Elastomeric bladders for medical infusers

• US 4,938,751 A
• Filed: 07/21/1988
• Issued: 07/03/1990
• Est. Priority Date: 02/23/1981
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Leeper, Harold M., Guittard, George V.
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Rose, Sharon
• Application Number:
  US07/222,448
• Time in Patent Office: 712 Days
• Field of Search: 604/132, 604/133, 128/DIG. 12
• US Class Current: 604/132
• CPC Class Codes: A61M 5/152 pressurised by contraction of elastic reservoirs containers for dispensing contents by contraction of an elastic bag provided therein, in general B65D83/0061
• CPC Class Codes: C08L 9/00 Compositions of homopolymers or copolymers of conjugated diene hydrocarbons
• CPC Class Codes: Y10S 128/12 Pressure infusion

Abstract

Elastomeric bladders having improved resistance to spontaneous rupture when inflated are made by vulcanizing a homogeneous mixture of synthetic polyisoprene having 90% to 98% cis-1,4 linkages, 3 to 10 phr fumed silicon dioxide, and vulcanizing agent while simultaneously forming the mixture into hollow cylindrical bodies. After being formed the bodies are solvent extracted to remove unreacted vulcanizing agent and the degradation products of the vulcanizing agent. Following the solvent extraction about 0.2 to 2 phr of a nontoxic, nonleachable antioxidant are imbibed into the bodies by contacting the bodies with a liquid solution of the antioxidant.

Claims

1. An elastomeric bladder that is for use in a medical infuser and has improved resistance to rupture when inflated, the bladder being a tubular body:

(a) made from a vulcanized homogeneous mixture of synthetic polyisoprene having about 90% to about 98% cis-1,4 linkages and a material selected from the group consisting of particulate silicon dioxide and particulate carbon black having a nominal average diameter in the range of about 1×

10^-5 to about 5×

10^-3 mm;

(b) into which a nontoxic, substantially nonleachable antioxidant has been diffused after vulcanization; and

(c) the amounts of silicon dioxide, carbon black and antioxidant being sufficient to make the inflated half-life of a population of the bladders at 40°

C. at least about ten times longer than the half-life of a comparable population of bladders made from said vulcanized synthetic polyisoprene but without the silicon dioxide, carbon black and the antioxidant.

2. The bladder of claim 1 wherein the said particulate material is silicon dioxide.

3. The bladder of claim 1 wherein the synthetic polyisoprene has about 96% to 98% cis-1,4 linkages.

4. The bladder of claim 1 wherein the vulcanized synthetic polyisoprene is characterized by having carbon-to-carbon crosslinks.

5. The bladder of claim 1 wherein said antioxidant is a hindered polyphenol.

6. The bladder of claim 2 wherein said antioxidant is a hindered polyphenol.

7. The bladder of claim 1 wherein said antioxidant is a material selected from the group consisting of tetrakis [methylene 3-(3'"'"',5'"'"',di-t-butyl-4'"'"'hydroxyphenyl) propionate] methane and 1,3,5-trimethyl-2,4,6-tris (3,5-di-t-butyl-4-hydroxybenzyl) benzene.

8. The bladder of claim 2 wherein said antioxidant is a material selected from the group consisting of tetrakis [methylene 3-(3'"'"',5'"'"',di-t-butyl-4'"'"'hydroxyphenyl) propionate] methane and 1,3,5-trimethyl-2,4,6-tris (3,5-di-t-butyl-4-hydroxybenzyl) benzene.

12. The bladder of claim 1 wherein the vulcanized synthetic polyisoprene is characterized by having carbon-to-carbon crosslinks.

9. An elastomeric bladder that is for use in a medical infuser and has improved resistance to rupture when inflated, the bladder being a tubular body:

(a) made from a vulcanized homogeneous mixture of synthetic polyisoprene having about 90% to about 98% cis-1,4 linkages and from about 3 to about 10 phr of a material selected from the group consisting of particulate silicon dioxide and particulate carbon black having a nominal average diameter in the range of about 1×

10^-5 to about 5×

10^-3 mm;

(b) into which from about 0.2 to about 2 phr of a nontoxic, substantially nonleachable antioxidant has been diffused after vulcanization; and

(c) the inflated half-life of a population of said bladders at 40°

C. being at least about ten times longer than the half-life of a comparable population of bladders made from said vulcanized synthetic polyisoprene but without the silicon dioxide, carbon black and antioxidant.

10. The bladder of claim 9 wherein the particulate material is silicon dioxide.

11. The bladder of claim 9 wherein the synthetic polyisoprene has about 96% to 98% cis-1,4 linkages.

13. The bladder of claim 9 wherein said antioxidant is a hindered polyphenol.

14. The bladder of claim 10 wherein said antioxidant is a hindered polyphenol.

15. The bladder of claim 9 wherein said antioxidant is selected from the group consisting of tetrakis [methylene 3-(3'"'"',5'"'"',di-t-butyl-4'"'"'hydroxyphenyl) propionate] methane and 1,3,5-trimethyl-2,4,6-tris (3,5-di-t-butyl-4-hydroxybenzyl) benzene.

17. An elastomeric bladder that is for use in a medical infuser, the bladder being a tubular body:

(a) made from a homogeneous vulcanized mixture of polyisoprene having about 90% to 98% cis-1,4 linkages and about 3 to about 10 phr fumed silicon dioxide; and

(b) into which about 0.2 to about 2 phr of a nontoxic, substantially nonleachable antioxidant has been diffused after vulcanization;

whereby said bladder will have an improved resistance to rupture when inflated at 40°

C., as compared to bladders formed from said polyisoprene without said silicon dioxide and said antioxidant.

18. The bladder of claim 17 wherein the synthetic polyisoprene has about 96% to 98% cis-1,4 linkages and the vulcanized polyisoprene is characterized by having carbon-to-carbon crosslinks.

19. The bladder of claim 18 wherein said silicon dioxide is present in amounts of about 3 to about 7 phr and said silicon dioxide has a surface area in the range of about 150 to about 450 m² /gram.

20. The bladder of claim 19 wherein the surface area is 200±

20 m² /gram.

21. The bladder of claim 17 wherein the antioxidant is a hindered polyphenol.

22. The bladder of claim 21 wherein the hindered polyphenol is tetrakis [methylene 3-(3'"'"',5'"'"',di-t-butyl-4'"'"'hydroxyphenyl) propionate] methane or 1,3,5-trimethyl-2,4,6-tris (3,5-di-t-butyl-4-hydroxybenzyl) benzene.

27. The process of claim 21 wherein the amount of silicon dioxide is about 3 to about 10 phr, the antioxidant is a hindered polyphenol, and the amount of antioxidant is about 0.5 to about 2 phr.

28. The process of claim 27 wherein the amount of silicon dioxide is about 3 to about 7 phr, the antioxidant is a hindered polyphenol, and the amount of antioxidant is about 0.5 to about 2 phr.

39. The bladder produced by the process of claim 27.

40. The bladder produced by the process of claim 28.

23. An elastomeric bladder that is for use in a medical infuser and has improved resistance to spontaneous rupture when inflated at 40°

C., the bladder being a tubular body;

(a) made from a homogeneous mixture of synthetic polyisoprene having about 96% to about 98% cis-1,4 linkages and about 5 phr fumed silicon dioxide having a surface area of 200±

20 m² /gram, the mixture being vulcanized with about 1.5 phr dicumyl peroxide; and

(b) into which about 1 phr of 1,3,5-trimethyl-2,4,6-tris (3,5-di-t-butyl-4-hydroxybenzyl) benzene has been diffused after vulcanization.

24. A process for making an elastomeric bladder for use in a medical infuser and having improved resistance to rupture when inflated comprising:

(a) mixing homogeneously a synthetic polyisoprene having a molecular structure with about 90% to about 98% cis-1,4 linkages, a material selected from the group consisting of particulate silicon dioxide and particulate carbon black having a nominal average diameter in the range of about 1×

10^-5 to about 5×

10^-3 mm and an amount of vulcanizing agent sufficient to vulcanize the mixture;

(b) subjecting the mixture to vulcanizing conditions while simultaneously forming the mixture into a tubular body;

(c) solvent extracting unreacted vulcanizing agent and the degradation products of the vulcanizing agent from the body; and

(d) diffusing an amount of a nontoxic, substantially nonleachable antioxidant into the body by contacting the body with a liquid solution of the antioxidant;

the amount of particulate material together with the amount of antioxidant diffused into the body after vulcanization being sufficient to make the inflated half-life at 40°

C. of a population of bladders so formed at least about ten times longer than a comparable population of bladders without the particulate material and the antioxidant.

25. The process of claim 24 wherein in step (a) said particulate material is silicon dioxide.

26. The process of claim 25 wherein the synthetic polyisoprene has about 96% to about 98% cis-1,4 linkages and the vulcanizing agent effects carbon-to-carbon crosslinks in the polyisoprene.

29. The process of claim 25 wherein the silicon dioxide has a surface area of 200±

20 m² /gram, the amount of silicon dioxide is 5 phr, the amount of vulcanizing agent is 1.5 phr, the antioxidant is selected from the group consisting of tetrakis [methylene 3-(3'"'"',5'"'"',di-t-butyl-4'"'"'hydroxyphenyl) propionate] methane and 1,3,5-trimethyl-2,4,6-tris (3,5-di-t-butyl-4-hydroxybenzyl) benzene, and the amount of antioxidant is about 0.2 to about 2 phr.

30. The process of claim 29 wherein the antioxidant is 1,3,5-trimethyl-2,4,6-tris(3,5-di-t-butyl-4-hydroxybenzyl) benzene, the amount of antioxidant is 1 phr, the solvent is ethyl acetate, and the antioxidant is dissolved in ethyl acetate.

36. The bladder produced by the process of claim 24.

37. The bladder produced by the process of claim 25.

38. The bladder produced by the process of claim 26.

41. The bladder produced by the process of claim 29.

42. The bladder produced by the process of claim 30.

31. A process for making an elastomeric bladder having an improved resistance to rupture when inflated, said process comprising the steps of:

(a) mixing homogeneously (i) a synthetic polyisoprene having a molecular structure with about 90% to about 98% cis-1,4 linkages, (ii) an amount of dicumyl peroxide sufficient to vulcanize the mixture, and (iii) from about 3 to about 10 phr of particulate silicon dioxide having a nominal average diameter in the range of about 1×

10^-5 to about 5×

10^-3 mm;

(b) subjecting the mixture to vulcanizing conditions while simultaneously forming the mixture into a tubular body;

(c) solvent extracting unreacted vulcanizing agent and the degradation products of the vulcanizing agent from the body with ethyl acetate;

(d) diffusing from about 0.2 to about 2 phr of a nontoxic, substantially nonleachable hindered polyphenol antioxidant into the body by contacting the vulcanized body with an ethyl acetate solution of the antioxidant;

whereby the inflated half-life at 40°

C. of a population of bladders so formed is at least ten times greater than a comparable population of bladders formed without the silicon dioxide and antioxidant.

16. The bladder of claim 32 wherein said antioxidant is selected from the group consisting of tetrakis [methylene 3-(3'"'"',5'"'"',di-t-butyl-4'"'"'hydroxyphenyl) propionate] methane and 1,3,5-trimethyl-2,4,6-tris (3,5-di-t-butyl-4-hydroxybenzyl) benzene.

32. The process of claim 31 wherein the synthetic polyisoprene has about 96% to about 98% cis-1,4 linkages.

33. The process of claim 31 wherein the amount of silicon dioxide is about 3 to about 7 phr and the amount of antioxidant is about 0.5 to about 2 phr.

34. The process of claim 31 wherein the silicon dioxide has a surface area of 200 20 m² /gram, the amount of silicon dioxide is about 5 phr, the amount of vulcanizing agent is about 1.5 phr and the antioxidant is selected from the group consisting of tetrakis [methylene 3-(3'"'"',5'"'"',di-t-butyl-4'"'"'hydroxyphenyl) propionate] methane and 1,3,5-trimethyl-2,4,6-tris (3,5-di-t-butyl-4-hydroxybenzyl) benzene.

35. The process of claim 34 wherein the antioxidant is 1,3,5-trimethyl-2,4,6-tris (3,5-di-t-butyl-4-hydroxybenzyl) benzene and the amount of antioxidant is about 1 phr.

43. The bladder produced by the process of claim 31.

44. The bladder produced by the process of claim 32.

45. The bladder produced by the process of claim 33.

46. The bladder produced by the process of claim 34.

47. The bladder produced by the process of claim 35.