Claims for Patent: 9,616,088

Summary for Patent: 9,616,088

Title:	Advanced functional biocompatible polymer putty used as a hemostatic agent for treating damaged tissue and cells
Abstract:	A hemostatic putty for treatment of a variety of wounds topographies, including but not limited to highly three dimensional wounds, for example gunshot wounds and impalements, is disclosed. The putty is comprised of a matrix polymer weakly crosslinked or not crosslinked such that a viscoelastic matrix is formed. The viscoelastic nature of the putty is tunable by the composition and enables the putty to conform to a variety of wound topographies. Likewise, a hemostatic polymer, for example chitosan or hydrophobically modified chitosan, is included in this matrix to impart hemostatic properties and tissue adhesive on the putty. The hemostatic polymers disclosed prevent microbial infection and are suitable for oxygen transfer required during normal wound metabolism.
Inventor(s):	Diehn; Kevin (Towson, MD), Dowling; Matthew (College Park, MD), Raghavan; Srinivasa R. (Silver Spring, MD), King; David R. (Boston, MA)
Assignee:	Gel-E, Inc. (College Park, MD) University of Maryland, College Park (College Park, MD) The General Hospital Corporation (Boston, MA)
Application Number:	14/208,820
Patent Claims:	1. A putty, comprising: a hemostatic biopolymer comprising hydrophobically modified chitosan, polyvinyl alcohol as a secondary polymer, a borate salt ionic crosslinker, and a solvent. 2. The putty of claim 1, wherein the hydrophobically modified chitosan comprises hydrophobic substituents covalently attached to the biopolymer. 3. The putty of claim 2, wherein the hydrophobic substituents comprise from eight to eighteen carbon atoms. 4. The putty of claim 3, wherein the hydrophobic modification is of 1 to 100 moles of hydrophobic substituent per 1 mole of biopolymer. 5. The putty of claim 1, wherein the hydrophobically modified chitosan is selected from the group consisting of chitosan lactate, chitosan salicylate, chitosan pyrrolidone carboxylate, chitosan itaconate, chitosan niacinate, chitosan formate, chitosan acetate, chitosan gallate, chitosan glutamate, chitosan maleate, chitosan aspartate, chitosan glycolate and quaternary amine substituted chitosan and salts thereof. 6. The putty of claim 1, wherein the polyvinyl alcohol is present in a concentration of between 5 wt % and 15 wt %. 7. The putty of claim 1, wherein the polyvinyl alcohol has a molecular weight in of between 50,000 Da and 300,000 Da. 8. The putty of claim 1, wherein the polyvinyl alcohol has a molecular weight in of between 125,000 Da and 140,000 Da. 9. The putty of claim 1, wherein the polyvinyl alcohol is hydrolyzed in a range of 70% to 100%. 10. The putty of claim 1, wherein the crosslinker is present in a concentration of between 0.1 wt % and 1.0 wt %. 11. The putty of claim 1, wherein the borate salt is selected from the group consisting of sodium tetraborate decahydrate, sodium peroborate, and sodium metaborate. 12. The putty of claim 1, wherein the hydrophobically modified chitosan is present in a concentration of between 0.1 wt % and 3.0 wt %. 13. The putty of claim 1 capable of providing a compressing force of between 5 and 15 N, 15 and 30 N, or 0.1 and 5N. 14. The putty of claim 1, further comprising a water soluble reagent. 15. The putty of claim 1, further comprising a water soluble reagent selected from the group consisting of human thrombin, bovine thrombin, recombinant thrombin, and human fibrinogen. 16. The putty of claim 1, further comprising a reagent selected from the group consisting of fibrinogen, factor VIIa, Factor XIII. 17. The putty of claim 1, further comprising a reagent that prevent microbial infections. 18. The putty of claim 1, further comprising a reagent selected from the group consisting of an anti-microbial and an antibiotic. 19. The putty of claim 1, further comprising a reagent selected from the group consisting of ampicillin, and penicillin. 20. The putty of claim 1, further comprising a reagent selected from the group consisting of norfolxacin and silver.

Details for Patent 9,616,088

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	Solution	125247	08/27/2007		2033-03-13
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	For Injection	125247	09/17/2009		2033-03-13