Outer exchange catheter system

• US 4,976,689 A
• Filed: 11/04/1988
• Issued: 12/11/1990
• Est. Priority Date: 09/18/1984
• Status: Expired due to Fees

• Current Assignee: Medtronic Interventional Vascular, Inc. (Massachusetts) (Medtronic Plc)
• Original Assignee: Medtronic Versaflex Incorporated
• Inventors: Solar, Ronald J., Buchbinder, Maurice
• Primary Examiner(s): Pellegrino, Stephen C.
• Application Number:
  US07/267,047
• Time in Patent Office: 767 Days
• Field of Search: 604/95-103, 604/52, 604/53, 604/170, 604/280, 604/282, 128/344, 128/656-658, 128/898, 606/194
• US Class Current: 604/95.04
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/09025 with sliding mandrils
• CPC Class Codes: A61M 25/09033 with fixed mandrils, e.g. mandrils fixed to tip; Tensionable wires
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

This invention relates to corporeal catheters. More particularly, this invention relates to an outer exchange catheter system comprising an outer catheter sheath and at least one inner catheter having a control means, the outer catheter sheath extending less than the full length of each inner catheter and being slidable thereover. This invention also relates to the method of using this outer exchange catheter system.

Claims

1. An outer exchange catheter system comprising an outer catheter sheath having a plurality of openings on the outer periphery wherein at least a first of said plurality of openings is positioned on said outer periphery at a point to permit fluid entry into said outer catheter sheath at a point proximal to a stenosis and at least a second of said plurality of openings is positioned on said outer periphery to permit fluid exit from said outer catheter sheath at a point distal to said stenosis and one or more inner catheters, at least one of which inner catheters comprises:

a flexible catheter member having distal and proximal ends and one or more lumens extending therethrough, at least one of said lumens being closed at its distal end,

a deflection wire having distal and proximal ends and extending the length of a lumen having a closed end, the distal end of the deflection wire being embedded in said closed end,

control means attached to the proximal end of the catheter member, the proximal end of the deflection wire extending to the control means and the control means having an engaging means which fixedly engages said deflection wire, rotation of said engaging means causing the deflection wire to longitudinally displace either toward or away from the distal end of the catheter member, said displacement causing the distal end of the catheter member to bend out of or toward the line of the longitudinal axis of the catheter member, and the engaging means of the control means fixedly engaging the deflection wire so that when the control means is rotated, the catheter member and the deflection wire both rotate substantially together to cause the distal end of the catheter member to rotate about its longitudinal axis, and

said outer catheter sheath extending less than the full length of each said inner catheter and being slidable thereover.

2. The catheter system of claim 1, wherein said outer catheter sheath extends from about 40% to 90% of the length of each said inner catheter

3. The catheter system of claim 1, wherein said outer catheter sheath and each said inner catheter have respective inner and outer surfaces and the inner surface of said outer catheter sheath and/or the outer surface of at least one said inner catheter has a coating thereon which promotes or facilitates slidability.

4. The catheter system of claim 1, wherein at least one of said outer catheter sheath and/or at least one said inner catheter is comprised of a polymeric substance having a low coefficient of friction.

5. An outer exchange catheter system comprising an outer catheter sheath and one or more inner catheters, wherein at least one of which inner catheters comprises:

a flexible catheter member comprising a spring coil body defining a lumen, said spring coil body having proximal and distal ends, the distal end of said spring coil body being closed, and said spring coil body having a flexible covering thereon,

dilatation balloon means positioned adjacent to the distal end of said spring coil body, and

control means attached to the proximal end of said catheter member, so that when said control means is rotated, the catheter member rotates to cause the distal end of the catheter member to rotate about its longitudinal axis.

6. An outer exchange catheter system comprising an outer catheter sheath and one or more inner catheters, wherein at least one inner catheter comprises:

a flexible catheter member comprising a spring coil body defining a lumen, said spring coil body having proximal and distal ends, the distal end of said spring coil body being open, and said spring coil body having a flexible covering thereon, and

control means attached to the proximal end of said catheter member, so that when said control means is rotated, the catheter member rotates to cause the distal end of the catheter member to rotate about its longitudinal axis.

7. An outer exchange catheter system comprising an outer catheter sheath and one or more inner catheters, at least one of which inner catheters comprises:

a flexible catheter member comprising a spring coil body defining a lumen, said spring coil body having proximal and distal ends, the distal end of said spring coil body being closed, and said spring coil body having a flexible covering thereon,

dilatation balloon means positioned adjacent to the distal end of said spring coil body,

a deflection wire having proximal and distal ends and being substantially co-extensive with said spring coil body, the distal end of said deflection wire being attached to the distal end of said spring coil body, and

control means attached to the proximal end of said catheter member, the proximal end of said deflection wire extending to the control means, the control means having engaging means which fixedly engages the proximal end of said deflection wire, rotation of said engaging means causing the deflection wire to longitudinally displace either toward or away from the distal end of the catheter member, said displacement causing the distal end of the catheter member to bend out of or toward the line of the longitudinal axis of the catheter member, and the engaging means of the control means fixedly engaging the deflection wire so that when the control means is rotated, the catheter member and the deflection wire both rotate substantially together to cause the distal end of the catheter member to rotate about its longitudinal axis,

said outer catheter sheath extending less than the full length of each said inner catheter and being slidable thereover.

8. The catheter system of claim 7, wherein said outer catheter sheath extends from about 40% to 90% of the length of each said inner catheter.

9. The catheter system of claim 7, wherein said outer catheter sheath and each said inner catheter have respective inner and outer surfaces and the inner surface of said outer catheter sheath and/or the outer surface of at least one said inner catheter have a coating thereon which promotes or facilitates slidability.

10. The catheter system of claim 7, wherein at least one of said outer catheter sheath and/or at least one said inner catheter is comprised of a polymeric substance having a low coefficient of friction.

11. The catheter system of claim 7, wherein at least one inner catheter comprises:

a flexible catheter member comprising a spring coil body defining a lumen, said spring coil body having proximal and distal ends, the distal end of said spring coil body being closed, and said spring coil body having a flexible covering thereon,

dilatation balloon means positioned adjacent to the distal end of said spring coil body, and

control means attached to the proximal end of said catheter member, so that when said control means is rotated, the catheter member rotates to cause the distal end of the catheter member to rotate about its longitudinal axis.

12. The catheter member of claim 7, wherein at least one inner catheter member comprises:

a flexible catheter member comprising a spring coil body defining a lumen, said spring coil body having proximal and distal ends, the distal end of said spring coil body being open, and said spring coil body having a flexible covering thereon, and

control means attached to the proximal end of said catheter member, so that when said control means is rotated, the catheter member rotates to cause the distal end of the catheter member to rotate about its longitudinal axis.

13. An outer exchange catheter system comprising an outer catheter sheath and one or more inner catheters, at least one of which inner catheters comprises:

a flexible catheter member comprising a spring coil body defining a lumen, said spring coil body having proximal and distal ends, a flexible tip having proximal and distal ends, the proximal end of said flexible tip being positioned distally a short distance from the distal end of said spring coil body to form a discontinuity, and a flexible covering, said flexible covering extending from the proximal end of said spring coil body along the length of said spring coil body across said discontinuity to the proximal end of said flexible tip,

dilatation balloon means positioned around said discontinuity,

a deflection wire having proximal and distal ends, said deflection wire extending substantially co-extensively with said spring coil body, the distal end of said deflection wire being attached to the proximal end of said flexible tip and

control means having engaging means which fixedly engages the proximal end of said deflection wire, rotation of said engaging means causing the deflection wire to longitudinally displace either toward or away from the distal end of the catheter member, said displacement causing the distal end of the catheter member to bend out of or toward the line of the longitudinal axis of the catheter member, and the engaging means of the control means fixedly engaging the deflection wire so that when the control means is rotated, the catheter member and the deflection wire both rotate substantially together to cause the distal end of the catheter member to rotate about its longitudinal axis,

said outer catheter sheath extending less than the full length of each said inner catheter and being slidable thereover.

14. The catheter system of claim 13, wherein said outer catheter sheath extends from about 40% to 90% of the length of each said inner catheter.

15. The catheter system of claim 13, wherein said outer catheter sheath and each said inner catheter have respective inner and outer surfaces and the inner surface of said outer catheter sheath and/or the outer surface of at least one said inner catheter have a coating thereon which promotes or facilitates slidability.

16. The catheter system of claim 13, wherein at least one of said outer catheter sheath and/or at least one said inner catheter is comprised of a polymeric substance having a low coefficient of friction.

17. The catheter system of claim 13, wherein at least one inner catheter comprises:

a flexible catheter member comprising a spring coil body defining a lumen, said spring coil body having proximal and distal ends, the distal end of said spring coil body being closed, and said spring coil body having a flexible covering thereon,

dilatation balloon means positioned adjacent to the distal end of said spring coil body and

control means attached to the proximal end of said catheter member, so that when said control means is rotated, the catheter member rotates to cause the distal end of the catheter member to rotate about its longitudinal axis.

18. The catheter system of claim 13, wherein at least one inner catheter comprises:

a flexible catheter member comprising a spring coil body defining a lumen, said spring coil body having proximal and distal ends, the distal end of said spring coil body being open, and said spring coil body having a flexible covering thereon, and

control means attached to the proximal end of said catheter member, so that when said control is rotated, the catheter member rotates to cause the distal end of the catheter member to rotate about its longitudinal axis.

19. An outer exchange catheter system comprising an outer catheter sheath and one or more inner catheters, at least one of which inner catheters comprises:

a flexible catheter member comprising a spring coil body defining a lumen, said spring coil body having proximal and distal ends, the distal end of said spring coil body being open,

a deflection wire having proximal and distal ends and being substantially co-extensive with said spring coil body, the distal end of said deflection wire being attached to the distal end of said spring coil body, and

control means attached to the proximal end of said catheter, the proximal end of said deflection wire extending through the control means, the control means having engaging means which fixedly engages the proximal end of said deflection wire, rotation of said engaging means causing the deflection wire to longitudinally displace either toward or away from the distal end of the catheter member, said displacement causing the distal end of the catheter member to bend out of or toward the line of the longitudinal axis of the catheter member, and the engaging means of the control means fixedly engaging the deflection wire so that when the control means is rotated, the catheter member and the deflection wire both rotate substantially together to cause the distal end of the catheter member to rotate about its longitudinal axis,

said outer catheter sheath extending less than the full length of each said inner catheter and being slidable thereover.

20. The catheter system of claim 19, wherein said outer catheter sheath extends from about 40% to 90% of the length of each said inner catheter.

21. The catheter system of claim 19, wherein said outer catheter sheath and each said inner catheter have respective inner and outer surfaces and the inner surface of said outer catheter sheath and/or the outer surface of at least one said inner catheter have a coating thereon which promotes or facilitates slidability.

22. The catheter system of claim 19, wherein at least one of said outer catheter sheath and/or at least one said inner catheter is comprised of a polymeric substance having a low coefficient of friction.

23. The catheter system of claim 19, wherein at least one inner catheter comprises:

a flexible catheter member comprising a spring coil body defining a lumen, said spring coil body having proximal and distal ends, the distal end of said spring coil body being closed, and said spring coil body having a flexible covering thereon,

dilatation balloon means positioned adjacent to the distal end of said spring coil body, and

control means attached to the proximal end of said catheter member, so that when said control means is rotated, the catheter member rotates to cause the distal end of the catheter member to rotate about its longitudinal axis.

24. The catheter system of claim 19, wherein at least one inner catheter comprises:

a flexible catheter member comprising a spring coil body defining a lumen, said spring coil body having proximal and distal ends, the distal end of said spring coil body being open, and said spring coil body having a flexible covering thereon, and

control means attached to the proximal end of said catheter member, so that when said control means is rotated, the catheter member rotates to cause the distal end of the catheter member to rotate about its longitudinal axis.

25. A method for dilating a stenosis in a passageway in a body, which comprises:

(a) introducing a guide catheter having proximal and distal ends and a single lumen into the body through an incision or opening;

(b) advancing a catheter system comprising an outer sheath and a first inner dilatation catheter system, each of said outer sheath and said first dilatation catheter system having proximal and distal ends and said first dilatation catheter system having a first dilatation balloon means adjacent the distal end thereof, into and through the guide catheter to cause said first dilatation balloon means to be positioned across a stenosis in said passageway;

(c) inflating said first dilatation balloon means to cause the stenosis to dilate;

(d) deflating said first dilatation balloon means;

(e) withdrawing said first dilatation catheter system in the proximal direction;

(f) advancing a second dilatation catheter system having proximal and distal ends and second, larger dilatation balloon means distally within said outer sheath to cause the larger balloon dilatation means to be positioned across said stenosis;

(g) inflating said second balloon dilatation means; and

(h) repeating steps (d) to (g) until the stenosis is sufficiently dilated.

26. A method for dilating a stenosis in a passageway in a body, which comprises:

(a) introducing a guide catheter having proximal and distal ends and a single lumen into the body through an incision or opening;

(b) advancing a catheter system comprising an outer sheath and a first steerable inner dilatation catheter, each of said outer sheath and said first dilatation catheter having proximal and distal ends and said first dilatation catheter having first dilatation balloon means adjacent the distal end thereof, into and through the guide catheter to cause said first dilatation balloon means to be positioned across a stenosis in said passageway;

(c) inflating said first dilatation balloon means to cause the stenosis to dilate;

(d) deflating said first dilatation balloon means;

(e) slidably advancing the outer sheath distally along said first dilatation catheter to position said outer sheath across the stenosis;

(f) withdrawing said first dilatation catheter in the proximal direction;

(g) advancing a second dilatation catheter having proximal and distal ends and second, larger dilatation balloon means distally within said outer sheath to cause the larger balloon dilatation means to be positioned across said stenosis;

(h) withdrawing said outer sheath in the proximal direction to the extent that the outer sheath is no longer across the stenosis;

(i) inflating said second balloon dilatation means; and

(j) repeating steps (d) to (i) until the stenosis is sufficiently dilated.

27. The method of claim 26, wherein in step (h) the outer sheath is withdrawn to the extent that the proximal end of the outer sheath is positioned near the proximal end of the second dilatation catheter

28. The method of claim 26, wherein in step (h) the outer sheath is withdrawn to the extent that the distal end of the outer sheath is adjacent to the stenosis.

29. A method for dilating a stenosis in a passageway in a body, which comprises:

(a) introducing a guide catheter having proximal and distal ends and a single lumen into the body through an incision or opening;

(b) advancing a catheter system comprising an outer sheath and a guidewire, each of said outer sheath and said guidewire having proximal and distal ends, into and through the guide catheter to cause the distal ends of said outer sheath and said guidewire to be positioned proximally adjacent a stenosis in said passageway;

(c) advancing the distal end of said guidewire across the stenosis;

(d) advancing a balloon dilatation catheter system having a first balloon dilatation means over said guidewire to cause said first balloon dilatation means to be positioned across the stenosis;

(e) inflating said first dilatation balloon means to cause the stenosis to dilate;

(f) deflating said first dilatation balloon means;

(g) withdrawing said first dilatation catheter system in the proximal direction;

(h) advancing a second dilatation catheter system having proximal and distal ends and second, larger dilatation balloon means distally within said outer sheath and over said guidewire to cause the larger balloon dilatation means to be positioned across the stenosis;

(i) inflating said second balloon dilatation means; and

(j) repeating steps (d) to (i) until the stenosis is sufficiently dilated.

30. A method for dilating a stenosis in a passageway in a body, which comprises:

(a) introducing a guide catheter having proximal and distal ends and a single lumen into the body through an incision or opening;

(b) advancing a catheter system comprising an outer sheath and a guidewire, each of said outer sheath and said guidewire having proximal and distal ends, into and through the guide catheter to cause the distal ends of said outer sheath and said guidewire to be positioned proximally adjacent to a stenosis in said passageway;

(c) withdrawing said guidewire;

(d) advancing a first, fixed wire balloon dilatation catheter system having first balloon dilatation means adjacent the distal end thereof through the outer sheath and across the stenosis to cause said first balloon means to be positioned across the stenosis;

(e) inflating said first dilatation balloon means to cause the stenosis to dilate;

(f) deflating said first dilatation balloon means;

(g) withdrawing said first dilatation catheter in the proximal direction;

(h) advancing a second dilatation catheter having proximal and distal ends and second, larger dilatation balloon means distally within said outer sheath to cause the second balloon dilatation means to be positioned across said stenosis;

(i) inflating said second balloon dilatation means; and

(j) repeating steps (d) to (i) until the stenosis is sufficiently dilated.

31. A method for dilating a stenosis in a passageway in a body, which comprises:

(a) introducing a guide catheter having proximal and distal ends and a single lumen into the body through an incision or opening;

(b) advancing a catheter system comprising an outer sheath and a guidewire, each of said outer sheath and said guidewire having proximal and distal ends, into and through the guide catheter to cause the distal ends of said outer sheath and said guidewire to be positioned proximally adjacent to a stenosis in said passageway;

(c) withdrawing said guidewire;

(d) advancing a first fixed wire balloon dilatation catheter system having first balloon dilatation means adjacent the distal end thereof through the outer sheath and across the stenosis to cause said first balloon dilatation means to be positioned across the stenosis;

(e) inflating said first dilatation balloon means to cause the stenosis to dilate;

(f) deflating said first dilatation balloon means;

(g) slidably advancing the outer sheath distally along said first dilatation catheter to position said outer sheath across the stenosis;

(h) withdrawing said first dilatation catheter in the proximal direction;

(i) advancing a second dilatation catheter having proximal and distal ends and second, larger dilatation balloon means distally within said outer sheath to cause the larger balloon dilatation means to be positioned across the stenosis;

(j) withdrawing said outer sheath in the proximal direction to the extent that the outer sheath is no longer across the stenosis;

(k) inflating said second balloon dilatation means; and

(l) repeating steps (d) to (k) until the stenosis is sufficiently dilated.

32. The method of claim 31, wherein in step (j) the outer sheath is withdrawn to the extent that the proximal end of the outer sheath is positioned near the proximal end of the second dilatation catheter

33. The method of claim 31, wherein in step (j) the outer sheath is withdrawn to the extent that the distal end of the outer sheath is proximally adjacent to the stenosis.