ECM Biomaterial Density Gradient via Centrifugal Separation
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Solution Overview
Problem
Existing ECM-based medical devices often lack sufficient integrity and strength for stable engraftment, leading to challenges in suturing and attachment to body structures, and may become spongy, making them difficult to attach appropriately.
Innovation Solution
A method involving the creation of an ECM composition with particles differing in size, density, and shape, subjected to centrifugal force to form a flowable composition, which is then processed to create a dried ECM material with a density gradient, enhancing mechanical properties and bioactivity through the inclusion of bioactive agents like FGF-2.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If ECM-based materials are manipulated during manufacture to improve processability, then ease of manufacture is improved, but mechanical integrity and strength are degraded
Solution Approach 1:
The patent applies parameter changes by controlling the crosslinking degree of ECM molecules during manufacturing. By adjusting crosslinking parameters, the material achieves optimal balance between processability and mechanical strength, preventing degradation while enabling manageable processing characteristics.
Solution Approach 2:
The patent creates composite ECM materials with controlled density gradients and heterogeneous structures. This composite approach allows different regions to have different properties, maintaining overall mechanical integrity while providing zones with improved processability characteristics.
2Reliability
If ECM materials are made with higher porosity to improve cell infiltration, then bioactivity is improved, but mechanical strength is reduced
Solution Approach 1:
The patent implements local quality through density gradients within the ECM material. Different regions have different densities and porosity levels, allowing areas with high porosity for cell infiltration while maintaining denser regions for mechanical strength support.
Solution Approach 2:
The patent uses composite material structures with heterogeneous density distributions. The combination of porous and dense regions creates a material that simultaneously provides both high bioactivity through cell infiltration pathways and adequate mechanical strength through structural support zones.
3Ease of operation
If ECM materials are processed to reduce sponginess, then ease of operation is improved, but loss of bioactive components may occur
Solution Approach 1:
The patent applies parameter changes by precisely controlling crosslinking degree and density distribution. These parameter adjustments reduce sponginess and improve ease of suturing while the controlled process minimizes degradation and retention of bioactive components within the ECM structure.
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 resulting ECM material exhibits improved mechanical and compositional properties, facilitating stable engraftment and attachment to body structures while maintaining bioactivity, thus addressing the issues of spongy materials and migration risks.
Implementation Method 1
The flowable ECM composition is introduced to a mold and subjected to a centrifugal force about an axis of rotation for a period of time sufficient to distribute the ECM particles in the mold according to size, density, shape, or combinations thereof
Data Source
AI summary
A method for forming an extracellular matrix material (ECM) material includes providing at least an ECM composition containing ECM particles varying in their capacity for migration through a fluid medium, including at least one population of expanded ECM particles. The ECM composition is combined in a fluid medium to form a flowable ECM composition. The flowable ECM composition is subjected to a centrifugal force in a mold for a period of time sufficient to distribute the ECM particles according to differences in their physical characteristics. The ECM composition is dried to form a dried ECM material having a density gradient extending from a less dense region to a more dense region. The dried ECM material may formed as a porous, substantially acellular ECM material expandable in an aqueous fluid environment by at least 100% in volume.