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WO2025207348A1 - Système de réparation de tissu à ancrage souple - Google Patents

Système de réparation de tissu à ancrage souple

Info

Publication number
WO2025207348A1
WO2025207348A1 PCT/US2025/020036 US2025020036W WO2025207348A1 WO 2025207348 A1 WO2025207348 A1 WO 2025207348A1 US 2025020036 W US2025020036 W US 2025020036W WO 2025207348 A1 WO2025207348 A1 WO 2025207348A1
Authority
WO
WIPO (PCT)
Prior art keywords
tissue repair
region
lumen
distal
anchoring
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/US2025/020036
Other languages
English (en)
Inventor
Mark E. Housman
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Smith and Nephew Asia Pacific Pte Ltd
Smith and Nephew Inc
Original Assignee
Smith and Nephew Asia Pacific Pte Ltd
Smith and Nephew 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 Smith and Nephew Asia Pacific Pte Ltd, Smith and Nephew Inc filed Critical Smith and Nephew Asia Pacific Pte Ltd
Publication of WO2025207348A1 publication Critical patent/WO2025207348A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0485—Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0406—Pledgets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0409—Instruments for applying suture anchors

Definitions

  • the present disclosure relates to constructs and associated methods for repairing soft tissue. More specifically, this disclosure relates to a soft anchor tissue repair system that may repair soft tissue.
  • anchors and suture constructs for repairing tissues.
  • repairs are performed arthroscopically and preferably include anchors that are small, requiring less bone removal, while providing sufficient chronic fixation.
  • More recently anchors that are formed predominantly of soft materials, such as braided suture material have become preferable.
  • anchoring systems that do not require a knot to be tied (knotless) may be preferable.
  • various soft anchor systems that includes a small profile soft anchor and insertion system that may repair a soft tissue without the need to tie knots.
  • tissue repair systems which use a soft anchor.
  • the tissue repair systems of this disclosure may provide a high fixation strength, fixing the soft anchor within bone.
  • the tissue repair systems are may include a locking passage, avoiding the need for the surgeon to tie a knot.
  • the tissue repair systems may include at least one suture.
  • suture may include traditional sutures, that may be either hollow or may include braids along their core, unless were specified.
  • suture may include equivalent flexible members, such as but not limited to suture tape or flattened suture and may in some cases be cable, ribbon or wire, where appropriate.
  • Soft Anchor is intended to mean a flexible and/or deformable anchor, where the anchor body is formed of soft, flexible suture-like material.
  • the soft, flexible suture-like material of the anchor body changes to a more laterally and/or radially expanded configuration upon setting or deployment.
  • a tensioning member that is operatively coupled through a portion of the soft anchor may be tensioned to laterally expand the soft anchor body.
  • the term “soft anchor” does not preclude it from including supplemental portions that are somewhat rigid.
  • the soft anchor is formed entirely of braided strands.
  • “Deploy” is intended to mean to change the shape of the body of the soft anchor so that it is set, fixed or anchored with/within a tissue. Deploying may increase an outer lateral dimension of the anchor body to secure it with a tissue. For example, this may fix the soft anchor within a bone hole. To deploy an anchor changes the anchor to a deployed configuration.
  • Lock or “locked configuration” with respect to a suture construct is intended to mean locking a suture such that the suture may no longer slide in at least one direction. Sliding in this at least one direction for example may loosen a repair tissue that is secured in place. The suture may form a loop including a tissue coupled thereto and the loop perimeter is prevented from sliding and increasing in perimeter size.
  • a locked configuration is intended to mean locking the anchor body in a deployed configuration to inhibit the anchor body from relaxing/moving out of the deployed configuration.
  • Knotlessly locking or a word stemming derivative therefrom such as knotless locking or knotlessly locked, for example, is intended to mean a lock in a surgical construct or anchor system formed without having the tie a knot.
  • a system provided with a preformed knot may be defined as knotlessly locking.
  • Knotlessly locking may be achieved by passing at least one suture along a tortuous route through small openings, or through a suture locking passage construct, which may also be called Chinese finger traps, finger cinches or locking splices for example.
  • some of the sutures may extend through the suture locking passage of either the same suture or another suture, to form a self-locking adjustable suture construct as described herein.
  • Suture locking passage may be selectively elongated, by applying tension to the locking passage to cinch around the suture disposed therein, thereby locking a portion of the adjustable suture construct.
  • the insert member is entirely disposed within and along the distal bight end region lumen.
  • the insert member may be a length of suture.
  • the insertion instrument may also include two longitudinally extending prongs, extending distally from the tubular end effector, the anchoring region coextensive with the longitudinally extending prongs. Tension on the two limbs may draw the anchoring region against a distal end surface of the tubular end effector and deploy the anchoring region, thus setting the anchoring region in bone.
  • the two longitudinally extending prongs are circumferentially spaced to define two longitudinally extending slots configured to allow passage for the anchoring region therethough while deploying.
  • the construct may also include a snare construct extending along the distal bight end region lumen and insert member, and the snare construct may draw a suture through the distal bight end region lumen.
  • the snare construct may draw a limb of the two limbs through the distal bight end region lumen, forming a repair suture loop coupled to the soft tissue. Tension on a limb of the two limbs after being drawn through the distal bight end lumen may knotlessly lock the repair suture loop.
  • the soft anchoring construct includes a repair suture defining a distal bight end region and two limbs extending proximally from the distal bight end region.
  • the distal bight end region includes a lumen.
  • the soft anchoring construct also includes an insert member, formed separately from the repair suture, the insert member being elongate and flexible and having a length with a first and second end.
  • the insert member is disposed within the lumen at the distal bight end region and is configured to add bulk to the distal bight end region.
  • the first and second ends of the insert member both define a proximal end of an anchoring region of the soft anchoring construct.
  • FIG. 3A illustrates a soft anchor repair construct assembled to an insertion instrument distal end, in accordance with this disclosure
  • FIG. 30 illustrates the soft anchor repair construct assembled to the insertion instrument, inserted into bone, and deployed, in accordance with this disclosure
  • FIG. 4A schematically shows a second example soft anchor repair construct, deconstructed, in accordance with this disclosure
  • FIG. 4B schematically shows the second example soft anchor repair construct, assembled, in accordance with this disclosure
  • FIG. 4C schematically shows the second example soft anchor repair construct, assembled, deployed and knotlessly locked with a repair tissue, in accordance with this disclosure.
  • the terms “about” and “substantially” are used to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation.
  • the terms “about” and “substantially” are also used herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue.
  • “Comprise,” “include,” and/or plural forms of each are open ended and include the listed parts and can include additional parts that are not listed.
  • “And/or” is open-ended and includes one or more of the listed parts and combinations of the listed parts. Use of the terms “upper,” “lower,” “upwards,” and the like is intended only to help in the clear description of the present disclosure and are not intended to limit the structure, positioning and/or operation of the disclosure in any manner.
  • FIG. 1 schematically shows an example soft anchor construct 100 that may be inserted into and fix with bone to repair a soft tissue, in accordance with this disclosure.
  • construct 100 may fix with soft tissue, such as meniscus or labral tissue.
  • FIG. 1 illustrates construct 100 in an undeployed configuration.
  • Construct 100 may obtained in a configuration that may be low profile and may be changed to a deployed configuration (shown in later figures) that has a larger transverse dimension and a shorter axial dimension that may be characterized as a generally bunched up mass.
  • construct 100 may include a braided body 1 10 with two limbs 1 10a, 1 10b extending from a distal bight region 110c. Tension on at least one of the two limbs 110a, 1 10b may change the distal bight region 110c to a deployed configuration.
  • the braided body 1 10 may be a single continuously braided body along its length and may be braided to have a lumen or cannulation 1 1 1 along its entire length.
  • Braided body 1 10 may be a length of suture and may be USP size No. 2 having an outer diameter as obtained that is approximately 0.6mm.
  • braided body 110 may be continuously braided along its entire length, but the braiding pattern, may change therealong to define different functions.
  • limbs 1 10A, 110 B may be absent a lumen or cannulation 1 1 1 providing smaller outer diameter limbs, while distal bight region 1 10c may preferably include a lumen 11 1.
  • the braided body 110 may be continuously braided along its length, but the braiding pattern may change therealong.
  • the picks per inch (PPI) or total number of strands may change at a transition point between the distal bight region 1 10c and the two limbs 110A, 110B.
  • the distal bight region 110c may be a loosely braided portion, braided at less than 50 PPI, while the two limbs 1 10a, 1 10b may by tightly braided at greater than 10Oppi.
  • Tension on the limbs 110a, 110b may preferably allow the braid picks along the bight region 1 10C to rotate relative to each other and more readily deform during deployment.
  • Braided body 1 10 may be continuously braided so that the distal bight region 1 10c has a larger outer diameter and/or larger cannulation than the two limbs 110a, 1 10b.
  • Limbs 1 10a, 110b may couple directly to a repair tissue, such as a tendon or labrum, and therefore limbs 110a, 1 10b may define repair suture limbs.
  • Distal bight end region 1 10c may be formed as “II” and may include an insert 120 therealong, together defining an anchoring region 130.
  • Anchoring region 130 may be entirely inserted within bone and under the bone cortical layer and may, as its name suggest, upon deployment, fix, anchor or set the construct 100 with or within the bone. In other applications, anchoring region 130 may be inserted into or through other tissues, such as tendon, ligament or meniscal tissue and may, upon deployment, fix, anchor or set the construct 100 with or within a soft tissue.
  • Insert 120 is disposed at the distal bight end 1 10c. Insert 1 0 may be located in the cannulation 1 11 and has a length that may extend around and along the distal bight end 1 10c. Insert 120 is configured to add bulk to the distal bight end 1 10c. When assembled to an insertion instrument (discussed later herein) insert 120 may be sized, in cooperation with the distal bight end 1 10c to prevent the distal bight end 110c from being pulled into an instrument lumen. Insert 120 may reinforce the distal bight end 1 10c.
  • Insert 120 may be a short flexible tubular member. Insert 120 may be formed of a short length of soft, flexible suture-like material. Insert 120 may be separately fabricated relative to the braided body 110 and inserted into and along the distal bight end 110c. Insert 120 may be pre-formed or provided in a “LT shape. Inserting insert 120 may dilate distal bight end 110c, or in other embodiments distal bight end 1 10c may be pre-formed or dilated first, to receive insert 120. Insert 120 may be inserted between braids of the distal bight region 110c, and therefore braided body 1 10 may be preferably braided to easily allow insertion of insert 120.
  • An example method of construction of construct 100 may include obtaining a repair suture 1 10, that may be a size No. 2 suture and may include a lumen therealong.
  • the repair suture 110 may be folded to form a “LT or a distal bight end region 1 10c.
  • An insert member 120 may also be obtained, the insert member having a diameter or cross- sectional width that is at least an inner lumen diameter of the repair suture 110.
  • the insert member as obtained may be sized to at least fill the inner lumen 1 11.
  • Insert member 120 may have a diameter or cross-sectional width that is greater than an outside diameter of the repair suture 1 10.
  • the insert member may be a size No. 5 suture, that has an outside diameter between 0.7-0.8mm.
  • the insert member may then be inserted into the lumen 1 11 along the distal bight end region 110c. While being inserted, the braided body at the distal bight end region 110c may radially expand (dilate) to fit the insert member 120 therein.
  • a dilating tool may first be used to prepare the distal bight region 1 10c. Once inserted, the outer diameter of braided body along distal bight regionl 10c may be dilated to be double its original size. Stated another way, the outer diameter of braided body along distal bight regionl 10c may be double a corresponding outer diameter of limbs 1 10a, 100b due to assembly with the insert member 120.
  • FIG. 2A-2C schematically shows various views of an insertion instrument shaft distal end 200.
  • Distal end 200 may be tubular with a lumen 205 therealong.
  • Insertion instrument may include a proximal handle end (not shown), with insertion instrument tubular shaft extending distally therefrom.
  • Distal end 200 may include a tubular portion 208 defining a 360-degree bounded lumen 205 (FIG. 2B), with two prongs 220a, 220b extending distally therefrom.
  • Prongs 220a, 220b may be diametrically opposed from each other.
  • Prongs 220a, 220b may extend circumferentially (best seen in FIG. 2C) and be continuous with an outer circumferential surface of tubular portion 208.
  • Slots 210a, 210b may have a circumferential width configured to allow passage of the anchoring portion 130 therethrough during deployment. Slots 210a, 210b may have a circumferential width that is at least as wide as a diameter “D” of the anchoring portion 130 to receive the anchoring portion therethrough during deployment.
  • Insertion instrument distal end 200 is generally configured to be inserted through a small opening through the patient’s skin to access a joint and may be inserted through a prepared arthroscopic port. Insertion instrument may be termed an arthroscopic instrument.
  • Tension on limbs 1 10a, 110b may deploy anchoring region 130 to the configuration shown in FIG. 3C.
  • anchoring region 130 including insert member 120 may be drawn proximally, however, the anchoring region 130 is sized so that it is prevented from entering insertion instrument lumen 205.
  • lumen 205 is sized to prevent the anchoring region 130 from entering it and provide a back stop. While this may be achieved though instrument lumen size, other means are contemplated, such as a projecting member traversing the lumen 205 or at least partially narrowing of the lumen 205 at the lumen entrance.
  • Insertion instrument may then be removed and repair suture limbs 1 10a, 1 10b may then be coupled to a repair tissue.
  • the two repair suture limbs 1 10a, 1 10b may be tied together in a knot to couple the repair tissue.
  • at least one of the limbs 110a, 110b may be coupled to another anchor (not shown).
  • at least one of the limbs 1 10a, 110b may be coupled to a snare and snared through the anchoring portion 130 as is disclosed hereinafter.
  • Limb 1 10a may be coupled to a repair tissue 40 and then drawn through the distal bight region 1 10c, via one of the transfer sutures, in this example it is snared and transferred via transfer suture 410b. More specifically, limb 110a may be coupled to a loop end 454 of transfer suture 410b and then the opposite end of the transfer suture 410b may be withdrawn to transfer the end 110a through the lumen 11 1 of distal bight end 110c, including along an external surface of insert member 120. This forms a repair loop 440a that is unilateral in that it is on a single side of the construct longitudinal axis.
  • the repair loop 440a may extend across the longitudinal axis of the construct 400, by snaring the end 110a with the transfer suture 410a.
  • a similar repair loop may be formed, in a mirror image form with limb 1 10b and one of transfer suture 410a, or 410b to form another repair loop similar to loop 440a.
  • Tension on at least one of limb 110a or 1 10b before or after the repair loop(s) is/are formed may cinch the lumen 111 of distal bight end 1 10c around any suture disposed therein and knotlessly lock the repair.
  • a suture 460 that may be coupled to another portion of the tissue 40, another tissue, and/or to tissue anchor.
  • Suture 460 may be transferred through anchoring portion 130 via a transfer suture (410a shown) so as to be disposed within the lumen 1 11 and may be coextensive with and external to the insert member 120.
  • Tension on at least one of limb 110a or 110b thereafter may cinch the inner lumen 111 of distal bight end 1 10c around this separate suture disposed therein and knotlessly lock the separate suture 460 with the construct 400.
  • transfer suture(s) 410a, 410b may punch through an entire diameter of body 1 10 first, and then enter a lumen of braided body 1 10 adjacent insert member 120, which may improve control of tension and locations of any formed locking passages.
  • a transfer suture(s) 410a, (410b) may interweave pr punch through the insert member 120 as it extends along the lumen 1 1 1 , which may improve increase a fixation strength of any formed locking passages.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Rheumatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rehabilitation Therapy (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un système de réparation de tissu comprenant une construction d'ancrage souple avec une suture de réparation et un élément d'insert. La suture de réparation comprend une lumière, et l'élément d'insert est situé à l'intérieur de cette lumière sur une longueur, cette longueur définissant une partie d'ancrage de la suture de réparation. La construction d'ancrage souple peut être assemblée sur un instrument d'insertion qui comprend un effecteur terminal tubulaire avec une lumière qui a reçu de manière coulissante la suture de réparation. La partie d'ancrage est située de manière distale par rapport à l'effecteur terminal tubulaire et est empêchée de pénétrer dans la lumière de l'effecteur terminal tubulaire. La tension sur les extrémités de la suture de réparation peut déployer la partie d'ancrage pour la placer dans l'os.
PCT/US2025/020036 2024-03-26 2025-03-14 Système de réparation de tissu à ancrage souple Pending WO2025207348A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202463569865P 2024-03-26 2024-03-26
US63/569,865 2024-03-26

Publications (1)

Publication Number Publication Date
WO2025207348A1 true WO2025207348A1 (fr) 2025-10-02

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ID=97219736

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2025/020036 Pending WO2025207348A1 (fr) 2024-03-26 2025-03-14 Système de réparation de tissu à ancrage souple

Country Status (1)

Country Link
WO (1) WO2025207348A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20220240918A1 (en) * 2019-06-14 2022-08-04 Smith & Nephew, Inc. Soft anchoring tissue repair assembly and system
WO2022187614A1 (fr) * 2021-03-04 2022-09-09 Smith & Nephew, Inc. Procédés et systèmes liés à la réparation d'articulations
US20230320723A1 (en) * 2021-09-09 2023-10-12 Responsive Arthroscopy, LLC All-suture anchor
US20240057991A1 (en) * 2013-12-20 2024-02-22 Arthrocare Corporation Knotless all suture tissue repair

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20240057991A1 (en) * 2013-12-20 2024-02-22 Arthrocare Corporation Knotless all suture tissue repair
US20220240918A1 (en) * 2019-06-14 2022-08-04 Smith & Nephew, Inc. Soft anchoring tissue repair assembly and system
WO2022187614A1 (fr) * 2021-03-04 2022-09-09 Smith & Nephew, Inc. Procédés et systèmes liés à la réparation d'articulations
US20230320723A1 (en) * 2021-09-09 2023-10-12 Responsive Arthroscopy, LLC All-suture anchor

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