Knotless Tissue Repair Construct With Self-Locking Splice Fixation
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Solution Overview
Problem
Existing surgical techniques for tissue repairs, such as those described in EP 2 777 613 A1, US 2013/0116730 A1, US 2016/0175088 A1, US 2016/0183936 A1, and US 2018/0221133 A1, face challenges in achieving knotless, self-locking, and tensionable fixation of tissues without the need for knot formation, which is crucial for efficient and reproducible tissue repairs.
Innovation Solution
The development of surgical constructs incorporating a reinforcement material with a self-locking mechanism, featuring a flexible coupler and eyelets, allows for knotless, self-locking, tensionable, and self-cinching fixation by forming adjustable loops and splices within the construct, eliminating the need for traditional knot tying.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If traditional knot tying methods are used to secure suture material, then the suture can be anchored, but needle holes remain in the tissue creating pathways for bacterial migration and increasing infection risk
Solution Approach 1:
The invention extracts and eliminates the knot-tying step from the traditional suturing process. By using pre-tied surgical clips that self-anchor without requiring needle holes or traditional knot tying, the harmful needle puncture pathways are removed while maintaining secure tissue anchoring.
Solution Approach 2:
The surgical clip acts as an intermediary device that replaces the traditional needle-knot system. The clip with its integrated needle and pre-formed anchor structure mediates between the suture material and tissue, providing secure anchoring without creating harmful needle hole pathways through repeated punctures.
2Strength
If multiple passes of needle and suture material are used to achieve secure anchoring, then knot security is improved, but tissue damage and procedural time increase
Solution Approach 1:
The surgical clip incorporates a pre-formed anchor structure and pre-attached suture material before the surgical procedure. This preliminary preparation eliminates the need for multiple time-consuming passes of needle and suture material to achieve secure anchoring, while maintaining strong tissue attachment.
Solution Approach 2:
The invention merges the needle, suture material, and anchor structure into a single integrated surgical clip assembly. This combination allows all anchoring functions to be achieved in one application step, eliminating the need for separate multiple passes and reducing procedural time while maintaining security.
3Strength
If multiple passes of needle and suture material are used to achieve secure anchoring, then knot security is improved, but the number of needle holes and tissue damage increase
Solution Approach 1:
The invention extracts the multiple needle puncture passes from the anchoring process. By using a single-pass application of the pre-assembled surgical clip with integrated needle and anchor, the number of harmful needle holes in the tissue is dramatically reduced while maintaining secure anchoring strength.
Solution Approach 2:
The surgical clip serves as an intermediary that consolidates multiple needle passes into a single application. The integrated design with pre-attached suture and anchor structure allows the clip to achieve secure anchoring in one tissue penetration, minimizing tissue damage while maintaining knot security.
4Ease of manufacture
If traditional knot tying is performed, then suture material can be secured, but the process requires manual dexterity and training
Solution Approach 1:
The surgical clip is designed to be self-assembling and self-anchoring. The spring-loaded arms and pre-formed anchor structure automatically engage with the tissue and secure the suture material without requiring manual knot tying. This self-service mechanism simplifies the surgical procedure while the clip structure integrates multiple functions.
Solution Approach 2:
The surgical clip integrates multiple functions into a single device: the needle for tissue penetration, the spring-loaded arms for anchoring, and the pre-attached suture material for securing. This multi-functional design replaces the separate needle, suture, and knot-tying components, simplifying the overall procedure despite the increased complexity of the integrated clip structure.
Data Source
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AI summary
Surgical constructs, assemblies, and methods for tissue reinforcement with a reinforcement (reinforcing) material are disclosed. A surgical construct can include a reinforcement material with a self-locking mechanism. The self-locking mechanism can include at least one eyelet attached to a flexible coupler and secured to a reinforcement material, to form at least one splice located partially or totally within a surgical construct. The splice can be formed with a shuttle/pull device. The surgical construct can be provided with holes or eyelets to facilitate suture passes through a reinforcement material. The surgical construct can be knotless, self-locking, tensionable, self-cinching. The surgical construct provides self-locking, self-cinching, knotless soft tissue to bone fixation, without knot formation, with fewer passing steps, increased fixation, and uniform soft tissue compression.