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WO2025034353A1 - Surgical constructs and methods of tissue fixation - Google Patents

Surgical constructs and methods of tissue fixation Download PDF

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Publication number
WO2025034353A1
WO2025034353A1 PCT/US2024/037688 US2024037688W WO2025034353A1 WO 2025034353 A1 WO2025034353 A1 WO 2025034353A1 US 2024037688 W US2024037688 W US 2024037688W WO 2025034353 A1 WO2025034353 A1 WO 2025034353A1
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WO
WIPO (PCT)
Prior art keywords
tissue
suture
soft
flexible coupler
surgical
Prior art date
Application number
PCT/US2024/037688
Other languages
French (fr)
Inventor
Joshua J. Best
Andrew K. OSIKA
Matthew R. HERRINGTON
Original Assignee
Arthrex, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Arthrex, Inc. filed Critical Arthrex, Inc.
Publication of WO2025034353A1 publication Critical patent/WO2025034353A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/04Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/04Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0406Pledgets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/04Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0409Instruments for applying suture anchors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/04Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0414Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having a suture-receiving opening, e.g. lateral opening
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/04Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0417T-fasteners
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/08Muscles; Tendons; Ligaments
    • A61F2/0811Fixation devices for tendons or ligaments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/08Muscles; Tendons; Ligaments
    • A61F2/0811Fixation devices for tendons or ligaments
    • A61F2002/0847Mode of fixation of anchor to tendon or ligament
    • A61F2002/0852Fixation of a loop or U-turn, e.g. eyelets, anchor having multiple holes

Definitions

  • a construct can create a knotless repair.
  • a construct as described herein can be self-locking and knotless.
  • a construct can include (i) fixation devices in the form of soft anchors that are knotlessly attached to (ii) a flexible coupler and are secured within a first tissue, and (iii) at least another fixation device attached to the flexible coupler and secured within a second tissue.
  • fixation devices in the form of soft anchors that are knotlessly attached to (ii) a flexible coupler and are secured within a first tissue, and (iii) at least another fixation device attached to the flexible coupler and secured within a second tissue.
  • FIGS. 1 and 2 illustrate an inserter with surgical constructs.
  • FIGS. 3-5 illustrate a surgical assembly.
  • FIGS. 3-13 illustrate a tissue repair with a surgical construct of FIG. 2. Docket No.2464.0185WO01 Arthrex Ref. No.2023-042-KHS-PCT [0007]
  • FIGS. 14-16 illustrate an inserter with another surgical construct.
  • the disclosure provides surgical adjustable loop constructs, suture loop mechanisms, in-line surgical repairs, and methods for securing a first tissue to a second tissue (for example, meniscus to bone) with a tensionable construct including adjustable, knotless, flexible, closed loops.
  • a tensionable construct including adjustable, knotless, flexible, closed loops.
  • the disclosure provides an all-suture tissue fixation construct.
  • An implant construct can attach or re-attach normal anatomical structures, tissue to tissue, bone to bone, and/or bone to soft tissue.
  • the construct can include a flexible coupler of a fixation device attached to one or more soft-suture anchors.
  • a length of flexible coupler can attach directly to soft-suture anchors and/or to a link/attachment of a soft-suture anchor.
  • the link/attachment can be a ring, a loop, a hoop, an eyelet, or any similar structure that allows attachment of the flexible coupler to soft-suture anchors.
  • a flexible coupler of an independent fixation device can be attached to a plurality of soft anchors to connect or link the soft anchors to the independent fixation device.
  • a flexible coupler can be attached in a knotless manner to a plurality of soft suture anchors placed within a first tissue for knotless, serial, all- suture fixation. The flexible coupler attaches to an independent fixation device placed within a second tissue.
  • the first tissue can be meniscus.
  • the second tissue can be bone.
  • the independent fixation device can be a hard anchor or a soft anchor.
  • the independent fixation device can be a tensionable anchor such as a tensionable soft-suture anchor.
  • the construct can be shrunk by pulling on the flexible coupler attached to the independent fixation device. The construct allows the user (for example, surgeon) to control the tension of the flexible Docket No.2464.0185WO01 Arthrex Ref. No.2023-042-KHS-PCT coupler on a first tissue (for example, meniscus, tissue fragment, or cartilage) to be attached to a second tissue (for example, bone such as tibial plateau).
  • a tissue repair system includes one or more fixation devices each in the form of a soft-suture anchor; and a flexible coupler slidingly attached to the one or more fixation devices, wherein the flexible coupler is further attached to an independent fixation device.
  • the one or more fixation devices are secured within a first tissue (for example, meniscus) and the independent fixation device is secured within a second tissue (for example, tibial plateau).
  • the system can further include an insertion device (a delivery device) for inserting/delivering the one or more soft- suture anchors within the first tissue.
  • a flexible coupler can be of either round and/or flat design.
  • a flexible coupler can be suture and/or tape.
  • a tissue repair system can consist essentially of suture such as ultrahigh molecular weight polyethylene suture.
  • a tissue repair system can provide knotless, serial, all-suture tissue fixation without any knots and with increased tissue fixation.
  • a construct can be employed to re-attach normal anatomical structures, i.e., a first tissue to a second tissue, such as soft tissue, tendon, ligament, and/or bone, to each other and/or any combination of one another, by employing a serial, sequential, knotless mechanism.
  • a flexible coupler can be a fixed length of suture and/or tape.
  • a construct can be employed as a stand-alone construct or with additional fixation devices, for example, attached to one or more additional implants, anchors, screws, etc.
  • FIGS. 1-5 illustrate structural elements of surgical assembly 100, 200, 300 (construct 100, 200, 300; surgical meniscal fixation construct 100, 200, 300; knotless construct 100, 200, Docket No.2464.0185WO01 Arthrex Ref. No.2023-042-KHS-PCT fixation system 100, 200, 300; system 100, 200, 300) formed of one or more fixation devices 50a, 50b, . . . 50n in the form of soft anchors connected by at least one flexible coupler 20 and attached to an independent fixation device 120.
  • FIGS. 6-13 illustrate exemplary steps of tissue repair 101 (FIG. 13) with surgical assembly 100, 200, 300.
  • FIG. 1 illustrates exemplary insertion device 70 (inserter 70; delivery device 70) with two exemplary implants 50a, 50b (fixation devices 50a, 50b) each in the form of soft anchors 50a, 50b.
  • One of the two implants 50a, 50b is illustrated loaded onto insertion device 70.
  • each implant 50a, 50b is provided with an attachment, link, or securing element 55.
  • attachment 55 is in the form of a ring 55, i.e., a knotless, closed, fixed loop 55 passed through at least of a region/portion of soft-suture anchors 50a, 50b.
  • Ring 55 can be formed of suture.
  • Ring 55 can be formed of elastic suture.
  • soft anchors 50a, 50b are knotlessly linked to each other and attached to flexible strand 20 (coupler 20) passing through one or more rings 55.
  • at least one of attachments, links, or securing elements 55 can be a knotted, closed loop.
  • attachments, links, or securing elements 55 can be any loop, eyelet, hoop, or similar element that allows easy passage of the coupler 20 through it and attachment.
  • Each fixation device 50a, 50b can be in the form of a soft suture anchor (soft suture sheath, soft suture anchor, all-suture soft knotless anchor, implant) provided with a soft anchor sleeve 51 (sheath or tubular member 51) with two open ends 52, 53.
  • One or more flexible couplers 20 can extend through each of the soft anchor sleeve 51 (sheath 51) of each fixation device 50a, 50b to interconnect the anchor sleeves 51.
  • Details of an exemplary soft suture anchor with a soft anchor sleeve (sheath or tubular member) and flexible shuttling strands are set forth, Docket No.2464.0185WO01 Arthrex Ref.
  • FIG. 2 illustrates exemplary insertion device 70 with four exemplary implants 50a, 50b, 50c, 50d (fixation devices 50a, 50b, 50c, 50d) each in the form of soft-suture anchors 50a, 50b, 50c, 50d with attached rings 55.
  • fixation devices 50a, 50b, 50c, 50d and rings 55 can be formed essentially of suture.
  • fixation devices 50a, 50b, 50c, 50d and rings 55 can be formed of braided suture that can include fibers of ultrahigh molecular weight polyethylene (UHMWPE).
  • fixation devices 50a, 50b, 50c, 50d and rings 55 can be formed of elastic suture.
  • fixation devices 50a, 50b, 50c, 50d can be formed of UHMWPE braided with polyester.
  • UHMWPE is easy to splice and pierce; allows the construct to deform and remain in deformed shape; even at high PPI, it has minimal fraying and snagging; and has a low coefficient of friction.
  • Fixation devices 50a, 50b, 50c, 50d and rings 55 can be formed of same or different materials and/or compositions. [0018] Reference is now made to FIGS. 3-5 which illustrate surgical assemblies 100, 200, 300 formed of one or more fixation devices 50a, 50b, 50c, 50d connected by at least one flexible coupler 20 attached to fixation device 120 (FIG. 4).
  • Flexible coupler 20 (flexible strand 20; flexible material 20; construct 20; flexible tape 20; suture 20) can be formed of one single continuous coupler in form of suture, either round and/or flat suture, for example, a suture strand or suture tape.
  • Flexible coupler 20 can be provided with Docket No.2464.0185WO01 Arthrex Ref. No.2023-042-KHS-PCT two terminal ends, a first end 21 and a second end 23.
  • Flexible coupler 20 can be a fixed length of suture and/or tape, such as suture tape.
  • Flexible coupler 20 can be attached to one or more independent fixation devices such as fixation device 120 of FIG. 4.
  • Flexible coupler 20 can extend through the anchor sleeves 51 in similar or different directions and/or orientations and/or locations. Flexible coupler 20 can extend through the whole length of each sleeve, i.e., enters one of the two open ends 52, 53 and exits other of the two open ends 52, 53. In other embodiment, flexible coupler 20 can extend through only a portion of a length of the sleeve(s), i.e., can enter the sleeve at a location separate from one of the two open ends 52, 53 and exit at a location separate from other of the two open ends 52, 53.
  • flexible coupler 20 can enter one sleeve at an open end and exit the sleeve at a location spaced apart from the other open end.
  • surgical assembly 100 can be formed by passing one of two terminal ends 21, 23 (for example, first end 21) of the flexible coupler 20 through each of the soft-anchors 50a, 50b, 50c, 50d in a first direction, and then passing the same terminal end (first end 21) through each of the soft-anchors 50a, 50b, 50c, 50d in a second direction, wherein the first direction is different from the second direction.
  • the second direction can be opposite the first direction.
  • Terminal end 21 of flexible coupler 20 can be passed through at least a portion of body 51 of fixation device 50a, 50b, 50c, 50d.
  • the passes can be formed with suture passers and/or shuttle/pull devices and/or suture passing instruments such as needles, FiberLinkTM loops, nitinol loops, or any suture passing device that includes an eyelet/loop for passing the flexible coupler 20.
  • Flexible coupler 20 can be passed through the soft-anchors 50a, 50b, 50c, 50d at least once and in at least one direction.
  • flexible coupler 20 can be Docket No.2464.0185WO01 Arthrex Ref.
  • No.2023-042-KHS-PCT passed through the soft-anchors 50a, 50b, 50c, 50d a plurality of times and in a plurality of directions.
  • Additional flexible strands can be attached to construct 100 by passing the flexible strands through formed loop 20a of coupler 20. Additional strands can be FiberWire® suture, TigerWire® suture, FiberTape® suture tape, among many others. Construct 100 can be further attached to additional strands attached to one or more independent, additional fixation devices, such as fixation device 120 of FIG. 4. [0023] FIG.
  • FIG. 4 illustrates assembly 200 which consists of two exemplary soft suture sheaths 50a, 50b connected by way of a single continuous suture 20 (coupler 20) which loops through both before having each limb 21, 23 attached to independent fixation device 120 to create a means for knotless tensioning.
  • at least one of limbs 21, 23 is attached to fixation device 120.
  • the one or more independent fixation devices 120 can be any anchors, for example, any of knotted anchors, knotless anchors, or all-suture anchors, or any devices that confer secure attachment and fixation of first tissue to a second tissue.
  • Fixation device 120 can be a knotless anchor such as a two-piece Arthrex PushLock® anchor, disclosed in US 7,329,272, or an Arthrex SwiveLock® anchor, disclosed in US 8,012,174 and US 9,005,246, the disclosures of both of which are fully incorporated by reference in their entirety herein.
  • Fixation device 120 can also be another soft anchor like soft anchors 50a, 50b detailed above.
  • Fixation device 120 can be a soft anchor such as an “all-suture” anchor.
  • a soft anchor (soft suture anchor or all-suture soft knotless anchor) is provided with a soft anchor sleeve (sheath or tubular member) with two open ends, and at least two flexible shuttling strands extending through the soft anchor sleeve (sheath).
  • a soft anchor sleeve sheath or tubular member
  • FIG. 5 illustrates system 300 which is about similar to system 100 of FIG.
  • each of the four soft- anchors 50a, 50b, 50c, 50d of system 300 includes an additional ring such as suture ring 55 of FIG. 2.
  • the constructs and systems detailed above have applicability to various tissue repairs and tissue fixations, for example, secure fixation of a first tissue to a second tissue.
  • the flexible tissue anchors with flexible loading strand described above have applicability to the return of an extruded meniscus to anatomic function.
  • a suture anchor is placed in the tibial plateau along the periphery of the joint.
  • FIGS. 6-13 illustrate steps of an exemplary method of tissue repair with system 300 of FIG. 5.
  • the embodiment detailed below is an exemplary meniscal repair with insertion device 70 and only four implants 50a, 50b, 50c, 50d, each provided with a ring 55, and fixation device 120 with at least one flexible coupler 20.
  • FIG. 6 [0029] Knee Capsule encapsulates the entire knee joint (and illustrated only cut away for simplicity). Anterior adjustable fixation is provided by fixation device 120 secured into tibia 90 (second tissue 90). [0030] FIG. 7: Docket No.2464.0185WO01 Arthrex Ref. No.2023-042-KHS-PCT [0031] Insertion device 70 is shown loaded with implant consisting of meniscus anchor 50a and ring 55 (ring suture 55; suture ring 55). [0032] FIG.
  • Insertion device 70 loaded with implant (consisting of meniscus anchor 50a, ring suture 55, and peripheral suture 20 passed through ring 55) is arthroscopically placed under meniscus 80 (first tissue 80) and through the knee capsule.
  • FIG. 9 [0035] The anchor sheath 50a is then delivered on the outside of the knee capsule.
  • FIG. 9 illustrates the first anchor 50a placed through the meniscus 80 at a first location.
  • FIG. 10 [0037] The steps are repeated for a second anchor 50b with ring suture 55.
  • FIG. 10 shows second anchor 50b placed through the meniscus 80 at a second location which is different from first location.
  • FIG. 10 shows second anchor 50b placed through the meniscus 80 at a second location which is different from first location.
  • FIG. 11 [0039] The steps are repeated for a third anchor 50c with ring suture 55.
  • FIG. 11 shows third anchor 50c placed through the meniscus 80 at a third location which is different from first and second locations.
  • FIG. 12 [0041] The steps are repeated for a fourth anchor 50d with ring suture 55.
  • FIG. 12 shows fourth anchor 50d placed through the meniscus 80 at a fourth location which is different from first, second, and third locations.
  • Loop 20a of peripheral suture 20 (coupler 20) is loaded through suture connected to tensionable anchor 120 placed in the tibial plateau 90 at the anterior horn of meniscus 80.
  • FIG. 13 Docket No.2464.0185WO01 Arthrex Ref.
  • Peripheral suture 20 is secured to anterior horn anchor 120. Peripheral suture 20 is placed through tunnel leading from posterior meniscus horn attachment to anterior tibia for tensionable fixation of final repair 101. Peripheral suture 20 can be attached to anchor 120 by looping the suture 20 through loop 125 of anchor 120.
  • FIGS. 14-16 illustrate additional embodiments of insertion device 70 (inserter 70; delivery device 70) loaded with two exemplary implants 50a, 50b (fixation devices 50a, 50b) each in the form of soft anchors 50a, 50b.
  • Each implant 50a, 50b is provided with an attachment 155 (link or securing element 155) in the form of a separate flexible strand 155 that is passed through body 51 of the fixation device 50a, 50b to form a knotless, closed, fixed loop 155a.
  • attachment 155 link or securing element 155
  • soft-suture anchors 50a, 50b can be knotlessly linked to each other and attached to flexible strand 20 (coupler 20) passing through one or more loops 155a.
  • the disclosure contemplates additional embodiments wherein the soft anchors 50a, 50b, 50c, 50d placed within a first tissue (such as meniscus 80) are connected to one or more fixation devices 120 placed within a second tissue (such as tibial plateau 90) with coupler 20 provided already attached to fixation device 120.
  • coupler 20 can be looped through attachments/rings/loops/hoops 55, 155a and subsequently connected to the tensionable anchor 120 and/or additional fixation devices.
  • the constructs, assemblies, and systems of FIGS. 1-16 are adjustable, tensionable loop constructs.
  • System 100, 200, 300 is an in-line, serial, self-locking, adjustable, knotless construct.
  • System 100, 200, 300 can Docket No.2464.0185WO01 Arthrex Ref. No.2023-042-KHS-PCT be a suture/soft anchors construct in the form of an implant construct which can be utilized to attach or re-attach a first tissue to a second tissue, for example, meniscus to bone, among others.
  • the construct includes a flexible coupler run through one or more soft suture anchors, and further attached to another fixation device to create a tensionable, self-locking, adjustable loop, anchoring construct.
  • the construct can be provided assembled, disassembled, as part of a kit, with or without additional instruments (such as suture passers), fixation devices and/or flexible couplers, to facilitate loading onto the inserter instrument and passing through tunnels and/or bone sockets and/or openings.
  • additional instruments such as suture passers
  • fixation devices and/or flexible couplers to facilitate loading onto the inserter instrument and passing through tunnels and/or bone sockets and/or openings.
  • Serial, in-line, suture-based, arthroscopic tissue repair devices/constructs of the present disclosure can be employed for any tissue positioning and/or tissue adjustment applications, for example, in fixation of soft tissue to bone.
  • the suture implant with the self-locking mechanism can be utilized in surgical procedures such as rotator cuff repair, Achilles tendon repair, patellar tendon repair, ACL/PCL reconstruction, hip and shoulder reconstruction procedures, AC joint reconstruction, syndesmosis reconstruction, quad/patellar tendon rupture repair, hallux-valgus repair, proximal and/or distal biceps tendon repair, humerus and radius repair, and any other tendon repair to bone, among many others, all conducted in a knotless manner.
  • a surgical assembly 100, 200, 300 includes a plurality of fixation devices 50a, 50b, 50c, 50d and at least one flexible coupler 20 having a first end 21 and a second end 23 attached to body 51 of fixation devices 50a, 50b, 50c, 50d and/or loaded onto ring suture 55, 155a; and at least an independent fixation device 120.
  • Fixation devices 50a, 50b, 50c, 50d are all-suture soft anchors.
  • Fixation device 120 can be an all- suture soft anchor.
  • Surgical assembly 100, 200, 300 can connect first tissue 80 to second tissue 90.
  • First tissue 80 can be a meniscus
  • second tissue 90 can be bone.
  • a method of tissue repair 101 comprises inter alia: securing a fixation device 120 to a first tissue 90 (tibia 90); passing a flexible coupler 20 through sheaths 51 and/or loops 55, 155a of one or more fixation devices 50a, 50b, 50c, 50d; securing the one or more fixation devices 50a, 50b, 50c, 50d in a second tissue 80 (meniscus 80); and attaching the flexible coupler 20 to the fixation device 120.
  • a method of knotless repair 101 comprises: securing a fixation device 120 into tibia 90; loading an inserter 70 with a first fixation device 50a having a suture ring 55; passing peripheral suture 20 attached to fixation device 120 through suture ring 55; inserting the inserter 70 with first fixation device 50a under meniscus 80 and through the knee capsule, and placing the first fixation device 50a through the meniscus 80; loading inserter 70 with a second fixation device 50b having a suture ring 55; passing peripheral suture 20 through suture ring 55; inserting the inserter 70 with second fixation device 50b under meniscus 80 and through the knee capsule, and placing the second fixation device 50b through the meniscus 80; repeating the above steps of loading the inserter 70 with additional fixation devices 50
  • Flexible coupler 20, 155; fixation devices 50a, 50b, 50c, 50d; and attachments 55, 155a can be formed of various flexible materials and strands such as round suture, flat suture, ribbon, or flat tape (for Docket No.2464.0185WO01 Arthrex Ref. No.2023-042-KHS-PCT example, suture tape) or combination of suture and tape.
  • Exemplary materials can include suture, silk, cotton, nylon, polypropylene, polyethylene, ultrahigh molecular weight polyethylene (UHMWPE), polyethylene terephthalate (PET), and polyesters and copolymers thereof, or combinations thereof.
  • Flexible coupler 20, 155; fixation devices 50a, 50b, 50c, 50d; and attachments 55, 155a can have cross- sections of various forms and geometries, including round, oval, rectangular, or flat, among others, or combination of such forms and geometries.
  • flexible coupler 20, 155; fixation devices 50a, 50b, 50c, 50d; and attachments 55, 155a can be formed of a high strength suture material such as FiberWire® suture, sold by Arthrex, Inc. of Naples, Fla., and described in US 6,716,234, the disclosure of which is incorporated by reference herein.
  • a high strength suture material such as FiberWire® suture, sold by Arthrex, Inc. of Naples, Fla., and described in US 6,716,234, the disclosure of which is incorporated by reference herein.
  • FiberWire® suture is formed of an advanced, high-strength fiber material, namely ultrahigh molecular weight polyethylene (UHMWPE), sold under the tradenames Spectra® (Honeywell International Inc., Colonial Heights, Va.) and Dyneema® (DSM N.V., Heerlen, the Netherlands), braided with at least one other fiber, natural or synthetic, to form lengths of suture material.
  • UHMWPE ultrahigh molecular weight polyethylene
  • Dyneema® DSM N.V., Heerlen, the Netherlands
  • Flexible coupler 20, 155 can be braided or multi-filament suture such as FiberTape® suture tape (as disclosed in US 7,892,256, the disclosure of which is incorporated in its entirety herewith).
  • Various regions, or sections of flexible coupler 20, 155; fixation devices 50a, 50b, 50c, 50d; and attachments 55, 155a can be coated and/or provided in different colors for easy manipulation during the surgical procedure.
  • Flexible coupler 20, 155; fixation devices 50a, 50b, 50c, 50d; and attachments 55, 155a can be provided with tinted tracing strands, or otherwise contrast visually with the sheath 51 of the soft suture anchors 50a, 50b, which remains a plain, solid color, or displays a different tracing pattern, for example. Easy identification of suture in

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Abstract

Knotless constructs and methods of tissue repairs are disclosed herein.

Description

IN THE UNITED STATES PATENT AND TRADEMARK OFFICE PCT PATENT APPLICATION Title: SURGICAL CONSTRUCTS AND METHODS OF TISSUE FIXATION Inventors: Joshua J. Best Andrew K. Osika Matthew R. Herrington Gabriela I. Coman Potomac Law Group, PLLC 1717 Pennsylvania Ave, NW Washington, DC 20004 Docket No.2464.0185WO01 Arthrex Ref. No.2023-042-KHS-PCT SURGICAL CONSTRUCTS AND METHODS OF TISSUE FIXATION BACKGROUND [0001] The disclosure herein relates to the field of surgery and, more specifically, to tensionable suture constructs and associated methods of tissue repairs. SUMMARY [0002] Tensionable constructs, surgical systems, assemblies, and methods of tissue repairs are disclosed. A construct can create a knotless repair. In an embodiment, a construct as described herein can be self-locking and knotless. A construct can include (i) fixation devices in the form of soft anchors that are knotlessly attached to (ii) a flexible coupler and are secured within a first tissue, and (iii) at least another fixation device attached to the flexible coupler and secured within a second tissue. [0003] Methods of tissue repairs are also disclosed. A first tissue is approximated to a second tissue with a surgical construct that includes at least one tensionable construct with a knotless mechanism. A flexible coupler (flexible loading strand or repair suture) is attached to one or more soft anchors to connect or link the soft anchors and attach them to at least one fixation device. The soft anchors can be secured in a first tissue. The at least one fixation device can be secured in a second tissue. BRIEF DESCRIPTION OF THE DRAWINGS [0004] FIGS. 1 and 2 illustrate an inserter with surgical constructs. [0005] FIGS. 3-5 illustrate a surgical assembly. [0006] FIGS. 3-13 illustrate a tissue repair with a surgical construct of FIG. 2. Docket No.2464.0185WO01 Arthrex Ref. No.2023-042-KHS-PCT [0007] FIGS. 14-16 illustrate an inserter with another surgical construct. DETAILED DESCRIPTION [0008] The disclosure provides surgical adjustable loop constructs, suture loop mechanisms, in-line surgical repairs, and methods for securing a first tissue to a second tissue (for example, meniscus to bone) with a tensionable construct including adjustable, knotless, flexible, closed loops. [0009] In an embodiment, the disclosure provides an all-suture tissue fixation construct. An implant construct can attach or re-attach normal anatomical structures, tissue to tissue, bone to bone, and/or bone to soft tissue. The construct can include a flexible coupler of a fixation device attached to one or more soft-suture anchors. A length of flexible coupler can attach directly to soft-suture anchors and/or to a link/attachment of a soft-suture anchor. The link/attachment can be a ring, a loop, a hoop, an eyelet, or any similar structure that allows attachment of the flexible coupler to soft-suture anchors. A flexible coupler of an independent fixation device can be attached to a plurality of soft anchors to connect or link the soft anchors to the independent fixation device. [0010] A flexible coupler can be attached in a knotless manner to a plurality of soft suture anchors placed within a first tissue for knotless, serial, all- suture fixation. The flexible coupler attaches to an independent fixation device placed within a second tissue. The first tissue can be meniscus. The second tissue can be bone. The independent fixation device can be a hard anchor or a soft anchor. The independent fixation device can be a tensionable anchor such as a tensionable soft-suture anchor. The construct can be shrunk by pulling on the flexible coupler attached to the independent fixation device. The construct allows the user (for example, surgeon) to control the tension of the flexible Docket No.2464.0185WO01 Arthrex Ref. No.2023-042-KHS-PCT coupler on a first tissue (for example, meniscus, tissue fragment, or cartilage) to be attached to a second tissue (for example, bone such as tibial plateau). [0011] A tissue repair system includes one or more fixation devices each in the form of a soft-suture anchor; and a flexible coupler slidingly attached to the one or more fixation devices, wherein the flexible coupler is further attached to an independent fixation device. The one or more fixation devices are secured within a first tissue (for example, meniscus) and the independent fixation device is secured within a second tissue (for example, tibial plateau). The system can further include an insertion device (a delivery device) for inserting/delivering the one or more soft- suture anchors within the first tissue. A flexible coupler can be of either round and/or flat design. A flexible coupler can be suture and/or tape. A tissue repair system can consist essentially of suture such as ultrahigh molecular weight polyethylene suture. A tissue repair system can provide knotless, serial, all-suture tissue fixation without any knots and with increased tissue fixation. [0012] A construct can be employed to re-attach normal anatomical structures, i.e., a first tissue to a second tissue, such as soft tissue, tendon, ligament, and/or bone, to each other and/or any combination of one another, by employing a serial, sequential, knotless mechanism. A flexible coupler can be a fixed length of suture and/or tape. A construct can be employed as a stand-alone construct or with additional fixation devices, for example, attached to one or more additional implants, anchors, screws, etc. [0013] Referring now to the drawings, where like elements are designated by like reference numerals, FIGS. 1-5 illustrate structural elements of surgical assembly 100, 200, 300 (construct 100, 200, 300; surgical meniscal fixation construct 100, 200, 300; knotless construct 100, 200, Docket No.2464.0185WO01 Arthrex Ref. No.2023-042-KHS-PCT fixation system 100, 200, 300; system 100, 200, 300) formed of one or more fixation devices 50a, 50b, . . . 50n in the form of soft anchors connected by at least one flexible coupler 20 and attached to an independent fixation device 120. FIGS. 6-13 illustrate exemplary steps of tissue repair 101 (FIG. 13) with surgical assembly 100, 200, 300. [0014] FIG. 1 illustrates exemplary insertion device 70 (inserter 70; delivery device 70) with two exemplary implants 50a, 50b (fixation devices 50a, 50b) each in the form of soft anchors 50a, 50b. One of the two implants 50a, 50b is illustrated loaded onto insertion device 70. As also shown in FIG. 1, each implant 50a, 50b is provided with an attachment, link, or securing element 55. In the exemplary-only embodiment of FIG. 1, attachment 55 is in the form of a ring 55, i.e., a knotless, closed, fixed loop 55 passed through at least of a region/portion of soft-suture anchors 50a, 50b. Ring 55 can be formed of suture. Ring 55 can be formed of elastic suture. As detailed below, soft anchors 50a, 50b are knotlessly linked to each other and attached to flexible strand 20 (coupler 20) passing through one or more rings 55. In other embodiments, at least one of attachments, links, or securing elements 55 can be a knotted, closed loop. In yet additional embodiments, attachments, links, or securing elements 55 can be any loop, eyelet, hoop, or similar element that allows easy passage of the coupler 20 through it and attachment. [0015] Each fixation device 50a, 50b can be in the form of a soft suture anchor (soft suture sheath, soft suture anchor, all-suture soft knotless anchor, implant) provided with a soft anchor sleeve 51 (sheath or tubular member 51) with two open ends 52, 53. One or more flexible couplers 20 can extend through each of the soft anchor sleeve 51 (sheath 51) of each fixation device 50a, 50b to interconnect the anchor sleeves 51. Details of an exemplary soft suture anchor with a soft anchor sleeve (sheath or tubular member) and flexible shuttling strands are set forth, Docket No.2464.0185WO01 Arthrex Ref. No.2023-042-KHS-PCT for example, in US Patent 10,849,734 issued Dec. 1, 2020, entitled “Methods of Tissue Repairs,” the disclosure of which is incorporated by reference in its entirety herein. [0016] FIG. 2 illustrates exemplary insertion device 70 with four exemplary implants 50a, 50b, 50c, 50d (fixation devices 50a, 50b, 50c, 50d) each in the form of soft-suture anchors 50a, 50b, 50c, 50d with attached rings 55. [0017] In an embodiment, fixation devices 50a, 50b, 50c, 50d and rings 55 can be formed essentially of suture. In an embodiment, fixation devices 50a, 50b, 50c, 50d and rings 55 can be formed of braided suture that can include fibers of ultrahigh molecular weight polyethylene (UHMWPE). In an embodiment, fixation devices 50a, 50b, 50c, 50d and rings 55 can be formed of elastic suture. In an embodiment, fixation devices 50a, 50b, 50c, 50d can be formed of UHMWPE braided with polyester. UHMWPE is easy to splice and pierce; allows the construct to deform and remain in deformed shape; even at high PPI, it has minimal fraying and snagging; and has a low coefficient of friction. Polyester is difficult to splice without fraying suture; allows the construct to retain initial form; is difficult to pierce and pass suture without fraying and snagging; and has a high coefficient of friction. Fixation devices 50a, 50b, 50c, 50d and rings 55 can be formed of same or different materials and/or compositions. [0018] Reference is now made to FIGS. 3-5 which illustrate surgical assemblies 100, 200, 300 formed of one or more fixation devices 50a, 50b, 50c, 50d connected by at least one flexible coupler 20 attached to fixation device 120 (FIG. 4). [0019] Flexible coupler 20 (flexible strand 20; flexible material 20; construct 20; flexible tape 20; suture 20) can be formed of one single continuous coupler in form of suture, either round and/or flat suture, for example, a suture strand or suture tape. Flexible coupler 20 can be provided with Docket No.2464.0185WO01 Arthrex Ref. No.2023-042-KHS-PCT two terminal ends, a first end 21 and a second end 23. Flexible coupler 20 can be a fixed length of suture and/or tape, such as suture tape. Flexible coupler 20 can be attached to one or more independent fixation devices such as fixation device 120 of FIG. 4. [0020] Flexible coupler 20 can extend through the anchor sleeves 51 in similar or different directions and/or orientations and/or locations. Flexible coupler 20 can extend through the whole length of each sleeve, i.e., enters one of the two open ends 52, 53 and exits other of the two open ends 52, 53. In other embodiment, flexible coupler 20 can extend through only a portion of a length of the sleeve(s), i.e., can enter the sleeve at a location separate from one of the two open ends 52, 53 and exit at a location separate from other of the two open ends 52, 53. In yet other embodiments, flexible coupler 20 can enter one sleeve at an open end and exit the sleeve at a location spaced apart from the other open end. [0021] In the embodiment shown in FIG. 3, surgical assembly 100 can be formed by passing one of two terminal ends 21, 23 (for example, first end 21) of the flexible coupler 20 through each of the soft-anchors 50a, 50b, 50c, 50d in a first direction, and then passing the same terminal end (first end 21) through each of the soft-anchors 50a, 50b, 50c, 50d in a second direction, wherein the first direction is different from the second direction. The second direction can be opposite the first direction. Terminal end 21 of flexible coupler 20 can be passed through at least a portion of body 51 of fixation device 50a, 50b, 50c, 50d. The passes can be formed with suture passers and/or shuttle/pull devices and/or suture passing instruments such as needles, FiberLink™ loops, nitinol loops, or any suture passing device that includes an eyelet/loop for passing the flexible coupler 20. Flexible coupler 20 can be passed through the soft-anchors 50a, 50b, 50c, 50d at least once and in at least one direction. In an embodiment, flexible coupler 20 can be Docket No.2464.0185WO01 Arthrex Ref. No.2023-042-KHS-PCT passed through the soft-anchors 50a, 50b, 50c, 50d a plurality of times and in a plurality of directions. [0022] Additional flexible strands can be attached to construct 100 by passing the flexible strands through formed loop 20a of coupler 20. Additional strands can be FiberWire® suture, TigerWire® suture, FiberTape® suture tape, among many others. Construct 100 can be further attached to additional strands attached to one or more independent, additional fixation devices, such as fixation device 120 of FIG. 4. [0023] FIG. 4 illustrates assembly 200 which consists of two exemplary soft suture sheaths 50a, 50b connected by way of a single continuous suture 20 (coupler 20) which loops through both before having each limb 21, 23 attached to independent fixation device 120 to create a means for knotless tensioning. In one embodiment, at least one of limbs 21, 23 is attached to fixation device 120. [0024] In an embodiment, the one or more independent fixation devices 120 can be any anchors, for example, any of knotted anchors, knotless anchors, or all-suture anchors, or any devices that confer secure attachment and fixation of first tissue to a second tissue. Fixation device 120 can be a knotless anchor such as a two-piece Arthrex PushLock® anchor, disclosed in US 7,329,272, or an Arthrex SwiveLock® anchor, disclosed in US 8,012,174 and US 9,005,246, the disclosures of both of which are fully incorporated by reference in their entirety herein. Fixation device 120 can also be another soft anchor like soft anchors 50a, 50b detailed above. Fixation device 120 can be a soft anchor such as an “all-suture” anchor. A soft anchor (soft suture anchor or all-suture soft knotless anchor) is provided with a soft anchor sleeve (sheath or tubular member) with two open ends, and at least two flexible shuttling strands extending through the soft anchor sleeve (sheath). Docket No.2464.0185WO01 Arthrex Ref. No.2023-042-KHS-PCT [0025] FIG. 5 illustrates system 300 which is about similar to system 100 of FIG. 3 in that it also consists of four soft-anchors 50a, 50b, 50c, 50d linked/connected by flexible strand 20; however, each of the four soft- anchors 50a, 50b, 50c, 50d of system 300 includes an additional ring such as suture ring 55 of FIG. 2. [0026] The constructs and systems detailed above have applicability to various tissue repairs and tissue fixations, for example, secure fixation of a first tissue to a second tissue. In an exemplary-only embodiment, the flexible tissue anchors with flexible loading strand described above have applicability to the return of an extruded meniscus to anatomic function. A suture anchor is placed in the tibial plateau along the periphery of the joint. A repair suture from the suture anchor is placed through an independent anchor sheath on an inserter. The inserter is arthroscopically placed under the meniscus and through the capsule. The anchor sheath is then delivered on the outside of the knee capsule. The opposite end of the repair suture that was previously loaded into the anchor sheath is then secured back to the tibial plateau thus pulling the capsule and reducing the meniscus. [0027] Reference is now made to FIGS. 6-13 which illustrate steps of an exemplary method of tissue repair with system 300 of FIG. 5. The embodiment detailed below is an exemplary meniscal repair with insertion device 70 and only four implants 50a, 50b, 50c, 50d, each provided with a ring 55, and fixation device 120 with at least one flexible coupler 20. [0028] FIG. 6: [0029] Knee Capsule encapsulates the entire knee joint (and illustrated only cut away for simplicity). Anterior adjustable fixation is provided by fixation device 120 secured into tibia 90 (second tissue 90). [0030] FIG. 7: Docket No.2464.0185WO01 Arthrex Ref. No.2023-042-KHS-PCT [0031] Insertion device 70 is shown loaded with implant consisting of meniscus anchor 50a and ring 55 (ring suture 55; suture ring 55). [0032] FIG. 8: [0033] Insertion device 70 loaded with implant (consisting of meniscus anchor 50a, ring suture 55, and peripheral suture 20 passed through ring 55) is arthroscopically placed under meniscus 80 (first tissue 80) and through the knee capsule. [0034] FIG. 9: [0035] The anchor sheath 50a is then delivered on the outside of the knee capsule. FIG. 9 illustrates the first anchor 50a placed through the meniscus 80 at a first location. [0036] FIG. 10: [0037] The steps are repeated for a second anchor 50b with ring suture 55. FIG. 10 shows second anchor 50b placed through the meniscus 80 at a second location which is different from first location. [0038] FIG. 11: [0039] The steps are repeated for a third anchor 50c with ring suture 55. FIG. 11 shows third anchor 50c placed through the meniscus 80 at a third location which is different from first and second locations. [0040] FIG. 12: [0041] The steps are repeated for a fourth anchor 50d with ring suture 55. FIG. 12 shows fourth anchor 50d placed through the meniscus 80 at a fourth location which is different from first, second, and third locations. Loop 20a of peripheral suture 20 (coupler 20) is loaded through suture connected to tensionable anchor 120 placed in the tibial plateau 90 at the anterior horn of meniscus 80. [0042] FIG. 13: Docket No.2464.0185WO01 Arthrex Ref. No.2023-042-KHS-PCT [0043] Peripheral suture 20 is secured to anterior horn anchor 120. Peripheral suture 20 is placed through tunnel leading from posterior meniscus horn attachment to anterior tibia for tensionable fixation of final repair 101. Peripheral suture 20 can be attached to anchor 120 by looping the suture 20 through loop 125 of anchor 120. [0044] FIGS. 14-16 illustrate additional embodiments of insertion device 70 (inserter 70; delivery device 70) loaded with two exemplary implants 50a, 50b (fixation devices 50a, 50b) each in the form of soft anchors 50a, 50b. Each implant 50a, 50b is provided with an attachment 155 (link or securing element 155) in the form of a separate flexible strand 155 that is passed through body 51 of the fixation device 50a, 50b to form a knotless, closed, fixed loop 155a. [0045] As detailed above, soft-suture anchors 50a, 50b can be knotlessly linked to each other and attached to flexible strand 20 (coupler 20) passing through one or more loops 155a. [0046] Although the embodiments above have been described with reference to suture 20 provided separate from fixation device 120 and secured to it only after placement of soft anchors 50a, 50b, 50c, 50d, it must be understood that the disclosure is not limited to this exemplary-only embodiment. Thus, the disclosure contemplates additional embodiments wherein the soft anchors 50a, 50b, 50c, 50d placed within a first tissue (such as meniscus 80) are connected to one or more fixation devices 120 placed within a second tissue (such as tibial plateau 90) with coupler 20 provided already attached to fixation device 120. In such embodiments, coupler 20 can be looped through attachments/rings/loops/hoops 55, 155a and subsequently connected to the tensionable anchor 120 and/or additional fixation devices. [0047] The constructs, assemblies, and systems of FIGS. 1-16 are adjustable, tensionable loop constructs. System 100, 200, 300 is an in-line, serial, self-locking, adjustable, knotless construct. System 100, 200, 300 can Docket No.2464.0185WO01 Arthrex Ref. No.2023-042-KHS-PCT be a suture/soft anchors construct in the form of an implant construct which can be utilized to attach or re-attach a first tissue to a second tissue, for example, meniscus to bone, among others. The construct includes a flexible coupler run through one or more soft suture anchors, and further attached to another fixation device to create a tensionable, self-locking, adjustable loop, anchoring construct. The construct can be provided assembled, disassembled, as part of a kit, with or without additional instruments (such as suture passers), fixation devices and/or flexible couplers, to facilitate loading onto the inserter instrument and passing through tunnels and/or bone sockets and/or openings. [0048] Serial, in-line, suture-based, arthroscopic tissue repair devices/constructs of the present disclosure can be employed for any tissue positioning and/or tissue adjustment applications, for example, in fixation of soft tissue to bone. The suture implant with the self-locking mechanism can be utilized in surgical procedures such as rotator cuff repair, Achilles tendon repair, patellar tendon repair, ACL/PCL reconstruction, hip and shoulder reconstruction procedures, AC joint reconstruction, syndesmosis reconstruction, quad/patellar tendon rupture repair, hallux-valgus repair, proximal and/or distal biceps tendon repair, humerus and radius repair, and any other tendon repair to bone, among many others, all conducted in a knotless manner. [0049] A surgical assembly 100, 200, 300 includes a plurality of fixation devices 50a, 50b, 50c, 50d and at least one flexible coupler 20 having a first end 21 and a second end 23 attached to body 51 of fixation devices 50a, 50b, 50c, 50d and/or loaded onto ring suture 55, 155a; and at least an independent fixation device 120. Fixation devices 50a, 50b, 50c, 50d are all-suture soft anchors. Fixation device 120 can be an all- suture soft anchor. Surgical assembly 100, 200, 300 can connect first tissue 80 to second tissue 90. First tissue 80 can be a meniscus, and second tissue 90 can be bone. Surgical assembly 100, 200, 300 can Docket No.2464.0185WO01 Arthrex Ref. No.2023-042-KHS-PCT consist essentially of suture. Surgical assembly 100, 200, 300 can consist essentially of elastic suture. [0050] A method of tissue repair 101 comprises inter alia: securing a fixation device 120 to a first tissue 90 (tibia 90); passing a flexible coupler 20 through sheaths 51 and/or loops 55, 155a of one or more fixation devices 50a, 50b, 50c, 50d; securing the one or more fixation devices 50a, 50b, 50c, 50d in a second tissue 80 (meniscus 80); and attaching the flexible coupler 20 to the fixation device 120. The method can further include tensioning the construct by pulling on terminal ends 21, 23 of flexible coupler 20. Securing the one or more fixation devices 50a, 50b, 50c, 50d in second tissue 80 can be conducted sequentially or in a serial manner. [0051] A method of knotless repair 101 comprises: securing a fixation device 120 into tibia 90; loading an inserter 70 with a first fixation device 50a having a suture ring 55; passing peripheral suture 20 attached to fixation device 120 through suture ring 55; inserting the inserter 70 with first fixation device 50a under meniscus 80 and through the knee capsule, and placing the first fixation device 50a through the meniscus 80; loading inserter 70 with a second fixation device 50b having a suture ring 55; passing peripheral suture 20 through suture ring 55; inserting the inserter 70 with second fixation device 50b under meniscus 80 and through the knee capsule, and placing the second fixation device 50b through the meniscus 80; repeating the above steps of loading the inserter 70 with additional fixation devices 50c, 50d …. etc. to place additional fixation devices 50c, 50d …. etc. through the meniscus 80; and pulling on the peripheral suture 20 to tension repair 101 and approximate meniscus 80 to tibia 90. [0052] Flexible coupler 20, 155; fixation devices 50a, 50b, 50c, 50d; and attachments 55, 155a can be formed of various flexible materials and strands such as round suture, flat suture, ribbon, or flat tape (for Docket No.2464.0185WO01 Arthrex Ref. No.2023-042-KHS-PCT example, suture tape) or combination of suture and tape. Exemplary materials can include suture, silk, cotton, nylon, polypropylene, polyethylene, ultrahigh molecular weight polyethylene (UHMWPE), polyethylene terephthalate (PET), and polyesters and copolymers thereof, or combinations thereof. Flexible coupler 20, 155; fixation devices 50a, 50b, 50c, 50d; and attachments 55, 155a can have cross- sections of various forms and geometries, including round, oval, rectangular, or flat, among others, or combination of such forms and geometries. In an exemplary embodiment only, flexible coupler 20, 155; fixation devices 50a, 50b, 50c, 50d; and attachments 55, 155a can be formed of a high strength suture material such as FiberWire® suture, sold by Arthrex, Inc. of Naples, Fla., and described in US 6,716,234, the disclosure of which is incorporated by reference herein. FiberWire® suture is formed of an advanced, high-strength fiber material, namely ultrahigh molecular weight polyethylene (UHMWPE), sold under the tradenames Spectra® (Honeywell International Inc., Colonial Heights, Va.) and Dyneema® (DSM N.V., Heerlen, the Netherlands), braided with at least one other fiber, natural or synthetic, to form lengths of suture material. Flexible coupler 20, 155 can be braided or multi-filament suture such as FiberTape® suture tape (as disclosed in US 7,892,256, the disclosure of which is incorporated in its entirety herewith). [0053] Various regions, or sections of flexible coupler 20, 155; fixation devices 50a, 50b, 50c, 50d; and attachments 55, 155a can be coated and/or provided in different colors for easy manipulation during the surgical procedure. Flexible coupler 20, 155; fixation devices 50a, 50b, 50c, 50d; and attachments 55, 155a can be provided with tinted tracing strands, or otherwise contrast visually with the sheath 51 of the soft suture anchors 50a, 50b, which remains a plain, solid color, or displays a different tracing pattern, for example. Easy identification of suture in

Claims

Docket No.2464.0185WO01 Arthrex Ref. No.2023-042-KHS-PCT situ is advantageous in surgical procedures, particularly during arthroscopic surgeries, endoscopic and laparoscopic procedures. [0054] Various elements of assemblies 100, 200, 300 can be also coated (partially or totally) with wax (beeswax, petroleum wax, polyethylene wax, or others), silicone (Dow Corning silicone fluid 202A or others), silicone rubbers (Nusil Med 2245, Nusil Med 2174 with a bonding catalyst, or others) PTFE (Teflon, Hostaflon, or others), PBA (polybutylate acid), ethyl cellulose (Filodel) or other coatings, to improve lubricity of the suture or tape, knot security, pliability, handleability or abrasion resistance, for example. If desired, at least a region of flexible coupler 20, 155; fixation devices 50a, 50b, 50c, 50d; and attachments 55, 155a can be coated, impregnated, or otherwise stiffened with a material such as plastic, for example. [0055] The term “high strength suture” is defined as any elongated flexible member, the choice of material and size being dependent upon the particular application. For the purposes of illustration and without limitation, the term “suture” as used herein may be a cable, filament, thread, wire, fabric, or any other flexible member suitable for tissue fixation in the body.
Docket No.2464.0185WO01 Arthrex Ref. No.2023-042-KHS-PCT CLAIMS 1. A surgical assembly for tissue repairs, comprising: a plurality of fixation devices; and a flexible coupler attached to each of the plurality of fixation devices, the flexible coupler forming in a knotless manner at least one continuous, adjustable, tensionable loop extending between and connecting the plurality of fixation devices. 2. The surgical assembly of claim 1, further comprising a delivery device. 3. The surgical assembly of any of the preceding claims, wherein each of the plurality of fixation devices comprises suture. 4. The surgical assembly of any of the preceding claims, wherein at least one of the plurality of fixation devices comprises suture. 5. The surgical assembly of any of the preceding claims, wherein the flexible coupler forms at least one continuous, adjustable, tensionable loop extending between the plurality of fixation devices. 6. The surgical assembly of any of the preceding claims, wherein the flexible coupler is suture or suture tape. 7. The surgical assembly of any of the preceding claims, wherein the tissue repair is osteochondral repair. 8. A surgical construct comprising a flexible coupler knotlessly connected to a plurality of soft anchors, wherein at least one of the plurality of soft anchors is secured within a first tissue and wherein Docket No.2464.0185WO01 Arthrex Ref. No.2023-042-KHS-PCT at least one of the plurality of soft anchors is secured in a second tissue, wherein the first tissue is different from the second tissue. 9. The surgical construct of claim 8, wherein the flexible coupler forms at least one closed, continuous, flexible loop with an adjustable perimeter. 10. The surgical construct of any of claims 8 to 9, wherein the flexible coupler passes through an attachment of at least one of the plurality of soft anchor. 11. The surgical construct of claim 10, wherein the attachment is a ring, a loop, a hoop, or an eyelet attached to a tubular sheath of the soft anchor. 12. The surgical construct of any of claims 8 to 11, wherein the flexible coupler passes through a tubular sheath of at least one of the plurality of soft anchor. 13. The surgical construct of claim 12, wherein the flexible coupler enters the tubular sheath at a first location, extends within the tubular sheath and exits the tubular sheath at a second location, wherein the second location is different from the first location. 14. The surgical construct of any of claims 8 to 13, wherein each of the plurality of soft anchor is an all-suture anchor, and the flexible coupler is round suture. 15. The surgical construct of any of claims 8 to 14, wherein the construct consists essentially of suture. 16. The surgical construct of any of claims 8 to 15, wherein the first tissue is meniscus and the second tissue is tibial plateau. 17. A method of tissue repair comprising: Docket No.2464.0185WO01 Arthrex Ref. No.2023-042-KHS-PCT securing a fixation device to a first tissue; securing a plurality of soft anchors in a sequential manner into a second tissue; and knotlessly connecting the fixation device to each of the plurality of soft anchors by a flexible coupler. 18. The method of claim 17, further comprising: passing at least once the flexible coupler through a tubular sheath or an attachment of a first of the plurality of soft anchors; securing the first of the plurality of soft anchors into the second tissue; subsequently, passing at least once the flexible coupler through a tubular sheath or an attachment of a second of the plurality of soft anchors; securing the second of the plurality of soft anchors into the second tissue; subsequently, passing at least once the flexible coupler through a tubular sheath or an attachment of a third of the plurality of soft anchors; securing the third of the plurality of soft anchors into the second tissue; subsequently, passing at least once the flexible coupler through a tubular sheath or an attachment of a fourth of the plurality of soft anchors; securing the fourth of the plurality of soft anchors into the second tissue; and securing the flexible coupler to the fixation device. 19. The method of claim 17, wherein the fixation device is a soft suture anchor.
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US20080140093A1 (en) * 2006-02-03 2008-06-12 Stone Kevin T Soft tissue repair device and associated methods
US20120059417A1 (en) * 2006-02-03 2012-03-08 Biomet Sports Medicine, Llc Method and Apparatus for Coupling Soft Tissue to a Bone
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