Methods and apparatuses for coating balloon catheters

• US 9,180,485 B2
• Filed: 03/18/2013
• Issued: 11/10/2015
• 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:
  US13/846,358
• Publication Number:
  US 20130209662A1
• Time in Patent Office: 967 Days
• US Class Current: 1/1
• 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 uniform coated balloon catheter and increasing adhesion of a coating layer on the coated balloon catheter, the method 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, dimethylformide, 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) inflating the balloon catheter to 0 to 3 atm 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;

(7) drying the balloon catheter after the solvent is evaporated and then sterilizing the balloon catheter with ethylene oxide; and

(8) drying the sterilized balloon catheter under vacuum at about 0°

C. to 100°

C. for 2 hours to 56 hours, wherein adhesion of the substantially uniform coating layer to the balloon catheter is increased by the vacuum drying after the sterilization.

2. The method of 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 method of claim 1, 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.

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

5. The method of claim 1, wherein the concentration of the therapeutic agent in the coating layer is from 1 μ

g/mm² to 20 μ

g/mm².

6. The method of claim 1, wherein:

step (6) further comprises deflating the balloon catheter before folding and wrapping the balloon catheter and packaging the balloon catheter after folding and wrapping the balloon catheter;

step (7) comprises sterilizing the packaged balloon catheter; and

step (8) comprises drying the packaged balloon catheter after the packaged balloon catheter is sterilized.

7. The method of claim 1, wherein in step (8) the balloon catheter is dried under vacuum at about 5°

C. to 45°

C. for about 2 hours to 56 hours.

8. The method of claim 1, 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, dimethylformide, tetrahydrofuran, methylethyl ketone, dimethylsulfoxide, acetonitrile, ethyl acetate, chloroform, and mixtures thereof; and

the additive comprises octanoyl-N-methylglucamide, gluconolactone, lactobionic acid, a poly(ethylene glycol) sorbitan fatty ester, or a combination thereof.

9. The method of claim 1, wherein:

the therapeutic agent comprises paclitaxel;

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

the additive comprises gluconolactone, lactobionic acid, poly(ethylene glycol)-20 sorbitan monolaurate, or a combination thereof.

10. 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;

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

11. A method for preparing a substantially uniform coated balloon catheter and increasing adhesion of a coating layer on the coated balloon catheter, the method comprising:

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

the therapeutic agent comprises paclitaxel;

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

the additive is chosen from sorbitol, gluconolactone, lactobionic acid, poly(ethylene glycol)-20 sorbitan monolaurate, or a combination thereof;

the content of the additive in the coating solution is from 1% to 15% by weight based on the total weight of the coating solution;

the total content of the therapeutic agent and the additive in the solvent is from 2% to 20% by weight based on the total weight of the coating solution;

(2) loading a metering dispenser with the coating solution, the metering dispenser comprising a dispensing tip having a tip and a flexible tail;

(3) inflating the balloon catheter to 0 to 3 atm 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 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;

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

(6) drying the balloon catheter after the solvent is evaporated, then folding the balloon catheter, then wrapping the balloon catheter, and then packaging the balloon catheter;

(7) sterilizing the packaged balloon catheter with ethylene oxide; and

(8) drying the sterilized balloon catheter under vacuum at about 5°

C. to 45°

C. for 2 hours to 56 hours, wherein adhesion of the substantially uniform coating layer to the balloon catheter is increased by the drying under vacuum after the sterilizing.

12. The method of claim 11, wherein the additive comprises poly(ethylene glycol)-20 sorbitan monolaurate.