Balloon coating method and balloon coating apparatus

Patent metadata

Field	Value
Publication number	US-10610673-B2
Application number	US-201815975031-A
Country	US
Kind code	B2
Filing date	May 9, 2018
Priority date	Dec 21, 2013
Publication date	Apr 7, 2020
Grant date	Apr 7, 2020

Abstract

A balloon coating method and apparatus are disclosed which can perform coating while freely controlling, for example, the thickness of a coating layer and/or the morphological form of a drug. The method includes pulling a distal tip of the balloon in an axial direction of the balloon to straighten a bend of the balloon; rotating the balloon about an axis of the balloon; and coating the outer surface of the balloon with a coating liquid.

First claim

What is claimed is:

1. A method for forming a coating layer on an outer surface of a balloon of a balloon catheter, the method comprising:
pulling a distal tip of the balloon in an axial direction of the balloon to straighten a bend of the balloon;
rotating the balloon about an axis of the balloon;
rotating a member for applying the pulling force to the balloon at a same rotational speed as that of the balloon, by a second rotating mechanism different from a first rotating mechanism for rotating the balloon; and
coating the outer surface of the balloon with a coating liquid.

2. The method according to claim 1 , comprising:
maintaining the balloon in a bend-straightened state during the coating of the outer surface of the balloon.

3. The method according to claim 1 , comprising:
controlling a pulling force on the balloon according to the balloon.

4. The method according to claim 1 , wherein a length of the balloon of the balloon catheter is not less than 100 mm.

5. The method according to claim 1 , wherein the balloon of the balloon catheter is made of one or more of the following:
polyethylene, polypropylene, polybutene, ethylene-propylene copolymers, ethylene-vinyl acetate copolymers, ionomers, flexible polyvinyl chloride resin, polyamides, polyamide elastomers, polyesters, polyester elastomers, polyurethanes, fluororesins, silicone rubbers, and/or latex rubber.

6. The method according to claim 1 , wherein the balloon catheter includes a catheter main body, the catheter main body including an outer tube, an inner tube, and an inflation lumen located between the outer tube and the inner tube, and wherein the balloon is located at a distal portion of the catheter main body.

7. The method according to claim 1 , wherein an inner core member of the balloon is not pulled during the pulling of the distal tip of the balloon in the axial direction of the balloon.

8. The method according to claim 1 , wherein in the pulling step, the balloon is straightened such that a deflection amount of the balloon is not more than 0.5 mm.

9. A method for forming a coating layer on an outer surface of a balloon of a balloon catheter, the method comprising:
pulling a distal tip of the balloon in an axial direction of the balloon to straighten a bend of the balloon, wherein the pulling of the distal tip of the balloon in the axial direction of the balloon comprises:
clamping the distal tip of the balloon with a chuck, wherein the chuck is a mechanical chuck, a magnetic chuck, or a vacuum chuck;

rotating the balloon about an axis of the balloon; and
coating the outer surface of the balloon with a coating liquid.

10. The method according to claim 9 , wherein the clamping of the distal tip of the balloon with the chuck further comprises:
clamping the balloon from a radially outer side.

11. A method for forming a coating layer on an outer surface of a balloon of a balloon catheter, the method comprising:
clamping a distal-side end portion of the balloon in a balloon coating apparatus;
pulling the distal-end side portion of the balloon in an axial direction of the balloon to straighten a bend of the balloon;
rotating the balloon about an axis of the balloon;
maintaining the balloon in a bend-straightened state; and
coating the outer surface of the balloon with a coating liquid.

12. The method according to claim 11 , comprising:
controlling a pulling force on the balloon according to the balloon and the pulling force to straighten the bend of the balloon.

13. The method according to claim 11 , comprising:
rotating a member for applying the pulling force to the balloon at a same rotational speed as that of the balloon, by a second rotating mechanism different from a first rotating mechanism for rotating the balloon.

14. An apparatus for forming a coating layer on an outer surface of a balloon of a balloon catheter, the apparatus comprising:
a first rotating mechanism configured to rotate the balloon about an axis of the balloon;
a pulling mechanism configured to pull a distal tip of the balloon in an axial direction of the balloon, with the balloon maintained in a rotatable state;
a second rotating mechanism configured to rotate the pulling mechanism at a same rotational speed as that of the balloon; and
a coating mechanism configured to coat the outer surface of the balloon with a coating liquid.

15. The apparatus according to claim 14 , wherein the pulling mechanism is configured to arbitrarily control the pulling force.

16. The apparatus according to claim 14 , wherein the pulling mechanism includes an elastic member configured to apply the pulling force to the balloon.

17. The apparatus according to claim 14 , wherein a length of the balloon of the balloon catheter is not less than 100 mm.

18. The apparatus according to claim 14 , wherein the balloon of the balloon catheter is made of one or more of the following:
polyethylene, polypropylene, polybutene, ethylene-propylene copolymers, ethylene-vinyl acetate copolymers, ionomers, flexible polyvinyl chloride resin, polyamides, polyamide elastomers, polyesters, polyester elastomers, polyurethanes, fluororesins, silicone rubbers, and/or latex rubber.

19. The apparatus according to claim 14 , further comprising: the balloon catheter, the balloon catheter including a catheter main body, the catheter main body including an outer tube, an inner tube, and an inflation lumen located between the outer tube and the inner tube, and wherein the balloon is located at a distal portion of the catheter main body, and wherein a length of the balloon of the balloon catheter is not less than 100 mm.

20. The apparatus according to claim 14 , wherein a deflection amount of the balloon is not more than 0.5 mm during the pulling of the distal tip of the balloon in the axial direction of the balloon.

Assignees

• Terumo Corp

Inventors

• Goto Hiroshi
• FURUICHI Eisuke
• Kurosaki Yasuo

Classifications

• A61M2025/105

  having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes · CPC title

• A61M25/10

  Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00}) · CPC title

• A61M25/1029 Primary

  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 title

• A61M2025/1031

  Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface · CPC title

• B05B12/00

  Arrangements for controlling delivery; Arrangements for controlling the spray area · CPC title