# US 10,118,025 B2 · Balloon catheter and manufacturing method of balloon catheter

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- Number: US 10,118,025 B2
- Document ID: US10118025B2
- Status: Granted
- Kind: B2
- Application number: 14/872,693
- Filed: 2015-10-01
- Published: 2016-01-28
- Granted: 2018-11-06
- Earliest claimed: 2013-04-02
- Assignees: Terumo Kabushiki Kaisha
- Applicants: Terumo Kabushiki Kaisha
- Inventors: Yuta Doi
- Web page: https://patentgrep.com/patent/US10118025B2

## CPC

- A61M 25/10186: {One-way valves}
- A61M 25/10: 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})
- A61M 25/1027: {Making of balloon catheters}
- 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 25/104: {used for angioplasty}
- A61M 25/0054: {with regions for increasing flexibility}
- A61M 25/1034: {Joining of shaft and balloon}
- A61M 2025/1031: {Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface}
- A61M 2025/1093: {having particular tip characteristics}
- 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)}

## Abstract

A balloon catheter which can rather smoothly move inside living body organs, and can improve trackability and pushability. The balloon catheter has an inner shaft that includes a guidewire lumen into which a guidewire can be inserted, an outer shaft that forms a fluid lumen for introducing a fluid on an outer periphery of the inner shaft, a membranous material that causes a space portion into which the fluid can flow to communicate with the fluid lumen, and that partitions the space portion on the outer periphery of the distal portion side of the inner shaft, and an inflatable and deflatable balloon in which a lumen into which the fluid can flow is formed on an outer periphery of the membranous material.

## Claims

### Claim 1

A balloon catheter comprising:
an inner shaft that includes a guidewire lumen configured to receive a guidewire so that the balloon catheter can be guided along the guidewire;
an outer shaft that forms, together with the inner shaft, a fluid lumen into which a fluid is to be introduced;
a membranous material that defines, together with the inner shaft, a space portion located outwardly of an outer periphery of a distal portion of the inner shaft;
an inflatable and deflatable balloon in which a lumen is formed, the balloon being located outwardly of an outer periphery of the membranous material;
the membranous material including an ejection portion which permits the fluid in the space portion to flow into the lumen of the balloon when an internal pressure in the space portion increases to a predetermined pressure as the fluid flows into the space portion; and
the inner shaft including a contracting and transforming portion which transforms at least a portion of the inner shaft so as to contract radially inward in response to an increase in the internal pressure in the space portion.

### Claim 2 (depends on 1)

The balloon catheter according to claim 1,
wherein a distal portion of the outer shaft covers the inner shaft within a predetermined range in an axial direction,
wherein a proximal-most portion of the membranous material is positioned outwardly of and in axial overlapping relation to an outer periphery of a distal-most portion of the outer shaft, and
wherein a proximal-most portion of the balloon is positioned outwardly of and in axial overlapping relation to an outer periphery of the proximal-most portion of the membranous material.

### Claim 3 (depends on 2)

The balloon catheter according to claim 2,
wherein a proximal portion of the membranous material is fixed to an outer peripheral surface of a distal portion of the outer shaft, and
wherein a proximal portion of the balloon is fixed to an outer peripheral surface of the outer shaft at a position proximal of the proximal-most portion of the membranous material.

### Claim 4 (depends on 3)

The balloon catheter according to claim 3, wherein the ejection portion includes a fragile portion which forms an opening in the membranous material by rupturing a portion of the membranous material over a predetermined range in an axial direction.

### Claim 5 (depends on 1)

The balloon catheter according to claim 1,
wherein the membranous material possesses a proximal portion fixed to an outer peripheral surface of a distal portion of the outer shaft, and
wherein the balloon possesses a proximal portion fixed to an outer peripheral surface of the outer shaft at a position proximal of a proximal-most portion of the membranous material.

### Claim 6 (depends on 1)

The balloon catheter according to claim 1, wherein the ejection portion includes a fragile portion which forms an opening in the membranous material by rupturing a portion of the membranous material over a predetermined range in an axial direction.

### Claim 7 (depends on 1)

The balloon catheter according to claim 1, wherein the balloon possesses a distal portion fixed to an outer periphery of the inner shaft and a proximal portion fixed to an outer periphery of the outer shaft.

### Claim 8 (depends on 7)

The balloon catheter according to claim 7, wherein the membranous material possesses a distal portion fixed to an outer periphery of the inner shaft and a proximal portion fixed to an outer periphery of the outer shaft.

### Claim 9 (depends on 1)

The balloon catheter according to claim 1, wherein the membranous material possesses a distal portion fixed to an outer periphery of the inner shaft and a proximal portion fixed to an outer periphery of the outer shaft.

### Claim 10

A method of manufacturing a balloon catheter, the balloon catheter including an inner shaft into which a guidewire is insertable, an outer shaft positioned outwardly of on an outer periphery of the inner shaft, a membranous material positioned outwardly of an outer periphery of a distal portion of the inner shaft to form a space portion between the distal portion of the inner shaft and the membranous material, and a balloon positioned outwardly of an outer periphery of the membranous material to define a lumen between the balloon and the membranous material, at least a part of the inner shaft being transformable so as to contract radially inward in response to an increase in internal pressure in the space portion, the method comprising:
sealing one opening portion of a first tube material in a state in which a second tube material forming the membranous material is positioned inside the first tube material forming the balloon, the one opening portion of the first tube material being either a proximal opening portion at a proximal end of the first tube material or a distal opening portion at a distal end of the first tube material, the first tube material possessing an other opening portion at an end of the first tube opposite to the one opening portion;
discharging gas between the first tube material and the second tube material via the other opening portion which is not sealed;
sealing the other opening portion of the first tube material; and
joining the first tube material and the second tube material to a shaft assembly which includes the inner shaft and the outer shaft.

### Claim 11 (depends on 10)

The method according to claim 10, further comprising inserting a metal core into the second tube material before sealing the one opening portion of the first tube material.

### Claim 12 (depends on 10)

The method according to claim 10, wherein the discharging of the gas between the first tube material and the second tube material via the other opening portion is performed by suction.

### Claim 13

A method of using a balloon catheter comprising
inserting a balloon catheter into a living body organ, the balloon catheter comprising: an inner shaft that includes a guidewire lumen, an outer shaft positioned outwardly of the inner shaft, a membranous material positioned outwardly of the inner shaft, and an inflatable and deflatable balloon located outwardly of the membranous material, the membranous material possessing an inner peripheral surface and the inner shaft possessing an outer peripheral surface;
moving the balloon catheter in the living body organ by guiding the balloon catheter along a guidewire located in the guidewire lumen to move the balloon catheter relative to the guidewire within the living body organ;
introducing fluid into a space between the outer peripheral surface of the inner shaft and the inner peripheral surface of the membranous material to cause a portion of the inner shaft to deform inwardly into contact with the guidewire in the guidewire lumen so that the guidewire and the balloon catheter move together as a unit;
moving the balloon catheter while the portion of the inner shaft is in contact with the guidewire to move the guidewire and the balloon catheter together and position the balloon catheter at a stenosis; and
inflating the balloon into contact with the stenosis to spread out the stenosis.

### Claim 14 (depends on 13)

The method according to claim 13, wherein the inflation of the balloon comprises the fluid in the space between the outer peripheral surface of the inner shaft and the inner peripheral surface of the membranous material applying a force to a fragile portion of the membranous material causing the fragile portion to open and communicate the space with a lumen between the balloon and the membranous material so that the fluid in the space flows into the lumen between the balloon and the membranous material.

### Claim 15 (depends on 14)

The method according to claim 14, wherein the portion of the inner shaft deforms inwardly into contact with the guidewire before the fragile portion is opened.