Devices, systems, and methods for delivering and deploying implanted devices

Abstract

A delivery and deployment system has a control handle operable to (e.g., transluminal) deliver and / or deploy an implant device. The steering control system may include a steering control knob rotatable about a longitudinal axis of the handle to axially pull the steering element to steer the flexible elongate member to deliver the implant device to a desired site. An implant device deployment system may include a slider that is selectively slidable relative to a control handle to deploy an implant device, and optionally hold the implant device in a delivery position. The tether adjustment system may include a knob rotatable about a longitudinal axis of the handle to axially pull the 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 displace the tensioning and locking device to set the tension and / or length of the tether element.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Application No. 63 / 354,005, filed on June 21, 2022, the entire disclosure of which is incorporated herein by reference for all purposes. Technical Field

[0001] The present disclosure relates generally to the field of medical devices and systems. More specifically, the present disclosure relates to devices, systems and methods for delivering and deploying implant devices. Even more specifically, the present disclosure describes devices, systems and methods for steering elongated members (such as catheters), and devices, systems and methods for deploying implant devices such as tissue engaging elements (such as tissue anchors), and devices, systems and methods for adjusting tension on elements operably associated with tissue engaging elements. Background Art

[0002] Devices, systems and methods for delivering and / or deploying medical devices using minimally invasive techniques (such as percutaneous and / or intracavitary) are desirable for avoiding more complex and invasive open surgical procedures. Various techniques that do not require open surgery utilize systems and devices with various flexible elongated members that can navigate from a small insertion opening in the patient's body or via a natural orifice to an anatomical part inside the body; navigate via the body (e.g., via the vascular system) via the cavity; and reach the anatomical part. In order to reach the anatomical part inside the body, various elongated members must be steerable to navigate the tortuous path leading to the anatomical part via the body's interior. Improvements to the handle for steering the elongated member will be welcome in the art. In addition, in order to deploy an implant device inserted percutaneously and / or intracavitary, the delivery / deployment system must provide appropriate control of the implant device movement and appropriate control of any system for delivering and deploying the implant device inside the patient's body. Improvements to the handle for delivering and deploying the implant device and / or adjusting any other device operably associated therewith will be welcome in the art. Summary of the invention

[0003] The invention summary of the present disclosure is given to assist understanding, and those skilled in the art will appreciate that each of the various aspects and features of the present disclosure may be advantageously used alone in some cases, or in combination with other aspects and features of the present disclosure in other cases. The inclusion or exclusion of elements, components, etc. in the invention summary is not intended to limit the scope of the claimed subject matter.

[0004] According to various principles of the present disclosure, a delivery and deployment system for delivering and / or deploying an implant device to an anatomical site includes: a flexible, elongated member; an implant delivery device capable of being delivered to an anatomical site at the distal end of the flexible, elongated member; an implant device capable of being delivered by the implant 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, elongated member to control the movement of the flexible, elongated member to deliver the implant device to the anatomical site; an implant deployment system operably coupled to the implant device to deploy the implant device at the anatomical site; a tether adjustment system operably engageable with a tether element that is engageable with the implant device; or a tensioning and locking system operably engageable with the implant device to adjust the configuration of a tensioning and locking device operably associated with the implant device.

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

[0006] In some embodiments, the implant device is a tissue anchor.

[0007] In some embodiments, the flexible elongated member is tubular, and the delivery and deployment system further comprises a stylet operably coupled to the implant device and extending through the tubular flexible elongated member. In some embodiments, the control handle comprises at least an implant device deployment system operably coupled to the stylet to axially translate the stylet along the longitudinal axis of the control handle to advance and deploy the implant device from the implant device delivery device.

[0008] In some embodiments, the system further comprises a tether element extending relative to the implant device to a position spaced apart from the implant device, and the control handle comprises at least one tether adjustment system operably engageable with the tether element to adjust the tension and / or length of the tether element between the implant device and the position spaced apart from the implant device. In some embodiments, the tether adjustment system comprises a fine adjustment knob engageable 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 implant device and the position spaced apart from the implant device. In some embodiments, the system further comprises a tensioning and locking device operably associated with the tether element and capable of shifting from a tension adjustment configuration to a tension setting configuration, in which the tension on the tether element and / or the length of the tether element is adjustable, and in which the tension on the tether element and / or the length of the tether element is fixed relative to the implant device. In some embodiments, the control handle further comprises 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 comprises 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 comprises an anchoring 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 comprises a stylet operably coupled to an implant device. In some embodiments, the control handle comprises at least one implant device deployment system operably coupled to the stylet to axially translate the stylet along the longitudinal axis of the control handle to advance and deploy the implant device from the implant device delivery device. In some embodiments, a 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.

[0009] In some embodiments, the system further comprises a tether element and a tensioning and locking device operably associated with the tether element; the tether element extends from the implant device to a position spaced apart from the implant device; the tensioning and locking device is movable from a tension adjusting configuration to a tension setting configuration, wherein the tension on the tether element and / or the length of the tether element is adjustable, and wherein the tension on the tether element and / or the length of the tether element is fixed relative to the implant device; and the control handle comprises at least the tensioning and locking device to shift the tensioning and locking device between the tension adjusting configuration and the tension setting configuration.

[0010] In accordance with various principles of the present disclosure, a delivery and deployment system for delivering and / or deploying an implant device to an anatomical site includes a control handle having a longitudinal axis and includes at least one control knob that is rotatable about the longitudinal axis of the control handle and is operable to axially translate a component of the delivery and deployment system.

[0011] In some embodiments, the delivery and deployment system includes a flexible, elongated member configured to deliver an implant device through a cavity to an anatomical site; and a pulling element operably coupled to the flexible, elongated member and a control knob such that rotation of the control knob about a longitudinal axis of the control handle bends a distal region of the flexible, elongated member to deliver the implant device to the treatment site.

[0012] In some embodiments, a control knob is rotatable about a longitudinal axis of the control handle to adjust an element of the delivery and deployment system relative to a tether element operably associated with an implant device deliverable by the delivery and deployment system.

[0013] According to various principles of the present disclosure, a method for transluminal delivery and / or deployment of an implant device includes rotating a control knob operably associated with a delivery and deployment system control handle about a longitudinal axis of the control handle to axially translate an element of a delivery and deployment system associated with the implant device.

[0014] In some embodiments, the axially translatable element is at least one of: a pulling element that is operably associated with the steerable flexible, elongated member and is capable of axially translating to bend the steerable flexible, elongated member to steer the steerable flexible, elongated member within the patient's body to deliver an implant device operably associated with the steerable flexible, elongated member; or, a tether element that is operably associated with the implant device; or, a flexible, elongated member that is operably associated with the tether element and the implant device to adjust the tension on the tether element and / or its length relative to the implant device.

[0015] These and other features and advantages of the present disclosure will be apparent from the following detailed description, and the scope of the claimed invention is set forth in the appended claims. Although the following disclosure is presented in terms of multiple aspects or embodiments, it should be understood that each aspect may be claimed individually or in combination with multiple aspects and features of that or any other embodiment. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] 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 accompanying drawings may vary. For example, the device may be enlarged so that the details are discernible, but it is also intended to cover reduced solutions (e.g., with respect to fitting within a delivery catheter or working channel of an endoscope). For the purpose of clarity and simplicity, not every element is labeled in each of the accompanying drawings, nor is every element of each embodiment shown, where illustration is not necessary to allow a person of ordinary skill in the art to understand the present disclosure.

[0017] The “Detailed Description” will be better understood in conjunction with the accompanying drawings, wherein like reference numerals represent like elements, as shown below:

[0018] Figure 1 A perspective view of one example of an implementation of a delivery and deployment system and handle according to various aspects of the present disclosure is depicted.

[0019] Figure 2 A perspective view depicting an example of an embodiment of an implant device delivery and deployment system positioned by a delivery and deployment system formed according to various principles of the present disclosure to deploy an implant device relative to a schematic diagram of a heart.

[0020] Figure 3 Describes Figure 1An enlarged isolated perspective view of an implant device delivery and deployment system control handle is depicted.

[0021] Figure 4 Describes something like Figure 3 , but with a portion of the handle housing removed.

[0022] Figure 5 Depicted along Figure 3 A cross-sectional view along line VV of .

[0023] Figure 6 A perspective view of one example of an embodiment of an implant device deployed relative to a schematic diagram of a heart using a delivery and deployment system formed according to various principles of the present disclosure is depicted.

[0024] Figure 7 Depicted is a perspective view of an implant device with a housing portion shown in phantom to reveal a tensioning and locking device therein that is deliverable and deployable by a delivery and deployment system formed according to the principles of the present disclosure.

[0025] Fig. 8A Depicted in unlocked configuration Figure 7 A cross-sectional view of the artificial chord tensioning and locking device along line VIIIA-VIIIA.

[0026] Figure 8B Describes something like Fig. 8A A cross-sectional view of an artificial chord tensioning and locking device of FIG. 1 , but shown in a locked configuration.

[0027] Figure 8C Describes something like Figure 8B and Figure 8C sectional view showing an actuator formed according to the principles of the present disclosure disengaged from a synthetic chord tensioning and locking device.

[0028] Fig. 9A Describes Figure 4 Detailed view of the tensioning and locking system in the Fig. 8A The position corresponds to the position of the tensioning and locking device depicted in FIG.

[0029] Fig. 9B Describes something like Fig. 9A perspective view, but with the tensioning and locking knobs in the same position as Figure 8B The position corresponds to the position of the tensioning and locking device depicted in FIG.

[0030] Fig. 9C Describes something like Fig. 9A perspective view, but with the tensioning and locking knobs in the same position as Figure 8CThe position corresponds to the position of the tensioning and locking device depicted in FIG. DETAILED DESCRIPTION

[0031] The specific embodiments below should be read with reference to the drawings depicting illustrative embodiments. It should be understood that the present disclosure is not limited to the specific embodiments described, because these embodiments can be changed. All apparatuses and systems and methods discussed herein are examples of apparatuses and / or systems and / or methods implemented according to one or more principles of the present disclosure. Each example of the embodiment is provided by way of explanation, and is not the only way to implement these principles, but only 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 understood as limiting the present disclosure to the specific elements, structures or features shown. After reading the present disclosure, a person of ordinary skill in the art will think of other examples of ways to implement the disclosed principles. In fact, it will be obvious to those skilled in the art that various modifications and changes can be made to the disclosure without departing from the scope or spirit of the present technical subject. For example, a feature shown or described as part of an embodiment can be used together with another embodiment to produce another embodiment. Therefore, the present technical subject is intended to cover such modifications and changes that fall within the scope of the appended claims and their equivalents.

[0032] It should be understood that the present disclosure is set forth in various levels of detail in this application. In some cases, details that are not necessary for a person of ordinary skill in the art to understand the present disclosure, or details that make other details difficult to perceive, may be omitted. The terms used herein are only for the purpose of describing specific embodiments and are not intended to limit the scope beyond the appended claims. Unless otherwise defined, the technical terms used herein should be understood as commonly understood by a person of ordinary skill in the art to which the present disclosure belongs. According to the present disclosure, all devices and / or methods disclosed and claimed herein can be manufactured and performed without undue experimentation.

[0033] As used herein, the "proximal" side refers to the direction or position closest to a user (a medical professional or clinician or technician or operator or physician, etc., such terms are used interchangeably herein without limitation and include automated controller systems or other means), such as the direction or position closest to a user, etc. when the device is used (e.g., the device is introduced into a patient, or during implantation, positioning or delivery), and / or the direction or position closest to a delivery device, and the "distal" side refers to the direction or position farthest from the user, such as when the device is used (e.g., the device is introduced into a patient, or during implantation, positioning or delivery), and / or the direction or position closest to a delivery device. "Longitudinal" means extending along the longer or larger dimension of an element. A "longitudinal axis" extends along the longitudinal extent of an element, but is not necessarily straight, and the longitudinal axis does not necessarily remain in a fixed configuration if the element flexes or bends. "Center" means at least approximately bisecting a center point and / or approximately equidistant from a perimeter or border, and, for an opening, "central axis" means a line that at least approximately bisects a center point of the opening and extends longitudinally along the length of the opening when the opening comprises, for example, a tubular element, strut, passage, cavity, or hole. As used herein, a "passage" or "hole" is not limited to a circular cross-section. As used herein, a "free end" of an element refers to the end beyond which the element does not extend.

[0034] According to various principles of the present disclosure, the delivery and deployment system is configured to deliver and / or deploy implant devices relative to the treatment site. It should be understood that the delivery "and" deployment mentioned herein is for convenience rather than intended to be limited. In some aspects, the delivery and deployment system is configured to operate and / or include an implant device delivery and deployment system, and the implant device delivery and deployment system is configured to deliver and deploy implant devices relative to tissues at an anatomical site (such as a treatment site in a patient), and optionally deliver and deploy implant devices relative to another anatomical site. It should be understood that anatomical sites, delivery sites, deployment sites, implants / implantation sites, implanted sites, target sites, treatment sites, etc. are interchangeably and are not intended to be limited herein. In some aspects, the delivery and deployment system includes a handle, which is configured to operate such an implant device deployment system to deploy an associated implant device. In some embodiments, the implant device is a tissue engaging element, such as a tissue anchor configured to be deployed to implant tissue. It should be understood that terms such as implant (and its other grammatical forms) may be used interchangeably herein with terms such as attach, anchor, attach, associate, connect, engage, embed, maintain, retain, fix, secure, etc. (and their grammatical forms) without limitation.

[0035] In an example of an embodiment of delivery and deployment system as described herein, the system includes a handle configured to facilitate the delivery of implant device and the steering of deployment system. For example, the handle may include a steering knob, which is rotatable to actuate a pulling element to guide the delivery of implant device and deployment system to the anatomical part where the implant device will be deployed. It should be understood that terms such as steering (and other grammatical forms thereof) and the like can be used interchangeably with terms such as actuation, advancement, articulation, bending, control, drive, flexure, manipulation, control, motion, navigation, operation, pulling, retraction, rotation, displacement, transition, translation, turning, etc. (and other grammatical forms thereof) in this article, and are not intended to limit.

[0036] It should be understood that, in order to deliver the implant device through the cavity, the implant device is capable of shifting between the delivery configuration and the expanded deployment configuration. The implant device can be delivered through the cavity inside the tubular element to keep the implant device in the delivery configuration and / or protect the implant device, and / or protect the body passage through which the implant device advances. The tubular element can be delivered by a flexible slender member. It should be understood that, for the sake of convenience and without intending to limit, the term flexible slender member or tubular flexible slender member is generally used in this article to refer to elements such as catheters, shafts, sleeves, sheaths, tubes, stylets, etc. Once in the treatment site, the implant device can be advanced distally, out of the tubular element to be deployed. For the sake of convenience and without intending to limit, the implant device is referred to as an anchor (anchor piece) in this article, and the tubular element (usually without additional intervention tubular delivery elements therebetween) of the delivery anchor is referred to as an anchor garage (anchor receiver) in this article, however, the principles of the present disclosure are also applicable to implant devices other than anchors and tubular elements other than anchor garages. The anchor garage can be specifically configured to keep the anchor therein. Optionally, the anchor magazine has additional features that facilitate the use of the anchor magazine with other devices or systems that can operate in conjunction with the anchor. For example, if the anchor is to be used in conjunction with another device, the anchor magazine may include features that allow the anchor and / or the anchor magazine to cooperate with such other device or system. Such an anchor magazine can be mounted at the distal end of a tubular flexible, slender member, which, for convenience and without limitation, may be referred to as a garage shaft. The anchor can be coupled to the flexible, slender member to be movable relative to the anchor magazine, such as to be deployed from the anchor magazine. For convenience and without limitation, the flexible, slender member coupled to the anchor is referred to herein as an anchor spool.

[0037] In one example of an embodiment of the delivery and deployment system described herein, the system includes a handle with a slider that is capable of deploying the anchor from a delivery configuration inside the anchor magazine to a deployment configuration outside the anchor magazine (such as within a tissue). In some embodiments, the slider is operably coupled to the anchor stylet to advance the anchor distally out of the anchor magazine to deploy the anchor. According to various principles of the present disclosure, the slider can be locked in place to prevent unintentional movement of the anchor.

[0038] As can be appreciated, the delivery and deployment system can be subjected to compressive forces during transluminal navigation to the 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 deployed prematurely due to the force on the system. For example, in some embodiments, the anchor magazine and / or the magazine shaft can be subjected to compressive forces that can cause the anchor magazine to retract relative to the anchor and prematurely deploy or at least partially deploy the anchor. In some embodiments, the slider can be movable to selectively apply tension to the anchor stylet to keep the anchor inside the anchor magazine and prevent it from being deployed prematurely. If the anchor automatically transitions from a delivery configuration to a deployment configuration (e.g., by expanding when leaving the anchor magazine), this ability to keep the anchor in the anchor magazine can be particularly beneficial.

[0039] In some aspects, an implant device (such as a tissue anchor) can be connected to another implant device and / or a tether element can be connected to the tissue anchor. For example, a tether element can be operably connected between a first implant device and a second implant device. In some embodiments, a tether element is operably associated with an implant device at a first position at an anatomical site, and is operably associated at a second position spaced apart from the first position. For example, a tether element can be connected to another implant device, and the other implant device is spaced apart from the initial implant device for deployment. For example, a tether element can extend between an implantable tissue engagement element and another tissue engagement device (such as a clip or a clamp). The tether element can be attached to one of the tissue engagement elements or the tissue engagement device in a generally fixed manner, and is movably connected to another element or device. In the depicted example of the embodiment of the implant device described herein and the associated delivery and deployment device and system, the implant device is in the form of a tissue anchor connected to a tissue clip or a clamp via a suture. More specifically, in the depicted examples of the embodiments described herein, the tissue anchor is an anchor configured to be implanted in cardiac tissue (e.g., papillary muscle tissue), the suture is an artificial chord, and the tissue clip is a leaflet clip (valve leaflet clip). For convenience and without limitation, the tether element may be alternatively referred to herein as a tether or suture or artificial chord, without limitation. In addition, for convenience and without limitation, the second implant device to which the anchor is connected is referred to herein as a clip (or leaflet clip). It should be understood that the principles of the present disclosure may still be applicable to devices other than cardiac tissue anchors, leaflet clips, and / or sutures or artificial chords.

[0040] In some cases, it may be desirable to control the movement of the tether relative to the implant device, such as applying tension to the implant device via the tether and / or applying tension between the first implant device and the second implant device. In some embodiments, the tether is connected to one of the implant devices and is movable relative to another in the implant device. In some embodiments, an implant device connected to the tether is first implanted, and secondly, another in the implant device is implanted, and the tether can be pulled proximally relative to another in the implant device (e.g., by a delivery and deployment system and relative to its handle) to adjust the length and / or tension of the tether between the implant devices. This adjustment of the tether can be considered as a total adjustment because it is not usually a measured and precisely controlled adjustment.

[0041] In various anatomical locations, precise and fine adjustment of the tether is required. For example, in the depicted example of the embodiment described herein, the first implant device is a cardiac tissue anchor and the second implant device is a leaflet clip. The leaflet clip is clamped to the heart valve leaflet, and the tissue anchor is then anchored relative to the ventricle, wherein the artificial chords are connected to the leaflet clip and extend to the tissue anchor. The artificial chords are movable relative to the tissue anchor to adjust the tension on the leaflet clip to restore the normal function of the leaflet (e.g., to prevent the leaflet from extending or swinging into the atrium, thereby preventing the heart valve from closing properly, which may cause regurgitation and various harmful consequences). In order to achieve proper closure of the heart valve, the tension on the heart valve leaflet must be sufficient to prevent flutter, but not so high that the leaflet cannot return to a closed position once blood flows from the atrium to the ventricle.

[0042] According to various principles of the present disclosure, the delivery and deployment system includes a tether control knob for finely adjusting the length and / or tension of the tether. A tether lock can be provided to lock the tether relative to the tether control knob. The tether lock can be shifted (converted) between a disengaged position and an engaged position, in which the tether can move relatively freely relative to the tether control knob, and in which the tether is locked relative to the tether control knob in the engaged position. 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 increase the tension on the tether and / or shorten the length of the tether in the anatomical part. When the rotatable tether control knob is rotated in a second direction (opposite to the first direction), the tension on the tether is reduced or the tether is released to increase the length of the tether in the anatomical part (such as pulling the tether through the leaflet to increase the length of the tether between the leaflet clip and the anchor, and / or reducing the tension therebetween).

[0043] It should be understood that once the desired tension on the tether and / or the length of the tether is reached or achieved, it may be desirable to set or fix or lock such a configuration. In one example of an embodiment of the delivery and deployment system described herein, the system includes a tensioning and locking device that is operably associated with the tether to set or fix the desired tether tension and / or length. In some embodiments, the tensioning and locking device adjusts the position of the tether relative to the implant device, and / or the tension on one or two implant devices, and / or the length of the tether extending between the implant devices. The tensioning and locking device can be capable of shifting between a tension adjustment configuration and a tension setting or locking configuration. In the tension adjustment configuration, the tensioning and locking device allows the tether to move relative to the tensioning and locking device so as to adjust the tension of the tether relative to the clip and / or anchor. For example, the locking element can be in a position that is not engaged / disengaged with the tether to allow the tether to move freely. In a tension setting or locking configuration (such terms are used interchangeably herein without limitation), the tensioning and locking device inhibits movement of the tether, for example relative to movement of the tensioning and locking device, to set the length and / or tension of the tether. For example, a locking element can be displaced to engage with the tether to inhibit or prevent movement of the tether relative to the tensioning and locking device. It should be understood that terms such as inhibit, prevent, lock, restrict, etc. can be used interchangeably herein without limitation. Once the desired position of the tether relative to the implant device and / or the length of the tether extending between the implant devices and / or the tension on one or both implant devices has been achieved, the tensioning and locking device can be displaced into a tension locking configuration.

[0044] According to various principles of the present disclosure, the delivery and deployment system control handle includes a tensioning and locking knob that is actuatable to adjust the configuration of the tensioning and locking device to adjust the tension and / or its length on the tether element associated with one or more implant devices. In some embodiments, the anchor stylet is operably connected to a component of the 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 connected to a movable locking element that is displaced relative to the tether to convert the configuration of the tensioning and locking device. In some embodiments, the stylet is rotatable to change the configuration of the tensioning and locking device. In some embodiments, the rotation of the stylet causes the locking element to move axially relative to the housing to change the configuration of the tensioning and locking device. In such an embodiment, the rotation of the stylet control knob causes the stylet to rotate so that the tensioning and locking device is displaced between the tension adjustment configuration and the 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 secure the tether relative to the anchor and / or allow the tether to be adjusted relative to the anchor (e.g., to adjust the length of the tether and / or the tension thereon relative to the anchor and leaflet clip). In some embodiments, rotating the stylet a sufficient amount disengages the stylet from operable engagement with the anchor and / or the tensioning and locking device to release and deploy the implant device. In some embodiments, the tensioning and locking device is operably associated with the implant device. In some embodiments, the tensioning and locking device is contained in a housing coupled to the implant device. It should be understood that the principles of the present disclosure are applicable to setting the tension on the tether regardless of whether a stylet is used.

[0045] In some embodiments, an indicator is provided to indicate the state of the implant device and / or the tensioning and locking device, such as a state relative to or related to the position of the tensioning and locking knob. For example, the indicator can have markings indicating whether the tensioning and locking device is in a tension adjustment or tension setting configuration, and / or whether the stylet is operably engaged with the implant device or has been decoupled / disengaged therefrom.

[0046] It should be understood that the devices, systems, and methods of the present disclosure may be used alone or in conjunction with other devices, systems, and methods to treat heart disease. Examples of devices, systems, and methods that may be used to implement embodiments of the present disclosure include, but are not limited to, those described in U.S. patent application publication US2021 / 0007847, entitled Devices, Systems, and Methods For Clamping A Leaflet Of A Heart Valve, published on January 14, 2021; those described in U.S. patent application publication US2021 / 0000597, entitled Devices, Systems, and Methods For Adjustably Tensioning An Artificial Chordae Tendineae Between A Leaflet And A Papillary Muscle Or Heart Wall, published on January 7, 2021; and those described in U.S. patent application publication US2021 / 0000597, entitled Devices, Systems, and Methods For Anchoring An Artificial Chordae Tendineae To A Papillary Muscle Or Heart Wall, published on January 7, 2021. those described in U.S. Patent Application Publication No. US2021 / 0000598, entitled Devices, Systems, and Methods For Artificial Chordae Tendineae Wall and published on January 7, 2021; those described in U.S. Patent Application Publication No. US2021 / 0000599, entitled Devices, Systems, and Methods For Artificial Chordae Tendineae and published on January 7, 2021; those described in U.S. Patent Application Publication No. 2022 / 0096235, entitled Devices, Systems, and Methods For Adjustably Tensioning Artificial Chordae Tendineae In A Heart and published on March 31, 2022;Those described in U.S. Patent Application Publication 2023 / 0062599, entitled Devices, Systems, And Methods For Anchoring An Artificial Chordae Tendineae To Cardiac Tissue, published on March 2, 2023; and those described in U.S. Provisional Application __ / __, __ [Attorney Docket 2001.2715100, formerly 8150.0817Z], published on December 20, 2021, each of which is incorporated herein by reference in its entirety and for all purposes. The examples of devices described herein may be modified to include embodiments or one or more features of the present disclosure. ;

[0047] Various embodiments of the delivery and deployment system formed according to various principles of the present disclosure will now be described with reference to examples of the embodiments depicted in the accompanying drawings. References to "one embodiment", "embodiments", "some embodiments", "other embodiments", etc. in this specification indicate that one or more specific features, structures, concepts and / or characteristics according to the principles of the present disclosure can be included in conjunction with the embodiments. However, such references do not necessarily mean that all embodiments include specific features, structures, concepts and / or characteristics, or that one embodiment includes all features, structures, concepts and / or characteristics. Some embodiments may include one or more such features, structures, concepts and / or characteristics in various combinations thereof. It should be understood that one or more of the features, structures, concepts and / or characteristics described with reference to one embodiment may be combined with one or more of the features, structures, concepts and / or characteristics of any other embodiment provided herein. That is, any features, structures, concepts and / or characteristics described herein can be mixed and matched to create a mixed embodiment, and such a mixed embodiment is within the scope of the present disclosure. In addition, references to "one embodiment", "embodiments", "some embodiments", "other embodiments", etc. in various places in the specification do not necessarily all refer to the same embodiment, nor are they necessarily separate or alternative embodiments that are mutually exclusive with other embodiments. It should also be understood that the various features, structures, concepts and / or characteristics of the disclosed embodiments are independent and separate from each other, and may be used or present individually or in various combinations with each other to create alternative embodiments that are considered to be part of the present disclosure. Therefore, the present disclosure is not limited to the embodiments specifically described herein, as it would be too cumbersome to describe all the many possible combinations and sub-combinations of features, structures, concepts and / or characteristics, 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 illustrative example of an embodiment and is not intended to limit the broader aspects of the present disclosure.

[0048] Turning now to the accompanying drawings, it will be appreciated that common features are identified by common reference elements, and for simplicity and convenience, and without intent to limit, the description of common features is generally not repeated. For clarity, not all parts with the same reference numerals are numbered. In addition, a group of similar elements may be indicated by numbers and letters, and generally an element or such element or a group of such elements may be referred to only by numbers (excluding letters associated with each similar element). In addition, certain features in one embodiment may be used across different embodiments, and may not necessarily be individually labeled when appearing in different embodiments.

[0049] Now turning to the attached figure, Figure 1An example of an embodiment of a delivery and deployment system 1000 formed according to various principles of the present disclosure is depicted in . The delivery and deployment system 1000 is optionally part of a larger delivery / deployment system 100, such as further described in detail in co-pending provisional patent application __ / ___,___[Attorney Docket 2001.2787100], entitled Devices, Systems, And Methods For Steering A Catheter, filed on June 21, 2022; and co-pending provisional patent application __ / ___,___[Attorney Docket 2001.2754100], entitled Devices, Systems, And Methods For Deploying An Implantable Device, filed on June 21, 2022, each of which is incorporated herein by reference in its entirety and for all purposes. The depicted example of an embodiment of a larger delivery / deployment system 100 includes a delivery system 200 having an introducer shaft 210 (which may also be referred to as a delivery sheath, but is not intended to be limiting) that is configured to deliver and guide the devices, systems, and components of the delivery / deployment system 100 to a treatment area. Thus, the introducer shaft (introducing shaft) 210 is a tubular, flexible, elongated member that defines an inner cavity therethrough, the size, shape, configuration, and / or dimensions of the inner cavity being designed to allow additional devices and / or systems to pass therethrough for delivery to a treatment site, such as a device and / or system delivered / deployed by the delivery and deployment system 1000. As described herein, a treatment area is an area on or within a patient's body where a treatment site is located. As described herein, a treatment site is an anatomical site at which a procedure is performed using a system and / or device delivered by the delivery / deployment system 100, the delivery and deployment system 1000. It should be understood that reference to "at" a treatment site is intended to include at or near (e.g., along, adjacent to, etc.) a treatment site, and is not limited to only the exact treatment site. The introducer shaft 210 can be steerable, such as unidirectionally or bidirectionally steerable at least within a steering plane, such as by manipulation using a control handle 220 operably associated therewith.

[0050] The delivery / deployment system 100 may include an additional steerable delivery system 300 having a steerable flexible elongated member 310 configured to provide further steering capability to the delivery / deployment system 100 to guide and direct the device and / or system closer to the desired treatment site, as described with reference to Figure 1The steerable flexible elongated member 310 can be tubular, defining an inner cavity therethrough, the size, shape, configuration and / or dimensions of the inner cavity being designed to allow another device and / or system to pass therethrough for delivery to a treatment site, such as a device and / or system delivered / deployed by the delivery and deployment system 1000, and is therefore referred to herein as a steerable "tubular" flexible elongated member to distinguish it from other flexible elongated members described herein. The steerable tubular flexible elongated member 310 can be steerable in one direction or in two directions at least within a steering plane, and steerable in four directions within two lateral steering planes, for example using a control handle 320 operably associated therewith. It should be understood that further details of examples of embodiments of the delivery system 200 and examples of embodiments of the steerable delivery system 300 are provided in co-pending provisional patent application __ / ___, ___ [Attorney Docket 2001.2787100], entitled Devices, Systems, And Methods For Steering A Catheter and filed on June 21, 2022. However, the present disclosure need not be limited to the examples of embodiments disclosed therein.

[0051] Optionally, the delivery / deployment system 100 includes an additional device delivery and deployment system 400 having a flexible, elongated member 410 that is delivered through the steerable, tubular, flexible, elongated member 310 and through the introducer shaft 210 to a deployment site. Although the additional device delivery and deployment system 400 may include a control handle 420 to control its operation, the steerable delivery system 300 (e.g., via the steerable, tubular, flexible, elongated member 310) may be used to steer a deployment system 430 mounted at a distal end 411 of the flexible, elongated member 410 to a desired position relative to the deployment site. In some embodiments, the deployment system 430 may be larger than the lumen of the steerable, tubular, flexible, elongated member 310 and thus may be delivered to the exterior and distal side of the steerable, tubular, flexible, elongated member 310, such as Figure 1It should be understood that further details of examples of embodiments of the delivery and deployment system 400 are provided in co-pending provisional patent application __ / ___, ___ [Attorney Docket 2001.2754100], entitled Devices, Systems, And Methods For Deploying An Implantable Device, filed on June 21, 2022. However, the present disclosure need not be limited to the examples of embodiments disclosed therein.

[0052] According to various principles of the present disclosure, the delivery and deployment system 1000 can deliver, manipulate and / or deploy an implant device (e.g., a tissue anchor) to an anatomical site. Figure 1 (which can be more easily seen in its detail view) and Figure 2 In the example of an embodiment of the delivery and deployment system depicted in , the delivery and deployment system 1000 includes a flexible elongated member 1100 that delivers an implant device delivery device 1200 that is configured to deliver an implant device 1300. In the depicted example of the embodiment, the implant device delivery device 1300 is a generally tubular anchor cartridge 1200 having an implant device 1300 in the form of a tissue anchor delivered therein. It should be understood that the implant device delivery device 1300 can be of other forms or configurations, and the present disclosure is not limited to anchor cartridges. However, the anchor cartridges are mentioned herein for convenience and are not intended to be limiting. The anchor cartridge 1200 can be mounted on the distal end 1101 of the flexible elongated member 1100 (which may alternatively be referred to as a cartridge shaft) and is optionally not positioned within the steerable tubular flexible elongated member 310. If the additional deployment system 430 is delivered with the assistance of the steerable tubular flexible elongated member 310 and is delivered externally and distally of the steerable tubular flexible elongated member 310 , the anchor cartridge 1200 may optionally be positioned externally and distally of such additional deployment system 430 .

[0053] The flexible elongated member 1100 of the delivery and deployment system 1000 can be delivered inside the introducer shaft (introducing shaft) 210 and the steerable tubular flexible elongated member 310 of the delivery / deployment system 100, with the anchor cartridge (anchor receiver) 1200 inside or outside the introducer shaft 210, as described above. The introducer shaft 210 delivers the anchor cartridge 1200 to the general treatment area, e.g. Figure 2The steerable tubular flexible elongated member 310 can further guide and direct the flexible elongated member 1100 of the delivery and deployment system 1000 to deliver the anchor cartridge 1200 to the deployment site where the anchor 1300 carried therein is to be deployed. For example, as shown in Figure 2 As depicted, steerable tubular flexible elongate member 310 is steerable to direct flexible elongate member 1100 toward the ventricular wall.

[0054] exist Figure 1 In the example of an embodiment of the delivery and deployment system 1000 depicted in , the delivery and deployment system control handle 1020 (operably associated with the flexible elongated member 1100) can be generally axially translated relative to the other control handles 220, 320, 420 to advance the flexible elongated member 1100 and the anchor cartridge 1200 relative to the steerable tubular flexible elongated member 310 and reach the deployment site. Additionally or alternatively, the delivery and deployment system control handle 1020 (operably associated with the flexible elongated member 1100) can be rotated relative to the other control handles 220, 320, 420 of the delivery / deployment system 100 to rotate the flexible elongated member 1100 and the anchor cartridge 1200 relative to the steerable tubular flexible elongated member 310 and reach the deployment site. For example, in Figure 1In the example of the embodiment depicted, the distal end 1021 of the delivery and deployment system control handle 1020 can be supported and / or mounted on a connecting tube 1110 (which, for convenience and without intent to be limiting, can be referred to as a cartridge telescoping shaft) to couple and axially translate (e.g., telescope) and / or rotate the delivery and deployment system control handle 1020 relative to the other control handles 220, 320, 420 of the delivery / deployment system 100 to axially translate (e.g., telescope) and / or rotate the flexible elongated member 1100 relative to the steerable tubular flexible elongated member 310 and the general treatment site. In some embodiments, the distal end 1021 of the deployment system control handle 1020 is fixed relative to the proximal end 1113 of the connecting tube 1110, and the connecting tube 1110 is capable of sliding and rotating relative to the control handle 420 proximal and distal to the deployment system control handle 1020. For example, the control handle 420 may include a sliding tube therein to telescopically receive the connecting tube 1110 (as shown and described in the co-pending provisional patent application __ / ___, ___ [Attorney Docket 2001.2754100] incorporated above and entitled Devices, Systems, And Methods For Deploying An Implantable Device and filed on June 21, 2022). Axial movement of the deployment 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 sliding tube therein).

[0055] Reference Figure 4 and Figure 5 (Provide as Figure 3 1420 ), an example of the manner in which the delivery and deployment control handle 1020 may be mounted relative to the proximal end 1113 of the connecting tube 1110 and / or the manner in which the flexible elongated member 1100 may be mounted relative to the delivery and deployment system control handle 1020 for movement therewith may be understood. In the depicted example of an embodiment, the proximal end 1113 of the connecting tube 1110 extends into the anchor cartridge hub 1130 within the steering control knob 1420 and terminates in a counterbore within the cartridge hub 1130, and optionally incorporates a counterbore within the cartridge hub 1130 (cartridge shaft coupling portion). Figure 5 The flexible elongated member 1100 extends proximally beyond the proximal end 1113 of the connecting tube 1110 and the proximal end 1103 of the flexible elongated member 1100 and terminates in a counterbore in the cartridge hub 1130, and is optionally coupled to the interior of the counterbore in the cartridge hub 1130 (e.g., Figure 51020 ), proximal to the counterbore therein at the proximal end 1113 of the connecting tube 1110. Optionally, a tubular spacer 1134 guides or supports (and optionally seals) the flexible elongated member 1100 inside the connecting tube 1110. With the connecting tube 1110 and the flexible elongated member 1100 coupled to the cartridge hub 1130, movement of the cartridge hub 1130 is imparted to the connecting tube 1110 and the flexible elongated member 1100. In turn, the cartridge hub 1130 is mounted within the delivery and deployment system control handle 1020 such that movement of the delivery and deployment system control handle 1020 is imparted to the connecting tube 1110 and the flexible elongated member 1100. For example, the cartridge hub 1130 and the delivery and deployment system control handle 1020 may include keying features that allow the delivery and deployment system control handle 1020 to move to the cartridge hub 1130 (and thus connect the tube 1110 and the flexible elongated member 1100), and the keying features may also mount the cartridge hub 1130 relative to the delivery and deployment system control handle 1020. Figure 4 In the example of the depicted embodiment, the keying feature includes wings 1132 that extend radially from the cartridge hub 1130 to engage a corresponding key or keyhole (not shown, but readily understood by one of ordinary skill in the art) within the delivery and deployment system control handle 1020. It should be understood that other configurations are within the scope and spirit of the present disclosure, the details of which are not critical to the present disclosure.

[0056] Once the desired position of the delivery and deployment system control handle 1020 has been reached, the delivery and deployment system control handle 1020 can be substantially fixed in the desired position by being fixed relative to the support 500 that supports the delivery and deployment system control handle 1020. Figure 1 In the example of the depicted embodiment, a wing screw 520 or the like may be provided to maintain the delivery and deployment system control handle 1020 in the proper position relative to the stent 500. Further details of the stent are provided and described in co-pending provisional patent application __ / __,__ [Attorney Docket 2001.2787100] entitled Devices, Systems, And Methods For Steering A Catheter and filed on June 21, 2022.

[0057] exist Figure 2In the example of the embodiment depicted, an example of an embodiment of the deployment system 430 is depicted in a position to deploy a second implant device relative to a treatment site. In some embodiments, the steerable tubular flexible elongated member 310 steers the flexible elongated member 410 to the treatment site, and the deployment system 430 can be axially translated distally from the steerable tubular flexible elongated member 310 to be deployed / deploy the second implant device. For example, in Figure 2 In the depicted example of an anatomical site in which a delivery and deployment system 1000 formed according to various principles of the present disclosure may be used, a deployment system 430 is deployed relative to a heart valve leaflet L. A flexible elongated member 1100 carrying an anchor cartridge 1200 is delivered through a lumen within the interior of the flexible elongated member 410. As shown in FIG. Figure 2 It is understood that once the deployment system 430 has deployed the implant device (e.g., leaflet clip 440) relative to a first anatomical site (e.g., a heart valve leaflet L), the steerable tubular flexible elongated member 310 is typically not further steered to navigate the flexible elongated member 1100 to a second, different anatomical site (e.g., a papillary muscle of the heart). Therefore, it is desirable for the flexible elongated member 1100 to have a steering capability independent of the steerable delivery system 300.

[0058] According to various principles of the present disclosure, the flexible elongated member 1100 may include a steering element that is operably associated (e.g., connected or engaged to operate the portion) with a portion of the wall of the flexible elongated member 1100 along the steerable region of the flexible elongated member 1100 (usually adjacent to its distal end 1101) to achieve the movement of the steerable region by pulling or otherwise manipulating the steering element. The steering element may be coupled to a portion of the wall of the flexible elongated member 1100, such as by adhering, bonding, welding, etc. to a portion of the wall of the flexible elongated member 1100 or within a portion of the wall of the flexible elongated member 1100 (e.g., embedded therein). Pulling the steering element proximally causes the distal region of the flexible elongated member 1100 (e.g., near the distal end 1101) to bend. It should be understood that any of the various steering elements known in the art may be used, and the present disclosure is not limited to a specific steering element configuration. The steering element may be a generally elongated flexible element that extends axially approximately along the longitudinal axis LA of the delivery and deployment system control handle 1020 and the flexible elongated member 1100. 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, elongated pulling element (e.g., a pull wire). Non-limiting examples of embodiments of the steering element are disclosed in U.S. Patent Application Publication 2023 / 0011214, entitled Radially Clocked Steerable Cathether and filed on January 12, 2023; and U.S. Provisional Patent Application __ / __, __[Agent File 2001.2757100], entitled Steerable Member And System And Methods Of Making And Using Same and filed on April 25, 2022, each of which is incorporated herein by reference in its entirety for all purposes. The steering element can be configured to steer the flexible elongated member 1100 in a single plane (e.g., unidirectional or bidirectional steering), wherein rotation of the delivery and deployment system control handle 1020 (e.g., as described above) allows steering of the flexible elongated member 1100 in different planes. It should be appreciated that because the delivery and deployment system control handle 1020 can be rotatable (e.g., as a unit, including the flexible elongated member 1100), bidirectional or even unidirectional steering of the steering element can be sufficient.

[0059] exist Figure 1 As shown and in Figure 3 , Figure 4 and Figure 5In an example of an embodiment of a delivery and deployment system control handle 1020 depicted in more detail in FIG, the steering system 1400 is provided with a steering control knob 1420 that is operably coupled to the flexible elongated member 1100 to control the steering of the flexible elongated member 1100. For example, the steering element 1410 can extend proximally from the flexible elongated member 1100 to operably engage with the steering control knob 1420. Figure 5 In the example of the embodiment depicted, the steering element 1410 extends proximally from the flexible elongated member 1100 through a gasket 1136 that forms a seal between the interior of the anchor cartridge hub 1130 and the interior of the delivery and deployment system control handle 1020. In some embodiments, the gasket 1136 has an elongated shape, such as a teardrop shape, to seal around the steering element 1410 and around the stylet 1510, which extends proximally out of the proximal end 1103 of the flexible elongated member 1100 (which is operably coupled to the implant device 1300 at its distal end, as described in further detail below). The cap 1138 can close the proximal end 1133 of the anchor cartridge hub 1130 in which the gasket 1136 is located, and the steering element 1410 and the stylet 1510 extend proximally therethrough. The proximal end of the steering element 1410 can then extend to and be fixed to the axially translatable member 1430, such as by bonding, interference fit, fixed post, fixed screw, etc. Rotation of the steering control knob 1420 about the longitudinal axis LA of the delivery and deployment system control handle 1020 causes the axially translatable member 1430 to translate axially approximately along the longitudinal axis LA to pull the steering element 1410, thereby pulling the distal region of the flexible elongated member 1100 proximally, thereby steering the flexible elongated member 1100, such as in the manner described above. Rotation in the opposite direction releases the tension on the distal region of the flexible elongated member 1100 (e.g., to allow the distal region of the flexible elongated member 1100 to return to an initial, neutral, straight, unactuated, etc. configuration). The steering control knob 1420 may have a gripping surface, such as textured, knurled, coated or otherwise, that is configured to facilitate a non-slip grip thereof to rotate the steering control knob 1420, such as in a manner known to those of ordinary skill in the art. Figure 4 and by Figure 5 Provided along Figure 3 From the cross-sectional view of line VV, it can be understood Figure 1 and Figure 3 Further details of an example of an implementation of the steering control system 1400 are depicted in FIG. 1400. It should be noted that Figure 4 Describes Figure 31020, but with a portion of its housing 1022 removed. For example, in some embodiments, the delivery and deployment system control handle housing 1022 can be formed of separable first and second housing halves 1022a, 1022b to mount components of the delivery and deployment system control handle 1020 therein.

[0060] According to various principles of the present disclosure, Figure 1 , Figure 3 , Figure 4 and Figure 5 In the depicted example of an embodiment of the steering control system 1400, the steering control knob 1420 is rotatable about the longitudinal axis LA of the delivery and deployment system control handle 1020. Such rotation allows the flexible elongated member 1100 to be steered in a steering plane that is considered intuitive, which can generally correspond to the direction in which the steering control knob 1420 is rotated. However, as described above, the steering element generally extends longitudinally along the longitudinal axis LA of the delivery and deployment system control handle 1020 and the flexible elongated member 1100. Thus, rotational movement of the steering control knob 1420 causes axial or longitudinal movement of the axially translatable member 1430 to pull the steering element to bend the flexible elongated member 1100 in the direction in which the steering element is operably engaged therewith. In some embodiments, retraction of the flexible, elongated member 1100 into the flexible, elongated member 410 and / or the additional deployment system 430 can help return the flexible, elongated member 1100 to its position prior to actuation by the axially translatable component 1430, such as an initial, neutral, straight, unactuated, etc. position.

[0061] According to various principles of the present disclosure, as shown in FIG. Figure 4 and Figure 5 As can be appreciated, the steering control knob 1420 includes an internal engagement element 1422 that is operably engaged with an external engagement element 1432 on the axially translatable component 1430 to convert the rotational movement of the steering control knob 1420 into axial movement of the axially translatable component 1430, thereby pulling 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 or a sliding 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 with external threaded components (e.g., at least two or at least three) on the axially translatable component 1430. As can be easily appreciated, the steering control knob 1420 is rotatable in the steering direction SD (which can be indicated on the delivery and deployment system control handle 1020 together with a mark indicating the steering / bending of the flexible slender member 1100, such as, for example Figure 31020) causes axial translation of the axially translatable member 1430 in the proximal direction (i.e., toward the proximal end 1023 of the delivery and deployment system control handle 1020) to bend the distal region (adjacent the distal end 1101) of the flexible elongated member 1100. In some embodiments, the flexible elongated member 1100 bends generally in a direction corresponding to the direction in which the steering control knob 1420 is turned, for example, as can be seen in FIG. Figure 1 understand.

[0062] Once the delivery and deployment system 1000 delivers the flexible elongated member 1100 to the treatment site (e.g., using the steering control system 1400), the implant device 1300 can be deployed. Figure 1-5 In the example of the embodiment shown, implant device 1300 is delivered to a treatment site, such as described above, within anchor cartridge 1200 at distal end 1101 of flexible elongate member 1100. Once anchor cartridge 1200 is at the treatment site, implant device 1300 may be deployed therefrom.

[0063] Figure 1-5 An example of an embodiment of the delivery and deployment system 1000 depicted in the drawings includes an implant device deployment system 1500 (referred to herein as anchor deployment system 1500, for convenience and without limitation) configured to deploy an implant device 1300 from an implant device delivery device 1200. In the depicted example of the embodiment, the anchor deployment system 1500 includes a stylet 1510 (in the drawings) operably coupled to the implant device 1300 to deliver and deploy the implant device 1300. Figure 2 For example, the implant device 1300 can be coupled to the distal end 1511 of the stylet 1510, as shown in phantom. Figure 7 and Fig. 8A -8D. Figure 2 In the example of the depicted embodiment, implant device 1300 is shown as a tissue anchor, and thus implant device 1300 or anchor 1300 may be referred to interchangeably herein without limitation. Figure 2 As can be appreciated, anchor 1300 is delivered in anchor cartridge 1200 in a delivery configuration in which flukes 1320 are extended distally and thus anchor 1300 is in a relatively compact configuration. When deployed distally out of anchor cartridge 1200, anchor 1300 transitions to an expanded deployment configuration, such as Figure 6 , Figure 7 and Fig. 8A-8D. In the depicted example of an embodiment of anchor 1300, in the deployed configuration, flukes 1320 are curled proximally (e.g., toward proximal end 1303 of anchor 1300) into an expanded configuration, optionally an arched configuration (bent configuration). Flukes 1320 may be formed of a shape memory material (e.g., nitinol) to transition from the delivery configuration to the deployed configuration upon exiting anchor cartridge 1200 without the need for further force to be applied thereto. Thus, as anchor 1300 is advanced out of anchor cartridge 1200, it is important that distal ends 1321 of flukes 1320 pierce the tissue into which anchor 1300 is to be engaged, such that flukes 1320 are stretched into the deployed configuration within the tissue (and not while extended out of anchor cartridge 1200 and prior to being advanced into the tissue). Distal ends 1321 may be shaped (e.g., sharp, pointed, etc.) to facilitate piercing and penetration into the tissue.

[0064] According to various principles of the present disclosure, anchor deployment system 1500 is configured to control the deployment of anchor 1300. Figure 1 , Figure 3 , Figure 4 and Figure 5 In the example of the depicted embodiment, actuation of the anchor deployment system 1500 causes the anchor 1300 to translate axially relative to the anchor magazine 1200, to advance the anchor 1300 relative to the anchor magazine 1200 (e.g., to deploy the anchor 1300), and / or to retract the anchor 1300 relative to the anchor magazine 1200 (e.g., to withdraw into the interior of the anchor magazine 1200). Advancing the anchor 1300 out of the anchor magazine 1200 deploys the anchor 1300, for example, into tissue. If desired, the anchor 1300 can be recaptured within the anchor magazine 1200 by retracting the anchor 1300 (such as using the anchor deployment system 1500), typically prior to deployment.

[0065] Figure 1 , Figure 3 , Figure 4 and Figure 5 The depicted example of an embodiment of the anchor deployment system 1500 includes an anchor control slider (slider) 1520 operable to advance or retract (e.g., axially translate) the stylet 1510 relative to the delivery and deployment system control handle 1020, the flexible elongated member 1100, and the anchor cartridge 1200 to advance or retract the anchor 1300 relative to the anchor cartridge 1200. More specifically, as Figure 4 and Figure 5As depicted, the stylet 1510 of the depicted example of an embodiment of the anchor deployment system 1500 extends proximally from within the flexible elongated member 1100 to be mounted (e.g., fixedly, such as with a mating engagement, adhesive, bonding, etc.) within a stylet hub 1530. As described above, a gasket 1136 may be disposed within the proximal end 1133 of the cartridge hub 1130 to seal (prevent) any fluid from within the flexible elongated member 1100 from extending proximally to the interior of the delivery and deployment system control handle 1020 by forming a seal around the stylet 1510 and between the interior of the cartridge hub 1130 (including the counterbore in which the proximal end 1103 of the flexible elongated member 1100 is located) and the interior of the delivery and deployment system control handle 1020. The stylet hub (coupling) 1530 is configured to operably engage with a carriage (sled) 1540, which is operably coupled to the anchor control slide 1520 for axial translation therewith. For example, the stylet hub 1530 and the bracket 1540 can include one or more (e.g., two or more or three or more, etc.) protrusions 1532 and one or more (e.g., two or more or three or more, etc.) corresponding recesses 1542 that are matingly engaged. It should be understood that although the protrusions 1532 are shown on the stylet hub 1530 and the recesses 1542 are depicted on the bracket 1540, the opposite arrangement is also within the scope and spirit of the present disclosure. As discussed in further detail below, the stylet hub 1530 and the bracket 1540 are preferably rotatably engaged relative to each other to allow the stylet 1510 to rotate relative to the delivery and deployment system control handle housing 1022. The bracket 1540 is matingly engaged with an anchor control slider base 1524 having a protrusion 1526 extending through a slot 1026 in the delivery and deployment system control handle housing 1022 (see, e.g., Figure 3), and the slider button 1522 is mounted on the protrusion 1526. For example, the anchor control slider base 1524 can include legs 1525a, 1525b extending on either side of the bracket 1540, so that 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 deployment system control handle 1020 is transmitted to the bracket 1540. It should be understood that the reverse arrangement of the bracket 1540 having legs on either side 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 to slide the anchor control slider base 1524 relative to the delivery and deployment system control handle 1020, thereby sliding the bracket 1540 and the stylet hub 1530 relative to the delivery and deployment system control handle 1020 to extend or retract the anchor 1300 from the anchor magazine 1200 into the anchor magazine 1200. Optionally, the slider button 1522 has a gripping surface (e.g., textured, coated, grooved, or otherwise promotes non-slip engagement thereof) to facilitate user engagement of the slider button 1522, thereby enhancing grip / reducing slippage of the user's fingers relative to the slider button 1522.

[0066] As described above, distal translation of the slider button 1522 relative to the delivery and deployment system control handle housing 1022 can deploy the anchor 1300 from the anchor magazine 1200. Generally, it is desirable to prevent the anchor 1300 from being prematurely extended from the anchor magazine 1200, particularly if the anchor 1300 is transformed into a deployed configuration upon exiting the anchor magazine 1200, even before contacting the desired deployment site. In accordance with various principles of the present disclosure, the anchor control slider 1520 can be locked in one or more positions relative to the delivery and deployment system control handle housing 1022. For example, as described in reference Figure 3 and Figure 4It will be appreciated that the anchor control slider base 1524 may include a boss 1528 that may engage with a recess 1028 in the delivery and deployment system control handle housing 1022. It will be appreciated that other configurations and structures are also within the scope and spirit of the present disclosure. The slider button 1522 may be locked relative to the delivery and deployment system control handle 1020 to prevent accidental advancement of the anchor 1300 from the anchor magazine 1200, which may result in accidental deployment of the anchor 1300. In some embodiments, the slider button 1522 is biased relative to the bracket 1540 to lock the boss 1528 thereon into a corresponding recess 1028 in the delivery and deployment system control handle housing 1022. For example, a biasing element (such as a coil spring) may be provided between the slider button 1522 and the bracket 1540. Pressing the slider button 1522 toward the bracket 1540 and against the biasing force of the biasing element releases the boss 1528 from the notch 1028 to allow the anchor control slider 1520 to be selectively moved to translate the stylet 1510 and, therefore, the anchor 1300 as desired. As described above, as the flexible elongated member 1100 is navigated through a passage in a patient's body, a compressive force may act on the flexible elongated member 1100. To counteract such forces, which may cause the anchor cartridge 1200 to retract relative to the anchor 1300 therein and inadvertently deploy the anchor 1300 prematurely, tension may be applied to the stylet 1510 to retain the anchor 1300 within the anchor cartridge 1200. For example, as the flexible elongate member 1100 and stylet 1510 are distally advanced transluminally through the patient's body, the anchor control slider 1520 may be progressively retracted as needed to apply tension to the stylet 1510 to maintain the anchor 1300 retracted within the anchor cartridge 1200 .

[0067] exist Figure 2 In the depicted example of an anatomical site to which the flexible elongated member 1100 may be navigated, the delivery and deployment system 1000 delivers an implant device 1300 in the form of a tissue anchor 1300 to cardiac tissue to be implanted therein. As mentioned above, the delivery / deployment system 100 may deliver, manipulate, and / or deploy cardiac repair devices and / or systems, such as heart valve leaflet repair devices and / or systems. For example, as described above, the delivery / deployment system 100 may include an additional delivery and deployment system 400 that may deliver a deployment system 430 to a deployment site to deploy an additional implant device 440. In Figure 2 and Figure 6In the example of the depicted embodiment, the deployment system 430 is a leaflet clip deployer configured to deploy an additional implant device 440 in the form of a leaflet clip. Thus, the deployment system 430 may alternatively be referred to herein as a leaflet clip deployer 430, and the additional implant device 440 may alternatively be referred to herein as a leaflet clip 440, without limitation. The leaflet clip 440 and the anchor 1300 may be used in conjunction with one another to implant a tether element 450, such as a suture or artificial chord 450 (such elements are referred to interchangeably herein without limitation), such as a tether element 450, relative to the heart valve leaflet L and the ventricle V. Figure 6 , to repair the function of the heart valve leaflets L. The leaflet clip 440 can be deployed on the heart valve leaflets L by the leaflet clip deployer 430 , wherein the artificial chord 450 is coupled thereto and extends to the anchor 1300 in the anchor cartridge 1200 .

[0068] As can be appreciated, it may be desirable to adjust the tension on the synthetic chord 450. According to various principles of the present disclosure, the synthetic chord 450 is movably coupled relative to the anchor 1300. For example, in Figure 2 and Figure 6 and in more detail in Figure 7 , Fig. 8A , Figure 8B , Figure 8C In the example of the embodiment depicted in FIG. 8D , the artificial chord 450 can be movably extended through the anchor housing 1330 of the anchor 1300 (the fluke 1320 extends distally from the anchor housing). In particular, the artificial chord 450 can extend through the lumen 1517 of the stylet 1510 and operably engage with the anchor 1300. However, other entry points for the artificial chord 450 are within the scope and spirit of the present disclosure. The amount of tension on the artificial chord 450 extending between the leaflet clip 440 and the anchor 1300 and / or its length can be adjusted by pulling or releasing the artificial chord 450 relative to the anchor 1300. For example, the artificial chord 450 can extend through the proximal end 1023 of the delivery and deployment system control handle 1020 and can be manually manipulated by a medical professional operating the delivery and deployment system 1000, such as by directly manipulating the artificial chord 450 by hand (e.g., grasping and pulling the artificial chord 450). However, it should be understood that such adjustments may be considered gross adjustments, and fine adjustments are typically required to achieve proper heart valve leaflet function by implanting the leaflet clip 440 , anchor 1300 , and artificial chords 450 .

[0069] According to various principles of the present disclosure, Figure 1 , Figure 3 , Figure 4 and Figure 5The example of an embodiment of the delivery and deployment system control handle 1020 depicted in the drawings includes a tether adjustment system 1600 that is configured to engage and adjust the tension on the tether element and / or the length of the tether element. The depicted example of an embodiment of the tether adjustment system 1600 (interchangeably referred to herein as the suture adjustment system 1600) includes a suture tail lock 1610 and a suture fine adjustment knob 1620 that is mounted adjacent to / along the proximal end 1023 of the delivery and deployment system control handle 1020 for general and fine control of the length / tension on the tether element 450 (also referred to herein as the suture 450). As may be referenced Figure 5 As further understood, the suture tail lock 1610 includes a suture locking knob 1612 and a suture locking cam 1614. The suture 450 extends axially through the suture locking cam 1614, and the suture locking cam 1614 is capable of shifting relative to another element (such as a suture tensioning lead screw 1630) between a position in which the suture 450 is free to move through the suture locking cam 1614 and a position in which the suture 450 is locked to prevent movement. More specifically, the suture locking cam 1614 is movable to clamp or wedge the suture 450 between the suture locking cam 1614 and the suture tensioning lead screw 1630 on which the suture locking cam 1614 is mounted. As Figure 4 In the example depicted in the detailed view of FIG, the suture locking knob 1612 has a cam surface 1615 that engages the suture locking cam 1614 so that when the suture locking knob 1612 is rotated about the longitudinal axis LA of the delivery and deployment system control handle 1020, the suture locking cam 1614 is displaced transverse to the longitudinal axis LA into and out of a position that locks the suture 450 in place relative to the suture tensioning lead screw 1630. A medical professional can adjust the tension and / or length of the artificial chord 450 between the leaflet clip 440 and the anchor 1300 with the suture locking knob 1612 in the unlocked position, for example, by using appropriate imaging techniques to observe the effect of tension on the heart valve being repaired (e.g., observing blood flow therethrough, where appropriate tension on the heart valve eliminates any regurgitation therethrough). Once desired heart valve function is observed and confirmed, for example, once regurgitant blood flow has been eliminated or at least sufficiently reduced, the suture locking knob 1612 can be rotated to shift the suture locking cam 1614 to a locked position, thereby locking the suture adjustment system 1600 and setting the tension on the artificial chord 450 / the length of the artificial chord 450.

[0070] Once the approximate tension / length of the artificial chord 450 has been adjusted, fine adjustments may still be medically indicated to fine tune heart valve function. According to various additional principles of the present disclosure, the suture adjustment system 1600 also includes a suture fine adjustment knob 1620, which can then be actuated to further adjust the tension / length of the artificial chord 450 in finer / smaller increments than is achieved when the tension / length is simply adjusted manually by a medical professional grasping the artificial chord 450 by hand. Figure 1 , Figure 3 , Figure 4 and Figure 5 An example of an embodiment of the suture fine-tuning knob 1620 depicted in the drawings is rotatable about the longitudinal axis LA of the delivery and deployment system control handle 1020 to axially advance or retract the suture tensioning lead screw 1630. With the artificial chord 450 substantially fixed in a locked position relative to the suture tensioning lead screw 1630 by the suture locking cam 1614, axial translation of the suture tensioning lead screw 1630 results in corresponding axial translation of the artificial chord 450 to adjust the tension / length of the artificial chord 450. Movement of the suture fine-tuning knob 1620 can be translated into movement of the suture tensioning lead screw 1630 in any of a variety of ways. Figure 4 and Figure 5 In the example of the embodiment depicted, the rotational movement of the suture fine adjustment knob 1620 can cause the axial translation of the suture tensioning lead screw 1630 in a manner similar to that described with respect to the steering control knob 1420 and the axially translatable component 1430. For example, the suture fine adjustment knob 1620 can include an internal engagement element 1622 that operably engages an external engagement element 1632 on the suture tensioning lead screw 1630 to convert the rotational movement of the suture fine adjustment knob 1620 into an axial movement of the suture tensioning lead screw 1630, thereby pulling the steering element. In some embodiments, the engagement elements 1622, 1632 are threads or components thereof. For example, the suture tensioning lead screw 1630 can be a rack gear or a sliding screw (e.g., a partial screw) having an external thread component (e.g., at least two or at least three) that is operably engaged with an internal thread (e.g., at least two or at least three) provided on the suture fine adjustment knob 1620. As can be readily appreciated, rotation of the suture fine adjustment knob 1620 causes axial translation of the suture tensioning lead screw 1630 to adjust the tension / length of the synthetic chord 450 .

[0071] Once the desired tension and / or length of the synthetic chord 450 is achieved using the suture fine adjustment knob 1620, it may be desirable to lock the synthetic chord 450 to prevent further adjustment relative to the anchor 1300. Figure 7In the example of the embodiment of the anchor 1300 depicted, a tensioning and locking device 1340 can be disposed within the anchor housing 1330 to lock the synthetic chord 450 relative to the anchor housing 1330. According to various principles of the present disclosure, the stylet 1510 is operably engaged with the tensioning and locking device 1340 to move the tensioning and locking device 1340 relative to the anchor housing 1330, such as between a tension adjustment configuration in which the synthetic chord 450 is adjustable, such as between a tension setting configuration. Fig. 8A As depicted in FIG. 1 , in the tension setting configuration, the tension of the artificial tendon 450 and / or its length is set / fixed / locked (such terms are used interchangeably herein and are not intended to be limiting), such as Figure 8B Once the tension on the artificial chord 450 / the length of the artificial chord 450 is set, the stylet 1510 can be detached from the anchor 1300, as shown in FIG. Figure 8C shown.

[0072] More specifically, Figure 1 , Figure 3 , Figure 4 , Figure 5 , Fig. 9A , Fig. 9B and Fig. 9C The example of an embodiment of the delivery and deployment system 1000 depicted in FIG. 1 includes a tensioning and locking system 1700 having a tensioning and locking knob 1720 operably engaged with the stylet 1510, such as with the stylet hub 1530, to actuate the stylet 1510. In the depicted example of the embodiment, the tensioning and locking knob 1720 is positioned within the delivery and deployment system control handle housing 1022 to be rotatable about the longitudinal axis LA of the delivery and deployment system control handle 1020. The outer surface of the tensioning and locking knob 1720 is accessible through a window 1070 in the delivery and deployment system control handle housing 1022 and may have a gripping surface (e.g., textured, knurled, coated, or otherwise) configured to facilitate a non-slip grip thereof to rotate the steering control knob 1420, such as in a manner known to one of ordinary skill in the art. The stylet 1510 can be operably engaged with the tensioning and locking knob 1720 to rotate therewith about the longitudinal axis LA of the delivery and deployment system control handle 1020, but remain free to translate axially along the longitudinal axis LA relative to the tensioning and locking knob 1720. Fig. 9A , Fig. 9B and Fig. 9CIn the example of the depicted embodiment, the exterior of the stylet hub 1530 includes one or more flat surfaces 1534 (planar surfaces) that engage corresponding flat surfaces within the tensioning and locking knob 1720. As such, rotation of the tensioning and locking knob 1720 imparts rotational motion to the stylet hub 1530 and the stylet 1510. However, the stylet hub 1530 remains free to move axially relative to the tensioning and locking knob 1720, such as to advance or retract (e.g., as described above, using the anchor control slider 1520, or to adjust the tensioning and locking device 1340, as described below).

[0073] Adjustment of the tensioning and locking knob 1720 actuates the stylet 1510 to shift the tensioning and locking device 1340 between the tension adjustment configuration and the tension setting configuration, and optionally also disengages the stylet 1510 from the anchor 1300 (to deploy the anchor 1300). Figure 7 , Fig. 8A , Figure 8B and Figure 8C In the example of an embodiment of the tensioning and locking device 1340 shown, the stylet 1510 is operably coupled to the tensioning and locking device bracket 1342 via the coupling 1344 so that the tensioning and locking device bracket 1342 is in the tension adjustment configuration ( Fig. 8A ) and tension setting configuration ( Figure 8B ) between the anchor housing 1330 and the tensioning and locking device bracket 1342. For example, the stylet 1510 can be operably engaged with the coupler 1344 to impart rotational motion 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 rotation thereof also causes axial translation thereof relative to the anchor housing 1330. The coupler 1344 can be operably coupled relative to the tensioning and locking device bracket 1342 for rotation relative thereto such that rotation of the coupler 1344 (such as caused by rotation of the stylet 1510) does not cause rotation of the tensioning and locking device bracket 1342, but axial translation of the coupler 1344 does cause axial translation of the tensioning and locking device bracket 1342. As such, rotation of the tensioning and locking 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 tensioning and locking device bracket 1342 relative to the anchor housing 1330 .

[0074] exist Figure 7 , Fig. 8A , Figure 8B ,and Figure 8CIn the example of the embodiment depicted, the synthetic chord 450 generally extends from a proximal direction (e.g., from the delivery and deployment system control handle 1020) through or along the stylet 1510, generally axially through the proximal end 1343 of the tensioning and locking device bracket 1342 and laterally out of the tensioning and locking device bracket 1342 and the anchor housing 1330 (e.g., through a window 1337 in the anchor housing 1330). The synthetic chord 450 can then be extended to another implant device, such as a leaflet clip 440, such as Figure 6 In the tension-adjusting configuration, for example Fig. 8A As depicted in FIG. 1 , the synthetic chord 450 is freely movable relative to the tensioning and locking device bracket 1342. In this configuration, the tension on the synthetic chord and / or the length of the synthetic chord 450 can be adjusted in any of the ways described above. Rotation of the tensioning and locking knob 1720 proximally advances the tensioning and locking device bracket 1342 relative to the anchor housing 1330 to the anchor housing 1330. Figure 8B In the depicted tension setting configuration, the synthetic chord 450 is locked to prevent movement by being caught or held in place (e.g., clamped) between the tensioning and locking device bracket 1342 and the interior 1330 of the anchor shell. Further rotation of the tensioning and locking knob 1720 decouples the probe 1510 from the coupler 1344, as shown in FIG. Figure 8C , to deploy the anchor 1300. Any of a variety of tensioning and locking devices may be used in conjunction with the delivery and deployment system 1000 of the present disclosure, such as, but not limited to, any tensioning and locking device or system described in U.S. Patent Application Publication US2022 / 0096235, entitled Devices, Systems, And Methods For Adjustably Tensioning Artificial Chordae Tendineae In A Heart, published on March 31, 2022, the entire contents of which are incorporated herein by reference in their entirety for all purposes. It should be understood that the present disclosure need not be limited by the structure, form, function, etc. of the tensioning and locking device 1340 depicted and described in such patents or herein.

[0075] According to various principles of the present disclosure, the tensioning and locking system 1700 includes an anchor status indicator 1730 operably associated with the tensioning and locking knob 1720 to indicate the state or configuration of the tensioning and locking device 1340 of the anchor 1300. For example, Fig. 9A , Fig. 9B and Fig. 9CAs depicted, the anchor status indicator 1730 may include an anchor status dial 1732 having markings 1732A, 1732B, and 1732C indicating the configuration or operational state of the tensioning and locking device 1340. The markings 1732A, 1732B, and 1732C may be visible through a window 1070 in the delivery and deployment system control handle housing 1022, such as Figure 3 More specifically, when the tensioning and locking device 1340 is in a position such as Fig. 8A When in the tension adjustment configuration depicted in FIG. 1 , the anchor state dial 1732 may be positioned with a corresponding “unlocked” marking 1732A, such as Fig. 9A As depicted in FIG. 10, which can be seen through window 1070. When the tensioning and locking device 1340 is in the tensioning setting configuration (eg, Figure 8B ), the anchored state dial 1732 may be positioned with a corresponding “locked” mark 1732B (as depicted in FIG. Fig. 9B ), which is visible through window 1070. Finally, when stylet 1510 has been decoupled from anchor 1300 (as depicted in FIG. Figure 8C ), the anchored state dial 1732 may be positioned with a corresponding “detached” or “disengaged” marking 1732C (as shown in FIG. Fig. 9C 1070 ), which can be seen through window 1070 .

[0076] The tension and lock knob 1720 can be operably coupled to the anchor status dial 1732 in any of a variety of ways known to those of ordinary skill in the art. Fig. 9A -C, rotation of the tension and lock knob 1720 can be transmitted to rotation of the anchor state dial 1732 via the gear coupling 1740. More specifically, the depicted example of an embodiment of the gear coupling 1740 includes an actuator spur gear 1734 that is engageable by an actuator finger 1724 extending axially and proximally from the tension and lock knob 1720. The tension and lock knob 1720 can be rotated in a tensioning direction TD (which can be indicated on the delivery and deployment system control handle 1020, such as, for example Figure 31720) to transition the tensioning and locking device 1340 from the tension adjustment configuration to the tension setting configuration. At each full rotation (360 degrees) of the tensioning and locking knob 1720, the actuator finger 1724 causes an incremental rotation of the actuator spur gear 1734. The actuator spur gear 1734, in turn, causes an incremental rotation of the dial spur gear 1736 that rotates with the anchoring state dial 1732. The gear ratios of the spur gears 1734 and 1736 can be selected based on the diameter of the anchoring state dial 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 bracket 1342 and / or the coupling 1344, etc., to correlate the configuration of the tensioning and locking device 1340 with the anchoring state dial 1732, as will be appreciated by one of ordinary skill in the art.

[0077] As will be appreciated by those of ordinary skill in the art, the delivery and deployment system 1000 and the delivery and deployment system control handle 1020 as described herein have a variety of structures, uses, and functions, which may be separate and independent from one another, and / or may operate in conjunction with one another. The delivery and deployment system control handle 1020 described herein may be used in conjunction with the delivery system 200 and / or the steerable delivery system 300 and / or the additional device delivery and deployment system 400 of the delivery / deployment system 100, such as described above. For example, in some embodiments, using the delivery system 200, the steerable delivery system 300, and the additional device delivery and deployment system 400, the implant device and the additional implant device may be delivered to the heart valve to perform a cardiac repair procedure, such as described above. The cardiac repair procedure may be a cardiac valve repair procedure in which the leaflet clip 440 is coupled to the heart valve via an artificial chord 450 coupled thereto. In such an embodiment, the additional device delivery and deployment system 400 can be delivered and steered into position to deliver and deploy the leaflet clip 440, such as by clamping the leaflet clip 440 onto the heart valve leaflets L. The steering control system 1400 (e.g., as described above) can then be operated to steer the anchor cartridge 1200 into position (e.g., relative to the papillary muscles) to anchor the artificial chord 450 to the ventricle V. The anchor deployment system 1500 can then be used to advance the anchor 1300 into the heart tissue to anchor the artificial chord 450 relative to the ventricle V. Optionally, the leaflet clip 440 is deployed and the deployment system 430 is withdrawn from the ventricle so that the correct placement of the leaflet clip 440 and anchor 1300 can be confirmed, and the tension / length on the artificial chord 450 can be adjusted to promote correct function of the heart valve leaflets L and the heart valve. The tension on the artificial chord 450 / length of the artificial chord 450 can be adjusted using the suture adjustment system 1600 as described above. Once healthy function of the heart valve leaflets L has been achieved, the tensioning and locking system 1700 can be used, e.g., as described above, to set / lock the tension / length on the artificial chords 450. The stylet 1510 coupled to the anchor 1300 to aid in delivery and deployment of the anchor 1300 can then be decoupled from the anchor 1300 and withdrawn from the heart. At this point, the remaining artificial chords 450 extending proximally from the artificial chords 450 to the medical professional (e.g., for adjustment) can be cut at an appropriate location proximal to the anchor 1300 so that excess loose artificial chords 450 do not hang within the heart.

[0078] Although embodiments of the present disclosure may be described with specific reference to implants for mitral valves, it should be understood that various other implants may similarly benefit from the structures and manufacturing methods disclosed herein. In view of the above, it should be understood that the various embodiments depicted in the accompanying drawings have several separate and independent features and methods of use, each of which has unique benefits at least individually, which are desirable but not critical to the devices, systems and methods currently disclosed. Therefore, in order to achieve at least some of the desired characteristics and / or benefits described herein, the various individual features, devices, systems, methods, etc. described herein do not need to be present in their entirety. According to various principles of the present disclosure, only one of the various features, devices, systems, methods, etc. may be present. Alternatively, one or more of the features, devices, systems, methods, etc. may be used in various combinations with each other. In addition to those discussed above, a person of ordinary skill in the art may understand various additional benefits of various aspects, features, components and structures of devices, systems, methods, etc. (such as those described above).

[0079] The foregoing discussion has wide applicability and has been proposed for the purpose of illustration and description, and is not intended to limit the present disclosure to one or more forms disclosed herein. It should be understood that, without departing from the concept, spirit and scope of the present disclosure, various additions, modifications and substitutions can be made to the embodiments disclosed herein. In particular, it will be clear to those skilled in the art that, without departing from its concept, spirit or scope or feature, the principles of the present disclosure can be implemented in other forms, structures, arrangements, proportions and using other elements, materials and components. For example, for the purpose of simplifying the present disclosure, various features of the present disclosure are combined together in one or more aspects, embodiments or configurations or configurations. However, it should be understood that various features of certain aspects, embodiments or configurations or configurations of the present disclosure can be combined in alternative aspects, embodiments or configurations or configurations. Although the present disclosure is presented according to embodiments, it should be understood that the various individual features of the present subject do not need to exist in full, so as to achieve at least some desired characteristics and / or benefits of the present subject or such individual features. Those skilled in the art will appreciate that, without departing from the principles or spirit or scope of the present disclosure, the present disclosure can be used with many modifications or changes in the structure, arrangement, ratio, material, components, etc. used in the practice of the present disclosure, which are particularly suitable for specific environments and operational requirements. For example, an element shown as being formed in one piece can be composed of multiple parts, or an element shown as multiple parts can be formed in one piece, the operation of the element can be reversed or otherwise changed, and the size or size of the element can be changed. Similarly, although operations or actions or processes are described in a particular order, this should not be understood as requiring such a particular order, or that all operations or actions or processes must be performed to achieve the desired result. In addition, other embodiments are within the scope of the appended claims. In some cases, the actions recorded in the claims can be performed in different orders and still achieve the desired results. Therefore, the embodiments currently disclosed are considered to be illustrative and non-restrictive in all respects, and the scope of the subject matter claimed for protection is indicated by the appended claims, and is not limited to the foregoing description or the specific embodiments or arrangements described or shown herein. In view of the foregoing, various features of any embodiment may be used and claimed individually or in combination with features of that or any other embodiment, the scope of the subject matter being indicated by the appended claims, and not limited to the foregoing description.

[0080] In the foregoing description and the appended claims, the following will be understood. As used herein, the phrases "at least one", "one or more" and "and / or" are open expressions that are both conjunctions and disjunctions in operation. The terms "a", "said", "first", "second", etc. or the situation where no quantifier is used do not exclude multiple. For example, as used herein, the term "a" entity refers to one or more of the entity. Therefore, the terms "a", "one or more" and "at least one" can be used interchangeably in this article. As used in this specification and the appended claims, the term "or" is usually used in its sense including "and / or", unless the content clearly stipulates otherwise. As used herein, unless the context clearly indicates otherwise, the conjunction "and", "and" includes each of the structures, components, features, etc. so combined, and the conjunction "or" includes one or other of the structures, components, features, etc. so continuous individually and in any combination and quantity, unless the context clearly indicates otherwise. All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, and / or the like) are used only for identification purposes to help the reader understand the present disclosure, and / or to distinguish the regions of the associated elements from each other, and do not limit the associated elements, particularly the position, orientation, or use of the present disclosure. Unless otherwise indicated, connection references (e.g., attachment, connection, connection, engagement, and combination) will be interpreted broadly and may include intermediate members between sets of elements and relative movement between elements. Therefore, connection references do not necessarily imply that two elements are directly connected and are in a fixed relationship to each other. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to mean importance or priority, but are used to distinguish one feature from another.

[0081] The following claims are hereby incorporated by reference into the detailed description of the present invention, wherein each claim independently serves as a separate embodiment of the present disclosure. In the claims, the terms "comprise" and "comprising" do not exclude the presence of other elements, components, features, groups, regions, integers, steps, operations, etc. In addition, although individual features may be included in different claims, these features may be advantageously combined, and inclusion in different claims does not mean that the combination of features is not feasible and / or advantageous. In addition, singular references do not exclude a plurality. The figure numerals in the claims are provided only as illustrative examples and should not be interpreted as limiting the scope of the claims in any way.

Claims

1. A delivery and deployment system for delivering and / or deploying an implant device to an anatomical site, the delivery and deployment system comprising: a flexible elongated member; an implant device delivery device capable of being delivered to an anatomical site at the distal end of the flexible elongate member; an implant device capable of being delivered by said implant device delivery device; and Control handles, including one or more of the following: a steering system operably coupled to the flexible, elongated member to control movement of the flexible, elongated member to deliver the implant device to an anatomical site; an implant device deployment system operably coupled to the implant device to deploy the implant device at an anatomical site; a tether adjustment system operably engageable with a tether element engageable with the implant device; or A tensioning and locking system is operably engageable with the implant device to adjust the configuration of a tensioning and locking device operably associated with the implant device.

2. The delivery and deployment system of claim 1, wherein: The flexible elongated member includes a pulling 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 pulling element to steer the flexible elongated member.

3. The delivery and deployment system of any one of claims 1-2, wherein the implant device is a tissue anchor.

4. The delivery and deployment system of any one of claims 1-3, wherein the flexible, elongated member is tubular, the delivery and deployment system further comprising a stylet operably coupled to the implant device and extending through the tubular, flexible, elongated member.

5. A delivery and deployment system according to claim 4, wherein the control handle includes at least an implant device deployment system operably connected to the stylet to axially translate the stylet along the longitudinal axis of the control handle to advance and deploy the implant device from the implant device delivery device.

6. The delivery and deployment system according to any one of claims 1-5, further comprising a tether element extending relative to the implant device to a position spaced apart from the implant device, wherein the control handle comprises at least a tether adjustment system capable of being operably engaged with the tether element to adjust the tension on the tether element and / or the length of the tether element between the implant device and the position spaced apart from the implant device.

7. A delivery and deployment system according to claim 6, wherein the tether adjustment system includes a fine-tuning knob that is capable of engaging with the tether element and being capable of rotating about the longitudinal axis of the control handle to adjust the tension on the tether element and / or the length of the tether element between the implant device and the position spaced apart from the implant device.

8. The delivery and deployment system according to any one of claims 1-7 further comprising a tensioning and locking device, which is operably associated with the tether element and is capable of shifting from a tension adjustment configuration to a tension setting configuration, wherein the tension on the tether element and / or the length of the tether element is adjustable, and wherein the tension on the tether element and / or the length of the tether element is fixed relative to the implant device in the tension setting configuration.

9. The delivery and deployment system of claim 8, wherein the control handle further comprises a tensioning and locking system operably associated with the tensioning and locking device to enable the tensioning and locking device to be converted between the tension adjustment configuration and the tension setting configuration.

10. A delivery and deployment system according to claim 9, wherein the tensioning and locking system includes a tensioning and locking knob, which is capable of rotating about the longitudinal axis of the control handle to convert the tensioning and locking device between the tension adjustment configuration and the tension setting configuration.

11. The delivery and deployment system of any one of claims 9-10, wherein the tensioning and locking system further comprises an anchor status indicator operably associated with the tensioning and locking knob to indicate a configuration of the tensioning and locking device.

12. A delivery and deployment system according to any one of claims 4-12, wherein the stylet is operably connected to the tensioning and locking device and the tensioning and locking system, so that rotation of the tensioning and locking knob rotates the stylet, and rotation of the stylet causes the tensioning and locking device to switch between the tension adjustment configuration and the tension setting configuration.

13. A delivery and deployment system for delivering and / or deploying an implant device to an anatomical site, the delivery and deployment system comprising a control handle having a longitudinal axis and comprising at least one control knob capable of rotating about the longitudinal axis of the control handle and operable to axially translate components of the delivery and deployment system.

14. The delivery and deployment system of claim 13, wherein: The delivery and deployment system includes a flexible, elongated member configured to deliver an implant device transluminally to an anatomical site; and A pulling element is operably coupled to the flexible elongated member and the control knob such that rotation of the control knob about the longitudinal axis of the control handle bends the distal region of the flexible elongated member to deliver an implant device to a treatment site.

15. A delivery and deployment system according to any one of claims 13-14, wherein the control knob is capable of rotating about the longitudinal axis of the control handle to adjust an element of the delivery and deployment system relative to a tether element, wherein the tether element is operably associated with an implant device capable of being delivered by the delivery and deployment system.

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