Structured Tissue Augmentation Construct for Soft Tissue Fixation
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Solution Overview
Problem
Current methods for securing soft tissue to bone, such as screws, staples, and sutures, often cause trauma to the tissue and can lead to further damage, especially in degenerated tissue. Additionally, existing tissue augmentation patches can be cumbersome to deliver and may not provide adequate fixation or promote healing effectively.
Innovation Solution
The use of structured tissue augmentation constructs, which include a flexible or semi-flexible skeleton integrated with a biologically active tissue augmentation material. These constructs can expand the footprint of sutures, distribute force more evenly across the tissue, and promote tissue growth and repair. They can be delivered arthroscopically and fixed using integrated sutures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If sutures are used to secure soft tissue to bone, then fixation is achieved, but tissue trauma and damage occur due to concentrated force on small surface area
Solution Approach 1:
A tissue augmentation patch is introduced as an intermediary element between the suture and the soft tissue. The patch distributes the suture force over a larger surface area of the tissue, preventing concentrated stress and trauma. The patch acts as a mediator that transfers the fixation force from the small suture contact point to a broader tissue area, thereby reducing tissue damage while maintaining fixation strength.
Solution Approach 2:
The invention changes the surface area parameter of the force distribution interface. Instead of the suture contacting a small area of tissue directly, the patch increases the effective surface area to several square centimeters. This parameter change from small contact area to large distributed area reduces the pressure and stress concentration on the tissue, preventing trauma and cheese-wiring effects.
2Object-affected harmful factors
If allograft or xenograft formation is applied to expand suture footprint, then tissue damage is reduced, but procedure time and cost increase significantly
Solution Approach 1:
The tissue augmentation patch is designed as a disposable, cost-effective alternative to expensive allograft or xenograft materials. The patch provides the necessary footprint expansion function without the high cost and lengthy processing requirements of biological grafts. It can be applied quickly during surgery and serves its purpose of distributing suture force, after which it is replaced by healed tissue.
Solution Approach 2:
The patch is pre-formed with the appropriate size, shape, and mechanical properties needed for force distribution. This preliminary preparation eliminates the need for intraoperative manipulation, sizing, and attachment procedures that would extend surgical time. The patch is ready for immediate application, allowing quick deployment to protect the tissue during suture tensioning.
3Strength
If membrane is integrated into repair construct for strength, then construct strength is improved, but orientation control becomes difficult
Solution Approach 1:
The tissue augmentation patch is designed with asymmetric features including a distinct front surface and back surface, with the front surface having different properties (such as texture, porosity, or surface treatment) optimized for tissue contact. This asymmetry provides visual and tactile cues to the surgeon for correct orientation during implantation, ensuring the properly oriented surface contacts the soft tissue while maintaining the structural strength provided by the integrated membrane.
Data Source
AI summary
Devices, systems, and methods to improve both the reliability of soft tissue repair procedures and the speed at which the procedures are completed are provided. The devices and systems include one or more structured tissue augmentation constructs, which include constructs that are configured to increase a footprint across which suture applied force to tissue when the suture is tied down onto the tissue. The tissue augmentation constructs can be quickly and easily associated with the repair suture and can be useful in many different tissue repair procedures that are disclosed in the application. The present disclosure includes structured tissue augmentation blocks for tendon repair that have a flexible or semi-flexible skeleton integrated into the block. The skeleton can be bioabsorbable and can create both in-plane and out-of-plane curvature in the block.