Native Soft Tissue Matrix for Regenerative Repair
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Solution Overview
Problem
Current methods for repairing or regenerating soft tissues such as cartilage, meniscus, and blood vessels are inadequate due to limited availability of autologous tissue, risks associated with allografts, and poor integration of synthetic implants, leading to tissue necrosis and degradation over time.
Innovation Solution
Development of a native soft tissue matrix (NSTM) processed to remove immunogenic material and pathogens, which can be used as an acellular filler or combined with cells and bioactive molecules to promote tissue repair and regeneration, and can be implanted or injected at specific sites in the body.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If fresh allograft tissues are used for soft tissue repair, then tissue availability is improved, but disease transmission risk increases
Solution Approach 1:
The patent extracts and removes immunogenic material and pathogens from allograft soft tissue while retaining the extracellular matrix structure and bioactive molecules. This extraction process eliminates disease transmission risk while preserving the therapeutic benefits of allograft tissue, resolving the contradiction between tissue availability and safety.
Solution Approach 2:
The patent applies different processing treatments to different components of the allograft tissue: immunogenic material and pathogens are removed, while extracellular matrix proteins and growth factors are preserved. This selective local quality modification allows the tissue to be both safe and therapeutically effective.
2Reliability
If radiation sterilized allografts are used, then pathogen elimination is improved, but biomechanical function is lost
Solution Approach 1:
Instead of using radiation sterilization that damages the tissue structure, the patent extracts and removes pathogens through enzymatic digestion and washing processes. This alternative approach achieves pathogen elimination while preserving the biomechanical properties and structural integrity of the allograft tissue.
3Quantity of substance
If intact allograft tissues are implanted, then tissue replacement is achieved, but host cell infiltration is minimal
Solution Approach 1:
The patent processes intact allograft tissue into pulverized morsels, breaking down the tissue structure into smaller particles. This segmentation increases the surface area and creates pathways for host cell infiltration, while the preserved extracellular matrix provides scaffolding for tissue regeneration. The segmented structure allows both tissue replacement and host cell integration.
Solution Approach 2:
The processing method creates a porous structure in the pulverized allograft morsels, with interconnected spaces that facilitate host cell migration and infiltration. This porous architecture maintains the extracellular matrix framework while enabling cellular integration, resolving the contradiction between tissue replacement and host cell infiltration.
4Quantity of substance
If synthetic implants are used, then tissue replacement is achieved, but integration problems occur
Solution Approach 1:
The patent creates a composite material by combining pulverized allograft soft tissue morsels with biomaterials or biologically active molecules. This composite structure integrates the structural replacement function with the biological integration capabilities of the native extracellular matrix, achieving both tissue replacement and reliable integration with host tissue.
Data Source
AI summary
A product for implantation within a soft tissue site of the human or animal body comprises a matrix of pulverized or morselized substantially non-mineralized native soft tissue (NSTM) of the human or animal body, provided in a therapeutic amount to induce growth of native tissue or organs and healing at the tissue site. The NSTM is composed of at least one soft tissue selected from the group consisting of cartilage, meniscus, intervertebral disc, ligament, tendon, muscle, fascia, periosteum, pericardium, perichondrium, skin, nerve, blood vessels, and heart valves or from organs such as bladder, lung, kidney, liver, pancreas, thyroid, or thymus. Preferably, the NSTM is composed of a soft tissue of the same type of tissue native to the repair site.