Knotless soft anchor system
The knotless soft anchor system addresses anatomical risks and procedural complexity by deploying a flexible anchor with a knotless locking mechanism and optimized suture loop, ensuring strong fixation and easy handling.
Patent Information
- Application Number
- JP2024524563
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2022-06-30
- Filing Date
- 2022-11-02
- Publication Date
- 2025-08-06
- Estimated Expiration
- 2042-11-02
AI Technical Summary
Existing orthopedic surgical anchors made of rigid materials pose risks of anatomical damage and require complex knot-tying, while soft anchors with knots complicate procedures and form knot stacks, and smaller sutures are prone to breakage and handling difficulties.
A knotless soft anchor system using flexible materials that deploys to a laterally expanded configuration, secured with a knotless locking mechanism, and a suture loop structure that minimizes force requirements and enhances strength.
The system provides high fixation strength with reduced anatomical disruption and simplified deployment, avoiding knots and minimizing force requirements for suture passage through small surgical openings.
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Abstract
Description
[Technical Field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application Serial No. 63 / 275,491, entitled "Knotless Soft Anchor System," filed November 4, 2021, and U.S. Provisional Application Serial No. 63 / 357,181, entitled "Knotless Soft Anchor System," filed June 30, 2022. This application also claims priority to U.S. Provisional Application Serial No. 63 / 317,671, entitled "Smooth Transfer Suture Loop," filed March 8, 2022, and U.S. Provisional Application Serial No. 63 / 342,843, entitled "Transfer Suture Loop," filed May 17, 2022. This application also claims priority to U.S. Provisional Application Serial No. 63 / 317,673, entitled "Q-fix Knotless with Tape," filed March 8, 2022. All of these provisional applications are incorporated herein by reference in their entirety as if reproduced in full below.
[0002] The present disclosure relates to systems and methods relating to repair systems that may include knotless soft anchor systems. [Background technology]
[0003] Many orthopedic surgical procedures use anchoring devices in procedures to secure tissue, such as soft tissue, to bone. Such procedures include, for example, tendon-to-bone attachment, bone-to-bone attachment, tendon-to-tendon attachment, ligament or graft attachment to bone, and primary repair and ligament reconstruction. These procedures typically rely on the use of anchors made of polymeric, metallic, or biodegradable hard materials to which sutures are attached. The sutures are threaded through the tissue, and a knot secures the anchor and tissue together. However, the use of these anchors often requires the placement of rigid, hard materials within the tissue, such as bone. If the anchor loosens, surgeons or surgical technicians face the problem of potentially allowing the rigid device to intrude into the patient's joint, putting the patient at risk for arthritis. Therefore, anchors that use only soft materials are believed to pose a low risk of anatomical damage within the joint cavity or body cavity, even if they become dislodged after surgery.
[0004] Currently available soft material anchors may be formed from sutures or soft, flexible materials and may include braided bodies. Soft anchors may anchor to tissue by deforming, or in some cases, simply relaxing to a radially or laterally expanded state, and may be locked into this anchored state by tying a knot. However, tying knots can complicate the procedure, require greater expertise, be time-consuming, and / or cause greater anatomical disruption to surrounding structures. Additional knots tend to form so-called knot stacks, which can increase the bulk and palpability of the repair site. Therefore, there is a need for a soft anchor system that includes a knotless locking structure, thereby avoiding the knot-tying step and addressing the problems listed herein.
[0005] Additionally, not all soft anchors are created equal. These anchors can differ in various ways, including deployment consistency, required bone removal, and fixation strength, depending on the soft anchor configuration and deployment mechanism. Therefore, there is a need for improved knotless anchor systems, including high-fixation soft anchors that can be consistently deployed and minimize bone tissue removal, and that can be securely locked in a knotless manner, allowing the soft anchor to be secured in a deployed configuration and / or allowing repair tissue to be knotlessly bonded to the soft anchor.
[0006] Sutures are used throughout many surgical procedures for a variety of functions, including, but not limited to, tissue repair, driving surgical devices, or capture. Capture may pull another suture or equivalent flexible member, or tissue / graft, into a target tissue and / or through a surgical device, including, but not limited to, another suture or equivalent flexible member, or an implant, or a surgical tool. In some embodiments, at least one end of the suture may be formed into a loop. This loop may provide a means for capture. This loop may provide a means for connecting the suture to a surgical instrument. This loop may provide a means for a user to hold the suture. Suture loops in the related art may be formed by knots or by joints. However, both knots and joints create discontinuities or bulges along the suture, locally increasing its cross-section. As surgical devices continue to evolve toward smaller and thinner sizes, any openings therethrough, such as openings, tunnels, shaft holes, etc., also become smaller and thinner. Although smaller-sized sutures exist that can pass through such small openings and tunnels, such smaller sutures also have drawbacks. For example, such smaller sutures may be more susceptible to breakage under load. They may also be more susceptible to cutting (cheese-wiring) the repair tissue and may be more difficult to handle. Adding loops to the ends of the sutures can further compound these drawbacks. The force required to pull a suture loop (which inherently has a larger cross-section due to the formation of this suture loop) through these openings with their associated bulges / discontinuities can be greater. Such greater force may require additional tools, may require a larger-than-desired opening through the surgical device, and / or may apply uncomfortable force to the user's hand. Therefore, there is a need for a suture loop structure that addresses these drawbacks.There is a need for suture loop structures that are designed to avoid or reduce the significant increase in force required to pull the loop through an opening in a surgical device. In addition, there may be a need for such smaller sutures to withstand the increased loads.
[0007] definition Described herein is a tissue repair system using soft anchors. The tissue repair system of the present disclosure provides high fixation strength while securing the soft anchors within bone. The tissue repair system is preferably knotlessly locked into the repaired configuration, thereby avoiding the need for the surgeon to tie knots. The tissue repair system may include at least one suture. The term "suture," unless otherwise specified, may include conventional sutures, which may be hollow or may include a braid along their core. The term "suture" may also include equivalent flexible members, such as, but not limited to, suture tapes or flat sutures, and may in some cases be cables, ribbons, or wires, as desired.
[0008] A "soft anchor" is intended to mean a flexible and / or deformable anchor formed of a soft, flexible material that changes to a more laterally expanded configuration upon deployment. A tensioning member operably coupled through a portion of the soft anchor may apply tension to laterally expand the soft anchor. The term "soft anchor" does not exclude the inclusion of select portions that are rigid, but only means that the soft anchor body is substantially formed from a flexible, soft material, such as suture or suture tape. In some embodiments, the soft anchor is formed entirely from braided suture. A soft anchor changes to a deployed configuration that changes to a laterally or radially expanded configuration and may also include longitudinal contraction.
[0009] "Deployment" is intended to mean changing the shape of a soft anchor body ("anchor body") to harden, secure, or anchor the anchor body to / in tissue. Deployment may increase the lateral dimensions of the anchor body to secure the anchor to tissue. For example, this may secure the soft anchor within a hole in bone. For deployment, the anchor body changes the anchor to a deployed configuration.
[0010] "Lock" or "locking configuration," with respect to a suture structure, is intended to mean locking the suture so that it cannot slide in at least one direction. For example, this sliding in at least one direction could loosen repair tissue secured in place. The suture may form a loop with the tissue bound to it, the periphery of which is spun to prevent sliding and increasing in circumference. With respect to an anchor body, a locking configuration is intended to mean locking the anchor body in a deployed configuration, preventing the anchor body from relaxing / moving from the deployed configuration.
[0011] "Knotless locking," or derivative expressions such as knotless locking, are intended to mean locking in a surgical structure formed without tying a knot, i.e., in an anchoring system. A system provided with a preformed knot may be defined as knotless locking. A system configured to form a knot by routing a suture during operation of the surgical structure is also defined as knotless locking. Knotless locking may also be achieved by threading at least one suture through a small opening or along a tortuous path through a suture locking passage structure, which may also be referred to as, for example, a Chinese finger trap, a finger cinch, or a locking interface. To lock a system knotlessly, some of the sutures may extend through a suture locking passage in either the same suture or another suture, forming a self-locking adjustable suture structure as described herein. The suture locking passage may be selectively stretched by applying tension to the locking passage to tighten around a suture disposed therein, thereby locking a portion of the adjustable suture structure.
[0012] "Transport member" refers to a structure or suture that transports a flexible member, such as a suture, through a knotless anchor structure. The transport member may be a suture or a wire.
[0013] "Deployment member" is intended to mean an elongate member, which may be a suture (or equivalent as defined herein), that typically deploys a soft anchor body when tension is applied to the deployment member. In some embodiments, the deployment member may also serve other functions.
[0014] A "repair suture" is a suture (or equivalent as defined herein) that passes through a target soft tissue and is used to secure the target tissue to bone.
[0015] "Static loop" shall mean a loop having a circumference that is not adjustable under normal operating load conditions.
[0016] A "working aperture" is intended to mean an aperture through a surgical device that is limited in size to provide a challenging force for pulling a suture structure, including discontinuities such as knots or suture loop joint ends, therethrough. A "working aperture" may be designed to receive a loop of a suture structure therethrough during normal operation of the surgical device and suture structure. A "working aperture" may be an opening, tunnel, cannula, passageway, or shaft hole in one or more surgical devices. A "working aperture" has an aperture size that may be a diameter, or, if the aperture is a shape other than a circle, an equivalent width. By minimizing aperture size, this "working aperture" may generally contribute to an overall small profile of a surgical device for surgical repair. A surgical device may include apertures of various aperture sizes, some of which may not provide a challenging force, and thus some, but not all, of the apertures may be "working apertures" as defined herein.
[0017] "Surgical device" is intended to include at least one of a surgical tool or instrument, such as an insertion instrument, an implant, such as a tissue anchor, which may be rigid or flexible, and / or a flexible member, such as a suture, suture tape, cable, wire, flexible spring, ring, or tube.
[0018] "Working length" shall mean the entire axial length of the suture loop bond extending from the suture entry point, through itself at the loop end, to the bond end. Summary of the Invention
[0019] Described herein are various improved methods and devices for tissue repair using knotless locking structures, including soft anchors. These and other features and advantages will become apparent upon reading the following detailed description and upon review of the associated drawings. It is understood that both the general description above and the detailed description below are illustrative and are not limiting of the aspects set forth in the claims.
[0020] Disclosed herein is a knotless tissue repair structure including an anchor body formed from a flexible material, the anchor body having a proximal end, a distal end, and a longitudinal axis extending between the proximal and distal ends. The anchor body may be formed with braided strands. The structure also includes a repair suture, the repair suture having a first end, a second end, and a cannulated length between the first and second ends, the first end being fixedly attached to the anchor body. The first end of the repair suture may be fixedly attached to an exterior portion of the anchor body at its distal end. The repair suture may have a cannulated length along the repair suture, the cannulated length being woven along and through a first sidewall of the anchor body. The second end of the repair suture may extend proximally from the proximal end of the anchor body. The knotless tissue repair structure may also include a deployment suture woven repeatedly through and along the anchor body and through and along the cannulated lengths of the repair suture. The deployment suture may be woven through and along the coextensive cannulated lengths of the anchor body, thereby defining a longitudinal suture locking passage. Tension on the deployment suture is configured to change the anchor body from the elongated configuration to the deployed configuration. The deployment suture is configured to operably couple to a second end of the repair suture and to retract the second end of the repair suture through the anchor body and through the longitudinal locking passage, thereby defining the knotless locking configuration of the knotless tissue repair structure.
[0021] In some embodiments, in the knotless locking configuration, the deployment suture may be detached from the knotless tissue repair structure. In some exemplary embodiments, the repair suture may be securely attached to the distal end of the anchor body via two axially overlapping knots, which may be half-hitch knots disposed on the exterior of the anchor body. In some embodiments, tension is simultaneously applied to both the second end of the repair suture and the end of the deployment suture via an instrument drive means to deploy the anchor body. In some embodiments, the anchor body includes an internal lumen with an opening at the proximal end of the anchor body, and the repair suture and the deployment suture are both woven through the anchor body and extend from the opening in the internal lumen so that they both extend proximally from the proximal end of the anchor body. The anchor body may be tubular, for example, with an open proximal lumen.
[0022] In some embodiments, the repair suture includes a tape length segment extending from the cannulated length, the tape length segment being positioned along the segment of the repair suture that is external to the anchor body. The repair suture may also include a tapered suture segment that may extend from the tape length segment on the opposite end of the repair suture to the cannulated length. The tape length segment may have a sufficient length to extend through the anchor body and through the cannulated length when in a knotless locking configuration.
[0023] In some embodiments, the deployment suture may include a bonding loop at a first end of the deployment suture, the bonding loop having a bonding length that extends through all of the working apertures of the tissue repair structure. The bonding length may extend entirely through the anchor body and entirely through the suture lock passage. The bonding length may extend entirely through the anchor body and entirely through the cannulated length and may be operatively coupled to a tensioning drive means of the knotless tissue repair structure such that applying tension to the deployment suture applies tension to a continuous, uninterrupted length of the deployment member bonding length. The deployment suture may include a cannulated first length segment and a second length segment having a smaller diameter than the first length segment, the loop portion of the bonding loop may include the second length segment, and the bonding length may include both the first and second length segments that are coaxially arranged.
[0024] Another exemplary embodiment of a knot-free tissue repair structure is disclosed, the structure including a soft anchor body formed by braided strands having a proximal end, a distal end, and a longitudinal axis extending between the proximal and distal ends. The structure also includes a repair suture having a first end, a second end, and a cannulated length between the first and second ends, the first end being fixed relative to the distal end of the anchor body, the cannulated length being woven along and through a first sidewall of the anchor body, and the second end extending proximally from the proximal end of the anchor body. The structure also includes a deployment suture that is repeatedly woven between the braided strands through and along the second side wall of the anchor body and through and within a cannulated length of the repair suture woven along and through the first side wall. Tension on both the deployment suture and the second end of the repair suture is configured to transition the anchor body to the deployed configuration. The deployment suture is configured to operably couple to the second end of the repair suture after the repair suture is coupled to the repair tissue, and is configured to pull the second end of the repair suture back through the deployed anchor body and through the cannulated length woven through the first side wall, thereby defining a knotless locking configuration.
[0025] In some embodiments, the repair suture includes a tape length segment extending from a cannulated length at a location along the repair suture exterior to the anchor body. A tapered suture segment may extend from the tape length segment on an opposite end of the repair suture to the cannulated length. The tape length segment may have a length sufficiently long to extend through the repair tissue, the anchor body, and the cannulated length when in a knotless locking configuration. The deployment suture may include a bonding loop at a first end of the deployment suture, the bonding loop being a static loop and configured to operably receive the second end of the repair suture therethrough. The bonding loop may define a bonding length that extends entirely through the anchor body and entirely through the cannulated length when the anchor is deployed. The joint length may extend entirely through the anchor body and entirely through the cannulated length and may be operatively coupled to a tensioning drive means of the knotless tissue repair structure such that tensioning the deployment suture applies tension to a continuous, uninterrupted length of the deployment member joint length.
[0026] An exemplary method for constructing a knotless tissue repair structure is disclosed, the exemplary method including providing a soft anchor body having a proximal end, a distal end, and a longitudinal axis extending between the proximal and distal ends, the soft anchor body being tubular and formed from braided strands. The method also includes providing a repair suture having a braided wall and a cannulated length along the braided wall. A first capture tool may be inserted through the braided wall of the repair suture, defining an entrance opening, and then along the cannulated length, again through the braided wall, defining an exit opening. The entrance and exit openings are axially spaced apart along the repair suture and define the axial length of a longitudinal suture locking passage. A transfer suture may then be provided, and the transfer suture may be pulled through the suture locking passage with a first end of the transfer suture extending from the entrance opening and a second end of the transfer suture extending from the exit opening. A braided path may then be formed through and along the first sidewall of the anchor body using a second capturing tool. A second end of the repair suture and a second end of the transfer suture may then be pulled through the anchor body along the braided path using the second capturing tool, thereby positioning a suture locking passage with the transfer suture disposed therein along the braided path, wherein the second end of the repair suture and the second end of the transfer suture may extend from a proximal end of the anchor body. A first end of the transfer suture may be pulled along another braided path disposed through the anchor body on the opposite side of the anchor body, such that the first end of the transfer suture extends from the proximal end of the anchor body.
[0027] In some exemplary methods, the method may include securely coupling a repair suture to a distal end of the anchor body, which may include forming an axially overlapping half-hitch knot at the distal end of the repair suture before inserting a first capturing tool through the braided wall of the repair suture, and the first capturing tool may be inserted directly adjacent to the axially overlapping half-hitch knot.
[0028] In some exemplary methods, the suture locking passage may be formed with an axial length approximately equal to the maximum axial length of the anchor body, the maximum axial length extending from the proximal edge to the distal edge of the anchor body when the anchor body is in the elongated or undeployed configuration.
[0029] The second end of the repair suture and the second end of the transfer suture may be pulled along the braided path using a second capturing tool to position the locking passage entrance opening directly adjacent to the distal end of the anchor body. The anchor body may be tubular with a lumen defined therethrough, the lumen may open at the proximal end of the anchor body, and forming the braided path through and along the first side wall of the anchor body using the second capturing tool may involve first extending the tip of the second capturing tool directly along the lumen a first axial distance into the open end of the lumen, then extending along the outer surface of the anchor body a second axial distance from between the braided strands of the first side wall to the outer surface of the anchor body, and then passing back between the braided strands of the first side wall into the lumen. The first axial distance may be a length that includes at least two braided strands of the anchor body. The first axial distance and the second axial distance may be equivalent in axial length. The method may also include operably coupling the first and second ends of the delivery suture and the second end of the repair suture to a deployment actuator of the insertion instrument.
[0030] An exemplary method for repairing tissue with a knotless tissue repair structure is also disclosed, the exemplary method including providing a knotless tissue repair structure as disclosed herein. The knotless tissue repair may include an anchor body formed from a soft material, the anchor body having a proximal end, a distal end, and a longitudinal axis extending between the proximal and distal ends. The anchor body may be formed with braided strands. The structure also includes a repair suture, the repair suture having a first end, a second end, and a cannulated length between the first and second ends, the first end being fixedly attached to the anchor body. The first end may be fixedly attached to an exterior portion of the anchor body. The cannulated length of the repair suture may be woven along and through a first sidewall of the anchor body. The second end of the repair suture extends proximally from the proximal end of the anchor body. The structure also includes a deployment suture repeatedly woven through and along the anchor body and through and along the cannulated length of the repair suture. The deployment suture may be woven through and along the cannulated length of the repair suture, thereby defining a longitudinal suture locking passage woven through and along the anchor body. Tension on the deployment suture is configured to change the anchor body from the elongated configuration to the deployed configuration. The deployment suture is configured to operably couple to a second end of the repair suture and to retract the second end of the repair suture through the deployed anchor body and through the longitudinal locking passage, thereby defining a knotless locking configuration of the knotless tissue repair structure. The knotless tissue repair structure may be inserted into the target tissue and the soft anchor bodies may be deployed by applying tension to at least the deployment sutures, and the repair sutures may be tied to the repair tissue after the soft anchor bodies are deployed.The repair suture is then tied to the deployment suture after the anchor is deployed. The deployment suture may be pulled through the soft anchor body when the anchor is in the deployed configuration, thereby pulling the second end of the repair suture through the deployed anchor body and through the cannulated length woven along and through the first sidewall. Tension may then be applied to the repair suture to lock the construct knotlessly.
[0031] In some exemplary methods, withdrawing the deployment suture may remove the deployment suture from the knotless tissue repair structure. Deploying the soft anchor body may include applying tension to a second end of the repair suture. The repair suture may include a tape length segment and a tapered suture segment on an opposite end of the repair suture extending from the tape length segment to a cannulated length, and after the soft anchor body is deployed, the repair suture may be tied to the repair tissue to engage the tape length segment, and withdrawing the deployment suture through the soft anchor body may position the suture of the tape length segment through and along the anchor body and through and along the cannulated length. In a knotless locking configuration, the locking passage may include the tape length segment.
[0032] Also disclosed herein is a suture structure for assembly to a surgical device. The suture structure includes a first length having a first diameter, the first length having a cannula. The suture structure also includes a second length extending from the first length, the second length forming a static loop at a single end of the first length by extending the second length into and along the cannula of the first length, thereby defining a joint, the joint having a working length having a static loop end and an opposite end. In the assembled configuration, the joint is disposed through and along the surgical device, including through and along the working aperture of the surgical device, and when the surgical device and suture structure are transformed into a repair configuration, the suture structure, including the static loop, is driven translationally through the working aperture without the opposite end of the joint being introduced into the working aperture.
[0033] In some exemplary embodiments, the second length has a smaller diameter than the first length. The second length may have a braided core. The surgical device may include an all-suture soft anchor and a repair suture, the repair suture being formed separately from the suture loop structure. The repair suture may have a hollow passage portion, and the bond may extend along the hollow passage portion, and the hollow passage portion may define at least one working aperture. The bond may extend along and through the soft anchor from a proximal end of the anchor to a distal end of the anchor and from the distal end to a proximal end. The surgical device may include an insertion tool for an implant such as a soft anchor, and the surgical device includes a shaft bore defining at least one working aperture. The bond may extend along the entire length of the first length to an open end of the cannula of the first length.
[0034] An exemplary tissue repair assembly is disclosed, including a suture loop structure formed from a suture having a first length and a second length and formed from braided strands. The first length defines a longitudinally extending hollow passage. The suture structure includes a splice loop formed by threading the second length through the braided body and along the longitudinally extending hollow passage, thereby defining a splice having a working length along the braided body, thereby defining a loop end and a splice end. The tissue repair assembly also includes a surgical device having at least one working aperture. The working length is threaded along the surgical device and through the at least one working aperture, and the working length is configured such that upon withdrawal of the splice loop through the at least one working aperture, the suture structure is removed from the surgical device without introducing the working end into the at least one working aperture.
[0035] In some exemplary configurations, the second length extends directly from the first length and defines a braided body portion having a smaller cross-section than the first length. The second length may include a braided core. The surgical device may include a soft anchor and a repair suture, the repair suture being formed separately from the suture loop structure and operably coupled to the soft anchor. The repair suture may also define a braided body having a hollow passage therethrough, the hollow passage defining one of the at least one working apertures. The bond may extend continuously along and through the soft anchor from the proximal end of the soft anchor to the distal end of the soft anchor and from the distal end to the proximal end. The surgical device may include an insertion tool for the implant, the surgical device including a shaft bore defining one of the at least one working apertures. The loop may be a static loop. The joint may extend along the entire length of the first length, with the second length extending along the hollow passage of the first length to the open end of the hollow passage of the first length.
[0036] Another exemplary tissue repair assembly is disclosed herein, including a transport structure including a suture formed by braiding strands as a braided body and having a first length including a longitudinal hollow passage. The suture structure includes a splice loop formed by threading a second length of the suture along the longitudinal hollow passage between the braided strands, thereby defining a splice working length along the first length. The assembly also includes a soft anchor having a repair suture operably coupled thereto, the repair suture also formed from a braided body having a longitudinal hollow passage. In the assembled configuration, the splice loop is disposed proximal to the soft anchor, and the splice is threaded along the soft anchor and along the longitudinal hollow passage device of the repair suture.
[0037] In some embodiments, the delivery structure, including the bonding loop, is configured to be pulled through the soft anchor and through the longitudinal hollow passage of the repair suture to remove the delivery structure from the longitudinal hollow passage of the repair suture without the bonded end of the working length being pulled into either the soft anchor or the longitudinal hollow passage of the repair suture. The bonding loop may be formed entirely from a second length of suture, the second length having a smaller cross-section than the corresponding cross-section of the first length.
[0038] Disclosed herein is a knotless tissue repair structure including an anchor body formed from a soft, flexible material and including a proximal end, a distal end, and a longitudinal axis extending between the proximal and distal ends. The structure also includes a repair suture having a first end fixedly attached to the anchor body and a second end extending proximally from the proximal end of the anchor body, the length of the repair suture between the first and second ends extending along and through the anchor body. A transport member is repeatedly woven through and along the anchor body, thereby defining a transport path. Both the first end or first limb and the second end or second limb of the transport suture extend from the proximal end of the anchor body. The first end of the transport member may include a loop that can be operably coupled to the second end of the repair suture. Tension on at least one of the repair suture and the transfer suture deploys the anchor body to the deployed configuration, and with the repair suture coupled to the first end of the transfer member, tension on the second end of the transfer member slidably drives the transfer member and the repair suture through the anchor body, thereby displacing the transfer member with the repair suture along a transfer path through and along the anchor body.
[0039] In some embodiments, the transfer member also extends through and along the repair suture cannula. The transfer member may extend through and along the cannula in a portion of the repair suture disposed along the lumen of the anchor body. The transfer member may be introduced into the cannula outside the anchor body and introduced into the anchor body lumen while located inside the cannula. The transfer member may be introduced into the repair suture cannula at the distal end of the anchor body and led out of the repair suture cannula at the proximal end of the anchor body. A second end of the repair suture may extend from the open lumen at the proximal end of the anchor body. The transfer member may include a capture tool configured to couple a first end of the transfer member to a second end of the repair suture by drawing the second end of the repair suture into and along the transfer member cannula.
[0040] Also disclosed is an exemplary method for routing a repair suture to a surgical structure, the surgical structure including a transfer member extending therethrough, the method including coupling a first limb of the transfer member to the limb of the repair suture by pulling the limb of the repair suture into and along the core of the first limb of the transfer member, whereby the limb of the repair suture, including a distal end of the limb of the repair suture, is coaxially disposed within the first limb of the transfer suture, thereby defining a binding length, wherein the transfer suture extends from a first end of the binding length and the repair suture extends from an opposite end of the binding length. The method may also include applying tension to the transfer suture to tighten the bond length, and applying tension to the transfer member to pull the transfer member, and subsequently the bond length, through the surgical structure, thereby placing the repair suture extending from the opposite end of the bond length into the surgical structure.
[0041] Another exemplary knotless tissue repair structure is disclosed, including an anchor body formed from a flexible material and having a proximal end, a distal end, and a longitudinal axis extending between the proximal and distal ends. The structure also includes a repair suture having a first end fixedly attached to the distal end of the anchor body and a second end extending proximally from the proximal end of the anchor body, a length of the repair suture between the first and second ends extending along the anchor body. The structure also includes a transport member repeatedly woven through and along the anchor body to define a transport path, the first and second ends of the transport member extending from the proximal end of the anchor body, and the first end of the transport suture configured to be operably attached to the second end of the repair suture. Tension on at least one of the second end of the repair suture, the first end of the transfer member, and / or the second end of the transfer member is configured to change the anchor body to the deployed configuration, and with the repair suture coupled to the first end of the transfer member, tension on the second end of the transfer member is configured to slidably drive the first end of the transfer member through the anchor body along the transfer path and remove the transfer suture from the anchor body.
[0042] In some embodiments, the transport path may also extend through and along the repair suture cannula. The transport member may extend through and along the repair suture cannula, which is disposed along the lumen of the anchor body and repeatedly between strands of the anchor body. The transport member may be introduced into the repair suture cannula at the distal end of the anchor body and exit the repair suture cannula at the proximal end of the anchor body. The second end of the repair suture may extend directly from the open lumen at the proximal end of the anchor body. The anchor body may define a sealed distal end and an annular, heat-sealed, open proximal end.
[0043] Disclosed is a suture structure including a suture loop configured to control the size and location of any cross-sectional changes resulting from forming the loop. The suture structure may also be configured to increase the ultimate strength of the suture structure. The suture structure may be operably coupled to a surgical device, such as a surgical instrument, implant, or suture (or the like), and at least one suture loop of the suture structure may be configured to pass through an opening through the surgical device. The suture loop is preferably configured to limit any increase in the force required to translate the suture loop through the surgical device. The surgical device may be, in particular, an insertion instrument, and the opening may be a shaft bore thereof. The surgical device may be, in particular, an implant, such as a tissue anchor, and the opening may be a lumen, cannula, hole, or tunnel through the implant. The tissue anchor may be a full-suture tissue anchor, and the one or more openings may be entrances between the braids of the full-suture tissue anchor. The surgical device may be, inter alia, another suture or equivalent flexible member having a hollow passage therethrough, and the opening may be the hollow passage. [Brief explanation of the drawings]
[0044] The present disclosure will be more fully understood from the following detailed description taken in conjunction with the drawings, in which:
[0045] [Figure 1A] FIG. 1A illustrates a knotless locking soft anchor structure of the present disclosure in an undeployed (elongated) configuration in accordance with the present disclosure. [Figure 1B] FIG. 1B schematically illustrates the knotless locking soft anchor structure of FIG. 1A in simplified form to more clearly show the suture path, according to the present disclosure. [Figure 1C] FIG. 1C shows the knotless locking soft anchor structure of FIGS. 1A and 1B in a deployed configuration. [Figure 1D] FIG. 1D is a schematic illustration of a method of tissue repair using the knotless locking soft anchor structure of the present disclosure. [Figure 1E] FIG. 1E schematically illustrates a further step in a method for tissue repair with a knotless locking soft anchor structure of the present disclosure, with the structure in a knotless locking configuration in accordance with the present disclosure. [Figure 2A] FIG. 2A schematically illustrates another knotless locking soft anchor structure of the present disclosure in an undeployed configuration in accordance with the present disclosure. [Figure 2B] FIG. 2B illustrates a schematic representation of a portion of a method for deploying the disclosed knotless locking soft anchor structure into a knotless locking configuration in accordance with the present disclosure. [Figure 2C] FIG. 2C is a schematic illustration of the knotless locking soft anchor structure of FIG. 2A in a knotless locking configuration in accordance with the present disclosure. [Figure 3A] FIG. 3A is a schematic illustration of another knotless locking soft anchor design in accordance with the present disclosure. [Figure 3B] FIG. 3B is a schematic illustration of the knotless locking soft anchor structure of FIG. 3A in a deployed and locked configuration according to the present disclosure. [Figure 4A]4A, 4B, 4C, and 4D illustrate a method for constructing the knotless locking structure of FIG. 3A. [Figure 4B] Same as above. [Figure 4C] Same as above. [Figure 4D] Same as above. [Figure 5A] 5A, 5B, 5C, 5D, and 5E schematically illustrate another embodiment of a knotless locking structure in an undeployed, unlocked configuration in accordance with the present disclosure. [Figure 5B] Same as above. [Figure 5C] Same as above. [Figure 5D] Same as above. [Figure 5E] Same as above. [Figure 6A] FIG. 6A illustrates a needle-based knotless structure inserted into bone according to the present disclosure. [Figure 6B] 6B and 6C illustrate various views of an insertion tool for inserting a knotless structure in accordance with the present disclosure. [Figure 6C] Same as above. [Figure 7A] FIG. 7A illustrates a suture loop capture element. [Figure 7B] FIG. 7B illustrates a cross section of the suture loop capture element in FIG. 7A. [Figure 8] FIG. 8 illustrates a suture capture structure having a reduced profile in accordance with the present disclosure. [Figure 9A] 9A, 9B, and 9C illustrate a method for capturing a suture using a suture capture structure 800 in accordance with the present disclosure. [Figure 9B] Same as above. [Figure 9C] Same as above. [Figure 10A] For reference purposes, Figures 10A and 10B illustrate a prior art suture loop structure. [Figure 10B] Same as above. [Figure 11A]11A, 11B, and 11C illustrate a method of forming a transfer member structure according to the present disclosure. [Figure 11B] Same as above. [Figure 11C] Same as above. [Figure 11D] FIG. 11D illustrates a transfer member structure for a device according to the present disclosure. [Figure 12A] FIG. 12A illustrates a transfer member structure assembled to an exemplary knotless soft anchor structure within the distal end of an insertion tool according to the present disclosure. [Figure 12B] FIG. 12B illustrates a delivery member structure and repair sutures in an exemplary knotless soft anchor structure assembled within the proximal end of an insertion tool in accordance with the present disclosure. [Figure 13] FIG. 13 illustrates a transfer member structure having two looped ends in accordance with the present disclosure. [Figure 14] FIG. 14 illustrates a transfer member structure having a handle cross section in accordance with the present disclosure. [Figure 15A] 15A and 15B illustrate a method for manufacturing an anchor having annularly sealed ends in accordance with the present disclosure. [Figure 15B] Same as above. [Figure 15C] FIG. 15C illustrates a soft anchor having a linearly sealed distal end and an annularly sealed open proximal end in accordance with the present disclosure. [Figure 16A] FIG. 16A illustrates a variable cross-section repair suture for a knotless soft anchor structure in accordance with the present disclosure. [Figure 16B] FIG. 16B illustrates a variable cross-section repair suture assembled to a knotless soft anchor structure in accordance with the present disclosure, in a prepared state. [Figure 16C] FIG. 16C illustrates a variable cross-section repair suture assembled to a knotless soft anchor structure in accordance with the present disclosure in a repaired configuration. DETAILED DESCRIPTION OF THE INVENTION
[0046] In the following description, like components are designated by the same reference numerals, whether shown in different examples. For clarity and conciseness in illustrating the examples, the drawings may not necessarily be to scale, and certain features may be shown somewhat diagrammatically. Features described and / or illustrated with respect to one example may be used in the same or similar manner in one or more other examples and / or may be used in combination with or instead of features in the other examples.
[0047] As used herein and in the claims, for purposes of describing and defining the present invention, the terms "about" and "substantially" are used to represent the inherent degree of uncertainty that may result from any quantitative comparison, value, measurement, or other representation. The terms "about" and "substantially" are also used herein to represent the extent to which a quantitative representation may vary from the stated basis without changing the basic functionality of the subject matter at issue. The terms "comprises," "comprises," and / or, each plural, are used in an open-ended manner and include the listed elements, as well as additional elements that are not listed. "And / or" is used in an open-ended manner and includes one or more of the listed elements, as well as combinations of the listed elements. The use of terms such as "upper," "lower," "upward," and similar terms is intended only to aid in the clarity of the disclosure and is not intended to limit in any way the structure, positioning, and / or operation of the disclosure.
[0048] A first exemplary knotless locking soft anchor structure 100 and method of use are illustrated in Figures 1A, 1B, 1C, 1D, and 1E. The structure 100 includes a soft anchor 102, which may be similar to the Q-fix™ soft anchor sold by Smith & Nephew. The soft anchor 102 may be similar to at least the anchor disclosed in commonly owned U.S. Patent No. 9,962,149, entitled "Tissue Repair Assembly," which is incorporated herein by reference in its entirety. The soft anchor 102 may be provided in operative association with an insertion system that actively deploys the anchor 102, which upon deployment creates a deployed anchor having high fixation strength within or against tissue. Active deployment, such as that disclosed in U.S. Pat. No. 9,962,149, entitled "Tissue Repair Assembly," deploys the anchor 102 by applying a high tension load to the deployment member while providing a dorsal locking member to hold the anchor 102 in place, thereby creating a deployed anchor configuration with high fixation strength.
[0049] The soft anchor 102 may define a tubular braided body 104, which may include an occluded or sealed distal end 112. The tubular body 104 may be formed from braided strands 110. The occluded distal end 112 may be sealed to define a straight edge 113, which may be formed using an adhesive or heat sealing.
[0050] The knotless locking soft anchor structure 100 may be prepared in the elongated configuration shown in both FIGS. 1A and 1B, which is the preferred configuration for both reception within an insertion tool and insertion into or through a bone hole. The first suture 120 may extend along the anchor 102 and may be repeatedly woven through the wall of the anchor 102. The first suture 120 may extend along a first side of the longitudinal axis 106 of the anchor 102, wrap around the straight distal edge 113, and return to the opposite side of the axis 106. Two limbs 122a, 122b of the first suture 120 may extend from the proximal end 116 of the anchor 102. The first limb 122a may terminate with a capture loop, which may be a static loop as defined herein. The first suture 120 may be slidably coupled to the anchor 102.
[0051] The structure 100 may also include a second suture 130 formed separately from the first suture 120 and fixedly attached to the anchor 102. The second suture 130 may be a repair suture that permanently attaches the repair tissue to the anchor, as described in more detail below, and thus may be fixedly attached to the anchor 102 so that it does not become detached from the anchor 102. The second suture 130 may extend along the lumen 105 of the tubular body 104. The second suture 130 may enter the open end of the lumen 105 at the proximal end 116 of the anchor. The second suture 130 may be fixedly attached at a location along the anchor 102 that may be adjacent to the distal end 112. The second suture 130 may extend from within the lumen 105 between the braided strands 110 and may include a knot 132 on the exterior of the anchor 102. The knot 132 may secure the second suture 130 to the anchor 102. The knot 132 may be located at a distal end 134 of the second suture 130. In forming the knot 132, the suture 130 may be looped around and between several of the braided strands 110, thereby forming multiple paths through the tubular body wall. The knot 132 may be a locking knot, which is a knot large enough to resist being pulled back through the braided strands 110.
[0052] In some embodiments, the knot 132 may extend through and beyond the distal end 112 of the anchor, or the knot 132 may be located external to the anchor 102 and distal to the entire anchor 102. In other embodiments, the end 134 may be fixedly attached using an adhesive or heat sealing in addition to or instead of the knot 132. In some embodiments, the end 134 may be coextensive with the distal end 112 and fixedly attached at the distal end 112, forming a closed, sealed straight edge 113. Thus, the end 134 of the suture 130 may be sealed within the seal of the straight edge 113. The proximal end 136 of the second suture 130 may extend from the proximal end 116 of the anchor. The suture 130 may extend along the lumen 105 and may be routed out a proximal opening of the lumen 105.
[0053] FIG. 1B is a simplified schematic diagram of the structure 100 shown in FIG. 1A to more clearly understand the internal routing of the sutures (120, 130). The anchor 102 may be prepared in this first elongate configuration housed within an insertion-deployment device similar to at least the device disclosed in commonly owned U.S. Patent No. 9,962,149, entitled "Tissue Repair Assembly," which is incorporated herein by reference in its entirety. When the anchor 102 is inserted into or through the target tissue, tension applied to at least one of the first or second sutures (120, 130) may deploy the anchor 102 to a deployed state, as shown in FIG. 1C. Thus, the first and / or second sutures (120, 130) may function as deployment members. In some embodiments, tension T may be applied to all proximally extending limbs (122a, 122b, 136) to deploy anchor 102. Because the superior fixation strength of the anchor is achieved, at least in part, by applying a large tensile load (100N-150N, up to 200N) to anchor 102, the inventors have discovered that applying this high load across the three suture limbs allows for a reduced size of sutures (120, 130) while still withstanding such high loads. Applying tension to the three limbs (122a, 122b, 136) bunches anchor 102, transforming it into deployed configuration 102' as shown in FIG. 1C and securing anchor 102 within the target tissue.
[0054] Applicants have found that the deployment member is preferably formed from a suture material, including suture, suture tape, or flattened suture, that is flexible enough to bend around and through the anchor 102 and be able to withstand large deployment loads. Flexible wires, particularly nitinol wires, can defeat the purpose of the deployment member. Flexible wires or cables cannot be easily bent and can kink when threaded around such small anchors. Wires, particularly nitinol wires, can lengthen under such large tensile loads. Flexible wires can sever the braided strands 110 under such large tensile loads. The first suture 120 can be a polyester size #0 suture. The second suture 130 can be an ULTRABRAID #2 suture.
[0055] 1D and 1E, second suture 130 may also function as a repair suture and may be operably coupled to tissue 150 during repair before being coupled to rim end 122a. Thus, second suture 130 may first function as a deployment member and then as a repair member. After being coupled to tissue 150, second suture 130 may be threaded through a capture loop at rim end 122a, as shown in FIG. 1D. With second suture end 136 captured, pulling first suture end 122b may slide first suture 120 through and remove first suture 120 from deployed anchor 102′, whereby first suture 120 is replaced by second suture end 136 / suture 130. Thus, first suture 120 may be defined as both a deployment member and a transport member. By withdrawing suture end 122b in the direction of arrow "A," repair suture 130 can be transported into and along deployed anchor 102', causing repair suture 130 to follow the same path defined by first suture 120 when construct 100 was prepared (FIGS. 1A, 1B). In the resulting configuration, as shown in FIG. 1E, second suture / repair suture 130 is fixedly attached at one end 134 and attached to repair tissue 150, and is braided around and through deployed anchor 102'. This configuration may be defined as a deployed knotless locking configuration. The tortuous path that the second / repair suture 130 takes through the anchor in its deployed bundled state can provide enough friction to lock the second suture 130 in place and prevent it from sliding or loosening. The anchor 102 is deployed and locked in the deployed configuration (102'). The structure 100 is bound to the repair tissue 150 and prevented from moving.
[0056] The second suture 130 may be attached to the first suture limb 122a outside the patient's body after the anchor has been inserted and deployed. The inventors have found that first deploying the anchor 102 and then attaching the repair tissue to the deployed anchor 102' is a more streamlined method than repairing tissue before implanting the anchor within bone tissue, for example. This allows the repair suture 130 to be prepared or ready in a pre-assembled state with any deployment drive means on the insertion tool, so that the anchor deployment member may include both sutures (120, 130), thereby improving fixation strength. This allows for better alignment with the surgical procedure. If the repair suture 130 were not employed as a deployment member and attached to the repair tissue 150 before deploying the soft anchor 102, an additional pair of hands or means may be required to hold the instrument near the target treatment site while attaching the repair suture to tissue inside the patient. This is not preferred.
[0057] FIGS. 2A, 2B, and 2C illustrate various aspects and methods of use of another soft anchor knotless structure 200. Similar components are designated by the same reference numerals. The structure 200 includes a soft anchor 102, which may be similar to Q-fix™ available from Smith & Nephew. In this embodiment, a first suture 120 is routed through a cannula of a second suture 130 within and along the anchor lumen 105. FIGS. 2A, 2B, and 2C illustrate partial or simplified cross-sectional views of the anchor 102 to illustrate this internal pathway. FIG. 2A schematically illustrates the structure 200 in an elongated configuration that can be received within the distal end bore of an insertion tool. Similar to its path in structure 100, first suture 120 is repeatedly woven from the outer surface of anchor 102 into lumen 105 through a first side of anchor 102's longitudinal axis 106. Toward anchor distal end 112, first suture 120 may extend through braided strands in the anchor wall into anchor lumen 105 and remain within lumen 105 until emerging from anchor lumen 105's proximal end, which may be the open proximal end. First suture 120 does not have to extend across to the opposite side of anchor longitudinal axis 106. In other embodiments, suture 120 may extend beyond anchor distal edge 113 and then emerge from the opposite side of the tubular wall (not shown) into lumen 105. This may improve deployment even on both sides of the anchor's longitudinal axis.
[0058] First suture 120 extends proximally along lumen 105 and also extends within cannula or passageway 137 of second suture 130. Thus, first suture 120 is coextensively positioned within both cannula 137 and anchor lumen 105. First suture 120 enters cannula 137 at entry opening 137a and exits at opening 137b. Openings 137a and 137b may not be preformed and may be positioned such that first suture 120 extends therethrough between the strands of second suture 130. The distance between openings 137a and 137b defines the axial length of the locking passageway. Second suture 130 includes a cannula 137 for receiving first suture 120 therein. Second suture 130 may be formed without strands along its entire length and along its core, thus defining a cannulated or hollow suture. First suture 120 may include strands along its core because this allows first suture 120 to have a smaller outer diameter for advancing through second suture 130 while still maintaining strength requirements (strength requirements for deploying anchor 102). In some embodiments, second suture 130 may have a distal end 134 on an exterior portion of anchor 102, similar to that shown in FIG. 1A , and first suture 120 may be introduced into cannula 137 of second suture 130 at a location exterior to anchor 102. Stated another way, entrance 137a of first suture 120 into cannula 137 may be located exterior to anchor 102.
[0059] The distal end of the second suture may be fixedly coupled to the anchor 102 to prevent proximal movement relative to the anchor 102 in a manner similar to that described for the system 100. The second suture 130 may extend along and within the lumen 105 of the anchor 102. The second suture 130 may extend from the open proximal end of the lumen 105 at the proximal end 116 of the anchor. The second suture 130 may be fixedly coupled at a location along the tubular body 104 that may be adjacent to the distal end 112. The second suture 130 may extend between the strands of the anchor 102 and may include a knot 132 for coupling the second suture 130 to the tubular body 104. The knot 132 may be located at a terminal end 134 of the second suture 130. The knot 132 may be looped around and between the strands 110, or may be large enough so that it cannot pass between the braids 110. The knot 132 may extend through and beyond the distal end 116, or the knot may be located outside the tubular body 104 and distal to the entire tubular body 104. In other embodiments, the end 134 may be fixedly attached using an adhesive or heat sealing. In some embodiments, the end 134 may be coextensive with the distal end 112 and fixedly attached at the distal end 112, forming a closed, sealed linear edge 113. The end 134 will be sealed within the sealed linear edge 113. The proximal end 135 of the second suture 130 may extend from the proximal end 116 of the anchor.
[0060] The anchor 102 may be prepared in this first, elongated configuration, as shown in FIG. 2A, contained within an insertion-deployment device similar to at least the device disclosed in commonly owned U.S. Patent No. 9,962,149, entitled "Tissue Repair Assembly," which is incorporated herein by reference in its entirety. When the anchor 102 is inserted into the target tissue, tension applied to at least one of the first or second sutures (120, 130) may deploy the anchor 102 to a deployed state, as shown in FIG. 2B. As described herein, to apply a large deployment load, it may be preferable to apply tension to all three proximally extending limbs (122a, 122b, 136). Thus, the first and / or second sutures (120, 130) may function as deployment members. In some embodiments, tension may be applied to all of the proximally extending limbs (122a, 122b, 136) to deploy the anchor 102. This bunches the anchor 102 and anchors the anchor 102 to the target tissue. The second suture 130 may then function as a repair suture and be operably coupled to the tissue 150 before being threaded through the capture loop at the limb end 122a. The second suture 130 may then be passed through the loop at the limb end 122a outside the patient's body. Pulling on the end 122b of the first suture 120 may then slide the first suture 120 through the deployed anchor 102′ and remove the first suture 120 from the anchor 102, thereby replacing it with a portion of the second suture 130. Thus, the first suture 120 may be defined as both a deployment member and a transfer member. By withdrawing suture end 122b, repair suture 130 can be transported into and along deployed anchor 102', causing repair suture 130 to follow the same path defined by first suture 130 when initially prepared (FIG. 2A).In the resulting configuration, as shown in FIG. 2C , second suture 130 is fixedly attached at one end 134 and attached to repair tissue 150, and is further braided around and through deployed anchor 102′. Second suture 130 is also braided (also referred to as splicing) through itself along cannula 137. The application of tension (arrow B) to second suture 130 from either suture end 136 or resulting loop portion 139 reduces the diameter of cannula 137 and tightens second suture 130 around itself in a manner similar to a Chinese finger trap. This may further lock structure 200. The configuration shown in FIG. 2C may be defined as a deployed knotless locking configuration. The tortuous path that second suture 130 takes in its deployed bundled state through deployed anchor 102' and along at least cannula 137 can provide sufficient friction to lock second suture 130 in place and prevent second suture 130 from sliding or loosening. Deployed anchor 102' is also knotlessly locked in the deployed configuration. Structure 200 is also bonded to repair tissue 150, preventing the repair tissue 150 from migrating.
[0061] The length of the locking passage may be sufficient to knotlessly lock the system 200. In other embodiments, the second end 122b of the first suture may also include a loop such that the repair loop is reversed. In this alternative reverse loop, the second suture may be tied to the second end 122b and the first end 122a may be withdrawn, such that the second suture 130 first passes through the cannula 137 and the anchor lumen 105 before being woven through the deployed anchor 102'.
[0062] FIG. 3A illustrates various aspects of another knotless locking soft anchor structure 300. Components similar to structures 100 and 200 are labeled with the same reference numerals. Structure 300 may include a locking passage similar to structure 200. FIG. 3A illustrates structure 300 in a prepared state. In this configuration, anchor 102 may be elongated and housed within a tube of an insertion tool. In this configuration, first suture 120 may be threaded through cannula 137 of second suture 130 to define and form suture locking passage portion 337 of structure 300 upon subsequent operation of structure 300. Locking passage portion 337 may extend along anchor 102 and may be repeatedly woven between braided strands 110 of the anchor wall, where braided strands 110 are most clearly visible in FIG. 1A. By weaving the repair sutures 130 along the anchor wall, rather than extending through the interior of the anchor lumen 105 (as shown in structure 200), overall anchor fixation strength may be improved compared to structure 200. Weaving the repair sutures 130 along the anchor wall, in combination with deploying the woven sutures through both sides of the anchor 102, may allow the anchor 102 to deploy more evenly between each side (along the longitudinal axis), which may improve anchor fixation strength. A locking passage portion 337 may be woven between the outermost surface of the side wall of the anchor 102 and the anchor lumen 105. The passage portion 337 may extend from the proximal-most edge of the anchor 102 to the distal-most edge of the anchor 102 when in the elongated configuration as shown in FIG. 3A . 3A illustrates a simplified schematic diagram of a structure 300 to illustrate the routing of sutures 120, 130 through each other and through anchor 102. Anchor 102 defines a tubular body 104, with first suture 120 repeatedly woven across the entire width of a first sidewall of tubular body 104, where the first sidewall extends along a first side of longitudinal axis 106 of anchor 102.First suture 130 is woven back and forth between the outer surface of anchor 102 and lumen 105, and as shown, is woven three times as it extends along anchor 102. Toward distal end 112, first suture 120 may extend through the anchor wall into anchor body lumen 105 and then into second suture cannula 137 at entrance 137a.
[0063] First suture 120 may extend along anchor 102 and may be woven through opposing sidewalls of the longitudinal axis while simultaneously being disposed within second suture cannula 137. First suture 120 is introduced into cannula 137 at entry opening 137a and exits at opening 137b. Openings 137a, 137b may not be preformed and may be positioned therethrough where first suture 120 extends between strands of suture 130. Opening 137a may be located within anchor lumen 105 at distal end 116. The axial distance between openings 137a, 137b defines the length of the locking passage. First suture 120 may include a braid along its core, which allows first suture 120 to maintain great strength while having a smaller diameter for threading through second suture 130. In some embodiments, first suture 120 may be introduced into cannula 137 of second suture 130 at a location external to anchor 102. Stated another way, entrance 137a of first suture 120 into cannula 137 may be located external to anchor 102.
[0064] The distal end 134 of the second suture may be fixedly coupled to the anchor 102 to prevent proximal movement relative to the anchor 102. The second suture 130 may extend through the open proximal end of the lumen 105 at the proximal end 116 of the anchor. The second suture 130 may be fixedly coupled at a location along the anchor 102 that may be adjacent to the distal end 112. The distal end 112 may be sealingly occluded, such that the second suture 130 may extend between the braided strands 110 of the anchor 102 and may include a knot 132 on the exterior of the anchor 102 to couple the second suture 130 to the anchor 102. The knot 132 may be located at the end 134 of the second suture 130. Knot 132 may be formed by two half-hitch knots or by a locking knot, such as an Ashley locking knot or a square knot. If two half-hitch knots are used, it may be preferable for the second half-hitch knot to axially overlap the first half-hitch knot to shorten the overall axial length of knot 132. Knot 132 is preferably large enough to prevent second suture 130 from disengaging from anchor 102. Knot 132 may be located distal to anchor distal end 112. In other embodiments, end 134 may be fixedly attached using adhesive or heat sealing instead of or in addition to knot 132.
[0065] The knotless locking soft anchor system 300 may be prepared in this first configuration, as shown in FIG. 3A , housed within an insertion-deployment device similar to at least the device disclosed in commonly owned U.S. Patent No. 9,962,149, entitled "Tissue Repair Assembly," which is incorporated herein by reference in its entirety. When the anchor 102 is inserted into or through the target tissue, tension applied to at least one of the first or second sutures (120, 130) may deploy the anchor 102. Thus, the first and / or second sutures (120, 130) may function as deployment members. In some embodiments, tension may be applied to all of the proximally extending limbs (122 a, 122 b, 136) to deploy the anchor 102, which may provide several advantages, as described herein above.
[0066] Second suture 130 may then function as a repair suture and may be operably coupled to tissue 150 before being threaded through the capture loop at limb end 122 a. Second suture 130 may be passed through loop 123 at limb end 122 a outside the patient's body. Then, by pulling end 122 b of first suture 120, first suture 120 may be slid through anchor 102 and first suture 120 may be removed from anchor 102, whereby first suture 120 is replaced by second suture 130. First suture 120 may therefore be defined as a deployment member / suture and a transfer member / suture. Withdrawal of suture end 122b may transport repair suture 130 into and along deployed anchor 102', causing repair suture 130 to follow the same path defined by first suture 130 when initially prepared. In the resulting configuration, as shown schematically in FIG. 3B , second suture 130 is fixedly attached at one end 134, attached to repair tissue 150, and braided around and through deployed anchor 102'. Tension (arrow B) applied to second suture 130 from either suture end 136 or resulting loop portion 139 reduces the diameter of cannula 137 and tightens second suture 130 around itself in a manner similar to a Chinese finger trap. This may further lock structure 300. The configuration shown in Figure 3B may be defined as a deployed, knotless, locking configuration. Figure 3B illustrates system 300 in a simplified, circuit-like manner for ease of understanding. The tortuous path that second suture 130 takes through deployed anchor 102' and at least along cannula 137 provides sufficient friction to lock second suture 130 in place and prevent second suture 130 from sliding or loosening. Deployed anchor 102' is also knotless locked in the deployed configuration.
[0067] Deploying anchor 102 may transition locking passage 337 from being entirely within anchor 102 to protruding proximally from within anchor 102, thereby spacing exit port 137b to a location proximal to anchor 102. Some of the suture ends (either suture 120 and / or suture 130) may be tapered in diameter to reduce the force required to pull the suture into and along the anchor and second suture 130 (described in more detail below). Additional sutures may be operably coupled to anchor 102. For example, a third suture may be operably coupled to anchor 102 along a path circumferentially offset from the illustrated sutures. Another knotless structure (having another repair suture and a transport suture) may also be threaded through anchor 102 at a circumferentially offset location.
[0068] 4A, 4B, 4C, and 4D illustrate a method for constructing a knotless locking soft anchor structure 300. First, a repair suture 130 may be prepared. Preparing includes providing a suture 130 including at least a portion (cannula 137) with a hollow core. The suture 130 may be trimmed to a length of approximately 24 inches (609.6 mm), and a locking knot 132 may be formed at a first end 134. Forming the locking knot 132 may include forming a first half hitch and then forming a second half hitch axially overlapping the first half hitch. The suture 130 may then be aligned adjacent to the anchor 102, the knot 132 may be placed at the distal end 112 of the anchor 102, and a mark 411 may be formed on the suture 130 to align with the proximal end 116 of the anchor 102. This mark may be relative to the passageway exit 137b. The anchor 102 may be in a relaxed, possibly slightly stretched, or elongated configuration during construction. The axial distance along the second suture 130 between the knot 132 and the mark 411 may define a locking passageway linear length that may approximate the axial length of the anchor 102 in the relaxed or elongated configuration. The suture locking passageway (337) may have a linear length of 15 mm, sufficient to form a knotless lock of sufficient strength. In other embodiments, this length may be shorter than the axial length of the anchor 102. Having a locking passageway linear length shorter than the overall axial length of the anchor 102 may be advantageous for applications in smaller or softer bones. Given that the anchor 102 tends to shorten axially upon deployment, deployment may cause the locking passageway to protrude slightly from the proximal end 116 of the anchor. This can be a concern for the surgeon, and can be problematic in small bones with thin cortical layers, as there may not be enough space for a protruding channel.Thus, an alternative method of construction may include placing mark 411 at a location along the axial length of the anchor body, for example at location 411a.
[0069] 4B, a capturing tool 400 having a looped end 405 may be provided and may be threaded into and along cannula 137 through repair suture 130 between the braided strands. Capturing tool 400 may be advanced from cannula 137 between the braided strands of suture 130 immediately adjacent knot 132. Capturing tool 400 may define an entrance 137a and an exit 137b.
[0070] Thereafter, another suture may be prepared, which may be first suture 120. First suture 120 may be smaller in diameter (or cross-sectional dimension) than repair suture 130. First suture 120 may be prepared or trimmed to a maximum length approximately twice the length of second suture / repair suture 130. First suture 120 may include looped end 123 when prepared, or looped end 123 may be prepared first. Looped end 123 may be configured to engage or capture end 136 of the repair suture. A capturing tool 400 may then be operably coupled to first suture 120 and withdrawn to assemble first suture 120 through cannula 137, as shown in FIG. 4C. First suture 120 may be pulled and threaded through cannula 137 so that first end 122a of the first suture extends from outlet 137a and second end 122b of the first suture extends from outlet 137b, as also shown in FIG. 4C.
[0071] 4D , a pathway through anchor 102 may be formed using a needle tool 450, which may be similar to capture tool 400. Needle tool 450 may be woven between braided strands 110 of anchor 102, as shown in FIG. 4D . Needle tool 450 may include looped ends 455. Both ends of needle tool 450 may extend directly from lumen 105 of anchor 102. In some embodiments, distal end 116 may be a closed, heat-sealed straight edge, and a small opening may be formed through the closed end upon insertion of needle tool 450. To improve consistent and uniform deformability of anchor 102 during deployment, it is preferred that the spacing between each port between braids 110 and each port through the anchor sidewall be approximately equal to one another. The needle tool 450 preferably first extends through the lumen 105 and then passes through the side wall of the anchor 102 at least two braided strands 110 from the most proximal or most distal end edge of the anchor 102, thereby reducing the chance of the braid unraveling.
[0072] Looped end 455 of needle 450 may simultaneously capture suture end 122b and suture end 136, pulling the two sutures (130, 120) through anchor 102 along the path defined by the needle path through anchor 102. Ends 122b, 136 may then be used to pull cannula 137 (locking passage 337) into and along anchor 102 until knot 132 abuts distal end 112 on the outer surface of anchor 102. Needle 450 may then repeat this operation along the opposite side of anchor longitudinal axis 106, thereby threading only suture end 122a (and also loop 123) along and through anchor 102. The suture may then be threaded through the shaft of the insertion instrument, with ends (122a, 122b, 136) operatively coupled to the deployment drive means of the insertion instrument. Anchor 102 may be positioned within or at the distal end of the instrument shaft.
[0073] 5A illustrates another knotless locking soft anchor structure 500. Structure 500 is similar to structure 300 except where otherwise noted. Notably, inlet 137a and outlet 137b for cannula 137 may be spaced apart from anchor distal end 112 and anchor proximal end 116, respectively. Suture locking passage 537 may be shorter than the axial length of the anchor in the elongated configuration, as described herein, such that upon deployment, locking passage 537 is less likely to protrude proximally from the deployed anchor 102′. Additionally, inlet 137a may be located exterior to anchor body 102. In this manner, transfer suture 120 may be woven along anchor 102, along a first sidewall (the right sidewall as shown in FIG. 5A ) and around the exterior of anchor distal end 112, such that transfer suture 120 remains external to anchor 102 at anchor distal end 112 and is introduced through cannula entrance 137a before returning into anchor 102. By winding transfer suture 120 around anchor distal end 112, deployment and fixation strength may be improved. By making locking passage 537 shorter than the maximum axial length of the anchor, the length that locking passage 537 extends from anchor proximal end 114 may be reduced after anchor 102 is deployed (which may shorten the axial length of anchor 102).
[0074] 5B illustrates another knotless locking soft anchor structure 820 in a pre-deployed configuration. Structure 520 is similar to structure 300 except where noted. Structure 520 includes a knot 132 on the proximal end 116. The suture locking passage 537 may be shorter than the entire axial length of the anchor 102 and still be woven between the braided strands 110. In this embodiment, the repair suture 130 is introduced into the locking passage 537 at the proximal end and extends distally through the locking passage 537 before being woven around and along the anchor 102.
[0075] 5C illustrates another knotless locking soft anchor structure 840 in a pre-deployed configuration. Structure 550 is similar to structure 300 except where noted. Structure 540 includes a non-locking passageway 537 that zigzags back and forth across the cross section of anchor 102. This may allow locking passageway 537 to be long enough for adequate knotless locking, but this path may limit locking passageway 537 from protruding from anchor proximal end 116 after anchor 102 is deployed.
[0076] 5D illustrates another knotless locking soft anchor structure 560 in a pre-deployed configuration. Structure 560 is similar to structure 300 except where otherwise noted. Structure 560 includes a locking passage 537 located at the proximal end 116 of anchor 102. This may reduce the force required to thread repair suture 130 through locking passage 537. However, locking passage 537 protrudes from proximal end 116.
[0077] 5E illustrates another knotless locking soft anchor structure 580 in a pre-deployed configuration. The structure 580 includes a locking passage 537 extending along the lumen 105, the locking passage 537 being shorter than the maximum axial length of the anchor 102. The locking passage 537 may be positioned toward the distal end 112 of the anchor 102, thereby maintaining the locking passage 537 in a distal orientation and limiting the locking passage 537 from proximal end 116 after deployment of the anchor. Furthermore, to maintain the position of the locking passage 537, the locking passage 537 extends directly from the knot 132, and the suture 120 may extend from the locking passage 537 and be woven directly through the proximal portion of the anchor 102. During deployment, tension is applied to the limb of the suture 120 and the proximally extending limb of the suture 130. After deployment, suture 120 functions as a transfer suture in a manner similar to that described herein, pulling repair suture 130 through the anchor and repeatedly weaving it through the anchor wall on a first side of longitudinal axis 106 and into locking passage 537, then weaving it again through the anchor wall on the opposite side of the longitudinal axis.
[0078] FIG. 6A illustrates an exemplary knotless structure inserted into bone. In this example, repair suture 130 may include a needle 605 pre-attached to end 136. Any knotless structure disclosed herein may include at least one suture with a pre-attached needle, including structures 100, 200, 300, 500, 520, 540, 560, and 580. Structure 300 is shown in FIG. 6A with a pre-attached needle 605. This allows the surgeon to attach repair tissue to repair suture 130 without performing a needle attachment step during the procedure. Repair suture 130 may extend along an open slot along instrument shaft 642, as needle 605 is generally too large to fit within the shaft bore. Needle 605 may be housed within the handle of insertion instrument 650, as shown in FIGS. 6B and 6C. In some embodiments, the repair suture 130 may be operatively free from the instrument deployment mechanism, such that tension is applied only to the deployment suture 120 to deploy the anchor 102. In other embodiments, a third suture may be operatively coupled to the anchor 102 to enhance deployment, and the third suture may be removed after the anchor 102 has been deployed to the desired high load.
[0079] As shown in FIG. 6B , deployment of anchor 102 via drive knob 626 may simultaneously apply tension to multiple ends of any suture operably coupled to drive knob 626, and housing cover 635 may be removed. The instrument 650 and system may operate similarly to the system disclosed in patent application PCT / US21 / 34590, entitled "Tissue Repair System," filed May 27, 2021, which is commonly owned by the present applicant and incorporated herein by reference in its entirety. In other embodiments, repair suture 130 may be routed along instrument 650 and operably coupled to a deployment drive mechanism at a first location. Repair suture 130 may be pre-attached to needle 605 at a second location spaced apart from the first location. For example, the second location may be located at the distal end of the second end 136 of the repair suture, and the first location may be spaced apart between the anchor 102 and the second location.
[0080] Thus, a method of use may include inserting a knotless structure (100, 200, 300, 500, 520, 540, 560, 580) into a target tissue using the instrument 650 and deploying the anchor 102 by actuating the knob 626. Actuating the knob 626 may apply tension to at least a first suture 120 of the knotless structure (100, 200, 300, 500, 520, 540, 560, 580). Actuating the knob 626 may apply tension to an end of the repair suture 130 at a location along the repair suture 130 spaced apart from the pre-attached needle. Actuating the knob 626 (627) may remove or unlock the housing cover 635 of the instrument 650, thereby exposing the pre-attached needle 605. After the anchor 102 is deployed within the target tissue, the repair suture 130 and pre-attached needle 605 may be removed from the instrument 650. The repair suture 130 may be tied to the repair tissue 150 using the needle 605. The first suture 120 may also be removed from the instrument 650. After the repair suture 130 is tied to the repair tissue 150, the needle 605 may be removed, and the end 136 of the repair suture is tied to the first end of the first suture 120. The second end of the suture 120 may then be pulled, allowing the suture 130 to slide through the deployed anchor 102' while removing the suture 120 from the deployed anchor 102'. This allows the repair suture 130 to be positioned along a tortuous path through the anchor 102', which may form a knotless locking configuration, as disclosed herein.
[0081] Capture / Transfer Loop Embodiments Reference is now made herein to embodiments for coupling a first suture 120 to a second suture 130. FIG. 7A schematically illustrates a close-up view of a first structure for capturing two sutures, such as capturing a first suture limb 122a with a second suture limb 136. This may be referred to as a looped capture structure. This structure may require significant pulling force to pull the suture end 136 through the soft anchor 102, between the braids, and through itself in at least the exemplary structures 200, 300. The second suture 130 doubles over the loop 122a, forming a cross-section (FIG. 7B) that includes four (4) suture cross-sections. Considering the application of tension to pull all of these suture cross-sections through the knotless locking structures disclosed herein, the link may include up to four suture cross-sections, as illustrated in FIG. 7B. Keeping in mind that knotless locking structures are generally minimized in size to reduce the overall profile of the structure, it has been found that a relatively large pulling force is required to tension the four sections of suture, which in turn can deform or loosen the locking passage (337, 537), thereby preventing or damaging the formation of a strong knotless lock along the locking passage.
[0082] A first improved connecting or capture structure 800 according to the present disclosure is illustrated in FIG. 8. The connecting structure 800 coaxially joins two suture ends to define an outer suture 820 and an inner suture, which may be the repair suture 130. The outer suture 820 may function similarly to the suture 120 disclosed herein, except that the suture 820 may not have a looped end (122a) and may include a cannulated portion 826 having an open cannulated end 826a. Similar to the locking passages disclosed herein, tension applied to the outer suture 820 may reduce the size of the opening in the cannula 826, locking the two sutures (820, 130) together. More specifically, open cannulated end 826a may receive suture end 136, including distal end 136a, therein and lock around suture end 136. Thus, in comparison to the structure shown in Figures 7A and 7B, this connection structure 800 is now achieved by two coaxial lengths of suture (130, 820).
[0083] FIG. 9A illustrates the proximal end of a knotless locking soft anchor structure 200 having a suture 820 captivatingly coupled to a repair suture 130 by forming a connecting structure 800. A method is illustrated in FIGS. 9A, 9B, and 9C. The method and structure 800 may be employed with any of the knotless locking soft anchor structures (100, 300, ...) disclosed herein. In this embodiment, the method may include preparing a knotless structure, except that the first suture 820 has a cannula 826 and does not have a looped end (122a). The first suture 820 may be prepared through the anchor 102 along a path similar to that disclosed herein. The first suture 820 may be prepared with a capturing tool 930 extending along the first suture 820. The capturing tool 930 may extend from an open, cannulated end 826a. The capturing tool 930 may be assembled to an insertion instrument (not shown). The capturing tool 930 may extend along the cannula 826 a length to define a connection portion of sufficient strength, such as connection portion 800, for capturing and pulling a second suture (such as second / repair suture 130) through the knotless structure. In some embodiments, the capturing tool 930 may be repeatedly woven in and out of the cannula 826, thereby forming several serial connections.
[0084] After anchor 102 is deployed, second suture 130 may be tied to tissue 150 via tension on at least one end of suture 820 and / or second suture 130 (FIGS. 1D, 2B, and 3B), after which connection 800 may be formed (FIG. 9B). Second suture 130 may be captured by looped end 930a of capturing tool 930. Pulling on handle end 930b of capturing tool 930 may pull second suture 130 through open cannulated end 826a and along cannula 826. In some embodiments, second suture 130 may be introduced through the sidewall of first suture 820 rather than directly into open cannulated end 826a, although this is less preferred as it may increase the bulk of the resulting connection 800. The capture loop 930a may be deformable or may have a reduced opening size before pulling the second suture 130 into the cannula 826. The capture tool 930 may release the end 136a of the second suture so that it is fully enclosed within the cannula 826. In other embodiments, the capturing step may be performed outside the body, so that the end 136a may be pulled outside the first suture 820 between the braids of the first suture wall (820), thereby releasing the capture loop 930a from the end 136a, and then the second suture 130 may be slightly withdrawn, thereby returning the end 136a to the interior of the cannula 826. Enclosing distal end 136a completely within cannula 826 provides a smooth, continuous exterior surface for connecting portion 800, which is less likely to snag as it is pulled through the anchor structure (100, 200, 300). Pulling on first suture end 822b may lock connecting portion 800. Pulling on first suture end 822b may pull second suture 130 along the path defined by first suture 820, thereby displacing first suture 820 and forming a knotless locking structure similar to those described herein.The connecting portion 800 may be pulled entirely through the anchor structure (100, 200, 300) to sever the second suture 130, thereby detaching the connecting portion 800 from the structure (100, 200, 300). Figure 9C depicts the circuit or pathway of the anchor structure 300 with the connecting portion 800 pulling the second suture 130 through the deployed anchor 102' prior to detachment of the connecting portion 800. This connecting portion 800 may be used to capture and pull a repair suture through any of the structures disclosed herein.
[0085] The mechanical connection between the first and second sutures has a smaller profile (cross-section) compared to a double-over suture loop. The finger flap mechanism is essentially two cross-sections of suture, while a double-over suture loop is essentially four cross-sections of suture. The reduced cross-section of the suture makes it easier to pull the suture of the present invention through the implant structure. In other embodiments, the connection can be reversed so that the first suture extends into and along the cannula of the second suture.
[0086] Returning to structures including looped ends, FIG. 10A illustrates a prior art suture capture structure 1100 that may be prepared by insertion through a representative surgical device aperture 1111, such as between the braided walls of an anchor 102, and / or by insertion through a cannula 137 as disclosed herein. The surgical device 1110 is shown in a representative or simplified form, including only a representative aperture, with other features or portions of the device omitted for ease of understanding. The prior art suture structure 1100 may include at least one loop 1105 (which may be looped end 122a) formed by looping a suture end to form a knot 1106. The knot 106 may be a sliding or non-sliding knot as known in the art, thus correspondingly providing either an adjustable or static loop. The knot 1106 essentially increases the cross-section of the structure locally, as shown by cross-section D2. Additionally, although a single length of suture may have a cross-section D3, when the loop 1105 is collapsed for delivery through the opening 1111, the cross-section may essentially double, as described herein with respect to Figures 7A and 7B. Now consider the situation where the suture structure 1100, including the loop 1105 and knot 1106, is pulled through the opening 1111 of the device 1110, and the opening 1111 has an opening size D1. This occurs in the knotless soft anchor structures disclosed herein when the looped end 122a is pulled through the deployed anchor 102' and through the cannula 137. Although the aperture 1111 may easily slidingly receive with little resistance a length of the suture structure limited to only a single cross-section D3, the suture end 1108 may require an auxiliary pulling force (F) from the user to pull the knot 1106 and loop 1105 through the aperture 1111. As surgical devices evolve to include more compact profiles with smaller aperture sizes (D1), maintaining an acceptable limit for this auxiliary pulling force becomes more difficult.Too much pulling force can damage the structure 1100, the local tissue, or the device 1110. Too much pulling force can cause discomfort to the user's hand and can cause problems with on-site disinfection as the glove may tear. Too much pulling force can require a tool to apply the force, which can result in additional cost or tooling.
[0087] FIG. 10B illustrates another prior art suture capture loop structure 1120 that may be prepared, in this case with a suture threaded through a representative surgical device aperture 1111. Again, the illustrated surgical device 1110 is in a representative or simplified form, including only the aperture, with other features omitted for ease of understanding. The suture structure 1120 may include a hollow passageway, cannula, lumen, anchor, or suture and may have a cross-section D4. The suture structure 1120 may include at least one loop 1125 formed by looping a suture end 1126 and extending a portion of the suture end 1126 into and along a hollow lumen to form a joint 1150. The joint 1150 essentially locally expands the cross-section of the structure, expanding it from the as-prepared cross-section D4 to a cross-section D5. Additionally, although a single length of suture may have cross-section D4, by folding loop 1125 to pass through aperture 1111, this cross-section may essentially double, similar to loop 1105. Returning to the exemplary situation where suture structure 1120, including loop 1125 and joint 1150, is pulled through aperture 1111 of device 1110, aperture 1111 having aperture size D1. Although aperture 1111 may easily and slidingly receive the length of the suture structure limited to only single cross-section D4 with little resistance, additional pulling force (F) from the user may be required to pull the expanded region, including joint 1150 with cross-section D5 and loop 1125, through aperture 1111. As with the previously disclosed prior art devices, this increased pulling force may cause problems during use similar to those listed above.
[0088] Although the joint 1150 may define a smoother or tapered transition in cross section compared to the knot 1106, the inventors have found that this transition in cross section (from D4 to D5) still results in difficult forces for the operating opening. This transition defines a discontinuity or bulge, which may require an unacceptable increase in pulling force in some surgical devices. More specifically, the inventors have found that the greatest pulling force is required upon initial introduction of the discontinuity or bulge into the opening 1111, and that after entry into the opening entrance (assuming the opening 1111 has a constant opening size along the opening 1111), the pulling force, while still high, may be less than during initial introduction.
[0089] Reducing the suture size, or cross-section (D3, D4), to address these shortcomings can introduce other problems. For example, smaller cross-sections can cause discomfort to the user's hand when pulled, form tears through the repair tissue, or break under operational loads. During operation of the knotless soft anchor structure, high loads may be desired to deploy the soft anchor and achieve robust fixation to the bone tissue. Such high loads may require a larger suture cross-section.
[0090] One embodiment of a transfer member structure 1200 that addresses the shortcomings of structures 1100, 1120 is illustrated in FIGS. 11A, 11B, and 11C by illustrating the structure. Structure 1200 may begin with a length of suture defining a braided body that may include two lengths 1210, 1220, which may be distinct from one another. First length 1210 may be cannulated (hollow lumen, or longitudinal passage) and may define a first cross-section CS1 substantially along its length. First length 1210 may be formed by a first number of braided strands, which may be between 8 and 32 braided strands. Second length 1220 may be of a smaller cross-section (CS2) substantially along its length and may include braided strands through its core, thus not having a longitudinal passage along its length. The second length 1220 may be formed by a second number of braided strands, which may be between 8 and 32. The first length 1210 may have a greater number of braided strands than the second length 1220. In some embodiments, the first length 1210 may include 16 strands, and the second length 1220 may include 8 strands. The first cross-section CS1 may be larger than the second cross-section CS2. The first length 1210 may be similar to a size 2 suture, while the second length 1220 may be similar to a size 2.0 suture. A transition portion 1230 between the first and second lengths (1210, 1220) is tapered, with a transition portion first end 1230a extending directly from the first length 1210 and a transition portion second end 1230b extending directly from the second length 1220. The first length and the second length may share the same braid, whereby some braid strands are located in both sections and form a continuous braid across both sections.
[0091] 11B , a loop structure (such as looped end 122a) may employ a capture member 1240 threaded along and within the longitudinal passage 1211, and the capture member 1240 may also extend along the transition length 1230. The capture member 1240 may be a thin, flexible nitinol wire having a loop 1245 at its operative end. The capture member 1240 is configured to operatively couple to the second length 1220 and to pull the end 1222 of the second length 1220 into and along the longitudinal passage 1211. The capture member 1240 may include a capture loop 1245 at one end, and a second end 1246 of the capture member may extend directly from the open passage end 1212 of the longitudinal passage 1211. Other means in the construction may include forcing second length 1220 along a path indicated by capture member 1240 .
[0092] The capture member 1240 is used to form a joint loop 1270 (FIG. 11C) where the joint 1280 extends along the first length 1210 and defines a loop 1270 for attachment to the repair suture (130) and a joint 1280 having a joint working length, hereinafter referred to as "SL." The SL is the length defined by the surgical device and its working aperture through which the transfer member structure 1200 extends. The SL may be the entire length of the first length 1210 (as shown), extending from the transition portion 1230 to the open lumen end 1212 of the second length. Thus, in this example, the first length 1210 is the length defined by the surgical device and its working aperture through which the transfer member structure 1200 extends. In other examples (described below), the end 1222 of the second length may terminate within the longitudinal passage of the first length at a location axially spaced apart from the end 1212. In other words, SL may be axially shorter than the axial length of the first length, but still have a length as described herein.
[0093] Structure 1200 is configured to avoid the difficult buildup of forces that may be experienced when transporting a transport structure having a loop through an operating aperture (as defined herein). Avoiding this buildup of forces is achieved by several features, which individually may partially contribute toward reducing or mitigating this large transport force. For example, joint 1280 is formed with the reduced cross section (CS2) of second length 1220 coaxially disposed within the longitudinal passage of first length 1210, thereby limiting the expansion or bulging of joint 1280. Preferably, no portion of first length 1210 extends along itself or along longitudinal passage 1211. Second, joint loop 1270 preferably includes only second length 1220, which preferably has a smaller diameter than first length 1210. This reduces the resulting collapsed cross section of loop 1270 as it is pulled through any operating aperture. More specifically, the capture member 1240 (and thus the second length 1220) may preferably extend between the braided strands at a location 1271 immediately adjacent to the transition portion 1230. Preferably, the capture member 1240 (and thus the second length 1220) may extend between the braided strands at a location 1271 closer to the second end 1230b of the transition length 1230 compared to the first end 1230a. This may avoid or reduce bulging in cross section along the transition portion 1230. This may result in the formation of a joining loop 1270 formed entirely from the second length 1220 having a cross section CS2 that is smaller than the cross section CS1 of the corresponding first length. In some embodiments, the SL may include a substantial portion or all of the transition portion 1230. In some embodiments, the SL may include all of the transition length 1230 and may extend slightly apart between the braided strands along the second length 1220 to ensure that the loop 1270 is completely formed from the second length 1220.
[0094] Additionally, the joint working length SL is configured to be long enough relative to the path through any of the operating apertures of the surgical device so that none of the joint ends 1282 are introduced or pulled into any entrance of any of the operating apertures during operation of the surgical device. An example of this is shown in FIG. 11D , where the joint length has been assembled to an exemplary surgical device 1110, which, according to the previous figure, has an aperture 1111. When assembled, the aperture 1111 is axially closer to the loop 1270 along the structure 1200 than the end 1282 of the joint 1280. When a force is applied to pull the loop 1270 into the aperture 1111, no bulge or discontinuity, such as that associated with the joint end 1282, is introduced into the aperture 1111. Because it has been found that a maximum load is required to introduce or penetrate any discontinuities in suture cross section associated with the bond, bond length SL need only be slightly longer than distance 1290. Stated another way, at least a portion of bond 1280 is preferably disposed within any working apertures as defined herein for the surgical device.
[0095] Turning now to the other end, the joining length SL may extend entirely along the entire first length 1210. In other embodiments (described below), the capture end 1246 may extend between the braided strands both axially spaced from the transition section 1230 and also axially spaced from the end 1212. Thus, the joining length SL may be an axial segment of the first length 1210. The end edge 1222 of the second length 1220 preferably remains completely enclosed within the longitudinal passage 1211 of the first length 1210.
[0096] In some embodiments, the transfer member structure 1200 forms a static loop 1270 in that the perimeter length is fixed under normal operating loads. The bond 1280 may have a length that is long enough to frictionally resist sliding of the loop 1270 so as to resist size changes under normal operating loads.
[0097] An exemplary system that may include delivery member structure 1200 is shown in Figures 12A and 12B, which illustrate a tissue repair system 1250 having multiple exemplary working apertures. While tissue repair system 1250 may include a knotless locking soft anchor structure similar to structure 300, this is an exemplary structure, and any structure disclosed herein may benefit from the joining loop delivery structure 1200 using similar concepts. System 1250 may include an insertion instrument 1255 for inserting tissue anchor 102 into the target bone. Tissue anchor 102 may include repair suture 130 including cannula 137 and deployment / delivery suture structure 1200 extending through anchor 102 and through cannula 137.
[0098] The insertion tool 1255 may define at least one shaft having an elongated bore 1260 therealong that may define a first working aperture, as defined herein. The tissue anchor 102 may define a tubular body that may include a lumen 105 that may define a second working aperture, as defined herein. In this example, the structure 1200 may be repeatedly woven between the braids 110 in the braided wall of the anchor 102, thus defining the gaps between the braids as well as the working aperture of the system. Additionally, the repair suture 130 may define a braided body having a cannula 137, and the delivery structure 1200 may extend into and along the cannula of the repair suture 130 for a knotless locking repair, the cannula also potentially defining the working aperture.
[0099] To briefly discuss the multiple working apertures listed in this example, it is important to distinguish between working apertures and all openings in the system through which the structure 1200 may slide. In operation, some openings (tunnels, holes, openings) in the system 1250 may be sized to slidingly receive the suture structure 1200, including the loop 1270, therethrough while offering minimal or no resistance to discontinuous or bulging portions thereof. For example, the hole 1254 may be an aperture as described herein and therefore not be a working aperture as defined herein. Furthermore, an aperture in the formed state may not define a working aperture, but may become one in operation or when assembled. For example, the inner hole 1260 may also accommodate the repair suture 130, reducing the available opening size so that the hole 1260 can be adjusted to the working aperture when the repair suture 130 is positioned along the interior. Additionally, the apertures may be varied to provide operational apertures during operation of the system 1250. For example, when the soft anchor 102 is in a first configuration, the first configuration may be an elongated configuration as shown in FIG. 3A and the gaps between the braids 110 may be loose enough or large enough to provide little or no resistance to the bulging created by the bonds 1280 and bond loops 1270, but upon deployment of the anchor, the deployed anchor 102′ may change configuration and bundle, and the anchor braids 110 may change orientation to define smaller and denser apertures, which may provide operational apertures as defined herein.
[0100] 12A and 12B, the transport structure 1200 can extend through the anchor 102 (FIG. 12A), along the hole 1260 (FIG. 12A), through the handle 1256 (FIG. 12B), and can be wrapped around the hub 1257 (FIG. 12B). FIG. 12B is a cross-sectional view of the handle end of an insertion tool 1255 that can have an internally threaded shaft tensioning mechanism. A rotatable knob 1258 is mounted on the rear or proximal end of the handle 1256. A threaded block 1259 can be mounted axially along the handle 1256, with the threaded block 1259 threadably coupled to a cavity in the knob 1258. The knob 1258 includes internal female threads to receive the threaded block 1259. As shown here, the suture structure 1200 and the repair suture 130 extend proximally from the hub 1257; however, when prepared, the repair suture 130 and structure 1200 (or any other deployment member 120) may extend along the holes 1260 and be wrapped around the hub 1257. Thus, rotating the knob 1258 retracts the block 1259, applying tension onto the suture structure 1200 and onto the second suture 130, thereby deploying the anchor 102.
[0101] During a procedure, after deploying the anchor, repair suture 130 may be detached from hub 1257 and tied to tissue 150 ( FIG. 3B ), then pulled along itself using delivery structure 1200. This may involve first deploying anchor 102 within the target tissue using insertion tool 1255 before withdrawing repair suture 130 and structure 1200, including loop 1270, through inner bore 1260 and distal opening 1251. In cases where shaft bore 1260 defines a working opening (whether or not a repair suture is present), it may be preferable for the joint length (SL) to have a length that extends from the joint loop (point A), along shaft bore 1260, along structure 1200, along anchor 102, and through anchor 102, including back through cannula 137 to bore 1260, so that joint end 1222 is located at at least point B. This defines a joint working length SL that prevents the joint end 1222 from being pulled into the entrance 1260 of the hole 1260 .
[0102] Continuing with another example, repair suture 130 may define at least one cannula 137 defining a locking passage for knotless, locked repair. Cannula 137 may include an entrance 137b defined by an end through which loop 1270 is introduced during operation of system 1250, more specifically, by an end through which loop 1270 is introduced when pulling repair suture 130 through cannula 137. In some exemplary systems, bore 1260 may not be an operating aperture, and thus, bonding working length SL may extend further along cannula 137, at least beyond entrance 137b. In this example, SL preferably extends from point A (FIG. 12B) to at least point C (FIG. 12A). Notably, bonding length SL to point D is also functional in this example.
[0103] In some tissue repair systems, the transport member structure 1200 may extend between the braided strands 110 of the tissue anchor. For example, as shown in Figure 12A, the transport member structure 1200 may be woven between the braided strands of the anchor 102 along the side of the anchor, and the openings between the braided strands 110 may define the working openings.
[0104] There may be other advantages to having the bonded length extend throughout the entire anchor system to point B. The inventors have also discovered that forming a bond along the suture can advantageously increase the ultimate tensile strength of the suture without increasing the diameter of the suture when two different diameters (or the like) are employed. Because the second length 1220 has a smaller diameter (or the like), the bond does not significantly expand the OD of the first length 1210. In systems where the transfer member structure 1200 is also the deployment member, this may allow for a greater tensile load to be applied to the deployment member, and therefore the deployed soft anchor 102′ may have a stronger pullout force. For example, anchoring of the soft anchor 102 relies on applying a certain amount of tension to the deployment member threaded through and along the anchor 102. These deployment members act like drawstrings; applying tension to them in combination with the rear locking member 1261 bunches the anchors 102 into an expanded, deployed state. The greater the tension on the deployment members, the denser the anchor bunch will be, which can correlate with stronger anchoring (greater pull-out force) within the target tissue. This tension may be limited by the ultimate tensile strength of the deployment members, and the flexible member is limited in size to fit through the anchors and device. In this system, the transfer member structure 1200 may also function as a tensioning or deployment member. The inventors have found that bonds can increase the ultimate tensile strength of the suture, such that increased tension can be applied to deploy the anchors 102 without breaking the deployment member / transfer member structure 1200, provided the bonds extend along the entire length where tension is applied. Thus, the anchors 102 may be more strongly anchored within the target tissue.In the exemplary system, assuming tension is driven at or adjacent points A and B along the structure, when the suture structure 1200 is wrapped around the hub 1257, the bond length portion SL preferably extends continuously from point A through the anchor to point B without any interruptions.
[0105] Thus, a method of tissue repair may include providing a system 1250 having a transfer member structure 1200 with a joint 1280 having a joint working length SL extending through all of the working apertures as defined herein. The anchor 102 may be inserted into a first tissue, which may be bone. By applying tension proximally to both ends of the structure 1200, the anchor 102 may be deployed within the first tissue. Applying tension along an uninterrupted length of the joint working length SL may apply greater tension, which, in combination with the rear locking member 1261, may increase the pullout strength of the deployed anchor 102′. For example, tensions of up to 200 N may be applied. Tension may also be applied to the repair suture 130 simultaneously to deploy the anchor 102 within the first tissue. The repair suture 130 and structure 1200 may then be removed from the anchor insertion tool, including pulling the loop 1270 distally through the tool hole 1260. The bore 1260 may define a working aperture, and the joint length SL, when prepared, may be positioned along the bore 1260. The joint 1280 may extend twice along the bore 1260, extending toward and through the anchor 102 and extending back proximally along the bore 1260.
[0106] Thereafter, with the instrument removed, repair suture end 130 may be operatively coupled to repair tissue 150 and then threaded through joint loop 1270. Loop 1270 coupled to end 136 may then be pulled through deployed anchor 102' and through at least one cannula 137 of repair suture 130. Deployed anchor 102' may include a working aperture. Joint 1280 in the primed state may extend through cannula 137 in the primed state. Joint length SL is sufficiently long so that joint 1280 is not introduced into any of the defined working apertures when loop 1270 is pulled through the working apertures. The bond lengths SL are sufficiently long so that, upon pulling the loops 1270 through the repair suture cannulas 137, the bond 1280 is driven from a first position, where the bond 1280 is coaxially disposed within the cannula 137, to a second position, where the bond 1280 is removed from the cannula, so that the bond is not initially introduced into the repair suture 130 as it is pulled through it. In some embodiments, the SL preferably extend in their entirety through all of the repair suture cannulas 137 when provided.
[0107] Joint length SL is a function of the length of the surgical device through which joint 1280 extends during operation of the surgical device. For example, in an arthroscopic device that can place an anchor, such as anchor 102, in a shoulder bone, insertion tool 1255 may be 5 to 10 inches (127 mm to 254 mm) long, and joint 1280 may be at least 10 inches (254 mm) long to extend along the shaft bore 1260 of the insertion tool, through anchor 102, and through cannula 137. Joint 1280 may be closer to 20 inches (508 mm), which is long enough to extend along the shaft bore twice so that both ends of the joint are at the proximal end of the insertion tool.
[0108] FIG. 13 illustrates another suture structure 1300, including a first length 1310 similar to portion 1210. Suture structure 1200 includes two joining loops 1370a, 1370b formed from second lengths 1320a, 1320b, which may be similar to second length 1220. In essence, structure 1300 is similar to structure 1200, with a second, similar, or mirrored, joining loop at each end of the structure. Structure 1300 includes first joining loops 1380a, 1380b with corresponding joining working lengths WLa, WLb. Each working length may be the same as the other, or may be a different length. Returning to exemplary system 1250, loop 1370a may be configured to couple to repair suture 130 and to pull repair suture 130 through cannula 137, such that first splicing working length portion WLa may be long enough to extend through all of the entrances in all of the working apertures as defined herein when assembled. First splicing working length portion WLa may have a length similar to splicing working length portion SL of structure 1200. Second splicing working length portion WLb may be configured to be pulled only through shaft bore 1260 and therefore may have a length shorter than first length portion WLa and may be long enough to extend through bore 1260 when prepared.
[0109] Having two loops 1370a, 1370b, like structure 300, can cause confusion during operation of the system. Distinguishing one loop from another can be important to ensure repair suture 130 is pulled through anchor 102 in a targeted direction. Accordingly, each loop 1370a, 1370b may have different markings or a different color indicator on its upper surface. In some exemplary embodiments, transfer loop 1370a, which is configured to couple to repair suture end 130 and pull repair suture end 130 through the anchor and through cannula 137, may have the same markings, indicators, and / or colors as the markings, indicators, and / or colors along repair suture 130. In some embodiments, loop 1370b may be operably coupled to a tensioning handle or tool (not shown), which may assist in pulling structure 1200 through the system. The tensioning handle may include markings, indicators, and / or colors that correspond to the markings, indicators, and / or colors of the second loop 1370b.
[0110] Referring now to FIG. 14 , another approach for managing the force required to apply tension along a flexible member is disclosed. Generally, this approach involves adding a length of flexible material to the end of the flexible member, defining a handle cross-section. This can be advantageous in place of, for example, structure 1200, or in addition to, for example, structure 1200. This may also be added to any tensioning member (a member intended to be tensioned during operation). Managing the load on the operator's hand while applying tension through a small diameter flexible member is often accomplished by wrapping the flexible member around a surgical tool or handle, thereby reducing any pressure concentrations on the operator's hand. Tension on the flexible member may, for example, deploy a device, reduce the loop circumference of a suture, or transport another device or suture through the device or assembly. This may require the use, sterilization, and / or purchase of additional components. The approach illustrated in Figure 14 involves adding a length of flexible member having a handle cross section 1410. This additional flexible member may be continuous with the remainder of the flexible member, and may be a continuous braided portion of the flexible member.
[0111] FIG. 14 illustrates a transfer member structure 1400 that may be similar to structure 1200 at a first end with an additional handle cross-section 1410 added. The handle cross-section may be a third cross-section 1410 that is larger than the first cross-section 1210 and the second cross-section 1220 of structure 1200. The third cross-section 1410 may be a length of suture that is a suture tape. As disclosed herein, the forces to pull a transfer member (120, 1200) through a knotless structure may be uncomfortably large. These forces may be applied by hand. Therefore, the transfer member (120, 1200) may have an operating cross-section configured to handle this operation and to handle interaction with a device or assembly. The transfer member (120, 1200) may have a variable cross-section, including an end 1410 having a length (LT) and a larger or wider cross-section that defines a handle cross-section. The handle cross-section may be a wide, flat shape, such as a suture tape, and is sized and shaped to be a more ergonomic portion of the member along which tension is intended to be applied during operation. The handle cross-section may be of sufficient length (LT) ranging from 4 inches to 10 inches (101.6 mm to 254 mm) to fit within or wrap around an operator's hand and reduce discomfort during tensioning. The handle cross-section may include cross-sectional dimensions from 0.25 inches to 1 inch (6.35 mm to 25.4 mm). The variable suture cross-section may be a continuously braided suture rather than separate suture cross-sections attached after formation. The handle cross-section is disposed external to the anchor 102 and is pulled away from the anchor 102.
[0112] As shown in FIG. 14 , the transfer member structure 1400 may include a first end formed within a capture loop 1270 for selectively coupling to a second suture, a joining working length WL extending through the tissue anchor, and a handle section 1410 located at an end opposite the first end. By applying tension on the transfer member structure 1200 via the handle section 1410, the second suture can be pulled / transferred through the tissue anchor. The handle section 1410 may remain external to the anchor 102 and may be detached from the anchor after use. The handle section 1410 preferably remains external to the anchor 102 and external to the cannula. The transfer members (120, 1200), and therefore the handle section 1410, may be completely detached from the tissue repair system in the final knotless locking and repair configuration.
[0113] Disclosed herein is a flexible member of variable cross-section that can shuttle a repair suture through an opening in a surgical device, which may contain an anchor, cannula, or suture. The flexible member may include a first end including a loop for selectively coupling to a repair suture. The flexible member may include a second end. The flexible member may have a length between the first and second ends, the length configured to extend through the surgical device and be operably coupled to the surgical device. The first end, the second end, and the length between the first and second ends may all be formed as a continuous braid. Tension on the second end may shuttle the first end, and thus the repair suture, through the surgical device. The second end may define a cross-section that is larger than the corresponding cross-section of the length, thereby defining an ergonomic or handle cross-section, where ergonomic is defined as the length of the second end having a cross-section that reduces pressure concentrations on a user's hand.
[0114] Disclosed herein is a suture structure including a first end, a second end, and a working length of suture extending between the first and second ends, the working length configured to extend through a surgical device. The first end, second end, and working length form a continuous braid. The second end defines an ergonomic cross-section that is larger than the corresponding cross-section of the working length, the second end configured to be grasped as a handle for applying tension onto the suture structure, the ergonomic cross-section configured to limit handle pressure concentrations on a user's hand.
[0115] Anchor opening In some embodiments, controlling the working aperture size may also be beneficial when it comes to reciprocating the flexible member through the aperture with moderate force. For example, referring to FIG. 3A, one working aperture may be the proximal lumen 105 through which the suture 120 may extend. Alternatively, the structure 1200 may extend therethrough. During preparation of the braided anchor body 102, the axial length may be trimmed and heat-sealed. This may reduce fraying of the braid. The proposed approach describes a tubular soft anchor formed in an open configuration with a sealed working aperture. During at least the step shown in FIG. 4D, the end may be at least partially reopened by the needle tool 450 to draw the delivery structure (120, 1200) and repair suture therethrough. This tends to create small openings, which may result in unnecessary additional strain for reciprocating the suture and / or structure (120, 130, 1200) therethrough.
[0116] Thus, in some embodiments, the braided body of anchor 102 may be trimmed and heat sealed to form an opening, rather than being heat sealed to form a closed, straight end edge, which may be formed at one or both ends (112, 116) of anchor body 102, preferably at least at proximal end 116.
[0117] The method, shown in Figures 15A and 15B, can include providing a braided body 1550 and inserting a gauge pin 1510 into a central lumen 1505 of the braided body 1550, where the braided body 1550 is prepared to be an anchor 102 having a lumen 105. The pin 1510 is configured to keep the lumen 1505 open. Thus, the gauge pin 1510 is sized to fit within and support the lumen 1505. The outer periphery of the braided body 1550 is then held by a collet 1520, thereby constraining the OD of the braided body 1550. Without the collet 1520 (only the gauge pin), the fibers may splay outward in an uncontrolled manner, which can cause problems when loading into the bore of an insertion tool. A heat knife 1580 may then travel around the braided body 1550 to heat seal the strand / fiber ends and trim the braided body to define the open end of the anchor 102. Figure 15B illustrates the open annular sealed anchor end 1555 with the pin 1510 still inserted. The braided body 1550 with the trimmed and sealed end may then be turned inside out, and the process repeated to trim the opposite end of the body to form the anchor 102.
[0118] FIG. 15C illustrates an anchor 1570 that may be similar to anchor 102, with a distal end that is heat-sealed to form a closed end 1575 to form a straight distal edge, and the anchor 1570 may have a proximal open end 1580 that is heat-sealed to define an open proximal end of lumen 105 (1505), with exemplary suture ends 120 / 130 extending through the proximal open end 1580.
[0119] Disclosed herein is an anchor for securing tissue to bone or tissue to tissue, the anchor defining a soft anchor implant 102 comprising a braided tube containing a braided suture 110. The soft anchor implant 102 may have a first configuration for insertion into a cavity in an animal or human bone or tissue and a second configuration having a laterally expanded configuration for securing the anchor within the bone or tissue. The braided tube may define a central lumen 105 terminating in an occluded distal end 1575 and an open proximal end 1580 of the tube, the open proximal end defining a working opening having an annular sealing edge 1555. The annular sealing edge 1555 may define a working opening sized to slidingly receive a multi-section delivery suture structure (120, 1200) therethrough without excessive delivery force to slide the suture structure therethrough.
[0120] A manufacturing method for all suture anchors is also disclosed, the method including providing a tubular body formed from braided threads or fibers; inserting a gauge pin into a central lumen of the tubular body; engaging the outer circumferential surface of the tubular body with a collar at a location along the tubular body that axially overlaps the gauge pin; and cutting the tubular body adjacent the end of the collar to form an open free end of the tubular body, the cutting including means for forming an annular sealing edge at the open free end, the sealing edge configured to resist fraying of the fibers.
[0121] One embodiment of a repair suture 1600 with multiple segments having different cross-sections is illustrated in FIG. 16A. Each segment (1610, 1620, 1630, 1640) may be shaped according to its function. Segment 1610 may be a flexible member with a cannula 1612 for forming a locking passage, similar to cannula 137 in repair suture 130. Continuously braided with segment 1610 may be segment 1620 of a larger cross-section, which may be a tape or mini-tape. The number of strands between segments 1610 and 1620 may be the same, or may differ only in shape. This segment 1620 may engage the repair tissue with a large footprint and avoid cheese-wiring (failure) of the repair. A third segment 1630 may extend from tape segment 1620. In some embodiments, segment 1630, like segment 1610, may be a flexible member having a hollow lumen and may define a transition portion of repair suture 1600. In some embodiments, the third segment may have a braided core. Segment 1640 may be the smallest segment of repair suture 1600 and is configured to be captured by delivery structure loops (122a, 1270). As such, segment 1610 is sufficiently long to be easily captured without being accidentally pulled out of loops 122a, 1270.
[0122] Referring to FIG. 16B, first segment 1610 may be long enough to extend through anchor 102 and form locking knot 1632 and may be 3 to 5 inches (76.2 to 127 mm) long. Segment 1610 may be a #2 suture with 16 to 32 braided strands along it around a hollow core. Segment 1620 may be a tape up to 0.25 inches (6.35 mm) wide and long enough to extend around the target tissue for the targeted procedure. Segment 1620 may be continuously braided with segment 1630, which may also be a #2 suture with 16 to 32 braided strands along it. Once in the repair configuration, either tape segment 1620 or third segment 1630 may extend through anchor 102 and through cannula 137. The additional tapered segment may have a reduced strand count compared to the remainder of the repair suture 1600 and may have a diameter equivalent to that of a 2.0 suture. Tapered segment 1640 is preferably not positioned along cannula 137 in a knotless locking configuration because such a reduced diameter would not allow for effective knotless locking within cannula 137.
[0123] One exemplary method may include employing a knotless soft anchor structure for meniscal root repair, which may be all-internal. The knotless suture anchor structure 100, 200, 300 may be implanted into the tibia at an insertion location relative to the meniscal root. The repair suture 130 may then be threaded as a mattress stitch through the meniscal tissue. The repair suture 130 may then be tied to the transfer suture 120. The repair suture 130 may then be pulled through the structure 100, 200, 300 via the transfer suture 120 or structure 1200, thereby removing the transfer suture 120 or structure 1200 from the structure 100, 200, 300. The tension on the repair suture 130 may pull the meniscus (or ligament) against the bone surface. This approach is compatible with curved guides and drills, allowing easier access to the implantation site than current approaches using externally drilled tunnels and buttons. Furthermore, because the constructs 100, 200, 300 are soft and made of sutures, complications are less likely to occur when the tunnel trajectory penetrates the tibial cortex compared to rigid anchors. Another exemplary method disclosed herein is a MPFL reconstruction method, in which the constructs 100, 200, 300 may connect the implant to the patella. Repair sutures 130 may be connected to the implant tissue. Those skilled in the art will recognize that the present disclosure may be embodied in other specific forms without departing from its spirit or essential characteristics. Accordingly, the foregoing examples are not intended to limit the disclosure described herein and are to be considered in all respects illustrative. The scope of the disclosure is, therefore, indicated by the appended claims, rather than by the foregoing description, and all changes that come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. [Additional note 1] 1. A knot-free tissue repair structure, comprising: an anchor body formed from a flexible 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 cannulated length, the first end being fixedly attached to the anchor body, the cannulated length being woven along and through a first side wall of the anchor body, and the second end extending proximally from the proximal end of the anchor body; a deployment suture repeatedly woven through and along the anchor body and also within the cannulated length of the repair suture woven along and through the first side wall of the anchor body; tension on the deployment suture is configured to change the anchor body to a deployed configuration; a deployment suture configured to operably couple to the second end of the repair suture and to pull the second end of the repair suture back through the anchor body and through the cannulated length, thereby forming a repair loop, and wherein tension on the second end of the repair suture is configured to lock the repair loop in a knotless manner. [Additional note 2] 2. The knotless tissue repair structure of claim 1, wherein the deployment suture is configured to operably couple to the second end of the repair suture when the anchor body is in the deployed configuration and to retract the second end of the repair suture through the anchor body. [Additional note 3] 2. The knotless tissue repair structure of claim 1, wherein the repair suture is fixedly attached to the anchor body via two axially overlapping knots formed by the first end of the repair suture, the two axially overlapping knots being located exterior to the anchor body. [Additional note 4] 2. The knotless tissue repair structure of claim 1, wherein tension applied to both the second end of the repair suture and the deployed suture is configured to cause the anchor body to change to the deployed configuration. [Additional note 5] 2. The knot-free tissue repair structure of claim 1, wherein the anchor body defines a tubular braided body having an internal lumen, the internal lumen having an open proximal end, and the repair suture and the deployment suture are both woven through the anchor body and both extend directly from the open proximal end of the internal lumen. [Additional note 6] 2. The knotless tissue repair structure of claim 1, wherein the repair suture includes a tape length segment extending from the cannulated length portion, the tape length segment being positioned outside the anchor body. [Additional note 7] 7. The knot-free tissue repair structure of claim 6, wherein the tape length segment defines a length portion that extends back through the anchor body and around the repair tissue when the repair suture is formed into a repair loop. [Additional note 8] 2. The knotless tissue repair structure of claim 1, wherein the deployment suture includes a bonding loop at a first end of the deployment suture, the bonding loop configured to bond to the second end of the repair suture, and the bonding loop having a bonding length that extends through all working openings of the knotless tissue repair structure. [Additional note 9] 9. The knotless tissue repair structure of claim 8, wherein the joint length extends entirely through the anchor body and entirely through the cannulated length of the repair suture. [Additional Note 10] 9. The knotless tissue repair structure of claim 8, wherein the attachment length extends entirely through the anchor body and entirely through the cannulated length and is operably coupled to a tensioning drive means of the knotless tissue repair structure such that tensioning the deployment suture applies tension to a continuous, uninterrupted length of the deployment member attachment length. [Additional Note 11] 9. The knot-free tissue repair structure of claim 8, wherein the deployed suture includes a first length segment that is cannulated and a second length segment that is smaller in diameter than the first length segment, the joining loop includes the second length segment, and the joining length portion includes both the first length segment and the second length segment that are coaxially arranged. [Additional Note 12] 1. A knot-free tissue repair structure, comprising: an anchor body formed from a flexible material having a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end, the anchor body being formed by braided strands; a repair suture having a first end, a second end, and a cannulated length between the first end and the second end, the first end being fixed relative to the anchor body, the cannulated length being woven along and through a first side wall of the anchor body, and the second end extending proximally from the proximal end of the anchor body; a deployment suture repeatedly woven between the braided strands through and along a second side wall of the anchor body and also within the cannulated length of the repair suture woven along and through the first side wall; tension on the deployment suture and the second end of the repair suture is configured to change the anchor body to a deployed configuration; When the anchor body is in the deployed configuration, the deployment suture is configured to operably couple to the second end of the repair suture and to retract the second end of the repair suture through the anchor body and also through the cannulated length woven through the first sidewall, thereby defining a knotless locking configuration. [Additional Note 13] 13. The knotless tissue repair structure of claim 12, wherein the repair suture includes a tape length segment extending from the cannulated length at a location along the repair suture exterior to the anchor body, the tape length segment defining a length sufficiently long to extend around the repair tissue and then back through the anchor body when in the knotless locking configuration. [Additional Note 14] 13. The knot-free tissue repair structure of claim 12, wherein the deployment suture includes a joint loop at a first end of the deployment suture, the joint loop defining a static loop and having a joint length extending through the anchor body and through the cannulated length. [Additional Note 15] 15. The knotless tissue repair structure of claim 14, wherein the attachment length extends through the anchor body and is operatively coupled to a tensioning drive of the knotless tissue repair structure such that tensioning the deployment suture applies tension to a continuous, uninterrupted length of the deployment member attachment length. [Additional Note 16] 1. A method for constructing a knot-free tissue repair structure, comprising: providing an anchor body formed of a flexible material having a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end, the anchor body being tubular and formed from braided strands; providing a repair suture having a braided wall and a cannulated length along said braided wall; inserting a first capture tool through the braided wall of the repair suture defining an entrance opening and then along the cannulated length and again through the braided wall defining an exit opening, the entrance opening and the exit opening being axially spaced apart along the repair suture and defining an axial length of a knotless locking passage; providing a deployment suture and pulling the deployment suture through the knotless locking passageway with a first end of the deployment suture extending from the entrance opening and a second end of the deployment suture extending from the exit opening; forming a weaving path through and along a first side wall of the anchor body using a second capturing tool; tensioning a second end of the repair suture and using the second capturing tool to deploy the second end of the deployment suture along the weaving path, thereby positioning the knotless locking channel with the deployment suture disposed therein along the weaving path, wherein the second end of the repair suture and the second end of the deployment suture extend from the proximal end of the anchor body; and pulling the first end of the deployment suture along another braided path disposed through the anchor body such that the first end of the deployment suture extends from the proximal end of the anchor body. [Additional Note 17] 17. The method of claim 16, further comprising fixedly attaching the repair suture to the distal end of the anchor body. [Additional Note 18] 18. The method of claim 17, further comprising forming an axially overlapping half-hitch knot in an end of the repair suture before inserting the first capture tool through the braided wall of the repair suture. [Additional Note 19] 18. The method of clause 17, further comprising inserting the first capturing tool directly adjacent to the axially overlapping half hitch knot. [Additional Note 20] 17. The method of claim 16, further comprising forming a locking passageway having an axial length approximately equal to a maximum axial length of the anchor body. [Additional Note 21] 17. The method of claim 16, further comprising pulling the second end of the repair suture until an entrance opening of the knotless locking passage is directly adjacent to the distal end of the anchor body, and using the second capturing tool to deploy the second end of the suture along the weaving path. [Additional Note 22] 17. The method of claim 16, wherein the anchor body is tubular defining a lumen therethrough, the lumen being open at the proximal end of the anchor body, and wherein forming a braided path through and along a first side wall of the anchor body using a second capturing tool comprises first extending a tip of the second capturing tool directly along the lumen a first axial distance into the open end of the lumen, then extending a second axial distance along an outer surface of the anchor body from between the braided strands of the first side wall to the outer surface, and then passing the tip of the second capturing tool back between the braided strands of the first side wall into the lumen. [Additional note 23] 23. The method of claim 22, wherein the first axial distance is a length that includes at least two braided strands of the anchor body. [Additional note 24] 23. The method of claim 22, wherein the first axial distance and the second axial distance are equal in axial length. [Additional note 25] 17. The method of claim 16, further comprising operably coupling the first and second ends of the deployment suture and the second end of the repair suture to a tension actuator of an insertion tool. [Additional note 26] 1. A method for repairing tissue with a knot-free tissue repair construct, comprising: Providing a knot-free tissue repair structure according to claim 1; inserting the knot-free tissue repair structure into the target tissue; deploying the anchor body by applying tension to the deployment suture to anchor the anchor body to the target tissue; tying the repair suture to the repair tissue after deploying the anchor body; tying the repair suture to the deployment suture; withdrawing the deployment suture through the anchor body when in a deployed configuration, thereby withdrawing the second end of the repair suture through the anchor body and through the cannulated length woven along and through the first side wall. and applying tension to the repair suture to lock the construct in a knotless manner. [Additional note 27] 27. The method of claim 26, wherein the deployed suture is removed from the knotless tissue repair structure by withdrawing the deployed suture. [Additional note 28] 27. The method of claim 26, wherein deploying the anchor body also includes applying tension to the second end of the repair suture simultaneously with applying tension to the deployment suture. [Additional note 29] 27. The method of claim 26, wherein the repair suture includes a tape length segment, and after the anchor body is deployed, the repair suture is tied to the repair tissue, thereby engaging the tape length segment against the repair tissue, and the deployed suture is pulled through the anchor body, thereby positioning the suture of the tape length segment through and along the anchor body. [Additional note 30] 1. A suture structure for assembly to a surgical device, comprising: a first length having a cannula therealong, the first length having a first diameter; a second length extending from the first length, the second length forming a static loop at a single end of the first length formed by extending the second length into and along the cannula of the first length, thereby defining a junction, the junction having a working length having a static loop end and an opposite end; A suture structure wherein, in an assembled configuration, the joint is positioned through and along the surgical device, including through and along the working aperture of the surgical device, and when the surgical device and the suture structure are transformed into a repair configuration, the suture structure, including the static loop, is driven translationally through the working aperture without the opposite end of the joint being introduced into the working aperture. [Additional note 31] 27. The suture structure of claim 26, wherein the second length defines a length having a smaller diameter than the first length. [Additional note 32] 27. The suture structure of claim 26, wherein the second length comprises a braided core. [Additional note 33] 27. The suture structure of claim 26, wherein the surgical device includes an all-suture tissue anchor and a repair suture, the repair suture being formed separately from the suture structure. [Additional note 34] 27. The suture structure of claim 26, wherein the repair suture has a hollow passage portion therealong, the joint extending along the hollow passage portion, and the hollow passage portion defining at least one of the working openings. [Additional note 35] 27. The suture structure of claim 26, wherein the bond extends along and through the tissue anchor from a proximal end of the tissue anchor to a distal end of the tissue anchor and from the distal end to the proximal end. [Additional note 36] 27. The suture structure of claim 26, wherein the surgical device includes an insertion tool for an implant, and the surgical device includes a shaft hole defining at least one of the working openings. [Additional note 37] 27. The suture structure of claim 26, wherein the bond extends along the entire length of the first length to the cannula open end of the first length. [Additional note 38] 1. A tissue repair assembly comprising: a suture structure including a suture formed from a braided body having a first length and a second length, the first length defining a longitudinally formed hollow passage, the suture structure including a loop formed by threading the second length through the braided body and along the longitudinally formed hollow passage, thereby defining a joint having a working length along the braided body, thereby defining a loop end and a joint end; a surgical device having at least one working aperture; a tissue repair assembly, wherein the working length is threaded along the surgical device and through the at least one working opening, and the joint working length is configured such that upon withdrawal of the loop through the at least one working opening, the suture structure is detached from the at least one working opening. [Additional note 39] 35. The tissue repair assembly of claim 34, wherein the second length of suture extends directly from the first length and defines a portion of the braided body having a smaller cross-section than the first length. [Additional note 40] 36. The tissue repair assembly of clause 35, wherein the second length comprises a braided core. [Additional note 41] 35. The tissue repair assembly of claim 34, wherein the surgical device includes a soft anchor and a repair suture, the repair suture being formed separately from the suture structure and the soft anchor. [Additional note 42] 38. The tissue repair assembly of claim 37, wherein the repair suture also defines a braided body having a hollow passageway therethrough, the hollow passageway defining one of the at least one working opening. [Additional note 43] 38. The tissue repair assembly of claim 37, wherein the joint extends along and through the tissue anchor from a proximal end of the tissue anchor to a distal end of the tissue anchor and from the distal end to the proximal end. [Additional note 44] 35. The tissue repair assembly of claim 34, wherein the surgical device includes an insertion tool for an implant, and the surgical device includes a shaft hole defining one of the at least one working openings. [Additional note 45] 35. The tissue repair assembly of clause 34, wherein the loop is a static loop. [Additional note 46] 37. The suture structure of claim 36, wherein the bond extends along the entire length of the first length and the second length extends along the hollow passage of the first length to an open end of the hollow passage of the first length. [Additional note 47] 1. A tissue repair assembly comprising: a delivery structure including a suture having a first length and a second length and formed from a braided body, the first length including a longitudinal hollow passage, the suture structure including a joining loop formed by threading a second end through the braided body and along the longitudinal hollow passage, thereby defining a joining working length along the braided body; a soft anchor having a repair suture operably coupled thereto, the repair suture also being formed from a braided body having a longitudinal hollow passage; A tissue repair assembly, wherein in the assembled configuration, the joint loop is located proximal to the soft anchor, and the joint is threaded along the soft anchor and also along a longitudinal hollow passage device of the repair suture. [Additional note 48] 44. The tissue repair assembly of claim 43, wherein the transport structure, including the joint loop, is configured to be pulled through the soft anchor and through the longitudinal hollow passage of the repair suture to remove the transport structure from the longitudinal hollow passage of the repair suture without the joint end of the working length being pulled into either the soft anchor or the longitudinal hollow passage of the repair suture. [Additional note 49] 45. The tissue repair assembly of claim 44, wherein the joining loop is formed entirely from the second length of the suture, the second length having a smaller cross-section than a corresponding cross-section of the first length.
Claims
1. 1. A knot-free tissue repair structure, comprising: an anchor body formed from a flexible 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 cannulated length, the first end being fixedly attached to the anchor body, the cannulated length being woven along and through a first side wall of the anchor body, and the second end extending proximally from the proximal end of the anchor body; a deployment suture repeatedly woven through and along the anchor body and also within the cannulated length of the repair suture woven along and through the first side wall of the anchor body; tension on the deployment suture is configured to change the anchor body to a deployed configuration; a knotless tissue repair structure, wherein the deployment suture is operably coupled to the second end of the repair suture and configured to form a loop of the repair suture by pulling the second end of the repair suture back through the anchor body and through the cannulated length to achieve the deployed configuration, thereby knotlessly locking the repair suture loop to the anchor body.
2. 2. The knotless tissue repair structure of claim 1, wherein the repair suture is fixedly attached to the anchor body via two knots formed adjacent the first end of the repair suture along the repair suture, the two knots being located exterior to the anchor body.
3. The knotless tissue repair structure of claim 1 , wherein tension on both the second end of the repair suture and the deployed suture is configured to cause the anchor body to change to the deployed configuration.
4. 10. The knotless tissue repair structure of claim 1, wherein the anchor body defines a tubular braided body having an internal lumen, the internal lumen having an open proximal end, and the repair suture and the deployment suture are both woven through the anchor body and both extend directly from the open proximal end of the internal lumen.
5. The knotless tissue repair structure of claim 1 , wherein the repair suture includes a tape length segment extending from the cannulated length, the tape length segment being disposed external to the anchor body.
6. 6. The knotless tissue repair structure of claim 5, wherein the tape length segment extends around the repair tissue secured to the anchor body when the repair suture is formed into a loop, and the tape length segment returns through the anchor body.
7. 2. The knotless tissue repair structure of claim 1, wherein the deployment suture includes a joining loop at a first end of the deployment suture, the joining loop configured to join to the second end of the repair suture, the joining loop having a joining length extending entirely through the anchor body and entirely through the cannulated length of the repair suture.
8. 8. The knotless tissue repair structure of claim 7, wherein the coaptation lengths extend entirely through the anchor body and entirely through the cannulated lengths and are operably coupled to a tensioning drive means of the knotless tissue repair structure such that tensioning the deployment suture applies tension to a continuous, uninterrupted length of the coaptation lengths.
9. 8. The knot-free tissue repair structure of claim 7, wherein the deployed suture includes a first length segment that is cannulated and a second length segment having a smaller diameter than the first length segment, the joining loop includes the second length segment, and the joining length portion includes both the first length segment and the second length segment that are coaxially arranged.
10. 1. A knot-free tissue repair structure, comprising: an anchor body formed from a flexible material having a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end, the anchor body being formed by braided strands; a repair suture having a first end, a second end, and a cannulated length between the first end and the second end, the first end being fixed relative to the anchor body, the cannulated length being woven along and through a first side wall of the anchor body, and the second end extending proximally from the proximal end of the anchor body; a deployment suture repeatedly woven between the braided strands through and along a second side wall of the anchor body and also within the cannulated length of the repair suture woven along and through the first side wall; tension on the deployment suture and the second end of the repair suture is configured to change the anchor body to a deployed configuration; a deployment suture operably coupled to the second end of the repair suture, the deployment suture being configured to retract the second end of the repair suture through the anchor body and also through the cannulated length woven through the first sidewall to place the anchor body in the deployed configuration, thereby defining a knotless locking configuration of the braided suture to the anchor body.
11. 11. The knotless tissue repair structure of claim 10, wherein the repair suture includes a tape length segment extending from the cannulated length at a location along the repair suture exterior to the anchor body, the tape length segment defining a length sufficiently long to extend around the repair tissue and back through the anchor body when in the knotless, locked configuration.
12. 11. The knot-free tissue repair structure of claim 10, wherein the deployment suture includes a joint loop at a first end of the deployment suture, the joint loop defining a static loop and having a joint length extending through the anchor body and through the cannulated length.
13. 13. The knotless tissue repair structure of claim 12, wherein the joint lengths extend through the anchor body and are operatively coupled to a tensioning drive means of the knotless tissue repair structure such that tensioning the deployed suture applies tension to a continuous, uninterrupted length of the joint lengths.
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