Soft anchor system
By using a knotless locking soft anchor system, the tension of the sutures is used to change the shape of the anchor and multiple weave passes, which solves the problems of loosening and knotting complexity of soft anchors, achieves high fixation strength and stability, and reduces the risk of arthritis.
Patent Information
- Application Number
- CN202480040704.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2023-12-01
- Filing Date
- 2024-07-25
- Publication Date
- 2026-01-13
AI Technical Summary
Existing soft anchor systems are prone to loosening during deployment and use, leading to potential arthritis risks. Furthermore, the knotting process increases surgical complexity and the risk of damage to anatomical structures, and the knotless locking strength is insufficient.
The system employs a knotless locking soft anchor system, which changes the shape of the anchor body by the tension of the sutures, forming multiple weaving and locking channels to avoid knotting, providing multiple fixing points, and enhancing the fixing strength and anti-loosening ability by utilizing the interwoven structure of transfer sutures and repair sutures.
This technology improves the fixation strength and anti-loosening ability of the anchor system in a knotless locking state, reduces surgical complexity and the risk of damage to anatomical structures, and maintains long-term stability.
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Figure CN121335673A_ABST
Abstract
Description
[0001] Cross-references to related applications
[0002] This application claims priority to U.S. Provisional Application Serial No. 63 / 529,041, filed July 26, 2023, entitled “Suturestopper Knot Construct,” and U.S. Provisional Application Serial No. 63 / 604,942, filed December 1, 2023, entitled “Soft Anchor Knotless System.” These provisional applications are incorporated herein by reference in their entirety, as if reproduced hereinafter in their entirety. Technical Field
[0003] This disclosure relates to systems and methods associated with repair systems that may include knotless soft anchor systems. Background Technology
[0004] Many orthopedic surgeries involve the use of anchoring devices in procedures used to attach tissues, such as soft tissues, to bone. Such surgeries include, for example, tendon-to-bone, bone-to-bone, tendon-to-tendon, ligament or graft-to-bone, and reinforcement of primary repairs and ligament reconstructions. Typically, these surgeries rely on the use of rigid anchors made of polymers, metals, or biodegradable materials with attached sutures. The sutures pass through the tissue, and knots secure the anchor to the tissue. However, using these anchors often requires placing a rigid, hard material within tissue such as bone. If the anchor loosens, the surgeon or surgical technician faces the problem of the potential hard device migrating into the patient's joint, putting the patient at risk of arthritis. Therefore, anchors made solely of soft materials may pose a lower risk of damage to the anatomy of the joint or body cavity (if the anchor detaches post-operatively).
[0005] Currently available soft material anchors can be formed from sutures or soft, flexible materials, which may include a braided body. These soft anchors can be anchored to tissue by deformation or, in some cases, by simply relaxing to a radially or laterally expanded state (which can be locked in this anchored state by knotting). However, knotting can increase surgical complexity, may require a higher level of expertise, can be time-consuming, and / or be anatomically more destructive to surrounding structures. Adding knots can also tend to form so-called knot stacks, which can increase the size and palpability of the repair site. Therefore, there is a need for a soft anchor system that includes a knotless locking construction, avoids the knotting step, and addresses the problems listed herein.
[0006] During deployment of these soft material anchors, they can deform to embed into the target tissue. Higher loads used to deploy the anchors (typically via higher loads on the deployment suture(s)) can provide stronger anchor fixation. However, these higher deployment loads can also adjust the position and length of portions of the anchor construct, which can inadvertently affect the final knotless fixation strength of the anchor system.
[0007] For example, consider the exemplary no structure construct shown in Figures 1A-1B Figure 1A An exemplary no structure construct 100 as obtained is depicted. In this configuration, the soft anchor 102 is a tubular body in an elongated configuration. During subsequent operation of the construct 100, the transfer suture 120 can be routed through the cannulated portion 137 of the repair suture 130 to define and form a suture locking passage portion 147 of the construct 100. The locking passage portion 147 can extend along the anchor 102 and can be repeatedly interwoven between the braided strands of the anchor wall. The locking passage portion 147 is shown extending from an entry 137a to an exit 137b of the repair suture cannulated portion 137. In use, the repair suture end portion 136 can be coupled to a target repair tissue and then to the transfer suture end portion 122a. The transfer suture 120 can then shuttle the repair suture end portion 136 back through the anchor 102 and through the locking passage 147 to form a knotless locking loop construct. Details regarding this construct and its operation, as well as other exemplary prior art constructs, are disclosed in commonly owned International Patent Application No. PCT / US2022 / 048644, filed November 2, 2022, and entitled “KNOTLESS SOFT ANCHOR SYSTEM,” which is incorporated by reference herein in its entirety.
[0008] The repair suture 130 can be fixedly coupled at the distal end of the anchor 102 via an axially overlapping double half hitch 132. The knot 132 is large enough to prevent the repair suture 130 from being pulled between the braided wall of the anchor 102 and thus from disengaging from the anchor 102. The knot 132 can be disposed distal to the anchor distal end 112.
[0009] Turning now to Figure 1B To facilitate understanding, a close-up view of the knot 132 is shown with the anchor removed from the figure. The inventors have found that tension on the repair end 136 can increase the length "L" defined as between the top end position of the knot 132 and the passage entrance 137a. Tension can be applied to the end 136 at three different times, all of which can increase this length "L": first, during anchor deployment; second, when the knotlessly locking the repair loop (constriction sleeve); and third, during cyclic use after the patient's surgery. The increase in length "L" can be due to knot slippage and / or knot tightening during deployment, thereby moving the knot position relative to the entrance 137a. Additionally, the suture length "L" can elongate due to these loads. Subsequent cyclic loads can occur postoperatively as the repair construct is subjected to loads during use throughout the healing period, further tightening the knot and / or elongating the suture length "L". This increase in length "L" can decrease the knotless locking strength of the locking passage portion 147, as this sleeve mechanism relies on tension to hold the outer tubular wall of the repair suture 130 in an elongated and reduced diameter configuration along the locking passage 147. Additionally, this increase in length "L" can allow the proximal end of the locking passage (137b) to move proximally and out of the anchor 102, causing concern for some clinicians and / or potentially causing irritation to the local tissue. Various methods and suture constructs are disclosed herein to limit the increase in length "L".
[0010] In some repairs, a low profile soft anchor system is desired that can be coupled to multiple locations, in some cases without the need for a knot. The multiple locations can be coupled independently along one or more tissues. Unlike rigid anchor systems, which tend to maintain their outer profile with the addition of suture, the addition of suture and / or no structure to a soft anchor generally increases the volume and size of the soft anchor construct. Various methods and soft anchor constructs are disclosed herein to add multiple repair locations while limiting the addition of suture and volume / size.
[0011] Definitions
[0012] A tissue repair system using a soft anchor is described herein. The tissue repair system of the present disclosure provides high fixation strength, fixing the soft anchor within bone. The tissue repair system is preferably locked in a repair configuration without a knot, thereby avoiding the need for a surgeon to tie a knot. The tissue repair system can include at least one suture. The term "suture" can include a traditional suture, which can be hollow or can include a braid along its core, unless otherwise specified. The term "suture" can include equivalent flexible members such as, but not limited to, a suture tape or flat suture, and in some cases can be a cable, ribbon, or wire where appropriate.
[0013] “Soft anchor” is intended to mean a flexible and / or deformable anchor that changes into a more laterally and / or radially expanded configuration when set or deployed, where the anchor body is formed of a soft, flexible suture-like material. A tensioning member operatively coupled by a portion of the soft anchor can be tensioned to laterally expand the soft anchor. The term “soft anchor” does not exclude that it comprises a rigid supplemental portion. In some embodiments, the soft anchor is formed entirely of braided strands. Some soft anchors deform into a deployed configuration that also comprises a longitudinal contraction.
[0014] “Deploy” is intended to mean changing the shape of the body of the soft anchor so that it is set, fixed or anchored with / in the tissue. Deploying can increase the outer lateral dimension of the anchor body to fix the anchor body with the tissue. This can for example fix the soft anchor within a bone hole. To deploy the anchor, the anchor is changed into a deployed configuration.
[0015] “Locking” or “locked configuration” in relation to a suture configuration is intended to mean locking the suture so that it can no longer slide in at least one direction. Sliding in this at least one direction can for example loosen a repair tissue that is fixed in place. The suture can form a loop comprising tissue coupled therewith and prevent the loop perimeter from sliding and the perimeter dimension from increasing. In relation to the anchor body, the locked configuration is intended to mean locking the anchor body in the deployed configuration to inhibit the anchor body from relaxing / moving out of the deployed configuration.
[0016] “Locking without a knot” or words derived therefrom, such as knotless locking or locking without a knot, is for example intended to mean a locking that can be formed without a knot in a surgical construct or anchor system. A system provided with a pre-formed knot can be defined as locking without a knot. A system configured to route a suture during operation of a surgical construct to form a knot can also be defined as locking without a knot. Locking without a knot can also be achieved by passing at least one suture along a tortuous route through a small opening or through a suture locking passage construct, which can also be referred to as for example a Chinese finger cot, a finger constrictor or a locking joint. For a system locking without a knot, some sutures can extend through a suture locking passage of the same suture or another suture to form a self-locking adjustable suture configuration as described herein. The suture locking passage can be selectively elongated by applying tension to the locking passage to constrict around a suture disposed therein, thereby locking a portion of the adjustable suture configuration.
[0017] “Transfer suture” is a flexible member that transfers another flexible member, such as a suture, through an anchor construct. The transfer member can be a suture, a suture tape or a wire.
[0018] A "deployment suture" is intended to mean an elongate flexible member, which can be a suture (or equivalent as defined herein) or sutures, that deploys the soft anchor body, typically when tension is applied to the deployment member. In some embodiments, the deployment member can also provide other functions.
[0019] A "repair suture" is a suture (or equivalent as defined herein) that passes through the repair tissue and is used to attach the repair tissue to bone. SUMMARY
[0020] Various improved methods and devices for tissue repair with knotless locked configurations including soft anchors are described herein. These and other features and advantages will be apparent from a reading of the following detailed description and a review of the associated drawings. It is to be understood that both the foregoing general description and the following detailed description are explanatory only and are not restrictive of the aspects claimed.
[0021] A first exemplary knotless tissue repair configuration is disclosed that includes a soft anchor body formed of a soft suture-like material and having a proximal end, a distal end, and a longitudinal axis along the anchor body. The configuration further includes a repair suture having a first end, a second end, and at least a length segment of the repair suture can be cannulated. The first end is fixedly coupled to the anchor body, the length segment is interwoven along and through a first side wall of the anchor body, and the repair second end extends proximally from the anchor body proximal end. The configuration further includes a transfer suture threaded through and along a second side wall of the anchor body into a length segment defining an entry location, along and within the length segment, the length segment being interwoven along and through the repair suture first side wall. The transfer suture further extends through or perforates the repair suture at a location proximal to the length segment entry, thereby defining a repair suture perforation.
[0022] In some example embodiments, tension on at least one of the transfer suture or the repair suture can change the anchor body to a deployed configuration. In the deployed configuration, the transfer suture can be operatively coupled to the repair suture second end, and tension on the transfer suture can pull the repair suture second end back through the deployed anchor body. The tension on the transfer suture can pull the repair suture second end proximate the length segment entrance through the repair suture perforation, and then into and along the length segment, and thereby form a locked passageway. The tension on the transfer suture can pull the repair suture second end and form a knotlessly locked repair loop. The repair suture can be fixedly coupled to the anchor body with two axially overlapping knots formed by the repair suture first end, and the two axially overlapping knots can be external to the anchor body and proximate the repair suture perforation. The transfer suture can perforate through the repair suture between the two axially overlapping knots and the entrance location. The anchor body can be tubular and include a lumen, and the transfer suture can be threaded through and along a second side wall of the anchor body, such that the weaves through the second side wall form multiple weaves between the external anchor body surfaces while remaining spaced apart from the lumen. Weaving while avoiding the lumen can provide a high-friction repair loop configuration that can improve resistance to loosening during cyclic loading. The repair suture can also interweave through the anchor body side wall, defining multiple weaves, and at least one of the multiple weaves can extend from an external side surface of the anchor into the first side wall and exit to the external side surface without entering the lumen. The transfer suture can extend around a distal-most external surface of the anchor body prior to perforating through the repair suture, such that the anchor body distal-most surface provides a bearing surface for the transfer suture, which can reduce stress on the perforation and length segment entrance. This can mitigate damage to the perforation and the length segment entrance via tension on the transfer suture during anchor deployment. The repair suture can interweave through the anchor body first side wall in a first multiple of weaves, and the transfer suture can interweave through the anchor body second side wall in a second multiple of weaves, the second multiple of weaves being greater than the first multiple of weaves.
[0023] Another example knotless tissue repair construct is disclosed, the construct including an anchor body formed of a soft material and having a proximal end, a distal end, and a longitudinal axis. The construct further includes a repair suture having a first end, a second end, and a cannulated length segment. The first end is fixedly coupled to the anchor body, the length segment is interwoven along and through a first sidewall of the anchor body, and the second end extends proximally from the anchor body proximal end. A transfer suture is threaded through and along a second sidewall of the anchor body, through and along the repair suture length segment, and further pierces the repair suture proximate a distal end of the length segment, defining a repair suture piercing. Tension on at least one of the transfer suture or the repair suture changes the anchor body to a deployed configuration. The transfer suture can have a looped end that is operably coupled to the repair suture second end and pulls the repair suture second end back through the anchor body when the anchor body is in the deployed configuration. The transfer suture can pull the repair suture second end such that the repair suture pierces itself proximate the length segment piercing. The transfer suture can pull the repair suture second end through the length segment to form a locking passageway and thereby form a knotlessly locked repair loop when it is in the deployed configuration.
[0024] In some embodiments, the repair suture can be fixedly coupled to the anchor body with two axially overlapping knots formed by the repair suture first end, the two axially overlapping knots being external to the anchor body and distal to the repair suture piercing. The anchor body can be tubular and include an inner lumen, and the transfer suture can be threaded through and along a second sidewall of the anchor body, such that the weaves through the second sidewall form multiple weaves between external anchor body surfaces while remaining spaced apart from the inner lumen. This weaving while avoiding the inner lumen can provide a high-friction repair loop construct that is resistant to loosening. The repair suture can be interwoven through the anchor body sidewall, defining multiple weaves, and at least one of the multiple weaves can extend from an external side surface of the anchor body into the first sidewall and exit to the external side surface without entering the inner lumen. The transfer suture can extend around a distal most external surface of the anchor body prior to piercing the repair suture. The repair suture can be interwoven through the anchor body first sidewall in a first plurality of weaves, and the transfer suture can be interwoven through the anchor body second sidewall in a second plurality of weaves, the number of the first plurality of weaves and the second plurality of weaves can be different.
[0025] Another example knotless tissue repair construct is disclosed, the construct including an anchor body formed of a soft material and having a proximal end, a distal end, and a longitudinal axis. The construct further includes a repair suture having a first end, a second end, and a length segment that is cannulated. The first end is fixedly coupled to the anchor body, the length segment is interwoven along and through a first sidewall of the anchor body, and the second end extends proximally from the anchor body proximal end. The construct further includes a transfer suture threaded along a path that includes through and along a second sidewall of the anchor body, around a distal most surface of the anchor body, through an entire thickness of the repair suture thereby defining a repair suture perforation, and then through and along the length segment of the repair suture.
[0026] In some example embodiments, tension on at least one of the transfer suture or the repair suture can change the anchor body to a deployed configuration. After deployment, the repair suture can be coupled to repair tissue and then to the transfer suture. Once coupled, tension on one end of the transfer suture can slide the transfer suture through the anchor body and also pull or shuttle the repair suture second end back through the anchor body such that the repair suture passes through itself adjacent the length segment perforation. Tension can also shuttle the repair suture second end into and along the length segment, thereby forming a locked passageway and a knotlessly locked repair loop. The repair suture can be fixedly coupled to the anchor body with two axially overlapping knots formed by the repair suture first end, the two axially overlapping knots being external to the anchor body and adjacent the repair suture perforation. The transfer suture can perforate the repair suture between the two axially overlapping knots and the length segment. The anchor body can be tubular and include an inner lumen. The repair suture can be interwoven through the anchor body sidewall defining a plurality of passes, and wherein at least one of the plurality of passes can extend from an external side surface of the anchor body into the first sidewall and exit to the external side surface without entering the inner lumen. The repair suture can be interwoven through the anchor body first sidewall in a first plurality of passes, and the transfer suture can be interwoven through the anchor body second sidewall in a second plurality of passes, the second plurality of passes being greater than the first plurality of passes.
[0027] Another exemplary knotless full suture anchor system is disclosed that provides multiple fixation points. The system can include a full suture anchor body or a soft anchor body having a single repair suture interwoven therethrough. The single repair suture can be formed as a single continuous length of braid of flexible material and have a first branch and a second branch both extending from a proximal end of the anchor body. The single repair suture has a lumen along it. The system includes a first transfer suture repeatedly interwoven through the anchor body including into the single repair suture lumen for a length coextensive with the anchor body so as to define a first locked passage length. The first transfer suture also includes two branches extending directly from the proximal end of the anchor body. The system also includes a second transfer suture repeatedly interwoven through the anchor body including into the single repair suture lumen for a length defining a second locked passage length, the second shuttle suture having two branches extending directly from the proximal end of the full suture anchor. At least one of the first transfer suture and the second transfer suture is operatively coupled to a deployment mechanism of an insertion instrument, and tension on at least one of the first transfer suture and the second transfer suture changes the anchor body to a deployed configuration within target tissue. When the anchor body is in the deployed configuration, a first one of the single repair suture branches can be pulled back through both the anchor body and the first knotless locked length by the first transfer suture once coupled to a first repair tissue. A second one of the single repair suture branches is configured to be coupled to a second repair tissue when the anchor body is in the deployed configuration before being pulled back through both the anchor body and the second knotless locked length by the second transfer suture.
[0028] In some embodiments, the first knotless locked length and the second knotless locked length are the same segment of the repair suture. Both the first branch of the single repair suture and the second branch of the single repair suture can be pulled through the anchor body continuously. The first knotlessly locked length can be positioned toward the proximal end of the anchor body, and the second knotlessly locked length can be disposed along the repair suture distal to the first knotlessly locked length.
[0029] Also disclosed herein are example methods of tissue repair using the knotless tissue repair constructs. The methods can include obtaining any of the knotless tissue repair constructs disclosed herein, and inserting it into a target tissue. The anchor body can then be deployed by applying tension to the transfer suture so as to dispose the anchor body with the target tissue. The repair suture first branch can be coupled to the repair tissue after the anchor body has been deployed. The repair suture first branch can be coupled to a first transfer suture. The first transfer suture can then be pulled through the anchor body when in a deployed configuration, and the repair suture first branch is thereby pulled through the anchor body and through a first knotlessly locked length to form a first locked passageway. The repair suture first branch can then be tensioned to knotlessly lock the construct.
[0030] In some example methods, the suture second branch can be coupled to another repair tissue after the anchor body has been deployed, and the repair suture second branch can then be coupled to a second transfer suture. The second transfer suture can then be pulled through the anchor body when in a deployed configuration to pull the repair suture second branch through the anchor body and through a second knotlessly locked length to define a locked passageway. The repair suture second branch can then be tensioned to knotlessly lock the construct. Tensioning of both the repair suture first branch and the repair suture second branch can be accomplished simultaneously after both repair suture branches have been pulled and both locked passageways have been formed. The repair tissue and the another repair tissue can be different locations along the same tissue. The repair tissue and the another repair tissue can be different tissues. BRIEF DESCRIPTION OF DRAWINGS
[0031] The present disclosure will be more fully understood from the following detailed description, taken in connection with the accompanying drawings, in which:
[0032] Figure 1A A knotlessly locked soft anchor construct of an example prior art is schematically illustrated; disclosed;
[0033] Figure 1B A knotlessly locked soft anchor construct of an example prior art is schematically illustrated; Figure 1A A close-up view of a fixed end of the knotlessly locked soft anchor construct of an example prior art shown in FIG. 1 1 is schematically illustrated;
[0034] Figure 2A A knotlessly locked soft anchor construct of an example prior art is schematically illustrated; disclosed;
[0035] Figure 2B A close-up view of a fixed end of the knotlessly locked soft anchor construct of an example prior art shown in FIG. 1 1 is schematically illustrated;
[0036] Figure 2C Another close-up view schematically illustrating another example fixed end of the first example knotless, locked soft anchor construct according to the present disclosure;
[0037] Figure 2D Another close-up view schematically illustrating another example fixed end of the first example knotless, locked soft anchor construct according to the present disclosure;
[0038] Figures 3A-3C Another close-up view schematically illustrating another example fixed end of the first example knotless, locked soft anchor construct according to the present disclosure;
[0039] Figures 4A-4B Another close-up view schematically illustrating another example fixed end of the first example knotless, locked soft anchor construct according to the present disclosure;
[0040] Figure 4C Another close-up view schematically illustrating another example fixed end of the first example knotless, locked soft anchor construct according to the present disclosure;
[0041] Figure 5 Another close-up view schematically illustrating another example fixed end of the first example knotless, locked soft anchor construct according to the present disclosure;
[0042] Figure 6 Another close-up view schematically illustrating another example fixed end of the first example knotless, locked soft anchor construct according to the present disclosure;
[0043] Figure 7 Another close-up view schematically illustrating another example fixed end of the first example knotless, locked soft anchor construct according to the present disclosure;
[0044] Figure 8 Another close-up view schematically illustrating another example fixed end of the first example knotless, locked soft anchor construct according to the present disclosure;
[0045] Figure 9 Another close-up view schematically illustrating another example fixed end of the first example knotless, locked soft anchor construct according to the present disclosure;
[0046] Figure 10 Another close-up view schematically illustrating another example fixed end of the first example knotless, locked soft anchor construct according to the present disclosure; Figure 9 Another close-up view schematically illustrating another example fixed end of the first example knotless, locked soft anchor construct according to the present disclosure;
[0047] Figure 11 Another close-up view schematically illustrating another example fixed end of the first example knotless, locked soft anchor construct according to the present disclosure;
[0048] Figure 12A An exemplary tri-loop suture construct according to the present disclosure is schematically illustrated; and
[0049] Figure 12B An exemplary anchor having a tri-loop suture construct assembled thereto according to the present disclosure is schematically illustrated. DETAILED DESCRIPTION
[0050] In the following description, like components have been given the same reference numerals, regardless of whether they are illustrated in different examples. The drawings can not necessarily be to scale, and certain features can be shown in slightly schematic form in order to illustrate (multiple) examples clearly and concisely. Features described and / or illustrated in relation to one example can be used in the same way or in a similar way in one or more other examples and / or in combination with or in place of features of other examples.
[0051] As used in the specification and claims, the terms "about" and "substantially" for the purpose of describing and defining the present invention are used to represent an amount that can, within a desired degree of accuracy, be equated to a stated base value. The terms "about" and "substantially" are also used herein to mean amounts that can vary from the stated base value without resulting in a change in the basic function of the subject matter discussed. "Comprise," "include," and / or variations thereof are open-ended and include a stated component, and also include additional components not stated. "And / or" is open-ended and includes one or more stated components and combinations thereof. The use of the terms "upper," "lower," "upward," "downward," and the like are used for clarity in describing the present disclosure and are not intended to limit the structure, positioning, and / or operation of the present disclosure in any manner.
[0052] Figure 2AA first exemplary knotless soft anchor configuration 200 is shown in FIG. 1, which can provide strong fixation and maintain such strong fixation over time and use. Unless otherwise noted, configuration 200 is similar to configuration 100, and like parts are given like number designators. Soft anchor 102 can be similar to the anchors disclosed at least in U.S. Patent 9,962,149, entitled “Tissue Repair Assembly,” which is commonly owned and incorporated herein in its entirety by this reference. Soft anchor 102 can be obtained in operative coupling with an insertion system that actively deploys anchor 102, which when deployed, creates a deployed anchor within or with tissue that has a strong strength of fixation. Active deployment as disclosed in U.S. Patent 9,962,149, entitled “Tissue Repair Assembly,” provides a backstop to hold anchor 102 in place while it is being deployed via high tension loads on the deployment suture to create a high fixation within the target tissue when the anchor is deployed. Soft anchor 102 can define a tubular braided body 104, which can include a closed or partially closed distal end 112. Tubular body 104 can be formed from braided strands 110. Distal end 112 can be at least partially sealed using adhesive or heat sealing.
[0053] Similar to Figure 1AIn the embodiment shown in FIG. 1, the construct 200 can include a transfer suture 120 that is repeatedly interwoven through the wall of the anchor body 104. The transfer suture 120 can extend along a first side of the longitudinal axis 106 of the body 104, around and outside of the distal end 112, and back along the wall on the opposite side of the axis 106. Extending both around and outside of the distal end 112 of the transfer suture 120 can shield the perforation (133, disclosed later herein) and the locking passage entrance 137a from damage caused by high deployment loads applied to the construct 200 via the transfer suture 120. As explained herein, the transfer suture 120 can deploy the anchor via tension on the transfer suture ends (122a, 112b), the higher the tension, the stronger the anchor fixation, and the less likely this fixation will decrease over time and use. However, these high tension loads can tear the cannula portion entrance 137a. The shielding can help maintain the integrity of the repair suture fixation device. In other words, when the transfer suture 120 extends around and outside of the distal end 112, the distal end edge of the body 104 provides a bearing surface for the transfer suture 120. Without this bearing surface, the high tension loads along the transfer suture 120 during anchor deployment can tear the cannula portion entrance 137a and the perforation 133, and result in a damaged construct and reduced locking passage length. Accordingly, the inventors have found that this additional bearing surface helps mitigate damage to the construct 200 while still permitting high tension loads; high tension loads that provide strong anchor fixation within the target tissue.
[0054] Two branches 122a, 122b of the transfer suture 120 can extend from the proximal end 116 of the anchor 102. The first branch 122a can terminate in a snare loop. The transfer suture 120 is slidably coupled to the anchor body 104. Notably, in this embodiment, the transfer suture 120 can extend only partially through the wall of the tubular body 104, so as to interweave through the wall, turning at least once in the weave or weave through the tubular wall without reaching the inner wall of the lumen 105. In this figure, two weaves through are shown that do not reach the lumen 105. It has been found that keeping the transfer suture 120 within the wall of the anchor body 104 and preferably absent from the lumen 105 increases the friction in the final, locked, and deployed configuration of the construct. While too much friction can result in a higher than desirable load to shuttle the repair suture to form the repair loop (described below), some friction is beneficial as it provides supplemental anti-malting capability of the locking passage 147 during post-operative cyclic loading. After surgery, the repair can be subjected to cyclic loading as the person moves, which can cause a knotless locked configuration to loosen. The additional friction created by weaving the transfer suture 120 (and thereby the repair suture after shuttling) primarily within the body sidewall can help resist loosening.
[0055] The repair suture 130, formed separately from the transfer suture 120, can be fixedly coupled to the anchor body 104 via a knot 132. As discussed herein, the knot 132 can prevent removal of the repair suture 130 from the anchor body 104. The repair suture 130 can extend along the lumen 105 of the tubular body 104 at the proximal and distal ends of the body 104, but can interweave between the proximal and distal ends (116, 112, respectively), again preferably not extending along the lumen 105 at least once in the weave or weave through the tubular wall of the anchor body.
[0056] As Figure 2AAs shown in the embodiment, the transfer suture 120 can make three passes (1, 2, 3) through the anchor body 104 as it weaves along the transfer suture side of the anchor body 104, while the locking passage side (left hand side on the figure) of the anchor body can make less than three passes. The repair suture 130 can make only 2 passes through the tubular wall on the locking passage side of the anchor body. The more passes, the higher the friction along the final repair loop configuration. However, too much friction can cause higher loads to shuttle the repair suture 130 through the anchor body 104 and the cannula portion 137. Therefore, the locking passage 147 can make fewer passes through the anchor side wall to reduce this resistance compared to the transfer suture side. In this example, the locking passage 147 makes two passes through the anchor body 104 to balance the shuttle load through the locking passage 147 with the preferred higher friction of the final repair loop. The number of passes depends on the suture size and the anchor configuration. Therefore, the number of locking passage passes is configured to provide sufficient friction to the knotless locking configuration while providing an acceptable functional shuttle load to the user.
[0057] In this embodiment, the view is looking proximally Figure 2B The transfer suture 120 extends around the outer surface of the distal end 112 and then can be perforated 133. This perforation 133 can extend through the repair suture thickness from the first outer side all the way to the second opposite outer side at a location immediately proximal to the knot 132. In some embodiments, the transfer suture 120 can be perforated through the knot 132 (not shown). Similar to the embodiment configuration 100, the transfer suture 120 can then partially pass through the repair suture to enter the cannula portion 137 defining the entry 137a. Therefore, this embodiment includes an additional pass or perforation 133 of the transfer suture 120 through the repair suture 130 that can be between the knot 132 and the locking passage entry 137a.
[0058] This routing can improve knotless locking by increasing the friction in this configuration at the distal end of the locking passage 147. This increase in friction can help mitigate loosening of the locking passage 147 that can allow slippage within the locking passage 147, especially when the knotless locking loop is used to capture a large amount of soft tissue. Additionally, the perforation 133 can shield the knot 132 from the higher fixation loads on the repair configuration. The perforation 133 can reinforce the fixation means of the repair suture fixation end and prevent or inhibit the knot 132 from tightening further. In some alternative embodiments, the perforation can be a partial perforation and can not extend all the way through the thickness of the repair suture 130, an example of which is shown in Figure 2D Figure 2D In the example shown, the transfer suture 120 can form a tortuous path along the sidewall of the repair suture 130 and between the strands of the repair suture, and can remain within the repair suture 130, directly entering the cannulation section 137 without first leaving the repair suture 130.
[0059] In addition to or instead of the perforation 133, the end 134 of the repair suture can be ultrasonically welded to the anchor body 104. In addition to or instead of the perforation 133, the knot 132 can be pre-tensioned to a high load using tools to tighten the knot 132 and reduce the possibility of slippage. The knot 132 can be further secured by applying heat to fuse the suture fibers together and resist slippage. For example, a hot knife can be used to form a tail stop structure, where the end immediately outside the knot 132 can be melted into an amorphous spherical shape, thereby making the knot resist slippage. This effectively creates a stop structure for the stop knot 132.
[0060] Figure 2C Construction 200 is shown in a deployed, repaired, and knot-free locked configuration (hereinafter referred to as the final configuration). Deployment can not only laterally increase the anchor body 104, but also longitudinally decrease the anchor length (from the distal end to the proximal end), and can also increase the wall thickness of the tubular body 104, such that the space defined by the lumen 105 is filled or substantially reduced by the braided wall. In some embodiments, the space defined by the lumen is completely filled by the braided wall. To achieve this final configuration, the anchor 102 can be deployed first via tension on at least one of the transfer suture 120 or the repair suture 130. The repair suture 130 can then be operatively coupled to the tissue 150, subsequently at the branch end 122a (see Figure 2A The suture is threaded through the loop at the point of attachment. Then, pulling on the end 122b of the transfer suture 120 allows it to slide through the deployed anchor body 104', simultaneously removing the transfer suture 120 from the deployed anchor body 104' and replacing it with the repair suture 130. Therefore, the transfer suture 120 can be defined as both a deployment suture and a transfer suture. Retracting the suture end 122b allows the repair suture 130 to be transferred into the deployed anchor body 104' and along the deployed anchor body, such that the repair suture 130 moves along the same path defined by the transfer suture 120 (upon initial acquisition). Figure 2CAs schematically shown, the resulting final configuration is a repair suture 130, which is fixedly connected at its distal end 112 to the repair tissue 150 and weaves around and through the deployed anchor body 104'. Tension on the repair suture 130 (arrow B), whether from the suture end 136 or from the resulting loop portion 139, serves to reduce the diameter of the cannula portion 137 and to tighten the repair suture 130 around itself in a manner similar to a Chinese finger cot. This further locks the construction 200.
[0061] Figure 2C For ease of understanding, a simplified, more circuit-like diagram of system 200 is shown. The repair suture 130 provides sufficient friction through its tortuous path, both passing through the deployed anchor body 104' and along the cannula section 137, to lock the repair suture 130 in place and prevent slippage or loosening. The deployed anchor body 104' is also knot-free locked in the deployment configuration. Before entering the cannula section inlet 137a, the repair suture 130 in its final configuration can now be perforated through itself at a perforation 133 that may be adjacent to the knot 132. This perforation 133 can reinforce / protect the knot 132 as explained herein and improve tension on the locking passage 147. The repair suture 130 can pass through the first side of the anchor body 104', making three passes, interlacing through the anchor body wall, but turning at least once during its passes through the anchor sidewall without reaching the lumen 105. This can increase friction along the knot-free loop construction as described herein. The repair suture 130 may be wound around the distal end of the anchor 120 to protect the cannula inlet 137a from deterioration due to high deployment and fixation loads. The repair suture 130 may pass through the other side of the anchor body 104', making two interlacing passes, while also interlacing through the anchor wall within the cannula portion 137, but turning at least once during its passage through the tubular wall without reaching the lumen 105. As described herein, this can increase friction along the knotless loop construction and particularly along the locking passage 147.
[0062] Deploying the anchor body 104 may cause the locking passage 147 to move from being completely within the anchor body 104 to protruding proximally from the anchor body, such that the outlet 137b is proximally spaced from the anchor body 104. Some of the suture ends (sutures 120 and / or 130) may taper in diameter at their ends, which may advantageously reduce the load required to pull the repair suture 130 into the body 104 and the cannula portion 137 and along the body and cannula portion.
[0063] Figures 3A-3CA schematic representation of another embodiment of the knotless locking construction is shown, which provides a more secure attachment of the repair suture 130 to the anchor body 104. For ease of understanding, all three figures are simplified and, unless otherwise stated, can be similar to construction 100, with identical components given the same numerical designations. All three figures illustrate the construction obtained prior to the repair suture 130 traversing the anchor body 104. Figure 3A An alternative wiring for the repair suture 130 is shown, wherein the repair suture 130 loops around the distal end of the anchor body 104 and then folds back into the cannula portion 137. This embodiment utilizes the locking properties of the cannula portion (locking passage 147) to secure the repair suture 130 to the anchor body 104. The repair suture 130 may include a knot 332 at the proximal end of the locking passage 147. The repair suture 130 may loop around the distal end 112 and interweave between the braids of the anchor braided wall at the distal end.
[0064] Figure 3B A repair suture 130 is shown interlacing through one side of the anchor body 104 and then back through a different second locking passage 348. This second locking passage 348 is configured to secure the repair suture 130 to the anchor body 104. The second locking passage 348 may not have a transfer suture 120. As shown, the second locking passage 348 may form a loop 349 extending from the distal end of the locking passage 348. In other embodiments, the loop 349 may loop around the opposite end and enter the locking passage 348 from the opposite end. The second locking passage 348 does not have a transfer suture 120. The repair suture 130 may form a loop 349 interlacing through the distal end 112 of the anchor braided wall. Tension on the end 134 can then secure the end of the repair suture to the distal end 112 of the anchor. An advantage of the second locking passage 348 is that the end of the joint does not move with tightening like a loop. The end is defined only by the suture's inlet (or outlet). Figure 3C In this design, the repair suture 130 may be perforated twice (310, 320) to create a tortuous path to prevent the repair suture 130 from retracting. These perforations are shown as loose loops to illustrate the suture path, but may be two consecutive perforations similar to perforation 133. The repair suture 130 may pass between the braided strands of the distal end 112 of the anchor before the two perforations 310, 320.
[0065] Figures 4A-4BOther connector knot embodiments 400, which can be alternatives to knot 132, are shown. Connector knot 400 includes a cannula length 437, similar to locking passage 147, having an inlet 437a and an outlet 437b. Connector knot 400 can provide a knot with a fixed position along suture 130, which cannot slip like a conventional knot. The position is defined by the inlet or outlet (437a, 437b). Figure 4A A first exemplary joint wiring for repair suture 130 is shown, wherein the inlet 437a of repair suture 130 is distal to the outlet 437b. Figure 4B The opposite case is shown, where the repair suture 130 inlet 437a is the proximal outlet 437b. Figure 4A and 4B A structural model with an open or loose loop configuration is shown to illustrate the wiring. However, in practice, the tensioned ends 134 and / or repair sutures 130 are used to form a final knot 400, as... Figure 4C As shown in the image. Figure 4C The final one shown is Figure 4B The diagram shows a tightened version of the wiring. Unlike the finger cot, which is tensioned to reduce the diameter of the locking passage portion and tightened around the suture bundle disposed within the passage, in this connector knot 400, the passage portion is shortened or folded via the inlet or outlet of the cannula length 437, thereby forming a large-volume knot with the defined end. The cannula length becomes shorter.
[0066] Knotless anchor construct for repairing multiple locations.
[0067] Figure 5 A low-profile knotless anchor configuration 500 is shown because it provides two repair suture ends 530a, 530b from a single repair suture 530. Each end 530a, 530b provides a fixation or repair location that can separately form a repair loop at different fixation locations that may be spaced apart from each other. The two fixation locations can be the same tissue at different locations or two separate tissues. This system can be independently coupled to multiple fixation locations and can also be independently knotless locked. Although the inventors envisioned replicating the two sutures 120, 130 disclosed in the previous embodiments disclosed herein, they found that adding two additional sutures (additional transfer and repair sutures) along the soft anchor 102 significantly increases volume and complexity and is therefore less preferred. Configuration 500 provides a lower-volume (low-profile) solution for knotless anchor configurations at multiple repair locations.
[0068] Still Figure 5On the above, components identical to those in configuration 100 are given the same identifiers. Configuration 500 may include an anchor body 104, a single repair suture 530 (which may be similar to repair suture 130), a first transfer suture 220, and a second transfer suture 225. Similar to repair suture 130, repair suture 530 may be cannulated to form locking pathways(s) at selective locations along it. Configuration 500 is shown in a configuration obtained or positioned before deploying anchor body 104 and shuttling repair suture ends 530a, 530b. The single repair suture 530 may be interlaced through both sides of anchor body 104 such that both ends 530a, 530b extend from the proximal end 116 of the anchor. In some embodiments, each end 530a, 530b may be pre-assembled to needles 505a, 505b, respectively. The first transfer suture 220 may interlace through the anchor body 104 and also enter and along a portion of the cannulation portion 537 of the repair suture 530, thereby defining a first knotless locking length 547a of the system. The second transfer suture 225 may interlace through the anchor body 104 and also along the cannulation portion 537 or lumen of the same repair suture 530, thereby defining a second knotless locking length 547b. The first knotless locking length 547a and the second knotless locking length 547b may be on opposite sides of the anchor body 104. Therefore, the configuration 500 includes two repair suture ends 530a, 530b, each end (530a, 530b) which can be individually attached to the repair tissue and separately pulled through the anchor body 104 to lock knotless with a single anchor body 104. Preferably, the body 104 is positioned within the target bone before the repair suture ends 530a, 530b are attached and shuttled to the target tissue(s). Repair suture 530 can be fixedly connected to anchor body 104 approximately at its midpoint. Repair suture 530 may include knot 532, which may include loops formed between braided strands of anchor body to hold the knot in a central position along anchor body axis 106. Two locking passages 547a, 547b may each interweave through anchor body 104 on opposite sides of anchor lumen 105. Repair suture 530 may partially interweave through the wall, avoiding lumen 105 in at least one pass. Repair suture ends 530a and 530a may be shuttled by transfer sutures 220 or 225.
[0069] Figure 6Another exemplary low-profile knotless anchor configuration 600, similar to at least configuration 500, is shown, and components identical to those in configurations 100 and 500 are given the same identifiers. Configuration 600 has a single locking passage 637 through which two repair suture ends 530a, 530b shuttle. Each repair suture end 530a, 530b can be sequentially attached to one or more tissues and then sequentially shuttles through a repair suture cannula 537 located at the same position along the repair suture 530. Thus, the locking passage 637 can be tightened around both segments of the repair suture 530. The repair suture ends 530a, 530b first shuttle from the proximal end to the distal end, through the anchor body 104, and then enter the cannula 537 as they turn and shuttle from the distal end 112 to the proximal end 116. Preferably, the locking passage 637 is located at the end of the formed knotless locking ring, such that when the ends of the repair sutures (530a, 530b) leave the anchor body 104, the locking passage is directly adjacent to the end of the locking ring.
[0070] Figure 7 Another exemplary low-profile knotless anchor configuration 700, similar to at least configurations 100, 500, or 600, is shown, and components identical to those configurations are given the same identifiers. Configuration 700 has two locking passages 747a, 747b. Each repair suture end 530a, 530b may be sequentially or simultaneously connected to one or more tissues, and then simultaneously or sequentially shuttled or pulled through the repair suture cannula 537. The two locking passages 747a, 747b may be arranged continuously along the repair suture 530 along the same side axis 106 of the anchor body 104.
[0071] Figure 8Another exemplary low-profile knotless anchor configuration 800 similar to the previously disclosed configurations is shown herein, and components identical to those in these configurations are given the same identifiers. Configuration 800 has a single knotless locking passage 847 and a single transfer suture 220. The single transfer suture 220 has two loop ends 221a, 221b, which can be offset from each other along the transfer suture 220. During repair, after the anchor 104 has been deployed, the first repair suture end 530a can be attached to tissue at a first location and then to the first loop end 221a of the transfer suture 220. The second repair suture end 530b can be attached to tissue or to a different tissue at a second separation location before being attached to the second loop end 221b, and then both repair suture ends 230a, 230b can be pulled into the structureless configuration. Having both repair sutures pulled using a single transfer suture can further reduce the volume of the configuration as obtained. Slightly offsetting the two loops (221a, 221b) from each other reduces the step increase in suture volume, as it is pulled between the strands of the deployed anchor 104' and the cannula 537. This facilitates staggered volume increases, which are introduced as a whole into the construction and more specifically into the repair suture lumen at the entrance of the locking passage 837. This reduces the force required to pull the two repair suture ends 530a, 530b into the deployed anchor body 104' and the repair suture cannula 537.
[0072] If the system is equipped with a needle, the transfer suture 220 (or sutures 220, 225) can be operatively coupled to the anchor deployment mechanism, while the repair suture 530 can be accommodated in a separate location detached from the deployment mechanism. Exemplary insertion devices that can separately accommodate repair sutures may be similar to the system disclosed in International Patent Application No. PCT / US21 / 34590, filed May 27, 2021, entitled “Tissue Repair System,” which is jointly owned and incorporated herein by reference in its entirety.
[0073] Therefore, one method of use may include inserting an unstructured structure (500, 600, 700) into a target tissue using an insertion instrument, and deploying an anchor body 104. Deployment may include applying tension, which may be applied via the insertion instrument to transfer sutures 220 (and / or 225, if present). Once the anchor body 104 is deployed within the target tissue, repair suture ends 530a, 530b (and pre-attached needles 505, if present) may be removed from the insertion instrument. A first repair suture end 530a may be attached to a first repair tissue. After the first repair suture end 530a has been attached to the first repair tissue, needles 505 may be removed, and the repair suture end 530a may be attached to a first loop end of the transfer suture 220. Then, pulling on a second end of the transfer suture 220 may slide the first repair suture end 530a through the deployed anchor body 104', while removing the transfer suture 220 therefrom. This allows the end of the first repair suture 530a to pass through the deployed anchor body 104' along a tortuous path, as disclosed herein, which can form a knotless locking configuration.
[0074] The second repair suture 530b can be attached to another location or another tissue of the first repair tissue. After the end of the second repair suture 530b has been attached, the corresponding needle 505 (if present) can be removed, and the end of the second repair suture 530b can be attached to the first loop end of another transfer suture 225. Then, pulling on the second end of the transfer suture 225 can slide the end of the second repair suture 530b through the deployed anchor body 104' while removing the other transfer suture 225 from the configuration. This allows the end of the second repair suture 530b to pass through the deployed anchor body 104' along a zigzag path, as disclosed herein, which can form a knotless locking configuration. In some exemplary methods, transfer sutures 220, 225 can be attached to their respective repair suture ends (530a, 530b) and simultaneously withdrawn.
[0075] In some exemplary embodiments, the repair suture 530 may not be configured to come pre-assembled with needles. In some exemplary embodiments, the repair suture 530 may include a tapered portion at each end. For example, for the last 2 to 10 inches, the repair suture 530 may taper from the larger suture size to a 2-0 segment at both free ends. The middle length portion of the repair suture 530 may have a cross-section similar to that of a No. 2 suture. This tapering segment may allow the repair suture 530 to more easily pass through itself at the entrance of the locking passage (e.g., 547, 747).
[0076] Another method of use may include inserting the unstructured structure 800 into the target tissue using an insertion instrument, and deploying the anchor body 104. Deployment may include applying tension, which may be applied to the transfer suture 220 via the insertion instrument. Once the anchor body 104 is deployed within the target tissue, the repair suture ends 530a, 530b (and pre-attached needles 505, if present) may be removed from the insertion instrument. The first repair suture end 530a may be attached to the first repair tissue. After the first repair suture end 530a has been attached to the first repair tissue, the needle 505 (if present) may be removed, and the repair suture end 530a may be attached to the first loop end 221a of the transfer suture 220. The second repair suture end 530b may be attached to another location or another tissue along the first repair tissue. After the second repair suture end 530b has been attached, the needle 505 (if present) can be removed, and the repair suture end 530b can be attached to the second annular end 221b of the transfer suture 220. Then, pulling on the second end 222 of the transfer suture 220 allows both the first repair suture end 530a and the second repair suture end 530b to slide through the deployed anchor body 104'. Pulling on the second end 222 of the transfer suture 220 allows the first repair suture end 530a and the second repair suture end 530b to be pulled continuously through the deployed anchor body 104' with a slight offset from each other, the offset being defined by the offset between the annular ends 221a, 221b. This allows the two repair suture ends 530a, 530b to pass through the same locking passage 847, and the configuration 800 is in a knotless locking configuration. Similar to other embodiments disclosed herein, further tension on the repair suture ends 530a, 530b can lock the construction 800 knot-free.
[0077] Figure 9Another exemplary unstructured embodiment 900, similar to at least configuration 500, is schematically illustrated. In this embodiment, a repair suture 530 may define an insertion portion 537, with portions of a first transfer suture 220 and a second transfer suture 225 extending along the insertion portion to define a first locking passage 947a and a second locking passage 947b. Similar to previously disclosed embodiments, after the repair suture ends 530a, 530b are attached to one or more tissues, they may be attached to the annular ends of the transfer sutures 220, 225, similar to the method disclosed herein. The ends 530a, 530b can then be pulled into the deployed anchor body 104' and the insertion portion 537 of the repair suture 530. If no pre-assembled needle is present, all transfer suture ends 220, 225 and repair ends 530a, 530b are operable to be attached to the deployment mechanism of the insert. The tension at all these suture ends allows the anchor body 104 to be deployed in a tighter, more bundled shape, which improves fixation of the anchor body 104 within the target tissue. In this embodiment, locking passages 947a, 947b may extend only along a portion of the anchor body 104, leaving the proximal portion of the anchor body 104 without any locking passages. Locking passages 947a, 947b may be short enough to limit any proximal protrusions of locking passages 947a, 947b from the proximal end of the anchor after anchor deployment (and anchor shortening). Since the anchor body 104 is typically positioned or tensioned immediately beneath the cortical bone layer to engage the underside of this cortical bone layer, any protrusions of locking passages 947a, 947b may be unsightly. Additionally, any protruding portion of the locking passage may extend into the bone foramen, raising concerns about potential local tissue irritation and perceptibility through the skin.
[0078] Still Figure 9As shown, and unlike configuration 500, each transfer suture is limited to one side of itself. In other words, the first transfer suture 220 is limited to the first side of the anchor body 104, and the second transfer suture 225 is limited to the second side of the anchor body 104. This reduces any overlap between the paths of the two repair ring configurations, which can help avoid any entanglement or knotting between the first and second repair ring configurations; entanglement or knotting can hinder shuttle and / or knotless locking. More specifically, the transfer suture 220 is assembled to configuration 900 such that when the transfer suture pulls the repair suture 530 through configuration 900 along the path that the transfer suture can first pull the repair suture end 530a along and through the anchor body 104 (limited to the first side of the anchor longitudinal axis 106) to the distal end 112 of the anchor. This path can extend adjacent to the repair suture locking passage 947a, on the same side of the anchor body axis 106. Then, the transfer suture pulls the repair suture end 530a into the locking passage 947a at a position adjacent to the distal end 112 of the anchor, and then pulls the repair suture end proximally along the repair suture cannula 537, such that the repair suture end 530a exits the locking passage 947a at a position spaced distally from the nearest end 116 of the anchor. The path continues such that the repair suture end 530a can interweave in the proximal direction and pass through the anchor body 104 before exiting the proximal end 116 of the anchor. The transfer suture 220 causes the repair suture end 530a to shuttle along one side of the anchor body 104. Similarly, the transfer suture 225 is assembled to the structure 900 such that when the transfer suture pulls the second end 530b of the repair suture through the structure 900, the transfer suture can mirror the path taken by the end 530a, which is limited to the opposite side of the longitudinal axis 106 of the anchor. The end 530b can first be pulled along the anchor body 104 to the distal end 112 of the anchor, then pulled into the second locking passage 947b at a position adjacent to the distal end 112 of the anchor, then pulled proximally along the repair suture cannula 537, and exits the second locking passage 937b at a position spaced distally from the nearest end 116 of the anchor. The second end 530b can then be pulled so that it interweaves in the proximal direction and along the anchor body 104 before exiting the proximal end 116 of the anchor. The transfer suture 225 causes the second repair suture end 530b to shuttle along one side of the anchor body 104, which side of the anchor body may be opposite to the path diameter defined by the transfer suture 220 (opposite side of the longitudinal axis 106).
[0079] Figure 10The final configuration 900 is shown. Anchor body 104 is deployed within target bone 50. As shown, the bone is slightly spaced from anchor body 104 to keep the diagram clear and show suture routing. However, in practice, the lateral edges of the anchor and the interlacing repair suture portions are embedded in the cancellous bone, deforming the softer cancellous bone while the harder cortical (apical) layer remains relatively unchanged. In the final configuration, the first repair end 530a is attached to the first repair tissue 52 and is also pulled through the deployed anchor body 104' and through itself. Figure 10A configuration 900 is also shown, in which a second repair end 530b is coupled to a second tissue 53 (which may be a different portion of the first tissue 52 or a separate tissue) and is also pulled through the deployed anchor body 104' and through itself along the second opposite side. This forms a first repair ring 960 and a second repair ring 970. The repair suture 530 is shown transitioning to a narrower diameter at a location between the repair tissue (52, 53) and the anchor body 104'. The repair suture 530 may taper and have smaller diameter ends to reduce the load required to shuttle the repair suture ends 530a, 530b through the anchor body 104 and the cannula portion 537. In other embodiments, the taper may transition closer to each end (530a, 530b). The first ring 960 can be formed by, for example, first attaching the first repair suture end 530a of the repair suture 530 to the target repair tissue 52, then attaching the repair suture end 530a to the loop end of the first transfer suture 220, and then using the transfer suture 220 to pull the first end 530a into the deployed anchor body 104'', and then into the end of the locking passage 947a. Once completed, the first repair ring 960 wires the end 530a around or through the repair tissue 52, wires back into the deployed anchor body 104'' on a first side of the deployed anchor body 104' and wires along the deployed anchor body, enters the locking passage 947a at the distal end 112 of the anchor, and extends along the passage 947a such that the end 530a extends from the locking passage 947a and the proximal end of the deployed anchor body 104'. Tension on end 530a can tighten locking passage 937a and lock the first repair ring 960 knotlessly. In some embodiments, once completed, the first repair ring 960 routes the first end 530a around tissue 52, routing back along the first side of the anchor to the deployed anchor body 104' and along the deployed anchor body, weaving along the sidewall on the first side of the anchor longitudinal axis 106 until the distal end 112 of the deployed anchor body 104', and then into the distal end of the locking passage 947a, exiting at the proximal end of the locking passage 937a before weaving along the remainder of the deployed anchor body 104' toward the proximal end 116 of the anchor. In some embodiments, configuration 900 may include perforations similar to perforations 133 at the distal ends of each locking passage (947a, 947b). The second repair ring 970 may be formed in a similar manner on the opposite side of the deployed anchor body 104'.
[0080] Figure 11Another knotless locking configuration is shown, having a single anchor body 104 and three repair suture ends 530a, 530b, and 1030. At least two of the repair suture ends may be ends of a single suture, such as suture ends 530a and 530b disclosed herein. A third repair suture 1030 may be securely coupled to the anchor body 104 and / or other (multiple) repair sutures. In other embodiments, three separate repair sutures are assembled to the anchor body 104. The repair sutures may be securely coupled to each other and / or securely coupled to the anchor body 104 to restrict movement of each locking pathway (1037a, 1037b, and 1037c) relative to the anchor body 104. The repair sutures (530, 1030) may be securely coupled to each other and / or securely coupled to the anchor body 104, for example, via securing means as disclosed herein, such as via knots, joint knots, welds, adhesives. The construction may include three corresponding transfer sutures 220, 225, and 1020, which may be pre-assembled to the insertion device deployment mechanism to deploy the anchor body 104. At least one of the transfer sutures 220, 225, and 1020 is preferably coupled to the deployment mechanism. Similar to the previous embodiments disclosed herein, the transfer sutures 220, 225, and 1020 may also each form a separate repair loop construction. Each transfer suture may be selectively coupled to a corresponding repair suture end such that the repair suture shuttles through the deployed anchor body 104' and through the repair suture locking passages (1037a, 1037b, 1037c). Additionally, similar to the previously disclosed embodiments, at least one of the transfer sutures (all three shown) may first pass through the corresponding repair suture thickness via a point perforation adjacent to the point of entry into the repair suture locking passages (1037a, 1037b, 1037c), similar to the perforation 133 disclosed at least in construction embodiment 200. In this embodiment, each transfer suture 220, 225 and 1020 passes directly through the corresponding inlet perforation of the repair suture cannula (133a, 133b, 133c) adjacent to the repair suture cannula.
[0081] The end 1030 of the third repair suture may extend only along the lumen 105 of the anchor. This maintains the separation of the third repair suture from other repair structures and avoids entanglement. This also helps to keep the structure volume small. Embodiment 1000 can form three separate knotless locking repair loops that can be connected to, for example, three different tissues or three parts of the same tissue.
[0082] Multi-loop transfer suture
[0083] Construction 800 discloses a transfer suture 220 having a plurality of loops 221a, 221b. The transfer suture loops are preferably formed in a smooth manner to avoid introducing protrusions or discontinuities that could increase the forces that would allow other sutures to shuttle through the construction. For example, forming loops with knots can create these protrusions. The plurality of loops 221a, 221b can be formed during the manufacturing process, and the strands can be forked to a certain length before being reassembled to form a single length. Examples of forked braids are disclosed at least in U.S. Application No. 20220233302, filed June 2020, entitled “Methods and Devices for Tissue Graft Fixation.” Figure 12a illustrates another apparatus for forming a suture with a plurality of loops, which may include an exemplary suture construction 1220 having a plurality of axially spaced splice loops 1221a, 1221b, and 1221c. In this figure, three splice loops are shown, but two splice loops, such as those used in embodiment 800, or more splice loops, can be formed for other configurations. Configuration 1220 can be a transfer suture configured to allow at least three suture ends (in this exemplary configuration) to shuttle through. In some embodiments, each joint may also include a perforation similar to perforation 133 to prevent each joint loop 1221a, 1221b, and 1221c from slipping and changing size.
[0084] Transfer sutures with multiple loops (such as configuration 1220) can pull (multiple) repair sutures through any anchor body. As disclosed herein, transfer sutures such as 1220 can pull (multiple) repair sutures through the cannulation portion of the suture to form a locking pathway. Figure 12BA transfer suture, such as 1220, is shown interlacing through the anchor body 104. The transfer suture, such as 1220, having multiple loops, can be woven along different paths and through different soft anchor configurations. In some embodiments, as shown, this configuration 1250 can be configured without repair sutures. The (multiple) repair sutures can then be selected by the clinician and may include larger sutures and / or suture bands. The clinician can then pull these selected sutures through the anchor body 104 to attach the repair sutures to the anchor body. The clinician can then pull these selected sutures through the anchor body 104 after the soft anchor has been deployed. In this example, the clinician can therefore attach three separate and selectable sutures to the anchor body 104 after deployment. Arranging the repair sutures axially spaced along the transfer suture configuration 1220 reduces the force required to shuttle the repair sutures through the deployed anchor body 104, because each suture can be sequentially introduced into the deployed anchor body 104', which can, for example, gradually expand the space between the braids of the anchors. Furthermore, in embodiments including knotless locking configurations (such as some of those disclosed herein), sequentially pulling the suture ends reduces the force required to shuttle the repair sutures into and through the suture cannula.
[0085] The inventors have discovered that shuttles of larger sutures into the anchor body 104 after deployment allows for a smaller initial volume of the insertion instrument and anchor, thus requiring a smaller borehole or tissue opening for insertion. As stated in the alternative, if three large sutures are pre-assembled into the anchor and along the insertion device, the initial diameter of the anchor and insertion tube can be larger to accommodate components that may require an increased number of larger tissue openings.
[0086] Those skilled in the art will recognize that this disclosure may be implemented in other specific forms without departing from its spirit or essential characteristics. Therefore, the foregoing examples are to be considered illustrative in all respects and not to limit the disclosure described herein. The scope of this disclosure is thus indicated by the appended claims rather than by the foregoing description, and therefore all variations in the meaning and scope of the equivalents of the claims are intended to be included therein.
Claims
1. A knotless tissue repair structure, comprising: An anchor body formed of a soft material, the anchor body having a proximal end, a distal end, and a longitudinal axis; A repair suture having a first end, a second end, and a cannula length, the first end being fixedly connected to the anchor body, the cannula length being interwoven along and through a first sidewall of the anchor body, and the second end extending proximally from a proximal end of the anchor body; as well as A transfer suture is inserted through and along the second sidewall of the anchor body, into the insertion length of the repair suture and along the insertion length, and also perforated through the repair suture before entering the insertion length to form a tortuous path.
2. The knotless tissue repair structure according to claim 1, wherein the tension on at least one of the transfer suture or the repair suture is configured to change the anchor body into a deployment configuration, and when in the deployment configuration, the transfer suture is configured to be operatively coupled to a second end of the repair suture and to pull the second end of the repair suture back through the anchor body, through the cannula length, and the repair suture also perforates itself along the tortuous path adjacent to the cannula length, thereby forming a knotless locked repair loop.
3. The knotless tissue repair structure according to claim 1, wherein the repair suture is fixedly connected to the anchor body by a knot formed from a first end of the repair suture, the knot being outside the anchor body, and the transfer suture passing through the repair suture adjacent to the knot perforation.
4. The knotless tissue repair structure according to claim 3, wherein the transfer suture passes through the repair suture via a perforation between the knot and the cannula length.
5. The knotless tissue repair structure of claim 1, wherein the anchor body defines an inner lumen, and wherein the transfer suture passes through and along a second sidewall of the anchor, thereby forming multiple braided passes between the outer anchor body surfaces while remaining spaced apart from the inner lumen to increase friction along the locking repair ring.
6. The knotless tissue repair structure of claim 1, wherein the anchor body defines an inner lumen, and wherein the repair sutures interweave through the sidewall of the anchor body to define multiple passes, and wherein at least one of the multiple passes extends from the outer side surface of the anchor body into the first sidewall and exits into the outer side surface without entering the inner lumen.
7. The knotless tissue repair structure of claim 1, wherein the transfer suture extends around the farthest outer surface of the anchor body before the perforation passes through the repair suture, such that the farthest surface provides a bearing surface to reduce stress at the inlet of the cannula length.
8. The knotless tissue repair structure according to claim 7, wherein the repair sutures interweave through the first sidewall of the anchor body in a first multiple pass, and wherein the transfer sutures interweave through the second sidewall of the anchor body in a second multiple pass, the second multiple pass being more than the first multiple pass.
9. A knotless tissue repair structure, comprising: An anchor body formed of a soft material, the anchor body having a proximal end, a distal end, and a longitudinal axis; A repair suture having a first end, a second end, and a cannula length, the first end being fixedly connected to the anchor body, the cannula length being interwoven along and through a first sidewall of the anchor body, and the second end extending proximally from a proximal end of the anchor body; as well as A transfer suture is inserted through and along the second sidewall of the anchor body, through and along the insertion length of the repair suture, and also through a perforation adjacent to the distal end of the insertion length of the repair suture, thereby defining a repair suture perforation. The tension on at least one of the transfer suture or the repair suture is configured to change the anchor body into a deployment configuration, and in the deployment configuration, the transfer suture is configured to be operatively coupled to a second end of the repair suture and to pull the second end of the repair suture back through the anchor body such that the repair suture passes through itself adjacent to the cannula length perforation, thereby forming a knotless locked repair loop.
10. The knotless tissue repair structure according to claim 9, wherein the repair suture is fixedly connected to the anchor body by two axially overlapping knots formed from a first end of the repair suture, the two axially overlapping knots being external to the anchor body and distal to the perforation of the repair suture.
11. The knotless tissue repair construction of claim 9, wherein the anchor body defines an inner lumen, and wherein the transfer suture passes through and along a second sidewall of the anchor, such that the braid passing through the second sidewall forms multiple braided runs between the surfaces of the outer anchor body while remaining spaced apart from the inner lumen, configured to provide a high-friction repair ring construction.
12. The knotless tissue repair structure of claim 9, wherein the anchor body defines an inner lumen, and wherein the repair sutures interweave through the sidewall of the anchor body to define multiple passes, and wherein at least one of the multiple passes extends from the outer side surface of the anchor into the first sidewall and exits into the outer side surface without entering the inner lumen.
13. The knotless tissue repair structure of claim 9, wherein the transfer suture extends around the farthest outer surface of the anchor body before the perforation passes through the repair suture.
14. The knotless tissue repair structure according to claim 13, wherein the repair sutures interweave through the first sidewall of the anchor body in a first multiple pass, and wherein the transfer sutures interweave through the second sidewall of the anchor body in a second multiple pass, the second multiple pass being more than the first multiple pass.
15. A knotless tissue repair structure, comprising: An anchor body formed of a soft material, the anchor body having a proximal end, a distal end, and a longitudinal axis; A repair suture having a first end, a second end, and a cannula length, the first end being fixedly connected to the anchor body, the cannula length being interwoven along and through a first sidewall of the anchor body, and the second end extending proximally from a proximal end of the anchor body; as well as A transfer suture passes through and along the second sidewall of the anchor body, around the farthest side surface of the anchor body, through the entire thickness of the repair suture to define a repair suture perforation, and then through and along the insertion length of the repair suture.
16. The knotless tissue repair structure of claim 15, wherein the tension on at least one of the transfer suture or the repair suture is configured to change the anchor body into a deployment configuration, and wherein the transfer suture is configured to be operatively coupled to a second end of the repair suture and to pull the second end of the repair suture back through the anchor body, wherein in the deployment configuration, the repair suture passes through itself adjacent to the cannula length perforation, thereby forming a knotless locked repair loop.
17. The knotless tissue repair structure of claim 15, wherein the repair suture is fixedly connected to the anchor body by two axially overlapping knots formed from a first end of the repair suture, the two axially overlapping knots being outside the anchor body and adjacent to the repair suture perforation.
18. The knotless tissue repair structure of claim 17, wherein the transfer suture passes through the repair suture between the two axially overlapping knots and the cannula length.
19. The knotless tissue repair structure of claim 15, wherein the anchor body defines an inner lumen, and wherein the repair sutures interweave through the sidewall of the anchor body to define multiple passes, and wherein at least one of the multiple passes extends from the outer side surface of the anchor into the first sidewall and exits into the outer side surface without entering the inner lumen.
20. The knotless tissue repair structure of claim 15, wherein the repair sutures interweave through the first sidewall of the anchor body in a first multiple pass, and wherein the transfer sutures interweave through the second sidewall of the anchor body in a second multiple pass, the second multiple pass being more than the first multiple pass.
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