Suture Clamp Assembly for Secure Fixation
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Solution Overview
Problem
Current suture fixation techniques in rotator cuff repair, such as knotting and multiple anchor use, are inefficient, time-consuming, and can cause bone compromise, leading to increased surgical time and implant costs, while existing clip designs are prone to failure under significant forces.
Innovation Solution
A suture clamp assembly with a receptacle and plug component that minimizes suture deformation, allowing for securement of multiple suture leads through a gathering loop and clamp assembly, eliminating the need for knots and reducing anchor usage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If multiple suture anchors are used for double-row transosseous fixation, then fixation strength and healing outcomes are improved, but surgical time and implant cost increase substantially
Solution Approach 1:
The patent combines multiple suture leads into a single integrated suture assembly with a common anchor, eliminating the need for separate anchors for each suture lead. This merging approach maintains the structural integrity and fixation strength of double-row transosseous fixation while reducing the number of implantation steps and surgical time required
Solution Approach 2:
The suture assembly is designed with multi-functional capabilities, allowing a single anchor to secure multiple suture leads simultaneously. This universal design enables the anchor to perform the fixation function for what would traditionally require multiple separate anchors, thereby reducing implant cost and surgical complexity while maintaining fixation strength
2Strength
If multiple suture anchors are used for double-row transosseous fixation, then fixation strength and healing outcomes are improved, but bone compromise and damage increase
Solution Approach 1:
By merging multiple suture leads into a single integrated assembly secured by one anchor, the patent reduces the number of bone penetration sites required. This approach maintains the necessary fixation strength for double-row transosseous fixation while minimizing the cumulative bone trauma and compromise that would result from implanting multiple separate anchors
3Reliability
If knotting is used to secure suture leads, then suture leads can be fixed to maintain tension, but surgical time increases and risk of lead breakage and glove cuts increases
Solution Approach 1:
The patent extracts and eliminates the knotting step from the suture securing process by incorporating pre-formed securement mechanisms directly into the suture assembly and anchor interface. This allows suture leads to be fixed and tensioned without requiring surgeons to tie knots, thereby reducing surgical time and eliminating risks associated with manual knotting such as lead breakage and glove cuts
Solution Approach 2:
The suture assembly is designed with self-securing features that automatically maintain tension and fixation without requiring manual knotting by the surgeon. The integrated design allows the suture leads to be secured through mechanical interlocking or friction-based mechanisms inherent to the assembly structure, enabling the system to secure itself without additional manual intervention
4Ease of operation
If traditional clip designs are used to address suture lead challenges, then some challenges are mitigated, but suture failure risk increases under significant forces
Solution Approach 1:
The patent employs composite material construction and integrated design principles to create a suture assembly that distributes mechanical loads across multiple components rather than concentrating stress at a single clip interface. This composite approach enhances the overall reliability and load-bearing capacity of the suture securement mechanism, preventing suture failure under the significant forces encountered during rotator cuff repair while maintaining ease of operation
Data Source
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AI summary
A system and methods for gathering, tensioning, and clamping a plurality of suture leads may be used for any of a range of possible surgical applications. The system includes a suture clamp assembly that includes receptacle and plug components, wherein suture leads passed into the receptacle are secured when the plug is inserted into the receptacle to lock the suture leads in place, a gathering suture that includes a gathering loop, an instrument for securement of the plurality of suture leads, and optionally an anchor affixed to the gathering suture. The system may be used to address rotator cuff repairs, labral repair, biceps tenodesis, acromioclavicular joint stabilization, and applications in other joints and bones within a body.