Systems, devices and methods for remodeling a valve annulus

Abstract

A valve ring repair system that incorporates anchors at one or both of its proximal and distal ends to construct an implant to reshape the ring. A removable frame can be used to position the anchors adjacent to the ring and adjust the shape of the ring. The frame can support the anchors during deployment of the system, can release the anchors during construction of the implant, can adjust the shape of the implant (and simultaneously adjust the shape of the reconstructed valve) during the adjustment / tightening process, can maintain the adjusted shape of the valve ring while the relative anchor position is fixed, and can release the anchors to allow the frame to be removed from the deployment site after implant construction. Utilizing such a system, a low-profile flexible annular valve implant can be provided in which the risk of migration, fracture, embolism, and thrombosis is reduced.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority under 35 U.S.C. §119 to U.S. Provisional Patent Application No. 62 / 858,547, filed on June 7, 2019, which is incorporated herein by reference in its entirety for all purposes. Technical Field

[0003] The present disclosure relates generally to the field of implantable medical devices, and more particularly to implantable devices, systems, and methods for reconfiguring cardiac characteristics. Background Art

[0004] The mitral valve is located between the left atrium and the left ventricle of the heart. The mitral valve includes two leaflets, anterior and posterior, which close together during systole. The opening of the mitral valve is surrounded by the mitral annulus, which includes a fibrous ring that supports the leaflets of the valve. In a healthy heart, blood flows through the open mitral valve during diastole as the left atrium contracts, and the mitral valve leaflets close during systole as the left ventricle contracts.

[0005] Mitral insufficiency (MI) (also called mitral regurgitation or mitral regurgitation) is a form of heart disease in which the mitral valve annulus is over-dilated and the valve leaflets no longer close, or snap together, effectively during systole. As a result, blood flows backward when the ventricles contract, and cardiac output is reduced.

[0006] The goal of mitral annuloplasty is to regain mitral valve competence by restoring the physiologic morphology and function of the normal mitral valve apparatus, including one or more of the mitral valve and the mitral annulus. One method of mitral annuloplasty includes surgical implantation of an annuloplasty ring. During surgery, the surgeon places the annuloplasty ring adjacent to the annulus and sutures it in place, thereby restoring the annulus to approximately its original configuration. Annuloplasty ring placement is an invasive and time-consuming procedure that carries the risk of morbidity and mortality due to stroke, thrombosis, heart attack, and prolonged recovery time.

[0007] Some percutaneous mitral annuloplasty techniques utilize a deployment catheter and percutaneous navigation to deliver a reconstructive implant to the mitral valve treatment site. In such systems, the implant can be compressed to a first reduced diameter for percutaneous navigation and deployment to the left atrium of the heart. The implant can then be expanded to a second enlarged diameter to embed its anchor into tissue surrounding and / or including the mitral valve. The implant can then be collapsed to a third intermediate diameter, pulling the tissue radially inward, thereby reducing the mitral valve and alleviating any associated symptoms, including mitral regurgitation.

[0008] Whether delivered surgically or percutaneously, existing valve ring implants may tend to suffer from problems associated with migration and / or device fracture. In addition, the implant size may cause the implant to protrude into the atrium, thereby undesirably contacting patient tissue and exposing the patient to the risk of embolism and / or thrombosis for a long time. It is based on these considerations that the improved scheme of the present disclosure may be useful. Summary of the invention

[0009] Embodiments of the present disclosure relate to systems, devices, and methods for remodeling a valve annulus, such as a heart valve annulus. According to one aspect, the system includes a catheter including a plurality of lumens extending from a proximal end of the catheter to a distal end of the catheter. The system includes a frame having a compression structure that allows the frame to be advanced by translation of the catheter; the frame includes a first structure and at least one tightening mechanism that allows the frame to be positioned at least partially around the valve annulus, the at least one tightening mechanism being coupled to the frame and configured to convert the frame between a first structure and a second structure that is different from the first structure. A plurality of anchors may be supported by the frame, each anchor including a proximal end and a distal end, the proximal end including an anchor head, the distal end configured for mating engagement with another anchor of the plurality of anchors to form a combined anchor pair, each anchor including an anchor lumen extending from a proximal anchor end to a distal anchor end. The system includes a guide device that is axially translatable within the anchor lumen and through tissue of the valve annulus, the guide device being configured to define a path through the tissue of the valve annulus from a first anchor toward a second anchor, the first anchor being translatable on the guide device along the path through the tissue of the valve annulus toward the second anchor to form a combined anchor pair.

[0010] In various embodiments, the first configuration comprises a tissue engaging configuration and the second configuration comprises a loop remodeling configuration, and wherein the first configuration is larger than the second configuration. The tethering mechanism may be configured to secure a plurality of anchors in a position associated with the loop remodeling configuration to maintain the loop remodeling configuration. The tethering mechanism may include one or more of a lacing wire, a suture wire, or an anchor clamp, and one or more of a lacing clamp or a resistive welding tape.

[0011] The system may include a plurality of drive tubes, each drive tube disposed within one of a plurality of lumens of the catheter, one drive tube coupled to each anchor, wherein each drive tube is configured to advance the associated anchor on a guide device. The guide device may be configured for axial translation through the drive tube lumen of the drive tube into the anchor lumen. In some embodiments, the guide device may include a curved distal end configured to direct the anchor away from a plane perpendicular to the valve annulus. In various embodiments, the drive tube may be configured to translate the distal anchor end through the curved distal end of the guide device. In some embodiments, the guide device includes at least one of a guide wire or a guide tube. In some embodiments, the guide device may include a guide tube, and wherein the restraining mechanism couples the paired anchor heads by coupling the lumen of the pair of anchors.

[0012] In various embodiments, the frame may include a plurality of anchor sleeves corresponding in number to the plurality of anchors, each anchor sleeve configured to releasably support an associated anchor for deployment of the associated anchor at least partially around the valve annulus. The tightening mechanism may include a tightening wire and a drive tube, the tightening wire surrounding one of the inner radius or the outer radius of the frame, the drive tube configured to withdraw the tightening wire to reduce the internal volume of the frame. In some embodiments, the frame may include a plurality of upper crowns, each upper crown comprising a pair of struts with a space therebetween, and the tightening mechanism comprises a plurality of collars, each collar at least partially surrounding each upper crown and configured to translate axially relative to the frame to adjust the space between a pair of struts of the associated upper crown. In some embodiments, the plurality of anchors may include a plurality of helical coils, and wherein the anchor pairs are combined to include a plurality of overlapping coils of the helical coil pairs.

[0013] According to another aspect, the implant includes multiple anchors and a restraining mechanism; each anchor includes a distal end, which is sharpened for advancement through the tissue of the valve ring toward another one of the multiple anchors, and each anchor is constructed to mate with another one of the multiple anchors when embedded in the tissue of the valve ring to form a combined anchor pair; the restraining mechanism connects the proximal ends of at least two anchors to maintain the at least two anchors in a predetermined structure.

[0014] According to some embodiments, the predetermined configuration is a valve ring remodeling configuration, and the tethering mechanism includes one or more of a rope, a wire, a filament, and a clamp. Each anchor may include a proximal end including an anchor head, and wherein the tethering mechanism couples at least some of the anchor heads of the plurality of anchors together. The combined anchor pair may include an anchor lumen extending at least partially therethrough, and the tethering mechanism may couple a pair of anchor heads using a path including the anchor lumen.

[0015] According to another aspect, a method for remodeling a valve annulus includes the following steps: deploying an expandable frame to a valve annulus repair site via a delivery catheter, the expandable frame releasably supporting a plurality of anchors. The method may include driving at least two of the plurality of anchors into tissue surrounding the valve annulus, including matchingly engaging the distal tips of the anchors to form an anchor pair that at least partially surrounds the valve annulus and compressing the expandable frame used to remodel the valve annulus to an annular remodeling configuration. The method may include tying the proximal ends of the anchor pair, releasing the plurality of anchors from the expandable frame, and removing at least a portion of the expandable frame from the valve annulus repair site.

[0016] According to various embodiments, the step of driving multiple anchors into tissue around the valve annulus includes the following steps: for each pair of anchors in the multiple anchors, selecting an anchor including identifying the paired anchors; inserting a guide device through a first lumen extending from the proximal end of the delivery catheter through the distal anchor tip of the selected anchor, wherein the guide device includes a bend at the distal tip, the bend is configured to guide the selected anchor to the paired anchor, and wherein inserting the guide device through the distal anchor tip of the selected anchor cuts a first path through the tissue toward the paired anchors; advancing the selected anchor toward the anchor pair on the guide device; inserting the guide device through a second lumen extending from the proximal end of the catheter through the distal anchor tip of the paired anchors, wherein the bend at the distal tip of the guide device cuts a path through the tissue toward the selected anchor; advancing one or both of the selected anchor and the paired anchors toward each other to combine the distal ends of the selected anchor and the paired anchors.

[0017] Utilizing such a system, a low-profile annulus implant is provided with increased flexibility and reduced risk of migration, fracture, embolism, and thrombosis. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. In the drawings, each identical or nearly identical component shown is generally represented by a single numeral. For purposes of clarity, not every component is labeled in every drawing, and every component of each embodiment is not shown where an illustration is not necessary to allow a person skilled in the art to understand the present disclosure. In the drawings:

[0019] Figure 1 A diagram showing an implant deployment system according to an embodiment of the present disclosure;

[0020] Figure 2 An expansion framework is shown according to an embodiment of the present disclosure;

[0021] FIG. 3A to FIG. 3C Shown in more detail Figure 2 aspects of the framework;

[0022] Figure 4 According to an embodiment of the present disclosure, corresponding guide wires and guide tubes are shown;

[0023] FIG. 5A to FIG. 5D Exemplary steps are shown that may be performed to incorporate an anchor pair of an implant according to an embodiment of the present disclosure;

[0024] Fig. 6A and Figure 6B Various embodiments of frames as disclosed herein are shown in respective expanded and tightened configurations;

[0025] Figure 7 An alternative embodiment of a frame tightening mechanism is shown according to an embodiment of the present disclosure;

[0026] Figure 8 An embodiment of the present disclosure is a diagram of an embodiment of a guiding device;

[0027] Fig. 9A , Fig. 9B and Fig. 9C Several steps of a restraint system and method are shown according to an embodiment of the present disclosure;

[0028] Fig.10 An illustration showing an apparatus and method that allows lacing of proximal side anchor ends using a single lacing cord for multiple anchor pairs in accordance with an embodiment of the present disclosure;

[0029] FIG. 11A to FIG. 11E A process for approaching the end of a side anchor using an anchor clamp is shown according to an embodiment of the present disclosure;

[0030] FIG. 12A to FIG. 12D Shows the available FIG. 11A to FIG. 11E Various exemplary anchor fixtures in the process;

[0031] Fig.13 Embodiments according to the present disclosure show an implant constructed as disclosed herein after framework removal;

[0032] Fig.14 One embodiment of a deployment catheter that may be used according to various embodiments of the present disclosure is shown; and

[0033] Fig.15 for Fig.13 Cross section of a deployment catheter. DETAILED DESCRIPTION

[0034] According to one aspect, an improved annular remodeling system allows construction of an annular implant adjacent to the annulus by deployment and engagement of implant anchors. The anchors may advantageously be configured to engage at one or both of their proximal and distal ends to construct the implant. In one embodiment, the positioning of the anchor adjacent to the valve may be facilitated by utilizing a removable frame or other structure. The frame may be configured to support the anchors during deployment of the system, release the anchors for construction of the implant, adjust the shape of the implant (and simultaneously adjust the shape of the reconstructed valve) during the adjustment / tightening process, maintain the adjusted shape of the annulus while fixing the relative anchor position, and release the anchors for removal from the frame at the deployment site.

[0035] Utilizing such a system, a low-profile annular implant with increased flexibility is provided, which has several advantages over the prior art. The combined anchor design of the constructed implant provides a low-profile solution that minimizes the implant volume and the associated likelihood of implant breakage and / or contact between cardiac tissue and the implant, thereby reducing the risk of embolism and thrombosis. The angled embedded and combined anchor architecture provides structural integrity and improved implant retention over prior art methods that drive the anchors relatively straight down into the tissue. As a result, the force required to displace the implant is greatly increased in strength and complexity, thereby reducing the likelihood of implant migration. In addition, the combined anchor structure moves more flexibly with the patient's anatomy, thereby reducing trauma over time.

[0036] These and other beneficial aspects of the embedded implant and deployment method are described in more detail below. It should be noted that while embodiments of the present disclosure may be described with particular reference to the mitral valve, the principles disclosed herein may be readily adapted to facilitate reconstruction of any valve annulus, including, for example, the tricuspid annulus, and / or may similarly be beneficial for any other dilatation, valvular weakness, valvular leakage, and other similar heart failure conditions.

[0037] As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "include" and / or "comprise", or "contain" and / or "have" when used herein specify the presence of stated features, regions, steps, elements and / or components, but do not exclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components and / or groups thereof.

[0038] As used herein, the term "distal" refers to the end farthest from the medical professional when the medical device is introduced into the patient, and the term "proximal" refers to the end closest to the medical professional when the medical device is introduced into the patient.

[0039] As used herein, unless the context clearly indicates otherwise, the conjunction "and" includes each of the structures, components, features, etc. so combined; and unless the context clearly indicates otherwise, the conjunction "or" includes one or the other of the structures, components, features, etc. so combined (either individually or in any combination and quantity).

[0040] All numerical values ​​are assumed herein to be modified by the term "about", whether or not explicitly indicated. In the context of numerical values, the term "about" is generally an index range that is considered by those skilled in the art to be 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 ordinary and customary definitions, as understood and consistent with the context of the specification, unless otherwise indicated.

[0041] The recitation of numerical ranges by endpoints includes all numbers within that range, inclusive of the endpoints (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0042] It should be noted that references in the specification to "one embodiment," "some embodiments," "other embodiments," etc. indicate that the described embodiments may include a particular feature, structure, or characteristic, but each embodiment may not necessarily include the particular feature, structure, or characteristic. Furthermore, such phrases do not necessarily refer to the same embodiment. Additionally, when a particular feature, structure, or characteristic is described in conjunction with one embodiment, those skilled in the art will appreciate that such feature, structure, or characteristic is affected in conjunction with other embodiments, whether or not explicitly described, unless clearly stated to the contrary. That is, the various individual elements described below, even if not explicitly shown in a particular combination, are contemplated to be combinable or arrangable with each other to form other additional embodiments or to supplement and / or enrich the described embodiments, as will be understood by those skilled in the art.

[0043] Reference Figure 1 , an exemplary annular remodeling system 100 includes a deployment catheter 110 having a distal tip 120 and an extendable guidewire 125, the distal tip 120 including a distal sheath 140, the extendable guidewire 125 extending through the deployment catheter 110 to guide it to a position adjacent to the valve annulus 160. The diameter of the guidewire 125 can measure, for example, between 0.010 inches and 0.038 inches. The length of the deployment catheter 110 can measure about twenty to thirty centimeters for accessing the mitral valve through the apex of the heart. The deployment catheter can enter the leg vessels, particularly the femoral vein or iliac vein, for percutaneous deployment to the heart annulus.

[0044] In one embodiment, the components of the anchor implant deployment system 130 are disposed within the distal sheath 140 of the deployment catheter during deployment. Figure 1 , the distal end of the deployment catheter 110 is manipulated into the left atrium 165 to a position above and / or around and / or partially around the mitral annulus 160. According to one aspect, the deployment catheter can have various positioning and imaging capabilities, such as, for example, those described in U.S. Patent Serial No. 15 / 280,004, entitled “Methods for Deployment of Heart Valve Devices Using Intravascular Ultrasound Imaging,” filed on September 29, 2016, which is incorporated herein by reference.

[0045] Reference Figure 2 , when the distal tip of the deployment catheter 110 is properly positioned, the components of the implant 130 can be exposed (by advancing the implant 130 through the distal sheath 140 or by withdrawing the distal sheath 140 over the implant) and expanded to the working diameter. Expansion can occur naturally, for example, when the frame is formed of nitinol or other shape memory or superelastic material (which is biased toward the expanded state). In alternative embodiments, expansion can be mechanically controlled, such as by using an inflatable balloon or the like to use a force applied within the frame. The systems and methods disclosed herein are not limited to any particular mechanism for positioning anchors for annular reconstruction, whether such positioning utilizes an annulus or an expandable frame, and may utilize, for example, the techniques described in U.S. Patent No. 9,610,156, filed on December 24, 2014, for “Mitral Valve Inversion Prostheses,” U.S. Patent No. 9,180,005, filed on November 24, 2015, for “Adjustable Endoluminal Mitral Valve Ring,” and U.S. Patent Serial No. 15 / 352,288, filed on November 16, 2016, entitled “Implantable Device And Deployment System For Reshaping a Heart Valve Annulus,” each of which is incorporated herein by reference.

[0046] FIG. 3A to FIG. 3CExemplary components are shown that may be included in the embedded implant deployment system 300 disclosed herein. Components of the deployment system 300 may include a frame 350 including one or more anchor sleeves 320, each for releasably supporting an anchor 310. Each anchor 310 may include an anchor head 325 configured to engage a drive tube 330 to allow the drive tube to advance the anchor through the frame 350, as described in more detail below.

[0047] The frame 350 may be constructed of, for example, a metal material and / or a polymer having sufficient structural integrity to reshape the mitral valve. The material may also be selected based on biocompatibility and fatigue resistance. The frame material may include stainless steel, nickel titanium, cobalt chromium, pyrolytic carbon, nitinol, a polymer material (e.g., PEEK), and / or other suitable frame materials. In some cases, the frame may also be coated with a drug eluting material to prevent fibrosis and / or coagulation.

[0048] The frame 350 may be laser cut from a tubular member to form a basic shape. The frame may also be heat set into a shape for further assembly, which may include other steps of electrochemical etching and / or secondary polishing to remove irregularities and / or unwanted material. These other steps may be used to smooth the surface of the frame. Alternatively, and as described in more detail below, the frame may be formed by or include a tubular frame structure, wherein the lumen defined by the tubular frame may be configured to carry a lacing cord and / or suture material for connecting the proximal anchor head of the anchor pair.

[0049] exist Figure 3A In the embodiment of the present invention, the frame 350 is shown to include a plurality of sinusoidal strut elements that are joined at the proximal and distal vertices to form a zigzag pattern. Anchor sleeves 320 may be located at one or more distal vertices of the frame 350, wherein each anchor sleeve 320 is configured to releasably support an anchor.

[0050] In various embodiments, the anchor sleeve 320 can be configured to secure the anchor 310 during positioning and deployment of the frame 350 and to allow the anchor to be advanced through the sleeve and away from the frame during anchor deployment. Figure 3B A cross-section of an exemplary embodiment of an anchor sleeve 320 is shown supporting the anchor 310 .

[0051] The anchor 310 is shown to include a proximal end and a distal end, the proximal end including an anchor head 325, the distal end including a spiral coil with a sharpened distal tip. In various embodiments, the anchor 310 can be made of a suitable biocompatible metal alloy, such as stainless steel, cobalt chromium, platinum iridium, nickel titanium, other suitable materials, or a combination thereof. Each anchor 310 can be sharpened at its distal point or leading edge (leading tum) to facilitate penetration into cardiac tissue. The total axial length of each anchor 310 can be about ten millimeters (mm) to about fifteen millimeters. In some embodiments, the total axial length of the anchor 310 can be shorter or longer than ten millimeters (mm) to fifteen millimeters. With respect to the "total" axial length, it means the axial length of the anchor 310 from the end of the distal piercing tip to the relative proximal end anchor head 325. The axial length (i.e., in the axial direction) of the spiral portion of the anchor 310 can be about six millimeters (mm) to about twelve millimeters. In some embodiments, the axial length of the helical portion of the anchor 310 may be shorter or longer than six millimeters (mm) to twelve millimeters. The axial length of the anchor head and / or other non-helical portions of the anchor 310 may be about three millimeters (mm) to about four millimeters. In some embodiments, the axial length of the anchor head 325 and / or other non-helical portions may be shorter or longer than three millimeters (mm) to four millimeters. As described in more detail later herein, according to one aspect, the pitch and angle of the helical coils are selected to allow paired helical coils to be combined when the distal end is rotated for mating engagement. According to one aspect, the helical coils of the anchor 310 define an anchor lumen L 326 (having a lumen L 326 formed by Figure 3B ), the anchor lumen L 326 may extend at least partially from the anchor head 325 through the distal bend 329 of the anchor 310. In some embodiments, the helix diameter range may extend within (0.050"-0.080"), while the pitch is within (0.030"-0.080"), such that the coil pitch angle is approximately twenty (20) degrees.

[0052] The shape of the anchor sleeve 320 can be roughly cylindrical and formed of a metallic material and / or a polymer having sufficient structural integrity to support an anchor for driving into the heart ring. The length of the sleeve can be in the range of about half the length of the coil (in some embodiments, about 3 mm) to about twice the length of the coil (e.g., within the range of 20 mm). The material can also be selected based on biocompatibility and fatigue resistance. The material can include stainless steel, nickel titanium, cobalt chromium, pyrolytic carbon, nitinol, polymer materials (e.g., PEEK), and / or other suitable frame materials. In some cases, the anchor sleeve can also be coated with a drug eluting material to prevent fibrosis and / or coagulation.

[0053] The anchor sleeve 320 can be formed within the frame 350, or can be attached or otherwise coupled to the frame. The anchor sleeve can be located on the frame to orient the anchor toward the annular tissue when the system is positioned for annular reconstruction. For example, in transabdominal deployment of the implant, the distal vertex 351 of the frame 350 contacts the valve annulus when the embedded implant component is positioned for annular reconstruction. For transabdominal deployment, the proximal vertex of the frame can surround the annular tissue, and the anchor sleeve can be mounted on or near the proximal vertex of the frame to orient the anchor toward the annular tissue.

[0054] The anchor sleeve 320 is shown to include internal features, such as grooves 335, that match the pitch and angle of the anchor 310 in pitch and angle, such that rotation of the anchor results in translation of the anchor along the longitudinal axis L of the anchor sleeve 320. According to one aspect, the inner diameter of the anchor sleeve is configured to slidably accommodate a drive tube while allowing the grooves 335 to support the anchor 310 while it is within the sleeve 320. With such an arrangement, a drive tube coupled to the anchor head can freely advance the anchor 310 away from the frame 350, into the annular tissue, and toward a pair of anchors as described below.

[0055] According to one aspect, the anchor head 325 can be configured for releasable engagement with the drive tube 330. The anchor head 325 can include one or more cutouts for engaging with one or more retractable hooks, flanges, or extensions within the drive tube 330. The drive tube 330 can include a hypotube or similar device configured to transmit torque along its length for anchor rotation. A cross-section of an exemplary anchor head 325 is shown in FIG. Figure 3C 327a, 327b. In one embodiment, an extension in the drive tube can extend into the cutouts 327a, 327b to allow the anchor to be rotated through the drive tube. The extension can then be withdrawn to release the anchor when the annuloplasty is complete.

[0056] Reference Figure 4 According to one aspect, the embedded implant deployment system includes a guide device, such as a guide wire 402 or a guide tube 404. The shape of the guide device is generally curved to provide a displacement between 45 degrees and 90 degrees between the head H of the guide device and the tail T of the guide device. The guide wire can include, for example, an inner mandrel, an outer coating or sheath, and a tip, such as a stainless steel preformed coil that covers a filament core and is coated with a thin layer of Teflon to reduce surface friction.

[0057] The guide tube 404 may include a preformed cylindrical tube formed of a material selected based on biocompatibility and fatigue resistance. The material may include stainless steel, nickel titanium, cobalt chromium, pyrolytic carbon, nitinol, polymer materials (e.g., PEEK), and / or other suitable frame materials.

[0058] The guide device 400 may be used during construction of an embedded implant, as will be described with reference to FIG. 5A to FIG. 5D as described.

[0059] Figure 5A A frame portion 500 that can be used in the system described herein is shown as a pair of struts 510 and 520. The strut 510 is shown to include an anchor sleeve 512, which can be as described in reference Figure 3B The described structure is configured to support the anchor 514 to the valve annulus during deployment. The strut 520 is similarly shown as including an anchor sleeve 522 for supporting the anchor 524 during deployment. Each anchor 514, 524 is shown as including a corresponding anchor head 516, 526 that connects the associated anchor to a corresponding drive tube 518, 528. According to one embodiment, the drive tube includes a rotating drive tube that is configured so that rotation of the drive tube causes the connected anchor to translate distally. In one embodiment, the anchors 514, 524 include helical coils, each helical coil defining an anchor lumen that extends from the distal tip of the anchor through the corresponding anchor head 516, 526.

[0060] It should be noted that while helical coil anchors are described, other forms of anchors (which include one or more features, such as a sharpened distal tip that allows the anchor to be driven through tissue, features that promote tissue growth for securing the anchor in the tissue, and a lumen extending at least partially therethrough for guiding the anchor through the tissue) may be interchangeably substituted herein without affecting the scope of the invention.

[0061] When the framework portion 500 is positioned at the deployment site adjacent the valve annulus, the implant construction process begins, including the bonding of at least some of the distal anchor ends and the bonding of at least some of the proximal anchor ends.

[0062] Joining at least some of the distal ends of the anchors includes joining the distal ends of pairs of adjacent anchors, such as FIG. 5B to FIG. 5D As shown and described in Figure 5B As shown, engaging the anchor pair includes inserting the guide 550 through the drive tube 518, the anchor head 516, and the anchor lumen. Figure 5A and Figure 5B As described above, the guide device 550 may include a curved guide wire or a guide tube. Figure 5AAs shown, the guide 550 is generally advanced before advancing the anchors 514, 524. In some embodiments, the guide 550 is a J-shaped wire. The anchors 514, 524 can be partially pushed out of the anchor housing or sleeve 512 until the bend in the guide 550. The bend in the guide 550 is preferably advanced before advancing the subsequent anchors 514, 524. The guide 550 can be advanced into the annular tissue in a position adjacent to the anchor sleeve 512. Due to the curved nature of the guide 550, as the guide 550 is inserted into the tissue, the reaction force turns the distal tip of the guide away from the vertical plane of the ring. In one embodiment, the guide 550 can be advanced to an intermediate position between a pair of anchors (such as the anchor 514 and the anchor 524). The navigation of the guide 550 can be performed using any of a variety of imaging techniques, including but not limited to intravascular cardiac ultrasound (ICE) catheters. The drive tube 518 can be activated to advance the anchor 514 translationally on the guide 550 to a position such as Figure 5B The middle position shown. Figure 5B Anchor 514 is shown advanced to an intermediate position such that the distal end of anchor 514 is adjacent the distal end of guide 550 .

[0063] Once the anchor 524 is positioned, reference is now made to Figure 5C , the second anchor of the pair (here anchor 524) can be advanced into the annular valve tissue. The guide device 555 can be inserted through the drive tube 528, which extends through the anchor sleeve 522, the anchor head 526, the anchor lumen 529 and through the distal tip of the anchor 524. In some embodiments, rotation of the drive tube 528 causes the anchor to translate through the anchor sleeve 522 and toward the distal tip of the anchor 514.

[0064] like Figure 5DAs shown, once the distal tips of the anchors 514 and 524 are aligned, either of the drive tubes 518 and 528 can continue to drive their respective anchors 514 and 524 toward each other. When the anchors rotate, the turns of the helical anchor 524 engage with the turns of the helical anchor 514 to form a combined anchor lumen 570. The anchors can continue to rotate relative to each other to provide structural integrity to the anchor lumen. In various embodiments, structural integrity can be measured based on factors including the possibility of migration or displacement of one or both of the anchors forming the anchor. According to one aspect, when 20% to 50% of one anchor overlaps the other, structural integrity of the combined anchor lumen can be achieved. In some embodiments, it can be determined that when 30% of one anchor overlaps the other, structural integrity can be achieved. It should be understood that the degree of overlap can vary from case to case, depending on factors such as the thickness and / or state of the tissue at the anchoring location. Thus, the present invention is not limited to any particular degree of anchor coil overlap in conjunction with the anchor lumen.

[0065] As mentioned above, one advantage of the implants disclosed herein arises from the angled introduction of the anchors into the annular tissue, such as FIG. 5A to FIG. 5D As shown. By introducing the anchor along the curved portion of the guide (or at other angles, generally toward the paired anchor pair) rather than the normal to the annular surface, the depth of anchor penetration can be reduced. By reducing the depth of anchor penetration in vulnerable cardiac regions, the possibility of inadvertent injury is reduced. Although the penetration depth is reduced, the strength of the anchor is not sacrificed, but rather enhanced by the combination of paired anchors.

[0066] In one embodiment, consecutive pairs of anchors may be bonded around the valve annulus at their distal ends. Fig. 6A , an exemplary frame 600 is shown having several constructed binding anchor lumens, such as lumen 602 and lumen 604. In an exemplary embodiment, the frame can releasably support sixteen (16) anchors that can be combined to form eight anchor lumens. Other embodiments are also contemplated, including variations to form two, three, four, and five binding anchor lumens. Additionally, embodiments utilizing a combination of anchors positioned perpendicular to the annulus and one or more binding anchor lumens are also contemplated. In short, the present disclosure is not limited to any particular embedded anchor architecture.

[0067] Once the anchoring portion of the implant is constructed, the frame can be used to adjust the shape of the valve, such as by compressing, tightening, or otherwise reducing the diameter of the opening defined by the frame 600. Various methods of tightening the frame can be used. Fig. 6A, a lasso-type lacing rope 660 is shown disposed within the frame. The lacing rope may be coupled to a lacing drive tube 870, which may be configured to be wound around the lacing rope to pull the struts 628 together into a lacing configuration. This configuration is shown in Figure 6B In. Figure 6B As shown, pulling the lacing rope pulls the distal ends of the frame struts 628 together, thereby reducing the diameter of the distal ends of the frame and bringing the anchor sleeves 620 closer together, so that the anchors 610 are pulled relatively closer together. In some embodiments, the lacing drive tube 670 can be adapted to retract the lacing rope into the catheter using a hook or other device to reduce the diameter of the frame 600.

[0068] Various other methods can be used to cinch the anchors together. For example, in some embodiments, the frame can be constructed of a shape memory material that biases the frame to compress, but remains open during construction of the anchor lumen using struts or other support devices. In such designs, compression can be achieved by removing or otherwise moving struts to allow compression.

[0069] In other embodiments, Figure 7 As shown, the movable collar can be located at the upper apex of the frame struts, and the frame adjustment can be achieved by driving the collar axially up and down at the upper apex to expand and contract the relative distance between the struts. One such method is described in U.S. Patent Application Serial No. 15 / 352,288, entitled "IMPLANTABLE DEVICE AND DELIVERY SYSTEM FOR RESHAPING A HEART VALVEANNULUS", filed in November 2016 (hereinafter referred to as "'288"). Figure 7A frame 700 is shown that can utilize the concepts of '288 to provide a tightening mechanism for use in the systems, devices, and methods disclosed herein, wherein pairs of adjacent struts (704, 705, 706) meet at an apex. At least a first pair of adjacent struts (704, 705) meet at an upper apex or crown 703 of an upper portion of the frame 700. At least a second pair of adjacent struts (705, 706) meet at a lower apex or crown 707 of a lower portion of the frame 700. Unless otherwise noted, as used herein and as used in any reference incorporated herein by reference, the terms "apex," "apices," and the like may be used interchangeably with the terms "crown," "crowns," and the like. The upper and lower crowns may be sequentially spaced along the circumference of the frame 700, with one of the upper crowns 703 followed by one of the lower crowns 707, followed by another of the upper crowns 709, etc. In the illustrated embodiment, there are eight upper crowns and eight lower crowns, but the disclosed embodiments are not limited to any particular frame architecture.

[0070] According to one aspect, the upper crown can be configured with a constraint, such as a collar 702a-702h that fits on and / or around the upper crown. Thus, the upper crown can include various features, dimensions, etc., as described herein for coupling collars 702a-702h.

[0071] According to one embodiment, the collars 703a-703h provide a tightening mechanism to reduce the diameter of the frame and thus the connected valve annulus. To "tighten" the frame, or to bring one or both of the distal tip and / or the proximal tip of the frame 700 closer in other ways, according to one embodiment, the collar 702a can be axially translated along the struts 704, 705. The distal advancement of the collar 702a along the struts 704, 705 forces the struts 704 and 705 closer, thereby pulling the frame (which has been fixed to the valve annular tissue, as described above) together, thereby changing the relative position of the implanted anchors, while also changing the shape of the valve annulus. In one embodiment, the collar 702a can be configured so that the action of the driver on the collar moves the collar along the struts 704, 705 by pushing, rotating or other methods. With such an arrangement, each collar is independently controllable to allow increased control over the relative spacing of the anchors.

[0072] Various other methods of adjusting the frame to change the shape of the ring may be substituted herein without affecting the scope of the present disclosure.

[0073] After adjustment, the relative position of the bonding anchors can be cinched or otherwise fixed by coupling the anchor heads of the bonding anchors with lacing cords (e.g., such as lacing wires and / or suture materials, such as nylon filaments, etc.).

[0074] According to one aspect, in one embodiment, securing the proximal anchor end in the desired adjustment configuration advantageously utilizes the lumen path provided by the guide / combination anchor to advance the lacing tether to the anchor head position of the embedded implant. For example, Figure 8 Components of the frame 800 are shown that can be translated through the anchor sleeve using the methods disclosed herein. The guide device 720 can be advanced through the anchor head 730 to the valve annulus site during deployment of the anchor 740. The lacing tether 710 (including lacing wire, suture material or coupling material) can be advanced through the luminal path of one anchor to the luminal path of another anchor.

[0075] 9A to 9C Provided to illustrate an exemplary method for tying together the anchor heads to position an implant using the lumen path formed by the guide and anchors. Fig. 9A 800, a portion of the frame 800 includes four anchor sleeves 801-804, four anchor heads 806-809 coupled to four drive tubes 811-814, and four anchors 816-819, wherein pairs of anchors 816, 817 and 818, 819 form respective combined anchor portions 810, 820. A guide device including guide tubes 826-829 may extend through the drive tubes 811-814, through the anchor sleeves 801-804 and the anchor heads 806-809, through the anchors 816-819 and into the combined anchor portions 810, 820, as described with respect to FIG. Fig. 9A For each anchor pair, the guide tube may thus provide (together with the joining portion of the distal anchor pair) a single lumen between the anchor heads of the anchor pair.

[0076] According to an exemplary embodiment, the anchor heads may be tethered or otherwise coupled using one or more lacing cords that are advanced through a single lumen between the anchor heads and secured at the anchor heads. For example, a lacing cord 870 may extend through the drive tube 814 and the anchor head 809 of the anchor 819, traverse the single lumen of the anchor pair 818, 819, through the anchor 818, and upward through the drive tube 813. Similarly, a lacing cord 877 may extend through the drive tube 812 and the anchor head 807 of the anchor 817, traverse the joined anchor portion 810 of the anchor pair 816, 817, through the anchor 816, and upward through the drive tube 813.

[0077] According to one aspect, tying off the anchor head may include advancing a lacing cord through the anchor pair (and associated bonded anchor portion), and after advancing the lacing cord through the anchor head, terminating the end of the lacing cord, and removing the drive tube to expose the terminated lacing cord end, such as Fig. 9B The deployment catheter may include a working lumen for receiving a working catheter configured to connect a free end of a lacing line adjacent to the anchor end. In one embodiment, lacing may occur after the anchor collar is removed from the frame to reduce interference of the lacing line with the anchor sleeve or other features of the frame. Fig. 9B The implant is shown after placement of two lacing cords 870, 877 and removal of the driver tubes 811-814, freeing the framework for removal.

[0078] Once the frame is removed, the working catheter may be configured to place a cinching mechanism (such as a cinching clamp) between the ends of the cinching cables 870, 877, as shown. Fig. 9C Alternatively, the working conduit may be configured to resistance weld the ends of the lacing cords 870, 877.

[0079] Exemplary lacing mechanisms and processes may involve tightening the frame to a desired adjusted radial profile, wherein the surgeon couples pairs of anchor heads to sequential radial positions around the valve annulus. In other embodiments, the anchor head pairs may be secured in a non-sequential and / or random order. In some embodiments, fixation may occur after the release of all drive tubes from the anchor heads, or after the release of only some drive tubes through the anchor heads. In some embodiments, fixation may occur after the frame is removed from the valve annulus site, but it should be understood that the frame may advantageously provide structure, support, and stability during the deployment of the lacing cord. In some embodiments, the frame may be used to support an ICE catheter, which may be used to radially observe the anchor head position during the securing of the lacing cord to the anchor heads.

[0080] Fig.10 A second system for tying or otherwise securing the anchor head after implant adjustment is shown. Fig.10In an embodiment of the present invention, the system may include a tubular frame 910 (shown in cross-section) having a spool housing 915 mounted thereon, wherein the spool housing may be positioned relatively close to the frame in a manner that reduces interference with frame expansion, anchor deployment, tightening, and other frame functions. The spool housing 915 may store a tightening cord 950, such as a tightening wire, suture material, etc. that may be used to connect the anchor head. A working catheter 940 may be advanced toward the anchor head 960 within the working channel of the deployment catheter and may be configured to push the tightening cord through the anchor head. As the tightening cord is pushed through the anchor head, additional tightening cord 950 may be wound out of the spool housing 915 or otherwise released from the spool housing 915. The working catheter may be moved between the anchor heads to direct the advancing tightening cord as the tightening cord is wound from the spool housing 915.

[0081] When the lacing cord has been advanced through a selected number of anchor heads (including all anchor heads or a subset of anchor heads), the lacing cord may be cut at both ends and the ends joined using clamps or resistance welding, as described with respect to 9A to 9C Utilizing a single lacing cord and thus a single clamp or weld also advantageously reduces the overall profile and the likelihood of implant failure. In some embodiments, the use of a single lacing cord can facilitate later removal of the cord, such as in situations where the shape of the loop can be stabilized solely in conjunction with the healing properties of the anchor (e.g., tissue growth, etc.).

[0082] FIG. 11A to FIG. 11E An alternative restraining mechanism is provided to illustrate the use of securing the anchor head. The system includes a working catheter 1020, which may be preloaded with anchor clamps, such as anchor clamps 1022, 1024, and 1026. A flange or other feature is adjacent each proximal and distal end of each anchor clamp, the flange or other feature being configured for fixed engagement with the anchor head. For example, anchor clamps 1022, 1024, and 1026 are shown as including arms 1023, 1025, which are configured to engage features of the anchor head when inserted through the loop. In an exemplary embodiment, each arm is configured to extend away from the longitudinal axis of the clamp in a direction generally perpendicular to the clamp.

[0083] FIG. 11A to FIG. 11E A representative section of an implant 1000 constructed according to the principles disclosed herein is shown. Although it should be understood that an annular valve is generally circular or elliptical in nature, the representative portion is shown linearly for ease of explanation. In addition, for the purpose of explanation, only the anchor heads (including anchor heads 1002, 1004, 1006, 1008, 1010 and 1012), combined anchor pairs 1003, 1007 and 1011 are shown.

[0084] According to one aspect, once implant 1000 is positioned and the annulus adjusted (e.g., utilizing combined anchor pairs 1003, 1007, and 1011), working catheter 1020 can be used to insert anchor clamps 1022, 1024, and 1026 into the anchor head to secure its position relative to the remodeled annulus. Fig. 11B A working catheter 1020 is shown positioned adjacent to the anchor head 1004. In one embodiment, the working catheter 1020 is releasably coupled to the anchor head 1004 using a detachable hook or other device, although this is not required. The working catheter 1020 can be controlled to advance the distal end of the anchor clamp 1022 through the anchor head 1004 until the anchor clamp arm 1023 is released from the anchor head 1004. The reverse bias of the anchor clamp arm 1023 can engage the distal end of the anchor head 1004, securing the anchor clamp 1022 within the collar. The working catheter can include features to prevent the proximal end of the anchor clamp from leaving the working catheter.

[0085] like Fig. 11C As shown, the working catheter can then be advanced to the anchor head 1006, wherein the proximal end of the anchor clamp 1022 can be inserted into the anchor head 1006 via manipulation of the working catheter. For example, in one embodiment, the working catheter can include a push rod configured to push the anchor clamp 1022 through the anchor head 1006 until the anchor clamp arm 1025 extends through the distal end of the anchor head 1006, thereby releasing the arm and allowing the arm to engage the anchor head. Thus, the anchor clamp 1022 fixes the position of the anchor heads 1004 and 1006.

[0086] After placement of the anchor fixture 1022, the working catheter can be advanced to the anchor heads 1008 and 1010 (eg, Fig.11D and Fig.11E ), to deploy the anchor clamp 1024 (with arms 1029, 1027 extending through the anchor housing) and hold or otherwise restrain the anchor head in position.

[0087] FIG. 12A to FIG. 12D Exemplary configurations of anchor clamps 1201, 1202, 1203, and 1204 are shown. In general, the anchor clamps include a first compressed configuration that allows the anchor clamp to be slidably moved through the working catheter; and a second at least partially expanded configuration in which one or more flanges or other clamp features fixedly engage the clamp to the anchor head. For example, the anchor clamp can have an expanded configuration in which at least a portion of the clamp extends away from the longitudinal axis of the anchor clamp to facilitate engagement with the anchor head. FIG. 12A to FIG. 12DExamples of such are shown, including bends, arms, protrusions, or other features that may be included in an anchor clamp to secure the clamp to the anchor head. FIG. 12A to FIG. 12D As shown, there may be various different mechanisms, and the proximal and distal features of the anchor clamp may be different. It should be understood that the illustrated embodiments are provided by way of example only, and different configurations may be identified by one skilled in the art for engagement with various different anchor head designs. In various embodiments, the anchor clamp may be made of a suitable biocompatible metal alloy, such as stainless steel, cobalt chromium, platinum iridium, nickel titanium, other suitable materials, or combinations thereof, and / or may be coated with a drug eluting material to prevent fibrosis and / or coagulation.

[0088] Thus, a variety of tethering mechanisms for coupling anchor heads have been shown and described, including mechanisms utilizing binding to the anchor lumen and mechanisms clamping the anchor head. It should be understood that the various systems and methods may be used alone or in combination, and the order of delivery to the anchor head is a matter of design.

[0089] Once the proximal and distal ends of the anchors are secured, the frame can be removed from the ring deployment site. In some embodiments, the release of the frame can be achieved by releasing the drive tube, as described with respect to Fig. 9B Various methods of releasing the drive tube from the anchor head are contemplated. In one embodiment, as described with respect to Figure 3C As briefly described, the drive tube can be constructed with one or more keys or flanges that engage one or more cutouts (327a, 327b) of the anchor head; and release of the drive tube can be achieved by withdrawing the flange from the cutout of the anchor head. Other forms of keying or braking mechanisms can be easily substituted herein by those skilled in the art and are considered to be within the scope of the present disclosure.

[0090] Once the drive tube is released, the frame can compress. Compression of the frame can occur automatically; for example, as the drive tube is released from the anchor head, a frame formed of a shape memory material that is biased toward a compressed state can naturally assume a compressed state. Alternatively, a frame design that includes a mechanical method for compressing the frame can be used. Such designs include, but are not limited to, a frame that includes a slidable collar that surrounds the proximal strut apex, which can be advanced distally to draw the struts together and compress the frame, as described with respect to Figure 7 The compression frame may be withdrawn into the deployment catheter for removal from the patient, leaving only the anchor head, lacing cord, and binding fastener pair in place.

[0091] Fig.13A perspective view of the valve annulus (generally indicated by dashed line 1300) is shown showing a portion of a combined anchor implant 1310 constructed according to the principles disclosed herein after the framework has been removed. Fig.13 As shown, only a small portion of the implant is above the tissue line of the atrium, with the remainder of the implant embedded in the patient's tissue. The low profile of the combined anchor implant 1310 minimizes the implant volume and the associated likelihood of implant breakage and / or contact between cardiac tissue and the implant, thereby reducing embolic and thrombotic risks. The angled embedding and combined anchors provide structural integrity and improved implant retention while more flexibly moving with the patient's anatomy to reduce trauma over time.

[0092] Fig.14 1400 is a stereogram of an exemplary deployment system, which can be used for annular remodeling as described herein. The deployment system 1400 includes a steerable sheath 1402, a sheath steering knob 1404, a tightening knob 1406, an anchor knob 1408, an implant deployment component (which can be used to construct a combined anchor implant described herein), an ICE probe 1470, all of which are supported and fixed to a base 1410. The tightening knob 1406 and the anchor knob 1408 can be spring loaded to maintain tension. The rotation of the anchor knob 1408 can rotate and advance the spirally wound anchor 1420 into the combined anchor pair in the annular tissue so that the combined anchor pair surrounds or partially surrounds the valve ring. The tightening knob 1406 can be manipulated by an operator to compress the expandable frame connected to the anchor to reduce the valve ring. The tightening / suturing knob 1450 can control the entry of the working catheter and / or the ability of the working catheter to fix the proximal end of the anchor in a fixed position to maintain the reduced valve ring, as described herein. The anchor knob 1408 can be further controlled to release the expandable frame, thereby leaving the implant in its fixed position.

[0093] Fig.15 Shown along Fig.14The cross section taken by line 15-15 of . The pull wire 1412 can be attached to the sheath steering knob 1404 to deflect the distal end of the sheath 1402. The sheath 1402 can be a steerable outer sheath 1402, for example made of a braided polymer or metal, such as nitinol or stainless steel. The ICE catheter shaft 1470 can be centrally positioned with the guidewire lumen 1303 located in the ICE catheter lumen 1471, wherein the implant frame can be deployed through the ICE catheter lumen 1471 before inserting the ICE catheter for positioning adjacent to the valve ring. In some embodiments, there may be eight anchor driver wires 1403 (e.g., nitinol), which are circumferentially located in the sheath 1402. The anchor driver wire 1403 is located in an anchor driver sheath (e.g., a laser cut hypotube). As described above, the anchor driver sheath may include a working channel through which a guide may be inserted for directing anchor placement. In one embodiment, there may be eight pusher tubes 1456', which may be braided, positioned around the ICE catheter shaft 1470. The pusher tubes 1456' may include a cinch retention tube (e.g., laser cut hypotube) and a cinch retention wire (e.g., nitinol).

[0094] Thus, there has been shown and described a system and method for remodeling a valve annulus that utilizes a removable frame to construct an implant with an incorporated anchor. In accordance with the present disclosure, the devices and / or methods disclosed and claimed herein may be made and performed without undue experimentation. Although various embodiments of the devices and methods of the present disclosure have been described, it may be apparent to those skilled in the art that modifications may be applied to the devices and / or methods and the steps or sequence of steps of the methods described herein without departing from the concept, spirit, and scope of the present disclosure. It will be apparent to those skilled in the art that all such similar substitutions and changes are deemed to be within the spirit, scope, and concept of the present disclosure as defined by the appended claims.

Claims

1. A system for reshaping a valve annulus, comprising: a catheter comprising a plurality of lumens extending from a proximal end of the catheter to a distal end of the catheter; a frame having a compressed configuration that allows the frame to be advanced by translation of the catheter, the frame including a first configuration that allows the frame to be positioned at least partially around the valve annulus; at least one tightening mechanism coupled to the frame and configured to transition the frame between the first configuration and a second configuration different from the first configuration; a plurality of anchors supported by the frame, each anchor including a proximal end and a distal end, the proximal end including an anchor head, the distal end configured for mating engagement with another anchor of the plurality of anchors to form a bonded anchor pair, each anchor including an anchor lumen extending from the proximal anchor end to the distal anchor end; and A guide device, which is axially translatable within the anchor lumen and through the tissue of the valve annulus, and the guide device is configured to define a path through the tissue of the valve annulus from the first anchor toward the second anchor, and the first anchor is translatable on the guide device toward the second anchor along the path through the tissue of the valve annulus to form a combined anchor pair.

2. The system of claim 1, wherein the first structure comprises a tissue engaging structure and the second structure comprises an annulus remodeling structure, and wherein the first structure is larger than the second structure.

3. The system of claim 2, further comprising a tie-down mechanism to secure the plurality of anchors in a position associated with the second configuration.

4. The system according to claim 3 further includes a plurality of drive tubes, each drive tube being disposed within one of the plurality of lumens of the catheter, one drive tube being connected to each anchor, wherein each drive tube is configured to advance a corresponding anchor on the guide device.

5. The system of claim 4, wherein the guide device is configured for axial translation through the driver tube lumen of each driver tube into the anchor lumen.

6. The system of claim 5, wherein the guide comprises a curved distal end.

7. The system of claim 6, wherein each drive tube is configured to translate the distal anchor end through the curved distal end of the guide.

8. A system according to claim 7, wherein the curved distal end is configured to direct the anchor away from a plane perpendicular to the valve annulus.

9. The system of claim 4 or 5, wherein the tethering mechanism comprises one or more of a lacing wire, a suture wire, an anchor clamp, a lacing clamp, or a resistance welding tape.

10. The system of claim 4 or 5, wherein the guide device comprises one of a guide wire or a guide tube.

11. The system of claim 10, wherein the guide device comprises a guide tube, and wherein the tethering mechanism couples the paired anchor heads through a lumen formed by the joined pair of anchors.

12. The system of claim 1, wherein the frame comprises a plurality of anchor sleeves corresponding in number to the plurality of anchors, each anchor sleeve being configured to releasably support an associated anchor.

13. The system of claim 1 or 12, wherein the tightening mechanism comprises a tightening wire surrounding one of an inner radius or an outer radius of the frame and a drive tube configured to withdraw the tightening wire to reduce an internal volume of the frame.

14. A system according to claim 1 or 12, wherein the frame includes a plurality of upper crowns, each upper crown including a pair of struts with a space therebetween, and the tightening mechanism includes a plurality of rings, each ring at least partially surrounding each upper crown and configured to translate axially relative to the frame to adjust the space between the pair of struts of the associated upper crown.

15. The system of claim 1 or 4 or 5 or 12, wherein the plurality of anchors comprises a plurality of helical coils, and wherein the bonded anchor pair comprises a plurality of overlapping coils of the helical coil pair.

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