System and method for coating an implantable medical device

• US 7,563,324 B1
• Filed: 12/29/2003
• Issued: 07/21/2009
• Est. Priority Date: 12/29/2003
• Status: Expired due to Fees

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Chen, Yung-Ming, Ho, Henjen
• Primary Examiner(s): EDWARDS, LAURA ESTELLE
• Application Number:
  US10/747,996
• Time in Patent Office: 2,031 Days
• Field of Search: 118/264, 118/268, 118/269, 118/500, 118/270, 118/271, 118/422, 118/429, 206/205, 206/207, 206/210, 206/212, 206/523, 427/2.1, 427/2.24, 427/429, 427/430.1, 623/1.45, 623/1.46
• US Class Current: 118/270
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: B05C 1/022 to the outer surface of hollow articles B05C1/027 takes precedence
• CPC Class Codes: B05C 1/06 by rubbing contact, e.g. by brushes, by pads brushes in general A46B
• CPC Class Codes: B05C 13/025 relatively small cylindrical objects, e.g. cans, bottles
• CPC Class Codes: B05D 1/26 performed by applying the liquid or other fluent material from an outlet device in contact with, or almost in contact with, the surface
• CPC Class Codes: B05D 1/28 performed by transfer from the surfaces of elements carrying the liquid or other fluent material, e.g. brushes, pads, rollers

Abstract

A system and method for coating an implantable medical device, such as a stent, are provided.

Claims

1. A system for coating an implantable medical device with a coating composition, comprising:

a reservoir holding a coating composition;

an applicator including a coating surface and a porous region in fluid communication with the coating composition in the reservoir, wherein the porous region is capable of conveying the coating composition from the reservoir to the coating surface, the applicator further including;

a first section having a porous region disposed in the coating composition in the reservoir, and

a second section having a porous region in fluid communication with the porous region of the first section, the second section being disposed over the first section so as to provide a sealed space between the second section and the coating composition in the reservoir, wherein the second section includes the coating surface to coat the implantable medical device;

a support element to support an implantable medical device in close proximity to or in contact with the coating surface of the applicator;

a temperature controller in communication with the applicator, the support element or the reservoir for heating or cooling the coating composition; and

a pressurizing device in communication with the applicator or the reservoir for enhancing the conveyance of the coating composition from the reservoir to the coating surface wherein the pressurizing device is in fluid communication with the sealed space.

2. The system of claim 1, wherein the applicator comprises a hollow tubular body having a bore, the bore being configured to received the device.

3. The system of claim 1, wherein the applicator comprises a half-tubular body configured to receive the device.

4. The system of claim 1, wherein the coating surface comprises a completely or substantially flat substrate on which the device can be placed.

5. The system of claim 1, wherein the at least one of the porous regions comprises pores having an average pore radius of about 0.1 microns to about 1000 microns.

6. The system of claim 1, wherein at least one of the porous regions has a porosity of about 20% to about 60%.

7. The system of claim 1, additionally including an apparatus to rotate the support element.

8. The system of claim 1, wherein the applicator is movable in a linear direction.

9. The system of claim 1, wherein the device is a stent.

10. The system of claim 1, wherein the applicator is made from a ceramic or polymeric material.

11. The system of claim 1, wherein the applicator is made from a rigid material such that the coating surface does not comply when the device contacts the coating surface.

12. The system of claim 1, wherein the second section of the applicator comprises a hollow tubular body having a longitudinal bore configured to receive the implantable medical device.

13. The system of claim 1, wherein the porous region of the first section has an average pore size smaller than the average pore size of the porous region of the second section.

14. The system of claim 1, wherein the applicator has a uniform pore pattern.

15. The system of claim 1, wherein the applicator includes a network of interconnected pores.

16. The system of claim 1, wherein the applicator includes pores that are sized such that particles within the coating composition that exceed a predetermined size are not capable of being conveyed to the coating surface.

17. A system for coating an implantable medical device with a coating composition, comprising:

a reservoir of coating composition;

an applicator in fluid communication with the reservoir, the applicator including a porous coating portion having a coating surface, and a porous portion for conveying coating composition from the reservoir to the coating portion, wherein a length and/or width of the coating portion is substantially greater than a length and/or width of the porous portion; and

a support element to support an implantable medical device in close proximity to or in contact with the coating surface of the applicator;

wherein the reservoir has walls and the walls, the porous portion and the coating portion form a closed space containing at least a portion of the coating composition contained in the reservoir, further including;

a pressure device in fluid communication with the space and configured for regulating the coating composition conveyed to the coating surface by regulating the pressure in the space.

18. The system of claim 17, wherein the coating surface is horizontally disposed above the reservoir.

19. The system of claim 17, wherein a portion of the applicator is partially submerged in the reservoir.

20. The system of claim 17, wherein a surface of the coating portion facing the coating composition contained in the space is sealed.

21. The system of claim 17, wherein the coating portion includes a coating surface formed by a horizontally disposed cylinder.

22. The system of claim 17, wherein the coating portion has a first average pore size and the porous portion has a second average pore size that is smaller than the first average pore size.

23. A system for coating an implantable medical device with a coating composition, comprising:

a reservoir holding a coating composition;

an applicator including a coating surface and a porous region in fluid communication with the coating composition in the reservoir, wherein the porous region is capable of conveying the coating composition from the reservoir to the coating surface;

a support element to support an implantable medical device in close proximity to or in contact with the coating surface of the applicator; and

a pressure apparatus configured to supply a gas to, and being in fluid communication with the coating composition so as to enhance the loading of the coating surface.

24. The system of claim 23, further including the reservoir, coating composition and/or applicator forming a closed space and the pressure apparatus draws a vacuum in the closed space.

25. The system of claim 23, wherein the pressure apparatus supplies a gas to the coating composition to enhance the loading of the coating surface.