Biologically functional soft tissue scaffolds and implants
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Publication Number
US-12338457-B2
Publication Date
2025-06-24
Expiration Date
Abstract
The invention relates to biologically functional scaffolds having a porous structure, methods of preparing, and methods of use thereof. The invention also relates to methods of repairing a defect, methods of culturing cells and promoting differentiation of stem cells using the same.
Core Innovation
The invention relates to a biologically functional scaffold comprising one or more dispersed soft tissue(s) prepared from one or more native soft tissue(s). The dispersed soft tissue(s) comprise randomly interwoven collagen fibers and/or collagen fiber bundles, forming a porous, sponge-like structure.
The scaffold is defined by structural and compositional preservation features, including a density in a dry state from about 0.005 g/cm3 to 0.5 g/cm3 and a porous structure wherein a porosity of the biologically functional scaffold is greater than a porosity of the one or more native soft tissue(s). The relative ratio of extracellular matrix macromolecule components in the dispersed soft tissue(s) is about the same as a relative ratio of extracellular matrix macromolecule components in the native soft tissue(s).
The description further supports processing to obtain coherency/cohesiveness and rehydration behavior, along with characterization of porosity and structure. Reported evaluation includes fibroblast viability and growth, host-cell infiltration and angiogenesis after subcutaneous implantation, re-epithelialization in an open wound model, and longer-term tissue response/volume retention measured by implant cross-sectional area compared to controls.
Claims Coverage
The document contains one independent claim (clm-00001) that defines the core scaffold structure and compositional constraint, and dependent claims that refine this framework with porosity-related parameters and post-implant performance metrics. The main inventive features center on dispersed native soft tissue into randomly interwoven collagen fibers/bundles while preserving extracellular matrix macromolecule component ratios, and on producing a porous structure with higher porosity than the native tissue under a defined dry-state density range.
Dispersed native soft tissue into randomly interwoven collagen fibers/bundles
The dispersed soft tissue(s) comprise randomly interwoven collagen fibers and/or collagen fiber bundles, wherein the dispersed soft tissue(s) are prepared from one or more native soft tissue(s).
Porous sponge-like structure with higher porosity than native tissue
The biologically functional scaffold has a porous structure wherein a porosity of the biologically functional scaffold is greater than a porosity of the one or more native soft tissue(s).
Dry-state density within a defined range
The density of the biologically functional scaffold is from about 0.005 g/cm3 to 0.5 g/cm3 in a dry state.
Extracellular matrix macromolecule component ratio preservation
A relative ratio of extracellular matrix macromolecule components in the dispersed soft tissue(s) is about the same as a relative ratio of extracellular matrix macromolecule components in the native soft tissue(s).
Overall claim coverage is anchored by clm-00001, which combines dispersed native soft tissue into randomly interwoven collagen fibers/bundles, a porous structure with greater porosity than the native tissue, a specified dry-state density range, and preservation of extracellular matrix macromolecule component ratios. Dependent claims further tighten porosity-related parameters and include refinements describing coherence/shape retention and cellular and tissue responses after implantation.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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