Balloon coating method and balloon rotating method

Patent metadata

Field	Value
Publication number	US-10022523-B2
Application number	US-201615136566-A
Country	US
Kind code	B2
Filing date	Apr 22, 2016
Priority date	Apr 23, 2015
Publication date	Jul 17, 2018
Grant date	Jul 17, 2018

Abstract

A balloon coating method for forming a coating layer containing a water-insoluble drug on an outer surface of a balloon of a balloon catheter includes: inserting a core member into a guide wire lumen penetrating the balloon, disposing a proximal portion of the core member on a proximal side of a region of inflation of the balloon, with a distal portion of the core member protruded distally beyond a distal opening portion of the guide wire lumen, and fixing by clamping together with the core member a part of the balloon catheter that is on a distal side of the region of inflation; and moving a dispensing tube for supplying a coating liquid containing the drug relative to the balloon in an axial direction of the balloon, while rotating the balloon about an axis of the balloon, thereby to apply the coating liquid to the outer surface of the balloon.

First claim

What is claimed is:

1. A balloon coating method for applying a coating layer containing a water-insoluble drug on an outer surface of a balloon of a balloon catheter, the balloon coating method comprising:
inserting a core member into a guide wire lumen penetrating the balloon so that a proximal portion of the core member is positioned proximally of a region of inflation of the balloon and so that a distal portion of the core member protrudes distally beyond a distal opening of the guide wire lumen;
fixing by clamping, together with the core member, a part of the balloon catheter that is distal of the region of inflation of the balloon; and
moving a dispensing tube relative to the balloon in an axial direction of the balloon while rotating the balloon about an axis of the balloon and while also dispensing the coating liquid containing the water-insoluble drug from the dispensing tube to apply the coating liquid to the outer surface of the balloon.

2. The balloon coating method according to claim 1 ,
wherein the balloon catheter is a rapid exchange type balloon catheter, and
the fixing of the balloon catheter includes fixing the balloon catheter while the proximal portion of the core member does not protrude from a proximal opening portion of the guide wire lumen and is located distal of the proximal opening portion.

3. The balloon coating method according to claim 1 , wherein the balloon catheter is an over the wire type balloon catheter, and the fixing of the balloon catheter includes fixing the balloon catheter while the proximal portion of the core member does not protrude from a proximal opening portion of the guide wire lumen and is located distal of the proximal opening portion.

4. The balloon coating method according to claim 1 , wherein the proximal portion of the core member is coincident with a proximal end of the balloon or is proximal of the proximal end of the balloon such that the proximal portion of the core member does not protrude from the proximal opening portion.

5. The balloon coating method according to claim 2 , wherein a distance between the proximal portion of the core member and the proximal opening portion is up to 50 mm.

6. The balloon coating method according to claim 1 , wherein a value obtained by subtracting an outside diameter of the core member from an inside diameter of the guide wire lumen is greater than 0 mm and not greater than 0.5 mm.

7. The balloon coating method according to claim 1 , wherein the guide wire lumen is located in a tube, the balloon possessing a distal portion joined in a fluid-tight manner to an outer circumferential surface of a portion of the tube, and the fixing including clamping the distal portion of the balloon that is joined in the fluid-tight manner to the outer circumferential surface of the portion of the tube.

8. The balloon coating method according to claim 1 , wherein the rotating of the balloon about the axis of the balloon includes rotating the balloon catheter by operation of two motors which both rotate the balloon catheter.

9. The balloon coating method according to claim 1 , wherein the rotating of the balloon about the axis of the balloon includes rotating the balloon catheter by operation of a first motor positioned at the distal end of the balloon catheter and a second motor positioned at the proximal end of the balloon catheter.

10. A balloon rotating method for rotating a balloon catheter, comprising:
inserting a core member into a guide wire lumen penetrating a balloon so that, a proximal portion of the core member is positioned proximally of a region of inflation of the balloon and so that a distal portion of the core member protrudes distally beyond a distal opening of the guide wire lumen;
fixing by clamping, together with the core member, a part of the balloon catheter that is distal of the region of inflation of the balloon; and
rotating the balloon about an axis of the balloon.

11. The balloon rotating method according to claim 10 ,
wherein the balloon catheter is a rapid exchange type balloon catheter, and
the fixing of the balloon catheter includes fixing the balloon catheter while the proximal portion of the core member does not protrude from a proximal opening portion of the guide wire lumen and is disposed distal of the proximal opening portion.

12. The balloon rotating method according to claim 10 , wherein a distance between the proximal portion of the core member and the proximal opening portion is up to 50 mm.

13. The balloon rotating method according to claim 10 , wherein a value obtained by subtracting an outside diameter of the core member from an inside diameter of the guide wire lumen is greater than 0 mm and not greater than 0.5 mm.

14. The balloon coating method according to claim 10 , wherein the guide wire lumen is located in a tube, the balloon possessing a distal portion joined in a fluid-tight manner to an outer circumferential surface of a portion of the tube, and the fixing including clamping the distal portion of the balloon that is joined in the fluid-tight manner to the outer circumferential surface of the portion of the tube.

15. The balloon coating method according to claim 10 , wherein the rotating of the balloon about the axis of the balloon includes rotating the balloon catheter by operation of two motors which both rotate the balloon catheter.

16. The balloon coating method according to claim 10 , wherein the rotating of the balloon about the axis of the balloon includes rotating the balloon catheter by operation of a first motor positioned at the distal end of the balloon catheter and a second motor positioned at the proximal end of the balloon catheter.

17. A balloon coating method for forming a coating layer containing a water-insoluble drug on an outer surface of a balloon of a balloon catheter, the balloon coating method comprising:
positioning the balloon of the balloon catheter adjacent a clamp, the balloon catheter comprising: a tubular shaft to which a proximal portion of the balloon is fixed at a proximal joined region in a fluid-tight manner; a tube to which a distal portion of the balloon is fixed at a distal joined region in a fluid-tight manner, the balloon including an inflatable region between the distal joined region and the proximal joined region; a guide wire lumen passing through a portion of the tubular shaft and through the balloon, the guide wire lumen possessing a distal open end and a proximal open end; a core member positioned in the guide wire lumen, the core member possessing a distal end protruding distally beyond the distal open end of the guide wire lumen and possessing a proximal end protruding proximally beyond the joined region;
clamping a part of the balloon catheter that is distal of the inflatable region and a part of the core member using the clamp; and
apply the coating liquid to the outer surface of the balloon by dispensing the coating liquid from an axially moving dispensing tube while rotating the balloon about an axis of the balloon.

18. The balloon coating method according to claim 17 , wherein the rotating of the balloon comprises rotating the clamp while the balloon is clamped by the clamp.

19. The balloon coating method according to claim 17 , wherein the rotating of the balloon comprises rotating the balloon catheter by operation of two motors which both rotate the balloon catheter.

20. The balloon coating method according to claim 17 , wherein the rotating of the balloon comprises rotating the balloon catheter by operation of a first motor positione

Assignees

• Terumo Corp

Inventors

• Gotou Hiroshi
• Kurosaki Yasuo
• FURUICHI Eisuke

Classifications

• B05D1/002

  the substrate being rotated · CPC title

• B05C13/02

  for particular articles · CPC title

• B05D1/26

  performed by applying the liquid or other fluent material from an outlet device in contact with, or almost in contact with, the surface · CPC title

• B05C5/0216

  by relative movement of article and outlet according to a predetermined path · CPC title

• A61M2025/105

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