Claims
- 1. A composition for sealing a vascular puncture site comprising
a first component including an electrophilic polymer material having a functionality of at least three, a second component including a nucleophilic material that, when mixed with the first component within a reaction pH range of between 7 to 9, cross-links with the first component to form a non-liquid, three-dimensional barrier, and a buffer material mixed with the second component and having a pH within the reaction pH range.
- 2. A composition according to claim 1wherein the first component includes poly(ethylene glycol), poly(ethylene oxide), poly(vinyl alcohol), poly(vinylpyrrolidinone), poly(ethyloxazoline), and poly(ethylene glycol)-co-poly(propylene glycol) block copolymers.
- 3. A composition according to claim 1wherein the first component comprises poly(ethylene glycol) having a molecular weight between 9000 and 12,000.
- 4. A composition according to claim 4wherein the molecular weight is 10,500±1500.
- 5. A composition according to claim 1wherein the first component includes a degradation control region selected to achieve a desired degradation period, during which the non-liquid, three-dimensional barrier degrades over time back to a liquid form.
- 6. A material according to claim 1wherein the first component comprises a compound of the formula PEG-(DCR-CG)n, where PEG is poly(ethylene glycol), DCR is a degradation control region, CG is a cross-linking group, and n is equal to or greater than three.
- 7. A composition according to claim 6wherein the second component and buffer material, when mixed, have a pH of between 8.3 and 8.5 prior to mixing with the first component.
- 8. A material according to claim 6wherein the cross-linking group is selected to react with at least one thiol.
- 9. A material according to claim 8wherein the cross-linking group is selected from a group consisting essentially of vinyl sulfone, N-ethyl maleimide, iodoacetamide, and orthopyridyl disulfide.
- 10. A material according to claim 6wherein the cross-linking group is selected to react with at least one amine.
- 11. A material according to claim 10wherein the cross-linking group is selected from a group consisting essentially of aldehydes.
- 12. A material according to claim 6 wherein the cross-linking group is selected from a group consisting essentially of active esters, epoxides, oxycarbonylimidazole, nitrophenyl carbonates, tresylate, mesylate, tosylate, and isocyanate.
- 13. A material according to claim 6wherein the cross-linking group includes an ester of N-hydroxysuccinimide.
- 14. A composition according to claim 1wherein the first component comprises a multi-armed polymer structure.
- 15. A composition according to claim 1wherein the second component comprises a hydrophilic protein.
- 16. A composition according to claim 15wherein the hydrophilic protein is selected from a group consisting essentially of serum, serum fractions, and solutions of albumin, gelatin, antibodies, fibrinogen, and serum proteins.
- 17. A composition according to claim 15wherein the hydrophilic protein comprises at least one water soluble derivative of a hydrophobic protein.
- 18. A composition according to claim 17wherein the water soluble derivative of a hydrophobic protein is selected from a group consisting essentially of comprising solutions of collagen, elastin, chitosan, and hyaluronic acid.
- 19. A composition according to claim 17wherein the hydrophilic protein comprises at least one hybrid protein.
- 20. A composition according to claim 15wherein the hydrophilic protein comprises at least one synthetic amino acid sequence.
- 21. A composition according to claim 15wherein the hydrophilic protein comprises recombinant or natural human serum albumin.
- 22. A material according to claim 15wherein the hydrophilic protein comprises human serum albumin at a concentration of about 25% or less.
- 23. A composition according to claim 1wherein the buffer material includes tris-hydroxymethylaminomethane.
- 24. A composition according to claim 23wherein the buffer material includes sodium carbonate anhydrous.
- 25. A composition for sealing a vascular puncture site comprising
a first component including poly (ethylene glycol) having a molecular weight between 9000 and 12,000 and having a functionality of at least three, a second component including human albumin at a concentration not greater than 25% that, when mixed with the first component within a reaction pH range of between 7 to 9, cross-links with the first component to form a non-liquid, three-dimensional barrier, and a buffer material including tris-hydroxymethylaminomethane mixed with the second component and having a pH within the reaction pH range.
- 26. A composition according to claim 25wherein the composition comprises a buffered albumin formulation comprising about 0.217 to 0.290 grams of tris-hydroxymethylaminomethane per 20 ml of human albumin, mixed with a poly(ethylene glycol) formulation comprising poly(ethylene glycol) suspended in water, the mixture of the buffer albumin formulation and the poly(ethylene glycol) formulation having a weight to weight ratio between the poly(ethylene glycol) and the human albumin that lays within a range of about 1 to about 0.6 to 1.8.
- 27. A composition according to claim 26wherein the weight to weight ratio is about 1 to 1.
- 28. A composition according to claim 25wherein the buffer material includes sodium carbonate anhydrous.
- 29. A composition according to claim 25wherein the composition comprises a buffered albumin formulation comprising about 0.217 to 0.290 grams of tris-hydroxymethylaminomethane and about 0.075 to 0.138 grams of sodium carbonate anhydrous per 20 ml of human albumin, mixed with a poly(ethylene glycol) formulation comprising poly(ethylene glycol) suspended in water, the mixture of the buffer albumin formulation and the poly(ethylene glycol) formulation having a weight to weight ratio between the poly(ethylene glycol) and the human albumin that lays within a range of about 1 to about 0.6 to 1.8.
- 30. A composition according to claim 29wherein the weight to weight ratio is about 1 to 1.
- 31. A composition according to claim 25wherein the first component has a molecular weight of 10,500±1500.
- 32. A composition according to claim 25wherein the second component, when mixed with the buffer material, has a pH of between 8.3 and 8.5 prior to mixing with the first component.
- 33. A system for forming a biocompatible material comprising
a first component including electrophilic polymer material having a functionality of at least three, a second component including a nucleophilic material that, when mixed with the first component within a reaction pH range of between 7 to 9, cross-links with the first component to form a non-liquid, three-dimensional barrier, a buffer material mixed with the second component and having a pH within the reaction pH range, and instructions for forming a mixture of the first component, second component, and buffer material and for applying the mixture to seal a vascular puncture site.
- 34. A system according to claim 33wherein the first component comprises poly(ethylene glycol) having a molecular weight between 9000 and 12,000.
- 35. A system according to claim 34wherein the poly(ethylene glycol) has a molecular weight of 10,500±1500.
- 36. A system according to claim 34wherein the second component comprises human serum albumin at a concentration of about 25% or less.
- 37. A system according to claim 36wherein the buffer material includes tris-hydroxymethylaminomethane.
- 38. A system according to claim 37wherein the buffer material includes sodium carbonate anhydrous.
- 39. A system according to claim 38wherein the second component, when mixed with the buffer material, has a pH of between 8.3 and 8.5 prior to mixing with the first component.
- 40. A method for sealing a vascular puncture site comprising the steps of
mixing a first component, a second component, and a buffer material, the first component including an electrophilic polymer material having a functionality of at least three, the second component including a nucleophilic material that, when mixed with the first component within a reaction pH range of between 7 to 9, cross-links with the first component to form a non-liquid, three-dimensional barrier, and the buffer material having a pH within the reaction pH range, and applying the mixture to seal a vascular puncture site.
- 41. A method according to claim 40wherein the first component comprises poly(ethylene glycol) having a molecular weight between 9000 and 12,000.
- 42. A method according to claim 41wherein the poly(ethylene glycol) has a molecular weight of 10,500±1500.
- 43. A method according to claim 41wherein the second component comprises human serum albumin at a concentration of about 25% or less.
- 44. A method according to claim 43wherein the buffer material includes tris-hydroxymethylaminomethane.
- 45. A method according to claim 44wherein the buffer material includes sodium carbonate anhydrous.
- 46. A method according to claim 45wherein the second component, when mixed with the buffer material, has a pH of between 8.3 and 8.5 prior to mixing with the first component.
RELATED APPLICATION
[0001] This application is a continuation-in-part of U.S. patent application Ser. No. 09/283,535, filed Apr. 1, 1999, and entitled “Compositions, Systems, And Methods For Arresting or Controlling Bleeding or Fluid Leakage in Body Tissue,” which is itself a continuation-in-part of U.S. patent application Ser. No. 09/188,083, filed Nov. 6, 1998 and entitled “Compositions, Systems, and Methods for Creating in Situ, Chemically Cross-linked, Mechanical Barriers.”
Continuation in Parts (2)
|
Number |
Date |
Country |
Parent |
09283535 |
Apr 1999 |
US |
Child |
09780014 |
Feb 2001 |
US |
Parent |
09188083 |
Nov 1998 |
US |
Child |
09283535 |
Apr 1999 |
US |