Tandem balloon catheter

• US 5,674,198 A
• Filed: 06/23/1995
• Issued: 10/07/1997
• Est. Priority Date: 06/23/1995
• Status: Expired due to Term

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Leone, James E.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/493,903
• Time in Patent Office: 837 Days
• Field of Search: 604/96, 604/101, 604/49-54, 604/280, 604/102, 604/103, 604/104
• 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 2025/1097 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 25/1011 Multiple balloon catheters

Abstract

A balloon catheter comprises a catheter shaft and a plurality of lumens, having a pair of spaced, inflatable balloons carried on the shaft to define an interballoon space between the balloons. Each of the balloons are connected to a separate inflation lumen to permit separate inflation and deflation. A fluid flow lumen extends through the catheter shaft and communicates with the interballoon space. Preferably, a perfusion lumen extends through the catheter shaft and the distal end to permit the shunting of blood past the inflated balloons. The spaced balloons are made of an elastomeric material, and are capable of being inflated to a diameter greater than their length. The catheter may be used by inflating a first catheter balloon to block a blood vessel. One then adds a therapeutic agent to the blood vessel at a position on one side of the first balloon through a flow lumen in the catheter. One then inflates a second catheter balloon to block the blood vessel and isolate the medication between the two balloons, while avoiding undue pressure increase in the interballoon space.

Claims

1. A balloon catheter which comprises:

a catheter shaft defining a plurality of lumens and proximal and distal catheter ends;

a pair of spaced, inflatable balloons carried on said shaft to define an interballoon space between said balloons, each of said balloons being connected to a separate inflation lumen;

a fluid flow lumen extending through said catheter shaft and communicating with the interballoon space to provide a therapeutic agent to the interballoon space, both of the spaced balloons being made of an elastomeric material having an elongation to break of at least 100 percent and capable of being inflated to a diameter that is greater than their length.

2. The catheter of claim 1 in which said fluid flow lumen communicates with the interballoon space at a position that is nearer to the distal balloon of said spaced, inflatable balloons than the proximal balloon of said balloons.

4. The catheter of claim 1 in which said fluid flow lumen communicates with the interballoon space at a position that is adjacent to one of the spaced balloons and remote from the other spaced balloon.

6. The catheter of claim 1 further comprising a perfusion lumen extending through said catheter shaft and said distal end, to provide a shunting circuit for blood through said balloons while said balloons are inflated.

10. The balloon catheter of claim 1 in which at least one of said spaced balloons has a length of 2 to 4 mm.

11. The balloon catheter of claim 1 in which at least one of said spaced balloons has a length of 2 to 4 mm.

3. A balloon catheter which comprises:

a catheter shaft defining a plurality of lumens and proximal and distal catheter ends;

a pair of spaced, inflatable balloons carried on said shaft to define an interballoon space between said balloons, each of said balloons being connected to a separate inflation lumen;

a fluid flow lumen extending through said catheter shaft and communicating with the interballoon space, the spaced balloons being made of an elastomeric material and capable of being inflated to a diameter that is greater than their length;

said balloons being made of a polyurethane having a more accurate pressure-diameter relation than polyolefin rubber latex, said polyurethane having a Shore A durometer of 40 to 90 and an elongation to break of 150 to 500 percent.

5. A balloon catheter which comprises:

a catheter shaft defining a plurality of lumens and proximal and distal catheter ends;

a pair of spaced, inflatable balloons carried on said shaft to define an interballoon space between said balloons, each of said balloons being connected to a separate inflation lumen;

a fluid flow lumen extending through said catheter shaft and communicating with the interballoon space, the spaced balloons being made of an elastomeric material and capable of being inflated to a diameter that is greater than their length;

said fluid flow lumen communicates with the interballoon space at a position that is adjacent to one of the spaced balloons and remote from the other spaced balloon;

said balloons being made of a polyurethane having a more accurate pressure-diameter relation than natural rubber latex.

7. A balloon catheter which comprises:

a catheter shaft defining a plurality of lumens and proximal and distal catheter ends;

a pair of spaced, inflatable balloons carried on said shaft to define an interballoon space between said balloons, each of said balloons being connected to a separate inflation lumen;

a fluid flow lumen extending through said catheter shaft and communicating with the interballoon space, the spaced balloons being made of an elastomeric material and capable of being inflated to a diameter that is greater than their length;

a perfusion lumen extending through said catheter shaft and said distal end, to provide a shunting circuit for blood through said balloons while said balloons are inflated;

said perfusion lumen being of larger cross sectional area than any of said inflation lumens and fluid flow lumen, said perfusion lumen being substantially circular in cross-sectional area while said inflation lumens and fluid flow lumen have a cross section comprising a wide dimension and a perpendicular narrow dimension, said wide dimension being less than the diameter of said perfusion lumen.

8. The catheter of claim 7 in which said fluid flow lumen communicates with the interballoon space at a position which is adjacent to one of said balloons and remote from the other of said balloons.

9. The catheter of claim 8 in which said balloons are made of a polyurethane having a more accurate pressure-diameter relation than polyolefin rubber latex.

12. The method of inserting a catheter into a blood vessel of a patient;

inflating a first catheter balloon to block said blood vessel;

adding a therapeutic agent to said blood vessel at a position on one side of said first catheter balloon through a flow lumen in said catheter; and

then inflating a second catheter balloon to block said blood vessel, said second balloon being longitudinally spaced from said first balloon on said one side to enclose said therapeutic agent between said balloons, both of the spaced balloons being made of an elastomeric material having an elongation to break of at least 100 percent and capable of being inflated to a diameter that is greater than their length.

13. The method of inserting a catheter into a blood vessel of a patient;

inflating a first catheter balloon to block said blood vessel;

adding a therapeutic agent to said blood vessel at a position on one side of said first catheter balloon through a flow lumen in said catheter; and

then inflating a second catheter balloon to block said blood vessel, said second balloon being longitudinally spaced from said first balloon on said one side to enclose said therapeutic agent between said balloons; and

passing blood through a portion of said catheter to bypass said catheter balloons while said first and second balloons are inflated.

14. The method of claim 13 in which one thereafter deflates one of said balloons and withdraws at least some of said therapeutic agent from said blood vessel back into said catheter flow lumen, prior to deflating the other of said balloons.

15. The method of inserting a catheter into a blood vessel of a patient;

inflating a first catheter balloon to block said blood vessel;

adding a therapeutic agent to said blood vessel at a position on one side of said first catheter balloon through a flow lumen in said catheter; and

then inflating a second catheter balloon to block said blood vessel, said second balloon being longitudinally spaced from said first balloon on said one side to enclose said therapeutic agent between said balloons;

thereafter deflating one of said balloons and withdraws at least some of said therapeutic agent from said blood vessel back into said catheter flow lumen prior to deflating the other of said balloons.

16. A balloon catheter which comprises:

a catheter shaft defining a plurality of lumens and proximal and distal catheter ends;

a pair of spaced, inflatable balloons carried on said shaft to define an interballoon space between said balloons, each of said balloons being connected to an inflation lumen;

a fluid flow lumen extending through said catheter shaft and communicating with the interballoon space, the spaced balloons being made of an elastomeric material and capable of being inflated to a diameter that is greater than their length, said catheter further comprising a perfusion lumen extending through said catheter shaft and said distal end, to provide a shunting path for blood through said balloons while said balloons are inflated, in which said perfusion lumen is of larger cross-sectional area than any of said inflation lumens and fluid flow lumen, said perfusion lumen being substantially circular in cross-section, said inflation lumens and fluid flow lumen having cross sections which have a large dimension and a substantially smaller perpendicular dimension, the large dimensions of said inflation lumens and fluid flow lumen being each less than the diameter of the cross section of said perfusion lumen.

17. The catheter of claim 16 in which said balloons are made of a polyurethane having a more accurate pressure-diameter relation than polyolefin rubber latex, said polyurethane having a Shore A durometer of 40 to 90 and an elongation to break of 150 to 500 percent.

18. The catheter of claim 16 in which said fluid flow lumen communicates with the interballoon space at a position that is adjacent to one of the spaced balloons and remote from the other spaced balloon.

19. The balloon catheter of claim 16 in which at least one of said spaced balloons has a length of 2 to 4 mm.