Spring-loaded self-locking reversible anchor

Abstract

The present invention relates to a spring-loaded self-locking anchoring assembly that converts a driving force applied to an anchor of the anchoring assembly into one or both of an axial translational force or a compressive force. The axial translational force can be used to drive the anchor into tissue, while the compressive force can be used to further drag anchor components and tissue together and / or lock anchor components together to improve the efficacy of the anchor in the event of changes in the anatomy.

Description

[0001] Cross Reference to Related Applications

[0002] This application claims priority under 35 U.S.C. § 119 to U.S. Provisional Patent Application No. 62 / 898,240, filed September 10, 2019, the entire contents of which are incorporated herein by reference for all purposes. TECHNICAL FIELD

[0003] The present disclosure relates generally to the field of implantable medical devices. In particular, the present disclosure relates to medical devices, systems, and methods for annuloplasty and other cardiac treatment techniques. BACKGROUND

[0004] Mitral insufficiency (MI), also known as mitral regurgitation or mitral incompetence, is a heart condition in which the mitral annulus dilates excessively and the valve leaflets no longer close or coapt effectively during systole of the heart. During ventricular contraction, blood regurgitates, and as a result, cardiac output can be reduced. Surgical and endovascular annuloplasty techniques have been introduced that aim to restore the mitral valve to its natural configuration, for example, by implanting an annuloplasty ring around the valve annulus. Due to the characteristics of the heart’s uneven topology, which can be difficult to effectively anchor the implant, a challenge arises when deploying such implants. In view of these difficulties, the solution of the present disclosure is provided. SUMMARY

[0005] According to one aspect, an anchor assembly includes an anchor including an anchor head and an anchor coil including a proximal portion disposed about the anchor head and a distal portion extending distally from the anchor head. The anchor head can include a proximal end having a drive coupler, a distal tip, and a threadless shaft disposed between the drive coupler and the distal tip of the anchor head. The proximal portion of the anchor coil can include a compressible coil coupled to the distal tip of the anchor head.

[0006] In various embodiments, the anchor head can further include a flange disposed between the drive coupler and the unthreaded shaft of the anchor head, the flange configured to limit distal translation of the anchor through the bore of the anchor housing. The anchor head can include a locking feature, and the anchor housing can include a proximal slot configured to affix the locking feature to the anchor housing. The locking feature can include a flange, tab, tooth, ridge, or some combination thereof, and the proximal slot can include a slot, detent, aperture, track, or some combination thereof. In some embodiments, the flange can include the locking feature. Some embodiments can include an anchor housing having a bore extending therethrough, the bore including a threaded portion and an unthreaded portion, the threaded portion of the bore interacting with the anchor coil to provide axial translation of the anchor through the bore, and the unthreaded portion of the bore interacting with the anchor coil to provide compression of the compressible coil.

[0007] According to another aspect, an annuloplasty system includes a delivery catheter having a drive tube with a proximal end and a distal end, and an implant having an anchor assembly. The anchor assembly can include an anchor including an anchor head and an anchor coil including a compressible portion disposed free to move about an unthreaded shaft of the anchor head, the compressible portion coupled to a distal tip of the anchor head at the distal end. The anchor assembly can further include an anchor housing having a bore extending therethrough, the bore including a threaded portion and an unthreaded portion, the anchor coil interacting with the threaded portion of the bore to provide axial translation of the anchor through the bore and with the unthreaded portion of the bore to provide compression of the compressible portion of the anchor coil.

[0008] In various embodiments, the anchor head can include a proximal drive coupler coupled to the distal end of the drive tube. The drive tube can be configured to provide a drive force, wherein the anchor assembly converts the drive force of the drive tube to an axial translation force, a compression force, or both.

[0009] In one embodiment, the anchor assembly can convert the drive force to an axial translation force when the proximal end of the compressible coil is within the threaded portion of the bore and to a compression force when the proximal end of the compressible coil is within the unthreaded portion of the bore. The axial translation force can be configured to advance a distal portion of the anchor coil or remove it from tissue, the compression force can be configured to draw the anchor assembly and tissue together, and the anchor assembly can be configured to automatically convert the drive force from an axial translation force to a compression force in response to an interaction between the anchor head and the anchor housing.

[0010] In some embodiments, compressive forces on the compressible portion of the anchor coil can generate tensile loads on the compressible coil, which pull the anchor housing and tissue together. The anchor head may also include a flange disposed between the drive connector and the unthreaded shaft of the anchor head, the flange being configured to restrict distal translation of the anchor through a hole in the anchor housing to convert the drive force into a compressive force.

[0011] In some embodiments, the anchor head may include a locking feature, and the anchor housing may include a proximal slot configured to attach the locking feature to the anchor housing. The locking feature may include a flange, tab, tooth, ridge, or a combination thereof, and the proximal slot may include a slot, pawl, hole, track, or a combination thereof. In some embodiments, the flange includes the locking feature. In one embodiment, the drive tube may include a drive sheath that shields the locking feature of the anchor head to prevent engagement between the locking feature and the proximal slot of the anchor housing. The locking feature of the anchor head may be biased by a compressive force to drag the locking feature into the proximal slot of the anchor housing when the drive sheath is retracted from the locking feature.

[0012] In one embodiment, the anchor may be one of a plurality of anchors of the implant, the anchor housing may be one of a plurality of anchor housings of the implant, and the drive tube may be one of a plurality of drive tubes of the delivery catheter, each of the plurality of drive tubes being coupled to one of the plurality of anchors, wherein the drive tubes may be independently controlled to drive each anchor according to the anatomy of the anchoring location.

[0013] According to another aspect, the valve annulus reconstruction method includes the step of deploying an implant system to a valve annulus, the implant including an anchor housing having an aperture extending therethrough, an anchor disposed within the aperture of the anchor housing, an anchor head, and an anchor coil, the anchor coil including a compressible portion disposed around the anchor head and a tissue engagement portion distally from the compressible portion. The anchor coil may be attached to the anchor head at a distal end of the anchor head. In one embodiment, a flange may be disposed at a proximal end of the anchor head, the flange being configured to restrict translation of the anchor through the aperture of the anchor housing. The method includes the steps of: driving the anchor through the aperture of the anchor housing into the tissue until the flange of the anchor restricts distal translation of the anchor through the anchor housing, and driving the anchor to compress the compressible coil to pull the anchor housing and tissue together when distal translation of the anchor through the anchor housing is impeded.

[0014] In various embodiments, the anchor head includes a locking feature configured to engage a proximal slot of the anchor housing, and the step of continuing to drive the anchor when translation of the anchor to the distal side is impeded generates a tensile load in the anchor housing that causes the locking feature to be biased toward the proximal slot of the anchor housing.

[0015] This arrangement provides a spring-loaded anchoring assembly with improved anchor attachment and retention. Attached Figure Description

[0016] 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). In the drawings, each identical or substantially identical component shown is generally indicated by a single reference numeral. For clarity, not every component is labeled in every drawing, and not every component of every embodiment is shown where the illustrations are not essential for those skilled in the art to understand the disclosure. In the drawings:

[0017] Figure 1 This is a schematic diagram of one embodiment of an implant, which includes an anchoring component as disclosed in the various embodiments herein;

[0018] Figure 2A and Figure 2B An example of an anchoring assembly as disclosed in the various embodiments herein is shown;

[0019] Figures 3A-3C Show in more detail Figure 2A and Figure 2B Components of the intermediate anchoring assembly;

[0020] Figures 4A-4C for Figure 2A and Figure 2B A cross-sectional view of an embodiment of the anchoring assembly;

[0021] Figure 5A and Figure 5B A perspective view of one embodiment of the locking features of the anchoring assembly as disclosed herein;

[0022] Figures 6A-6B An example of a method for deploying an implant is shown, the implant including an anchoring component as disclosed in various embodiments herein; and

[0023] Figure 7 An example of a control handle embodiment of a valve annuloplasty system is shown, which can be used to control the placement and attachment of anchoring components such as those disclosed herein. Detailed Implementation

[0024] Spring-loaded self-locking anchoring assemblies convert the driving force applied to the anchor members into one or both of axial translational or compressive forces. The axial translational force can be used to drive the anchor members into the tissue, while the compressive force can be used to further pull the anchor members and tissue together and / or lock the anchor members together, improving anchor adhesion under anatomical changes.

[0025] In one embodiment, the anchor of the anchoring assembly disclosed herein may include an anchor head coupled to an anchor coil. The anchor head may include a proximal flange, a distal end, and a threadless shaft disposed between the proximal flange and the distal end. The anchor coil may include a proximal compressible portion and a distal tissue-jointing portion. The compressible portion may be securely attached at its distal end to the distal end of the threadless shaft. The compressible portion of the anchor coil may otherwise be configured to move freely on the threadless shaft of the anchor head.

[0026] The anchoring assembly also includes an anchor housing having a hole extending through it, the hole being sized to support the anchor. In one embodiment, the hole includes a threaded portion and a non-threaded portion. The threaded portion of the hole interacts with the anchor coil of the anchor to convert the driving force applied to the anchor into an axial translational force, thereby driving the tissue-engaging portion of the anchor coil into the tissue.

[0027] In one embodiment, the anchor cooperates when it translates distally through the anchor housing such that the unthreaded portion of the hole aligns with the unthreaded shaft of the anchor head within the anchor housing. In another embodiment, the flange of the anchor head restricts distal travel of the anchor through the anchor housing, thereby aligning the unthreaded shaft of the anchor head with the unthreaded portion of the hole.

[0028] As described in more detail below, the unthreaded shaft of the anchor head provides a so-called "free rotation" space in which the anchor coil can be compressed to provide tensile load. For example, when the axial translation of the anchor is restricted, further actuation of the anchor will cause the compressed portion of the anchor coil (which rides freely across the shaft, as described) to continue rotating into the unthreaded portion of the bore. Further actuation of the actuator within this free rotation space increases the tensile load on the anchor coil, which pulls the anchor assembly and patient tissue together to improve implant integrity. In one embodiment, the cooperative feature of the anchor and anchor housing utilizes the tensile load to lock the anchor to the anchor housing.

[0029] These and other advantages of the implant and deployment method are described in more detail below. Although embodiments of the present disclosure may be specifically described with reference to the mitral valve, the principles disclosed herein can be readily adapted to facilitate the remodeling of any valvular annulus, including the tricuspid valve annulus; and / or may similarly benefit any other dilatation, valvular insufficiency, valvular leakage, and other similar heart failure conditions.

[0030] As used herein, the term "distal" refers to the end furthest from the medical professional when a medical device is introduced into the patient, while the term "proximal" refers to the end closest to the medical professional when a medical device is introduced into the patient.

[0031] Figure 1 An embodiment of implant 100 is shown, which may include a spring-loaded self-locking anchoring assembly 170, such as those disclosed in the various embodiments herein, the anchoring assembly 170 including an anchor housing 120 and an anchor 124.

[0032] The implant is shown to include a frame 110, which may be positioned around a heart valve or other cardiac feature. For clarity, not all components of the implant are numbered. In one embodiment, the frame 110 may extend circumferentially and partially axially about a central frame axis Y, which extends proximally-distally through the center point of the frame. The frame 110 may be substantially symmetrical with respect to the central frame axis, although symmetry is not required. The frame 110 may be formed generally in a tubular shape, where “tubular” includes annular and other circular or otherwise closed shapes. The frame 110 may be configured to vary in shape, size, and / or configuration. For example, the frame 110 may present various shapes, sizes, configurations, etc., at different stages of deployment, such as during pre-delivery, delivery, tissue engagement, and tightening.

[0033] According to one embodiment, the frame 110 may be formed by one or more pillars 112, which may form all or part of the frame 110, wherein the pillars 112 may include elongated structural members formed of metal alloys, shape memory materials (such as nickel-titanium or other metal alloys), plastics, polymers, composites, other suitable materials, or combinations thereof. Figure 1 The diagram shows sixteen pillars 112, but it should be understood that in some embodiments, there may be fewer or more than sixteen pillars.

[0034] In one embodiment, the struts 112 of the frame 110 may be formed from the same monolithic material (e.g., a tube blank). Therefore, reference to strut 112 may refer to different portions of the same broad component. Alternatively, reference to strut 112 may refer to components that are formed separately and permanently attached together, for example, by welding or other methods. In some embodiments, strut 112 may be a separate component detachably coupled to form a proximal end 150 and a distal end 152. For example, strut 112 is shown connected at its proximal end by an actuator 130 and at its distal end by an anchor housing 120.

[0035] In some embodiments, the terms “apex” 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, “apex” may include the proximal or distal portion of the frame.

[0036] In one embodiment, actuator 130 includes an actuator shaft 134 rotatably carried by the proximal end of frame 110. For example, the head of actuator shaft 134 may be included within actuator collar 132 and carried by a window or other opening (not shown) at the proximal end 150 of frame 110 to allow shaft 134 to rotate within actuator collar 132. Actuator shaft 134 may include a drive coupling 136 disposed at the proximal end.

[0037] The actuator collar 132 may include internal features configured to interact with features of the actuator shaft 134 such that rotation of the actuator shaft 134 via the actuator drive tube coupled to the drive connector 136 causes axial translation of the actuator collar 132 over the actuator shaft 134 and the strut 112. In some embodiments, “axial” as applied to the axial movement or restraint of the actuator collar includes directions that are at least partially along the proximal or distal direction and directions that are parallel or substantially parallel to the central axis extending through (e.g., proximal-distal) the frame. Figure 1 As shown, the strut 112 extends away from the proximal tip in the opposite direction. The actuator collar 132 translates distally, pulling the struts 112 together within the actuator collar 132, thereby reducing the distance between the anchor housings 120 for ring fitting. The actuator collar 132 can be actuated independently according to the reshaping target of the relevant anchor pair.

[0038] Anchor housings 120 are shown connected by tethers 140. Each anchor housing 120 carries an anchor 124 having an anchor head 126 coupled to an anchor coil 127. A drive connector 125 (located proximal to the anchor head 126) is configured to cooperate with complementary features of a drive tube (not shown) to axially translate the anchor 124 through the anchor housing 120 into the tissue. As described in more detail below, once the anchor 124 is driven through the anchor housing 120 into the tissue, features of the anchor head 126 inhibit further distal translation of the anchor 124 through the housing 120. At this point, as described in more detail below, features of the anchor 124 cooperate with features of the anchor housing 120 to build compressive forces within the anchor housing that pull the anchor housing 120 together with the tissue (e.g., annular tissue). The compressive forces can also be used to lock the anchor to the anchor housing.

[0039] For example, Figure 2A and Figure 2B Anchoring assembly 170 is shown in more detail. Figure 2A An anchoring assembly 170 is shown prior to anchor deployment into the tissue. Anchoring assembly 170 is shown including an anchor 124 carried by an anchor housing 120. Anchor housing 120 may define a tether cavity 104, for example, for carrying a tether 140. Figure 1 ).

[0040] Anchor 124 includes an anchor head 126 having a proximal end 180 and a distal end 182. A drive connector 125 (located at the proximal end 180 of the anchor head) is configured to engage a driver (not shown) operable to push the anchor forward or backward translationally through the anchor housing 120.

[0041] The anchor head 126 also includes a flange 121 coupled to or integral with a proximal end 180 of the anchor head 126. The flange 121 may include a collar, tab, or other feature extending radially or partially radially about the central axis A of the anchor head 126. In one embodiment, the flange 121 may limit the extent to which the anchor 124 travels distally through the anchor housing 120 when it contacts the anchor housing 120 during the distal travel of the anchor 124 through the anchor housing 120.

[0042] Anchor 124 may also include anchor coil 127. In one embodiment, anchor coil 127 includes a proximal compressible portion 204 configured to slide freely along anchor head 126 in response to rotation of anchor head 126.

[0043] The anchor coil 127 also includes a fixing portion 206 fixedly connected to the anchor head 126. The anchor coil 207 also includes a distal tissue engagement portion 129, wherein the tissue engagement portion 129 of the anchor coil 127 may be a portion of the anchor coil extending distally from the fixing portion 206 of the anchor coil 127.

[0044] The anchor housing 120 includes a hole through which the anchor 124 translates during use. (See also: Regarding...) Figure 4A and Figure 4B In a more detailed description, in one embodiment, the hole in the anchor housing may include one or more features that interact with features of the anchor coil 127 to cause the anchor coil 127 to translate through the anchor housing and / or generate compressive force to pull the anchor housing 120 toward the tissue at the treatment site.

[0045] Figure 2B An embodiment of the anchoring assembly 170 is shown, wherein the anchor 124 has been translated through the anchor housing 120 by actuation of the drive connector 125 until the flange 121 of the anchor head 126 contacts the anchor housing 120, thereby preventing further distal travel of the anchor 124. The tissue engagement portion 129 of the anchor coil 127 is shown extending beyond the anchor housing 120 to a maximum extent 210. When the tissue engagement portion 129 has been advanced to its distal maximum extent 210, the compressible portion of the anchor coil 127 ( Figure 2B (Not shown) is installed inside the anchor housing 120.

[0046] Figures 3A-3C Examples of the anchoring assembly components are shown in both individual and assembled states. Figure 3A In this embodiment, the anchor head 126 is shown to include a generally hook-shaped drive connector 125 configured to cooperate with a complementary connector of a drive tube (not shown) to drive the anchor of the implant. The anchor head 126 includes a threadless shaft 304 and a distal end 306. In one embodiment, the distal end 306 may be threaded to support complementary threads of the anchor coil, but this disclosure is not limited thereto. A flange 121 may be disposed between the threadless shaft 304 and the drive connector 125. The flange 121 may include tabs, collars, etc., extending radially from the central axis of the anchor head 126 to a diameter exceeding the diameter of the hole in the anchor housing (which supports the anchor).

[0047] In various embodiments, the length of the unthreaded portion 304 of the anchor head 126 may be selected to allow the anchor to rotate freely within the anchor housing to pull the anchor housing and tissue together to accommodate changes in tissue anatomy at the treatment area. For example, because implants are rarely deployed on flat surfaces, the implant may be configured such that while some tips contact the tissue surface, other tips of the implant are spaced at different distances from the tissue surface. Therefore, different compressive forces can be used to effectively pull the tissue and the tips of the implant together. The length of the unthreaded portion 304 is selected to accommodate the expected range of compressive forces of the implant. In some embodiments, the length of the unthreaded portion may be between 1% and 95% of the anchor head length. In some embodiments, the length of the unthreaded portion is greater than the hole (410, Figure 4A The length of the threaded portion of the anchor head 126. In some embodiments, the distal end 306 of the anchor head 126 includes, as shown in the figure, the length of the threaded portion of the anchor head 126. Figure 3B The portion shown is the fixing part 206 that is attached to the anchor coil 127 by welding or other means.

[0048] Figure 3B An example of an anchor coil 127 embodiment is shown, including a proximal end 330, a distal end 333, a compressible portion 204, a fixing portion 206, and a tissue-jointing portion 129. In some embodiments, the anchor coil 127 may be formed from a round wire. In other embodiments, the anchor coil 127 may be laser-cut from a stainless steel tube to provide a helical anchor, the stainless steel tube being formed from the highest hardness cold-rolled steel sheet (full hard temper), type 304 stainless steel. In other embodiments, the anchor coil 127 may be cut from a stainless steel sheet to form a helical anchor configuration. In some embodiments, the thickness of the stainless steel sheet and / or the tube may range from 0.020 mm to about 2 mm. In some embodiments, the thickness or width of the anchor coil may increase, decrease, and / or otherwise change along the length of the anchor coil 127. For example, as... Figure 3B As shown, the width W of the anchor coil 127 gradually decreases downward from the distal end 333 to the proximal end 330.

[0049] In some embodiments, the compressible portion 204 of the anchor coil 127 constitutes 1% to 30% of the anchor coil. In some embodiments, the compressible portion 204 constitutes more than 30% of the anchor coil. In some embodiments, the compressible portion 204 may constitute only a quarter turn of the anchor coil.

[0050] Figure 3CAn anchor 124 in its assembled state is shown. The anchor 124 has an anchor head 126 and an anchor coil 127. The anchor coil 127 is connected to the distal end 306 of the anchor head 126 at the fixed portion 206, and the compressible portion 204 forms a spring that freely spans along the unthreaded portion 304 of the anchor head 126.

[0051] In various embodiments, anchors 124 may be made of suitable biocompatible metal alloys such as stainless steel, cobalt-chromium, platinum-iridium, nickel-titanium, other suitable materials, or combinations thereof. Each anchor may be sharpened at its distal end 333 or leading edge coil to penetrate into cardiac tissue. In some embodiments, barbs 131 or other features may be provided at one or more locations of the tissue engagement portion 129 of the anchor coil 127 to increase the interaction between the anchor coil 127 and the tissue. The total axial length of each anchor 124 may be about ten to about fifteen millimeters (mm). In some embodiments, the total axial length of the anchor 124 may be less than or more than ten to fifteen millimeters (mm). "Total" axial length refers to the axial length of the anchor 124 from the distal end of the anchor coil 127 to the relatively proximal end of the anchor head 126. The axial length of the anchor coil 127 may be about six to about twenty millimeters (mm). In some embodiments, the axial length of the anchor coil 127 may be less than or more than six to twenty millimeters (mm). The axial length of the anchor head 126 and / or other non-helical portion of the anchor 124 may be about three to about four millimeters (mm). In some embodiments, the axial length of the anchor head 126 and / or other non-helical portion may be less than or longer than three to seven millimeters (mm). In some embodiments, the distal end 129 may extend into the cardiac tissue about four to about ten millimeters (mm).

[0052] Figure 4A This is a cross-sectional view of an anchor housing 120 in one embodiment. The anchor housing 120 is shown to include a hole 405 extending through it, the hole including a threaded portion 410 and a non-threaded portion 420.

[0053] Figure 4BThis is a cross-sectional view of the anchor 124 disposed within the anchor housing 120. The coil T1 of the anchor coil 127 is shown disposed within the threaded portion 410 of the hole in the anchor housing 120, while the coil T2 is disposed within the unthreaded portion 420. Translation of the anchor 124 until the flange 121 contacts the anchor housing generally indicates a displacement of 202 between the collar 121 and the proximal end of the anchor coil 127. At this point, applying more force to the anchor 124 causes the anchor to rotate freely, for example, further without axial translation. Because the proximal end of the anchor coil 127 is not attached to the anchor head, the free rotation of the anchor pulls the coil T1 into the compression chamber defined by the unthreaded portion of the hole, thereby allowing the compressed portion of the anchor coil 127 to move freely on the unthreaded portion 310 of the anchor head 126, thus increasing friction and tension within the anchor housing 120.

[0054] Figure 4C The image shows the compression of the compressible portion 204 of the anchor coil 127 during free rotation. The continuous rotation of the anchor head 126 creates tensile force within the hole, thereby pulling the coil T1 into the unthreaded portion 420 of the hole and increasing the displacement 202 between the proximal end of the anchor coil 127 and the flange 121. Consequently, the tensile load on the anchor coil 127 increases, thus pulling the anchor housing 120 and the structure 404 together.

[0055] Therefore, anchoring components have been shown and described as enabling anchors to be axially translated (forward and / or reverse) into cardiac features, such as to attach cardiac treatment components, including but not limited to annulusoplasty components. The anchoring components are configured to generate spring-loaded compressive forces to pull tissues and components together, thereby improving implant integrity and effectiveness.

[0056] Furthermore, according to one embodiment, compressive force can also be used to securely connect the anchor housing and the anchor after anchor deployment, reducing problems associated with anchor detachment. In one embodiment, the anchor may include a feature capable of self-locking with the anchor housing using compressive load accumulated during free rotation of the anchor head. For example, the anchor may include complementary slots, tabs, or other features of the housing to securely attach the anchor to the tabs, slots, or other features of the anchor housing. Locking the anchor to the anchor housing as described below inhibits further distal and / or proximal translation of the anchor within the anchor housing, thereby effectively securing the anchor to the anchor housing. Therefore, in the event of anchor detachment from tissue during prolonged use, the locking feature securely holds the anchor within the anchor housing, thereby eliminating the possibility of the anchor detaching from the implant and being released into the heart chambers.

[0057] Figure 5A andFigure 5B This is a perspective view of one embodiment of the locking feature of the anchoring assembly as disclosed herein. Figure 5A In this embodiment, a portion of the deployment system is shown including a drive sleeve 500 disposed on a drive connector 125 of the anchor head. The anchor head is shown including a locking feature 520, which may include a flange, tab, lug, protrusion, or other feature cooperating with complementary features 510 of the anchor housing 120 (such as slots, breaks, etc.). In one embodiment, the locking feature 520 is shielded by the drive sleeve 500, which is coupled to the drive connector 125 of the anchor head. Shielding the locking feature 520 with the drive sleeve 500 advantageously prevents the locking feature 520 from engaging the complementary feature 510 on the anchor housing 120 during axial translation and free rotation of the anchor head by the drive.

[0058] After the anchor is attached to the tissue, including after further engagement of the tissue and the anchor housing 120 using free rotation to pull the housing and tissue together, the actuator can be released from the drive connector 125, as follows: Figure 5B As shown. For ease of explanation, Figure 5B The anchor coil is omitted. As described above, tensile loads are generated within the anchor housing during free rotation. Because the anchor coil is attached to the distal end 182 of the anchor head, the tensile load pushes the anchor head 126 distally. Therefore, when the drive sleeve is removed from the drive coupling 125, the locking mechanism is pulled downward into the slot 510 of the housing, thereby securing the anchor within the housing and minimizing the possibility of disengagement.

[0059] As mentioned above Figure 1 As described herein, the anchoring components can be beneficial for annular reconstruction systems that deliver and attach components to cardiac features. Such annular reconstruction systems generally include mechanisms for deploying implant components (including anchors), mechanisms as described herein for driving the anchors, including driving the anchors to achieve axial translation and building compressive forces within the anchor housing.

[0060] For example, now refer to Figure 6A and Figure 6BSuch annulus remodeling system 600 may include a deployment catheter 610 carrying an annulus remodeling component 630 at a distal end 620. The distal end of the deployment catheter 610 may be cavitarily manipulated into the left atrium, for example, to position the component above and / or around and / or partially around the mitral valve annulus using a guidewire 625. According to one aspect, the deployment catheter may have various positioning and imaging capabilities, such as those described in U.S. Patent Serial No. 15 / 280,004, filed September 29, 2016, entitled “Methods for Deployment of Heart Valve Devices Using Intravascular Ultrasound Imaging,” which is incorporated herein by reference.

[0061] For reference Figure 6B When the distal end 620 of the deployment catheter 610 is properly positioned, the annulus shaping component 630 can be exposed (by advancing the component 630 through the distal end of the deployment catheter 610, or by retracting the distal sheath on the component) and extended to the tissue engagement diameter. Extension can occur naturally, for example, when the frame is formed of a nickel-titanium alloy or other shape memory or hyperelastic material and biased toward the extended state. In an alternative embodiment, extension can be mechanically controlled, for example, by using forces applied within the frame using an inflatable balloon, etc. The systems and methods disclosed herein are not limited to any particular mechanism for positioning anchors for reshaping the annulus, regardless of whether such positioning utilizes annulus or an expandable frame, and may utilize, for example, the techniques described in the following patents: U.S. Patent 9,610,156, filed December 24, 2014, entitled "Mitral Valve Inversion Prostheses"; U.S. Patent 9,180,005, filed November 24, 2015, entitled "Adjustable Endoluminal Mitral Valve Ring"; and U.S. Patent Application Serial No. 15 / 352,288, filed November 16, 2016, entitled "Implantable Device and Deployment System For Reshaping a Heart Valve Annulus," published as U.S. Patent 10,555,813, each of which is incorporated herein by reference in its entirety for all purposes.

[0062] After the annulus shaping component is deployed to the heart valve, as described above, the anchor can be axially translated through the anchor housing until further distal translation is blocked. Thereafter, the anchor can be driven to provide compressive force, thereby pulling the anchor housing closer to the tissue. The actuator can then be removed, where the compressive force locks the anchor to the anchor housing.

[0063] Figure 7 This is a perspective view of an example of a deployment system 1000, which can be used to deploy an implant 1001 including anchoring components as disclosed herein. The deployment system 1000 includes a maneuverable sheath 1010, a sheath control knob 1003, an anchor knob 1004, a tightening knob 1006, the implant 1001, and an intracardiac echocardiography (ICE) probe 1027, all supported and secured to a base 1002. The tightening knob 1006 and the anchor knob 1004 are spring-loaded to maintain tension. Rotation of the anchor knob 1004 can rotatably advance the anchor into the anchor housing and further into the annular tissue, further driving the anchor to pull the tissue and anchor together and release the anchor when distal translation is impeded, thereby allowing compressive forces to self-lock the anchor to the anchor housing.

[0064] Therefore, various embodiments of spring-loaded self-locking anchoring assemblies have been shown and described. While embodiments of this disclosure may be described specifically with reference to medical devices and systems that selectively access cardiac tissue (e.g., transcavitary devices for insertion into the femoral vein, etc.), it should be understood that such medical devices and systems can be used for a variety of medical procedures requiring anchorage to cardiac tissue. The disclosed medical devices and systems can also be inserted via different entry points and methods, such as percutaneously, endoscopically, laparoscopically, or combinations thereof.

[0065] As used herein, the singular forms “an,” “a,” and “the” are intended to also include the plural forms unless the context clearly indicates otherwise. The terms “comprising” and / or “including,” or “containing” and / or “having,” when used herein, indicate the presence of the stated feature, region, step, element, and / or component, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components, and / or groups thereof.

[0066] As used herein, the conjunction “and” includes each of the structures, parts, features, etc. so combined, unless the context clearly indicates otherwise; and the conjunction “or” includes one or more of the structures, parts, features, etc. so combined alone or in any combination and number, unless the context clearly indicates otherwise.

[0067] All numerical values ​​herein are assumed to be modified by the term "about," whether explicitly indicated or not. In the context of numerical values, the term "about" generally refers to a range of numbers that a person skilled in the art would consider equivalent to the stated value (i.e., having the same function or result). In many cases, the term "about" may include numbers rounded to the nearest significant figure. Other uses of the term "about" (i.e., in contexts other than numerical values) may be assumed to have their common and customary definition, as understood and consistent with the context of the specification, unless otherwise specified. A range of numerical values ​​expressed by endpoints includes all numbers within that range, including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0068] It should be noted that references to "one embodiment," "some embodiments," "other embodiments," etc., in the specification indicate that the described embodiments may include specific features, structures, or characteristics, but not every embodiment necessarily includes that specific feature, structure, or characteristic. Furthermore, such phrases do not necessarily refer to the same embodiment. Additionally, when a specific feature, structure, or characteristic is described in conjunction with one embodiment, combining such feature, structure, or characteristic with other embodiments is also within the understanding of those skilled in the art, unless expressly stated otherwise. That is, the various independent components described herein (even if not explicitly shown in a specific combination) are also considered to be combinable or arrangeable to form other additional embodiments or to supplement and / or enrich the described embodiments, as understood by those skilled in the art.

[0069] According to this disclosure, the apparatus and / or methods disclosed and claimed herein can be made and performed without extensive experimentation. Although various embodiments of the apparatus and methods of this disclosure have been described, it will be apparent to those skilled in the art that various modifications can be made to the apparatus and / or methods, and the steps or sequence of steps of said methods, without departing from the principles, spirit, and scope of this disclosure. It will be apparent to those skilled in the art that all such similar alternatives and modifications are considered to be within the principles, scope, and concept of this disclosure as defined by the appended claims.

Claims

1. An anchor, comprising: Anchor head and anchor coil; in: The anchor coil includes a proximal portion disposed around the anchor head and a distal portion extending distally from the anchor head. The anchor head includes a proximal end with a drive connector, a distal end, and a threadless shaft disposed between the drive connector and the distal end of the anchor head; and The proximal portion of the anchor coil includes a compressible coil slidably coupled to the distal end of the anchor head to allow compression of the compressible coil.

2. The anchor of claim 1, wherein the anchor head further comprises a flange disposed between the drive connector and the unthreaded shaft of the anchor head, the flange being configured to restrict distal translation of the anchor through a hole in the anchor housing.

3. The anchor of claim 2, wherein the anchor head includes a locking feature, and the anchor housing includes a proximal slot configured to attach the locking feature to the anchor housing.

4. The anchor of claim 3, wherein the locking feature comprises a flange, a tab, a tooth, a ridge, or a combination thereof, and the proximal slot comprises a slot, a pawl, a hole, a track, or a combination thereof.

5. The anchor according to claim 3 or 4, wherein the flange includes the locking feature.

6. An anchoring assembly having an anchoring member according to any one of claims 1 to 5, the anchoring assembly comprising: An anchor housing having a hole extending through it, the hole comprising a threaded portion and a non-threaded portion, the anchor being configured to translate axially within the hole of the anchor housing.

7. An annulusoplasty system, wherein the anchoring assembly of claim 6 is part of an implant of the annulusoplasty system, the annulusoplasty system comprising a delivery catheter including a drive tube having a proximal end and a distal end, the anchoring member being coupled to the distal end of the drive tube via a drive connector at the head of the anchoring member, wherein the drive tube provides a driving force, and wherein the anchoring assembly converts the driving force into an axial translational force, a compressive force, or both.

8. The valve ring forming system of claim 7, wherein the anchoring component converts the driving force into the axial translational force when the proximal end of the compressible coil is within the threaded portion of the hole, and into the compressive force when the proximal end of the compressible coil is within the unthreaded portion of the hole.

9. The valve ring forming system of claim 8, wherein the axial translational force is configured to advance the distal portion of the anchor coil or remove it from the tissue, the compressive force is configured to pull the anchoring assembly and the tissue together, and the anchoring assembly is configured to automatically convert the driving force from the axial translational force to the compressive force in response to the interaction between the flange and the anchor housing.

10. The valve ring forming system of claim 9, wherein the compressive force on the compressible coil generates a tensile load on the compressible coil, the tensile load pulling the anchor housing and the tissue together.

11. The valve ring forming system of claim 7, wherein the drive tube includes a drive sheath that shields the locking feature of the anchor head to prevent engagement between the locking feature and the proximal slot of the anchor housing.

12. The lobed ring forming system of claim 11, wherein the locking feature of the anchor head is biased by the compressive force to drag the locking feature into the proximal slot of the anchor housing when the drive sheath is retracted from the locking feature.

13. The valve annuloplasty system of claim 7, wherein the anchor is one of a plurality of anchors of the implant, the anchor housing is one of a plurality of anchor housings of the implant, and the drive tube is one of a plurality of drive tubes of the delivery catheter, each of the plurality of drive tubes being coupled to one of the plurality of anchors, wherein the drive tube is independently controlled to drive each anchor according to the anatomy of the anchoring location.

14. The valve annuloplasty system of claim 13, wherein the implant includes a frame, the frame including a plurality of adjacent struts connected to form a plurality of apexes, and wherein the anchor housing is coupled to the plurality of apexes of the frame.

15. The valve annulus shaping system of claim 14, wherein the frame is expandable from a compression delivery configuration to an extended configuration corresponding to the annulus of the heart valve, and wherein when the frame is in the extended configuration, the anchor housing is coupled to the top of the frame adjacent to the annulus of the heart valve.

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