# US 10,369,334 B2 · Balloon coating method and balloon rotating method

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- Number: US 10,369,334 B2
- Document ID: US10369334B2
- Status: Granted
- Kind: B2
- Application number: 16/033,566
- Filed: 2018-07-12
- Published: 2018-11-08
- Granted: 2019-08-06
- Earliest claimed: 2015-04-23
- Assignees: Terumo Kabushiki Kaisha
- Applicants: Terumo Kabushiki Kaisha
- Inventors: Hiroshi Gotou; Yasuo Kurosaki; Eisuke Furuichi
- Web page: https://patentgrep.com/patent/US10369334B2

## CPC

- 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}
- A61M 2025/1031: {Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface}
- A61M 2025/105: {having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes}
- B05C 5/0216: {by relative movement of article and outlet according to a predetermined path}
- B05C 13/02: for particular articles
- B05C 13/025: {relatively small cylindrical objects, e.g. cans, bottles}
- B05D 1/002: {the substrate being rotated}
- 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
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- B05C: APPARATUS FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL (spraying apparatus, atomising apparatus, nozzles B05B; plant for applying liquids or other fluent materials to objects by electrostatic spraying B05B5/08)
- B05D: PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL (conveying articles or workpieces through baths of liquid B65G, e.g. B65G49/02)

## Abstract

A balloon coating method for forming a coating layer on the 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.

## Claims

### Claim 1

A balloon coating method for applying a coating layer 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 from the dispensing tube to apply the coating liquid to the outer surface of the balloon.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 1)

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.

### Claim 4 (depends on 1)

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.

### Claim 5 (depends on 2)

The balloon coating method according to claim 2, wherein the dispensing of the coating liquid from the dispensing tube includes dispensing a coating layer containing a water-insoluble drug to apply the coating liquid containing the water-insoluble drug to the outer surface of the balloon.

### Claim 6 (depends on 1)

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.

### Claim 7 (depends on 1)

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.

### Claim 8 (depends on 1)

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.

### Claim 9 (depends on 1)

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.

### Claim 10

A balloon coating method for forming a coating layer 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.

### Claim 11 (depends on 10)

The balloon coating method according to claim 10, wherein the rotating of the balloon comprises rotating the clamp while the balloon is clamped by the clamp.

### Claim 12 (depends on 10)

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

### Claim 13 (depends on 10)

The balloon coating method according to claim 10, wherein the rotating of the balloon comprises 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.