Balloon catheter and method

• US 6,056,721 A
• Filed: 08/08/1997
• Issued: 05/02/2000
• Est. Priority Date: 08/08/1997
• Status: Expired due to Term

• Current Assignee: Biosensors International Group, Ltd.
• Original Assignee: Sunscope International Incorporated
• Inventors: Shulze, John E.
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): KLINE, ERIC E
• Application Number:
  US08/907,718
• Time in Patent Office: 998 Days
• Field of Search: 604/49, 604/52, 604/53, 604/96, 604/101, 604/103, 604/104, 604/102, 606/191, 606/192, 606/194, 606/198, 600/116
• US Class Current: 604/101.05
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

A balloon catheter device for treating an obstructing material within a vascular conduit or other body passageway. The device comprises an elongate catheter body extending between a proximal end and a distal end. A high compliance balloon and a spaced apart angioplasty balloon are coaxially disposed along the distal end. The catheter device includes a plurality of longitudinal lumens which extend along the catheter body from the proximal end. At least one of the lumens has a cross section which is non circular and is configured, in conjunction with the other lumens to provide a maximum total lumen cross sectional area within a minimum diameter catheter body.

Claims

1. A balloon catheter device for treating an obstructing material within a body passageway, said device comprising:

an elongate, flexible catheter body having a longitudinal axis extending between a proximal end and a distal end, said catheter body further comprising an outer wall and a plurality of lumens extending along said longitudinal axis from said proximal end, at least one of said lumens extending to an infusion port in said outer wall, said infusion port being disposed adjacent the distal end;

a first inflatable and deflatable balloon, disposed coaxially about the catheter body proximally of the infusion port, said first balloon being in fluid communication with a second of said plurality of lumens for inflation and deflation of said first balloon;

said

a second inflatable and deflatable balloon disposed coaxially about the catheter body distally and spaced apart from said first balloon, distally of the infusion port, said second balloon being in fluid communication with a fourth of said plurality of lumens for inflation and deflation by passage of a second fluid;

one of said first and second balloons comprising a high compliance cuff and the other comprising a low compliance angioplasty balloon;

wherein there is no balloon disposed between said infusion port and said low compliance cuff.

2. The balloon catheter device as recited in claim 1, and further comprising:

at least one perfusion port disposed on the outer wall of the catheter body proximally of the first balloon, said perfusion port being in fluid communication with the fourth lumen;

wherein a bodily fluid within the body passageway may pass through said fourth lumen between said perfusion port and said open tip and bypass said first balloon and said second balloon when the catheter guidewire in said fourth lumen is moved proximally of said perfusion port.

3. The balloon catheter device as recited in claim 2, wherein said fourth lumen comprises a seal disposed proximally of said perfusion port, said seal being configured for movably supporting said catheter guidewire and for preventing the passage of fluid.

4. The balloon catheter as recited in claim 1 wherein said catheter body comprises an extruded polymer.

5. The balloon catheter as recited in claim 4 wherein said polymer comprises a polyurethane, polyethylene, a Nylon or a PBAX.

6. The balloon catheter device as recited in claim 1 wherein said first balloon is a high compliance cuff and said second balloon is a low compliance angioplasty balloon.

7. The balloon catheter device as recited in claim 1 wherein said second balloon is a high compliance cuff and said first balloon is a low compliance angioplasty balloon.

8. A balloon catheter device for treating an obstructing material within a body passageway, said device comprising:

an elongate, flexible catheter body having a longitudinal axis extending between a proximal end and a distal end, said catheter body further comprising an outer wall and at least four lumens extending along said longitudinal axis from said proximal end, a first of said four lumens extending to an open distal tip at the distal end and being configured for movably supporting a catheter guidewire, a second of said lumens extending to an infusion port within said outer wall, said infusion port being disposed adjacent the distal end;

a first inflatable and deflatable balloon disposed coaxially about the catheter body proximally of the infusion port, said first balloon being in fluid communication with a third of said plurality of lumens for inflation and deflation by passage of a fluid; and

a second inflatable and deflatable balloon disposed coaxially about the catheter body distally and spaced apart from said first balloon, distally of the infusion port, said second balloon being in fluid communication with a fourth of said plurality of lumens for inflation and deflation by passage of a second fluid;

one of said first and second balloons comprising a high compliance cuff and the other comprising a low compliance angioplasty balloon;

wherein there is no balloon disposed between said infusion port and said low compliance cuff; and

wherein at least one of said plurality of lumens has a non-circular cross-section.

9. The balloon catheter device as recited in claim 8 wherein said angioplasty balloon comprises a proximal balloon end which is attached to said catheter body and, when inflated, tapers away from said longitudinal axis at a first acute angle to a central balloon portion, said central balloon portion tapering at a second acute angle to a distal balloon end which is attached to said catheter body distally from said proximal balloon end.

10. The balloon catheter device as recited in claim 8 wherein said first acute angle and said second acute angle are different.

11. The balloon catheter device as recited in claim 9 wherein one of said angioplasty balloon and said high compliance cuff are attached to a necked down portion of said catheter body.

12. The balloon catheter device as recited in claim 8 wherein said open distal tip is tapered inwardly toward the longitudinal axis.

13. The balloon catheter device as recited in claim 8 wherein said first lumen and at least one of said third and fourth lumens each have a generally circular cross section.

14. The balloon catheter device as recited in claim 8 wherein said second lumen and at least one of said third and fourth lumens each have a generally rounded triangular cross section.

15. The balloon catheter device as recited in claim 8, and further comprising a radiolucent marker located under the angioplasty balloon.

16. The balloon catheter device as recited in claim 8 wherein said catheter body comprises an extruded polymer.

17. The balloon catheter device as recited in claim 8 wherein said high compliance cuff comprises a proximal balloon end and a distal balloon end and wherein at least one of said proximal and distal balloon ends is secured to said catheter body using a thin filament.

18. The balloon catheter device as recited in claim 8 wherein said high compliance cuff comprises a proximal balloon end and a distal balloon end and wherein at least one of said proximal and distal balloon ends is secured to said catheter body using a cyanoacrylate adhesive.

19. A method for relieving a constriction in a vascular conduit using a balloon catheter device having an elongate catheter body extending along a longitudinal axis between a proximal catheter end and a distal catheter end, a high compliance cuff and a low compliance angioplasty balloon being disposed coaxially about the distal end of said catheter body, said method comprising the steps of:

inserting the balloon catheter device into the vascular conduit such that said angioplasty balloon is within said constriction;

inflating said low compliance angioplasty balloon within said vascular conduit;

inflating said high compliance cuff within said vascular conduit;

infusing a therapeutic agent through a lumen in said catheter and out of an infusion port disposed on said catheter body between said high compliance cuff and said angioplasty balloon;

partially deflating said angioplasty balloon so that the therapeutic agent flows over said constriction in order to more effectively treat said constriction.