Self-Deploying Tissue Augmentation Patches for Soft Tissue Repair
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Solution Overview
Problem
Current soft tissue repair methods, such as rotator cuff repairs, face challenges with existing devices that cause trauma to tissues due to small suture surface areas, leading to further damage and complex, costly procedures, especially in degenerated tissues, and cumbersome delivery of tissue augmentation patches.
Innovation Solution
Self-deploying tissue augmentation constructs with flexible resilient members, like nitinol wire rings, that transition from a compact state for easy insertion through small openings to an expanded state for increased surface area contact and distribution of suture force, promoting healing and reducing tissue trauma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a small surface area suture is used to repair soft tissue, then the surgical procedure is simpler and faster, but the suture causes trauma to the tissue and may cause further damage such as abrasion or cheese-wiring
Solution Approach 1:
The tissue repair system is segmented into multiple components: a tissue augmentation patch and a suture. The patch is divided into a first portion and a second portion, with the suture passing through both portions. This segmentation allows the suture to distribute force across a larger area through the patch, reducing tissue trauma while maintaining surgical efficiency.
Solution Approach 2:
The tissue augmentation patch serves as an intermediary between the suture and the soft tissue. The patch distributes the suture force over a larger area, preventing direct concentration of force on the tissue that would cause abrasion or cheese-wiring. The patch material acts as a mediator that protects the tissue from harmful suture effects.
2Object-affected harmful factors
If a relatively large formation of allograft or xenograft is applied to increase suture surface area, then tissue trauma is reduced, but the procedure becomes more expensive, time-consuming, and requires higher skill level
Solution Approach 1:
The tissue augmentation patch is designed as a disposable, synthetic alternative to expensive allograft or xenograft materials. The patch can be manufactured at lower cost using synthetic materials and does not require the same level of surgical skill for application as biological grafts, reducing both cost and procedure complexity while still providing the benefit of increased suture surface area.
Solution Approach 2:
The invention changes the material parameters from biological materials (allograft/xenograft) to synthetic materials. This parameter change allows for controlled physical and chemical properties in the patch, enabling it to provide the necessary mechanical support and surface area distribution without the complexity and cost associated with processing and handling biological grafts.
3Ease of operation
If a tissue augmentation patch is delivered through a small opening or cannula, then access to the surgical site is achieved, but the patch becomes deformed prior to and/or during insertion
Solution Approach 1:
The tissue augmentation patch is designed with dynamic properties that allow it to transition between different states. The patch can be compressed or folded into a compact configuration for delivery through a small cannula, then automatically or manually deployed to its full geometric configuration at the surgical site. This dynamic transformation preserves the patch shape during insertion while enabling easy delivery.
Solution Approach 2:
The tissue augmentation patch is nested within a delivery device or cannula in a compacted state. The patch is inserted through the cannula in a folded or rolled configuration, then deployed by unrolling or unfolding at the surgical site. This nesting approach allows the large-area patch to be delivered through a small opening without permanent deformation.
4Strength
If repair constructs include a membrane that provides strength, then structural support is improved, but it becomes difficult to ensure the preferred side of the repair construct is in contact with the host tissue
Solution Approach 1:
The tissue augmentation patch is designed with asymmetric properties, where the first portion and second portion have different characteristics. This asymmetry allows the surgeon to identify and orient the preferred side of the patch toward the host tissue. The asymmetric design may include different surface textures, material compositions, or geometric features on each side, making it easy to distinguish the correct orientation while maintaining structural strength.
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 self-deploying constructs facilitate easier and less traumatic soft tissue repair by distributing suture force over a larger area, reducing the risk of further tissue damage and simplifying the surgical procedure, while allowing for effective tissue growth and repair.
Implementation Method 1
Self-deploying tissue augmentation constructs with flexible resilient members, like nitinol wire rings, that transition from a compact state for easy insertion through small openings to an expanded state for increased surface area contact and distribution of suture force
Data Source
AI summary
Self-deploying devices, systems, and methods of use 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 surgical implants that include a sheet of biocompatible or bioabsorbable material that can be positioned as an implant within a patient's body, the sheet of material being introduced into the patient's body in a mechanically compressed or folded or rolled form. The sheet of material can include a self-expanding ring or framework that resiliently biases the sheet of material to open into a flat sheet once mechanically released within the patient's body. The sheet of material can be used for performing a surgical repair by attaching the deployed sheet to tissue within the body. The surgical repair can comprise an orthopedic repair or a muscular repair. In some examples, the self-expanding ring or framework is removable after the sheet of material is implanted.