Detachable annuloplasty ring holder
By designing a valve annuloplasty ring retainer that can be cut and disassembled in one operation, the problem of cumbersome operation in the existing technology is solved, and the assembly and disassembly process is simplified, thus improving surgical efficiency.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- EDWARDS LIFESCIENCES CORP
- Filing Date
- 2024-09-13
- Publication Date
- 2026-04-24
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Figure CN121925236A_ABST
Abstract
Description
[0001] Cross-reference to related applications
[0002] This application claims the benefit of U.S. Application No. 63 / 582,809, filed September 14, 2023, the entire disclosure of which is incorporated herein by reference for all purposes. Technical Field
[0003] This disclosure generally relates to annulusoplasty ring retainers, and more particularly, to a retainer that is easy to assemble and disassemble from annulusoplasty rings. Background Technology
[0004] In vertebrates, the heart is a hollow muscular organ with four pumping chambers: the left and right atria and the left and right ventricles, each with its own one-way valve. Natural heart valves are identified as the aortic valve, mitral valve (or bicuspid), tricuspid valve, and pulmonary valve, each with flexible leaflets that interlock to prevent backflow.
[0005] Various surgical techniques can be used to repair diseased or damaged valves. A commonly used repair technique for effectively treating mitral regurgitation is annuloplasty, which typically involves reshaping or reconstructing the valve annulus by attaching a prosthetic annuloplasty repair fragment or ring to the annulus. The procedure is performed with the patient's heart stopped and cardiopulmonary bypass (“cardiopulmonary bypass”) being used. For example, the goal of posterior mitral valve annulus repair is to move the posterior mitral valve leaflet anteriorly to the anterior leaflet to improve leaflet engagement. The annuloplasty ring can be rigid, flexible, or semi-rigid, and the “reconstructed” annuloplasty ring typically has a “bulky rigid” or “semi-rigid” core because it will flex to a lesser extent but resist deformation when subjected to stresses exerted on the core by the mitral valve annulus of a running human heart.
[0006] Surgically implanted annulusoplasty rings are typically delivered through the resected left atrium above the mitral valve when the heart has stopped beating. As the surgeon advances the assembly at the end of the handle into the annulus, the ring is secured to the periphery of a template or retainer by sutures connecting it through the annulusoplasty ring. The ring is then sutured to the annulus, and the handle and template are disconnected and removed, sometimes in two stages due to handle obstruction.
[0007] There is still a need for an annulusoplasty ring retainer that allows for easier assembly and disassembly from the annulusoplasty ring. Summary of the Invention
[0008] This document discloses a retainer for an annulusoplasty ring that is removed using a single cut. The annulusoplasty ring is installed around the periphery of the retainer without the use of connecting sutures. The retainer has a proximal plate and a distal retainer, the proximal plate defining a lip on one side of the ring and the distal retainer defining a second lip on the other side, both lips retaining the ring around the periphery of the retainer. The distal retainer is formed by two hinged wings. When the annulusoplasty ring is delivered and secured to the implantation site, a truss suture holds the retainer in a truss configuration. Once the ring is secured at the annulus, the truss suture is cut using a single cut, thereby allowing the hinged wings to pivot and enabling the retainer to be pulled away from the ring.
[0009] A first system for retaining and delivering annular rings includes a retainer having a proximal plate opposite a distal retainer. The distal retainer includes a pair of hinged wings extending outward from each other and attached to an internal hinge to allow movement toward and away from the proximal plate. A truss suture fixed to the retainer passes through alignment holes in the proximal plate and the distal retainer. The truss suture maintains the retainer in a truss configuration, wherein the wings are hinged to contact the proximal plate. The retainer defines a peripheral groove in the truss configuration, the peripheral groove being sized to receive the annular ring therein, the peripheral groove being formed distally by the wings. The truss stitching crosses a cutting guide that projects proximal to upward from the proximal side plate and is secured to the retainer such that cutting the truss stitching at the cutting guide allows the retainer to switch from the truss configuration to a relaxed configuration, wherein the wing freely pivots away from the proximal side plate and releases the ring from the peripheral groove.
[0010] In the first system, the annulusoplasty ring is configured for implantation at the mitral valve annulus and has a generally circular D-shaped periphery with a major axis perpendicular to the minor axis, and the peripheral groove at least partially conforms to the periphery of the annulusoplasty ring. The wings are hinged to pivot about an axis parallel to the minor axis. Preferably, only a single truss suture and a single cutting guide are present. The truss suture may be secured to both wings and pass through the alignment hole multiple times before crossing the cutting guide. In one embodiment, both the proximal plate and the wings define a channel between at least two of the alignment holes, and the truss suture is recessed into the channel. The peripheral groove is preferably defined by opposing concave surfaces formed radially inward of the outer lip of both the proximal plate and the wings. The concave surface on the proximal plate may extend around the entire retainer, while the combined concave surface on the two wings extends only partially around the retainer.
[0011] The first system may further include an annulusoplasty ring for implantation at the mitral valve annulus, the annulusoplasty ring having a generally circular D-shaped periphery with a major axis perpendicular to the minor axis, wherein the peripheral groove at least partially conforms to the periphery of the annulusoplasty ring. The annulusoplasty ring may be size-adjustable and includes an internal adjusting tether extending around the periphery of the ring within an inner cavity.
[0012] A second system for retaining and delivering an annulusoplasty ring includes an annulusoplasty ring for implantation at the mitral valve annulus, the annulusoplasty ring having a generally circular D-shaped periphery with a major axis perpendicular to the minor axis. A ring retainer has a proximal plate opposite a distal retainer, wherein the distal retainer includes a pair of wings extending outward from each other and attached to the proximal plate to allow movement toward and away from the proximal plate. A truss suture secured to the retainer maintains the retainer in a truss configuration, wherein the wings remain in contact with the proximal plate. The retainer defines a peripheral groove in the truss configuration, the peripheral groove being sized to receive the annulusoplasty ring therein, and the peripheral groove is formed distally by the wings. The truss stitching crosses a cutting guide that projects proximal to upward from the proximal side plate and is secured to the retainer such that cutting the truss stitching at the cutting guide allows the retainer to switch from the truss configuration to a relaxed configuration, wherein the wing moves freely away from the proximal side plate and releases the ring from the peripheral groove.
[0013] In the second system, the wing is hinged to a partition fixed relative to the proximal plate and thereby pivots about an axis parallel to the short axis. Only a single truss seam and a single cutting guide may be present. The truss seam is preferably secured to both wings before crossing the cutting guide and passes multiple times through alignment holes in the proximal plate and the distal retainer. Both the proximal plate and the wing may define a channel between at least two of the alignment holes, into which the truss seam is recessed. Preferably, the peripheral groove is defined by opposing concave surfaces formed radially inward of the outer lip in both the proximal plate and the wing. The concave surface on the proximal plate may extend around the entire retainer, while the combined concave surface on the two wings extends only partially around the retainer.
[0014] In the second system, the annulusoplasty ring may be size-adjustable and includes an internal adjusting cord extending around the periphery of the ring within an inner cavity. The annulusoplasty ring may be partially formed by an internal coil around a body and is expandable for manual expansion when the ring is fitted into the peripheral groove of the retainer in the truss configuration. The annulusoplasty ring may further include an outer suture edge formed by a peripheral band of material through which sutures are embedded in a peripheral recess of an outer fabric covering on the ring.
[0015] A further understanding of the properties and advantages will become apparent by referring to the remainder of the instruction manual and the diagrams. Attached Figure Description
[0016] The features and advantages of this disclosure will become clearer with reference to the specification, claims, and drawings, in which:
[0017] Figure 1A This is a top plan view of the annulus angioplasty ring mounted on the template or retainer of this application, and Figure 1B It is its upward-viewing plan view;
[0018] Figure 2A and 2B This is a perspective view of an exemplary annulusoplasty ring holder of this application in a truss configuration, without an annulusoplasty ring mounted on it.
[0019] Figures 3A to 3C These are top view, front view and bottom view of the valve annuloplasty ring retainer of this application in a relaxed configuration;
[0020] Figure 4 This is a partial cross-sectional perspective view of an annulusoplasty ring, which can be mounted on the exemplary retainer described herein, and Figure 4A It is a radial cross-sectional view passing through one side of the annulusoplasty ring;
[0021] Figure 5A It is in the cross-sectional view just before the ring is installed on the retainer. Figure 4 The front view of the retainer of this application, which is in a truss configuration above the annulus angioplasty ring, and Figure 5B The assembly is shown after the ring has been mounted on the retainer; and
[0022] Figure 6A This is a top plan view of the assembled retainer and ring, indicating a single cutting and disassembly step. Figure 6B This is a frontal view after a cutting and disassembly step, showing the retainer in a release configuration being removed from the annulus angioplasty ring. Detailed Implementation
[0023] The right ventricle and left ventricle are separated from the right atrium and left atrium by the tricuspid valve and mitral valve (e.g., atrioventricular valve), respectively. Although the annuloplasty ring used to correct the mitral valve annulus is the main focus of this application, it should be understood that the annuloplasty ring and its retainer described herein are equally applicable to the treatment of tricuspid valve, and therefore, unless explicitly limited, the claims should not be limited to the mitral valve side.
[0024] The term "axis" in the context of annuloplasty rings and other non-circular or non-flat rings illustrated herein refers to a line that generally passes through the center of mass of the ring's periphery when viewed in a plan view. The direction of the "axial direction" or "axis line" can also be considered parallel to the average direction of blood flow within the valve orifice and thus within the ring implanted in the valve orifice. In other words, the implanted mitral valve annulus is oriented about a central flow axis aligned with the average direction of blood flow through the mitral valve annulus from the left atrium to the left ventricle. The plan view of the annuloplasty ring illustrated herein is taken from the atrial side in the direction of blood flow. Therefore, for orientation purposes, the atrial side of the ring faces upward and the ventricular side faces downward.
[0025] Figure 1A This is a top plan view of the annulus angioplasty ring 20 mounted on the template or retainer 40 of this application, and Figure 1B This is its bottom plan view. The annulusoplasty ring 20 is shown as configured for repairing the mitral valve annulus and thus has a generally circular D-shape with a slightly straight anterior peripheral face 22 opposite to the more circular posterior peripheral face 24. The major axis X through the annulusoplasty ring 20 is indicated, as is the vertical minor axis Y. The anterior face 22 can be demarcated by a pair of triangular markings 26, typically provided by radially oriented sutures sewn to the outer fabric covering 28. The midpoint of the posterior face 24 can be indicated by similar markings 30. As will be explained below, the annulusoplasty ring 20 has a configuration capable of adjusting its peripheral size and thus has an engagement housing 32 at the midpoint of the anterior face 22, from which an adjustment tether 34 extends.
[0026] Also refer to Figure 2A and 2B The perspective view shows an exemplary annulusoplasty ring retainer 20 in a truss configuration, incorporating a single truss suture 42. The retainer 20 comprises multiple movable parts, most notably a generally planar atrial or proximal plate 44, which opposes a ventricular or distal retainer composed of multiple elements, including two hinged wings 46. More specifically, and in particular, see... Figure 2BIn addition to the hinged wing 46, the distal retainer also includes a central partition defined by spaced-apart partition members 48a, 48b and a hinge 50. As shown, each of the wings 46 is hingedly connected to the two partition members 48a, 48b via the hinge 50. The partition members 48a, 48b are fixed to the distal side of the proximal plate 44, such as by being part of the same homogeneous portion, and thus the wings 46 are hingedly connected to the underside of the proximal plate 44.
[0027] It should be understood that although the proximal plate 44 and retainer 40 are generally described and shown as planar, they can also be three-dimensional. That is, some mitral annulusoplasty rings are saddle-shaped to better conform to the typical contour of the mitral annulus, and retainer 40 can mimic this 3D shape to have wavy peripheral grooves to hold the annulus. Furthermore, Figure 2A The size of the ring on the proximal plate 44 is indicated as "32". This refers to the mm dimension of the large diameter X of the ring 20, which is 32 mm in this case, and helps to ensure that the right retainer is used with the 32 mm ring, while also providing a quick identification of the retainer size.
[0028] For orientation purposes, and when mounted on the annulusoplasty ring 20, the septum members 48a, 48b are aligned relative to the annulusoplasty ring along the minor axis Y, wherein the wings 46 extend in opposite directions along the major axis X. Each of the wings 46 pivots relative to the septum members 48a, 48b about a hinge 50 along an axis generally parallel to the minor axis Y. The wings 46 pivot from a first position generally directly away from each other and parallel to the proximal plate 44 to a second position at an angle to the proximal plate 44. Figure 3B The wing 46 is shown in a pivoting position. These two positions will also be referred to as truss and slack. That is, when the truss stitch 42 passes through the various parts of the retainer 20 and is taut, the wing 46 is in the first or truss position. Conversely, when the truss stitch 42 has been cut or is not integral with the retainer 20, the wing 46 is in a slack position. Figure 3B The second or relaxed position. Hinge 50 may be biased to push wing 46 into the relaxed position, or it may simply be relatively weak, such that when retainer 20 is oriented upwards together with proximal side plate 44, gravity causes wing 46 to fall into the relaxed position again, as... Figure 3B What I saw.
[0029] Figures 3A to 3C A valvular annuloplasty ring retainer 20 in a relaxed configuration is shown. Both the proximal plate 44 and the wing 46 of the distal retainer have multiple through holes therein. Holes numbered #1-8 are shown on the distal retainer, while only holes #3-8 are shown on the proximal plate 44. Truss stitching 42 passes back and forth through these holes and is tightened to convert the retainer 20 from a relaxed configuration to a truss configuration.
[0030] use Figure 2A A comparison between / 2B and 3A / 3C reveals that the free end of the truss seam 42 is secured to the opposing wing 46 using knots 60 through holes #1-2 and #6-7. Starting from knot 60 and either hole #2 or hole #7, the truss seam 42 traverses the proximal plate 44 between holes #2-3 and #7-6. Short channels 62 may be provided on the proximal plate 44 between holes #2-3 and #7-6, while on the two distal retainer wings 46, elongated, angled channels 64 extend sequentially between holes #1-4 and #5-8. Thus, the truss seam 42 is recessed within channels 62, 64 to help conceal the truss seam between the holes and reduce any chance of the seam snagging during or after assembly.
[0031] Then, the truss seam 42 crosses from holes #3 and #6 to holes #4 and #5 respectively, and passes through the angled channel 64 on the distal retainer wing 46, as shown. Figure 3C As seen. Then, the truss seam 42 passes upward from the distal side through holes #4 and #5 to the proximal plate 44, and crosses the cutting guide defined by two spaced-apart cutting guide brackets 66, as... Figure 2A Best visibility is achieved. The cutting guide bracket 66 includes a wall that projects proximal upward from the proximal plate 44 and defines a central recess 68 that receives and centers the truss suture 42. The spacing of the cutting guide bracket 66 exposes a middle section length 70 of the truss suture 42 on the proximal plate 44 for final cutting if necessary. The cutting guide bracket 66 is positioned such that the middle section length 70 is centered on and perpendicular to the short axis Y, approximately halfway between the center of the ring 20 and the retainer 40 and the rear face 24 of the ring. This position is away from the engagement housing 32 to which the retainer (see below) is attached, and thus provides the surgeon with good visibility to cut the middle section length 70 on the cutting guide.
[0032] Therefore, by attaching the truss stitch 42 to holes #1-2 (or #7-8), the assembler can thread the truss stitch 42 around the retainer 20 until the truss stitch reaches hole #7-8 (or #1-2), where the truss stitch is secured by a knot 60. Before attaching the truss stitch 42 to hole #7-8, the assembler pulls the stitch taut to hold the retainer 20 in its truss configuration. This pulls the wing 26 upward against the underside of the near-side plate 44.
[0033] Return to reference Figures 3A to 3CThe peripheral edge of the proximal plate 44 defines an outer lip leading to an angled concave surface 72 in the distal direction, while the two wings 46 define outer lips leading to mirrored concave surfaces 74 partially surrounding their outer peripheries. When the retainer 20 is in a truss configuration, the combination of the outer lips and the opposing concave surfaces 72, 74 defines a generally semi-circular groove 76 for receiving and retaining the annulusoplasty ring 20, as... Figure 5A As seen. Before explaining the mounting ring 20 and then removing the ring from the retainer 40, a better understanding of the adjustable annulusoplasty ring is needed.
[0034] Figure 4 This is a partial sectional perspective view of the annulus valvuloplasty ring 20, and Figure 4A This is a radial cross-sectional view through one side. The adjusting cord 34 has a continuous central loop 80 passing through the inner cavity of the ring. (As shown) Figure 4A As seen in the cross-section, the central ring 80 extends through the inner cavity of the compressible filling member 82, and the central ring in turn extends through the spiral coiled body 84. Although not shown, the coiled body 84 is secured to the tubular extension of the engaging housing 32.
[0035] The exposed portion of the adjusting cord 34 at the engagement housing 32 can be pulled to tighten the ring 20 into a smaller overall shape. Both the coiled body 84 and the filling member 82 (not to mention the outer fabric cover 66) are flexible in terms of contraction, thus the adjusting cord 34 determines its final size. The coiled body 84 is ideally a highly elastic metal, such as nitinol, and can be heat-set into the shape shown. The tubular filling member 82 can be silicone or other soft materials, such as fabric. The adjusting cord 34, on the other hand, is made of a metal such as a creep-resistant cobalt-chromium alloy. After the ring 20 is tensioned to the appropriate size, the adjusting cord 34 can be locked within the engagement housing 32 in its contracted state with a reduced diameter. Due to the metallic nature of the adjusting cord 34, the ring size remains unchanged after contraction and is not subjected to stretching from material creep.
[0036] Further details of the adjustable annulusoplasty ring 20 are disclosed in International Patent Application No. PCT / US23 / 14440 (10948WO01), filed on March 23, 2023, the contents of which are expressly incorporated herein by reference for all purposes.
[0037] Figure 4AAn outer suture edge 86 formed around the outer periphery of the ring 20 is also shown. For example, the suture edge 86 can be created by a peripheral band 88 of a suture-permeable material (e.g., silicone or fabric) that is trapped within a peripheral recess 90 of the outer fabric covering 28. A suture 92 can be used to hold the band 88 within the recess 90, thereby maintaining the shape of the suture edge 86. The suture edge 86 is particularly useful when anchoring the annulusoplasty ring 20 to the natural annulus. That is, anchoring sutures are typically used to secure the ring 20 to the annulus, and providing an enlarged suture edge 86 as shown makes the task easier. Furthermore, the suture edge 86 reduces the risk of any anchoring sutures circling around the coiled internal structures that pass through the ring.
[0038] Now for reference Figure 5A The assembly of the annulusoplasty ring 20 with the retainer 40 will be described. As mentioned above, the retainer 40, in its truss configuration, defines a peripheral concave groove 76. The annulusoplasty ring 20 can be manually installed in the groove 76 around the retainer 40 by hand or by simply expanding the ring using some kind of expansion tool. Due to the flexible nature of the components of the ring 20 (particularly the coiled body 84), it is relatively elastic. Of course, this assumes that the adjusting tether 34 remains loose.
[0039] Figure 5B A ring 20 is shown mounted around the periphery of a retainer 40 in its truss configuration. A delivery handle 100 is shown attached to an engagement housing 32 on the front face of the ring 20. The delivery handle 100 terminates at a generally cup-shaped distal end 102, which is connected to the engagement housing 32, for example, by threads as shown. The delivery handle 100 includes an internal adjustment mechanism (not shown) that engages an adjustment tether 34, thereby enabling tensioning of the tether and reduction of the size of the ring 20. Details of this delivery handle can also be seen in International Patent Application No. PCT / US23 / 14440 (10948WO01). The delivery handle 100 may be long enough to extend from the exterior of the body to the vicinity of the target lobe ring, allowing the size of the ring 20 to be remotely adjusted.
[0040] The implantation of the annuloplasty ring 20 begins by establishing a cardiopulmonary bypass in the patient and opening an access pathway to the target annulus (typically the mitral valve annulus). The annuloplasty ring 20 is then advanced over the retainer 40 using the delivery handle 100 until the annuloplasty ring is positioned against the annulus. At this stage, the delivery handle 100 can be detached from the retainer 40 to provide greater access for securing the anchoring sutures via the suture edge 86. Alternatively, the delivery handle 100 remains attached for subsequent sizing adjustments of the ring 20.
[0041] Figure 6A and 6BA cutting and disassembly step is illustrated, showing the retainer 40 in a released configuration being removed from the annulusoplasty ring. A sharp instrument, such as a scalpel or scissors 100, is introduced into the surgical area, and the middle section 70 of the truss suture 42 is cut. This releases the tension on the truss suture 42, allowing the retainer 40 to transition from a truss configuration to a relaxed configuration. Figure 6B The cut end of the truss suture 42 and the retainer 40 are shown being lifted and detached from the annulusoplasty ring 20. Because the distal wing 46 is now freely pivotable about the hinge 50, the surgeon can simply pull the entire retainer 40 upward away from the ring 20, which remains fixed to the annulus.
[0042] Figure 6B The advantages of this application are effectively demonstrated. First, no connecting sutures pass through the two rings 20 in the retainer 40. Previous annuloplasty ring retainers required connecting sutures to pass through the rings, which necessitated pulling the connecting sutures out of the rings when disassembling the retainer. The retainer 40 of the present invention simply detaches from the ring, wherein the truss sutures 42 are only connected to the respective portions of the retainer and never pass through the rings 20. Second, the retainer 40 can be released using a single cut. Many previous annuloplasty ring retainers required two or more steps to cut the connecting sutures that pass through the rings again. These advantages enable elegant and efficient release of the annuloplasty ring retainer.
[0043] While the foregoing is a complete description of preferred examples, various alternatives, modifications, and equivalents may be used. Furthermore, it will be apparent that certain other modifications may be practiced within the scope of the appended claims.
Claims
1. A system for retaining and delivering annularoplasty rings, comprising: A retainer having a proximal plate opposite a distal retainer, wherein the distal retainer includes a pair of hinged wings that extend outward from each other and are attached to an internal hinge to allow movement toward and away from the proximal plate. as well as A truss stitch, secured to the retainer and passing through alignment holes in the proximal plate and the distal retainer, wherein the truss stitch holds the retainer in a truss configuration, wherein the wing is hinged to contact the proximal plate, and wherein the retainer defines a peripheral groove in the truss configuration, the peripheral groove being sized to receive a flap ring forming ring therein, the peripheral groove being formed by the wing on the distal side, the truss stitch crossing a cutting guide projecting proximally upward from the proximal plate and secured to the retainer such that cutting the truss stitch at the cutting guide allows the retainer to transition from the truss configuration to a relaxed configuration, wherein the wing freely pivots away from the proximal plate and releases the ring from the peripheral groove.
2. The system of claim 1, wherein the annuloplasty ring is configured for implantation at the mitral valve annulus and has a generally circular D-shaped periphery having a major axis perpendicular to the minor axis, and the peripheral groove at least partially conforms to the periphery of the annuloplasty ring.
3. The system of claim 2, wherein the wing is hinged to pivot about an axis parallel to the short axis.
4. The system according to any one of the preceding claims, wherein a single truss seam and a single cutting guide are present.
5. The system according to any one of the preceding claims, wherein the truss stitching is secured to the two wings and passes through the alignment hole multiple times before crossing the cutting guide.
6. The system of claim 5, wherein the proximal side plate and the wing define a channel between at least two of the alignment holes, and the truss seam is recessed into the channel.
7. The system according to any one of the preceding claims, wherein the peripheral groove is defined by opposing concave surfaces formed radially inward of the outer lip in both the proximal plate and the wing.
8. The system of claim 7, wherein the concave surface on the proximal plate extends around the entire retainer, and the combined concave surface on the two wings extends only partially around the retainer.
9. The system according to any one of the preceding claims, further comprising an annulusoplasty ring for implantation at the mitral valve annulus, the annulusoplasty ring having a generally circular D-shaped periphery having a major axis perpendicular to the minor axis, and the peripheral groove at least partially conforming to the periphery of the annulusoplasty ring.
10. The system of claim 9, wherein the annulusoplasty ring is size-adjustable and includes an internal adjusting tether extending around the periphery of the ring within the cavity.
11. A system for retaining and delivering annularoplasty rings, comprising: An annuloplasty ring, which is implanted in the annulus of the mitral valve, has a generally circular D-shaped periphery, the generally circular D-shaped periphery having a long axis perpendicular to the short axis; A ring retainer having a proximal plate opposite a distal retainer, wherein the distal retainer includes a pair of wings that extend outward from each other and are attached to the proximal plate to enable movement toward and away from the proximal plate; as well as A truss stitch, secured to the retainer, holds the retainer in a truss configuration, wherein the wing remains in contact with the proximal plate, wherein the retainer defines a peripheral groove in the truss configuration, the peripheral groove being sized to receive the annulus-forming ring therein, the peripheral groove being formed by the wing on the distal side, the truss stitch crossing a cutting guide projecting proximally upward from the proximal plate and secured to the retainer such that cutting the truss stitch at the cutting guide allows the retainer to transition from the truss configuration to a relaxed configuration, wherein the wing moves freely away from the proximal plate and releases the ring from the peripheral groove.
12. The system of claim 11, wherein the wing is hinged to a partition fixed relative to the proximal side plate and pivots about an axis parallel to the short axis.
13. The system according to any one of claims 11 to 12, wherein a single truss seam and a single cutting guide are present.
14. The system according to any one of claims 11 to 13, wherein the truss stitching is secured to the two wings before crossing the cutting guide and passes multiple times through alignment holes in the proximal plate and the distal retainer.
15. The system of claim 14, wherein the proximal side plate and the wing define a channel between at least two of the alignment holes, and the truss seam is recessed into the channel.
16. The system according to any one of claims 11 to 15, wherein the peripheral groove is defined by opposing concave surfaces formed radially inward of the outer lip in both the proximal plate and the wing.
17. The system of claim 16, wherein the concave surface on the proximal plate extends around the entire retainer, and the combined concave surface on the two wings extends only partially around the retainer.
18. The system according to any one of claims 11 to 17, wherein the annulusoplasty ring is size-adjustable and includes an internal adjusting tether extending around the periphery of the ring within the cavity.
19. The system of claim 18, wherein the annulus angioplasty ring is partially formed by an inner coiled body and is expandable to allow for manual expansion when the ring is mounted into the peripheral groove of the retainer in the truss configuration.
20. The system according to any one of claims 18 to 19, wherein the annulusoplasty ring further comprises an outer suture edge formed by a peripheral band of material through which sutures are trapped in a peripheral recess of an outer fabric covering on the ring.