Percutaneous mechanical fragmentation catheter system

• US 6,824,551 B2
• Filed: 12/03/2002
• Issued: 11/30/2004
• Est. Priority Date: 04/07/1992
• Status: Expired due to Fees

• Current Assignee: Johns Hopkins University
• Original Assignee: Johns Hopkins University
• Inventors: Trerotola, Scott O.
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US10/309,323
• Publication Number:
  US 20030130673A1
• Time in Patent Office: 728 Days
• Field of Search: 606/1, 606/110-115, 606/127, 606/128, 606/159, 606/167-180, 606/198, 606/19, 606/22, 606/35, 606/507-510, 606/104-109, 606/18, 604/500, 604/508, 604/510, 604/105-109
• US Class Current: 606/159
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2217/005 with suction drainage system

Abstract

A percutaneous thrombolytic device, also referred to herein as a percutaneous mechanical fragmentation catheter system, that includes a wire cage or basket attached to a rotational drive motor. The fragmentation basket, ensheathed in an outer catheter, is introduced into the clotted graft or vessel via an introducer sheath. When deployed, the basket will automatically conform to the inner dimensions of the vessel lumen. The rotating basket is slowly withdrawn through the clotted graft, mechanically fragmenting the clot. The fragmented, homogenized debris can be flushed into the venous system or aspirated.

Claims

1. A method for fragmenting thrombotic material in a vascular conduit comprising the steps of:

(a) introducing a fragmentation catheter in a vascular conduit to a thrombotic occlusion, wherein the fragmentation catheter comprises a fragmentation member on a distal end portion thereof that automatically expands to conform to the shape and diameter of the inner lumen of the vascular conduit upon deployment of the fragmentation member, wherein the fragmentation member comprises a wire basket, wherein said basket comprises a tapered tip on its distal end, and wherein the distal portion of said tip is soft and flexible;

(b) deploying the fragmentation member; and

(c) rotating the fragmentation member at a speed to homogenize the thrombotic material.

2. The method of claim 1, wherein the soft, flexible tip is a soft, flexible plastic tip.

3. The method of claim 1, wherein the wire basket is made of spring tempered wire.

4. The method of claim 1, wherein the fragmentation catheter is coupled to a side arm for applying fluid or suction to the inner lumen of the vascular conduit.

5. The method of claim 1, wherein the fragmentation catheter is operably coupled at a proximal end portion thereof to a rotator unit for rotating the fragmentation member.

6. The method of claim 1, wherein the rotary speed is 2000-6000 rpm.

7. The method of claim 1, wherein the fragmentation catheter comprises a flexible drive shaft, where the fragmentation member is connected to a distal end portion of the flexible drive shaft.

8. The method of claim 7, wherein the fragmentation catheter comprises an outer sheath assembly slidably disposed on the flexible drive shaft for selectively receiving the fragmentation member therewithin, where the fragmentation member is deployed from the outer sheath assembly.

21. The method of any one of claim 1, 9, 16 or 19, wherein the fragmentation member is rotated at a speed in excess of 2000 rpm.

22. The method of any one of claim 1, 9, 16 or 19, wherein the fragmentation member is rotated at a speed of 3000-4500 rpm.

23. The method of any one of claim 1, 9, 16 or 19, wherein the fragmentation member is rotated at a speed of 4000 rpm.

24. The method of any one of claim 1, 9, 16 or 19, wherein the speed at which the fragmentation member is rotated is controlled by a motor.

25. The method of claim 24, wherein the motor is battery operated.

26. The method of any one of claim 1, 9, 16 or 19, wherein the vascular conduit is a dialysis fistulae.

27. The method of any one of claim 1, 9, 16 or 19, wherein the vascular conduit is a synthetic vascular graft.

28. The method of any one of claim 1, 9, 16 or 19, wherein the fragmentation catheter comprises a suction means for withdrawing homogenized thrombotic material.

29. The method of any one of claim 1, 9, 16 or 19, which further comprises checking the vascular conduit for residual thrombotic material using radiographic contrast dye under fluoroscopy.

30. The method of any one of claim 1, 9, 16 or 19, wherein the fragmentation catheter comprises an outer sheath from which the fragmentation member is deployed.

31. The method of claim 30, wherein the fragmentation member is contained within the outer sheath upon introduction of the fragmentation catheter in the vascular conduit.

32. The method of any one of claim 1, 9, 16 or 19, wherein a handle is attached to a proximal end of the fragmentation catheter for deploying the fragmentation member.

33. The method of any one of claim 1, 9, 16 or 19, wherein the fragmentation catheter is withdrawn and advanced a second time for further homogenizing the thrombotic material.

34. The method of any one of claim 1, 9, 16 or 19, wherein the fragmentation member is made of memory wire, the speed at which the fragmentation member is rotated is controlled by a motor, a handle is attached to a proximal end of the fragmentation catheter for deploying the fragmentation member, the fragmentation catheter comprises an outer sheath from which the fragmentation member is deployed, the fragmentation member is contained within the outer sheath upon introduction of the fragmentation catheter in the vascular conduit, and the vascular conduit is a dialysis fistulae or a synthetic vascular graft.

35. The method of any one of claim 1, 9, 16 or 19, wherein the fragmentation member is made of memory wire, the speed at which the fragmentation member is rotated is controlled by a motor, a handle is attached to a proximal end of the fragmentation catheter for deploying the fragmentation member, the fragmentation catheter comprises an outer sheath from which the fragmentation member is deployed, the fragmentation member is contained within the outer sheath upon introduction of the fragmentation catheter in the vascular conduit, the fragmentation catheter comprises a suction means for withdrawing homogenized thrombotic material, and the vascular conduit is a dialysis fistulae or a synthetic vascular graft.

37. The method of any one of claim 1, 9, 16 or 19, wherein the fragmentation member is made of memory wire, the speed at which the fragmentation member is rotated is controlled by a motor, a handle is attached to a proximal end of the fragmentation catheter for deploying the fragmentation member, the fragmentation catheter comprises an outer sheath from which the fragmentation member is deployed, the fragmentation member is contained within the outer sheath upon introduction of the fragmentation catheter in the vascular conduit, the fragmentation member is rotated at a speed in excess of 2000 rpm, and the vascular conduit is a dialysis fistulae or a synthetic vascular graft.

38. The method of any one of claim 1, 9, 16 or 19, wherein the fragmentation member is made of memory wire, the speed at which the fragmentation member is rotated is controlled by a motor, a handle is attached to a proximal end of the fragmentation catheter for deploying the fragmentation member, the fragmentation catheter comprises an outer sheath from which the fragmentation member is deployed, the fragmentation member is contained within the outer sheath upon introduction of the fragmentation catheter in the vascular conduit, the fragmentation member is rotated at a speed of 3000-4500 rpm, and the vascular conduit is a dialysis fistulae or a synthetic vascular graft.

39. The method of any one of claim 1, 9, 16 or 19, wherein the fragmentation member is made of memory wire, the speed at which the fragmentation member is rotated is controlled by a motor, a handle is attached to a proximal end of the fragmentation catheter for deploying the fragmentation member, the fragmentation. catheter comprises an outer sheath from which the fragmentation member is deployed, the fragmentation member is contained within the outer sheath upon introduction of the fragmentation catheter in the vascular conduit, the fragmentation member is rotated at a speed of 4000 rpm, and the vascular conduit is a dialysis fistulae or a synthetic vascular graft.

9. A method for fragmenting thrombotic material in a vascular conduit comprising the steps of:

(a) introducing a guide wire in a vascular conduit to a thrombotic occlusion;

(b) moving a fragmentation catheter along the guide wire to the thrombotic occlusion, wherein the fragmentation catheter comprises a flexible drive shaft having an inner lumen and a fragmentation member connected to a distal end portion of the flexible drive shaft, wherein the guide wire can be extended through the inner lumen of the shaft and through the fragmentation member into the vascular conduit and wherein the fragmentation member automatically expands to conform to the shape and diameter of the inner lumen of the vascular conduit upon deployment of the fragmentation member;

(c) deploying the fragmentation member; and

(d) rotating the fragmentation member at a speed to homogenize the thrombotic material.

10. The method of claim 9, wherein the fragmentation member comprises a wire basket.

11. The method of claim 10, wherein the wire basket is made of spring tempered wire.

12. The method of claim 9, wherein the fragmentation catheter is coupled to a side arm for applying fluid or suction to the inner lumen of the vascular conduit.

13. The method of claim 9, wherein the fragmentation catheter is operably coupled at a proximal end portion thereof to a rotator unit for rotating the fragmentation member.

14. The method of claim 9, wherein the rotary speed is 2000-6000 rpm.

15. The method of claim 9, wherein the fragmentation catheter comprises an outer sheath assembly slidably disposed on the flexible drive shaft for selectively receiving the fragmentation member therewithin, wherein the fragmentation member is deployed from the outer sheath assembly.

16. A method for fragmenting thrombotic material in a vascular conduit comprising the steps of:

introducing a fragmentation catheter in a vascular conduit to a thrombotic occlusion, wherein the fragmentation catheter comprises a fragmentation member at a distal end portion thereof that automatically expands to conform to the shape and diameter of the inner lumen of the vascular conduit; and

rotating the fragmentation member at a speed to homogenize the thrombotic material.

17. The method of claim 16, wherein the fragmentation member is made of spring tempered wire.

18. The method of claim 16, wherein the fragmentation catheter is operably coupled at a proximal end portion thereof to a rotator unit for rotating the fragmentation member.

36. The method of any one of claim 9, 16 or 19, wherein the fragmentation member is made of memory wire, the speed at which the fragmentation member is rotated is controlled by a motor, a handle is attached to a proximal end of the fragmentation catheter for deploying the fragmentation member, the fragmentation catheter comprises an outer sheath from which the fragmentation member is deployed, the fragmentation member is contained within the outer sheath upon introduction of the fragmentation catheter in the vascular conduit, the fragmentation catheter comprises a suction means for withdrawing homogenized thrombotic material, the fragmentation member comprises a soft, flexible tip at its distal end, and the vascular conduit is a dialysis fistulae or a synthetic vascular graft.

19. A method for fragmenting thrombotic material in a vascular conduit comprising the steps of:

introducing a fragmentation catheter in a vascular conduit to a thrombotic occlusion, wherein the fragmentation catheter comprises a flexible drive shaft operably coupled to a rotator unit at a proximal end portion thereof and a fragmentation member connected to a distal end portion of the flexible drive shaft, wherein the fragmentation member automatically expands to conform to the shape and diameter of the inner lumen of the vascular conduit; and

rotating the fragmentation member at a speed to homogenize the thrombotic material.

20. The method of claim 19, wherein the fragmentation member is made of spring tempered wire.