Liquid embolic agents

• US 5,925,683 A
• Filed: 10/17/1996
• Issued: 07/20/1999
• Est. Priority Date: 10/17/1996
• Status: Expired due to Term

• Current Assignee: Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Target Therapeutics, Inc. (Boston Scientific Corporation)
• Inventors: Park, Sangsoo
• Primary Examiner(s): FAY, ZOHREH A
• Application Number:
  US08/734,442
• Time in Patent Office: 1,006 Days
• Field of Search: 514/772.2, 514/772.1
• US Class Current: 514/772.1
• CPC Class Codes: A61L 24/06 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L24/043, A61L24/046 take precedence
• CPC Class Codes: A61L 2430/36 for embolization or occlusion, e.g. vaso-occlusive compositions or devices
• CPC Class Codes: A61L 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C08L 29/04 Polyvinyl alcohol; Partially hydrolysed homopolymers or copolymers of esters of unsaturated alcohols with saturated carboxylic acids

Abstract

This relates to a composition of matter comprising partially hydrolyzed polyvinyl acetate solutions suitable for use as embolic agent precursors. In addition, a procedure for introducing the solutions into the human body to form precipitated embolic occlusion masses is shown. Finally, a procedure for treatment of hepatic tumors using portal vein embolism is described.

Claims

1. An occludant precursor composition for forming an occlusion mass upon introduction of the precursor into a mammalian body comprising a solution of:

a.) partially hydrolyzed polyvinylacetate,

b.) a pharmaceutically acceptable solvent, and

c.) a soluble radio-opaque material.

2. The occludant precursor composition of claim 1 wherein the partially hydrolyzed polyvinylacetate has a molecular weight in the range of 10,000 to 500,000.

3. The occludant precursor composition of claim 1 wherein the partially hydrolyzed polyvinylacetate has a molecular weight in the range of 50,000 to 100,000.

4. The occludant precursor composition of claim 1 wherein the partially hydrolyzed polyvinylacetate has a ratio of acetate groups to hydrolyzed acetate sites in the range of 2.0 to 6.0.

5. The occludant precursor composition of claim 1 wherein the partially hydrolyzed polyvinylacetate has a ratio of acetate groups to hydrolyzed acetate sites in the range of 2.3 to 5.6.

6. The occludant precursor composition of claim 5 wherein the composition contains between 7.5 and 30% (wt) of partially hydrolyzed polyvinylacetate.

7. The occludant precursor composition of claim 1 wherein the pharmaceutically acceptable solvent comprises ethanol.

8. The occludant precursor composition of claim 1 wherein the pharmaceutically acceptable solvent comprises an aqueous ethanolic solution.

9. The occludant precursor composition of claim 1 wherein the pharmaceutically acceptable solvent comprises an aqueous ethanolic solution containing 30 to 55% (vol) ethanol.

10. The occludant precursor composition of claim 1 wherein the radio-opaque material comprises a material selected from the group consisting of iopromide, metrizamide, and mixtures and solutions thereof.

11. The occludant precursor composition of claim 10 wherein the radio-opaque material comprises iopromide.

12. The occludant precursor composition of claim 10 wherein the radio-opaque material comprises metrizamide.

13. A method for occluding a selected site in a mammalian body comprising the steps of:

a.) introducing to said selected site an occludant precursor composition for forming an occlusion mass, said precursor comprising a solution of;

i) partially hydrolyzed polyvinylacetate, and

ii.) a pharmaceutically acceptable solvent,

iii.) a soluble radio-opaque material, and

b.) releasing said occludant precursor composition at said selected site to form said occlusion mass.

14. The method of claim 13 wherein the introducing step is carried out using a tubular member.

15. The method of claim 13 wherein the partially hydrolyzed polyvinylacetate has a molecular weight in the range of 10,000 to 500,000.

16. The method of claim 13 wherein the partially hydrolyzed polyvinylacetate has a molecular weight in the range of 50,000 to 100,000.

17. The method of claim 13 wherein the partially hydrolyzed polyvinylacetate has a ratio of acetate groups to hydrolyzed acetate sites in the range of 2.0 to 6.0.

18. The method of claim 13 wherein the partially hydrolyzed polyvinylacetate has a ratio of acetate groups to hydrolyzed acetate sites in the range of 2.3 to 5.6.

19. The method of claim 13 wherein the composition contains between 7.5 and 30% (wt) of partially hydrolyzed polyvinylacetate.

20. The method of claim 13 wherein the pharmaceutically acceptable solvent comprises ethanol.

21. The method of claim 13 wherein the pharmaceutically acceptable solvent comprises an aqueous ethanolic solution.

22. The method of claim 13 wherein the pharmaceutically acceptable solvent comprises an aqueous ethanolic solution containing 30 to 55% (vol) ethanol.

23. The method of claim 13 wherein the radio-opaque material comprises a material selected from the group consisting of iopromide, metrizamide, and mixtures and solutions thereof.

24. The method of claim 13 wherein the radio-opaque material comprises iopromide.

25. The method of claim 13 wherein the radio-opaque material comprises metrizamide.

26. The method of claim 14 wherein the tubular member is passed into the portal vein proximal of the liver.

27. An occludant precursor composition for forming an occlusion mass upon introduction of the precursor into a mammalian body comprising a solution of:

a.) partially hydrolyzed polyvinylacetate, and

b.) a pharmaceutically acceptable solvent comprising an aqueous ethanolic solution containing 30 to 55% (vol) ethanol.

28. The occludant precursor composition of claim 27 wherein the partially hydrolyzed polyvinylacetate has a molecular weight in the range of 10,000 to 500,000.

29. The occludant precursor composition of claim 27 wherein the partially hydrolyzed polyvinylacetate has a molecular weight in the range of 50,000 to 100,000.

30. The occludant precursor composition of claim 27 wherein the partially hydrolyzed polyvinylacetate has a ratio of acetate groups to hydrolyzed acetate sites in the range of 2.0 to 6.0.

31. The occludant precursor composition of claim 27 wherein the partially hydrolyzed polyvinylacetate has a ratio of acetate groups to hydrolyzed acetate sites in the range of 2.3 to 5.6.

32. The occludant precursor composition of claim 31 wherein the composition contains between 7.5 and 30% (wt) of partially hydrolyzed polyvinylacetate.

33. The occludant precursor composition of claim 27 further comprising a radio-opaque material.

34. The occludant precursor composition of claim 33 wherein the radio-opaque material comprises a material selected from the group consisting of iopromide, metrizamide, and mixtures and solutions thereof.

35. The occludant precursor composition of claim 33 wherein the radio-opaque material comprises iopromide.

36. The occludant precursor composition of claim 33 wherein the radio-opaque material comprises metrizamide.

37. A method for occluding a selected site in a mammalian body comprising the steps of:

a.) introducing to said selected site an occludant precursor composition for forming an occlusion mass, said precursor comprising a solution of;

i) partially hydrolyzed polyvinylacetate, and

ii.) a pharmaceutically acceptable solvent comprising an aqueous ethanolic solution containing 30 to 55% (vol) ethanol, and

b.) releasing said occludant precursor composition to form said occlusion mass.

38. The method of claim 37 wherein the introducing step is carried out using a tubular member.

39. The method of claim 37 wherein the partially hydrolyzed polyvinylacetate has a molecular weight in the range of 10,000 to 500,000.

40. The method of claim 37 wherein the partially hydrolyzed polyvinylacetate has a molecular weight in the range of 50,000 to 100,000.

41. The method of claim 37 wherein the partially hydrolyzed polyvinylacetate has a ratio of acetate groups to hydrolyzed acetate sites in the range of 2.0 to 6.0.

42. The method of claim 37 wherein the partially hydrolyzed polyvinylacetate has a ratio of acetate groups to hydrolyzed acetate sites in the range of 2.3 to 5.6.

43. The method of claim 37 wherein the composition contains between 7.5 and 30% (wt) of partially hydrolyzed polyvinylacetate.

44. The method of claim 37 wherein the composition further comprises a radio-opaque material.

45. The method of claim 44 wherein the radio-opaque material comprises a material selected from the group consisting of iopromide, metrizamide, and mixtures and solutions thereof.

46. The method of claim 44 wherein the radio-opaque material comprises iopromide.

47. The method of claim 44 wherein the radio-opaque material comprises metrizamide.

48. The method of claim 37 wherein the tubular member is passed into the portal vein proximal of the liver.