Balloon coating method and balloon coating apparatus

Patent metadata

Field	Value
Publication number	US-2016296969-A1
Application number	US-201615188192-A
Country	US
Kind code	A1
Filing date	Jun 21, 2016
Priority date	Dec 21, 2013
Publication date	Oct 13, 2016
Grant date	—

Abstract

A balloon coating method and a balloon coating apparatus are disclosed by which the thickness and/or morphological form of a drug in a coating formed on a balloon can be appropriately set. The balloon coating method can include moving a coating section for applying a coating liquid containing a drug relative to the balloon in the direction of an axis, while rotating the balloon about the axis of the balloon, thereby to apply the coating liquid to an outer surface of the balloon; detecting the distance of a dried part where the coating liquid applied to the outer surface of the balloon has been dried from the coating section; and controlling moving velocity of the coating section relative to the balloon in such a manner that the distance of the dried part from the coating section is maintained at a preliminarily set designated distance.

First claim

What is claimed is:

1 . A balloon coating method for forming a coating layer on an outer surface of a balloon of a balloon catheter, the method comprising:
a coating step of moving a coating section relative to the balloon in an axial direction for applying a coating liquid containing a drug, while rotating the balloon about an axis of the balloon, thereby to apply the coating liquid to an outer surface of the balloon; a detection step of detecting a distance of a dried part where the coating liquid applied to the outer surface of the balloon has been dried from the coating section; and a control step of controlling a moving velocity of the coating section relative to the balloon in such a manner that the distance of the dried part from the coating section is maintained at a preliminarily set designated distance.

2 . The balloon coating method according to claim 1 , wherein in the control step, a rotational speed of the balloon and a quantity of the coating liquid ejected from the coating section per unit time are controlled according to variation in moving velocity of the coating section in such a manner that the quantity of the coating liquid applied to the balloon surface per unit time is equal to a preliminarily set value.

3 . The balloon coating method according to claim 1 , wherein in the control step, a rotational speed of the balloon is controlled in such a manner that the rotational speed will be equal to a value obtained by dividing a changed moving velocity of the coating section by a coating width along the axial direction by which the coating liquid is applied at a time by the coating section.

4 . The balloon coating method according to claim 1 , wherein in the detection step, a position of the dried part on the outer surface of the balloon is detected from a radially outer side of the balloon.

5 . The balloon coating method according to claim 1 , wherein in the detection step, a position of the dried part on the outer surface of the balloon is detected from a radially outer side of the balloon by use of a detection section moved together with the coating section.

6 . The balloon coating method according to claim 1 ,
wherein in the detection step, detection of the undried part where the coating liquid has not yet been dried is performed on a side nearer to the coating section than a reference position spaced by a designated distance from the coating section, by a first detection section moved together with the coating section, whereas detection of the dried part is performed on a side farther from the coating section than the reference position, by a second detection section moved together with the coating section; and in the control step, the moving velocity of the coating section is not changed in a case where the undried part is detected by the first detection section and the dried part is detected by the second detection section, the moving velocity of the coating section is increased in a case where the undried part is not detected by the first detection section, and the moving velocity of the coating section is lowered in a case where the dried part is not detected by the second detection section.

7 . The balloon coating method according to claim 1 , wherein in the detection step, a control is conducted such that the width along the axial direction of the undried part detected by a first detection section is in a range of 2 mm to 20 mm.

8 . The balloon coating method according to claim 1 , wherein in the detection step, a control is conducted such that the length from an allowable upper limit to an allowable lower limit of the width along the axial direction of the undried part detected by a first detection section is not more than 12 mm during a period from start of coating to end of coating.

9 . The balloon coating method according to claim 1 , comprising:
using a sensor for detecting transmittance of light as the detection section.

10 . The balloon coating method according to claim 1 , comprising:
using a color difference meter as the detection section.

11 . A balloon coating method for forming a coating layer on an outer surface of a balloon of a balloon catheter, the method comprising:
rotating the balloon about an axis of the balloon; applying a coating liquid containing a drug to an outer surface of the balloon by moving a coating section relative to the balloon in an axial direction; detecting a distance of a dried part where the coating liquid applied to the outer surface of the balloon has been dried from the coating section; and controlling a moving velocity of the coating section relative to the balloon and maintaining the distance of the dried part from the coating section at a preliminarily set designated distance.

12 . The balloon coating method according to claim 11 , comprising:
controlling a rotational speed of the balloon and a quantity of the coating liquid ejected from the coating section per unit time according to variation in moving velocity of the coating section in such a manner that the quantity of the coating liquid applied to the balloon surface per unit time is equal to a preliminarily set value.

13 . The balloon coating method according to claim 11 , comprising:
controlling a rotational speed of the balloon such that the rotational speed is equal to a value obtained by dividing a changed moving velocity of the coating section by a coating width along the axial direction by which the coating liquid is applied at a time by the coating section.

14 . The balloon coating method according to claim 11 , comprising:
detecting a position of the dried part on the outer surface of the balloon from a radially outer side of the balloon.

15 . The balloon coating method according to claim 11 , comprising:
detecting a position of the dried part on the outer surface of the balloon from a radially outer side of the balloon by use of a detection section moved together with the coating section.

16 . The balloon coating method according to claim 11 , comprising:
detecting the undried part where the coating liquid has not yet been dried on a side nearer to the coating section than a reference position spaced by a designated distance from the coating section, by a first detection section moved together with the coating section; detecting the dried part on a side farther from the coating section than the reference position, by a second detection section moved together with the coating section; and detecting the moving velocity of the coating section is not changed in a case where the undried part is detected by the first detection section and the dried part is detected by the second detection section, increasing the moving velocity of the coating section when the undried part is not detected by the first detection section, and reducing the moving velocity of the coating section in a case where the dried part is not detected by the second detection section.

17 . The balloon coating method according to claim 11 , comprising:
conducting a control such that the width along the axial direction of the undried part detected by a first detection section is in a range of 2 mm to 20 mm, or, conducting a control such that the length from an allowable upper limit to an allowable lower limit of the width along the axial direction of the undried part detected by a first detection section is not more than 12 mm during a period from start of coating to end of coating.

18 . The balloon coating method according to claim 11 , comprising:
using a sensor for detecting transmittance of

Assignees

• Terumo Corp

Inventors

• Kurosaki Yasuo
• FURUICHI Eisuke
• Goto Hiroshi

Classifications

• A61K31/337

  having four-membered rings, e.g. taxol · CPC title

• A61M25/1029

  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 title

• A61M2025/105

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

• A61L2300/416

  Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus · 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