Asymmetric water jet atherectomy

• US 5,496,267 A
• Filed: 11/08/1990
• Issued: 03/05/1996
• Est. Priority Date: 11/08/1990
• Status: Expired due to Term

• Current Assignee: Medrad Incorporated (Bayer AG)
• Original Assignee: Possis Medical, Inc. (Bayer AG)
• Inventors: Jenson, Mark L., Drasler, William J., Thielen, Joseph M., Protonotarios, Emmanuil I., Dutcher, Robert G.
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Assistant Examiner(s): Rafa, Michael
• Application Number:
  US07/610,846
• Time in Patent Office: 1,944 Days
• Field of Search: 604/22, 604/43, 604/35, 606/159, 606/167
• US Class Current: 604/22
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• 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 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system

Abstract

A technique for ablation and removal of plaque deposits from the arterial, venous, vascular graft or other tissue wall of a patient. Ablation is accomplished by directing a high pressure jet of sterile saline solution at the plaque deposit. The high pressure jet is located at the distal end of a catheter which is advanced through the vascular system to the site of the plaque deposit. Removal of the debris is via an evacuation lumen within the catheter.

The arterial wall is protected from damage by the catheter design which directs the high pressure jet towards a portion of the distal end of the catheter which serves as a target. The distal end of the catheter is placed such that the plaque or other deposit to be ablated is positioned between the high pressure jet and the target.

An optional ultrasonic transducer array located adjacent the high pressure jet and the evacuation lumen permits the attending physician to monitor the procedure.

A balloon may be used to hold the catheter against the deposit allowing it to protrude into the ablation jet and be removed from the vessel.

Claims

1. An apparatus for ablating at least a portion of a deposit within a vessel of a patient comprising:

a. catheter having a proximal end and a distal end;

b. a working fluid;

c. means coupled to said proximal end of said catheter for supplying said working fluid under high pressure;

d. means coupled to said distal end of said catheter for directing said working fluid in the form of a stream at a deposit within a vessel of a patient, said means for supplying said working fluid under high pressure and said means for directing said working fluid in the form of a stream being capable of supplying and directing said working fluid at a velocity high enough to generate a stagnation pressure sufficient to remove ablated deposit debris without the use of a vacuum; and

,

e. target means coupled to said distal end of said catheter at a location longitudinally spaced from said directing means for preventing said working fluid from directly impinging upon a vessel of a patient;

said longitudinal spacing being sufficient to accommodate at least a portion of deposit being ablated.

2. An apparatus according to claim 1 wherein said working fluid is a saline solution.

3. An apparatus according to claim 2 wherein said target means is positioned with respect to said directing means such that in use said target means can be interposed between said directing means and a vessel of a patient.

4. An apparatus according to claim 3 wherein said directing means comprises a plurality of high pressure jets.

5. An apparatus according to claim 1 wherein said directing means comprises a plurality of high pressure jets.

6. An apparatus according to claim 1 wherein said directing means comprises a high pressure jet.

7. An apparatus according to claim 6 wherein said target is distal to said directing means.

8. An apparatus according to claim 6 wherein said directing means is distal to said target.

9. An apparatus according to any one of claims 1, 2, 3, 6, 4 or 5 further comprising an ultrasonic transducer array coupled to said distal end of said catheter.

10. An apparatus according to claim 9 wherein said ultrasonic transducer array is oriented at said distal end of said catheter such that when it is inserted into a vessel of a patient, it will be directed toward the vessel or a deposit within the vessel.

11. An apparatus according to claim 9 further comprising a reflecting device toward which said ultrasonic transducer array is directed.

12. An apparatus according to claim 9 further comprising means coupled to said distal end of said catheter for evacuating particulate matter ablated from the deposit.

13. An apparatus according to claim 12 wherein said evacuating means comprises an evacuation lumen toward which said stream of said working fluid is directed.

14. An apparatus according to claim 13 further comprising an inflatable balloon for positioning said distal end of said catheter in the vessel.

15. An apparatus according to any one of claims 1, 2, 3 or 6 wherein said directing means is oriented to direct said working fluid in the form of a stream parallel to the longitudinal axis of said catheter.

16. An apparatus according to claim 15 further comprising an ultrasonic transducer array coupled to said distal end of said catheter.

17. An apparatus according to claim 15 further comprising means coupled to said distal end of said catheter for evacuating particulate matter ablated from the deposit.

18. An apparatus according to claim 17 wherein said evacuating means comprises an evacuation lumen toward which said stream of said working fluid is directed.

19. An apparatus according to claim 18 further comprising an inflatable balloon for positioning said distal end of said catheter in the vessel.

20. An apparatus according to any one of claims 1, 2, 3, 6, 4 or 5 further comprising means coupled to said distal end of said catheter for evacuating particular matter ablated from a deposit within a vessel of a patient.

21. An apparatus according to claim 20 wherein said evacuating means comprises an evacuation lumen toward which said stream of said working fluid is directed.

22. An apparatus according to claim 21 further comprising an inflatable balloon for positioning said distal end of said catheter in the vessel.

23. An apparatus according to any one of claims 1, 2, 3, 6, 4 or 5 wherein said target means comprises means coupled to said distal end of said catheter for evacuating particulate matter ablated from the deposit.

24. An apparatus according to any one of claims 1, 2, 3 or 6 wherein said directing means is oriented to direct said working fluid in the form of a stream nonparallel to the longitudinal axis of said catheter.

25. An apparatus according to claim 24 further comprising means coupled to said distal end of said catheter for evacuating particulate matter ablated from a deposit within a vessel of a patient.

26. An apparatus according to claim 25 wherein said evacuating means comprises an evacuation lumen toward which said stream of said working fluid is directed.

27. An apparatus according to claim 26 further comprising an inflatable balloon for positioning said distal end of said catheter in the vessel.

28. An apparatus according to claim 24 further comprising an ultrasonic transducer array coupled to said distal end of said catheter.

29. In a method for ablating at least a portion of a deposit in a vessel of a patient by advancing a catheter with a proximal end and a distal end into the vessel until said distal end of said catheter is positioned at the site of the deposit, supplying pressurized fluid to the catheter, and using this fluid to create a stream which impinges upon the deposit to ablate the deposit, the improvements comprising:

a. applying said stream at a velocity high enough to generate a stagnation pressure sufficient to remove deposit debris without the use of a vacuum; and

,

b. interposing a target intermediate said stream of fluid and the vessel to protect the vessel from said stream yet provided space to accommodate at least a portion of the deposit.

30. The method of claim 29 further comprising monitoring said ablating with an ultrasonic transducer array coupled to said distal end of said catheter.

31. The method of claim 29 wherein said stream of fluid is directed away from said proximal end of said catheter.

32. The method of claim 29 wherein said pressurized fluid is supplied at a pressure within the range of 5,000 to 50,000 psi.

33. The method of claim 29 wherein said pressurized fluid is supplied at a pressure of about 30,000 psi.