Method for deploying a thermo-mechanically expandable stent

• US 6,607,553 B1
• Filed: 11/17/2000
• Issued: 08/19/2003
• Est. Priority Date: 11/17/2000
• Status: Expired due to Fees

• Current Assignee: B Braun Medical Incorporated (B. Braun Holding GmbH & Co. KG)
• Original Assignee: B Braun Medical Incorporated (B. Braun Holding GmbH & Co. KG)
• Inventors: Healy, Kevin E., Walsh, Joseph T., Dorfman, Gary S.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): BLANCO, JAVIER G
• Application Number:
  US09/715,215
• Time in Patent Office: 1,005 Days
• Field of Search: 623/1.11, 623/1.19, 623/1.21, 623/1.46, 427/2.25, 424/426
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials

Abstract

An expandable stent for use within a body lumen that is coated with a radiation-absorbing material and that is not plastically expandable at normal body temperatures but is expandable at a temperature between about 38° C. to 60° C. following exposure to radiation. The invention also relates to a method of deploying such a stent within the body.

Claims

1. A method for deploying a stent in a body lumen, the method comprising the steps of:

coating the stent with a radiation-absorbing material;

introducing the stent into a lumen of the body;

applying radiation from a radiation source to the radiation-absorbing material to thereby heat the stent to at least its glass transition temperature;

while the stent is at a temperature at or above its glass transition temperature, expanding the stent to a predetermined size; and

discontinuing application of radiation to the radiation-absorbing material and allowing the stent to cool to a temperature below its glass transition temperature.

2. The method of claim 1, further comprising the step of forming the stent from a material that is degradable within the body lumen.

3. The method of claim 1, further comprising the step of introducing a balloon catheter into the stent and inflating the balloon to thereby expand the stent.

4. The method of claim 3, further comprising the step of introducing a contrast medium into the balloon to thereby inflate the balloon.

5. The method of claim 4, further comprising the step of adding the radiation-absorbing material to the contrast medium, to thereby absorb the radiation and heat the contrast medium.

6. The method of claim 5, wherein the radiation-absorbing material is added to the contrast medium in an amount sufficient to maintain the temperature of the stent at or above its glass transition temperature while absorbing excess radiation to thereby prevent damage to tissue surrounding the stent.

7. The method of claim 1, wherein the radiation source comprises a laser.

8. The method of claim 1, wherein the radiation-absorbing material comprises a chromophore.

9. The method of claim 8, wherein the chromophore is selected from the group consisting of indocyanine green, vital blue, carbon black and methylene blue.

10. The method of claim 1, further comprising the step of blending the radiation-absorbing material with a coating material prior to coating the stent.

11. The method of claim 10, wherein the coating material comprises a polymer, copolymer, or polymer blend containing one or more compounds selected from the group consisting of D,L-lactide, glycolide, L-lactide, and ε

-caprolactone.

12. The method of claim 11, wherein the coating material further comprises a lubricious material.

13. The method of claim 12, wherein the lubricious material is selected from the group consisting of poly(ethylene glycol), acrylated poly(ethylene glycol), poly(vinyl alcohol), poly(vinyl pyrrolidone), poly(acrylic acid), poly(methacrylic acid) and polyacrylamide.

14. The method of claim 1, further comprising the step of applying a multilayer laminate to the stent, the multilayer laminate comprising at least one layer of radiation-absorbing material and at least one layer of a coating material.

15. The method of claim 14, wherein the coating material comprises a polymer, copolymer, or polymer blend containing one or more compounds selected from the group consisting of D,L-lactide, glycolide, L-lactide, ε

-caprolactone.

16. The method of claim 15, wherein the coating material further comprises a lubricious material.

17. The method of claim 16, wherein the lubricious material is selected from the group consisting of poly(ethylene glycol), acrylated poly(ethylene glycol), poly(vinyl alcohol), poly(vinyl pyrrolidone), poly(acrylic acid), poly(methacrylic acid) and polyacrylamide.

18. A method for thermomechanically deploying a stent in a body lumen comprising the steps of:

coating the stent with a radiation-absorbing material;

providing a balloon catheter, the catheter including a radiation source at a distal end, the radiation source selected to emit radiation that will be absorbed selectively by the radiation-absorbing material;

placing the stent at the distal end of catheter;

inserting the catheter and the stent into the body lumen;

heating the stent by generating radiation from the radiation source to be absorbed by the radiation-absorbing material and converted to heat, until the stent exceeds its glass transition temperature;

inflating the balloon catheter to a predetermined size, thereby expanding the stent to a predetermined size;

terminating the generation of radiation from the radiation source and allowing the stent to cool below its glass transition temperature;

deflating the balloon catheter and withdrawing it from the body lumen, leaving the expanded stent within the body lumen.

19. The method of claim 18, further comprising the step of selecting a stent that is degradable within the body lumen.

20. The method of claim 18, further comprising the step of selecting a radiation source comprising a laser and a diffuser, the diffuser being positioned along the longitudinal axis of the catheter at the distal end of the catheter and the laser being coupled to the diffuser through an optical fiber, the optical fiber being positioned within the catheter.

21. The method of claim 18, wherein the catheter and stent are inserted into the body percutaneously.

22. The method of claim 18, wherein the radiation-absorbing material comprises a chromophore selected from the group consisting of indocyanine green, vital blue, carbon black and methylene blue.

23. The method of claim 22, wherein the radiation-absorbing material comprises indocyanine green.

24. The method of claim 18, further comprising the step of blending the radiation-absorbing material with a coating material prior to coating the stent.

25. The method of claim 24, wherein the coating material is composed of the same polymeric material as the stent, said coating material having a lower molecular weight than the polymeric material of the stent.

26. The method of claim 24, wherein the coating material comprises a polymer, copolymer, or polymer blend containing one or more compounds selected from the group consisting of D,L-lactide, glycolide, L-lactide, ε

-caprolactone, and poly(ethylene glycol).

27. The method of claim 24, wherein the coating material further comprises a drug.

28. The method of claim 27, wherein the drug is selected from the group consisting of antithrombotics, anticoagulants, antimitogens, antimitotoxins, antisense oligonucleotides, gene therapy vehicles, nitric oxide, photo-activated agents, growth factors and inhibitors, hirudin, hirugen, HIRULOG, PPACK, D-FPRCH₂CL, peptide-based inhibitors, heparin and warfarin.

29. The method of claim 24, wherein the radiation-absorbing material/coating material is applied to the stent to a thickness of about 40 micrometers to about 200 micrometers.

30. The method of claim 29, wherein the radiation-absorbing material/coating material is applied to the stent to a thickness of about 60 micrometers to about 110 micrometers.

31. The method of claim 18, further comprising the step of selecting a radiation source that emits optical radiation.

32. The method of claim 18, further comprising the step of selecting a radiation source that emits radiation at a wavelength from about 350 nanometers to about 1100 nanometers.

33. The method of claim 18, wherein the radiation source is selected to emit radiation at a wavelength of about 770 nanometers to about 830 nanometers.

34. The method of claim 18, wherein the radiation source is selected to emit radiation at a wavelength of about 580 nanometers to about 700 nanometers.

35. The method of claim 18, wherein the radiation-absorbing material is sprayed on the stent.

36. The method of claim 18, wherein the radiation-absorbing material is applied to the stent in an amount sufficient to absorb between 75% and 100% of the radiation.

37. The method of claim 18, further comprising the step of providing at least one thermocouple to thereby provide a measure of the temperature of the stent.

38. The method of claim 37, further comprising the step of providing a controller that detects the temperature sensed by the thermocouple, said controller modulating the power delivered to the stent to maintain a predetermined temperature of the stent.

39. The method of claim 38, wherein the controller modulates the power delivered to the stent to maintain the temperature of the stent in a range from about 38°

C. to about 60°

C.

40. The method of claim 18, further comprising the step of selecting a stent that has a glass transition temperature between about 38°

C. and about 60°

C.

41. The method of claim 18, further comprising the step of introducing a contrast medium into the balloon to thereby inflate the balloon.

42. The method of claim 41, further comprising the step of adding the radiation-absorbing material to the contrast medium.