Tensionable Knotless Anchor With Pre-Loaded Loop
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Solution Overview
Problem
Current surgical methods for soft tissue repair to bone often require knot-tying, which can be time-consuming and prone to complications such as knot failure or irritation against adjacent structures, and lack the ability to adjust tension and tissue location effectively.
Innovation Solution
The development of tensionable knotless fixation devices with a pre-loaded tensioning construct, comprising a tensioning strand, adjustable self-cinching loop, and splice, which are inserted into bone and used in conjunction with flexible materials like suture or suture tape to achieve secure fixation without knots, allowing for adjustable tension and precise tissue placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If knot-tying is used for soft tissue fixation, then the fixation can be achieved with simple devices, but the surgical time increases and complications such as knot failure or irritation may occur
Solution Approach 1:
The patent extracts the knot-tying step from the fixation process by using a pre-formed loop construct that eliminates the need for surgical knot tying. The loop is pre-configured on the fixation device, allowing direct insertion and tissue capture without time-consuming knot manipulation, thereby reducing surgical time while maintaining fixation reliability
Solution Approach 2:
The loop construct is prepared in advance (pre-loaded) on the fixation device before insertion. This preliminary configuration of the loop allows the surgeon to simply insert the device and capture tissue without performing knot-tying during surgery, significantly reducing surgical time while ensuring reliable fixation through the pre-engineered loop structure
2Adaptability or versatility
If knot-tying is used for soft tissue fixation, then the procedure can be completed with basic surgical tools, but the ability to adjust tension and tissue location is limited
Solution Approach 1:
The patent implements a dynamic, adjustable loop construct that can be tensioned and repositioned after insertion. The loop is designed to accommodate adjustment of tissue location and tension levels post-insertion, providing adaptability without requiring complex pre-configured device structures. The simplicity of the basic loop design is maintained while adding the capability for intraoperative adjustment
3Reliability
If traditional fixation methods are used, then the surgical procedure is well-established, but complications such as knot failure or irritation against adjacent structures may occur
Solution Approach 1:
The patent removes the knot element from the fixation system entirely, replacing it with a pre-formed loop construct. This extraction eliminates the source of knot-related complications such as knot failure, slippage, or irritation of adjacent structures, while maintaining secure fixation through the engineered loop geometry and tissue capture mechanism
Solution Approach 2:
The patent converts the potential harm of knot-related complications into a benefit by using a knotless loop design. The loop construct provides inherent security against fixation failure without the adverse effects of knots, transforming the design approach to eliminate harmful factors while improving reliability through the simplified, irritation-free loop structure
Data Source
AI summary
Surgical devices and methods of soft tissue repair using pre-looped tensionable and non-pre-looped tensionable knotless fixation devices. A flexible material (for example, suture or suture tape) may be attached to the fixation device. A flexible material may be threaded through an eyelet of a tip provided as part of a swivel anchor assembly to provide added stability to the fixation devices.