DEVICES, SYSTEMS AND METHODS FOR CONTROLLING DEPLOYMENT OF MEDICAL DEVICES - Patent application

Abstract

A delivery / deployment system for delivering an implantable device into an implantable device housing and deploying the implantable device from the implantable device housing. A stylet may be used to longitudinally advance or retract the implantable device relative to the implantable device housing to extend and deploy the implantable device from the implantable device housing. The delivery / deployment system has an implantable device extension limiting mechanism configured to limit the distance the implantable device may extend from the implantable device housing. The delivery / deployment system also optionally has an implantable device rotation limiting mechanism configured to limit rotation of the implantable device relative to the implantable device housing.

Description

[Technical field]

[0001] The present disclosure relates generally to the field of implantable medical devices. In particular, the present disclosure relates to devices, systems, and methods for controlling the deployment of medical devices, such as implantable medical devices. More particularly, the present disclosure relates to devices, systems, and methods for controlling the insertion depth of an implantable device within tissue and / or the rotation of an implantable device relative to tissue. This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 335,995, filed April 28, 2022, the entire disclosure of which is incorporated herein by reference for all purposes. [Background technology]

[0002] Various transluminal techniques (e.g., transcatheter techniques) provide minimally invasive solutions for treating or repairing sites within the body without the need for open, more invasive surgery. However, controlling the deployment of implantable devices can be difficult. Transluminal deployment of implantable devices typically requires a delivery / deployment system assembly, such as one or more catheters, shafts, coils, rods, etc., to navigate through tortuous pathways within the body and deliver the implantable devices and systems to the treatment site. Furthermore, the implantable devices and systems are typically pushed distally from the delivery / deployment system to anchor the device within the tissue at the treatment site. Typically, such delivery / deployment systems have little space for additional components, and visualization can be difficult.

[0003] It is generally desirable to deploy an implantable device to a desired depth within tissue without overextending the device through the implantation tissue wall or inadvertently perforating or puncturing it. Thus, it is generally desirable to deploy an implantable device to a predetermined distance from its associated delivery / deployment system for each implantation to verify that the implantable device has been properly deployed, regardless of the location of the delivery / deployment system. However, delivery / deployment systems typically subject the implantable device and associated systems to varying degrees of stress, steerability, and compression that can adversely affect the predictability of the distance the implantable device travels relative to the delivery / deployment system. Thus, there is a need for improvements to devices, systems, and methods for delivering and deploying an implantable device, such as by controlling the depth of insertion of the implantable device (e.g., to avoid puncturing the tissue into which the implantable device is inserted).

[0004] Additionally or alternatively, it is often desirable to remove a delivery / deployment system from an implantable device without causing removal that would affect the site (e.g., tissue) in which the implantable device is implanted. Typically, the delivery / deployment system moves in one or more directions (i.e., axially and / or rotationally) relative to the implantable device being delivered / deployed. It is desirable that such movement of the delivery / deployment system not cause movement of the implantable device relative to the implantation site that may exert undue stress on the body tissue at the implantation site (e.g., to resist movement of the implantable device). Thus, there is a need for improvements to devices, systems, and methods for delivering and deploying tissue anchors, such as by controlling movement of the tissue anchors during deployment and implantation (e.g., to release them from the deployment device and system without affecting the tissue in which they are embedded).

[0005] Various improvements to transluminal repair devices, systems, and methods would be desirable, and solutions applicable to other surgical disciplines would be of interest and value as well. Summary of the Invention

[0006] This summary of the disclosure is intended to aid in understanding, as those skilled in the art will appreciate that each of the various aspects and features of the disclosure may be used advantageously separately in some cases, or in combination with other aspects and features of the disclosure in other cases. No limitations on the scope of the claimed subject matter are intended by the inclusion or exclusion of elements, components, etc. in this summary.

[0007] In accordance with various principles of the present disclosure, an anchor garage is configured to limit the extent to which a tissue anchor contained within the anchor garage can move distally out of the anchor garage. In some aspects, the anchor garage has a wall defining a lumen configured to house a tissue anchor therein, and a stop extending radially inward from the wall of the anchor garage into the lumen and configured to limit distal movement of an elongate member operably coupled to the tissue anchor to extend the tissue anchor within the anchor garage distally from the anchor garage.

[0008] In some embodiments, the stopper is a tab formed by a notch in the wall of the anchor garage, with the tab bent radially inward into the lumen defined in the anchor garage.

[0009] In some embodiments, the stopper is configured to fit within a longitudinal groove in an anchor housing of an anchor disposed within the lumen of the anchor garage to limit rotational movement of the anchor relative to the anchor garage.

[0010] In some embodiments, a longitudinal slot is defined in the wall of the anchor garage sized to receive a rotational stop that projects radially outward from an anchor disposed within the lumen of the anchor garage and limits rotational movement of the anchor relative to the anchor garage, and the longitudinal slot is positioned and configured to allow a component for coupling with an anchor disposed within the lumen of the anchor garage to pass through the longitudinal slot.

[0011] In accordance with various principles of the present disclosure, a delivery / deployment system for delivering and / or deploying tissue anchors to a treatment site includes a leaflet clip spreader, a leaflet clip operably associated with the leaflet clip spreader, an anchor garage, an anchor operably associated with the anchor garage, a stylet operably coupled to the anchor to move the anchor distally relative to the anchor garage, and an implantable device extension limiting mechanism. The implantable device extension limiting mechanism includes an anchor garage stopper component operably associated with the anchor garage and a stylet stopper component operably associated with the stylet. In some embodiments, the stylet stopper component is configured to engage the anchor garage stopper component to limit a distance that the stylet can extend the anchor distally from the anchor garage.

[0012] In some embodiments, the anchor garage has a wall defining a lumen therein, and the anchor is positionable within the lumen of the anchor garage. In some embodiments, the anchor garage stop component includes a tab formed by a notch in the wall of the anchor garage, the tab bent radially inwardly into the lumen defined in the anchor garage. In some embodiments, the stylet stop component is a radially extending portion engageable with the tab in the wall of the anchor garage to limit distal extension of the tab relative to the anchor garage. In some embodiments, the anchor has an anchor housing having a longitudinal groove through which the tab in the wall of the anchor garage extends to limit rotational movement of the anchor relative to the anchor garage.

[0013] In some embodiments, the stylet is rotatable and separable relative to the anchor, the anchor including a rotation limiting component operably engaged with an anchor garage rotation limiting component to prevent rotation of the anchor when the stylet is rotated, in some embodiments, the anchor garage has a wall defining a lumen therein, the anchor garage rotation limiting component includes a slot extending longitudinally in the wall of the anchor garage, the anchor is disposed within the lumen of the anchor garage, and the rotation limiting component of the anchor includes a radially outwardly extending protrusion that extends into the slot in the wall of the anchor garage. In some embodiments, the anchor garage has a wall defining a lumen therein, the anchor is disposed within the lumen of the anchor garage, the anchor garage stopper component has a radially inwardly extending component that protrudes into the lumen of the anchor garage, the anchor includes an anchor housing operatively associated with the anchor, the rotation limiting component of the anchor has a longitudinally extending groove extending along the anchor housing, and the anchor garage stopper component extends into the longitudinally extending groove along the anchor housing to form the anchor garage rotation limiting component. In some embodiments, the anchor garage stopper comprises a tab formed by a notch in the wall of the anchor garage, the tab bent radially inwardly into the lumen defined in the anchor garage and extending into the longitudinally extending groove along the anchor housing.

[0014] In some embodiments, the anchor further includes a housing, an artificial chordae tensioning and locking device operably associated with the housing of the anchor, the system further includes an artificial chordae coupled between the leaflet clip and the artificial chordae tensioning and locking device, the stylet operably coupled to the artificial chordae tensioning and locking device to actuate the artificial chordae tensioning and locking device, and the anchor has a rotation limiting component operably engaged with an anchor garage rotation limiting component to prevent rotation of the anchor when the stylet is rotated to actuate the artificial chordae tensioning and locking device. In some embodiments, the anchor garage has a wall defining a lumen therein, the anchor garage rotation limiting component includes a slot extending longitudinally in the wall of the anchor garage, the anchor is disposed within the lumen of the anchor garage, the rotation limiting component of the anchor has a radially outwardly extending protrusion that extends into the slot in the wall of the anchor garage, and the artificial chordae extend from the leaflet clip through the slot in the wall of the anchor garage to the anchor. [Brief description of the drawings]

[0015] [Figure 1] FIG. 1 is a perspective view of one example of an embodiment of a delivery / deployment device and system shown in a schematic diagram of a heart formed in accordance with various principles of the present disclosure. [Diagram 2] FIG. 2 is a perspective view of one example embodiment of a delivery and deployment device and system formed in accordance with various principles of the present disclosure, with optional components shown in phantom. [Diagram 3] FIG. 3 is a perspective view of one example of an embodiment of an anchor delivery device formed in accordance with various principles of the present disclosure. [Figure 4A]FIG. 4A is a perspective view of an example of an embodiment of the anchor delivery and deployment device and system of FIG. 2, showing the anchor delivery device of FIG. 3 in phantom and an anchor stored in the anchor delivery device of the delivery mechanism. [Figure 4B] FIG. 4B is a perspective view of an example embodiment of the anchor delivery and deployment device and system of FIG. 4A as anchor deployment begins. [Figure 4C] FIG. 4C is a perspective view of an example embodiment of the anchor delivery and deployment device and system of FIG. 4B, with the anchor in a partially deployed configuration. [Figure 4D] FIG. 4D is a perspective view of one example of the embodiment of the anchor delivery and deployment device and system of FIG. 4C, with the anchor in a deployed configuration. [Figure 5A] FIG. 5A is a cross-sectional view taken along line VA-VA in FIG. 4A. [Figure 5B] FIG. 5B is a cross-sectional view taken along line VB-VB of FIG. 4D. [Figure 6] FIG. 6 is a perspective view of another example embodiment of an anchor delivery and deployment device and system formed in accordance with various principles of the present disclosure, with anchors shown in phantom. [Figure 7] FIG. 7 is a cross-sectional view taken along line VII-VII in FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings. The accompanying drawings 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 drawings may be altered. For example, the device may be enlarged so that details can be discerned, but is intended to be reduced in size to fit within, for example, a delivery catheter or working channel of an endoscope. In the drawings, identical or nearly identical or equivalent elements are typically represented by the same reference characters, and similar elements are designated by similar reference numbers typically followed by a dash ('), and redundant descriptions are generally omitted for brevity. For clarity and brevity, not all elements are shown in every figure, and not all elements of each embodiment are shown when illustration is not necessary to enable a person skilled in the art to understand the present disclosure. The detailed description may be better understood in conjunction with the accompanying drawings, in which like reference characters represent similar elements.

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

[0018] The present disclosure is described at various levels of detail in this application. In some instances, details that are not necessary for a person skilled in the art to understand the present 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 present 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 a direction toward or a location closest to a user (such as a medical professional, clinician, technician, operator, or physician, such terms are used interchangeably herein without limitation and include an automated controller system or other aspects) closest to the delivery device when using the device (e.g., when introducing the device into a patient or during implantation, placement, or delivery), and "distal" refers to a direction away from or a location furthest from a user closest to the delivery device when using the device (e.g., when introducing the device into a patient or during implantation, placement, or delivery). "Longitudinal" means a direction extending along the longer or greater dimension of an element. A "longitudinal axis" extends along the longitudinal extent of an element, but is not necessarily a straight line and does not necessarily maintain a constant configuration when the element flexes or bends. "Center" means at least approximately bisecting the center point and / or approximately equidistant from the periphery or boundary, and "central axis" means, with respect to an opening, a line at least approximately bisecting the center point of the opening and extending longitudinally along the length of the opening when the opening comprises, for example, a tubular element, a strut, a channel, a cavity, or a hole. As used herein, a "channel" or "hole" is not limited to a circular cross section. As used herein, a "free end" of an element is an end beyond which the element does not extend. Finally, the terms part, region, section, segment, and the like may be used interchangeably herein without any intention of limitation, and generally, sections are referred to as general regions and segments as specific parts, but these are for ease of distinction and are not intended to be limiting.

[0020] Heart disease, including atrioventricular heart valve dysfunction, impedes a patient's cardiac output and reduces the patient's quality of life and longevity. The proper flow of blood through the heart is regulated by the heart valves, including the atrioventricular heart valves, which, among other things, include soft tissue valve leaflets that open and close periodically to allow blood to flow in one direction. Healthy valve leaflets prevent blood flow in the opposite direction (regurgitation). Chordae tendineae extend from the valve leaflets to the papillary muscles and support the proper function of the leaflets by distributing the load to the papillary muscles during systolic closure, preventing the leaflets from flailing in the atrium, etc. Chordae tendineae dysfunction impairs the leaflets' ability to form a seal in the heart valve. Various defects in chordae tendineae dysfunction, such as stretching, rupture, thickening, contraction, calcification, inelastic stretching, or other changes in elasticity, can result in improper closure of the heart valve and / or flail leaflets that no longer have the ability to form a valve seal for normal heart function. When the ability of the valve leaflets to form a seal is compromised, valve regurgitation, or backflow of blood, typically occurs, which typically prevents an adequate supply of blood from being delivered throughout the cardiovascular system.

[0021] Heart valve disease is typically repaired by invasive surgical intervention (e.g., open surgery in which the patient is cut open), by complex pinching of the valve leaflets to create a double small opening, or by native valve replacement. These methods involve opening the patient's chest and heart chambers to expose the heart valve for direct visualization and repair. Resection, partial removal, and / or repair of the patient's valve leaflets, along with implantation of surgical rings, are complex techniques used by surgeons to reduce the diameter of the patient's heart valve annulus, allowing the leaflets to properly coapt and reduce regurgitation. While some techniques may slightly reduce regurgitation, they may not provide a durable solution and do not repair and / or replace the damaged chordae of the valve. Various transluminal techniques (e.g., transcatheter techniques) provide a minimally invasive solution to repair heart valves, including their leaflets. Transcatheter prosthetic valve replacement, while less invasive than open surgical methods, typically requires lifelong treatment with anticoagulants afterward. Transcatheter limbal fixation of the valve leaflets is another minimally invasive option, but typically precludes options for future minimally invasive valve replacement. Various improvements to such systems and devices and methods would be welcome.

[0022] In accordance with various principles of the present disclosure, the delivery / deployment system is configured to provide repeatable and predictable delivery and / or deployment of an implantable device, e.g., a repeatable and predictable insertion depth of such an implantable device into an implantation site. Anatomical sites, delivery sites, deployment sites, implantation / implantation sites, target sites, treatment sites, and the like may be referred to interchangeably and without limitation herein. Also, terms such as embed (and other grammatical forms) may be used interchangeably and without limitation herein with terms such as affix, anchor, attach, associate, couple, engage, embed, hold, hold, grasp, clamp, and the like (and grammatical forms thereof). In some embodiments, the extent to which an implantable device extends from a delivery / deployment system (generally into a treatment site) is determined by the geometry and configuration of the delivery and deployment devices, rather than by control of the various elongate members that deliver the implantable device, and therefore is not affected by potential compression of the delivery / deployment system. In some embodiments, the delivery and deployment devices are less susceptible to compression than the various elongate members used therewith, for example, while the various elongate members are typically flexible, the delivery and deployment devices tend to be less flexible and, in some cases, may have thicker walls than the walls of the flexible tubular elongate members used therewith, making them more susceptible to compression.

[0023] According to various further principles of the present disclosure, the delivery / deployment system is configured to limit rotational movement of the implantable device during its deployment. For example, the configuration and / or geometry of the implantable device and / or the device delivering the implantable device prevents rotation of the implantable device relative to the treatment site when the implantable device is deployed (e.g., implanted in the treatment site) and / or released from the delivery / deployment system. In some embodiments, the implantable device is delivered to the treatment site with or within a device such as a housing or garage. The housing or garage may be configured to interact (e.g., operably engage or operably engage) with the implantable device to prevent rotational movement of the implantable device relative to the treatment site and / or relative to the housing or garage during deployment of the implantable device. In some embodiments, rotational movement of the implantable device is prevented relative to the device and system used to deliver such implantable device.

[0024] In some embodiments, the implantable device, and / or devices and / or systems for delivering / deploying such devices, are shaped and configured to predictably and repeatably define the depth of deployment of the implantable device and the rotational movement of the implantable device 200 relative to the delivery / deployment devices and systems.

[0025] The principles of the present disclosure may be applied to various transluminal devices, systems, and methods, such as transcatheter, for repairing heart valve dysfunction. One example of a technique for repairing heart valve dysfunction is to clip a leaflet clip to the heart valve leaflet, extend artificial chordae from the leaflet clip to tissue of the heart wall (e.g., ventricle, such as papillary muscle), and secure the artificial chordae to the heart tissue with tissue anchors. Specifically, a delivery / deployment system transcatheterically delivers a leaflet gripping mechanism carrying (e.g., housing) the leaflet clip to the heart valve. The leaflet gripping mechanism includes a clip spreader that can bend open the spring arms of the leaflet clip to capture the free edge of the heart valve leaflet between the arms of the leaflet clip. The clip spreader then releases the spring arms to close and secure the leaflet clip on the leaflet. The delivery / deployment system is then advanced from the heart valve to the heart wall, extending the artificial chordae from the leaflet clip to the heart wall (typically, the ventricular wall). An anchor garage carrying (e.g., housing) the tissue anchor is brought to a desired implantation location for the tissue anchor (e.g., papillary muscle). The anchor garage is delivered to the treatment site within a leaflet clip spreader and may be extendable distally from the leaflet clip spreader, for example, when the treatment site is reached. Typically, the tissue anchor is delivered in a delivery configuration that may be a compact or compressed or contracted configuration that allows for its transcatheter delivery. The tissue anchor is extended from the anchor garage and expands into and anchors to the tissue at the implantation site. The tension of the artificial chordae may be adjusted, such as by pulling the proximal end of the artificial chordae that extends through the delivery / deployment system to its proximal control end (such as a control handle). The desired or medically prescribed or indicated tension in the artificial chordae is generally achieved when the desired leaflet repair is achieved, thereby resulting in proper valve function. An artificial chordae tension and locking device may be used to set the tension and / or length of the artificial chordae. The leaflet clip spreader can remain in place along with the leaflet clips until proper valve function is achieved, after which it can be removed along with the delivery / deployment system leaving the leaflet clips in place.The delivery / deployment system can be retracted, optionally cutting the artificial chordae (e.g., when removed) and / or delivering another leaflet clip and artificial chordae and anchor set.

[0026] The term anchor (and other grammatical forms) is used herein for convenience, but may be used interchangeably with terms such as anchor component, anchor device, anchor element, anchor mechanism, and the like (and other grammatical forms). Such terms are known in the art to refer to structures configured to hold another object in place. Reference is made herein to a tissue anchor as an example of an embodiment of an implantable device. However, such reference is for convenience and is not intended to be limiting, and tissue anchors / implantable devices usable with the principles of the present disclosure should be understood to include other devices. Moreover, the principles described above are equally applicable to other devices, systems, and methods, and the present disclosure is not limited to implantable devices.

[0027] Various embodiments of devices, systems, and methods formed according to various principles of the present disclosure will now be described with reference to examples shown in the accompanying drawings. References herein to "one embodiment," "embodiment," "some embodiments," "other embodiments," and the like indicate that one or more particular features, structures, concepts, and / or characteristics according to the principles of the present disclosure may be included in connection with the embodiment. However, such references do not necessarily mean that all embodiments include the particular features, structures, concepts, and / or characteristics, or that an embodiment includes all features, structures, concepts, and / or characteristics. Some embodiments may include one or more such features, structures, concepts, and / or characteristics in various combinations thereof. One or more of the features, structures, concepts, and / or characteristics described with reference to one embodiment may be combined with one or more of the features, structures, concepts, and / or characteristics of any of the other embodiments provided herein. That is, any of the features, structures, concepts, and / or characteristics described herein may be mixed and matched to form hybrid embodiments, and such hybrid embodiments are within the scope of the present disclosure. Furthermore, references in various places herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc., do not necessarily all refer to the same embodiment, and separate or alternative embodiments do not necessarily mutually exclude other embodiments. Moreover, the various features, structures, concepts, and / or properties of the disclosed embodiments are independent and distinct from one another, and may be used or exist individually or in various combinations with one another to make alternative embodiments that are considered part of this disclosure. Thus, the disclosure is not limited to only the embodiments specifically described herein, and it would be extremely cumbersome to describe all of the many possible combinations and subcombinations of features, structures, concepts, and / or properties, and the example embodiments disclosed herein are not intended to limit the broader aspects of the disclosure. The following description is merely an example of an embodiment, and is not intended to limit the broader aspects of the disclosure.

[0028] In the drawings, common features are identified by common reference elements, and for brevity and convenience, without the intention of limitation, the description of common features is generally not repeated. For clarity, not all components with the same reference number are numbered. Groups of similar elements may be indicated by numbers and letters. Generally, reference to one or such elements or such elements as a group may be made only by numbers (without including letters associated with each similar element). Furthermore, a particular feature in one embodiment may be used across different embodiments and is not necessarily labeled separately when appearing in different embodiments.

[0029] Referring now to the drawings, FIG. 1 illustrates an example embodiment of an implantable device delivery / deployment system 100 formed in accordance with various principles of the present disclosure, shown being delivered to a treatment site (in this example embodiment, ventricle V) by an example embodiment of the delivery / deployment system 1000. The delivery / deployment system 1000 includes a number of flexible elongate members, such as a delivery sheath 1010, that navigate and deliver the system 1000 to the area of ​​the treatment site. A steerable delivery catheter 1020 extends through the delivery sheath 1010 and exits from a distal end 1011 of the delivery sheath 1010. The steerable delivery catheter 1020 is steerable to position the implantable device delivery / deployment system 100 and optionally another device delivery / deployment system 200 for delivery and / or deployment of a device carried thereby. The device delivery / deployment system 200 may be delivered using a device catheter 1030 that extends through the steerable catheter 1020 and out its distal end 1021. An implantable device delivery catheter 1040 may extend through the device catheter 1030 for delivery of the implantable device delivery / deployment system 100 .

[0030] In the example embodiment shown in Figure 1, a device catheter 1030 delivers a device delivery / deployment system 200 including a delivery / deployment device 210, illustrated in Figure 1 in the form of a leaflet clip spreader 210 configured to deliver leaflet clips 220 to the heart valve leaflets L. For convenience, the device catheter 1030 may be referred to herein as a grasper device shaft 1030 to distinguish it from other catheters described herein. The leaflet clips 220 are shown in Figure 1 as being clamped onto the leaflets L by spreader arms 212 of the leaflet clip spreader 210, which are shown in further detail in Figure 2.

[0031] In the example embodiment shown in FIG. 1, the implantable device delivery / deployment system 100 is delivered on a distal end 1041 of a generally flexible, tubular, elongated implantable device delivery catheter 1040 that extends through a gripping device shaft 1030. The example embodiment of the implantable device delivery / deployment system 100 shown in FIG. 1 includes an implantable device delivery / deployment device in the form of an anchor garage 110. As shown in more detail in FIG. 2, the distal end 1041 of the implantable device delivery catheter 1040 (which may be referred to herein for convenience as the anchor garage catheter 1040) may be coupled to the proximal end 113 of the anchor garage 110 in any manner known to those skilled in the art. Terms such as couple (and other grammatical forms) may be used interchangeably herein with terms such as engage, grasp, hold, clasp, clip, anchor, attach, affix, clamp (and other grammatical forms), and the like, without any intended limitation. The anchor garage 110 can be delivered within and through the leaflet clip spreader 210 to a treatment site to deliver the implantable device. An example of one embodiment of an implantable device is shown in Figures 1, 2, 4A-4D, 5A, and 5B as a tissue anchor 120 having claws 122 configured to penetrate and extend into tissue to be anchored to the tissue, as described in further detail below. An anchor garage catheter 1040 can be extended distally from the distal end 211 of the leaflet clip spreader 210 to deliver the anchor garage 110 to a desired anatomical site for implanting the anchor 120 as shown in Figure 1.

[0032] The anchor 120 may be delivered within a lumen 117 defined within the anchor garage 110. As shown in FIG. 2, the anchor 120 is delivered in a delivery configuration (e.g., a compact configuration) in which a distal end 121 of its claw 122 is located within the anchor garage 110 proximal to the distal end 111 of the anchor garage 110. The anchor 120 is extendable out of the distal end 111 of the anchor garage 110 and embedded within tissue (e.g., cardiac tissue such as papillary muscle tissue) in a deployed configuration (e.g., in an expanded state, as shown in FIG. 4D and described in more detail below). The anchor garage 110 may have a rounded open distal end 111 (tip or free end) having a size, shape, configuration, and dimensions that facilitate pushing the anchor garage 110 against the cardiac tissue to deploy the anchor 120 from the anchor garage 110 into tissue at a deployment site without potentially forcing the distal end 111 of the anchor garage 110 into the cardiac tissue. By embedding the anchor 120 within the cardiac tissue, the artificial chordae 250 (e.g., expanded polytetrafluoroethylene (ePTFE) sutures) extending from the leaflet clip 220 to the anchor 120 are secured to the cardiac wall (e.g., papillary muscles) to restore proper function of the leaflet L.

[0033] An artificial chordae tensioning and locking device 130 may be used as desired, indicated, needed, etc. to set tension on the artificial chordae 250. As shown in more detail in FIG. 5, the artificial chordae tensioning and locking device 130 may be coupled to the anchor 120. For example, the artificial chordae tensioning and locking device 130 may be disposed within a housing 124 that is coupled to the anchor 120 (e.g., that forms part of the anchor 120 and from which the claws 122 extend).

[0034] The anchor 120 of the implantable device delivery / deployment system 100 is delivered at the distal end 1051 of a stylet 1050, as shown in FIGS. 2, 4A-4D, 5A, and 5B. The stylet 1050 is operably coupled to the proximal end 123 of the anchor 120 (e.g., threadably coupled to, e.g., within, the proximal end 125 of the anchor housing 124) to deploy the anchor 120, such as by advancing or retracting the anchor 120 relative to the anchor garage 110 to advance the anchor 120 into tissue. For example, the stylet 1050 may be axially advanced or retracted to axially advance or retract the anchor 120 relative to the anchor garage 110. Additionally or alternatively, the stylet 1050 may be operably coupled to the artificial chordae tensioning and locking device 130 to adjust the tension applied by the artificial chordae tensioning and locking device 130 to the artificial chordae 250. 5A and 5B, a stylet coupling 1052 formed on a distal end 1051 of the stylet 1050 is operably coupled to a tension coupling 134 operably associated with the artificial chordae tensioning and locking device 130 such that movement of the stylet 1050 actuates the artificial chordae tensioning and locking device 130. In some embodiments, the stylet coupling 1052 and the tension coupling 134 are threadedly engaged within the proximal end 125 of the anchor housing 124 and operably coupled to one another such that rotation of the stylet 1050 imparts rotation to the tension coupling 134. Thus, rotation of the stylet 1050 causes axial advancement or retraction of the tension coupling 134, thereby adjusting the tension applied to the artificial chordae 250 by the artificial chordae tensioning and locking device 130. At the most proximal position of the tension bond 134, the artificial chordae tension and locking device 130 fixes or locks the tension on the artificial chordae 250. Further rotation of the stylet 1050 withdraws the stylet 1050 from the tension bond 134 and anchor 120, leaving the anchor 120 positioned within the target site in the target tissue.It should be understood that other configurations of stylets, anchors, and artificial chordae tensioning and locking devices are within the scope and spirit of the present disclosure, and the details of such elements are not intended to limit the scope of the present disclosure.

[0035] Further details of the structure and function of the leaflet clip spreaders, leaflet clips, anchor garages, anchors, artificial chordae, and artificial chordae tensioning and locking devices, without limiting the scope of the present disclosure, can be found, for example, in U.S. Patent Application Publication No. 2021 / 0007847, published on January 14, 2021, and 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, and 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 / 0000621, published on January 7, 2021, and entitled "Devices, Systems, And Methods For Adjustably Tensioning An Artificial Chordae Tendineae Between A Leaflet And A Papillary Muscle Or Heart Wall," and U.S. Patent Application Publication No. 2021 / 0000597, published on January 7, 2021, and entitled "Devices, Systems, And Methods For Adjustably Tensioning An Artificial Chordae Tendineae Between A Leaflet And A Papillary Muscle Or Heart Wall." No. 2021 / 0000599, entitled "Devices, Systems, And Methods For Anchoring An Artificial Chordae Tendineae To A Papillary Muscle Or Heart Wall," published on January 7, 2021; U.S. Patent Application Publication No. 2021 / 0000598, entitled "Devices, Systems, And Methods For Anchoring An Artificial Chordae Tendineae To A Papillary Muscle Or Heart Wall," filed on September 23, 2021; U.S. Provisional Patent Application No. 63 / 239,467, entitled "Devices, Systems, And Methods For Clamping A Leaflet Of A Heart Valve," filed on September 1, 2021;No. 63 / 239,469, entitled "Devices, Systems, And Methods For Anchoring An Artificial Chordae Tendineae To Cardiac Tissue," filed on November 15, 2021; U.S. Provisional Patent Application No. 63 / 279,473, entitled "Devices, Systems, And Methods For Positioning A Leaflet Clip," filed on December 20, 2021; and U.S. Provisional Patent Application No. 63 / 291,758, entitled "Devices, Systems, And Methods For Positioning An Anchor For An Artificial Chordae Tendineae," filed on December 20, 2021, all of which applications are incorporated herein by reference in their entirety and for all purposes.

[0036] In accordance with various principles of the present disclosure, the implantable device delivery / deployment system 100 includes an implantable device extension limiting mechanism shaped, arranged, and configured to limit extension of the implantable device into tissue, such as to prevent inadvertent overextension with potentially adverse consequences. In some embodiments, the implantable device extension limiting mechanism includes a corresponding stop component operatively associated with the anchor garage 110 and the stylet 1050 to limit distal extension of the stylet 1050 relative to the anchor garage 110, thereby limiting distal extension of the anchor 120 such that advancement of the anchor does not exceed a desired range, distance, etc. For example, the implantable device extension limiting mechanism includes a stopper 140 associated with the anchor garage 110 and arranged to interact with a radially extending portion 1054 of the stylet 1050. In some embodiments, the anchor garage stopper 140 is a radially inward extending element that protrudes into a lumen 117 defined within the anchor garage 110, as shown in FIGS. 5A and 5B. Specifically, in the example embodiment of the implantable device delivery / deployment system 100 shown in Figures 3, 4A, 4B, 4C, 4D, 5A, and 5B, the stopper 140 is formed by a notch 142 in the wall of the anchor 120 that forms a tab 144 that is pushed radially inward into the lumen 117 within the anchor garage 110 (as shown in the detailed view of Figure 3). The notch 142 may be laser cut, machine cut, sheared slot / groove, etc., or other suitable configuration known to those of skill in the art. The radially extended portion 1054 of the stylet 1050 in the example embodiment shown in Figures 3, 4A, 4B, 4C, 4D, 5A, and 5B has a limited axial extent along the stylet 1050 and has a larger diameter than regions of the stylet 1050 proximal and distal to it. The radially expanding portion of the stylet 1050 may be referred to herein for convenience and without any limitation as a shoulder 1054.

[0037] Forming the stopper components as radially inwardly oriented tabs in the walls of the anchor garage 110 can facilitate assembly of the implantable device delivery / deployment system 100. Specifically, the stopper 140 can act as a spring to return to the implantable device extension limiting mechanism / position after allowing forward loading of the anchor 120 into the anchor garage 110 (i.e., insertion in a distal to proximal direction along the anchor garage 110). For example, forward loading of the implantable device delivery / deployment system 100 and the delivery / deployment system 1000 in general may be desirable to allow the anchor garage 110 having an expanded distal end 111 to be carried within the leaflet clip spreader 210, as shown in FIG.

[0038] Operation of the implantable device stretch limiting mechanism in the illustrated example embodiment of implantable device delivery / deployment system 100 may be understood with reference to Figures 4A, 4B, 4C, 4D, 5A, and 5B.

[0039] In Figure 4A, the anchor 120 is shown in a delivery configuration within the anchor garage 110. The distal end 121 of the claw 122 is located proximal to the distal end 111 of the anchor garage 110. The shoulder 1054 of the stylet 1050 is spaced proximally from the tab 144 on the anchor garage 110 and thus is capable of moving distally relative to the anchor garage 110. The relative positions of the shoulder 1054 and the tab 144 can be further understood with reference to the cross-sectional view taken along line VA-VA of Figure 4A shown in Figure 5A.

[0040] As shown in FIG. 4B, when the stylet 1050 is advanced distally, the claws 122 of the anchor 120 extend out from the distal end 111 of the anchor garage 110. In some embodiments, the distal end 121 of the claws 122 is configured (e.g., tapered, pointed, etc.) to facilitate puncturing or penetrating tissue. As mentioned above, in some embodiments, the distal end 111 of the anchor garage 110 may be rounded so as not to damage the tissue against which the distal end 111 is pressed. In use, the rounded distal end 111 of the anchor garage 110 can be pressed against tissue at the implantation site, and the stylet 1050 is advanced distally to cause the distal end 121 of the claws 122 to extend out from the distal end 111 of the anchor garage 110 and pierce the tissue at the implantation site.

[0041] Further distal advancement of the stylet 1050 causes the claws 122 of the anchor 120 to transition to a deployed configuration within the tissue, as shown in FIG. 4C. The claws 122 may be formed of a superelastic or shape memory material, such as Nitinol (a nickel-titanium alloy), such that the claws 122 transition to the deployed configuration substantially automatically (without further input or action thereon) once they are no longer within the anchor garage 110 (e.g., constrained or contracted or trapped within a delivery configuration therein). For example, as shown in FIG. 4C, in the example embodiment of the anchor 120, the claws 122 curl, curve, bow, bend, etc., toward the proximal end 123 of the anchor 120.

[0042] The claws 122 reach their final deployed configuration when the distal end 131 of the anchor housing 124 reaches (and optionally extends out of) the distal end 111 of the anchor garage 110, as shown in Figure 4D. As can be seen by comparing the relative positions of the stylet 1050 and the anchor garage 110 shown in Figures 4A-4D, the stylet 1050 allows the anchor 120 to extend distally from the anchor garage 110 until the shoulder 1054 of the stylet 1050 advances and abuts the stop 140 (particularly the tab 144) of the anchor garage 110, as shown in Figure 4D and in further detail in the cross-sectional view of Figure 5B along line VB-VB of Figure 4D. Thus, the illustrated example of an embodiment of an implantable device stretch limiting mechanism predictably and repeatably limits the distal axial movement of the anchor 120 relative to the anchor garage 110 and relative to the tissue, thereby predictably and repeatably managing the deployment range, deployment distance, deployment depth, etc. (such and other such terms are used interchangeably herein without any intent to be limiting) of the anchor 120 within the tissue.

[0043] In accordance with various principles of the present disclosure, the implantable device delivery / deployment system 100 additionally or alternatively includes an implantable device rotation limiting mechanism having a rotation limiting component shaped, arranged, and configured to limit rotational movement of the implantable device relative to the tissue in which it is implanted. In some embodiments, as described above, the stylet 1050 may be rotated to actuate the artificial chordae tensioning and locking device 130 and / or to unscrew / disconnect / detach (such terms and similar terms, including other grammatical forms, are used interchangeably herein without limitation) from the anchor 120. It may be desirable to limit rotation of the anchor 120 by the stylet 1050, such as to prevent unwanted pressure or torque against the tissue in which the anchor 120 is implanted. In the example embodiment of the implantable device delivery / deployment system 100 shown in Figures 3, 4A, 4B, 4C, 4D, 5A, and 5B, the implantable device rotation limiting mechanism includes corresponding rotational stop elements 150 on the anchor garage 110 and the anchor housing 124 to limit rotational movement of the anchor housing 124 relative to the anchor garage 110. For example, in the illustrated example embodiment, the implantable device rotation limiting mechanism includes a rotational stop 154 ​​(e.g., a protrusion or projection) associated with (e.g., protruding radially outward from) the anchor housing 124 and disposed within a longitudinally extending slot 152 (i.e., extending generally parallel to the longitudinal axis LA of the device / system) defined in the anchor garage 110. The slot 152 allows longitudinal extension or retraction of the anchor 120 relative to the anchor garage 110. However, the walls defining the slot 152 limit (eg, prevent) rotational movement of the rotation stop 154 ​​within the slot 152 , thereby limiting (eg, preventing) rotational movement of the anchor 120 relative to the anchor garage 110 .Thus, the stylet 1050 can be rotated relative to the anchor 120 to actuate the artificial tendon tensioning and locking device 130 and / or to deploy the anchor 120 by withdrawing it (e.g., detaching, separating, etc.) from the anchor 120, as described above, without rotating the anchor 120 within the tissue.

[0044] 2, it can be seen that the slots 152 can also facilitate coupling of the artificial chordae 250 between the leaflet clip 220 and the anchor 120 by allowing the artificial chordae 250 to easily extend from the leaflet clip 1050 into the lumen 117 of the anchor garage 110 (into which the anchor 120 is delivered) for coupling with the anchor 120. The anchor garage 110 can also be formed with a leaflet clip spreader seat 156 upon which the leaflet clip spreader 210 can be seated, as can be seen with reference to FIGS. 2 and 3. The slots 152 are circumferentially spaced from the leaflet clip spreader seat 156 to allow the rotation stop 154 ​​on the anchor housing 124 to move within the slots 152 in the anchor garage 110 and / or to allow the artificial chordae 250 to extend within the anchor garage 110 from the leaflet clip 1050 to the anchor 120.

[0045] In accordance with various principles of the present disclosure, as shown in FIGS. 4A-4D, 5A, and 5B, longitudinal grooves may be provided along the outer surface of the anchor housing 124 of an embodiment of an implantable device delivery / deployment system 100 to prevent radially inwardly oriented tabs 144 from impeding axial movement of the anchor housing 124 (such as to deploy the anchor 120). In an example of an alternative embodiment of an implantable device delivery / deployment system 100′ shown in FIG. 6, the anchor housing 124′ has one or more circumferentially spaced longitudinal grooves 154′ along its exterior. Such grooves may be equally spaced or otherwise spaced, such as to take into account the configuration of other associated devices or structures. In some embodiments, the longitudinal grooves 154′ are corrugated or hollowed out along at least a portion of the longitudinal extent of the anchor housing 124′. Such longitudinal grooves 154' prevent the radially inwardly oriented tabs 144' in the anchor garage 110' from contacting or impeding axial movement of the anchor 120' as the anchor 120' is advanced or retracted in the manner described above with respect to the example embodiment shown in Figures 4A-4D. Additionally or alternatively, the longitudinal grooves 154' may cooperate with tabs 144' formed in the anchor garage 110' to together form an implantable device rotation limiting mechanism 150'. Similar to the implantable device rotation limiting mechanism 150 shown in Figures 4A-4D and 5, the implantable device rotation limiting mechanism 150' shown in Figure 6 inhibits / prevents rotational movement of the anchor housing 124' relative to the anchor garage 110', such as when rotating a stylet 1050' to actuate and / or withdraw / detach an artificial chordae tensioning and locking device 130' operably associated with the anchor 120'. The artificial tendon tensioning and locking device 130' may be configured as or in any other manner as the artificial tendon tensioning and locking device 130 shown in Figures 5A and 5B. In some embodiments, the anchor garage 110' includes two or more tabs 144', each of which fits within a different longitudinal groove 154' along the anchor housing 124'.Such a tab 144' is shown in more detail in FIG. 7, which shows a cross-sectional view along line VII-VII of FIG.

[0046] Various modifications and substitutions can be made to the above-described examples of the implantable device extension limiting mechanism and / or the implantable device rotation limiting mechanism. For example, the shape, number, configuration, etc. of the stop components of the implantable device extension limiting mechanism may be changed. For example, as in the example embodiment shown in Figures 6 and 7, two or more stop components (e.g., tabs) may be provided along the periphery of the anchor garage to distribute the stopping force against the corresponding stop components associated with the stylet. Furthermore, although the notch 142 forming the stop 144 of the element of the implantable device extension limiting mechanism in the anchor garage 110 shown in Figure 3A is generally rectangular, other shapes of the notch and / or stop are within the scope and spirit of the present disclosure. For example, the notch 142' forming the tab 144' of the element of the implantable device extension limiting mechanism in the anchor garage 110' shown in Figures 6 and 7 is curved rather than rectangular, as shown in the detailed view of Figure 6.

[0047] The extension limiting mechanism as described herein may be utilized with any deployed / implantable device that requires a defined deployment depth and is not limited to anchors as described herein. Additionally, the rotation limiting mechanism as described herein may be utilized with any implantable device delivery / deployment system that may require limiting rotation of the implantable device while imparting rotational motion (e.g., from a handle or other delivery / deployment device or component).

[0048] Although reference has been made generally to delivery / deployment systems, such systems may provide and / or perform other functions and may include additional delivery / deployment systems and devices for various components of the overall system.

[0049] It may be understood by those skilled in the art that the above description is merely an illustrative description of the embodiments and is not intended as a limitation of the broader aspects of the present disclosure. All devices and methods described herein are examples of devices and / or methods implemented according to one or more principles of the present disclosure. These examples are not the only ways to implement these principles, but are merely examples and are not intended as a limitation of the broader aspects of the present disclosure. Thus, references to elements, structures, or features in the drawings should be recognized as references to examples of embodiments of the present disclosure and should not be understood as limiting the present 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 this disclosure. It may be understood that features described with respect to one embodiment may typically be applied to another embodiment, whether or not explicitly shown. Various features described herein may be used alone or in any combination thereof. Thus, the present invention is not limited to only the embodiments specifically described herein.

[0050] Thus, although the embodiments of the present disclosure have been described with specific reference to implants for use with a mitral valve, a variety of other implants may similarly benefit from the structures and methods of manufacture disclosed herein. For example, implants that must withstand palpation forces to repair the tricuspid annulus and / or address other dilatation, valve insufficiency, valve leakage, and other similar heart failure conditions may also benefit from the concepts disclosed herein.

[0051] The above description is presented for the purpose of illustration and explanation as having a wide range of applications, and is not intended to limit the present disclosure to the form disclosed herein. Various additions, modifications, and substitutions may be made to the embodiments disclosed herein without departing from the concept, spirit, and scope of the present disclosure. In particular, it is clear to those skilled in the art that the principles of the present disclosure may be embodied in other forms, structures, arrangements, ratios, and with other elements, materials, and components without departing from the concept, spirit, scope, or characteristics thereof. For example, various features of the present disclosure are grouped together in one or more aspects, embodiments, or configurations for the purpose of streamlining the present disclosure. However, various features of an aspect, embodiment, or configuration of the present disclosure may be combined in alternative aspects, embodiments, or configurations. Although the present disclosure is presented in terms of embodiments, various separate features of the present subject matter need not all be present to achieve at least some of the desired properties and / or advantages of the present subject matter or such individual features. Those skilled in the art will appreciate that the present disclosure may be used with many variations in the structures, features, proportions, materials, components, and other aspects used in the practice of the disclosure that are specifically adapted to particular environments and operational requirements without departing from the principles or spirit or scope of the disclosure. For example, elements shown as integrally formed may be constructed from multiple pieces, or elements shown as multiple pieces may be integrally formed, the operation of elements may be reversed or otherwise altered, and the size or dimensions of elements may be altered. Similarly, although operations or acts or steps have been described in a particular order, this should not be construed as requiring such a particular order to achieve desired results, or that all operations or acts or steps should be performed. Also, other implementations are within the scope of the appended claims. In some cases, the operations recited in the claims can be performed in a different order and still achieve desirable results.Accordingly, the embodiments disclosed herein should be considered in all respects as illustrative and not restrictive, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to the above description or the specific embodiments or configurations described or illustrated herein. In view of the above, 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 is indicated by the appended claims and is not limited to the above description.

[0052] In the above description and in the following claims, it can be understood that: The phrases "at least one", "one or more", "and / or" as used herein are open-ended expressions operating both conjunctively and disjunctively. Terms such as "a", "the", "first", "second", etc. do not exclude a plurality. For example, an "entity" as used herein refers to one or more of that entity. Thus, the terms "a", "one or more", and "at least one" can be used interchangeably herein. The term "or" as used herein and in the appended claims is generally used in the sense of including "and / or" unless the content clearly dictates otherwise. As used herein, the conjunction "and" includes each of the structures, components, features, or equivalents so combined, unless the context clearly dictates otherwise, and the conjunction "or" includes one or the other of the structures, components, features, or equivalents so combined, alone and in any combination and number, unless the context clearly dictates otherwise. 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 the location, orientation, or use of this disclosure. Connection references (e.g., attached, coupled, connected, engaged, 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.

[0053] The following claims are 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 terms "comprises", "comprises", "includes" and "comprising" do not exclude the presence of other elements, components, features, groups, regions, integers, steps, operations, etc. Also, 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 the combination of features is not feasible and / or advantageous. Also, 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. an anchor garage configured to limit the extent to which a tissue anchor contained therein can be externally and distally displaced, a wall defining a lumen configured to receive a tissue anchor therein; a stopper extending radially inwardly from the wall of the anchor garage into the lumen and disposed to limit distal movement of an elongate member operably coupled to the tissue anchor within the anchor garage to extend the tissue anchor distally from the anchor garage; Anchor garage equipped with.

2. The anchor garage of claim 1 , wherein the stopper comprises a tab formed by a notch in the wall of the anchor garage, the tab bent radially inward into the lumen defined in the anchor garage.

3. 3. The anchor garage of claim 1, wherein the stopper is configured to fit into a longitudinal groove in an anchor housing of an anchor disposed within the lumen of the anchor garage to limit rotational movement of the anchor relative to the anchor garage.

4. The anchor garage of any one of claims 1 to 3, wherein a longitudinal slot is defined in the wall of the anchor garage sized to receive a rotational stopper that protrudes radially outward from an anchor disposed in the lumen of the anchor garage to limit rotational movement of the anchor relative to the anchor garage.

5. The anchor garage of claim 4 , wherein the longitudinal slot is arranged and configured to allow a component for coupling with an anchor disposed within the lumen of the anchor garage to pass through the longitudinal slot.

6. 1. A delivery / deployment system for delivering and / or deploying a tissue anchor to a treatment site, comprising: a leaflet clip spreader; a leaflet clip operatively associated with the leaflet clip spreader; Anchor Garage and an anchor operatively associated with the anchor garage; a stylet operably coupled to the anchor to move the anchor distally relative to the anchor garage; an implantable device extension limiting mechanism including an anchor garage stopper component operably associated with the anchor garage and a stylet stopper component operably associated with the stylet; The stylet stop component is configured to engage with the anchor garage stop component to limit the distance the stylet can extend the anchor distally from the anchor garage.

7. 7. The delivery / deployment system of claim 6, wherein the anchor garage has a wall defining a lumen therein, the anchor being positionable within the lumen of the anchor garage.

8. 8. The delivery / deployment system of claim 7, wherein the anchor garage stop component comprises a tab formed by a notch in the wall of the anchor garage, the tab bent radially inward into the lumen defined in the anchor garage.

9. The delivery / deployment system of claim 8 , wherein the stylet stop component includes a radially expanding portion engageable with the tab on the wall of the anchor garage to limit distal extension relative to the anchor garage.

10. the stylet is rotatable and separable relative to the anchor; 10. The delivery / deployment system of claim 6, wherein the anchor includes a rotation limiting component operably engaged with an anchor garage rotation limiting component to prevent rotation of the anchor when the stylet is rotated.

11. The anchor garage has a wall defining a lumen within the anchor garage; The anchor garage rotation limiting component includes a slot extending longitudinally in the wall of the anchor garage; the anchor is disposed within the lumen of the anchor garage; 11. The delivery / deployment system of claim 10, wherein the rotation-limiting component of the anchor includes a radially outwardly extending protrusion that extends into the slot in the wall of the anchor garage.

12. The anchor garage has a wall defining a lumen within the anchor garage; the anchor is disposed within the lumen of the anchor garage; the anchor garage stopper component includes a component extending radially inwardly to protrude into the lumen of the anchor garage; the anchor includes an anchor housing operatively associated with the anchor; the rotation-limiting component of the anchor includes a longitudinally extending groove extending along the anchor housing; The delivery / deployment system of claim 10 , wherein the anchor garage stop component extends into the longitudinally extending groove along the anchor housing to provide the anchor garage rotation limiting component.

13. 1. A delivery / deployment system for delivering and / or deploying an implantable device to a treatment site, comprising: an implantable device housing defining a lumen therethrough and having a proximal end and a distal end; an implantable device positionable within the lumen of the implantable device housing for delivery to the treatment site; an elongate member operably coupled to the implantable device for moving the implantable device distally from the implantable device housing; an implantable device extension limiting mechanism comprising a stop component operably associated with the implantable device housing and a stop component operably associated with the elongate member, the elongate member configured to engage with the stop component operably associated with the implantable device housing to limit the distance the elongate member can extend the implantable device distally from the implantable device housing.

14. the stop component of the implantable device housing includes a radially inward extending component extending radially inward into the lumen of the implantable device housing; 14. The delivery / deployment system of claim 13, wherein the stop component of the elongate member includes a radially expanding portion engageable with the radially inward extending component of the implantable device housing to limit distal extension relative to the implantable device housing.

15. 15. The delivery / deployment system of claim 14, further comprising a rotation limiting component operably associated with the implantable device and engageable with the implantable device housing to limit rotation of the implantable device relative to the implantable device housing, wherein the stop component of the implantable device housing operably engages with the rotation limiting component of the implantable device to limit rotation of the implantable device relative to the implantable device housing.

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