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Publication Number

US-8557874-B2

Patent

Publication Date

2013-10-15

Expiration Date


Abstract

The present invention relates to hemostatic fabric materials, and to the methods for making and using such materials. In particular, the present invention relates to hemostatic fabric materials made from chemically treated cellulose, where the hemostatic material can be soluble on wound surfaces.

Core Innovation

Bioabsorbable, water-soluble hemostatic fabric materials are described that are made from chemically treated plant cellulose. The materials use a polymer of oxidized derivatized esterified cellulose, configured as a hemostatic fabric that can dissolve or expand on a wound surface to form a viscous gel. The gel is described to promote hemostasis through physical, chemical, and physiology-related mechanisms, including thrombin generation.

The described cellulose polymer is based on beta-(1-4)-D-glucopyranose chain residues and includes defined monomer functional groups through derivatization and esterification. The material is described in terms of monomer structural formula concepts using substituents identified as R, R1, and R2 with specific forms, including acetic and ethyl carboxymethyl-type substituents. The polymer size range is described as corresponding to n values from about 2 to about 150,000.

The document further describes usage as wound dressing forms such as sheet/gauze/fleece/sponge/puff, with configurations that may be removable or left in situ. It also states that additional hemostatic agents and auxiliary therapeutic substances can be integrated or loaded with the hemostatic fabric, and that pressure sensitive adhesive configurations are possible for at least one side of the dressing. Claimed examples and concepts include oxidizing/derivatizing/esterifying treatments to obtain the water-soluble hemostatic fabric material.

Claims Coverage

The document includes one independent claim and dependent claims that refine the same inventive concept. The independent claim covers a polymer of oxidized derivatized esterified cellulose with monomer substituent structures defined for first and second pluralities of monomers, with additional claim coverage provided by dependent refinements for further substituents, optional add-ons, and specific dressing formats.

Polymer of oxidized derivatized esterified cellulose with first plurality of monomers

A hemostatic material comprising a polymer of oxidized derivatized esterified cellulose having a chain of monomers, where for a first plurality of the monomers R is —OCH2(COO)CH2CH3, R1 is —OCH2(COO)CH2CH3, and R2 is —CH2OCH2(COO)CH2CH3.

Polymer of oxidized derivatized esterified cellulose with second plurality of monomers

A hemostatic material comprising a polymer of oxidized derivatized esterified cellulose having a chain of monomers, where for a second plurality of the monomers R is —OCH2(COO)CH2CH3, R1 is —OCH2(COO)CH2CH3, and R2 is —(COO)CH2CH3.

Additional monomer substituents for a third plurality of monomers

The hemostatic material is defined such that for a third plurality of monomers in the polymer chain, R, R1, and R2 take on the listed substituent groups as further constrained by the claim.

Hemostatic material including a therapeutic agent

A hemostatic material according to the composition of the oxidized derivatized esterified cellulose polymer, further including a therapeutic agent.

Hemostatic material with adhesive on at least one side

The hemostatic material includes an adhesive on at least one side of the hemostatic material.

Hemostatic material in sheet, towel, or sponge form

The hemostatic material is configured in a sheet, towel, or sponge form.

Fabric strips sized for insertion into the human nose

The hemostatic material is a fabric shaped into one or more strips sized for insertion into the human nose.

Overall, the claim coverage centers on a hemostatic material formed from an oxidized derivatized esterified cellulose polymer with monomers defined by specific R/R1/R2 substituent structures for multiple monomer pluralities. Dependent claims then expand coverage by adding a therapeutic agent, adding an adhesive feature, and specifying article formats including sheet/towel/sponge and nasal insertion fabric strips.

Stated Advantages

Rapid efficacy.

Reduced need for other medicine.

Stability.

Low pain on removal.

Conformance.

Usefulness even for coagulopathy/defect patients.

Documented Applications

Wound dressing configurations including sheet, gauze/fleece/sponge/puff forms are described for use on a wound surface where the material dissolves/expands into a viscous gel.

Device configurations described as removable or left in situ on wound surfaces.

A fabric shaped into one or more strips sized for insertion into the human nose is described.

Applications include use even for coagulopathy/defect patients, as stated in the described advantages.

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