Dry inflated decellularized extracellular matrix
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Publication Number
US-12138365-B1
Publication Date
2024-11-12
Expiration Date
Abstract
An inflated and suspension dried decellularized extracellular matrix of a mammalian organ or tissue, or a vascularized portion thereof, and methods of making and using the inflated and suspension dried material, are provided.
Core Innovation
The invention relates to a method for manufacturing a collagen matrix using a vascularized mammalian organ or tissue, or a vascularized portion thereof. The organ or tissue is decellularized via perfusion decellularization through vascular pathways, producing a decellularized organ or tissue or portion thereof.
The decellularized material is then subjected to suspension drying by forcing a gas through the vascular pathways. During suspension drying, the gas is forced through the vascular pathways at a flow rate of up to about 4,000 mL/minute for about 2 to about 120 hours, and the organ or tissue or portion thereof expands three-dimensionally relative to its non-inflated configuration, forming a matrix scaffold comprising a plurality of pores.
The disclosed approach emphasizes preservation of a decellularized vascular architecture that supports three-dimensional inflation during drying. The resulting pore-containing collagen matrix scaffold retains morphology and vascular architecture and may be converted into layered, compressed, or milled/granularized/morselized particles or fibers for scaffold use.
The described system context includes decellularization and preservation criteria directed to successful decellularization and vascular preservation, and it further supports converting the scaffold into particles or fibers in defined size ranges. The disclosure also describes optional downstream treatments and forms intended for use in wound or void augmentation and treatment contexts such as fistula and hernia.
Claims Coverage
The independent claim defines a manufacturing method with three core inventive elements: obtaining a vascularized mammalian organ or tissue, perfusion decellularization through vascular pathways, and suspension drying that forces gas through the vascular pathways to three-dimensionally expand the structure into a pore-containing collagen matrix scaffold. It further requires a moisture content limit of no more than 8%.
Vascularized organ or tissue decellularized by perfusion through vascular pathways
Obtaining a vascularized mammalian organ or tissue or a vascularized portion thereof, and decellularizing the organ or tissue or portion thereof via perfusion decellularization through vascular pathways of the organ or tissue or portion thereof.
Suspension drying by forcing gas through vascular pathways to form a pore-containing scaffold
Suspension drying the decellularized organ or tissue or portion thereof, including forcing a gas through the vascular pathways at a flow rate of up to about 4,000 mL/minute for about 2 to about 120 hours, such that the organ or tissue or portion thereof expands three-dimensionally relative to its non-inflated configuration and forms a matrix scaffold comprising a plurality of pores.
Moisture content limited to no more than 8% after suspension drying
Wherein suspension drying the decellularized organ or tissue or portion thereof results in a matrix scaffold having a moisture content of no more than 8%.
Gas flow rate and duration constraints for suspension drying
The gas is forced through the vascular pathways at a flow rate of up to about 4,000 mL/minute for about 2 to about 120 hours.
Gas forcing based on monitored in-line pressure
Suspension drying includes controlling the gas flow through the vascular pathways based on monitored in-line pressure.
Optional removal of an exterior surface prior to suspension drying
Removing an exterior surface of the decellularized organ/tissue/portion is performed prior to suspension drying.
Conversion into particles or fibers with defined length range
Processing the matrix scaffold yields particles or fibers with a length from about 0.05 millimeters to about 25 millimeters.
Across the claim set coverage provided, the invention is directed to forming a collagen matrix scaffold by decellularizing a vascularized mammalian organ or tissue via perfusion decellularization through vascular pathways and then suspension drying by forcing gas through the same vascular pathways to three-dimensionally expand the structure into a plurality-of-pores scaffold, while ensuring the scaffold has moisture content of no more than 8%. Dependent features further specify process control, numeric constraints, optional removal of an exterior surface, and conversion into particles or fibers within a defined length range.
Stated Advantages
Produces a three-dimensionally expanded matrix scaffold comprising a plurality of pores.
Results in a matrix scaffold having a moisture content of no more than 8%.
Documented Applications
Wound or void augmentation using matrix scaffold forms.
Treatment of fistulas.
Treatment of hernias.
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