Methods and apparatuses for coating balloon catheters

• US 8,430,055 B2
• Filed: 08/27/2009
• Issued: 04/30/2013
• Est. Priority Date: 08/29/2008
• Status: Active Grant

• Current Assignee: Lutonix, Inc. (Becton, Dickinson & Co)
• Original Assignee: Lutonix, Inc. (Becton, Dickinson & Co)
• Inventors: Malinoff, Harrison, Wang, Lixiao, Wahr, Dennis W., Naisbitt, Scott R., Barry, Christopher M., Wang, Jeffrey
• Primary Examiner(s): TADESSE, YEWEBDAR T
• Application Number:
  US12/549,180
• Publication Number:
  US 20100055294A1
• Time in Patent Office: 1,342 Days
• Field of Search: 118/320, 118/665, 118/261, 118/203, 118/249, 118/246, 118/305, 118/307, 118/321, 118/323, 118679-682, 118/686, 118/687, 118/697, 427/2.24, 427/2.25, 427/2.21, 427/2.28, 427/2.1, 427/2.3, 427/426, 623 142- 146
• US Class Current: 118/261
• 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. An apparatus for dispensing a coating solution onto a surface of a balloon of a balloon catheter, the balloon catheter having a longitudinal axis that defines a longitudinal direction along the longitudinal axis, the apparatus comprising:

a metering dispenser connected to a dispensing tip that dispenses the coating solution onto the surface of the balloon by contact or non-contact;

a coating solution storage container that supplies the coating solution to the metering dispenser;

a movement assembly that rotates the balloon catheter about the longitudinal axis and translocates the balloon catheter, the dispensing tip, or both back and forth in the longitudinal direction; and

a controller that coordinates the dispensing of the coating solution through the metering dispenser with the rotation and translocation of the balloon catheter by the movement assembly,

wherein;

the dispensing tip comprises a hub portion connected to the metering dispenser and a tip portion connected to the hub portion;

the tip portion comprises a tip opening through which the coating solution is dispensed; and

the dispensing tip further comprises a flexible tail connected to the tip portion, such that coating solution flows from the tip opening along the flexible tail to the surface of the balloon.

2. The apparatus 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.

3. The apparatus according to claim 1, wherein the movement assembly concurrently rotates the balloon catheter about the longitudinal axis at a uniform tangential speed and translocates the balloon catheter, the dispensing tip, or both back and forth in the longitudinal direction at a uniform frequency.

4. The apparatus according to claim 1, wherein the movement assembly concurrently rotates the balloon catheter about the longitudinal axis and translocates only the dispensing tip back and forth in the longitudinal direction.

5. The apparatus according to claim 1, wherein the movement assembly concurrently rotates the balloon catheter about the longitudinal axis and translocates only the balloon catheter back and forth in the longitudinal direction.

6. The apparatus according to claim 1, wherein the movement assembly concurrently rotates the balloon catheter about the longitudinal axis and translocates both the balloon catheter and the dispensing tip back and forth in the longitudinal direction.

7. The apparatus according to claim 1, wherein the diameter of the tip opening is from 0.05 mm to 2 mm and the length of the dispensing tip is from 5 mm to 30 mm.

8. The apparatus according to claim 1, wherein the flexible tail contacts the surface of the balloon when the coating solution is dispensed to the surface of the balloon.

9. The apparatus according to claim 1, wherein the flexible tail is attached to an outer side of the tip portion of the dispensing tip.

10. The apparatus according to claim 1, wherein the flexible tail is threaded through the tip opening of the tip portion.

11. The apparatus according to claim 1, wherein the balloon is selected from the group consisting of a perforated balloon, a porous balloon, a spaced double balloon, and a weeping balloon.

12. The apparatus according to claim 1, wherein the balloon catheter is selected from the group consisting of a perfusion balloon catheter, a cutting balloon catheter, and a scoring balloon catheter.