Balloon catheter

• US 5,460,607 A
• Filed: 09/24/1993
• Issued: 10/24/1995
• Est. Priority Date: 09/30/1992
• Status: Expired due to Term

• Current Assignee: Nippon Zeon Co., Ltd.
• Original Assignee: Nippon Zeon Co., Ltd.
• Inventors: Kawabata, Takashi, Miyata, Shinichi, Sakai, Kouichi, Toyokawa, Tetsuo
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US08/125,843
• Time in Patent Office: 760 Days
• Field of Search: 604/256, 604/264, 604/284, 604/96, 604/280-283, 604/101, 606/191-194
• US Class Current: 604/99.04
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 39/0613 with means for adjusting the seal opening or pressure A61M39/0693 takes precedence
• 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
• CPC Class Codes: A61M 60/865 Devices for guiding or inserting pumps or pumping devices into the patient's body
• CPC Class Codes: A61M 60/892 Active valves, i.e. actuated by an external force

Abstract

A balloon catheter used for intra-aortic balloon pumping (IABP). In the balloon catheter, an outer diameter of a catheter tube is not made constant in the axial direction. Rather, the outer diameter of the catheter tube from a hemostatic valve to a bifurcation, the portion which is positioned outside the patient'"'"'s blood vessel, is made 3 to 30 percent larger than the outer diameter of the catheter tube from the balloon portion to the hemostatic valve, which is positioned inside the patient'"'"'s blood vessel. The bifurcation has a first passage and a second passage. The first passage is communicating with a shuttle gas port and is disposed straight along the direction of the axial center of the catheter tube. In the balloon catheter, improvements in a channel resistance of a shuttle gas and in the response can be expected compared with the conventional balloon catheter, where the blood pressure measurement port (the second passage) was disposed straight along the direction of the axial center of the catheter tube and the outer diameter of the catheter tube was made constant in the axial direction.

Claims

1. A balloon catheter comprising:

a balloon portion which is inserted into an aorta and expands and contracts to assist a heart beating;

a catheter tube having a distal end connected to a proximal end of the balloon portion and said catheter tube introduces and releases shuttle gas into and from the balloon portion;

a hemostatic valve attached on an outer circumference of a proximal end portion of the catheter tube in a manner movable in an axial direction of the catheter tube;

a hemostatic sheath portion, which is provided at a distal end of the hemostatic valve and which moves with the hemostatic valve in the axial direction of the catheter tube on the outer circumference of the catheter tube, the hemostatic sheath portion has a distal end which is pushed into an insertion opening formed in a blood vessel of a patient so as to plug the insertion opening; and

a bifurcation to which the proximal end portion of the catheter tube is connected and having formed therein a shuttle gas port for introducing and releasing shuttle gas into and from the balloon portion through the catheter tube,

wherein the proximal end portion of the catheter tube having 3 to 30 percent larger inner diameter than other portion of the catheter tube, and the proximal end portion being 5 to 35 percent of a total length of the catheter tube from the bifurcation.

2. A balloon catheter as set forth in claim 1, wherein an inner tube extends in the balloon portion and the catheter tube in the axial direction thereof, a distal end of the inner tube is connected with a distal end of the balloon portion and a proximal end of the inner tube is connected with a proximal end of the bifurcation so that a shuttle gas lumen is formed between the catheter tube and the inner tube and a blood lumen is formed along the inner tube therein.

3. The balloon catheter as set forth in claim 2, wherein the bifurcation has formed in it, separate from the shuttle gas port, a blood pressure measurement port for measuring a pressure of a blood taken in from a blood port formed in a distal end of the balloon portion through the blood lumen of the inner tube;

the shuttle gas port is disposed straight along the axial direction of the catheter tube; and

the blood pressure measurement port is disposed at a predetermined angle with respect to an axial center of the shuttle gas port.

4. The balloon catheter as set forth in claim 3, wherein the blood pressure measurement port of the bifurcation has attached to it an inner tube end holder for holding a proximal end of the inner tube and for disposing the inner tube eccentrically in the catheter tube so as to contact an inner wall of the catheter tube.

5. The balloon catheter as set forth in claims 1, 2, 3 or 4, wherein

said hemostatic valve having

a hemostatic valve body which is attached to the outer circumference of the catheter tube in a manner freely movable along the axial direction,

a cap portion which can be screwed with the hemostatic valve body and is attached to the outer circumference of the catheter tube in a manner freely movable along the axial direction, and

a holding ring which is attached to the outer circumference of the catheter tube positioned between the hemostatic valve body and the cap portion, has a predetermined clearance with the outer circumference of the catheter tube in a state with the hemostatic valve body and cap portion not screwed together, and elastically deforms to press against the outer circumference of the catheter tube by the hemostatic valve body and the cap portion being screwed together more than a predetermined number of screw turns,

the JIS hardness of the holding ring being at least 52.

6. The balloon catheter as set forth in claims 2, 3 or 4, wherein the inner tube is comprised of a metal tube, a distal end portion of the balloon portion is attached to an outer periphery of a distal end portion of the inner tube and the distal end portion of the inner tube is set to a lower hardness by heat treatment than other portions of the inner tube.

7. The balloon catheter as set forth in claims 2, 3 or 4, wherein the inner tube is comprised of a metal tube, a distal end portion of the balloon portion is attached to an outer periphery of a distal end portion of the inner tube and the distal end portion of the inner tube is formed thinner than other portions of the inner tube.

8. The balloon catheter as set forth in claims 2, 3 or 4, wherein the inner tube is comprised of a metal tube, a distal end portion of the balloon portion is attached to an outer periphery of a distal end portion of the inner tube and the distal end portion of the inner tube is formed with slits to improve its flexibility.

9. The balloon catheter as set forth in claims 2, 3 or 4, wherein the inner tube is comprised of a metal tube, a distal end portion of the balloon portion is attached to an outer periphery of a distal end portion of the inner tube and the distal end portion of the inner tube is formed with a bellows-like irregularity to improve its flexibility.

10. The balloon catheter as set forth in claims 1, 2, 3 or 4, wherein

the proximal end of the balloon portion and a distal end of the catheter tube being joined at an outer circumference of two ends of a metal connection tube so as not to be superposed on each other.

11. The balloon catheter as set forth in claims 1, 2, 3 or 4, wherein

the length of the proximal end portion of the catheter of which outer diameter is larger than the other portion of the catheter tube is 5 to 35 percent of the total length of the catheter tube.

12. The balloon catheter for intra-aortic balloon pumping as set forth in claims 1, 2, 3 or 4, wherein the balloon portion expands and contracts in timing with a heart beating.

13. A balloon catheter comprising:

a balloon portion which is inserted into an aorta and expands and contracts to assist a heart beating;

a catheter tube which is connected to a proximal end of the balloon portion and introduces and releases shuttle gas into and from the balloon portion; and

a bifurcation to which the proximal end of the catheter tube is connected and having formed therein a shuttle gas port for introducing and releasing shuttle gas into and from the balloon portion through the catheter tube,

wherein a proximal end portion of the catheter tube has 2 to 50 percent larger outer diameter than other portion of the catheter tube,

the proximal end portion of the catheter tube has 3 to 30 percent larger inner diameter than the other portion of the catheter tube, and

the proximal end portion of the catheter tube is 5 to 35 percent of the total length of the catheter tube from the bifurcation.

14. The balloon catheter as set forth in claim 13, wherein

the length of the proximal end portion of the catheter tube of which outer diameter is larger than the other portion of the catheter tube is 1.5 to 50 percent of the total length of the catheter tube.