Biodegradable stent

• US 5,670,161 A
• Filed: 05/28/1996
• Issued: 09/23/1997
• Est. Priority Date: 05/28/1996
• Status: Expired due to Term

• Current Assignee: General Vascular Devices Limited
• Original Assignee: General Vascular Devices Limited
• Inventors: Healy, Kevin E., Dorfman, Gary S.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): Shelborne, Kathryne E.
• Application Number:
  US08/654,314
• Time in Patent Office: 483 Days
• Field of Search: 424/422, 424/426, 604/8, 604/154, 604/281, 128/656, 128/657, 128/659, 128/898
• US Class Current: 623/1.42
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2210/0004 bioabsorbable

Abstract

An expandable, biodegradable stent for use within a body lumen comprises a hollow tube made from a copolymer of L-lactide and ε-caprolactone that is not plastically expandable at normal body temperatures, and that is expandable using thermo-mechanical means at a temperature between about 38°-55° C. using a balloon catheter. The invention also relates to a method of making such a stent and to a method of deploying such a stent within the body.

Claims

1. An expandable, biodegradable stent for use within a body lumen comprising a hollow tube made from a copolymer of L-lactide and ε

-caprolactone that, in unexpanded form, is of a first diameter sufficient to be retained upon a balloon catheter for placement within the body lumen, and that is not plastically expandable at normal body temperatures, and that is expandable using thermo-mechanical means at a temperature between about 38°

-55°

C. when the balloon catheter is inflated to a second diameter sufficient to be retained within the body lumen.

2. The stent of claim 1, wherein the molar ratio of L-lactide to ε

-caprolactone is in the range from about 90;

10 to about 98;

2.

3. The stent of claim 1, wherein the tube is imperforate.

4. The stent of claim 1, wherein the tube is perforated, the perforations placed at a distance relative to each other corresponding to cell ingrowth within the body lumen.

5. The stent of claim 1, wherein the tube is nonwoven.

6. The stent of claim 1, wherein the tube incorporates a radio-opaque material.

7. The stent of claim 1, wherein the tube includes a drug blended with the copolymer.

8. The stent of claim 7, wherein the drug is selected from the group consisting of antithrombotics, anticoagulants, antimitogens, antimitotoxins, antisense oligonucleotides, gene therapy vehicles, nitric oxide, growth factors and inhibitors, Hirudin, Hirugen, Hirulog, PPACK, D-FPRCH₂ Cl, Heparin, and Warfarin.

9. The stent of claim 1, wherein the tube is coated with a lubricious material.

10. The stent of claim 9, wherein the thickness of the coating is about 25 μ

m.

11. The stent of claim 9, wherein the coating is blended with a drug.

12. The stent of claim 11, wherein the drug is selected from the group consisting of antithrombotics, anticoagulants, antimitogens, antimitotoxins, antisense oligonucleotides, gene therapy vehicles, nitric oxide, growth factors and inhibitors, Hirudin, Hirugen, Hirulog, PPACK, D-FPRCH₂ Cl, Heparin, and Warfarin.

13. The stent of claim 9, wherein the coating is a blend of a biodegradable material with lubricious materials selected from the group consisting of poly(ethylene glycol), poly(vinyl alcohol), poly(vinyl pyrrolidone), poly(acrylic acid), poly(methacrylic acid) and polyacrylamide.

14. The stent of claim 9, wherein the coating is a copolymer of a biodegradable material with lubricious materials selected from the group consisting of monomer constituents of poly(ethylene glycol), poly(vinyl alcohol), poly(vinyl pyrrolidone), poly(acrylic acid), poly(methacrylic acid) and polyacrylamide.

15. An expandable, biodegradable stent for use within a body lumen comprising a hollow tube made from a copolymer of L-lactide and ε

-caprolactone that, in unexpanded form, is of a first diameter sufficient to be retained upon a balloon catheter for placement within the body lumen, and that is not plastically expandable at normal body temperatures, and that is expandable using thermo-mechanical means at a temperature between about 38°

-55°

C. when the balloon catheter is inflated to a second diameter sufficient to be retained within the body lumen, further comprising a lubricious coating.

16. The stent of claim 15, wherein the thickness of the coating is about 25 μ

m.

17. The stent of claim 15, wherein the coating is a blend of a biodegradable material with lubricious materials selected from the group consisting of poly(ethylene glycol), poly(vinyl alcohol), poly(vinyl pyrrolidone), poly(acrylic acid), poly(methacrylic acid) and polyacrylamide.

18. The stent of claim 15, wherein the coating is a copolymer of a biodegradable material with lubricious materials selected from the group consisting of monomer constituents of poly(ethylene glycol), poly(vinyl alcohol), poly(vinyl pyrrolidone), poly(acrylic acid), poly(methacrylic acid) and polyacrylamide.

19. The stent of claim 15, wherein the coating is blended with a drug.

20. The stent of claim 19, wherein the drug is selected from the group consisting of antithrombotics, anticoagulants, antimitogens, antimitotoxins, antisense oligonucleotides, gene therapy vehicles, nitric oxide, growth factors and inhibitors, Hirudin, Hirugen, Hirulog, PPACK, D-FPRCH₂ Cl, Heparin, and Warfarin.

21. A method for making a stent comprising the steps of:

providing a copolymer of L-lactide and ε

-caprolactone that is not expandable at normal body temperatures, and that is thermo-mechanically expandable at a temperature between about 38°

-55°

C.;

creating a tube from the copolymer having a diameter sufficient to permit the tube to be retained upon an unexpanded balloon catheter for insertion into a body lumen; and

cutting the tube into lengths for use as a stent within the body lumen.

22. The method of claim 21, wherein the tube is created by extrusion.

23. The method of claim 21, wherein the tube is created by dip-coating.

24. The method of making a stent of claim 21, wherein the ratio of L-lactide to ε

-caprolactone is in the range from about 90;

10 to about 98;

2.

25. The method of making a stent of claim 21, further comprising the step of micromachining perforations in the tube using a laser.

26. The method of making a stent of claim 21, further comprising the step of incorporating radio-opaque material in the tube.

27. The method of making a stent of claim 21, further comprising the step of blending a drug with the copolymer.

28. The method of making a stent of claim 27, wherein the drug is selected from the group consisting of antithrombotics, anticoagulants, antimitogens, antimitotoxins, antisense oligonucleotides, gene therapy vehicles, nitric oxide, growth factors and inhibitors, Hirudin, Hirugen, Hirulog, PPACK, D-FPRCH₂ Cl, Heparin, and Warfarin.

29. The method of making a stent of claim 21, further comprising the step of coating the stent with a lubricious material.

30. The method of making a stent of claim 29, further comprising the step of blending a drug with the coating.

31. The method of making a stent of claim 30, wherein the drug is selected from the group consisting of antithrombotics, anticoagulants, antimitogens, antimitotoxins, antisense oligonucleotides, gene therapy vehicles, nitric oxide, growth factors and inhibitors, Hirudin, Hirugen, Hirulog, PPACK, D-FPRCH₂ Cl, Heparin, and Warfarin.

32. The method of making a stent of claim 29, wherein the coating is a blend of a biodegradable material with a lubricious materials selected from the group consisting of poly(ethylene glycol), poly(vinyl alcohol), poly(vinyl pyrrolidone), poly(methacrylic acid) and polyacrylamide.

33. The method of making a stent of claim 29, wherein the coating is a copolymer of a biodegradable material with a lubricious materials selected from the group consisting of monomer constituents of poly(ethylene glycol), poly(vinyl alcohol), poly(vinyl pyrrolidone), poly(methacrylic acid) and polyacrylamide.

34. A method for making a stent comprising the steps of:

providing a copolymer of L-lactide and ε

-caprolactone that is not expandable at normal body temperatures, and that is thermo-mechanically expandable at a temperature between about 38°

-55°

C.;

creating a tube from the copolymer having a diameter sufficient to permit the tube to be retained upon an unexpanded balloon catheter for insertion into a body lumen;

cutting the tube into lengths for use as a stent within the body lumen; and

,

thermo-mechanically expanding the stent within the body lumen to increase the hoop strength of the stent by a sufficient amount to substantially support the body lumen.

35. The method of making a stent of claim 34, wherein the stent is thermo-mechanically expanded so that the draw ratio of the expanded stent is greater than 2.0.

36. A method of deploying an expandable, biodegradable stent within a body lumen, comprising the steps of:

providing percutaneous access to the body lumen;

placing the unexpanded stent, in the form of an unexpanded hollow, nonwoven tube made from a copolymer of L-lactide and ε

-caprolactone, upon a balloon portion of a balloon catheter;

transporting the stent to a desired location in the body lumen using the catheter;

heating the stent to a temperature between 38°

-55°

C., to permit thermo-mechanical expansion of the stent;

expanding the stent to a desired diameter by inflating the balloon catheter;

allowing the stent to cool at least below about 38°

C. without applying any positive cooling;

deflating the balloon portion of the catheter; and

,

withdrawing the catheter.

37. The method of deploying a stent of claim 36, wherein the stent is heated by employing a heated material within the catheter to expand the balloon portion of the catheter.

38. The method of deploying a stent of claim 36, wherein the stent is heated using a heating method selected from the group consisting of microwave heating, DC heating, RF heating, and heating using ultraviolet radiation.

39. The method of deploying a stent of claim 36, wherein the stent is made from a copolymer having a ratio of L-lactide to ε

-caprolactone in the range from about 90;

10 to about 98;

2.

40. The method of deploying a stent of claim 36, wherein the stent is imperforate.

41. The method of deploying a stent of claim 36, wherein the stent is perforated, the perforations placed at a distance relative to each other corresponding to cell ingrowth patterns within the body lumen.

42. The method of deploying a stent of claim 36, wherein the stent is nonwoven.

43. The method of deploying a stent of claim 36, wherein the stent includes a radio-opaque material.

44. The method of deploying a stent of claim 36, wherein the stent includes a drug blended with the copolymer.

45. The method of deploying a stent of claim 44, wherein the drug is selected from the group consisting of antithrombotics, anticoagulants, antimitogens, antimitotoxins, antisense oligonucleotides, gene therapy vehicles, nitric oxide, growth factors and inhibitors, Hirudin, Hirugen, Himlog, PPACK, D-FPRCH₂ Cl, Heparin, and Warfarin.

46. The method of deploying a stent of claim 36, wherein the stent is coated with a lubricious material.

47. The method of making a stent of claim 46, further comprising the step of blending a drug with the coating.

48. The method of making a stent of claim 47, wherein the drug is selected from the group consisting of antithrombotics, anticoagulants, antimitogens, antimitotoxins, antisense oligonucleotides, gene therapy vehicles, nitric oxide, growth factors and inhibitors, Hirudin, Hirugen, Hirulog, PPACK, D-FPRCH₂ Cl, Heparin, and Warfarin.

49. The method of deploying a stent of claim 46, wherein the coating is a blend of a biodegradable material with a lubricious materials selected from the group consisting of poly(ethylene glycol), poly(vinyl alcohol), poly(vinyl pyrrolidone), poly(methacrylic acid) and polyacrylamide.

50. The method of deploying a stent of claim 46, wherein the coating is a copolymer of a biodegradable material with a lubricious materials selected from the group consisting of monomer constituents of poly(ethylene glycol), poly(vinyl alcohol), poly(vinyl pyrrolidone), poly(methacrylic acid) and polyacrylamide.

51. A method of deploying an expandable, biodegradable stent within a body lumen, comprising the steps of:

providing percutaneous access to the body lumen;

placing the unexpanded stent, in the form of an unexpanded hollow, nonwoven tube made from a copolymer of L-lactide and ε

-caprolactone, upon a balloon portion of a balloon catheter;

transporting the stent to a desired location in the body lumen using the catheter;

heating the stent to a temperature between 38°

-55°

C., to permit thermo-mechanical expansion of the stent;

expanding the stent to a desired diameter by inflating the balloon catheter so that the draw ratio of the expanded stent is greater than 2.0;

allowing the stent to cool at least below about 38°

C.;

deflating the balloon portion of the catheter; and

,

withdrawing the catheter.