Two-Part Wedge Suture Anchor for Bone Fixation
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Solution Overview
Problem
Current suture anchor designs face challenges such as high insertion forces, risk of anchor breakage, damage to bone, and variability in securing tissue tension due to the need for knot-tying, which can lead to under- or over-tensioning and require significant surgical skill and time.
Innovation Solution
A two-part wedge design suture anchor system that allows for adjustable tension before locking, eliminating the need for knot-tying and reducing insertion force requirements, featuring a screw-lock mechanism and external surface features for secure bone engagement, with a removable inserter and internal texturing for suture retention.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If interference features (barbs, ribs, ridges) are used to provide fixation strength, then anchor holding strength is improved, but insertion force requirement increases
Solution Approach 1:
The anchor is divided into two separate components: a distal component with interference features for bone engagement, and a proximal component that applies compression force. This segmentation allows each component to perform its specific function independently, reducing the insertion force required while maintaining holding strength.
Solution Approach 2:
The distal component with interference features is inserted into the bone hole first, establishing the anchor position and engagement with the bone before the proximal component is added. This preliminary action allows the interference features to be properly seated without requiring excessive force during final assembly.
2Reliability
If a knot is tied to secure the suture to the anchor, then suture retention is improved, but surgical time and skill requirement increase
Solution Approach 1:
The knot-tying step is completely removed from the surgical procedure. Instead of requiring the surgeon to tie a knot to secure the suture, the system uses a compression mechanism where the proximal component applies force to hold the suture against the distal component, eliminating the need for knotting and associated surgical skill requirements.
3Ease of operation
If tension is added to the suture during deployment to pull tissue into contact with bone, then tissue approximation is improved, but tension control accuracy decreases
Solution Approach 1:
The system provides mechanical feedback through the compression mechanism. As the proximal component is driven into the distal component, it applies controlled compression force that automatically maintains appropriate suture tension. This mechanical feedback system eliminates the need for the surgeon to estimate and manually control tension, ensuring consistent and accurate tissue approximation.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system simplifies the implantation process by reducing the force required for anchor insertion, ensuring consistent tissue tension, and minimizing the risk of anchor failure or bone damage, while eliminating the complexity of knot-tying and reducing surgical time and variability.
Implementation Method 1
A proximal member is provided, which is movable distally to engage the implant and to fix the suture in place within the implant
Implementation Method 2
The proximal member comprises a screw member... the screw is advanced to pinch the suture against the distal tip
Implementation Method 3
external surface features for securing the implant within surrounding bone
Data Source
AI summary
A method for securing suture to bone comprises drilling a hole in a desired portion of bone at a desired procedural site, passing a strand of suture through a portion of soft tissue to be approximated to the portion of bone, and extending the free suture ends proximally from the soft tissue. The suture is loaded into an anchor implant. Using an inserter, on a distal end of which is attached the anchor implant, the anchor implant is manipulated into the bone hole. The suture is then tensioned to a desired level by pulling on the free suture ends, after the anchor implant is positioned in the bone hole. The free suture ends are wrapped about a suture cleat on an inserter handle once the desired tension level is achieved. A proximal anchor component is moved distally to engage with a distal anchor component to lock the anchor in place within the bone hole, and to lock the suture in place within the anchor. Then, the inserter is removed from the procedural site.