 606 and the steerable catheter assembly 608 can be used, for example, to access an implantation location (e.g., a native mitral valve region or native tricuspid valve region of a heart) and/or to position the implant catheter assembly 610 at the implantation location. Accordingly, in some implementations, the delivery catheter assembly 606 and the steerable catheter assembly 608 are configured to be steerable. The catheter assemblies or features of the catheter assemblies disclosed by U.S. Patent No. 10,653,862 and U.S. Patent No. 10,646,342 can be used as or in the catheter assemblies 606, 608, 610. U.S. Patent No. 10,653,862 and U.S. Patent No. 10,646,342 are hereby incorporated by reference in their entireties.

[0612] Figures 96A and 96B illustrate examples of implant catheter assemblies 610. Figure 96A illustrates a generalized implant catheter assembly 610 while Figure 97 is a schematic illustration of an example implant catheter assembly 610, in which each of the clasp actuation lines 624 is coupled to a clasp control member positioned on the handle 616 and the actuation element 112 is coupled (directly or indirectly) to a control element (e.g., knob 626, but the control element can also be a button, switch, slider, motor, button that controls a motor, combination of these, etc.) positioned on the handle. In each of the examples illustrated by Figures 96A and 96B, the implant catheter assembly 610 can comprise the inner or actuation element 112, a coupler 620, an outer shaft 611, a handle 616 (shown schematically), and clasp actuation lines 624. A proximal end portion 622a of the outer shaft 611 can be coupled to extend distally from the handle 616, and a distal end portion 622b of the outer shaft 611 can be coupled to the coupler 620. The actuation element 112 can extend distally from the control element or knob 626 (shown schematically in Figure 96A), through the handle 616, through the outer shaft 611, and through the coupler 620. The actuation element 112 can be movable (e.g., axially and/or rotationally) relative to the outer shaft 611 and the handle 616. The clasp actuation lines 624 can extend through and be axially movable relative to the handle 616 and the outer shaft 611. The clasp actuation lines 624 can also be axially movable relative to the actuation element 112.

[0613] In some implementations, the outer shaft 611 of the implant catheter assembly 610 can optionally be configured to be steerable.

[0614] As shown in Figures 96A and 96B, the actuation element 112 of the implant catheter assembly 610 can be releasably coupled to the cap 114 of the device 604. For example, in some implementations, the distal end portion 112b of the actuation element 112 can comprise external threads configured to releasably engage interior threads of the cap 114 of the device 604. As such, rotating the actuation element 112 in a first direction (e.g., clockwise) relative to the cap 114 of the device 604 releasably secures the actuation element 112 to the cap 114, while rotating the actuation element 112 in a second direction (e.g., counterclockwise) relative to the cap 114 of the device 604 releases the actuation element 112 from the cap 114.

[0615] In the examples of Figures 96A and 96B, the outer shaft 611 of the implant catheter assembly 610 is an elongate shaft extending axially between the proximal end portion 622a, which is coupled to the handle 616, and the distal end portion 622b, which is coupled to the coupler 620. The outer shaft 611 can also include an intermediate portion 622c disposed between the proximal and distal end portions 622a, 622b. The outer shaft 611 can be formed from various materials, including metals and polymers. For example, in some implementations, the proximal end portion 622a can comprise stainless steel and the distal and intermediate portions 622b, 622c can comprise polyether block amide (PEBA). The outer shaft 611 can also comprise an outer covering or coating, such as a polymer that is reflowed over the portions 622a, 622b, and 622c.

[0616] As shown in Figures 96A and 96B, the clasp actuation lines 624 are coupled to the clasps 130 through holes 235 in the clasps 130 and extend axially through the outer shaft 611 between the clasps 130 and the handle 616. In some implementations, e.g., as illustrated by Figure 97, at the proximal end of the clasp actuation lines 624, the clasp actuation lines 624 are each operatively and/or physically coupled to a clasp control member 628. Each clasp control member 628 is configured such that actuation thereof can cause axial movement of the clasp actuation line 624 relative to the handle 616, outer shaft 611 and/or the actuation element 112. As will be described in greater detail, in some implementations, each of the clasp control members 628 can be actuated/operated independently of the other clasp control member such that each clasp actuation line 624 is moved independently relative to the handle 616, outer shaft 611, the actuation element 112, and/or the other clasp actuation line 624. In some implementations, the clasp control members 628 can be operatively or physically fixed (or synchronized) with respect to one another (e.g., locked) such that the clasp actuation lines 624 are axially moved together relative to the outer shaft 611 and the actuation element 112. In some implementations, the clasp control members 628 are configured such that they can be toggled by the end user between independently actuatable and actuatable together (e.g., synchronized).

[0617] The clasp control members 628 can be configured in a variety of ways. In some implementations, one or more of the clasp control members 628 is an axially-moving control or slider coupled to a corresponding clasp actuation line 624 to axially move the clasp actuation line 624 relative to the outer shaft 611 and the actuation element 112. In some implementations, one or more of the clasp control members 628 comprises a button, switch, latch, gear, etc.

[0618] As described above, in some implementations, the actuation element 112 is coupled at a distal end to the cap 114 of the device 604. The actuation element 112 extends axially through the outer shaft 611 to the handle 616 and is coupled at a proximal end portion 112a to the control element or knob 626. Although described with respect to various figures herein as being configured as a knob, it should be appreciated that the actuation element 112 can be coupled to any other type of control element, such as another type of rotational control member that is rotatable about the axis of the handle 616.

[0619] As will be described in greater detail, in some implementations, as the knob 626 is rotated about the axis of the handle 616, the rotation is translated to axial movement of the actuation element 112, and is effective to axially advance or retract the actuation element, such a as a rod or wire, to open or close the valve repair device. Optionally, the knob can also drive a paddle release knob 630 (sometimes referred to as an indicator component) between a proximal, or extended, position, and a distal, or retracted, position. In some implementations, the control element can be a button, switch, or the like that causes a motor to rotate a shaft, gear, screw, or other component to cause axial movement of the actuation element 112.

[0620] Referring briefly to Figure 95, in some implementations, implant catheter assembly 610 includes a haptic feedback device 632 such as, for example, one or more vibration motor(s) or devices. Additional feedback devices can also be provided including, for example, one or more audio devices 634 (e.g., speakers), and/or one or more visual devices (not shown, e.g., one or more lights and/or LEDs). As previously described, these feedback devices can provide qualitative and/or quantitative feedback indicators with regard to, for example, the amount or depth of leaflet insertion into the capture area (e.g., between the paddles and clasps) of the implant repair device. In some implementations there can be a single feedback device provided on the handle.

[0621] In some examples, a single sensor can be provided on each paddle. The sensor can be located at a designated insertion depth that is indicative of an appropriate leaflet capture configuration. In some implementations, the sensor can be located at a designated insertion depth of 6 mm. In some implementations, the sensor can be located at a designated insertion depth of 9 mm. Other insertion depth locations can also be used. In some implementations, feedback is provided (e.g., haptic feedback) when the leaflet tissue is sensed at the designated insertion depth thereby providing an indication of an appropriate leaflet capture configuration.

[0622] In another example, more than one sensor (e.g., three sensors) can be provided on each paddle. The sensors can be located at various insertion depths including, for example, 3 mm, 6 mm, 9 mm. Other insertion depth locations can also be used. In this example, the first feedback (e.g., haptic feedback) can be provided when the leaflet tissue contacts the sensor located at the 3 mm insertion depth. A second feedback (e.g., an increased haptic feedback) can be provided when the leaflet tissue contacts the sensor located at the 6 mm insertion depth. And, a third feedback (e.g., greatest haptic feedback) can be provided when the leaflet tissue contacts the sensor located at the 9 mm insertion depth. In this manner, qualitative feedback is provided of the insertion depth of the leaflet tissue. As previously described, each feedback (e.g., first, second, and third) can be distinctive and recognizable for the insertion depth being sensed. For example, the first feedback (e.g., 3 mm insertion depth) can be a single vibration pattern. The second feedback (e.g., 6 mm depth insertion) can be a double vibration pattern. And, the third feedback (e.g., 9 mm depth insertion) can be a triple vibration pattern. These are nonlimiting examples and other vibration sequences and patterns can also be used. And, as previously described, visual feedback can also be provided in addition or in the alternative to the haptic feedback. In this manner, a dynamic or real-time sensing and feedback arrangement can be provided with regard to tissue, organ, or other biological matter during the procedure.

[0623] Figures 97 and 98 illustrate an implementation of a system and logic for feedback having visual and/or haptic indications. In this implementation, a dynamic feedback display is provided for leaflet insertion depth. Figure 97 shows logic 9700 and Figure 98 shows one implementation of the visual feedback in the form of system 9800. The logic 9700 and system 9800 provides a customizable indication of whether proper leaflet depth insertion is achieved when the device is implanted.

[0624] Referring to Figure 97, the logic starts in block 9702 where the leaflet length is entered. For instance an operator can enter the native leaflet size of the heart valve where the device is to be implanted. Native leaflets occur in many sizes and ranges and can be determined from imaging (e.g., ultrasound, MRI, X-Ray, CT scan, etc.)

[0625] If the native leaflet size is less than 6 mm, then the logic proceeds to block 9704. As the implantable repair device is maneuvered into position, the native leaflet is placed and captured between the inner paddle and the clasps. As previously described, the inner paddle includes one or more sensors for sensing leaflet insertion depth. In block 9706, a yellow indicator 9810 and/or 9816 (e.g., Light Emitting Display (LED) or other suitable indicator)) are illuminated to indicate the leaflet has contacted the 3 mm insertion depth. In block 9708, a green indicator 9812 and/or 9818 are illuminated to indicate the leaflet has contacted the 6 mm insertion depth thus achieving proper insertion depth.

[0626] For larger native leaflets (e.g., greater than 6 mm in length), the logic proceeds from block 9702 to block 9710. In block 9712, a red indicator 9808 and/or 9814 are illuminated to indicate the leaflet has contacted the 3 mm insertion depth. In block 9714, a yellow indicator 9810 and/or 9816 are illuminated to indicate the leaflet has contacted the 6 mm insertion depth. And, in block 9716, a green indicator 9812 and/or 9818 is illuminated to indicate the leaflet has contacted the 9 mm insertion depth, thus achieving proper insertion depth. The aforementioned insertion depths are meant to be illustrative of examples and other insertion depths can be used as appropriate or necessary.

[0627] Figure 98 shows an example arrangement of the system control and display indicators. System 9800 can include a housing 9802 which include all the processing, memory, power, input and output elements for operation. System 9800 includes "ON" input 9826, "OFF" input 9830, and "TEST" 9834 input (e.g., buttons) for those functions. In some implementations, system 9800 can include a "START" input 9820, "CALIBRATE" input 9822, and "DISPLAY" input 9824 (e.g., buttons) for those functions. In some implementations, the system 9800 can include additional inputs (e.g., buttons). In some implementations, the system 9800 can include less inputs (e.g., may not include the "START" input 9820, "CALIBRATE" input 9822, and "DISPLAY" input 9824).

[0628] Two displays are also provided for the feedback indicators. Feedback display 9804 is for a first clasp of the implantable repair device and feedback display 9806 is for a second clasp of the implantable repair device. While two such displays are illustrated, additionally or alternatively, one or more can be provided. Each display 9804 and 9806 have one or more visual indicators (e.g., 9808-9823 and 9814-9818) to provide feedback as to leaflet position and/or location. In the implementation shown, each display 9804 and 9806 include 3 visual indicators and each can be different. For example, display 9804 includes a red indicator 9808 (e.g., indicator of insufficient leaflet insertion depth or grasping), yellow indicator 9810 (e.g., sufficient leaflet insertion depth or grasping) and green indicator 9812 (e.g., optimal leaflet insertion depth or grasping). Display 9806 similarly includes a red indicator 9814, yellow indicator 9816, and green indicator 9818. As previously described, these indicators can provide real-time dynamic feedback of the leaflet position. System 9800 can further include audio output indicators as previously described to indicate leaflet position. Other indicators can also be provided such as, for example, battery status 9832 and battery charge status 9828.

[0629] Figure 99 illustrates one example of a control system 9900 block diagram for implementing the feedback examples described herein. System 9900 includes a controller 9902 for controlling the feedback implementation(s), which can be microprocessor-based. System 9900 further includes inputs and outputs 9906, which can include, for example, the previous described lights, displays, buttons, speakers, vibration devices, communication ports, etc. System 9900 also includes memory 9908 associated with controller 9902 for storage and retrieval of data, logic, and software instructions including, for example, the logic of FIGS. 97 and 98. Further yet, system 9900 can include a communication device 9910, which can be for example, wireless/wired modem for sending and receiving information (e.g., Wi-Fi, cellular, LAN, WLAN, etc.) The exact arrangement and make-up of system 9900 is not critical so long as it is capable of receiving and outputting the signals/data described herein.

[0630] In this manner, data or information (e.g., leaflet anatomy and position) during the implant procedure is personalized to the patient's anatomy and process so that optimum results can be achieved. The systems and methods described herein provide optimized clasping according to native leaflet anatomy.

[0631] EXAMPLES

[0632] Example 1. A device comprising:

[0633] a flexible printed circuit board body comprising:

[0634] an implantable portion having a first portion of one or more electrical traces connected to at least one of one or more electrodes and one or more sensors;

[0635] a removable portion having a second portion of the one or more electrical traces;

[0636] a stress disconnect portion, the stress disconnect portion comprising at least one stress concentration area; and

[0637] wherein the stress concentration area is configured to separate the removable portion from the implantable portion upon application of one or more stresses thereto.

[0638] Example 2. The device of example 1 wherein the stress concentration area comprises a high electrical resistance.

[0639] Example 3. The device of any one of examples 1-2 wherein the stress concentration area comprises one or more stress concentration portions.

[0640] Example 4. The device of any one of examples 1-3 wherein the body comprises a plurality of electrical layers including a first layer comprising one or more electrical traces that connect to the one or more electrodes and a second layer comprising high resistance electrical trace portions. [0641] Example 5. The device of any one of examples 1-4 wherein the implantable portion comprises a fixation portion.

[0642] Example 6. The device of any one of examples 1-5 wherein the one or more stresses comprise heat stress.

[0643] Example 7. The device of any one of examples 1-5 wherein the one or more stresses comprise heat stress generated by electricity.

[0644] Example 8. The device of any one of examples 1-7 wherein the one or more stresses comprise mechanical stress.

[0645] Example 9. The device of any one of examples 1-7 wherein the one or more stresses comprise mechanical stress generated by a pulling force.

[0646] Example 10. The device of any one of examples 1-9 wherein the stress disconnect portion comprises a plurality of perforations.

[0647] Example 11. The device of any one of examples 1-10 wherein the stress disconnect portion comprises an electrical resistor.

[0648] Example 12. The device of any one of examples 1-11 wherein the stress disconnect portion comprises a thickness that is less than a thickness of the removable portion.

[0649] Example 13. The device of any one of examples 1-12 wherein the stress disconnect portion comprises a thickness that is less than a thickness of the implantable portion.

[0650] Example 14. The device of any one of examples 1-13 wherein the stress disconnect portion is configured to separate the removable portion and the implantable portion into separate parts.

[0651] Example 15. The device of any one of examples 1-14 wherein the stress disconnect portion is positioned between the removable portion and the implantable portion.

[0652] Example 16. The device of any one of examples 1-14 wherein the implantable portion is positioned between the removable portion and the stress disconnect portion.

[0653] Example 17. The device of any one of examples 1-16 further comprising:

[0654] a tissue engagement portion comprising a first arm and a second arm configured such that the first arm and the second arm can close or be moved closer together to capture tissue in the tissue engagement portion, at least one of the first arm and the second arm being movable to form a capture region therebetween for capturing the tissue; and

[0655] one or more electrodes coupled to the tissue engagement portion.

[0656] Example 18. The device of any one of examples 1-17 further comprising a mechanical leaflet depth indicator.

[0657] Example 19. A method comprising:

[0658] fixating a flexible printed circuit board (PCB) to a device;

[0659] releasing the flexible PCB from the device,

[0660] wherein the step of releasing comprises:

[0661] applying heat to a stress disconnect portion of the flexible PCB; and

[0662] applying a pulling force to the flexible PCB while the stress disconnect portion is in a heated state.

[0663] Example 20. The method of example 19 wherein applying heat to a stress disconnect portion of the flexible PCB comprises applying an electrical current to a high resistance area with the stress disconnect portion.

[0664] Example 21. The method of any one of example 19-20 wherein applying heat to a stress disconnect portion of the flexible PCB comprises using heat to plasticize an area of the stress disconnect portion.

[0665] Example 22. A device comprising:

[0666] a flexible PCB having a fixation portion;

[0667] a base member having at least one opening through which the flexible PCB extends;

[0668] a fixation device connected to the fixation portion;

[0669] wherein the fixation device comprises a loop portion that maintains the fixation device connected to the fixation portion and prevents the flexible PCB from withdrawing from the base member opening; and [0670] wherein the loop portion unloops in response to a pulling force that allows the fixation device to be disconnected from the flexible PCB.

[0671] Example 23. The device of example 22 wherein the fixation device comprises a wire.

[0672] Example 24. The device of any one of examples 22-23 wherein the fixation device comprises a nitinol wire.

[0673] Example 25. The device of any one of examples 22-24 wherein the fixation portion comprises an opening.

[0674] Example 26. The device of any one of examples 22-25 wherein the fixation portion comprises an opening through which the loop portion extends.

[0675] Example 27. The device of any one of examples 22-26 further comprising:

[0676] a tissue engagement portion comprising a first arm and a second arm configured such that the first arm and the second arm can close or be moved closer together to capture tissue in the tissue engagement portion, at least one of the first arm and the second arm being movable to form a capture region therebetween for capturing the tissue; and

[0677] one or more electrodes coupled to the tissue engagement portion.

[0678] Example 28. A method comprising:

[0679] fixating a flexible printed circuit board (PCB) to a device;

[0680] releasing the flexible PCB from the device;

[0681] wherein the step of releasing comprises; and

[0682] unlooping a holding portion connected to the flexible PCB by applying a pulling force to the holding portion.

[0683] Example 29. The method of any one of example 28 further comprising disconnecting the holding portion from the flexible PCB.

[0684] Example 30. The method of any one of examples 28-29 further comprising applying a pulling force to the flexible PCB after the holding portion disconnects from the flexible PCB. [0685] Example 31. The method of any one of examples 28-30 further comprising unlooping a wire of the holding portion by applying a pulling force to the wire.

[0686] Example 32. A device comprising:

[0687] a flexible printed circuit board (PCB) body comprising:

[0688] the flexible PCB body configured to be withdrawn through a catheter lumen;

[0689] an electrode portion having one or more electrodes, and

[0690] at least one electrode extension extending beyond the flexible PCB body and the electrode portion.

[0691] Example 33. The device of example 32 wherein the at least one electrode extension extends laterally beyond the flexible PCB body and the electrode portion.

[0692] Example 34. The device of any one of examples 32-33 wherein the at least one electrode extension extends vertically beyond the flexible PCB body and the electrode portion.

[0693] Example 35. The device of any one of examples 32-34 wherein the at least one electrode extension comprises a curled extension body.

[0694] Example 36. The device of any one of examples 32-35 wherein the at least one electrode extension comprises a curled extension body extending laterally beyond the flexible PCB body and the electrode portion.

[0695] Example 37. The device of any one of examples 32-36 wherein the at least one electrode extension comprises a curled extension body extending vertically beyond the flexible PCB body and the electrode portion.

[0696] Example 38. The device of any one of examples 32-37 wherein the at least one electrode extension comprises a curled wire.

[0697] Example 39. The device of any one of examples 32-38 wherein the at least one electrode extension comprises a coiled wire.

[0698] Example 40. The device of any one of examples 32-39 wherein the at least one electrode extension comprises a wire extending above the one or more electrodes and connected to a top surface of the one or more electrodes. [0699] Example 41. The device of any one of example 32-40 wherein the at least one electrode extension comprises a first shape during operation and a second shape during withdrawal of the flexible PCB.

[0700] Example 42. A device comprising:

[0701] a flexible printed circuit board (PCB) body comprising:

[0702] the flexible PCB body configured to be withdrawn through a catheter lumen;

[0703] an electrode portion having first and second pads, wherein the second pad comprises a variable resistance portion, and

[0704] a sensing device comprising a first portion connected to the first pad and a second portion in moveable contact with the variable resistance portion of the second pad.

[0705] Example 43. The device of example 42 wherein the sensing device comprises a wire.

[0706] Example 44. The device of any one of examples 42-43 wherein the sensing device comprises Nitinol material.

[0707] Example 45. The device of any one of examples 42-44 wherein the sensing device comprises a spring.

[0708] Example 46. The device of any one of examples 42-45 wherein the sensing device comprises a conductive material.

[0709] Example 47. The device of any one of examples 42-46 wherein the sensing device deflects under an applied force.

[0710] Example 48. The device of any one of examples 42-47 wherein the sensing device provides a leaflet capture status indication.

[0711] Example 49. The device of any one of examples 42-48 wherein the sensing device provides a leaflet tension status indication.

[0712] Example 50. The device of any one of examples 42-49 wherein the sensing device provides a change in voltage when deflected. [0713] Example 51. The device of any one of example 42-50 wherein the sensing device deflects upon withdrawal of the flexible PCB through a catheter lumen.

[0714] Example 52. The device of any one of examples 42-51 further comprising:

[0715] a tissue engagement portion comprising a first arm and a second arm configured such that the first arm and the second arm can close or be moved closer together to capture tissue in the tissue engagement portion, at least one of the first arm and the second arm being movable to form a capture region therebetween for capturing the tissue; and

[0716] one or more electrodes coupled to the tissue engagement portion.

[0717] Example 53. A method of using any one of the devices of any one of examples 42-52 and comprising:

[0718] sensing movement of the sensing device along the variable resistance portion of the second pad to indicate leaflet capture status and/or leaflet tension.

[0719] Example 54. A device comprising:

[0720] a tissue engagement portion comprising a first surface and a second surface, at least one of the first surface and the second surface being movable to form a capture region between the first surface and the second surface for capturing tissue;

[0721] a sensing unit comprising one or more electrodes, the sensing unit coupled to the tissue engagement portion,

[0722] wherein the device is configured such that the one or more electrodes:

[0723] receive an electrical current,

[0724] generate a signal responsive to the electrical current received, the signal providing an indication of a status of the tissue within the tissue engagement portion, and

[0725] wherein at least a portion of the sensing unit is configured to be decoupled from the tissue engagement portion.

[0726] Example 55. The device of example 54, wherein the sensing unit comprises: [0727] an implantable portion comprising a first portion of one or more electrical traces connected to at least one of the one or more electrodes;

[0728] a removable portion comprising a second portion of the one or more electrical traces;

[0729] a stress disconnect portion, the stress disconnect portion comprising at least one stress concentration area,

[0730] wherein the stress concentration area is configured to separate the removable portion from the implantable portion upon application of one or more stresses thereto.

[0731] Example 56. The device of example 55 wherein the sensing unit comprises a plurality of electrical layers including a first layer comprising one or more electrical traces that connect to the one or more electrodes and a second layer comprising high resistance electrical trace portions.

[0732] Example 57. The device of any one of examples 55-56 wherein the one or more stresses comprise at least one of heat stress and mechanical stress.

[0733] Example 58. The device of any one of examples 55-57 wherein the stress disconnect portion comprises a plurality of perforations.

[0734] Example 59. The device of any one of examples 55-58 wherein the stress disconnect portion comprises an electrical resistor.

[0735] Example 60. The device of any one of examples 55-59 wherein the stress disconnect portion is configured to separate the removable portion and the implantable portion into separate parts.

[0736] Example 61. The device of any of examples 54-60, wherein the sensing unit comprises a fixation portion.

[0737] Example 62. The device of example 61, wherein the device further comprises:

[0738] a base member having at least one opening through which the sensing unit extends;

[0739] a fixation device connected to the fixation portion,

[0740] wherein the fixation device comprises a loop portion that maintains the fixation device connected to the fixation portion and prevents the sensing unit from withdrawing from the base member opening, and [0741] wherein the loop portion unloops in response to a pulling force that allows the fixation device to be disconnected or decoupled from the sensing unit.

[0742] Example 63. The device of example 62, wherein the fixation portion comprises an opening through which the loop portion extends.

[0743] Example 64. The device of any of examples 54-63, wherein the sensing unit comprises a PCB body, the PCB body comprising:

[0744] an electrode portion comprising the one or more electrodes; and

[0745] at least one electrode extension extending beyond the PCB body and the electrode portion,

[0746] wherein the PCB body is configured to be withdrawn through a catheter lumen.

[0747] Example 65. The device of example 64, wherein the at least one electrode extension comprises a wire extending above the one or more electrodes and connected to a top surface of the one or more electrodes.

[0748] Example 66. The device of any one of examples 64-65, wherein the at least one electrode extension comprises a first shape during operation and a second shape during withdrawal of the sensing unit.

[0749] Example 67. The device of any of examples 54-66, wherein the sensing unit comprises a PCB body, the PCB body comprising:

[0750] an electrode portion comprising the one or more electrodes, the one or more electrodes comprising a first pad and a second pad, wherein the second pad comprises a variable resistance portion;

[0751] a sensing device, the sensing device comprising a first portion connected to the first pad and a second portion in moveable contact with the variable resistance portion of the second pad,

[0752] wherein the PCB body is configured to be withdrawn through a catheter lumen.

[0753] Example 68. The device of example 67, wherein the sensing device deflects upon withdrawal of the sensing unit through a catheter lumen.

[0754] Example 69. The device of any of examples 54-68, wherein the device is usable and/or configured for use with a real or simulated heart of a real or simulated subject. [0755] Example 70. A system for repairing a native valve, the system comprising:

[0756] a delivery system comprising:

[0757] a catheter with a proximal end and a distal end;

[0758] an actuation element;

[0759] a wire extending within a lumen of the catheter from the proximal end of the catheter to the distal end of the catheter; and

[0760] a capture mechanism at a distal end of the delivery system; and

[0761] a treatment device comprising:

[0762] an attachment portion comprising a proximal component configured to engage with the capture mechanism of the delivery system;

[0763] an anchor portion comprising a tissue engagement portion having a first surface and a second surface configured to capture tissue;

[0764] a distal portion configured to engage with the actuation element of the delivery system, the actuation element configured to deploy the anchor portion and to release the capture mechanism from the proximal component;

[0765] a sensing unit comprising an electrode, the sensing unit coupled to the tissue engagement portion;

[0766] wherein the treatment device is configured such that:

[0767] the electrode can receive an electrical current,

[0768] the electrode generates a signal responsive to the electrical current, the signal providing an indication of a status of the tissue within the tissue engagement portion, and

[0769] at least a portion of the sensing unit is configured to be decoupled from the tissue engagement portion.

[0770] Example 71. The system of example 70, wherein the sensing unit comprises:

[0771] an implantable portion having a first portion of one or more electrical traces connected to the electrode; [0772] a removable portion having a second portion of the one or more electrical traces;

[0773] a stress disconnect portion, the stress disconnect portion comprising at least one stress concentration area,

[0774] wherein the stress concentration area is configured to separate the removable portion from the implantable portion upon application of one or more stresses thereto.

[0775] Example 72. The system of example 71, wherein the sensing unit comprises a plurality of electrical layers including a first layer comprising one or more electrical traces that connect to the one or more electrodes and a second layer comprising high resistance electrical trace portions.

[0776] Example 73. The system of any one of examples 71-72, wherein the one or more stresses comprise at least one of heat stress and mechanical stress.

[0777] Example 74. The system of any one of examples 71-73, wherein the stress disconnect portion comprises a plurality of perforations.

[0778] Example 75. The system of any one of examples 71-74, wherein the stress disconnect portion comprises an electrical resistor.

[0779] Example 76. The system of any one of examples 71-75, wherein the stress disconnect portion is configured to separate the removable portion and the implantable portion into separate parts.

[0780] Example 77. The system of any of examples 70-76, wherein the sensing unit comprises a fixation portion.

[0781] Example 78. The system of example 77, wherein the treatment device further comprises:

[0782] a base member having at least one opening through which the sensing unit extends;

[0783] a fixation device connected to the fixation portion,

[0784] wherein the fixation device comprises a loop portion that maintains the fixation device connected to the fixation portion and prevents the sensing unit from withdrawing from the base member opening, and

[0785] wherein the loop portion unloops in response to a pulling force that allows the fixation device to be disconnected or decoupled from the sensing unit. [0786] Example 79. The system of example 78, wherein the fixation portion comprises an opening through which the loop portion extends.

[0787] Example 80. The system of any of examples 70-79, wherein the sensing unit comprises a PCB body, the PCB body comprising:

[0788] an electrode portion comprising the electrode;

[0789] at least one electrode extension extending beyond the PCB body and the electrode portion,

[0790] wherein the PCB body is configured to be withdrawn through the lumen of the catheter.

[0791] Example 81. The system of example 80, wherein the at least one electrode extension comprises a wire extending above the one or more electrodes and connected to a top surface of the one or more electrodes.

[0792] Example 82. The system of any one of examples 80-81, wherein the at least one electrode extension comprises a first shape during operation and a second shape during withdrawal of the sensing unit.

[0793] Example 83. The system of any of examples 70-82, wherein the sensing unit comprises a PCB body, the PCB body comprising:

[0794] an electrode portion comprising the electrode, the electrode comprising a first pad and a second pad, wherein the second pad comprises a variable resistance portion;

[0795] a sensing device, the sensing device comprising a first portion connected to the first pad and a second portion in moveable contact with the variable resistance portion of the second pad,

[0796] wherein the PCB body is configured to be withdrawn through the lumen of the catheter.

[0797] Example 84. The system of example 83, wherein the sensing device deflects upon withdrawal of the sensing unit through a catheter lumen.

[0798] Example 85. The system of any of examples 70-84, wherein the system is usable and/or configured for use with a real or simulated heart of a real or simulated subject.

[0799] Example 86. A fixation apparatus for a flexible printed circuit used with an implantable medical device, the fixation device comprising: [0800] a body having:

[0801] a first cantilevered lug portion;

[0802] a second cantilevered lug portion;

[0803] a beam portion between the first and second lug portions, the beam portion comprising one or more spaced apart recesses in a first side, and

[0804] a projecting portion comprising at least one opening.

[0805] Example 87. The fixation apparatus of example 86 wherein the first and second cantilevered lug portions extend from the first side of the beam portion.

[0806] Example 88. The fixation apparatus of any one of examples 86-87 wherein the beam comprises a second side having a plurality of angled surfaces.

[0807]

[0808] Example 89. The fixation apparatus of any one of examples 86-87 wherein the beam comprises a second side having a plurality of surfaces disposed with a non-zero degree angle between each surface.

[0809] Example 90. The fixation apparatus of any one of examples 86-89 wherein the first cantilevered lug portion and the second cantilevered lug portion each comprise an extension portion and hook portion.

[0810] Example 91. The fixation apparatus of any one of examples 86-90 wherein the first cantilevered lug portion and the second cantilevered lug portion each comprise flexible material.

[0811] Example 92. The fixation apparatus of any one of examples 86-91 wherein the first lug comprises the projecting portion, the opening configured to receive a fixating element.

[0812] Example 93. The fixation apparatus of any one of examples 86-92 wherein the first lug portion is disposed on a first end of the beam portion and the second lug portion is disposed on a second distal end of the beam portion.

[0813] Example 94. The fixation apparatus of any one of examples 86-93 further comprising one or more flexible bands disposed around the beam portion. [0814] Example 95. The fixation apparatus of any one of examples 86-94 further comprises holder having a holder body comprising third and fourth cantilevered lug portions and an aperture.

[0815] Example 96. A system comprising:

[0816] a heart valve repair device having one or more paddles, each paddle comprising at least first and second openings;

[0817] a flexible printed circuit having a distal end portion;

[0818] a fixation mechanism comprising a body having:

[0819] a first cantilevered lug portion;

[0820] a second cantilevered lug portion;

[0821] a beam portion between the first and second lug portions, the beam portion comprising one or more recesses in a first side, and

[0822] a projecting portion comprising at least one opening.

[0823] Example 97. The system of example 96 wherein the first and second cantilevered lug portions extend from the first side of the beam portion.

[0824] Example 98. The system of any one of examples 96-97 wherein the beam comprises a second side having a plurality of angled surfaces.

[0825] Example 99. The system of any one of examples 96-98 wherein the beam comprises a second side having a plurality of surfaces disposed with a non-zero degree angle between each surface.

[0826] Example 100. The system of any one of examples 96-99 wherein the cantilevered lug portions each comprise an extension portion and hook portion.

[0827] Example 101. The system of any one of examples 96-100 wherein the cantilevered lug portions each comprise flexible material.

[0828] Example 102. The system of any one of examples 96-101 wherein the first lug comprises the projecting portion, the opening configured to receive a fixating element. [0829] Example 103. The system of any one of examples 96-102 wherein the first lug portion is disposed on a first end of the beam portion and the second lug portion is disposed on a second distal end of the beam portion.

[0830] Example 104. The system of any one of examples 96-103 further comprising one or more flexible bands disposed around the beam portion.

[0831] Example 105. The system of any one of examples 96-104 further comprising a holder having a holder body comprising third and fourth cantilevered lug portions and an aperture.

[0832] Example 106. The system of any one of examples 96-105 further comprising a fixation element having a wire body received within the projecting portion of the fixation mechanism and further received in the distal end portion of the flexible printed circuit.

[0833] Example 107. A system comprising:

[0834] an implantable medical device comprising:

[0835] one or more paddles;

[0836] one or more claps spaced apart from the paddles, such that a space is formed between the clasps and paddles;

[0837] one or more sensors located in the space between the paddles and clasps;

[0838] a controller having inputs for reading signals generated by the one or more sensors and outputs for outputting one or more output signals;

[0839] logic for reading the sensor signals and converting the read sensor signals to one or more status indicators that are output via the one or more output signals; and

[0840] one or more output devices receiving the one or more output signals and generating outputs according to the output signals.

[0841] Example 108. The system of example 107 wherein the status indicators comprise one or more leaflet insertion depth indicators.

[0842] Example 109. The system of any one of examples 107-108 wherein the output signals comprise haptic output signals. [0843] Example 110. The system of any one of examples 107-109 wherein the output signals comprise visual output signals.

[0844] Example 111. The system of any one of examples 107-110 wherein the output signals comprise audio output signals.

[0845] Example 112. The system of any one of examples 107-111 wherein the output signals comprise first and second signal patterns indicative of first and second status indicators, respectively.

[0846] Example 113. The system of any one of examples 107-112 wherein the output signals comprise vibration signals.

[0847] Example 114. The system of any one of examples 107-113 wherein the output signals comprise illuminable indicator signals.

[0848] Example 115. The system of any one of examples 107-114 wherein the output signals comprise a plurality of color indicators.

[0849] Example 116. The system of any one of examples 107-115 wherein one of the status indicators comprises an insufficient leaflet grasping indicator.

[0850] Example 117. The system of any one of examples 107-116 wherein one of the status indicators comprises a sufficient leaflet grasping indicator.

[0851] Example 118. The system of any one of examples 107-117 wherein one of the status indicators comprises an optimal leaflet grasping indicator.

[0852] Example 119. The system of any one of examples 107-118 further comprising logic for reading leaflet length.

[0853] Example 120. The system of any one of examples 107-119 further comprising a handle having a vibration motor.

[0854] Example 121. The system of any one of examples 107-120 wherein the one or more output devices comprises a handle having an audio output device.

[0855] Example 122. The system of any one of examples 107-121 one or more output devices comprises a housing having a plurality of visual indicators. [0856] Example 123. The system of any one of examples 107-122 wherein the sensors are positioned on the paddles at first, second and third insertion depths.

[0857] Example 124. The system of any one of examples 107-123 wherein the sensors are positioned on the paddles at insertion depths comprising 3 mm, 6 mm, and 9 mm.

[0858] Example 125. The system of any one of examples 107-124 wherein the implantable medical device comprises a heart valve repair device.

[0859] Example 126. A system comprising:

[0860] an implantable medical device comprising:

[0861] one or more paddles;

[0862] one or more clasps spaced apart from the paddles, such that a space is formed between the clasps and paddles;

[0863] one or more sensors coupled to the implantable medical device, wherein the one or more sensors are disposed in the space between the paddles and clasps;

[0864] a controller configured to receive one or more sensor signals from the one or more sensors via an input and further configured to output one or more output signals via an output;

[0865] wherein logic associated with the controller generates the one or more output signals indicative of one or more status indicators based on the sensor signals; and

[0866] one or more output devices configured to receive the one or more output signals and generate outputs according to the output signals.

[0867] Any of the various systems, assemblies, devices, components, apparatuses, etc. in this disclosure, including those in the examples above, can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise (or additional methods comprise or consist of) sterilization of the associated system, device, component, apparatus, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0868] As described herein, when one or more components are described as being connected, joined, affixed, coupled, attached, or otherwise interconnected, such interconnection can be direct as between the components or can be indirect such as through the use of one or more intermediary components. Also as described herein, reference to a "member," "component," or "portion" shall not be limited to a single structural member, component, or element but can include an assembly of components, members, or elements. Also as described herein, the terms "substantially" and "about" are defined as at least close to (and includes) a given value or state (preferably within 10% of, more preferably within 1% of, and most preferably within 0.1% of).

[0869] The various inventive aspects, concepts and features of the disclosures may be described and illustrated herein as embodied in combination in the examples herein, these various aspects, concepts, and features may be used in many alternative implementations, either individually or in various combinations and sub-combinations thereof. Unless expressly excluded herein all such combinations and sub-combinations are intended to be within the scope of the present application. Still further, while various alternative implementations as to the various aspects, concepts, and features of the disclosures— such as alternative materials, structures, configurations, methods, devices, and components, alternatives as to form, fit, and function, and so on— may be described herein, such descriptions are not intended to be a complete or exhaustive list of available implementations, whether presently known or later developed. Those skilled in the art may readily adopt one or more of the inventive aspects, concepts, or features into additional implementations and uses within the scope of the present application even if such implementations are not expressly disclosed herein.

[0870] Additionally, even though some features, concepts, or aspects of the disclosures may be described herein as being a preferred arrangement or method, such description is not intended to suggest that such feature is required or necessary unless expressly so stated. Sb’ll further, example or representative values and ranges may be included to assist in understanding the present application, however, such values and ranges are not to be construed in a limiting sense and are intended to be critical values or ranges only if so expressly stated.

[0871] Moreover, while various aspects, features and concepts may be expressly identified herein as being inventive or forming part of a disclosure, such identification is not intended to be exclusive, but rather there may be inventive aspects, concepts, and features that are fully described herein without being expressly identified as such or as part of a specific disclosure, the disclosures instead being set forth in the appended claims. Descriptions of example methods or processes are not limited to inclusion of all steps as being required in all cases, nor is the order that the steps are presented to be construed as required or necessary unless expressly so stated. Further, the techniques, methods, operations, steps, etc. described or suggested herein or in the references incorporated herein can be performed on a living subject (e.g., human, other animal, etc.) or on a simulation, such as a cadaver, cadaver heart, simulator, imaginary person, etc.). When performed on a simulation, the body parts, e.g., heart, tissue, valve, etc., can be assumed to be simulated or can optionally be referred to as "simulated" (e.g., simulated heart, simulated tissue, simulated valve, etc.) and can optionally comprise computerized and/or physical representations of body parts, tissue, etc. The term "simulation" covers use on a cadaver, computer simulator, imaginary person (e.g., if they are just demonstrating in the air on an imaginary heart), etc. The words used in the claims have their full ordinary meanings and are not limited in any way by the description of the implementations in the specification.

Claims

CLAIMS What is claimed is:

1. A device comprising: a flexible printed circuit board body comprising: an implantable portion having a first portion of one or more electrical traces connected to at least one of one or more electrodes and one or more sensors; a removable portion having a second portion of the one or more electrical traces; a stress disconnect portion, the stress disconnect portion comprising at least one stress concentration area; and wherein the stress concentration area is configured to separate the removable portion from the implantable portion upon application of one or more stresses thereto.

2. The device of claim 1 wherein the stress concentration area comprises a high electrical resistance.

3. The device of any one of claims 1-2 wherein the stress concentration area comprises one or more stress concentration portions.

4. The device of any one of claims 1-3 wherein the body comprises a plurality of electrical layers including a first layer comprising one or more electrical traces that connect to the one or more electrodes and a second layer comprising high resistance electrical trace portions.

5. The device of any one of claims 1-4 wherein the implantable portion comprises a fixation portion.

6. The device of any one of claims 1-5 wherein the one or more stresses comprise heat stress generated by electricity.

7. The device of any one of claims 1-5 wherein the one or more stresses comprise mechanical stress generated by a pulling force.

8. The device of any one of claims 1-7 wherein the stress disconnect portion comprises a plurality of perforations.

9. The device of any one of claims 1-8 wherein the stress disconnect portion comprises a thickness that is less than one or more of a thickness of the removable portion and a thickness of the implantable portion.

10. The device of any one of claims 1-9 further comprising: a tissue engagement portion comprising a first arm and a second arm configured such that the first arm and the second arm can close or be moved closer together to capture tissue in the tissue engagement portion, at least one of the first arm and the second arm being movable to form a capture region therebetween for capturing the tissue; and one or more electrodes coupled to the tissue engagement portion.

11. A method comprising: fixating a flexible printed circuit board (PCB) to a device; releasing the flexible PCB from the device, wherein the step of releasing comprises: applying heat to a stress disconnect portion of the flexible PCB; and applying a pulling force to the flexible PCB while the stress disconnect portion is in a heated state.

12. A device comprising: a flexible PCB having a fixation portion; a base member having at least one opening through which the flexible PCB extends; a fixation device connected to the fixation portion; wherein the fixation device comprises a loop portion that maintains the fixation device connected to the fixation portion and prevents the flexible PCB from withdrawing from the base member opening; and wherein the loop portion unloops in response to a pulling force that allows the fixation device to be disconnected from the flexible PCB.

13. The device of claim 12 further comprising: a tissue engagement portion comprising a first arm and a second arm configured such that the first arm and the second arm can close or be moved closer together to capture tissue in the tissue engagement portion, at least one of the first arm and the second arm being movable to form a capture region therebetween for capturing the tissue; and one or more electrodes coupled to the tissue engagement portion.

14. A method comprising: fixating a flexible printed circuit board (PCB) to a device; releasing the flexible PCB from the device; wherein the step of releasing comprises; and unlooping a holding portion connected to the flexible PCB by applying a pulling force to the holding portion.

15. A device comprising: a flexible printed circuit board (PCB) body comprising: the flexible PCB body configured to be withdrawn through a catheter lumen; an electrode portion having one or more electrodes, and at least one electrode extension extending beyond the flexible PCB body and the electrode portion.

16. The device of claim 15 wherein the at least one electrode extension extends laterally beyond the flexible PCB body and the electrode portion.

17. The device of any one of claims 15-16 wherein the at least one electrode extension extends vertically beyond the flexible PCB body and the electrode portion.

18. A device comprising: a flexible printed circuit board (PCB) body comprising: the flexible PCB body configured to be withdrawn through a catheter lumen; an electrode portion having first and second pads, wherein the second pad comprises a variable resistance portion, and a sensing device comprising a first portion connected to the first pad and a second portion in moveable contact with the variable resistance portion of the second pad.

19. The device of claim 18 wherein the sensing device provides at least one of a leaflet capture status indication and a leaflet tension status indication.

20. The device of any one of claims 18-19 wherein the sensing device provides a change in voltage when deflected.

21. A device comprising: a tissue engagement portion comprising a first surface and a second surface, at least one of the first surface and the second surface being movable to form a capture region between the first surface and the second surface for capturing tissue; a sensing unit comprising one or more electrodes, the sensing unit coupled to the tissue engagement portion, wherein the device is configured such that the one or more electrodes: receive an electrical current, generate a signal responsive to the electrical current received, the signal providing an indication of a status of the tissue within the tissue engagement portion, and wherein at least a portion of the sensing unit is configured to be decoupled from the tissue engagement portion.

22. The device of claim 21, wherein the sensing unit comprises: an implantable portion comprising a first portion of one or more electrical traces connected to at least one of the one or more electrodes; a removable portion comprising a second portion of the one or more electrical traces; a stress disconnect portion, the stress disconnect portion comprising at least one stress concentration area, wherein the stress concentration area is configured to separate the removable portion from the implantable portion upon application of one or more stresses thereto.

23. The device of claim 22 wherein the sensing unit comprises a plurality of electrical layers including a first layer comprising one or more electrical traces that connect to the one or more electrodes and a second layer comprising high resistance electrical trace portions.

24. A system for repairing a native valve, the system comprising: a delivery system comprising: a catheter with a proximal end and a distal end; an actuation element; a wire extending within a lumen of the catheter from the proximal end of the catheter to the distal end of the catheter; and a capture mechanism at a distal end of the delivery system; and a treatment device comprising: an attachment portion comprising a proximal component configured to engage with the capture mechanism of the delivery system; an anchor portion comprising a tissue engagement portion having a first surface and a second surface configured to capture tissue; a distal portion configured to engage with the actuation element of the delivery system, the actuation element configured to deploy the anchor portion and to release the capture mechanism from the proximal component; a sensing unit comprising an electrode, the sensing unit coupled to the tissue engagement portion; wherein the treatment device is configured such that: the electrode can receive an electrical current, the electrode generates a signal responsive to the electrical current, the signal providing an indication of a status of the tissue within the tissue engagement portion, and at least a portion of the sensing unit is configured to be decoupled from the tissue engagement portion.

25. The system of claim 24, wherein the sensing unit comprises: an implantable portion having a first portion of one or more electrical traces connected to the electrode; a removable portion having a second portion of the one or more electrical traces; a stress disconnect portion, the stress disconnect portion comprising at least one stress concentration area, wherein the stress concentration area is configured to separate the removable portion from the implantable portion upon application of one or more stresses thereto.

26. The system of claim 25, wherein the sensing unit comprises a plurality of electrical layers including a first layer comprising one or more electrical traces that connect to the one or more electrodes and a second layer comprising high resistance electrical trace portions.

27. The system of any of claims 24-26, wherein the sensing unit comprises a PCB body, the PCB body comprising: an electrode portion comprising the electrode; at least one electrode extension extending beyond the PCB body and the electrode portion, wherein the PCB body is configured to be withdrawn through the lumen of the catheter.

28. The system of any of claims 24-27, wherein the sensing unit comprises a PCB body, the PCB body comprising: an electrode portion comprising the electrode, the electrode comprising a first pad and a second pad, wherein the second pad comprises a variable resistance portion; a sensing device, the sensing device comprising a first portion connected to the first pad and a second portion in moveable contact with the variable resistance portion of the second pad, wherein the PCB body is configured to be withdrawn through the lumen of the catheter.

29. The system of claim 28, wherein the sensing device deflects upon withdrawal of the sensing unit through a catheter lumen.

30. The system of any of claims 24-29, wherein the system is usable and/or configured for use with a real or simulated heart of a real or simulated subject.

31. A fixation apparatus for a flexible printed circuit used with an implantable medical device, the fixation device comprising: a body having: a first cantilevered lug portion; a second cantilevered lug portion; a beam portion between the first and second lug portions, the beam portion comprising one or more spaced apart recesses in a first side, and a projecting portion comprising at least one opening.

32. The fixation apparatus of claim 31 wherein the beam comprises a second side having a plurality of angled surfaces.

33. The fixation apparatus of any one of claims 31-32 wherein the first cantilevered lug portion and the second cantilevered lug portion each comprise an extension portion and hook portion.

34. A system comprising: a heart valve repair device having one or more paddles, each paddle comprising at least first and second openings; a flexible printed circuit having a distal end portion; a fixation mechanism comprising a body having: a first cantilevered lug portion; a second cantilevered lug portion; a beam portion between the first and second lug portions, the beam portion comprising one or more recesses in a first side, and a projecting portion comprising at least one opening.

35. The system of claim 34 wherein the first and second cantilevered lug portions extend from the first side of the beam portion.

36. The system of any one of claims 33-34 wherein the beam comprises a second side having a plurality of angled surfaces.

37. A system comprising: an implantable medical device comprising: one or more paddles; one or more claps spaced apart from the paddles, such that a space is formed between the clasps and paddles; one or more sensors located in the space between the paddles and clasps; a controller having inputs for reading signals generated by the one or more sensors and outputs for outputting one or more output signals; logic for reading the sensor signals and converting the read sensor signals to one or more status indicators that are output via the one or more output signals; and one or more output devices receiving the one or more output signals and generating outputs according to the output signals.

38. The system of claim 37 wherein the status indicators comprise one or more leaflet insertion depth indicators.

39. The system of any one of claims 37-38 wherein the output signals comprise haptic output signals.

40. The system of any one of claims 37-39 wherein the sensors are positioned on the paddles at first, second and third insertion depths.

41. The system of claim 40 wherein the sensors are positioned on the paddles at insertion depths comprising 3 mm, 6 mm, and 9 mm.

42. A system comprising: an implantable medical device comprising: one or more paddles; one or more clasps spaced apart from the paddles, such that a space is formed between the clasps and paddles; one or more sensors coupled to the implantable medical device, wherein the one or more sensors are disposed in the space between the paddles and clasps; a controller configured to receive one or more sensor signals from the one or more sensors via an input and further configured to output one or more output signals via an output; wherein logic associated with the controller generates the one or more output signals indicative of one or more status indicators based on the sensor signals; and one or more output devices configured to receive the one or more output signals and generate outputs according to the output signals.