Removable sliding actuator for valve repair devices

Abstract

This invention describes various embodiments of an implant delivery system comprising at least one removable actuator for reshaping the valve annulus. The system can use the removable actuator to customize annulus reshaping at the treatment site and, after customized reshaping, withdraw the actuator from the treatment site to deliver a low-profile annulusoplasty implant.

Description

[0001] Cross-references to related applications

[0002] Pursuant to 35 U.S.SC §119, this application claims the benefit of priority to U.S. Provisional Patent Application 62 / 869,227, filed July 1, 2019, the entire contents of which are incorporated herein by reference for all purposes. Technical Field

[0003] This invention relates generally to the field of implantable medical devices, and more particularly to implantable devices, systems and methods for modifying cardiac characteristics. Background Technology

[0004] The mitral valve is located between the left atrium and left ventricle of the heart. The mitral valve consists of two leaflets, an anterior leaflet and a posterior leaflet, which close during the contraction of the heart. The mitral annulus is a saddle-shaped fibrous ring that surrounds the mitral valve and supports the leaflets. In a healthy heart, blood flows through the open mitral valve during diastole as the left ventricle contracts, and the mitral valve leaflets close during systole as the left atrium contracts.

[0005] Mitral regurgitation (MI) (also known as mitral regurgitation or mitral atresia) is a form of heart disease in which the mitral valve annulus is excessively dilated and the valve leaflets no longer effectively close or shut off during systole. As a result, blood flows back during ventricular systole, leading to a decrease in cardiac output.

[0006] The goal of mitral annuloplasty is to restore the mitral valve's function by restoring the physiological morphology and function of the normal mitral valve assembly (including the mitral valve and one or more of the mitral annulus). Some intracavitary mitral annuloplasty techniques use a deployment catheter and transcavitary navigation to deliver the implant to the mitral valve treatment site.

[0007] While intracardiac annuloplasty is less invasive than open-heart annuloplasty, cardiac implants are not without risks. For example, devices attached to the heart are subjected to stresses and strains associated with myocardial palpitations. For these reasons, the improvements of this invention may be useful. Summary of the Invention

[0008] Embodiments of the present invention relate to a system and method for deploying low-profile valvular annulus implants, such as for reshaping heart valvular annulus. According to one aspect, the implant delivery system includes a frame having a proximal end, a distal end, and adjacent struts joined at a proximal apex. The system includes an actuator removably coupled to the frame and comprising one or more axially translatable adjustment components configured to expand or contract the frame.

[0009] In some embodiments, one or more axially translatable adjustment components of the actuator may include a shaft including a distal shaft end, the distal shaft end including a shaft head positioned within an opening at a proximal apex of the frame; and a collar disposed on at least a portion of the shaft including the shaft head to retain the shaft head within the opening at the proximal apex, the collar being configured to travel distally along the shaft and at the proximal apex of the frame in response to a first activation of the shaft to engage an adjacent strut. The collar may be configured to travel axially proximal in response to a second activation of the shaft to release the shaft head from the proximal end of the frame.

[0010] The shaft may include a proximal shaft end having a drive connector and a shaft engagement feature disposed along a portion of an engagement portion between the drive connector and the shaft end. A collar may include a proximal end, a distal end, and a hole extending therethrough, the hole including a hole engagement feature disposed on at least a portion of the hole's inner surface, the shaft engagement feature being configured to engage with the hole engagement feature to allow translation of the collar along the shaft. In some embodiments, the length of the shaft engagement portion may be at least equal to the length of the collar. In some embodiments, at least one of the shaft engagement feature or the hole engagement feature includes one or more threads, and one of a first activation or a second activation of the shaft includes rotation of the shaft. In some embodiments, the frame may include a second plurality of struts joined at a distal apex, the distal apex supporting an anchor housing, the anchor housing including a tightening cavity extending therethrough, the tightening cavity being configured to slidably receive a tightening band.

[0011] In some embodiments, adjacent struts of the frame include an offset configuration, and the collar includes an extension mechanism configured to push the adjacent struts to prevent them from returning to the offset configuration. The extension mechanism may include at least one arm configured to engage at least one of the adjacent struts to push at least one strut to prevent it from returning to the offset configuration.

[0012] In some embodiments, the release head from the proximal vertex releases the extension mechanism between adjacent struts, thereby returning the adjacent struts to the offset configuration.

[0013] In other embodiments, the frame may include a plurality of distal vertices, and a plurality of anchor housings may be disposed on at least a subset of the plurality of distal vertices, each anchor housing supporting an anchor, and the actuator may include a sleeve; a plurality of cantilever tubes disposed within the sleeve and coupled at their proximal ends to a distal portion of the sleeve; a plurality of drive shafts, each translatably disposed within one of the plurality of cantilever tubes and configured to extend beyond the distal end of the associated cantilever tube to drive one of the anchors; a core disposed within the sleeve such that the plurality of cantilever tubes slidably engage the outer surface of the core, the core being configured to translate axially within the sleeve, wherein each cantilever tube includes a flexural portion. In such an embodiment, the axial translation of the core causes the cantilever tubes to rotate at the flexural portions to change the angular deflection of the distal ends of the cantilever tubes to expand the distal vertices of the frame.

[0014] In some embodiments, the core may include a plurality of arms circumferentially arranged within a sleeve, wherein the plurality of arms may translate independently within the sleeve to independently control the angular deflection of the respective cantilever tube. In some embodiments, each drive shaft may translate axially beyond the distal end of the associated cantilever tube to control the shape of the frame.

[0015] In some embodiments, the inflatable device may be disposed within the central cavity of the core and configured to control the angular deflection of the plurality of cantilever tubes. In some embodiments, the core may include a plurality of deflectors, each deflector being used to slidably support one of the plurality of cantilever tubes.

[0016] According to another aspect, the system includes a frame having a proximal end, a distal end, and adjacent struts joined at multiple distal vertices and multiple proximal vertices. The system includes multiple anchors supported by the distal vertices of the frame, and actuators removably coupled to the frame and including one or more axially translatable adjustment components configured to expand or contract the frame. The axially translatable adjustment components are configurable to be removed via a conduit after the frame has been attached to the annular tissue by the multiple anchors.

[0017] In some embodiments, one or more axially translatable adjustment components may include a shaft including a distal shaft end, the distal shaft end including a shaft head positioned within an opening at a proximal vertex of the frame; and a collar disposed on at least a portion of the shaft including the shaft head to retain the shaft head within the opening at the proximal vertex, the collar being configured to travel distally along the shaft and at one of a plurality of proximal vertices of the frame in response to a first activation of the shaft to engage adjacent struts to expand or compress the frame, and the collar being configured to travel axially proximally in response to a second activation of the shaft to release the shaft head from the proximal vertex of the frame.

[0018] In some embodiments, the system may include a plurality of anchor housings disposed on at least a subset of a plurality of distal vertices, each anchor housing supporting one of the plurality of anchors. One or more axially translatable adjustment components of the actuator may include a sleeve; a plurality of cantilever tubes disposed within the sleeve and coupled at their proximal ends to a distal portion of the sleeve; a plurality of drive shafts, each translatably disposed within one of the plurality of cantilever tubes and configured to extend beyond the distal end of the associated cantilever tube to drive one of the anchors; and a core disposed within the sleeve such that the plurality of cantilever tubes slidably engage the outer surface of the core, the core being configured to translate axially within the sleeve, wherein each cantilever tube includes a flexural portion, and wherein the axial translation of the core causes the cantilever tube to rotate at the flexural portion to change the angular deflection of the distal end of the cantilever tube to expand the distal vertices of the frame.

[0019] According to another aspect, a method for deploying an implant delivery system to a valve annulus repair site includes the step of delivering the distal end of a catheter including an implant component transluminally to the valve annulus repair site. In some embodiments, the implant delivery system may include a frame including a first plurality of struts joined at a plurality of vertices; and an actuator coupled to the frame and including one or more axially translatable adjustment components. The method includes releasing the frame from the catheter, adjusting the shape of the frame by expanding or contracting the frame via the axially translatable adjustment components, anchoring the frame to the valve annulus repair site, and releasing the anchor from the frame.

[0020] In some embodiments, the implant delivery system may include a plurality of collars, each collar being disposed at one of a plurality of vertices of a frame, wherein the step of adjusting the shape of the frame includes translating the collars along the plurality of vertices of the frame, and the step of releasing the anchors from the frame includes removing the collars from the plurality of vertices of the frame.

[0021] In other embodiments, the implant delivery system may further include a cannula; a plurality of cantilever tubes disposed within the cannula; a plurality of drive shafts, each translatably disposed within one of the plurality of cantilever tubes and coupled to a frame; and a mandrel extending through the cannula; and the step of adjusting the shape of the frame includes axially translating the mandrel within the cannula to change the angular deflection of the distal end of the cantilever tube.

[0022] Using this arrangement provides the potential for low-profile valve ring implants with increased flexibility and reduced risk of migration, breakage, thrombosis, and embolism. Attached Figure Description

[0023] Non-limiting embodiments of the invention are described by way of example with reference to the illustrative and not scaled-up accompanying drawings. In the drawings, each identical or nearly identical component shown is generally represented by a single number. For clarity, not every component is labeled in every figure, and not every component in each illustrated embodiment is necessary for those skilled in the art to understand the invention. In the drawings:

[0024] Figure 1 illustrates an embodiment of a reconstructed valve annulus implant in the prior art;

[0025] Figure 2 is a detailed view of a portion of the prior art reconstructed valve annulus implant shown in Figure 1;

[0026] Figures 3A-3D This is a perspective view of an exemplary actuator according to an embodiment of the present invention;

[0027] Figure 4A and 4B This is a diagram of an exemplary implant according to an embodiment of the present invention;

[0028] Figure 5 This is a diagram of an implant that is anchored and tightened according to an embodiment of the present invention;

[0029] Figures 6A-6C An embodiment of an anchor housing configured according to the present invention is shown;

[0030] Figure 7 This is a diagram showing the actuator removed according to an embodiment of the present invention;

[0031] Figure 8A and 8B An exemplary implant with the actuator removed according to an embodiment of the present invention is shown;

[0032] Figure 9A and 9B This is a perspective view of an embodiment of a collar including an extension mechanism according to an embodiment of the present invention;

[0033] Figure 10A and 10B An exemplary implant comprising an extender mechanism in a deployment and anchoring configuration is shown according to an embodiment of the present invention;

[0034] Figure 11A and 11B This is a diagram showing the removal of an actuator including an extender mechanism according to an embodiment of the present invention;

[0035] Figure 12 An exemplary implant is shown as part of the exemplary implant delivery and actuator removal method of the present invention;

[0036] Figure 13 An exemplary deployment apparatus for use with an implant, according to an embodiment of the invention, is shown.

[0037] Figure 14 An exemplary embodiment of an implant delivery system including a removable actuator as disclosed herein is shown;

[0038] Figure 15A and 15B An embodiment of the implant delivery system as disclosed herein is shown in an expanded configuration;

[0039] Figure 16 An exemplary embodiment of the flared tube configuration as disclosed herein is shown;

[0040] Figures 17A-17C Various views of the core assembly with independently controlled arms, as disclosed herein, are shown;

[0041] Figure 18A and 18B Examples of implant delivery systems as disclosed herein are shown; and

[0042] Figure 19A and 19B Alternative embodiments of implant delivery systems including inflatable actuation mechanisms, as disclosed herein, are shown. Detailed Implementation

[0043] Valve annulusoplasty implants may include independently controlled actuators capable of customizing valve annulus remodeling during deployment. Figure 1 illustrates an atrium 120 in which a prior art implant 100 is deployed around a heart valve 150, such that a plurality of anchors 102a-102f of the implant are positioned to engage with a valve annulus 175. The implant 100 includes a basic tubular frame 110 formed by a plurality of struts 112a-112f, which are engaged proximally by collars 104a-104d and distally by anchors 102a-102f. Anchors 102a-102f may each be coupled to anchor drivers 106a-106f. In one embodiment, the anchor drivers are configured to rotate the anchors 102a-102f during the anchoring step of implant deployment to drive the anchors into tissue adjacent to the valve annulus 175. In one embodiment, the collars may be configured to advance distally on the struts. For example, collar 104b may translate along axis A in FIG1. ​​In some embodiments, “axial” as applied to the axial movement or constraint of the collar includes a direction at least partially proximal or distal and a direction parallel or substantially parallel to the central axis extending through (e.g., proximal-distal) the frame.

[0044] As shown in Figure 1, struts 112c and 112d can extend in opposite directions away from the proximal apex of the support collar 104b. The collar 104b advances distally over struts 112c and 112d, pulling struts 112c and 112d together within the collar 104b, thus reducing the distance between anchors 102c and 102d and reshaping the petal ring 175. Collars 104a-104d can be actuated independently according to the reshaping target of each anchor pair. In one embodiment, once each collar is actuated, the drive cable can be released from the actuator drivers 108a, 108b, and 108c.

[0045] Figure 2 illustrates a deployed prior art implant 200, such as a portion of implant 100 in Figure 1. For example, due to activation of shaft 205a, collar 204a is advanced distally along struts 212a, 212b to pull anchors 202b and 202c together. By activating shaft 205b, collar 204b is advanced distally along struts 212c, 212d to pull anchors 202c and 202d together. According to one aspect, the strut may include features configured to restrict translation of the collar along the strut. For example, strut 212b is shown including a flange 213 positioned to restrict distal translation of collar 204a along strut 212b, and a lip 207 disposed at the proximal end of strut 212b to restrict proximal translation of collar 204a.

[0046] The prior art devices shown in Figures 1 and 2 enable a less invasive, anatomically preserved, and patient-specific valve repositioning solution. However, over time, prolonged contact between struts 212a, 212b and the rigid collar 204a can create high-strain regions on the struts, increasing the likelihood of material fatigue and fracture. For example, when the collar 204a slides downwards on struts 212a, 212b, pressure from the collar can be transmitted to point P1 on strut 212a, resulting in high strain at point S1. Similarly, pressure at clamp point P2 leads to high strain at point S2 on strut 212b. Over time, these high-strain regions may become fatigued and fractured, reducing implant effectiveness.

[0047] In addition to device fatigue, it should be recognized that, according to one aspect, it is desirable to reduce the profile of the implant to minimize the possibility of unintentional contact between the implant and the heart wall. Furthermore, it is desirable to minimize the presence of threads or other features (such as screws) in the implant that could potentially lead to thrombosis.

[0048] According to one aspect, an improved implant design, system, and deployment method overcomes these problems by removing at least a portion of the implant after anchoring and actuation. Using such an arrangement, the advantages of valve annulus customization can be achieved without associated risks.

[0049] According to one embodiment, removal of at least a portion of the implant can be achieved by introducing an implant including a removable actuator. In one embodiment, the removable actuator may include an axle supported by a frame apex and a collar translatably disposed on at least a portion of the axle. The collar may be configured to travel distally along the axle and at a proximal apex of the frame to engage adjacent struts at the proximal apex, thereby reducing the spacing between anchors. According to one aspect, the implant may include a clamping mechanism to hold the frame in an actuated configuration. Once actuated and held, the collar may be configured to travel proximal along the axial direction to expose the axle, thereby releasing it from the frame. In one embodiment, the collar may include a locking mechanism to secure the axle within the collar for removal. Removing both the collar and the axle provides several advantages. For example, removing the collar and the axle provides a low-profile implant, which minimizes the possibility of unintentional contact with the heart wall. Removing the axle reduces threads and other features, thereby minimizing the risk of thrombosis. Removing the collar relieves stress on the frame, thereby reducing the risk of fracture. In addition, removing the collar from the valve annulus implant allows for the use of lighter, less robust frame materials, since the frame does not need to be designed to withstand fracture forces during long-term use.

[0050] These and other beneficial aspects of the disclosed implant are described in more detail below. It should be noted that while embodiments of the invention may be specifically described with reference to the mitral valve, the principles disclosed herein can be readily adapted to facilitate the reconstruction of any valvular annulus (e.g., including the tricuspid valve annulus) and / or may similarly benefit any other dilatation, valvular insufficiency, valvular leakage, or other similar heart failure conditions.

[0051] As used herein, the term "distal" refers to the end furthest from the medical professional when the medical device is introduced into the patient, while the term "proximal" refers to the end closest to the medical professional when the medical device is introduced into the patient.

[0052] Figures 3A-3D An embodiment of the actuator 300 of the present invention is shown in various views and configurations. Figure 3A It is actuator 300 along Figure 3B Cross-sectional view along centerline 3A-3A. Figure 3AIn this embodiment, actuator 300 is shown as including shaft 320 disposed within bore 350 of collar 340. In one embodiment, collar 340 is an axially translatable adjustment assembly configured to control one of expansion and / or contraction of the implant frame. Shaft is shown including proximal end 322, engagement portion 324, and distal end 326. In one embodiment, shaft head 325 may be disposed at the distal end 326 of shaft 320 and carried by a portion of the frame on which collar 340 translates. For example, the frame may define a window or other opening for carrying shaft head, such that shaft 320 can rotate freely or substantially freely within the opening about its axis of rotation, but is constrained or substantially constrained for axial movement and / or release from the frame.

[0053] In some embodiments, shaft 320 includes an elongated structural member extending through a central axis of bore 350. Shaft 320 may include a threaded shaft having one or more threads and is rotatable inward to collar 340. Rotational forces on shaft 320 may be transmitted from external engagement features of shaft 320, such as external threads 323, to corresponding internal features of collar 340, such as teeth or internal threads 343, thereby causing axial movement of collar 340. It should be noted that external threads 323 may be included only on a portion of shaft 320. For example, Figure 3A In the example, the thread within a length of 324 can be provided only in the lower half or one-third of the threaded portion shown to achieve the same function. The upper half or two-thirds can be a simple circle without threads, or at or below the minor diameter of the thread.

[0054] According to one aspect, the length of the engagement portion, for example, the length of the portion of the shaft including the external thread 323, may be at least equal to the length of the collar 340, to ensure that the collar 340 can be translated proximally on the shaft 320, thereby exposing the shaft head 325 for release.

[0055] In some embodiments, shaft 320 may be columnar. In other embodiments, shaft 320 may have other shapes or be partially columnar, etc. The width of shaft 320 may be constant along all or part of the shaft. In some embodiments, the width may vary along all or part of the shaft. Shaft 320 may be solid, hollow, partially solid, or partially hollow. Shaft 320 may be formed of stainless steel, cobalt-chromium, titanium, other implant-grade materials, polymers, plastics, alloys, other suitable materials, or combinations thereof.

[0056] The external thread 323 of shaft 320 may have a variety of different pitches and inner / outer diameters. Shaft 320 may have one or more portions of the external thread 323 with a measured diameter of about 0.010 to about 0.090 inches, about 0.020 to about 0.080 inches, about 0.030 to about 0.070 inches, or about 0.040 to 0.060 inches, or other numbers or ranges. This diameter may be the outer diameter measured from one peak of thread 323 to the opposite peak. Shaft 320 may have about 10 to about 150 threads per inch, about 20 to about 140 threads per inch, about 30 to about 130 threads per inch, about 40 to about 120 threads per inch, about 50 to about 130 threads per inch, about 60 to about 120 threads per inch, about 70 to about 110 threads per inch, about 80 to about 100 threads per inch, or other numbers or ranges. In some embodiments, the shaft may include a portion with an external thread having a measuring diameter of about 0.040 to about 0.060 inches and about 60 to about 120 threads per inch. The thread pitch and inner / outer diameter may be complementary to the corresponding internal thread 343 of the collar 340.

[0057] The shaft 320 may also include a drive coupling 327 integrally formed with or coupled to the proximal end 322 of the shaft 322 and a neck 321. In one embodiment, the neck 321 includes a portion of the shaft 320 having a reduced diameter. In one embodiment, a flange 329 extends radially beyond the neck 321 and is positioned proximal to the neck 321. In some embodiments, the flange 329 may be configured to limit the proximal extension of a collar on the shaft.

[0058] The collar 340 includes a bore 350 extending from a proximal end 370 to a distal end 360. As described above, the bore 350 may include an internal thread 343 or other features disposed on the inner wall of the bore 350 that cooperate with the external thread 323 of the shaft 320 to translate the collar 340 onto the shaft 320 when the shaft is driven. For example, the internal thread 343 may be a thread or other feature that is a complementary, continuous or discontinuous helical pattern configured to slidably and / or rotatably engage some or all of the external thread 323 of the shaft 320.

[0059] The collar 340 may also include features that cooperate with the shaft to restrict the travel of the collar 320 and / or lock the collar to the shaft. Such features may include a pair of arms 346a, 346b that can be biased inward toward the central axis of the bore 350 in a relaxed biased configuration. Arms 346a, 346b may be fixed at a distal end within the bore 350 of the collar, and / or may be integrally formed with the collar at a distal end. Arm lugs 344a, 344b coupled to the distal ends of arms 346a, 346b may be configured to engage the neck 321 when the collar is advanced proximally to align the lugs 344a, 344b with the neck 321 of the shaft.

[0060] The collar 340 and / or its features, such as arms 346a, 346b and lugs 344a, 344b, may be formed of a shape memory material, such as a nickel-titanium alloy, such as nitinol. In some embodiments, the collar 340 and / or its features, such as lugs 344a, 344b, may be formed of other materials, such as metals, other metal alloys, plastics, polymers, composite materials, other suitable materials, or combinations thereof.

[0061] Figure 3B yes Figure 3A A perspective view of the actuator 300 facing the distal side. In one embodiment, the collar may have a generally rectangular shape and a length L. 轴环 and width W 轴环 The collar 340 may include an inwardly facing surface 310 oriented towards the central axis of the implant frame during use. An opposing surface (not shown) may be the surface of the collar 340 opposite the inner surface 310. Figure 3B In the configuration, lugs 344a and 344b are shown in the unlocked position, with the shaft freely riding within the bore of collar 340. Neck 321 is shown extending beyond the proximal end of collar 340.

[0062] Figure 3C This is a cross-section of the actuator 300 in a locked state, where the shaft 320 is fixed within the collar 340 for removal from the valve treatment site, along... Figure 3D The line 3C-3C is cut off. Figure 3C In this process, the collar 340 is translated proximally to expose the shaft head 325, thereby enabling the shaft head 325 to be released from the opening in the frame. During the proximal advancement of the collar 340 on the shaft 320, as the neck 321 aligns with the lugs 344a, 344b, the arms 346a, 346b are biased inward to engage the lugs 344a, 344b with the neck 321. As a result, the proximal surface of the lugs contacts the distal surface of the flange 329, thereby limiting further proximal movement of the shaft during removal to effectively lock the shaft to the collar.

[0063] Figure 3D yes Figure 3C A three-dimensional view of the actuator 300 facing the distal side. Figure 3D In the image, lugs 344a and 344b are seen to be biased inward and held by flange 329. With this arrangement, the threads or other features of the actuator can be surrounded by a collar during actuator removal, thereby reducing the likelihood of thrombosis and other embolic risks caused by the threads and / or sharp edges of the implant.

[0064] Such as Figures 3A to 3DRemovable actuators can be advantageously utilized in transluminal implants to customize valve annulus reshaping while minimizing safety and efficacy risks. It should be understood that transluminal implants can take many forms; for example, some implants may include shape memory frames biased to present a compressed morphology, while others may include shape memory frames biased to present an expanded or partially contracted morphology. There are also some that utilize mechanically controlled expansion or contraction techniques.

[0065] This article describes various embodiments of removable actuators. It should be understood that the actuator can be incorporated for use with a variety of implantable devices, including, but not limited to, those described in, for example, U.S. Patent Application 14 / 861,877 (Published April 11, 2017, Patent No. 9,615,926), entitled "Adjustable Intravascular Imaging for Reshaping the Mitral Valve Annulus," filed September 22, 2015; those described in, for example, U.S. Patent Application 15 / 280,004 (Published July 2, 2019, Patent No. 10,335,275), entitled "Method for Delivering a Heart Valve Device Using Intravascular Ultrasound Imaging," filed September 29, 2016; and those described in, for example, U.S. Patent Application 15 / 043,301 (Published December 26, 2017, Patent No. 9,848,983), entitled "Valve Replacement Using Rotating Anchors," filed February 12, 2016; and so on. The entire contents of each of these patent applications are incorporated herein by reference for all purposes and form part of this specification, including, for example, U.S. Patent Application 15 / 352,288 (released February 11, 2020, Patent No. 10,555,813) entitled "Implantable Device and Delivery System for Reshaping Heart Valve Annulus," filed November 15, 2016; U.S. Patent Application 14 / 427,909 (released April 4, 2017, Patent No. 9,610,156) entitled "Mitral Valve Reversal Prosthesis," filed March 12, 2015; and / or, for example, U.S. Patent Application 15 / 893,122 (released February 4, 2020, Patent No. 10,548,731) entitled "Implantable Device and Delivery System for Reshaping Heart Valve Annulus," filed February 16, 2006. Therefore, the description of specific features and functions in this paper does not imply the exclusion of other equivalent features and functions, such as those described in the incorporated references.

[0066] Figure 4AOne embodiment of implant 400 is shown, wherein only a subset of components are numbered for ease of description. The implant is shown as including a frame 420 releasably carrying actuators (such as actuator 403), each actuator 403 including a shaft 401 and a collar 402. Implant 400 is also shown as including a plurality of anchor housings coupled to the frame 420, such as anchor housing 440 disposed at the distal end of the frame 420. In one embodiment, anchor housing 440 may be used for a variety of purposes, including providing a cavity for allowing anchor 410 to pass through into the valve annulus tissue, coupling the frame 420 to anchor 410, and providing a clamping cavity for a clamping band 450, as described in more detail later herein, which may be used to clamp, restrain, and / or otherwise adjust and / or maintain the relative position of anchor 410 after or as part of valve annulus reconfiguration.

[0067] Frame 420 may extend circumferentially about its central axis Y and partially along its axial direction. Frame 420 may be generally symmetrical about axis Y, although it does not need to be symmetrical about axis Y. Frame 420 may have a generally tubular shape, where "tubular" includes annular, as well as other circular or otherwise closed shapes. Frame 420 may be configured to change shape, size, and / or morphology. For example, frame 420 may take on various shapes, sizes, morphologies, etc., at various stages of deployment, such as before delivery, during delivery, tissue engagement, and tightening.

[0068] According to one embodiment, the frame 420 may be formed by one or more pillars 412a, 412b, which may form all or part of the frame 420, wherein the pillars 412a, 412b may comprise elongated structural members formed of a metal alloy. The pillars 412a, 412b and / or other portions of the frame 420 may be formed of a shape memory material, such as a nickel-titanium alloy. In some embodiments, the pillars 412a, 412b and / or other portions of the frame 420 may be formed of other metals, metal alloys, plastics, polymers, composite materials, other suitable materials, or combinations thereof. Figure 4A The diagram shows sixteen pillars, but it should be understood that in some embodiments, there may be fewer or more than sixteen pillars 412a, 412b. In some embodiments, there may be at least two, four, six, eight, ten, twelve, fourteen, eighteen, twenty, twenty-two, twenty-four, twenty-six, twenty-eight, thirty, or more pillars. It should be understood that the invention is not limited to implants having a specific number of pillars.

[0069] In one embodiment, the struts may be formed from the same single piece of material (e.g., a tube blank). Therefore, struts 412a and 412b may refer to different portions of the same extension assembly. Alternatively, struts 412a and 412b may be formed separately and permanently attached together, for example, by welding or other methods. In some embodiments, struts 412a and 412b may be separate components detachably joined together by other components of the implant 400. For example, struts 412a and 412b may be held together via various components described herein, such as collar 402, anchor 410, anchor housing 440, other features, or combinations thereof. In some embodiments, a single strut may include two or more struts, such as those permanently attached together at the apex, and individual units may be permanently or detachably joined together to form frame 420. In some embodiments, struts 412a and 412b may be attached by hinges, pins, or other suitable means.

[0070] The struts 412a and 412b may have a generally rectangular cross-section, but may vary in circumferential width and radial thickness to allow for different bundle characteristics and forces to be applied as the collar is advanced on the strut. As further described below, this can facilitate, for example, the tightening or reshaping of the valve annulus after implantation.

[0071] The supports 412a and 412b may extend about the axis to form various shapes of the frame 420. The supports 412a and 412b may be arranged such that the wall pattern of the frame 420 approximates a sine curve or a sawtooth shape. In some embodiments, the wall pattern may have other suitable shapes, sine curve shapes, or other shapes. The apexes of the sine curve-shaped frame 420 may be pointed or rounded.

[0072] In some embodiments, individual support units may include two or more supports, such as those permanently attached together at the apex, and the individual units may be permanently or detachably joined together to form a frame. Figure 4B As shown, adjacent supports 412a, 412b are shown to meet at a proximal vertex 450. The terms “vertex” and the like may be used interchangeably with the terms “crown” and the like, as used herein and in any reference incorporated herein by reference, unless otherwise stated. In one embodiment, a “vertex” may include a proximal or distal portion of the frame, such as a portion of the frame including the adjoining of the supports and / or a portion of the frame along which collars may travel and / or a portion of the frame that collars may cover during translation.

[0073] The proximal vertex 460 may be configured to have constraints, such as a collar 402 fitted on and / or around at least a portion of the proximal vertex 460. Figure 4B In one embodiment, the exposed proximal vertex 460 of the frame is shown as including a proximal vertex window 515 configured to releasably carry the shaft head 512. For example... Figure 4B As shown, the collar 402 is advanced proximally on the shaft head 512 and the shaft head 512 is released from the proximity vertex window 515, thereby enabling the collar 402 to be removed from the frame.

[0074] Return to reference Figure 4A The implant 400 may include one or more anchors 410. In some embodiments, the anchor 410 may include a helical portion 426 and a proximal anchor head 428, the proximal anchor head 428 including a drive coupling that may include a hook or other feature for engaging a drive tool. The anchors may be made of a suitable biocompatible metallic alloy, such as stainless steel, cobalt-chromium, platinum-iridium, nickel-titanium, other suitable materials, or combinations thereof. Each anchor 410 may be sharpened at its distal point or anterior leading turn to penetrate into cardiac tissue. The total axial length of each anchor 410 may be about ten to about fifteen millimeters (mm). In some embodiments, the total axial length of the anchor 410 may be shorter or longer than ten to fifteen millimeters (mm). The “total” axial length refers to the axial length of the anchor 410 from the distal end of the puncture tip to the proximal end opposite the head 428. The axial length of the helical portion 426 of the anchor 410 may be about six to about twelve millimeters (mm). In some embodiments, the axial length of the helical portion 426 of the anchor may be shorter than or longer than six to twelve millimeters (mm). The axial length of the anchor head 428 and / or other non-helical portions of the anchor 410 may be about three to about four millimeters (mm). In some embodiments, the axial length of the anchor head 428 and / or other non-helical portions may be shorter than or longer than three to four millimeters (mm). The anchor 410 is capable of extending axially beyond the anchor housing 440 by about four to about seven millimeters (mm). For example, the helical portion 426 of the anchor 410 may extend into the cardiac tissue by four to seven millimeters (mm). The anchor 410 is shown with a non-parallel angle (e.g., acute or obtuse) relative to the axis Y, which may be advantageous for engaging the valve annulus tissue and reducing the likelihood of anchor pull-out. However, the embodiments are not limited thereto. For example, the anchor 410 may be substantially parallel to the axis Y, such that the anchor 410 extends in a substantially axial (e.g., vertical) direction relative to the plane forming each base in the anchor housing 440.

[0075] Figure 4A An implant 400 is shown deployed in a tissue-attached configuration, for example, after deployment and expansion at an adjacency of the treatment site and before anchoring the implant 400 to the tissue. In the tissue-attached configuration, the frame 420 may have an overall axial height ranging from 15 to 20 millimeters (mm). This height or height range may vary further from the 15 to 20 mm range depending on the size and pattern of the frame 420 and the length of the anchor 410. In some embodiments, the frame may have a height of approximately 17 millimeters.

[0076] Figure 5 The image depicts the implant 400 after it has been anchored to the tissue. Anchor 410 is shown in... Figure 5 The middle part shows the anchor 410 being rotated and advanced through the anchor housing 440, causing the tissue-piercing end of the anchor 410 to be rotated and advanced into the tissue. Figure 5 In this embodiment, implant 400 is shown reconfigured into a contracted or tightened shape. The tightened shape of implant 400 may correspond to annular remodeling diameter and / or annular remodeling height, which differs from the diameter and / or height of the tissue-joint shape. For example, the annular remodeling height of implant 400 may be greater than the tissue-joint height of implant 400 in the tissue-joint shape. The annular remodeling diameter of implant 400 may be smaller than the tissue-joint diameter of implant 400 in the tissue-joint shape. In various embodiments, the reduction in diameter may be asymmetrical due to the customizability provided by independently controllable actuators. For example, before tightening, implant 400 may be generally elliptical, oval, or other shapes, while after tightening, implant 400 may be generally “D” shaped or other shapes (with a relatively reduced circumference). Thus, implant 400 may have various shapes before or after tightening, and during tightening. For example, collar 402 may be advanced individually (e.g., not simultaneously). Thus, implant 400 may have an irregular shape when tightened. In some embodiments, even in the tightened state, not all collars 402 are advanced, and / or not all collars are advanced by the same amount, such that the angular displacement between adjacent struts of different pairs may not be the same in the tightened state. Therefore, the implant 400 can be tightened in a customized manner according to the needs of a particular patient. In some embodiments, approximately half of the implant 400 may be tightened, for example, to bring the anterior autologous lobule closer to the posterior autologous lobule, or vice versa. Therefore, the “tightened” state of the implant 400 is not limited to the specific shapes shown and described herein, but includes a variety of possible shapes, sizes, etc., which can be selected based on the patient's needs.

[0077] According to one aspect, the implant may include a retention feature that maintains the tightened shape of the implant after the actuator is removed. The retention feature may be a physical component of the implant, such as a tightening band 450 extending through the anchor housing 440, or alternatively may include frame physical properties that contribute to retention, as will be discussed in more detail later herein.

[0078] According to one aspect, the tightening band 450 may include tightening thread, suture material, etc., and is slidably disposed within the tightening cavity of the anchor housing 440, thereby allowing the anchors to be interconnected in the tightened state of the implant 400, such as... Figure 5 As shown.

[0079] Figures 6A-6CExemplary embodiments of anchor housings 600 and 625 are shown, which can be used to support the tightening band 450 as described above. Anchor housing 600 is shown to include a body 610 having a plurality of cavities extending at least partially therethrough. For example, anchor housing 600 may include an anchor cavity 630 through which an anchor is advanced to attach an implant to tissue; and a slot 620 for securing a strut of a frame to the anchor housing. In some embodiments, anchor housing may also include a flange 611. Flange 611 may be used in conjunction with a retainer (not shown) to hold the anchor housing in a compressed configuration for deployment via a catheter.

[0080] The anchor housing 600 may also include a tightening cavity 640 configured to extend at least partially through the anchor housing body 610. For example, Figure 6A and 6B A perspective view of the anchor housing body 610 is shown, through which a tension band can be advanced. In one embodiment, the tension cavity of the anchor housing, together with the tension band, provides a holding feature for maintaining the relative position of the anchor for securing the implant. In one embodiment, the tension cavity is positioned such that the tension band is positioned within or around the inner circumference of the frame. In other embodiments, the tension cavity may be disposed around the outer circumference of the frame.

[0081] Figure 6C An alternative embodiment of the anchor housing 625 is shown. Similar to the anchor housing 600, the anchor housing 625 is shown having a body 655 that includes an anchor cavity 635, a slot 645, and a flange 651. The anchor housing 625 includes an eyelet 665 providing a tightening cavity 675. In one embodiment, the eyelet may advantageously be a swivel eyelet, providing greater freedom and flexibility as the tightening band passes between the anchor housings. Figure 6C In the diagram, the eyelet is shown as being provided on the proximal oriented surface of the anchor housing 625; however, in other embodiments, the eyelet or other form of the tightening cavity may be provided on the distal oriented surface of the anchor housing 625 or on another surface.

[0082] In an alternative embodiment, the tightening cavity can be similar to Figure 5 The illustrated form extends through flange 651, or alternatively through different features of the anchor housing. The invention is not limited to any particular placement of the tightening cavity in or on the anchor housing.

[0083] According to one aspect, it should be recognized that a tension band 450 can be advantageously used to secure the implant in a compression form for delivery via the cavity to the treatment site. This arrangement eliminates the need for a flange 651, thereby minimizing the cross-section of the implant before deployment.

[0084] like Figure 7As shown, once the frame 420 is secured by the retaining mechanism (here, the tension band 450), the actuator collar 402 and shaft 401 can be released from the frame 420 and withdrawn from the treatment site via a deployment catheter. As described above, releasing the actuator may include activating the shaft 401 to proximally translate the collar 402 at least until the shaft head 512 is exposed and can be released from the window 515 formed within the proximal apex 460 of the frame 420. In various embodiments, the actuator may be actuated individually, simultaneously, or in some combination thereof for release.

[0085] Figure 8A and 8B The corresponding implants 800 and 820 are shown after the actuator is released. Figure 8A As shown, the restraint band 850 can be secured by tying or other methods, such as the restraint clip 815, resistance welding tape, or other methods. The removal of the actuator significantly reduces the height of the implant, reduces the number of components remaining in the atrium, and removes ridge elements, such as screws, from the atrium, thus providing an implant with reduced risks of breakage and other complications.

[0086] According to another aspect, because the frame does not require support for the actuator structure during long-term use, it can be formed from a lightweight material. In some embodiments, the proximal apex 812 may be rounded to further reduce the impact of unintended contact between the implant and cardiac features. Although Figure 8A and 8B A frame extending radially outward from the clamping diameter of the implant is shown, but in some embodiments, the frame may be made of a material radially offset toward the central axis of the frame to further minimize the possibility of unintentional contact.

[0087] Figure 8B An implant 820 is shown, including a linked tightening band 852. According to one aspect, as described later herein, in one embodiment, the tightening band may include multiple links, hooks, or other features, such as link 825, which can be configured to advance through the tightening cavity in one direction but prevent travel in the opposite direction, much like a ratchet band or other restraints of this type. Such embodiments can advantageously tighten the anchor collars together while still maintaining the desired spacing between the anchor housings, thereby further customizing the implant reconstruction.

[0088] Therefore, embodiments of implants including removable actuators have been shown and described as including mechanisms for expanding a compression frame, actuating the frame to reshape the valve annulus, and attaching a retention mechanism to the frame to retain the reshaped valve annulus. In various embodiments, removable actuators can be used in implants with different mechanisms of action for implant placement, implant actuation, and actuator removal. Depending on the mechanism of action of a given implant, it is conceivable that the annulus can be modified to aid deployment while the actuator is removable.

[0089] For example, Figure 9A and 9B This is a perspective view of one embodiment of collar 900, which may be included as part of an actuator used with a self-binding implant, wherein the self-binding implant may be an implant at least partially oriented toward a compressed state, for example, having a shape bias equal to or smaller than that of a target valve annulus. Collar 900 is shown including a cannula portion 902, which may be designed similarly to the... Figures 3A-3D The described collar. Member 904 may be attached to or integral with sleeve 902 and extends distally from sleeve 902 along an axis parallel to the plane defined by the frame struts. Extending from member 904 is an extender mechanism 905, which includes an arm 906, wherein the arm is configured to extend into the plane defined by the struts of the frame connection, such that ends 907a, 907b engage the struts. The width W of arm 906 is... 臂 The spacing between the struts can be selected based on the expansion state corresponding to the tissue joining morphology. The length L of the member 904 can be selected. 构件 This allows the arm 906 to expand the device to a tissue-joining configuration when the cannula portion 902 is actuated proximally along the proximal apex. Length L 构件 The width W of the arm 906 is compatible. 臂 Related. Adjustable width W 臂 and the length L of the component 构件 To optimize the expansion of the device. Based on the geometry of the proximal vertex, W 臂 It can be as low as 1 to 2 times the width of the support, three times the width of the support, or higher. 构件 It can be between one-quarter and one-half of the support length.

[0090] Figure 10A and 10B A portion of implant 1000 is shown. Although only a relatively linear portion of the implant is shown, it should be understood that implant 1000 includes a generally tubular implant for annular remodeling.

[0091] In one embodiment, the implant 1000 may include a frame 1050 formed of a thermosetting material, the frame 1050 being biased toward a compression morphology, for example, toward a compression morphology having a diameter related to the valve annulus size. According to one aspect, it should be appreciated that the natural bias of the frame can be used as a retention mechanism after implant placement, anchoring, and actuation. In such an embodiment, an actuator 1010 including an extension mechanism 1025 can be used to expand the frame 1050 to a tissue-engaged morphology, for example, by proximally driving the actuator 1010 along the struts 1012a, 1012b, as... Figure 10AAs shown. The actuator 1010 advances proximally along the supports 1012a and 1012b, causing the extension mechanism 1025, located in the plane defined by the supports 1012a and 1012b, to apply a lateral force to the supports 1012a and 1012b, thereby expanding the frame to a tissue-joined configuration. Figure 10A As shown, during positioning, the distal end of the anchor 1011 can be positioned within the anchor housing 1040.

[0092] Once the frame 1050 expands into the tissue engagement configuration, the anchor 1011 can be driven through the anchor housing 1040 into the tissue, such as Figure 10B As shown. In one embodiment, once the anchor 1011 secures the implant 1000 to the valve annulus, actuation can be performed to shape the valve annulus, as described above. For example, the actuator 1010 can be independently driven on its respective struts to pull the anchor 1011 together to shape the valve annulus. As the actuator 1010 travels distally on struts 1012a, 1012b, the arm 1020 similarly travels distally along the plane defined by the struts. As the arm 1020 travels distally along the plane defined by the struts, the force exerted by the arm 1020 on the struts decreases due to the increased distal spacing between the struts. This decrease in the force exerted by the arm 1020 on the struts 1012a, 1012b allows the struts 1012a, 1012b to return to their biased shape to varying degrees depending on the distance traveled by the struts 1012a, 1012b. In an alternative embodiment, the implant 1000 can be positioned, the actuator 1010 can be advanced distally to shape the implant, and then the anchor 1011 can be driven through the anchor housing 1040 into the tissue to maintain the actuated shape.

[0093] Figure 11A and 11B The diagram shows the release of actuator 1010 after anchor 1011 has been anchored by translation through anchor housing 1040. Actuator 1010 can be advanced proximally on supports 1012a, 1012b until shaft head 1052 is exposed and can be released from the proximal apex of frame 1050, as shown. Figure 11A As shown. Releasing the shaft head 1052 from the frame 1050 also removes the arm 1020 from between the supports 1012a and 1012b. Releasing the actuator 1010 from the frame 1050 allows the frame 1050 to return to the biased, tightened configuration. Figure 11B As shown, the released actuator 1010 can then be withdrawn from the treatment site via a deployment catheter. As a result, only the frame 1050, anchor 1011, and anchor housing 1040 remain. (See also: Regarding...) Figure 8A and 8BIn one embodiment, the proximal ends 1026 of the struts 1012a, 1012b of the frame 1050 may be bent or otherwise blunted to minimize trauma caused by unintentional contact between the implant and cardiac features. In various embodiments, the frame 1050 may be thermoformed to radially inwardly bias the struts 1012a, 1012b toward the central axis of the frame 1050 upon release by the actuator 1010, to further limit the possibility of unintentional contact.

[0094] Therefore, various embodiments of valve ring implants with removable actuators, providing customizable valve shaping, have been shown and described. Such implants can be, for example... Figure 12 This is part of a transcavitary valve annulus remodeling system 1200, shown as including a deployment catheter 1210. The deployment catheter 1210 includes a distal sheath 1240 having a distal tip 1220 coupled to an extendable guidewire 1225. During implant deployment, the deployment catheter 1210 can be advanced transcavitarily to a treatment site, such as an atrium 1265, using the guidewire 1225. The diameter of the guidewire 1225 is measurable, for example, between 0.010 inches and 0.038 inches. The length of the deployment catheter 1210 is measurable in the range of approximately twenty to thirty centimeters to access the mitral valve through the apex of the heart. The deployment catheter 1210 can be accessed through the vascular system of the leg, such as the femoral or iliac veins, for transcavitary deployment to the heart valve annulus.

[0095] An implant 1230, including removable actuators such as those disclosed herein, can be positioned within the distal sheath 1240 of the deployment catheter during deployment. Figure 12 In the diagram, the distal tip 1220 of the deployment catheter 1210 is shown manipulated into the treatment position 1265 of the left atrium adjacent to the mitral valve annulus 1260. After deployment to the treatment site, the implant can be released from the deployment catheter, expanded to a tissue-conforming morphology, tightened to a valve-remodeling morphology, and anchored adjacent to the mitral valve. As described herein, the actuator can then be released from the frame and withdrawn through the deployment catheter 1210.

[0096] Figure 13An exemplary deployment system 1300 is shown, which can be used to deploy an implant 1305 to reshape the valve annulus as described herein. The deployment system 1300 includes a maneuverable sheath 1302, a sheath manipulation knob 1304, an anchor knob 1306, a tightening knob 1308, and an intracardiac echocardiography (ICE) probe 1370, all of which are supported and secured to a base 1310. The tightening knob 1308 and the anchor knob 1306 are spring-loaded to maintain tension. Rotation of the anchor knob 1306 allows the anchor of the implant to be rotatably advanced into the valve annulus tissue. The tightening knob 1308 can be operated by an operator to compress an expandable frame coupled to the anchor to reduce the valve annulus size, and to remove the actuator from the frame to provide a low-profile implant. It should be understood that the invention is not limited to the mechanism used to drive the actuator described herein, and may be replaced by other embodiments without affecting the scope of the invention.

[0097] Various embodiments of implant delivery systems with removable collar-based actuators have been described, enabling customizable low-profile valve reconstruction solutions. It should be understood that those skilled in the art can apply the principles disclosed herein to other implant delivery systems using different actuation mechanisms.

[0098] For example, Figure 14 An implant deployment system 1400 is shown. This implant deployment system 1400 can be carried in a deployment catheter (1210, Figure 12 The distal sheath 1240 ( Figure 12 It is then transported within and to the valve annulus, as per relevant information. Figure 12 The implant deployment system 1400 is shown to include an implant 1425, which includes a resilient frame 1430 having anchor housings, such as anchor housings 1440, disposed at one or more distal vertices of the frame 1430. Each anchor housing 1440 is configurable to translateably support an anchor 1427.

[0099] The implant deployment system 1400 also includes a cannula 1410, which may be formed, for example, from an extruded polymer, such as PEBAX supplied by ARKEMAcorporation of Colombes in France. Alternatively, nylon, polyurethane, polyester, silicone, or other similar materials may be used to provide thin walls, which may be extruded and layered on braided threads or coils to achieve tensile and clamping strength, but the disclosed system is not limited to any particular material composition for the implant catheter.

[0100] Multiple flexible tubes, such as tube 1420, may be attached or otherwise coupled to sheath 1410 at their proximal ends, such that tube 1420 is cantilevered relative to sheath 1410. Drive shaft 1429 may extend through each of the flexible tubes 1420 to engage and drive coupled anchors 1427 through anchor housing 1440 into the annular tissue.

[0101] In one embodiment, the core 1450 may be disposed within the central lumen of the cannula 1410. In some embodiments, the core may have a lumen extending therethrough, for example, for a working catheter and / or visualization device, such as an ICE probe 1370. Figure 13 Translational support. According to one aspect, the core 1450 may include a mandrel 1451 extending at its distal end to one or more flanges 1452, wherein the one or more flanges 1452 extend radially to a distal edge 1457, such that the outer diameter D... 远侧芯体 Larger than the outer diameter D of the mandrel 芯体 In one embodiment, flange 1452 can be from D 远侧芯体 The diameter gradually decreases to D towards the proximal side. 芯体 This allows the core 1450 to be translated proximally beyond the anchor housing 1440. In various embodiments, the core 1450 may be integral to form a sleeve disposed within the sleeve 1410. In other embodiments, as described later herein, the core 1450 may include formed discrete, independently controllable arms configured to customize the frame 1430.

[0102] According to one aspect, each tube 1420 includes a flexible portion proximal to its connection with the cannula. When pressure is applied to the tube via the flange 1452 of the core 1450, the flexible portion allows the tube 1420 to open at an angle away from the central longitudinal axis of the cannula 1410. During proximal translation of the core 1450, the distal edge 1457 of the flange 1452 pushes the tube 1420, causing the tube to deflect radially outward from the central axis of the cannula 1410. Because the tube 1420 is coupled to the anchor housing 1440 via the actuator 1429 and the anchor 1427, and because the anchor housing 1440 is coupled to the frame 1430, proximal translation of the core 1450 also serves to expand the frame 1430. In various embodiments, the core 1450 and the flange 1452 therefore include axially translatable adjustment components configured to control the expansion and / or contraction of the implant frame 1430.

[0103] Therefore, according to one aspect, the core 1450 is translatably disposed within the cannula 1410. Deploying the system 1400 to the mitral valve may include the following steps: advancing the distal end of the deployment catheter through the lumen into the ventricle and withdrawing the introducer sheath or advancing the system 1400 beyond the distal end of the introducer sheath to position the implant within the ventricle. The core 1450 may be as follows: Figure 14The positioning is such that the core 1450 and flange 1452 extend beyond the anchor housing 1440, and the frame 1430 is held in a compressed state to minimize the diameter of the system 1400 during transcavitary implantation of the implant 1425. In the compressed state, the frame 1430 can be flush with the core 1450, as shown. Figure 14 As shown. In an alternative embodiment, frame 1430 may be oriented in a semi-compressed state, for example, where the bias diameter of frame 1430 corresponds to the state bias of the shape and / or diameter of the healthy valve annulus. In such an embodiment, frame 1430 may be deployed via catheter (1210, Figure 12 The pressure on the frame 1430 is maintained flush with the core during delivery, and the removal of the deployment conduit 1210 from the frame 1430 for deployment and / or the body heat acting on the frame after insertion may cause the frame 1430 to expand to a semi-compressed state.

[0104] Now for reference Figure 15A After the implant 1500 is delivered to the ventricle, the frame 1520 can expand to position anchors, such as anchors 1535, in a tissue-engagement morphology. According to one embodiment, the expansion of the frame is controlled by translating the core 1550 proximally (as indicated by arrow B) within the cannula 1510. Proximity advancement of the core 1550 within the cannula causes the flange 1557 of the core 1550 to exert a force on a tube, such as tube 1525, thereby causing the tube 1525 to deflect at an angle away from the longitudinal axis defined by the cannula 1510. The tube 1525 then radially outwards pushes the anchor housing 1530, thereby expanding the frame 1520.

[0105] Figure 15B It is a stereoscopic view of the expanded implant 1500 facing the proximal side, for example, via... Figure 15A The perspective view is indicated by arrow B. In the illustrated embodiment, the proximal end of tube 1525 is slidably disposed within a latch 1551 provided on the flange of core 1550. Implant 1500 is shown in an expanded state for tissue engagement. Once configured in this way, a drive shaft within the flared tube 1525 can be activated to drive anchor 1535 through anchor housing 1530 for tissue engagement. In one embodiment, the drive shaft may be a torque shaft that rotates to drive anchor 1535 through anchor housing 1530 for tissue engagement. Thus, in various embodiments, the drive shaft can be axially translated distally into and / or through the anchor housing to further fine-tune the expansion and / or contraction of the implant frame.

[0106] Figure 16An embodiment of an actuator 1600 is shown that can be used to control the expansion, anchoring, and tightening of an implant frame as disclosed herein. The actuator 1600 is shown as including a cannula 1605 (shown in cross-section) having a tube 1625 coupled or attached near the distal end of the cannula 1605. According to one embodiment, the tube 1625 may not be fully attached to the tube 1605, but may be unattached along at least a portion of the outer contact surface of the tube to form a swivel joint at the flexible portion 1620. When the implant expands, the swivel joint formed by the flexible portion 1620 allows the tube 1625 to open away from the axis defined by the cannula 1605. Thus, a tube having a flexible portion that allows the tube to form a swivel joint, such as tube 1625, may be referred to herein as a “flared tube.”

[0107] A flexible portion 1620 of the flared tube 1625 may be disposed near the proximal end of the tube outside the sleeve 1605, and a relatively rigid portion 1630 of the flared tube may extend from the flexible portion 1620 through the distal end of the tube 1625. The flexible portion can be made more flexible by modifying the tube, for example by cutting portions of the tube. Alternatively, the tube may include an elastic sheath (such as a braided catheter, etc.) comprising a relatively flexible polymer coating on the flexible portion 1620 and a relatively rigid polymer coating along the portion 1630. In some embodiments, the flared tube may be constructed of a coated braid with different weaves or a composite material with different fabrics. Additionally, some designs may find it helpful to reduce stiffness only in one direction (radial) while maintaining stiffness in other directions (circumferential). According to one embodiment, the flared tube may increase stiffness and / or decrease elasticity as it extends distally. Providing increased stiffness as the tube extends distally allows the flared tube to deform / bend more easily to fine-tune the anchor spacing, while providing sufficient distal stiffness to drive the anchors into the tissue.

[0108] According to one embodiment, the drive shaft 1610 may extend through the sleeve 1605 and through the distal end of the tube 1625 to engage an anchor (not shown). In one embodiment, the drive shaft 1610 is a torque shaft and includes a connector 1640 for engaging the proximal end of the anchor.

[0109] According to one aspect, the drive shaft 1610 can be configured to translate axially within the sheath 1605 and tube 1630. An actuator, such as actuator 1600, can be provided for each anchor, and the independent axial movement of the drive shaft 1610 within the sheath 1605 and tube 1625 can be used to push / pull or otherwise independently adjust the length between the various anchor heads and their associated flared tubes to fine-tune the implant configuration adjustment provided by the proximal translation of the core. This arrangement allows the implant to be configured according to the specific needs of the patient and / or the disease state of the valve.

[0110] Figures 17A-17C Various views of alternative embodiments of the core 1710 are shown, which can be used to open the tube outwards, as per [reference to...]. Figure 15A As mentioned above. Figure 17A In the diagram, core 1710 is shown to include multiple arms, such as arms 1715a, 1715b, and 1715c, each arm including or supporting flanges 1720a, 1720b, and 1720c. Each arm may be disposed within a sleeve (not shown) and configured to extend from the proximal end of the sleeve through the distal end of the frame, as... Figure 14 As shown. Each arm is advantageously configured for independent axial translation. For example, as Figure 13 The handle shown may be adapted to include a rotary knob that advances and retracts to a rigid line or rod attached to the arm, which may extend proximally to the handle to enable user operation. Each flange 1720a, 1720b, 1720c is shown to include a stop 1721a, 1721b, 1721c configured to support a flared tube. In one embodiment, each flange 1720a, 1720b, 1720c tapers proximally from its distal edge diameter to approximately the outer diameter of the core, so that during frame expansion, when the core is withdrawn proximally into the sleeve, the anchor housing is translated proximally beyond flanges 1720a, 1720b, and 1720c.

[0111] Figure 17B This is a perspective view of the distal end of the core 1710 facing proximally. The core 1710 includes eight independently translatable arms connected to eight flanges 1720a-1720h. Although eight arms are shown, it should be understood that the specific number of arms used is a design issue, and equivalent embodiments may include, for example, as few as one or two, or as many as eight, ten, or a maximum number, depending on the available space within the deployment catheter. The profiles of the levers 1721a-1721h may be complementary to the tube profile, for example, curved, thereby providing a guide-type support for the circular flared tube as the core translates within the cannula. The ability to independently translate each arm 1720a-1720c of the core 1710 further enhances the actuation system's ability to customize the implant configuration by enabling the degree of deflection to be tailored for each tube.

[0112] Figure 17CThe core 1710 is shown, wherein each arm 1715a-1715d is translated to different proximal extents, resulting in different degrees of angular deflection for each tube supported by flanges 1720a, 1720b, 1720c, and 1720d. For example, arm 1715b, coupled to flange 1720b, extends further distally than arm 1715d, coupled to flange 1720d. As a result, the flared tube supported by flange 1720b will have a lower angular expansion than the flared tube supported by flange 1720d. Consequently, the anchor driven by the actuator extending through the flared tube supported by flange 1720b can be positioned closer to the central axis of the core 1710, and the flared tube supported by flange 1720d can be positioned relatively further away from the central axis of the core 1710. Using this arrangement, asymmetrical implant configuration can be achieved by pushing and / or pulling the anchors prior to attachment to shape the implant using independent actuation of the core and independent control of the drive shaft. Providing two mechanisms for implant configuration—for example, initial asymmetrical shaping using core flange positioning and fine-tuning positioning using the drive shaft—enhances the ability to customize implants for their specific purposes.

[0113] Figure 18A An embodiment of the frame 1830 in an anchored configuration is shown, wherein the anchor 1840 is configured to be embedded in the tissue, for example, by rotating or otherwise manipulating the drive shaft within the flared tube 1820. Once the anchor 1840 is embedded in the tissue, the core can be advanced distally from the sleeve 1810, thereby releasing the force of the flange 1857 on the flared tube 1820.

[0114] According to one embodiment, frame 1830 may be a “self-tightening” frame biased toward a compression configuration (e.g., a frame formed of an elastic shape memory material, such as nitinol). As the core is advanced distally, the pressure applied to the flared tube 1820 and its associated anchors 1840 is reduced, and frame 1830 returns to its bias configuration, thereby pulling the attached anchors together to reduce the size of the valve ring.

[0115] After anchoring and tightening, the actuator system, including tube 1820 and sleeve 1810, can be removed from the treatment site. For example... Figure 18BAs shown, in one embodiment, the drive shaft is released from the anchor head and pulled out through tube 1820 and proximally through sleeve 1810. The flexible portion of the flared tube allows for realignment of the tube and sleeve's longitudinal axes for easy removal. In some embodiments, tube 1820 may be formed at least partially of a shape-memory-based material that pushes the tube to a position flush with the core for easy removal. In some embodiments, after the drive shaft is released from the anchor head, sleeve 1810, core 1850, and tube 1820 can be removed from the cavity by deploying a conduit, leaving only frame 1830, anchor housing 1844, and anchor 1840.

[0116] Figure 19A An alternative embodiment of an implant delivery system is shown, comprising a cannula 1910 having a flared tube 1930 disposed therein, a core 1940 consisting of independently translatable arms, a frame 1950, at least one anchor housing 1960, and at least one anchor 1970. According to one aspect, an inflation device, such as a balloon 1945, is inserted through a cavity 1920 of the core 1940, thereby expanding inward from the core to engage the flared tube 1930. Similar to the method disclosed above, the core may include independent arms that translate proximally to adjust the angular deflection of the flared tube 1930, thereby shaping the frame 1950. According to one aspect, manipulation of the arms of the flared tube 1930 and / or the core is controlled via the balloon 1945, wherein, upon expansion, the balloon applies force to the core and / or the flared tube. Applying pressure to the arm of the core 1940 and / or the flared tube 1930 alters the angular deflection of the flared tube, thereby moving the anchor housing 1960 and reshaping the frame 1950.

[0117] Therefore, the balloon 1945 can be used in conjunction with the arms of the core 1940 and the flare tube 1930 to shape the frame. For example, in some embodiments, the balloon may be asymmetrical in shape, such as saddle-shaped, to match the shape of the valve annulus. In some embodiments, the balloon may be used without a core. When inflated, the balloon may expand beyond the edge of the core 1940. The pressure of the balloon 1945 on the flare tube 1930 may contribute to the ability of the flare tube 1930 to expand beyond the core, thereby providing control over the customized enhancement of the implant. Figure 19B A perspective view of a core 2000 having multiple flanges 2020a-2020h is shown, facing proximally. A balloon 2025 is shown disposed within the cavity of the core. When the balloon 2025 is inflated, pressure is applied radially outward along the direction generally indicated by arrows 2030a-2030d onto the flanges 2020a-2020h. Figure 19B As shown, the individual pressure applied to each arm varies based on the shape of the balloon, allowing asymmetric balloons to be used to customize the shape and deployment of the implant.

[0118] In various embodiments, the balloon can be used to control the expansion of the frame using a flared tube. For example, the balloon can be positioned within a unified core that does not include independently controllable arms, within a core that includes arms that translate uniformly or individually, or directly within the cannula without using a core.

[0119] Therefore, several embodiments of systems and methods using implant deployment components including removable actuators have been shown and described. It should be noted that while the particularly disclosed embodiments include expandable frames, the invention is not limited to use with implants having expandable frames, but should be understood to be usable with other forms of implants. Various modifications to the embodiments described herein will be apparent to those skilled in the art, and the general principles defined herein can be applied to other embodiments without departing from the spirit and scope of the invention. Therefore, the invention is not intended to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the claims, principles, and novel features disclosed herein. The word “example” is used herein specifically to mean “served as an example, instance, or illustration.” Unless otherwise stated, any embodiment described herein as an “example” is not necessarily to be construed as more preferred or advantageous than other embodiments.

[0120] Some features described in this specification in the context of a single implementation may also be implemented in combination in a single implementation. Conversely, various features described in the context of a single implementation may also be implemented individually or in any suitable sub-combination in multiple implementations. Furthermore, although the features above may be described as functioning in a certain combination, and even initially stated so, in some cases, one or more features derived from the claimed combination may be removed from that combination, and the claimed combination may point to a sub-combination or a variation of the sub-combination. Similarly, although operations are depicted in a specific order in the drawings, this should not be construed as requiring that such operations be performed in the specific order shown or sequentially, or that all shown operations be performed to achieve the desired result. Exceptions include other embodiments within the scope of the following claims. In some cases, the actions recited in the claims may be performed in a different order and still achieve the desired result.

[0121] Those skilled in the art will understand that, generally, the terms used herein are intended to be “open” terms (e.g., the term “comprising” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” the term “including” should be interpreted as “including but not limited to,” etc.). Those skilled in the art will further understand that if a particular number is intended to be introduced in the statement of a claim, such intention will be expressly stated in the claim; without such a statement, such intention does not exist. For example, to aid understanding, the appended claims may contain the use of the introductory phrases “at least one” and “one or more” to introduce the statement of the claim. However, the use of these phrases should not be construed as implying that any particular claim containing such an indefinite article "a" or "an" is limited to an embodiment containing only one such indefinite article, even when the same claim includes the introductory phrase "one or more" or "at least one" and indefinite articles such as "a" or "an" (e.g., "a" and / or "an" should generally be interpreted as meaning "at least one" or "one or more"); the same applies to the use of definite articles used to introduce an indefinite article. Furthermore, even when a specific number is explicitly stated in an indefinite article, those skilled in the art will recognize that such a statement should generally be interpreted as meaning at least the number stated (e.g., a simple statement of "two statements" without other modifiers generally means at least two statements, or two or more statements). Moreover, in those cases where conventions such as "at least one of A, B, and C" are used, such a structure is generally intended to make the meaning clear to those skilled in the art. The meaning of this convention should be understood (e.g., "a system having at least one of A, B, and C" includes, but is not limited to, systems having only A, only B, only C, A and B, A and C, B and C, and / or systems having A, B, and C, etc.). In those cases where a convention similar to "at least one of A, B, and C, etc." is used, such a structure is generally intended to make the meaning of the convention clear to those skilled in the art (e.g., "a system having at least one of A, B, and C" includes, but is not limited to, systems having only A, only B, only C, A and B, A and C, B and C, and / or systems having A, B, and C, etc.). Those skilled in the art should further understand that any transitional words and / or phrases presenting two or more alternative terms, whether in the specification, claims, or drawings, should be understood to contemplate the possibility of including one or more of the terms. For example, the phrase "A or B" should be understood to include the possibility of "A" or "B" or "A and B".

[0122] According to the present invention, the apparatus and / or methods disclosed and claimed herein can be manufactured and performed without requiring extensive experimentation. While various embodiments of the apparatus and methods of the present invention have been described, it will be apparent to those skilled in the art that variations can be made to the apparatus and / or methods and the steps or sequences of steps of the methods described herein without departing from the concept, spirit, and scope of the invention. It will be apparent to those skilled in the art that all such similar substitutions and modifications are considered to be within the spirit, scope, and principle of the invention as defined by the appended claims.

Claims

1. An implant delivery system, comprising: A frame having a proximal end, a distal end, and adjacent struts joined at a proximal vertex; as well as An actuator removably coupled to the frame, the actuator including one or more axially translatable adjustment components configured to expand or contract the frame. The one or more axially translatable adjustment components of the actuator include: A shaft, the shaft including a distal shaft end having a shaft head positioned within an opening at the proximal apex of the frame; and A collar disposed on at least a portion of the shaft, including the shaft head, to retain the shaft head within the opening at the proximal vertex, the collar being configured to travel distally along the shaft and at the proximal vertex of the frame in response to a first activation of the shaft to engage the adjacent support. The shaft includes a proximal shaft end having a drive connector and a shaft engagement feature disposed along a portion of an engagement portion between the drive connector and the shaft head. The collar includes a proximal end, a distal end, and a hole extending therethrough. The hole includes a hole engagement feature disposed on at least a portion of the inner surface of the hole. The shaft engagement feature is configured to engage with the hole engagement feature to allow the collar to translate along the shaft.

2. The implant delivery system according to claim 1, The collar is configured to travel proximally along the axis in response to a second activation of the shaft to release the shaft head from the proximal end of the frame.

3. The implant delivery system of claim 2, wherein the length of the engagement portion of the shaft is at least equal to the length of the collar.

4. The implant delivery system of claim 3, wherein at least one of the shaft engagement feature or the hole engagement feature includes one or more threads, and wherein one of the first activation or the second activation of the shaft includes rotation of the shaft.

5. The implant delivery system of claim 3, wherein the frame includes a second plurality of struts joined at a distal apex, and wherein the distal apex supports an anchor housing, the anchor housing including a tightening cavity extending therethrough, the tightening cavity being configured to slidably receive a tightening band.

6. The implant delivery system of claim 2, wherein the adjacent strut has an offset configuration, and wherein the collar includes an extension mechanism configured to push the adjacent strut to prevent it from returning to the offset configuration.

7. The implant delivery system of claim 6, wherein the extension mechanism includes at least one arm configured to engage at least one of the adjacent struts to push at least one adjacent strut to prevent it from returning to the biased configuration.

8. The implant delivery system of claim 7, wherein releasing the shaft head from the proximal apex releases the extension mechanism between the adjacent struts, thereby returning the adjacent struts to the biased configuration.

9. The implant delivery system of claim 1, wherein the frame includes a plurality of distal vertices and a plurality of anchor housings disposed at least on a subset of the plurality of distal vertices, each anchor housing supporting an anchor, and wherein the one or more axially translatable adjustment components of the actuator include: casing; Multiple cantilever tubes disposed within the sleeve and connected at the proximal end to the distal portion of the sleeve; Multiple drive shafts, each translatably disposed within one of the multiple cantilever tubes and configured to extend beyond the distal end of the associated cantilever tube to drive one of the anchors; as well as A core disposed within the sleeve such that the plurality of cantilever tubes slidably engage the outer surface of the core, the core being configured to translate axially within the sleeve, wherein each cantilever tube includes a flexural portion, and wherein the axial translation of the core causes the cantilever tube to rotate at the flexural portion to change the angular deflection of the distal end of the cantilever tube, thereby expanding the distal apex of the frame.

10. The implant delivery system of claim 9, wherein the core includes a plurality of arms circumferentially arranged within the cannula, and wherein the plurality of arms are independently translatable within the cannula to independently control the angular deflection of the respective cantilever tube.

11. The implant delivery system of claim 9 or 10, wherein each drive shaft is axially translatable beyond the distal end of the associated cantilever tube to control the shape of the frame.

12. The implant delivery system according to claim 9 or 10, further comprising an inflatable device disposed within the central cavity of the core and configured to control the angular deflection of the plurality of cantilever tubes.

13. The implant delivery system of claim 12, wherein the core includes a plurality of levers, each lever being configured to slidably support one of the plurality of cantilever tubes.

14. The implant delivery system of claim 2 or 9, wherein the frame has a shape memory material and is biased to one of an expanded state or a contracted state.

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