Hemostatic compositions and therapeutic regimens
Inventors
Finkielsztein, Sergio • Vournakis, John N.
Assignees
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Publication Number
US-9139663-B2
Publication Date
2015-09-22
Expiration Date
Abstract
The present invention relates generally to the field of hemostasis, including methods, compositions, and devices that can be employed to treat wounds. More specifically the present invention relates to hemostatic compositions that reduce the need for, and cost of, nursing care of patients with chronic wounds by reducing the frequency of wound dressing changes.
Core Innovation
The invention relates to a hemostatic wound-treatment approach using topical wound dressings and therapeutic regimens based on poly-β-1→4-N-acetylglucosamine (pGlcNAc) derived from microalgae and irradiated shortened forms. The shortened form is referred to as sNAG, produced as a fiber composition in which irradiation reduces fiber length and molecular weight while preserving fiber microstructure and infrared (IR) spectrum similarity to the non-irradiated fibers.
The problem addressed is chronic wounds requiring improved wound healing outcomes, including hemostasis, and the background indicates that such wounds are difficult to treat. The disclosed solution uses the shortened poly-β-1→4-N-acetylglucosamine fiber composition as a therapeutic agent in wound dressings, with wound healing effects evaluated in diabetic mouse models.
Documented results include improved wound healing in diabetic mouse models, including faster wound closure and enhanced reepithelialization and angiogenesis. The disclosed observations also include reduced or no foreign body reaction or encapsulation and functional effects on endothelial cells related to migration, metabolic activity and/or apoptosis as measured by MTT and trypan blue exclusion test outcomes.
Claims Coverage
The provided independent claims are clm-00001 and clm-00023. Each claim centers on producing a shortened poly-β-1→4-N-acetylglucosamine fiber composition by irradiating pGlcNAc fibers, with clm-00023 additionally requiring a defined monosaccharide content and a shortening outcome threshold.
Shortened poly-β-1→4-N-acetylglucosamine fiber composition by gamma irradiation after dry or wet formulation
Formulating poly-β-1→4-N-acetylglucosamine fibers into dry fibers, a dry fiber membrane or a dry lyophilized material and irradiating by gamma irradiation at 500-2,000 kgy, or formulating into a suspension, a slurry or a wet cake and irradiating by gamma irradiation at 100-500 kgy, thereby producing the shortened poly-β-1→4-N-acetylglucosamine fiber composition.
Shortened poly-β-1→4-N-acetylglucosamine fiber composition via irradiation with specified monosaccharide content and shortening outcome
Irradiating poly-β-1→4-N-acetylglucosamine fibers wherein the poly-β-1→4-N-acetylglucosamine comprises at least 70% of N-acetylglucosamine monosaccharides with a dose of irradiation that reduces the length of more than 50% of the fibers to less than about 15 μm in length, thereby producing the shortened poly-β-1→4-N-acetylglucosamine fiber composition.
Across clm-00001 and clm-00023, the core claim coverage is directed to producing shortened pGlcNAc fibers by irradiation, with clm-00001 emphasizing formulation-dependent gamma irradiation ranges and clm-00023 emphasizing monosaccharide content and an explicit post-irradiation fiber-length reduction threshold.
Stated Advantages
Improved wound healing in diabetic mouse models, including faster wound closure.
Enhanced reepithelialization.
Enhanced angiogenesis.
No foreign body reaction or encapsulation reported in the wound-healing context.
Documented Applications
Topical wound dressings and therapeutic regimens for hemostatic wound-treatment, including chronic wounds.
Wound healing evaluation in diabetic mouse models (db/db) for improved closure and healing outcomes.
Assessment of endothelial cell functional effects (migration, metabolic activity and/or apoptosis-related outcomes) using MTT and trypan blue exclusion test outcomes.
Biocompatibility and irritation evaluation using ISO 10993 elution, intramuscular implantation, intracutaneous injection, and Kligman maximization testing.
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