Compressible Tissue Augmentation Scaffolds for Soft Tissue Fixation
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Solution Overview
Problem
Current soft tissue repair methods, such as rotator cuff repairs, face challenges with existing devices that cause tissue damage due to inadequate suture-to-anchor fixation, especially in degenerated tissues, and require complex and time-consuming procedures for tissue augmentation, leading to increased costs and procedural time.
Innovation Solution
The development of tissue augmentation constructs, including tapes, tubes, blocks, and patches, that can be easily associated with sutures to expand their footprint, distribute force over a larger surface area, and promote tissue growth, using materials like collagen and biodegradable polymers, allowing for on-demand application during procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Area of moving object
If a relatively large formation of allograft or xenograft is applied to the soft tissue, then the suture surface area is increased to reduce tissue damage, but the procedural time increases significantly (additional half hour to one hour per formation applied) and costs increase
Solution Approach 1:
The tissue augmentation construct is divided into multiple compression strips that can be individually applied to the soft tissue. Each strip can be independently positioned and secured, allowing the surgeon to apply only the necessary number and size of strips to achieve adequate suture surface area without the time-consuming process of applying a single large formation of allograft or xenograft.
Solution Approach 2:
The invention changes the physical parameters of the tissue augmentation material by using compressible strips that can be compressed to a reduced size for delivery through a cannula and then expanded to their full size at the surgical site. This allows the material to be delivered in a compact form and then deployed to provide the necessary surface area, eliminating the need to apply large formations in their final form.
2Area of moving object
If a relatively large formation of allograft or xenograft is applied to the soft tissue, then the suture surface area is increased to reduce tissue damage, but the cost increases significantly
Solution Approach 1:
The tissue augmentation construct uses compressible strips made from biocompatible materials that can be delivered in a compact form and deployed at the surgical site. These strips provide the necessary surface area enhancement without requiring expensive allograft or xenograft formations, reducing the quantity of expensive biological material needed while achieving the same functional outcome.
3Length of moving object
If repair constructs are delivered through a small opening or cannula, then the surgical access is minimized, but the construct is deformed prior to and/or during insertion
Solution Approach 1:
The tissue augmentation construct is designed with dynamic properties that allow it to change shape and size. The compressible strips can be compressed to a reduced size for delivery through a small cannula and then expanded to their full size and shape at the surgical site. This dynamic transformation allows the construct to pass through narrow delivery pathways while maintaining its functional form at the destination.
Solution Approach 2:
The compressible strips are configured to be nested or stacked within a delivery device or cannula in a compact arrangement. Each strip can be positioned within the cannula in a space-efficient manner, allowing multiple strips to be delivered through a single small opening. Once deployed, the strips expand from their nested configuration to their full functional size and shape.
4Strength
If the suture applies significant force to the soft tissue over a small surface area, then the fixation strength is maintained, but the tissue is damaged by abrasion or cheese-wiring
Solution Approach 1:
The compressible strips serve as an intermediary between the suture and the soft tissue. The strips are positioned between the suture and the tissue, increasing the surface area over which the suture force is distributed. This intermediary layer prevents direct contact between the suture and the tissue, eliminating abrasion and cheese-wiring while maintaining fixation strength through the expanded contact area.
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 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. Tissue augmentation constructs can include various blocks and scaffolds, among other formations. The present disclosure includes, among other disclosures, methods for using tissue augmentation scaffolds, including folding scaffolds, and descriptions and methods associated with extra-wide tissue augmentation blocks.