Bailout receptacle for angioplasty catheter

• US 5,342,297 A
• Filed: 07/10/1992
• Issued: 08/30/1994
• Est. Priority Date: 07/10/1992
• Status: Expired due to Term

• Current Assignee: Jang, G. David
• Original Assignee: Jang, G. David
• Inventors: Jang, G. David
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Maglione, Corrine
• Application Number:
  US07/911,779
• Time in Patent Office: 781 Days
• Field of Search: 604/96, 604/101, 604/102, 604/264, 604/280, 604/49.52-49.53, 606/192-194, 128/656-658
• US Class Current: 604/508
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A bailout system for procedures involving angioplasty catheters, comprising a receptacle sized to fit inside an angioplasty guiding catheter, comprising an elongate tubular shaft having a lumen extending longitudinally therethrough from a proximal end to a distal end, a balloon angioplasty catheter extending through the lumen, the angioplasty catheter and the receptacle each adapted to slide longitudinally with respect to each other, and a longitudinally movable guidewire extending through the lumen but outside of the angioplasty catheter. Also disclosed is a method for using the system.

Claims

1. A method for practicing balloon angioplasty, comprising the steps of:

a. providing a bailout system, said bailout system comprising;

a receptacle comprising an elongate tubular shaft having a lumen of a substantially constant diameter extending longitudinally therethrough from a proximal end to a distal end, said receptacle being adapted to extend longitudinally through a guiding catheter; and

a balloon angioplasty catheter having a proximal end and a distal end and an angioplasty balloon at or near the distal end of the catheter, said balloon in communication with a balloon inflation lumen and said balloon further having a maximum inflated diameter, said angioplasty catheter extending through said lumen, said angioplasty catheter and said receptacle each adapted to freely slide longitudinally with respect to each other, and wherein the diameter of the lumen in the receptacle is not greater than the maximum inflated diameter of the balloon;

b. positioning the bailout system in a patient, so that the angioplasty balloon of the angioplasty catheter is positioned in a stenosis;

c. inflating and deflating the balloon to dilate the stenosis;

d. advancing the distal end of the bailout receptacle through the stenosis;

e. then advancing a guidewire through the bailout receptacle and through the lesion, such that the guidewire is outside of said catheter along the entire length of said catheter; and

f. withdrawing the angioplasty catheter from the patient, leaving the guidewire in the dilated lesion.

2. The method of claim 1, wherein said receptacle further comprises guidewire removing means for permitting removal of a guidewire laterally through the shaft, said guidewire removing means extending longitudinally along at least a portion of the shaft, further comprising the final step of removing the receptacle from the patient while maintaining the position of the bailout guidewire in the lesion, so that the bailout guidewire is removed laterally from the receptacle through the guidewire removing means.

3. A method for dilating a bifurcation double lesion, comprising the ordered steps of:

(a) providing a bailout system, said bailout system comprising;

a receptacle comprising an elongate tubular shaft having a lumen of a substantially constant diameter extending longitudinally therethrough from a proximal end to a distal end, said receptacle being adapted to extend longitudinally through a guiding catheter; and

a balloon angioplasty catheter having a proximal end and a distal end and an angioplasty balloon at or near the distal end of the catheter, said balloon in communication with a balloon inflation lumen and said balloon further having a maximum inflated diameter, said angioplasty catheter extending through said lumen, said angioplasty catheter and said receptacle each adapted to freely slide longitudinally with respect to each other, and wherein the diameter of the lumen in the receptacle is not greater than the maximum inflated diameter of the balloon;

(b) advancing the system into the coronary artery of a human patient having coronary bifurcation lesion disease at a branch of said artery, so that the angioplasty balloon is in a first bifurcation lesion, and advancing a guidewire through said bailout receptacle so that the guidewire is extending through a second bifurcation lesion, such that the guidewire is outside of said catheter along the entire length of said catheter;

(c) inflating and deflating the balloon to dilate the first bifurcation lesion;

(d) reversing the respective positions of the balloon and the bailout guidewire, so that the guidewire is in the dilated first bifurcation lesion and the balloon is in the second bifurcation lesion; and

(e) inflating and deflating the balloon to dilate the second bifurcation lesion.

4. The method of claim 3, comprising, in addition to steps (a)-(d), the step of withdrawing the balloon catheter from the second dilated lesion, and allowing the guidewire to remain in one of the two dilated lesions for bailout purposes.

5. A bailout system for procedures involving angioplasty catheters, comprising:

a guiding catheter;

a receptacle of a substantially constant diameter extending logitudinally through the guiding catheter, comprising an elongate tubular shaft having a lumen extending longitudinally therethrough from a proximal end to a distal end;

a balloon angioplasty catheter extending through said lumen, said angioplasty catheter and said receptacle each adapted to slide longitudinally with respect to each other; and

a longitudinally movable guidewire extending through said lumen, wherein said guidewire is outside of said angioplasty catheter along the entire length of the catheter.

6. The system of claim 5, wherein said angioplasty catheter is a peripheral angioplasty catheter.

7. The system of claim 5, wherein said angioplasty catheter is a fixed wire coronary balloon angioplasty catheter.

8. The system of claim 5, wherein the diameter of said receptacle shaft is 3.9 French or smaller.

9. The system of claim 8, wherein said receptacle further comprises an enlarged connector at the proximal end thereof through which said angioplasty catheter extends into said lumen.

10. The system of claim 5, wherein said receptacle includes a side port extending through said shaft and adapted to receive a guidewire extending therethrough.

11. The system of claim 10, wherein said side port is located toward the proximal end of said receptacle at a point ordinarily outside a patient during use of said system.

12. The system of claim 5, wherein said receptacle further includes a guidewire removing means for permitting removal of the guidewire laterally through said shaft, said guidewire removing means extending longitudinally along at least a portion of said shaft.

13. The system of claim 12, wherein said guidewire removing means comprises a slit.

14. The system of claim 12, wherein said guidewire removing means is adapted to form a slit when lateral removal of said guidewire is desired.

15. The system of claim 12, wherein said guidewire removing means extends distally along said shaft to within about 40 cm of the distal end of said receptacle.

16. The system of claim 12, wherein said guidewire removing means extends distally along said shaft to the distal end of said receptacle.

17. The system of claim 12, wherein said shaft further includes a side port adapted to receive a guidewire extending therethrough into said lumen, said side port located at a point ordinarily outside the body during use, and wherein said guidewire removing means extends distally from said side port.

18. The system of claim 5, wherein said shaft has a first proximal segment and a second distal segment, and wherein said first segment is more rigid than said second segment.

19. The system of claim 18, wherein said first segment is made of a different material than said second segment.

20. The system of claim 18, wherein said second segment is between about 1 and about 20 cm in length.

21. A bailout system for procedures involving balloon angioplasty catheters, comprising:

a receptacle comprising an elongate tubular shaft having a lumen of a substantially constant diameter extending longitudinally therethrough from a proximal end to a distal end, said receptacle being adapted to extend longitudinally through a guiding catheter, and a side port extending through said shaft adapted to receive a guidewire extending therethrough;

a balloon angioplasty catheter extending through said lumen, said angioplasty catheter and said receptacle each adapted to freely slide longitudinally with respect to each other, wherein the balloon angioplasty catheter has an angioplasty balloon having a maximum inflated diameter, and wherein the diameter of the lumen in the receptacle is not greater than the maximum inflated diameter of the balloon; and

a longitudinally movable guidewire extending through said lumen, wherein said guidewire is outside of said catheter along the entire length of said catheter.

22. The system of claim 21, wherein said side port is located toward the proximal end of said receptacle at a point ordinarily outside a patient during use of said system.

23. The system of claim 21, wherein said receptacle further includes a guidewire removing means for permitting removal of the guidewire laterally through said shaft, said guidewire removing means extending longitudinally along at least a portion of said shaft.

24. The system of claim 23, wherein said guidewire removing means comprises a slit.

25. The system of claim 23, wherein said guidewire removing means is adapted to form a slit when lateral removal of said guidewire is desired.

26. The system of claim 23, wherein said guidewire removing means extends distally along said shaft to within about 40 cm of the distal end of said receptacle.

27. The system of claim 23, wherein said guidewire removing means extends distally along said shaft to the distal end of said receptacle.

28. The system of claim 23, wherein said shaft further includes a proximal side port adapted to receive a guidewire extending therethrough into said lumen, and wherein said guidewire removing means extends distally from said side port.

29. The system of claim 21, wherein said shaft has a first proximal segment and a second distal segment, and wherein said first segment is more rigid than said second segment.

30. The system of claim 29, wherein said first segment is made of a different material than said second segment.

31. The system of claim 29, wherein said second segment is between about 1 and about 20 cm in length.