Device, System, and Method for Delivering and Implanting an Implantable Device

Abstract

A delivery and implantation system having a control handle operable to deliver and / or implant an implantable device, e.g., trans-luminally, is disclosed. The steering control system may include a steering control knob rotatable about the longitudinal axis of the handle to axially draw a steering element to steer a flexible elongate member to deliver the implantable device to a desired site. The implantable device implantation system may include a slider selectively slidable relative to the control handle to implant the implantable device and, optionally, to hold the implantable device in a delivery position. The tether adjustment system may include a knob rotatable about the longitudinal axis of the handle to axially draw a tether element to adjust its tension and / or length. The tensioning and locking system may include a knob rotatable about the longitudinal axis of the handle to shift a tensioning and locking device to set the tension and / or length of the tether element.

Description

Technical Field

[0001] The present disclosure generally relates to the technical field of medical devices and systems. More particularly, the present disclosure relates to devices, systems, and methods for delivering and implanting implantable devices. Even more particularly, the present disclosure describes devices, systems, and methods for steering an elongate member such as a catheter, for implanting an implantable device such as a tissue engagement element (such as a tissue anchor), and for adjusting the tension of an element operably associated with the tissue engagement element.

Background Art

[0002] Devices, systems, and methods for delivering and / or implanting medical devices using minimally invasive techniques, e.g., percutaneously and / or trans-luminally, are desirable to avoid more complex and invasive open surgical procedures. Various techniques that do not require open surgery utilize systems and devices having various flexible elongate members capable of navigating through the body (such as through the vasculature) to an anatomical site within the body, from a small insertion opening in the patient's body or through a natural opening. To reach an anatomical site within the body, various elongate members must be steerable to navigate through a tortuous path within the body leading to the anatomical site. Improvements in handles for steering elongate members would be welcome in the art. Further, for implanting an implantable device inserted percutaneously and / or trans-luminally, a delivery / implantation system must provide appropriate control of the movement of the implantable device and of any system for delivering and implanting the implantable device within the patient's body. Improvements in handles for delivering and implanting an implantable device and / or for adjusting any additional device operably associated therewith would be welcome in the art.

Summary of the Invention

[0003] This summary of the disclosure is provided to facilitate understanding and it will be appreciated by those skilled in the art that each of the various aspects and features of the disclosure can advantageously be used, in some instances separately or in other instances in combination with other aspects and features of the disclosure. It is not intended that the scope of the claimed subject matter be limited by whether elements, components, etc. are included or not included in this summary.

[0004] According to various principles of the present disclosure, a delivery and retention system for delivering and / or retaining an implantable device to an anatomical site includes a flexible elongate member, an implantable device delivery device deliverable to the anatomical site at a distal end of the flexible elongate member, an implantable device deliverable by the implantable device delivery device, and a control handle. In some aspects, the control handle includes one or more of the following: a steering system operably coupled to the flexible elongate member to control movement of the flexible elongate member to deliver the implantable device to the anatomical site; an implantable device retention system operably coupled to the implantable device to retain the implantable device at the anatomical site; a tether adjustment system operably engageable with a tether element engagable with the implantable device; or a tensioning and locking system operably engageable with the implantable device to adjust a configuration of a tensioning and locking device operably associated with the implantable device.

[0005] In some embodiments, the flexible elongate member includes a tension element operably associated therewith, and the control handle includes at least a steering system including a steering control knob rotatable about a longitudinal axis of the control handle to axially pull the tension element to steer the flexible elongate member.

[0006] In some embodiments, the implantable device is a tissue anchor. In some embodiments, the flexible elongate member is tubular and the delivery and placement system further includes a stylet operably coupled to the implantable device, the stylet extending through the tubular flexible elongate member. In some embodiments, the control handle includes an implantable device placement system operably coupled to the stylet to axially translate the stylet along the longitudinal axis of the control handle to advance and place the implantable device from the implantable device delivery device, at least.

[0007] In some embodiments, the system further includes a tether element extending from the implantable device to a location spaced apart from the implantable device, and the control handle includes at least a tether adjustment system operably engagable with the tether element to adjust the tension and / or length of the tether element between the implantable device and the location spaced apart from the implantable device. In some embodiments, the tether adjustment system includes a fine adjustment knob engagable with the tether element and rotatable about the longitudinal axis of the control handle to adjust the tension and / or length of the tether element between the implantable device and the location spaced apart from the implantable device. In some embodiments, the system further includes a tensioning and locking device operably associated with the tether element and shiftable from a tension adjustment configuration in which the tension and / or length of the tether element is adjustable to a tension setting configuration in which the tension and / or length of the tether element is fixed relative to the implantable device. In some embodiments, the control handle further includes a tensioning and locking system operably associated with the tensioning and locking device to shift the tensioning and locking device between the tension adjustment configuration and the tension setting configuration. In some embodiments, the tensioning and locking system includes a tensioning and locking knob rotatable about the longitudinal axis of the control handle to shift the tensioning and locking device between the tension adjustment configuration and the tension setting configuration. In some embodiments, the tensioning and locking system further includes an anchor status indicator operably associated with the tensioning and locking knob to indicate the configuration of the tensioning and locking device. In some embodiments, the system further includes a stylet operably coupled to the implantable device. In some embodiments, the control handle includes at least an implantable device retention system operably coupled to the stylet to axially translate the stylet along the longitudinal axis of the control handle to advance and retain the implantable device from the implantable device delivery device.In some embodiments, the stylet is operably coupled to a tensioning and locking device and a tensioning and locking system such that rotation of the tensioning and locking knob rotates the stylet and rotation of the stylet shifts the tensioning and locking device between a tension adjustment configuration and a tension setting configuration.

[0008] In some embodiments, the system further includes a tether element and a tensioning and locking device operably associated with the tether element, the tether element extending from an implantable device to a location spaced from the implantable device, the tensioning and locking device being shiftable from a tension adjustment configuration in which the tension and / or length of the tether element is adjustable to a tension setting configuration in which the tension and / or length of the tether element is fixed relative to the implantable device, and the control handle including at least a tensioning and locking device for shifting the tensioning and locking device between the tension adjustment configuration and the tension setting configuration.

[0009] According to various principles of the present disclosure, a delivery and placement system for delivering and / or placing an implantable device at an anatomical site includes a control handle having a longitudinal axis, the control handle including at least one control knob rotatable about the longitudinal axis of the control handle and operable to axially translate components of the delivery and placement system.

[0010] In some embodiments, the delivery and placement system includes a flexible elongate member configured to deliver the implantable device trans-luminally to an anatomical site, and a tension element is operably coupled to the flexible elongate member and the control knob such that rotation of the control knob about the longitudinal axis of the control handle flexes a distal region of the flexible elongate member to deliver the implantable device to a treatment site.

[0011] In some embodiments, the control knob is rotatable about the longitudinal axis of the control handle to adjust elements of the delivery and retention system relative to a tether element operably associated with an implantable device deliverable by the delivery and retention system.

[0012] According to various principles of the present disclosure, a method of transvascularly delivering and / or retaining an implantable device includes rotating a control knob operably associated with a delivery and retention system control handle about the longitudinal axis of the control handle to axially translate elements of the delivery and retention system associated with the implantable device.

[0013] In some embodiments, the element to be axially translated is a tension element operably associated with a steerable flexible elongate member, the implantable device operably associated with the steerable flexible elongate member, or a tension element that is axially translatable to bend the steerable flexible elongate member to steer the steerable flexible elongate member within the patient's body to deliver the implantable device or a tether element operably associated with the implantable device, or at least one of the tether element and a flexible elongate member operably associated with the implantable device to adjust the tension and / or length of the tether element relative to the implantable device.

[0014] These and other features and advantages of the present disclosure will become readily apparent from the following detailed description, and the scope of the claimed invention is set forth in the appended claims. The following disclosure is presented from the perspective of aspects or embodiments, but it should be understood that individual aspects can be claimed separately or in combination with aspects and features of that embodiment or any other embodiment.

[0015] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and are not intended to be drawn to scale. The accompanying drawings are provided for illustrative purposes only, and the dimensions, positions, orders, and relative sizes reflected in the figures in the drawings may be changed. For example, a device may be enlarged so that details are distinguishable, but is intended to be correspondingly reduced, for example, to fit within a delivery catheter or the working channel of an endoscope. For purposes of clarity and simplification, not all elements in all figures are labeled, and not all elements of each embodiment are shown, when illustration is not necessary to enable those skilled in the art to understand the present disclosure.

[0016] The detailed description will be better understood in conjunction with the following accompanying drawings in which like reference characters represent like elements.

Brief Description of the Drawings

[0017]

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DETAILED DESCRIPTION OF THE INVENTION

[0018] The following detailed description should be read with reference to the drawings that illustrate exemplary embodiments. It is to be understood that the present disclosure is not limited to the particular embodiments described, and thus may be subject to change. All of the apparatus, systems, and methods discussed herein are examples of apparatus, systems, and / or methods implemented in accordance with one or more principles of the present disclosure. Each example of an embodiment is provided for purposes of explanation and is not the only way to implement these principles, but is merely an example. Therefore, references to elements, structures, or features in the drawings should be understood as references to examples of embodiments of the present disclosure and should not be construed as limiting the present disclosure to the particular elements, structures, or features shown. Other examples of ways to implement the disclosed principles will occur to those skilled in the art upon reading the present disclosure. Indeed, it will become apparent to those skilled in the art that various modifications and variations can be made to 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 can be used with another embodiment to yield still further embodiments. Therefore, the subject matter is intended to embrace such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0019] In this application, it will be understood that the present disclosure is described in detail at various levels. In certain instances, details that are not necessary for one skilled in the art to understand the present disclosure, or details that make it difficult to recognize other details, may be omitted. The terms used herein are for the purpose of describing only particular embodiments and are not intended to be limiting beyond the scope of the appended claims. Unless otherwise defined, technical terms used herein are to be understood as commonly understood by one of ordinary skill in the technical field to which the present disclosure pertains. 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.

[0020] As used herein, "proximal" refers to the direction or location that is closest to the user (such as a medical professional, clinician, technician, surgeon, physician, etc., which are used interchangeably herein without intention of limitation and include an automated controller system or other means) when using the device (e.g., when introducing the device into a patient, or during implantation, placement, or delivery), and / or the direction or location that is closest to the delivery device. "Distal" refers to the direction or location that is farthest from the user when using the device (e.g., when introducing the device into a patient, or during implantation, placement, or delivery), and / or the direction or location that is farthest from the delivery device. "Longitudinal" means extending along the longer dimension or greater 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 fixed configuration if the element is bent or curved. "Center" means at least generally bisecting the center point and / or being generally equidistant from the perimeter or boundary. The "central axis" with respect to an opening is a line that at least generally bisects the center point of the opening and, when the opening includes, for example, a tubular element, strut, channel, cavity, or hole, means a line that extends longitudinally along the length of the opening. As used herein, "channel" or "hole" is not limited to a circular cross-section. As used herein, the "free end" of an element is the end portion beyond which such an element does not extend.

[0021] According to various principles of the present disclosure, a delivery and implantation system is configured to deliver and / or implant an implantable device to a treatment site. It will be understood that references to delivery “and” implantation are made herein for convenience only and without intention of limitation. In some aspects, the delivery and implantation system is configured to operate an implantable device delivery and implantation system configured to deliver and implant an implantable device to tissue at an anatomical site, such as a treatment site within a patient's body, and optionally to another anatomical site, and / or includes the same. It will be understood that references herein to anatomical sites, delivery sites, implantation sites, implant / implantation sites, sites of implantation, target sites, treatment sites, etc. may be made interchangeably and without intention of limitation. In some aspects, the delivery and implantation system includes a handle configured to operate such an implantable device implantation system to cause the associated implantable device to be implanted. In some embodiments, the implantable device is a tissue engagement element, such as a tissue anchor, configured to be implanted within tissue. It will be understood that terms such as implant (and other grammatical forms thereof) may be used interchangeably herein with terms such as attach, anchor, affix, associate, couple, engage, embed, hold, retain, grasp, secure, etc. (and their grammatical forms) without intention of limitation.

[0022] In one example of an embodiment of the delivery and implantation system described herein, the system includes a handle configured to facilitate steering of an implantable device delivery and implantation system. For example, the handle may include a rotatable steering knob to actuate a pulling element to direct the implantable device delivery and implantation system to an anatomical site where the implantable device is to be implanted. It will be understood that terms such as "steer" (and other grammatical forms thereof) are used interchangeably herein, without limitation, with such terms (and other grammatical forms thereof), actuate, advance, articulate, flex, control, drive, bend, operate, maneuver, move, navigate, actuate, pull, retract, rotate, shift, transition, translate, turn, etc.

[0023] It will be understood that an implantable device may be shiftable between a delivery configuration and an expanded deployment configuration for trans-luminal delivery of the implantable device. The implantable device may be delivered trans-luminally within a tubular element, for example, to hold the implantable device in the delivery configuration and / or to protect the implantable device and / or to protect the body passage through which the implantable device is advanced. The tubular element may be delivered by a flexible elongate member. It will be understood that the terms flexible elongate member or tubular flexible elongate member are used generically herein for convenience and without intent to limit to refer to elements such as catheters, shafts, cannulas, sheaths, tubes, stylets, etc. Upon reaching the treatment site, the implantable device may be advanced distally out of the tubular element for deployment. For convenience and without intent to limit, the implantable device is referred to herein as an anchor, and the tubular element within which the anchor is delivered (generally without additional intervening tubular delivery elements therebetween) is referred to herein as an anchor garage, although the principles of the present disclosure are applicable to implantable devices other than anchors and tubular elements other than anchor garages. The anchor garage may be specifically configured to hold an anchor therein. Optionally, the anchor garage has additional features that facilitate the use of the anchor garage with other devices or systems operable in association with the anchor. For example, if the anchor is to be used in association with another device, the anchor garage may then include features that enable cooperation of the anchor and / or the anchor garage with such other device or system. Such an anchor garage may be attached to the distal end of a tubular flexible elongate member, referred to for convenience and without intent to limit as a garage shaft. The anchor may be coupled to the flexible elongate member to be movable relative to the anchor garage, for example, for deployment from the anchor garage. For convenience and without intent to limit, the flexible elongate member to which the anchor is coupled is referred to herein as an anchor stylet.

[0024] In one example of an embodiment of the delivery and retention system described herein, the system includes a handle having a slider operable to move an anchor from a delivery configuration within an anchor garage to a retention configuration outside of the anchor garage, such as within tissue. In some embodiments, the slider is operably coupled to an anchor stylet to distally advance the anchor out of the anchor garage to retain the anchor. According to various principles of the present disclosure, the slider can be locked in place to prevent inadvertent movement of the anchor.

[0025] As can be appreciated, the delivery and retention system can be subjected to compressive forces during trans-luminal navigation to a treatment site. In some embodiments, the slider can be actuated to apply tension to at least one component of the system so that the anchor is not prematurely retained as a result of forces on the system. For example, in some embodiments, the anchor garage and / or the garage shaft can be subjected to compressive forces that can cause the anchor garage to retreat relative to the anchor, causing the anchor to be prematurely retained or at least partially retained. In some embodiments, the slider can be moved to selectively apply tension to the anchor stylet to maintain the anchor within the anchor garage and prevent its premature retention. Such an ability to maintain the anchor within the anchor garage can be particularly advantageous when the anchor automatically shifts from the delivery configuration to the retention configuration, for example, by expanding as it exits the anchor garage.

[0026] In some embodiments, an implantable device, such as a tissue anchor, can be coupled to another implantable device and / or a tether element can be coupled to the tissue anchor. For example, the tether element can be operably coupled between a first implantable device and a second implantable device. In some embodiments, the tether element is operably associated with an implantable device at a first location in an anatomical site and is operably associated with a second location spaced apart from the first location. For example, the tether element can be coupled to another implantable device positioned distally from the first implantable device. For example, the tether element can extend between an implantable tissue engagement element and another tissue engagement device, such as a clip or clamp. The tether element can be attached in a generally fixed manner to one of the tissue engagement element or the tissue engagement device and can be movably coupled to another element or device. In an illustrative example of one embodiment of the implantable devices and related delivery and placement devices and systems described herein, the implantable device is in the form of a tissue anchor that is coupled to a tissue clip or clamp via a suture. More specifically, in an illustrative example of one embodiment described herein, the tissue anchor is an anchor configured to be implanted within heart tissue (e.g., papillary muscle tissue), the suture is an artificial chordae tendineae, and the tissue clip is a leaflet clip. For convenience and without limitation, the tether element can alternatively be referred to herein as a tether, or a suture, or an artificial chordae tendineae, without limitation. Further, for convenience and without limitation, the second implantable device to which the anchor is coupled is referred to herein as a clip (or leaflet clip). Nevertheless, it will be understood that the principles of the present disclosure can be applicable to devices other than heart tissue anchors, leaflet clips, and / or sutures or artificial chordae tendineae.

[0027] In some cases, for example, to apply tension to an implantable device and / or between a first implantable device and a second implantable device via a tether, it may be desirable to control the movement of the tether relative to the implantable device. In some embodiments, the tether is coupled to one of the implantable devices and is movable relative to the other of the implantable devices. In some embodiments, the implantable device to which the tether is coupled is implanted first, the other of the implantable devices is implanted second, and the tether can be pulled proximally relative to the other of the implantable devices (e.g., through a delivery and retention system and relative to its handle) to adjust the length and / or tension of the tether between the implantable devices. Such adjustment of the tether may generally be considered a coarse adjustment since it is not a precisely controlled adjustment that is measured.

[0028] Precise fine-tuning of the tether is required at various anatomical sites. For example, in the illustrated example of one embodiment described herein, the first implantable device is a heart tissue anchor and the second implantable device is a valve leaflet clip. The valve leaflet clip is clamped onto the heart valve leaflet, and then the tissue anchor is anchored to the ventricle with the artificial chordae tendineae coupled to the valve leaflet clip and extending to the tissue anchor. The artificial chordae tendineae are movable relative to the tissue anchor to adjust the tension of the valve leaflet clip to restore proper function to the valve leaflet (e.g., to prevent the valve leaflet from extending into or fluttering in the atrium, which can inhibit proper closure of the heart valve, resulting in regurgitation and various adverse consequences). To achieve proper closure of the heart valve, the tension of the heart valve leaflet must be sufficient to prevent fluttering but not so high as to prevent the valve leaflet from returning to the closed position as blood flows from the atrium to the ventricle.

[0029] According to various principles of the present disclosure, a delivery and retention system includes a tether control knob for fine-tuning the length and / or tension of a tether. A tether lock may be provided for locking the tether against the tether control knob. The tether lock may be shiftable between a disengaged position where the tether can move relatively freely against the tether control knob and an engaged position where the tether is locked against the tether control knob. In some embodiments, the tether control knob is in the form of a rotatable knob that controls the axial movement of the tether. When the rotatable tether control knob is rotated in a first direction, the tether is pulled proximally to add tension to the tether and / or shorten the length of the tether within an anatomical site. When the rotatable tether control knob is rotated in a second direction (opposite the first direction), the tension of the tether is reduced or the tether is fed out to increase the length of the tether within the anatomical site (e.g., such that the valve tip pulls the tether to increase the length of the tether between the valve tip clip and the anchor and / or decrease the tension therebetween).

[0030] It will be appreciated that it may be desirable to set, or fix, or lock such a configuration when the desired tension and / or length of the tether is reached, or achieved. In an example of one embodiment of the delivery and retention system described herein, the system includes a tensioning and locking device operably associated with the tether to set or fix the desired tension and / or length of the tether. In some embodiments, the tensioning and locking device adjusts the position of the tether relative to the implantable device, and / or the tension of one or both of the implantable devices, and / or the length of the tether extending between the implantable devices. The tensioning and locking device may be shiftable between a tension adjustment configuration and a tension setting or locking configuration. In the tension adjustment configuration, the tensioning and locking device allows movement of the tether relative to the tensioning and locking device, for example, to adjust the tension of the tether relative to a clip and / or an anchor. For example, the locking element may be in a position disengaged from / disengaged from the tether to allow free movement of the tether. In the tension setting or locking configuration (such terms are used interchangeably herein without intention of limitation), the tensioning and locking device prohibits movement of the tether relative to the tensioning and locking device, for example, to set the length and / or tension of the tether. For example, the locking element may be shifted into engagement with the tether to prohibit or prevent movement of the tether relative to the tensioning and locking device. It should be understood that the terms prohibit, prevent, lock, restrict, etc., including their various other grammatical forms, may be used interchangeably herein without intention of limitation. When the desired position of the tether relative to the implantable device, and / or the length of the tether extending between the implantable devices, and / or the tension of one or both of the implantable devices is achieved, the tensioning and locking device may be shifted into a tension lock configuration.

[0031] According to various principles of the present disclosure, a delivery and retention system control handle includes a tensioning and locking knob operable to adjust the configuration of a tensioning and locking device to adjust the tension and / or length of a tether element associated with one or more implantable devices. In some embodiments, an anchor stylet is operably coupled to components of a tensioning and locking device to shift the tensioning and locking device between a tension adjustment configuration and a tension setting configuration. In some embodiments, the stylet is operably coupled to a movable locking element that is shifted relative to the tether to shift the configuration of the tensioning and locking device. In some embodiments, the stylet is rotatable to shift the configuration of the tensioning and locking device. In some embodiments, rotation of the stylet axially moves a locking element relative to a housing to shift the configuration of the tensioning and locking device. In such embodiments, rotation of the stylet control knob rotates the stylet to shift the tensioning and locking device between a tension adjustment configuration and a tension setting configuration. More specifically, in some embodiments, rotation of the stylet causes a generally linear translation of the movable locking element relative to the tether to fix the tether relative to the anchor and / or to enable adjustment of the tether relative to the anchor (e.g., to adjust the length and / or tension of the tether relative to the anchor and the valve tip clip). In some embodiments, a sufficient amount of rotation of the stylet disengages the stylet from operative engagement with the anchor and / or the tensioning and locking device, for example, to release and retain the implantable device. In some embodiments, the tensioning and locking device is operably associated with the implantable device. In some embodiments, the tensioning and locking device is housed within a housing coupled to the implantable device. It will be understood that the principles of the present disclosure are applicable to setting the tension of the tether whether or not a stylet is used.

[0032] In some embodiments, for example, an indicator is provided to indicate the status of the implantable device and / or the tensioning and locking device relative to, or in association with, the position of the tensioning and locking knob. For example, the indicator may have indicia indicating whether the tensioning and locking device is in a tension adjustment configuration or a tension setting configuration, and / or whether the stylet is operably engaged with or disengaged / separated from the implantable device.

[0033] It will be understood that the devices, systems, and methods of the present disclosure may be used alone or in combination with other devices, systems, and methods for treating heart disease.Examples of devices, systems, and methods in which embodiments of the present disclosure may be implemented include, but are not limited to, U.S. Patent Application Publication No. 2021 / 0007847, 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; 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, published on January 7, 2021; U.S. Patent Application Publication No. 2021 / 0000599, entitled Devices, Systems, And Methods For Artificial Chordae Tendineae, published on January 7, 2021; U.S. Patent Application Publication No. 2022 / 0096235, entitled Devices, Systems, And Methods For Adjustably Tensioning Artificial Chordae Tendineae In A Heart, published on March 31, 2022; U.S. Patent Application Publication No. 2023 / 0062599, entitled Devices, Systems, And Methods For Anchoring An Artificial Chordae Tendineae To Cardiac Tissue, published on March 2, 2023; and U.S. Provisional Patent Application No. __ / ___,___, filed on December 20, 2021, [Attorney Docket No. 2001.2715100, formerly 8150.0817Z], the entireties of each of which are incorporated herein by reference for all purposes.Examples of the devices described herein may be modified to incorporate embodiments or one or more features of the present disclosure.

[0034] Next, with reference to examples of embodiments shown in the accompanying drawings, various embodiments of a delivery and retention system formed in accordance with various principles of the present disclosure will be described. References herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc., indicate that one or more specific features, structures, concepts, and / or characteristics according to the principles of the present disclosure may be included in that embodiment. However, such references do not necessarily mean that all embodiments include that specific feature, structure, concept, and / or characteristic, 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. It should be understood that 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 or aligned to create hybrid embodiments, and such hybrid embodiments are within the scope of the present disclosure. Further, references herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc., in various places do not necessarily all refer to the same embodiment, and distinct or alternative embodiments are not necessarily mutually exclusive of other embodiments. Moreover, it should be understood that the various features, structures, concepts, and / or characteristics of the embodiments of the present disclosure are independent and distinct from each other and can be used individually or in various combinations with each other to create alternative embodiments that are considered part of the present disclosure or can exist. Therefore, since it would be too cumbersome to describe all of the numerous possible combinations and sub-combinations of features, structures, concepts, and / or characteristics, the present disclosure is not limited to only the embodiments specifically described herein, and the examples of embodiments disclosed herein are not intended to limit the broader aspects of the present disclosure.The following description is merely an exemplary example of an embodiment and is not intended to limit the broader aspects of the present disclosure.

[0035] Referring now to the drawings, common features are identified by common reference elements, and it will be understood that, for the sake of brevity and convenience and without intent to limit, the description of common features will not generally be repeated. For clarity, not all components having the same reference numeral are labeled. Further, groups of like elements may be indicated by numbers and letters, and reference to one or such elements, or such elements as a group, may generally be made by numbers only (without including the letters associated with each like element). Further, a particular feature in one embodiment may be used across different embodiments and not necessarily individually labeled when appearing in different embodiments.

[0036] Next, referring to the drawings, FIG. 1 shows an example of one embodiment of a delivery and retention system 1000 formed in accordance with various principles of the present disclosure. The delivery and retention system 1000 is optionally part of a larger delivery / retention system 100, such as that described in more detail in co-pending provisional patent application Ser. No. __ / ___,___, filed Jun. 21, 2022, entitled Devices, Systems, And Methods For Steering A Catheter [Attorney Docket No. 2001.2787100], and co-pending provisional patent application Ser. No. __ / ___,___, filed Jun. 21, 2022, entitled Devices, Systems, And Methods For Deploying An Implantable Device [Attorney Docket No. 2001.2754100]. Each of these applications is hereby incorporated by reference in its entirety for all purposes. An illustrative example of one embodiment of the larger delivery / retention system 100 includes a delivery system 200 having an introducer shaft 210 (which may also be referred to as a delivery sheath, without limitation) configured to deliver and guide the devices, systems, and components of the delivery / retention system 100 to a treatment area. Accordingly, the introducer shaft 210 defines therein a lumen and is sized, shaped, configured, and / or dimensioned to pass therethrough additional devices and / or systems, such as devices and / or systems to be delivered / retained by the delivery and retention system 1000, to a treatment site. As used herein, a treatment area is an area on or within the patient's body where the treatment site is located. As used herein, a treatment site is an anatomical site at which a procedure is to be performed using the delivery / retention system 100 and the systems and / or devices delivered by the delivery and retention system 1000.References to the treatment site “at” are intended to include at the treatment site or in the vicinity of the treatment site (e.g., along the treatment site, adjacent to the treatment site, etc.) and are understood not to be limited to the exact treatment site alone. The introducer shaft 210 may be steerable, for example, using a control handle 220 operably associated therewith, and may be steerable, for example, in at least one or two directions within a steering plane.

[0037] The delivery / implantation system 100 may include an additional steerable delivery system 300 having a steerable flexible elongate member 310 configured to provide further steering capabilities to the delivery / implantation system 100 to guide and direct the device and / or system closer to the desired treatment site, as may be understood with reference to the detailed figures in FIG. 1. The steerable flexible elongate member 310 may be tubular and may define a lumen therein sized, shaped, configured, and / or dimensioned to pass therethrough additional devices and / or systems, such as devices and / or systems delivered / implanted by the delivery and implantation system 1000, to the treatment site and is therefore referred to herein as a steerable “tubular” flexible elongate member to distinguish it from other flexible elongate members described herein. The steerable tubular flexible elongate member 310 may be steerable in at least one direction or two directions within a steering plane, four directions in two transverse steering planes, etc., for example, using a control handle 320 operably associated therewith. Further details of an example of one embodiment of the delivery system 200 and an example of one embodiment of the steerable delivery system 300 are provided in the co-pending provisional patent application Ser. No. __ / ___,___, filed Jun. 21, 2022, titled Devices, Systems, And Methods For Steering A Catheter [Attorney Docket No. 2001.2787100], which is incorporated herein by reference. However, the present disclosure need not be limited by the examples of the embodiments disclosed therein.

[0038] Optionally, the delivery / implantation system 100 includes an additional device delivery and implantation system 400 having a flexible elongate member 410 that is delivered to the implantation site through the steerable tubular flexible elongate member 310 and the introducer shaft 210. The additional device delivery and implantation system 400 may include a control handle 420 for controlling its operation, but the steerable delivery system 300 can be used (e.g., via the steerable tubular flexible elongate member 310) to steer the implantation system 430 attached to the distal end 411 of the flexible elongate member 410 to a desired position relative to the implantation site. In some embodiments, the implantation system 430 may be larger than the lumen of the steerable tubular flexible elongate member 310 and thus can be delivered external to and distal of the steerable tubular flexible elongate member 310 as shown in the detailed view in FIG. 1. Further details of an example of one embodiment of the delivery and implantation system 400 are provided in the co-pending provisional patent application Ser. No. __ / ___,__ [Attorney Docket No. 2001.2754100], filed Jun. 21, 2022, entitled Devices, Systems, And Methods For Deploying An Implantable Device, which is incorporated herein by reference. However, the present disclosure need not be limited by the examples of the embodiments disclosed therein.

[0039] According to various principles of the present disclosure, a delivery and retention system 1000 can deliver, operate, and / or retain an implantable device, such as a tissue anchor, to an anatomical site. In an example of one embodiment of the delivery and retention system shown in FIG. 1 (which can be more readily seen in its detailed view) and FIG. 2, the delivery and retention system 1000 includes a flexible elongate member 1100 that delivers an implantable device delivery device 1200 configured to deliver an implantable device 1300. In the illustrated example of one embodiment, the implantable device delivery device 1300 is a generally tubular anchor garage 1200 within which an implantable device in the form of a tissue anchor 1300 is delivered internally. The implantable device delivery device 1300 may be of other forms or configurations, and it will be understood that the present disclosure is not limited to an anchor garage. However, for convenience and without intention of limitation, the anchor garage is referred to herein. The anchor garage 1200 may be mounted on the distal end 1101 of the flexible elongate member 1100 (alternatively referred to as a garage shaft) and optionally may not be positioned within a steerable tubular flexible elongate member 310. When an additional retention system 430 is delivered with the assistance of the steerable tubular flexible elongate member 310 and is delivered external and distal to the steerable tubular flexible elongate member 310, the anchor garage 1200 may optionally be positioned external and distal to such an additional retention system 430.

[0040] The flexible elongate member 1100 of the delivery and retention system 1000 can be delivered within the introducer shaft 210 of the delivery / retention system 100 and within the steerable tubular flexible elongate member 310, with the anchor garage 1200 either within the introducer shaft 210 or, as described above, external to the introducer shaft 210. The introducer shaft 210 delivers the anchor garage 1200 to a general treatment area, such as a ventricle, in the example of one embodiment shown in FIG. 2. The steerable tubular flexible elongate member 310 can further guide and direct the flexible elongate member 1100 of the delivery and retention system 1000 in order to deliver the anchor garage 1200 to a retention site where the anchor 1300 carried therein is to be retained. For example, as shown in FIG. 2, the steerable tubular flexible elongate member 310 is steerable to direct the flexible elongate member 1100 toward the ventricular wall.

[0041] In an example of an embodiment of the delivery and retention system 1000 shown in FIG. 1, a delivery and retention system control handle 1020 operably associated with the flexible elongate member 1100 can move the flexible elongate member 1100 and the anchor garage 1200 generally axially parallel with respect to the steerable tubular flexible elongate member 310 and with respect to the other control handles 220, 320, 420 of the delivery / retention system 100 for advancement to the retention site. Additionally or alternatively, the delivery and retention system control handle 1020 operably associated with the flexible elongate member 1100 can rotate the flexible elongate member 1100 and the anchor garage 1200 with respect to the steerable tubular flexible elongate member 310 and with respect to the other control handles 220, 320, 420 of the delivery / retention system 100 for rotation to the retention site. For example, in an example of the embodiment shown in FIG. 1, the distal end 1021 of the delivery and retention system control handle 1020 couples the delivery and retention system control handle 1020 to the other control handles 220, 320, 420 of the delivery / retention system 100 and is supported and / or mounted on a connecting tube 1110 (which may be referred to, for convenience and without limitation, as a garage telescoping shaft) for axially translating (e.g., telescoping) and / or rotating the delivery and retention system control handle 1020 with respect to the other control handles 220, 320, 420 of the delivery / retention system 100 to axially translate (e.g., telescoping) and / or rotate the flexible elongate member 1100 generally axially parallel with respect to the steerable tubular flexible elongate member 310 and the treatment site. In some embodiments, the distal end 1021 of the retention system control handle 1020 is fixed to the proximal end 1113 of the connecting tube 1110, and the connecting tube 1110 is slidable and rotatable with respect to the distal control handle 420 adjacent to the retention system control handle 1020.For example, the control handle 420 may include, therein, a slider tube for telescopically receiving, in a nested fashion, a connecting tube 1110 (as shown and described in the co-pending provisional patent application Ser. No. __ / ___,___ [Attorney Docket No. 2001.2754100] entitled Devices, Systems, And Methods For Deploying An Implantable Device, filed on Jun. 21, 2022). Axial movement of the indwelling system control handle 1020 relative to the control handle 420 causes the connecting tube 1110 to telescope relative to the control handle 420 (and, optionally, relative to the slider tube therein).

[0042] An example of a manner in which the delivery and placement system control handle 1020 can be attached to the proximal end portion 1113 of the connecting tube 1110, and / or a manner in which the flexible elongate member 1100 is attached to the delivery and placement system control handle 1020 for movement integral therewith, can be understood with reference to FIGS. 4 and 5 (providing an internal view of the delivery and placement system control handle 1020 shown in FIG. 3). In the illustrated example of one embodiment, the proximal end portion 1113 of the connecting tube 1110 extends into the garage shaft hub 1130 within the steering control knob 1420, terminates within a counterbore within the garage shaft hub 1130, and optionally (as shown in FIG. 5) is joined therein. The flexible elongate member 1100 extends proximally beyond the proximal end portion 1113 of the connecting tube 1110 and the proximal end portion 1103 of the flexible elongate member 1100, terminates within a counterbore within the garage shaft hub 1130 proximal to the counterbore where the proximal end portion 1113 of the connecting tube 1110 terminates, and optionally (as shown in FIG. 5) is joined therein. Optionally, a tubular spacer 1134 guides or supports (and optionally seals) the flexible elongate member 1100 within the connecting tube 1110. By the connecting tube 1110 and the flexible elongate member 1100 being joined to the garage shaft hub 1130, movement of the garage shaft hub 1130 is transmitted to the connecting tube 1110 and the flexible elongate member 1100. Next, the garage shaft hub 1130 is mounted within the delivery and placement system control handle 1020, whereby movement of the delivery and placement system control handle 1020 is transmitted to the connecting tube 1110 and the flexible elongate member 1100. For example, the garage shaft hub 1130 and the delivery and placement system control handle 1020 can include a key mechanism that transmits movement of the delivery and placement system control handle 1020 to the garage shaft hub 1130 (and thus, the connecting tube 1110 and the flexible elongate member 1100), and that mounts the garage shaft hub 1130 to the delivery and placement system control handle 1020.In an example of one embodiment shown in FIG. 4, the key mechanism includes a wing 1132 that extends radially from the garage shaft hub 1130 to engage a corresponding key or keyhole (not shown but readily understandable by those skilled in the art) within the delivery and placement system control handle 1020. It will be understood that other configurations not critical to the present disclosure are also included within the scope and spirit of the present disclosure.

[0043] Once the desired position of the delivery and placement system control handle 1020 is achieved, the delivery and placement system control handle 1020 can be substantially fixed in the desired position by being fixed relative to the stand 500 that supports the delivery and placement system control handle 1020. In an example of one embodiment shown in FIG. 1, a wing nut 520, or the like, for holding the delivery and placement system control handle 1020 in a predetermined position relative to the stand 500 may be provided. Further details of the stand are provided and described in the co-pending provisional patent application Ser. No. __ / ___,___, entitled Devices, Systems, And Methods For Steering A Catheter, filed Jun. 21, 2022, incorporated above [Attorney Docket No. 2001.2787100].

[0044] In an example of an embodiment shown in FIG. 2, an example of an embodiment of an implantation system 430 in a predetermined position for implanting a second implantable device relative to a treatment site is shown. In some embodiments, the steerable tubular flexible elongate member 310 steers the flexible elongate member 410 to the treatment site, and the implantation system 430 is axially translatable distally from the steerable tubular flexible elongate member 310 for implantation / to implant the second implantable device. For example, in an example of an anatomical site shown in FIG. 2, a delivery and implantation system 1000 formed in accordance with various principles of the present disclosure may be used, and the implantation system 430 is implanted relative to the heart valve tip L. The flexible elongate member 1100 that conveys the anchor engagement 1200 is delivered through the lumen within the flexible elongate member 410. As can be understood with reference to FIG. 2, when the implantation system 430 implants an implantable device (e.g., valve tip clip 440) relative to a first anatomical site (e.g., heart valve tip L), the steerable tubular flexible elongate member 310 will generally not be further steered, for example, to navigate the flexible elongate member 1100 to a second different anatomical site (e.g., heart papillary muscle). Therefore, it may be desirable for the flexible elongate member 1100 to have a steering ability independent of the steerable delivery system 300.

[0045] According to various principles of the present disclosure, the flexible elongate member 1100 can be in any of various manners for causing movement of the steerable region, such as by pulling or otherwise operating a steering element, and is operably associated (e.g., coupled or engaged for operation) with a portion of the wall of the flexible elongate member 1100 along the steerable region (generally adjacent its distal end 1101). The steering element can be coupled to a portion of the wall of the flexible elongate member 1100 by being adhered, joined, welded, etc. (e.g., embedded therein) to a portion of the wall of the flexible elongate member 1100 or within it. Pulling the steering element proximally bends the distal end region of the flexible elongate member 1100 (e.g., in the vicinity of the distal end 1101). It will be understood that any of various steering elements well known in the art can be used and the present disclosure is not limited to a particular steering element configuration. The steering element can be a generally elongate flexible element that extends generally axially along the longitudinal axis LA of the flexible elongate member 1100 and the delivery and retention system control handle 1020. In some embodiments, the steering element is a pulling mechanism such as a pulling element. In some embodiments, the pulling mechanism is a two-part mechanism such as a Bowden cable having an outer tubular sheath and an inner pulling element such as a flexible elongate pulling element (e.g., a pull wire). Non-limiting examples of embodiments of the steering element are disclosed in U.S. Patent Application Publication No. 2023 / 0011214, titled Radially Clocked Steerable Cathether, published on January 12, 2023, and U.S. Provisional Patent Application No. __ / ___,__ [Attorney Docket No. 2001.2757100], titled Steerable Member And System And Methods Of Making And Using Same, filed on April 25, 2022. Each of these applications is hereby incorporated by reference in its entirety for all purposes.The steering element can be configured to steer the flexible elongate member 1100 within a single plane (e.g., one - direction or two - direction steering), and rotation of the delivery and placement system control handle 1020 (such as those described above) enables steering of the flexible elongate member 1100 in a different plane. Since the delivery and placement system control handle 1020 can be rotatable (e.g., as a unit including the flexible elongate member 1100), it will be understood that two - direction or even one - direction steering of the steering element may be sufficient.

[0046] In an example of one embodiment of a delivery and retention system control handle 1020 shown in FIG. 1 and shown in more detail in FIGS. 3, 4, and 5, a steering system 1400 is provided having a steering control knob 1420 operably coupled to a flexible elongate member 1100 to control steering of the flexible elongate member 1100. For example, a steering element 1410 may extend proximally from the flexible elongate member 1100 and is operably engaged with the steering control knob 1420. In an example of one embodiment shown in FIG. 5, the steering element 1410 extends proximally from the flexible elongate member 1100 through a gasket 1136 that creates a seal between the interior of the garage shaft hub 1130 and the interior of the delivery and retention system control handle 1020. In some embodiments, the gasket 1136 has an elongate shape, such as a teardrop shape, to seal around the steering element 1410 and around a stylet 1510 that extends proximally outward from the proximal end 1103 of the flexible elongate member 1100 and is operably coupled to the implantable device 1300 at its distal end, as described in more detail below. A cap 1138 may close the proximal end 1133 of the garage shaft hub 1130 with the gasket 1136 therein and the steering element 1410 and the stylet 1510 extending proximally therethrough. The proximal end of the steering element 1410 then extends to an axially translatable component 1430 and may be fixed thereto by joining, interference fitting, fixed struts, fixing screws, and the like. Rotation of the steering control knob 1420 about the longitudinal axis LA of the delivery and retention system control handle 1020 causes a generally axial translation of the axially translatable component 1430 along the longitudinal axis LA to pull the steering element 1410 to pull the distal region of the flexible elongate member 1100 proximally to steer the flexible elongate member 1100 in the manner described above, for example. Rotation in the opposite direction releases the tension on the distal region of the flexible elongate member 1100 (e.g., to allow the distal region of the flexible elongate member 1100 to return to an initial, neutral, straight, non-activated, etc. configuration).The steering control knob 1420 may have a gripping surface configured to facilitate a non-slip grip for rotating the steering control knob 1420 in a manner known to those skilled in the art, for example, texturing, knurling, coating, or other modalities. Further details of an example of one embodiment of the steering control system 1400 shown in FIGS. 1 and 3 can be understood with reference to the cross-sectional view taken along line V-V of FIG. 3 provided by FIGS. 4 and 5. It is noted that FIG. 4 shows the control handle 1020 which is similar to FIG. 3 but with a portion of its housing 1022 removed. For example, in some embodiments, the delivery and placement system control handle housing 1022 may be formed from first and second housing halves 1022a, 1022b that are separable, for example, to house components of the delivery and placement system control handle 1020 internally.

[0047] According to various principles of the present disclosure, in an example of one embodiment of the steering control system 1400 shown in FIGS. 1, 3, 4, and 5, the steering control knob 1420 is rotatable about the longitudinal axis LA of the delivery and placement system control handle 1020. Such rotation enables an intuitive steering of the flexible elongate member 1100 within a steering plane that can generally coincide with the direction in which the steering control knob 1420 is rotated. However, as described above, the steering element extends generally longitudinally along the flexible elongate member 1100 and the longitudinal axis LA of the delivery and placement system control handle 1020. Thus, the rotational movement of the steering control knob 1420 causes an axial or longitudinal movement of the axially translatable component 1430 to pull the steering element to bend the flexible elongate member 1100 in a direction in which the steering element is operably engaged therewith. In some embodiments, the retraction of the flexible elongate member 1100 into the flexible elongate member 410 and / or the additional placement system 430 can facilitate returning the flexible elongate member 1100 to its position prior to actuation by the axially translatable component 1430, such as an initial, neutral, straight, non-operating position, etc.

[0048] According to various principles of the present disclosure, as can be understood with reference to FIGS. 4 and 5, the steering control knob 1420 includes an internal engagement element 1422 that operably engages an external engagement element 1432 on the axially translatable component 1430 to convert the rotational movement of the steering control knob 1420 in the rotational direction into the axial movement of the axially translatable component 1430 to pull the steering element. In some embodiments, the engagement elements 1422, 1432 are threads or components thereof, and the axially translatable component 1430 is a rack gear or a lead screw (e.g., a partial screw). For example, the steering control knob 1420 may include internal threads (e.g., at least two or at least three) that engage external thread components (e.g., at least two or at least three) on the axially translatable component 1430. As can be readily understood, the rotation of the steering control knob 1420 in the steering direction SD (e.g., as indicated on the delivery and placement system control handle 1020, with an indication of the steering / bending of the flexible elongate member 1100, such as that shown in FIG. 3) causes an axial translation of the axially translatable component 1430 in the proximal direction (i.e., toward the proximal end 1023 of the delivery and placement system control handle 1020) to bend the distal region of the flexible elongate member 1100 (adjacent to the distal end 1101). In some embodiments, the flexible elongate member 1100 bends in a direction generally corresponding to the direction in which the steering control knob 1420 is rotated, as can be understood with reference to FIG. 1, for example.

[0049] When the delivery and placement system 1000 delivers the flexible elongate member 1100 to the treatment site, such as by using the steering control system 1400, the implantable device 1300 can be implanted. For example, in an example of one embodiment shown in FIGS. 1 - 5, the implantable device 1300 is delivered to the treatment site within the anchor engagement 1200 at the distal end 1101 of the flexible elongate member 1100, such as those described above. When the anchor engagement 1200 reaches the treatment site, the implantable device 1300 can be implanted therefrom.

[0050] An example of one embodiment of the delivery and retention system 1000 shown in FIGS. 1-5 includes an implant device retention system 1500 (referred to herein as the anchor retention system 1500 for convenience and without intention of limitation) configured to retain an implant device 1300 from an implant device delivery device 1200. In the illustrated example of one embodiment, the anchor retention system 1500 includes a stylet 1510 (shown in phantom in FIG. 2) operably engaged with the implant device 1300 for delivering and retaining the implant device 1300. For example, the implant device 1300 can be coupled to the distal end 1511 of the stylet 1510 as shown in FIGS. 7 and 8A-8D. In the example of one embodiment shown in FIG. 2, the implant device 1300 is shown as a tissue anchor, and thus, either the implant device 1300 or the anchor 1300 is referred to interchangeably and without intention of limitation herein. As can be understood with reference to FIG. 2, the anchor 1300 is delivered within the anchor garage 1200 in a delivery configuration where the anchor pawl 1320 is distally extended, and thus the anchor 1300 is in a relatively compact configuration. When distally retained out of the anchor garage 1200, the anchor 1300 shifts to an expanded retention configuration such as that shown in FIGS. 6, 7, and 8A-8D. In the illustrated example of one embodiment of the anchor 1300, in the retention configuration, the anchor pawl 1320 curves proximally rearward (e.g., toward the proximal end 1303 of the anchor 1300) into an expanded, optionally bow-like configuration. The anchor pawl 1320 can be formed of a shape memory material (e.g., nitinol) to shift from the delivery configuration to the retention configuration without further force being applied thereto when exiting the anchor garage 1200. Thus, when the anchor 1300 is advanced out of the anchor garage 1200, it is important that the distal end 1321 of the anchor pawl 1320 perforates the tissue to be engaged within the anchor 1300 such that the anchor pawl 1320 extends into the retention configuration within the tissue (and not after extending out of the anchor garage 1200 but before being advanced into the tissue).The distal end 1321 can be shaped (e.g., sharp, pointed, etc.) to facilitate piercing and penetrating tissue.

[0051] According to various principles of the present disclosure, the anchor placement system 1500 is configured to control the placement of the anchor 1300. In an example of one embodiment shown in FIGS. 1, 3, 4, and 5, the operation of the anchor placement system 1500 axially translates the anchor 1300 relative to the anchor garage 1200 to advance the anchor 1300 relative to the anchor garage 1200 (e.g., to place the anchor 1300) and / or to retract the anchor 1300 relative to the anchor garage 1200 (e.g., to draw it into the anchor garage 1200). Advancing the anchor 1300 out of the anchor garage 1200 places the anchor 1300, for example, into tissue. If desired, generally prior to placement, the anchor 1300 can be recaptured within the anchor garage 1200, for example, by retracting the anchor 1300 using the anchor placement system 1500.

[0052] An example of one embodiment of the anchor delivery system 1500 shown in FIGS. 1, 3, 4, and 5 includes a stylet 1510 for advancing or retracting the anchor 1300 relative to the anchor garage 1200, and an anchor control slider 1520 operable to advance or retract (e.g., translate axially) relative to the delivery and placement system control handle 1020, the flexible elongate member 1100, and the anchor garage 1200. More specifically, as shown in FIGS. 4 and 5 illustrated, the stylet 1510 of the illustrated example of one embodiment of the anchor delivery system 1500 extends proximally from within the flexible elongate member 1100 and is mounted (e.g., fixedly, using a mating engagement, an adhesive, a bond, etc.) within the stylet hub 1530. As described above, a gasket 1136 may be provided within the proximal end 1133 of the garage shaft hub 1130 to seal any fluid from within the flexible elongate member 1100 from spreading proximally into the interior of the delivery and placement system control handle 1020 by forming a seal between the interior of the garage shaft hub 1130 (including the counterbore where the proximal end 1103 of the flexible elongate member 1100 is seated) around the stylet 1510 and the interior of the delivery and placement system control handle 1020. The stylet hub 1530 is configured to operably engage an anchor control slider 1520 and a carriage 1540 operably coupled to move axially therewith. For example, the stylet hub 1530 and the carriage 1540 may include one or more (e.g., two or more or three or more) mating protrusions 1532 and one or more (e.g., two or more or three or more) corresponding recesses 1542. The protrusions 1532 are shown on the stylet hub 1530 and the recesses 1542 are shown on the carriage 1540, but it will be understood that the reverse arrangement is also within the scope and spirit of the present disclosure. As will be described in more detail below, the stylet hub 1530 and the carriage 1540 are preferably rotatably engaged with respect to each other to allow rotation of the stylet 1510 relative to the delivery and placement system control handle housing 1022.The carriage 1540 extends through a slot 1026 within the delivery and retention system control handle housing 1022 (see, e.g., FIG. 3), and is fitted in mating engagement with an anchor control slider base 1524 having a protrusion 1526 to which a slider button 1522 is attached. For example, the anchor control slider base 1524 may include legs 1525a, 1525b that extend along both sides of the carriage 1540, whereby axial translation or sliding of the slider button 1522 and the anchor control slider base 1524 along the longitudinal axis LA of the delivery and retention system control handle 1020 is transmitted to the carriage 1540. It will be understood that the reverse arrangement in which the carriage 1540 has legs on both sides of the anchor control slider base 1524 is also within the scope and spirit of the present disclosure. Therefore, the user can engage the slider button 1522 and slide the anchor control slider base 1524, and thus the carriage 1540 and the stylet hub 1530, relative to the delivery and retention system control handle 1020 to extend or retract the anchor 1300 from or into the anchor garage 1200. Optionally, the slider button 1522 has a gripping surface (e.g., texturing, coating, grooving, or other means for promoting the user's engagement of the slider button 1522 to improve the user's grip on the slider button 1522 / reduce slippage).

[0053] As described above, distal translation of the slider button 1522 relative to the delivery and retention system control handle housing 1022 can lodge the anchor 1300 from the anchor garage 1200. Generally, and particularly when the anchor 1300 shifts into a retention configuration upon exiting the anchor garage 1200 but before contacting the desired retention site, it is desirable to prevent premature extension of the anchor 1300 from the anchor garage 1200. According to various principles of the present disclosure, the anchor control slider 1520 can be locked at one or more positions relative to the delivery and retention system control handle housing 1022. For example, the anchor control slider base 1524 can include a boss 1528 engageable with a notch 1028 within the delivery and retention system control handle housing 1022, as can be understood with reference to FIGS. 3 and 4. It will be understood that other configurations and structures are also within the scope and spirit of the present disclosure. The slider button 1522 can be locked relative to the delivery and retention system control handle 1020 to prevent inadvertent advancement of the anchor 1300 from the anchor garage 1200, which could cause inadvertent lodging of the anchor 1300. In some embodiments, the slider button 1522 is biased relative to the carriage 1540 to lock the boss 1528 thereon within a corresponding notch 1028 within the delivery and retention system control handle housing 1022. For example, a biasing element such as a coil spring can be provided between the slider button 1522 and the carriage 1540. Pushing the slider button 1522 toward the carriage 1540 and against the biasing force of the biasing element releases the boss 1528 from the notch 1028 to allow selective movement of the anchor control slider 1520 for translating the stylet 1510 and thus the anchor 1300 parallel as desired. As described above, compressive forces can act on the flexible elongate member 1100 as it is navigated through a passageway within a patient's body. A tension can be applied to the stylet 1510 to maintain the anchor 1300 within the anchor garage 1200 to counteract such forces that can cause the anchor garage 1200 to retract relative to the anchor 1300 therein and result in inadvertent premature lodging of the anchor 1300.For example, as the flexible elongate member 1100 and the stylet 1510 are advanced distally trans-luminally through the patient's body, the anchor control slider 1520 can be gradually retracted as needed to apply tension to the stylet 1510 to keep the anchor 1300 retracted within the anchor garage 1200.

[0054] In an example of an anatomical site shown in FIG. 2 where the flexible elongate member 1100 can be navigated, the delivery and implantation system 1000 delivers an implantable device 1300 in the form of a tissue anchor 1300 to the heart tissue for implantation therein. As described above, the delivery / implantation system 100 can deliver, operate, and / or implant a heart repair device and / or system, such as a heart valve cusp repair device and / or system. For example, as described above, the delivery / implantation system 100 can include an additional delivery and implantation system 400 that can deliver the implantation system 430 to the implantation site to implant an additional implantable device 440. In an example of one embodiment shown in FIGS. 2 and 6, the implantation system 430 is a cusp clip spreader configured to implant an additional implantable device 440 in the form of a cusp clip. Therefore, without intending to be limiting, the implantation system 430 can alternatively be referred to herein as the cusp clip spreader 430, and the additional implantable device 440 can alternatively be referred to herein as the cusp clip 440. The cusp clip 440 and the anchor 1300 can be used in association with each other to implant a tethering element 450, such as a suture or artificial chordae tendineae 450 (references to such elements are made interchangeably herein without intending to be limiting), for example, as shown in FIG. 6, to the heart valve cusp L and ventricle V to repair the function of the heart valve cusp L. The cusp clip 440 can be implanted on the heart valve cusp L by the cusp clip spreader 430 with the artificial chordae tendineae 450 coupled thereto and extending to the anchor 1300 within the anchor garage 1200.

[0055] As can be appreciated, it may be desirable to adjust the tension of the artificial chord 450. According to various principles of the present disclosure, the artificial chord 450 is movably coupled to the anchor 1300. For example, in an example of one embodiment shown in FIGS. 2 and 6, and more particularly in FIGS. 7, 8A, 8B, 8C, and 8D, the artificial chord 450 may extend movably through the anchor housing 1330 of the anchor 1300 (where the anchor key 1320 extends distally). Specifically, the artificial chord 450 may extend through the lumen 1517 that penetrates the stylet 1510 and may operably engage the anchor 1300. However, other entry points for the artificial chord 450 are also within the scope and spirit of the present disclosure. The amount of tension and / or length of the artificial chord 450 extending between the valve leaflet clip 440 and the anchor 1300 may be adjusted by pulling or feeding the artificial chord 450 relative to the anchor 1300. For example, the artificial chord 450 may extend through the proximal end 1023 of the delivery and placement system control handle 1020 and may be manually operated by a medical professional operating the delivery and placement system 1000, for example, by directly manually manipulating the artificial chord 450 (e.g., gripping and pulling the artificial chord 450). However, such adjustments may be considered coarse adjustments, and generally, it will be understood that fine adjustments are desired to achieve the appropriate heart valve leaflet function to be achieved by implanting the valve leaflet clip 440, the anchor 1300, and the artificial chord 450.

[0056] According to various principles of the present disclosure, an example of one embodiment of the delivery and retention system control handle 1020 shown in FIGS. 1, 3, 4, and 5 includes a tether adjustment system 1600 configured to engage a tether element and adjust its tension and / or length. An illustrated example of one embodiment of the tether adjustment system 1600, alternatively referred to herein as a suture adjustment system 1600, includes a suture end lock 1610 and a suture fine adjustment knob 1620 mounted adjacent to / along the proximal end 1023 of the delivery and retention system control handle 1020 for coarse and fine control of the length / tension of a tether element 450, alternatively referred to herein as a suture 450. As can be further understood with reference to FIG. 5, the suture end lock 1610 includes a suture lock knob 1612 and a suture lock cam 1614. The suture 450 extends axially through the suture lock cam 1614, and the suture lock cam 1614 is shiftable relative to another element such as a suture tension feed screw 1630 between a position where the suture 450 moves freely through the suture lock cam 1614 and a position where the suture 450 is locked against movement. More specifically, the suture lock cam 1614 is shiftable to sandwich or wedge the suture 450 between the suture lock cam 1614 and the suture tension feed screw 1630 to which the suture lock cam 1614 is mounted. As in the illustrated example in the detailed view of FIG. 4, the suture lock knob 1612 has a cam surface 1615 that engages the suture lock cam 1614 such that when the suture lock knob 1612 rotates about the longitudinal axis LA of the delivery and retention system control handle 1020, the suture lock cam 1614 shifts laterally relative to the longitudinal axis LA into and out of a position that locks the suture 450 in a predetermined position relative to the suture tension feed screw 1630. A medical professional can adjust the tension and / or length of the artificial chord 450 between the valve tip clip 440 and the anchor 1300 with the suture lock knob 1612 in the unlocked position, for example, by using appropriate imaging techniques to observe the effect of the tension on the repaired heart valve (e.g., observing the blood flow through it, observing the appropriate tension of the heart valve that eliminates any backflow through it).Once the desired cardiac valve function is observed and confirmed, e.g., when regurgitant blood flow is eliminated or at least sufficiently reduced, the suture lock cam 1614 is shifted within the lock position, thereby locking the suture adjustment system 1600, and the suture lock knob 1612 can be rotated to set the tension / length of the artificial chordae tendineae 450.

[0057] Once the gross tension / length of the artificial chord 450 is adjusted, fine tuning to adjust the cardiac valve function may still be medically indicated. According to various further principles of the present disclosure, the suture adjustment system 1600 may also be operated to further adjust the tension / length of the artificial chord 450 in finer / smaller increments than can be achieved when a medical professional simply manually adjusts the tension / length by gripping the artificial chord 450 by hand. An example of one embodiment of the suture fine adjustment knob 1620 shown in FIGS. 1, 3, 4, and 5 is rotatable about the longitudinal axis LA of the delivery and placement system control handle 1020 to axially advance or retract the suture tension feed screw 1630. With the artificial chord 450 substantially fixed relative to the suture tension feed screw 1630 by the suture lock cam 1614 in the locked position, axial translation of the suture tension feed screw 1630 results in a corresponding axial translation of the artificial chord 450 to adjust the tension / length of the artificial chord 450. The movement of the suture fine adjustment knob 1620 can be converted into the movement of the suture tension feed screw 1630 in any of various manners. In an example of one embodiment shown in FIGS. 4 and 5, the rotational movement of the suture fine adjustment knob 1620 can result in axial translation of the suture tension feed screw 1630 in a manner similar to that described with reference to the steering control knob 1420 and the axially translatable component 1430. For example, the suture fine adjustment knob 1620 may include an internal engagement element 1622 that operably engages an external engagement element 1632 on the suture tension feed screw 1630 to convert the rotational movement of the suture fine adjustment knob 1620 into axial movement of the suture tension feed screw 1630 to pull on a steering element. In some embodiments, the engagement elements 1622, 1632 are threads or components thereof. For example, the suture tension feed screw 1630 can be a rack gear or a lead screw (e.g., a partial screw) having external thread components (e.g., at least two or at least three) that are operably engaged with internal threads (e.g., at least two or at least three) provided on the suture fine adjustment knob 1620.As can be readily understood, rotation of the suture fine adjustment knob 1620 causes axial parallel movement of the suture tension feed screw 1630 for adjusting the tension / length of the artificial chord 450.

[0058] Once the desired tension and / or length of the artificial chord 450 is achieved using the suture fine adjustment knob 1620, it may be desirable to lock the artificial chord 450 against further adjustment relative to the anchor 1300. In one example of an embodiment of the anchor 1300 shown in FIG. 7, a tension and lock device 1340 for locking the artificial chord 450 against the anchor housing 1330 may be provided within the anchor housing 1330. According to various principles of the present disclosure, the stylet 1510 is operably engaged with the tension and lock device 1340 to move the tension and lock device 1340 relative to the anchor housing 1330 to shift between, for example, a tension adjustment configuration as shown in FIG. 8A where the artificial chord 450 is adjustable, and a tension setting configuration as shown in FIG. 8B where the tension and / or length of the artificial chord 450 is set / fixed / locked (such terms are used interchangeably herein without intent to limit). Once the tension / length of the artificial chord 450 is set, the stylet 1510 may be disengaged from the anchor 1300, for example, as shown in FIG. 8C.

[0059] More specifically, an example of one embodiment of the delivery and retention system 1000 shown in FIGS. 1, 3, 4, 5, 9A, 9B, and 9C includes a tensioning and locking system 1700 having a tensioning and locking knob 1720 operatively engaged with the stylet 1510, for example, with a stylet hub 1530, to actuate the stylet 1510. In the illustrated example of one embodiment, the tensioning and locking knob 1720 is positioned within a delivery and retention system control handle housing 1022 so as to be rotatable about the longitudinal axis LA of the delivery and retention system control handle 1020. The outer surface of the tensioning and locking knob 1720 is accessible through a window 1070 within the delivery and retention system control handle housing 1022 and may have, for example, a gripping surface configured to facilitate a non-slip grip for rotating the steering control knob 1420 in a manner known to those skilled in the art, such as texturing, knurling, coating, or other modalities. The stylet 1510 is operatively engaged with the tensioning and locking knob 1720 such that it rotates about the longitudinal axis LA of the delivery and retention system control handle 1020 therewith, but may still be axially freely translatable relative to the tensioning and locking knob 1720 along the longitudinal axis LA. For example, in the example of one embodiment shown in FIGS. 9A, 9B, and 9C, the exterior of the stylet hub 1530 includes one or more flats 1534 (flat surfaces) that engage respective flats within the tensioning and locking knob 1720. Therefore, rotation of the tensioning and locking knob 1720 transmits the rotational movement to the stylet hub 1530 and the stylet 1510. However, the stylet hub 1530 can still move axially freely relative to the tensioning and locking knob 1720, for example, to be advanced or retracted (e.g., using the anchor control slider 1520 as described above, or to adjust the tensioning and locking device 1340 as described below).

[0060] Adjustment of the tension and lock knob 1720 causes the tension and lock device 1340 to shift between a tension adjustment configuration and a tension setting configuration and, optionally, also causes the stylet 1510 to disengage from the anchor 1300 (e.g., to lodge the anchor 1300). For example, in an example of one embodiment of the tension and lock device 1340 shown in FIGS. 7, 8A, 8B, and 8C, the stylet 1510 is operably coupled to the tension and lock device carriage 1342 via a coupler 1344 to axially translate the tension and lock device carriage 1342 between a tension adjustment configuration (FIG. 8A) and a tension setting configuration (FIG. 8B). For example, the stylet 1510 can be operably engaged with the coupler 1344 to transmit movement in a rotational direction thereto. Additionally, the stylet 1510 (e.g., its distal end 1511) and the coupler 1344 can be threadedly engaged within the anchor housing 1330 such that its rotation also causes its axial translation relative to the anchor housing 1330. The coupler 1344 can be operably coupled to the tension and lock device carriage 1342 to rotate relative thereto such that rotation of the coupler 1344 (e.g., caused by rotation of the stylet 1510) does not cause rotation of the tension and lock device carriage 1342, but axial translation of the coupler 1344 causes axial translation of the tension and lock device carriage 1342. Therefore, rotation of the tension and lock knob 1720 causes rotation of the stylet 1510 and the coupler 1344 to cause axial translation of the stylet 1510, the coupler 1344, and the tension and lock device carriage 1342 relative to the anchor housing 1330.

[0061] In an example of an embodiment shown in FIGS. 7, 8A, 8B, and 8C, the artificial chord 450 extends proximally through or along the stylet 1510 (e.g., from the delivery and implantation system control handle 1020), extends generally axially through the proximal end 1343 of the tensioning and locking device carriage 1342, and extends laterally out of the tensioning and locking device carriage 1342 and the anchor housing 1330 (e.g., through the window 1337 in the anchor housing 1330). Next, the artificial chord 450 can extend to another implantable device, such as the valve leaflet clip 440, such as that shown in FIG. 6. In a tension adjustment configuration, such as that shown in FIG. 8A, the artificial chord 450 is able to move freely relative to the tensioning and locking device carriage 1342. In such a configuration, the tension and / or length of the artificial chord 450 can be adjusted in any of the manners described above. Rotation of the tensioning and locking knob 1720 advances the tensioning and locking device carriage 1342 proximally relative to the anchor housing 1330 to the tension setting configuration shown in FIG. 8B. In the illustrated tension setting configuration, the artificial chord 450 is locked against movement by being captured or held (e.g., pinched) in a predetermined position between the tensioning and locking device carriage 1342 and the interior of the anchor housing 1330. Further rotation of the tensioning and locking knob 1720 disconnects the stylet 1510 from the coupler 1344, for example, to implant the anchor 1300, as shown in FIG. 8C. Any of various tensioning and locking devices can be used in connection with the delivery and implantation system 1000 of the present disclosure, such as any of the tensioning and locking devices or systems described in U.S. Patent Application Publication No. 2022 / 0096235, entitled Devices, Systems, And Methods For Adjustably Tensioning Artificial Chordae Tendineae In A Heart, published Mar. 31, 2022. The entire disclosure of that application is hereby incorporated by reference in its entirety for all purposes.It will be understood that the present disclosure need not be limited by the structure, form, function, etc. of the tensioning and locking device 1340 as shown and described in such patents or in this specification.

[0062] According to various principles of the present disclosure, the tensioning and locking system 1700 includes an anchor state indicator 1730 operably associated with a tensioning and locking knob 1720 to indicate the state or configuration of the tensioning and locking device 1340 of the anchor 1300. For example, as shown in FIGS. 9A, 9B, and 9C, the anchor state indicator 1730 may include an anchor state indicating surface 1732 having indicia 1732A, 1732B, and 1732C representing the state of operation or configuration of the tensioning and locking device 1340. The indicia 1732A, 1732B, and 1732C may be visible, for example, through a window 1070 within the delivery and retention system control handle housing 1022 as shown in FIG. 3. More specifically, when the tensioning and locking device 1340 is in a tension adjustment configuration, as shown, for example, in FIG. 8A, the anchor state indicating surface 1732 may be positioned such that the corresponding "unlock" indicium 1732A, as shown in FIG. 9A, is visible through the window 1070. When the tensioning and locking device 1340 is in a tension setting configuration, as shown, for example, in FIG. 8B, the anchor state indicating surface 1732 may be positioned such that the corresponding "lock" indicium 1732B, as shown in FIG. 9B, is visible through the window 1070. Finally, when the stylet 1510 is detached from the anchor 1300, as shown, for example, in FIG. 8C, the anchor state indicating surface 1732 may be positioned such that the corresponding "detach" or "separation" indicium 1732C, as shown in FIG. 9C, is visible through the window 1070.

[0063] The tensioning and locking knob 1720 can be operably coupled to the anchor status indicating surface 1732 in any of various manners known to those skilled in the art. For example, in the example of one embodiment shown in FIGS. 9A - C, rotation of the tensioning and locking knob 1720 can be transmitted to rotation of the anchor status indicating surface 1732 via a gear coupling 1740. More specifically, the illustrated example of one embodiment of the gear coupling 1740 includes an actuator spur gear 1734 engageable by an actuator finger 1724 that extends axially and proximally from the tensioning and locking knob 1720. The tensioning and locking knob 1720 can be bent in the tensioning direction TD (such as may be shown on the delivery and retention system control handle 1020, such as that shown in FIG. 3, for example) to shift the tensioning and locking device 1340 from a tension adjustment configuration to a tension setting configuration. Each time the tensioning and locking knob 1720 makes one rotation (360 degrees), the actuator finger 1724 causes progressive rotation of the actuator spur gear 1734. The actuator spur gear 1734, in turn, causes progressive rotation of an indicating surface spur gear 1736 that rotates with the anchor status indicating surface 1732. The gear ratios of the spur gears 1734 and 1736 can be selected based on, for example, the diameter of the anchor status indicating surface 1732, the diameter of the stylet 1510 and / or the stylet hub 1530, the length of the tensioning and locking device 1340 and / or the tensioning and locking device carriage 1342 and / or the coupler 1344, etc., so as to correlate the configuration of the tensioning and locking device 1340 with the anchor status indicating surface 1732, as can be understood by those skilled in the art.

[0064] As will be appreciated by those skilled in the art, the delivery and placement system 1000 and the delivery and placement system control handle 1020 as described herein can be separate and independent of each other and / or can operate in association with each other, having various structures, uses, and functions. The delivery and placement system control handle 1020 described herein can be used in association with a delivery system 200 of a delivery / placement system 100, and / or a steerable delivery system 300, and / or an additional device delivery and placement system 400, such as those described above. For example, in some embodiments, an implantable device and additional implantable devices can be delivered to a heart valve to perform a heart repair procedure using, for example, the delivery system 200, the steerable delivery system 300, and the additional device delivery and placement system 400 as described above. The heart repair procedure can be a heart valve repair procedure in which a valve leaflet clip 440 is coupled to the heart valve with an artificial chordae tendineae 450 coupled thereto. In such embodiments, for example, the additional device delivery and placement system 400 can be delivered and steered to an appropriate position for delivering and placing the valve leaflet clip 440 by clamping the valve leaflet clip 440 onto the heart valve leaflet L. Next, the steering control system 1400 can be operated to steer, for example, the anchor gauge 1200 to an appropriate position (e.g., with respect to the papillary muscle) for anchoring the artificial chordae tendineae 450 to the ventricle V as described above. Next, the anchor placement system 1500 can be used to advance the anchor 1300 into the heart tissue to anchor the artificial chordae tendineae 450 to the ventricle V. Optionally, the valve leaflet clip 440 can be left in place, an appropriate placement of the valve leaflet clip 440 and the anchor 1300 can be confirmed, and the placement system 430 can be withdrawn from the ventricle such that the tension / length of the artificial chordae tendineae 450 can be adjusted to provide appropriate function of the heart valve leaflet L and the heart valve. For example, the tension / length of the artificial chordae tendineae 450 can be adjusted using the suture adjustment system 1600 as described above. When a sound function of the heart valve leaflet L is achieved, the tension / length of the artificial chordae tendineae 450 can be set / locked using, for example, the tensioning and locking system 1700 as described above.Next, the stylet 1510 coupled to the anchor 1300 can be detached from the anchor 1300 and withdrawn from the heart to assist in the delivery and placement of the anchor 1300. The remaining artificial chord 450 that proximally extends from the artificial chord 450 to the medical professional (e.g., for adjustment) can be cut at an appropriate location proximate to the anchor 1300 so that no extra slack artificial chord 450 remains hanging within the heart.

[0065] Embodiments of the present disclosure may be described specifically with reference to implants for use with mitral valves, but it is understood that various other implants may similarly benefit from the structures and manufacturing methods disclosed herein. Considering the above, it is to be understood that the various embodiments shown in the figures each have, at least alone, several distinct and independent features and methods of use that are desirable, but not essential, to the devices, systems, and methods of the present disclosure. Thus, it is not necessary that all of the various distinct features, devices, systems, methods, etc. described herein be present to achieve at least some of the desired characteristics and / or advantages described herein. Only one of the various features, devices, systems, methods, etc. may exist in accordance with the various principles of the present disclosure. Alternatively, one or more of the features, devices, systems, methods, etc. may be used in various combinations with each other. In addition to those described above, various further advantages of the various aspects, features, components, and structures of devices, systems, methods, etc., such as those described above, may be understood by those skilled in the art.

[0066] The foregoing discussion has broad applicability and is presented for purposes of illustration and explanation and is not intended to limit the disclosure to one or more of the forms disclosed herein. It will be understood that various additions, modifications, and substitutions can be made to the embodiments disclosed herein without departing from the concepts, spirit, and scope of the disclosure. In particular, it will be apparent to those skilled in the art that the principles of the disclosure can be embodied in other forms, structures, arrangements, ratios, and using other elements, materials, and components without departing from its concepts, spirit, or scope or characteristics. For example, various features of the disclosure are grouped together in one or more aspects, embodiments, or configurations for the purpose of streamlining the disclosure. However, it should be understood that the various features of a particular aspect, embodiment, or configuration of the disclosure can be combined in alternative aspects, embodiments, or configurations. The disclosure is presented from the perspective of embodiments, but it should be understood that not all of the various distinct features of the subject matter need to be present to achieve at least some of the desired characteristics and / or advantages of the subject matter or such individual features. Those skilled in the art will understand that, without departing from the principles, spirit, or scope of the disclosure, the disclosure can be used with many modifications or with structures, arrangements, ratios, materials, components, and other modifications specifically adapted to particular environments and operating requirements used in the practice of the disclosure. For example, elements shown as being integrally formed can be composed of multiple parts, or elements shown as multiple parts can be integrally formed, the operation of an element can be reversed or otherwise changed, and the size or dimensions of an element can be changed. Similarly, although operations, actions, or procedures are described in a particular order, this should not be understood to mean that such a particular order is required to achieve a desired result or that all operations, actions, or procedures should be performed. Furthermore, other implementations are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve a desired result.Therefore, embodiments of the present disclosure should be considered illustrative in all respects and not restrictive, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to the foregoing description or to the specific embodiments or configurations described or illustrated herein. In view of the foregoing, the individual features of any embodiment can be used separately or in combination with the features of that embodiment or any other embodiment and can be claimed, and the scope of the subject matter is indicated by the appended claims and is not limited to the foregoing description.

[0067] In the foregoing description and the following claims, the following points will be understood. The phrases “at least one,” “one or more,” and “and / or” are open-ended expressions that are used as both conjunctive and disjunctive when used in this specification. The terms “a,” “an,” “the,” “first,” “second,” etc. do not exclude a plurality. For example, the term “a” or “an” entity, when used in this specification, refers to one or more of that entity. Therefore, the terms “a” (or “an”), “one or more,” and “at least one” can be used interchangeably in this specification. When used in this specification and the appended claims, the term “or” is generally used in the sense of “and / or” unless the context clearly indicates otherwise. When used in this specification, the conjunction “and” includes each of the structures, components, features, etc. so combined, unless the context clearly indicates otherwise, and the conjunction “or” includes one or the other of the structures, components, features, etc. so combined, alone and in any combination and number, unless the context clearly indicates otherwise. All references to direction (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, etc.) are used only for identification purposes to assist the reader's understanding of the present disclosure and / or to help distinguish the areas of the associated elements from each other, and do not particularly limit the associated elements with respect to the position, orientation, or use of the present disclosure. References to connection (e.g., attached, coupled, connected, engaged, and joined) should be construed broadly and may include intermediate members between sets of elements and relative movement between elements, unless otherwise indicated. Therefore, references to connection do not necessarily imply that two elements are directly connected and in a fixed relationship with each other.References to identification (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority and are used to distinguish one feature from another.

[0068] The following claims are hereby incorporated by reference into this "Detailed Description of the Invention", and each claim is independent as a separate embodiment of the present disclosure. In the claims, the terms "comprises", "comprising", "includes", and "including" do not exclude the presence of other elements, components, features, groups, regions, integers, steps, acts, etc. Additionally, individual features may be included in different claims, and although these may, in some cases, be advantageously combined, inclusion in different claims does not imply that a combination of features is not feasible and / or not advantageous. Furthermore, references to the singular do not exclude the plural. Reference numerals in the claims are provided merely as examples for clarity and should in no way be construed as limiting the claims.

Claims

1. A delivery and implantation system for delivering and / or implanting an implantable device into an anatomical site, the delivery and implantation system comprising: a flexible elongate member; an implantable device delivery device deliverable to the anatomical site at a distal end of the flexible elongate member; an implantable device deliverable by the implantable device delivery device; a control handle comprising: a steering system operably coupled to the flexible elongate member to control movement of the flexible elongate member to deliver the implantable device to the anatomical site; an implantable device implantation system operably coupled to the implantable device to implant the implantable device at the anatomical site; a tether adjustment system operably engageable with a tether element engageable with the implantable device; or a tensioning and locking system operably engageable with the implantable device to adjust a configuration of a tensioning and locking device operably associated with the implantable device, wherein the control handle includes one or more of the foregoing, and a delivery and implantation system.

2. The flexible elongate member includes a tension element operably associated with the flexible elongate member, wherein the control handle includes at least a steering system, the steering system including a steering control knob rotatable about a longitudinal axis of the control handle to axially tension the tension element to steer the flexible elongate member, The delivery and implantation system according to claim 1.

3. The delivery and implantation system according to claim 1 or 2, wherein the implantable device is a tissue anchor.

4. The flexible elongate member is tubular, and the delivery and implantation system further comprises a stylet operably coupled to the implantable device and extending through the tubular flexible elongate member, The delivery and implantation system according to any one of claims 1 to 3. The delivery and retention system according to claim 4, wherein the control handle includes an implant device retention system operably coupled to the stylet to axially translate the stylet along the longitudinal axis of the control handle to at least advance and retain the implant device from the implant device delivery device.

6. The delivery and retention system according to any one of claims 1 to 5, further comprising a tether element extending to a location spaced from the implant device with respect to the implant device, wherein the control handle includes a tether adjustment system operably engagable with the tether element to adjust at least the tension and / or length of the tether element between the implant device and the location spaced from the implant device.

7. The delivery and retention system according to claim 6, wherein the tether adjustment system includes a fine adjustment knob rotatable about the longitudinal axis of the control handle and engagable with the tether element to adjust the tension and / or length of the tether element between the implant device and the location spaced from the implant device.

8. The delivery and retention system according to any one of claims 1 to 7, further comprising a tensioning and locking device associated with the tether element and operable to shift the tension and / or length of the tether element from a tension adjustment configuration, in which the tension and / or length of the tether element is adjustable, to a tension setting configuration, in which the tension and / or length of the tether element is fixed with respect to the implant device.

9. The delivery and retention system according to claim 8, wherein the control handle further includes a tensioning and locking system operably associated with the tensioning and locking device to shift the tensioning and locking device between the tension adjustment configuration and the tension setting configuration.

10. The delivery and retention system according to claim 9, wherein the tensioning and locking system includes a tensioning and locking knob rotatable about the longitudinal axis of the control handle to shift the tensioning and locking device between the tension adjustment configuration and the tension setting configuration.

11. The delivery and retention system according to claim 9 or 10, wherein the tensioning and locking system further includes an anchor state indicator operably associated with the tensioning and locking knob to indicate the configuration of the tensioning and locking device.

12. The stylet is operably coupled to the tensioning and locking device and the tensioning and locking system such that rotation of the tensioning and locking knob rotates the stylet, and rotation of the stylet shifts the tensioning and locking device between the tension adjustment configuration and the tension setting configuration. The delivery and retention system according to any one of claims 4 to 12.

13. A delivery and retention system for delivering and / or retaining an implantable device to an anatomical site, the delivery and retention system comprising a control handle having a longitudinal axis, the control handle being rotatable about the longitudinal axis of the control handle and operable to axially translate components of the delivery and retention system. A delivery and retention system comprising a control handle including at least one control knob.

14. The delivery and retention system includes a flexible elongate member configured to deliver the implantable device trans-luminally to an anatomical site. The delivery and retention system according to claim 13, wherein a pull element is operably coupled to the flexible elongate member and the control knob such that rotation of the control knob about the longitudinal axis of the control handle bends a distal region of the flexible elongate member to deliver the implantable device to a treatment site.

15. The delivery and retention system according to claim 13 or 14, wherein the control knob is rotatable about the longitudinal axis of the control handle to adjust elements of the delivery and retention system relative to a tether element operably associated with an implantable device deliverable by the delivery and retention system.

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