Method and apparatus for catheter exchange by guide wire-captivation

• US 6,270,465 B1
• Filed: 02/04/1992
• Issued: 08/07/2001
• Est. Priority Date: 08/25/1989
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Keith, Peter T., Adams, Daniel O.
• Primary Examiner(s): Lewis, Ralph A.
• Application Number:
  US07/830,479
• Time in Patent Office: 3,472 Days
• Field of Search: 604/53, 604/96-103, 604/165, 604/169, 604/170, 604/280, 604/510, 604/101-1-1, 604/103.04, 604/164.13, 606/194, 128/657, 128/658, 128/772, 600/585
• US Class Current: 600/585
• CPC Class Codes: A61M 2025/0098 having a strain relief at the proximal end, e.g. sleeve
• CPC Class Codes: A61M 2025/09125 Device for locking a guide wire in a fixed position with respect to the catheter or the human body
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B

Abstract

An apparatus for exchanging over-the-wire balloon catheters engages a guide wire within a guide catheter. In one embodiment the engagement is by an inflatable balloon in the guide catheter. Alternatively, the engagement is accomplished by a captivation wire in the guide catheter that has a collapsible loop portion through which the guide wire extends. Inflation of the balloon or closing the loop portion of the captivation wire within the guide catheter traps the guide wire and restricts its movement relative to the guide catheter. Once the guide wire position is fixed, withdrawal of a first balloon catheter and subsequent introduction of a second balloon catheter over the guide wire is possible without moving the guide wire longitudinally. Thus, the positioning of the guide wire over a stenosis to be dilated is not disturbed.

Claims

1. An angioplasty catheter system, comprising:

a. a guide wire;

b. a balloon catheter including an elongated tubular shaft with a balloon connected at a distal end thereof, the shaft including a guide wire lumen receiving the guide wire therethrough;

c. an elongated tubular guide catheter defining a guide lumen having a proximal end and a distal end and receiving the balloon catheter therethrough;

d. means, nearer the distal end of the guide catheter than the proximal end, for selectively engaging the guide wire to the guide catheter to restrict longitudinal movement of the guide wire relative to the guide catheter, said means for selectively engaging including means for urging a portion of the guide wire against an inner portion of the guide catheter, wherein said means for urging includes a captivation wire extending longitudinally within the guide catheter, the captivation wire having a proximal end, a loop portion, and a distal end, with the distal end being within and adjacent to the distal end of the guide catheter, and the loop portion being just proximal of the distal end of the guide catheter, and wherein the guide wire extends through the loop portion of the captivation wire, with the loop portion having an open loop state whereby unrestricted longitudinal movement of the guide wire through the loop portion and relative to the guide catheter is allowed and a closed loop state whereby longitudinal movement of the guide wire through the loop portion and relative to the guide catheter is limited.

2. The angioplasty catheter system of claim 1 wherein the guide catheter has a spiraled recess formed within an inner wall of the guide catheter to receive the loop portion of the captivation wire in its open loop state.

3. The angioplasty catheter system of claim 1 wherein the guide catheter has a longitudinally extending lumen formed in a wall of the guide catheter for slidable reception of the captivation wire.

4. The angioplasty catheter system of claim 1 wherein the distal end of the captivation wire is fixed within the distal end of the guide catheter.

5. The angioplasty catheter system of claim 1 wherein the means for urging further includes

means for moving the captivation wire between its open loop state and closed loop state.

6. The angioplasty catheter system of claim 5 wherein the distal end of the captivation wire is affixed to the guide catheter, and wherein the means for moving includes:

means for pulling the proximal end of the captivation wire in a proximal direction.

7. The angioplasty catheter system of claim 6 wherein the means for moving includes:

means for holding the captivation wire in its open loop state and in its closed loop state.

8. The angioplasty catheter system of claim 6 wherein the means for pulling includes:

a tab member mounted to the guide catheter adjacent a proximal end thereof, the tab member having the proximal end of the captivation wire connected thereto, and the tab member being movable longitudinally with respect to the guide catheter between a first distal position whereby the captivation wire is in its open loop state, and a second proximal position whereby the captivation wire is in its closed loop state.

9. The angioplasty catheter system of claim 8 wherein the means for pulling further includes:

detent means for selectively retaining the tab member in its first distal position or its second proximal position.

10. A method for operating an angioplasty catheter system to limit guide wire movement, the method comprising the steps of:

a. providing a guide catheter having a first end and a second end with a lumen defined therebetween;

b. providing a catheter guide wire within the lumen of the guide catheter;

c. providing an angioplasty balloon catheter within the lumen of the guide catheter slidably disposed relative to the guide wire;

d. providing means for selectively engaging the guide wire to the guide catheter, said means for selectively engaging including a wire-captivation wire having a loop portion within the guide catheter for receiving the guide wire; and

,

e. manipulating the means for engaging to force the guide wire against an inner portion of the guide catheter.

11. The method of claim 10 wherein the step of manipulating the means for engaging further includes:

maneuvering the wire-captivation wire to close the loop portion of the wire-captivation wire and thereby force the guide wire against an inner portion of the guide catheter.

12. A method for exchanging a first over-the-wire catheter on a guide wire in a patient'"'"'s vascular system for a second over-the-wire catheter on the guide wire, wherein the guide wire extends through and past a distal end of a guide catheter, the method comprising the steps of:

providing a guide wire-captivation wire within the guide catheter;

holding a proximal end of the guide wire outside of the vascular system to maintain position of the guide wire longitudinally relative to the guide catheter and the vascular system;

moving the first over-the-wire catheter on the guide wire into the guide catheter to a position proximal of an open

portion of the wire-captivation wire;

closing the open portion of the wire-captivation wire whereby movement of the guide wire longitudinally relative to the guide catheter is limited;

releasing the proximal end of the guide wire;

withdrawing the first over-the-wire catheter from a proximal end of the guide wire;

installing the second over-the-wire catheter onto the proximal end of the guide wire;

moving the second over-the-wire catheter to a position just proximal of the closed open portion of the wire-captivation wire;

holding the proximal end of the guide wire outside of the vascular system to maintain position of the guide wire longitudinally relative to the guide catheter and the vascular system;

reopening the open portion of the wire-captivation wire to release the guide wire from its fixed position relative to the guide catheter; and

moving the second over-the-wire catheter distally of the open portion of the wire-captivation wire.

13. The method of claim 12, and further comprising the step of:

positioning the open portion of the wire-captivation wire within the guide catheter adjacent a distal end of the guide catheter.

14. An angioplasty catheter system, comprising:

a. a guide wire;

b. a balloon catheter including an elongated tubular shaft with a balloon connected at a distal end thereof, the shaft including a guide wire lumen receiving the guide wire therethrough;

c. an elongated tubular guide catheter defining a guide lumen having a proximal end and a distal end and receiving the balloon catheter therethrough;

d. means, nearer the distal end of the guide catheter than the proximal end, for selectively engaging the guide wire to the guide catheter to restrict longitudinal movement of the guide wire relative to the guide catheter, said means for selectively engaging including means for urging a portion of the guide wire against an inner portion of the guide catheter, wherein said means for urging includes an inflatable restriction balloon, within the distal end of the guide lumen, designed to engage the guide wire relative to the guide catheter when inflated, and means, coupled to the inflatable restriction balloon, for inflating the inflatable restriction balloon, the inflation of which restricts longitudinal movement of the guide wire relative to the guide catheter; and

,

e. said inflatable restriction balloon is carried at a distal end of an elongated tubular flexible shaft, the shaft is adapted for insertion within the guide catheter to position the inflatable restriction balloon proximate to the distal end of the guide catheter and an inflation lumen is defined through said shaft to provide a means for inflating the inflatable restriction balloon.

15. An angioplasty catheter system, comprising:

a. a guide wire;

b. a balloon catheter including an elongated tubular shaft with a balloon connected at a distal end thereof, the shaft including a guide wire lumen receiving the guide wire therethrough;

c. an elongated tubular guide catheter defining a guide lumen having a proximal end and a distal end and receiving the balloon catheter therethrough;

d. means, nearer the distal end of the guide catheter than the proximal end, for selectively engaging the guide wire to the guide catheter to restrict longitudinal movement of the guide wire relative to the guide catheter, said means for selectively engaging including means for urging a portion of the guide wire against an inner portion of the guide catheter, wherein said means for urging includes an inflatable restriction balloon, within the distal end of the guide lumen, designed to engage the guide wire relative to the guide catheter when inflated, and means, coupled to the inflatable restriction balloon, for inflating the inflatable restriction balloon, the inflation of which restricts longitudinal movement of the guide wire relative to the guide catheter; and

,

e. said means for inflating further including a tube with an inflation lumen which is separate from the guide catheter.

16. The angioplasty catheter system of claim 15 wherein the tube is movable longitudinally with respect to the guide catheter.

17. An angioplasty catheter system, comprising:

a. a guide wire;

b. a balloon catheter including an elongated tubular shaft with a balloon connected at a distal end thereof, the shaft including a guide wire lumen receiving the guide wire therethrough;

c. an elongated tubular guide catheter defining a guide lumen having a proximal end and a distal end and receiving the balloon catheter therethrough;

d. means, nearer the distal end of the guide catheter than the proximal end, for selectively engaging the guide wire to the guide catheter to restrict longitudinal movement of the guide wire relative to the guide catheter, said means for selectively engaging including means for urging a portion of the guide wire against an inner portion of the guide catheter, wherein said means for urging includes an inflatable restriction balloon, within the distal end of the guide lumen, designed to engage the guide wire relative to the guide catheter when inflated, and means, coupled to the inflatable restriction balloon, for inflating the inflatable restriction balloon, the inflation of which restricts longitudinal movement of the guide wire relative to the guide catheter; and

,

e. said means for urging includes means for carrying the inflatable balloon separate from the guide catheter.

18. The angioplasty catheter system of claim 17 wherein the inflatable balloon is movable longitudinally with respect to the guide catheter.

19. An angioplasty catheter system, comprising:

a guide wire;

an elongated tubular guide catheter defining a guide lumen having a proximal end and a distal end;

a balloon catheter received in the guide lumen of the guide catheter, the balloon catheter including an elongated tubular shaft with a balloon connected at a distal end thereof, the guide wire being slidably disposed through a guide wire lumen defined through said shaft; and

a movable captivation catheter which is separate from the guide wire and received in the lumen of the guide catheter, the captivation catheter including an elongated tubular shaft with a captivation balloon connected at a distal end thereof, the captivation balloon designed to selectively engage the guide wire relative to the guide catheter when inflated within the lumen of the guide catheter at a position distal to the distal end of the balloon catheter.

20. A method for operating an angioplasty catheter system to limit guide wire movement, the method comprising the steps of:

providing a guide catheter having a proximal end and a distal end with a lumen defined therebetween;

providing a catheter guide wire within the lumen of the guide catheter;

providing an angioplasty balloon catheter within the lumen of the guide catheter slidably disposed relative to the guide wire, the balloon catheter having a proximal end and a distal end;

providing a movable captivation catheter within the lumen of the guide catheter, which includes an elongated tubular shaft with a captivation balloon connected at a distal end thereof;

advancing the captivation catheter through the lumen of the guide catheter until the captivation balloon is positioned distal to the distal end of the balloon catheter and proximal to the distal end of the guide catheter; and

inflating the captivation balloon to force the guide wire against an inner wall of the lumen in the guide catheter.