Interlocking peel-away dilation catheter

Abstract

A dilatation balloon catheter which is capable of being removed from a patient while leaving a guide wire in place has a longitudinal slit extending from its proximal end to a position near its inflatable balloon. The catheter has an inflation lumen for applying fluid to inflate the balloon, and an insertion lumen through which the guide wire passes. The slit communicates with the insertion lumen so that the catheter can be peeled off of the guide wire as the catheter is withdrawn from the patient and the guide wire remains in place in the patient.

What is claimed is: 
     
       1. A catheter which is insertable and removable over a guide wire which has one end adapted for insertion into a vessel of a patient and an opposite end which extends outside of the patient, the catheter comprising: a tubular member having a proximal end, a distal end, a first lumen for transmitting fluid, and a second lumen through which the guide wire passes;   an inflatable balloon carried by the tubular member adjacent the distal end and in communication with the first lumen;   wherein the tubular member includes a longitudinal opening through a side wall of the tubular member and connected to the second lumen, the longitudinal opening extending from adjacent the proximal end of the tubular member to a position spaced from a proximal end of the inflatable balloon and dividing the side wall into first and second wall portions on opposite sides of the longitudinal opening, with the longitudinal opening permitting movement of the guide wire through the longitudinal opening as the tubular member is removed from the patient while the guide wire remains in the patient; interlocking means carried adjacent longitudinal free edge portions of the first and second wall portions, and including first interlocking means carried at a longitudinal free edge of the first wall portion and second interlocking means carried at a longitudinal free edge of the second wall portion, the first and second interlocking means being selectively interlockable to close the longitudinal opening; and   a generally cylindrical sleeve member slidably mounted about the tubular member, the sleeve member having a tubular section through which the guide wire extends and which disengages the interlocking means and locally spreads apart the longitudinal opening to permit passage of the tubular section and guide wire therethrough.   
     
     
       2. The catheter of claim 1 wherein the interlocking means includes a pair of cooperable resilient flaps which resiliently closes the longitudinal opening to prevent passage of the guide wire therethrough with a first flap extending along the longitudinal free edge portion of the first wall portion and overlapping a second flap extending along the longitudinal free edge portion of the second wall portion. 
     
     
       3. The catheter of claim 2 wherein the flaps have thinner wall sections adjacent the longitudinal opening and thicker wall sections away from the opening. 
     
     
       4. The catheter of claim 1 wherein the tubular section of the sleeve member includes an insertion hub having: a first tubular portion generally axially aligned with the tubular member and positioned within the second lumen;   a second tubular portion extending at an angle from the first tubular section outward through the longitudinal opening; and   wherein the guide wire passes through the first and second portions of the insertion hub.   
     
     
       5. The catheter of claim 4 wherein the second tubular portion of the insertion hub includes a luer fitting through which the guide wire passes. 
     
     
       6. The catheter of claim 4 wherein the sleeve member includes: a side port therethrough for the second tubular portion; and   wherein the sleeve member is slidable on the tubular member of the catheter over a span of the longitudinal opening.   
     
     
       7. The catheter of claim 1 wherein the sleeve member includes at least one exterior rib which extends circumferentially about the sleeve member for facilitating gripping of the sleeve member. 
     
     
       8. The catheter of claim 1 wherein the tubular member includes a stop collar adjacent the proximal end for limiting the motion of the sleeve member in a proximal direction. 
     
     
       9. The catheter of claim 1 wherein a distance from the position spaced from the proximal end of the inflatable balloon to the distal tip of the catheter is approximately ten inches. 
     
     
       10. The catheter of claim 1 wherein the first and second interlocking means further comprise: a first C-shaped hook and a second C-shaped hook, the first C-shaped hook extending along the longitudinal free edge of the first wall portion and being cooperable with the second C-shaped hook extending along the longitudinal free edge of the second wall portion.   
     
     
       11. The catheter of claim 1 wherein the first and second interlocking means further comprise: a first ramp-shaped hook and a second ramp-shaped hook, the first hook extending along the longitudinal free edge of the first wall portion and being cooperable with the second hook extending along the longitudinal free edge of the second wall portion.   
     
     
       12. The catheter of claim 1 wherein the first and second interlocking means further comprise: a first barb-shaped hook and a second barb-shaped hook, the first hook extending along the longitudinal free edge of the first wall portion and being cooperable with the second hook extending along the longitudinal free edge of the second wall portion.   
     
     
       13. The catheter of claim 1 wherein the first and second interlocking means further comprise: a rib portion and a groove portion, the rib portion extending along the longitudinal free edge of the first wall portion and being cooperable with the groove portion extending along the longitudinal free edge of the second wall portion.   
     
     
       14. A method of removing a balloon catheter from a patient while leaving a guide wire in place with a proximal end of the guide wire outside the patient and a distal end of the guide wire within the patient, the method comprising: providing a generally cylindrical stripper hub about a proximal end of the balloon catheter which extends outside of the patient;   applying force to the balloon catheter at its proximal end in a direction which causes the balloon catheter to be withdrawn proximally through the stripper hub and out of the patient;   maintaining the guide wire in an essentially stationary position, by grasping the stripper hub and maintaining the stripper hub in an essentially stationary position relative to the patient to cause a longitudinal slit in a side wall of the balloon catheter to open by separating interlocked interlocking means carried on opposing wall portions of the side wall defining the slit, as the balloon catheter passes proximally through the stationary stripper hub and to permit the guide wire to pass generally laterally out through the longitudinal slit in the side wall of the balloon catheter until a remaining length of the catheter positioned over the guide wire is shorter than a length of the guide wire extending outside the patient; and   removing the remaining length of balloon catheter proximally off of the guide wire.   
     
     
       15. The method of claim 14 wherein the applying force step and the maintaining the guide wire position step are performed simultaneously. 
     
     
       16. The method of claim 14 and further comprising: grasping a portion of the guide wire located distally of a distal tip of the balloon catheter when that portion of the balloon catheter becomes exposed outside of the patient.   
     
     
       17. The method of claim 16 wherein the grasping step and the removing step are performed essentially simultaneously. 
     
     
       18. A method of exchanging a first angioplasty dilation catheter in a patient with a second angioplasty dilation catheter while leaving a guide wire in place with a proximal end of the guide wire outside the patient and a distal end of the guide wire within the patient, the method comprising: providing a generally cylindrical stripper hub about a proximal end of the first angioplasty dilation catheter which extends outside of the patient;   applying force to the first catheter at its proximal end in a direction which causes the first catheter to be withdrawn proximally through the stripper hub and out of the patient;   maintaining the guide wire in an essentially stationary position, by grasping the stripper hub and maintaining the stripper hub in an essentially stationary position relative to the patient to cause a longitudinal slit in a side wall of the first catheter to open by separating interlocked interlocking means carried on opposing wall portions of the side wall defining the slit as the first balloon catheter passes proximally through the stationary stripper hub and to permit the guide wire to pass laterally out through the longitudinal slit in the side wall of the first catheter and through a side port in the stripper hub until a remaining length of the first catheter positioned over the guide wire is shorter than length of the guide wire extending outside the patient;   removing a remaining length of the first catheter proximally off of the guide wire;   threading the second angioplasty dilation catheter onto the proximal end of the guide wire; and   inserting the second angioplasty dilation catheter into the patient and over the guide wire within the patient.   
     
     
       19. A catheter which is insertable and removable over a guide wire, the catheter comprising: an inflatable balloon;   a shaft supporting the balloon at a distal end thereof, and having an inflation port at a proximal end thereof, the shaft having an inflation lumen extending from the inflation port to an interior of the balloon and a guide wire lumen extending through the interior of the balloon, with the guide wire lumen comprising means for releasably holding a guide wire adjacent to the inflation lumen along substantially an entire length of the shaft and said guide wire lumen including interlocking parting means for permitting the shaft and the guide wire to be peeled away from one another along substantially the entire length of the shaft; and   a generally cylindrical sleeve member mounted about the shaft which is capable of relative longitudinal movement with respect to the shaft for causing the parting means to unlock and be parted, thereby permitting the shaft and guide wire to be peeled apart. .Iadd.   
     
     
       20.  A balloon catheter, comprising: a. an elongate shaft having a proximal end, a distal end, an exterior and a guide wire lumen extending therethrough, the distal end of the shaft including an inner tube disposed in an outer tube, the elongate shaft also having a longitudinal slit extending distally from the proximal end of the shaft to provide access to the guidewire lumen from the exterior of the shaft, wherein the slit is defined between adjacent flaps when the slit is open, and wherein the flaps provide structural strength to the shaft when the slit is closed;   b. an inflatable balloon having a proximal end and a distal end, the proximal end of the balloon connected to the distal end of the shaft;   c. a guide wire having a proximal end and a distal end, the distal end being disposed in the guide wire lumen and the proximal end being laterally displaced from the elongate shaft; and   d. a sliding member disposed on the elongate shaft and extending at least partially into the longitudinal slit, the sliding member engaging the guide wire disposed in the guide wire lumen. .Iaddend..Iadd.21. A balloon catheter as in claim 20, wherein a distal end of the inner tube is connected to the distal end of the balloon and a distal end of the outer tube is connected to the proximal end of the balloon. .Iaddend..Iadd.22. A balloon catheter as in claim 21, wherein the inner tube is about 10 inches long. .Iaddend..Iadd.23. A balloon catheter, comprising:   a. a proximal shaft having a proximal end, a distal end, an exterior and a proximal guide wire lumen extending therethrough, the proximal shaft also having a longitudinal slit to provide access to the proximal guide wire lumen from the exterior of the shaft, wherein the slit is defined between adjacent flaps when the slit is open and wherein the flaps provide structural strength to the proximal shaft when the slit is closed;   b. an outer tube having a proximal end and a distal end, the proximal end of the outer tube connected to the distal end of the proximal shaft;   c. an inner tube having a proximal end, a distal end and a distal guide wire lumen extending therethrough, the inner tube disposed in the outer tube to define an annular lumen therebetween; and   d. a balloon having a proximal end and a distal end, the proximal end of the balloon connected to the distal end of the outer tube, the distal end of the balloon connected to the distal end of the inner tube. .Iaddend..Iadd.24. A balloon catheter as in claim 23, further comprising:   e. a sliding member disposed on the proximal shaft and extending at least   
     
     
        partially into the longitudinal slit. .Iaddend..Iadd.25.  A balloon catheter as in claim 24, further including a guide wire disposed in the proximal guide wire lumen, wherein the sliding member engages the guide wire. .Iaddend..Iadd.26. A balloon catheter as in claim 25, wherein the inner tube is about 10 inches long. .Iaddend..Iadd.27. A balloon catheter, comprising: a. a first shaft having a proximal end, a distal end, a first inflation lumen extending therethrough, and a first guide wire lumen extending therethrough, the first shaft also having a slit extending therealong to provide access to the first guide wire lumen, wherein the slit is defined between adjacent flaps when the slit is open, and wherein the flaps provide structural strength to the first shaft when the slit is closed;   b. a second shaft having a proximal end, a distal end, a second inflation lumen extending therethrough, and a second guide wire lumen extending therethrough, the proximal end of the second shaft connected to the distal end of the first shaft, the second shaft having a length of about 10 inches; and   c. a balloon connected to the distal end of the second shaft. .Iaddend..Iadd.28. A balloon catheter as in claim 27, wherein the slit terminates at the distal end of the first shaft. .Iaddend..Iadd.29. A balloon catheter as in claim 27, further comprising:   
     
     
       d. a sliding member disposed in the slit. .Iaddend..Iadd.30.  A balloon catheter as in claim 29, further including a guide wire disposed in the proximal guide wire lumen, wherein the sliding member engages the guide wire. .Iaddend..Iadd.31. A balloon catheter as in claim 30, wherein the slit terminates at the distal end of the first shaft. .Iaddend..Iadd.32. A balloon catheter, comprising: a. an elongate shaft having a proximal end, a distal end, an exterior, a guide wire lumen, an inflation lumen, and a longitudinally-extending lateral opening which provides access to the guide wire lumen from the exterior of the shaft, wherein the lateral opening is defined between adjacent flaps when the lateral opening is open, and wherein the flaps provide structural strength to the shaft when the lateral opening is closed;   b. an inflatable balloon connected to the distal end of the elongate shaft, the inflatable balloon being in fluid communication with the inflation lumen;   c. a guide wire disposed in the guide wire lumen; and   d. a sleeve member slidably disposed on the shaft, the sleeve member including a portion which penetrates the lateral opening into the guide wire lumen and at least partially surrounds the guide wire disposed in the guide wire lumen, the portion of the shaft proximal of the sleeve member remaining substantially coaxially aligned with the portion of the shaft distal of the sleeve member. .Iaddend..Iadd.33. A balloon catheter as in claim 32, wherein the longitudinally extending lateral opening extends to a point about 10 inches proximal of the balloon. .Iaddend..Iadd.34. A balloon catheter as in claim 32, wherein the distal end of the elongate shaft includes an inner tube disposed in an outer tube.   
     
     
        .Iaddend..Iadd.     A balloon catheter as in claim 34, wherein a distal end of the inner tube is connected to a distal end of the balloon and a distal end of the outer tube is connected to a proximal end of the balloon. .Iaddend..Iadd.36. A balloon catheter as in claim 35, wherein the inner tube is about 10 inches long. .Iaddend.