Claims for Patent: 5,073,171

Summary for Patent: 5,073,171

Title:	Biocompatible materials comprising albumin-binding dyes
Abstract:	A biocompatible prosthetic device is provided which comprises a solid polymeric body incorporating an amount of an albumin-binding dye effective to form a coating of endogenous albumin on said device when the device is in contact with a physiological fluid containing albumin. A method of increasing the albumin-binding ability of a prosthetic device is also provided.
Inventor(s):	Eaton; John W. (Minneapolis, MN)
Assignee:
Application Number:	07/296,496
Patent Claims:	1. A biocompatible prosthetic device having a solid polymeric body incorporating an amount of an albumin-binding dye effective to provide a means to form a coating of endogenous albumin on said device when said device is in contact with a physiological fluid containing albumin. 2. The biocompatible prosthetic device of claim 1 wherein said albumin-binding dye comprises an aromatic albumin-binding dye. 3. The biocompatible prosthetic device of claim 2 wherein said aromatic albumin-binding dye comprises a diazo dye; a sulfonic acid dye; or the physiologically-acceptable salts thereof. 4. The biocompatible prosthetic device of claim 3 wherein said aromatic albumin-binding dye is selected from the group consisting of Reactive Blue 2, Evans Blue, Trypan Blue, Bromcresol Green, Bromcresol Purple, Methyl Orange, 2-(4'-hydroxyazobenzene)benzoic acid, Procion red HE 3B, and mixtures thereof. 5. The biocompatible prosthetic device of claim 1 wherein said albumin-binding dye is conjugated to a physiologically acceptable water-soluble polysaccharide. 6. The biocompatible prosthetic device of claim 5 wherein said polysaccharide comprises dextran. 7. The biocompatible prosthetic device of claim 6 wherein said albumin-binding dye comprises an aromatic albumin-binding dye. 8. The biocompatible prosthetic device of claim 7 wherein said aromatic albumin-binding dye comprises a diazo dye; a physiologically acceptable salt of said diazo dye; a sulfonic acid dye; a physiologically acceptable salt of said sulfonic acid dye; or mixtures thereof. 9. The biocompatible prosthetic device of claim 8 wherein said aromatic albumin-binding dye is selected from the group consisting of Reactive Blue 2, Evans Blue, Trypan Blue, Bromcresol Green, Bromcresol Purple, Methyl Orange, 2-(4'-hydroxyazobenzene)benzoic acid, Procion red HE 3B, and mixtures thereof. 10. The biocompatible prosthetic device of claim 1 wherein said solid polymeric body comprises a polyurethane, a silicone elastomer, a polycarbonate, or mixtures thereof. 11. The biocompatible prosthetic device of claim 10 wherein said polyurethane comprises a polyether polyurethane. 12. The biocompatible prosthetic device of claim 10 wherein said silicone elastomer comprises a medical grade elastomer. 13. The biocompatible prosthetic device of claim 1 wherein the endogenous albumin is human serum albumin. 14. The biocompatible prosthetic device of claim 1 wherein said device is a catheter. 15. The biocompatible prosthetic device of claim 1 wherein said device is a heart valve. 16. The biocompatible prosthetic device of claim 1 wherein said device is a vascular graft. 17. The biocompatible prosthetic device of claim 1 wherein the physiological fluid is blood, lymph, saliva, urine, tears or cerebro-spinal fluid. 18. A method of increasing the albumin-binding ability of a prosthetic device having a solid polymeric body, said method comprising the step of: (a) incorporating into said polymeric body an amount of an albumin-binding dye; wherein the amount of the albumin binding dye is effective to provide a means to form a coating of endogenous albumin on a surface of said polymeric body when the surface is in contact with a physiological fluid containing albumin. 19. The method of claim 18 wherein the albumin-binding dye comprises an aromatic albumin-binding dye. 20. The method of claim 19 wherein the aromatic albumin-binding dye comprises a diazo dye; a physiologically acceptable salt of said diazo dye; a sulfonic acid dye; a physiologically acceptable salt of said sulfonic acid dye; or mixtures thereof. 21. The method of claim 20 wherein the aromatic albumin-binding dye is selected from the group consisting of Reactive Blue 2, Evans Blue, Trypan Blue, Bromcresol Green, Bromcresol Purple, Methyl Orange, 2-(4-hydroxyazobenzene)benzoic acid, Procion red HE 3B, and mixtures thereof. 22. The method of claim 18 wherein the physiological fluid is blood, lymph, saliva, urine, tears, or cerebrospinal fluid.

Details for Patent 5,073,171

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138	10/21/1942		2040-01-28
Baxalta Us Inc.	BUMINATE, FLEXBUMIN	albumin (human)	Injection	101452	03/03/1954		2040-01-28
Csl Behring Ag	ALBURX	albumin (human)	Injection	102366	07/23/1976		2040-01-28
Grifols Biologicals Llc	ALBUTEIN	albumin (human)	Injection	102478	08/15/1978		2040-01-28