Interlocked ECM Laminate Structure to Prevent Graft Delamination
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Solution Overview
Problem
Existing laminated graft products made from extracellular matrix (ECM) face issues such as delamination during hydration, damage from drying processes, and introduction of foreign materials like sutures or adhesives, which can cause inflammation and alter tissue remodelling, limiting their utility in applications requiring tensile strength and biotrophic properties.
Innovation Solution
A laminated tissue graft product composed of multiple ECM or polymeric layers interlocked without synthetic materials, using lugs and holes to secure the layers together, maintaining structural integrity in wet and dry conditions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If traditional lamination techniques (compression, drying, chemical cross-linking, sutures, or adhesives) are used to fabricate laminated graft products, then the graft can be customized to meet site specific requirements, but the ECM is damaged, immune response is altered, and the product tends to delaminate after rehydration
Solution Approach 1:
The invention divides the graft product into multiple discrete ECM sheets that are layered and secured with spacers. Each sheet can be independently processed and handled, allowing customization while maintaining individual sheet integrity. The spacers create discrete attachment points that distribute stress and prevent delamination during rehydration.
Solution Approach 2:
The invention introduces spacers as intermediary elements between ECM sheets. These spacers act as mediators that physically separate and secure adjacent sheets without requiring direct adhesion between ECM surfaces, thereby preventing delamination while allowing each sheet to maintain its native structure and biochemical properties.
2Duration of action of stationary object
If drying processes (air drying, heat drying, or lyophilisation) are used to fabricate laminated graft products, then the graft can be stabilized for storage, but the ECM is damaged due to water loss and ice crystal formation
Solution Approach 1:
The invention applies protective coatings or treatments to ECM sheets before lamination that cushion against the harmful effects of drying processes. These protective layers preserve moisture and prevent ice crystal formation during freezing, thereby stabilizing the graft for storage while protecting ECM integrity.
Solution Approach 2:
The invention modifies processing parameters such as freezing rate, drying temperature, and humidity control during fabrication. By carefully controlling these parameters, the graft can be stabilized for storage without subjecting ECM to damaging conditions that cause water loss or ice crystal formation.
3Strength
If permanent synthetic sutures are used to secure ECM sheets together, then the graft maintains structural integrity, but foreign material remains in the graft causing inflammation, scarring, and encapsulation
Solution Approach 1:
The invention removes permanent synthetic sutures from the graft construction process entirely. Instead, it uses absorbable sutures or alternative securing methods that eliminate persistent foreign material, thereby maintaining structural integrity during healing while avoiding long-term inflammation, scarring, and encapsulation.
Solution Approach 2:
The invention employs absorbable sutures or temporary securing elements that are discarded (absorbed) by the body after serving their structural purpose during initial healing. This temporary support allows the graft to maintain integrity while the foreign material is eventually recovered by the body, avoiding chronic inflammatory responses.
4Object-generated harmful factors
If absorbable sutures are used to secure ECM sheets together, then foreign material is avoided, but the graft has limited shelf life in wet presentation because sutures break down through hydrolysis
Solution Approach 1:
The invention performs preliminary actions such as freezing, drying, or chemical treatment of absorbable sutures before graft assembly to enhance their stability. This preliminary preparation extends the shelf life of the graft in wet presentation by pre-conditioning the sutures to resist hydrolysis during storage, while still maintaining their absorbable properties for long-term biocompatibility.
Data Source
AI summary
A tissue graft product comprising two or more layers of material wherein each layer comprises extracellular matrix (ECM) or polymeric material and wherein the layers are laminated together by interlocking portions of one layer with portions of another layer.