Variable density soft anchor
By introducing variable-density soft anchor sheaths and flexible strands into the surgical suture structure, the problem of poor knotless fixation in existing technologies is solved, achieving knotless, self-tensioning, and self-locking tissue fixation, and enhancing the connection stability between bone and soft tissue.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- ARTHREX INC
- Filing Date
- 2024-07-15
- Publication Date
- 2026-04-17
AI Technical Summary
Existing surgical suture structures are difficult to use for knot-free fixation during tissue fixation, and the fixation effect is poor, especially in the connection between bone and soft tissue, which leads to unstable fixation and complicated operation.
The use of a soft anchor sheath with variable density allows for knotless fixation by varying the density along the sheath's length. Combined with the use of flexible strands, this allows the sheath to better converge and deform within the bone, thereby enhancing the fixation effect.
It achieves knotless, self-tensioning, and self-locking tissue fixation, reduces the need for needle insertion, and improves fixation effect and stability. It is suitable for various surgical repair procedures such as rotator cuff repair and Achilles tendon repair.
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Figure CN121889093A_ABST
Abstract
Description
Background Technology
[0001] This disclosure relates to the field of surgery, and more specifically to surgical suture structures and methods of manufacturing them, as well as tissue repair for reconstructive surgery. Summary of the Invention
[0002] The surgical flexible structure, fixation device, manufacturing method, and tissue repair method are disclosed.
[0003] Surgical structures may include soft anchor sheaths with varying densities along their length. The soft anchor sheaths may have irregular woven, machine-knitted, or woven density patterns, or combinations thereof. The soft anchor sheaths may be manufactured with varying and controlled sheath densities based on a specific application. Surgical structures can produce knot-free, self-tensioning, self-locking, and reinforced repairs. Surgical structures can be used to secure a first tissue to a second tissue, either knot-free or knotted, such as securing soft tissue to bone.
[0004] Methods for tissue repair were also disclosed. Knotless surgical structures enable tissue-to-tissue fixation without forming any knots, reducing the need for needle insertion and enhancing fixation and soft tissue compression. Soft anchor sheaths with varying densities allow for better bundled anchors or placement within the bone. Soft anchor sheaths with varying densities also allow for more reproducible anchor placement. Attached Figure Description
[0005] Figure 1 An example of a soft anchor fastener sleeve is shown.
[0006] Figure 2 Another example of a soft anchor sleeve is shown.
[0007] Figure 3 and Figure 4 Examples of using Figure 1 A schematic procedure for tissue repair of the anchor sleeve.
[0008] Figure 5 and Figure 6 Examples of using Figure 2 A schematic procedure for tissue repair of the anchor sleeve.
[0009] Figure 7 illustrates the sheath of a prior art soft anchor.
[0010] Figures 8 and 9 illustrate schematic steps for tissue repair using the prior art sheath of Figure 7. Detailed Implementation
[0011] This disclosure provides surgical fixation devices, structures, manufacturing methods, and tissue repair and reconstruction.
[0012] The soft anchor sheath may have a variable density. Placement of the soft anchor sheath requires deformation within the bone tunnel to anchor it in place. By varying the density of the sheath in certain areas, the sheath deforms initially in those areas, allowing it to anchor in the bone in different ways. Variations include changes in sheath density from high latitude and longitude (H) to low latitude and longitude (L). Sheath types may include, for example, HLH or LHL, or HLHL or LHLH, which will allow the sheath to deform in different ways to anchor in the bone. When tension is applied to place the sheath, the bundled or deformed sheath occurs differently in different areas / different regions.
[0013] A method for tissue repair using variable-density soft anchors is also disclosed. Exemplary method. special The procedure includes the following steps: (i) varying the density of the soft anchor sheath along its length; and (ii) applying the sheath to one or more tissue repair applications. One or more tissue repair applications may include soft tissue repair; orthopedic repairs such as rotator cuff repair, Achilles tendon repair, patellar tendon repair, ACL / PCL reconstruction, hip and shoulder reconstruction, etc.
[0014] Referring now to the accompanying drawings, in which the same elements are indicated by the same reference numerals. Figure 1 and Figure 2 Exemplary anchor structures 100, 200 of this disclosure are illustrated (soft anchor 100, 200; soft anchor sheath 100, 200; sheath 100, 200; full suture anchor 100, 200; surgical structure 100, 200). Figures 3 to 6 Schematic steps for exemplary anchor bundles 101 and 201 (tissue repair 101 and 201) using anchor structures 100 and 200 are illustrated. Figure 7 illustrates a prior art soft anchor structure 300. Figures 8 and 9 illustrate schematic steps for prior art tissue repair 301 using anchor structure 300.
[0015] The anchor structure detailed below is a soft anchor formed of a "soft" material (such as suture material), which provides the ability to be inserted into an acetabulum / bone foramen / bone tunnel and to bundle together, collapse, expand, and / or change shape to secure itself within the acetabulum / bone foramen / bone tunnel. In some embodiments, the soft anchor includes a sheath and at least one flexible suture attached to the sheath. The at least one flexible suture may be fixed (adhered) relative to the sheath or be able to slide relative to the sheath. In other embodiments, the soft anchor includes a sheath and multiple flexible sutures, wherein some or all of the flexible sutures are adhered to the sheath to prevent sliding, and wherein some or all of the flexible sutures are able to slide relative to the sheath. Soft anchors can be used in various surgical techniques to attach tissue to bone.
[0016] Figure 1 Examples include soft anchors 100 comprising multiple regions / segments 125, 126, 127, etc., with different densities (mass density; M / V) along the sheath 12.
[0017] The sheath 12 can be in the form of a tubular sleeve or tubular member made of a flexible material, such as a braided, woven, or knitted structure made of yarn, fiber, filament, thread, or similar materials or combinations thereof. In one embodiment, the sheath 12 is made of ultra-high molecular weight polyethylene (UHMWPE). In one embodiment, the sheath 12 is made of UHMWPE and polyester. In another embodiment, the sheath 12 is made of UHMWPE with an elastic component. In another embodiment, the sheath 12 is made of polyester thread material with an elastic component. The elastic component can be elastic fibers. The elastic component can be incorporated into the sheath via braiding, weaving, and / or knitting. In one embodiment, the elastic sheath may comprise a combination of elastic material, polyester, and UHMWPE woven entirely into the tubular sheath. In one embodiment, the elastic sheath may consist essentially of elastic fibers, polyester, and UHMWPE. The elastic component provides elasticity, while other components provide strength and limit the elongation of the thread.
[0018] In one embodiment, the ends of the sheath 12 may be joined together. In one embodiment, the ends of the sheath 12 may be glued together. In one embodiment, the ends of the sheath 12 may be abraded. In one embodiment, the sheath 12 may be a tape, such as a stitching tape. The sheath 12 may also be any non-tubular structure.
[0019] The flexible anchor 100 may include at least one flexible strand 14 passing through at least a portion of the sheath 12. The sheath 12 includes a tubular body extending between opposing ends 18a, 18b. The opposing ends 18a, 18b may be open or closed. The tubular body forms a hole extending between the opposing ends 18a, 18b. Figure 1 As shown, one or more flexible strands 14 (flexible connectors 14; sutures 14) pass through at least a portion of the holes in the sheath 12. Once the soft anchor 100 is inserted into or secured above the bone and the flexible strands 14 are tensioned, the flexible strands 14 assist in binding the sheath 12 together.
[0020] In one embodiment, the flexible strand 14 may pass through an opening 22 that is formed through the tubular body and spaced apart from the opposite ends 18a, 18b of the sheath 12 (e.g., as shown in the image). Figure 1(As shown). The flexible strand 14 can have any length and may include one or more free ends extending outside the sheath 12. This configuration can be used if the opposing ends 18a, 18b are closed ends. If the opposing ends 18a, 18b are configured as open ends, the flexible strand 14 may alternatively pass directly through the opposing ends 18a, 18b. As needed and depending on the specific surgical procedure to be performed, additional strands may pass through the tubular body of the sheath 12, such as suture threaders and / or additional filaments and / or flexible connectors, with the same or different orientations. In additional embodiments, the flexible strand 14 may enter and exit the sheath multiple times at the same or different locations. For example, a suture exiting the sheath may enter the sheath and exit again to even further aid in bundling.
[0021] The flexible strand 14 can be a suture thread. Non-limiting examples of suitable suture threads include FiberWire®, TigerWire®, or FiberChain® suture threads, although any type of suture thread, including cored or uncored suture threads, can be used. In another embodiment, the flexible strand 14 can be a suture tape, such as FiberTape®. The flexible strand 14 can comprise any soft, flexible material strand.
[0022] The flexible strand 14 can be adhered such that it does not slide relative to the sheath 12 (i.e., it cannot slide inside the hole to change its positioning relative to the sheath 12) or it can slide relative to the sheath 12. For example, details of the flexible strand 14 adhered such that it does not slide relative to the sheath 12 can be found in U.S. Patent No. 9,622,738, issued April 18, 2017, assigned to Arthrex, Inc., the disclosure of which is incorporated herein by reference in its entirety.
[0023] The soft anchor 100 is configured for use in various soft tissue repairs or fixations and can be fixed inside or above bone for attaching tissues (e.g., ligaments, tendons, grafts, etc.) to the bone. For example, the soft anchor 100 can be used in conjunction with various orthopedic repairs, including but not limited to rotator cuff repair, Achilles tendon repair, patellar tendon repair, ACL / PCL reconstruction, hip and shoulder joint reconstruction, etc. Fixation can be performed on or above the bone.
[0024] The soft anchor 100 is referred to as a "soft" structure because it is formed of soft materials such as yarn, fiber, filament, rope, fibrils, strands, thread, etc., or any combination of these materials. Within the scope of this disclosure, the soft material can be synthetic or natural, or a combination of synthetic and natural materials, and can be biodegradable or non-degradable, and can be elastic or inelastic. In one non-limiting embodiment, the soft anchor 100 is made solely of soft, thread-based materials.
[0025] As described in detail below, the soft anchor 100 may be manufactured by braiding, weaving and / or knitting processes or a combination of these processes, having or not having an elastic component, and always having a variable warp and weft density that allows the soft anchor 100 to deform according to the warp and weft density.
[0026] like Figure 1 As shown, the sheath 12 of the soft anchor 100 includes multiple segments / parts / regions / lengths with different densities. In a non-limiting embodiment, the sheath 12 includes a first portion 125 (first segment 125; first length 125; first region 125) adjacent to a second portion 126 (second segment 126; second length 126; second region 126), which in turn is adjacent to a third portion 127 (third segment 127; third length 127; third region 127). In one embodiment, one of the first portion 125, the second portion 126, and the third portion 127 may have a first density (first mass density; first weave pattern density; first weft per inch; first programmable weft per inch (PPI)), wherein adjacent portions have a second density (second mass density; second weave pattern density; second weft per inch; second programmable weft per inch (PPI)). The first density is different from the second density.
[0027] One of the first portion 125, the second portion 126, and the third portion 127 may be a high-density (H) portion, wherein the remaining portions are low-density (L) portions. In other embodiments, one of the first portion 125, the second portion 126, and the third portion 127 may be a low-density (L) portion, wherein the remaining portions are high-density (H) portions. In an exemplary embodiment, L may be about 2 mm, and H may be about 3 mm.
[0028] In one embodiment, portions or segments of the sheath 12 may alternate with a pattern of high-density and low-density segments along the length of the sheath. In another embodiment, high-density and / or low-density segments or portions of the sheath 12 may alternate randomly along the length of the sheath. In yet another embodiment, a regular pattern of high-density and / or low-density segments may alternate with randomly provided segments (high-density and / or low-density segments) along the length of the sheath. In an additional embodiment, different segments of the sheath may be provided with two or more different densities, wherein the two or more densities are all different. Different segments of the sheath may have different lengths and / or different diameters and / or compositions.
[0029] Figure 1An exemplary embodiment of the sheath 12 of the soft anchor 100 is illustrated, wherein the first segment 125 and the third segment 127 are configured as H-density segments, and the second segment 126 is configured as an L-density segment. In this exemplary embodiment only, L may be about 2 mm, and H may be about 3 mm.
[0030] Figure 2 An exemplary embodiment of the sheath 212 of the soft anchor 200 is illustrated, wherein the first segment 225 and the third segment 227 are configured as L-density segments, and the second segment 226 is configured as an H-density segment.
[0031] Although only three segments or regions of different densities of sheath 12 and 112 have been described with reference, Figure 1 and Figure 2 The disclosure describes various implementation schemes, but it must be understood that this disclosure is not limited to these exemplary embodiments only. Therefore, this disclosure envisions any number of segments, regions, lengths, or portions of the tubular sheath, which are provided with at least two different densities and in a regular or irregular pattern. The number and length of the segments can vary along the length of the sheaths 12, 112 in a regular or irregular pattern. The density can also vary. The sheaths 12, 112 can be provided with any number of segments having any number of varying densities, all of which are different. Depending on the specific anchor bundle repair, the length of the segments can also vary.
[0032] The soft anchors 100 and 200 can be woven stitch structures constructed in the warp or weft direction using parallel, twisted, and / or braided, knitted, or woven monofilaments. Density behavior can be manipulated via the amount or composition of the fibers woven together (e.g., by adding monofilaments) to create segments of varying densities along the sheath length. One or more filaments of an elastic material (such as elastic fibers) can be incorporated into the sheath.
[0033] The soft anchors 100 and 200 can be configured to allow the monofilament and / or elastic material to be turned, inserted, or removed at desired locations, regardless of the stitch configuration forming high-density and low-density segments within the same stitch braid / sheath. The soft anchors 100 and 200 can be manufactured as a single-piece structure.
[0034] Tubular sheaths 12, 112 with circular and / or elliptical cross-sections can be manufactured via braiding, woven, and / or knitting processes, wherein monofilaments and / or elastic components are incorporated into the remaining carriers (bundles). In exemplary embodiments only, sheaths 12, 112 may include individual monofilaments incorporated within 15 carriers to form one or more H-density segments as part of the sheath. Sheaths 12, 112 may also contain an elastic component.
[0035] Figure 3 and Figure 4 A soft anchor 100, which secures the first tissue 80 to the second tissue 90 as part of an anchor bundle 101 (surgical repair 101), is schematically illustrated. Figure 3 and Figure 4 An example is illustrated of a soft anchor 100 inserted as part of a repair 101 through a first tissue 80 (e.g., cortical bone) to a second tissue 90 (e.g., cancellous bone). A sheath 12 is secured against the first tissue 80 (bone 80), such that variations in the density of the sheath material allow for increased convergence and deformation within bone pores, sockets, or tunnels, thereby allowing the sheath to anchor in different ways and enhancing overall fixation. A flexible connector 14 can pass through the tissue to secure it to the bone.
[0036] Similarly, Figure 5 and Figure 6 A soft anchor 200, as part of an anchor bundle 201 (surgical repair 201), is schematically illustrated to secure a first tissue 80 (e.g., soft tissue) to a second tissue 90 (e.g., bone). A sheath 112 is secured to the first tissue 90 (bone 90) such that variations in the density of the sheath material allow for increased bundle bonding and deformation within bone pores, acetabulum, or bone tunnels, thereby allowing the sheath to anchor in different ways and enhancing overall fixation. A flexible connector 14 can pass through the tissue to secure it to the bone.
[0037] The flexible connector 14 of repairs 101 and 201 can be used to attach soft tissue 80 to bone 90 by passing the flexible connector through or around the soft tissue and forming at least one adjustable, flexible, continuous, knotless, tensionable loop around or through the soft tissue 80. One or more flexible connectors 14 and optional shuttle strands may extend through the holes of sleeves 12 and 112 in similar or different directions and / or orientations and / or positions. The flexible tubular sleeves 12 and 112 with flexible connectors and shuttle strands can be secured to or within the bone, and the flexible strands may cross the soft tissue (rotator cuff) and be secured to the bone to bring the soft tissue close to the bone. Details of an exemplary soft suture anchor having a soft anchor sleeve (sheath or tubular member) and flexible shuttle strands are set forth in, for example, U.S. Patent No. 10,849,734 entitled “Methods of Tissue Repairs”, published December 1, 2020, the disclosure of which is incorporated herein by reference in its entirety.
[0038] The flexible connector 14 may also be attached to one or more fixation devices, such as any anchor (e.g., knotted anchor, knotless anchor, or fully sutured anchor), or any device that allows the soft tissue 80 to be securely attached and fixed above the bone 90. The fixation device may be a knotless anchor, such as the two-piece Arthrex PushLock® anchor disclosed in US 7,329,272, or the Arthrex SwiveLock® anchor disclosed in US 8,012,174 and US 9,005,246, the entire contents of which are incorporated herein by reference. The fixation device may also be another fully sutured soft anchor, such as the soft anchors 100 and 200 detailed above. The flexible connector 14 may consist substantially of elastic sutures.
[0039] Another exemplary fastening device is a soft anchor or a "fully stitched" anchor. A soft anchor (soft stitched anchor or fully stitched knotless anchor) is provided with a soft anchor sleeve (sheath or tubular member) with two open ends, and at least two flexible shuttle strands extending through the soft anchor sleeve (sheath).
[0040] Figures 7 through 9 illustrate a prior art soft anchor 300 used as part of a prior art surgical repair 301 to secure a first tissue 80 (e.g., soft tissue) to a second tissue 90 (e.g., bone). The sheath 212 secured to the second tissue 90 (bone 90) exhibits no density variation in the sheath material and therefore exhibits minimal bundle aggregation and deformation relative to the repairs 101, 201 detailed above.
[0041] Methods for manufacturing soft anchor sheaths with different densities and / or elasticities are also disclosed. An exemplary method for manufacturing soft anchor sheaths 12, 112 includes the step of incorporating monofilaments and optional elastic components into the sheath via braiding, weaving, and / or knitting to form a regular or irregular weave density pattern in the sheaths 12, 112. The method may also include the step of attaching one or more flexible strands 14 to the soft anchor sheaths 12, 112. The one or more flexible strands 14 may be elastic.
[0042] A method for soft tissue reconstruction includes attaching soft tissue 80 to bone 90 using at least one soft anchor 100, 200. The method may include: forming at least two segments of different densities along the length of sheaths 12, 112 of the soft anchor 100, 200; attaching at least one flexible connector 14 to the sheaths 12, 112; and securing the soft anchor 100, 200 to the bone. The method may further include securing the soft anchor 100, 200 to the bone 90 such that the at least two segments of different densities are bundled together within the bone 90 in different ways; and allowing at least one flexible connector 14 to pass through or around the soft tissue 80 to attach the soft tissue to the bone. The method may further include forming at least one adjustable, flexible, continuous, knotless, tensionable loop around or through the soft tissue 80 using at least one flexible connector 14. The method may further include securing at least one flexible connector 14 to a fixation device. The fixation device may be a knotless anchor. The fixation device may be a rigid anchor. The fixation device may be a soft anchor. At least one flexible connector 14 may consist substantially of elastic sutures. Soft tissue 80 may be a rotator cuff. Multiple soft anchors 100, 200 may be used for soft tissue repairs, such as rotator cuff repairs.
[0043] The structure and method disclosed herein enhance fixation and exert more sustained pressure on the tissue.
[0044] The structures disclosed herein are applicable to any tissue repair and surgical procedure, such as rotator cuff repair, Achilles tendon repair, patellar tendon repair, ACL / PCL reconstruction, hip and shoulder reconstruction procedures, and the application of elastic sutures used in or with suture anchors. The surgical structures and repair methods disclosed herein can be employed in tissue repairs that do not involve knotting, such as for use with suture anchors (such as PushLock® and / or SwiveLock® suture anchors) or for knotless arthroscopic suture repairs (such as knotless single-row rotator cuff repair, or knotless suture needle insertion using only the SpeedBridge™ step), and many other methods.
[0045] An exemplary SutureBridge™ tendon repair technique, developed by Arthrex, Inc. and disclosed in US 8,012,174 (the disclosure of which is incorporated herein by reference in its entirety), comprises a knotted medial column constructed with two threaded suture anchors, combined with knotless lateral fixation using two Arthrex PushLocks® structures. This structure enhances plantar compression and promotes tendon-to-bone healing with minimal knotting.
[0046] The exemplary SpeedBridge™ technology, also developed by Arthrex, Inc. and disclosed in US 9,005,246 (the entire disclosure of which is incorporated herein by reference), uses a threaded rotary anchor that can be combined with either of structures 100 or 200 to produce a fast and secure SutureBridge™ structure that has no knots and only two stitching steps.
[0047] A method for soft tissue reconstruction includes attaching soft tissue 80 to bone 90 using at least one surgical structure 100, 200. The method may further include: securing the surgical structures 100, 200 to the bone 90; and securing at least one flexible connector 14 to the soft tissue 80. The surgical structures 100, 200 may be single-piece structures comprising an elastic material. The flexible connector 14 may comprise an elastic material. The method may further include attaching the flexible connector 14 to a fixation device. The fixation device may be a knotless or knotted anchor.
[0048] The flexible connector 14 may be formed of a high-strength suture material, such as FiberWire® suture, sold by Arthrex, Inc., Naples, Fla. and described in US 6,716,234 (the disclosure of which is incorporated herein by reference). FiberWire® suture is formed of an advanced high-strength fiber material, namely ultra-high molecular weight polyethylene (UHMWPE), sold under the trade names Spectra® (Honeywell International Inc., Colonial Heights, Va.) and Dyneema® (DSM NV, Heerlen, the Netherlands), and optionally woven with at least one other natural or synthetic elastic fiber to form a length of suture material. The flexible connector 14 may also include suture tape, such as FiberTape® suture tape (as disclosed in US 7,892,256, the disclosure of which is incorporated herein by reference in its entirety), or collagen tape, or a wide “strip” material, or a combination thereof.
[0049] The flexible connector 14 may be substantially composed of a stitching material and elastic fibers, or a combination of stitching material and elastic fibers with other materials such as long-chain synthetic polymers (e.g., polyester and nylon), or materials such as PET, nylon filament, or absorbable polymers, or coating materials (e.g., wax, silk, or silicone products). The flexible connector 14 may consist of strands of thread with cross-sections having various forms and geometries, including circular, elliptical, rectangular, or flat shapes, or combinations of these forms and geometries. In one embodiment, at least one flexible connector 14 may be provided as a braided, knitted, or woven stitch.
[0050] The soft anchors 100, 200, including sheaths 12, 112 and flexible connectors 14, may also be partially or entirely coated and / or provided in different colors. In one embodiment, for example, parts (or all) of sheaths 12, 112 and flexible connectors 14 may be coated (partially or entirely) with wax (beeswax, petroleum wax, polyethylene wax or others), silicone (DowCorning silicone fluid 202A or others), silicone rubber (Nusil Med 2245, Nusil Med 2174 with adhesive catalyst or others), PTFE (Teflon, Hostaflon or others) or PBA (polylactic acid), ethyl cellulose (Filodel) or other coatings to improve the lubricity, flexibility, handleability or abrasion resistance of the structure.
[0051] Parts or all of the sheaths 12, 112 and / or flexible connectors 14 may also be provided with colored tracking threads, or otherwise visually contrast with other parts of the structure, for example, these parts may remain in a solid color or present different tracking patterns. Various structural elements of the surgical structure can be visually encoded, thereby simplifying the identification and handling of suture legs. In surgical procedures, it is easy to... In situ Identifying sutures is helpful.
[0052] The term "high-strength suture" is defined as any slender, flexible member, with the choice of material and size depending on the specific application. For illustrative and not limiting purposes, the term "suture" as used herein can refer to cable, filament, thread, metal wire, fabric, or any other flexible member suitable for fixation of tissues in vivo.
Claims
1. A soft anchor comprising a tubular sheath having at least two different mass densities along its length.
2. The soft anchor as claimed in claim 1, wherein the tubular sheath has at least one segment with a first mass density and at least another segment with a second mass density, wherein the first mass density is different from the second mass density.
3. The soft anchor as claimed in claim 2, wherein the tubular sheath has two segments of the first mass density and one segment of the second mass density.
4. The soft anchor as claimed in claim 2, the soft anchor further comprising a first plurality of segments of the first mass density and a second plurality of segments of the second mass density, wherein the first plurality of segments and the second plurality of segments form a pattern along the length of the tubular sheath.
5. The soft anchor as claimed in claim 1, wherein the tubular sheath comprises monofilaments woven, machine-woven, or knitted together with additional filaments.
6. The soft anchor as claimed in claim 1, wherein the soft anchor further comprises at least one flexible connector that passes through the tubular sheath at least once.
7. The soft anchor as claimed in claim 6, wherein the at least one flexible connector enters the tubular sheath at a first position, extends within the tubular sheath, and exits the tubular sheath at a second position, wherein the second position is different from the first position.
8. The soft anchor as claimed in claim 7, wherein the first position is the first open end of the tubular sheath, and the second position is the second open end of the tubular sheath.
9. The soft anchor as claimed in claim 7, wherein the first position is spaced apart from the open end of the tubular sheath.
10. The soft anchor as claimed in claim 6, wherein at least one region of the flexible connector is attached to the fixing device.
11. The soft anchor as claimed in claim 10, wherein the fixing device is a knotless anchor.
12. The soft anchor as claimed in claim 6, wherein the soft anchor is a fully stitched anchor, and the flexible connector is a circular stitch.
13. The soft anchor as claimed in claim 1, wherein the tubular sheath is substantially composed of polyester and UHMWPE.
14. The soft anchor as claimed in claim 1, wherein the tubular sheath is substantially composed of polyester, UHMWPE and elastic fibers.
15. The soft anchor as claimed in claim 1, wherein the tubular sheath is resilient.
16. The soft anchor as claimed in claim 1, wherein the tubular sheath is inelastic.
17. The soft anchor as claimed in claim 1, wherein the soft anchor is manufactured as a single-piece structure.
18. A method for soft tissue repair, the method comprising attaching soft tissue to bone using at least one soft anchor sheath having a different mass density.
19. The method of claim 18, further comprising: At least one flexible connector is attached to the soft anchor sleeve; Secure the soft anchor sheath to the bone; as well as The at least one flexible connector is secured to the soft tissue.
20. The method of claim 19, wherein the soft anchor sheath has at least two separate segments having different mass densities.
21. The method of claim 20, wherein when the soft anchor sheath is secured to the bone, the soft anchor sheath deforms differently at at least two individual segments.
22. The method of claim 19, wherein the at least two individual segments have different lengths.
23. The method of claim 18, wherein the material of the soft anchor sheath is substantially composed of polyester and UHMWPE.
24. The method of claim 18, wherein the soft tissue is the rotator cuff.
25. A method for tissue repair, the method comprising attaching a first tissue to a second tissue using at least one soft anchor sheath having a different density along its length.
26. The method of claim 25, wherein the first tissue is cortical bone and the second tissue is cancellous bone.
27. The method of claim 25, wherein the soft anchor sheath has at least two separate segments having different densities.
28. The method of claim 27, wherein one of the at least two individual segments has a length of about 2 mm, and the other of the at least two individual segments has a length of about 3 mm.
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