Catheter system for treating a vascular occlusion

• US 5,968,064 A
• Filed: 02/28/1997
• Issued: 10/19/1999
• Est. Priority Date: 02/28/1997
• Status: Expired due to Term

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: LuMend, Inc. (Cardinal Health, Inc.)
• Inventors: Milo, Charles, Selmon, Matthew R., Hansen, Gerald
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Lewis, William W.
• Application Number:
  US08/775,264
• Time in Patent Office: 963 Days
• Field of Search: 606/1, 606/159, 606/170, 606/171, 606/180, 606/198, 606/191, 604/22, 604/104, 604/105
• US Class Current: 606/189
• CPC Class Codes: A61B 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 takes precedence
• CPC Class Codes: A61B 2017/00845 of moving parts with respect to each other
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/2933 camming or guiding means
• CPC Class Codes: A61B 2017/2937 with flexible part
• CPC Class Codes: A61B 2017/320044 Blunt dissectors
• CPC Class Codes: A61B 2017/320741 for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Disclosed herein is a blunt end assembly including a catheter and a blunt end member. The blunt end member includes jaw sections which have a first closed position for locating the blunt end member at the site of the occlusion within the native lumen of the blood vessel and a second open position wherein the jaw sections are able to press against the interior walls of the lumen adjacent the occlusion. The assembly includes an actuation member for moving the jaw sections from the closed to the open positions repeatedly resulting in a fracturing of the occlusion. A guide wire may be thread through an internal opening in the catheter and the blunt end member and after fracturing, across the occlusion.

Claims

1. An assembly for a catheter having a proximal end and a distal end and longitudinal axis between the ends, the assembly designed for fracturing an occlusion within a blood vessel, the assembly comprising:

a blunt end member connectable to the distal end of the catheter, the blunt end member sized and shaped for fitting within the blood vessel and for fracturing the occlusion, the blunt end member having a first position for allowing the blunt end member to be located at the occlusion and a second position for fracturing the occlusion; and

an actuation member for moving the blunt end member between the first and second positions, whereby the blunt end member is connectable to the distal end of the catheter and the blunt end member is deliverable to the occlusion in the first position and is actuable to a second position for fracturing the occlusion wherein the actuation member comprises;

an actuation shaft extending from the blunt end member to the proximal end of the catheter; and

a ferrule, fixed to the distal end of the actuation shaft, impinging upon the blunt end member, whereby, upon actuation, the shaft is pulled toward the proximal end, urging the blunt end member to a second position.

2. The assembly as set forth in claim 1 wherein the catheter includes a selectively activatable securing member for holding the catheter in place at the location of the occlusion.

3. The assembly as set forth in claim 2 wherein the securing member comprises an inflatable balloon disposed about the outer surface of the catheter proximate the blunt end member and the catheter includes at least one balloon inflation lumen communicating with the interior of the balloon.

4. The assembly as set forth in claim 1 wherein the catheter includes a securing member for holding the catheter in place at the location of the occlusion;

the securing member being selectively activatable.

5. The assembly as set forth in claim 1, wherein the catheter has multiple lumens, at least one lumen for actuation shaft.

6. The assembly as set forth in claim 1, wherein the blunt end member includes a plurality of jaw sections disposed about the longitudinal axis of the catheter, the jaw sections having a first position wherein the jaw sections are closed for location adjacent the occlusion and a second position wherein the jaws are open for fracturing the occlusion.

7. The assembly as set forth in claim 6 further comprising a guidewire disposed in the catheter, wherein the jaw sections are so shaped that, in at least one position, the jaw sections form a channel substantially confining the guidewire to the longitudinal axis of the assembly.

8. The assembly as set forth in claim 6, wherein the jaw sections are fabricated from an alloy comprising Nickel and Titanium.

9. The assembly as set forth in claim 6, wherein the ferrule includes a longitudinal center opening for accommodating a guidewire.

10. The assembly as set forth in claim 6, wherein the blunt end member is fabricated from a single piece of material.

11. The assembly as set forth in claim 1, wherein at least a part of the lumen of the actuating member includes a friction reducing coating.

12. The assembly as set forth in claim 1, wherein the actuation member slides against the blunt end member along a region that defines at least one mating surface and wherein the mating surface includes a friction reducing coating.

13. The assembly as set forth in claim 1, wherein the blunt end member further comprises:

a rigid tubular reinforcing member fixed within the distal end zone of the catheter and slidably disposed about the actuation shaft;

a tubular support member including a proximal end fixedly disposed on the outer surface of the distal end of the catheter and further including a distal end; and

a spring member including a proximal end connected to the distal end of the support member and a distal end deformably supporting a plurality of jaw sections.

14. The assembly as set forth in claim 13, wherein the support member is crimped onto the distal end zone of the catheter.

15. The assembly as set forth in claim 1, wherein the catheter has multiple lumens, at least one lumen for the securing member.

16. The assembly as set forth in claim 1, wherein the actuating member includes an outer surface and at least a part of the outer surface of the actuating member includes a friction reducing coating.

17. A catheter assembly for crossing a vascular occlusion comprising:

a catheter having a proximal end and a distal end defined by a longitudinal axis extending between the proximal and distal ends of the catheter;

at least one hinged jaw section sized and shaped for placement within a blood vessel that is formed with a deformably supportive elbow wherein the jaw section is positioned at the distal end portion of the catheter and is movable about the supportive elbow between an open position and a closed position to displace a vascular occlusion; and

an actuation member positioned along a relative portion of the catheter for moving the at least one jaw section between its open and closed position.

18. The assembly as set forth in claim 17 wherein at least one jaw section is spade-shaped.

19. The assembly as set forth in claim 17 wherein at least one jaw section includes a distal end having a rectangular shape.

20. The assembly as set forth in claim 17 wherein at least one jaw section has a rectangular paw disposed at the distal end thereof.

21. The assembly as set forth in claim 17 wherein the actuation member comprises:

an actuation shaft, disposed in the catheter, having a proximal end manipulable from the proximal end of the catheter and a distal end proximate the distal end of the catheter and proximate the jaw section, and

a ferrule, attached to the distal end of the actuation shaft, disposed proximate the jaw section.

22. The assembly as set forth in claim 21 wherein the ferrule has a frusto-conical profile.

23. The assembly as set forth in claim 21 wherein the ferrule has a ball-shaped profile.

24. The assembly as set forth in claim 21 further comprising an actuation cable, disposed in the catheter, having a proximal end manipulable from the proximal end of the catheter and a distal end attached to the ferrule.

25. The assembly as set forth in claim 17 wherein the catheter includes a securing member for holding the catheter in place at the location of the occlusion;

the securing member being selectively activatable.

26. The assembly as set forth in claim 17, wherein the actuating member includes a proximal end, a distal end, and a lumen therebetween for accommodating a guidewire.

27. The assembly as set forth in claim 26, wherein at least a part of the lumen of the actuating member includes a friction reducing coating.