Positioning method for balloon coating

Patent metadata

Field	Value
Publication number	US-9937328-B2
Application number	US-201615282563-A
Country	US
Kind code	B2
Filing date	Sep 30, 2016
Priority date	Apr 1, 2014
Publication date	Apr 10, 2018
Grant date	Apr 10, 2018

Abstract

A positioning method for balloon coating by which the thickness and morphological form of a drug in a coating formed on a balloon can be suitably set. This method is a positioning method for balloon coating for forming a coating layer containing a water-insoluble drug on an outer surface of a balloon of a balloon catheter. The positioning method includes a positioning step in which a dispensing tube is moved, from a state of non-contact with the balloon, in a direction intersecting the extending direction of the dispensing tube, and an opening portion-formed end portion side of the dispensing tube formed at its end portion with an opening portion for discharging a coating solution is thereby placed in contact with the outer surface of the balloon.

First claim

What is claimed is:

1. A positioning method for balloon coating for forming a coating layer containing a water-insoluble drug on an outer surface of a balloon of a balloon catheter, the positioning method comprising:
a positioning step in which a dispensing tube is moved, from a state of non-contact with the balloon, in a direction intersecting an extending direction of the dispensing tube, and an opening portion-formed end portion side of the dispensing tube formed at its end portion with an opening portion for discharging the coating solution is thereby placed in contact with the outer surface of the balloon.

2. The positioning method for balloon coating according to claim 1 , further comprising:
an application step in which the coating solution is discharged through the opening portion and applied to the outer surface of the balloon while the dispensing tube is moved relative to the balloon in an axial direction of the balloon.

3. The positioning method for balloon coating according to claim 2 , wherein in the positioning step, the dispensing tube is moved in the extending direction of the dispensing tube without making contact with the balloon, after which the dispensing tube is moved in the direction intersecting the extending direction of the dispensing tube, and the opening portion-formed end portion side of the dispensing tube is thereby placed in contact with the outer surface of the balloon.

4. The positioning method for balloon coating according to claim 1 , wherein in the positioning step, the dispensing tube is moved in the extending direction of the dispensing tube without making contact with the balloon, after which the dispensing tube is moved in the direction intersecting the extending direction of the dispensing tube, and the opening portion-formed end portion side of the dispensing tube is thereby placed in contact with the outer surface of the balloon.

5. The positioning method for balloon coating according to claim 1 , wherein the coating solution is discharged in a state where a continuous length of a side surface on the opening portion-formed end portion side of the dispensing tube is kept in contact with the outer surface of the balloon.

6. The positioning method for balloon coating according to claim 1 ,
wherein a plane which is perpendicular to the extending direction of the dispensing tube in a state of non-contact with the balloon and which passes through an axis of the balloon is defined as a reference plane, and
in the contact step, the dispensing tube is positioned relative to the balloon in such a manner that a virtual position at which the opening portion would be located if the dispensing tube is assumed to be non-flexible is located at a position deviated from the reference plane toward the balloon rotating direction side by an angle within the range of 0 degrees to 40 degrees, with the axis of the balloon as the vertex of the angle, in a region extending from the reference plane in a direction opposite to a discharge direction of the dispensing tube.

7. The positioning method for balloon coating according to claim 1 , wherein in the contact step, the dispensing tube, which is flexible, is pressed against the outer surface of the balloon while being bent.

8. The positioning method for balloon coating according to claim 1 , wherein the water-insoluble drug is rapamycin, paclitaxel, docetaxel, or everolimus.

9. A balloon of a balloon catheter, the balloon coated according to the positioning method for balloon coating of claim 1 .

10. The method according to claim 1 , wherein the dispensing tube has a length of up to five times a diameter of the balloon.

11. A positioning method for balloon coating for forming a coating layer containing a water-insoluble drug on an outer surface of a balloon of a balloon catheter, the positioning method comprising:
moving a dispensing tube from a state of non-contact with the balloon, in a direction intersecting an extending direction of the dispensing tube; and
placing an opening portion-formed end portion side of the dispensing tube formed at an end portion of dispensing tube with an opening portion for discharging the coating solution in contact with the outer surface of the balloon.

12. The positioning method for balloon coating according to claim 11 , comprising:
discharging the coating solution is discharged through the opening portion and applied to the outer surface of the balloon while the dispensing tube is moved relative to the balloon in an axial direction of the balloon.

13. The positioning method for balloon coating according to claim 11 , comprising:
moving the dispensing tube in the extending direction of the dispensing tube without making contact with the balloon, after which the dispensing tube is moved in the direction intersecting the extending direction of the dispensing tube, and the opening portion-formed end portion side of the dispensing tube is thereby placed in contact with the outer surface of the balloon.

14. The positioning method for balloon coating according to claim 12 , comprising:
moving the dispensing tube in the extending direction of the dispensing tube without making contact with the balloon, after which the dispensing tube is moved in the direction intersecting the extending direction of the dispensing tube, and the opening portion-formed end portion side of the dispensing tube is thereby placed in contact with the outer surface of the balloon.

15. The positioning method for balloon coating according to claim 11 , comprising:
discharging the coating solution in a state where a continuous length of a side surface on the opening portion-formed end portion side of the dispensing tube is kept in contact with the outer surface of the balloon.

16. The positioning method for balloon coating according to claim 11 ,
wherein a plane which is perpendicular to the extending direction of the dispensing tube in a state of non-contact with the balloon and which passes through an axis of the balloon is defined as a reference plane, and
the dispensing tube is positioned relative to the balloon in such a manner that a virtual position at which the opening portion would be located if the dispensing tube is assumed to be non-flexible is located at a position deviated from the reference plane toward the balloon rotating direction side by an angle within the range of 0 degrees to 40 degrees, with the axis of the balloon as the vertex of the angle, in a region extending from the reference plane in a direction opposite to a discharge direction of the dispensing tube.

17. The positioning method for balloon coating according to claim 11 , comprising:
pressing the dispensing tube against the outer surface of the balloon while being bent.

18. The positioning method for balloon coating according to claim 17 , wherein the dispensing tube is flexible.

19. The positioning method for balloon coating according to claim 11 , wherein the water-insoluble drug is rapamycin, paclitaxel, docetaxel, or everolimus.

20. The method according to claim 11 , wherein the dispensing tube has a length of up to five times a diameter of the balloon.

Assignees

• Terumo Corp

Inventors

• Kurosaki Yasuo
• Suzuki Ryosuke
• FURUICHI Eisuke

Classifications

• A61M2025/1031

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

• B05C13/025

  relatively small cylindrical objects, e.g. cans, bottles · CPC title

• A61M2025/105

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

• B05B13/0442

  Installation or apparatus for applying liquid or other fluent material to separate articles rotated during spraying operation · CPC title

• A61M25/10 Primary

  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