Methods of coating an implantable device

• US 8,741,378 B1
• Filed: 12/23/2004
• Issued: 06/03/2014
• Est. Priority Date: 06/27/2001
• Status: Expired due to Fees

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Roorda, Wouter E., Ding, Ni
• Primary Examiner(s): WEDDLE, ALEXANDER MARION
• Application Number:
  US11/022,228
• Time in Patent Office: 3,449 Days
• Field of Search: 427/140, 427 21- 231, 427/226, 427/299, 427/314, 427/316, 427/318, 427/372.2, 427/375, 427/398.1, 604/527, 623 11- 112, 623/1.42, 623/1.43, 623/1.44, 623/1.45, 623/1.46, 623/1.47, 623/1.48
• US Class Current: 427/2.24
• 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 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30064 Coating or prosthesis-covering structure made of biodegradable material
• CPC Class Codes: A61K 31/436 the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
• CPC Class Codes: A61K 31/439 the ring forming part of a bridged ring system, e.g. quinuclidine 8-azabicyclo [3.2.1] octanes A61K31/46
• CPC Class Codes: A61L 2300/216 with other specific functional groups, e.g. aldehydes, ketones, phenols, quaternary phosphonium groups
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 2420/06 Coatings containing a mixture of two or more compounds
• CPC Class Codes: A61L 31/08 Materials for coatings
• 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: B05D 1/02 performed by spraying

Abstract

Methods of coating an implantable device, such as a stent, are provided.

Claims

1. A method of coating an implantable device or an implantable portion of a medical device comprising:

providing, on a support structure, a medical device capable of being implanted;

adjusting the temperature of the implantable medical device to a target temperature;

atomizing a coating substance with a gaseous propellant, the coating substance comprising a solvent, a polymer dissolved in the solvent, and a therapeutic substance; and

applying the coating substance onto the implantable medical device after starting the act of adjusting the temperature and while the implantable medical device is supported by the support structure,

wherein the implantable medical device is not a catheter liner, the target temperature selected is below a temperature which causes thermal degradation of the therapeutic substance, and

the adjusting step ending is selected from the following;

the adjusting step ends before the applying step begins;

the adjusting step does not end before the applying step begins;

the adjusting step ends before the applying step ends; and

the adjusting step ends after the applying step ends.

2. The method of claim 1 wherein the implantable medical device is a stent.

3. The method of claim 2 wherein the stent is polymeric or metallic.

4. The method of claim 2 wherein the stent is at least partially expanded during the acts of applying and adjusting.

5. The method of claim 1 wherein the target temperature is above ambient temperature.

6. The method of claim 5 wherein the solvent is a non-volatile solvent.

7. The method of claim 6 wherein the target temperature is greater than 20°

C.

8. The method of claim 1 wherein the implantable medical device is

maintained at the target temperature during the applying step;

or

maintained near the target temperature during the applying step.

9. The method of claim 1 additionally comprising repeating the acts of adjusting and applying to form a coating of a desirable thickness or weight.

10. The method of claim 1 where in the therapeutic substance inhibits, reduces, help in diagnosis, or treats a human or animal disease.

11. The method of claim 1 wherein the therapeutic substance comprises any substance capable of exerting a therapeutic, diagnostic or prophylactic effect.

12. The method of claim 1 wherein therapeutic substance is at least one or any combination of antibiotics;

anticoagulants;

antifibrins;

antiinflammatories;

antimitotics;

antineoplastics;

antioxidants;

antiplatelets;

antiproliferatives;

or antithrombins.

13. The method of claim 1 wherein the coating substance additionally includes a radiopaque element or a radioactive isotope.

14. The method of claim 1 wherein the target temperature is about 35°

C. to about 80°

C.

15. The method of claim 1 wherein the adjusting step ends before the applying step begins.

16. The method of claim 1 wherein the adjusting step does not end before the applying step begins.

17. The method of claim 1 wherein the adjusting step ends before the applying step ends.

18. The method of claim 1 wherein the adjusting step ends after the applying step ends.

19. A method of coating an implantable device or an implantable portion of a medical device comprising:

providing, on a support structure, a medical device capable of being implanted;

adjusting the temperature of the implantable medical device to a target temperature;

atomizing a coating substance with a gaseous propellant, the coating substance comprising a solvent, a polymer dissolved in the solvent, and a therapeutic substance; and

applying the coating substance onto the implantable medical device after starting the act of adjusting the temperature and while the implantable medical device is supported by the support structure,

wherein the implantable medical device is not a catheter liner, the target temperature selected is below a temperature which causes thermal degradation of the therapeutic substance, and

the adjusting step ending is selected from the following;

the adjusting step ends before the applying step begins;

the adjusting step does not end before the applying step begins;

the adjusting step ends before the applying step ends; and

the adjusting step ends after the applying step ends,

wherein the target temperature is below ambient temperature.

20. The method of claim 19 wherein the solvent is a volatile solvent.

21. The method of claim 20 wherein the target temperature is less than 20°

C.

22. A method of coating an implantable device comprising:

adjusting the temperature of the implantable device to a target temperature; and

applying a coating substance, after the act of adjusting the temperature begins, comprising a volatile solvent, a polymer and a therapeutic substance, to the implantable device while the implantable device is supported by a support structure,

wherein the implantable device is not a catheter liner and wherein the implantable device is a polymeric or metallic stent,

wherein

the adjusting step ends before the applying step begins;

the adjusting step does not end before the applying step begins;

the adjusting step ends before the applying step ends;

or

the adjusting step ends after the applying step ends,

wherein the target temperature is less than 20°

C., and

wherein the therapeutic agent

inhibits, reduces, helps in diagnosis, or treats a human or animal disease; and

is at least one or any combination of antibiotics;

anticoagulants;

antifibrins;

antiinflammatories;

antimitotics;

antineoplastics;

antioxidants;

antiplatelets;

antiproliferatives;

or antithrombins.

23. A method of coating an implantable device comprising:

adjusting the temperature of the implantable device to a target temperature; and

applying a coating substance, after the act of adjusting the temperature begins, comprising a non-volatile solvent, a polymer and a therapeutic substance, to the implantable device while the implantable device is supported by a support structure,

wherein the implantable device is not a catheter liner, the target temperature selected is below a temperature which causes thermal degradation of the therapeutic substance, and wherein the implantable medical device is a polymeric or metallic stent,

wherein

the adjusting step ends before the applying step begins;

the adjusting step does not end before the applying step begins;

the adjusting step ends before the applying step ends;

or

the adjusting step ends after the applying step ends,

wherein the target temperature is greater than 20°

C., and

wherein the therapeutic agent

inhibits, reduces, diagnosis, or treats a human or animal disease; and

is at least one or any combination of antibiotics;

anticoagulants;

antifibrins;

antiinflammatories;

antimitotics;

antineoplastics;

antioxidants;

antiplatelets;

antiproliferatives;

or antithrombins.