Devices and Systems for Implanting Embedded Devices

Abstract

A delivery / implantation system having a control handle configured to control the delivery / implantation of a medical device having an arm configured to grip tissue therebetween. The system may include a device spreader engaged with the arm of the medical device and controlled by an actuator operably coupled to the control handle. The control handle may include a pivotable lever that similarly pivots the device spreader and the arm of the medical device to an open or closed state. A device holding assembly may be provided for holding the medical device against the device spreader. The control handle may include a release element movable to shift the holding assembly to 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, upon reaching the desired position, may be fixable in a predetermined position by a handle lock.

Description

Technical Field

[0001] The present disclosure generally relates to the technical field of medical devices and systems. More particularly, the present disclosure relates to devices, systems, and methods for implanting implantable devices such as clips or clamps.

Background Art

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

Summary of the Invention

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

[0004] Disclosed herein is that a delivery / implantation system is configured to deliver and / or implant a medical device having a first arm and a second arm that are shiftable between a closed configuration adjacent to each other and a closed configuration that shifts away from each other. According to the principles of the present disclosure, the delivery / implantation system comprises a control handle having a control handle housing and an actuator controller movable relative to the control handle housing, and comprises a device spreader configured to deliver and implant a medical device and 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, and an actuator coupled to the spreader 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 shift the actuator to shift the arms of the device spreader between a closed configuration and an open configuration to shift the medical device between a closed configuration and an open configuration.

[0005] In some embodiments, the actuator is coupled to the first arm of the device spreader, extends distally therefrom, further extends proximally to the actuator controller, is guided around a pulley, and is coupled to the lever handle.

[0006] In some embodiments, the system further includes a grip limiter operably associated with a control handle that limits the range in which the device spreader opens the medical device. In some embodiments, the grip limiter includes a limit stop movable relative to a lever handle that limits the range of motion of the lever handle for the actuator to shift the device spreader to an open configuration. In some embodiments, the grip limiter includes an adjustment gauge movable relative to a control handle housing that indicates the degree to which the lever handle can open the device spreader to open the medical device.

[0007] In some embodiments, the actuator controller shifts the actuator from a neutral position to an operating position, and the system further includes a spring assist within the control handle housing configured to assist in returning the actuator to the neutral position when the lever handle is released. In some embodiments, the system further includes an actuator guide housing through which the actuator passes and extends to the actuator controller, and the spring assist includes a spring and a spring plate within the actuator guide housing, the spring plate being coupled to the actuator and the spring biasing the spring plate to return the actuator to the neutral position. In some embodiments, the spring assist includes an elastic actuator guide housing configured to return the actuator to the neutral position.

[0008] In some embodiments, the device spreader includes a movable retention element configured to shift between an engagement retention position that holds the medical device against the device spreader and a disengagement position that enables the medical device to be released from the device spreader, and the control handle further includes a release system configured to shift the movable retention element from the engagement retention position to the disengagement position. In some embodiments, the release system includes a clip release slider mounted to the control handle housing, the movable retention element extends from the device spreader to the clip release slider and is coupled to the clip release slider, and pulling the clip release slider from the control handle housing shifts the movable retention element to the disengagement position. In some embodiments, the system further includes a safety button biased to hold the clip release slider against the control handle housing.

[0009] In some embodiments, the system further includes a flexible elongate member having a distal end and a proximal end and extending distally through a steerable flexible elongate member from the control handle. In some aspects, the device spreader is attached to the distal end of the flexible elongate member, the proximal end of the flexible elongate member is fixed to the control handle, and the control handle is movably attached to a connecting tube for moving the flexible elongate member and the device spreader axially or rotationally or axially and rotationally with respect to the steerable flexible elongate member.

[0010] In some embodiments, the system further includes a handle lock operably associated with the control handle to fix the positions of the control handle and the device spreader with respect to the steerable flexible elongate member.

[0011] According to the principles of the present disclosure, a control handle operably associated with a device spreader is configured to deliver and implant a medical device, and the device spreader has 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 embodiments, the control handle includes a control handle housing and an actuator controller movable relative to the control handle housing. The actuator controller includes a lever handle pivotable relative to the control handle housing such that the device spreader and an actuator operably engaged with the actuator controller shift the arms of the device spreader between a closed configuration and an open configuration to shift the medical device between a closed configuration and an open configuration.

[0012] In some embodiments, the control handle further includes a grip limiter operably associated with the control handle that limits the range in which the lever handle shifts the device spreader to open the medical device. In some embodiments, the grip limiter includes a limit stop movable relative to the lever handle that limits the range of movement of the lever handle. In some embodiments, the grip limiter includes an adjustment gauge movable relative to the control handle housing that indicates the degree to which the lever handle can open the device spreader to open the medical device.

[0013] In addition, a method of implanting a medical device having first and second arms shiftable between a delivery configuration, an open configuration that permits entry of tissue between the arms, and a closed configuration in which the medical device grips the tissue is disclosed herein. The method includes pivoting a lever handle away from a control handle to shift the medical device to the open configuration and enabling the lever handle to return to a position along the control handle to enable the medical device to shift to the closed configuration.

[0014] In some embodiments, the first and second arms of the medical device are biased towards each other to shift the medical device into a neutral configuration, and a spring assist is provided within the control handle to assist the medical device in returning to the neutral configuration.

[0015] In some embodiments, the method further includes moving a clip release slider relative to the control handle to lodge the medical device by releasing the medical device from a device spreader controlled by the control handle.

[0016] These and other features and advantages of the present disclosure will become readily apparent from the following detailed description, and the scope of the claimed invention is set forth in the appended claims. The following disclosure is presented from the perspective of embodiments or implementations, but it should be understood that individual embodiments can be claimed separately or in combination with the aspects and features of that embodiment or any other implementation.

[0017] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. The accompanying drawings are provided for illustrative purposes only, and the dimensions, positions, order, and relative sizes reflected in the figures in the drawings may be changed. For example, the device may be enlarged so that details are distinguishable, but is intended to be scaled down in relation, for example, to fit within a delivery catheter or the working channel of an endoscope. Considering the length of certain elements, some elements may be identified in more than one location for clarity. On the other hand, not all elements in all figures are labeled, nor are all elements of each embodiment shown, where illustration is not necessary for those skilled in the art to understand the present disclosure for purposes of clarification and simplification.

[0018] The detailed description will be better understood in conjunction with the following appended drawings, in which like reference characters represent like elements.

Brief Description of the Drawings

[0019]

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Modes for Carrying Out the Invention

[0020] The following detailed description should be read with reference to the drawings that illustrate exemplary embodiments. It should be understood that the present disclosure is not limited to the specific embodiments described and may therefore be subject to change. All of the apparatus, systems, and methods discussed herein are examples of apparatus, systems, and / or methods implemented in accordance with one or more principles of the present disclosure. Each example of an embodiment is provided for purposes of explanation and is not the only way to implement these principles, but is merely an example. Therefore, references to elements, structures, or features in the drawings 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. Other examples of ways to implement the disclosed principles will occur to those skilled in the art upon reading the present disclosure. In fact, it will become apparent to those skilled in the art that various modifications and variations can be made to the present disclosure without departing from the scope or spirit of the subject matter. For example, features illustrated or described as part of one embodiment can be used with another embodiment to yield a still further embodiment. Therefore, the subject matter is intended to embrace such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0021] It will be understood that the present disclosure is described in detail at various levels in this application. In certain instances, details that are not necessary for one skilled in the art to understand the present disclosure, or details that make it difficult to recognize other details, may be omitted. The terms used herein are for the purpose of describing only specific embodiments and are not intended to be limiting beyond the scope of the appended claims. Unless otherwise defined, technical terms used herein should be understood as being generally understood by those skilled in the art to which the present disclosure pertains. All of the devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure.

[0022] As used herein, "proximal" refers to the direction or location that is closest to the user (such as a medical professional, clinician, technician, surgeon, physician, etc., which terms are used interchangeably herein without intent to limit and include an automated controller system or other means) when using the device (e.g., when introducing the device into a patient, or during implantation, placement, or delivery), and / or the direction or location that is closest to the delivery device. "Distal" refers to the direction or location that is farthest from the user when using the device (e.g., when introducing the device into a patient, or during implantation, placement, or delivery), and / or the direction or location that is farthest from the delivery device. "Longitudinal" means extending along the longer dimension or greater dimension of an element. The "longitudinal axis" extends along the longitudinal extent of the element but is not necessarily straight and does not necessarily maintain a fixed configuration if the element is bent or curved. "Center" means at least generally intersecting the center point and / or being generally equidistant from the perimeter or boundary. The "central axis" with respect to an opening is a line that at least generally intersects the center point of the opening and, if the opening includes, for example, a tubular element, channel, cavity, or hole, extends longitudinally along the length of the opening. As used herein, "channel" or "hole" is not limited to a circular cross-section. As used herein, the "free end" of an element is the end portion beyond which such element does not extend.

[0023] According to the principles of the present disclosure, a delivery / implantation system is configured to deliver and / or implant a device. According to the principles of the present disclosure, the delivery / implantation system is configured to cause the device to be implanted relative to a treatment site or otherwise cause it in another manner. In some aspects, the delivery / implantation system is configured to operate and / or include a device delivery / implantation system configured to deliver and / or implant a device. In some aspects, the delivery / implantation system includes a handle configured to operate such a device delivery / implantation system to deliver and / or implant an associated device. In some aspects, the device is an implantable device and the device delivery / implantation system is configured to deliver and implant the implantable device, for example, relative to an anatomical site such as a treatment site on or within a patient's body. In some embodiments, the implantable device is a clip or clamp.

[0024] According to the principles of the present disclosure, a delivery / implantation system includes a flexible elongate member, a handle attached to the proximal end of the flexible elongate member, and a device delivery / implantation system attached to the distal end of the flexible elongate member. In some embodiments, the position of the flexible elongate member can be fixed in a desired linear position and / or angular orientation relative to the handle, for example, to prevent linear and / or rotational movement of the handle.

[0025] According to the principles of the present disclosure, repositioning, repairing, and / or replacing one or more valve leaflets of a valve and / or chordae tendineae may be desirable for treating heart disease and may include one or more devices to be secured to one or more valve leaflets of a heart valve. Such devices may include valve leaflet clips or clamps (hereinafter, for convenience and without limitation, "clips"). According to the principles of the present disclosure, a valve leaflet clip delivery and retention system may be used to deliver a valve leaflet clip and retain it against a heart valve leaflet. The valve leaflet clip delivery and retention system may include, for example, a clip spreader configured to deliver and retain a valve leaflet clip to clip the valve leaflet clip onto a heart valve leaflet. As used herein, terms such as clip, attach, affix, clamp, fasten, couple, engage, mount, retain, grip, hold, secure, etc. (including other grammatical forms of those words) are understood to be used interchangeably, without limitation, with respect to, for example, the interaction of a clip with tissue engaged by the clip. Further, it will be understood that an element being coupled or engaged to another element includes both direct and indirect coupling or engagement.

[0026] According to the principles of the present disclosure, a delivery / implantation system is configured to deliver to a treatment site, such as a heart valve (mitral valve or tricuspid valve), and in particular to its leaflet, a device such as a leaflet clip and / or a leaflet clip delivery and implantation system including a leaflet clip. In some aspects, a delivery / implantation system formed in accordance with the principles of the present disclosure is configured to operate or otherwise control a clip delivery and implantation system, such as a clip spreader, to implant a clip. More specifically, in some aspects, the clip delivery and implantation system controls a leaflet clip spreader to implant a leaflet clip against a heart valve leaflet. In some aspects, a delivery / implantation system formed in accordance with the principles of the present disclosure includes a handle configured to deliver a clip, such as a leaflet clip, and / or implant it against a heart valve leaflet. In some aspects, the handle is configured to operate or otherwise control a clip delivery and implantation system, such as a leaflet clip spreader, to implant a clip, such as a leaflet clip, against a heart valve leaflet. Although leaflet clips and leaflet clip spreaders are referred to herein, it will be understood that the present disclosure need not be limited to clips and spreaders specifically configured to grasp a heart valve leaflet, and that the principles of the present disclosure are broader than the examples of the embodiments described herein.

[0027] The leaflet clip can be biased to a closed configuration, for example, to clamp onto tissue. The clip spreader is configured to move the leaflet clip to a configuration for placement relative to the heart leaflet. For example, the leaflet clip can have a first and a second arm coupled together via a flexure zone that can bias the leaflet clip arms towards each other. A leaflet clip delivery and retention system formed in accordance with the principles of the present disclosure is configured to move the clip spreader to an open configuration to separate (e.g., spread) the first and second arms of the leaflet clip. The leaflet clip delivery and retention system is further configured to move (or at least enable movement of) the clip spreader to move the first and second arms of the leaflet clip to a closed configuration clamped onto the heart leaflet. In embodiments where the leaflet clip arms are biased to a closed configuration, the leaflet clip delivery and retention system enables the leaflet clip arms to return to the closed configuration, for example, to clamp onto the heart leaflet. In some embodiments, the leaflet clip delivery and retention system is configured to operate the clip spreader to reopen the leaflet clip that has been released for clamping onto the heart leaflet prior to release of the leaflet clip from the clip spreader when repositioning of the leaflet clip is desired. The spreader arms of the clip spreader and the leaflet clip arms can be coupled to move together. Thus, operating to separate the clip spreader arms causes the leaflet clip arms to separate. The leaflet clip arms can be biased to a closed configuration (towards each other to clamp onto tissue), such that release of the actuating force to the clip spreader arms enables the leaflet clip arms to return to the closed position and also returns the clip spreader arms to the closed position. The leaflet clip delivery and retention system can be further configured to release the leaflet clip from the clip spreader when the leaflet clip is clamped onto the heart leaflet.

[0028] According to various aspects of the present disclosure, a leaflet clip delivery and retention system includes a handle that facilitates the operations described above. The handle can be configured to actuate a leaflet clip spreader, for example, to open or close a leaflet clip to receive or clamp onto a heart leaflet, such as by causing movement of the spreader arms of the leaflet clip spreader. In some embodiments, the handle includes a lever pivotable relative to the body of the handle to open or close the leaflet clip, for example, by operating the leaflet clip spreader to open or close the leaflet clip. In some embodiments, a limiter is positioned to limit the range of movement of the lever, for example, to limit the range in which the lever opens the leaflet clip.

[0029] According to one aspect of the present disclosure, a leaflet clip delivery and retention system includes a release element configured to cause release of a leaflet clip from a leaflet clip spreader when the leaflet clip is at a retention site and optionally engaged with tissue (e.g., a heart leaflet) at the retention site. More specifically, in some embodiments, the leaflet clip spreader can include a movable retention element shiftable between an engaged position engaged with the leaflet clip to maintain the leaflet clip in engagement with the leaflet clip spreader and a disengaged position that allows release of the leaflet clip from the leaflet clip spreader to retain the leaflet clip and remove the leaflet clip spreader and the leaflet clip delivery and retention system. The leaflet clip can be configured to be slidably engaged with the leaflet clip spreader and to be easily releasable from the leaflet clip spreader when the retaining element comes to the disengaged position. When the leaflet clip is positioned as desired, a clip release slider can be actuated to release the leaflet clip from the leaflet clip spreader and thus from the leaflet clip delivery / retention system.

[0030] According to the principles of the present disclosure, the delivery / retention system is configured to shift a movable retention element between an engaged position and a disengaged position. In some embodiments, the delivery / retention system includes a clip release element. In some embodiments, the clip release element is operably associated with the handle of the delivery / retention system. In some embodiments, the clip release element is a clip release slider that is slidable relative to the handle body. For example, the clip release element may be in a lip code configuration. A safety latch may be provided to prevent inadvertent sliding of the clip release slider.

[0031] 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 in which embodiments of the present disclosure may be implemented include, but are not limited to, U.S. Patent Application Publication No. 2021 / 0007847, entitled Devices, Systems, And Methods For Clamping A Leaflet Of A Heart Valve, published on January 14, 2021; U.S. Patent Application Publication No. 2021 / 0000597, entitled Devices, Systems, And Methods For Adjustably Tensioning An Artificial Chordae Tendineae Between A Leaflet And A Papillary Muscle Or Heart Wall, published on January 7, 2021; U.S. Patent Application Publication No. 2021 / 0000598, entitled Devices, Systems, And Methods For Anchoring An Artificial Chordae Tendineae To A Papillary Muscle Or Heart Wall, published on January 7, 2021; U.S. Patent Application Publication No. 2021 / 0000599, entitled Devices, Systems, And Methods For Artificial Chordae Tendineae, published on January 7, 2021; U.S. Patent Application Publication No. 2022 / 0096235, entitled Devices, Systems, And Methods For Adjustably Tensioning Artificial Chordae Tendineae In A Heart, published on March 31, 2022; U.S. Patent Application Publication No. 2023 / 0123832, entitled Devices, Systems, And Methods For Clamping A Leaflet Of A Heart Valve, published on April 20, 2023; and U.S. Patent Application Publication No. 2023 / 0149170, entitled Devices, Systems, And Methods For Positioning A Leaflet Clip, published on May 18, 2023, each of these applications being hereby incorporated by reference in its entirety for all purposes.Examples of devices described herein may be modified to incorporate embodiments or one or more features of the present disclosure.

[0032] Implant systems formed in accordance with the principles of the present disclosure may be used to implant various configurations of implantable devices, such as, but not limited to, various configurations of valve tip clips. It will be understood that the present disclosure is not limited to implantable devices such as valve tip clips shown and described herein.

[0033] Various aspects of a delivery / deployment system formed in accordance with the principles of the present disclosure will now be described with reference to examples shown in the accompanying drawings. Reference herein to "one embodiment," "an embodiment," "several embodiments," "other embodiments," etc. indicates that one or more particular features, structures, concepts, and / or characteristics according to the principles of the present disclosure may be included in association with that embodiment. However, such reference does not necessarily mean that all embodiments include that particular feature, structure, concept, and / or characteristic, or that an embodiment includes all features, structures, concepts, and / or characteristics. Some embodiments may include one or more such features, structures, concepts, and / or characteristics in various combinations 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 of the other embodiments provided herein. That is, any of the features, structures, concepts, and / or characteristics described herein may be mixed or matched to create hybrid embodiments, and such hybrid embodiments are within the scope of the present disclosure. Moreover, references in various places herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc., are not necessarily all referring to the same embodiment, and separate or alternative embodiments are not necessarily mutually exclusive of other embodiments. Furthermore, it is to be understood that various features, structures, concepts, and / or properties of the embodiments of the present disclosure are independent and separate from one another and may be used or exist individually or in various combinations with one another to create alternative embodiments that are considered part of the present disclosure. Thus, since describing all of the numerous possible combinations and subcombinations of features, structures, concepts, and / or properties would be overly burdensome, the present disclosure is not limited to only the embodiments specifically described herein, and the example embodiments disclosed herein are not intended as limiting the broader aspects of the present disclosure.The following description is merely an exemplary example of an embodiment and is not intended to limit the broader aspects of the present disclosure.

[0034] Common features are identified by common reference elements, and it will be understood that, for the sake of brevity and convenience and without intending to limit, the description of common features will not normally be repeated. For clarity, not all components having the same reference numeral are labeled. Further, groups of like elements may be indicated by numbers and letters, and reference to one or such elements, or such elements as a group, may generally be made by numbers only (without including the letters associated with each like element). Further, a particular feature in one embodiment may be used across different embodiments and need not necessarily be individually labeled when it appears in different embodiments.

[0035] Next, referring to the drawings, FIG. 1 shows an example of an embodiment of a delivery / implantation system 1000 formed in accordance with the principles of the present disclosure. The delivery / implantation system 1000 is optionally part of a larger delivery / implantation system 100, such as those described in more detail in the co-pending provisional patent application [Attorney Docket No. 2001.2787100] filed on June 21, 2022, entitled Devices, Systems, And Methods For Steering A Catheter, and the co-pending provisional patent application [Attorney Docket No. 2001.2755100] filed on June 21, 2022, entitled Devices, Systems, And Methods For Deploying An Implantable Device. Each of these applications is hereby incorporated by reference in its entirety for all purposes. As shown in the detailed figures, an illustrative example of an embodiment of the larger delivery / implantation system 100 includes an introducer shaft 110 (which may also be referred to as a delivery sheath, without intending to be limiting) configured to guide / deliver the delivery / implantation system 100 to a treatment area. Therefore, the introducer shaft 110 defines a lumen therein that is sized, shaped, configured, and / or dimensioned to allow a further device and / or system, such as a device and / or system to be delivered / implanted by the delivery / implantation system 1000, to pass through the lumen for delivery to the treatment site. As used herein, a treatment area is an area of a patient's body where the treatment site is located on or within. As used herein, a treatment site is an anatomical site at which treatment will be performed using the system and / or device delivered by the delivery / implantation systems 100, 1000. The reference to "at" a treatment site is intended to include at the treatment site or in the vicinity thereof (e.g., along, adjacent to, etc. the treatment site) and is understood not to be limited to the exact treatment site only.Furthermore, it will be understood that in this specification, references to treatment sites, anatomical sites, delivery sites, retention sites, implant / implantation sites, sites of implantation, target sites, etc. are made interchangeably and without intention of limitation. The introducer shaft 110, for example, may be steerable using a control handle 120 operably associated therewith, and may be steerable, for example, in one or two directions within a steering plane. The delivery / retention system 100 may include an additional steerable flexible elongate member 210 configured to provide the delivery / retention system 1000 with additional steering capabilities to guide and direct the device and / or system closer to the desired treatment site. The steerable flexible elongate member 210 may be tubular and define a lumen therein. The sizing, shaping, structure, and / or dimensions of the lumen are designed to allow further devices and / or systems to be passed therethrough for delivery to the treatment site. For example, devices and / or systems such as those delivered / retained by the delivery / retention system 1000 can pass through the lumen. The steerable flexible elongate member 210 is steerable and may be capable of, for example, bi-directional steering within a steering plane or four-directional steering within two orthogonal steering planes. For example, this may include using a control handle 220 operably associated therewith.

[0036] An example of one embodiment of the delivery / retention system 1000 shown in FIG. 1 includes a flexible elongate member 1100 (e.g., a delivery catheter, shaft, tube, etc.) having a control handle 1200 operably associated therewith. The flexible elongate member 1100 is configured to deliver the device delivery / retention system 1300 to a treatment site. The control handle 1200 is operably associated with the flexible elongate member 1100 and / or the device delivery / retention system 1300 to deliver the device delivery / retention system 1300 to the treatment site and / or to operate the device delivery / retention system 1300 to retain the device at the treatment site.

[0037] According to the principles of the present disclosure, the delivery / implantation system 1000 can deliver, activate, and / or implant a heart repair device and / or system, such as a heart valve leaflet repair device and / or system. According to various further principles of the present disclosure, the delivery / implantation system 1000 can deliver, activate, and / or implant a leaflet clip and / or a delivery / implantation system 1300 for delivering / implanting the leaflet clip. As an example of a device delivery / implantation system 1300 delivered, activated, and / or implanted by the delivery / implantation system 1000, one in the form of a clip delivery / implantation system 1300 for a heart valve leaflet repair device is shown in FIG. 2 as an example of a treatment area within the heart. More specifically, an example of an embodiment of the leaflet clip delivery / implantation system 1300 is shown in FIG. 2 as being delivered by the delivery / implantation system 1000 via an insertion sheath 110 and a steerable flexible elongate member 210. The introducer shaft 110 delivers the leaflet clip delivery and implantation system 1300 to a treatment area such as a ventricle in an example of an embodiment shown in FIG. 2. The steerable flexible elongate member 210 can further guide and direct the flexible elongate member 1100 of the delivery / implantation system 1000 to deliver the leaflet clip delivery and implantation system 1300 to a treatment site such as a heart valve leaflet L in an example of an embodiment shown in FIG. 2. It will be understood that further details of an example of an embodiment of the components and operations of the introducer shaft 110 and the steerable flexible elongate member 210 are provided in the co-pending provisional patent application [Attorney Docket No. 2001.2787100] incorporated as described above. However, the present disclosure need not be limited by the examples of the embodiments disclosed therein.

[0038] According to one aspect of the present disclosure, the valve tip clip delivery and retention system 1300 delivered by the delivery / retention system 1000 is configured based on the principles of the present disclosure. The valve tip clip delivery and retention system 1300 includes a valve tip clip spreader 1310 configured to deliver and retain a valve tip clip 1050, as shown in more detail in FIGS. 3 and 4. The valve tip clip delivery and retention system 1300 can be mounted and delivered to the distal end 1101 of the flexible elongate member 1100. The flexible elongate member 1100 may be referred to herein as a spreader shaft or a grasping portion shaft 1100, but is not intended to be limited thereby. The valve tip clip spreader 1310 includes a ventricular spreader arm 1312 and an atrial spreader arm 1314, which may be pivotally coupled to each other, for example, around a hinge or pivot 1316. The ventricular spreader arm 1312 is configured to engage a ventricular clip arm 1322 of the valve tip clip 1320 (the arm of the valve tip clip 1320 configured to be positioned on the side of the cardiac valve tip L facing the ventricle). The atrial spreader arm 1314 is configured to engage an atrial clip arm 1324 of the valve tip clip 1320 (configured to be positioned on the side of the cardiac valve tip L facing the atrium). In embodiments where the ventricular clip arm 1322 and the atrial clip arm 1324 of the valve tip clip 1320 are biased towards each other, the coupling of the valve tip clip spreader 1310 to the valve tip clip 1320 may enable the valve tip clip 1320 to generally maintain the ventricular spreader arm 1312 and the atrial spreader arm 1314 of the valve tip clip spreader 1310 in a closed configuration until actuated to an open configuration.

[0039] According to one aspect of the present disclosure, the valve tip clip delivery and retention system 1300 can be navigated to the heart valve tip L by the operation of the control handle 1200. For example, the grasping portion shaft 1100 can be coupled to the control handle 1200. Thereby, the rotation and / or axial movement of the control handle 1200 causes a corresponding rotational movement and / or axial movement of the grasping portion shaft 1100 (e.g., around or along the longitudinal axis LA indicated in FIGS. 3 and 7, by way of example). In the example of the embodiment shown in FIGS. 7-10, the grasping portion shaft 1100 is operably coupled to the control handle 1200 via a hub system 1230. The hub system 1230 can also serve to position and support the grasping portion shaft 1100 within and relative to the connection tube 1110. The connection tube 1110 can be fixedly attached to the control handle 220 of the steerable flexible elongate member 210, and the control handle 1200 is movably mounted axially and rotationally on the connection tube 1110. The proximal end 1103 of the grasping portion shaft 1100 can be joined within a seat groove within an adapter 1232 (such as that shown in FIG. 9). The adapter 1232 is also coupled to the control handle housing 1210, and the grasping portion shaft 1100 moves with the movement of the control handle housing 1210 (e.g., relative to the connection tube 1110). More specifically, in the example of the embodiment shown in FIG. 9, the adapter 1232 is joined on a hub 1234, and the hub 1234 is joined on the distal end 1241 of the grasping portion extension shaft 1240. The proximal end 1243 of the grasping portion extension shaft 1240 is joined within an extension shaft hub 1242 mounted within the proximal end 1203 of the control handle housing 1210. The extension shaft hub 1242 is mounted within the control handle housing 1210 to be movable with the control handle housing 1210 using, for example, a key connection or the like. Therefore, the axial or rotational movement of the control handle housing 1210 is transmitted to the grasping portion shaft 1100 via the grasping portion extension shaft 1240, the hub 1234, and the adapter 1232.It will be understood that it is not essential to join any or all of the control handle housing 1210, the gripping portion extension shaft 1240, the hub 1234, the adapter 1232, and the gripping portion shaft 1110 in order to couple one movement to cause the movement of another. For example, a key connection, or other mechanical connection, or connection by other means that enables the axial or rotational movement of one element to be transmitted to an element connected thereto will also be understood by those skilled in the art to be within the scope and spirit of the present disclosure.

[0040] After the desired position of the valve tip clip delivery and retention 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 valve tip clip delivery and retention system 1300. In the example of the embodiments shown in FIGS. 7, 8, 9, and 10, a handle lock 1202 (such as a collet) can be operably associated (e.g., provided thereon) with the distal end 1211 of the control handle housing 1210. By fixing the position of the control handle 1200, it becomes possible to fix the position of the grasping portion shaft 1100 and the valve tip clip delivery and retention system 1300 in the desired position. More specifically, the control handle 1200 can be attached to a connection tube 1110 that extends between the valve tip clip delivery and retention system control handle 1200 and the steerable flexible elongate member control handle 220 (e.g., as shown in FIG. 1). Therefore, the connection tube 1110 can be considered as a grasping portion telescopic shaft that expands and contracts in the direction of extending the grasping portion shaft 1100 out of and retracting it into the steerable flexible elongate member 210, and enables rotation of the grasping portion shaft 1100 relative to the steerable flexible elongate member 210. The handle lock 1202 can be rotatable relative to the distal end 1211 of the control handle housing 1210. For example, it can be configured to clamp a gripping finger 1212 formed on the distal end 1211 of the control handle housing 1210 onto the connection tube 1110 to fix the control handle 1200 relative to the connection tube 1110. The handle lock 1202 can be threadedly engaged with the distal end 1211 of the control handle housing 1210. Thereby, rotation in one direction clamps the gripping finger 1212 onto the connection tube 1110, and rotation in the opposite direction loosens the engagement of the gripping finger 1212 with the connection tube 1110, allowing the control handle 1200 to move relative to the connection tube 1110. A set screw 1214 can hold the handle lock 1202 on the distal end 1211 of the control handle housing 1210. Thereby, the handle lock 1202 can be configured to be movable relative to the control handle housing 1210 (e.g., movable in the distal or proximal direction) while not coming off the control handle housing 1210.

[0041] According to a further aspect of the present disclosure, a valve tip clip delivery and retention system 1300 formed based on the principles of the present disclosure includes an actuator 1330 (e.g., a pull wire) operably engaged with a valve tip clip spreader 1310, thereby driving the valve tip clip spreader 1310 and shifting it between a delivery configuration (e.g., shown in FIGS. 2, 3, and 4) and an open configuration (e.g., shown in FIG. 5). More specifically, when the valve tip clip 1320 is in the delivery configuration, the valve tip clip spreader arms 1312, 1314 and the valve tip clip arms 1322, 1324 are generally in a neutral position, e.g., a closed configuration. The actuator 1330 operates the valve tip clip spreader 1310 to shift the valve tip clip spreader arms 1312, 1314 and the valve tip clip arms 1322, 1324 to an open position (spreading and separating the valve tip clip spreader arms 1312, 1314) to facilitate retention of the valve tip clip 1320. In the open configuration, the heart valve tip L can enter between the valve tip clip arms 1322, 1324. This entry can occur by the natural movement of the heart valve tip L (enabling the heart valve tip L to "catch" by allowing the heart valve tip L to move into the space between the valve tip clip arms 1322, 1324) or by moving the valve tip clip spreader 1310 such that the valve tip clip arms 1322, 1324 surround the heart valve tip L. In the closed configuration, the valve tip clip 1320 is clamped onto and gripping the heart valve tip L, e.g., as shown in FIG. 6.

[0042] In some embodiments, the actuator 1330 is coupled to at least one of the arms 1312, 1314 of the valve tip clip spreader 1310, e.g., as shown in FIG. 3, and can be configured to move the ventricular spreader arm 1312 relative to the atrial spreader arm 1314. In an illustrated example of one embodiment, the actuator 1330 includes an actuator cable 1332 having a distal end portion 1331 coupled to the ventricular spreader arm 1312. The proximal end of the actuator cable 1332 1333 is coupled to the control handle 1200 (shown schematically in FIGS. 8 and 9 and described in further detail below), enabling a medical professional to operate the actuator 1330 (e.g., outside the patient's body). The actuator cable 1332 can be made of metal, polymer, or other suitable biocompatible material. The material has the ability to withstand the forces necessary to operate the valve tip clip spreader 1310 and can be navigated through a tortuous path within the patient's body. In some embodiments, the actuator cable 1332 takes the form of a Bowden cable having an outer cable sheath 1335 and an inner cable 1337 (e.g., a pull wire). The outer cable sheath 1335 extends distally from the control handle 1200 and can terminate, for example, at a Bowden end attached to the valve tip clip spreader 1310 and within a pull cable passage 1334. The inner cable 1337 proceeds further distally, wraps around the distal end 1311 of the valve tip clip spreader 1310 and the valve tip clip 1320, and is coupled to the valve tip clip spreader arms 1312, 1314 (e.g., the ventricular spreader arm 1312). Thereby, for example, when the actuator cable 1332 is pulled (e.g., when the inner cable 1335 is pulled proximally), the valve tip clip spreader arms 1312, 1314 are configured to move relative to the other valve tip clip arms 1324, 1322. The distal end 1331 of the actuator cable 1332 can be secured to the ventricular spreader arm 1312, for example, by coupling the inner cable 1337 to a cable holder 1336 (e.g., a boss). The cable holder 1336 (e.g., a boss) can be attached to, coupled to, or otherwise secured to the ventricular spreader arm 1312. The distal end 1331 of the actuator cable 1332 (e.g., the inner cable 1337) can pass through a hole 1339 in the cable holder 1336 and can have a widened most distal end (e.g., a free end). The most distal end prevents the actuator cable 1332 from being pulled out of the hole 1339 when the ventricular spreader arm 1312 is actuated to open.The widened distal end of the actuator cable 1332 can be formed by the actuator cable 1332 itself (e.g., a knot or loop in the actuator cable 1332, or a crimping or widening or stretching process). Alternatively, it can be formed by an element coupled to the distal end, such as a metal attachment part 1338 (e.g., a crimp collar, cylinder, bead, overmold holder positioned to cover the actuator cable 1332, or a pin or other element around which the actuator cable 1332 is wound, etc.). Other methods of coupling elements of the actuator 1330, such as the actuator cable 1332, to the valve tip clipper 1310 (e.g., welding, brazing, adhesion, interference fit, etc.) are also within the scope and spirit of the present disclosure, and it will be understood that their details are not crucial to the general principles of the present disclosure. In some embodiments, the actuator 1330 is coupled to the valve tip clipper 1310 with its distal end 1331 positioned adjacent to the free end of the ventricular spreader arm 1312. It then extends distally towards the pivot 1316, further extending around the perimeter of the distal end 1311 of the valve tip clipper 1310, and then extending towards the proximal end 1313 of the valve tip clipper 1310 and further proximally towards the control handle 1200. Such a configuration can generally be understood to allow an optimal force vector to be applied to operate the valve tip clipper 1310.

[0043] Actuator 1330 extends proximally within the grasping portion shaft 1100, for example, from a valve tip clip delivery and retention system 1300 (as shown, for example, in FIG. 3) to a control handle 1200 of the valve tip clip delivery and retention system 1000 shown in FIG. 1. As can be more readily understood by reference to the enlarged view of FIG. 7, the control handle 1200 includes a body, i.e., a housing 1210, to which an actuator controller 1220 is operably associated. The control handle housing 1210 can be formed by two housing sections or halves 1210a, 1210b. The halves 1210a, 1210b are coupled to each other to form the control handle housing 1210 and define an interior 1215 shown in further detail in FIGS. 8-10. In the example of the embodiment shown in FIGS. 8-10, actuator 1330 extends into interior 1215 of control handle housing 1210 (e.g., through an opening 1205 generally within distal end 1201 of control handle 1200) and is operably engaged with an actuator controller 1220 operably associated with control handle 1200. For example, as shown in FIGS. 8, 9, and 10, actuator 1330 can extend through a hub system 1230 within distal end 1211 of control handle housing 1210. More specifically, hub 1234 of hub system 1230 can include an actuator guide 1235 through which actuator 1330 is guided. In some embodiments, actuator guide 1235 is attached to a cap 1236 at the distal end of hub 1234. Hub 1234 can also accommodate a gasket 1238 that seals the interior 1215 of housing 1210 from additional components of the larger delivery / retention system 100 that extend proximally from the grasping portion shaft 1110 and hub system 1230 thereto. Thereby, gasket 1238 can seal the interior 1215 of housing 1210 from body fluids and / or saline or other fluids that may be within the grasping portion shaft 1110. In some embodiments, gasket 1238 is accommodated, for example, as in the example of the embodiment shown in FIG. 8, between the body of hub 1234 and cap 1236.An additional guide ring 1244 may be mounted along the gripping portion extension shaft 1240 to further guide elements such as the actuator 1330 inside the interior 1215 of the control handle housing 1210.

[0044] 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 control handle housing 1210. The actuator guide housing 1250 is supported within the control handle housing 1210, for example, by engaging a housing extension 1250a (e.g., a wing) with the interior 1215 of the control handle housing 1210 (e.g., support elements formed therein). In one embodiment where the actuator 1330 is formed from a two-part actuator cable 1332, the outer sheath 1335 of the actuator cable 1332 may terminate at a distal cap 1252a mounted to the distal end 1251 of the actuator guide housing 1250. The inner cable 1337 extends through the actuator guide housing 1250 to its proximal end 1253 and extends through a proximal seal cap 1252b mounted to the proximal end 1253 of the actuator guide housing 1250. The proximal seal cap 1252b may function as a seal or gasket for the actuator cable 1332. For example, it may serve to seal the inner cable 1337 from any body fluid within the interior 1215 of the control handle housing 1210.

[0045] The actuator 1330 can be operably coupled to the actuator controller 1220 in some manner, for example, the movement of the actuator controller 1220 via the movement of the lever handle 1222 causes the movement of the actuator 1330 to operate the valve tip clip delivery and retention system 1300. In the example of the embodiments shown in FIGS. 8, 9, and 10, the actuator 1330 extends proximally towards the proximal end 1203 of the housing 1210, loops around the proximal pulley 1204, extends distally and loops around the distal pulley 1206, and further extends towards a fixed location on the actuator controller 1220. The proximal end 1333 of the actuator 1330 is fixed to the actuator controller 1220 via, for example, one or more fixed posts or screws 1208. In the example of the embodiment shown in FIG. 9, the proximal end 1333 of the actuator 1330 can loop around two fixed posts 1208 to fix the actuator 1330 to the actuator controller 1220. As can be understood with reference to FIG. 10, for example, by pivoting the lever handle 1222 relative to the handle housing 1210, the actuator controller 1220 moves. This movement of the actuator controller 1220 pulls the actuator 1330 proximally. Further, as can be understood with reference to FIG. 3, by pulling the actuator 1330 proximally, the spreader arms 1312, 1314 of the valve tip clip spreader 1310 open. For example, by pulling to separate the ventricular spreader arm 1312 from the atrial spreader arm 1314, the valve tip clip spreader 1310 opens as shown in FIG. 5. Finally, it can be understood that the pulleys 1204, 1206 can not only facilitate the movement of the actuator 1330, but also align the actuator 1330 with the gripping portion shaft 1100 when the actuator 1330 transitions between the actuator controller 1220 and the gripping portion shaft 1100.

[0046] More specifically, in an example of an embodiment shown in FIGS. 7, 8, 9, and 10, the actuator controller 1220 includes a lever handle 1222 that is movably associated with the control handle housing 1210 and extends along its side (e.g., generally parallel to its longitudinal axis LA). As can be understood with reference to FIGS. 7, 8, 9, and 10, an illustrated example of an embodiment of the lever handle 1222 is pivotally coupled (e.g., via a lever pivot pin 1223) to the proximal end portion 1203 of the control handle housing 1210, extends through a lever opening 1207 formed in the control handle housing 1210, and extends distally toward the distal end portion 1211 of the control handle housing 1210. However, it will be understood that other configurations are also within the scope and spirit of the present disclosure. In some aspects, the lever handle 1222 pivots away from the control handle housing 1210 to operate the actuator controller 1220 to operate the actuator 1330 to open the valve tip clip 1320. Similarly, in some aspects, pivoting of the lever handle 1222 toward the control handle housing 1210 enables the valve tip clip 1320 to close, for example, by operating the actuator controller 1220 to operate the actuator 1330 to close the valve tip clip 1320. Such movement of the lever handle 1222 may be considered to correspond to the associated opening and closing movement of the valve tip clip 1330.

[0047] Various features and structures can be provided. The features and structures regulate, modify, or adjust, for example, the actuator 1330 and the tip clip delivery and retention system 1300 by regulating, modifying, or adjusting the movement of the actuator controller 1220. For example, in some embodiments, a grip limiter 1260 is provided for the control handle housing 1210 and the lever handle 1222 that limits the extent to which the actuator controller 1220 can be opened, thereby limiting the amount by which the tip clip 1320 can be opened. An example of one embodiment of the grip limiter 1260 shown in FIGS. 8 - 10 includes a grip limiter control knob 1262 that advances or retracts a limit stop 1264 relative to a shoulder stop 1224 on the actuator controller 1220. As 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 grip limiter 1260. Contact of the shoulder stop 1224 with the limit stop 1264 limits the movement of the actuator controller 1220, thereby limiting the linear movement of the actuator 1330. By limiting the movement of the actuator 1330, the grip limiter 1260 limits the level at which the tip clip spreader 1310 and the tip clip 1320 are opened and determines the angle at which the tip clip 1320 opens. Therefore, the grip limiter 1260 can be considered an angle setting mechanism that sets a correlation between the operation of the actuator controller 1220, such as the operation of opening or pivoting the lever handle 1222, and the range in which the tip clip spreader 1310 opens the tip clip 1320. The grip limiter 1260 may include an adjustment gauge 1266. The adjustment gauge 1266 is operably associated with (e.g., attached to) the grip limiter control knob 1262 and has an indicator 1267 that represents the range in which the tip clip 1320 is opened by the operation of the lever handle 1222.More specifically, by the movement (e.g., rotation) of the grasping portion limiter control knob 1262, the grasping portion limiter control knob 1262, the limit stop 1264, and the adjustment gauge 1266 move forward or backward relative to the control handle housing 1210 and the shoulder stop 1224 on the lever handle 1222. With the movement of the grasping portion limiter control knob 1262, the adjustment gauge 1266 extends into or advances out of the opening 1209 within 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 range within which the valve tip clip 1320 opens. When used in a heart valve repair procedure, the valve tip clip arms 1322, 1324 can be opened approximately 45° or approximately 60° relative to each other, for example, to capture the heart valve tip L therebetween. The valve tip clip arms 1322, 1324 can be opened further, for example, up to a maximum of approximately 135°, to adjust the position of the valve tip clip 1320 relative to the heart valve tip L or one or more chordae tendineae. If the valve tip clip 1320 becomes entangled with one or more chordae tendineae, the valve tip clip arms 1322, 1324 can be opened up to approximately 180° (which can be referred to as "escape") so as to be more easily removed from the treatment area. Such opening of the valve tip clip 1320 exceeds the strain rate of the valve tip clip 1320 and, therefore, can deform and break the valve tip clip 1320 for further use. However, it extends (exceeds the strain rate). The indicator 1267 can be advantageously used to control the opening of the valve tip clip arms 1322, 1324 as desired.

[0048] When the leaflet clip arms 1322, 1324 are biased against each other into a closed configuration to clamp an element such as tissue (e.g., heart leaflet L) therebetween, then at this time, the leaflet clip arms 1322, 1324 can be enabled to close simply by removing the opening force against, for example, 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., as shown in FIGS. 7, 8, and 9). For example, in some embodiments, a spring such as the torsion spring 1270 returns the lever handle 1222 to a neutral position that does not actuate the actuator 1330, in order to enable, for example, the leaflet clip 1320 to return to a neutral position (e.g., a closed position as shown by way of example in FIG. 3). Thereby, the torsion spring 1270 serves as a spring assist that enables the leaflet clip 1320 to return to a neutral configuration such as a closed configuration when the opening force is no longer applied to the lever handle 1222.

[0049] In some embodiments, after the force to the actuator 1330 is released, one or more aids are provided to reduce the effect that forces such as friction (within the systems 100, 1000, etc.) can have on the previous pulling force to the actuator 1330, to enable the actuator 1330 to return to a neutral closed configuration where the valve tip clip 1320 (e.g., clamps on the heart valve tip L). For example, in the example of the embodiment shown in FIG. 9, the actuator guide housing 1250 can exert a frictional force on the actuator 1330, for example, through one or both of its caps 1252a, 1252b, and / or a gasket within the actuator guide housing 1250. For example, in some embodiments, one or more additional gaskets can be provided within the actuator guide housing 1250. In the example of the embodiment shown in FIG. 9, the outer sheath 1335 of the actuator 1330 is joined to the distal sealing cap 1252a, and the inner cable 1337 extends through and is joined to its proximal spring plate 1254a adjacent to the distal sealing cap 1252a. The inner cable 1337 extends proximally through the actuator guide housing 1250 and optionally also through its distal proximal gasket 1254b adjacent to the proximal sealing cap 1252b. The illustrated actuator guide housing 1250 includes a spring 1256 operably associated with the actuator 1330 to assist the actuator 1330 in moving distally relative to the actuator guide housing 1250. More specifically, when the actuator controller 1220 is actuated to pull the actuator 1330 in the proximal direction and open the valve tip clip spreader 1310, the spring 1256 is compressed. That is, the spring plate 1254a is pulled in the proximal direction, and the spring 1256 is compressed 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 location adjacent to the distal sealing cap 1252a.This assists in pulling / returning the actuator 1330 to its original position (before actuation of the actuator controller 1220) and returning the valve tip clip 1230 to a neutral (e.g., closed) configuration. The proximal end of the spring 1258 abuts against and / or may push away from a spring washer 1258 positioned between the spring 1258 and the proximal gasket 1254b to protect the proximal gasket 1254b.

[0050] Alternatively, in an example of one embodiment shown in FIG. 11, the actuator guide housing 1250 may be an actuator guide housing 1250' having elasticity such as elasticity, stretchability, expandability, etc. The distal end 1251' of the actuator guide housing 1250' may be joined to the hub assembly 1230, and the proximal end 1253' of the actuator guide housing 1250' may be joined to the inner cable 1337 of the actuator 1330 (the outer sheath 1335 of the actuator 1330 terminates within the hub assembly 1230). Therefore, the actuator guide housing 1250' expands with the proximal movement of the actuator 1330 when the actuator controller 1220 is actuated. When the actuator controller 1220 is no longer actuated, the expanded actuator guide housing 1250' returns to its neutral configuration and returns the actuator 1330 to its original position to assist in returning the valve tip clip 1320 to a neutral (e.g., closed) configuration. Optionally, to eliminate the need for additional gaskets to seal around (and potentially add friction to the sliding of) moving cables / pull wires such as the actuator 1330, the actuator guide housing 1250' is a sealed pull wire gasket coupled (e.g., joined) to the actuator 1330 (e.g., the inner cable 1337).

[0051] If for any reason it is desired or medically indicated to adjust the position of the valve leaflet clip 1320 (e.g., if a different position or orientation of the valve leaflet clip 1320 is desired and / or medically indicated, and / or if any component of the valve leaflet clip delivery and implantation system 1000 becomes snagged on a chordae tendineae, etc.), the valve leaflet clip spreader 1310 can be actuated again to release the valve leaflet clip 1320, and the valve leaflet clip delivery and implantation system 1000 can be shifted to the desired position for implantation of the valve leaflet clip 1320.

[0052] After the valve leaflet clip 1320 is closed onto tissue such as the heart valve leaflet L (as shown in FIG. 6) and closed at the desired and / or medically indicated implantation position, the valve leaflet clip spreader 1310 can be removed to leave the valve leaflet clip 1320 in a predetermined position at the implantation position. Optionally, the valve leaflet clip 1320 can be coupled (in any manner well known to those skilled in the art) to an artificial chordae tendineae that extends therefrom and is anchored, for example, to a papillary muscle of the ventricle at another location. The artificial chordae tendineae anchor and associated delivery / implantation system can be any as known to those skilled in the art or as described in U.S. Patent Application Publication No. 2023 / 0123832, incorporated hereinabove, and Provisional Patent Application [Attorney Docket No. 2001.2755100] filed on June 21, 2022. The artificial chordae tendineae can be coupled to the valve leaflet clip 1320 during delivery and implantation of the valve leaflet clip 1320 and extend outwardly from the side of the valve leaflet clip spreader 1310 (as shown in FIGS. 3 and 4, for example) toward and be coupled to the artificial chordae tendineae anchor carried within the valve leaflet clip spreader 1310, it will be understood.

[0053] Generally, it will be understood that it is desirable to maintain the valve tip clip spreader 1310 operably associated with the valve tip clip 1320 until the valve tip clip 1320 and associated anchor are fully deployed. In some embodiments, a retention assembly 1340 is operably associated with the valve tip clip spreader 1310 and the valve tip clip 1320 to hold the valve tip clip spreader 1310 integrally with the valve tip clip 1320 and avoid their inadvertent separation. In one embodiment, such as that shown in FIG. 4, the atrial spreader arm 1314 of the valve tip clip spreader 1310 includes an atrial spreader arm retaining element 1342 in the form of a protrusion, and the atrial clip arm 1324 of the valve tip clip 1320 includes a mating atrial valve tip clip arm retaining element 1344 in the form of a detent or aperture. In some embodiments, the atrial spreader arm retaining element 1342 is in the form of a boss and is insertable within the atrial valve tip clip arm retaining element 1344 in the form of an aperture. A movable retention element 1350 may hold the atrial spreader arm retaining element 1342 and the atrial valve tip clip arm retaining element 1344 in an engaged retention position (as shown in FIG. 3). For example, the movable retention element 1350 can be a wire having a distal end 1351 insertable through an aperture 1347 that passes through the atrial spreader arm retaining element 1342. In such a configuration, the movable retention element 1350 prevents or inhibits movement of the atrial clip arm 1324 of the valve tip clip 1320 relative to the valve tip clip spreader 1310. The movable retention element 1350 can be shifted to a release position to allow the valve tip clip 1320 and the valve tip clip spreader 1310 to move relative to each other. For example, the movable retention element 1350 can be pulled out (e.g., proximally) from the aperture 1347 within the atrial spreader arm retaining element 1342 to allow the valve tip clip 1320 to separate from the valve tip clip spreader 1310. In some embodiments, the movable retention element 1350 is in the form of a wire, filament, tether, cable (such as a Bowden cable), or the like.These are withdrawn from the atrial valve leaflet clip arm retaining element 1344 in the form of bosses. This removes the obstacle that prevents the movement of the valve leaflet clip 1320 relative to the valve leaflet clip spreader 1310, and the valve leaflet clip 1320 can be moved proximally. The movement between the atrial spreader arm 1314 and the atrial clip arm 1324 can generally be sliding and may not include further movement in other directions.

[0054] According to the principles of the present disclosure, the control handle 1200 of the delivery / retention system 1000 includes a release system 1280, such as shown in FIG. 7, to which the movable retention element 1350 is operatively coupled. Operation of the release system 1280 causes the movable retention element 1350 to operate and the valve tip clip 1320 to be released from the valve tip clip spreader 1310. More specifically, the release system 1280 of the example embodiments shown in FIGS. 7-10 includes a clip release slider 1282 operable to shift the movable retention element 1350 from an engaged position to a disengaged position. Optionally, the clip release slider 1282 includes a finger grip formation 1285 (such as the raised portion or other friction-reducing formation shown in FIGS. 9 and 10). The finger grip formation 1285 facilitates gripping of the clip release slider 1282 when moving the clip release slider 1282 relative to the control handle housing 1210 to actuate the movable retention element 1350 to release the valve tip clip 1320 from the valve tip clip spreader 1310. The movable retention element 1350 may extend proximally into the control handle housing 1210 from the valve tip clip spreader 1310 (e.g., through the opening 1205 at the distal end 1201 of the control handle 1200) and is operatively engaged with the clip release slider 1282 of the release system 1280. In the example embodiments shown in FIGS. 8, 9, and 10, the movable retention element 1350 may extend through the gasket housing 1244 and the gasket 1246 within the gasket housing 1244. In some embodiments, the movable retention element 1350 may be formed as a two-part actuator cable similar to the actuator 1330 described above, having an outer cable sheath that terminates at a distal inlet into the gasket housing 1244 and an inner cable that extends out of the gasket housing 1244 through the gasket 1246.The proximal end 1353 of the movable retention element 1350, e.g., the proximal end of its inner cable, can be fixed to the clip release slider 1282 via, for example, one or more fixed posts or screws 1286, as in the example of one embodiment shown in FIGS. 8 and 9. The proximal movement of the clip release slider 1282 causes a proximal movement of the movable retention element 1350 that shifts to the disengaged configuration.

[0055] When the movable retention element 1350 is shifted to the disengaged position, such release of the tip clip 1320 from the tip clip spreader 1310 can be a generally irreversible, one-way release. To prevent inadvertent release of the tip clip 1320, a safety button 1290 can be provided as in the example of the embodiment shown in FIG. 7. The safety button 1290 can be operably engaged with the clip release slider 1282, hold the clip release slider 1282 in a position that holds the movable retention element 1350 in the engaged position, and maintain the tip clip 1320 in an engaged state with the tip clip spreader 1310. Intentional operation of the safety button 1290, such as moving the safety button 1290, etc., releases the engagement of the safety button 1290 and the clip release slider 1282, allowing the clip release slider 1282 to be moved to retract the movable retention element 1350 proximally, shift the movable retention element 1350 to the disengaged configuration, and release the tip clip 1320 from the tip clip spreader 1310. In the examples of the embodiments shown in FIGS. 8, 9, and 10, the safety button 1290 includes a biasing element 1292 such as a coil spring and holds the safety button 1290 in an engaged lock configuration. The safety button 1290 and the clip release slider 1282 can be engaged in a locked configuration by the engagement of respective lock elements 1288, 1298 on the clip release slider 1282 and the safety button 1290. In the examples of the embodiments shown in FIGS. 8, 9, and 10, the lock elements 1288, 1298 are interlocking protrusions or teeth, or protrusions and receiving slots. A lateral shift of the safety button 1290 against the biasing force of the biasing element 1292 releases the interlocking engagement of the lock elements 1288, 1298, enabling the lock elements 1288, 1298 to disengage so that the clip release slider 1282 can be moved to shift the movable retention element 1350 to the release position.

[0056] In this specification, although the cusp clip delivery and retention system 1000 is described as being delivered to a heart valve as a treatment site (as shown in FIG. 2), the principles of the present disclosure may also be applicable to the tricuspid valve, or other anatomical sites. Further, the principles of the present disclosure may also be applicable to clips or grasping elements other than those configured for use at a heart valve cusp. For example, the principles of the present disclosure may be applied to operate other devices having movable elements, such as elements that are movable relative to each other (away from and / or towards each other), and / or biased to at least one of a closed or open position, moved to the other of the open or closed positions, and enabled to return to a position to which the device is biased to return.

[0057] In view of the above, it should be understood that the various embodiments shown in the figures each have several distinct and independent features that are each, at least alone, desirable, but not essential, inherent advantages for the cusp clip delivery and retention devices, systems, and methods of the present disclosure. Accordingly, the various distinct features and structures described herein need not all be present to achieve at least some of the desired characteristics and / or advantages described herein. Only one of the various features or structures may be present to achieve the desired characteristics and / or advantages described herein. Alternatively, one or more of the features or structures described with reference to one embodiment may be combined with one or more of the features or structures of any of the other embodiments provided herein. That is, any of the features described herein may be mixed or coordinated to create a hybrid design, and such hybrid designs are within the scope of the present disclosure. Further, throughout the present disclosure, reference numerals are used to indicate general elements or features of embodiments of the present disclosure. The same or similar reference numerals may be used to indicate elements or features that are not identical in form, shape, structure, etc., but that provide similar functions or advantages. Additional reference characters (such as letters as opposed to numbers) may be used to distinguish similar elements or features from each other.

[0058] All of the devices and / or methods disclosed and claimed in this specification can be made and executed without undue experimentation in light of this disclosure. Although the devices and methods of this disclosure have been described in terms of preferred embodiments, it may be apparent to those skilled in the art that variations can be applied to the devices and / or methods described herein and to the steps or series of steps of the methods without departing from the concept, spirit, and scope of this disclosure. All such similar substitutes and modifications apparent to those skilled in the art are considered to be within the scope of the spirit, scope, and concept of this disclosure as defined by the appended claims.

[0059] The foregoing discussion has broad applicability and is presented for purposes of illustration and explanation and is not intended to limit the disclosure to one or more forms disclosed herein. It will be understood that various additions, modifications, and substitutions can be made to the embodiments disclosed herein without departing from the concepts, spirit, and scope of the disclosure. In particular, it will be apparent to those skilled in the art that the principles of the disclosure can be embodied in other forms, structures, arrangements, ratios, and using other elements, materials, and components without departing from its concepts, spirit, or scope, or its characteristics. For example, various features of the disclosure are grouped together as one or more aspects, embodiments, or configurations for purposes of streamlining the disclosure. However, it should be understood that the various features of a particular aspect, embodiment, or configuration of the disclosure can be combined as alternative aspects, embodiments, or configurations. The disclosure is presented from the perspective of embodiments, but it should be understood that the various distinct features of the subject matter need not all be present to achieve at least some of the desired characteristics and / or advantages of the subject matter or such individual features. Those skilled in the art will understand that the disclosure can be used with many modifications, or structures, arrangements, ratios, materials, components, and other modifications used in the practice of the disclosure, specifically adapted to particular environments and operating requirements without departing from the principles, spirit, or scope of the disclosure. For example, an element shown as being integrally formed can be composed of multiple parts, or an element shown as multiple parts can be integrally formed, the operation of an element can be reversed or otherwise changed, and the size or dimensions of an element can be changed. Similarly, although operations, actions, or procedures are described in a particular order, this should not be understood to mean that such a particular order is required to achieve a desired result, or that all operations, actions, or procedures should be performed. Further, other implementations are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve a desired result.Therefore, embodiments of the present disclosure should be considered illustrative in all respects and not restrictive, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to the foregoing description or to the specific embodiments or configurations described or illustrated herein. In view of the foregoing, the individual features of any embodiment can be used separately or in combination with the features of that embodiment or any other embodiment and can be claimed, and the scope of the subject matter is indicated by the appended claims and is not limited to the foregoing description.

[0060] In the foregoing description and the following claims, the following points will be understood. The phrases “at least one,” “one or more,” and “and / or” are open-ended expressions that are used as both conjunctive and disjunctive when used in this specification. The terms “a,” “an,” “the,” “first,” “second,” etc. do not exclude a plurality. For example, the term “a” or “an” entity, when used in this specification, refers to one or more of that entity. Therefore, the terms “a” (or “an”), “one or more,” and “at least one” can be used interchangeably in this specification. When used in this specification and the appended claims, the term “or” is generally used in the sense of “and / or” unless the context clearly indicates otherwise. When used in this specification, the conjunction “and” includes each of the structures, components, features, etc. so combined, unless the context clearly indicates otherwise, and the conjunction “or” includes one or the other of the structures, components, features, etc. so combined, alone as well as in any combination and number, unless the context clearly indicates otherwise. All references to direction (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, etc.) are used for identification purposes only to assist the reader's understanding of the present disclosure and / or to help distinguish the areas of the associated elements from each other and do not particularly limit the associated elements with respect to the position, orientation, or use of the present disclosure. References to connection (e.g., attached, coupled, connected, engaged, and joined) should be construed broadly and may include intermediate members between sets of elements and relative movement between elements unless otherwise indicated. Therefore, references to connection do not necessarily imply that two elements are directly connected and in a fixed relationship to each other.References to identification (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority and are used to distinguish one feature from another.

[0061] The following claims are hereby incorporated by reference into this "Detailed Description of the Invention", and each claim stands on its own as a separate embodiment of the present disclosure. In a claim, the terms "comprises", "comprising", "includes", and "including" do not exclude the presence of other elements, components, features, groups, regions, integers, steps, acts, etc. Additionally, individual features may be included in different claims, and these may, in some cases, be advantageously combined, and being included in different claims does not imply that combinations of features are not feasible and / or not advantageous. Further, references to the singular are not intended to exclude the plural. Reference numerals in the claims are provided merely as examples for clarity and should in no way be construed as limiting the claims.

Claims

1. A delivery / implantation system for delivering or implanting or delivering and implanting a medical device having a first arm and a second arm that are shiftable between a closed configuration adjacent to each other and a closed configuration that shifts away from each other, said system comprising: a control handle, said control handle having a control handle housing and an actuator controller movable relative to said control handle housing; a device spreader, said device spreader being configured to deliver and implant said medical device and having a first arm configured to engage said first arm of said medical device and a second arm configured to engage said second arm of said medical device; an actuator, said actuator being coupled to said spreader device and extending to and coupled to said actuator controller; said actuator controller includes a lever handle, said lever handle being pivotable relative to said control handle housing to shift said actuator to shift the arms of said device spreader between a closed configuration and an open configuration to shift said medical device between a closed configuration and an open configuration. A delivery / implantation system.

2. The system of claim 1, wherein said actuator is coupled to said first arm of said device spreader, extends distally from said first arm, further extends proximally to said actuator controller, and is guided around a pulley to be coupled to said lever handle.

3. The system of claim 1 or 2, wherein said device spreader further comprises a grip limiter operably associated with said control handle that limits the range of opening of said medical device.

4. The actuator controller is configured to shift the actuator from a neutral position to an operating position, and the system further comprises a spring assist within the control handle housing configured to assist in returning the actuator to the neutral position when the lever handle is released. The system according to any one of claims 1 to 3.

5. Further comprising an actuator guide housing, the actuator extends through the actuator guide housing to the actuator controller, The spring assist includes a spring and a spring plate within the actuator guide housing, The spring plate is coupled to the actuator, The spring biases the spring plate to return the actuator to the neutral position, the system according to claim 4.

6. The spring assist includes an elastic actuator guide housing configured to return the actuator to the neutral position, the system according to claim 4.

7. The device spreader includes a movable retention element, the movable retention element is configured to shift between an engagement retention position that holds the medical device against the device spreader and a release position that allows the medical device to be released from the device spreader, The control handle further comprises a release system, the release system is configured to shift the movable retention element from the engagement retention position to the release position, The system according to any one of claims 1 to 6.

8. The release system includes a clip release slider, the clip release slider is mounted to the control handle housing The movable retention element extends from the device spreader to the clip release slider and is coupled to the clip release slider, Withdrawal of the clip release slider from the control handle housing shifts the movable retention element to the release position, The system according to claim 7.

9. The system according to claim 8, further comprising a safety button biased to hold the clip release slider against the control handle housing.

10. Further comprising a flexible elongate member having a distal end and a proximal end, the flexible elongate member extends distally from the control handle through a steerable flexible elongate member, The device spreader is mounted to the distal end of the flexible elongate member, The proximal end of the flexible elongate member is fixed to the control handle, The control handle is movably attached to a connecting tube for moving the flexible elongate member and the device spreader axially or rotationally or both axially and rotationally relative to the steerable flexible elongate member, the system of claim 1.

11. The system of claim 10, further comprising a handle lock, the handle lock being operably associated with the control handle for fixing the positions of the control handle and the device spreader relative to the steerable flexible elongate member.

12. A control handle, the control handle being operably associated with a device spreader, the device spreader being configured to deliver and implant a medical device having a first arm configured to engage a first arm of the device spreader and a second arm configured to engage a second arm of the device spreader, the control handle comprising: a control handle housing, and an actuator controller movable relative to the control handle housing, the actuator controller including a lever handle pivotable relative to the control handle housing for shifting an arm of the device spreader between a closed configuration and an open configuration so that an actuator operably engaged with the device spreader and the actuator controller shifts the medical device between a closed configuration and an open configuration. Control handle.

13. The control handle of claim 12, further comprising a grip limiter, the grip limiter being operably associated with the control handle for limiting the range in which the lever handle shifts the device spreader to open the medical device.

14. The grip limiter of claim 13 includes a limit stop, the limit stop being movable relative to the lever handle that limits the range of movement.

15. The grip limiter of claim 14 includes an adjustment gauge, the adjustment gauge being movable relative to the control handle housing to indicate the range in which the lever handle can open the device spreader to open the medical device.

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