Perfusion balloon catheter

• US 5,108,370 A
• Filed: 10/03/1989
• Issued: 04/28/1992
• Est. Priority Date: 10/03/1989
• Status: Expired due to Fees

• Current Assignee: Walinsky, Paul
• Original Assignee: Walinsky, Paul
• Inventors: Walinsky, Paul
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Lewis, William W.
• Application Number:
  US07/416,709
• Time in Patent Office: 938 Days
• Field of Search: 604/96-104, 606/192, 606/194
• US Class Current: 604/102.02
• CPC Class Codes: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A perfusion balloon catheter, as for angioplasty, has the balloon formed so that, when inflated within a vas or coronary artery, one or more channels are provided for the flow of bodily fluids or blood past the inflated balloon. In one embodiment, the balloon has a toroidal shape which defines a central open channel. In another embodiment, the balloon defines a multiply-lobed form which allows flow between the lobes. Balloon catheters with open channels, when used for angioplasty, reduce the likelihood of early termination of the procedure due to chest pain.

Claims

1. A catheter, comprising:

an elongated portion defining proximal and distal ends and also defining at least one elongated lumen adapted for the flow of fluid therethrough;

balloon membrane means coupled near said distal end of said elongated portion, said balloon membrane means including an exterior surface, said balloon membrane means being adapted for inflation within a vas and being configured, when so inflated within a vas, to define a toroidal balloon including a central opening adjacent said exterior surface of said balloon membrane means, said central opening extending from a distal end of said balloon to a proximal end of said balloon, said central opening being larger in diameter than said elongated portion, said elongated portion passing through said central opening and being affixed to said exterior of said balloon membrane means of said central opening to thereby define an aperture for the flow of fluids therethrough from said proximal to said distal ends of said balloon membrane means; and

at least one aperture between said elongated lumen defined by said elongated portion and the interior of said balloon.

2. A method for making a balloon catheter, said method comprising the steps of:

forming an elongated cylindrical membrane defining an axis, at least one inner diameter in a plane perpendicular to said axis, a length parallel to said axis, and open first and second ends;

inserting through said open first end of said cylindrical membrane, in a direction about parallel with said axis, an elongated portion of said catheter defining an axial lumen adapted for the flow of inflation fluid therethrough, said elongated portion having an overall outer diameter smaller than said inner diameter of said cylindrical membrane;

attaching a portion of said inner wall of said cylindrical membrane to the exterior of said elongated portion of said catheter near a distal end of said elongated portion of said catheter, said attachment being performed at least at locations along a line approximately parallel with said axis;

opening said lumen to the exterior of said elongated portion of said catheter at a location which when said balloon catheter is made lies between first and second ends of said balloon; and

after said attaching step, closing said open first and second ends in such a manner as to cause said membrane to form a toroidal balloon defining a central opening having said inner diameter, through which central opening said elongated portion passes, to thereby leave a portion of said central opening free for passage of body fluids therethrough.

3. A method according to claim 2 wherein said step of open said lumen is performed before said step of closing.

4. A method according to claim 3 wherein said step of opening said lumen comprises:

an initial step preceding said step of inserting, said initial step including the steps of defining an aperture in the side of said elongated portion of said catheter, said aperture extending into said axial lumen; and

wherein

said step of attaching includes the step of positioning said balloon membrane over said aperture in said elongated portion of said catheter.

5. A method according to claim 2 wherein said step of closing includes the step of pulling said balloon membrane at said first and second ends of said cylindrical membrane relatively toward each other exteriorly of the cylinder of said cylindrical membrane;

and

attaching the periphery of said first open end to the periphery of said second open end to thereby close said first and second ends on each other to form said balloon and thereby define, when said balloon is inflated, a toroidal shape.

6. A method for making a balloon catheter, comprising the steps of:

forming an elongated cylindrical membrane including a right circular portion defining a central opening and at least one flared portion, said cylindrical membrane defining a first open end and also a second open end adjacent the large end of said flared portion, with said central opening extending between said first and second open ends;

defining an aperture through said flared portion of said balloon membrane;

inserting through said aperture the distal end of an elongated portion of said catheter defining a lumen adapted for the flow of fluid therethrough;

sealing the periphery of said aperture to the exterior surface of said elongated portion; and

closing said first and second open ends in such a manner as to cause said membrane to form a toroidal balloon with said central opening extending parallel with said elongated portion.