Methods and apparatuses for coating balloon catheters

• US 9,770,576 B2
• Filed: 11/04/2015
• Issued: 09/26/2017
• Est. Priority Date: 08/29/2008
• Status: Active Grant

• Current Assignee: Lutonix, Inc. (Becton, Dickinson & Co)
• Original Assignee: Lutonix, Inc. (Becton, Dickinson & Co)
• Inventors: Wang, Jeffrey, Malinoff, Harrison, Wang, Lixiao, Barry, Christopher M., Wahr, Dennis W., Naisbitt, Scott R.
• Primary Examiner(s): Yuan, Dah-Wei D
• Assistant Examiner(s): Hernandez-Diaz, Jose
• Application Number:
  US14/932,033
• Publication Number:
  US 20160067462A1
• Time in Patent Office: 692 Days
• Field of Search: 427 21, 427 225, 427 231, 427 224, 427 23
• CPC Class Codes: A61M 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1088 having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 25/1038 Wrapping or folding devices for use with balloon catheters
• CPC Class Codes: B05D 1/002 the substrate being rotated
• 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 3/0493 using vacuum
• CPC Class Codes: B05D 3/107 Post-treatment of applied coatings
• CPC Class Codes: B05D 5/00 Processes for applying liquids or other fluent materials to surfaces to obtain special surface effects, finishes or structures

Abstract

Methods and apparatus for coating a medical device are provided. In one embodiment, the method for preparing a substantially uniform coated medical device includes (1) preparing a coating solution comprising a solvent, a therapeutic agent, and an additive; (2) loading a metering dispenser with the coating solution; (3) rotating the medical device about the longitudinal axis of the device and/or moving the medical device along the longitudinal or transverse axis of the device; (4) dispensing the coating solution from the metering dispenser onto a surface of the medical device and flowing the coating solution on the surface of the medical device while the medical device is rotating and/or linearly moving; and (5) evaporating the solvent, forming a substantially uniform coating layer on the medical device.

Claims

1. A method for preparing a substantially uniformly coated medical device, comprising:

(1) preparing a coating solution consisting of a solvent, a therapeutic agent, and an additive, wherein;

the therapeutic agent is chosen from paclitaxel, rapamycin, daunorubicin, doxorubicin, lapachone, vitamin D2, vitamin D3, and combinations thereof;

the solvent is chosen from water, methanol, ethanol, isopropanol, acetone, dimethylformamide, tetrahydrofuran, methylethyl ketone, dimethylsulfoxide, acetonitrile, ethyl acetate, chloroform, and mixtures thereof; and

the additive is chosen from sorbitol, octanoyl-N-methylglucamide, gluconolactone, lactobionic acid, a poly(ethylene glycol) sorbitan fatty ester, or a combination thereof;

(2) loading a metering dispenser with the coating solution;

(3) rotating the medical device about the longitudinal axis of the medical device and/or moving the medical device in a linear direction along the longitudinal or transverse axis of the medical device;

(4) dispensing the coating solution from the metering dispenser onto a surface of the medical device and flowing the coating solution on the surface of the medical device while the medical device is rotating and/or linearly moving; and

(5) evaporating the solvent, forming a substantially uniform coating layer on the medical device.

2. The method of claim 1, wherein the method further comprises:

(6) sterilizing the medical device; and

(7) drying the medical device after sterilization.

3. The method of claim 1, wherein the medical device is chosen from a balloon catheter, a perfusion balloon catheter, an infusion catheter, a perforated balloon, a spaced double balloon, a porous balloon, a weeping balloon, a cutting balloon catheter, a scoring balloon catheter, a laser catheter, an atherectomy device, a debulking catheter, a stent, a filter, a stent graft, a covered stent, a patch, a wire, and a valve.

4. The method of claim 1, wherein the medical device is chosen from a balloon catheter, a perfusion balloon catheter, a perforated balloon, a spaced double balloon, a porous balloon, a weeping balloon, a cutting balloon catheter, or a scoring balloon catheter.

5. The method of claim 1, wherein the medical device is a balloon catheter.

6. The method of claim 1, wherein at least steps (4) and (5) are repeated until the from 1 μ

g/mm² to 20 μ

g/mm² of the therapeutic agent in the coating is deposited on the surface of the medical device.

7. The method of claim 1, wherein in step (7) the medical device is dried under vacuum at from 5°

C. to 60°

C. for about 1 hour to 120 hours.

8. The method of claim 1, wherein in step (7) the medical device is dried under vacuum at from 5°

C. to 45°

C. for about 2 hours to 56 hours.

9. The method of claim 1, wherein:

the therapeutic agent comprises paclitaxel;

the solvent is chosen from mixtures of water and ethanol, mixtures of water and acetone, mixtures of water and methanol, and mixtures of water and ethanol and acetone; and

the additive comprises poly(ethylene glycol)-20 sorbitan monolaurate.

10. The method of claim 9, wherein the medical device is chosen from a balloon catheter, a perfusion balloon catheter, a perforated balloon, a spaced double balloon, a porous balloon, a weeping balloon, a cutting balloon catheter, or a scoring balloon catheter.

11. The method of claim 9, wherein the medical device is a balloon catheter.

12. The method of claim 1, wherein:

the therapeutic agent comprises paclitaxel;

the solvent is chosen from mixtures of water and ethanol, mixtures of water and acetone, mixtures of water and methanol, and mixtures of water and ethanol and acetone; and

the additive comprises sorbitol.

13. The method of claim 12, wherein the medical device is chosen from a balloon catheter, a perfusion balloon catheter, a perforated balloon, a spaced double balloon, a porous balloon, a weeping balloon, a cutting balloon catheter, or a scoring balloon catheter.

14. The method of claim 12, wherein the medical device is a balloon catheter.

15. The method of claim 1, wherein:

the therapeutic agent comprises paclitaxel;

the solvent is chosen from mixtures of water and ethanol, mixtures of water and acetone, mixtures of water and methanol, and mixtures of water and ethanol and acetone; and

the additive comprises a mixture of poly(ethylene glycol)-20 sorbitan monolaurate and sorbitol.

16. The method of claim 15, wherein the medical device is chosen from a balloon catheter, a perfusion balloon catheter, a perforated balloon, a spaced double balloon, a porous balloon, a weeping balloon, a cutting balloon catheter, or a scoring balloon catheter.

17. The method of claim 15, wherein the medical device is a balloon catheter.

18. The method of claim 1, wherein:

the therapeutic agent comprises paclitaxel;

the solvent is chosen from mixtures of water and ethanol, mixtures of water and acetone, mixtures of water and methanol, and mixtures of water and ethanol and acetone; and

the additive comprises gluconolactone.

19. The method of claim 18, wherein the medical device is chosen from a balloon catheter, a perfusion balloon catheter, a perforated balloon, a spaced double balloon, a porous balloon, a weeping balloon, a cutting balloon catheter, or a scoring balloon catheter.

20. The method of claim 18, wherein the medical device is a balloon catheter.