WO2023095097A1

WO2023095097A1 - Cable management tools for annuloplasty implant systems and associated methods

Info

Publication number: WO2023095097A1
Application number: PCT/IB2022/061503
Authority: WO
Inventors: Eugene Serina; Minh Nguyen; Sherrie YANG
Original assignee: Bluesail New Valve Technology Asia Ltd.
Priority date: 2021-11-29
Filing date: 2022-11-29
Publication date: 2023-06-01

Abstract

Annuloplasty implant systems (100) and methods of deployment within a catheter-based procedure and associated cable management tools are provided. Such systems (100) can utilize anchor delivery catheters (200) that deploy multiple anchors (20) over multiple torque wires or cables (222), and implant delivery catheters (300) that subsequently advance the annuloplasty ring implant (10) over the same wires (222) to the anchors (20). A cable holding fixture (400) can be applied to the multiple wires (222) to secure the positions or orientation of the wires (222) after deployment of the anchors (20) to ensure the implant (10) can be advanced fully to the anchors (20) disposed about the valve annulus. A cable tensioner (500) can be used to hold the wires (222) taut during advancement of the implant (10) over the wires (222).

Description

CABLE MANAGEMENT TOOLS FOR ANNULOPLASTY IMPLANT SYSTEMS AND ASSOCIATED METHODS

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims the benefit of priority to U.S. Provisional Application No. 63/283,830, filed November 29, 2021 the contents of which are hereby incorporated by reference in their entirety for all purposes.

[0002] The present application is generally related to co-pending and co-owned Application Nos. 17/475,086 (Atty Docket No. 107360-1263240-000110US) and 17/475,089 (Atty Docket No. 107360-000210US), the contents of which are hereby incorporated by reference in their entirety for all purposes.

BACKGROUND

[0003] Treatments for heart valve deficiencies, in particular mitral valve regurgitation, are widely varied. Mitral valve regurgitation is a condition that occurs when the mitral valve annulus is dilated or misshapen such that there is insufficient coaptation between the posterior mitral leaflet (PML) and the anterior mitral leaflet (AML), which allows blood to flow backward from the left ventricle (LV) into the left atrium of the heart (see heart anatomy in FIG. 1). Over time, this deficiency worsens and can lead to congestive heart failure, atrial fibrillation, pulmonary hypertension and ultimately death. Among the earliest approaches to mitral valve repair is the prosthetic annuloplasty ring developed in 1968. The prosthetic aimed to reform the proper shape of the valve annulus to provide proper leaflet coaptation so that normal valve function was restored. As compared to earlier approaches, the prosthetic annuloplasty ring to remodel the shape of the valve annulus has provided consistent and reliably positive patient outcomes and long-lasting results. One major drawback of this early approach, however, is that the annuloplasty ring is manually sutured into place around the valve annulus so that the implantation required an open-heart surgical procedure, which present considerable risks and challenges, particularly for patients already in poor health. In recent decades, a number of catheter-based approaches have been developed that attempt to similarly remodel the shape of the valve annulus while avoiding the risks associated with an open-heart surgical procedure. These catheter-based approaches include a variety of approaches, including cinching implants, leaflet clips, as well as sutures and splints that span across a heart cavity. However, few if any approaches thus far have provided the consistency and reliability in implantation and patient outcomes as the original prosthetic annuloplasty ring approach noted above. In addition, as with many catheter based procedures, precise placement and implantation is more challenging due to the enclosed environment and limited visualization. Accordingly, these catheter-based procedures can be tedious and timeconsuming, with the outcome of the procedure often heavily reliant on the skill of the physician. Recent developments have sought to replicate the advantages of a prosthetic annuloplasty ring within a catheter-based approach that delivers multiple anchors over multiple torque wires or cables, then advances an annuloplasty ring implant from an implant delivery catheter over the same wires. However, this can prove challenging due to relative movement between adjacent cables and slack in cables during deployment, which can frustrate or prevent the implant from being advanced smoothly and fully to the valve annulus. Thus, there is need for improved systems and methods devices that allow for improved ease and consistency in implantation by this catheter-based approach.

BRIEF SUMMARY

[0004] The present disclosure relates to anchor delivery and annuloplasty implant delivery systems and associated cable management tools and methods of use. While the systems and methods are described in regard to treatment of the mitral valve, it is appreciated that these concepts can be applicable to any heart valve and any implant anchored within a body lumen.

[0005] In one aspect, the invention pertains to a cable holding fixture that maintains the relative positions and orientation of the cables after deployment of the anchors to ensure the implant can be advanced over the same cables to the valve annulus. In some embodiments, the cable holding fixture includes: a pair of arms pivotally attached at proximal portions thereof and movable between an open position and a closed position. A circular band is disposed at the distal end of the pair of arms, the circular band having multiple recesses defined on an inside surface that are configured for receiving the plurality of cables within so that each recess receives an individual wire. In the closed position, the circular band encloses the plurality of cables, and in the open position, the circular band is open so as to laterally received the cables within the recesses. In some embodiments, a permanent magnet is disposed within each of the recesses to releasably couple the cables within. In some embodiments, the fixture includes a slider dimensioned to be received within the cables, the slider having multiple grooves on an outer surface that are configured for receiving the cables. The slider is configured for being releasably attached inside the circular band to lock the cables in place. In some embodiments, the slider releasably attaches inside the circular band by a friction fit. In some embodiments, the cable holding fixture is handheld and hand operated.

[0006] In another aspect, the invention pertains to a cable tensioner for holding multiple cables extending in parallel taut, the cables arranged in a circle corresponding to the anchors disposed about the valve annulus. In some embodiments, the cable tensioner includes: a base; a support ring extending from the base; and a cylindrical cable support disposed in the support ring. The cylindrical cable support has multiple apertures distributed about the periphery, each aperture configured for passage of an individual wire, and multiple clamps distributed about an outside, each clamp having a channel through which a respective individual wire extends, each clamp includes a screw (e.g. thumb screw) for securing a respective individual cable to the spring clamp. In some embodiments, the clamps are slidable in a proximal direction within a respective track in the cylindrical support so that individual cables can be manually tensioned by loosening the thumbscrew, sliding the clamp until the cable is at a desired tightness, then locking the thumbscrew. In some embodiments, the clamps are biased in the proximal direction by a respective spring between the distal facing side of the cylindrical support and the clamp so as to be self-adjusting. In some embodiments, the cylindrical support is rotatable within the ring support by 360 degrees to allow the cables to rotate during the procedure while maintaining the relative positions of the cables, and can be fixed by one or more thumbscrews or any suitable fastening means.

BRIEF DESCRIPTION OF THE DRAWINGS

[0007] FIG. 1 shows an overview of an exemplary anchor and implant delivery system utilizing a cable holding fixture and a cable tensioner, in accordance with some embodiments of the invention.

[0008] FIG. 2A shows a cross-sectional side view of an implanted annuloplasty implant system, in accordance with some embodiments.

[0009] FIGS. 2B-2C show the anatomy of the mitral valve.

[0010] FIGS. 3A-3D show a conventional prosthetic annuloplasty ring implanted in an open-heart surgical procedure. [0011] FIG. 4A shows an anchor delivery catheter in accordance with some embodiments.

[0012] FIG. 4B shows a distal anchor delivery portion of the anchor delivery catheter in accordance with some embodiments.

[0013] FIG. 4C shows a proximal control handle of the anchor delivery catheter in accordance with some embodiments.

[0014] FIGS. 5A-5C show several views of a screw anchor in accordance with some embodiments.

[0015] FIGS. 6A-6B show a torque wire and anchor coupled and decoupled by a torque wire couple-release mechanism, respectively, in accordance with some embodiments.

[0016] FIGS. 7A-7D show cross-sectional views of the torque-wire couple-release mechanism of the embodiment of FIGS. 6A-8B.

[0017] FIGS. 8 and 9A-9B show an alternative coupling -release mechanism having a rotatable cam lock in accordance with some embodiments.

[0018] FIGS. 10A-10C shows an adjustable ring locking feature for securing the ring to the anchors in accordance with some embodiments.

[0019] FIGS. 11A-1 IB show alternative ring locking features. FIG. 11A shows a ring locking feature having a hook coupling for securing the ring to the anchors in accordance with some embodiments. FIG. 1 IB shows a ring locking feature having a ball-detent coupling for securing the ring to the anchors in accordance with some embodiments.

[0020] FIGS. 12A-12D show several views of an annuloplasty ring design in accordance with some embodiments.

[0021] FIGS. 13A-14B show an adjustable annuloplasty ring design in accordance with some embodiments.

[0022] FIG. 15A shows an exemplary annuloplasty ring design configured to slide on multiple cables in accordance with some embodiments. [0023] FIGS. 15B and 15C show the annuloplasty ring of FIG. 15A in a delivery configuration and a deployed implantation configuration, respectively, in accordance with some embodiments.

[0024] FIG. 15D shows an exemplary annuloplasty implant system implanted on a model of a mitral valve annulus in accordance with some embodiments.

[0025] FIG. 16 shows an exemplary annuloplasty ring, in accordance with some embodiments.

[0026] FIGS. 17A-17D show an exemplary annuloplasty ring having a D-shape and curved saddle shape to better conform with a natural shape of the annulus, in accordance with some embodiments.

[0027] FIGS. 18A-18B show views of an annuloplasty ring being deployed from an annuloplasty ring delivery catheter in accordance with some embodiments.

[0028] FIGS. 19A-19C show several views of an annuloplasty ring delivery catheter in accordance with some embodiments.

[0029] FIG. 20 shows an articulable access sheath that can be advanced intravascularly to an atrium of the heart, such as in a transfemoral approach, to provide access for the respective delivery catheters of the anchors and annuloplasty ring in accordance with some embodiments.

[0030] FIG. 21 shows the access sheath advanced and penetrating through the septal wall and into the left atrium to provide access to mitral valve in the left atrium.

[0031] FIGS. 22A-22H show sequential views of delivery and implantation of the annuloplasty implant system in accordance with some embodiments.

[0032] FIG. 23 shows an exemplary ring coupling/release mechanism in accordance with some embodiments.

[0033] FIGS. 24A and 24B shows locked and unlocked positions, respectively, of the exemplary ring coupling/release mechanism in accordance with some embodiments.

[0034] FIGS. 25A-25D show steps of using a cable holding fixture to maintain relative positioning of the cables after anchor deployment, in accordance with some embodiments. [0035] FIG. 26 shows a cable tensioner used for holding the cables taut while secured in their relative positions during deployment of the implant along the same cables attached to the anchors, in accordance with some embodiments.

[0036] FIG. 27 shows a sliding clamp mechanism of the cable tensioner used to adjust and maintain tension in individual cables, in accordance with some embodiments.

DESCRIPTION OF THE INVENTION

[0037] The present invention pertains to an implants system and associated delivery catheters and associated cable management tools and methods of use, in particular systems that facilitate implantation of a heart implant in a minimally invasive manner that is similar reliability and consistency in patient outcomes as a conventional open-heart surgical procedures. Advantageously, the invention allows for a similar approach but within a minimally invasive catheter-based approach by utilizing multiple anchors deployed around the valve annulus over multiple torque wires or cables, after which the implant is advanced over the same cables to the valve annulus. This approach can be further understood by referring to Figures 4A-24B. While this implantation approach provides marked advantages over open-surgical procedures, one challenge is that the multiple cables can easily change positions between deployment of the anchors and deployment of the implant. Any change in the relative positions of adjacent cables prevents the implant from being advanced to the annulus due to crossing of the cables as the implant is being slid over the cables. Thus, in order to successfully advance the implant to the anchors fully to the valve annulus, the relative positions or orientation of the cables must be maintained after anchor deployment. Another challenge is that since the valve annulus is non-planar, the cables may be differing lengths such that slack in one or more cables may frustrate or prevent advancement of the implant over the cables. Accordingly, it is preferable for the cables to be held taught when the implant is advanced, however, this feat can prove difficult due to the number of cables and adjustments needed during the procedure. One approach to address these challenges is to utilize one or more cable management tools, such as any of those described herein.

[0038] In one aspect, the cable management tools include a cable holding fixture that engages each of the cables and maintains their relative positions and orientation. Typically, the cables extend in parallel about a circle that corresponds to the arrangement of anchors about the valve annulus. In some embodiments, the cable holding fixture is a hand-held tool that has an open position for receiving the cables and a closed position for securing the cables in place in their proper position or orientation. In some embodiments, the cable holding fixture includes two movable arms that are joined at a proximal end and held by the user. The arms extend to a distal portion having a generally circular band with multiple recesses along the inside that are configured for receiving the individual cables. Typically, the recesses engage the outer facing sides of the cables. In some embodiments, a permanent magnet can be included in each of the recesses to further maintain the ferromagnetic cables within the recesses. In some embodiments, the cable holding fixture can further include a slider that engages in inner facing side of the cables, the slider having recesses or fluting along an outside for receiving individual cables therein. The slider can slide along the cables and be fittingly received within the inside of the circular band, thereby locking the cables in place between the slider and the circular clamp portion. The slider can lock by a friction-fit, snap-fit, magnetic force, a fastener or any suitable means. In some embodiments, after clamping to the cables in the closed position, the entire tool can still be slid along the cables, to facilitate various steps of the procedure (e.g. removal of the anchor catheter, loading of the implant delivery catheter. An example of such a tool is shown in FIGS. 25A-25D, discussed further below.

[0039] In another aspect, the cable management tools include a cable tensioner that maintains the relative positioning of the multiple cables and holds the cables taut despite any variations in length between cables. In some embodiments, the cable tensioner includes a base that can be secured to a tabletop or any suitable surface (e.g. by a clamp, magnet or any suitable means), and main body having a cylindrical cable support with apertures disposed in a distal facing side along the periphery through which the cables extend and are held taut by adjustable clamps. The clamps can be individually adjusted until each cable is taut. In some embodiments, each screw clamp can further include a spring that further applies tension so as to be self-adjusting and accommodate minor changes in cable length during advancement of the implant over the anchors. An example of such a tool is shown in FIGS. 26-27 discussed further below.

[0040] The above described cable management tools can be utilized in any of the deployment systems and methods described in further detail below. In one aspect, as shown in FIG. 1, the systems are configured for deployment of an annuloplasty implant system 100 having an annuloplasty ring 10 attached to anchors 20 distributed about a mitral valve (MV). The system includes an anchor delivery catheter 200, which includes a proximal handle 210, a shaft 220, and an expandable anchor support structure 230 and centering element 240 that facilitates screwing of multiple anchors 20 around the mitral valve by actuation of multiple torque wires or cables 220 extending through the delivery catheter. After the anchors 20 are deployed, the delivery catheter 200 is removed, leaving the cables in place. The cables are then loaded through the implant, which is placed into an implant delivery catheter, which is then inserted into the patient. The annuloplasty implant ring 10 is then advanced from the implant delivery catheter over the cables 222 and locked to the anchors 20 so that the implant reshapes the mitral valve to the desired shape. The implant delivery catheter 300 and cables 22 can then be removed, leaving the annuloplasty implant ring system 100 secured to the mitral valve, as shown in FIG. 2A.

[0041] As noted previously, after deployment of the anchors 20, the relative positions and orientation of the cables 22 must be maintained to ensure that the implant can be fully advanced over the cables 222 and onto the anchors 20 around the valve annulus. To ensure the position and orientation of the cables is maintained after deployment of the anchors, the cables 22 can be secured by the cable holding fixture 400. In some embodiments, the cable holding fixture is slidable to differing positions along the cables so as to allow retraction/removal of the anchor delivery catheter. After removal of the anchor delivery catheter, the cables 222 are fed onto sleeves or eyelets on the implant 10, which is then placed inside the implant delivery catheter, and through the implant delivery catheter. The cables can then be fed through the cable tensioner 500 to hold each individual cable 22 taut during advancement of the implant over the cables 22 and onto the anchors 20 at the mitral valve. Since the mitral valve surface is non-planar, the lengths of different cables between the mitral valve and the cable tensioner may vary, which can cause slack to develop in one or more cables, frustrating advancement of the implant over the cables. To avoid this dilemma, the tensioner can include adjustable clamps to ensure each individual cable is held taut and can further include springs so that the cables are self-adjusting to accommodate any minor changes in length during the procedure.

[0042] In one aspect, the system separates deployment of the anchors from deployment of the annuloplasty ring, thereby allowing the physician greater focus on proper anchor placement and implantation before implantation of the annuloplasty ring. The invention further allows for improved ease of use and time efficiency by allowing the physician to implant multiple anchors simultaneously, while still allowing for independent anchor deployment as needed to ensure optimal placement of all anchors. In another aspect, the invention provides for an improved three-dimensional (3D) annuloplasty ring that allows for improved reformation of the valve annulus as compared to a conventional annuloplasty ring. While the system and methods described herein utilize this improved 3D annuloplasty ring, it is appreciated that the anchor deployment catheter and methods can be used with a variety of different types of annuloplasty rings, including two-dimensional (2D) annuloplasty rings. Further, it is appreciated that the improved 3D annuloplasty ring can be used with various other anchor deployment technologies and still provide the benefits of its improved design.

[0043] FIG. 2A shows a cross-sectional side view of an exemplary annuloplasty implant system 100 in accordance with some embodiments. The implant system includes multiple screw anchors 20 that are implanted in tissue surrounding the mitral valve annulus. The anchors are implanted at positions distributed evenly about the valve annulus. In some embodiments, the anchors are distributed unevenly, for example at location where more anchoring forces are needed due to the morphology of the valve. Typically, between 5-20 anchors are used, typically within a range of 6 to 12, preferably about 8 anchors, although any suitable number of anchors can be used. A 3D annuloplasty ring 10 is disposed adjacent the valve annulus and securely locked to the anchors by a ring locking mechanism, thereby reforming the shape of the valve annulus. The annuloplasty ring 10 can be specially configured to reform the 3D shape of the valve annulus to improve coaptation of the AML and PML leaflets and restore normal valve function. The means by which the implant system is delivered and implanted is described in detail below. FIGS. 2A and 2B shows the anatomy of the mitral valve and in particular the location of the annulus A relative the atrium above the annulus and the ventricle below the annulus. As can be seen in FIG. 2C, the natural shape of a healthy mitral valve annulus generally has a D-shaped two-dimensional shape and a three-dimensional shape that is saddle-shaped.

[0044] FIGS. 3A-3D show a conventional annuloplasty ring implantation in an open-heart surgical procedure. This conventional procedure is often considered the gold standard in surgical of mitral regurgitation repair and involves implantation of a semi-rigid annuloplasty ring 1 around the valve annulus. As shown in FIG. 3A, sutures 2 are implanted along the valve annulus, spaced precisely around the valve annulus. The sutures 2 are then sewn through the smaller sized annuloplasty ring 1, as shown in FIG. 3B. As shown, the spacing of the sutures is smaller on the ring. The ring is then pushed down upon the annulus, as shown in FIG. 3C, drawing the dilated valve annulus to the smaller diameter of the annuloplasty ring. The sutured are then tied off completing the repair, as shown in FIG. 3D. As noted above, this approach has provided reliably consistent results, yet suffers the considerable drawbacks associated with manually suturing tissues in an open-heart surgical procedure.

[0045] In one aspect, the annuloplasty implant system of FIG. 2C is designed to replicate the conventional annuloplasty ring surgical procedure, depicted in FIGS. 3A-3D, in order to provide similar consistency and reliability in patient outcomes. Advantageously, the concepts described herein allow this procedure to be performed in a catheter-based approach (e.g. a transfemoral catheter approach) that avoids the drawback and risks associated with an open-heart surgical procedure. In one aspect, the implantation method of the annuloplasty implant system described herein involves two main steps: (i) delivering and deploying multiple anchors with cables; and (ii) delivering an annuloplasty ring over the cables to secure with the anchors. Separating anchor deployment from ring deployment allows for greater design focus on improving ease and consistency in positioning and implanting the anchors around the valve annulus. In another aspect, this approach allows for use of an improved annuloplasty ring design having a 3D shape that remodels the valve annulus to a more anatomically correct shape and leads to better clinical performance. Conventional annuloplasty rings typically have a 2D shape (e.g. flat), which neglect the contours and morphology of the patient’s natural valve annulus. Utilizing a 3D shape allows for an annuloplasty ring that can not only conform to the patient’s morphology, but can also reform the overall shape and contours of the valve annulus to a desired 3D shape, rather than just reducing the diameter to a 2D shape. In some embodiments, this improved annuloplasty design can be customized specifically for a patient’s anatomy to reform the valve annulus to the desired form.

[0046] FIG. 4A shows an anchor delivery catheter 200 in accordance with some embodiments. Anchor delivery catheter 200 includes a proximal handle 210, an elongate flexible shaft 220, and an expandable anchor support 230 and expandable centering member 240 that are advanceable from the distal end. In some embodiments, the anchor support 230 and centering member 240 are each expandable frames, scaffolds or baskets, the anchor support 230 being an outer basket and the centering member 240 being an inner basket such that expansion of the inner basket expands the outer basket. In some embodiments, the centering member is a balloon, however, in this embodiment, the centering member is a scaffold or basket, which is advantageous as it allows blood to circulate while the centering member is expanded. In addition, the centering member is separable from the anchor support such that the centering member can be contracted while the anchor support remains expanded, which allows the valve to function while the anchors are adjusted and/or driven into the tissue. This also allows the physician to spend more time to accurately position and reliably deploy the anchors, as compared to systems where centering structures are integral with the anchor deployment mechanism.

[0047] FIG. 4B shows a detail view of the distal portion of the anchor delivery catheter 200. The anchor support 230 includes support guides 231 with torque wires (not visible) therein. Multiple screw anchors 20 are releasably coupled to the distal ends of the torque wires and extend distally of the support guides 231. In some embodiments, the catheter includes between five and ten anchors, preferably about eight anchors, disposed radially about the anchor support. Torquing of the individual torque wires, by torque mechanisms that are disposed within the handle, drives each anchor 20 into the tissue after positioning of the anchors about the valve annulus. The support guides 231 are evenly spaced and may be interconnected by an expandable struts, mesh or frame 234 extending between the support guides. The distal portion of the support guides 231 splay outward so that the distal anchors are spaced apart from the centering member, which avoids interference between the anchors and centering basket during anchor delivery. The distal portion of the support guides 230 also include a spring portion 232, which allows the anchor support frame and anchors to be more conformable during delivery and allows for more uniform anchor and tissue interaction before deployment. The centering member 240 includes a central shaft 241 to which is attached an expandable mesh or basket 242 that when foreshortened expands laterally outward. For example, axial movement of the central shaft from the proximal handle expands and contracts the centering member 240 to facilitate centering during anchor delivery. As discussed in more detail in FIGS. 22A-22D, the anchor support 230 and centering member 240 are advanced from the distal end of catheter 200, the centering member is expanded, thereby centering the assembly within the valve annulus and also expanding the anchor support thereon to position the anchors about the valve annulus.

Further advancement engages the anchors with the tissue surrounding the valve annulus, after which the centering member can be contracted and withdrawn to allow blood flow while the anchors are implanted into the tissue.

[0048] FIG. 4C shows a proximal control handle 210 of the anchor delivery catheter and includes control features for controlling delivery and deployment of the anchors. Centering switch 201 effects axial linear motion for opening and closing of the centering basket 240. Torque actuator 202 engages torque mechanisms that torque the individual torque wires for rotational deployment or removal of anchors. Rotation of torque actuator 202 in one direction (e.g. clockwise) effect clockwise rotation of engaged torque wires to screw anchors into tissue, while rotation of the torque actuator 202 in the opposite direction effects counterclockwise rotation of engage torque wires to effect removal of anchors. This feature allows for simultaneous deployment of all screw anchors 20. Selector switches 203 allows the physician to select one or more individual anchors to apply torque for removing one or more anchors, after which the physician can adjust or reattempt deployment on an individual basis. As shown, moving the switch 203 in one direction engages the torque tube with the torque mechanism such that rotation of actuator 2 effects torquing of the respective torque wire, while moving the switch in the opposite direction disengages the torque wire from the torque mechanism such that the respective torque tube is not torqued when the actuator 2 is rotated. This feature allows a physician to select any, all or any combination of anchors for deployment. However, if the position of a single anchor is then determined to be suboptimal by visualization techniques, an individual anchor can be selected and removed, repositioned as needed, then subsequently redeployed into the tissue.

[0049] FIGS. 5A-5C show several views of screw anchors 20 in accordance with some embodiments. As described above, the anchors are analogous in function to the sutures in a conventional annuloplasty procedure. Each anchor 20 includes a distal penetrating tip 21 and a proximal shaft 22. In this embodiment, the distal tip is a helical screw that engages tissue and implants by rotation. Components of a locking mechanism 23, and a couple-release mechanism 24 are disposed on a proximal region of the shaft 22. The ring lock mechanism 23 secures a locking collar 25 attached to the annuloplasty ring (not shown) to the anchor shaft. The torque wire couple-release mechanism 24 couples the torque wire 220 to the proximal end of shaft 22 to facilitate driving of the screw anchor into tissue by torque of the torque wire and decouples the anchor from the torque wire when the ring is positioned and reformation of the valve annulus is determined to be sufficient. [0050] In the embodiment shown, the ring locking mechanism 23 includes a ridge 23a within the locking collar 25 that is inwardly biased in a proximal direction such that advancing the ring and locking collar 25 beyond a shoulder 23b on a proximal region of the anchor shaft 22, causes ridge 23a to deflects inwardly toward anchor shaft 22 and abut against the shoulder 23b, thereby locking the collar 25 and attached ring to the anchor. The couple -release mechanism 24 can includes a slot 24b at a proximal end of the anchor shaft 22 that receives a corresponding distal ridge 24a on inwardly biased members at a distal end of the torque wire so as to interlock and couple the torque wire with the anchor shaft. The operation of the torque wire couple -release mechanism 24 is further depicted in FIGS. 6A-6B and 7A-7D.

[0051] FIG. 6A shows the anchor shaft 22 attached to the torque wire 222 with locking collar 25 (ring not shown) locked to the anchor shaft. FIG. 6B shows the torque wire 222 detached from the anchor shaft 22, disengaged by the couple-release mechanism 24. As shown, the ridge 24a is disposed on inwardly biased members that deflect inwardly upon removal of an inner core wire 223 so that ridge 24a disengaged from slot 24b along the proximal end of anchor shaft 22. FIGS. 7A-7B show cross-sectional views of the assembly before and after release of the torque wire 222 after the locking collar 25 with ring (not shown) has been secured to the anchor. As shown in FIGS. 7A-7B, central core wire 223 extends through torque tube 222 forcing the inwardly biased members apart so that distal ridge 24a extends laterally outward into the slot 24b of the anchor shaft 22, thereby locking torque wire 222 to the anchor. As shown in FIG. 7C, when core wire 223 is removed, the inwardly biased members of locking component 24a recover to their stress free state so that the members are drawn inward and ridge 24a is removed from slot 24b, thereby disengaging from the anchor shaft 22 to allow withdrawal of torque wire 222, as shown in FIG. 7D.

[0052] In another embodiment, the couple-release mechanism can include a rotating cam lock. As shown in the embodiments of FIGS. 8-11, the rotating cam lock 30 can include a cam lock 31 that interfaces with a locking sleeve 33 attached to the anchor shaft 22. As shown in the detail views of FIGS. 9A-9B, cam lock 31 includes a shaft and a distal cam 32 that can be positioned in a locked position (see FIG. 9A) during anchor delivery and deployment. As shown, the cam 32 is in a turned locked position within a corresponding shaped cavity 33a within the distal portion of the locking sleeve 33, which prevents the cam lock and attached torque tube from sliding out of the locking sleeve. After the annuloplasty ring is placed and secured to the anchors, the torque wires are released by twisting the cam lock 31. The cam lock 31 shaft can be rotated from their proximal end outside the patient, which rotates the cam 32 to align with a longitudinally extending slot 33b to allow cam 32 to be proximally retracted from the locking sleeve 33, thereby releasing the torque wires from the anchors.

[0053] In another aspect, the ring locking mechanism can include a protruding element of a locking collar attached to the ring that interfaces with a hole or recess within the anchor body. Examples of such mechanisms are shown in the embodiments in FIGS. 10-11. In one embodiment, the ring coupling mechanism includes a hook coupling in which a hook or resiliently biased member on the annuloplasty ring or attached locking collar interface with a hole or recess on the anchor.

[0054] As shown in FIGS. 10A-10C, the anchor shaft 22 can include one or more hypotube features 29 that lock against one or more inwardly extending tabs 25a of the collars 25 inclined in the proximal direction. In this embodiment, the anchor includes a series of three hypotube features 29, which allows for adjustability, and the collar includes at least two inwardly extending tabs. As can be seen in FIG. 10A, each of the locking hypotube features has a tapered proximal end 29a, which allows the sleeve to be slid over the hypotube, thereby pushing the inwardly extending resilient tabs of the sleeve outward, as shown in FIG. 10B. Further advancement of the sleeve allows the inwardly extending tabs to resiliently deflect inward to their set position and lock against a distal flat end 29b of the hypotube, as shown in FIG. 10C. The inwardly extending tabs 25a can be formed of any suitable material, including the same material as the collar or a differing material. In some embodiments, the one or more tabs are integrally formed with the collar. In other embodiments, the one or more tabs are separately formed and coupled with the collar. In some embodiments, the one or more tabs are formed of Nitinol and are set in the inwardly extended positions. As shown, the ring can lock onto any of the three locking hypotube features. This configuration allows the ring to accommodate variations in anchor positioning and depth relative the ring/annulus.

[0055] As shown in FIG. 11A, the anchor shaft 22 is attached to a locking collar 25 which includes a distally extending hook 26 that extends through a hole 27 in the anchor shaft 22 when the ring 10 and attached collar 25 is advanced over the torque wires 222, thereby locking the ring to the anchor. In another embodiment, the ring coupling mechanism includes a locking collar with a spring-loaded member that interfaces with a recess in the anchor body. [0056] As shown in FIG. 1 IB, the locking collar 25 attached to the ring 10 includes a laterally extending, inwardly biased ball 28 that interfaces with the hole or detent 23. As shown in the detail view, member 28 includes a spring 28a that biases a distal ball 28b inwardly so that when the collar is advanced over the anchor, the ball 28b is forced by spring 28a into detent 23, thereby locking the ring to the anchor, after which the torque wire can be detached as described above. While these examples are shown with the cam lock couplerelease mechanism, it is appreciated that these ring coupling mechanisms could be used with various other embodiments as well.

[0057] In some embodiments, the couple-release mechanism can be configured such that engagement the ring locking mechanism actuates the torque wire couple-release mechanism to decouple the torque wire. For example, engagement of inwardly biased ridge 23a with the anchor shaft 22 can actuate a member that decouples coupling features 24a, 24b to allow release of the torque wire. This design is advantageous as locking of the ring with the lock mechanism effects release of the torque wires. While a particular design of the lock mechanism and couple-release mechanism are shown and described above, it is appreciated that these mechanisms can include any interfacing components or any suitable connectors configured to provide the functionality noted above.

[0058] In this embodiment, the anchor tip and shaft are fabricated from stainless steel, although any suitable material can be used. The anchor can be formed of an integral component or can include multiple components attached together. Typically, the anchors are provided as described with the lock mechanism and couple-release mechanism attached thereto. While screw anchors are described herein, it is appreciated that any suitable type of anchor can be used including barbed anchors that are driven into tissue by applying an axial force from driving members connected to the anchor shaft. In this approach, the anchors can be deployed and removed in a similar manner, selecting any, all or any combination of anchors.

[0059] FIGS. 12A-12C show several views of an annuloplasty ring 10 in accordance with some embodiments. The ring 10 includes multiple concentric loops or rings 11 and a series of openings or eyelets 12 that receive the anchors to implant and secure the ring 11 against the valve annulus. In this embodiment, the annuloplasty ring is formed of a shape-memory alloy, such as Nitinol, and heat-set into three dimensional shape that mimics the healthy anatomical shape of the annulus. This allows the ring to be collapsed into a relatively small sized delivery catheter and to resume the desired shape when deployed from the catheter and secured to the anchors surrounding the valve annulus. Typically, the annuloplasty ring is semi-rigid. Advantageously, the three-dimensional design allows a variety of shapes and sizes to match the patient anatomy and specific characteristics of the mitral regurgitation in the patient, thereby providing a customized treatment approach. Evaluation of the patient pre-procedure with standard imaging techniques can be used to determine the shape and size ring for a given patient’s anatomy. As shown in FIG. 12D, the ring 10 can include eyelets, each having a collar 25 to facilitate advancement of the ring over wires or cables. In this embodiment, the ring 10 includes eight collars at the eyelet locations, which are spaced non- uniformly at locations desired to anchor the ring along the valve. It is appreciated that the ring can include more or fewer collars at various other locations. The collar 25 can further include a ring locking feature, such as any of those described herein. In another aspect, the annuloplasty ring can be adjustable, for example as show in FIGS. 13A-13B described further below.

[0060] As shown, the annuloplasty ring 10 includes multiple concentric loops or rings that together form the ring structure. In some embodiments, the ring include any suitable number of loops, for example between 2 and 50, 5 and 30, or 10 and 20. The loops are generally of a similar 2D shape as each other, as can be seen in FIG. 6A, that corresponds to the desired 2D shape of the valve annulus. In this regard, the ring is similar to a shape of a conventional annuloplasty ring along two dimensions (x-y direction). However, the multiple loops can have differing shapes along the third dimension (z-direction), as can be seen from the side view in FIG. 6C. This 3D shape allows the annuloplasty ring to reform the valve annulus along an additional dimension, thereby better reforming the dilated valve annulus to a desired 3D shape to further improve coaptation of the leaflets of the valve. In one aspect, the annuloplasty ring designs can be optimized and evaluated for radial strength, ability to deploy and low profde.

[0061] In another aspect, the annuloplasty ring can include adjustable sections or portions that can be tightened or loosened to adjust the overall shape and/or size of the ring from outside the patient during deployment. In some embodiments, the function of the heart can be monitored during deployment and the ring adjusted accordingly until a desired heart valve function is achieved. In some embodiments, the ring includes v-shaped elements at specific locations that can be cinched tighter, as needed in order to reduce the size of the ring. As shown in FIGS. 13A-13B, the adjustable annuloplasty ring 40 includes multiple concentric wire loops 41 with two v-shaped elements 42. In the embodiment shown, the v-shaped elements 42 are located on opposite sides, along to major axis of the oval. This results in a reduction of the minor axis which corresponds to the septal-lateral direction on the valve, which is typically the most effective direction for mitral valve reduction. It is appreciated, however, that the adjustment portions could be located at various other locations and utilize various other constructions.

[0062] As shown in FIG. 13B, each wire of the v-shaped element includes a collar 43 on opposite sides. Collars 43 are fixed on the wider portions of the v-shaped element and designed so that a cable can be passed through the collars. As shown in FIGS. 14A-14B, cable 43 is positioned through the multiple collars so that it is fixed on one collar and routed to span each of the v-shaped elements and extends outside of the of the patient so that the v- shaped portion can be tensioned/tightened by the clinician during deployment of the implant system. When the cable 43 is tensioned, the collars are brought closer together, reducing the dimension along the v-shaped element.

[0063] In another aspect, the annuloplasty ring can have a braided wire design that can be elongated and have a reduced diameter during delivery and then radially expanded to form the annuloplasty ring attached to the anchors. As shown in FIG. 15 A, the annuloplasty ring 50 is designed as an expandable scaffold formed of braided wire 51 that is interwoven about a central opening. In this embodiment, the wire 51 is a shape memory alloy, such as Nitinol. The scaffold includes eyelets 52 disposed near a distal portion of the scaffold, the eyelets having a locking collar 25, as described previously. Preferably, the scaffold has top end 54 and bottom end 53 that are each atraumatic, for example, without any exposed wire ends. As shown, the wire ends are connected to each other within the braid to form a continuous wire braid. In this embodiment, the top and bottom ends have a zig-zag design with peaks and valleys. In FIG. 15A, the scaffold is shown being advanced along cable wires midway between the delivery configuration, shown in FIG. 15B, and the deployed configuration, shown in FIG. 15C.

[0064] In the delivery configuration shown in FIG. 15B, the scaffold is axially elongated such that axial dimension al is larger than the diameter dl . As shown, the axial dimension is about 10 times as long as the diameter such that the scaffold resembles an elongated tubular shape along the longitudinal axis. The first diameter is sufficiently small to fit through a vascular access sheath, preferably a 18 French access sheath or smaller to allow delivery of the implant system to the heart valve through the femoral artery. The first axial dimension is typically between 2 cm and 10 cm.

[0065] In the deployed configuration shown in FIG. 15C, the scaffold is radially expanded and axially collapsed such that the diameter d2 is greater than the axial dimension a2. As shown, the average diameter is about five times greater than the axial dimension. When formed of a shape memory alloy, such as Nitinol, the scaffold is heat set into this deployed implantation configuration such that once delivered into the heart, the scaffold assumes this configuration. As shown, the scaffold resembles an oval shaped ring extending circumferentially about the central opening 55. Typically, the diameter d2 is within a range of 2 cm to 4 cm and suited for being secured around a heart valve, such as the mitral valve. The axial dimension a2 is relatively small, typically within a range of 0.5 cm to 3 cm.

[0066] FIG. 15D shows an exemplary annuloplasty implant system 100 implanted on a model of a mitral valve annulus (MV) in accordance with some embodiments. In accordance with the embodiments described above, the implant system includes annuloplasty ring 50 and multiple screw anchors 20 implanted in tissue surrounding the MV. As can be seen, the torque wires 220 are still attached to the proximal end of the anchors 20 and the implant 50 has been advanced over the torque wires extending through the eyelets 12 and collars 25 and assumed the deployed configuration adjacent the annulus. The ring can then be locked to the anchor shafts while the torque wires 222 are decoupled from the anchors and removed leaving the implant in place. In some embodiments, the function of the valve can be assessed before the ring is locked into place so that adjustments can be made to the anchors or ring before decoupling the torque wires.

[0067] In some embodiments, the annuloplasty ring can include one or more tissue ingrowth features that promote tissue growth around implant to secure ring implant to the mitral annulus after implantation. These features can include but are not limited to coatings, sutures, filaments, biodegradable polymers, mesh or fabric disposed on select portions of the annuloplasty ring structure. FIG. 16 show an exemplary annuloplasty ring 50 comprised of braided wires 51 that include a tissue ingrowth feature of a braided polyester yam or suture 60 that are wrapped about every other wire of the structure. In the embodiment shown, the ring is defined by loops of Nitinol wire. The suture 60 is wrapped and secured with a series of knots around the wires, avoiding wire crossover points to reduce fraying or damaging suture. By covering every other wire and avoiding wire crossover points, the suture does not restrict expansion of the implant. In some embodiments, other biocompatible fabrics, coatings or surface modifications can be added to the wires to improve tissue or blood interaction with the implant.

[0068] FIG. 17A shows an exemplary annuloplasty ring 50 that has been formed in a two- dimensional shape of D-shaped ring to better conform the annulus to a natural shape of a healthy mitral valve. Specifically, the D-shape has specific dimensions that correspond to relative to anatomic features within the mitral annulus, as shown in FIG. 1C, such that the ring is designed to reshape the heart in an anatomically advantageous shape, similar to a healthy annular shape. Rings can also be shaped to preferentially shape specific sections of the valve annulus depending on the patient. In some embodiments, the annuloplasty ring is further designed to assume a 3 -dimensional shape that corresponds to a natural shape of a health mitral valve annulus, which resembles a saddle-shape, as can be seen in FIG. 1C. As shown in FIGS. 17B-17D, the multiple wire loops of the annuloplasty ring, which are typically Nitinol wire, can be formed/set along this desired shape (indicated by dashed line) and thereby provide a more anatomically correct remodeling of the heart.

[0069] FIGS. 18A-18B shows the annuloplasty ring 50 being deployed from a ring deployment catheter. As can be seen, the annuloplasty ring can be constrained within a relatively small lumen of a catheter shaft 320 of the delivery catheter. The flexible braided scaffold design allows the entire ring to be axially elongated and radially collapsed and drawn into the catheter. The braided design has a mesh-like appearance, as shown in FIGS. 18A- 18B, before the is distally advanced and deployed to form the annuloplasty ring.

[0070] FIGS. 19A-19C show several views of an annuloplasty ring delivery catheter 300 in accordance with some embodiments. The delivery catheter 300 includes a proximal handle 310, an elongate flexible shaft 320, and an annuloplasty ring 50 constrained within a distal portion of the shaft. After removal of the anchor delivery catheter, the torque wires are left in place and the proximal ends of the torque wires are fed through the eyelets of the annuloplasty ring and then the ring is compressed and loaded into the shaft 320 with the torque wires 220 extending proximally from the shaft, as shown in FIG. 19A. The entire assembly is advanced over the torque wires to the mitral annulus. The ring can be deployed by proximal retraction of the shaft and/or by advancement of the pusher members 312 that engage the ring. The pusher members 312 extend to a control switch 311 on the handle. In this embodiment, the pusher elements are attached to the smaller catheter shaft which is attached to the handle. Advancement of the handle body will deploy the ring. Retraction of the handle body will pull the ring back into the larger shaft. The control switch on the handle disengages the pusher members from the ring and releases the ring from the catheter. Once released, the ring assumes its deployed configuration and can be attached to the anchors around the valve annulus, as described above.

[0071] As shown in FIG. 19C, pusher member 312 can include multiple arms that engage the ring to facilitate advancement and deployment of the ring adjacent the valve annulus. At this point, the shape and/or function of the reformed valve can be assessed by visualization techniques. If the physician determines the shape of the valve or valve performance is unsatisfactory, the ring can be removed by pulling the torque wires taut from the proximal end and drawing the ring within the sheath. The ring can then be withdrawn and adjusted or replaced as needed and the procedure repeated and re-assessed. Once the shape of the valve and/or valve function is satisfactory, the ring can be further advanced to secure the ring to the lock mechanism of the anchor shafts by the ring locking mechanism and decouple the torque wires from the anchors by the couple-release mechanism.

[0072] As shown, the pusher element comprises multiple arms that splay laterally outward and engage the most proximal loop of the prosthetic to allow axial movement of the pusher member to advance or retract the ring. The arms can be engaged with the loop by hooks, a coupling mechanism or any suitable releasable connector. In some embodiments, the pusher member can include one or more tubes disposed over one or more of the torque wires. While the ring delivery catheter is described as a separate catheter that is used after removal of the anchor delivery catheter, it is appreciated that the catheters can be combined within a single catheter in some embodiments.

[0073] FIG. 20 shows an articulable access sheath 400 that can be advanced intravascularly to an atrium of the heart to provide access for the respective delivery catheters of the anchors and annuloplasty ring in accordance with some embodiments. The access sheath can include a proximal handle 410 with proximal access opening, an elongate flexible sheath body 420 and a flexible articulable distal region 430. In some embodiments, the access sheath is a deflectable 20F sheath to aid in delivery and positioning of the implant system. This access sheath allows the above-noted implantation procedure to be performed in a transfemoral- transseptal approach from a venous access site. The mitral valve can be accessed from the atrial side by a right to left atrial puncture. FIG. 21 shows the access sheath advanced through the septal wall and into the left atrium to provide access to mitral valve in the left atrium.

[0074] FIGS. 22A-22H show sequential views of an exemplary method of delivery and implantation of the annuloplasty implant system in accordance with some embodiments.

[0075] In FIG. 22A, the delivery catheter is advanced to the mitral valve from the atrial side. The assembly of the anchor support 230 and centering member 240 is then advanced so that the center shaft 241 of the centering basket enters the mitral valve, as shown in FIG. 22B. As shown, the assembly is positioned so that the center shaft of the centering assembly extends through the valve annulus into the ventricle, while the anchor support frame remains above the valve annulus in the atrium. The position of the assembly within the valve annulus can be confirmed by visualization techniques.

[0076] As shown in FIG. 22C, the centering member 240 is expanded within the valve annulus (for example by axial movement of a control switch on the proximal handle), thereby centering the assembly within the valve annulus. As can be seen, since the anchors 20 are supported further outside of the centering member, thereby positioning anchors surrounding the valve annulus. If needed, the anchor support 230 can be further advanced to ensure sufficient contact with surrounding tissues. As discussed previously, the anchor support can include spring portions that allow the anchors more leeway and conformability so that all anchors can suitably engage with surrounding tissue regardless of uneven contours of the tissues. Advantageously, the centering member can be a basket or scaffold to allow blood flow between the atrium and the ventricle even during the centering procedure.

[0077] As can be seen in FIG. 22D, the centering member has been contracted and axially retracted into the delivery catheter. Advantageously, this allows the valve to function while the physician continues the process of securing the anchors into the surrounding tissue. While the anchor support 230 supports the torque wires (not shown) and anchors in the proper position, the physician actuates the torque wires to drive the screw anchors into the surrounding tissue. As noted above, the physician can select any, all, or any combination of the screw anchors or can explant individual anchors as needed. Preferably, multiple anchors are deployed concurrently, which improves the ease of implantation and reduces the length of the overall procedure. [0078] As shown in FIG. 22E, after the screw anchors 20 are satisfactorily implanted in the surrounding tissue, the anchor support can be withdrawn, along with the delivery catheter, leaving the torque wires in place extending through access sheath 400. The annuloplasty ring is then fed onto the proximal ends of the torque wires via the eyelets and loaded into the ring delivery catheter as described previously.

[0079] As shown in FIG. 22F, the annuloplasty ring is then advanced from the ring delivery catheter 300 over the torque wires 221). As can be seen in FIG. 22G, the ring can be further advanced from the catheter by a pusher member(s) 312 so that the scaffold emerges from the delivery sheath and assumes the deployed configuration and then is secured to the anchors adjacent the valve annulus. At this point, the shape of the reformed valve and/or valve function can be assessed, and if needed, the ring can be retracted and adjusted or replaced based on the assessment. Once the physician determined the shape of the reformed valve and/or valve function is suitable, the annuloplasty ring 10 is locked to the anchor shaft via a lock mechanism (for example, by further advancement of the ring) and the torque wires are decoupled from the anchor shafts. The ring delivery catheter and access sheath can then be removed, leaving the annuloplasty implant system in place, as shown in FIG. 22H.

[0080] In the embodiment of FIG. 23, the implant delivery catheter 300 includes pusher members 312 that each include an implant holding-release mechanism 350 on a distal portion thereof, which releasably engages the ring 50 while it is being advanced over the cables, and release the ring after locking of the collars 25 to the anchors. The ring holding -re lease mechanism 350 can be further understood by referring to FIGS. 24 and 25 which depict the mechanism in the locked and released positions, respectively.

[0081] As shown in FIGS. 24A and 24B, each ring holding -release mechanism 350 is a spring loaded hypotube sleeve 351, which includes an inner retractable hypotube sleeve 352 that retains ring 50 in the locked position constrained between inner sleeve 352 and outer hypotube sleeve 353 when the inner sleeve is pushed in the fully extended position by spring 354. As shown, each hypotube sleeve has teeth 352a, 353a that engage a wire of the ring in the locked position. The spring loaded release mechanism can be released from the proximal end of the catheter by retracting pull wire 355, which is attached to and retracts the inner sleeve and compresses the spring. Additional spring length creates slack and prevents inadvertent pre-release of any individual prong arm during delivery. While the ring is locked to the mechanism 350, the ring 50 is advanced over the torque wires and against the anchors, thereby locking the collars of the ring to the anchors, as described previously. Once the ring is locked in place, the pull wire(s) can be pulled to release the spring-mechanism and retract the inner sleeve(s) 352 proximally, thereby releasing the ring 50 from all the pusher members. In this embodiment, a wedge surface 352b, 353b on both the inner and outer hypotube sleeves interface when in the released position, thereby forcing the ring out when the inner sleeve retracts. In some embodiments, the pushing members can be locked together at the proximal end and pushed together so as to maintain planarity and uniform advancement of the ring along the cables. In some embodiments, push members can be individually controlled or advanced further relative other pushing members so as to conform the ring to a non-planar shape against the annulus. After release, the pusher members can then be retracted into the outer sheath of the implant delivery catheter and withdrawn from the body.

[0082] FIGS. 25A-25D show an exemplary cable holding fixture 400 used to secure the relative positions or orientations of the multiple cables 222. As shown in FIGS. 25A-25B, the cable holding fixture 400 is a handheld device with two arms 410 connected at a proximal pivot 401 such that the arms move between an open position (as shown in FIG. 25 A) and a closed position (as shown in FIG. 25B). The two arms extend to a distal circular band 420 having multiple grooves or recessed 422 in an inside surface, the recesses being configured to receive the cables 222 therein so that each groove holds a single cable. When in the closed position, the circular band 420 encircles the bundles of cables, and the outer facing surfaces of the cables are engaged within the recesses or grooves of the circular band 420. In some embodiments, each recess 422 includes a permanent magnet 342 that releasably couples with a respective cable to facilitate retention of the cable in the recess. As shown in FIG. 25C, after the cables 222 are disposed in their respective recesses 422, a slider 450 can be inserted in the center of the bundle of cables 222. The slider 450 can include fluting or recesses 452 on an outer surface, each receiving a single cable 22 and arranged to correspond to the recesses of the circular band 420. The slider 450 can then be slid into the center of the circular band 420 and locked or secured into place, as shown in FIG. 25D. The slider can be held in place by a friction fit, snap-fit, magnetic force, a fastener or any suitable means. In this configuration, the entire cable holding fixture can be slid in either direction, while the cables 222 remain secured and maintained in their relative positions and orientation. This is advantageous as the cable holding fixture can be slid proximally so that the anchor delivery catheter can then be removed. In some embodiments, another cable holding fixture can be secured on the cables 222 distally of the anchor delivery catheter to allow the catheter to be slid proximally over the cables and removed completely. The cable holding fixture can then be slid to the proximal ends of the cables to ensure proper positioning before the cables are fed into the sleeves or eyelets of the annuloplasty implant and through the anchor delivery catheter, and into the cable tensioning device.

[0083] FIG. 26 shows an exemplary cable tensioner 500 for holding the cables taught during advancement of the implant to the valve annulus. Cable tensioner 500 includes a base 510 that can be affixed to a surgical table top or any suitable surface, the base extending to a ring 520 that supports a cylindrical cable support 521 with adjustable clamps 530 that allow tension on each individual cable 222 to be adjusted to ensure all cables are held taut. The cables 222 extend through corresponding apertures 522 in the cable support 521 and through the adjustable clamps 530. The cable support 521 can rotate 360 degrees in the ring 521 during the procedure without losing the order of cables and can be held fixed by tightening of thumbscrew 523. FIG. 27 shows a detail view of a respective clamp 530. The spring clamp includes a channel 532 through which a respective cable extends and a screw 535 that secures the cable to the spring clamp. The spring clamp body slides back-and-forth in a track 531 in the cable support 521 of the tensioner and is biased proximally by spring 534 so as to be self- adjusting and hold each cable taut during the procedure.

[0084] In the foregoing specification, the invention is described with reference to specific embodiments thereof, but those skilled in the art will recognize that the invention is not limited thereto. Various features, embodiments and aspects of the above-described invention can be used individually or jointly. Further, the invention can be utilized in any number of environments and applications beyond those described herein without departing from the broader spirit and scope of the specification. The specification and drawings are, accordingly, to be regarded as illustrative rather than restrictive. It will be recognized that the terms “comprising,” “including,” and “having,” as used herein, are specifically intended to be read as open-ended terms of art. Each reference cited herein are incorporated herein by reference for all purposes. Further, the terms “wires”, “torque wires” and “cables” are used interchangeably herein.

Claims

WHAT IS CLAIMED IS:

1. A cable holding fixture for maintaining relative positions or orientations of a plurality of wires extending in parallel and arranged around a circle: a pair of arms pivotally attached at proximal portions thereof and movable between an open position and a closed position; and a circular band disposed at the distal end of the pair of arms, each arm being attached to at least a portion of the circular band, wherein the circular band includes a plurality of recesses defined on an inside surface thereof and configured for receiving the plurality of wires therein so that each recess receives an individual wire, wherein in the closed position, the circular band encloses the plurality of wires; wherein in the open position, the circular band is open so as to laterally receive the plurality of wires within the plurality of recesses.

2. The cable holding fixture of claim 1, further comprising: a permanent magnet disposed within each of the plurality of recesses so as to releasably couple the plurality of wires within the plurality of recesses.

3. The cable holding fixture of claim 1, a slider dimensioned to be received within the circle about which the wires extend, the slider includes a plurality of grooves on an outer surface thereof, the plurality of grooves configured for receiving the plurality of wires therein.

4. The cable holding fixture of claim 3, wherein the slider is configured for being releasably attached inside the circular band.

5. The cable holding fixture of claim 4, wherein the slider releasably attaches inside the circular band by a friction fit or snap-fit.

6. The cable holding fixture of claim 1, wherein the cable holding fixture is configured to be handheld and operated.

25

7. The cable holding fixture of claim 1, wherein the cable holding fixture is configured to remain slidable over the plurality of cables when secured within the closed position.

8. A cable tensioner for holding taut a plurality of wires extending in parallel and arrange about a circle, the cable tensioner comprising: a base extending to a support ring; a cylindrical cable support disposed in the support ring, wherein the cable support includes a plurality of apertures distributed about the periphery and extending at least partly therethrough, each configured for passage of an individual wire of the plurality; and a plurality of clamps distributed about an outside of the cable support, each having a channel through which a respective individual wire of the plurality extends, wherein each clamps includes a screw for securing a respective individual cable to the clamp and is movable in a proximal direction to allow adjustment of tension within the individual cable secured thereto.

9. The cable tensioner of claim 8, wherein each of the plurality of clamps are slidable in a respective track defined in the cable support.

10. The cable tensioner of claim 9, wherein each of the plurality of clamps are biased in the proximal direction by a respective spring between a distal portion of the clamp support.

11. A method of deploying an implant about in a valve annulus, the method comprising: deploying a plurality of anchors about a valve annulus with an anchor deployment catheter, wherein the anchors are deployed with a plurality of wires attached thereto; securing the relative positions or orientations of the plurality of wires with a cable holding fixture; removing the anchor deployment catheter; feeding the plurality of wires through a valve implant in an arrangement that corresponds to that of the plurality of anchors deployed at the valve annulus; and advancing the implant over the plurality of wires to the valve annulus.

12. The method of claim 11, wherein the cable holding fixture has movable arms attached to a distal circular band having an open position and a closed position, the method further comprising: placing the cable holding fixture in an open position over the plurality of wires and closing the fixture to a closed position so as to enclose the plurality of wires such that each wire of the plurality is received within an inner recess of the circular band.

13. The method of claim 12, further comprising: placing a slider inside the plurality of wires and sliding the slider into the circular band of the holding fixture to lock the cables in place.

14. The method of claim 12, further comprising: sliding the cable holding fixture in the closed position in a proximal direction to facilitate removal of the anchor delivery catheter.

15. The method of claim 12, further comprising: sliding the cable holding fixture in the closed position to a proximal end of the plurality of cables to facilitate feeding of the plurality of cables through the implant while maintaining the relative positions and orientation of the cables.

16. The method of claim 11, further comprising: holding each of the plurality of cables taut with a cable tensioner before advancing the implant over the plurality of cables.

17. A method of deploying a valve implant about in a valve annulus, the method comprising: deploying a plurality of anchors about a valve annulus with an anchor deployment catheter, wherein the anchors are deployed by a plurality of cables attached thereto; removing the anchor deployment catheter; feeding the plurality of cables through a valve implant so that an orientation of the cables corresponds to that of the plurality of anchors deployed at the valve annulus; and holding each of the plurality of cables taut with a cable tensioner before advancing the implant over the plurality of cables to the valve annulus.

18. The cable tensioner of claim 17, wherein holding each of the plurality of cables taut comprises manually pulling each wire through a clamp and cylindrical cable support of the cable tensioner and securing the respective cable with the clamp when taut.

19. The cable tensioner of claim 18, wherein holding each of the plurality of cables taut further comprises self-adjusting the tensions in the cable with a spring engaged with the clamp.

20. The cable tensioner of claim 17, further comprising: rotating the cylindrical cable support to a desired rotation during the procedure.

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