Perfusion balloon brace and method of use

• US 6,245,040 B1
• Filed: 08/29/1996
• Issued: 06/12/2001
• Est. Priority Date: 01/14/1994
• Status: Expired due to Term

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Johnson, Kirk, Martinez, Susana, Inderbitzen, Mark
• Primary Examiner(s): Thaler, Michael H.
• Assistant Examiner(s): Lewis, William W.
• Application Number:
  US08/705,005
• Time in Patent Office: 1,748 Days
• Field of Search: 602/192, 602/194, 602/159, 604/96, 604/103, 604/96.01, 604/103.07, 604/103.08, 606/195, 606/198
• US Class Current: 604/103.07
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 2025/1059 having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties with different compartments A61M2025/1072
• CPC Class Codes: A61M 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• 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 25/104 used for angioplasty

Abstract

A dilation catheter suitable for use in medical procedures is provided which includes a balloon disposed on an elongated flexible tube. The tube is capable of passing fluid between the balloon and the tube for varying the balloon between a collapsed and expanded condition. The catheter includes a brace fitted over the balloon for restricting expansion of a selected portion of the balloon for forming a perfusion channel that allows fluid to be perfused past the balloon when it is expanded in a body vessel. A medical procedure for dilation under perfusion conditions is also provided.

Claims

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

an elongated tubular shaft;

a dilation balloon disposed on said tubular shaft, said balloon having opposite ends and exterior surface;

means for passing fluid between said tubular shaft and said balloon to vary said balloon between a collapsed condition of a size allowing said catheter to be transported through a body vessel and an expanded condition of a size allowing said exterior surface to engage a body vessel wall;

a profusion brace disposed about said balloon independently of and in substantially non-compressive relationship to the exterior surface of said balloon when said balloon is in its collapsed condition, said perfusion brace being positioned to engage and restrict the expansion of a selected portion of said balloon when said balloon is radially expanded while permitting radial expansion of the remaining portion of said balloon to an extent greater than the expansion of the selected portion to define a perfusion channel spaced radially outwardly from said selected portion of the balloon when said balloon is in its expanded condition, spaced radially inwardly from said remaining portion of the balloon in its expanded condition, and communicating between said opposite ends of said balloon; and

both of said selected portion and said remaining portion of the exterior surface of the balloon are radially spaced from said tubular shaft when said balloon is in its expanded condition.

2. The perfusion catheter of claim 1, wherein said remaining portion of the exterior surface, when said balloon is in its collapsed condition, has a radial extent which is substantially no greater than the radial extent of said brace.

3. The perfusion catheter of claim 1, wherein said remaining portion of the exterior surface is spaced radially outwardly from said brace when said balloon is in its expanded condition.

4. The perfusion catheter of claim 1, wherein said brace includes a pair of spaced rings connected by a helical member that extends substantially the entire length of the balloon.

5. The perfusion catheter of claim 1, wherein said means for passing fluid includes at least one pathway between said tubular shaft and said balloon.

6. The perfusion catheter of claim 1, wherein said balloon is integrally formed with said tubular shaft.

7. The perfusion catheter of claim 1, wherein said brace includes a pair of spaced rings connected by at least one longitudinally extending strut.

8. The perfusion catheter of claim 1, wherein said balloon is constructed of a relatively compliant material.

9. The perfusion catheter of claim 1, wherein said perfusion brace is radially spaced from said tubular shaft when said balloon is in its collapsed condition.

10. A perfusion brace for transforming a dilation balloon catheter into a perfusion balloon catheter, said perfusion brace comprising:

at least two spaced apart rings, said rings being substantially coaxial with each other and connected by at least one perfusion channel defining member to define a perfusion brace that is slidable onto a collapsed dilation balloon of a catheter to transform the catheter into a perfusion balloon catheter;

said perfusion channel defining member being independent of and dimensioned to be in substantially non-compressive relationship to the exterior surface of the balloon when positioned on the collapsed balloon, but restricting radial expansion of a selected portion of the dilation balloon when the balloon is radially expanded with the brace thereon, said perfusion channel defining member also being dimensioned to extend over substantially the length of the dilation balloon and having a radial extent which is less than the radial extent of the dilation balloon when expanded in order to define a perfusion channel on the balloon radially outwardly of said perfusion channel defining member when said perfusion brace is positioned on the dilation balloon and the dilation balloon is expanded.

11. The perfusion brace of claim 10, further including means for preventing longitudinal movement of said brace with respect to said balloon catheter after the perfusion brace has been slid onto the dilation balloon.

12. The perfusion brace of claim 11, wherein said means for preventing longitudinal movement includes a flange extending from one of said annular rings for cooperating with a portion of said catheter.

13. The perfusion brace of claim 10, wherein said perfusion channel defining member is helically shaped.

14. The perfusion brace of claim 10, wherein said perfusion channel defining member includes at least one longitudinally extending strut.

15. An improved perfusion balloon catheter of a type having an elongated flexible tubular shaft, an extensible balloon disposed on said shaft, said balloon having opposite ends and an exterior surface and being inflatable between a collapsed condition of a size allowing transport through a body vessel and an expanded condition of a size allowing said exterior surface to engage a body vessel wall, and means for passing fluid between said tubular shaft and said balloon for varying said balloon between said collapsed and expanded conditions, the improvement comprising:

a brace disposed about said balloon independently of and in substantially non-compressive relationship to the exterior surface of said balloon when said balloon is in its collapsed condition;

said brace being positioned to engage and restrict expansion of a selected portion of said balloon when said balloon is radially expanded while permitting radial expansion of the remaining portion of said balloon to an extent greater than the expansion of the selected portion to define a perfusion channel when said balloon is in its expanded condition, spaced radially inwardly from said remaining portion of the balloon in its expanded condition, and communicating between said opposite ends of said balloon; and

both of said selected portion and said remaining portion of the exterior surface of the balloon are radially spaced from said tubular shaft when said balloon is in its expanded condition.

16. The improved perfusion balloon catheter of claim 15, wherein said brace includes at least two spaced coaxial rings, said rings connected by at least one perfusion channel defining member that extends substantially the entire length of the expanded balloon in its expanded condition.

17. The improved perfusion balloon catheter of claim 16, wherein said perfusion channel defining member is substantially helically shaped.

18. The improved perfusion balloon catheter of claim 16, wherein said perfusion channel defining member is at least one longitudinally extending strut.

19. The improved perfusion balloon catheter of claim 15, further including means for preventing longitudinal movement of said brace in a first direction.

20. The improved perfusion balloon catheter of claim 19, wherein said means for preventing longitudinal movement includes a barb disposed on said tubular shaft for cooperating with a portion of said brace.

21. The improved perfusion balloon catheter of claim 15, wherein said balloon is constructed of a relatively compliant material.

22. The improved perfusion balloon catheter of claim 15, wherein said brace is radially spaced from said tubular shaft when said balloon is in its collapsed condition.

23. A method of performing percutaneous transluminal coronary angioplasty comprising the steps of:

providing an elongated tubular catheter shaft and a dilation balloon disposed on said shaft, said balloon having an exterior surface and being inflatable between a collapsed condition and an expanded condition;

placing a perfusion brace over the exterior surface of said balloon and said shaft when said balloon is in its collapsed condition, said perfusion brace being independent of and in substantially non-compressive relationship to the exterior surface of said balloon when said balloon is in its collapsed condition;

inserting said catheter into a body vessel and aligning said balloon adjacent an area of said body vessel upon which the angioplasty is to be performed;

inflating said balloon to its expanded condition in which a dilating portion of said exterior surface of the balloon engages said area of said body vessel while simultaneously restricting expansion of a selected portion of said exterior surface of the balloon by engaging the perfusion brace to form a perfusion channel spaced radially inwardly from said dilating portion of the exterior surface of the balloon; and

perfusing body fluid past said balloon through the perfusion channel.

24. The method of claim 23, further including the step of deflating said balloon from its expanded condition to its collapsed condition and repositioning and reinflating said balloon in said body vessel to insure that the entire said area of the body vessel is engaged by said balloon in its expanded condition.

25. The method of claim 24, wherein said repositioning step includes moving the balloon in a longitudinal direction until the dilating portion of the balloon moves to a location along the vessel area that had been opposite to said selected portion of the balloon during said inflating step.

26. The method of claim 24, wherein said repositioning step includes rotating the balloon until the dilating portion of the balloon moves to a location along the vessel area that had been opposite to said selected portion of the balloon during said inflating step.

27. The method of claim 23, wherein said perfusion brace is radially spaced from said tubular shaft when said balloon is in its collapsed condition.

28. The method of claim 23, wherein both of said selected portion and said dilating portion of the exterior surface of the balloon are radially spaced from said tubular catheter shaft when said balloon is in its expanded condition.