Method for coating implantable devices

• US 7,335,391 B1
• Filed: 12/05/2003
• Issued: 02/26/2008
• Est. Priority Date: 05/31/2001
• Status: Expired due to Fees

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Pacetti, Stephen D.
• Primary Examiner(s): CAMERON, ERMA C
• Application Number:
  US10/729,551
• Time in Patent Office: 1,544 Days
• Field of Search: 427/2.24, 427/2.1, 427/2.25, 427/2.28, 427/2.3, 427231-236, 427/238, 427/398.4, 427/421, 427/424, 427/425
• US Class Current: 427/2.24
• CPC Class Codes: A61L 2300/00 Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: B05B 13/0235 the movement of the objects being a combination of rotation and linear displacement B05B13/0242 takes precedence
• CPC Class Codes: B05B 16/00 Spray booths arrangements for collecting, re-using or eliminating excess spraying material in spray booths B05B14/40
• CPC Class Codes: B05D 1/02 performed by spraying
• CPC Class Codes: B05D 3/0486 Operating the coating or treatment in a controlled atmosphere
• CPC Class Codes: B05D 3/0493 using vacuum

Abstract

A method of forming a coating for an implantable medical device, such as a stent, is provided which includes applying a composition to the device in an environment having a selected pressure.

Claims

1. A method of forming a coating for an implantable medical device, comprising:

inserting the device into a chamber;

adjusting the pressure of the chamber to a pressure greater than ambient pressure;

followed by applying a composition comprising a solvent to the implantable device while the device is disposed in an environment having the pressure at greater than ambient pressure,

wherein a coating is formed on the device through evaporation of the solvent.

2. The method of claim 1 wherein the composition comprises a polymer dissolved in the solvent and optionally a therapeutic substance added thereto.

3. The method of claim 2 wherein the therapeutic substance is

an antiproliferative antineoplastic, antiinflammatory, antiplatelet, anticoagulant, antifibrin, antithrombin, antimitotic, antioxidant, or a combination of these;

or

an antibiotic combined with an antiproliferative antineoplastic, antiinflammatory, antiplatelet, anticoagulant, antifibrin, antithrombin, antimitotic, antioxidant, or a combination of these.

4. The method of claim 2 wherein the solvent comprises a compound selected from chloroform, acetone, water, buffered saline, dimethylsulfoxide, propylene glycol methyl ether, isopropyl alcohol, n-propyl alcohol, methanol, ethanol, tetrahydrofuran, dimethylformamide, dimethyl acetamide, benzene, toluene, xylene, hexane, cyclohexane, heptane, octane, nonane, decane, decalin, ethyl acetate, butyl acetate, isobutyl acetate, isopropyl acetate, butanol, diacetone alcohol, benzyl alcohol, acetone, 2-butanone, cyclohexanone, dioxane, methylene chloride, carbon tetrachloride, tetrachloroethylene, tetrachloroethane, chlorobenzene, 1,1,1-trichloroethane, formamide, and their combinations.

5. The method of claim 1 wherein the act of applying comprises spraying the composition on the implantable device.

6. The method of claim 1 wherein the implantable device is a stent and the act of applying comprises spraying the composition while rotating the stent about the longitudinal axis of the stent.

7. The method of claim 1 wherein the implantable device is a stent and the act of applying comprises spraying the composition while moving the stent in a linear direction along the longitudinal axis of the stent.

8. The method of claim 1 wherein the composition includes a therapeutic substance and wherein the temperature of the chamber is adjusted to a temperature that does not adversely affect the therapeutic substance.

9. The method of claim 8 wherein the composition includes a polymer dissolved in the solvent.

10. The method of claim 3 wherein the therapeutic substance is paclitaxel, docetaxel, dexamethasone, or rapamycin.

11. A method of forming a coating for an implantable medical device, comprising

inserting the device into a chamber;

adjusting the pressure of the chamber to a pressure greater than ambient pressure;

applying a composition comprising a solvent and a therapeutic substance to the implantable device while the device is disposed in an environment having the pressure at greater than ambient pressure, wherein the act of applying comprises spraying the composition on the implantable device; and

wherein the therapeutic substance is

an antiproliferative antineoplastic, antiinflammatory, antiplatelet, anticoagulant, antifibrin, antithrombin, antimitotic, antioxidant, or a combination of these;

or

an antibiotic combined with an antiproliferative antineoplastic, antiinflammatory, antiplatelet, anticoagulant, antifibrin, antithrombin, antimitotic, antioxidant, or a combination of these.

12. The method of claim 11 wherein the composition comprises a polymer dissolved in the solvent.

13. The method of claim 11 wherein the therapeutic substance is paclitaxel, docetaxel, rapamycin, dexamethasone, or any combination of these.

14. The method of claim 12 wherein the solvent comprises a compound selected from chloroform, acetone, water, buffered saline, dimethylsulfoxide, propylene glycol methyl ether, isopropyl alcohol, n-propyl alcohol, methanol, ethanol, tetrahydrofuran, dimethylformamide, dimethyl acetamide, benzene, toluene, xylene, hexane, cyclohexane, heptane, octane, nonane, decane, decalin, ethyl acetate, butyl acetate, isobutyl acetate, isopropyl acetate, butanol, diacetone alcohol, benzyl alcohol, acetone, 2-butanone, cyclohexanone, dioxane, methylene chloride, carbon tetrachloride, tetrachloroethylene, tetrachloroethane, chlorobenzene, 1,1,1-trichloroethane, formamide, and their combinations.

15. The method of claim 11 wherein the implantable device is a stent and the act of applying further comprises spraying the composition while rotating the stent about the longitudinal axis of the stent.

16. The method of claim 11 wherein the implantable device is a stent and the act of applying further comprises spraying the composition while moving the stent in a linear direction along the longitudinal axis of the stent.

17. The method of claim 11 wherein the temperature of the chamber is adjusted to a temperature that does not adversely affect the therapeutic substance.

18. The method of claim 17 wherein the composition comprises a polymer dissolved in the solvent.

19. A method of forming a coating for an implantable medical device, comprising

inserting the device into a chamber;

adjusting the pressure of the chamber to a pressure greater than ambient pressure;

applying a composition comprising;

a solvent; and

a therapeutic substance,

to the implantable device while the device is disposed in an environment having the pressure at greater than ambient pressure

wherein the pressure is selected based on the vapor pressure of the solvent and wherein the therapeutic substance is

an antiproliferative antineoplastic, antiinflammatory, antiplatelet, anticoagulant, antifibrin, antithrombin, antimitotic, antioxidant, or a combination of these;

or

an antibiotic combined with an antiproliferative antineoplastic, antiinflammatory, antiplatelet, anticoagulant, antifibrin, antithrombin, antimitotic, antioxidant, or a combination of these.

20. The method of claim 19 wherein the composition comprises a polymer dissolved in the solvent and the therapeutic substance added thereto.

21. The method of claim 20 wherein the therapeutic substance is paclitaxel, docetaxel, rapamycin, dexamethasone, or any combination of these.

22. The method of claim 20 wherein the solvent comprises a compound selected from chloroform, acetone, water, buffered saline, dimethylsulfoxide, propylene glycol methyl ether, isopropyl alcohol, n-propyl alcohol, methanol, ethanol, tetrahydrofuran, dimethylformamide, dimethyl acetamide, benzene, toluene, xylene, hexane, cyclohexane, heptane, octane, nonane, decane, decalin, ethyl acetate, butyl acetate, isobutyl acetate, isopropyl acetate, butanol, diacetone alcohol, benzyl alcohol, acetone, 2-butanone, cyclohexanone, dioxane, methylene chloride, carbon tetrachloride, tetrachloroethylene, tetrachloroethane, chlorobenzene, 1,1,1-trichloroethane, formamide, and their combinations.

23. The method of claim 19 wherein the act of applying comprises spraying the composition on the implantable device.

24. The method of claim 19 wherein the implantable device is a stent and the act of applying comprises spraying the composition while rotating the stent about the longitudinal axis of the stent.

25. The method of claim 19 wherein the implantable device is a stent and the act of applying comprises spraying the composition while moving the stent in a linear direction along the longitudinal axis of the stent.

26. The method of claim 19 wherein the temperature of the chamber is adjusted to a temperature that does not adversely affect the therapeutic substance.

27. The method of claim 26 wherein the composition includes a polymer dissolved in the solvent.