Abstract: The present chitosan-based superfine fiber invention relates to compositions, formulations, and processes that result in numerous significant advantages for the production and use of superfine fiber bioactive matrices in biomedical applications. The present invention relates to superfine, chitosan-based fibers, wherein the chitosan-based fibers have a percentage chitosan content of at least about 20% w/w, and highly conformable and compliant matrices comprising such fibers, processes for their production, and related formulations. The superfine chitosan-based fibers of the invention preferably include microfibers with diameter less than or equal to about 10 microns and micron and submicron fibers that are about 2 microns and less.

Abstract: The invention relates to biocompatible, bioabsorbable derivatized non-crosslinked chitosan compositions optionally crosslinked to gelatin/collagen by 1-ethyl-3-[3-dimethylaminopropyl] carbodiimide hydrochloride (EDC) for biomedical use and methods of making and testing such compositions, including a modified acute systemic toxicity test. The compositions comprise derivatized chitosan reacetylated to a degree of N-deacetylation (DDA) of between about 15% and 40%. The compositions are typically bioabsorbed in about 90 days or less and can be made to bioabsorb at differing rates of speed. The compositions are initially soluble in aqueous solution below pH 6.5. The compositions have an acid content that can be adjusted between about 0% (w/w) and about 8% (w/w) to customize the composition for uses that require and/or tolerate differing levels of cytotoxicity, adhesion, composition cohesion, and cell infiltration into the composition.

Abstract: The invention relates to biocompatible, bioabsorbable derivatized non-crosslinked chitosan compositions optionally crosslinked to gelatin/collagen by 1-ethyl-3-[3-dimethylaminopropyl]carbodiimide hydrochloride (EDC) for biomedical use and methods of making and testing such compositions, including a modified acute systemic toxicity test. The compositions comprise derivatized chitosan reacetylated to a degree of N-deacetylation (DDA) of between about 15% and 40%. The compositions are typically bioabsorbed in about 90 days or less and can be made to bioabsorb at differing rates of speed. The compositions are initially soluble in aqueous solution below pH 6.5. The compositions have an acid content that can be adjusted between about 0% (w/w) and about 8% (w/w) to customize the composition for uses that require and/or tolerate differing levels of cytotoxicity, adhesion, composition cohesion, and cell infiltration into the composition.

Abstract: The invention relates to biocompatible, bioabsorbable derivatized non-crosslinked chitosan compositions optionally crosslinked to gelatin/collagen by 1-ethyl-3-[3-dimethylaminopropyl]carbodiimide hydrochloride (EDC) for biomedical use and methods of making and testing such compositions, including a modified acute systemic toxicity test. The compositions comprise derivatized chitosan reacetylated to a degree of N-deacetylation (DDA) of between about 15% and 40%. The compositions are typically bioabsorbed in about 90 days or less and can be made to bioabsorb at differing rates of speed. The compositions are initially soluble in aqueous solution below pH 6.5. The compositions have an acid content that can be adjusted between about 0% (w/w) and about 8% (w/w) to customize the composition for uses that require and/or tolerate differing levels of cytotoxicity, adhesion, composition cohesion, and cell infiltration into the composition.

Abstract: The present invention comprises chitosan materials and methods of using carbonic acid for aqueous solubilization of neutralized or pre-treated chitosan gels and provides, among other things, substantially acid salt free composition native final forms without requiring subsequent acid salt elution. The invention includes chitosan-based solid and semi-solid material forms, optionally reinforced with chitosan fibers, such as powders, fibers, films, matrices, sponges, implants, scaffolds, fillers, and hydrogels. Native final forms are produced from chitosan powder solubilized in an aqueous acidic solution, processed to form a high pH hydrated chitosan gel precipitate material that is then neutralized by water washing and re-solubilized substantially to chitosan solution using carbonic acid.

Abstract: The inventive device and methods described herein address the introduction of a safe and effective freeze-dried biological product, and particularly a plasma product, to a subject in need thereof. The present invention relates to a multifunctional, staged closure device, which also is described as a lyophilization container for plasma (LCP). The device and methods described herein address how to reproducibly achieve a low moisture and substantially oxygen-free atmosphere within a finally hermetically sealed biocompatible low aspect plastic vessel within a standard shelf-stoppering freeze dryer. The present inventive device and methods provide a freeze-dried plasma product that is fully traceable, preserves the constituent plasma activity, is readily prepared in a sterile fashion, is stable, ensures ease of storage and permits rapid reconstitution and delivery to a patient.

Abstract: The invention relates to biocompatible, bioabsorbable derivatized non-crosslinked chitosan compositions optionally crosslinked to gelatin/collagen by 1-ethyl-3-[3-dimethylaminopropyl]carbodiimide hydrochloride (EDC) for biomedical use and methods of making and testing such compositions, including a modified acute systemic toxicity test. The compositions comprise derivatized chitosan reacetylated to a degree of N-deacetylation (DDA) of between about 15% and 40%. The compositions are typically bioabsorbed in about 90 days or less and can be made to bioabsorb at differing rates of speed. The compositions are initially soluble in aqueous solution below pH 6.5. The compositions have an acid content that can be adjusted between about 0% (w/w) and about 8% (w/w) to customize the composition for uses that require and/or tolerate differing levels of cytotoxicity, adhesion, composition cohesion, and cell infiltration into the composition.

Abstract: Absorbable tissue dressing assemblies are formed from hydrophilic polymer sponge structures, such as chitosan.

Abstract: Wound dressing assemblies and methods of producing the wound dressing assemblies. The wound dressing assemblies various comprise individual layers of nanomaterials that have been formed according to an electrospinning process. Each of the layers can have different characteristics and qualities. The invention also provides guidance in selecting materials to form a wound dressing assembly, as well as possible adaptations to the electrospinning process to provide different characteristics for particular materials.

Abstract: A chitosan biomaterial is frozen in aqueous solution to form a frozen chitosan structure from which water is removed by a prescribed freeze-drying process to form a sponge-like chitosan structure having a thickness and a density. The sponge-like chitosan structure is compressed by application of heat and pressure to reduce the thickness and increase the density of the sponge-like chitosan structure to form a densified chitosan structure. The densified chitosan structure is further preconditioned by heating the densified chitosan structure according to prescribed conditions to form a wound dressing. The wound dressing possesses an adhesion strength and resistance to dissolution in high blood flow bleeding situations.

Abstract: This invention is directed to advanced hemorrhage control wound dressings, and methods of using a producing same. The subject wound dressing is constructed from a non-mammalian material for control of severe bleeding. The wound dressing is formed of a biomaterial comprising chitosan for controlling severe bleeding. The kind of severe, life-threatening bleeding contemplated by this invention is typically of the type not capable of being stanched when a conventional gauze wound dressing is applied with conventional pressure to the subject wound. The wound dressing being capable of substantially stanching the flow of the severe life-threatening bleeding from the wound by adhering to the wound site, to seal the wound, to accelerate blood clot formation at the wound site, to reinforce clot information at the wound site and prevent bleed out from the wound site, and to substantially prohibit the flow of blood out of the wound site.

Abstract: Absorbable tissue dressing assemblies are formed from hydrophilic polymer sponge structures, such as chitosan.

Abstract: Absorbable tissue dressing assemblies are formed from hydrophilic polymer sponge structures, such as chitosan.

Abstract: A chitosan biomaterial is frozen in aqueous solution to form a frozen chitosan structure from which water is removed by a prescribed freeze-drying process to form a sponge-like chitosan structure having a thickness and a density. The sponge-like chitosan structure is compressed by application of heat and pressure to reduce the thickness and increase the density of the sponge-like chitosan structure to form a densified chitosan structure. The densified chitosan structure is further preconditioned by heating the densified chitopsan structure according to prescribed conditions to form a wound dressing. The wound dressing possesses an adhesion strength and resistance to dissolution in high blood flow bleeding situations.

Abstract: A granule or particle made of a chitosan material either carries within it a polymer mesh material of poly-4-hydroxy butyrate, or has interspersed with it a polymer mesh material of poly-4-hydroxy butyrate. The granule or particle can be carried within a polymer mesh socklet made of a material consisting essentially of poly-4-hydroxy butyrate. The granule or particle can be used to treat intracavity bleeding.

Abstract: Supple tissue dressing assemblies are formed from hydrophilic polymer sponge structures, such as chitosan. The supple tissue dressing assemblies are characterized by suppleness or multi-dimensional flexibility. The assemblies can be flexed, bent, folded, twisted, and even rolled upon itself before and during use, without creasing, cracking, fracturing, otherwise compromising the integrity and mechanical and/or therapeutic characteristics of the assemblies.

Abstract: Supple tissue dressing assemblies are formed from hydrophilic polymer sponge structures, such as chitosan. The supple tissue dressing assemblies are characterized by suppleness or multi-dimensional flexibility. The assemblies can be flexed, bent, folded, twisted, and even rolled upon itself before and during use, without creasing, cracking, fracturing, otherwise compromising the integrity and mechanical and/or therapeutic characteristics of the assemblies.

Abstract: Supple tissue dressing assemblies are formed from hydrophilic polymer sponge structures, such as chitosan. The supple tissue dressing assemblies are characterized by suppleness or multi-dimensional flexibility. The assemblies can be flexed, bent, folded, twisted, and even rolled upon itself before and during use, without creasing, cracking, fracturing, otherwise compromising the integrity and mechanical and/or therapeutic characteristics of the assemblies.

Abstract: Supple tissue dressing assemblies are formed from hydrophilic polymer sponge structures, such as chitosan. The supple tissue dressing assemblies are characterized by suppleness or multi-dimensional flexibility. The assemblies can be flexed, bent, folded, twisted, and even rolled upon itself before and during use, without creasing, cracking, fracturing, otherwise compromising the integrity and mechanical and/or therapeutic characteristics of the assemblies.

Abstract: Improved hemostatic agents take the form of granules or particles that can be used to stanch, seal, or stabilize a site of hemorrhage, including a noncompressible hemorrhage.