Balloon catheters

• US 5,160,321 A
• Filed: 11/27/1991
• Issued: 11/03/1992
• Est. Priority Date: 11/23/1988
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Harvinder Sahota
• Inventors: Sahota, Harvinder
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): SMITH, CHALIN A
• Application Number:
  US07/799,563
• Time in Patent Office: 342 Days
• Field of Search: 606/191, 606/192, 606/194, 604/96-103, 128/565, 128/657, 128/772
• US Class Current: 604/101.03
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• CPC Class Codes: A61M 2025/107 having a longitudinal slit in the balloon
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Dilatation catheters for use in administering treatments to relieve stenotic regions within a body lumen are described. In one aspect of the invention, a two wire catheter system, of minimal diameter for treating distal arteries is disclosed, In addition, a number of various dilatation balloon configurations, for treating stenotic areas which are present in tortuous vessels, as well as hardened, or calcified stenotic portions are also described. Finally, a catheter system which provides a path for conducting blood past the stenosis and inflated dilatation balloon is discussed.

Claims

1. A dilation catheter for relieving an obstructed coronary artery while maintaining a steady flow of blood past the obstruction, comprising:

an axially elongate catheter shaft;

a guidewire conduit in said catheter shaft;

a dilatation balloon, secured to said catheter shaft, said dilatation balloon having a proximal end and a distal end;

an inflation lumen in said catheter shaft for transmitting pressurized fluid into and out of said dilatation balloon, for selective inflation and deflation thereof;

a perfusion conduit in said catheter shaft for providing a path through which blood may bypass said dilatation balloon when said balloon is in an inflated state and occluding said artery, said perfusion conduit separate from said guidewire conduit, obviating the need to withdraw said guidewire to allow blood to bypass said dilatation balloon;

a plurality of influent perfusion ports, disposed proximate to the proximal end of said dilatation balloon, said influent ports opening into said perfusion conduit so as to enable blood to enter said perfusion conduit; and

at least one effluent perfusion port opening into said perfusion conduit, said effluent perfusion port disposed proximate said distal end of said dilatation balloon so as to conduct blood from said perfusion conduit back into said artery and maintain a steady flow of blood past said dilatation balloon during the dilatation process.

2. A catheter for dilatation of an obstructed artery while maintaining a steady flow of blood past the obstruction, comprising:

an axially elongate catheter shaft, constructed and arranged for insertion into a body lumen, said catheter shaft having a perfusion conduit and a separate guide wire conduit extending axially therethrough;

a dilatation balloon, secured to said catheter shaft, said dilatation balloon having a proximal end and a distal end;

an inflation lumen adjacent at least one of said guide wire conduit and said perfusion conduit, said inflation lumen in fluid communication with said dilatation balloon for selective inflation and deflation of said dilatation balloon;

at least one influent perfusion port, disposed upstream of the proximal end of said dilatation balloon, said influent port opening into said perfusion conduit to enable blood from said artery to enter said perfusion conduit; and

at least one effluent perfusion port opening into said perfusion conduit, said effluent perfusion port disposed downstream of the distal end of said dilatation balloon to conduct blood from said perfusion conduit back into said artery and maintain a steady flow of blood past said dilatation balloon during the dilatation process.

3. A catheter as defined by claim 2, wherein the guide wire conduit extends axially through and within said perfusion conduit.

4. A catheter as defined by claim 2, further comprising a guide wire, constructed and arranged for insertion into said guide wire conduit, said guide wire aiding in steering said catheter through said artery.

5. A dilatation catheter for relieving an obstructed artery while maintaining a steady flow of blood past the obstruction, comprising:

an elongate tubular body;

a dilatation balloon, secured to said tubular body, said balloon having two ends;

a first conduit extending axially through at least a portion of said elongate tubular body for receiving a guide wire;

a second conduit extending axially through at least a portion of the tubular body for allowing blood flow to bypass the dilatation balloon;

at least one influent perfusion port in fluid communication with said second conduit, said influent perfusion port disposed upstream from said dilatation balloon so as to enable blood from said artery to enter said second conduit; and

at least one effluent perfusion port in fluid communication with said second conduit, said effluent perfusion port disposed downstream from said dilatation balloon so as to conduct blood from said second conduit back into said artery and maintain a steady flow of blood past said dilatation balloon during the dilatation process.

6. A method of relieving stenotic regions of a body lumen while maintaining a steady flow of blood distal to the stenotic region, said method comprising the steps of:

positioning a guide wire within a body lumen;

mounting an axially elongate dilatation catheter with a separate perfusion conduit and guide wire conduit on the guide wire by positioning the guide wire within the guide wire conduit;

advancing the dilatation catheter along the guide wire into the body lumen to position a dilatation balloon proximate said stenosis;

injecting a suitable pressurized fluid into said dilatation balloon to increase radially the size of said dilatation balloon so as to increase the size of said lumen by radial expansion;

channeling blood flow through said perfusion conduit so as to bypass said dilatation balloon without the need to move the guide wire;

deflating the dilatation balloon; and

withdrawing said dilatation catheter from said body lumen.

7. The method of claim 6, further comprising the step of leaving the catheter in the body lumen with said dilatation balloon across the stenosis, such that blood will perfuse through the perfusion conduit and bypass the stenotic region to maintain a steady flow of blood through said stenotic region.

8. A method for maintaining steady blood flow through a stenotic region in a vascular lumen, said method comprising the steps of:

positioning a guide wire within a body lumen;

mounting an axially elongate dilatation catheter with a separate perfusion conduit and guide wire conduit on the guide wire by positioning the guide wire within the guide wire conduit;

advancing the dilatation catheter along the guide wire into the body lumen to position a dilatation balloon proximate said stenotic region;

channeling blood from said body lumen through at least one upstream influent perfusion port in fluid communication with said perfusion conduit; and

channeling blood from said perfusion conduit through at least one downstream effluent perfusion port in fluid communication with said perfusion conduit without the need to move the guide wire, such that blood from said perfusion conduit flows back into said body lumen to maintain a steady blood flow through said stenotic region.

9. A method for maintaining steady blood flow through a stenotic region in a vascular lumen, said method comprising the steps of:

positioning a guide wire within said vascular lumen;

mounting an axially elongate dilatation catheter having a first conduit adapted to receive a guide wire and a second conduit for allowing blood to bypass a dilatation balloon on the guide wire by positioning the guide wire within the guide wire conduit;

advancing the catheter along the guide wire into said vascular lumen to position said dilatation balloon proximate said stenotic region; and

channeling blood flow through said second conduit to bypass said dilatation balloon to allow a steady blood flow through said stenotic region without the need to move the guide wire.

10. A dilatation catheter for relieving an obstructed artery while maintaining a steady flow of blood past the obstruction, comprising:

an elongate tubular body;

a dilatation balloon, secured to said tubular body, said balloon having an upstream end and a downstream end;

a first conduit extending axially through at least a portion of said elongate tubular body for receiving a guide wire;

a second conduit extending axially about the first conduit and through at least a portion of the tubular body for allowing blood flow to bypass the dilatation balloon;

a plurality of influent perfusion ports in fluid communication with said second conduit and disposed upstream from the upstream end of said dilatation balloon so as to enable blood from said artery to enter said second conduit; and

at least one effluent perfusion port in fluid communication with said second conduit, and said effluent perfusion port disposed downstream from the downstream end of said dilatation balloon so as to conduct blood from said second conduit back into said artery and maintain a steady flow of blood past said dilatation balloon during the dilatation process.

11. A catheter for dilatation of an obstructed artery while maintaining a steady flow of blood past the obstruction, comprising:

an axially elongate catheter shaft, constructed and arranged for insertion into a body lumen, said catheter shaft having a perfusion conduit and a separate guide wire conduit extending axially therethrough, wherein the guide wire conduit extends co-axially through and within said perfusion conduit;

a dilatation balloon, secured to said catheter shaft, said dilatation balloon having a proximal end and a distal end;

an inflation lumen adjacent at least one of said guide wire conduit and said perfusion conduit, said inflation lumen in fluid communication with said dilatation balloon for selective inflation and deflation of said dilatation balloon;

a plurality of influent perfusion ports disposed upstream from the proximal end of said dilatation balloon, said influent perfusion ports opening into said perfusion conduit to enable blood from said artery to enter said perfusion conduit; and

at least one effluent perfusion pot disposed downstream from the distal end of said dilatation balloon to conduct blood from said perfusion conduit back into said artery and maintain a steady flow of blood past said dilatation balloon during the dilatation process.

12. A dilatation catheter for relieving an obstructed coronary artery while maintaining a steady flow of blood past the obstruction, comprising:

an axially elongate catheter shaft;

a guide wire conduit in said catheter shaft adapted to receive a guide wire;

a dilatation balloon, secured to said catheter shaft, said dilatation balloon having a proximal end and a distal end;

an inflation lumen in said catheter shaft for transmitting pressurized fluid into and out of said dilatation balloon, for selective inflation and deflation thereof;

a perfusion conduit in said catheter shaft for providing a path through which blood may bypass said dilatation balloon when said balloon is in an inflated state and occluding said artery, said perfusion conduit separate from said guide wire conduit and extending along at least a portion of the guide wire conduit, obviating the need to withdraw said guide wire to allow blood to bypass said dilatation balloon;

a plurality of influent perfusion ports disposed proximate to the proximal end of said dilatation balloon, said influent ports opening into said perfusion conduit so as to enable blood to enter said perfusion conduit; and

at least one effluent perfusion port disposed proximal to said distal end of said dilatation balloon so as to conduct blood from said perfusion conduit back into said artery and maintain a steady flow of blood past said dilatation balloon during the dilatation process.