METHODS AND APPARATUSES FOR COATING BALLOON CATHETERS

• US 20100055294A1
• Filed: 08/27/2009
• Published: 03/04/2010
• 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, Lixiao, Wahr, Dennis W., Barry, Christopher M., Naisbitt, Scott, WANG, Jeffrey, Malinoff, Harrison
• Granted Patent: US 8,430,055 B2
• Time in Patent Office: Days
• US Class Current: 427/2.250
• 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

Embodiments of the invention relate to a method and apparatus for coating a medical device. 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 uniform coated medical device, comprising:

(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 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 according to claim 1, wherein the medical device is chosen from a balloon catheter, a perfusion balloon catheter, an infusion catheter such as a distal perforated drug infusion tube, 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.

3. The method according to claim 1, wherein the metering dispenser comprises at least one of a syringe, a syringe pump, a metering pipette, and an automatic metering system.

4. The method according to claim 1, wherein steps (2), (3), (4) and (5) occur concomitantly.

5. The method according to claim 1, wherein steps (2), (3), (4) and (5) are repeated until a therapeutically effective amount of the therapeutic agent in the coating is deposited on the surface of the medical device.

6. The method according to claim 1, wherein the total thickness of the coating layer is from about 0.1 to 200 microns.

7. The method according to claim 1, wherein the concentration of the therapeutic agent in the coating layer is from 1 to 20 μ

g/mm².

8. The method according to claim 1, wherein the method further comprises (6) drying the medical device, (7) sterilizing the medical device, and (8) drying the medical device after sterilization.

9. The method according to claim 8, wherein in step (7) the medical device is sterilized with ethylene oxide, and wherein in step (8) the medical device is dried under vacuum at about 0 to 100°

C. for approximately 2 to 56 hours.

27. The method according to claims 1, 10, or 26, wherein the medical device or a portion thereof has a continuous surface.

28. The method according to claim 1 or 10, wherein in step (5), the solvent is evaporated while the coating solution is moving at uniform speed, forming a substantially uniform dry coating layer over the surface of the medical device.

10. A method for preparing a substantially uniform coated balloon catheter, the method comprising:

(1) preparing a coating solution comprising a solvent, a therapeutic agent, and an additive;

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

(3) inflating the balloon catheter to a low pressure and rotating the balloon catheter about the longitudinal axis of the catheter and/or moving the balloon catheter in a linear direction along the longitudinal or transverse axis of the catheter;

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

(5) evaporating the solvent, forming a substantially uniform coating layer on the balloon catheter;

(6) folding and wrapping the balloon catheter; and

(7) drying and then sterilizing the balloon catheter.

11. The method according to claim 10, wherein the metering dispenser comprises at least one of a syringe, a syringe pump, a metering pipette, and an automatic metering system.

12. The method according to claim 10, wherein steps (2), (3), (4) and (5) occur concomitantly.

13. The method according to claim 10, wherein the metering dispenser comprises a dispensing tip, wherein the dispensing tip includes a tip and a flexible tail, and wherein in step (4) the method further comprises dispensing the coating solution from the metering dispenser to the flexible tail and flowing the coating solution from the flexible tail onto the surface of the medical device while the medical device is rotating and/or linearly moving.

14. The method according to claims 13, wherein the diameter of the opening of the dispensing tip ranges from 0.05 mm to 2 mm;

the length of the dispensing tip ranges from 5 mm to 30 mm; and

the length of the flexible tail ranges from 5 mm to 30 mm.

15. The method according to claim 10, wherein steps (2), (3), (4) and (5) are repeated until a therapeutically effective amount of the therapeutic agent in the coating is deposited on the surface of the medical device.

16. The method according to claim 10, wherein the total thickness of the coating layer is from about 0.1 to 200 microns.

17. The method according to claim 10, wherein the concentration of the therapeutic agent in the coating layer is from 1 to 20 μ

g/mm².

18. The method according to claim 10, wherein the balloon catheter is chosen from an over-the-wire and rapid exchange catheter, wherein the balloon catheter has a diameter from 1 mm to 40 mm, wherein the balloon catheter has a length from 5 mm to 300 mm, and wherein the balloon catheter includes 0.014-inch, 0.018-inch and 0.035-inch wire compatible lumen.

19. The method according to claim 10, wherein the method further comprises (8) drying the medical device after sterilization.

20. The method according to claim 19, wherein the balloon catheter is sterilized with ethylene oxide, and wherein in step (8) the balloon catheter is dried under vacuum at about 0 to 100°

C. for approximately 2 to 56 hours.

21. An apparatus for dispensing a coating solution on the surface of a medical device, the apparatus comprising:

a metering dispenser;

a coating solution storage container connected to the metering dispenser;

an apparatus that rotates a medical device around its longitudinal axis and moves the medical device back and forth in the direction of its longitudinal or transverse axis; and

a controller coordinating the metering dispenser and the apparatus.

22. The apparatus according to claim 21, wherein the metering dispenser comprises at least one of a syringe, a syringe pump, a metering pipette, and an automatic metering system.

23. The apparatus according to claim 21, wherein the apparatus concurrently rotates the medical device around its longitudinal axis at uniform tangential speed and translocates the device back and forth in a longitudinal direction at uniform frequency.

24. The apparatus according to claim 21, further comprising a dispensing tip connected to the metering dispenser, wherein the dispensing tip comprises a flexible tail connected to the tip.

25. The method according to claims 24, wherein the diameter of the opening of the tip is from 0.05 mm to 2 mm and the length of the tip is from 5 mm to 30 mm.

26. A method for preparing a substantially uniform coated medical device, comprising:

(1) preparing a first coating solution comprising a solvent, a therapeutic agent, and an additive;

(2) loading a metering dispenser with an amount of the first 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 device;

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

(5) evaporating the solvent, forming a substantially uniform first coating layer, and (6) repeating steps of (1), (2), (3), (4) and (5) with a second coating solution, which is the same or different from the first coating solution until a desired number of coating layers are obtained.

29. The method according to claim 26, wherein the method further comprises (7) sterilizing the medical device, and (8) drying the medical device after sterilization.

30. The method according to claim 29, wherein in step (7) the medical device is sterilized with ethylene oxide, and wherein in step (8) the medical device is dried under vacuum at about 0 to 100°

C. for approximately 2 to 56 hours.

31. A method for preparing a substantially uniform coating for medical device, the method comprising:

(1) preparing a coating solution comprising a solvent, a therapeutic agent, and an additive;

(2) applying the coating solution to a medical device;

(3) drying the coating solution, forming a coating layer;

(4) sterilizing the medical device; and

(5) drying the medical device after sterilization.

32. The method according to claim 31, wherein the medical device is a balloon catheter.

33. The method according to claim 31, wherein in step (5), the medical device is dried under vacuum at about 0 to 100°

C. for approximately 2 to 56 hours.