Intra-aortic balloon catheter

• US 5,711,754 A
• Filed: 01/19/1996
• Issued: 01/27/1998
• Est. Priority Date: 06/27/1991
• Status: Expired due to Fees

• Current Assignee: Nippon Zeon Co., Ltd. (BASF SE)
• Original Assignee: Nippon Zeon Co., Ltd. (BASF SE)
• Inventors: Tsuji, Takashi, Miyata, Shinichi, Sakai, Kouichi, Toyokawa, Tetsuo, Miyahara, Masaru, Kirkpatrick, Donald Robert
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US08/582,348
• Time in Patent Office: 739 Days
• Field of Search: 604/96-102, 604/283, 604/280, 604/43, 604/282, 606/192-195, 600/18, 128/672-675
• US Class Current: 600/18
• CPC Class Codes: A61M 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• CPC Class Codes: A61M 2025/1059 having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: 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
• CPC Class Codes: A61M 25/1038 Wrapping or folding devices for use with balloon catheters
• CPC Class Codes: A61M 60/139 inside the aorta, e.g. intra-aortic balloon pumps
• CPC Class Codes: A61M 60/274 the inlet and outlet being the same, e.g. para-aortic counter-pulsation blood pumps
• CPC Class Codes: A61M 60/295 Balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/497 for balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/531 using blood pressure data, e.g. from blood pressure sensors
• CPC Class Codes: A61M 60/843 Balloon aspects, e.g. shapes or materials

Abstract

A balloon catheter has an inner tube communicating with a blood introduction port provided at a tip of the balloon portion. The inner tube is affixed to the inner wall of the catheter tube by adhesion, melt-bonding, or integral formation. The balloon catheter has a small channel resistance in the channel where the pressurized fluid which expands and contracts the balloon portion flows, even when the catheter tube has been bent, and enables expansion and contraction of the balloon portion with a good response. Another balloon catheter has the balloon portions at a range of the end sides of the balloon portions smaller in sectional area compared with the balloon portions at the tip sides. The catheter is able to effectively prevent side effects which occur only rarely but which are serious when they do occur. The catheter impairs as little as possible the effect of assisting the heart action inherent to the IABP method without special measurement of the diameter of the patient'"'"'s blood vessels.

Claims

1. An intra-aortic balloon catheter comprising:

a balloon portion which is inserted into an aorta and which repeatedly expands and contracts so as to assist pumping action of the heart;

a catheter tube connected at one end to an end of the balloon portion, the catheter tube having a first lumen introducing a pressurized gas into and leading the pressurized gas out from said balloon portion, the catheter tube having a branch portion at an end thereof opposite to the end having the balloon portion; and

an inner tube having a second lumen which communicates to a blood introduction port provided at the tip of said balloon portion and extends through said balloon portion and catheter tube in the axial direction, the catheter tube being empty except for the inner tube provided therein such that the inner tube is the only structure provided within the catheter tube, and the inner tube being empty,

the inner diameter and the thickness of said catheter tube being respectively from 1.5 to 4.0 mm and from 0.05 to 0.4 mm, the inner diameter and the thickness of said inner tube being respectively from 0.1 to 1.0 mm and from 0.05 to 0.4 mm,

the first lumen of said catheter tube having a larger cross-sectional area than that of the second lumen,

said inner tube being generally concentrically positioned within said balloon portion and being continuously affixed to the inside wall of said catheter tube from the end of the balloon portion to the branch portion of the catheter tube.

2. The intra-aortic balloon catheter as set forth in claim 1, wherein said catheter tube and inner tube are comprised of a selected material of polyurethane, polyvinyl chloride and polyethylene.

3. The intra-aortic balloon catheter as set forth in claim 1, wherein the circumferential position of said inner tube affixed to said catheter tube is generally in a straight line position along said catheter tube when the catheter tube is positioned in generally a straight line.

4. The intra-aortic balloon catheter as set forth in claim 1, wherein said inner tube is formed integrally with said catheter tube by means of an extrusion method.

5. The intra-aortic balloon catheter as set forth in claim 1, wherein said balloon catheter portion has varying cross-sectional areas from a tip side to an end side, the end side of the balloon portion being connected to the catheter tube and the cross-sectional area of the balloon portion gradually becomes smaller toward the end side from the tip side.

6. The intra-aortic balloon catheter as set forth in claim 1, wherein said balloon portion has a tip side and an end side, the end side being connected to the catheter tube, the balloon portion having cross-sectional areas of the tip side and the end side of the balloon portion which differ, the balloon portion having a step portion which is a boundary portion between the tip side and the end side, the length of the tip side of the balloon portion being more than about 1/4 of a total length of the balloon portion, and the cross-sectional area of the balloon portion being smaller at the end side than the tip side.

7. The intra-aortic balloon catheter as set forth in claim 1, wherein the balloon portion has an outer diameter of 12 to 20 mm and a total length of 100 to 450 mm.

8. The intra-aortic balloon catheter as set forth in claim 1, wherein the balloon portion is made of a flexible material.

9. The intra-aortic balloon catheter as set forth in claim 1, wherein:

said balloon portion has a tip side and an end side, the balloon portion having cross-sectional areas of the tip side and the end side which differ and the cross-sectional area gradually becoming smaller toward the end side from the tip side of the balloon portion.

10. The intra-aortic balloon catheter as set forth in claim 1, wherein said inner tube is one of adhered and heat-bonded with the inside wall of said catheter tube.

11. The intra-aortic balloon catheter as set forth in claim 10, wherein said catheter tube and inner tube are comprised of a selected material of polyurethane, polyvinyl chloride and polyethylene.

12. The intra-aortic balloon catheter as set forth in claim 10, wherein the circumferential position of said inner tube affixed to said catheter tube is generally in a straight line position along said catheter tube when the catheter tube is positioned in generally a straight line.

13. The intra-aortic balloon catheter as set forth in claim 10, wherein said balloon catheter portion has varying cross-sectional areas from a tip side to an end side, the end side of the balloon portion being connected to the catheter tube and the cross-sectional area of the balloon portion gradually becomes smaller toward the end side from the tip side.

14. The intra-aortic balloon catheter as set forth in claim 10, wherein said balloon portion has a tip side and an end side, the end side being connected to the catheter tube, the balloon portion having cross-sectional areas of the tip side and the end side of the balloon portion which differ, the balloon portion having a step portion which is a boundary portion between the tip side and the end side, the length of the tip side of the balloon portion being more than about 1/4 of a total length of the balloon portion, and the cross-sectional area of the balloon portion being smaller at the end side than the tip side.

15. The intra-aortic balloon catheter as set forth in claim 10, wherein the balloon portion has an outer diameter of 12 to 20 mm and a total length of 100 to 450 mm.

16. The intra-aortic balloon catheter as set forth in claim 10, wherein the balloon portion is made of a flexible material.

17. An intra-aortic balloon catheter comprising:

a balloon portion which is inserted into an aorta and which repeatedly expands and contracts so as to assist pumping action of the heart, the balloon portion having a tip and an end with a cross section of the balloon portion at the end being less than a cross section of the balloon of the tip such that a cross section of the balloon portion is non-uniform;

a catheter tube connected at one end to the end of the balloon portion, the catheter tube having a first lumen introducing a pressurized gas into and leading the pressurized gas out from said balloon portion, the catheter tube having a branch portion at an end thereof opposite to the end having the balloon portion; and

an inner tube having a second lumen which communicates to a blood introduction port provided at the tip of said balloon portion and extends through said balloon portion and catheter tube in the axial direction, the catheter tube being empty except for the inner tube provided therein such that the inner tube is the only structure provided within the catheter tube, and the inner tube being empty,

the inner diameter and the thickness of said catheter tube being respectively from 1.5 to 4.0 mm and from 0.05 to 0.4 mm, the inner diameter and the thickness of said inner tube being respectively from 0.1 to 1.0 mm and from 0.05 to 0.4 mm,

the first lumen of said catheter tube having a larger cross-sectional area than that of the second lumen,

said inner tube being positioned substantially in a concentric manner within said balloon portion and being continuously affixed to the inside wall of said catheter tube from the end of the balloon portion to the branch portion of the catheter tube.

18. An intra-aortic balloon catheter comprising:

a balloon portion which is inserted into an aorta and which repeatedly expands and contracts so as to assist pumping action of the heart, said balloon portion having a tip side and an end side, the balloon portion having cross-sectional areas of the tip side and the end side of the balloon portion which differ, the balloon portion having a step portion which is a boundary portion between the tip side and the end side, the length of the tip side of the balloon portion being more than about 1/4 of a total length of the balloon portion, and the cross-sectional area of the balloon portion being smaller at the end side than the tip side;

a catheter tube connected to the end side of the balloon portion, said catheter tube introducing a pressurized gas into and leading the pressurized gas out from said balloon portion; and

an inner tube which communicates with a blood introduction port provided at a tip of said balloon portion and extending through said balloon portion and catheter tube in the axial direction, said catheter tube being empty except for the inner tube provided therein such that the inner tube is the only structure provided within the catheter tube, and the inner tube being empty.