Devices, systems, and methods for controlling the deployment of medical devices

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 generally relates to the field of implantable medical devices. Specifically, the present disclosure relates to devices, systems, and methods for controlling the deployment of medical devices such as implantable medical devices. More specifically, 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 the tissue. This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 335,995, filed Apr. 28, 2022, the entire disclosure of which is incorporated herein by reference for all purposes.

Background Art

[0002] Various transcatheter techniques (e.g., trans-catheter techniques) provide minimally invasive solutions for treating or repairing sites within the body without the need for more invasive surgeries such as incisions. However, it can be difficult to control the deployment of an implantable device. Transcatheter deployment of an implantable device typically requires a delivery / deployment system assembly, such as one or more catheters, shafts, coils, rods, etc., to maneuver through a tortuous path within the body and deliver the implantable device and system to the treatment site. Further, the implantable device and system are typically pushed distally from the delivery / deployment system to secure the device within the tissue of the treatment site. Usually, there is little space for additional components in such a delivery / deployment system and visualization can be difficult.

[0003] Generally, it is desirable to deploy the implantable device to the desired depth within the tissue without excessively extending it through the tissue wall or inadvertently perforating or puncturing it. Therefore, it is generally desirable to deploy the implantable device to a predetermined distance from its associated delivery / deployment system after each implantation to verify that the implantable device has been properly deployed, regardless of the location of the delivery / deployment system. However, the degree of stress, maneuverability, and compression in the delivery / deployment system typically varies when delivering the implantable device and associated systems, which can negatively affect the predictability of the distance the implantable device travels relative to the delivery / deployment system. Therefore, there is a need for improvements to the devices, systems, and methods for delivering and deploying implantable devices, 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 the delivery / deployment system from the implanted device without causing removal that would affect the site where the implanted device is implanted (e.g., tissue). Typically, the delivery / deployment system moves in one or more directions (i.e., axial and / or rotational) relative to the implanted device being delivered / deployed. It is desirable that such movement of the delivery / deployment system does not cause movement of the implanted device relative to the implantation site, which could exert excessive stress on the body tissue at the implantation site (e.g., to resist the movement of the implanted device). Therefore, there is a need for improvements to the devices, systems, and methods for delivering and deploying tissue anchors, such as controlling the movement of tissue anchors during deployment and implantation (e.g., to release the tissue anchors from the deployment device and system without affecting the tissue in which they are implanted).

[0005] Various improvements to transcatheter repair devices, systems, and methods are desirable. Solutions applicable to other surgical fields are equally interesting and valuable. [Overview of the project]

[0006] This summary of the disclosure is for informational purposes only and will be useful to those skilled in the art. Each of the various aspects and features of the disclosure may be used advantageously, either separately in some cases or in combination with other aspects and features of the disclosure in other cases. The inclusion or exclusion of elements or components in this summary is not intended to limit the scope of the claimed subject matter.

[0007] According to various principles of this disclosure, an anchor garage is configured to restrict the extent to which a tissue anchor housed within the anchor garage moves distally outside the anchor garage. In some embodiments, the anchor garage includes a wall defining a lumen configured to house a tissue anchor, and a stopper extending radially inward from the wall of the anchor garage into the lumen and positioned to restrict the distal movement of an elongated member operably coupled to the tissue anchor in order to extend the tissue anchor 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, the tab being bent radially inward within the lumen defined within the anchor garage.

[0009] In some embodiments, the stopper is configured to restrict the rotational movement of the anchor relative to the anchor garage by fitting into a longitudinal groove in the anchor housing of the anchor, which is located within the lumen of the anchor garage.

[0010] In some embodiments, a longitudinal slot is defined in the wall of the anchor garage, having a size to receive a rotation stopper that protrudes radially outward from an anchor located within the lumen of the anchor garage and restricts the rotational movement of the anchor relative to the anchor garage. In some embodiments, the longitudinal slot is arranged and configured such that components for coupling with the anchor located within the lumen of the anchor garage can pass through the longitudinal slot.

[0011] According to various principles of this disclosure, a delivery / deployment system for delivering and / or deploying a tissue anchor to a treatment site comprises 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 with the anchor garage stopper component to limit the distance the stylet can extend distally from the anchor garage to the anchor.

[0012] In some embodiments, the anchor garage has a wall defining a lumen inside the anchor garage, and the anchor is configurable within the lumen of the anchor garage. In some embodiments, the anchor garage stopper component is a tab formed by a notch in the wall of the anchor garage, and includes the tab bent radially inward into the lumen defined within the anchor garage. In some embodiments, the stylet stopper component is a radially extending portion in the wall of the anchor garage that is configurable with the tab to restrict distal extension of the tab relative to the anchor garage. In some embodiments, the anchor has an anchor housing having a longitudinal groove in the wall of the anchor garage into which the tab extends to restrict rotational movement of the anchor relative to the anchor garage.

[0013] In some embodiments, the stylet is rotatable and separable from the anchor, and the anchor includes a rotation limiting component operably engaged with an anchor garage rotation limiting component to prevent the rotation of the anchor when the stylet is rotated. In some embodiments, the anchor garage has a wall defining a lumen inside the anchor garage, the anchor garage rotation limiting component has a slot extending longitudinally in the wall of the anchor garage, the anchor is located within the lumen of the anchor garage, and the rotation limiting component of the anchor includes a radially outward projection that extends into the slot in the wall of the anchor garage. In some embodiments, the anchor garage has a wall defining a lumen inside the anchor garage, the anchor is located within the lumen of the anchor garage, the anchor garage stopper component has a component extending radially inward so as to project into the lumen of the anchor garage, the anchor includes an anchor housing operably 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 within the longitudinally extending groove along the anchor housing to form the anchor garage rotation limiting component. In some embodiments, the anchor garage stopper is a tab formed by a notch in the wall of the anchor garage, having the tab bent radially inward into the lumen defined within the anchor garage and extending within the longitudinally extending groove along the anchor housing.

[0014] In some embodiments, the anchor further includes a housing to which an artificial chordal tensioning and locking device is operably associated; the system further includes an artificial chordae tendineae coupled between the leaflet clip and the artificial chordal tensioning and locking device; the stylet is operably coupled to the artificial chordal tensioning and locking device to actuate the artificial chordal 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 chordal tensioning and locking device. In some embodiments, the anchor garage has a wall defining a lumen inside the anchor garage, the rotation limiting component of the anchor garage includes a slot extending longitudinally in the wall of the anchor garage, the anchor is located within the lumen of the anchor garage, the rotation limiting component of the anchor is a radially outward projection having the projection extending into the slot in the wall of the anchor garage, and the artificial chordae tendineae extend from the leaflet clip through the slot in the wall of the anchor garage to the anchor. [Brief explanation of the drawing]

[0015] [Figure 1] Figure 1 is a perspective view showing an example of an embodiment of a delivery / deployment device and system, as shown in a schematic diagram of a heart formed according to various principles of this disclosure. [Figure 2] Figure 2 is a perspective view showing an example of an embodiment of a delivery and deployment device and system formed according to various principles of the present disclosure, in which selective components are indicated by dashed lines. [Figure 3] Figure 3 is a perspective view of an example of an embodiment of an anchor delivery device formed according to various principles of this disclosure. [Figure 4A]Figure 4A is a perspective view showing an example of an embodiment of the anchor delivery and deployment device and system in Figure 2, with the anchor delivery device in Figure 3 shown by dashed lines, and the anchors housed in the anchor delivery device of the delivery mechanism. [Figure 4B] Figure 4B is a perspective view showing an example of an embodiment of the anchor delivery and deployment device and system in Figure 4A, and depicts the moment when the anchor deployment begins. [Figure 4C] Figure 4C is a perspective view showing an example of an embodiment of the anchor delivery and deployment device and system in Figure 4B, where the anchor is in a partially deployed state. [Figure 4D] Figure 4D is a perspective view showing an example of an embodiment of the anchor delivery and deployment device and system in Figure 4C, where the anchor is in the deployed state. [Figure 5A] Figure 5A is a cross-sectional view along the line VA-VA in Figure 4A. [Figure 5B] Figure 5B is a cross-sectional view along the line VB-VB in Figure 4D. [Figure 6] Figure 6 is a perspective view showing another example of an embodiment of an anchor delivery and deployment device and system formed according to various principles of the present disclosure, in which the anchor is shown by dashed lines. [Figure 7] Figure 7 is a cross-sectional view along line VII-VII in Figure 6. [Modes for carrying out the invention]

[0016] Non-limiting embodiments of this disclosure are described by example with reference to the accompanying drawings. The accompanying drawings are schematic and not intended to be drawn to scale. The accompanying drawings are provided for illustrative purposes only, and dimensions, positions, order, and relative sizes reflected in the drawings may be modified. For example, devices may be enlarged to allow for the identification of details, but are intended to be reduced to fit within, for example, the working channel of a delivery catheter or endoscope. In the drawings, identical, nearly identical, or equivalent elements are typically represented by the same reference letter, and similar elements are typically designated by similar reference numbers followed by a dash (´), and redundant descriptions are generally omitted for the sake of brevity. For clarity and brevity, not all elements are shown in all drawings, nor are all elements of each embodiment shown where an example is not necessary to enable a person skilled in the art to understand this disclosure. Detailed descriptions may be better understood in conjunction with the accompanying drawings, where similar reference letters represent similar elements.

[0017] The following detailed description should be read with reference to the drawings illustrating exemplary embodiments. It should be understood that this 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 in accordance with one or more principles of this disclosure. Each example of an embodiment is provided for illustrative purposes only and is merely illustrative, not the only way to implement these principles. Accordingly, references to elements, structures, or features in the drawings should be understood as references to examples of embodiments of this disclosure and should not be understood as limiting this disclosure to any specific element, structure, or feature illustrated. Other examples of ways to implement the disclosed principles will be readily apparent to those skilled in the art upon reading this disclosure. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in this disclosure without departing from the scope or spirit of the subject matter. For example, a feature illustrated or described as part of one embodiment may, when used in conjunction with another embodiment, result in further embodiments. Therefore, this subject matter is intended to encompass modifications and variations that fall within the scope of the appended claims and their equivalents.

[0018] This disclosure provides details at various levels of detail in this application. In some cases, details that are not necessary for a person skilled in the art to understand this disclosure, or details that would make it difficult to recognize other details, have been omitted. The terms used herein are for the purpose of describing specific embodiments only and are not intended to limit the scope beyond the appended claims. Unless otherwise defined, the technical terms used herein should be understood as commonly understood by a person skilled in the art to which this disclosure belongs. All apparatus and / or methods disclosed and claimed herein can be constructed and performed without undue experimentation in light of this disclosure.

[0019] As used herein, "proximal" refers to the direction toward or the position closest to the user (such as a medical professional, clinician, technician, operator, or physician, etc., and such terms are used interchangeably herein without intention of limitation and include an automatic controller system or other aspects) when using the device (for example, when introducing the device into a patient or during implantation, placement, or delivery), and "distal" refers to the direction away from or the position farthest from the user closest to the delivery device when using the device (for example, when introducing the device into a patient or during implantation, placement, or delivery). "Longitudinal direction" means the direction extending along the longer or larger dimension of an element. The "longitudinal axis" extends along the longitudinal extent of the element but is not necessarily straight and does not necessarily maintain a constant form if the element bends or flexes. "Center" means at least generally bisecting a central point and / or being generally equidistant from the periphery or boundary, and the "central axis" means, with respect to an opening, a line that at least generally bisects the central point of the opening, and when the opening includes, for example, a tubular element, strut, channel, cavity, or hole, extends longitudinally along the length of the opening. As used herein, "channel" or "hole" is not limited to a circular cross-section. The "free end" of an element as used herein is the end at which the element does not extend beyond. Finally, terms such as part, region, section, segment, etc. can be used interchangeably herein without intention of limitation, and generally, a section is referred to as a general area and a segment as a specific part, but these are for ease of distinction and not intended to be limiting.

[0020] Heart disease, including atrioventricular valve dysfunction, impairs a patient's cardiac output, reducing their quality of life and lifespan. Proper blood flow through the heart is regulated by heart valves, including the atrioventricular valves, which contain soft tissue leaflets that open and close periodically to allow blood to flow in one direction. Healthy leaflets prevent blood flow in the opposite direction (regurgitation). Chordae tendineae extend from the leaflets to the papillary muscles and support proper leaflet function by distributing the load to the papillary muscles during systolic closure and preventing the leaflets from flailing within the atria. Chordae tendineae dysfunction impairs the ability of the leaflets to form a seal in the heart valve. Various defects of chordae tendineae, such as elongation, rupture, thickening, contraction, calcification, inelastic stretching, or other changes in elasticity, can result in flailed leaflets that can no longer form a valve seal for improper closure of the heart valve and / or normal cardiac function. When the valve leaflets lose their ability to form a seal, valve regurgitation or blood reflux typically occurs, which typically prevents an adequate supply of blood delivered through the cardiovascular system.

[0021] Heart valve diseases are typically repaired by invasive surgical intervention (e.g., an open surgery that cuts the patient open), or by a method that intricately sandwiches the valve leaflets to form a double small opening, or by native valve replacement. These methods involve opening the patient's chest and heart cavity to expose the heart valve for direct visualization and repair. Resection, partial removal, and / or repair of the patient's valve leaflets are complex techniques used by surgeons, along with the implantation of a surgical ring, to reduce the diameter of the patient's heart valve annulus, thereby enabling the valve leaflets to properly join and reduce regurgitation. Some techniques may be able to slightly reduce regurgitation but may not provide a durable solution and do not repair and / or replace damaged chordae tendineae of the valve. Various transcatheter techniques (e.g., transcatheter techniques) provide minimally invasive solutions for repairing heart valves, such as their valve leaflets. Transcatheter artificial valve replacement is less invasive than the open surgical method but typically requires lifelong treatment with anticoagulants thereafter. Transcatheter edge-to-edge 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 are welcomed.

[0022] According to various principles of this disclosure, the delivery / deployment system is configured to provide repeatable and predictable delivery and / or deployment of an implantable device, for example, a repeatable and predictable insertion depth of such an implantable device into an implantation site. In this specification, anatomical sites, delivery sites, deployment sites, implantation / implantation sites, target sites, treatment sites, etc., may be used interchangeably and without intent to limit. Also, terms such as implant (and other grammatical forms) may be used interchangeably and without intent to limit in this specification with terms such as attach, anchor, mount, associate, join, engage, embed, hold, retain, grasp, and fasten (and their grammatical forms). In some embodiments, the extent to which the implantable device extends from the delivery / deployment system (generally into the treatment site) is determined by the geometry and configuration of the delivery and deployment system, rather than by the control of various elongated members delivering the implantable device, and is therefore not affected by the potential compression of the delivery / deployment system. In some embodiments, delivery and deployment devices are less susceptible to compression than the various elongated members used with them. For example, while various elongated members are typically flexible, delivery and deployment devices tend to be less flexible and, in some cases, have thicker walls than the flexible tubular elongated members used with them, making them more susceptible to compression.

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

[0024] In some embodiments, the embedded device, and / or the device and / or system for delivering / deploying such device, is molded and configured to predictably and repeatedly define the depth of deployment of the embedded device and the rotational motion of the embedded device 200 relative to the delivery / deployment device and system.

[0025] The principles of this disclosure may be applied to various transcatheter devices, systems, and methods for repairing cardiac valve insufficiency. One example of a technique for repairing cardiac valve insufficiency involves clipping a leaflet clip to the cardiac valve leaflet, extending an artificial chordae tendineae from the leaflet clip to the cardiac wall tissue (e.g., the ventricle, such as the papillary muscle), and fixing the artificial chordae tendineae to the cardiac tissue with tissue anchors. Specifically, the delivery / deployment system delivers a leaflet grasping mechanism that carries (e.g., accommodates) the leaflet clip transcatheterally to the cardiac valve. The leaflet grasping mechanism includes a clip spreader that can bend and open the spring arms of the leaflet clip to capture the free edge of the cardiac valve leaflet between the arms of the leaflet clip. The clip spreader then closes and secures the leaflet clip on the leaflet by releasing the spring arms. The delivery / deployment system is then advanced from the cardiac valve to the cardiac wall, extending the artificial chordae tendineae from the leaflet clip to the cardiac wall (typically the ventricular wall). An anchor garage, which carries (e.g., houses) the tissue anchor, is delivered to the desired implantation site for the tissue anchor (e.g., the papillary muscle). The anchor garage is delivered to the treatment site within a leaflet clip spreader and may be made extendable distally from the leaflet clip spreader when it reaches the treatment site, for example. Typically, the tissue anchor is delivered in a delivery form that may be compact or compressed or contracted to allow for transcatheter delivery. The tissue anchor extends from the anchor garage and expands into the tissue at the implantation site to secure it to that tissue. The tension of the prosthetic chordae tendineae can be adjusted by pulling the proximal end of the prosthetic chordae tendineae, which extends through the delivery / deployment system to its proximal control end (e.g., a control handle). The desired or medically prescribed or indicated tension in the prosthetic chordae tendineae is generally achieved when the desired leaflet repair is achieved, thereby providing proper valve function. Prosthetic chordae tendineae tension and locking devices may be used to set the tension and / or length of the prosthetic chordae tendineae. The leaflet clip spreader can remain in place with the leaflet clip until proper valve function is achieved, and can then be removed along with the delivery / deployment system, leaving the leaflet clip in place.The delivery / deployment system can be retracted, and optionally, the artificial chordae tendineae can be cut (for example, when removed) and / or another valve leaflet clip as well as an artificial chordae tendineae and anchor set can be delivered.

[0026] In this specification, the term anchor (and other grammatical forms) is used for convenience but may be used interchangeably with terms such as anchor component, anchor device, anchor element, anchor mechanism, etc. (and other grammatical forms). Such terms are known in the art to describe structures configured to hold another object in place. In this specification, tissue anchors are referred to as an example of an embodiment of an implantable device. However, such references are for convenience only and are not intended to limit the scope, and tissue anchors / implantable devices that can be used with the principles of this disclosure should be understood to include other devices as well. Furthermore, the principles described above are equivalently applicable to other devices, systems, and methods, and this disclosure is not limited to implantable devices.

[0027] Hereinafter, various embodiments of apparatus, systems, and methods formed in accordance with the various principles of this disclosure will be described with reference to examples shown in the accompanying drawings. References in this specification to “one embodiment,” “embodiment,” “several embodiments,” “other embodiments,” etc., indicate that one or more specific features, structures, concepts, and / or characteristics in accordance with the principles of this disclosure may be included in relation to an embodiment. However, such references do not necessarily mean that all embodiments include a particular feature, structure, concept, and / or characteristic, or that a given embodiment includes all of those 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 can 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 can be mixed and adapted to form a hybrid embodiment, and such hybrid embodiments are included within the scope of this disclosure. Furthermore, references to “one embodiment,” “a certain embodiment,” “several embodiments,” and “other embodiments” in various parts of this specification do not necessarily all refer to the same embodiment, and separate or alternative embodiments do not necessarily exclude other embodiments from each other. Moreover, the various features, structures, concepts, and / or characteristics of the disclosed embodiments are independent and distinct from one another and may be used individually or in various combinations to form alternative embodiments that are considered part of this disclosure. Therefore, this disclosure is not limited to the embodiments specifically described herein, and describing all the numerous possible combinations and partial combinations of features, structures, concepts, and / or characteristics would be extremely cumbersome, and the examples of embodiments disclosed herein are not intended to limit broader aspects of this disclosure. The following description is merely illustrative of embodiments and is not intended to limit broader aspects of this disclosure.

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

[0029] Referring here to the drawings, Figure 1 shows an example of an embodiment of an implantable device delivery / deployment system 100 formed according to various principles of the present disclosure, and shows it being delivered to a treatment site (in this embodiment, ventricular V) by an example of an embodiment of the delivery / deployment system 1000. The delivery / deployment system 1000 includes a plurality of flexible elongated members, such as a delivery sheath 1010, which navigates and delivers the system 1000 to a region of the treatment site. A maneuverable delivery catheter 1020 extends through the delivery sheath 1010 and exits from the distal end 1011 of the delivery sheath 1010. The maneuverable delivery catheter 1020 is maneuverable to position the implantable device delivery / deployment system 100 and optionally another device delivery / deployment system 200 for delivery and / or deployment of the device it carries. The device delivery / deployment system 200 may be delivered using a device catheter 1030 that extends outward from its distal end 1021 through the maneuverable catheter 1020. The implantable device delivery catheter 1040 may extend through the device catheter 1030 to deliver the implantable device delivery / deployment system 100.

[0030] In an example of the embodiment shown in Figure 1, the device catheter 1030 delivers a device delivery / deployment system 200, which includes a delivery / deployment device 210. The delivery / deployment device 210 is exemplified in Figure 1 as a leaflet clip spreader 210 configured to deliver a leaflet clip 220 to a cardiac valve leaflet L. For convenience, the device catheter 1030 may be referred to as the gripping device shaft 1030 to distinguish it from other catheters described herein. The leaflet clip 220 is shown in Figure 1 as being clamped on the valve leaflet L by the spreader arm 212 of the leaflet clip spreader 210, and the leaflet clip 220 is shown in more detail in Figure 2.

[0031] In the example of the embodiment shown in Figure 1, the implantable device delivery / deployment system 100 is delivered on the distal end 1041 of a generally flexible, tubular, elongated implantable device delivery catheter 1040 extending through a gripping device shaft 1030. The example of the embodiment of the implantable device delivery / deployment system 100 shown in Figure 1 includes an implantable device delivery / deployment device having the form of an anchor garage 110. As shown in more detail in Figure 2, the distal end 1041 of the implantable device delivery catheter 1040 (which may be referred to herein as the anchor garage catheter 1040 for convenience) can be coupled to the proximal end 113 of the anchor garage 110 in any way known to those skilled in the art. The terms coupled (and other grammatical forms) may be used herein interchangeably with terms such as engaging, gripping, holding, fastening, clipping, anchoring, attaching, pasting, clamping (and other grammatical forms), without intent to limit them. The anchor garage 110 can be delivered to the treatment site within and through the leaflet clip spreader 210 in order to deliver the implantable device. Figures 1, 2, 4A–4D, 5A, and 5B show an example of one embodiment of the implantable device as a tissue anchor 120 having a claw 122 configured to penetrate and extend into the tissue and be fixed to the tissue, as will be described in more detail below. The anchor garage catheter 1040 is extendable 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 can be delivered within a lumen 117 defined within the anchor garage 110. As shown in Figure 2, the anchor 120 is delivered in a delivery configuration (e.g., compact configuration) in which the distal end 121 of its claw 122 is located proximal to the distal end 111 of the anchor garage 110. The anchor 120 is extendable outward from the distal end 111 of the anchor garage 110 and is embedded in tissue (e.g., cardiac tissue such as papillary muscle tissue) in an expanded configuration (e.g., expanded state as shown in Figure 4D and described in further 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 facilitates pushing the anchor garage 110 against cardiac tissue, thereby deploying the anchor 120 from the anchor garage 110 into the tissue of the deployment site without potentially pushing the distal end 111 of the anchor garage 110 into cardiac tissue. By implanting anchors 120 within the cardiac tissue, artificial chordae tendineae 250 (e.g., stretched polytetrafluoroethylene (ePTFE) sutures) extending from the valve leaflet clips 220 to the anchors 120 are fixed to the cardiac wall (e.g., papillary muscle), thereby restoring proper function of the valve leaflet L.

[0033] To set the tension on the artificial chordae tendineae 250, an artificial chordae tendineae tension and locking device 130 may be used, as desired, as instructed, as necessary, etc. As illustrated in more detail in Figure 5, the artificial chordae tendineae tension and locking device 130 may be coupled to an anchor 120. For example, the artificial chordae tendineae tension and locking device 130 may be located in a housing 124 coupled to the anchor 120 (for example, forming part of the anchor 120 from which a claw 122 extends).

[0034] The anchor 120 of the implantable device delivery / deployment system 100 is delivered at the distal end 1051 of the stylet 1050, as shown in Figures 2, 4A–4D, 5A, and 5B. The stylet 1050 is operably coupled to the proximal end 123 of the anchor 120 (for example, screw-coupled to the proximal end 125 of the anchor housing 124, for example, internally) to deploy the anchor 120 by advancing or retracting it relative to the anchor garage 110, thereby advancing the anchor 120 into the tissue. For example, the stylet 1050 can be advanced or retracted axially to 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 tendineae tension and locking device 130 to adjust the tension applied to the artificial chordae tendineae 250 by the artificial chordae tendineae tension and locking device 130. For example, in the embodiments shown in Figures 5A and 5B, a stylet connector 1052 formed at the distal end 1051 of the stylet 1050 is operably coupled to a tension connector 134 operably associated with the artificial chordae tendineae tension and locking device 130, such that movement of the stylet 1050 activates the artificial chordae tendineae tension and locking device 130. In some embodiments, the stylet connector 1052 and the tension connector 134 are screwed into the proximal end 125 of the anchor housing 124 and operably coupled to each other such that rotation of the stylet 1050 imparts rotation to the tension connector 134. Thus, rotation of the stylet 1050 causes axial advance or retraction of the tension connector 134, thereby adjusting the tension applied to the artificial chordae tendineae 250 by the artificial chordae tendineae tension and locking device 130. At the nearest position to the tension coupling 134, the artificial chordae tendineae tension and locking device 130 fixes or locks the tension on the artificial chordae tendineae 250. Further rotation of the stylet 1050 pulls the stylet 1050 away from the tension coupling 134 and anchor 120, leaving the anchor 120 positioned within the target site in the target tissue.Furthermore, other components of the stylet, anchor, and artificial chordae tendineae tensioning and locking devices are also within the scope and concept of this disclosure, and details of such elements do not limit the scope of this disclosure.

[0035] Further details of the structure and function of leaflet clip spreaders, leaflet clips, anchor garages, anchors, artificial chordae tendineae, and artificial chordae tendineae tensioning and locking devices, without limiting the scope of this disclosure, are, for example, U.S. Patent Application Publication No. 2021 / 0007847, entitled "Devices, Systems, And Methods For Clamping A Leaflet Of A Heart Valve," published on January 14, 2021; U.S. Patent Application Publication No. 2021 / 0000597, entitled "Devices, Systems, And Methods For Adjustably Tensioning An Artificial Chordae Tendineae Between A Leaflet And A Papillary Muscle Or Heart Wall," published on January 7, 2021; and "Devices, Systems, And Methods For Artificial Chordae Tendineae," published on January 7, 2021. U.S. Patent Application Publication No. 2021 / 0000599 titled "Tendineae", U.S. Patent Application Publication No. 2021 / 0000598 titled "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. 2022 / 0096253 titled "Devices, Systems, And Methods For Adjustably Tensioning Artificial Chordae Tendineae In A Heart", filed on September 23, 2021, U.S. Provisional Patent Application No. 63 / 239,467 titled "Devices, Systems, And Methods For Clamping A Leaflet Of A Heart Valve", filed on September 1, 2021, "Devices, Systems,These can be found in U.S. Provisional Patent Application No. 63 / 239,469, entitled “And Methods For Anchoring An Artificial Chordae Tendineae To Cardiac Tissue,” U.S. Provisional Patent Application No. 63 / 279,473, entitled “Devices, Systems, And Methods For Positioning A Leaflet Clip,” filed November 15, 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 December 20, 2021, all of which are incorporated herein by reference in their entirety for all purposes.

[0036] According to various principles of this disclosure, the implantable device delivery / deployment system 100 includes an implantable device extension limiting mechanism molded, positioned, and configured to limit the extension of the implantable device into tissue, for example, to prevent accidental overextension with potentially adverse consequences. In some embodiments, the implantable device extension limiting mechanism includes corresponding stopper components operably associated with the anchor garage 110 and the stylet 1050, thereby limiting the distal extension of the anchor 120 so that the advance of the anchor does not exceed a desired range, distance, etc., by restricting the distal extension of the stylet 1050 relative to the anchor garage 110. For example, the implantable device extension limiting mechanism includes a stopper 140 associated with the anchor garage 110 and positioned to interact with the radially expanding portion 1054 of the stylet 1050. In some embodiments, the anchor garage stopper 140 is a radially inward extending element projecting into a lumen 117 defined within the anchor garage 110, as shown in Figures 5A and 5B. Specifically, in the example of the embodiment of the embedded 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, which forms a tab 144 that is pushed radially inward into the lumen 117 inside the anchor garage 110 (as shown in the detailed view of Figure 3). The notch 142 may be laser cut, machine cut, shear slot / groove, or any other suitable configuration known to those skilled in the art. The radially extending portion 1054 of the stylet 1050 in the example of the embodiment shown in Figures 3, 4A, 4B, 4C, 4D, 5A, and 5B has a limited axial range along the stylet 1050 and has a larger diameter than the area of ​​the stylet 1050 at its proximal and distal ends. The radially extended portion of the stylet 1050 may, for convenience and without limitation, be referred to as the shoulder portion 1054 in this specification.

[0037] By forming the stopper component as a tab oriented radially inward in the wall of the anchor garage 110, assembly of the implantable device delivery / deployment system 100 can be facilitated. Specifically, the stopper 140 can act as a spring that allows forward loading of the anchor 120 into the anchor garage 110 (i.e., insertion in the distal-to-proximal direction along the anchor garage 110) and then returns to the implantable device extension limiting mechanism / position. For example, forward loading of the implantable device delivery / deployment system 100 and delivery / deployment system 1000 may be desirable in general, such as allowing the anchor garage 110 with an extended distal end 111 to be supported within the valve leaflet clip spreader 210, as shown in Figure 2.

[0038] The operation of the embedded device extension limiting mechanism in the illustrated example of an embodiment of the embedded device delivery / deployment system 100 can be understood by referring 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 proximal to the tab 144 on the anchor garage 110, and is therefore movable distally relative to the anchor garage 110. The relative positions of the shoulder 1054 and the tab 144 can be further understood by referring to the cross-sectional view along the line VA-VA in Figure 4A shown in Figure 5A.

[0040] As shown in Figure 4B, as the stylet 1050 is advanced distally, the claw 122 of the anchor 120 extends outward from the distal end 111 of the anchor garage 110. In some embodiments, the distal end 121 of the claw 122 is configured to facilitate perforation or penetration of tissue (e.g., tapered, pointed, etc.). As described 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. During use, the rounded distal end 111 of the anchor garage 110 can be pressed against the tissue at the implantation site, and the stylet 1050 is advanced distally to extend the distal end 121 of the claw 122 from the distal end 111 of the anchor garage 110 and pierce the tissue at the implantation site.

[0041] As the stylet 1050 is advanced further distally, the claws 122 of the anchor 120 transition to an unfolded form within the tissue, as shown in Figure 4C. The claws 122 may be formed of a superelastic or shape-memory material such as Nitinol (nickel-titanium alloy). Thus, once the claws 122 are no longer constrained, contracted, or trapped in the anchor garage 110 (for example, within it), they transition to an unfolded form almost automatically (without any further input or action on them). For example, in the example of the embodiment of the anchor 120 shown in Figure 4C, the claws 122 curl, curve, arch, bend, etc. toward the proximal end 123 of the anchor 120.

[0042] The claw 122 reaches its final deployed form when the distal end 131 of the anchor housing 124 reaches the distal end 111 of the anchor garage 110 (or optionally extends outward from the distal end 111), 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 to 4D, the stylet 1050 allows the anchor 120 to extend freely distally from the anchor garage 110 until the shoulder portion 1054 of the stylet 1050 advances and contacts the stopper 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 in Figure 4D. Accordingly, illustrated examples of embodiments of the embedded device extension limiting mechanism predictably and repeatedly limit the axial distal movement of the anchor 120 relative to the anchor garage 110 and to the tissue, thereby predictably and repeatedly controlling the deployment range, deployment distance, deployment depth, etc. (such terms and other such terms are used interchangeably herein without intent to limit) of the anchor 120 within the tissue.

[0043] According to various principles of this disclosure, the implantable device delivery / deployment system 100 additionally or alternatively includes an implantable device rotation limiting mechanism having rotation limiting components molded, positioned and configured to restrict the rotational movement of the implantable device relative to the implanted tissue. In some embodiments, as described above, the stylet 1050 may be rotated to actuate the artificial chordae tendineae tensioning and locking device 130 and / or to withdraw / detach / separate from the anchor 120 (similar terms, including such terms and other grammatical forms, are used synonymously herein without intent to limit). It may be desirable to limit the rotation of the anchor 120 by the stylet 1050, for example, to prevent unwanted pressure or torque on the implanted tissue. In the example of the embodiment of the embedded device delivery / deployment system 100 shown in Figures 3, 4A, 4B, 4C, 4D, 5A, and 5B, the embedded device rotation limiting mechanism includes a corresponding rotation stopper element 150 on the anchor garage 110 and the anchor housing 124 to limit the rotational movement of the anchor housing 124 relative to the anchor garage 110. For example, in the illustrated example of the embodiment, the embedded device rotation limiting mechanism includes a rotation stopper 154 (e.g., a projection or protrusion) associated with the anchor housing 124 (e.g., projecting radially outward from the anchor housing 124) and positioned within a longitudinally extending slot 152 defined within the anchor garage 110 (i.e., extending substantially parallel to the longitudinal axis LA of the device / system). The slot 152 allows for longitudinal extension or retraction of the anchor 120 relative to the anchor garage 110. However, the wall defining the slot 152 restricts (e.g., prevents) the rotational movement of the rotation stopper 154 within the slot 152, thereby restricting (e.g., preventing) the rotational movement of the anchor 120 relative to the anchor garage 110.Therefore, the stylet 1050 can be rotated relative to the anchor 120 to activate the artificial chordae tendineae tensioning and locking device 130 and / or to deploy the anchor 120 by withdrawing it from the anchor 120 (e.g., detaching, separating, etc.), without rotating the anchor 120 within the tissue.

[0044] Referring to Figure 2, it can be understood that the slot 152 also facilitates the connection of the artificial chordae tendineae 250 between the leaflet clip 220 and the anchor 120 by allowing the artificial chordae tendineae 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) and connect with the anchor 120. The anchor garage 110 may also be formed together with a leaflet clip spreader seat 156 on which the leaflet clip spreader 210 can be seated, as can be understood by referring to Figures 2 and 3. The slot 152 is circumferentially spaced from the leaflet clip spreader seat 156 so as to allow the rotation stopper 154 on the anchor housing 124 to move within the slot 152 in the anchor garage 110 and / or so as to allow the artificial chordae tendineae 250 to extend from the leaflet clip 1050 to the anchor 120 within the anchor garage 110.

[0045] According to various principles of this disclosure, as shown in Figures 4A–4D, 5A, and 5B, longitudinal grooves along the outer surface of the anchor housing 124 in an embodiment of the embedded device delivery / deployment system 100 can be provided so that the radially inwardly oriented tabs 144 do not obstruct the axial movement of the anchor housing 124 (for example, for deploying the anchor 120). In an example of an alternative embodiment of the embedded device delivery / deployment system 100' shown in Figure 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, for example, taking 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 range of the anchor housing 124'. Such longitudinal grooves 154' prevent the radially inward-oriented tabs 144' in the anchor garage 110' from contacting or hindering the axial movement of the anchor 120' when the anchor 120' moves forward or backward in the manner described above with respect to the examples of embodiments shown in Figures 4A to 4D. Additionally or alternatively, the longitudinal grooves 154' may work together with the tabs 144' formed in the anchor garage 110' to form an embedded device rotation limiting mechanism 150'. Similar to the embedded device rotation limiting mechanism 150' shown in Figures 4A to 4D and Figure 5, the embedded device rotation limiting mechanism 150' shown in Figure 6 prevents / prevents rotational movement of the anchor housing 124' relative to the anchor garage 110', for example, when rotating the stylet 1050' to activate and / or withdraw / separate from the anchor 120'. The artificial chordae tendineae tensioning and locking device 130' may be configured as the artificial chordae tendineae tensioning and locking device 130 shown in Figures 5A and 5B, or in other embodiments. In some embodiments, the anchor garage 110' includes two or more tabs 144', each tab 144' fitting into different longitudinal grooves 154' along the anchor housing 124'.Such a tab 144' is shown in more detail in Figure 7, which shows a cross-sectional view along line VII-VII in Figure 6.

[0046] Various modifications and substitutions can be made to the above-described examples of embedded device extension limiting mechanisms and / or embedded device rotation limiting mechanisms. For example, the shape, number, configuration, etc., of the stopper components of the embedded device extension limiting mechanism may be changed. For example, as in the embodiment shown in Figures 6 and 7, two or more stopper components (e.g., tabs) may be provided along the outer perimeter of the anchor garage to distribute stopping force to corresponding stopper components associated with the stylet. Furthermore, although the notches 142 forming the stoppers 144 of the elements of the embedded device extension limiting mechanism in the anchor garage 110 shown in Figure 3A are substantially rectangular, other shapes of notches and / or stoppers are also included in the scope and ideas of this disclosure. For example, the notches 142' forming the tabs 144' of the elements of the embedded device extension limiting mechanism in the anchor garage 110' shown in Figures 6 and 7 are curved rather than rectangular, as shown in the detailed view of Figure 6.

[0047] The extension limiting mechanisms described herein can be used in any deployable / embedded device requiring a specified deployment depth, and are not limited to anchors as described herein. Furthermore, the rotation limiting mechanisms described herein can be used in any embedded device delivery / deployment system that requires limiting the rotation of the embedded device while imparting rotational motion (e.g., from a handle or other delivery / deployment device or component).

[0048] Generally, delivery / deployment systems have been mentioned, but such systems may provide and / or perform other functions and may include further delivery / deployment systems and devices for various components of the overall system.

[0049] Those skilled in the art will understand that the above description is merely illustrative of embodiments and is not intended to limit the broader aspects of this disclosure. All apparatus and methods described herein are examples of apparatus and / or methods implemented in accordance with one or more principles of this disclosure. These examples are merely examples and not the only ways of carrying out these principles, and are not intended to limit the broader aspects of this disclosure. Accordingly, references to elements, structures, or features in the drawings should be recognized as references to examples of embodiments of this disclosure and should not be understood as limiting the disclosure to any specific element, structure, or feature illustrated. Other examples of ways of carrying out the disclosed principles will be conceivable to those skilled in the art upon reading this disclosure. Features described in relation to one embodiment can typically be understood to apply to another embodiment, whether expressly indicated or not. The various features described herein can be used individually or in any combination thereof. Accordingly, the present invention is not limited to the embodiments specifically described herein.

[0050] Therefore, although embodiments of this disclosure have been described with specific reference to implants for use with mitral valves, various other implants may also 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 to address other dilations, valvular dysfunction, valvular leakage, and other similar heart failure conditions may also benefit from the concepts disclosed herein.

[0051] The above description is presented for illustrative and explanatory purposes, as it has a broad range of applications, and is not intended to limit this disclosure to the forms disclosed herein. Various additions, modifications, and substitutions can be made to the embodiments disclosed herein without departing from the concepts, spirit, and scope of this disclosure. In particular, it will be apparent to those skilled in the art that the principles of this disclosure can be embodied in other forms, structures, arrangements, proportions, and with other elements, materials, and components without departing from the concepts, spirit, scope, or features thereof. For example, various features of this disclosure are grouped together in one or more aspects, embodiments, or configurations for the purpose of streamlining this disclosure. However, various features of a particular aspect, embodiment, or configuration of this disclosure can be combined in alternative aspects, embodiments, or configurations. Although this disclosure is presented in terms of embodiments, various distinct features of the subject matter do not all need to be present in order 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 understand that, without departing from the principles, ideas, or scope of this disclosure, it may be used with many variations of the structure, mechanism, proportions, materials, components, and other embodiments used in practice of this disclosure, particularly adapted to specific environmental and operating requirements. For example, an element shown as being formed as a whole may be constructed from multiple parts, or an element shown as multiple parts may be formed as a whole, the operation of an element may be reversed or otherwise modified, and the size or dimensions of an element may be modified. Similarly, while an operation or action or procedure is described in a particular order, this should not be understood as requiring such a particular order to achieve a desired result, or as meaning that all operations or actions or procedures should be performed. Other implementations are also included within the appended claims. In some cases, the operations described in the claims can be performed in a different order and still achieve the desired result.Accordingly, the embodiments disclosed herein should be considered in all respects as illustrative and not limiting, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to the above description or specific embodiments or configurations described or illustrated herein. In view of the foregoing, individual features of any embodiment may be used and claimed separately or in combination with features of that embodiment 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 foregoing description and the following claims, it should be understood that: The terms “at least one,” “one or more,” and “and / or” as used herein are open-ended expressions that can be used both conjunctively and disjunctively. Terms such as “one,” “it,” “first,” and “second” do not exclude plurals. For example, “one” entity, as used herein, refers to one or more of those entities. Thus, the terms “one,” “one or more,” and “at least one” may be used interchangeably herein. The term “or” as used herein and in the appended claims is used generally to include “and / or” unless otherwise explicitly indicated. The conjunction “and” as used herein includes each of the structures, components, features, or equivalents that are thus joined, unless the context explicitly indicates otherwise, and the conjunction “or” includes one or more of the structures, components, features, or equivalents that are thus joined, individually and in any combination and number, unless the context explicitly indicates otherwise. All references to direction (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 solely for identification purposes to aid the reader's understanding of this disclosure and / or to distinguish the regions of related elements from one another, and do not limit the related elements, particularly with respect to the position, orientation, or use of this disclosure. References to connections (e.g., attached, joined, connected, engaged, and joined) should be interpreted broadly and, unless otherwise indicated, may include intermediate members between sets of elements and relative motion between elements. Thus, references to connections do not necessarily imply that two elements are directly connected and in a fixed relationship with one another. References to identification (e.g., primary, secondary, first, second, third, 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 to embodiments for carrying out the present invention, and each claim stands independently as a distinct embodiment of the present disclosure. In the claims, the terms “equipped,” “equipped,” “included,” and “included” do not preclude the existence of other elements, components, features, groups, areas, integers, steps, operations, etc. Individual features may be included in different claims, but these features may be advantageously combined in some cases, and their inclusion in different claims does not imply that the combination of features is unfeasible and / or unfavorable. Furthermore, singular references do not preclude plurals. Reference numerals in the claims are provided merely as examples of clarification and should never be construed as limiting the claims.

Claims

1. An anchor garage configured to restrict the extent to which tissue anchors housed inside can move distally to the outside, A wall defining a lumen configured to house tissue anchors internally, A stopper is provided that extends radially inward from the wall of the anchor garage into the lumen and is positioned to restrict the distal movement of a long member movably coupled to the tissue anchor in order to extend the tissue anchor distally from the anchor garage, Equipped with, The stopper is a tab formed by a notch in the wall of the anchor garage, and the tab is bent radially inward within the lumen defined within the anchor garage.

2. The anchor garage according to claim 1, wherein the stopper is configured to restrict the rotational movement of the anchor relative to the anchor garage by fitting into a longitudinal groove in the anchor housing of the anchor, which is located within the lumen of the anchor garage.

3. The anchor garage according to claim 1, wherein a longitudinal slot is defined in the wall of the anchor garage, having a size for receiving a rotation stopper that protrudes radially outward from an anchor disposed within the lumen of the anchor garage and restricts the rotational movement of the anchor relative to the anchor garage.

4. The anchor garage according to claim 3, wherein the longitudinal slots are arranged and configured such that components for coupling with anchors located within the lumen of the anchor garage can pass through the longitudinal slots.

5. A delivery / deployment system for delivering and / or deploying tissue anchors to a treatment site, Leaflet clip spreader and, A valve leaf clip operably associated with the valve leaf clip spreader, Anchor garage and An anchor operably associated with the aforementioned anchor garage, A stylet movably coupled to the anchor in order to move the anchor distal to the anchor garage, The embedded 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, The stylet stopper component is configured to engage with the anchor garage stopper component to limit the distance the stylet can extend distally from the anchor garage, The anchor garage has a wall that defines a lumen inside the anchor garage, and the anchor can be placed within the lumen of the anchor garage. The anchor garage stopper component is a tab formed by a notch in the wall of the anchor garage, and includes the tab bent radially inward within the lumen defined within the anchor garage, in a delivery / deployment system.

6. The delivery / deployment system according to claim 5, wherein the stylet stopper component includes a radially expanding portion that can engage with the tab in the wall of the anchor garage to restrict distal extension toward the anchor garage.

7. The stylet is rotatable and detachable relative to the anchor, The delivery / deployment system according to claim 5 or 6, wherein the anchor includes a rotation limiting component operably engaged with an anchor garage rotation limiting component to prevent the anchor from rotating when the stylet is rotated.

8. The anchor garage rotation limiting component includes a slot extending longitudinally in the wall of the anchor garage, The delivery / deployment system according to claim 7, wherein the rotation limiting component of the anchor is a projection extending radially outward, the projection extending into the slot in the wall of the anchor garage.

9. The anchor includes an anchor housing operably associated with the anchor, The rotation limiting component of the anchor includes a longitudinally extending groove that extends along the anchor housing, The delivery / deployment system according to claim 7, wherein the anchor garage stopper component extends within the longitudinally extending groove along the anchor housing to constitute the anchor garage rotation limiting component.

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