Anchoring device with adaptive length control

Abstract

Implants, systems, and methods of deployment include a plurality of anchor housings coupled to one of a proximal end or a distal end of an implant frame. Each anchor housing can include an anchor sleeve disposed within a bore of the anchor housing, the anchor sleeve having a lumen extending therethrough, the lumen including a feature disposed on an inner wall of the lumen for translatably supporting at least one anchor. Each anchor sleeve can be independently translated within the bore of the anchor housing to control a range of travel of the at least one anchor through a distal end of the at least one anchor housing.

Description

[0001] Cross-references to related applications

[0002] Pursuant to 35 USC §119, this application claims priority to U.S. Provisional Patent Application No. 62 / 889,744, filed August 21, 2019, which is incorporated herein by reference in its entirety for all purposes. Technical Field

[0003] This technology typically involves implantable coronary artery medical devices, and more specifically, customizable coronary artery implants. Background Technology

[0004] Mitral regurgitation (MI) (also known as mitral regurgitation or mitral valve incompetence) is a heart condition in which the mitral valve annulus over-dilates and the leaflets no longer close or engage effectively during systole (the contraction of the heart). Blood flows back during ventricular systole, potentially resulting in reduced cardiac output. Surgical and endovascular annuloplasty techniques have been introduced to restore the mitral valve to its natural configuration, such as by implanting an annuloplasty ring around the valvular annulus. Changes in cardiac anatomy can present challenges when attempting to place an implant. It is necessary to identify implants that can be tailored to the heart's altered anatomy. Summary of the Invention

[0005] The following disclosure describes some non-limiting examples of embodiments. Each of the embodiments disclosed herein has several aspects, and no single aspect is solely responsible for the desired properties of this disclosure. For example, other embodiments of the disclosed systems and methods may include or exclude the features described herein. Furthermore, the advantages and benefits disclosed are applicable only to certain embodiments and should not be used to limit this disclosure.

[0006] According to one aspect, the implant includes a frame having a proximal end and a distal end, an anchor, and an anchor housing coupled to one of the proximal or distal ends of the frame. The anchor housing may include an anchor sleeve disposed within a bore in the anchor housing, the anchor sleeve having an inner cavity extending therethrough, the inner cavity including at least one feature disposed on an inner wall of the inner cavity for translatably engaging the anchor. The anchor sleeve is translatable within the bore in the anchor housing and configured to restrict translation of the anchor through the anchor housing.

[0007] In various embodiments, the anchor sleeve may include a collar disposed at a proximal end of the anchor sleeve to restrict translation of the anchor sleeve within the bore or translation of the anchor within the anchor sleeve, or both. The collar may include a proximal surface and at least one actuator engagement feature disposed on the proximal surface. The anchor may further include an anchor head disposed at a proximal end, the anchor head including a drive connector. The anchor head may include a distal surface having a sleeve engagement feature disposed thereon, the sleeve engagement feature being configured to engage with a drive engagement feature of a drive tube to cause translation of the anchor sleeve within the bore of the anchor housing.

[0008] In one embodiment, the anchor housing may be one of a plurality of anchor housings, the anchor sleeve may be one of a plurality of anchor sleeves, the anchor may be one of a plurality of anchors, and the plurality of anchor housings may be arranged around a frame. Each anchor housing may engage one of a plurality of anchor sleeves supporting one of the plurality of anchors, and each of the plurality of anchors may be coupled to one of a plurality of drive tubes to independently translate the connected anchor and the associated anchor sleeve.

[0009] According to another aspect, a system for annular valvuloplasty includes a delivery catheter having a proximal handle, a distal end, and a plurality of drive tubes extending therethrough. The system also includes an implant coupled to the plurality of drive tubes of the delivery catheter, wherein the implant may include a frame having proximal and distal ends. In one embodiment, the system may include a plurality of anchors, each anchor coupled to one of the drive tubes to independently translate the anchor. A plurality of anchor housings may be coupled to one of the proximal or distal ends of the frame, each anchor housing including an anchor sleeve disposed within a bore of the anchor housing, the anchor sleeve having an inner cavity extending therethrough, the inner cavity including at least one feature disposed on an inner wall of the inner cavity for translatably engaging at least one anchor. Each anchor sleeve is translatable within the bore of the anchor housing to control the extent of distal travel of at least one anchor through at least one anchor housing.

[0010] In various embodiments, the anchor sleeve may include a collar disposed at a proximal end of the anchor sleeve to restrict one or both of translational movement of the anchor sleeve within the bore and translational movement of the anchor within the anchor sleeve. The collar may include a proximal surface and at least one actuator engagement feature disposed on the proximal surface. Each anchor may also include an anchor head disposed at a proximal end, the anchor head including a drive connector. At least one drive tube may include a distal actuator configured to releasably engage with the anchor head to drive the anchor through the inner cavity of the anchor sleeve.

[0011] In various embodiments, the distal actuator may include a sleeve engagement feature extending radially from its distal end, the sleeve engagement feature being configured to engage with an actuator engagement feature on a proximal surface of a collar to cause translation of the anchor sleeve within a bore of the anchor housing. The anchor head may have a distal anchor head diameter larger than the inner diameter of the anchor sleeve cavity to prevent distal translation of the anchor head into the inner cavity of the anchor sleeve. The collar may extend radially from the inner cavity of the anchor sleeve, and the collar diameter may be larger than the bore diameter of the anchor housing to prevent distal translation of the collar into the bore. The anchor sleeve may include at least one external engagement feature disposed on an outer surface of the anchor sleeve, and the bore may include at least one internal engagement feature disposed on a bore wall, with at least one external engagement feature of the anchor sleeve engaging with at least one internal engagement feature of the bore to cause translation of the anchor sleeve within the bore of the anchor housing. At least one feature disposed on the inner wall of the anchor sleeve cavity may be configured to engage with at least one edge of the anchor to cause translation of the anchor within the anchor sleeve.

[0012] In one embodiment, the frame may include an expandable frame comprising at least two struts connected at a distal end to form a distal vertex, at least two struts connected at a proximal end to form a proximal vertex, and at least one anchor housing disposed about the distal vertex of the frame. An actuator may be translatably disposed about the proximal vertex of the frame to compress the frame. In various embodiments, each of the plurality of drive tubes may be independently controlled to customize the translation of the anchor, the translation of the anchor sleeve, or both.

[0013] According to another aspect, a method for annular plasty is described, wherein the annular plasty system includes a frame having a proximal end and a distal end, and a plurality of anchor housings coupled to one of the proximal or distal ends of the frame. Each anchor housing may include an anchor sleeve disposed within a bore of the anchor housing, and each anchor includes a proximal collar having a drive tube engagement feature. A plurality of anchors may be provided, each anchor including a proximal anchor head and a distal end coupled to a drive tube, wherein each anchor may be disposed within one of the anchor sleeves of the plurality of anchor housings. The method includes the steps of: advancing each anchor through each anchor sleeve until translation of the proximal anchor head is blocked by the proximal collar of the anchor sleeve and the drive tube engagement feature engages the sleeve engagement feature of the drive tube, and independently advancing each anchor sleeve through the anchor housing by the action of the drive tube engagement feature and the sleeve engagement feature to advance the distal end of the anchor beyond the anchor housing into the tissue to a customized degree until translation of the anchor sleeve is blocked. In one embodiment, the method may further include the following steps: when translation of the anchor sleeve is prevented, while maintaining connection with the anchor, releasing the drive tube from the anchor sleeve and continuing to drive the anchor to pull tissue into the anchor.

[0014] With this arrangement, the anchor sleeve can be used to limit the depth at which each individual anchor is driven, allowing for customized implant deployment based on variations in the patient's anatomy. Attached Figure Description

[0015] The foregoing and other features of this disclosure will become clearer from the following description and the appended claims, taken in conjunction with the accompanying drawings. In the drawings, similar symbols generally identify similar parts unless the context otherwise requires. The illustrative embodiments described in the detailed description, drawings, and claims are not intended to be limiting. Other embodiments may be utilized, and other changes may be made, without departing from the spirit or scope of the subject matter presented herein. It will be readily understood that various aspects of this disclosure, as generally described herein and shown in the drawings, can be arranged, substituted, combined, and designed in a variety of different configurations, all of which are expressly contemplated and are part of this disclosure.

[0016] Figure 1 This is an illustration of an embodiment of an implant including an anchor housing as disclosed herein;

[0017] Figure 2 This is a diagram of an anchoring component according to an embodiment disclosed herein;

[0018] Figure 3A and 3B Representative components of an embodiment of the deployment system disclosed herein are shown;

[0019] Figures 4A-4C A perspective view of one embodiment of a collaborative anchor drive tube / collar feature that can be used as described herein is provided;

[0020] Figure 5A and 5B The ventricular deployment of the implant as disclosed herein is shown;

[0021] Figures 6A-6C This is an illustrative diagram showing an implant anchoring process using one embodiment of the anchor housing assembly disclosed herein; and

[0022] Figure 7 An embodiment of an implant with a customized anchor depth is shown, which includes an anchor housing as described herein. Detailed Implementation

[0023] Heart disease impairs a patient's cardiac output, reducing their quality of life and lifespan. When a heart valve fails to engage or close during its cardiac cycle, blood may leak backward into the atrium with each left ventricular contraction. Various procedures have been implemented to overcome valvular insufficiency. These procedures include methods for restoring the structural integrity of the valve annulus (the fibrous ring that partially surrounds the heart valve) and / or repairing flail leaflets caused by stretched or torn chordae tendineae. Many of these methods involve anchoring implants or other objects to the heart tissue. For example, annuloplasty may involve using anchors to secure the valve annulus to a ring or frame.

[0024] Because of the anatomy of the heart valves, including the varying thickness of the surrounding tissue along their circumference, this solution presents a problem. Deploying the anchors uniformly to the same depth may cause them to penetrate too deeply into the heart tissue, potentially reducing the effectiveness of the procedure.

[0025] According to one aspect, these problems are overcome by using an implant with an improved anchor housing assembly. In some embodiments, the anchor housing may be coupled to one of the proximal or distal ends of an implant frame to be delivered to a treatment site, such as the proximal side of a valve annulus. Each anchor housing may include an anchor sleeve disposed within a bore in the anchor housing. The anchor sleeve may include an inner cavity extending therethrough, the cavity including features disposed on an inner wall of the cavity for translatably supporting at least one anchor. The anchor may include a proximal anchor head releasably coupled to an anchor drive tube, wherein actuation (e.g., rotation or translation) of the anchor drive tube on the anchor causes the anchor to translate through the anchor sleeve toward the treatment site.

[0026] An anchor sleeve may include a collar disposed at its proximal end, configured to limit the extent of distal travel of the anchor within the sleeve. For example, the diameter of the inner cavity of the anchor sleeve surrounded by the collar may be smaller than the diameter of the proximal anchor head, such that further distal travel is impeded due to the interaction between the proximal anchor head and the collar of the anchor sleeve as the anchor translates distally through the sleeve. Thus, the collar of the anchor sleeve can be used to limit distal translation of the anchor through the anchor housing to allow the anchor depth to conform to the patient's anatomy.

[0027] Further distal translation of the anchor through the anchor housing can be achieved by translating the anchor sleeve through the anchor housing. In some embodiments, the collar of the anchor sleeve may include features that allow the collar to releasably engage with the anchor drive tube. Thus, once the advance of the proximal anchor head is impeded by the collar of the anchor sleeve, the drive tube acts on features disposed on the collar to uniformly rotate the anchor sleeve and the anchor, thereby advancing the anchor sleeve distally, resulting in the anchor being advanced through the hole in the anchor housing.

[0028] The use of anchor sleeves and anchor shells provides adaptive control over anchor delivery depth, allowing surgeons to tailor the depth based on variations in anatomy at the treatment site. For example, anchors to be delivered to valve tissue with minimal thickness can be advanced only partially through the anchor sleeve and then through the anchor shell. Unlike exposing unused anchors and increasing the risk of thrombosis and other embolisms, anchor sleeves enclose the anchor threads, minimizing such risks and increasing the implant's resilience and strength to prevent fatigue.

[0029] However, for treatment sites with thicker valve tissue, the disclosed anchor housing assembly allows the anchor sleeve and anchor to travel to their maximum distal extent to fully utilize the anchoring capacity.

[0030] These and other advantages of the disclosed anchor housing assembly are described in more detail below. Although embodiments of this disclosure may be described with specific reference to the mitral valve, anchor housings such as those disclosed herein, which provide customizable depth anchoring, can be readily adapted to facilitate the reconstruction of any valvular annulus, including, for example, the tricuspid annulus, and / or may similarly benefit any other dilatation, valvular insufficiency, valvular leakage, and other similar heart failure conditions involving anchoring components to cardiac tissue.

[0031] As used in this article, 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.

[0032] Figure 1 An implant 100 including a frame 110 is shown, 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 along a central frame axis that extends proximally and distally through a central point of the frame. The frame 110 may be generally symmetrical with respect to the central frame axis, although it does not need to be symmetrical. The frame 110 may be formed into a generally 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., during different stages of deployment, such as before delivery, during delivery, during tissue engagement, and during 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, composite materials, 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 frame 110 may be formed from the same monolithic material. Therefore, reference to strut 112 may refer to different portions of the same broad component. Alternatively, reference to strut 112 may refer to components formed separately and permanently attached together, for example, by welding or other methods. In some embodiments, strut 112 may be separate components detachably joined together to form a proximal vertex and a distal vertex. For example, strut 112 is shown connected at its proximal vertex by actuator 130 and at its distal vertex by anchor housing assembly 120.

[0035] In some embodiments, the terms “vertices,” “multiple vertices,” etc., may be used interchangeably with the terms “crown,” “multiple crowns,” etc., as used herein and in any reference incorporated herein by reference, unless otherwise stated. In one embodiment, a “vertices” may include the proximal or distal portion of a 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 carried by a window or other opening (not shown) at the proximal apex of frame 110. Actuator shaft 134 may include a drive coupling 136 at the proximal end. Actuator 130 may also include actuator collar 132 having internal features configured to interact with features of actuator shaft 134 such that rotation of actuator shaft 134 by actuator drive tube coupled to drive coupling 136 causes actuator collar 132 to translate axially on actuator shaft 134 and on strut 112. In some embodiments, the “axial” of the axial movement or constraint applied to actuator collar includes a direction at least partially along the proximal or distal direction and parallel or substantially parallel to a central axis extending through (proximal-distal) the frame, for example, at least partially along axis Y. Figure 1As shown, strut 112 extends in opposite directions away from the proximal apex. Actuator collar 132 is advanced distally on strut 112, causing the struts to pull together within the actuator collar 132, thus reducing the distance between anchor housing assemblies 120 to reshape cardiac tissue anatomy, such as restoring valves to their original configuration. In one embodiment, each actuator collar 132 can be actuated independently according to the reshaping target of the relevant anchor pair.

[0037] The implant also includes an anchor housing assembly 120. Figure 1 In some embodiments, the anchor housing assembly is shown to be connected by a tether 140. In some embodiments, the tether 140 may be made of nylon or other stitching material and may be used to maintain and / or change the relative position of the anchor housing assembly 120.

[0038] Each anchor housing assembly 120 is shown to include an anchor housing 121, an anchor sleeve 122, and an anchor 124. Each anchor 124 may include an anchor drive connector 125 configured to connect the anchor 124 to an anchor drive tube. In one embodiment, the anchor 124 is translatably supported by the anchor sleeve 122, which in turn is translatably supported by the anchor housing 121. After or before advancing each actuator collar 132 on the strut 112, the anchor 124 may be driven through the anchor sleeve 122 and the anchor housing 121 to embed the distal end of the anchor 124 into tissue.

[0039] According to one aspect, the anchor housing assembly 120 disclosed herein in various embodiments enables surgeons to customize the extent of the anchor 124 traveling through the anchor housing 121, thereby adjusting the anchoring depth according to changes in tissue anatomy.

[0040] Figure 2 An embodiment of the anchor housing assembly 120 is shown in more detail. The anchor housing assembly 120 is shown to include an anchor housing 121, which includes a through hole 201 extending therethrough. The anchor housing 121 may also include a frame sleeve 220 configured to receive a frame 110 (…). Figure 1 One or more supports are used to attach the anchor housing assembly 120 to the frame 110. In other embodiments, the anchor housing assembly may be integral with the frame 110. In some embodiments, the anchor housing assembly may include a tether cavity 141 extending through a portion of the anchor housing for supporting a tether 140 of the implant. Figure 1 ).

[0041] A hole 201 extends from the proximal surface 203 through the distal surface 204 of the anchor housing 121. The hole 201 may include features 205, such as ridges, threads, or other types of features, provided on the inner wall of the hole 201. Features 205 on the inner wall of the hole 201 may engage with features 206 on the outer surface of the anchor sleeve 122 to allow the anchor sleeve 122 to translate axially through the hole 201 in the anchor housing 121.

[0042] Anchor sleeve 122 may consist of a collar 222 disposed at its proximal end and a sleeve shaft 230 extending from the collar 222 to the distal end 233 of the anchor sleeve 122. The collar 222 has an opening extending therethrough, which defines an inner cavity 202 extending from the collar 222 through the distal end 233 of the sleeve shaft 230. In some embodiments, the diameter of the collar 222 may be larger than the diameter of the hole 201 to limit the distal translation of the anchor sleeve 122 beyond the proximal surface 203 of the anchor housing 121.

[0043] In one embodiment, the collar 222 may include one or more actuator engagement features 223a, 223b disposed on a proximal surface of the collar 222. The actuator engagement features 223a, 223b may include tabs, notches, ridges, flanges, hooks, or other features that mate with complementary features of the anchor drive tube (not shown), such that the collar 222 can engage with the anchor drive tube and thus actuate the anchor sleeve 122 via the anchor drive tube, for example, to drive the anchor sleeve 122 through a hole 205 in the anchor housing 121.

[0044] In various embodiments, the inner surface of the anchor sleeve 122 defining the cavity 202 may have features disposed thereon to engage with the edges, ridges, threads or other features of the anchor 124, thereby supporting axial translation of the anchor 124 through the anchor sleeve 122.

[0045] Anchor 124 is shown including a proximal anchor head 128, a distal end 129, and a helical shaft 123 extending from the proximal anchor head 128 to the distal end 129. The proximal anchor head 128 includes a drive shaft 126 having a proximal anchor drive connector 125 configured to engage with an anchor drive tube (not shown). An anchor shaft collar 127 may extend radially outward from and at least partially around the drive shaft 126. In some embodiments, the diameter of the anchor shaft collar 127 may be larger than the diameter of the cavity 202 defined by the collar 222 of the anchor sleeve to limit the proximal anchor head 128 of the anchor 124 to translate distally beyond the collar 222 of the anchor sleeve 122.

[0046] In some embodiments, the anchor 124, anchor sleeve 122, and anchor housing 121 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. 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 shorter or longer than ten to fifteen millimeters (mm). The “total” axial length refers to the axial length of the anchor 124 from the end of the distal penetrating end 129 to the opposite proximal anchor head 128. The axial length of the helical shaft 123 of the anchor 124 may be about six to about twelve millimeters (mm). In some embodiments, the axial length of the helical shaft 123 may be shorter or longer than six to twelve millimeters (mm). The axial length of the proximal anchor head 128 and / or other non-helical portions of the anchor 124 may be about three to about four millimeters (mm). In some embodiments, the axial length of the proximal anchor head 128 and / or other non-helical portions may be less than or more than three to four millimeters (mm).

[0047] In some embodiments, the distal end 129 of the anchor 124 can extend axially beyond the corresponding distal surface 204 of the anchor housing 121 by about four to about seven millimeters (mm), such that the helical shaft 123 can extend into the heart tissue by four to seven millimeters (mm).

[0048] In some embodiments, the anchor housing 121 may have a height H ranging from 2.5 mm to 5 mm. The shaft 230 of the anchor sleeve 122 may be matched to the height H such that it extends through the entire bore 201 of the anchor housing 121, although it is not required that the shaft 230 of the anchor sleeve be matched to the height H of the anchor housing 121. It should be understood that the anchor sleeve 122 is used to accommodate the depth of the associated anchor, for example, to reduce the depth of anchor insertion at target treatment sites with fragile anatomy. Therefore, in some embodiments, the anchor sleeve 122 may be used to reduce the depth of the anchor to less than four millimeters (mm).

[0049] It should be noted that this disclosure is not limited to embodiments in which the length of the shaft 230 of the anchor sleeve 121 matches the height H of the anchor housing 121, but may also include embodiments in which the length of the anchor shaft 230 is 0.25–1 times the height H of the anchor housing.

[0050] In one example of the embodiment, the height H of the anchor housing may be, for example, 3 mm, the length of the anchor sleeve may be 3 mm, and the length of the anchor from the distal end to the collar 127 may be 7 mm, thereby allowing the delivery of anchors with a depth in the range of 1 to 4 mm.

[0051] Figure 3AAn example of a deployment system 300 for deploying implant 100 is shown, the implant 100 including... Figure 1 and 2 The described anchor housing assembly.

[0052] In one embodiment, the deployment system may include an implant sheath 310 made of a composite material with a thermoplastic elastomer (TPE) layer, such as PEBAX supplied by ARKEMA of Colombes, France. Alternatively, nylon, polyurethane, polyester, silicone, or other similar materials may be used. In some embodiments, the length of the implant shaft 310 is selected to allow minimally invasive transcavitary (e.g., transfemoral or transnasal septal) insertion of a distally carried implant into the heart chamber. Thus, the length of the implant shaft 310 may range from 24” to 52”, more specifically from 42” to 46”. In one embodiment, the inner diameter may range from 24 to 31 Fr, while the outer diameter may range from 26 Fr to 34 Fr or greater. In an example of the embodiment, the inner diameter may be, for example, 28 Fr, while the outer diameter may be 32 Fr.

[0053] In one embodiment, the inserter sheath 310 may be a maneuverable sheath capable of transluminal navigation to a cardiac treatment site. The proximal handle 330 may include various controls for steering the sheath 310 and operating components coupled to the sheath 310. For example, the proximal handle may include a sheath steering knob 303, an anchor knob 304, and a tightening knob 306. The inserter sheath 310 may include an operating line extending from the operating knob 303 of the proximal handle 330 to the distal end 333 of the inserter sheath 310, wherein rotation of the operating knob 303 controls the deflection of the distal end 333 of the inserter sheath 310 during transluminal navigation.

[0054] The proximal handle 330 may be supported by the platform 302 and also includes actuator control mechanisms such as a tightening knob 306 and an anchor knob 304. As described in more detail below, the implant sheath may carry multiple drive tubes. Each drive tube may include a thiopanthus tube or a similar device configured to transmit torque along its length to control the implantation of the implant 100. For example, the tightening knob 306 may be used to control the actuator drive tube coupled to the actuator shaft 134 to move the actuator 130 on the strut 112. Figure 1 Anchor knob 304 can be used to control the anchor drive tube connected to the proximal anchor head of anchor 124. Figure 1 and Figure 2 This allows the anchor knob 304 to rotate, thereby rotatably advancing the anchor 124 into the anchor housing assembly 120. Furthermore, as described in more detail below, rotation of the anchor knob 304 can cause the anchor drive tube to rotatably advance the anchor sleeve into the anchor housing.

[0055] In some embodiments, an intravascular cardiac ultrasound (ICE) catheter 327 may be disposed within the implant 100. The ICE catheter 327 may be coupled to an ICE catheter control handle 329 to monitor the placement of anchors during implant deployment.

[0056] Figure 3B An embodiment of the distal end 333 of the infeeder sheath 310 is shown, which carries a delivery conduit 320 within a working conduit 325, wherein the delivery conduit is shown as including a channel for supporting a drive tube 350. In one embodiment, the drive tube 350 may include an actuator drive tube and an anchor drive tube. The drive tube 350 may include a drive connector 352 for coupling the respective drive tube to an actuator, anchor, or other component of the deployment system 300.

[0057] Figures 4A-4C This is a perspective view of one embodiment of an anchor sleeve / anchor drive tube connection mechanism that can be used as disclosed herein. Anchor sleeve 122 is shown to include an anchor collar 222. An inner cavity 202 extends through the anchor sleeve 122. One or more drive tube engagement features 223a, 223b may be formed on a proximal-facing surface 225 connected to the anchor collar 222. Figure 4A The distal end of the anchor drive tube 400 is also shown, wherein the sleeve drive feature 402 is shown disposed at its distal end.

[0058] Figure 4B This is a view of the distal end of the anchor drive tube 400 facing the proximal side, wherein sleeve engagement features 402 and 404 are shown arranged around the outer circumference of the anchor drive tube. In one embodiment, it is configured to engage with a drive connector 125 of the proximal anchor head 128. Figure 2 The anchor drive connector 403 can be disposed in the inner circumference at the far end of the anchor drive tube 400. Figure 4C This is a side perspective view of one embodiment of the anchor driver, wherein the anchor driver connector 403 is shown disposed between sleeve engagement features 402, 404. See reference... Figures 6A-6C In more detail, when the anchor drive tube 400 drives the proximal head of the anchor through the inner cavity 202 of the sleeve 122, as the proximal head of the anchor approaches the collar 222, the sleeve engagement features 402, 404 of the anchor drive 400 contact the anchor drive features 223a, 223b of the collar 222. Through the interaction of the anchor drive features 223a, 223b and the sleeve engagement features 402, 404, the force from the drive tube can be transmitted to the anchor sleeve 122. In this arrangement, the anchor drive tube 400 can be used to drive both the anchor and the anchor sleeve.

[0059] Figure 5A , 5BThis is a sequential three-dimensional diagram of a method for delivering an implant, which includes adaptive anchor depth control as described herein, such as an implant for a valve annulus. (The remaining text appears to be incomplete and possibly contains errors.) Figure 3A The described delivery system is used to insert an implant to deliver the implant to the heart chamber, for example, by accessing the vascular system of the leg, such as the femoral vein or iliac vein.

[0060] like Figure 5A As shown, such a delivery system 501 may include a delivery catheter 510, which includes a guidewire 525 at its distal end for navigating the distal end 502 of the delivery catheter 510 into the left atrium of the heart to deploy an implant for mitral valve repair. Figure 5B In this embodiment, implant 550, such as an implant including an anchor housing configured as disclosed herein to adapt to the anchor depth, can be released from the distal end 502 of delivery catheter 510, for example by expelling the implant from delivery catheter 510 or withdrawing the inserter sheath to expose implant 100. Implant 550 can be positioned at a treatment site, such as near, around, or partially around the mitral valve annulus.

[0061] Figures 6A-6C This is a sequential view illustrating one embodiment of a method for deploying an anchor to a treatment site using the adaptive depth anchor housing assembly disclosed herein, wherein the anchor housing 121, anchor sleeve 122, and anchor driver 400 are shown in cross-section. Figure 6A In this process, the anchor drive tube 400 actuates the anchor 124, for example, by rotating the anchor. The anchor 124 interacts with an edge, ridge, or other thread on the inner surface 299 of the anchor sleeve 122 to cause the anchor 124 to translate through the anchor sleeve 122. The anchor drive tube 400 may continue to actuate the anchor 124 until, as Figure 6B As shown, the anchor bushing 127 contacts the anchor sleeve collar 222, limiting further translation of the anchor 124 within the anchor sleeve 122. In one embodiment, the sleeve is initially positioned within the bore 201 of the anchor housing 121 such that the anchor bushing 222 of the anchor sleeve 122 and the proximal surface 203 of the anchor housing 121 are spaced apart by a sleeve exposure range 600. It should be understood that the sleeve exposure range is a design choice that takes into account the length of the anchor and the minimum required depth of the anchor in the tissue. For example, as Figure 6B As shown, when the anchor sleeve 127 initially contacts the collar 222, the distal end 129 of the anchor 124 extends distally from the anchor housing 121 to a distal extent 602. The anchor drive tube 400 can translate the anchor sleeve 121 proximally or distally to change the distal extent 602 of the anchor exposed from the anchor housing 121. For example, Figure 6CAn anchor housing 121 is shown, wherein the anchor drive tube 400 continuously rotates to advance the anchor sleeve 122 into the bore of the anchor housing 121, thereby increasing the distal extent 602 of the anchor. The anchor drive tube 400 may continue to actuate the anchor sleeve 122 until the anchor collar 222 contacts the proximal surface 203 of the anchor housing, thereby limiting the extent to which the distal end 129 of the anchor 124 enters the tissue.

[0062] In one embodiment, the anchor drive tube may be configured to release the sleeve engagement features 402, 404 of the anchor collar 222. Figures 4A-4C For example, sleeve engagement features 402, 404 can retract within the anchor drive tube 400. The retraction of sleeve engagement features 402, 404 advantageously allows the anchor 124 to be further rotated into the tissue. When distal translation of the anchor is restricted by the interaction of the anchor collar 222 and the anchor shaft collar 127, further rotation of the anchor 124 into the tissue advantageously tightens the tissue to improve anchor fixation.

[0063] Figure 7 An embodiment of an implant having an adaptive anchor depth control mechanism as disclosed herein is shown. Figure 7 In the embodiment, implant 700 is shown comprising multiple anchors 724a-724d, wherein anchors 724a-724d are advanced to different depths through their respective anchor housings 721a-721d. For example, anchors 724c and 724d are advanced to a smaller distal extent than anchors 724a and 724b. As a result, anchor sleeves 722c and 722d are exposed from anchor housings 721c and 721d, which reduces the exposure of the cardiac chambers to the exposed threads of anchors 724c and 724d.

[0064] Various modifications to the embodiments described in this disclosure will be apparent to those skilled in the art, and the general principles defined herein may be applied to other embodiments without departing from the spirit or scope of this disclosure. Therefore, this disclosure is not intended to be limited to the embodiments shown herein, but is accorded the widest scope consistent with the claims, principles, and novel features disclosed herein. The word “example” is used herein only 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 superior or more advantageous than other embodiments.

[0065] Some features described in the context of different embodiments in this specification may also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may also be implemented individually or in any suitable sub-combination in multiple embodiments. Furthermore, although features may be described above as functioning in certain combinations and even initially claimed in this way, in some cases one or more features from the claimed combination may be removed from the combination, and the claimed combination may be for sub-combinations or variations of sub-combinations.

[0066] Similarly, although the operations are depicted in a specific order in the accompanying drawings, this should not be construed as requiring that such operations be performed in the specific order shown or sequentially, or that all illustrated operations be performed to achieve the desired result. Furthermore, other embodiments are also within the scope of the appended claims. In some cases, the actions recited in the claims may be performed in a different order, but the desired result may still be achieved.

[0067] Those skilled in the art will understand that, in general, 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 of claim references are intended to be introduced, such an intention will be explicitly stated in the claim, and the absence of such references will not imply that any particular claim containing such a reference is limited to containing only one embodiment of such a reference, even when the same claim includes the introductory phrases “one or more” or “at least one” and an indefinite article, such as “a” (e.g., “a” should generally be interpreted as “at least one” or “one or more”); the same applies to the use of definite articles to introduce claims. Furthermore, even when a specific number is explicitly referenced in an introduced claim, those skilled in the art should recognize that such references should generally be interpreted as indicating at least the referenced number (e.g., an empty reference to "two references," without other modifiers, generally means at least two references, or two or more references). Additionally, when using conventions such as "at least one of A, B, and C," generally, such a construction is intended to be understood by those skilled in the art in the sense of the convention (e.g., "a system having at least one of A, B, and C" will include, but is not limited to, systems where A is alone, B is alone, C is alone, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). Those skilled in the art will further understand that any separate word and / or phrase presenting two or more alternative terms, whether in the specification, claims, or drawings, should be understood to include the possibility of including one, one, or both of these terms. For example, the phrase “A or B” will be understood to include the possibility of including “A” or “B” or “A and B”.

Claims

1. An implant comprising: A frame with proximal and distal ends; Anchors; and An anchor housing is attached to one of the proximal or distal ends of the frame. The anchor housing includes an anchor sleeve disposed within a hole in the anchor housing. The anchor sleeve has an inner cavity extending therethrough. The inner cavity includes at least one feature disposed on the inner wall of the inner cavity to translatably engage the anchor. The anchor sleeve is threadedly engaged with the anchor housing. The anchor sleeve includes a collar disposed on the proximal end of the anchor sleeve; The anchor housing includes a proximal surface; and The anchor sleeve is rotatable and translatable within the bore of the anchor housing, and the engagement of the collar with the proximal surface restricts the translation of the anchor through the anchor housing.

2. The implant of claim 1, wherein the collar includes a proximal surface and at least one actuator engagement feature disposed on the proximal surface.

3. The implant of claim 1, wherein the anchor further comprises an anchor head disposed at the proximal end, the anchor head comprising a drive connector.

4. The implant of claim 3, wherein the anchor head has a distal anchor head diameter that is larger in size than the inner diameter of the inner cavity of the anchor sleeve to prevent the anchor head from translating distally into the inner cavity of the anchor sleeve.

5. The implant according to any one of claims 1-3, wherein the collar extends radially from the inner cavity of the anchor sleeve, and the collar diameter is larger than the hole diameter of the hole in the anchor housing to restrict the anchor sleeve from translating distally into the hole.

6. The implant according to any one of claims 1-3, wherein the anchor sleeve includes at least one external engagement feature disposed on the outer surface of the anchor sleeve, the hole includes at least one internal engagement feature disposed on the wall of the hole, and the at least one external engagement feature of the anchor sleeve engages with the at least one internal engagement feature of the hole to allow the anchor sleeve to translate within the hole of the anchor housing.

7. The implant as claimed in claim 6, characterized in that, At least one feature of the inner cavity of the anchor sleeve engages with at least one edge of the anchor to allow the anchor to translate within the anchor sleeve.

8. The implant according to any one of claims 1-3, wherein the frame comprises an expandable frame including a plurality of struts connected at the distal end to form a distal vertex, the anchor housing being one of a plurality of anchor housings disposed at the distal vertex of the frame, and the anchor being one of a plurality of anchors, each anchor being disposed within one of the plurality of anchor housings.

9. The implant of claim 8, wherein at least two of the plurality of struts of the frame are connected proximally to provide a proximal apex, and wherein the implant includes an actuator translatably disposed around the proximal apex to compress the frame.

10. The implant of claim 3, wherein the anchor head includes a distal surface having a sleeve engagement feature disposed thereon, the sleeve engagement feature being configured to engage with a driver engagement feature of a drive tube to cause the anchor sleeve to translate within a hole in the anchor housing.

11. An implant deployment system, with the implant of any one of claims 1-3 as part of the implant deployment system, the implant deployment system comprising a delivery conduit including a proximal handle, a distal end, and a drive tube extending from the proximal handle to the distal end, the drive tube including a distal actuator configured to releasably engage the anchor head to drive the anchor through the lumen of the anchor sleeve.

12. The implant deployment system of claim 11, wherein the distal actuator includes a sleeve engagement feature extending radially from its distal end, the sleeve engagement feature being configured to engage with an actuator engagement feature on a proximal surface of the collar to cause the anchor sleeve to translate within the hole in the anchor housing.

13. The implant deployment system of claim 11, wherein the anchor housing is one of a plurality of anchor housings, the anchor sleeve is one of a plurality of anchor sleeves, the anchor is one of a plurality of anchors, and wherein the plurality of anchor housings are disposed around the frame, and each anchor housing engages with one of the plurality of anchor sleeves supporting one of the plurality of anchors, and wherein each of the plurality of anchors is coupled to one of the plurality of drive tubes to independently translate the coupled anchor and the associated anchor sleeve.

14. The implant deployment system of claim 11, wherein each of the plurality of drive tubes is independently controlled to customize the translation of the anchor, the translation of the anchor sleeve, or both.

15. An implant deployment system, with the implant of claim 9 as part of the implant deployment system, the implant deployment system comprising a delivery conduit including a proximal handle, a distal end, and a plurality of drive tubes extending from the proximal handle to the distal end of the delivery conduit, the plurality of drive tubes being coupled to the plurality of anchors, wherein the drive tubes are independently controllable at the proximal handle to allow anchor sleeves to translate to different degrees within the plurality of anchor housings.

16. The implant of claim 15, wherein each drive tube includes a first release mechanism for releasing the drive tube from the anchor sleeve and a second release mechanism for releasing the drive tube from the anchor.

17. The implant of claim 16, wherein the anchor sleeve is configured to impede translation of the anchor while allowing rotation of the anchor.

18. A system for annular repair surgery, comprising: A delivery conduit having a proximal handle, a distal end, and a plurality of drive tubes extending therethrough; and An implant comprising a plurality of drive tubes connected to the delivery catheter, the implant including: A frame with proximal and distal ends; Multiple anchors, each anchor connected to one of the multiple drive tubes to independently translate the anchor; and A plurality of anchor housings are coupled to one of the proximal or distal ends of the frame. Each anchor housing includes an anchor sleeve disposed within a hole in the anchor housing. The anchor sleeve has an inner cavity extending therethrough. The inner cavity includes at least one feature disposed on the inner wall of the inner cavity for translatably engaging at least one anchor. The anchor sleeve is threadedly engaged with the anchor housing. The anchor sleeve includes a collar disposed on the proximal end of the anchor sleeve; The anchor housing includes a proximal surface; and At least one anchor sleeve is rotatable and translatable within a hole in at least one anchor housing, and the engagement of the collar with the proximal surface restricts the translation of at least one anchor through at least one anchor housing.

19. The system of claim 18, wherein the collar includes a proximal surface and at least one driver engagement feature disposed on the proximal surface.

20. The system of claim 19, wherein each anchor further includes an anchor head disposed at a proximal end, the anchor head including a drive connector.

21. The system of claim 20, wherein at least one drive tube includes a distal driver configured to releasably engage the anchor head to drive the anchor through the inner cavity of the anchor sleeve.

22. The system of claim 21, wherein the distal actuator includes a sleeve engagement feature extending radially from its distal end, the sleeve engagement feature being configured to engage with an actuator engagement feature on a proximal surface of the collar to cause the anchor sleeve to translate within the bore of the anchor housing.

23. The system of claim 22, wherein the anchor head has a distal anchor head diameter that is dimensionally larger than the inner diameter of the inner cavity of the anchor sleeve to prevent the anchor head from translating distally into the inner cavity of the anchor sleeve.

24. The system of claim 21, wherein the collar extends radially from the inner cavity of the anchor sleeve, and the collar diameter is larger than the bore diameter of the hole in the anchor housing to prevent the collar from translating distally into the hole.

25. The system of claim 24, wherein the anchor sleeve includes at least one external engagement feature disposed on the outer surface of the anchor sleeve, the hole includes at least one internal engagement feature disposed on the wall of the hole, and the at least one external engagement feature of the anchor sleeve engages with the at least one internal engagement feature of the hole to allow the anchor sleeve to translate within the hole of the anchor housing.

26. The system of claim 25, wherein the at least one feature disposed on the inner wall of the inner cavity of the anchor sleeve is configured to engage with at least one edge of the anchor to cause the anchor to translate within the anchor sleeve.

27. The system of claim 26, wherein the frame comprises an expandable frame including at least two pillars connected at a distal end to form a distal vertex, at least two pillars connected at a proximal end to form a proximal vertex, and wherein at least one anchor housing is disposed about the distal vertex of the frame, and an actuator is translatably disposed about the proximal vertex of the frame to compress the frame.

28. The system of claim 18, wherein each of the plurality of drive tubes is independently controlled to customize the translation of the anchor, the translation of the anchor sleeve, or both.

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