# US 10,869,995 B2 · Balloon wrapping apparatus and balloon wrapping method

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- Number: US 10,869,995 B2
- Document ID: US10869995B2
- Status: Granted
- Kind: B2
- Application number: 15/928,542
- Filed: 2018-03-22
- Published: 2018-07-26
- Granted: 2020-12-22
- Earliest claimed: 2015-09-25
- Assignees: Terumo Kabushiki Kaisha
- Applicants: Terumo Kabushiki Kaisha
- Inventors: Yasuo Kurosaki; Hiroshi Goto
- Web page: https://patentgrep.com/patent/US10869995B2

## CPC

- A61M 25/1038: {Wrapping or folding devices for use with balloon catheters}
- B29C 51/10: Forming by pressure difference, e.g. vacuum
- B29C 53/08: of tubes {or other profiled members}
- B29C 53/566: {for making tubular articles followed by compression}
- B29C 53/825: {for continuous winding}
- B29C 70/682: {Preformed parts characterised by their structure, e.g. form}
- A61M 2025/105: {having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes}
- B29L 2031/7543: {Balloon catheters}
- 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)}
- B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00)
- B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES

## Abstract

A balloon wrapping apparatus and a balloon wrapping method are disclosed by which a balloon can be accurately positioned in relation to a pleating section and to a folding section. The balloon wrapping apparatus for wrapping a balloon of a balloon catheter provided with the balloon at a distal portion of an elongated shaft includes: a pleating section having a plurality of blades aligned with space parts therebetween in a circumferential direction, and forms the balloon with wing shapes projecting in radial directions by clamping the balloon in the space parts by moving rotationally the blades; and a folding section having a plurality of blades aligned in a circumferential direction, and that folds the wing shapes formed in the balloon in the circumferential direction by moving rotationally the blades; and a support base that supports a part of the shaft which part is on a proximal side of the balloon.

## Claims

### Claim 1

A balloon wrapping apparatus for wrapping a balloon of a balloon catheter provided with the balloon at a distal portion of an elongated shaft, the balloon wrapping apparatus comprising:
a pleating section having a plurality of wing forming members aligned with spaces between the plurality of wing forming members in a circumferential direction, and configured to form the balloon with wing shapes projecting in radial directions by the wing forming members clamping the balloon, which causes the balloon to enter into the spaces, by moving rotationally the plurality of wing forming members;
a folding section that has a plurality of folding members aligned in the circumferential direction, and configured to fold the wing shapes formed in the balloon by moving rotationally the plurality of folding members, each of the pleating section and the folding section being disposed on a base;
a pivotable support base configured to support a part of the elongated shaft which part is on a proximal side of the balloon, the elongated shaft extending in one direction from the balloon, and the support base configured to arrange the distal portion of the elongated shaft positionable in relation to the pleating section and the folding section, the support base having a holding portion configured to maintain a position of the elongated shaft;
a grasping section provided in the pleating section and in the folding section, the grasping section capable of grasping a part of the balloon catheter which part is on a distal side of the balloon; and
a pulling section provided in the pleating section and in the folding section, the pulling section configured to apply a pulling force to the balloon catheter by moving the grasping section and the holding portion away from each other, and wherein the pulling section is moved in a distal direction relative to the distal side of the balloon.

### Claim 2 (depends on 1)

The balloon wrapping apparatus according to claim 1, wherein the grasping section has a grasping surface formed of a recessed curved surface.

### Claim 3 (depends on 1)

The balloon wrapping apparatus according to claim 1, comprising:
a core metal member that is inserted into the elongated shaft.

### Claim 4 (depends on 1)

The balloon wrapping apparatus according to claim 1, wherein each of the plurality of wing forming members is a plate-shaped member, which are disposed at equal angular intervals along the circumferential direction.

### Claim 5 (depends on 4)

The balloon wrapping apparatus according to claim 4, wherein the plurality of wing forming members is three in number.

### Claim 6 (depends on 4)

The balloon wrapping apparatus according to claim 4, wherein each of the plurality of wing forming members has a rotational center portion on an outer circumferential end portion of the wing forming member and a moving pin extending in an axial direction on an inner circumferential side of the rotational center portion, and wherein each of the moving pins is fitted in a fitting groove formed in a rotary member, which is configured to be rotatable in the pleating section.

### Claim 7 (depends on 6)

The balloon wrapping apparatus according to claim 6, wherein when the rotary member is rotated, the moving pins fitted in the fitting grooves are moved in the circumferential direction, whereby each of the plurality of wing shaped member is moved rotationally about the rotational center portion.

### Claim 8 (depends on 1)

The balloon wrapping apparatus according to claim 1, wherein each of the plurality of wing forming members is a plate-shaped member, and wherein the plurality of wing forming members are each positioned along an axial direction of the balloon catheter and are disposed such that each of the plurality of plate-shaped member are arranged at equal interval along the circumferential direction.

### Claim 9 (depends on 8)

The balloon wrapping apparatus according to claim 8, wherein each of the plurality of wing forming members has a moving pin extending in the axial direction, and wherein each of the moving pins is fitted in a fitting groove formed in a rotary member, which is rotatable in the folding section.

### Claim 10 (depends on 9)

The balloon wrapping apparatus according to claim 9, wherein each of the plurality of wing forming members are arranged at an angle of 36° from one another.

### Claim 11 (depends on 3)

The balloon wrapping apparatus according to claim 3, wherein the pulling force applied to the balloon catheter is applied by pulling the balloon catheter with a force of not less than 0.5 N.

### Claim 12 (depends on 11)

The balloon wrapping apparatus according to claim 11, wherein the pulling force applied to the balloon catheter is applied by grasping a distal portion of the balloon catheter and thereafter moving the distal portion of the balloon catheter by not less than 1 mm.

### Claim 13 (depends on 1)

The balloon wrapping apparatus according to claim 1, wherein the pulling section includes a sliding portion configured to fit to a guide groove portion on a base, a pinion configured to mesh with a rack having teeth arranged rectilinearly on the base, and a dial configured to rotate the pinion.

### Claim 14 (depends on 1)

The balloon wrapping apparatus according to claim 1, further comprising:
a first film supplying section configured to supply a film to the plurality of wing forming members in the pleating section, and wherein the film prevents direct contact of a surface of the plurality of wing forming members with the balloon in the pleating section; and
a second film supplying section configured to supply a film to the plurality of wing forming members in the folding section, and wherein the film prevents direct contact of the surface of the plurality of wing forming members with the balloon in the folding section.

### Claim 15

A balloon wrapping apparatus for wrapping a balloon of a balloon catheter arranged with the balloon at a distal portion of an elongated shaft, the elongated shaft extending in one direction from the balloon, the balloon wrapping apparatus comprising:
a pleating section having a plurality of blades aligned with spaces between the plurality of blades in a circumferential direction, and configured to form the balloon with wing shapes projecting in radial directions by rotating the blades of the pleating section;
a folding section having a plurality of blades aligned in a circumferential direction, and configured to fold the wing shapes formed in the balloon in the circumferential direction by rotating the blades of the folding section, each of the pleating section and the folding section being disposed on a base and oriented in a different direction by a predetermined angle from each other;
a pivotable support base configured to support a part of an elongated shaft which part is on a proximal side of the balloon, the support base having a holding portion configured to maintain a position of the elongated shaft;
a grasping section provided in the pleating section and in the folding section, the grasping section configured to grasp a part of the balloon catheter, which part is on a distal side of the balloon; and
a pulling section provided in the pleating section and in the folding section, the pulling section configured to apply a pulling force to the balloon catheter by moving the grasping section and the holding portion away from each other, and wherein the pulling section is moved in a distal direction relative to the distal side of the balloon.

### Claim 16 (depends on 15)

The balloon wrapping apparatus according to claim 15, wherein each of the plurality of blades of the pleating section are disposed at equal angular intervals along the circumferential direction;
wherein each of the plurality of blades of the pleating section has a rotational center portion on an outer circumferential end portion of the blade of the pleating section and a moving pin extending in an axial direction on an inner circumferential side of the rotational center portion, and wherein each of the moving pins is fitted in a fitting groove formed in a rotary member, which is configured to be rotatable in the pleating section; and
wherein when the rotary member is rotated, the moving pins fitted in the fitting grooves are moved in the circumferential direction, whereby each of the plurality of wing shaped member is moved rotationally about the rotational center portion.

### Claim 17 (depends on 15)

The balloon wrapping apparatus according to claim 15, wherein the plurality of blades are each positioned along an axial direction of the balloon catheter and are disposed such that each of the plurality of blades are arranged at equal intervals along the circumferential direction; and
wherein each of the plurality of blades has a moving pin extending in the axial direction, and wherein each of the moving pins is fitted in a fitting groove formed in a rotary member, which is rotatable in the folding section.

### Claim 18

A balloon wrapping method for wrapping a balloon of a balloon catheter provided with the balloon at a distal portion of an elongated shaft, the balloon wrapping method comprising:
supporting a part of the elongated shaft which part is on a proximal side of the balloon on a support base, the elongated shaft extending in one direction from the balloon, the support base having a holding portion configured to maintain a position of the elongated shaft;
inserting the balloon catheter into a pleating section;
grasping a part of the balloon catheter which part is on a distal side of the balloon with a grasping section in the pleating section;
forming the balloon with wing shapes projecting in radial directions in the pleating section;
pivoting the support base to a folding section;
inserting the balloon catheter into the folding section;
grasping the part of the balloon catheter which part is on the distal side of the balloon with a grasping section in the folding section; and
folding the wing shapes formed in the balloon along a circumferential direction in the folding section, wherein in at least one of the forming the wing shapes and the folding the wing shapes along the circumferential direction, the part of the balloon catheter which part is on the distal side of the balloon is grasped and a pulling force is applied to the balloon catheter in a state in which the position of the elongated shaft is maintained with a pulling section configured to move the grasping section and the holding portion away from each other and by moving the pulling section in a distal direction relative to the distal side of the balloon.

### Claim 19 (depends on 18)

The balloon wrapping method according to claim 18, wherein the pulling force applied to the balloon catheter is applied by pulling the balloon catheter with a force of not less than 0.5 N.

### Claim 20 (depends on 18)

The balloon wrapping method according to claim 18, wherein the pulling force applied to the balloon catheter is applied by grasping a distal portion of the balloon catheter and thereafter moving the distal portion of the balloon catheter by not less than 1 mm.