Deforming surface of drug eluting coating to alter drug release profile of a medical device

• US 8,221,824 B2
• Filed: 02/03/2005
• Issued: 07/17/2012
• Est. Priority Date: 02/03/2005
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Timm, Mary Jo
• Primary Examiner(s): Lundgren, Jeffrey S.
• Assistant Examiner(s): BLAKELY III, NELSON CLARENCE
• Application Number:
  US11/050,217
• Publication Number:
  US 20060171982A1
• Time in Patent Office: 2,721 Days
• Field of Search: 427/2.25
• US Class Current: 427/2.25
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: B05D 1/40 Distributing applied liquids or other fluent materials by members moving relatively to surface

Abstract

A method is provided for altering a drug release profile of a coating of a medical device by increasing a surface area of the coating of the medical device. The method may include indenting the coating using a crimping apparatus, a rolling apparatus, or a clamping device. The method may alternatively or additionally include changing a chemical composition of at least one coating component to increase a roughness of a texture of the coating, and/or drying or partially drying the coating before the coating impacts the medical device.

Claims

1. A method for altering a drug release profile of a coating on a medical device, comprising:

providing a medical device with a drug eluting coating on the medical device;

providing a crimping apparatus adapted to indent the coating on the medical device; and

using the crimping apparatus to indent the coating on the medical device, thereby increasing the surface area of the coating of the medical device to obtain an altered drug release profile.

2. The method of claim 1, wherein the indenting of the coating comprises creating at least one of angular indentations, rounded dimples, curved impressions, and linear edge impressions.

3. The method of claim 1, wherein the indenting of the coating comprises creating at least one of random indentations and regularly patterned indentations.

4. The method of claim 1, further comprising, prior to indenting the coating, the steps of:

determining a surface area of the coating of the medical device; and

determining an increased surface area necessary to alter the drug release profile to the altered drug release profile;

wherein the step of indenting the coating increases the surface area of the coating to achieve the altered drug release profile.

5. The method of claim 1, wherein the crimping apparatus comprises a plurality of iris elements, each iris element adapted to indent the coating on the medical device.

6. The method of claim 1, wherein the medical device is a stent, and wherein the crimping apparatus is used to crimp the stent onto a balloon catheter.

7. A method for improving a drug release profile of a coating of a medical device, comprising:

determining an expected drug release profile of the coating of the medical device using first process parameters of a coating method;

determining an increased surface area necessary to obtain an improved drug release profile; and

altering the first process parameters to second process parameters of the coating method to achieve the increased surface area;

wherein the altering of the first process parameters to the second process parameters comprises changing a chemical composition of at least one coating component to increase a roughness of a texture of the coating.

8. A method for improving a drug release profile of a coating of a medical device, comprising:

determining an expected drug release profile of the coating of the medical device using first process parameters of a coating method;

determining an increased surface area necessary to obtain an improved drug release profile; and

altering the first process parameters to second process parameters of the coating method to achieve the increased surface area;

wherein the altering of the first process parameters to the second process parameters comprises one of drying and partially drying the coating before the coating strikes the medical device.

9. A method for altering a drug release profile of a coating on a medical device, comprising:

providing a medical device with a drug eluting coating on the medical device;

providing a rolling apparatus adapted to indent the coating on the medical device by causing the medical device to roll against at least one indenting surface; and

using the rolling apparatus to indent the coating on the medical device, thereby increasing the surface area of the coating of the medical device to obtain an altered drug release profile.

10. The method of claim 9, wherein the indenting of the coating comprises creating at least one of angular indentations, rounded dimples, curved impressions, and linear edge impressions.

11. The method of claim 9, wherein the indenting of the coating comprises creating at least one of random indentations and regularly patterned indentations.

12. The method of claim 9, further comprising, prior to indenting the coating, the steps of:

determining a surface area of the coating of the medical device; and

determining an increased surface area necessary to alter the drug release profile to the altered drug release profile;

wherein the step of indenting the coating increases the surface area of the coating to achieve the altered drug release profile.

13. The method of claim 9, wherein the rolling apparatus comprises at least one plate having at least one indenting surface adapted to indent the coating on the medical device.

14. The method of claim 13, wherein the medical device is rolled relative to the plate.

15. A method for altering a drug release profile of a coating on a medical device, comprising:

providing a medical device with a drug eluting coating on the medical device;

providing a clamping device adapted to indent the coating on the medical device; and

using the clamping device to indent the coating on the medical device, thereby increasing the surface area of the coating of the medical device to obtain an altered drug release profile.

16. The method of claim 15, wherein the indenting of the coating comprises creating at least one of angular indentations, rounded dimples, curved impressions, and linear edge impressions.

17. The method of claim 15, wherein the indenting of the coating comprises creating at least one of random indentations and regularly patterned indentations.

18. The method of claim 15, further comprising, prior to indenting the coating, the steps of:

determining a surface area of the coating of the medical device; and

determining an increased surface area necessary to alter the drug release profile to the altered drug release profile;

wherein the step of indenting the coating increases the surface area of the coating to achieve the altered drug release profile.

19. The method of claim 15, wherein the clamping device comprises an upper clamp section and a lower clamp section.

20. The method of claim 19, wherein the upper clamp section and the lower clamp section are connected by a hinge.