Soft anchoring tissue repair assembly and system

Inventors

Qi, ZenanBalboa, Marc JosephYoung, TimothyKarasic, Geoffrey IanTorrie, Paul AlexanderTurner, Kyle Steven FrederickPatel, Nehal NavinbhaiHall, Benjamin MichaelLi, Kangqiao

Assignees

Smith and Nephew Orthopaedics AGSmith and Nephew Asia Pacific Pte LtdSmith and Nephew Inc

Publication Number

US-12262885-B2

Publication Date

2025-04-01

Expiration Date

2040-06-12

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Abstract

A tissue repair assembly is disclosed, including a soft anchor body and at least a first suture operably coupled to the anchor body. Tensioning on first and/or second ends of first suture may deploy the anchor body to a second configuration, in which the anchor body is axially compressed and radially extended. The tissue repair assembly may also include a means to cinch around a portion of a first and/or second suture and knotlessly lock the tissue repair assembly. Some embodiments may include a pre-formed knot. In some embodiments, the preformed knot may be a nail knot, provided wrapped around an insertion instrument and configured to receive and cinch around a suture extending therethrough.

Core Innovation

The invention provides a tissue repair assembly and system using a soft anchor body, at least one expansion suture, and at least one repair suture. The anchor body is designed to be primarily flexible, typically formed from braided suture or suture tape, and is capable of changing from an elongate configuration to a deployed configuration by tensioning the expansion suture. This transition results in axial compression and radial expansion of the anchor body, allowing it to become embedded within a bone tunnel and thereby effectively anchor tissue.

A central problem addressed is the reliance in prior art systems on rigid or hard anchors and complex knot-tying for fixation, which can pose anatomical risks and procedural difficulties. The disclosed system eliminates the need for forming knots during surgery by the user, and instead utilizes a pre-formed knot (such as a nail knot) or knotless locking mechanism that cinches and secures the anchor and tissue in position. The system also introduces a locking suture, which can be independently tensioned to tighten the pre-formed knot and lock the assembly in its deployed configuration.

The assembly further increases suture locking strength by allowing repair sutures (used to attach tissue) to be routed through specialized passages, pre-formed knots, or longitudinal passages within the sutures, facilitating selective locking upon deployment. Some embodiments use an insertion instrument to deliver the anchor and knot construct, with features such as slots for suture tails and knot pushers for final fixation. Altogether, the system provides secure tissue-to-bone fixation with a soft anchor, optional pre-formed knot integration, and a mechanism for knotless or pre-tied suture lock.

Claims Coverage

The patent claims three independent tissue repair assembly configurations featuring inventive mechanisms for anchor deployment and suture locking.

Tissue repair assembly with soft anchor, separate expansion, repair, and locking sutures, and pre-formed knot

This feature includes: - A soft anchor with proximal and distal ends and a longitudinal axis. - An expansion suture, whose first and second ends exit the anchor near the proximal end; tensioning these ends deploys (radially expands/compresses) the anchor. - A repair suture for coupling tissue to the anchor, formed separately from the expansion suture. - A locking suture, separately formed from both expansion and repair sutures, and coupled to the anchor. The locking suture includes a pre-formed knot (such as a nail knot) positioned for locking. - The pre-formed knot is configured to receive both expansion suture and repair suture therethrough, and tightening the locking suture selectively tightens the pre-formed knot to lock the soft anchor in its deployed configuration.

Tissue repair assembly with pre-formed knot disposed at proximal end of anchor

This feature adds: - The pre-formed knot (nail knot or other) is disposed specifically at the proximal end of the anchor, positioned external to the anchor itself. - The expansion suture’s ends extend proximally from the anchor’s proximal end. - Tensioning the expansion suture provides anchor deployment, and separately, tensioning a locking suture end tightens the pre-formed knot around at least the expansion suture and/or repair suture.

Tissue repair assembly with pre-formed knot for locking repair suture after tissue coupling

This feature is characterized by: - The pre-formed knot is configured to receive the repair suture after the repair suture has already been coupled to the tissue, allowing post tissue-coupling locking. - Tensioning an end of the locking suture tightens the pre-formed knot specifically around the repair suture to lock the tissue in place, in addition to anchor deployment through the expansion suture.

The claims broadly cover a tissue repair assembly utilizing a soft anchor, independently formed expansion, repair, and locking sutures, and a pre-formed locking knot (including embodiments with nail knot constructs) for deploying, securing, and locking the anchor and tissue without requiring intraoperative knot-tying by the surgeon.

Stated Advantages

Eliminates the need for knot-tying during surgery, simplifying the procedure and reducing the level of surgical expertise required.

Reduces the risk of anatomical damage associated with rigid anchors by providing a construct made substantially of soft, flexible materials.

Provides a reliable suture and anchor locking mechanism utilizing pre-formed knots or knotless features for secure fixation.

Allows for secure tissue-to-bone fixation with increased locking force by embedding the soft anchor within bone and constricting sutures via friction and knot mechanisms.

Permits independent tensioning and control of expansion and locking sutures, enhancing procedural flexibility and fixation reliability.

Documented Applications

Use in orthopedic surgeries involving the attachment of soft tissue to bone, such as tendon-to-bone, ligament-to-bone, labral repairs, and rotator cuff repairs.

Procedures including bone-to-bone, tendon-to-tendon, and ligament reconstruction, where secure fixation without rigid anchor materials is desired.

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