Devices, systems and methods for placing anchors for artificial chordae - Patents.com

Abstract

An implantable device formed from a material that is not easily imageable and that may shift from a delivery configuration to a deployment configuration upon deployment is delivered and deployed using a deployment / delivery device having a sensor that generates a signal indicative of contact of the delivery / deployment device with tissue to ensure that the implantable device grips tissue upon deployment. The implantable device may be a tissue anchor having a claw that shifts from the delivery configuration to the deployment configuration. The sensor may be positioned along a distal end of the delivery / deployment device to indicate that the device has gripped tissue to ensure that the claw grips tissue upon deployment. The sensor may include at least three sensors that may be spaced apart from one another to indicate complete contact of the distal end of the delivery / deployment device with tissue. The sensor may optionally be aligned with the claw.

Description

[Technical field]

[0001] The present disclosure relates generally to the field of implantable medical devices. In particular, the present disclosure relates to medical devices, systems, and methods for delivering and deploying implantable devices. More particularly, the present disclosure relates to medical devices, systems, and methods for delivering and deploying anchors to secure engagement with and within cardiac tissue. [Background technology]

[0002] To avoid more complicated and invasive open-heart procedures, devices, systems, and methods for delivering and placing implantable devices using minimally invasive techniques, for example, transluminally, are desirable. For example, various techniques have been developed for cardiac procedures, such as repair or replacement of artificial chordae, including fixing the artificial chordae to cardiac tissue using transcatheter techniques without the need for open-heart surgery. Transcatheter or other types of non-invasive procedures generally require simultaneous visualization of both the targeted anatomical structure and the implantation tool (delivery and placement tool, as well as the implant itself). Unfortunately, current visualization tools cannot distinguish both the inorganic material (e.g., metal, polymer, ceramic, etc.) from which the implantation tool is made and tissue. Ultrasound easily distinguishes tissue, but is difficult with many foreign bodies, especially metallic components that are commonly implemented in medical devices and associated mechanisms and systems. Thus, devices and systems tend to cast shadows under fluoroscopy, obstructing the viewing of the targeted tissue and often the viewing of the device and mechanism as well. Fluoroscopy is well suited to viewing dense materials, but is generally not well suited to visualizing many soft tissues (eg, heart valve cusps).

[0003] A solution for verifying accurate placement of devices for delivering and deploying implants, such as artificial chordae tendineae anchors, to cardiac tissue and / or proper implantation of such anchors would be welcome. Summary of the Invention

[0004] This Summary of the disclosure is provided to aid in understanding, as those skilled in the art will appreciate that each of the various aspects and features of the disclosure can be advantageously used separately in some instances, or in combination with other aspects and features of the disclosure in other instances. The inclusion or exclusion of an element, component, or the like in this Summary is not intended to limit the scope of the claimed subject matter.

[0005] In accordance with various principles of the present disclosure, a delivery device configured to deliver an implantable device includes three or more sensors disposed along a distal end of the delivery device, the three or more sensors configured to generate signals when the distal end of the delivery device contacts tissue to ensure gripping of the tissue by the implantable device during deployment.

[0006] In some embodiments, the three or more sensors are spaced apart around the circumference of the distal end of the delivery device, hi some embodiments, the three or more sensors are spaced equidistant from one another.

[0007] In some embodiments, the delivery device is an anchor garage configured to deliver a tissue anchor to a deployment site, the tissue anchor having two or more claws shiftable from a delivery configuration to a deployment configuration. In some embodiments, the three or more sensors include at least one sensor associated with each claw of the tissue anchor delivered by the anchor garage. In some embodiments, the anchor garage has a blunt distal end along which the three or more sensors are disposed.

[0008] In some embodiments, the three or more sensors include contact sensors. In some embodiments, the delivery and placement device further comprises a delivery shaft through which leads extend from the three or more sensors.

[0009] In accordance with various principles of the present disclosure, a system for delivering and deploying an implantable device at a deployment site within the body includes an implantable device, a delivery device configured to deliver the implantable device to the deployment site, and three or more sensors disposed along a distal end of the delivery device, the three or more sensors configured to generate signals when the distal end of the delivery device contacts tissue to ensure gripping of the tissue by the implantable device without the need for imaging during deployment.

[0010] In some embodiments, three or more sensors are spaced around the circumference of the distal end of the delivery device. In some embodiments, the implantable device is a tissue anchor and the delivery device is an anchor garage configured to deliver the tissue anchor to a placement site. In some embodiments, the tissue anchor is clocked relative to the anchor garage. In some embodiments, the tissue anchor has two or more claws shiftable from a delivery configuration to a placement configuration, and the three or more sensors include at least one sensor associated with the claws of the tissue anchor. In some embodiments, the anchor garage includes a protrusion extending longitudinally along a portion of the anchor garage, the protrusion engaging a groove extending longitudinally along a portion of the tissue anchor to clock the tissue anchor relative to the anchor garage. Leads from the three or more sensors extend along the anchor garage and within the protrusion to a device that generates a signal indicative of contact of the three or more sensors with tissue. In some embodiments, the tissue anchor is clocked relative to the anchor garage to align at least one of the claws of the tissue anchor with one of the three or more sensors. In some embodiments, the system further includes an artificial chordae tensioning and locking device associated with the tissue anchor, the tissue anchor being clocked relative to the anchor garage to align the artificial chordae associated with the artificial chordae tensioning and locking device with the grooves in the anchor garage.

[0011] In accordance with various principles of the present disclosure, a method of delivering and placing an implantable device includes transluminally delivering the delivery and placement device to a placement site within the body and contacting three or more sensors on a distal end of the delivery and placement device with tissue at the delivery site to generate a signal indicative of the position of the delivery and placement device to ensure that the implantable device grasps tissue at the placement site.

[0012] In some embodiments, the three or more sensors are spaced apart along a distal end of the delivery and placement device, and the method further includes placing the implantable device when three of the three or more sensors generate a signal indicative of contact with tissue. In some embodiments, the placement site is cardiac tissue and the implantable device is a tissue anchor, and the method further includes placing the tissue anchor in the cardiac tissue when all three of the three or more sensors generate a signal indicative of contact between the distal end of the delivery and placement device and tissue at the placement site, without imaging the implantable device or the placement site.

[0013] These and other features and advantages of the present disclosure will become readily apparent from the following detailed description, and the scope of the claimed invention is set forth in the appended claims. Although the following disclosure is presented in terms of aspects or embodiments, it should be understood that each aspect can be claimed separately or in combination with aspects and features of that embodiment or any other embodiment.

[0014] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and are not intended to be drawn to scale. The accompanying drawings are provided for illustrative purposes only, and the dimensions, positions, order, and relative sizes reflected in the figures in the drawings may be changed. For example, devices may be enlarged so that details are discernible, but are intended to be reduced in relation to, for example, fitting within a working channel of a delivery catheter or endoscope. In these figures, identical, nearly identical, or equivalent elements are typically represented by the same reference characters, and similar elements are typically designated by similar reference numbers that are different, incremented by 100, and redundant descriptions are omitted. For purposes of clarity and simplicity, not every element is labeled in every figure, and not every element of each embodiment is shown, unless illustration is necessary to enable a person skilled in the art to understand the present disclosure.

[0015] The detailed description will be better understood in conjunction with the accompanying drawings, in which like reference characters represent like elements and in which: [Brief description of the drawings]

[0016] [Figure 1] 1 shows a perspective view of one example of an embodiment of an anchor delivery and placement device and system formed in accordance with various principles of the present disclosure, shown within a schematic diagram of a heart, for placing anchors in cardiac tissue. [Diagram 2] 1 shows a perspective view of one example of an embodiment of an anchor delivery and deployment device and system formed in accordance with various principles of the present disclosure, optionally with associated delivery catheter and leaflet clip delivery / deployment system shown in dashed dotted lines. [Diagram 3] 3 shows a further perspective view of an example embodiment of an anchor delivery and placement device and system as shown in FIG. 2, further showing an example embodiment of a sensor disposed at the distal end of the anchor delivery and placement device and system according to various principles of the present disclosure. [Figure 4] FIG. 4 is an end view of the anchor delivery and placement device of FIG. 3. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] The following detailed description should be read with reference to the drawings showing exemplary embodiments. It should be understood that the disclosure is not limited to the specific embodiments described and may therefore be modified. All devices and systems and methods discussed herein are examples of devices, systems, and / or methods implemented according to one or more principles of the disclosure. Each example of an embodiment is provided as an illustration and is merely an example, not the only way to implement these principles. Thus, references to elements, or structures, or features in the drawings should be understood as references to examples of embodiments of the disclosure and should not be understood as limiting the disclosure to the specific elements, structures, or features shown. Other examples of ways to implement the disclosed principles will occur to those skilled in the art upon reading the disclosure. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in the disclosure without departing from the scope or spirit of the subject matter. For example, features illustrated or described as part of one embodiment can be used with another embodiment to yield still further embodiments. Thus, it is intended that the present subject matter covers such modifications and variations as come within the scope of the appended claims and their equivalents.

[0018] It will be understood that in this application, the disclosure is described in various levels of detail. In certain instances, details that are not necessary for a person skilled in the art to understand the disclosure or that make it difficult for the person skilled in the art to appreciate other details may be omitted. The terms used herein are for the purpose of describing certain embodiments only and are not intended to be limiting beyond the scope of the appended claims. Unless otherwise defined, technical terms used herein should be understood as commonly understood by those skilled in the art to which the disclosure belongs. All of the devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure.

[0019] As used herein, "proximal" refers to the direction or location closest to a user (such as a medical professional, or clinician, or technician, or operator, or physician, and such terms are used interchangeably herein without limitation and include automated controller systems or other modalities) and / or closest to a delivery device, such as when using the device (e.g., when introducing the device into a patient or when implanting, placing, or delivering), and "distal" refers to the direction or location furthest from a user and / or closest to a delivery device, such as when using the device (e.g., when introducing the device into a patient or when implanting, placing, or delivering). "Longitudinal" means extending along the longer or greater dimension of an element. "Center" means at least generally intersecting the center point and / or generally equidistant from the periphery or boundary, and "central axis" means, with respect to an opening, a line that at least generally intersects the center point of the opening and extends longitudinally along the length of the opening, e.g., if the opening comprises a tubular element, channel, cavity, or hole.

[0020] Various devices and systems delivered transluminally into a patient's body include components formed from metals or other materials that are not easily visible or visualized or otherwise identifiable with typical or current imaging systems for imaging body tissues (e.g., fluoroscopy or ultrasound imaging). Tools and systems for visualizing / imaging tissues generally do not provide sufficient clarity to visualize metallic or polymeric systems or devices delivered to such tissues. In accordance with various principles of the present disclosure, the devices, systems, and methods described herein facilitate manipulation of the devices and systems relative to body tissues without visualizing or imaging the devices or systems (e.g., with a tool or system used to visualize or image the body tissue). More specifically, various principles of the present disclosure facilitate fixation of one or more devices to tissues, such as cardiac tissues (e.g., papillary muscle tissue). Even more specifically, various principles of the present disclosure facilitate fixation of anchor devices to tissues. The term anchor device is used for convenience and may be used interchangeably herein with terms such as anchor, anchor element, anchor mechanism, anchor component, anchoring element, anchoring device, anchoring mechanism, anchoring component, and the like, with it being understood that such terms are known in the art to describe structures configured to be held in place, and optionally also structures configured to hold another object in place. It is further understood that various terms such as attach, fix, implant, secure, fasten, couple, engage, hold, maintain, embed, grasp, and the like may be used interchangeably herein (in various grammatical forms) to refer to the attachment of an anchor to tissue, without any intent of limitation.In accordance with various principles of the present disclosure, sensors, such as contact sensors, are associated with the implantable device and / or delivery and placement device and / or system to provide information not readily discernible with typical or current imaging techniques, such that the delivery / placement device and / or implantable device do not need to be imaged or visualized to determine the relationship (e.g., spacing, degree of contact, etc.) provided to at least a portion of the delivery and placement device to facilitate placement of the device relative to tissue.

[0021] The devices, systems, and methods of the present disclosure may be used alone or together with other devices, systems, and methods to treat cardiac disease. For example, the principles of the present disclosure may be applied to procedures for repairing cardiac valves (e.g., to ensure proper function and closure of the cardiac valve), such as repositioning, repairing, and / or replacing one or more cardiac valve leaflets and / or chordae tendineae. Examples of devices, systems, and methods in which embodiments of the present disclosure may be implemented include, but are not limited to, U.S. Patent Application Publication No. 2021 / 0007847, published on January 14, 2021, entitled Devices, Systems, And Methods For Clamping A Leaflet Of A Heart Valve, U.S. Patent Application Publication No. 2021 / 0000597, published on January 7, 2021, entitled Devices, Systems, And Methods For Adjustably Tensioning An Artificial Chordae Tendineae Between A Leaflet And A Papillary Muscle Or Heart Wall, U.S. Patent Application Publication No. 2021 / 0000599, published on January 7, 2021, entitled Devices, Systems, And Methods For Artificial Chordae Tendineae, and U.S. Patent Application Publication No. 2021 / 0000599, published on January 7, 2021, entitled Devices, Systems, And Methods For Anchoring An Artificial Chordae Tendineae To A Papillary Muscle No. 2021 / 0000598, entitled "Or Heart Wall," and U.S. patent application Ser. No. __ / _______, filed September 30, 2020 [Attorney Docket No. 8150.0752Z], U.S. patent application Ser. No. __ / _______, filed September 1, 2021 [Attorney Docket No. 2001.2700100, formerly 8150.0802Z], and U.S. Provisional Patent Application Ser. No. 63 / _______, filed September 1, 2021 [Attorney Docket No. 2001.2701100, formerly 8150.0803Z], the contents of each of which are incorporated herein by reference in their entirety for all purposes.It should be understood that the devices and systems described herein may be used in conjunction with the devices or systems disclosed in the above-referenced applications incorporated herein or may be used in conjunction with other devices and systems.

[0022] Intravenous / transcatheter exchange of one or more artificial chordae involves attaching the artificial chordae, such as expanded polytetrafluoroethylene (ePTFE) sutures, to cardiac tissue, such as the ventricular wall / papillary muscles. Various methods of attaching the artificial chordae use anchoring devices, such as anchors having one or more (typically two or more, three or more, or even four or more) claws. The anchors used according to various principles of the present disclosure may include multiple claws that are biased into a deployed configuration for engaging tissue, but may also be placed in a delivery configuration for delivery to tissue, such as in an anchor delivery and deployment device of an anchor delivery and deployment system. The delivery configuration may be a compact or compressed configuration, and the deployment configuration may be an open or expanded configuration (having a larger outer dimension than the anchor when in the delivery configuration). When pressed against body tissue, the claws of the anchor may pierce and penetrate the tissue and expand into a deployed configuration that is anchored within the body tissue. The anchor (including the anchor claws) may be formed from an elastic and / or shape memory material such as Nitinol, and may be formed (e.g., by heat treatment) into a desired open configuration and shaped to ensure a secure connection of the anchor with the cardiac tissue. Thus, the anchor claws are biased to open substantially automatically into the open configuration without the anchor claws being moved by an external force. It should be understood that terms such as open, expand, shift, move, transition, and the like (and various grammatical forms related to those terms) may be used interchangeably and without any limiting intent herein to refer to the movement of the anchor claws. An example of an artificial chordae anchor that may be used with the devices, systems, and methods disclosed herein includes, but is not limited to, the anchor disclosed in U.S. Provisional Patent Application No. 63 / _______, filed September 1, 2021 [Attorney Docket No. 2001.2700100, formerly 8150.0803Z], referenced above and incorporated by reference.

[0023] In general, it is desirable for the distal end of an anchoring device, such as an artificial chordae anchor, to adequately and / or completely engage the tissue with which it is engaged. For example, if an artificial chordae anchor includes one or more claws, it is generally desirable for the distal end of the claw to engage the tissue into which the claw is embedded prior to deployment from the delivery and deployment device. It should be understood that terms such as deploy, eject, push, release, push, eject, dispense, and the like (and various grammatical forms of those words) may be used interchangeably herein, without any intention of limitation. In some embodiments, the anchor is deployed by being pushed into the cardiac tissue from a delivery location relative to the delivery and deployment device (e.g., within a garage or other seat or delivery area on the delivery and deployment device). It may be particularly important for a portion of the anchor, such as the claw, to change position or configuration upon deployment (e.g., if the claw bends outward to tightly engage in tissue to hold the anchor in place) for such portion to engage the tissue prior to deployment. More specifically, engaging such portions of the anchor with the tissue prior to driving the anchor into the cardiac tissue allows such portions to penetrate the tissue before changing position or configuration.

[0024] Current visualization / imaging tools generally do not provide sufficient clarity to visualize both the body tissue and the device, such as the anchor, making it generally difficult to ensure proper tissue contact along the distal end of the anchor, such as visualizing the anchor's claws and the tissue entry point where the anchor's claws penetrate the tissue. Lack of contact between the anchor and the tissue typically results in that portion of the anchor (e.g., the claws) not gripping or penetrating the tissue. Additionally, it is generally desirable to place the anchor in the proper tissue, such as muscle tissue rather than adipose tissue, and / or in the proper location and / or orientation, such as papillary tissue rather than the apex of the heart.

[0025] In accordance with various principles of the present disclosure, one or more sensors are associated with the implantable device, the delivery and placement device, and / or the delivery and placement system to communicate information about the implantable device and placement site. The sensors may include electrodes (such as conductive pads) and corresponding electronics. The information may include, but is not limited to, the degree of engagement of the delivery and placement device with tissue at the placement site, the position of the implantable device with tissue at the placement site, and / or further information about the device or system. It should be understood that terms such as placement site, treatment site, implantation site, and the like may be used interchangeably herein without any intent of limitation. It should be understood that references herein to delivery and / or placement are intended to include delivery or placement, or both. It should be further understood that placement may include fixation of the device in addition to placement of the device. The delivery / placement device may be configured to hold and / or carry the implantable device for delivery to the placement site and / or to facilitate placement of the implantable device within tissue. For example, the delivery / deployment device may be configured to manipulate the implantable device to position and deploy (e.g., anchor, implant, secure, etc.) the implantable device relative to tissue at the deployment site. It will be understood that terms such as operate (and other grammatical forms of those words) may be used interchangeably herein with terms such as actuate, control, steer, move, operate, shift, transition, drive, advance, retract, rotate, translate, etc. (and other grammatical forms of those words) without any limitation intended.

[0026] In some embodiments, the one or more sensors are contact sensors. For example, the one or more sensors may directly indicate at least the level of engagement of the delivery and placement device with the tissue in which the anchor is to be placed. The one or more sensors relay a signal to a medical professional (e.g., a surgical team) using the system to implant the anchor when the anchor contacts tissue, or at least when the delivery and placement device contacts tissue sufficiently to ensure proper placement of the anchor. Such information is communicated in any of a variety of ways (e.g., visual or audible indications, such as on the delivery system or a separate associated device) to the medical professional (e.g., a surgical team, including any automated systems utilized) to facilitate placement, implantation, etc. of the anchor device. For example, such information may be used to guide placement of the anchor and the delivery and placement device and / or to determine whether repositioning is required prior to placement of the anchor. More than one sensor may be provided to indicate the spatial extent of contact with the tissue (e.g., length or surface area), the location of the delivery and placement device and anchor relative to the tissue (positioned to ensure placement resulting in implantation of the anchor), the degree to which the device grips the tissue, further information about the implantable device, etc. In some embodiments, multiple sensors may be used, e.g., to generate various information, e.g., to indicate both tissue contact and the location of the device relative to the tissue. Electronics associated with the sensors may sense the tissue in contact with the sensor, e.g., the resistance, impedance, capacitance, etc. of the tissue between the sensors (e.g., between the electrodes of the sensor). The optimal electrode spacing and the most appropriate sensing method may be determined based on the tissue with which the medical device will be associated. An optimal system will generally have the greatest signal-to-noise ratio (SNR), thereby improving the reliability of sensing. Two major factors that affect the SNR are the sensing method and the contact spacing. These values ​​may be determined by experimentation, and it is expected that the optimal configuration will depend on the target tissue and environment (e.g., in this case, the ventricular wall and blood region).In some embodiments, the one or more sensors transmit a signal that generates a visual indication (e.g., a lighted signal that generally indicates engagement or provides further detailed visual information) and / or an audible indication (e.g., a sound that generally indicates engagement or provides further information), e.g., on the delivery system or a separate associated device. Other forms and methods of providing information regarding devices, systems, methods, etc. are within the scope of this disclosure, and the broad concepts are not so limited.

[0027] It should be understood that the sensor may be formed from a conductive material. Additional conductive components, such as leads, traces, connecting paths, solder pads, wires, etc., may be associated with the sensor, for example, to communicate information to a medical professional and / or to provide power to the sensor. The conductive material may be selected from any of a variety of materials, such as, but not limited to, titanium, niobium, gold, nickel-copper, silver, tin, platinum, palladium, tantalum, tungsten, etc.

[0028] In examples disclosed herein, an anchor delivery and deployment system formed according to various principles of the present disclosure is configured to deliver an anchor disposed within a delivery and deployment device, such as an anchor garage, in a delivery configuration. In some embodiments, the anchor garage is disposed within a catheter typically having an inner diameter of about 0.22 inches (5.59 mm), and the anchor garage may have an outer diameter of about 0.12 inches (3.048 mm) (and in some embodiments, an inner diameter of about 0.1065 inches / 2.7051 mm). For example, the anchor garage may constrain or hold the anchor's claws in a compact configuration to fit within the inner diameter of the anchor garage. In some embodiments, the anchor's claws are elongated or elongated in the compact configuration to extend along the longitudinal axis of the anchor garage. An actuator, such as a pusher rod, may be used to move the anchor from the anchor garage for deployment in body tissue. Once the anchor is no longer within the anchor delivery and deployment device, the anchor's claws may be moved to an open configuration, such as an expanded configuration. In the expanded configuration, the anchor may have an outer diameter that is larger than its outer diameter when in the delivery configuration and larger than the inner diameter of the anchor garage. In accordance with various principles of the present disclosure, a sensor is provided at the distal end of the delivery and deployment device, such as at the distal end of the anchor garage. An anchor garage with an enlarged or blunt distal end, such as described in U.S. Provisional Patent Application No. 63 / _______, filed September 1, 2021, and incorporated herein by reference, provides sufficient surface area for one or more sensors to be spaced apart, for example, from one another.

[0029] Thus, various principles of the present disclosure are described herein with reference to embodiments of, for example, tissue anchors for anchoring artificial chordae, as well as associated devices, systems, and mechanisms. However, it will be understood that the principles of the present disclosure may be applied more broadly to other devices, systems, methods, etc. configured to engage body tissue. The devices, systems, and methods described herein provide a robust solution for patient safety, particularly with respect to implantable devices. Thus, it will be understood that the devices, systems, and methods described herein may be used with any of the devices, systems, methods, etc. disclosed in the applications referenced above and incorporated herein, or with devices, systems, methods, etc. described herein or in other ways.

[0030] Various embodiments of devices, systems, and methods for positioning an implantable device will now be described with reference to examples shown in the accompanying drawings. References herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc. indicate that one or more particular features, structures, and / or characteristics according to the principles of the present disclosure may be included in connection with that embodiment. However, such references do not necessarily mean that all embodiments include that particular feature, structure, and / or characteristic, or that an embodiment includes all features, structures, and / or characteristics. Some embodiments may include one or more such features, structures, and / or characteristics in various combinations thereof. Moreover, references in various places herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc. are not necessarily all referring to the same embodiment, and separate or alternative embodiments are not necessarily mutually exclusive of other embodiments. It is to be understood that when a particular feature, structure, and / or characteristic is described in connection with one embodiment, such feature, structure, and / or characteristic can also be used in connection with other embodiments, whether or not explicitly described, unless expressly stated otherwise. It is further to be understood that such features, structures, and / or characteristics may be used or presented alone, or may be used or presented in various combinations with each other to create alternative embodiments that are considered part of this disclosure, since describing all of the many possible combinations and subcombinations of features, structures, and / or characteristics would be overly burdensome. Furthermore, various features, structures, and / or characteristics are described that may be exhibited by some embodiments but not by other embodiments. Similarly, various features, structures, and / or characteristics or requirements are described that may be features, structures, and / or characteristics or requirements with respect to some embodiments but not with respect to other embodiments. Thus, the present disclosure is not limited to only the embodiments specifically described herein.

[0031] Referring now to the drawings, it will be understood that common features are identified by common reference elements and that for brevity and convenience, and without intent to be limiting, descriptions of common features will generally not be repeated. For purposes of clarity, not all components have been labeled with the same reference numerals.

[0032] An example of an embodiment of a system and device to which various principles of the disclosure may be applied is a delivery and deployment system 100 as shown in FIG. 1. The illustrated example is configured to deliver and deploy a device for cardiac surgery, such as cardiac valve leaflet repair, but the principles of the disclosure may also be applied to other transluminally / transcatheter delivered devices. The delivery and deployment system 100 includes an anchor delivery and deployment device 110 configured to deliver and deploy a cardiac anchor 120 to cardiac tissue, as shown. Optionally, the delivery and deployment system 100 also includes a leaflet clip spreader 1000 configured to deliver leaflet clips 1010 (clearly shown with the leaflet clip spreader 1000 in dashed lines in FIG. 2) to the cardiac valve leaflets. The delivery and deployment system 100, which may be guided within a delivery guide sheath 104, may be delivered to a deployment site by a delivery catheter 102. To enable transluminal (e.g., transcatheter, as opposed to open surgery) delivery of medical devices within the body, thereby avoiding invasive open surgery, the delivery catheter 102 and delivery guide sheath 104 may be flexible tubular elements (e.g., catheters, sheaths, shafts, tubes, etc.) that are steerable through tortuous paths through the body. The delivery guide sheath 104 may be introduced into the body through the femoral artery with a dilator and cross the septum into the ventricle. The delivery catheter 102 may be steerable (e.g., articulated) to be substantially centered above the mitral valve. The anchor delivery and placement device 110 may be carried by a shaft 106 that is extendable or retractable (e.g., telescopically into or out of the delivery catheter 102) from the delivery catheter 102 and positioned relative to (e.g., closer to) the treatment site in the heart.

[0033] In accordance with various principles of the present disclosure, the anchor delivery and placement device 110 is configured to house or hold an implantable device, such as the anchor 120. The implantable device may be shiftable from such a delivery configuration to a placement configuration. The delivery configuration of the implantable device may be a generally unexpanded configuration, and the placement configuration of the implantable device may be a generally expanded configuration. The anchor delivery and placement device 110 may be configured to deliver the implantable device in a delivery configuration, as may be understood with reference to FIGS. 2 and 3. In one illustrated example embodiment, the anchor delivery and placement device 110 includes a delivery device configured to carry or hold the implantable device during delivery of the implantable device, which may be in the form of, but is not limited to, a distal end of the delivery shaft 108 or an anchor garage 130 (which may be operatively associated with an end of the delivery shaft 108, as may be seen in FIG. 2). For convenience, and without any intent of limitation, reference is made herein to the anchor garage 130, and such reference is understood to include configurations of the delivery device other than the illustrated anchor garage 130. The anchor garage 130 may be configured with an open blunt distal end 131 (tip or free end) that is sized, shaped, configured, and dimensioned to facilitate pressing the anchor garage 130 against the cardiac tissue to deploy the anchor 120 from the anchor garage 130 into the tissue T at the deployment site without the possibility of forcing the distal end 131 of the anchor garage 130 into the cardiac tissue. For example, the distal end 131 of the anchor garage 130 may be inwardly rounded or curved (presenting a convexly curved outer surface) or otherwise formed to be sufficiently blunt so as not to injure the tissue against which the anchor garage 130 is pressed. For example, but not limited to, the edge of the distal end 131 of the anchor garage 130 may be curved with a radius of about 0.0275 inches (0.6985 mm).

[0034] As can be seen with reference to Figures 2 and 3, an anchor 120 formed according to various principles of the present disclosure has a plurality of claws 122 extending distally, for example from an anchor body 124 to its distal end 121. The anchor 120 can be coupled with an artificial chordae tensioning and locking device 140 to secure an artificial chordae 150 to the anchor 120. The artificial chordae tensioning and locking device 140 is structured and configured to receive the artificial chordae 150 and hold the artificial chordae 150 in a desired position and / or configuration, for example, relative to the anchor 120. The specific structure of the artificial chordae tensioning and locking device 140 is not critical to the present disclosure and can be of any desired structure, including, but not limited to, structures disclosed in any of the patent applications referenced herein and / or incorporated by reference.

[0035] In general, it is desirable for the anchors 120 used with the devices, systems, and methods of the present disclosure to establish a strong grip in or against tissue so that the anchors 120 are not inadvertently pulled out of the tissue. Thus, the anchors 120 may be sized, shaped, formed, and configured to resist tension on the anchors 120 (e.g., from movement of the valve leaflets to which the artificial chordae 150 coupled to the anchors 120 are also connected). The distal ends 121 of the anchors' claws 122 may each have a tapered or pointed tip suitable for piercing the tissue so that the claws 122 penetrate the tissue, thereby allowing the anchors 120 to be firmly secured to the tissue when the anchors 120 engage the tissue. The claws 122 may be curved, arcuate, or otherwise configured to move the distal ends 121 of the claws in a direction that anchors the anchors to the tissue. For example, when the anchor 120 is moved from a delivery configuration (e.g., within the anchor garage 130 as shown in FIG. 3) to a deployed configuration (e.g., outside the anchor garage 130), e.g., into tissue T at the deployment site, the claws 122 may shift radially outward from the longitudinal axis LA of the anchor delivery and deployment system 100, e.g., bending back toward the anchor body 124. It is understood that other movements or bending of the claws 122 (e.g., by moving radially inward or outward transversely to the longitudinal axis of the anchor 120) or other manners of ensuring that the anchor 120 grips into tissue T at the deployment site are within the scope of the present disclosure. In some embodiments, the claws 122 may be formed from a shape memory material and may optionally act as a spring to shift the distal end 121 into the deployed configuration. In embodiments in which the anchor is secured within cardiac tissue (eg, to secure artificial chordae to papillary muscles), the strength of the claw generally must be balanced with the flexibility of the claw.For example, the claws should be strong enough to withstand multiple palpatory forces (e.g., over 800 million) imposed on them, but not deform or break when changing shape (e.g., bending or straightening, such as when shifting between a delivery configuration and an indwelling configuration). The (radial) thickness of at least some of the claws may be varied to achieve a desired pull-out resistance / gripping strength in tissue without becoming so thick that it may deform or break (thicker claws are generally stronger and have greater retention). Additionally or alternatively, the width of the claws may be selected to achieve a desired tissue gripping strength as well as material strength (to resist deformation or breakage). The length of the claw formed therefrom may be selected such that the claw penetrates sufficiently into the tissue but is not so long that its distal end exits the tissue (e.g., enters from one side and exits from another, or enters the tissue and bends through the tissue and exits from the same side of the tissue as the entry point). Various further details of the shape and configuration of the anchor 120 and claw 122 may be understood by one of ordinary skill in the art, but the present disclosure is not limited by such details.

[0036] It should be appreciated that when an anchor 120 is deployed having a claw 122 that is pre-shaped to move from the anchor delivery and deployment device 110 upon deployment, as described above, without the distal end 121 of the anchor engaging the tissue into which the anchor 120 will be implanted, the claw 122 may move to the deployed configuration without penetrating tissue. As described above, to ensure proper deployment of the anchor 120, it is generally important that the distal end 121 of the claw 122 contacts tissue before the anchor 120 is deployed and the claw 122 is moved into the deployed configuration. Additionally, it is desirable to ensure that the anchor 120 is deployed in the right location and / or in the right type of tissue so that the anchor 120 is securely engaged with the tissue for a desired purpose (e.g., to secure the artificial chordae 150 to papillary muscle tissue).

[0037] In accordance with various principles of the present disclosure, one or more sensors 160 are associated with the anchor delivery and placement device 110, as well as associated with the anchor 120, to facilitate placement of the anchor 120 to ensure secure engagement with tissue (e.g., to secure another implantable device, such as artificial chordae 150, to tissue) and / or to facilitate proper placement of the anchor 120. For example, one or more sensors 160 may be associated with the anchor garage 130 and thereby associated with the anchor 120. More specifically, the sensors 160 may be spaced apart along the distal end 101 of the anchor delivery and placement device 110, such as on the distal end 131 of the anchor garage 130, spaced apart along the circumference of the distal end 131. As discussed above, the distal end 131 of the anchor garage 130 may be a blunt, rounded end, and may be sized, shaped, configured, and dimensioned in a manner understood by one of ordinary skill in the art to provide sufficient space to position the sensor 160 to effectively contact tissue to generate a desired signal upon contact with the tissue. For example, the distal end 131 of the anchor garage 130 may have an outer diameter of about 0.175 inches (4.445 mm) and an inner diameter of about 0.107 inches (2.718 mm), with an electrode size of about 0.015 inches (0.381 mm) by 0.030 inches (0.762 mm). In some embodiments, one or more sensors 160 may be positioned directly adjacent to each claw 122 of the anchor 120 to indicate contact of the anchor garage 130 with tissue. Contact of the anchor garage 130 with tissue should ensure the desired intimate contact of the claw 122 with tissue upon deployment of the anchor 120 to ensure gripping of the tissue by the claw 122. A variety of suitable sensors are available to generate a useful and usable signal that indicates whether the anchor delivery and deployment device 110 is in contact with tissue or is otherwise ready to deploy an anchor.For example, sensor 160 may be a contact sensor (e.g., including electrodes that generate a signal upon contact with tissue) that can indicate when anchor delivery and placement device 110 is in contact with tissue so as to ensure engagement of claws 122 of anchor 120, and / or an impedance sensor (measuring the impedance of a material with which the sensor is in contact). In some embodiments, sensors 160 can sense various parameters, such as impedance resistance, impedance, capacitance, etc. between each other to indicate contact, location, type of tissue in contact (e.g., fatty tissue vs. muscle tissue), and other information useful for proper / desired placement of anchor 120.

[0038] In accordance with various principles of the present disclosure, at least three sensors 160 are provided along the distal end 111 of the anchor delivery and placement device 110, as shown in Figures 2, 3, and 4. The at least three sensors 160 define a plane along the distal end 111 of the anchor delivery and placement device 110 such that when all three sensors 160 are in contact with tissue, the plane in which the distal end 111 of the anchor delivery and placement device 110 is located is in contact with tissue, and the claws 122 of the anchor 120 (delivered by the anchor delivery and placement device 110) should be in contact with tissue upon deployment from the anchor delivery and placement device 110. In other words, when all sensors 160 on the distal end 111 of the anchor delivery and placement device 110 are in contact with tissue, the distal end 111 should be "perpendicular" to the tissue (e.g., completely in contact with tissue along the circumference of the delivery and placement device 110) and not at an angle. Such position verification should ensure that all of the claws 122 of the anchor 120 engage tissue upon deployment to achieve the desired penetration and grip on the tissue. If the anchor delivery and deployment device 110 is angled, it is likely that some of the claws 122 will not grip the tissue T at the treatment site. It should be appreciated that four or more sensors 160 may be provided.

[0039] In some embodiments, each claw 122 of the deployed anchor 120 may have an associated sensor 160 disposed adjacent to and / or aligned with the claw 122. In the example embodiment shown in Figures 2, 3, and 4, four sensors 160 are provided, each aligned with a claw 122 of the anchor 120. At least a portion of the anchor 120 and at least a portion of the anchor delivery and placement device 110 may be provided with corresponding clocking elements to maintain alignment of the anchor 120 with the sensors 160 on the anchor delivery and placement device 110 or to otherwise hold the anchor 120 in a predetermined position or otherwise maintain a selected position relative to the delivery and placement device 110. In some embodiments, the clocking elements include a groove or protrusion on a portion of the anchor 120 and a corresponding mating protrusion or groove on the anchor delivery and placement device 110. In some embodiments, as shown in FIG. 4 , the anchor body and / or the artificial chordae tensioning and locking device 140 associated with or coupled to the anchor 120 may be provided with or formed with a clocking element 142 (e.g., in the form of a longitudinally extending groove), and the anchor garage 130 within which the anchor 120 is delivered to the deployment site may be provided with or formed with a corresponding clocking element 132 (e.g., in the form of a longitudinally extending protrusion or rib). Engagement of the clocking elements 142, 132 prevents relative rotation of the anchor 120 and its associated claw 122 with respect to the anchor delivery and deployment device 110 and its associated sensor 160. In some embodiments, the clocking elements 142, 132 may also align the artificial chordae 150 extending from the anchor 120 (e.g., from the artificial chordae tensioning and locking device 140) with the slot 132 of the anchor garage 130 to extend to the leaflet clip 1010.In some embodiments, the anchor garage 130 may be formed from a metal or a polymer and is adhered onto a delivery catheter or shaft 108 (shown in phantom in FIG. 2 ), which is typically formed from a polymer (but may optionally be formed from a combination of polymer and metal braid or coil, or from a metal). The anchor garage 130 and artificial chordae tensioning and locking device 140 may be machined or molded, or formed in other manners known to those skilled in the art, to include clocking elements 142, 132 (such as, but not limited to, those described above).

[0040] The sensors 160 may be formed in any desired manner to sense contact with tissue and generate an appropriate signal indicative of contact with tissue. For example, the sensors 160 are configured to sense and generate a signal (e.g., an impedance measurement), and therefore are typically conductive. A variety of suitable sensors, such as those known to those skilled in the art, are available to generate a useful and usable signal that indicates whether the anchor delivery and placement device 110 and the anchor 130 are in place or in contact, or otherwise ready to place the anchor 120. In accordance with various principles of the present disclosure, three or more sensors 160 are provided that can indicate contact with tissue. In some embodiments, a signal is generated when all three sensors 160 contact tissue. In some embodiments, a signal is generated separately for each sensor 160 (e.g., to indicate the angular position of the anchor delivery and placement device 110 relative to the tissue T at the treatment site). Such information may be used by a medical professional to adjust the position of the anchor delivery and placement device 110 as necessary to ensure proper delivery and placement of the anchor 120. One or more of the three or more sensors 160 may optionally identify the type of tissue contacted. For example, the sensor may be a contact sensor or an impedance sensor that measures the impedance of a material contacted by the sensor. Such impedance-based sensors may be used in techniques used in electrophysiology devices that map the heart, for example, based on the electrical activity of the heart, to distinguish body tissue from other materials and / or to distinguish different types of tissue (e.g., muscle, fat, etc.) based on the impedance measured upon contact with such tissue. The sensor 160 may be formed from a conductive biocompatible material, such as, but not limited to, niobium, silver, titanium, tungsten, tantalum, etc., as well as nitrides or oxides. The choice of material for the conductive layer 146 may be influenced by the desired sensing function (e.g., impedance measurement capability), associated circuitry, electrical requirements, signal output requirements, etc.

[0041] In some embodiments, the multiple sensors 160 are formed as a flexible circuit board with one or more contacts (e.g., exposed pads or other contact features). For example, the circuit board may include a metallized plate with various regions insulated from one another and a conductive sensor that generates a signal upon contact with tissue. The circuit board may be generally insulating, except for the exposed pads or other contact features of the sensor. Insulated wires, as known in the art, may pass through holes in the circuit board and run proximally through or along the various catheters / shafts 108, 106, 104, 102 of the delivery / deployment system 100, for example, to deliver power to the circuit board and transmit signals from the sensor to a device to indicate information to a medical professional (such as contact of the sensor 160 with tissue). Alternatively, the sensors may be individual pads, for example, with insulating material provided to insulate the pads from the anchor garage 130 or other conductive elements. The sensor 160 may be stamped, machined, printed, or formed on the substrate in any desired manner, including, but not limited to, adhesive bonding, interference fit (e.g., fitting into a groove, pocket, recess, etc.), physical vapor deposition (e.g., sputter coating, thermal evaporation, arc spray, etc.), electroless plating, electrolytic plating, brazing, or other bonding methods. The area of ​​the anchor delivery and placement device 110 in which the sensor 160 is provided (e.g., the anchor garage 130) may be masked or otherwise protected to limit the area to which the sensor 160 material and / or any associated leads, traces, connection paths, solder pads, etc. are applied. Other configurations of the sensor 160 are within the scope of the present disclosure, and the details are not critical to the principles of the present disclosure.

[0042] As mentioned above, at least one lead extends proximally along the delivery and placement system 100 from the at least one sensor 160 to a proximal location where power may be provided to the lead and / or the lead may be coupled to an indicator that generates a signal from the one or more sensors 160 to transmit information sensed by the one or more sensors 160 to a medical professional operating the delivery and placement system 100 and / or to transmit power to the one or more sensors 160. As can be appreciated, the indicator may be any known indicator configured to provide desired information in a desired form or configuration to a medical professional operating the delivery and placement system 100. For example, the signal may simply be a red light indicating insufficient or no contact, or a green light indicating sufficient or complete contact. Further detailed signals may be generated to provide more detailed information regarding, for example, the position, location, degree of grip or engagement of the anchor 120 (or another implantable device), the details of which are not important to the broad principles of the present disclosure. Each sensor 140 may have its own lead. Because the wall thickness of the anchor delivery and placement device 110 (e.g., anchor garage 130) is generally limited, the leads of the sensor 160 may run together along a common passageway within the anchor garage 130, into the delivery shaft 108, and proximally to a station (e.g., for a power source, or for a signal indicating device). In some embodiments, the common channel is formed in the clocking element 132 in the form of an axial protrusion along the anchor garage 130, which protrusion provides additional wall thickness to accommodate the leads.

[0043] As can be appreciated by those skilled in the art, it can be difficult to achieve proper gripping of tissue with various implantable devices, such as devices having shape memory components that bend or flex upon deployment, such as the claws of the tissue anchor. Providing one or more sensors as disclosed herein allows for confirmation of the desired engagement, placement, grip, etc., of the implantable device with tissue. The signal generated by the sensor can advantageously facilitate accurate and efficient placement and placement of the anchor within the cardiac tissue, for example, to secure an artificial chordae to the cardiac tissue to repair a valve leaflet. Although embodiments of the present disclosure may be described with particular reference to tissue anchors, for example, for implantation in the heart (and more particularly, for securing an artificial chordae to the cardiac tissue), it should be understood that various other implantable devices may benefit from the devices, systems, and methods described herein. For example, other implantable devices used in the heart and that need to withstand the compressive forces of the heart (e.g., implantable devices for use in the heart / for use in repairing the heart, such as the mitral or tricuspid valves, and / or for addressing other dilatation, valvular insufficiency, valvular leakage, and other similar heart failure conditions) may also benefit from the concepts disclosed herein. Moreover, it will be appreciated that the broad principles and concepts described above with respect to the heart are applicable to other delivery / deployment systems for other types of devices delivered and / or deployed elsewhere in the body.

[0044] It should be understood that, as described herein, an "embodiment" (as shown in the accompanying drawings) may refer to an exemplary representation of an environment or article or component in which a disclosed concept or feature may be provided or embodied, or a representation of a manner in which only the concept or feature may be provided or embodied. However, such illustrated embodiments should be understood as examples (unless otherwise specified), and other ways of embodying the described concept or feature, as may be understood by one of ordinary skill in the art upon learning the concept or feature from the present disclosure, are within the scope of the present disclosure. In addition, although the drawings may show one or more embodiments of a concept or feature together in a single embodiment of an environment, article, or component incorporating such concept or feature, it will be understood that such concepts or features should be understood as independent and separate from one another (unless otherwise specified), and are shown together for convenience and are not intended to be limited to existing or used together. For example, features illustrated or described as part of an embodiment may be used separately or together with one or more other features to yield still further embodiments. Thus, it is intended that the present subject matter covers such modifications and variations as come within the scope of the appended claims and their equivalents.

[0045] The above description has broad applicability and is presented for purposes of illustration and explanation, and is not intended to limit the disclosure to one or more forms disclosed herein. It will be understood that various additions, modifications, and substitutions can be made to the embodiments disclosed herein without departing from the concept, spirit, and scope of the disclosure. In particular, it will be apparent to those skilled in the art that the principles of the disclosure can be embodied in other forms, structures, arrangements, ratios, and using other elements, materials, and components without departing from the concept, spirit, or scope or characteristics thereof. For example, various features of the disclosure are grouped together as one or more aspects, embodiments, or configurations for the purpose of streamlining the disclosure. However, it should be understood that various features of a particular aspect, embodiment, or configuration of the disclosure can be combined as alternative aspects, embodiments, or configurations. Although the disclosure is presented in terms of embodiments, it should be understood that the various separate features of the subject matter need not all be present to achieve at least some of the desired properties and / or advantages of the subject matter or such individual features. Those skilled in the art will appreciate that the present disclosure can be used with many modifications specifically adapted to particular environments and operating requirements, or with structure, arrangement, proportions, materials, components, and other modifications used in the practice of the present disclosure, without departing from the principles, spirit, or scope of the present disclosure. For example, elements shown as integrally formed can be composed of multiple pieces, or elements shown as multiple pieces can be integrally formed, operations of elements can be reversed or otherwise changed, and elements can be sized or dimensioned. Similarly, although operations, actions, or steps are described in a particular order, this should not be understood as requiring such a particular order or that all operations, actions, or steps should be performed to achieve desired results. Moreover, other implementations are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve desirable results.The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the claimed subject matter being indicated by the appended claims and not limited to the above description or to the specific embodiments or configurations described or illustrated herein. In view of the above, the individual features of any embodiment can be used and claimed separately or in combination with the features of that or any other embodiment, and the scope of the subject matter being indicated by the appended claims and not limited to the above description.

[0046] In the above description and in the claims that follow, it will be understood that: The phrases "at least one," "one or more," and "and / or," as used herein, are open-ended expressions that operate both conjunctively and disjunctively. The terms "a," "an," "the," "first," "second," etc. do not exclude a plurality. For example, the term "a" or "an" entity, as used herein, refers to one or more of that entity. Thus, the terms "a" (or "an"), "one or more," and "at least one" can be used interchangeably herein. All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, upward, downward, vertical, horizontal, radial, axial, clockwise, counterclockwise, etc.) are used for identification purposes only to aid the reader in understanding this disclosure and / or serve to distinguish regions of associated elements from one another, and are not intended to limit the associated elements, particularly with respect to position, orientation, or use of this disclosure. Connection references (e.g., attached, coupled, connected, and joined) should be interpreted broadly and may include intermediate members between groups of elements and relative movement between the elements, unless otherwise indicated. Thus, connection references do not necessarily imply that two elements are directly connected and in a fixed relationship to one another. Distinguishing references (e.g., primary, secondary, first, second, tertiary, fourth, etc.) are not intended to imply importance or priority, but are used to distinguish one feature from another.

[0047] The following claims are hereby incorporated by reference into this Detailed Description, with each claim standing on its own as a separate embodiment of the present disclosure. In the claims, the term "comprising" does not exclude the presence of other elements, components, features, regions, steps, operations, etc. Furthermore, although individual features may be included in different claims, these features may in some cases be advantageously combined, and their inclusion in different claims does not imply that a combination of features is not feasible and / or advantageous. Furthermore, reference to the singular does not exclude a plurality. Reference signs in the claims are provided merely as a clarifying example and should not be construed as limiting the scope of the claims in any way.

Claims

1. 1. A delivery and placement device for transluminally delivering and / or placing an implantable device at a placement site within the body, the implantable device having a portion that shifts from a delivery configuration to a placement configuration upon placement, the delivery and placement device comprising: A delivery device configured to deliver the implantable device; three or more sensors disposed along a distal end of the delivery device, the three or more sensors configured to generate a signal when the distal end of the delivery device contacts tissue to ensure gripping of tissue by the implantable device during deployment; A delivery and placement device comprising:

2. The delivery and placement device of claim 1 , wherein the three or more sensors are spaced apart around a circumference of the distal end of the delivery device.

3. 3. The delivery and placement device of claim 1 or 2, wherein the three or more sensors are equidistantly spaced from one another.

4. 4. The delivery and placement device of claim 1, wherein the delivery device is an anchor garage configured to deliver a tissue anchor to a placement site, the tissue anchor having two or more claws shiftable from a delivery configuration to a placement configuration.

5. The delivery and deployment device of claim 4 , wherein the three or more sensors include at least one sensor associated with each claw of the tissue anchor delivered by the anchor garage.

6. 5. The delivery and deployment device of claim 4, wherein the anchor garage has a blunt distal end and the three or more sensors are disposed along the blunt distal end.

7. The delivery and placement device of claim 1 , wherein the three or more sensors include a contact sensor.

8. The delivery and placement device of any one of claims 1 to 7, further comprising a delivery shaft, with leads extending from the three or more sensors through the delivery shaft.

9. 1. A system for delivering and placing an implantable device at a placement site within the body, comprising: An implantable device; a delivery device configured to deliver the implantable device to the placement site; and three or more sensors disposed along a distal end of the delivery device, the three or more sensors configured to generate a signal when the distal end of the delivery device contacts tissue to ensure gripping of tissue by the implantable device without the need for imaging during placement; A system comprising:

10. The system of claim 9 , wherein the three or more sensors are spaced apart around a circumference of the distal end of the delivery device.

11. the implantable device is a tissue anchor; the delivery device is an anchor garage configured to deliver the tissue anchor to a placement site.

11. A delivery and placement system according to claim 9 or 10.

12. The system of claim 11 , wherein the tissue anchors are clocked relative to the anchor garage.

13. the tissue anchor having two or more claws shiftable from a delivery configuration to a deployment configuration; the three or more sensors including at least one sensor associated with a claw of the tissue anchor; 13. A system according to claim 11 or 12.

14. 14. The system of claim 11, wherein leads from the three or more sensors extend along the anchor garage and within the protrusion to a device that generates a signal indicative of contact of the three or more sensors with tissue.

15. The system of any one of claims 12-14, wherein the tissue anchor is clocked relative to the anchor garage to align at least one of the claws of the tissue anchor with one of the three or more sensors.

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