Perfusion balloon and method of use and manufacture

• US 5,501,667 A
• Filed: 03/15/1994
• Issued: 03/26/1996
• Est. Priority Date: 03/15/1994
• Status: Expired due to Term

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Verduin, Kenneth L. Jr.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/213,150
• Time in Patent Office: 742 Days
• Field of Search: 604/96-103, 604/51-53, 604/280-283, 606/191-194
• US Class Current: 604/101.01
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• 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 25/1009 Balloons anchored to a disc or plate
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

A dilation catheter suitable for use in medical procedures is provided. The catheter includes a balloon disposed on an elongated tube. The tube is capable of passing fluid between the balloon and the tube for varying the balloon between an inflated expanded condition and a deflated collapsed condition. The balloon includes a longitudinally extending septum which cooperates with the exterior skin of the balloon to separate the balloon into a plurality of substantially equally sized chambers. The septum further cooperates with the balloon to form at least one longitudinally extending channel disposed outwardly of the exterior surface between adjacent chambers of the balloon. The channels allow blood to be perfused past the balloon when the balloon is disposed in a body vessel in its expanded condition.

Claims

1. A dilation catheter for use in medical procedures comprising:

an elongated flexible tubular member;

a unitary multichamber balloon having an exterior surface and being disposed on said tubular member, said unitary multichamber balloon having a collapsed condition of a size allowing said balloon to be transported through a body vessel, and said balloon having an expanded condition of a size allowing said balloon to engage a body vessel wall;

a longitudinally extending septum formed integrally with said balloon and coaxial therewith, said septum being generally substantially thicker in width than said exterior surface of said balloon, said septum further including radially extending portions spaced inwardly of said exterior surface and cooperating with said balloon to define a plurality of chambers within said balloon, said septum further cooperating with said balloon to define a longitudinally extending channel exteriorly of and between adjacent chambers of said balloon when said balloon is in its expanded condition; and

means for passing fluid between said balloon chambers and said flexible tubular member to evenly vary said balloon between its collapsed and expanded conditions.

2. The dilation catheter of claim 1, wherein said multichamber balloon includes a first chamber and a second chamber separated by said longitudinally extending septum.

3. The dilation catheter of claim 1, wherein said plurality of chambers are equally sized.

4. The dilation catheter of claim 1, wherein said flexible tubular member includes a first lumen for transporting a fluid and a second lumen for receiving a guidewire.

5. The dilation catheter of claim 1, wherein said flexible tubular member includes an inner lumen for receiving a guidewire and an outer lumen for transporting a fluid.

6. The dilation catheter of claim 1, wherein said flexible tube is coaxial with the longitudinal axis of said longitudinally extending septum.

7. The dilation catheter of claim 1, wherein said means for passing fluid between said balloon member and said flexible tubing includes at least one pathway between said flexible tubular member and each chamber of said multichamber balloon.

8. The dilation catheter of claim 4, wherein the proximal end of said balloon is in seal-tight communication with a first tube defining said first lumen and the distal end of said balloon is sealingly connected to a second tube defining said second lumen.

9. The dilation catheter of claim 1, further including a membrane disposed over said longitudinally extending channel, said membrane sealingly connected to the exterior surface of the balloon.

10. The dilation catheter of claim 1, wherein said balloon dimensions increase approximately on the order of three times between its collapsed condition and its expanded condition.

11. The dilation catheter of claim 1, wherein said longitudinally extending septum is a common element to each of the chambers of said multichambered balloon.

12. A method of forming a dilation catheter having a unitary multichamber balloon with a longitudinally extending perfusion channel for perfusing fluid past the balloon when the balloon is disposed in a vessel, said balloon being inflatable between a collapsed condition and an expanded condition, said method comprising:

providing an outlet die having a single continuous outlet portion, said outlet portion having at least one narrow section and one wide section;

supplying a polymer to said outlet die;

extruding a multichambered parison through said outlet die wherein the portion of the polymer extruded through said wide section defines a septum common to each chamber and the portion of the polymer extruded through the narrow section defines an exterior portion of said multichambered parison, said septum being generally substantially thicker in width than said exterior portion of said multichambered parison;

blow molding said multichambered parison to form said unitary multichamber balloon; and

connecting said balloon in seal-tight communication to the distal end of a flexible tubular member.

13. A dilation catheter for use in medical procedures comprising:

an elongated flexible tubular member;

a unitary balloon disposed on said tubular member, said unitary balloon having an interior surface and an exterior surface, and said unitary balloon having a collapsed condition of a size allowing said unitary balloon to be transported through a body vessel and an expanded condition of a size allowing said exterior surface of said unitary balloon to engage a body vessel wall;

said unitary balloon further including a plurality of equally sized chambers defined by a portion of said exterior skin and a longitudinally extending septum formed integrally with said exterior skin and common to each of said chambers, said septum being generally substantially thicker in width than said exterior surface of said unitary balloon, said septum further being coaxial with said unitary balloon and cooperating with said exterior surface to define at least one longitudinally extending channel disposed outwardly of said exterior surface between adjacent chambers of said unitary balloon when said Unitary balloon is in its expanded condition; and

means for passing fluid between said chambers and said flexible tubular member to evenly vary said unitary balloon between its collapsed condition and its expanded condition.

14. The dilation catheter of claim 13, wherein said flexible tubular member includes a first lumen for transporting a fluid and a second lumen for receiving a guidewire.

15. The dilation catheter of claim 13, wherein said flexible tubular member includes an inner lumen for receiving a guidewire and an outer lumen for transporting a fluid.

16. The dilation catheter of claim 13, wherein said flexible tube is coaxial with said longitudinally extending septum.

17. The dilation catheter of claim 13, wherein said means for passing fluid between said balloon member and said flexible tubing includes at least one pathway between said flexible tubular member and each chamber of said multichamber balloon.

18. The dilation catheter of claim 13, wherein the proximal end of said balloon is in seal-tight communication with a first tube defining said first lumen and the distal end of said balloon is sealingly connected to a second tube defining said second lumen.

19. The dilation catheter of claim 13, further including a membrane disposed over said longitudinally extending channel, said membrane sealingly connected to the exterior surface of the balloon.

20. The dilation catheter of claim 13, further including a plurality of longitudinally extending channels.

21. The dilation catheter of claim 13, wherein said septum includes radially extending branches for forming said equally sized chambers.

22. The dilation catheter of claim 21, wherein said radially extending branches traverse the longitudinal extent of said balloon.

23. The dilation catheter of claim 22, wherein said radially extending branches cooperate with said exterior skin to define said longitudinally extending channel disposed outwardly of said exterior surface between adjacent chambers of said balloon.