Devices and systems for deploying implantable devices

Abstract

A delivery / deployment system has a control handle configured to control delivery and / or deployment of a medical device having an arm configured to grasp tissue therebetween. The system may include a device spreader having arms that engage the arms of the medical device and controlled by an actuator operably coupled with a control handle. The control handle may include a lever that is pivotable to similarly pivot the device opener and the medical device arm to open or close. A device retention assembly may be provided to retain the medical device relative to the device spreader. The control handle may include a release element that is movable to move the retention assembly into a disengaged configuration that allows release of the medical device from the device spreader. The control handle may axially translate and / or rotate the device spreader to a desired position, and once in the desired position, the control handle may be securable in place by a handle lock.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 354,001, filed on June 21, 2022, the entire disclosure of which is incorporated herein by reference for all purposes. Technical Field

[0002] 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 deploying implantable devices such as clips or clamps. Background Art

[0003] 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 opening to an anatomical site inside the body; navigate via the body (e.g., via the vascular system) transluminally; and reach the anatomical site. In order to reach the anatomical site inside the body, various elongated members must be steerable to navigate the tortuous path leading to the anatomical site via the body's interior. Improvements to the handle for steering the elongated member would be welcome in the art. In addition, in order to deploy an implantable device inserted percutaneously and / or transcavitary, the delivery / deployment system must provide appropriate control of the movement of the implantable device and appropriate control of any system for delivering and deploying the implantable device inside the patient's body. Improvements to the handle for delivering and deploying an implantable device and / or adjusting any other device operably associated therewith would be welcome in the art. Summary of the invention

[0004] 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.

[0005] A delivery / deployment system is disclosed herein, the delivery / deployment system being configured for delivering and / or deploying a medical device having a first arm and a second arm, the first arm and the second arm being movable between a closed configuration in which the arms are adjacent to each other and an open configuration in which the arms are displaced apart from each other. According to various principles of the present disclosure, the delivery / deployment system includes: a control handle having a control handle housing and an actuator controller movable relative to the control handle housing; a device opener configured to deliver and deploy the medical device and having a first arm configured to engage the first arm of the medical device and a second arm configured to engage the second arm of the medical device; and an actuator coupled to the opener device and extending to and coupled to the actuator controller. In some aspects, the actuator controller includes a lever handle pivotable relative to the control handle housing to cause the actuator to move the device opener arm between the closed configuration and the open configuration to move the medical device between the closed configuration and the open configuration.

[0006] In some embodiments, the actuator is coupled to and extends distally from the first arm of the device expander and then proximally to the actuator controller and is guided around a pulley to couple with the lever handle.

[0007] In some embodiments, the system further comprises a gripper limiter operably associated with the control handle to limit the extent to which the device opener can open the medical device. In some embodiments, the gripper limiter comprises a limit stop movable relative to the lever handle to limit the extent to which the lever handle can be moved to cause the actuator to move the device opener to an open configuration. In some embodiments, the gripper limiter comprises an adjustment gauge movable relative to the control handle housing to indicate the extent to which the lever handle can open the device opener to open the medical device.

[0008] In some embodiments, the actuator controller moves the actuator from a neutral position to an actuated position, and the system further comprises a spring assist device inside the control handle housing, the spring assist device being configured to assist the actuator in returning to the neutral position when the lever handle is released. In some embodiments, the system further comprises an actuator guide housing, the actuator extending to the actuator controller via the actuator guide housing, and the spring assist device comprises a spring plate and a spring within the actuator guide housing, the spring plate being coupled relative to the actuator, and the spring biasing the spring plate to return the actuator to the neutral position. In some embodiments, the spring assist device comprises an elastic actuator guide housing, the elastic actuator guide housing being configured to return the actuator to the neutral position.

[0009] In some embodiments, the device dispenser includes a movable retaining element configured to move between an engaged retaining position that retains the medical device relative to the device dispenser and a disengaged position that allows the medical device to be released from the device spreader; and the control handle further includes a release system configured to move the movable retaining element from the engaged retaining position to the disengaged position. In some embodiments, the release system includes a clamp release slider mounted relative to a control handle housing; the movable retaining element extends from the device spreader to the clamp release slider to couple to the clamp release slider; and withdrawing the clamp release slider from the control handle housing causes the movable retaining element to move to the disengaged position. In some embodiments, the system further includes a safety button that is biased to retain the clamp release slider relative to the control handle housing.

[0010] In some embodiments, the system further comprises a flexible elongated member having a distal end and a proximal end and extending distally from the control handle via the steerable flexible elongated member. In some aspects, a device opener is mounted on the distal end of the flexible elongated member; the proximal end of the flexible elongated member is fixed relative to the control handle; and the control handle is movably mounted on the connecting tube to axially and / or rotationally move the flexible elongated member and the device opener relative to the steerable flexible elongated member.

[0011] In some embodiments, the system further comprises a handle lock operably associated with the control handle to fix a position of the control handle and the device expander relative to the steerable flexible elongate member.

[0012] According to various principles of the present disclosure, a control handle operably associated with a device expander is configured to deliver and deploy a medical device, the control handle having a first arm configured to engage a first arm of the medical device and a second arm configured to engage a second arm of the medical device. In some aspects, the control handle includes a control handle housing; and an actuator controller that is movable relative to the control handle housing and includes a lever handle that is pivotable relative to the control handle housing to cause an actuator operably engaged with the device expander and the actuator controller to cause the device expander arm to move between a closed configuration and an open configuration to move the medical device between a closed configuration and an open configuration.

[0013] In some embodiments, the control handle further comprises a gripper limiter operably associated with the control handle to limit the extent to which the lever handle can move the device opener to open the medical device. In some embodiments, the gripper limiter comprises a limit stop movable relative to the lever handle to limit the extent to which the lever handle can move. In some embodiments, the gripper limiter comprises an adjustment gauge movable relative to the control handle housing to indicate the extent to which the lever handle can open the device opener to open the medical device.

[0014] Additionally, a method of deploying a medical device is disclosed herein, the medical device having a first arm and a second arm, the first arm and the second arm being movable between a delivery configuration, an open configuration allowing tissue to enter therebetween, and a closed configuration in which the medical device grasps tissue. The method includes pivoting a lever handle away from a control handle to cause the medical device to move to the open configuration; and allowing the lever handle to return to a position along the control handle to allow the medical device to move to the closed configuration.

[0015] In some aspects, the first arm and the second arm of the medical device are biased toward each other to move the medical device to a neutral configuration, and a spring assist is provided in the control handle to assist in returning the medical device to the neutral configuration.

[0016] In some aspects, the method further includes moving a clamp release slider relative to the control handle to deploy the medical device by releasing the medical device from a device expander controlled by the control handle.

[0017] 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

[0018] 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 schemes (e.g., with respect to fitting within the working channel of a delivery catheter or endoscope). In view of the length of certain elements, some elements may be identified in more than one position for clarity. On the other hand, for the purpose of clarity and simplicity, not every element is marked in each of the accompanying drawings, nor is every element of each embodiment shown, wherein illustration is unnecessary for allowing a person of ordinary skill in the art to understand the present disclosure.

[0019] The “Detailed Description” will be better understood in conjunction with the accompanying drawings, wherein like reference numerals represent like elements, as shown below:

[0020] Figure 1 A perspective view of one example of an implementation of a handle and deployment system according to various aspects of the present disclosure is depicted.

[0021] Figure 2 A perspective view depicting one example of an embodiment of a leaflet clip delivery and deployment system positioned by a delivery / deployment system formed according to various principles of the present disclosure to deploy a clip relative to a schematic illustration of a heart valve leaflet.

[0022] Figure 3 Describes Figure 2 and Figure 6 The leaflet clamp system in Figure 6 Cross-sectional view along line III-III.

[0023] Figure 4 Describes Figure 2 and Figure 6 The leaflet clamp system in Figure 6 A cross-sectional view along line IV-IV.

[0024] Figure 5 Describes something like Figure 2, but with the leaflet clamp delivery and deployment system in an open configuration to capture a heart valve leaflet between the leaflet clamp spreader arms and between its leaflet clamp arms.

[0025] Figure 6 Describes something like Figure 2 and Figure 5 , but with the leaflet clamp delivery and deployment system in a closed configuration, thereby grasping the heart valve leaflets between the leaflet clamp spreader arms and its leaflet clamp arms.

[0026] Figure 7 Describes Figure 1 An enlarged isolated perspective view of a leaflet clip delivery and deployment system control handle is depicted.

[0027] Figure 8 Describes something like Figure 7 , but with a portion of the handle housing removed.

[0028] Fig. 9 Depicted along Figure 8 A cross-sectional view along line IX-IX.

[0029] Fig.10 Describes Figure 7 A perspective view of a leaflet clip delivery and deployment system control handle is depicted, but with a portion of the handle housing removed and the actuator controls in a different position.

[0030] Fig.11 Depicted Figure 8-10 An enlarged perspective view of a detail of an alternative embodiment of the elements 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 or structures or features in the drawings must 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 that extends longitudinally along the length of the opening when the opening comprises, for example, a tubular element, a passage, a cavity, or a 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 is the end beyond which such an element does not extend.

[0034] According to various principles of the present disclosure, the delivery / deployment system is constructed to deliver and / or deploy a device. According to various principles of the present disclosure, the delivery / deployment system is constructed to operate or otherwise deploy a device relative to a treatment site. In some aspects, the delivery / deployment system is constructed to operate a device delivery / deployment system, and / or includes a device delivery / deployment system, and the device delivery / deployment system is constructed to deliver and / or deploy a device. In some aspects, the delivery / deployment system includes a handle, which is constructed to operate such a device delivery / deployment system to deliver and / or deploy an associated device. In some aspects, the device is an implantable device, and the device delivery / deployment system is constructed to deliver and deploy an implantable device, such as deploying an implantable device relative to an anatomical site (such as a treatment site on or inside the patient's body). In some embodiments, the implantable device is a clamp or a clip.

[0035] According to various principles of the present disclosure, a delivery / deployment system includes a flexible elongated member, a handle mounted on the proximal end of the flexible elongated member, and a device delivery / deployment system mounted on the distal end of the flexible elongated member. In some embodiments, the position of the flexible elongated member can be fixable relative to the handle at a desired linear position and / or angular orientation to prevent linear and / or rotational travel of the handle.

[0036] According to various principles of the present disclosure, repositioning, repairing and / or replacing one or more leaflets of the chordae tendineae and / or valve may be desirable for treating heart disease, and may include one or more devices fixed to one or more leaflets of the heart valve. Such devices may include leaflet clamps or clips (hereinafter referred to as "clamps" for convenience and without limitation). According to various principles of the present disclosure, leaflet clamp delivery and deployment systems may be used to deliver and deploy leaflet clamps relative to heart valve leaflets. Leaflet clamp delivery and deployment systems may include clamp openers that are configured to deliver and deploy leaflet clamps, such as clamping leaflet clamps to heart valve leaflets. It should be understood that terms such as clamping, attaching, attaching, clamping, snapping, coupling, engaging, attaching, deploying, grasping, holding, fixing, etc. (including other grammatical forms thereof) may be used interchangeably herein, such as with reference to the interaction of a clamp and tissue engaged by the clamp, without intent to limit. In addition, it will be understood that descriptions of elements connected or engaged with other elements include direct and indirect connections or engagements.

[0037] According to various principles of the present disclosure, a delivery / deployment system is constructed to deliver and / or deploy a device (such as a leaflet clamp) and / or a leaflet clamp delivery and deployment system including a leaflet clamp to a treatment site, such as a heart valve (mitral valve or tricuspid valve), and in particular its leaflets. In some aspects, a delivery / deployment system formed according to various principles of the present disclosure is constructed to operate or otherwise control a clamp delivery and deployment system (such as a clamp opener) to deploy the clamp. More specifically, in some aspects, the clamp delivery and deployment system controls the leaflet clamp opener to deploy the leaflet clamp relative to the heart valve leaflet. In some aspects, a delivery / deployment system formed according to various principles of the present disclosure includes a handle constructed to deliver and / or deploy a clamp (such as a leaflet clamp) relative to the heart valve leaflet. In some aspects, the handle is constructed to operate or otherwise control a clamp delivery and deployment system (such as a leaflet clamp opener) to deploy a clamp (such as a leaflet clamp) relative to the heart valve leaflet. It should be understood that although reference is made herein to leaflet clamps and leaflet clamp spreaders, the present disclosure need not be limited to clamps and spreaders specifically configured for grasping heart valve leaflets, and the principles of the present disclosure are broader than the examples of implementation described herein.

[0038] The leaflet clamp can be biased into a closed configuration, for example, to clamp onto tissue. The clamp opener is configured to actuate the leaflet clamp into a configuration for placement relative to the heart valve leaflet. For example, the leaflet clamp can have a first arm and a second arm connected together via a flexure zone, which can bias the leaflet clamp arms together. The leaflet clamp delivery and deployment system formed according to various principles of the present disclosure is configured to operate the leaflet clamp opener to switch to an open configuration to move the first arm and the second arm of the leaflet clamp separately (e.g., expand) into an open configuration. The leaflet clamp delivery and deployment system is also configured to operate the leaflet clamp opener to move the first arm and the second arm of the leaflet clamp (or at least allow the first arm and the second arm to move) to a closed configuration clamped on the heart valve leaflet. In an embodiment in which the leaflet clamp arms are biased to a closed configuration, the leaflet clamp delivery and deployment system allows the leaflet clamp arms to return to a closed configuration, such as clamped onto the heart valve leaflet. In some embodiments, if it is desired to reposition the leaflet clamp, the leaflet clamp delivery and deployment system is configured to actuate the leaflet clamp expander to reopen the leaflet clamp that has been released to clamp onto the heart valve leaflet before the leaflet clamp is released from the leaflet clamp expander. The expander arms of the clamp expander and the leaflet clamp arms can be connected together to move together. Therefore, actuating the clamp expander arms to move apart causes the leaflet clamp arms to move apart. The leaflet clamp arms can be biased into a closed configuration (close to each other to clamp onto tissue) so that the release of the actuation force on the clamp expander arms allows the leaflet clamp arms to return to the closed position, also returning the clamp expander arms to the closed position. The leaflet clamp delivery and deployment system can also be configured to release the leaflet clamp from the leaflet clamp expander once the leaflet clamp is clamped onto the heart valve leaflet.

[0039] According to various aspects of the present disclosure, a leaflet clamp delivery and deployment system includes a handle that facilitates the above-mentioned operations. The handle can be configured to actuate a leaflet clamp opener to cause movement of the opener arms of the leaflet clamp opener to open or close the leaflet clamp to receive or clamp onto the heart valve leaflets. In some embodiments, the handle includes a lever that is pivotable relative to the body of the handle to open or close the leaflet clamp, for example, by operating the leaflet clamp opener to open or close the leaflet clamp. In some embodiments, a limiter is positioned to limit the range of motion of the lever, such as to limit the extent to which the lever opens the leaflet clamp.

[0040] According to one aspect of the present disclosure, a leaflet clamp delivery and deployment system includes a release element configured to release the leaflet clamp from the leaflet clamp expander once the leaflet clamp is at a deployment site and optionally engage with tissue (e.g., a heart valve leaflet) at the deployment site. More specifically, in some embodiments, the leaflet clamp expander may include a movable retaining element movable between an engaged position that engages the leaflet clamp to maintain the leaflet clamp engaged with the leaflet clamp expander and a disengaged position that allows the leaflet clamp to be released from the leaflet clamp expander to unfold the leaflet clamp and remove the leaflet clamp expander and the leaflet clamp delivery and deployment system. The leaflet clamp may be configured to slidably engage with the leaflet clamp expander and be easily releasable from the leaflet clamp expander once the retaining element is in the disengaged position. Once the leaflet clips have been positioned as desired, the clip release slider may be actuated to release the leaflet clips from the leaflet clip spreader, thereby releasing the leaflet clips from the leaflet clip delivery / deployment system.

[0041] According to various principles of the present disclosure, a delivery / deployment system is configured to move a movable retaining element between an engaged position and a disengaged position. In some embodiments, the delivery / deployment system includes a clamp release element. In some embodiments, the clamp release element is operably associated with a handle of the delivery / deployment system. In some embodiments, the clamp release element is a clamp release slide that is slidable relative to the handle body. For example, the clamp release element can be in a rip cord configuration. A safety latch can be provided to prevent accidental sliding of the clamp release slide.

[0042] The devices, systems, and methods of the present disclosure may be used alone or in combination 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 and 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 and 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 and 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 / 0123832, entitled Devices, Systems, And Methods For Clamping A Leaflet Of A Heart Valve, published on April 20, 2023; and those described in U.S. Patent Application Publication 2023 / 0149170, entitled Devices, Systems, And Methods For Positioning A Leaflet Clip, published on May 18, 2023, 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. ;

[0043] It should be understood that the deployment system formed according to the various principles of the present disclosure can be used to deploy implantable devices of various structures, such as but not limited to leaflet clamps of various structures, and the present disclosure is not limited to the implantable devices (such as leaflet clamps) depicted and described herein.

[0044] Various aspects of the delivery / deployment system formed according to various principles of the present disclosure will now be described with reference to the examples depicted in the accompanying drawings. References to "one embodiment", "an embodiment", "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 combination 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", "an embodiment", "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.

[0045] It should be understood that common features are identified by common reference elements, and for simplicity and convenience, and without limitation, the description of common features is usually not repeated. For clarity, not all parts with the same reference numerals are numbered. In addition, a group of similar elements can be indicated by numbers and letters, and usually an element or such an element or a group of such elements can be referred to only by numbers (excluding letters associated with each similar element). In addition, some features in one embodiment can be used across different embodiments, and are not necessarily individually marked when appearing in different embodiments.

[0046] Now turning to the attached figure, Figure 1An example of an embodiment of a delivery / deployment system 1000 formed according to various principles of the present disclosure is depicted in . The delivery / 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 2001.2755100], 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. As depicted in the detail view, the depicted example of an embodiment of the larger delivery / deployment system 100 includes an introducer shaft 110 (which may also be referred to as a delivery sheath, not intended to be limiting) configured to guide / deliver the delivery / deployment system 100 to a treatment area. Thus, the introducer shaft 110 is a tubular, flexible, elongated element that defines a lumen therethrough, the size, shape, configuration, and / or dimensions of the lumen 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 / 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 surgery is performed using a system and / or device delivered by the delivery / deployment system 100, 1000. It should be understood that reference to "at" a treatment site is intended to include at or near (e.g., along, adjacent, etc.) a treatment site, and is not limited to only an exact treatment site. Furthermore, it should be understood that treatment sites, anatomical sites, delivery sites, deployment sites, implants / implantation sites, implanted sites, target sites, etc. are referred to herein interchangeably and are not intended to be limiting. The introducer shaft 110 can be steerable, such as unidirectionally or bidirectionally steerable within a steering plane, such as using a control handle 120 operably associated therewith. The delivery / deployment system 100 can include an additional steerable flexible elongated member 210 configured to provide further steering capability to the delivery / deployment system 1000 to guide and direct the device and / or system closer to the desired treatment site.The steerable flexible elongate member 210 can be tubular, defining a lumen therethrough, the lumen being sized, shaped, configured and / or dimensioned to allow passage of additional devices and / or systems therethrough for delivery to a treatment site, such as devices and / or systems delivered / deployed by the delivery / deployment system 1000. The steerable flexible elongate member 210 can be steerable, such as bi-directionally steerable within a steering plane, and four-directionally steerable within two lateral steering planes, such as using a control handle 220 operably associated therewith.

[0047] Figure 1 The example of an embodiment of the delivery / deployment system 1000 depicted in includes a flexible elongated member 1100 (e.g., a delivery catheter, shaft, tube, etc.) having a control handle 1200 operably associated therewith. The flexible elongated member 1100 is configured to deliver a device delivery / deployment system 1300 to a treatment site. The control handle 1200 is operably associated with the flexible elongated member 1100 and / or the device delivery / deployment system 1300 to deliver the device delivery / deployment system 1300 to a treatment site and / or to operate the device delivery / deployment system 1300 to deploy a device relative to a treatment site.

[0048] According to various principles of the present disclosure, the delivery / deployment system 1000 can deliver, operate and / or deploy a cardiac repair device and / or system, such as a heart valve leaflet repair device and / or system. According to various other principles of the present disclosure, the delivery / deployment system 1000 can deliver, operate and / or deploy a leaflet clip and / or a delivery and deployment system 1300 for delivering / deploying a leaflet clip. An example of an embodiment of a device delivery / deployment system 1300 delivered, operated and / or deployed by the delivery / deployment system 1000 is depicted in the form of a leaflet clip delivery and deployment system 1300. Figure 2 , which is in an example of a treatment area inside the heart. More specifically, an example of an embodiment of the leaflet clip delivery / deployment system 1300 is as follows Figure 2 As depicted, it is delivered by the delivery / deployment system 1000 via the introducer shaft 110 and the steerable flexible elongate member 210. The introducer shaft 110 delivers the leaflet clip delivery and deployment system 1300 to the treatment area, e.g. Figure 2 The steerable flexible elongate member 210 can further guide and direct the flexible elongate member 1100 of the delivery / deployment system 1000 to deliver the leaflet clip delivery and deployment system 1300 to the treatment site, for example, at Figure 2. It should be understood that further details of examples of embodiments of the steerable flexible elongated member 210 and the components and operations of the introducer shaft 110 are provided in the co-pending provisional patent application __ / ___,___ [attorney docket 2001.2787100] incorporated above. However, the present disclosure need not be limited to the examples of embodiments disclosed therein.

[0049] According to one aspect of the present disclosure, a leaflet clip delivery and deployment system 1300 delivered by a delivery / deployment system 1000 formed according to various principles of the present disclosure includes a leaflet clip expander 1310 configured to deliver and deploy a leaflet clip 1050, such as Figure 3 and Figure 4 The leaflet clamp delivery and deployment system 1300 can be delivered on the distal end 1101 of the flexible, elongated member 1100, and the flexible, elongated member 1100 can therefore be referred to herein as a spreader shaft or grasper shaft 1100, without limitation. The leaflet clamp spreader 1310 includes a ventricular spreader arm 1312 and an atrial spreader arm 1314, which can be pivotally coupled together (such as around a hinge or pivot 1316). The ventricular spreader arm 1312 is configured to engage the ventricular clamp arm 1322 of the leaflet clamp 1320 (an arm of the leaflet clamp 1320 configured to be positioned on a ventricle-facing side of the heart valve leaflet L), and the atrial spreader arm 1314 is configured to engage the atrial clamp arm 1324 of the leaflet clamp 1320 (configured to be positioned on a side of the heart valve leaflet L facing the atrium). In an embodiment where the ventricular clamp arms 1322 and atrial clamp arms 1324 of the leaflet clamp 1320 are offset toward each other, the connection between the leaflet clamp opener 1310 and the leaflet clamp 1320 can allow the leaflet clamp 1320 to maintain the ventricular opener arms 1312 and atrial opener arms 1314 of the leaflet clamp opener 1310 in a substantially closed configuration until actuated to an open configuration.

[0050] According to one aspect of the present disclosure, the leaflet clip delivery and deployment system 1300 can be navigated relative to the heart valve leaflet L by manipulating the control handle 1200. For example, the grasper shaft 1100 can be coupled to the control handle 1200 so that rotation and / or axial movement of the control handle 1200 causes corresponding rotation and / or axial movement of the grasper shaft 1100 (e.g., around or along a position such as Figure 3 and Figure 7 The longitudinal axis LA is indicated in FIG. Figure 7-Figure 10In the example of the embodiment shown, the grasper shaft 1100 is operably coupled to the control handle 1200 via a hub system 1230, which can also be used to position and support the grasper shaft 1100 within and relative to the connecting tube 1110. The connecting tube 1110 can be fixedly mounted relative to the control handle 220 of the steerable flexible elongated member 210, and the control handle 1200 is axially and rotationally movably mounted on the connecting tube 1110. The proximal end 1103 of the grasper shaft 1100 can be engaged within a counterbore in the adapter 1232 (such as Fig. 9 ), and the adapter 1232 is coupled to the control handle housing 1210 such that movement of the control handle housing 1210 (eg, relative to the connecting tube 1110) causes the gripper shaft 1100 to move. More specifically, in Fig. 9 In the example of the depicted embodiment, the adapter 1232 is coupled over the hub 1234, and the hub 1234 is coupled over the distal end 1241 of the gripper extension shaft 1240. The proximal end 1243 of the gripper extension shaft 1240 is coupled inside an extension shaft hub 1242 mounted inside the proximal end 1203 of the control handle housing 1210. The extension shaft hub 1242 is mounted inside the control handle housing 1210, for example with a keyed connection, so as to be movable with the control handle housing 1210. Thus, axial or rotational movement of the control handle housing 1210 is imparted to the gripper shaft 1100 via the gripper extension shaft 1240, the hub 1234, and the adapter 1232. It should be understood that bonding may not be required to couple any or all of the control handle housing 1210, the gripper extension shaft 1240, the hub 1234, the adapter 1232, and the gripper shaft 1110 so that movement of one causes movement of the other. For example, key connections or other mechanical connections, or other connections that enable axial or rotational movement of one component to be transmitted to a component connected thereto, are within the scope and spirit of the present disclosure, as will be understood by one of ordinary skill in the art.

[0051] Once the desired position of the leaflet clip delivery and deployment system 1300 is achieved, the position of the control handle 1200 can be substantially fixed or locked in place to maintain the desired position of the leaflet clip delivery and deployment system 1300. Figure 7 , Figure 8 , Fig. 9 and Fig.10In the example of the embodiment shown, a handle lock 1202 (such as a collet) can be operably associated with (e.g., disposed on) a distal end 1211 of a control handle housing 1210 to secure the position of the control handle 1200 and, therefore, the position of the grasper shaft 1100 and the leaflet clamp delivery and deployment system 1300 in a desired position. More specifically, the control handle 1200 can be mounted on a connecting tube 1110 that extends between the leaflet clamp delivery and deployment system control handle 1200 and the steerable flexible elongated member control handle 220 (such as a Figure 1 ). Thus, the connecting tube 1110 can be considered a gripper telescoping shaft that allows the gripper shaft 1100 to telescope out and into the steerable flexible elongated member 210, as well as rotation of the gripper shaft 1100 relative to the steerable flexible elongated member 1020. The handle lock 1202 can be rotated relative to the distal end 1211 of the control handle housing 1210 to secure the gripping fingers 1212 formed on the distal end 1211 of the control handle housing 1210 to the connecting tube 1110 to fix the control handle 1200 relative to the connecting tube 1110. The handle lock 1202 may be threadedly engaged with the distal end 1211 of the control handle housing 1210 such that rotation in one direction secures the gripping fingers 1212 to the connecting tube 1110 and rotation in the opposite direction releases the gripping fingers 1212 from engagement with the connecting tube 1110 to allow the control handle 1200 to move relative to the connecting tube 1110. The locking screw 1214 may retain the handle lock 1202 on the distal end 1211 of the control handle housing 1210 such that the handle lock 1202 may move (e.g., translate distally or proximally) relative to the control handle housing 1210 without disengaging therefrom.

[0052] According to another aspect of the present disclosure, a leaflet clamp delivery and deployment system 1300 formed according to various principles of the present disclosure includes an actuator 1330 (e.g., a pull wire) operably engaged with the leaflet clamp spreader 1310 to actuate the leaflet clamp spreader 1310 to move the leaflet clamp spreader 1310 in a delivery configuration (e.g., such as Figure 2 , Figure 3 and Figure 4 ) and an open configuration (e.g., Figure 5More specifically, when the leaflet clamp 1320 is in the delivery configuration, the leaflet clamp spreader arms 1312, 1314 and the leaflet clamp arms 1322, 1324 are in a generally neutral position, such as a closed configuration. The actuator 1330 actuates the leaflet clamp spreader 1310 to move the leaflet clamp spreader arms 1312, 1314 and the leaflet clamp arms 1322, 1324 to the open position (to expand the leaflet clamp spreader arms 1312, 1314 separately) to facilitate the deployment of the leaflet clamp 1320. In the open configuration, the heart valve leaflets L can enter between the leaflet clamp arms 1322, 1324 by the natural movement of the heart valve leaflets L ("catching" the heart valve leaflets L by allowing them to move into the space between the leaflet clamp arms 1322, 1324), or by moving the leaflet clamp opener 1310 so that the leaflet clamp arms 1322, 1324 surround the heart valve leaflets L. In the closed configuration, the leaflet clamp 1320 is clamped onto and grasps the heart valve leaflets L, such as Figure 6 Described in.

[0053] In some embodiments, the actuator 1330 is coupled to at least one of the arms 1312, 1314 of the leaflet clamp expander 1310, such as to move the ventricular expander arm 1312 relative to the atrial expander arm 1314, such as Figure 3 In the depicted example of one embodiment, the actuator 1330 includes an actuator cable 1332 having a distal end 1331 coupled to the ventricular opener arm 1312. The proximal end 1333 of the actuator cable 1332 is coupled to the control handle 1200 (eg, Figure 8 and Fig. 913 and discussed in further detail below) so as to be accessible (e.g., outside the patient) by a medical professional to actuate the actuator 1330. The actuator cable 1332 can be a metal, polymer, or other suitable biocompatible material that is capable of withstanding the forces required to actuate the leaflet clamp expander 1310 and capable of being navigated through a tortuous path inside the patient's body. In some embodiments, the actuator cable 1332 is in the form of a Bowden cable (e.g., a pull wire) having an outer cable sheath 1335 and an inner cable 1337. The outer cable sheath 1335 can extend distally from the control handle 1200 and terminate, for example, within a Bowden termination and pull cable channel 1334 mounted relative to the leaflet clamp expander 1310, and the inner cable 1337 can then continue distally around the distal end 1311 of the leaflet clamp expander 1310 and the leaflet clamp 1320 to connect to the leaflet clamp expander arm 1312, 1314 (e.g., the ventricular expander arm 1312) to move relative to the other leaflet clamp arm 1324, 1322 when, for example, the actuator cable 1332 is pulled (e.g., the inner cable 1335 is pulled proximally). The distal end 1331 of the actuator cable 1332 can be secured to the ventricular opener arm 1312, such as by coupling the inner cable 1337 with a cable retainer 1336 (e.g., a boss) that is mounted or coupled or otherwise secured relative to the ventricular opener arm 1312. The distal end 1331 of the actuator cable 1332 (e.g., the inner cable 1337) can extend through a hole 1339 within the cable retainer 1336 and have a widened distal-most end (e.g., a free end) to prevent the actuator cable 1332 from being withdrawn from the hole 1339 when the ventricular opener arm 1312 is actuated to open. The widened distal-most end of the actuator cable 1332 can be formed by the actuator cable 1332 itself (e.g., a knot or loop, or a curl or widening or flattening of the actuator cable 1332), or by an element coupled thereto, such as a metal fitting 1338 (e.g., an overmolded retainer positioned over the actuator cable 1332, a curled collar, a cylinder, a bead, or a pin or other element around which the actuator cable 1332 is wrapped, etc.). It should be understood that other ways of coupling elements of the actuator 1330 (such as the actuator cable 1332) to the leaflet clamp expander 1310 (e.g., welding, brazing, adhering, interference fit, etc.) are within the scope and spirit of the present disclosure, the details of which are not critical to the general principles of the present disclosure.In some embodiments, the actuator 1330 is coupled to the leaflet clamp expander 1310 such that its distal end 1331 is positioned adjacent to the free end of the ventricular expander arm 1312 and extends distally therefrom toward the pivot 1316, then around the distal end 1311 of the leaflet clamp expander 1310, then toward the proximal end 1313 of the leaflet clamp expander 1310 and proximally toward the control handle 1200. It will be appreciated that this configuration generally allows for an optimal force vector to be applied to actuate the leaflet clamp expander 1310.

[0054] The actuator 1330 extends proximally, for example, within the grasper shaft 1100, from the leaflet clamp delivery and deployment system 1300 (e.g., as Figure 3 shown) to Figure 1 The control handle 1200 of the leaflet clip delivery and deployment system 1000 is depicted. Figure 7 As can be more easily understood from the enlarged view of FIG. 1 , the control handle 1200 includes a body or housing 1210 having an actuator control 1220 operably associated therewith. The control handle housing 1210 can be formed of two housing portions or halves 1210a, 1210b that are coupled together to form the control handle housing 1210 and define a housing portion 1220 disposed within the control handle 1200. Figure 8-Figure 10 The interior 1215 is further described in detail. Figures 8 to 10 In the example of the embodiment depicted, the actuator 1330 extends into the interior 1215 of the control handle housing 1210 (e.g., generally through the opening 1205 in the distal end 1201 of the control handle 1200) to operably engage with the actuator controller 1220, which is operably associated with the control handle 1200. For example, Figure 8 , Fig. 9 and Fig.10As depicted, the actuator 1330 can extend through the hub system 1230 inside the distal end 1211 of the control handle housing 1210. More specifically, the hub 1234 of the hub system 1230 can include an actuator guide 1235 via which the actuator 1330 is guided. In some embodiments, the actuator guide 1235 is mounted on a cap 1236 at the distal end of the hub 1234. The hub 1234 can also accommodate a gasket 1238 to seal additional components of the larger delivery / deployment system 100 that extend proximally from the grasper shaft 1110 and the hub system 1230 into and proximally of the interior 1215 of the control handle housing 1210. The gasket 1238 can thereby seal the interior 1215 of the housing 1210 from bodily fluids and / or saline or other fluids that may be inside the grasper shaft 1110. In some embodiments, the washer 1238 is received between the body of the hub 1234 and the cap 1236, such as in Figure 8 In the example of the depicted embodiment, an additional guide ring 1244 may be installed along the gripper shaft extension 1240 to further guide components such as the actuator 1330 within the interior 1215 of the control handle housing 1210 .

[0055] Additional gaskets may be provided to guide, seal, etc. various elements within the interior 1215 of the control handle housing 1210. For example, the actuator 1330 may extend through an actuator guide housing 1250 supported within the interior of the control handle housing 1210, such as via engagement of a housing extension 1250a (e.g., a wing) with the interior 1215 of the control handle housing 1210 (e.g., a support element formed therein). In embodiments having an actuator 1330 formed of a two-part actuator cable 1332, an outer sheath 1335 of the actuator cable 1332 may terminate at a distal cap 1252a mounted at a distal end 1251 of the actuator guide housing 1250. The inner cable 1337 extends through the actuator guide housing 1250 to a proximal end 1253 thereof and through a proximal sealing cap 1252b mounted on the proximal end 1253 of the actuator guide housing 1250. The proximal sealing cap 1252b may function as a seal or gasket (sealing ring) for the actuator cable 1332 to seal the inner cable 1337 , for example, from any bodily fluids within the interior 1215 of the control handle housing 1210 .

[0056] The actuator 1330 may be operably coupled to the actuator controller 1220 in any of a variety of ways such that movement of the actuator controller 1220 (such as via movement of the lever handle 1222) causes movement of the actuator 1330 to actuate the leaflet clip delivery and deployment system 1300. Figure 8 , Fig. 9 and Fig.10 In the example of the embodiment shown, the actuator 1330 extends proximally toward the proximal end 1203 of the housing 1210 and loops around the proximal pulley 1204, extends distally to loop around the distal pulley 1206, and then toward a fixed position on the actuator controller 1220. The proximal end 1333 of the actuator 1330 is fixed relative to the actuator controller 1220 (e.g., via one or more fixing posts or screws 1208). Fig. 9 In the example of the embodiment shown, the proximal end 1333 of the actuator 1330 can be looped around the two fixing posts 1208 to fix the actuator 1330 to the actuator controller 1220. Fig.10 As will be appreciated, movement of the actuator controller 1220 (eg, by pivoting the lever handle 1222) relative to the handle housing 1210 pulls the actuator 1330 proximally. Figure 3 As will be appreciated, the proximal pull on the actuator 1330 causes the expander arms 1312, 1314 of the leaflet clamp expander 1310 to open, such as by pulling the ventricular expander arm 1312 away from the atrial expander arm 1314 and opening the leaflet clamp expander 1310, such as Figure 5 Finally, it will be appreciated that the pulleys 1204, 1206 may not only facilitate translation of the actuator 1330, but may also align the actuator 1330 with the gripper shaft 1100 as the actuator 1330 translates between the actuator controller 1220 and the gripper shaft 1100.

[0057] More specifically, in Figure 7 , Figure 8 , Fig. 9 and Fig.10 In the example of the embodiment shown, the actuator control 1220 includes a lever handle 1222 that is movably associated with the control handle housing 1210 and extends generally along the control handle housing 1210 (e.g., generally parallel to the longitudinal axis LA of the control handle housing). Figure 7 , Figure 8 , Fig. 9 and Fig.10It will be appreciated that the depicted example of an embodiment of the lever handle 1222 is pivotally coupled relative to the proximal end 1203 of the control handle housing 1210 (such as via a lever pivot pin 1223), extends through the lever opening 1207 of the control handle housing 1210, and extends distally toward the distal end 1211 of the control handle housing 1210. However, it will be appreciated that other configurations are within the scope and spirit of the present disclosure. In some aspects, the lever handle 1222 is pivoted away from the control handle housing 1210 to actuate the actuator controller 1220 to actuate the actuator 1330 to open the leaflet clamp 1320. Likewise, in some aspects, the pivoting of the lever handle 1222 toward the control handle housing 1210 allows the leaflet clamp 1320 to close, such as by actuating the actuator controller 1220 to actuate the actuator 1330 to close the leaflet clamp 1320. This movement of the lever handle 1222 can be considered to correspond to the associated opening and closing movement of the leaflet clamp 1330.

[0058] Various features and structures can be provided to adjust or modify or adjust the movement of the actuator controller 1220, such as adjusting or modifying or adjusting the actuator 1330 and the leaflet clamp delivery and deployment system 1300. For example, in some embodiments, the grasper limiter 1260 is provided relative to the control handle housing 1210 and the lever handle 1222 to limit the degree to which the actuator controller 1220 can be opened, thereby limiting the amount that the leaflet clamp 1320 can be opened. Figures 8 to 10An example of an embodiment of the gripper limiter 1260 depicted in FIG. 1 includes a gripper limiter control knob 1262 that advances or retracts a limit stop 1264 relative to a shoulder stop 1224 on the actuator controller 1220. When the lever handle 1222 moves relative to the control handle housing 1210, the limit stop 1264 moves (e.g., pivots, rotates, swings, etc.) toward the gripper limiter 1260. The contact of the shoulder stop 1224 with the limit stop 1264 limits the movement of the actuator controller 1220, thereby limiting the linear travel of the actuator 1330. By limiting the movement of the actuator 1330, the gripper limiter 1260 limits the extent to which the leaflet clamp opener 1310 and the leaflet clamp 1320 are opened, and determines the angle at which the leaflet clamp 1320 is opened. Thus, the gripper limiter 1260 can be considered an angle setting feature that relates movement of the actuator controller 1220 (such as opening or pivoting of the lever handle 1222) to the extent to which the leaflet clamps 1320 are opened by the leaflet clamp opener 1310. The gripper limiter 1260 can include an adjustment gauge 1266 that is operably associated with (e.g., mounted relative to) the gripper limiter control knob 1262 and has an indicator 1267 that represents the extent to which the leaflet clamps 1320 are opened by operation of the lever handle 1222. More specifically, movement (e.g., rotation) of the gripper limiter control knob 1262 advances or retracts the gripper limiter control knob 1262, the limit stop 1264, and the adjustment gauge 1266 relative to the control handle housing 1210 and the shoulder stop 1224 on the lever handle 1222. As the gripper limiter control knob 1262 moves, the adjustment gauge 1266 extends into or out of the opening 1209 in the control handle housing 1210. The position of the indicator 1257 on the adjustment gauge 1266 relative to the control handle housing 1210 provides an indication of the degree of opening of the leaflet clamp 1320. As used in a heart valve repair procedure, the leaflet clamp arms 1322, 1324 can be opened about 45° or about 60° relative to each other to capture the heart valve leaflets L therebetween. The leaflet clamp arms 1322, 1324 can be further opened, such as up to about 135°, to adjust the position of the leaflet clamp 1320 relative to the heart valve leaflets L or one or more chordae tendineae. If the leaflet clamp 1320 becomes entangled with one or more chordae tendineae, the leaflet clamp arms 1322, 1324 can be opened to about 180° for easier removal from the treatment area (which can be referred to as "bail out"). Such opening of the leaflet clamp 1320 can exceed the strain rate of the leaflet clamp 1320, thereby deforming and destroying the leaflet clamp 1320 and preventing further use.Indicator 1267 can be advantageously used to control the opening of leaflet clamp arms 1322, 1324 as desired.

[0059] If the leaflet clamp arms 1322, 1324 are biased relative to each other in a closed configuration to clamp an element, such as an element of tissue (e.g., a heart valve leaflet L), therebetween, the leaflet clamp arms 1322, 1324 can be simply allowed to close, for example, by removing the opening force on the actuator 1330 (e.g., by ceasing to pull the actuator 1330 distally). In some embodiments, the lever handle 1222 can be biased to return to a configuration that does not exert a proximal pulling force on the actuator 1330 (e.g., such as Figure 7 , Figure 8 and Fig. 9 For example, in some embodiments, a spring (such as torsion spring 1270) returns the lever handle 1222 to the neutral position without actuating the actuator 1330, such as to allow the leaflet clamp 1320 to return to the neutral position (e.g., as shown in FIG. Figure 3 ). Thus, the torsion spring 1270 acts as a spring assist device to allow the leaflet clamp 1320 to return to a neutral configuration, such as a closed configuration, when an opening force is no longer applied to the lever handle 1222.

[0060] In some embodiments, one or more assist devices are provided to mitigate the effects that forces such as friction (e.g., within the system 100, 1000) may have on the previous tension on the actuator 1330, so that the actuator 1330 allows the leaflet clamp 1320 to return to the neutral closed configuration (e.g., clamped on the heart valve leaflet L) after the force on the actuator 1330 has been released. Fig. 9 In the example of the embodiment shown, the actuator guide housing 1250 can apply a friction force on the actuator 1330, for example, via one or both of its caps 1252a, 1252b and / or a gasket inside the actuator guide housing 1250. For example, in some embodiments, one or more additional gaskets can be disposed inside the actuator guide housing 1250. Fig. 9In the example of the embodiment shown, the outer sheath 1335 of the actuator 1330 is coupled to the distal seal cap 1252a, and the internal cable 1337 extends through and is coupled to the spring plate 1254a, which is adjacent and close to the distal seal cap 1252a. The internal cable 1337 extends proximally through the actuator guide housing 1250, and optionally also through the proximal gasket 1254b, which is adjacent and away from the proximal seal cap 1252b. The depicted actuator guide housing 1250 includes a spring 1256 operably associated with the actuator 1330 to help the actuator 1330 move distally relative to the actuator guide housing 1250. More specifically, when the actuator controller 1220 is actuated, the spring 1256 is compressed to pull the actuator 1330 proximally to open the leaflet clamp opener 1310, pulling the spring plate 1254a proximally against the spring 1256 to compress the spring 1256 between the spring plate 1254a and the proximal gasket 1254b. When the actuator controller 1220 is no longer actuated, the spring 1256 returns the spring plate 1254a to a distal position adjacent the distal seal cap 1252a, thereby pulling / returning the actuator 1330 to its original position (before the actuator controller 1220 was actuated) to help return the leaflet clamp 1230 to a neutral (e.g., closed) configuration. The proximal end of the spring 1258 can abut and / or push away a spring washer 1258 positioned between the spring 1258 and the proximal washer 1254b to protect the proximal washer 1254b.

[0061] Alternatively, in Fig.11 In the example of the embodiment depicted, the actuator guide housing 1250 can be a resilient, e.g., elastic, stretchable, expandable, etc. actuator guide housing 1250'. The distal end 1251' of the actuator guide housing 1250' can be coupled to the hub assembly 1230, and the proximal end 1253' of the actuator guide housing 1250' can be coupled to the internal cable 1337 of the actuator 1330 (where the outer sheath 1335 of the actuator 1330 terminates inside the hub assembly 1230). Thus, upon actuation of the actuator controller 1220, the actuator guide housing 1250' stretches as the actuator 1330 moves proximally. Once the actuator controller 1220 is no longer actuated, the expanded actuator guide housing 1250' returns to its neutral configuration, thereby returning the actuator 1330 to its original position to help return the leaflet clamp 1320 to the neutral (e.g., closed) configuration. Optionally, the actuator guide housing 1250' is a sealing cable gasket (seal) coupled (e.g., bonded) to the actuator 1330 (e.g., internal cable 1337) to eliminate the need for an additional gasket to seal (and potentially increase sliding friction) around a moving cable / wire (such as actuator 1330).

[0062] If for any reason it is necessary or medically indicated to adjust the position of the leaflet clamp 1320 (e.g., if a different position or orientation of the leaflet clamp 1320 is desired and / or medically indicated, if any component of the leaflet clamp delivery and deployment system 1000 becomes stuck on the chordae tendineae, etc.), the leaflet clamp opener 1310 can be actuated again to release the leaflet clamp 1320 and the leaflet clamp delivery and deployment system 1000 can be moved to the desired position for deploying the leaflet clamp 1320.

[0063] After the leaflet clamp 1320 has been closed on the tissue (such as the heart valve leaflet L) (such as Figure 6 ) and in a desired and / or medically indicated deployed state, the leaflet clamp opener 1310 can be removed to leave the leaflet clamp 1320 in the proper position in the deployed state. Optionally, the leaflet clamp 1320 is connected to artificial chords (in any manner known to those of ordinary skill in the art) that extend from it to anchor at another location to anchor to the papillary muscles of the ventricle. The artificial chord anchors and associated delivery / deployment systems can be any known to those of ordinary skill in the art, or as described in provisional patent application __ / ____, ___ [attorney docket 2001.2755100] filed on June 21, 2022 and incorporated above, and U.S. Patent Application Publication 2023 / 0123832. It should be understood that the synthetic chords can be coupled to the leaflet clamp 1320 during delivery and deployment of the leaflet clamp 1320 and can extend out of a side of the leaflet clamp spreader 1310 and toward and couple to synthetic chord anchors carried within the leaflet clamp spreader 1310 (e.g., such as Figure 3 and Figure 4 shown).

[0064] It should be understood that it is generally desirable to maintain the leaflet clamp spreader 1310 operably associated with the leaflet clamp 1320 until the leaflet clamp 1320 and any associated anchors are fully deployed. In some embodiments, a retention assembly 1340 is operably associated with the leaflet clamp spreader 1310 and the leaflet clamp 1320 to hold the leaflet clamp spreader 1310 and the leaflet clamp 1320 together and prevent accidental separation thereof. In one embodiment, as Figure 4As depicted, the atrial expander arm 1314 of the leaflet clamp expander 1310 includes an atrial expander arm retaining element 1342 in the form of a protrusion, and the atrial clamp arm 1324 of the leaflet clamp 1320 includes a mating atrial leaflet clamp arm retaining element 1344 in the form of a detent or hole. In some embodiments, the atrial expander arm retaining element 1342 is in the form of a boss that can be inserted into the hole of the atrial leaflet clamp arm retaining element 1344. The movable retaining element 1350 can retain the atrial expander arm retaining element 1342 and the atrial leaflet clamp arm retaining element 1344 in an engaged retaining position (e.g., Figure 3 13). For example, the movable retaining element 1350 can be a wire having a distal end 1351 that can be inserted through the hole 1347 of the atrial expander arm retaining element 1342. In this configuration, the movable retaining element 1350 prevents or inhibits movement of the atrial clamp arm 1324 of the leaflet clamp 1320 relative to the leaflet clamp expander 1310. The movable retaining element 1350 can be moved to a disengaged position to allow relative movement of the leaflet clamp 1320 and the leaflet clamp expander 1310. For example, the movable retaining element 1350 can be pulled out (e.g., proximally) of the hole 1347 in the atrial expander arm retaining element 1342 to allow the leaflet clamp 1320 to be separated from the leaflet clamp expander 1310. In some embodiments, the movable retaining element 1350 is in the form of a wire, filament, tether, cable (such as a Bowden cable), etc., which can be moved proximally to withdraw from the atrial leaflet clamp arm retaining element 1344 in the form of a boss, thereby unlocking the movement of the leaflet clamp 1320 relative to the leaflet clamp spreader 1310. The movement between the atrial spreader arm 1314 and the atrial clamp arm 1324 is generally sliding and may not include further movement in other directions.

[0065] In accordance with various principles of the present disclosure, the control handle 1200 of the delivery / deployment system 1000 includes a release system 1280, such as Figure 7 As depicted in , the movable retaining element 1350 is operably coupled to the release system 1280. Operation of the release system 1280 manipulates the movable retaining element 1350 to release the leaflet clamp 1320 from the leaflet clamp spreader 1310. More specifically, Figure 7-Figure 10 The release system 1280 of the example embodiment depicted in FIG. 1 includes a clamp release slider 1282 that is operable to move the movable retaining element 1350 from the engaged position to the disengaged position. Optionally, the clamp release slider 1282 includes a finger grip structure 1285 (e.g., a ridge or other friction reducing structure, such as Fig. 9 and Fig.10), so as to grasp the clamp release slider 1282 to move the clamp release slider 1282 relative to the control handle housing 1210, thereby actuating the movable retaining element 1350 to release the leaflet clamp 1320 from the leaflet clamp opener 1310. The movable retaining element 1350 can extend proximally from the leaflet clamp opener 1310 toward the control handle 1200 and into the control handle housing 1210 (such as through the opening 1205 in the distal end 1201 of the control handle 1200) to operably engage with the clamp release slider 1282 of the release system 1280. Figure 8 , Fig. 9 and Fig.10 In the example of the embodiment shown, the movable retaining element 1350 can extend through the gasket housing 1244 and the gasket 1246 inside the gasket housing 1244. In some embodiments, the movable retaining element 1350 can be formed as a two-part actuator cable similar to the actuator 1330 described above, wherein the outer cable sheath terminates at a distal entrance into the gasket housing 1244 and the inner cable extends through the gasket 1246 and out of the gasket housing 1244. The proximal end 1353 of the movable retaining element 1350 (such as the proximal end of its inner cable) can be fixed relative to the clamp release slider 1282, such as via one or more fixing posts or screws 1286, such as in Figure 8 and Fig. 9 In the example of an embodiment depicted in . Proximal movement of the clamp release slider 1282 causes proximal movement of the movable retaining element 1350 to move to the disengaged configuration.

[0066] This release of the leaflet clamp 1320 from the leaflet clamp spreader 1310 when the movable retaining element 1350 is moved to the disengaged position can be a one-way release that is generally irreversible. To prevent accidental release of the leaflet clamp 1320, a safety button 1290 can be provided, such as in Figure 7 In the example of the embodiment depicted. The safety button 1290 can be operably engaged with the clamp release slider 1282 to retain the clamp release slider 1282 in a position that retains the movable retaining element 1350 in an engaged position to engage the leaflet clamp 1320 with the leaflet clamp expander 1310. Intentional operation of the safety button 1290 (such as movement of the safety button 1290) disengages the safety button 1290 and the clamp release slider 1282 to allow the clamp release slider 1282 to move to retract the movable retaining element 1350 proximally, thereby moving the movable retaining element 1350 into a disengaged configuration to release the leaflet clamp 1320 from the leaflet clamp expander 1310. In Figure 8 , Fig. 9 and Fig.10In the example of the embodiment shown, the safety button 1290 includes a biasing element 1292 (such as a coil spring) to maintain the safety button 1290 in an engaged locked configuration. The safety button 1290 and the clamp release slider 1282 can be engaged into a locked configuration by engaging corresponding locking elements 1288, 1298 on the clamp release slider 1282 and the safety button 1290, respectively. Figure 8 , Fig. 9 and Fig.10 In the example of the embodiment shown, the locking elements 1288, 1298 are interlocking protrusions or teeth or protrusions and receiving grooves. Lateral movement of the safety button 1290 against the biasing force of the biasing element 1292 releases the interlocking engagement of the locking elements 1288, 1298 to allow the locking elements 1288, 1298 to disengage so that the clamp release slider 1282 can move to move the movable retaining element 1350 to the release position.

[0067] Although the leaflet clip delivery and deployment system 1000 is described herein as being delivered to a heart valve (e.g., Figure 2 ), but the principles of the present disclosure may be applied to the tricuspid valve or other anatomical sites. In addition, the principles of the present disclosure may be applied to clamps or grasping elements other than those configured for use on heart valve leaflets. For example, the principles of the present disclosure may be applied to actuating other devices having movable elements, such as elements that are movable relative to each other (away from each other and / or closer to each other), and / or elements that are biased to at least one of a closed or open position and moved to the other of the open or closed positions and allowed to return to the position to which the device is biased to return.

[0068] In view of the above, it should be understood that the various embodiments shown in the drawings have several separate and independent features, each of which has at least a unique benefit individually, which is desirable, but not critical, for the currently disclosed leaflet clamp delivery and deployment device, system and method. Therefore, in order to achieve at least some of the desired characteristics and / or benefits described herein, the various individual features and structures described herein do not need to exist in full. There may be only one of the various features or structures to achieve the desired characteristics and / or benefits described herein. Alternatively, one or more features or structures described with reference to an embodiment may be combined with one or more features or structures of any other embodiment provided herein. That is, any feature described herein may be mixed and matched to create a mixed design, and such a mixed design is within the scope of the present disclosure. In addition, throughout the present disclosure, reference numerals are used to indicate the common elements or features of the disclosed embodiments. The same or similar reference numerals may be used to indicate elements or features that are not identical in form, shape, structure, etc. but provide similar functions or benefits. Additional reference numerals (e.g., letters, rather than numbers) may be used to distinguish similar elements or features from each other.

[0069] In accordance with the present disclosure, all devices and / or methods disclosed and claimed herein can be made and performed without undue experimentation. Although the devices and methods of the present disclosure have been described according to preferred embodiments, it is obvious to those skilled in the art that the steps or step sequences of the devices and / or methods and the methods described herein can be changed without departing from the concept, spirit and scope of the present disclosure. All such similar alternatives and modifications apparent to those skilled in the art are considered to be within the spirit, scope and concept of the present disclosure as defined by the appended claims.

[0070] 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.

[0071] 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 "one", "one", "said", "first", "second", etc. or the situation where no quantifier is used do not exclude multiple. For example, as used herein, the term "one" or "a kind of" entity refers to one or more of the entity. Therefore, the terms "one" (or "one"), "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 is otherwise clearly specified. As used herein, unless the context clearly indicates otherwise, the conjunction "and", "and" includes each of the structures, parts, features, etc. so combined, and the conjunction "or" includes one or other of the structures, parts, 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.

[0072] 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 / deployment system for delivering and / or deploying a medical device, the medical device having a first arm and a second arm, the first arm and the second arm being movable between a closed configuration in which the two arms are adjacent to each other and an open configuration in which the two arms are displaced apart from each other, the system comprising: a control handle having a control handle housing and an actuator controller movable relative to the control handle housing; a device expander configured to deliver and deploy the medical device and having a first arm configured to engage the first arm of the medical device and a second arm configured to engage the second arm of the medical device; and an actuator coupled to the device expander and extending to and coupled to the actuator controller; in: The actuator control includes a lever handle pivotable relative to the control handle housing to cause the actuator to move the two arms of the device opener between the closed configuration and the open configuration to move the medical device between the closed configuration and the open configuration.

2. The system of claim 1 wherein the actuator is coupled to a first arm of the device expander and extends distally therefrom and then proximally to the actuator controller and is guided around a pulley to couple with the lever handle.

3. The system of any one of claims 1-2, further comprising a grasper limiter operably associated with the control handle to limit the extent to which the device opener opens the medical device.

4. The system of any one of claims 1-3, wherein the actuator controller moves the actuator from a neutral position to an actuated position, the system further comprising a spring assist device within the control handle housing, the spring assist device being configured to assist the actuator in returning to the neutral position when the lever handle is released.

5. The system of claim 4, further comprising an actuator guide housing through which the actuator extends to the actuator controller, wherein: The spring assist device includes a spring plate and a spring within the actuator guide housing; The spring plate is coupled to the actuator; and The spring biases the spring plate to return the actuator to the neutral position.

6. The system according to claim 4, wherein: The spring assist device includes a resilient actuator guide housing configured to return the actuator to the neutral position.

7. The system of any one of claims 1 to 6, wherein: the device expander comprising a movable retaining element configured to move between an engaged retaining position retaining the medical device relative to the device expander and a disengaged position allowing the medical device to be released from the device expander; and The control handle also includes a release system configured to move the movable retaining element from the engaged retaining position to the disengaged position.

8. The system of claim 7, wherein: The release system includes a clamp release slide mounted relative to the control handle housing; the movable retaining element extends from the device expander to the clamp release slider to couple to the clamp release slider; and Withdrawing the clamp release slide from the control handle housing moves the movable retaining element to the disengaged position.

9. The system of claim 8, further comprising a safety button biased to retain the clamp release slide relative to the control handle housing.

10. The system of claim 1, further comprising a flexible elongated member having a distal end and a proximal end and extending distally from the control handle via a steerable flexible elongated member, wherein: The device expander is mounted on the distal end of the flexible elongated member; The proximal end of the flexible elongated member is fixed relative to the control handle; and The control handle is movably mounted on the connecting tube to axially and / or rotationally move the flexible elongated member and the device expander relative to the steerable flexible elongated member.

11. The system of claim 10, further comprising a handle lock operably associated with the control handle to fix a position of the control handle and the device expander relative to the steerable flexible elongate member.

12. A control handle operably associated with a device expander configured to deliver and deploy a medical device, the device expander having a first arm configured to engage a first arm of the medical device and a second arm configured to engage a second arm of the medical device; the control handle comprising: Control handle housing; and an actuator controller movable relative to the control handle housing and including a lever handle pivotable relative to the control handle housing to cause an actuator operably engaged with the device opener and the actuator controller to move the arms of the device opener between a closed configuration and an open configuration to move the medical device between the closed configuration and the open configuration.

13. The control handle of claim 12, further comprising a gripper limiter operably associated with the control handle to limit the extent to which the lever handle moves the device opener to open the medical device.

14. The control handle of claim 13, wherein the gripper limiter includes a limit stop movable relative to the lever handle to limit the extent to which the lever handle can be moved.

15. The control handle of claim 14, wherein the gripper limiter includes an adjustment gauge movable relative to the control handle housing to indicate the extent to which the lever handle can open the device opener to open the medical device.

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