Balloon catheter and manufacturing method of elongated member for balloon catheter

Patent metadata

Field	Value
Publication number	US-10850075-B2
Application number	US-201816131710-A
Country	US
Kind code	B2
Filing date	Sep 14, 2018
Priority date	Mar 16, 2016
Publication date	Dec 1, 2020
Grant date	Dec 1, 2020

Abstract

A balloon catheter is disclosed having a distal side shaft formed of a resin material, a proximal shaft formed of a metal material, and an inner tubular shaft disposed along an inclined portion and a concave portion of the proximal shaft. The distal side shaft is joined to the proximal shaft at the small diameter portion on the proximal side from a distal opening of the proximal shaft. The distal opening of the proximal shaft is disposed on the distal side from a guide wire proximal opening.

First claim

What is claimed is:

1. A balloon catheter comprising:
a distal side shaft formed of a resin material;
a proximal shaft disposed on a proximal side of the distal side shaft and formed of a metal material, the proximal shaft having a main body portion, an inclined portion disposed on a distal side of the main body portion and in which an outer peripheral surface of the proximal shaft is partially inclined, and a small diameter portion disposed on a distal side of the inclined portion and having a distal opening, and wherein in a cross section perpendicular to an axial direction of the proximal shaft, the small diameter portion having a concave portion recessed to a lumen side of the proximal shaft;
an inner tubular shaft disposed in a lumen of the distal side shaft and forming a guide wire lumen into which a guide wire is insertable, the inner tubular shaft being disposed along the inclined portion and the concave portion, the inner tubular shaft being open on an outer surface of the distal side shaft forming a guide wire proximal opening, and wherein the distal side shaft is joined to the proximal shaft at the small diameter portion on the proximal side from the distal opening of the proximal shaft, and the distal opening of the proximal shaft is disposed on the distal side from the guide wire proximal opening; and
a balloon fixed to a distal side of the inner tubular shaft and a distal side of the distal side shaft.

2. The balloon catheter according to claim 1 , wherein in the cross section perpendicular to the axial direction of the proximal shaft, the concave portion has a first curved portion curved to the lumen side of the proximal shaft, and a second curved portion and a third curved portion which are curved outward of the guide wire lumen while being apart from the first curved portion; and
the second curved portion and the third curved portion being substantially symmetrical with each other, in the cross section perpendicular to the axial direction of the proximal shaft.

3. The balloon catheter according to claim 1 , wherein at least a portion of the guide wire lumen is surrounded by the concave portion in the cross section perpendicular to the axial direction of the proximal shaft.

4. The balloon catheter according to claim 1 , wherein the inclined portion has a proximal side concave portion recessed to the lumen side of the proximal shaft in the cross section perpendicular to the axial direction of the proximal shaft.

5. The balloon catheter according to claim 1 , wherein the metal material of the proximal shaft is aluminum, stainless steel, brass, or Ni—Ti.

6. The balloon catheter according to claim 1 , wherein the resin material of the distal side shaft is polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, and ethylene-vinyl acetate copolymer, or ionomer.

7. The balloon catheter according to claim 1 , wherein the resin material is polyvinyl chloride resin, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, or polytetrafluoroethylene.

8. The balloon catheter according to claim 1 , wherein the inner tubular shaft is formed of a resin material.

9. The balloon catheter according to claim 1 , further comprising:
an inflation lumen on the distal side shaft, the inflation lumen being in fluid communication with the main body portion of the proximal shaft and located between an outer surface of the inner tubular member and the distal side shaft, and wherein the inflation lumen is configured to provide an inflation fluid to the balloon of the balloon catheter.

10. The balloon catheter according to claim 1 , further comprising:
an X-ray contrast marker arranged on the inner tubular shaft in a central position in an axial direction of an inflatable portion of the balloon.

11. The balloon catheter according to claim 1 , further comprising:
a hub configured to be connected to a proximal end of the proximal portion of the proximal shaft of the balloon catheter, the hub configured to supply an inflation fluid to the balloon catheter.

12. A treatment method comprising:
introducing a balloon catheter into a living body, the balloon catheter including a distal side shaft formed of a resin material, a proximal shaft disposed on a proximal side of the distal side shaft and formed of a metal material, the proximal shaft having a main body portion, an inclined portion disposed on a distal side of the main body portion and in which an outer peripheral surface of the proximal shaft is partially inclined, and a small diameter portion disposed on a distal side of the inclined portion and having a distal opening, and wherein in a cross section perpendicular to an axial direction of the proximal shaft, the small diameter portion having a concave portion recessed to a lumen side of the proximal shaft; and an inner tubular shaft disposed in a lumen of the distal side shaft and forming a guide wire lumen into which a guide wire is insertable, the inner tubular shaft being disposed along the inclined portion and the concave portion, the inner tubular shaft being open on an outer surface of the distal side shaft forming a guide wire proximal opening, and wherein the distal side shaft is joined to the proximal shaft at the small diameter portion on the proximal side from the distal opening of the proximal shaft, and the distal opening of the proximal shaft is disposed on the distal side from the guide wire proximal opening, and a balloon fixed to a distal side of the inner tubular shaft and a distal side of the distal side shaft;
introducing a guide wire into the guide wire proximal opening;
advancing the balloon catheter over the guide wire to a stenosed site in the living body; and
inflating the balloon of the balloon catheter into the stenosed site.

13. The treatment method according to claim 12 , wherein in the cross section perpendicular to the axial direction of the proximal shaft, the concave portion has a first curved portion curved to the lumen side of the proximal shaft, and a second curved portion and a third curved portion which are curved outward of the guide wire lumen while being apart from the first curved portion; and
the second curved portion and the third curved portion being substantially symmetrical with each other, in the cross section perpendicular to the axial direction of the proximal shaft.

14. The treatment method according to claim 12 , wherein at least a portion of the guide wire lumen is surrounded by the concave portion in the cross section perpendicular to the axial direction of the proximal shaft.

15. The treatment method according to claim 12 , wherein the inclined portion has a proximal side concave portion recessed to the lumen side of the proximal shaft in the cross section perpendicular to the axial direction of the proximal shaft.

16. The treatment method according to claim 12 , further comprising:
detecting a location of the balloon catheter in the living body with an X-ray contrast marker arranged on the inner tubular shaft in a central position in an axial direction of an inflatable portion of the balloon.

Assignees

• Terumo Corp

Inventors

• Tarunaga Akihiko
• Suzuki Kenta

Classifications

• A61M25/1036 Primary

  Making parts for balloon catheter systems, e.g. shafts or distal ends (A61M25/1029 takes precedence) · CPC title

• B29C63/0069

  of tubular articles · CPC title

• B29L2031/7543

  Balloon catheters · CPC title

• B29D23/00

  Producing tubular articles (B29D24/00 takes precedence) · CPC title

• A61M2025/0183

  Rapid exchange or monorail catheters · CPC title